,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32339032,SAFETY AND EFFICACY OF DDP4-INHIBITORS FOR MANAGEMENT OF HOSPITALIZED GENERAL MEDICINE AND SURGERY PATIENTS WITH TYPE 2 DIABETES.,"Background:  DPP4-inhibitors (DPP4-i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from three prospective studies using DPP4-i in general medicine and surgery patients with type 2 diabetes (T2D).  Research Design and Methods:  We combined data from three randomized studies comparing DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen. Medicine (n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with diet, oral agents or low-dose insulin therapy were included. Patients received DPP4-i alone (n=144), DPP4-i plus basal insulin (n=158) or basal bolus regimen (n=283). All groups received correctional doses with rapid-acting insulin for BG >140mg/dl. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.  Results:  There were no differences in mean hospital daily BG among patients treated with DPP4-i alone (170±37 mg/dl), DPP4-i plus basal (172±42 mg/dl) or basal bolus (172±43 mg/dl), p=0.94; or in the percentage of BG readings within target of 70-180 mg/dl (63±32%, 60±31% and 64±28% respectively, p=0.42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP4-i alone (2%) compared to DPP4-i plus basal (9%) and basal bolus (10%), p=0.004.  Conclusion:  Treatment with DPP4-i alone or in combination with basal insulin is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin re gimen in general medicine and surgery patients with T2D.",2020,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"['general medicine and surgery patients with T2D', 'general medicine and surgery patients with type 2 diabetes (T2D', 'n=266) and surgery (n=319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dl, treated with']","['DPP4-i alone', 'correctional doses with rapid-acting insulin for BG >140mg/dl', 'DPP4-i alone or in combination with basal insulin or basal bolus insulin regimen', ':  DPP4-inhibitors (DPP4-i', 'diet, oral agents or low-dose insulin therapy', 'DPP4-i plus basal insulin (n=158) or basal bolus regimen', 'DPP4-i', 'DPP4-i alone or in combination with basal insulin', 'Medicine']","['hypoglycemia and hospital complications', 'mean daily BG', 'mean hospital daily BG', 'length of stay or complications, but hypoglycemia', 'hypoglycemia']","[{'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0952002,is effective and results in lower incidence of hypoglycemia compared to a basal bolus insulin,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Lorenzo-González', 'Affiliation': 'From: Department of Endocrinology and Nutrition, Hospital Universitario Nuestra Señora de La Candelaria, Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Atienza-Sánchez', 'Affiliation': 'Department of Endocrinology and Nutrition, Hospital Universitario Príncipe de Asturias, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reyes-Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Schoolf of Public Health, Emory University.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Department of Medicine, Emory University School of Medicine.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0481']
1,32339359,A Pilot Randomized Controlled Trial of the PTSD Coach App Following Motor Vehicle Crash-related Injury.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients.
METHODS


From September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment.
RESULTS


Enrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months.
CONCLUSIONS


We demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.",2020,No differences emerged between groups in PTSS outcomes.,"['64 injured adults to either the', 'acute trauma among injured emergency department (ED) patients', 'acutely injured motor-vehicle crash (MVC) patients', 'From September 2017-September 2018', 'adult patients within 24 hours post-MVC from the EDs of two Level 1 trauma centers in the United States', 'Black subjects (n = 21']","['evidence-based mobile phone application with self-help tools (PTSD Coach', 'PTSD Coach']","['PTSS coping self-efficacy', 'PTSD symptoms (PTSS) and associated symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175845', 'cui_str': 'Motor vehicle'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}]",64.0,0.242411,No differences emerged between groups in PTSS outcomes.,"[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Pacella-LaBarbara', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Suffoletto', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'the, Dissemination and Training Division, National Center for PTSD, Palo Alto, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'and the, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Jaramillo', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Repine', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14000']
2,32347899,Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


EU Clinical Trials Register Identifier: 2014-000647-32.",2020,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","['committing child sexual abuse', 'Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention', 'Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited', 'Men With Pedophilic Disorder', '52 male participants (mean [SD] age, 36 [12] years']","['Gonadotropin-Releasing Hormone Antagonist', 'degarelix acetate or equal volume of placebo', 'gonadotropin-releasing hormone antagonist', 'degarelix (degarelix', 'degarelix', 'placebo']","['sexual preoccupation', 'intent-to-treat analysis', 'low empathy', 'efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events', 'composite risk score of 5 domains of child sexual abuse', 'Risk of Committing Child Sexual Abuse', 'composite risk score', 'suicidal ideation', 'hepatobiliary enzyme level elevations', 'composite score', 'impaired self-regulation', 'positive effects (eg, improved attitude or behavior) on sexuality', 'adverse effects', 'EuroQol visual analog scale', 'quality of life (EuroQol 5 Dimensions questionnaire index score', 'injection site reactions']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C2718533', 'cui_str': 'degarelix acetate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}]","[{'cui': 'C0423988', 'cui_str': 'Sexual preoccupation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",52.0,0.615958,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","[{'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Landgren', 'Affiliation': 'Institute of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Kinda', 'Initials': 'K', 'LastName': 'Malki', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Rahm', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0440']
3,32345543,"Effect of a novel low volume, high intensity concurrent training regimen on recruit fitness and resilience.","OBJECTIVES


To determine the effect of a novel low volume high intensity concurrent training regimen and warm-up on physiological performance and musculoskeletal injury in Australian recruits.
DESIGN


Controlled longitudinal intervention.
METHODS


Military recruits completed 12 weeks of either experimental (EXP: n=78, 6-8RM resistance loads, and high intensity intervals) or basic military (CON: n=69, usual practice) matched for total sessions and time. Endurance (3.2km 22kg-load carriage, V˙O 2 peak , multi-stage fitness test (MSFT)), 1RM strength and local muscle endurance (bench, squat, box-lift and push-ups) and power (squat jump) were assessed at Weeks 1,6,12. Body composition, physical activity (PAC·min -1 ) and heart rate reserve (HRR%), were assessed at Weeks 2,7,9. Musculoskeletal injury and mechanism were recorded. Two-way repeated measures ANOVA interaction (group×time), mean difference and effect size (ES) are reported p≤0.05.
RESULTS


A significant interaction over 12 weeks was observed for load carriage (ES -0.30), squat jump (ES 0.65), V˙O 2 peak  (ES 0.58), MSFT (ES 0.41), push-ups (ES 0.26), 1RM bench (ES 0.26), squat (ES 1.05) and box lift (ES 0.27) in EXP compared to CON. At Week 12 significantly greater squat (38.9kg), MSFT (2.1mL·kg -1 ·min -1 ), and faster load carriage (49.9s) was observed in EXP than CON, but no difference in body composition. EXP had a lower PAC·min -1  (641.1±63.1) but higher HRR% (21.8±4.0) compared to CON. EXP had a lower number of injuries (6) compared to CON (17).
CONCLUSIONS


The inclusion of compound-specific resistance exercise and high intensity intervals improved physical function and was associated with reduced musculoskeletal injury.",2020,"A significant interaction over 12 weeks was observed for load carriage (ES -0.30), squat jump (ES 0.65), V˙O 2 peak  (ES 0.58), MSFT (ES 0.41), push-ups (ES 0.26), 1RM bench (ES 0.26), squat (ES 1.05) and box lift (ES 0.27) in EXP compared to CON.","['Military recruits completed 12 weeks of either experimental (EXP: n=78, 6-8RM resistance loads, and high intensity intervals) or basic military (CON: n=69, usual practice) matched for total sessions and time', 'Australian recruits']","['novel low volume, high intensity concurrent training regimen', 'novel low volume high intensity concurrent training regimen and warm-up']","['recruit fitness and resilience', 'Endurance (3.2km 22kg-load carriage, V˙O 2\u202fpeak , multi-stage fitness test (MSFT)), 1RM strength and local muscle endurance (bench, squat, box-lift and push-ups) and power (squat jump', 'body composition', 'load carriage', 'Body composition, physical activity (PAC·min -1 ) and heart rate reserve (HRR', 'measures ANOVA interaction (group×time), mean difference and effect size (ES']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0648396,"A significant interaction over 12 weeks was observed for load carriage (ES -0.30), squat jump (ES 0.65), V˙O 2 peak  (ES 0.58), MSFT (ES 0.41), push-ups (ES 0.26), 1RM bench (ES 0.26), squat (ES 1.05) and box lift (ES 0.27) in EXP compared to CON.","[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Burley', 'Affiliation': 'Centre for Medical and Exercise Physiology, Faculty of Science, Medicine and Health, University of Wollongong, Australia.'}, {'ForeName': 'Jace R', 'Initials': 'JR', 'LastName': 'Drain', 'Affiliation': 'Land Division, Defence Science and Technology Group, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Sampson', 'Affiliation': 'Centre for Medical and Exercise Physiology, Faculty of Science, Medicine and Health, University of Wollongong, Australia.'}, {'ForeName': 'Bradley C', 'Initials': 'BC', 'LastName': 'Nindl', 'Affiliation': 'Neuromuscular Research Laboratory/Warrior Human Performance Research Centre, University of Pittsburgh, USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Groeller', 'Affiliation': 'Centre for Medical and Exercise Physiology, Faculty of Science, Medicine and Health, University of Wollongong, Australia. Electronic address: hgroell@uow.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.03.005']
4,32343634,A Multicomponent Nonpharmacological Intervention to Prevent Delirium for Hospitalized People with Advanced Cancer: A Phase II Cluster Randomized Waitlist Controlled Trial (The PRESERVE Pilot Study).,"Background:  Delirium is a common debilitating complication of advanced cancer.  Objective:  To determine if a multicomponent nonpharmacological delirium prevention intervention was feasible for adult patients with advanced cancer, before a phase III (efficacy) trial.  Design:  Phase II (feasibility) cluster randomized controlled trial. All sites implemented delirium screening and diagnostic assessment. Strategies within sleep, vision and hearing, hydration, orientation, mobility, and family domains were delivered to enrolled patients at intervention site admission days 1-7. Control sites then implemented the intervention (""waitlist sites"").  Setting:  Four Australian palliative care units.  Measurements:  The primary outcome was adherence, with an  a priori  endpoint of at least 60% patients achieving full adherence. Secondary outcomes were interdisciplinary care delivery, delirium measures, and adverse events, analyzed descriptively and inferentially.  Results:  Sixty-five enrolled patients (25 control, 20 intervention, and 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed. Nurses (67%), physicians (16%), allied health (8.4%), family (7%), patients (1%), and volunteers (0.5%) delivered the intervention. There was full adherence for 5% patients at intervention sites, partial for 25%. Both full and partial adherence were higher at waitlist sites: 25% and 45%, respectively. One-third of control site patients (32%) became delirious within seven days of admission compared to one-fifth (20%) at both intervention and waitlist sites ( p  = 0.5). Mean (standard deviation) Delirium Rating Scale-Revised-1998 scores were 16.8 + 12.0 control sites versus 18.4 + 8.2 ( p  = 0.6) intervention and 18.7 + 7.8 ( p  = 0.5) waitlist sites. The intervention caused no adverse events.  Conclusion:  The intervention requires modification for optimal adherence in a phase III trial.",2020,The intervention caused no adverse events.  ,"['Hospitalized People with Advanced Cancer', 'adult patients with advanced cancer, before a phase III (efficacy) trial', 'Results:  Sixty-five enrolled patients (25 control, 20 intervention, and 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed']","['multicomponent nonpharmacological delirium prevention intervention', 'Multicomponent Nonpharmacological Intervention']","['allied health', 'partial adherence', 'Mean (standard deviation) Delirium Rating Scale-Revised-1998 scores', 'Strategies within sleep, vision and hearing, hydration, orientation, mobility, and family domains', 'interdisciplinary care delivery, delirium measures, and adverse events, analyzed descriptively and inferentially', 'adherence, with an  a priori  endpoint of at least 60% patients achieving full adherence']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0011211', 'cui_str': 'Health Care Delivery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",65.0,0.0770757,The intervention caused no adverse events.  ,"[{'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Hosie', 'Affiliation': 'School of Nursing Sydney, The University of Notre Dame Australia, Darlinghurst, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Noble', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Brassil', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kurrle', 'Affiliation': 'Northern Clinical School, Hornsby Ku-ring-gai Health Service, University of Sydney, Hornsby, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cumming', 'Affiliation': 'Australian Commission on Safety and Quality in Health Care, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gideon A', 'Initials': 'GA', 'LastName': 'Caplan', 'Affiliation': 'Prince of Wales Hospital, Geriatric Medicine, Randwick, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chye', 'Affiliation': ""St. Vincent's Health Network Sydney, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Eugene Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': 'Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University, Nashville, Tennessee, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shirley H', 'Initials': 'SH', 'LastName': 'Bush', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jan Maree', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Palliative Care, Calvary Health Care Kogarah, Kogarah, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lovell', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Parr', 'Affiliation': 'HammondCare, Greenwich Hospital, Greenwich, New South Wales, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hauser', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McArdle', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jacquier', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Phillipson', 'Affiliation': 'The Queen Elizabeth Hospital, Woodville, South Australia, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Kuwahata', 'Affiliation': 'Camden Hospital, Camden, New South Wales, Australia.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Kerfoot', 'Affiliation': 'Camden Hospital, Camden, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Seong Leang', 'Initials': 'SL', 'LastName': 'Cheah', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hunt', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Attwood', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Assen', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wilcock', 'Affiliation': 'Ingham Institute, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0632']
5,32343918,Subcutaneous Lidocaine for Cancer-Related Pain.,"Background:  Intravenous lidocaine infusions have been shown to be effective for cancer related pain, but access is restricted to acute care settings. If able to be shown to be safe and effective, the subcutaneous route could expand access to residential hospices or patients' homes.  Objectives:  This randomized, double-blind, placebo controlled, 2 × 2 crossover trial evaluated the effectiveness, safety, toxicity, and impact on quality of life of a limited duration subcutaneous lidocaine infusion (SCLI) for chronic cancer pain.  Methods:  Patients with the life expectancy of three months or more, who were experiencing cancer-related pain with a worst severity of at least 4 on a 0-10 scale despite a trial of at least one opioid and appropriate adjuvant analgesic, received two subcutaneous infusions at least a week apart; lidocaine 10 mg/kg over 5.5 hours and saline placebo. The primary outcome was either a reduction in worst pain intensity of two points out of 10 or a reduction in 24 hours opioid dose of at least 30% without worsening of pain scores, in seven days.  Results:  The SCLI was only effective for two subjects. One of these subjects experienced a drop in worst pain score and the other experienced a reduction in opioid dose.  Conclusions:  A weight-based subcutaneous infusion of lidocaine does not achieve sufficiently predictable blood levels for determining lidocaine responsiveness. This study does not allow any conclusion to be drawn on whether or not lidocaine would have been more effective had it been titrated to higher blood levels.",2020,"The primary outcome was either a reduction in worst pain intensity of two points out of 10 or a reduction in 24 hours opioid dose of at least 30% without worsening of pain scores, in seven days.  ","['Patients with the life expectancy of three months or more, who were experiencing cancer-related pain with a worst severity of at least 4 on a 0-10 scale despite a trial of at least one opioid and appropriate adjuvant analgesic', 'Cancer-Related Pain', 'chronic cancer pain']","['lidocaine', 'Subcutaneous Lidocaine', 'lidocaine 10\u2009mg/kg over 5.5 hours and saline placebo', 'lidocaine infusion (SCLI', 'placebo']","['worst pain intensity', 'worsening of pain scores', 'worst pain score', 'effectiveness, safety, toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.520696,"The primary outcome was either a reduction in worst pain intensity of two points out of 10 or a reduction in 24 hours opioid dose of at least 30% without worsening of pain scores, in seven days.  ","[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hawley', 'Affiliation': 'Pain and Symptom Management/Palliative Care Department, BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Fyles', 'Affiliation': 'Division of Palliative Care, Interdepartmental Division of Departments of Medicine, Family Practice, and Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Jefferys', 'Affiliation': 'Pain and Symptom Management/Palliative Care Program, BC Cancer, Kelowna, British Columbia, Canada.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0621']
6,32365981,The Effect of  Lactobacillus plantarum  299v on Iron Status and Physical Performance in Female Iron-Deficient Athletes: A Randomized Controlled Trial.,"Iron is an essential micronutrient for oxygen transport and mitochondrial metabolism and is critical for physical performance. Compromised iron stores are more commonly found among athletes, and females are especially at risk. Iron deficiency is generally treated using oral iron supplements. However, only a small proportion of ingested iron is absorbed, necessitating higher intakes, which may result in adverse side effects, reduced compliance, and inefficient repletion of iron stores. The probiotic strain  Lactobacillus plantarum  299v (Lp299v) significantly increases intestinal iron absorption in meal studies. The present study was conducted to explore the effects of 20 mg of iron with or without Lp299v on iron status, mood state, and physical performance. Fifty-three healthy non-anemic female athletes with low iron stores (ferritin < 30 μg/L) were randomized, and 39 completed the study. Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone (13.6 vs. 8.2 µg/L), but the difference between the groups was not significant ( p  = 0.056). The mean reticulocyte hemoglobin content increased after intake of Lp299v compared to control (1.5 vs. 0.82 pg) after 12 weeks, but the difference between the group was not significant ( p  = 0.083). The Profile of Mood States (POMS) questionnaire showed increased vigor with Lp299v vs. iron alone after 12 weeks (3.5 vs. 0.1,  p  = 0.015). No conclusive effects on physical performance were observed. In conclusion, Lp299v, together with 20 mg of iron, could result in a more substantial and rapid improvement in iron status and improved vigor compared to 20 mg of iron alone. A larger clinical trial is needed to further explore these findings as well as the impact of Lp299v on physical performance.",2020,Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone,"['Fifty-three healthy non-anemic female athletes with low iron stores (ferritin < 30 μg/L', 'Female Iron-Deficient Athletes']","['20 mg of iron with or without Lp299v', 'iron alone', 'Lactobacillus plantarum  299v', 'probiotic strain  Lactobacillus plantarum  299v (Lp299v']","['Profile of Mood States (POMS) questionnaire', 'iron status, mood state, and physical performance', 'mean reticulocyte hemoglobin content', 'Iron Status and Physical Performance', 'intestinal iron absorption', 'physical performance', 'ferritin levels', 'iron status and improved vigor']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035286', 'cui_str': 'Reticulocyte'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",53.0,0.0766623,Intake of Lp299v with iron for four weeks increased ferritin levels more than iron alone,"[{'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Axling', 'Affiliation': 'Probi AB, 223 70 Lund, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Önning', 'Affiliation': 'Probi AB, 223 70 Lund, Sweden.'}, {'ForeName': 'Maile A', 'Initials': 'MA', 'LastName': 'Combs', 'Affiliation': ""Nutrition and Scientific Affairs Department, The Nature's Bounty Co., Ronkonkoma, NY 11779, USA.""}, {'ForeName': 'Alemtsehay', 'Initials': 'A', 'LastName': 'Bogale', 'Affiliation': ""Nutrition and Scientific Affairs Department, The Nature's Bounty Co., Ronkonkoma, NY 11779, USA.""}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Högström', 'Affiliation': 'Sports Medicine Umeå AB and Orthopedics, Department of Surgical and Perioperative Sciences, Umeå University, 901 87 Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Svensson', 'Affiliation': 'Section of Sports Medicine, Department of Community Medicine and Rehabilitation, Umeå University, 901 87 Umeå, Sweden.'}]",Nutrients,['10.3390/nu12051279']
7,32353962,Circulating Ionized Magnesium as a Measure of Supplement Bioavailability: Results from a Pilot Study for Randomized Clinical Trial.,"Oral supplementation may improve the dietary intake of magnesium, which has been identified as a shortfall nutrient. We conducted a pilot study to evaluate appropriate methods for assessing responses to the ingestion of oral magnesium supplements, including ionized magnesium in whole blood (iMg 2+ ) concentration, serum total magnesium concentration, and total urinary magnesium content. In a single-blinded crossover study, 17 healthy adults were randomly assigned to consume 300 mg of magnesium from MgCl 2  (ReMag ® , a picosized magnesium formulation) or placebo, while having a low-magnesium breakfast. Blood and urine samples were obtained for the measurement of iMg 2+ , serum total magnesium, and total urine magnesium, during 24 h following the magnesium supplement or placebo dosing. Bioavailability was assessed using area-under-the-curve (AUC) as well as maximum (C max ) and time-to-maximum (T max ) concentration. Depending on normality, data were expressed as the mean ± standard deviation or median (range), and differences between responses to MgCl 2  or placebo were measured using the paired  t -test or Wilcoxon signed-rank test. Following MgCl 2  administration versus placebo administration, we observed significantly greater increases in iMg 2+  concentrations (AUC = 1.51 ± 0.96 vs. 0.84 ± 0.82 mg/dL·24h; C max  = 1.38 ± 0.13 vs. 1.32 ± 0.07 mg/dL, respectively; both  p  < 0.05) but not in serum total magnesium (AUC = 27.00 [0, 172.93] vs. 14.55 [0, 91.18] mg/dL·24h; C max  = 2.38 [1.97, 4.01] vs. 2.24 [1.98, 4.31] mg/dL) or in urinary magnesium (AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12 [12.91, 88.63] vs. 24.38 [13.51, 81.51] mg/dL;  p  > 0.05). Whole blood iMg 2+  may be a more sensitive measure of acute oral intake of magnesium compared to serum and urinary magnesium and may be preferred for assessing supplement bioavailability.",2020,(AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12,['17 healthy adults'],"['urinary magnesium', 'consume 300 mg of magnesium from MgCl 2  (ReMag ® , a picosized magnesium formulation) or placebo, while having a low-magnesium breakfast', 'placebo']","['Blood and urine samples', 'ionized magnesium in whole blood (iMg 2+ ) concentration, serum total magnesium concentration, and total urinary magnesium content', 'Bioavailability', 'serum total magnesium, and total urine magnesium', 'iMg 2+  concentrations', 'maximum (C max ) and time-to-maximum (T max ) concentration', 'serum total magnesium', 'Supplement Bioavailability']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0240291', 'cui_str': 'Mg reduced'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0428308', 'cui_str': 'Magnesium measurement, urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",17.0,0.300493,(AUC = 201.74 ± 161.63 vs. 139.30 ± 92.84 mg·24h; C max  = 26.12,"[{'ForeName': 'Jiada', 'Initials': 'J', 'LastName': 'Zhan', 'Affiliation': 'Public Health Nutrition, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH 44106,USA.'}, {'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Wallace', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, MS1F7, 4400 University Drive,Fairfax, VA 22030, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Butts', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State Street, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State Street, West Lafayette, IN 47907, USA.'}, {'ForeName': 'Velarie', 'Initials': 'V', 'LastName': 'Ansu', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Spence', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Weaver and Associates Consulting, LLC, West Lafayette, IN 47906, USA.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Gletsu-Miller', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN 47405, USA.'}]",Nutrients,['10.3390/nu12051245']
8,32353974,"Suppression of Oral Sweet Sensations during Consumption of Sweet Food in Humans: Effects on Gastric Emptying Rate, Glycemic Response, Appetite, Food Satisfaction and Desire for Basic Tastes.","Suppression of oral sweet sensation (OSS) acutely reduces intake of sweet-tasting food due to lower liking. However, little is known about other physiological responses during both the prandial and postprandial phase. Here, we explored the effects of  Gymnema sylvestre  (GS)-based suppression of OSS of several types of sweet-tasting food (muffin, sweet yogurt, banana) on gastric emptying, blood glucose (BG), plasma insulin (PI), appetite indices (hunger, fullness and prospective consumption), satisfaction and desire for tastes. Fifteen healthy subjects (22 ± 3 years, 9 women) took part in the study. Subjects rinsed their mouth with either GS solution or distilled water before eating the sweet-tasting food. Subjects felt decreased sweet taste intensity and reduced taste liking associated with GS rinsing after consuming each food, compared with rinsing with distilled water ( p  < 0.05). Gastric emptying, BG, PI and appetite indices during and after the prandial phase did not significantly change with GS rinsing compared to rinsing with distilled water ( p  > 0.05). Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing. These results suggest that the suppression of OSS does not affect gastric emptying, glycemic response and appetite during and after consumption of sweet-tasting food.",2020,Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing.,"['Oral Sweet Sensations during Consumption of Sweet Food in Humans', 'Fifteen healthy subjects (22 ± 3 years, 9 women) took part in the study']","['oral sweet sensation (OSS', 'GS solution or distilled water before eating the sweet-tasting food', 'GS rinsing']","['Gastric Emptying Rate, Glycemic Response, Appetite, Food Satisfaction and Desire for Basic Tastes', 'gastric emptying, blood glucose (BG), plasma insulin (PI), appetite indices (hunger, fullness and prospective consumption), satisfaction and desire for tastes', 'Gastric emptying, BG, PI and appetite indices', 'gastric emptying, glycemic response and appetite', 'sweet taste intensity and reduced taste liking']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453865', 'cui_str': 'Sweet food'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",15.0,0.0208928,Higher desire for sweet taste as well as lower satisfaction ( p  < 0.05) in the postprandial phase were observed with GS rinsing.,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kashima', 'Affiliation': 'Faculty of Health Sciences, Hiroshima Shudo University, 1-1-1 Ozuka-higashi, Asaminami-ku, Hiroshima 731-3195, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Nishitani', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Yamaoka Endo', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fukuba', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kashima', 'Affiliation': 'School of Health Sciences, Prefectural University of Hiroshima, 1-1-71 Ujina-higashi, Minami-ku, Hiroshima 734-8558, Japan.'}]",Nutrients,['10.3390/nu12051249']
9,32358608,Online Acceptance and Commitment Therapy for People with Painful Diabetic Neuropathy in the United Kingdom: A Single-Arm Feasibility Trial.,"OBJECTIVE


This study aimed to assess the feasibility of online Acceptance and Commitment Therapy for painful diabetic neuropathy in the United Kingdom and to determine if a larger randomized controlled trial testing treatment efficacy is justified.
METHODS


Participants with painful diabetic neuropathy were recruited online and from hospital services. This was a single-arm study in which all participants received online Acceptance and Commitment Therapy. Participants completed questionnaires at baseline and three months post-treatment. Primary feasibility outcomes were recruitment, retention, and treatment completion rates. Secondary outcomes were pre- to post-treatment effects on pain outcomes and psychological flexibility.
RESULTS


Of 225 potentially eligible participants, 30 took part in this study. Regarding primary feasibility outcomes, the treatment completion and follow-up questionnaire completion rates were 40% and 100%, respectively. Generally, at baseline those who completed the treatment, compared with those who did not, had better daily functioning and higher psychological flexibility. With respect to secondary outcomes, results from the completers group showed clinically meaningful effects at post-treatment for 100% of participants for pain intensity and pain distress, 66.7% for depressive symptoms, 58.3% for functional impairment, 41.7% for cognitive fusion, 66.7% for committed action, 58.3% for self-as-context, and 41.7% for pain acceptance.
CONCLUSIONS


This preliminary trial suggests feasibility of recruitment and follow-up questionnaire completion rates, supporting planning for a larger randomized controlled trial. However, treatment completion rates did not achieve the prespecified feasibility target. Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.",2020,Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.,"['Of 225 potentially eligible participants', 'Participants with painful diabetic neuropathy were recruited online and from hospital services', 'people with painful diabetic neuropathy', 'People with Painful Diabetic Neuropathy in the United Kingdom']","['Online Acceptance and Commitment Therapy', 'online Acceptance and Commitment Therapy']","['pain intensity and pain distress', 'treatment completion and follow-up questionnaire completion rates', 'daily functioning and higher psychological flexibility', 'clinically meaningful effects', 'depressive symptoms', 'recruitment, retention, and treatment completion rates', 'pain outcomes and psychological flexibility']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",225.0,0.261831,Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.,"[{'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Kioskli', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Scott', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'McCracken', 'Affiliation': 'Uppsala University, Psychology Department, Uppsala, Sweden.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa110']
10,32289684,"A new, open-source 3D-printed transcranial magnetic stimulation (TMS) coil tracker holder for double blind, sham-controlled neuronavigation studies.",,2020,,[],['transcranial magnetic stimulation (TMS) coil tracker holder'],[],[],"[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C1551377', 'cui_str': 'Holder'}]",[],,0.16262,,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Caulfield', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: caulfiel@musc.edu.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Lopez', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Roberts', 'Affiliation': 'Department of Radiology & Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McTeague', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.02.003']
11,32354072,mcIRBP-19 of Bitter Melon Peptide Effectively Regulates Diabetes Mellitus (DM) Patients' Blood Sugar Levels.,"This study was conducted to test the effectiveness of a particular bitter melon peptide (BMP), with a specific sequence of 19 amino acids (mcIRBP-19), in regulating diabetic patients' blood glucose. In order to test the product with the specially processed BMP, a total of 142 diabetic patients were solicited as study subjects, of which 64 were assigned to an experiment group and 78 to a control group. Biochemical data were compared with a paired  t- test to verify the significance of changes over different time periods. The clinical results showed that BMP started to improve the subjects' glycated hemoglobin (HbA1c) levels at the end of the second month (T2), with mean values being significantly lowered from 7.8 ± 1.4% (T0) to 7.5 ± 1.4% (T2) ( p  = 0.004). The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3). HbA1c levels for the control group were 7.5 ± 1.2% in T0 and 7.5 ± 1.1% (T3), and not significantly different ( p  = 0.852) over the same period. This study provides clinical evidence that helps to verify the effectiveness of the new BMP product in regulating diabetic patients' blood sugar levels.",2020,"The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3).","[""diabetic patients' blood glucose"", '142 diabetic patients were solicited as study subjects, of which 64 were assigned to an experiment group and 78 to a control group']","['BMP', 'particular bitter melon peptide (BMP), with a specific sequence of 19 amino acids (mcIRBP-19']","[""subjects' glycated hemoglobin (HbA1c) levels"", 'HbA1c levels']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0330482', 'cui_str': 'Momordica charantia'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",142.0,0.0220155,"The values reduced continuously, eventually reaching 7.4 ± 1.1% ( p  = 0.000) at the end of the experiment (T3).","[{'ForeName': 'Pang-Kuei', 'Initials': 'PK', 'LastName': 'Hsu', 'Affiliation': 'Greenyn Biotechnology Co., Ltd., Taichung City 40768, Taiwan.'}, {'ForeName': 'Frank F C', 'Initials': 'FFC', 'LastName': 'Pan', 'Affiliation': 'Department of Pharmacy and Department of Hospitality, College of Pharmacy and Healthcare, Tajen University, Yanpu, Pingtung County 90741, Taiwan.'}, {'ForeName': 'Ching-Sen', 'Initials': 'CS', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pharmacy and Department of Hospitality, College of Pharmacy and Healthcare, Tajen University, Yanpu, Pingtung County 90741, Taiwan.'}]",Nutrients,['10.3390/nu12051252']
12,32345707,A novel decision aid to help plan for serious illness: a multisite randomized trial.,"BACKGROUND


Recent studies have shown substantial deficiencies in the quality or quantity (or both) of communication and decision-making during serious illness. We evaluated the efficacy of a novel decision support intervention, the Plan Well Guide, in increasing completion of a standard medical order form for advance medical care planning and improving decisional outcomes in nonacademic primary care settings.
METHODS


We conducted a randomized trial in 3 primary care practices in Lethbridge, Alberta in 2017-2018. We recruited ""patients at high risk"" referred by the primary care doctor who required establishment or review of their Goals of Care Designation (GCD). Enrolled patients were randomly allocated to receive the Plan Well Guide, delivered by a trained facilitator, or usual care. Eight to 12 weeks after the intervention, a research assistant blinded to intervention assignment contacted the patients in both groups by telephone to do a final outcome assessment. The primary outcome was completion of GCD forms; secondary outcomes included decisional conflict scores and ratings of satisfaction.
RESULTS


A total of 123 patients (59 women [48.0%]; mean age 73.9 yr) were enrolled, 66 in the intervention arm and 57 in the usualcare arm; 119 patients completed the trial. After the intervention, GCD completion rates in the intervention and usual-care groups were 95.3% and 90.9%, respectively (risk difference [RD] 4%, 95% confidence interval [CI] -14% to 22%), and the rate of concordance between medical orders and expressed preferences on follow-up was 78% and 66%, respectively (RD 12%, 95% CI -7% to 30%). Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%], RD -26%, 95% CI -42% to -8%). Patients in the intervention group had lower decisional conflict scores than those in the usual-care group (mean 30.9 v. 43.1, adjusted mean difference -12.0, 95% CI -23.2 to -0.8). Physicians considered patients in the intervention group to have lower decisional conflict than those in the usual-care group, although not significantly so (mean score 10.4 v. 14.9, adjusted mean difference -4.7, 95% CI -9.9 to 0.4) and spent less time with the former (mean 9.7 v. 13.2 min, adjusted mean difference -3.5, 95% CI -5.5 to -1.5 min).
INTERPRETATION


The decision-support intervention did not increase GCD completion rates but did seem to improve some aspects of decisional quality while reducing the physician's time to accomplish GCD decisions.  Trial registration:  ClinicalTrials.gov, no. NCT01297946.",2020,"Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%],","['3 primary care practices in Lethbridge, Alberta in 2017-2018', 'patients at high risk"" referred by the primary care doctor who required establishment or review of their Goals of Care Designation (GCD', '123 patients (59 women [48.0%]; mean age 73.9 yr) were enrolled, 66 in the intervention arm and 57 in the usualcare arm; 119 patients completed the trial']","['novel decision support intervention', 'Plan Well Guide, delivered by a trained facilitator, or usual care']","['rate of concordance between medical orders and expressed preferences', 'lower decisional conflict', 'decisional quality', 'lower decisional conflict scores', 'written medical orders for intensive care unit care and cardiopulmonary resuscitation', 'GCD completion rates', 'decisional conflict scores and ratings of satisfaction']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",3.0,0.122672,"Significantly fewer patients in the intervention group than in the usual-care group had written medical orders for intensive care unit care and cardiopulmonary resuscitation (22 [34%] v. 33 [60%],","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont. dkh2@queensu.ca.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': ""Department of Critical Care Medicine (D. Heyland), Kingston General Hospital; Department of Public Health Sciences (D. Heyland), Queen's University; Clinical Evaluation Research Unit (D. Heyland, R. Heyland), Kingston General Hospital, Kingston, Ont.; Bigelow Fowler Clinic (Bailey), Lethbridge, Alta.; Department of Family Medicine (Howard), McMaster University, Hamilton, Ont.""}]",CMAJ open,['10.9778/cmajo.20190179']
13,32376754,"Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease.","INTRODUCTION


During conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI) is inevitable and is associated with complications such as early allograft dysfunction (EAD), primary non-function and ischaemic-type biliary lesions. We have established a novel procedure called ischaemia-free liver transplantation (IFLT). The results from a pilot study suggest that IFLT might prevent IRI and yield better transplant outcomes than CLT. The purpose of this study was to further assess the efficacy and safety of IFLT versus CLT in patients with end-stage liver disease.
METHODS AND ANALYSIS


This is an investigator-initiated, open-label, phase III, prospective, single-centre randomised controlled trial on the effects of IFLT in patients with end-stage liver disease. Adult patients (aged 18-75 years) eligible for liver transplantation will be screened for participation in this trial and will be randomised between the IFLT group (n=34) and the CLT group (n=34). In the IFLT group, the donor liver will be procured, preserved and implanted with continuous normothermic machine perfusion (NMP). In the CLT group, the donor liver will be procured after a fast cold flush, preserved in 0°C-4°C solution and implanted under hypothermic and hypoxic conditions. Patients in both groups will be managed according to the standard protocol of our centre. The primary end point is the incidence of EAD after liver transplantation. Intraoperative and postoperative parameters of donor livers and recipients will be observed and recorded, and postoperative liver graft function, complications and recipient and graft survival will be evaluated. After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
ETHICS AND DISSEMINATION


The protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


ChiCTR1900021158.",2020,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","['patients with end-stage liver disease', 'end-stage liver disease', 'Adult patients (aged 18-75 years) eligible for liver transplantation']","['CLT', 'ischaemia-free liver transplantation (IFLT', 'IFLT', 'IFLT versus CLT', 'conventional liver transplantation (CLT), ischaemia-reperfusion injury (IRI']","['efficacy and safety', 'safety and efficacy', 'incidence of EAD after liver transplantation', 'postoperative liver graft function, complications and recipient and graft survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745744', 'cui_str': 'End stage liver disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",,0.0805885,"After a 12-month follow-up of the last enrolled recipient, the outcomes will be analysed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease.
","[{'ForeName': 'Changjun', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Shanzhou', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dongping', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maogen', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zebin', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linhe', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Caihui', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yixi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengjun', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuekun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Anbin', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiopulmonary Bypass, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Changjie', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Surgical Intensive Care Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}, {'ForeName': 'Xiaoshun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Organ Transplant Center, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China gdtrc@163.com rockyucsf1981@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-035374']
14,32375151,Transoral Endoscopic Coblation Tongue Base Surgery in Obstructive Sleep Apnea: Resection versus Ablation.,"BACKGROUND


A new transoral tongue base surgical procedure for the treatment of snoring and obstructive sleep apnea (OSA) is described. It is named ""Robo-Cob"" technique because it is similar to transoral robotic surgery (TORS) but it is performed by means of coblation technology in order to resect the tongue base in countries where TORS is not an available option for such benign conditions.
METHODS


In this prospective, randomized, controlled trial, the new Robo-Cob technique was carried out in 25 adult OSA patients with confirmed tongue base hypertrophy at preoperative drug-induced sedation endoscopy. The results of this procedure were compared with the coblation endoscopic lingual lightening (CELL) technique used to ablate (or minimally resect) the central part of the tongue base, in another 25 adult OSA patients with similar characteristics (age, sex, preoperative body mass index and Apnea-Hypopnea Index, AHI). The base of tongue surgery was part of multilevel surgery including also septoturbinoplasty and barbed reposition pharyngoplasty (with/without tonsillectomy).
RESULTS


In this study, the Robo-Cob technique is proved to be feasible and effective in all cases either alone or when combined with other procedures in multilevel surgical settings. No/minimal intraoperative or postoperative complications were observed. Postoperative pain as measured by visual analog scale ranged from 3 to 7. No tracheostomy was done in any patient. Objective clinical improvement was confirmed by a level 3 polygraphy performed 6 months after surgery. There was significant difference in operative time at the level of the tongue base between Robo-Cob and CELL techniques, with shorter times observed within the Robo-Cob group. Moreover, the Robo-Cob technique provided tongue base tissue specimens that allowed measurement of the volume that ranged from 5 to 17 cm3 (mean 11.64 ± 3.49 cm3). It was found that resection of at least 10 cm3 of tongue base tissue was associated with better outcomes in terms of postoperative AHI reduction.
CONCLUSION


In this study, the added values of using coblation for resection and not ablation appear to be the short surgical time, the low postoperative tissue edema, and the possibility of providing tissue specimens to measure resected volumes.",2020,"There was significant difference in operative time at the level of the tongue base between Robo-Cob and CELL techniques, with shorter times observed within the Robo-Cob group.","['Obstructive Sleep Apnea', 'snoring and obstructive sleep apnea (OSA', '25 adult OSA patients with similar characteristics (age, sex, preoperative body mass index and Apnea-Hypopnea Index, AHI', '25 adult OSA patients with confirmed tongue base hypertrophy at preoperative drug-induced sedation endoscopy']","['Transoral Endoscopic Coblation Tongue Base Surgery', 'coblation endoscopic lingual lightening (CELL) technique used to ablate (or minimally resect', 'transoral robotic surgery (TORS', 'multilevel surgery including also septoturbinoplasty and barbed reposition pharyngoplasty (with/without tonsillectomy']","['minimal intraoperative or postoperative complications', 'visual analog scale', 'operative time', 'Postoperative pain']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0226958', 'cui_str': 'Structure of root of tongue'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0192234', 'cui_str': 'Repair of pharynx'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",25.0,0.0183102,"There was significant difference in operative time at the level of the tongue base between Robo-Cob and CELL techniques, with shorter times observed within the Robo-Cob group.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Bahgat', 'Affiliation': 'Department of Otorhinolaryngology, Alexandria University, Alexandria, Egypt, ahmedyassinbahgat@gmail.com.'}, {'ForeName': 'Yassin', 'Initials': 'Y', 'LastName': 'Bahgat', 'Affiliation': 'Department of Otorhinolaryngology, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Rajab', 'Initials': 'R', 'LastName': 'Alzahrani', 'Affiliation': 'Department of Surgery, ENT Division, Medical College, Albaha University, Albaha, Saudi Arabia.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montevecchi', 'Affiliation': 'Department of Head-Neck Surgery, Otolaryngology, Head-Neck and Oral Surgery Unit, Morgagni Pierantoni Hospital, Azienda USL della Romagna, Forlì, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Department of Head-Neck Surgery, Otolaryngology, Head-Neck and Oral Surgery Unit, Morgagni Pierantoni Hospital, Azienda USL della Romagna, Forlì, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Department of Head-Neck Surgery, Otolaryngology, Head-Neck and Oral Surgery Unit, Morgagni Pierantoni Hospital, Azienda USL della Romagna, Forlì, Italy.'}]",ORL; journal for oto-rhino-laryngology and its related specialties,['10.1159/000506994']
15,32363940,"Oral Nutritional Supplementation in Cancer Patients Who Were Receiving Chemo/Chemoradiation Therapy: A Multicenter, Randomized Phase II Study.","Introduction:  Oral nutritional supplementation (ONS) in cancer patients is justified by the low food intake caused by several factors. However, ONS can be affected by adverse events (AEs) correlated to treatment. This study aimed to compare the safety and efficacy of ONS (whey protein isolated, leucin, zinc-IMMAX®) during oncologic treatment. Methods:  Patients in chemo/chemoradiotherapy were randomly assigned to receive IMMAX®+nutritional counseling (NC) according to daily requirements (S arm) or NC alone (C arm) for 4 weeks. Body weight (BW), %fat-free mass (%FFM) and nutrition intake were assessed before and after. In S arm, calories from IMMAX met the energy requirements. AEs were classified according to CTC-AE-NCI. Results:  Eighty-five patients were included (51 females). After 4 weeks, the median of caloric intake, BW and %FFM were not statistically different in C arm. In S arm, median ONS intake was 81 g/332 kcal/day, protein intake was higher (pre: 66.75 ± 31.57 g; post: 88.57 ± 35.11 g;  p  < 0.01) and calories as well (pre: 1,549 ± 596 kcal; post: 1,756 ± 614 kcal;  p  = 0.02). The most common treatment related AEs were anemia, nausea/vomiting, not different between the arms. AEs supplement related were constipation and diarrhea (2 patients/4.6% each). Conclusion:  IMMAX was safe, well tolerated, it did not interfere with oncologic treatment and provided significant amount of protein intake in this patient population, with few related AEs.",2021,"After 4 weeks, the median of caloric intake, BW and %FFM were not statistically different in C arm.","['Cancer Patients', 'cancer patients', 'Eighty-five patients were included (51 females']","['Chemo/Chemoradiation Therapy', 'chemo/chemoradiotherapy', 'ONS (whey protein isolated, leucin, zinc-IMMAX®', 'IMMAX', 'Oral Nutritional Supplementation', 'Oral nutritional supplementation (ONS', 'IMMAX®+nutritional counseling (NC) according to daily requirements (S arm) or NC alone']","['anemia, nausea/vomiting', 'protein intake', 'median ONS intake', 'Body weight (BW), %fat-free mass (%FFM) and nutrition intake', 'median of caloric intake, BW and %FFM', 'constipation and diarrhea']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",85.0,0.0435648,"After 4 weeks, the median of caloric intake, BW and %FFM were not statistically different in C arm.","[{'ForeName': 'Adilson Aparecido', 'Initials': 'AA', 'LastName': 'Faccio', 'Affiliation': 'Department of Oncology, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil.'}, {'ForeName': 'Cecilia Helena Peinado de Sampaio', 'Initials': 'CHPS', 'LastName': 'Mattos', 'Affiliation': 'Department of Nutrition, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil.'}, {'ForeName': 'Evandro Airton Sordi Dos', 'Initials': 'EASD', 'LastName': 'Santos', 'Affiliation': 'Department of Oncology, IRPCC - Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil.'}, {'ForeName': 'Natael Ribeiro Malta', 'Initials': 'NRM', 'LastName': 'Neto', 'Affiliation': 'Department of Oncology, Santa Casa de Misericordia de Passos, Passos, Brazil.'}, {'ForeName': 'Raquel Pedro', 'Initials': 'RP', 'LastName': 'Moreira', 'Affiliation': 'Department of Oncology, Santa Casa De Misericordia de Araraquara, Araraquara, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Luciara Tonelo Batella', 'Affiliation': 'Instituto Ribeiraopretano de Combate ao Cancer, Ribeirao Preto, Brazil.'}, {'ForeName': 'Hellin Dos', 'Initials': 'HD', 'LastName': 'Santos', 'Affiliation': 'Prodiet Clinical Nutrition, Curitiba, Brazil.'}, {'ForeName': 'Ana Paula Monnerat', 'Initials': 'APM', 'LastName': 'Celes', 'Affiliation': 'Prodiet Clinical Nutrition, Curitiba, Brazil.'}]",Nutrition and cancer,['10.1080/01635581.2020.1758170']
16,32371120,Impact of low-volume concurrent strength training distribution on muscular adaptation.,"OBJECTIVES


Military-, rescue- and law-enforcement personnel require a high physical capacity including muscular strength. The present study hypothesized that 9 weeks of volume matched concurrent short frequent training sessions increases strength more efficiently than less frequent longer training sessions.
DESIGN


A randomized training intervention study with functional and physiological tests before and after the intervention.
METHODS


Military conscripts (n=290) were assigned to micro-training (four 15-min strength and four 15-min endurance bouts weekly); classical-training (one 60-min strength and one 60-min endurance training session weekly) or a control-group (two 60-min standard military physical training sessions weekly).
RESULTS


There were no group difference between micro-training and classical-training in measures of strength. Standing long jump remained similar while shotput performance was reduced (P≤0.001) in all three groups. Pull-up performance increased (P≤0.001) in micro-training (7.4±4.6 vs. 8.5±4.0 repetitions, n=59) and classical-training (5.7±4.1 vs. 7.1±4.2 repetitions, n=50). Knee extensor MVC increased (P≤0.01) in all groups (micro-training, n=30, 11.5±8.9%; classical-training, n=24, 8.3±11.5% and control, n=19, 7.5±11.8%) while elbow flexor and hand grip MVC remained similar. Micro-training increased (P≤0.05) type IIa percentage from 32.5±11.0% to 37.6±12.3% (n=20) and control-group increased (P≤0.01) type IIax from 4.4±3.0% to 11.6±7.9% (n=8). In control-group type I, fiber size increased (P≤0.05) from 5121±959μm to 6481±2084μm (n=5). Satellite cell content remained similar in all groups.
CONCLUSIONS


Weekly distribution of low-volume concurrent training completed as either eight 15-min bouts or two 60-min sessions of which 50% was strength training did not impact strength gains in a real-world setting.",2020,Standing long jump remained similar while shotput performance was reduced (P≤0.001) in all three groups.,['Military conscripts (n=290'],"['low-volume concurrent strength training', 'micro-training (four 15-min strength and four 15-min endurance bouts weekly); classical-training (one 60-min strength and one 60-min endurance training session weekly) or a control-group (two 60-min standard military physical training sessions weekly']","['Satellite cell content', 'elbow flexor and hand grip MVC', 'shotput performance', 'fiber size', 'muscular adaptation', 'Knee extensor MVC', 'Micro-training increased (P≤0.05) type IIa percentage']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205868', 'cui_str': 'Perineuronal satellite cell'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",290.0,0.0118685,Standing long jump remained similar while shotput performance was reduced (P≤0.001) in all three groups.,"[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kilen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark; Center for Military Physical Training, Danish Armed Forces Health Services, Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bay', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Breenfeldt Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas Christian', 'Initials': 'TC', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Pernille Dyeremose', 'Initials': 'PD', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Carlsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Egelund', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nybo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Abigail Louise', 'Initials': 'AL', 'LastName': 'Mackey', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Niels Vidiendal', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'Department of Biomedicine, The Health Faculty, University of Copenhagen, Denmark.'}, {'ForeName': 'Niels Jacob', 'Initials': 'NJ', 'LastName': 'Aachmann-Andersen', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, Denmark.'}, {'ForeName': 'Jesper Løvind', 'Initials': 'JL', 'LastName': 'Andersen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery M, Bispebjerg Hospital and Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark. Electronic address: nbn@nexs.ku.dk.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.03.013']
17,32374352,Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial.,"Importance


Because exposure to UV radiation early in life is an important risk factor for melanoma development, reducing UV exposure in children and adolescents is of paramount importance. New interventions are urgently required.
Objective


To determine the effect of the free face-aging mobile app Sunface on the skin cancer protection behavior of adolescents.
Design, Setting, and Participants


This cluster-randomized clinical trial included a single intervention and a 6-month follow-up from February 1 to November 30, 2018. Randomization was performed on the class level in 52 school classes within 8 public secondary schools (grades 9-12) in Itauna, Southeast Brazil. Data were analyzed from May 1 to October 10, 2019.
Interventions


In a classroom seminar delivered by medical students, adolescents' selfies were altered by the app to show UV effects on their future faces and were shown in front of their class, accompanied by information about UV protection. Information about relevant parameters was collected via anonymous questionnaires before and 3 and 6 months after the intervention.
Main Outcomes and Measures


The primary end point of the study was the difference in daily sunscreen use at 6 months of follow-up. Secondary end points included the difference in daily sunscreen use at 3 months of follow-up, at least 1 skin self-examination within 6 months, and at least 1 tanning session in the preceding 30 days. All analyses were predefined and based on intention to treat. Cluster effects were taken into account.
Results


Participants included 1573 pupils (812 girls [51.6%] and 761 boys [48.4%]; mean [SD] age, 15.9 [1.3] years) from 52 school classes. Daily sunscreen use increased from 110 of 734 pupils (15.0%) to 139 of 607 (22.9%; P < .001) at the 6-month follow-up in the intervention group. The proportion of pupils performing at least 1 skin self-examination in the intervention group rose from 184 of 734 (25.1%) to 300 of 607 (49.4%; P < .001). Use of tanning decreased from 138 of 734 pupils (18.8%) to 92 of 607 (15.2%; P = .04). No significant changes were observed in the control group. The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
Conclusions and Relevance


These findings suggest that interventions based on face-aging apps may increase skin cancer protection behavior in Brazilian adolescents. Further studies are required to maximize the effect and to investigate the generalizability of the effects.
Trial Registration


ClinicalTrials.gov Identifier: NCT03178240.",2020,"The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
","['Secondary Schools in Brazil', 'Brazilian adolescents', 'Results\n\n\nParticipants included 1573 pupils (812 girls [51.6%] and 761 boys [48.4%]; mean [SD] age, 15.9 [1.3] years) from 52 school classes', '52 school classes within 8 public secondary schools (grades 9-12) in Itauna, Southeast Brazil', 'female students (number needed to treat for the primary end point: 8 for girls and 31 for boys', 'adolescents']","['Face-Aging Mobile App-Based Intervention', 'free face-aging mobile app Sunface']","['Daily sunscreen use', 'Skin Cancer Protection Behavior', 'proportion of pupils performing at least 1 skin self-examination', 'daily sunscreen use', 'skin cancer protection behavior']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}]",,0.0597811,"The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
","[{'ForeName': 'Titus J', 'Initials': 'TJ', 'LastName': 'Brinker', 'Affiliation': 'Department of Dermatology, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Bianca Lisa', 'Initials': 'BL', 'LastName': 'Faria', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Olber Moreira', 'Initials': 'OM', 'LastName': 'de Faria', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Klode', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jochen S', 'Initials': 'JS', 'LastName': 'Utikal', 'Affiliation': 'Department of Dermatology, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Mons', 'Affiliation': 'Cancer Prevention Unit, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krieghoff-Henning', 'Affiliation': 'Department of Dermatology, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Oscar Campos', 'Initials': 'OC', 'LastName': 'Lisboa', 'Affiliation': 'School of Medicine, Federal University of Ouro Preto, Ouro Preto, Brazil.'}, {'ForeName': 'Ana Carla Cruz', 'Initials': 'ACC', 'LastName': 'Oliveira', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Henrique Augusto', 'Initials': 'HA', 'LastName': 'Lino', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Bernardes-Souza', 'Affiliation': 'School of Medicine, Federal University of Ouro Preto, Ouro Preto, Brazil.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0511']
18,32371514,Impact of a farmers' market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation.,"INTRODUCTION


Low-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers' market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.
METHODS AND ANALYSIS


In a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10-15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers' markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25-30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants' experiences with and perceived outcomes from the programme.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03952338.",2020,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"['among low-income adults', ""low-income participants by providing coupons to purchase healthy foods from farmers' markets"", 'Farmers']","[""farmers' market nutrition coupon programme"", 'FMNCP', 'Market Nutrition Coupon Programme (FMNCP', 'FMNCP intervention (n=132) or a no-intervention control group', 'BC FMNCP']","['burden of chronic disease', 'Diet quality', 'diet quality and psychosocial well-being', 'Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}]","[{'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",30.0,0.199752,Farmers' Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers' markets.,"[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Aktary', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caron-Roy', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tolulope', 'Initials': 'T', 'LastName': 'Sajobi', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': ""O'Hara"", 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leblanc', 'Affiliation': ""British Columbia Association of Farmers' Markets, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sharlette', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Gavin R', 'Initials': 'GR', 'LastName': 'McCormack', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Timmins', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Downs', 'Affiliation': 'School of Public Health, Rutgers University, Newark, New Jersey, USA.'}, {'ForeName': 'Leia M', 'Initials': 'LM', 'LastName': 'Minaker', 'Affiliation': 'School of Planning, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Candace Ij', 'Initials': 'CI', 'LastName': 'Nykiforuk', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Godley', 'Affiliation': 'Department of Sociology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Milaney', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, Canada.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Elliott', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Raine', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Rachel Jl', 'Initials': 'RJ', 'LastName': 'Prowse', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dana Lee', 'Initials': 'DL', 'LastName': 'Olstad', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada dana.olstad@ucalgary.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035143']
19,32379608,The Impact of Childhood Maltreatment on Long-Term Outcomes in Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression.,"BACKGROUND


Childhood maltreatment (CM) predicted poorer outcomes in acute depression treatment with CBT, IPT and Supportive Psychotherapy (SP). The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) fared well in patients with chronic depression and CM during acute treatment, yet there is a considerable lack of empirical evidence for long-term outcomes.
METHODS


We analyzed one and two-year follow-up data of 268 patients randomized to 24 sessions (20 weeks) of acute and 8 sessions (28 weeks) of extended treatment with CBASP or SP. Primary outcome was the number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE). Secondary outcomes included self- and clinician-rated depression symptoms. We investigated this moderating effect for any CM and for specific subtypes of CM.
RESULTS


Intent-to-treat analyses revealed that the presence of CM did not significantly moderate long-term effects of CBASP compared to SP. The analysis of trauma subtypes revealed that patients with childhood emotional abuse had statistically significant worse outcomes than patients without (main effect, p=.015) and that the advantage of CBASP over SP was larger in patients with childhood emotional abuse than in patients without (interaction effect, p=.045) after 1 year. No significant effects were found for other trauma subtypes.
LIMITATIONS


The measurement of CM was limited to retrospective self-assessment.
CONCLUSIONS


The presence of CM did not significantly moderate long-term treatment effects of CBASP compared to SP. When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.",2020,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","['Disorder-Specific vs. Nonspecific Psychotherapy for Chronic Depression', 'patients with chronic depression and CM during acute treatment']","['CBT, IPT and Supportive Psychotherapy (SP', 'Psychotherapy (CBASP', 'CBASP', 'CBASP or SP']","['number of well weeks as measured by the Longitudinal Interval Follow-Up Evaluation Interview (LIFE', 'self- and clinician-rated depression symptoms']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",268.0,0.144678,"When trauma subtypes were considered, CBASP was more effective than SP after one year in patients who retrospectively reported emotional abuse.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bausch', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. Electronic address: paul.bausch@gmx.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Elsaeßer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.164']
20,32371518,Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol.,"INTRODUCTION


Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.
METHODS AND ANALYSIS


Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.
ETHICS AND DISSEMINATION


The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick's Biomedical and Scientific Research Ethics Committee (REGO-2019-2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.",2020,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","['People with severe mental disorders', 'patients aged 18-60 years with a hospital stay of 12-120 months and a primary diagnosis of psychosis', '100 people into each trial arm', 'psychiatric hospital in India']",['Individualised inTervention'],"['disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.266412,"It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life.","[{'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Raja', 'Affiliation': 'Mental Health, Tata Trusts, Mumbai, India T.Raja@warwick.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tuomainen', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Center for Health Economics, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Cinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, NIMHANS, Bangalore, Karnataka, India.'}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Director, Centre for Mental Health and Wellbeing Research, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035753']
21,32394686,Evaluation of the cardioprotective effects of crystalloid del Nido cardioplegia solution via a rapid and accurate cardiac marker: heart-type fatty acid-binding protein,"Background/aim


Our  aim  in  this  study  was  to  compare  the  efficacy  and  safety  of  crystalloid  del  Nido  solution  and  cold  blood  cardioplegia solution on clinical and laboratory parameters.
Materials and methods


Sixty patients who underwent elective coronary bypass operation between July 2019 and January 2020 were included in our study. Patients were divided into 2 groups of 30 patients using del Nido solution (DNS) and cold blood cardioplegia solution (CBCS), which were given for cardiac arrest. Demographic data, preoperative, postoperative 0th h, 6th h and 4th day creatine kinase myocardial band (CK-MB) and troponin I values were compared with a specific cardiac enzyme heart-type fatty acid-binding protein (H-FABP).
Results


We found that aortic cross clamp duration and cardiopulmonary bypass (CPB) time were shorter in patients using del Nido solution than cold blood cardioplegia solution (57.30 ± 23.57 min, 76.07 ± 27.18 min, P = 0.006) (95.07 ± 23.06 min, 114.13 ± 33.93, P = 0.014). Total cardioplegia solution volume was higher in the cold blood cardioplegia solution group (1426.67 ± 416.00 vs. 1200 ± 310.73 P = 0.02). Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
Conclusion


According to these results, when we compare both demographic data and CK-MB, troponin I and H-FABP levels, both cardioplegia solutions were comparable regarding safety and efficacy in terms of myocardial protection.",2020,"Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
",['Sixty patients who underwent elective coronary bypass operation between July 2019 and January 2020 were included in our study'],"['del Nido solution (DNS) and cold blood cardioplegia solution (CBCS', 'crystalloid del Nido cardioplegia solution', 'crystalloid del Nido solution and cold blood cardioplegia solution']","['aortic cross clamp duration and cardiopulmonary bypass (CPB) time', 'demographic data and CK-MB, Troponin-I and H-FABP levels', 'efficacy and safety', 'day Creatine Kinase Myocardial Band (CK-MB) and troponin', 'Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP', 'Total cardioplegia solution volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C1312696', 'cui_str': 'FABP3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0201934', 'cui_str': 'Cardiac enzymes/isoenzymes measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",60.0,0.0963738,"Preoperative and postoperative levels of cardiac enzymes including CK-MB, troponin I and H-FABP were comparable in del Nido solution and cold blood cardioplegia solution groups.
","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kirişci', 'Affiliation': 'Department of Cardiovascular Surgery, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}, {'ForeName': 'Aydemir', 'Initials': 'A', 'LastName': 'Koçarslan', 'Affiliation': 'Department of Cardiovascular Surgery, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}, {'ForeName': 'Duygun', 'Initials': 'D', 'LastName': 'Altintaş Aykan', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Alkan Baylan', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Doğaner', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Orak', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Kahramanmaraş Sütçü İmam University, Kahramanmaraş, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-2002-53']
22,31952985,Mild to moderate hyponatremia at discharge is associated with increased risk of recurrence in patients with community-acquired pneumonia.,"BACKGROUND


Hyponatremia is the most common electrolyte disorder in hospitalized patients with pneumonia. Different studies have shown an association of hyponatremia on admission and worse patient's outcome. Yet, the impact of hyponatremia at discharge or of hyponatremia correction on patient's prognosis is unknown.
METHODS


This is a preplanned secondary data analysis from a double-blind, randomized, placebo-controlled trial of hospitalized patients with community-acquired pneumonia and prednisone treatment. The primary outcome was the impact of hyponatremia on admission and at discharge on patient relevant outcomes (i.e. mortality, rehospitalization and recurrence rate) within 180 days.
RESULTS


Of the 708 included patients, 185 (26.1%) were hyponatremic on admission. Of these, 28 (15.1%) were still hyponatremic at discharge. 34 (4.8%) patients developed hyponatremia during hospitalization despite being normonatremic on admission. Patients with hyponatremia at discharge had a higher rate of pneumonia recurrence as compared to normonatremic patients (OR 2.68; 95%-CI 1.09-6.95; p = 0.037). Among patients with hyponatremia at discharge, patients who were already hyponatremic on admission showed the strongest association with increased recurrence rate (OR 4.01; 95%-CI 1.08-12.64; p = 0.022). In contrast, recurrence rate was not affected in patients who were hyponatremic on admission but had normalized serum sodium levels at discharge (p = 0.73).
CONCLUSION


Mild to moderate hyponatremia at discharge is associated with an increased risk of recurrence in hospitalized patients with pneumonia. This association is particularly strong for patients who are hyponatremic both on admission and at discharge, emphasizing the importance of hyponatremia correction during hospitalization.",2020,Patients with hyponatremia at discharge had a higher rate of pneumonia recurrence as compared to normonatremic patients (OR 2.68; 95%-CI 1.09-6.95; p = 0.037).,"['hospitalized patients with pneumonia', 'hospitalized patients with community-acquired pneumonia and prednisone treatment', 'patients who are hyponatremic both on admission and at discharge', 'Of the 708 included patients, 185 (26.1%) were hyponatremic on admission', 'patients with community-acquired pneumonia']",['placebo'],"['rate of pneumonia recurrence', 'recurrence rate', 'hyponatremia', 'impact of hyponatremia on admission and at discharge on patient relevant outcomes (i.e. mortality, rehospitalization and recurrence rate', 'risk of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0857122', 'cui_str': 'Hyponatraemic'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C4704925', 'cui_str': 'Patient-Relevant Outcome'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.372173,Patients with hyponatremia at discharge had a higher rate of pneumonia recurrence as compared to normonatremic patients (OR 2.68; 95%-CI 1.09-6.95; p = 0.037).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Potasso', 'Affiliation': 'Departments of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; Department of Clinical Research, University of Basel, Basel, Switzerland. Electronic address: laura.potasso@usb.ch.'}, {'ForeName': 'Clara Odilia', 'Initials': 'CO', 'LastName': 'Sailer', 'Affiliation': 'Departments of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; Department of Clinical Research, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Claudine Angela', 'Initials': 'CA', 'LastName': 'Blum', 'Affiliation': 'Departments of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; Division of General Internal and Emergency Medicine, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland; Division of Endocrinology, Diabetes, and Metabolism, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Cesana-Nigro', 'Affiliation': 'Department of Endocrinology and Diabetology, Bürgerspital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Division of General Internal and Emergency Medicine, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland; Division of Endocrinology, Diabetes, and Metabolism, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Division of General Internal and Emergency Medicine, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland; Division of Endocrinology, Diabetes, and Metabolism, University Department of Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Departments of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland; Department of Clinical Research, University of Basel, Basel, Switzerland.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.12.009']
23,32305457,"Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative.","BACKGROUND


Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2-3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings.
METHODS


Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost.
CONCLUSION


TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.",2020,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.",[],['stepped-wedge hybrid type'],"['time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction', 'acceptability, adoption/penetration, fidelity, sustainability and cost']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.050151,"The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care.","[{'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Battaglia', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America. Electronic address: Tracy.Battaglia@bmc.org.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Freund', 'Affiliation': 'Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, United States of America; Division of Internal Medicine and Primary Care, Department of Medicine, Tufts Medical Center, Boston, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Bak', 'Affiliation': ""Women's Health Unit, Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, United States of America; Boston University School of Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, United States of America.'}, {'ForeName': 'Karen Burns', 'Initials': 'KB', 'LastName': 'White', 'Affiliation': 'Initiative to Eliminate Cancer Disparities, Dana Farber/Harvard Cancer Center, Boston, MA, United States of America.'}, {'ForeName': 'Stephenie C', 'Initials': 'SC', 'LastName': 'Lemon', 'Affiliation': 'Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106007']
24,32398341,Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: study protocol.,"INTRODUCTION


Bloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied.
METHODS AND ANALYSIS


We will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors ( Staphylococcus aureus ,  Staphylococcus lugdunensis ,  Candida  and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms.
ETHICS AND DISSEMINATION


The study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study results via the Canadian Critical Care Trials Group and other collaborating networks to set the global paradigm for antibiotic treatment duration for non-staphylococcal Gram-positive, Gram-negative and anaerobic bacteraemia, among patients admitted to hospital.
TRIAL REGISTRATION NUMBER


The BALANCE (Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness) trial was registered at www.clinicaltrials.gov (registration number: NCT03005145).",2020,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","['patients with blood cultures confirming a pathogenic bacterium after hospital admission', 'hospitalised patients with bloodstream infections', '3626 patients across 60 hospitals and 6 countries', 'patients admitted to hospital']","['antibiotic treatment', 'placebo']","['Antibiotic Length', 'hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days,  C lostridium  difficile  infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms', '90-day survival', 'non-inferiority margin of 4% absolute mortality', 'Bacteremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0741103', 'cui_str': 'Allergy to antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",3626.0,0.403099,"The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases & Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada Nick.Daneman@sunnybrook.ca.'}, {'ForeName': 'Asgar H', 'Initials': 'AH', 'LastName': 'Rishu', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra L', 'Initials': 'RL', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': 'Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Royal Columbian Hospital, New Westminster, British Columbia, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Melborne, Victoria, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038300']
25,32398433,"High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial.","BACKGROUND


Over 6 million esophagogastroduodenoscopy (EGD) procedures are performed in the United States each year. Patients having anesthesia for advanced EGD procedures, such as interventional procedures, are at high risk for hypoxemia.
METHODS


Our primary study aim was to evaluate whether high-flow nasal cannula (HFNC) oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD. Secondarily, we studied whether HFNC oxygen reduces hypercarbia or hypotension. After obtaining written informed consent, adults having anesthesia for advanced EGD, expected to last longer than 15 minutes, were randomly assigned to receive HFNC oxygen or standard nasal cannula (SNC) oxygen. The primary outcome was occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation <92% for at least 15 consecutive seconds. Secondary outcomes were occurrence of one or more hypercarbia or hypotension events. A hypercarbia event was defined by a transcutaneous CO2 measurement 20 mm Hg or more above baseline, and a hypotension event was defined by a mean arterial blood pressure measurement 25% or more below baseline.
RESULTS


Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures. Eight randomized patients did not complete study procedures due to changes in their anesthesia or endoscopy plan. One patient was excluded from analysis because their procedure was aborted after 1 minute. Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03). There was no difference in the incidence of hypercarbia or hypotension between the groups. The HR for hypercarbia with HFNC oxygen was 1.29 (95% CI, 0.89-1.88; P = .17), and the HR for hypotension was 1.25 (95% CI, 0.86-1.82; P = .25).
CONCLUSIONS


HFNC oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD and may offer an opportunity to enhance patient safety during these procedures.",2021,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","['adults having anesthesia for advanced EGD, expected to last longer than 15 minutes', 'Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures', 'Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy']","['HFNC oxygen or standard nasal cannula (SNC) oxygen', 'High-Flow Nasal Cannula Oxygen', 'high-flow nasal cannula (HFNC) oxygen', 'HFNC oxygen']","['hypotension event', 'occurrence of one or more hypercarbia or hypotension events', 'occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation', 'incidence of hypoxemia', 'incidence of hypercarbia or hypotension', 'hypercarbia or hypotension', 'HR for hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",271.0,0.426427,"Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03).","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Mazzeffi', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Petrick', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Greenwald', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Darwin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Goldberg', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bigeleisen', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Chow', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Kaplowitz', 'Affiliation': 'From the Department of Anesthesiology.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrin', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rock', 'Affiliation': 'From the Department of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004837']
26,32320773,"Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial.","PURPOSE


Nodular basal cell carcinoma (nBCC) is mostly treated with surgical excision. Interest in minimally invasive treatment of these low-risk tumors is increasing. We assessed the effectiveness of nBCC treatment with curettage and imiquimod cream compared with surgical excision.
METHODS


Patients with nBCC included in this randomized, controlled noninferiority trial were randomly assigned to either a curettage and imiquimod cream group or a surgical excision group. The primary endpoint was the proportion of patients free from treatment failure 1 year after the end of treatment. A prespecified noninferiority margin of 8% was used. A modified intention-to-treat and a per-protocol analysis was performed (ClinicalTrials.gov identifier NCT02242929).
RESULTS


One hundred forty-five patients were randomized: 73 to the curettage and imiquimod cream group and 72 to the surgical excision group. The proportion of patients free of recurrence after 12 months was 86.3% (63/73) for the curettage and imiquimod group and 100% (72/72) for the surgical excision group. The difference in efficacy was -13.7% (95% confidence interval -21.6% to -5.8%; 1-sided P = .0004) favoring surgical excision.
CONCLUSION


Noninferiority of curettage and imiquimod cream cannot be concluded. Given the still high efficacy of curettage and imiquimod cream and the indolent growth pattern of nBCC, curettage and imiquimod could still be a valuable treatment option with the possibility to prevent overuse of excisions. However, it cannot replace surgical excision.",2020,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"['Nodular basal cell carcinoma (nBCC', '145 patients were randomized; 73 to', 'Patients with nodular BCC', 'Nodular basal cell carcinoma (SCIN']","['imiquimod cream', 'curettage and imiquimod cream and 72 to surgical excision', 'imiquimod', 'Surgery versus combined treatment with Curettage and Imiquimod', 'nBCC', 'curettage and imiquimod cream or surgical excision', 'curettage and imiquimod cream']","['efficacy', 'proportion of patients free from treatment failure one 1 year']","[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]","[{'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439234', 'cui_str': 'year'}]",145.0,0.0800048,Proportion of patients free of recurrence after 12 months was 86.3% for curettage and imiquimod (63/73) and 100% for excision (72/72).,"[{'ForeName': 'Kelly A E', 'Initials': 'KAE', 'LastName': 'Sinx', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: kelly.sinx@mumc.nl.'}, {'ForeName': 'Patty J', 'Initials': 'PJ', 'LastName': 'Nelemans', 'Affiliation': 'Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Nicole W J', 'Initials': 'NWJ', 'LastName': 'Kelleners-Smeets', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Veronique J L', 'Initials': 'VJL', 'LastName': 'Winnepenninckx', 'Affiliation': 'Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Aimee H M M', 'Initials': 'AHMM', 'LastName': 'Arits', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands; Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Dermatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Mosterd', 'Affiliation': 'Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.053']
27,32217340,Effects of vitamin D supplementation on depression and some involved neurotransmitters.,"BACKGROUND


Low vitamin D levels are associated with a dysregulated hypothalamic-pituitary-adrenal (HPA) axis and depression but a causal relationship has not been established. This study aimed to evaluate the effects of vitamin D supplementation on depression severity, serum 25(OH)D, and some neurotransmitters in patients with mild to moderate depression.
METHODS


An 8-week double-blind randomized clinical trial was conducted on 56 subjects with mild to moderate depression, aged 43.0 ± 1.15yrs. The patients were randomly allocated into two groups: intervention (50,000 IU cholecalciferol/2wks) and control (placebo). Biochemical parameters (serum 25(OH)D, iPTH, oxytocin and platelet serotonin), and depression severity (Beck Depression Inventory-II (BDI-II 1 )) were initially and finally assessed.
RESULTS


Following intervention, significant changes were observed in the intervention group compared to the controls: 25(OH)D concentrations increased (+40.83±28.57 vs. +5.14±23.44 nmol/L, P<0.001) and BDI scores decreased (-11.75±6.40 vs. -3.61±10.40, P = 0.003). Oxytocin concentrations were significantly reduced in controls (-6.49±13.69 ng/mL, P = 0.01), but between -group differences were insignificant. Within- and between-group differences of platelet serotonin concentrations were not significant; however, the increment in controls was higher (+0.86±10.82 vs. +0.26±9.38 ng/mL, P = 0.83).
LIMITATIONS


Study duration may not reflect the long-term effects of vitamin D on depression. It seems necessary to assess tryptophan-hydroxylasetypes1&2 in relation to vitamin D in serotonin pathways.
CONCLUSIONS


Eight-week supplementation with 50,000 IU/2wks vitamin D, elevated 25(OH)D concentration of subjects with mild to moderate depression and significantly improved their depression severity. However, there was no evidence that the anti-depressive effect of vitamin D supplementation is mediated by the measured neurotransmitters.",2020,"Oxytocin concentrations were significantly reduced in controls (-6.49±13.69 ng/mL, P = 0.01), but between -group differences were insignificant.","['patients with mild to moderate depression', '56 subjects with mild to moderate depression, aged 43.0\xa0±\xa01.15yrs']","['vitamin D supplementation', 'vitamin D', 'intervention (50,000 IU cholecalciferol/2wks) and control (placebo']","['Oxytocin concentrations', 'controls: 25(OH)D concentrations', 'Biochemical parameters (serum 25(OH)D, iPTH, oxytocin and platelet serotonin), and depression severity (Beck Depression Inventory-II (BDI-II 1 ', 'BDI scores', 'depression severity', 'depression severity, serum 25(OH)D', 'platelet serotonin concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",56.0,0.244194,"Oxytocin concentrations were significantly reduced in controls (-6.49±13.69 ng/mL, P = 0.01), but between -group differences were insignificant.","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Department of Biology Science and Research Branch, Islamic Azad University, Tehran, Iran. Electronic address: m_kaviani@sbmu.ac.ir.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Nikooyeh', 'Affiliation': 'Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Zand', 'Affiliation': 'Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parichehreh', 'Initials': 'P', 'LastName': 'Yaghmaei', 'Affiliation': 'Department of Biology Science and Research Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Tirang R', 'Initials': 'TR', 'LastName': 'Neyestani', 'Affiliation': 'Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: t.neyestani@sbmu.ac.ir.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.029']
28,32325534,"[Delegation of Home Visits and Qualification of Health Care Assistants in Family Practices in Saxony, Germany - Results of the Cross-Sectional Study SESAM-5].","BACKGROUND


In the context of demographic changes and the shortage of family physicians in the primary care sector in Germany, the delegability of home visits to health care assistants is discussed. There is little information on the extent of home visits delegated. The aim of this article is to examine differences in the socio-demographic and organizational profile of delegating vs. non-delegating family doctors in Saxony and to describe the level of qualification of health care assistants.
METHODOLOGY


This cross-sectional study is part of a series of epidemiological studies in the federal state of Saxony, Germany. All family doctors in Saxony were contacted in 2014 (n=2677), of whom 11,2% participated. In a period of 12 months, family practices documented home visits within a randomly assigned week. Socio-demographic characteristics of the family practice and the level of qualification of health care assistants were surveyed.
RESULTS


A total of 274 family practices participated; 52,9% of all participating family doctors declared their willingness to delegate home visits, but only 8,5% of home visits were made by health care assistants. There were non-significant trends between the willingness to delegate and self-employment vs. being employed (92,4 vs. 84,6%, p=0,06), establishment in a single vs. shared practice (35,2 vs. 31,4%, p=0,09) and higher patient numbers per 3 months (x̄+= 1183,08 vs. 1092,16, p=0,07). The 224 health care assistants that participated in the study were mostly trained in nursing (39,7%) or as medical assistants (50,8%). The vast majority of the health care assistants (82,5%) had no further training or additional qualification; 19,6% completed further training that qualified them to have home visits formally delegated to them.
CONCLUSION


Among family doctors in Saxony there is a reported high willingness to delegate, which is not implemented sufficiently in practice. Delegation is based on personal confidence in health care assistants without formal qualification. Qualified delegation ensures high standards in patient care and this potential is not used in Saxony, particularly in rural areas with imminent shortages of medical care. More education about the opportunities of qualified delegation seems necessary.",2021,"Qualified delegation ensures high standards in patient care and this potential is not used in Saxony, particularly in rural areas with imminent shortages of medical care.","['A total of 274 family practices participated; 52,9% of all participating family doctors declared their willingness to delegate home visits, but only 8,5% of home visits were made by health care assistants', 'family doctors in Saxony', '224 health care assistants that participated in the study were mostly trained in nursing (39,7%) or as medical assistants (50,8', 'All family doctors in Saxony were contacted in 2014 (n=2677), of whom 11,2% participated']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",[],[],,0.0214285,"Qualified delegation ensures high standards in patient care and this potential is not used in Saxony, particularly in rural areas with imminent shortages of medical care.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bortz', 'Affiliation': 'Bereich Allgemeinmedizin, Medizinische Fakultät Carl Gustav Carus, Dresden.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Schübel', 'Affiliation': 'Bereich Allgemeinmedizin, Medizinische Fakultät Carl Gustav Carus, Dresden.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Pochert', 'Affiliation': 'Bereich Allgemeinmedizin, Medizinische Fakultät Carl Gustav Carus, Dresden.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Bereich Allgemeinmedizin, Medizinische Fakultät Carl Gustav Carus, Dresden.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Voigt', 'Affiliation': 'Bereich Allgemeinmedizin, Medizinische Fakultät Carl Gustav Carus, Dresden.'}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-1130-6266']
29,32217557,"Study protocol for SFX-01 after subarachnoid haemorrhage (SAS): a multicentre randomised double-blinded, placebo controlled trial.","INTRODUCTION


Subarachnoid haemorrhage (SAH) from a ruptured cerebral aneurysm carries high morbidity and mortality. Despite huge advances in techniques to secure the aneurysm, there has been little progress in the treatment of the deleterious effects of the haemorrhage.Sulforaphane is an Nrf2 inducer with anti-oxidant and anti-inflammatory properties. It has been shown to improve clinical outcome in experimental models of SAH, but is unstable. SFX-01 (Evgen Pharma) is a novel composition comprised of synthetic sulforaphane stabilised within an α-cyclodextrin complex. On ingestion, the complex releases sulforaphane making SFX-01 an ideal vehicle for delivery of sulforaphane.
METHODS AND ANALYSIS


The objective of the study is to assess the safety, pharmacokinetics and efficacy of SFX-01. This is a prospective, multicentre, randomised, double-blind placebo-controlled trial in patients aged 18-80 years with aneurysmal subarachnoid haemorrhage in the previous 48 hours. 90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.Safety will be assessed using blood tests and adverse event reporting.Pharmacokinetics will be assessed based on paired blood and cerebrospinal fluid (CSF) sulforaphane levels on day 7. A subgroup will have hourly samples taken during 6 hours post-dosing on days 1 and 7. Pharmacodynamics will be assessed by haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery will be measured by transcranial Doppler ultrasound.Clinical outcomes will be assessed at days 28, 90 and 180 with modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke. MRI at 6 months including quantitative susceptibility mapping and volumetric T1 will measure iron deposition and cortical volume.Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity will be primary outcomes and all others secondary.
ETHICS AND DISSEMINATION


Ethical approval was obtained from South Central Hampshire A committee. Outcomes of the trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT02614742.",2020,90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.,"['after subarachnoid haemorrhage (SAS', '90 patients', 'patients aged 18-80 years with aneurysmal subarachnoid haemorrhage in the previous 48\u2009hours']","['SFX-01', 'placebo', 'Sulforaphane']","['paired blood and cerebrospinal fluid (CSF) sulforaphane levels', 'modified Rankin Scale, Glasgow Outcome Score, SAH Outcome Tool, Short Form-36, Brain Injury Community Rehabilitation Outcome Scales and Check List for Cognitive and Emotional consequences following stroke', 'haptoglobin and malondialdehyde levels, and maximum flow velocity of middle cerebral artery', 'safety, pharmacokinetics and efficacy', 'Safety, CSF sulforaphane concentration and middle cerebral artery flow velocity']","[{'cui': 'C0038525', 'cui_str': 'SAH (Subarachnoid Hemorrhage)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}]","[{'cui': 'C0005768'}, {'cui': 'C0007807'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0600378', 'cui_str': 'Rehabilitation Outcome'}, {'cui': 'C0222045'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",90.0,0.684954,90 patients will be randomised to receive SFX-01 (300 mg) or placebo two times per day for up to 28 days.,"[{'ForeName': 'Ardalan H', 'Initials': 'AH', 'LastName': 'Zolnourian', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK a.zolnourian@soton.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Franklin', 'Affiliation': 'Evgen Pharma, Liverpool, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Galea', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Diederik Oliver', 'Initials': 'DO', 'LastName': 'Bulters', 'Affiliation': 'Department of Clinical Neurosciences, University of Southampton, Southampton, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028514']
30,31809359,Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me).,"BACKGROUND


HIV testing is critical to HIV prevention and care. Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen. Novel interventions to increase HIV testing rates among young Black men who have sex with men and transwomen are needed.
METHODS


A randomized controlled trial among 236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach. Participants completed a computerized baseline assessment and were randomized to electronically receive either a personalized recommendation or standard HIV testing information. Follow-up surveys were conducted online at 3 and 6 months.
RESULTS


Retention was 92% and 93% at 3-month and 6-month follow-up, respectively. At baseline, 41% of participants reported that they tested for HIV in the past 3 months and another 25% between 4 and 6 months ago. Intent-to-treat analyses found that participants randomized to the experimental arm (personalized recommendation) were not significantly more likely to test for HIV compared with participants in the standard HIV testing information control arm at 3 months (76% vs. 71%; P = 0.40) and 6 months (73% vs. 72%; P = 0.81), respectively.
CONCLUSIONS


This study evaluated an innovative intervention to increase HIV testing by matching individuals to optimal HIV testing approaches. Participants in both arms increased past 3-month HIV testing, suggesting that providing information on options and/or raising risk awareness is sufficient to significantly increase HIV testing.
TRIAL REGISTRATION


ClinicalTrial.gov NCT02834572 https://clinicaltrials.gov/ct2/show/NCT02834572.",2020,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"['young Black men who have sex with men and transwomen', 'Young Black Men and Transwomen', 'young Black men who have sex with men and transwomen are needed', '236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach', 'Who Have Sex With Men or Transwomen to HIV Testing Options in New York City ']","['personalized recommendation or standard HIV testing information', 'Novel interventions']",['HIV testing rates'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",236.0,0.115138,Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen.,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Frye', 'Affiliation': 'Department of Community Health and Social Medicine,Department of Community Health and Social Medicine, Sophie Davis Biomedical Education Program, City University of New York School of Medicine, City University of New York, New York, NY.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Nandi', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Chiasson', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Wilton', 'Affiliation': 'Department of Human Development, Binghamton University, Binghamton, NY.'}, {'ForeName': 'DaShawn', 'Initials': 'D', 'LastName': 'Usher', 'Affiliation': 'Data Analytic Services (DAS) Laboratory, New York Blood Center, New York, NY.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Biostatistics and Institute for Health, Health Care Policy and Aging Research, Rutgers, The State University of New Jersey, Piscataway, NJ; and.'}, {'ForeName': 'Beryl A', 'Initials': 'BA', 'LastName': 'Koblin', 'Affiliation': 'Independent Consultant, Metuchen, NJ.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002223']
31,32179132,Outcomes for Hyperthermia Combined with Concurrent Radiochemotherapy for Patients with Cervical Cancer.,"PURPOSE


To evaluate the effect of hyperthermia combined with concurrent radiochemotherapy (RCT) and treatment-related toxicity in patients with cervical cancer (CC) stage IB-IV.
METHODS AND MATERIALS


This study was conducted between 2009 and 2013 in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV CC. The patients were randomly assigned into 2 treatment groups: RCT and RCT plus hyperthermia (RCHT). Five-year survival, treatment-related toxicity, and other prognostic factors were evaluated.
RESULTS


Three hundred seventy-three patients completed treatment and were analyzed by per-protocol (PP) analysis. The 5-year overall survival (OS) in the RCHT group (81.9%) was better than that in RCT group (72.3%), and the log-rank test showed a statistically significant difference between the 2 groups (P = .040). Univariate and multivariate Cox regression analysis for 5-year OS showed a statistically significant difference (P = .043, P = .045, respectively). The 5-year local relapse-free survival in RCHT (86.8%) was also better than that in RCT (82.7%), but the difference was not significant. Acute or late toxicity was not significantly different between the 2 groups. Advanced clinical stage (FIGO) and larger tumor size showed higher risk of death and a relatively poor prognosis in univariate and multivariate analysis.
CONCLUSIONS


The study confirmed that hyperthermia combined with RCT yielded a better 5-year OS in CC. Acute and late toxicity was similar between the RCT and RCHT groups. Clinical stage (FIGO) and tumor size were independent prognostic factors in CC.",2020,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"['373 patients completed treatment and were analyzed by per protocol (PP) analysis', '2009 and 2013 in CC patients with the International Federation of Gynecology and Obstetrics (FIGO) stage IB-IV', 'patients with cervical cancer (CC) stage IB-IV', 'patients with cervical cancer']","['RCT', 'RCT and RCT plus hyperthermia (RCHT', 'hyperthermia combined with concurrent radiochemotherapy', 'HT combined to RCT', 'hyperthermia (HT) combined with concurrent radiochemotherapy (RCT']","['5-year survival', '5-year OS', '5-year overall survival (OS', 'Acute or late toxicity', 'Clinical stage (FIGO) and tumor size', '5-year local relapse-free survival (LRFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.250432,The 5-year overall survival (OS) in RCHT group (81.9%) was better than that in RCT group (72.3%) and the log-rank test showed statistically significant difference between the two groups (p=0.040).,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Che', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yingbing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Du', 'Initials': 'D', 'LastName': 'Meng', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Su', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jiquan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Beina', 'Initials': 'B', 'LastName': 'Hui', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: chenhwdr@hotmail.com.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.006']
32,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


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


Medical research center.
METHODS


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


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


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


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


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
33,32317575,Forgot calcium? Admission ionized-calcium in two civilian randomized controlled trials of prehospital plasma for traumatic hemorrhagic shock.,"BACKGROUND


Randomized clinical trials (RCTs) support the use of prehospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most prehospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent prehospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that prehospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation. Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca of 1.0 mmol/L or less.
RESULTS


Of 160 subjects (76% men), 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34]). Prehospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03). Severe hypocalcemia was significantly associated with decreased survival (adjusted hazard ratio, 1.07; 95% CI, 1.02-1.13; p = 0.01) and massive transfusion (adjusted relative risk, 2.70; 95% CI, 1.13-6.46; p = 0.03), after adjustment for confounders (randomization group, age, ISS, and shock index).
CONCLUSION


Prehospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in prehospital hemotherapy.
LEVEL OF EVIDENCE


Therapeutic, level II.",2020,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","['160 subjects (76% men', 'Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible', ' 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34', 'traumatic hemorrhagic shock', 'We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation']",[],"['massive transfusion', 'survival', 'Severe hypocalcemia', 'rates of hypocalcemia', 'Hypocalcemia']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",160.0,0.491442,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'From the School of Medicine, Department of Surgery, University of Colorado Anschutz Medical Campus (H.B.M., E.E.M., M.J.C., M.P.C., A.S.), Aurora, CO; University of Colorado Anschutz Medical Campus, School of Public Health, Department of Health Systems, Management and Policy (A.S.); Aurora, Colorado; University of Pittsburgh (M.T.T., J.L.S., F.X.G., J.B.B., M.N., B.Z.), Pittsburgh, Pennsylvania; Ernest E. Moore Shock Trauma Center at Denver Health (E.E.M., M.J.C.), Denver, Colorado; and Combat Casualty Care Research Program (A.E.P.), US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': ''}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
34,32302682,No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial.,"PURPOSE


Radiation therapy (RT) after breast-conserving surgery reduces locoregional recurrences and improves survival but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomized clinical trial initiated in 1991 and to report dose-volume data based on individual 3-dimensional treatment plans for organs at risk.
METHODS AND MATERIALS


The trial included 1187 patients with T1-2 N0 breast cancer randomized to postoperative tangential whole breast RT or no further treatment. The prescription dose to the clinical target volume was 48 to 54 Gy. We present 20-year follow-up on survival, cause of death, morbidity, and later malignancies. For a cohort of patients (n = 157) with accessible computed tomography-based 3-dimensional treatment plans in Dicom-RT format, dose-volume descriptors for organs at risk were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques.
RESULTS


The cumulative incidence of cardiac mortality was 12.4% in the control group and 13.0% in the RT group (P = .8). There was an increase in stroke mortality: 3.4% in the control group versus 6.7% in the RT group (P = .018). Incidences of contralateral breast cancer and lung cancer were similar between groups. The median D mean  (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1), and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0).
CONCLUSIONS


In this trial, serious late side effects of whole breast RT were limited and less than previously reported in large meta-analyses. We observed no increase in cardiac mortality in irradiated patients. Doses to the heart were a median D mean  of 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation.",2020,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"['1187 T1-2 N0 breast cancer patients randomised to', 'breast cancer patients after breast conserving surgery', 'organs at risk (OR']","['radiotherapy', 'Radiotherapy (RT', 'postoperative tangential whole breast radiotherapy or no further treatment', 'whole breast radiotherapy']","['stroke mortality', 'cardiac mortality', 'median D mean  (range) heart dose', 'cardiac mortality or morbidity', 'loco-regional recurrences and improves survival', 'Incidences of contra lateral breast cancer and lung cancer', 'cumulative incidence of cardiac mortality', 'survival, cause of death, morbidity and later malignancies']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1187.0,0.0509719,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"[{'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden. Electronic address: fredrika.killander@med.lu.se.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Regional Oncologic Centre West, Gothenburg, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, Kingś College London, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Haghanegi', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellen', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.003']
35,32298407,Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals.,"BACKGROUND


Little is known about the effect of health professionals' advice on promoting healthy lifestyle behaviors (diet and exercise) among breast cancer patients.
PURPOSE


To identify predictors of receiving lifestyle advice from health professionals and its impact on healthy lifestyle behaviors.
METHODS


We used data from a randomized controlled trial of an interactive, cancer-communication video program using African American breast cancer survivor stories for newly diagnosed African American breast cancer patients (Stages 0-III). Participants completed five interviews over 2 years. This intervention did not significantly affect changes in quality-of-life outcomes. In secondary analysis, we examined differences in baseline variables between women with and without diabetes. Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up.
RESULTS


Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes. At 2 year follow-up, a greater proportion of women with (vs. without) diabetes reported receiving advice by a doctor/health professional to improve their diet (73% vs. 57%, p = .04,). Predictors of receiving dietary advice were obesity, diabetes, and breast-conserving surgery (each p < .05). Women receiving dietary advice were 2.75 times more likely to report improving their diet (95% confidence interval: 1.17, 6.46) at follow-up, but receiving physical activity advice was not significantly associated with patients reporting an increase in exercise.
CONCLUSIONS


Although receiving dietary advice predicted dietary improvements, receiving exercise advice did not lead to an increase in physical activity.
CLINICAL TRIAL REGISTRATION


Trial Number NCT00929084.",2021,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up.
","['Of 193 patients included (85% of 228 enrolled), 53 (28%) had diabetes', 'newly diagnosed African American breast cancer patients (Stages 0-III', 'African American Women', 'women with and without diabetes', 'breast cancer patients']","['interactive, cancer-communication video program', 'African American breast cancer survivor stories']","['physical activity', 'quality-of-life outcomes', 'obesity, diabetes, and breast-conserving surgery', 'physical activity advice', 'Lifestyle Behaviors', 'exercise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",228.0,0.0709718,"Logistic regression models identified independent predictors of receiving advice from ""a doctor or other health professional"" to improve diet and exercise and of self-reported change in diet and exercise habits at 2 year follow-up.
","[{'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'Jarvandi', 'Affiliation': 'Department of Family and Consumer Sciences, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pérez', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Margenthaler', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kreuter', 'Affiliation': 'Brown School of Social Work, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa020']
36,32302709,Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease.,"BACKGROUND & AIMS


Dietary therapies based on exclusion of usual dietary elements induce remission in children with Crohn's disease (CD), whereas re-exposure induces rebound inflammation. We investigated whether a short trial of dietary therapy, to identify patients with and without a rapid response or remission on the diet (DiRe), can be used to predict success or failure of long-term dietary therapy.
METHODS


We collected data from the multicenter randomized trial of the CD exclusion diet (CDED). We analyzed data from 73 children with mild to moderate CD (mean age, 14.2 ± 2.7 y) randomly assigned to groups given either exclusive enteral nutrition (EEN, n = 34) or the CDED with 50% (partial) enteral nutrition (n = 39). Patients were examined at baseline and at weeks 3 and 6 of the diet. Remission was defined as CD activity index scores below 10 and response was defined as a decrease in score of 12.5 points or clinical remission. Inflammation was assessed by measurement of C-reactive protein.
RESULTS


At week 3 of the diet, 82% of patients in the CDED group and 85% of patients in the EEN group had a DiRe. Median serum levels of C-reactive protein had decreased from 24 mg/L at baseline to 5.0 mg/L at week 3 (P < .001). Among the 49 patients in remission at week 6, 46 patients (94%) had a DiRe and 81% were in clinical remission by week 3. In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P = .008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P = .006).
CONCLUSIONS


For pediatric patients with active CD, dietary therapies (CDED and EEN) induce a rapid clinical response (by week 3). Identification of patients with and without a rapid response to diet might help identify those who, with compliance, will be in clinical remission by week 6 of the diet. ClinicalTrials.gov no: NCT01728870.",2020,"In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P=.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P=.006).
","[""children with Crohn's disease (CD"", 'pediatric patients with active CD', '73 children with mild to moderate CD (mean age, 14.2±2.7 y', 'patients with and without a rapid response or remission on the diet (DiRe', ""Pediatric Patients With Active Crohn's Disease""]","['dietary therapy', 'CD exclusion diet (CDED', 'dietary therapies (CDED and EEN', 'exclusive enteral nutrition (EEN, n=34) or the CDED with 50% (partial) enteral nutrition']","['Inflammation', 'Median serum levels of C-reactive protein', 'CD activity index scores', 'clinical remission', 'DiRe']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",73.0,0.0844188,"In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6-25; P=.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012-0.46; P=.006).
","[{'ForeName': 'Rotem', 'Initials': 'R', 'LastName': 'Sigall Boneh', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Limbergen', 'Affiliation': ""Emma Children's Hospital, Amsterdam University Medical Centers - location AMC, Amsterdam, the Netherlands.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Wine', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': 'The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel; Schneider Hospital, Petach Tikva, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': 'Meyer Hospital, Haifa, Israel.'}, {'ForeName': 'Peri', 'Initials': 'P', 'LastName': 'Milman', 'Affiliation': 'Hadassah Hospital, Jerusalem, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': '""Dana-Dwek"" Children\'s Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kori', 'Affiliation': 'Kaplan Hospital, Rehovot, Israel.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Peleg', 'Affiliation': 'HaEmek Hospital, Afula, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'On', 'Affiliation': 'Poriah Hospital, Tiberias, Israel.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Shamaly', 'Affiliation': 'French Hospital, Nazareth, Israel.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Abramas', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: arie.levine.dr@gmail.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.006']
37,32276301,"A double-blind, randomized, placebo-controlled trial of adjunctive blue-blocking glasses for the treatment of sleep and circadian rhythm in patients with bipolar disorder.","OBJECTIVES


Recent studies have suggested that evening blue light exposure is associated with sleep and circadian rhythm abnormalities. This study examined the effect of blue-blocking (BB) glasses on sleep and circadian rhythm in patients with bipolar disorder (BD).
METHODS


We used a randomized, placebo-controlled, double-blinded design. Outpatients with BD and also with insomnia were randomly assigned to wear either orange glasses (BB) or clear ones (placebo) and were instructed to use these from 20:00 hours until bedtime for 2 weeks. The primary outcome metric was the difference in change from baseline to after intervention in sleep quality, as measured by the visual analog scale (VAS).
RESULTS


Forty-three patients were included in this study (BB group, 21; placebo group, 22). The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = .13). However, the Morningness-Eveningness Questionnaire score had shifted to an advanced rhythm in the BB group and to a delayed rhythm in the placebo group, and the difference in these changes was statistically significant (95% CI, 1.69-7.45; P = .003). The change in the actigraphy sleep parameters and mood symptoms was not significantly different between the two groups.
CONCLUSION


Although concurrent medications may have influenced, our results suggest that BB glasses may be useful as an adjunctive treatment for circadian rhythm issues in patients with BD.",2020,"The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = 0.13).","['Forty-three patients were included in this study (BB group, 21; placebo group, 22', 'Outpatients with BD and also with insomnia', 'patients with BD', 'patients with bipolar disorder (BD', 'patients with bipolar disorder']","['adjunctive blue-blocking glasses', 'blue-blocking (BB) glasses', 'orange glasses (BB) or clear ones (placebo', 'placebo']","['sleep and circadian rhythm', 'advanced rhythm', 'sleep quality, as measured by the visual analog scale (VAS', 'VAS metric', 'actigraphy sleep parameters and mood symptoms', 'sleep quality', 'Morningness-Eveningness Questionnaire score']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.607403,"The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = 0.13).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Esaki', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Ipei', 'Initials': 'I', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Soji', 'Initials': 'S', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kitajima', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Aichi, Japan.'}]",Bipolar disorders,['10.1111/bdi.12912']
38,32165263,Processing speed and attention training modifies autonomic flexibility: A mechanistic intervention study.,"Adaptation capacity is critical for maintaining cognition, yet it is understudied in groups at risk for dementia. Autonomic nervous system (ANS) is critical for neurovisceral integration and is a key contributor to adaptation capacity. To determine the central nervous system's top-down regulation of ANS, we conducted a mechanistic randomized controlled trial study, using a 6-week processing speed and attention (PS/A)-targeted intervention. Eighty-four older adults with amnestic mild cognitive impairment (aMCI) were randomized to a 6-week PS/A-targeted intervention or an active control without PS/A. Utilizing repeated measures (i.e., PS/A test different from the intervention, resting and cognitive task-based ECG, and resting fMRI) at baseline, immediately post-intervention (post-test), and 6-month follow-up, we aimed to test whether PS/A causally influences vagal control of ANS via their shared central neural pathways in aMCI. We indexed vagal control of ANS using high-frequency heart rate variability (HF-HRV) extracted from ECG data. Functional brain connectivity patterns were extracted from fMRI using advanced statistical tools. Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up. Changes in PS/A and SN connectivity significantly predicted change in HF-HRV from baseline to post-test and/or 6-month-follow-up. Age, neurodegeneration, nor sex did not affect these relationships. This work provides novel support for top-down regulation of PS/A and associated SN on vagal control of ANS. Intervening PS/A may be a viable approach for promoting adaptation capacity in groups at risk for dementia.",2020,"Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up.",['Eighty-four older adults with amnestic mild cognitive impairment (aMCI'],"['6-week PS/A-targeted intervention or an active control without PS/A. Utilizing repeated measures (i.e., PS/A test different from the intervention, resting and cognitive task-based ECG, and resting fMRI', 'Processing speed and attention training', '6-week processing speed and attention (PS/A)-targeted intervention']","['SN, CEN, and FPN', 'HF-HRV', 'PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}]",84.0,0.0735346,"Compared to the control group, the intervention group showed significant improvement in PS/A, HF-HRV, salience network (SN), central executive network (CEN), and frontal parietal network (FPN) connectivity at post-test; the effect on SN, CEN, and FPN remained at 6-month follow-up.","[{'ForeName': 'Feng V', 'Initials': 'FV', 'LastName': 'Lin', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Department of Brain and Cognitive Sciences, University of Rochester, USA; Department of Neuroscience, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Department of Neurology, School of Medicine and Dentistry, University of Rochester Medical Center, USA. Electronic address: FengVankee_Lin@urmc.rochester.edu.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Electrical and Computational Engineering, University of Rochester, USA.'}, {'ForeName': 'Quanjing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Anthony', 'Affiliation': 'Department of Brain and Cognitive Sciences, University of Rochester, USA.'}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatics and Computational Biology, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Duje', 'Initials': 'D', 'LastName': 'Tadin', 'Affiliation': 'Department of Brain and Cognitive Sciences, University of Rochester, USA; Department of Neuroscience, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}, {'ForeName': 'Kathi L', 'Initials': 'KL', 'LastName': 'Heffner', 'Affiliation': 'Elaine C. Hubbard Center for Nursing Research on Aging, School of Nursing, University of Rochester Medical Center, USA; Department of Psychiatry, School of Medicine and Dentistry, University of Rochester Medical Center, USA; Division of Geriatrics & Aging, Department of Medicine, School of Medicine and Dentistry, University of Rochester Medical Center, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116730']
39,32034024,Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.,"BACKGROUND


Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties.
OBJECTIVE


Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention.
DESIGN


Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates.
SETTINGS


Two National Health Service health trusts and local authority children's social care.
PARTICIPANTS


Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties.
INTERVENTION


HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session.
OUTCOMES


Primary feasibility outcome: participant retention rate.
SECONDARY OUTCOMES


(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory).
SECONDARY OUTCOMES


child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation.
RESULTS


Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3).
CONCLUSION


HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported.
TRIAL REGISTRATION NUMBER


ISRCTN14573230.",2020,"No serious adverse events reported.
","['parents affected by severe personality difficulties', ""Two National Health Service health trusts and local authority children's social care"", 'child mental health', 'Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent', 'Child', '48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later']","[' 16-session home-based intervention using parenting and therapeutic engagement strategies', 'Specialist parenting intervention', 'Helping Families Programme-Modified (HFP-M', 'HFP-M', 'helping families programme-modified', 'Usual care: standard care augmented by single psychoeducational parenting session', 'intensive parenting intervention']","['coexistent parenting and child mental health difficulties', 'child behaviour (Eyberg Child Behaviour Inventory', ""Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27"", 'participant retention rate', 'i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised', 'alliance rating']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0222045'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",48.0,0.165181,"No serious adverse events reported.
","[{'ForeName': 'Crispin', 'Initials': 'C', 'LastName': 'Day', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK crispin.1.day@kcl.ac.uk.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Briskman', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mike J', 'Initials': 'MJ', 'LastName': 'Crawford', 'Affiliation': 'The Centre for Psychiatry, Imperial College, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Foote', 'Affiliation': 'McPin Foundation, London, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Harris', 'Affiliation': 'Centre for Parent and Child Support, South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Boadu', 'Affiliation': ""King's Health Economics, P024 David Goldberg Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's Health Economics, P024 David Goldberg Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McMurran', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Moran', 'Affiliation': 'Department of Population Health Sciences, Centre for Academic Mental Health, University of Bristol, Bristol, UK.'}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Mosse', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ramchandani', 'Affiliation': 'Faculty of Education, PEDAL Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Department of Mental Health, Middlesex University, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033637']
40,32299114,Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial.,"BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS:  171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %;  P  = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %;  P  = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively ( P  = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.",2020,"EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.","['171 patients with large CBD stones', '19 Japanese institutions', 'bile duct stones']","['EST', 'endoscopic sphincterotomy (EST), EPLBD alone without EST', 'EPLBD alone versus EST', 'Endoscopic papillary large balloon dilation (EPLBD', 'EPLBD', 'endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy']","['overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost', 'adverse events', 'pancreatitis', 'rates of overall adverse events', 'procedure costs', 'Lithotripsy use', 'rate of complete stone removal', 'efficacy and safety', 'complete stone removal', 'rates of early adverse events', 'rate of single-session complete stone removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009438', 'cui_str': 'Common bile duct calculus'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct'}]","[{'cui': 'C0085263', 'cui_str': 'Endoscopic Sphincterotomy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]",171.0,0.104249,"EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kogure', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kawahata', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Tesshin', 'Initials': 'T', 'LastName': 'Ban', 'Affiliation': 'Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sasahira', 'Affiliation': 'Department of Gastroenterology, Tokyo Takanawa Hospital of Japan Community Health-care Organization, Tokyo, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Division of Gastroenterology, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Hironari', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Okabe', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University of Medicine, Kurume, Japan.'}, {'ForeName': 'Saburo', 'Initials': 'S', 'LastName': 'Matsubara', 'Affiliation': 'Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yagioka', 'Affiliation': 'Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isayama', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Endoscopy,['10.1055/a-1145-3377']
41,32281592,The efficacy of pulsed radiofrequency intervention of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain.,"INTRODUCTION


In recent years, pulsed radiofrequency (PR) has been used as a minimally invasive pain intervention. However, various studies on the efficacy of PR as modalities for the treatment of radicular pain in lumbar disc herniation have had varied results.
OBJECTIVE


This study aims to determine the efficacy of PR in reducing radicular pain among lumbar disc herniation patients compared with conservative treatment.
METHODS


This study was conducted using the before-andafter quasi experimental design. There were 50 subjects that fulfilled the inclusion and exclusion criteria and they were divided into an intervention group (n=25) and control group (n=25). The intervention group was given once PR in the dorsal root ganglion. All subjects were assessed for Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) before treatment, at 1- , 2- and 4-week after treatment.
RESULTS


At1-, 2- and 4-week, the VAS reduction in the intervention group was statistically significant compared to the control group. Four weeks after the intervention, the VAS score decreased in the intervention group (mean VAS -78.5, SD 16.8) more significantly compared to the control group (p<0.001). The ODI score decreased in the intervention group (mean ODI -61.8, SD 20.1) more significantly than in the control group (p<0.001).
CONCLUSION


Finding showed that at1- , 2- and 4-weekPR was more efficacious in reducing radicular pain among lumbar disc herniation patients compared to the conservative therapy.",2020,"The ODI score decreased in the intervention group (mean ODI -61.8, SD 20.1) more significantly than in the control group (p<0.001).
","['lumbar disc herniation patients', 'lumbar disc herniation patients compared with conservative treatment', 'patients with chronic lumbar radicular pain', '50 subjects that fulfilled the inclusion and exclusion criteria and they were divided into an intervention group (n=25) and control group (n=25']","['pulsed radiofrequency (PR', 'PR', 'pulsed radiofrequency intervention', 'lumbar dorsal root ganglion']","['VAS reduction', 'VAS score', 'ODI score', 'Visual Analog Scale (VAS) and Oswestry Disability Index (ODI', 'radicular pain']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0457468', 'cui_str': 'Lumbar spinal ganglion'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}]",50.0,0.0162488,"The ODI score decreased in the intervention group (mean ODI -61.8, SD 20.1) more significantly than in the control group (p<0.001).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marliana', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yudianta', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Subagya', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Setyopranoto', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Setyaningsih', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tursina Srie', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Setyawan', 'Affiliation': 'Universitas Gadjah Mada, Faculty of Medicine, Public Health, and Nursing, Yogyakarta, Indonesia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rhatomy', 'Affiliation': 'Dr. Soeradji Tirtonegoro General Hospital, Department of Orthopaedics and Traumatology, Klaten, Indonesia. sholahuddin.rhatomy@mail.ugm.ac.id.'}]",The Medical journal of Malaysia,[]
42,32289853,"A prospective, randomized trial of thrombin versus cyanoacrylate injection in the control of acute gastric variceal hemorrhage.","BACKGROUND


Acute gastric variceal hemorrhage (AGVH) is a serious complication of portal hypertension. Endoscopic cyanoacrylate glue injection is standard therapy for acute hemostasis; however, it may be associated with serious complications. The role of thrombin injection has not been confirmed. This study compared endoscopic thrombin and glue injections in the hemostasis of AGVH.
METHODS


68 eligible patients with AGVH were randomized to receive thrombin injection (33 patients) or glue injection (35 patients). The primary end point was injection-induced gastric ulcers. Secondary end points were acute hemostasis, rebleeding, and mortality within 42 days.
RESULTS


Both groups had comparable baseline data. Hemostasis of active bleeding at endoscopy was 90.0 % (9/10) in the thrombin group and 90.9 % (10/11) in the glue group ( P  = 0.58), and 48-hour hemostasis was achieved in 93.9 % (31/33) and 97.1 % (34/35), respectively ( P  = 0.60). Treatment failure at 5 days occurred in two patients (6.1 %) in the thrombin group and two patients (5.7 %) in the glue group ( P  > 0.99). Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %). Complications occurred in 4 (12.1 %) and 18 (51.4 %) patients in the thrombin and glue groups, respectively ( P  < 0.001, 95 %CI 22 % - 45 %). Two patients who received glue had post-treatment gastric ulcer bleeding. One patient in each group died.
CONCLUSIONS


Endoscopic thrombin injection was similar to glue injection in achieving successful hemostasis of AGVH. However, a higher incidence of complications may be associated with glue injection.",2020,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","['acute gastric variceal hemorrhage', 'acute hemostasis', 'Acute gastric variceal hemorrhage (AGVH', 'Two patients who received glue had post-treatment gastric ulcer bleeding', '68 eligible patients with AGVH']","['glue injection', 'cyanoacrylate injection', 'thrombin', 'Endoscopic cyanoacrylate glue injection', 'Endoscopic thrombin injection', 'endoscopic thrombin and glue injections', 'thrombin injection']","['Treatment failure', '48-hour hemostasis', 'acute hemostasis, rebleeding, and mortality within 42 days', 'Complications', 'Gastric ulcers', 'injection-induced gastric ulcers', 'Hemostasis of active bleeding at endoscopy']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0333106', 'cui_str': 'Bleeding varices'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}]","[{'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",68.0,0.126385,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P  < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","[{'ForeName': 'Gin-Ho', 'Initials': 'GH', 'LastName': 'Lo', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chih-Wen', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Ming', 'Initials': 'CM', 'LastName': 'Tai', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Daw-Shyong', 'Initials': 'DS', 'LastName': 'Perng', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'I-Lin', 'Initials': 'IL', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jen-Hao', 'Initials': 'JH', 'LastName': 'Yeh', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}]",Endoscopy,['10.1055/a-1127-3170']
43,32108492,A prospective clinical trial of the effects produced by the Connecticut intrusion arch on the maxillary dental arch.,"OBJECTIVE


To assess and compare the effects produced in the maxillary dental arch by means of Connecticut intrusion arch (CIA) with or without a cinch back on the distal end of the tube of the first molars.
MATERIALS AND METHODS


This study included 44 patients with a mean age of 13.1 ± 1.8 years treated for deep bite with a CIA randomly divided into two groups: group 1 (G1), 22 patients with initial mean age of 12.72 ± 1.74 years treated with the CIA in the upper arch without a cinch back on the distal surface of the tube of the first molars, and group 2 (G2), 22 patients with an initial mean age of 13.67 ± 2.03 years treated with the CIA with a cinch back. Lateral cephalograms were available before treatment (T1) and after intrusion of maxillary incisors (T2). The mean treatment period was 5.5 ± 1.45 months. Intragroup and intergroup changes in the maxillary incisor and molar positions were analyzed by paired and independent  t -tests associated with the Holm-Bonferroni correction method for multiple comparisons ( P  < .05).
RESULTS


There were significant differences between groups in terms of maxillary incisor displacement. The maxillary incisors flared labially (2.17°) and proclined (1.68 mm) in group 1, whereas a palatal inclination (-1.99°) and retroclination (-1.13 mm) was observed in group 2. No significant differences were found for the molar positions between the groups.
CONCLUSIONS


The presence or absence of a distal bend in CIA affects incisor tipping and proclination during intrusion mechanics.",2020,There were significant differences between groups in terms of maxillary incisor displacement.,"['44 patients with a mean age of 13.1 ± 1.8 years treated for deep bite with a CIA randomly divided into two groups: group 1 (G1), 22 patients with initial mean age of 12.72 ± 1.74 years treated with the CIA in the upper arch without a cinch back on the distal surface of the tube of the first molars, and group 2 (G2), 22 patients with an initial mean age of 13.67 ± 2.03 years treated with the CIA with a cinch back']",[],"['maxillary incisor displacement', 'maxillary incisors flared labially', 'maxillary incisor and molar positions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1305740', 'cui_str': 'Over Bite'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0184987', 'cui_str': 'Plastic repair with shortening (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]",[],"[{'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",44.0,0.0156133,There were significant differences between groups in terms of maxillary incisor displacement.,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Schwertner', 'Affiliation': ''}, {'ForeName': 'Renato Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida', 'Affiliation': ''}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida-Pedrin', 'Affiliation': ''}, {'ForeName': 'Thais Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Oltramari', 'Affiliation': ''}, {'ForeName': 'Marcio Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/102219-666.1']
44,32078168,"The effect of sleep restriction, with or without high-intensity interval exercise, on myofibrillar protein synthesis in healthy young men.","KEY POINTS


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


The present study aimed to investigate the effect of sleep restriction, with or without high-intensity interval exercise (HIIE), on the potential mechanisms underpinning previously-reported sleep-loss-induced reductions to muscle mass. Twenty-four healthy, young men underwent a protocol consisting of two nights of controlled baseline sleep and a five-night intervention period. Participants were allocated into one of three parallel groups, matched for age,    V   ̇   O   2     peak        , body mass index and habitual sleep duration; a normal sleep (NS) group [8 h time in bed (TIB) each night], a sleep restriction (SR) group (4 h TIB each night), and a sleep restriction and exercise group (SR+EX, 4 h TIB each night, with three sessions of HIIE). Deuterium oxide was ingested prior to commencing the study and muscle biopsies obtained pre- and post-intervention were used to assess myofibrillar protein synthesis (MyoPS) and molecular markers of protein synthesis and degradation signalling pathways. MyoPS was lower in the SR group [fractional synthetic rate (% day -1  ), mean ± SD, 1.24 ± 0.21] compared to both the NS (1.53 ± 0.09) and SR+EX groups (1.61 ± 0.14) (P < 0.05). However, there were no changes in the purported regulators of protein synthesis (i.e. p-AKT ser473  and p-mTOR ser2448  ) and degradation (i.e. Foxo1/3 mRNA and LC3 protein) in any group. These data suggest that MyoPS is acutely reduced by sleep restriction, although MyoPS can be maintained by performing HIIE. These findings may explain the sleep-loss-induced reductions in muscle mass previously reported and also highlight the potential therapeutic benefit of HIIE to maintain myofibrillar remodelling in this context.",2020,MyoPS was lower in the SR group (FSR %,"['participants undergoing a', 'healthy young men', 'Twenty-four healthy, young men']","['sleep restriction, with or without high-intensity interval exercise (HIIE', 'Deuterium Oxide (D 2  O', 'sleep restriction protocol', 'MyoPS', 'normal sleep group (NS, 8\xa0h time in bed (TIB) each night), a sleep restriction group (SR, 4\xa0h TIB each night), and a sleep restriction and exercise group (SR+EX, 4\xa0h TIB each night, with three sessions of HIIE', 'sleep restriction, with or without high-intensity interval exercise']","['rates of MyoPS', 'rate of myofibrillar protein synthesis (MyoPS', 'MyoPS', 'rates of skeletal muscle MyoPS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}]",24.0,0.0152582,MyoPS was lower in the SR group (FSR %,"[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Matthew J-C', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Pitchford', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioural Science, Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Bartlett', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",The Journal of physiology,['10.1113/JP278828']
45,32289474,"5-Year Update of a Multi-Institution, Prospective Phase 2 Hypofractionated Postmastectomy Radiation Therapy Trial.","PURPOSE


Hypofractionation in the setting of postmastectomy radiation (PMRT) is not currently the standard of care in most countries. Here we present a 5-year update of our multi-institutional, phase 2 prospective trial evaluating a novel 15-day hypofractionated PMRT regimen.
METHODS AND MATERIALS


Patients were enrolled to receive 3.33 Gy daily to the chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4-fraction mastectomy scar boost. The primary endpoint was freedom from grade 3 or higher late non-reconstruction-related radiation toxicities. Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0. Secondary endpoints included local and locoregional recurrence rates, cosmesis, and reconstruction complications.
RESULTS


After enrolling 69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis. At a median follow up of 54 months, there were no acute or late grade 3 and 4 nonreconstruction reported toxicities. The grade 2 or greater late toxicity rate was only 12% and comprised grade 2 pain, fatigue, and lymphedema that persisted beyond 6 months after completion of radiation therapy. Only 3 women (4.6%) experienced a chest wall or nodal recurrence as a first site of relapse. Freedom from local failure, including local failure after distant relapse, was 92% at 5 years, and the 5-year overall survival was 90%.
CONCLUSIONS


This is the first prospective trial conducted in the United States to demonstrate the safe and effective use of hypofractionated PMRT. We have demonstrated a low complication rate while achieving excellent local control. Toxicity was better than anticipated based on previously published series of PMRT toxicities. Although our fractionation was novel, the radiobiological equivalent dose is similar to other hypofractionation schedules. This trial was the basis for the creation of Alliance A221505 (RT CHARM), which is currently accruing patients in a phase 3 randomized design.",2020,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%.
","['Patients were enrolled to receive 3.33 Gray (Gy) daily to the', '69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis']","['post mastectomy radiation (PMRT', 'chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4 fraction mastectomy scar boost', 'Alliance Axxxxx (xxxxx', 'hypofractionated PMRT']","['late toxicity rate', 'low complication rate', 'toxicities', 'local failure after distant relapse', 'chest wall or nodal recurrence', 'Toxicities', 'Toxicity', 'freedom from grade 3 or higher late non-reconstruction related radiation toxicities', 'pain, fatigue and lymphedema', 'local and locoregional recurrence rates, cosmesis and reconstruction complications', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517690', 'cui_str': '3.33'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",69.0,0.105768,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%.
","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Poppe', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah. Electronic address: matthew.poppe@hci.utah.edu.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Yehia', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.020']
46,32235930,Effects of underfeeding and oral vancomycin on gut microbiome and nutrient absorption in humans.,"Direct evidence in humans for the impact of the microbiome on nutrient absorption is lacking. We conducted an extended inpatient study using two interventions that we hypothesized would alter the gut microbiome and nutrient absorption. In each, stool calorie loss, a direct proxy of nutrient absorption, was measured. The first phase was a randomized cross-over dietary intervention in which all participants underwent in random order 3 d of over- and underfeeding. The second was a randomized, double-blind, placebo-controlled pharmacologic intervention using oral vancomycin or matching placebo (NCT02037295). Twenty-seven volunteers (17 men and 10 women, age 35.1 ± 7.3, BMI 32.3 ± 8.0), who were healthy other than having impaired glucose tolerance and obesity, were enrolled and 25 completed the entire trial. The primary endpoints were the effects of dietary and pharmacological intervention on stool calorie loss. We hypothesized that stool calories expressed as percentage of caloric intake would increase with underfeeding compared with overfeeding and increase during oral vancomycin treatment. Both primary endpoints were met. Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo. Key secondary endpoints were to evaluate the changes in gut microbial community structure as evidenced by amplicon sequencing and metagenomics. We observed only a modest perturbation of gut microbial community structure with under- versus overfeeding but a more widespread change in community structure with reduced diversity with oral vancomycin. Increase in Akkermansia muciniphila was common to both interventions that resulted in greater stool calorie loss. These results indicate that nutrient absorption is sensitive to environmental perturbations and support the translational relevance of preclinical models demonstrating a possible causal role for the gut microbiome in dietary energy harvest.",2020,Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo.,"['humans', 'Twenty-seven volunteers (17 men and 10 women, age 35.1\u2009±\u20097.3, BMI 32.3\u2009±\u20098.0), who were healthy other than having impaired glucose tolerance and obesity, were enrolled and 25 completed the entire trial']","['placebo', 'underfeeding and oral vancomycin', 'dietary and pharmacological intervention', 'vancomycin or matching placebo', 'vancomycin', 'dietary intervention']","['gut microbiome and nutrient absorption', 'gut microbial community structure as evidenced by amplicon sequencing and metagenomics', 'stool calorie loss', 'caloric intake']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C4704957', 'cui_str': 'Microbial Community Structure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",27.0,0.138031,Greater stool calorie loss was observed during underfeeding relative to overfeeding and during vancomycin treatment compared with placebo.,"[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Basolo', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA. alessio.basolo@nih.gov.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Hohenadel', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Qi Yan', 'Initials': 'QY', 'LastName': 'Ang', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Heinitz', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Clinical Mass Spectrometry Core, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Parrington', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA.'}, {'ForeName': 'Donovan D', 'Initials': 'DD', 'LastName': 'Trinidad', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Reiner Jumpertz', 'Initials': 'RJ', 'LastName': 'von Schwartzenberg', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Turnbaugh', 'Affiliation': 'Department of Microbiology and Immunology, University of California, San Francisco, CA, USA. peter.turnbaugh@ucsf.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ, USA. jkrakoff@mail.nih.gov.'}]",Nature medicine,['10.1038/s41591-020-0801-z']
47,32286906,Effects of Brief Nurse Advance Care Planning Intervention with Visual Materials on Goal-of-Care Preference of Japanese Elderly Patients with Chronic Disease: A Pilot Randomized-Controlled Trial.,"Purpose:  Advance care planning is an important component of quality palliative care. In Asian countries, few randomized clinical trials have been reported. This pilot randomized-controlled trial examined the effects of brief nurse intervention with visual materials on the goal-of-care preference, cardiopulmonary resuscitation (CPR) preference, and designation of a health care proxy.  Methods:  This randomized clinical trial was performed from January to February 2018 on elderly Japanese patients with chronic disease. The patients were randomly assigned to a control group (brief nurse intervention using verbal descriptions) or intervention group (using visual materials). The primary endpoint was goal-of-care preference, and secondary outcomes included the following: (1) CPR preference, (2) presence of a designated health care proxy, (3) knowledge of CPR, and (4) readiness for advance care planning. Outcome measures were obtained at baseline and just after completion of the intervention.  Results:  A total of 220 patients were enrolled (117 in the intervention group and 103 in the control group). All patients completed post-intervention measurement. There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline. Before/after comparisons indicated that, in both groups, the number of participants who designated a health care proxy significantly increased (29% to 65% vs. 22% to 52%, respectively;  p  < 0.001 each); and the knowledge and readiness scores significantly increased. Moreover, there was a significant increase in the number of patients who did not want CPR (55% to 67% with a terminal condition,  p  = 0.003; 67% to 80% with a bedridden condition,  p  < 0.001) in the intervention group.  Conclusions:  Brief nurse intervention increased documentation of a patient-designated health care proxy and improved the knowledge of CPR and patient readiness. Visual materials might help patients to imagine the actual situation regarding CPR.",2020,"There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline.","['January to February 2018 on elderly Japanese patients with chronic disease', '220 patients were enrolled (117 in the intervention group and 103 in the control group', 'Japanese Elderly Patients with Chronic Disease']","['nurse intervention with visual materials', 'control group (brief nurse intervention using verbal descriptions) or intervention group (using visual materials', 'Brief Nurse Advance Care Planning Intervention with Visual Materials']","['knowledge and readiness scores', 'Goal-of-Care Preference', 'goal-of-care preference, and secondary outcomes included the following: (1) CPR preference, (2) presence of a designated health care proxy, (3) knowledge of CPR, and (4) readiness for advance care planning', 'health care proxy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0303409', 'cui_str': 'Indium-117'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",220.0,0.0471153,"There was no significant difference between the groups in any of the outcome measures, while <5% of the participants wanted life-prolonging care as the goal of care at the baseline.","[{'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kizawa', 'Affiliation': 'Department of Palliative Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Department of Palliative and Supportive Care, Palliative Care Team, Seirei Mikatahara General Hospital, Shizuoka, Japan.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0512']
48,32184121,Cetuximab and Radiation Therapy Versus Cisplatin and Radiation Therapy for Locally Advanced Head and Neck Cancer: Long-Term Survival and Toxicity Outcomes of a Randomized Phase 2 Trial.,"PURPOSE


This study describes the long-term survival and toxicity outcomes of a multicenter randomized phase 2 trial comparing radiation therapy (RT) plus cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced head and neck cancer (LASCCHN).
METHODS AND MATERIALS


Between January 2011 and August 2014, 70 patients were enrolled and randomized to receive RT plus weekly CDDP (40 mg/m 2 ) or CTX (250 mg/m 2  plus a loading dose of 400 mg/m 2 ). This updated series focuses on late toxicities (graded by using Common Terminology Criteria for Adverse Events version 4.0) and long-term survival outcomes in terms of local control, overall survival, cancer-specific survival, and metastasis-free survival (MFS). A supplementary analysis based on human papilloma virus (HPV) status was also performed.
RESULTS


No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss). In the CDDP arm and the CTX arm, 5-year local control rates were 67% and 48%; 5-year MFS rates were 83% and 97%; 5-year overall survival rates were 61% and 52%; and 5-year cancer-specific survival rates were 70% and 59%, respectively. None of these differences reached statistical significance. A subgroup analysis by HPV status and anatomic subsites revealed that in HPV+ oropharyngeal carcinoma, better survival was obtained in the CDDP arm (although statistical tests were not performed owing to the small sample size). Conversely, no statistically significant differences were observed in HPV- oropharyngeal carcinoma and other anatomic subsites, except for the confirmed better MFS rates of the CTX arm.
CONCLUSIONS


Long-term results are in line with current literature suggesting that RT + CTX is inferior to RT + CDDP for the definitive treatment of LASCCHN. However, if not as an alternative to CDDP, CTX might still play a role in LASCCHN, particularly in HPV- cases.",2020,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","['ADVANCED HEAD AND NECK CANCER', 'Between January 2011 and August 2014, 70 patients', 'locally advanced head and neck cancer (LASCCHN']","['RT + CTX', 'radiotherapy (RT) plus cisplatin (CDDP) or cetuximab (CTX', 'CTX', 'RT plus weekly CDDP']","['5-year LC rates', 'late effects (xerostomia, fibrosis, mucosal atrophy, weight loss', '5-year CSS rates', 'HPV- OPC', '5-years OS rates', 'local control (LC), overall survival (OS), cancer-specific survival (CSS) and metastasis free survival (MFS', '5-year MFS rates', 'late toxicities', 'MFS rates', 'HPV+ oropharyngeal carcinoma (OPC) better survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1368999', 'cui_str': 'Late effect of'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2242595', 'cui_str': 'Mucosal atrophy'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",70.0,0.184636,"no statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss).","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maddalo', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Borghetti', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Tomasini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy. Electronic address: tomad88@libero.it.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Corvò', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Bonomo', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Petrucci', 'Affiliation': 'Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Paiar', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliera Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Lastrucci', 'Affiliation': 'S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo, Italy.'}, {'ForeName': 'Marco Lorenzo', 'Initials': 'ML', 'LastName': 'Bonù', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Greco', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Ludovica', 'Initials': 'L', 'LastName': 'Pegurri', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Triggiani', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Belgioia', 'Affiliation': 'Health Science Department (DISSAL) University of Genova, Genova - Radiation Oncology Department IRCCS San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Isacco', 'Initials': 'I', 'LastName': 'Desideri', 'Affiliation': 'Department of Radiation Oncology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grisanti', 'Affiliation': 'Medical Oncology ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Buglione', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}, {'ForeName': 'Stefano Maria', 'Initials': 'SM', 'LastName': 'Magrini', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - Brescia University, Brescia, Italy.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.02.637']
49,29655627,Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection.,"BACKGROUND


The single-dose live attenuated vaccine CVD 103-HgR protects against experimental Vibrio cholerae infection in cholera-naïve adults for at least 6 months after vaccination. While vaccine-induced vibriocidal seroconversion is associated with protection, vibriocidal titers decline rapidly from their peak 1-2 weeks after vaccination. Although vaccine-induced memory B cells (MBCs) might mediate sustained protection in individuals without detectable circulating antibodies, it is unknown whether oral cholera vaccination induces a MBC response.
METHODS


In a study that enrolled North American adults, we measured lipopolysaccharide (LPS)- and cholera toxin (CtxB)-specific MBC responses to PXVX0200 (derived from the CVD 103-HgR strain) and assessed stool volumes following experimental Vibrio cholerae infection. We then evaluated the association between vaccine-induced MBC responses and protection against cholera.
RESULTS


There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
DISCUSSION


Oral cholera vaccination induces antigen-specific MBC responses, and the anamnestic LPS-specific responses may contribute to long-term protection and provide correlates of the duration of vaccine-induced protection.
CLINICAL TRIALS REGISTRATION


NCT01895855.",2018,"There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
",['enrolled North American adults'],"['vaccine-induced memory B cells (MBCs', 'Oral cholera vaccination']","['lipopolysaccharide (LPS)- and cholera toxin (CtxB)-specific MBC responses to PXVX0200', 'LPS-specific IgA MBCs and lower post-challenge stool volume', ' CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042199', 'cui_str': 'Cholera vaccination (procedure)'}]","[{'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",,0.229401,"There was a significant increase in % CT-specific IgG, % LPS-specific IgG, and % LPS-specific IgA MBCs which persisted 180 days after vaccination as well as a significant association between vaccine-induced increase in % LPS-specific IgA MBCs and lower post-challenge stool volume (r = -0.56, p < 0.001).
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Haney', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States. Electronic address: haney_doug@hotmail.com.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Lock', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gurwith', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Jakub K', 'Initials': 'JK', 'LastName': 'Simon', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Ishioka', 'Affiliation': 'PaxVax, Inc., Redwood City, CA, United States.'}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Cohen', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'Vaccine Testing Center, University of Vermont, College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Lyon', 'Affiliation': 'Vaccine Testing Center, University of Vermont, College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Wilbur H', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Sztein', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Myron M', 'Initials': 'MM', 'LastName': 'Levine', 'Affiliation': 'Center for Vaccine Development (CVD), University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Harris', 'Affiliation': 'Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States; Department of Pediatrics, Harvard Medical School, Cambridge, MA, United States. Electronic address: jbharris@mgh.harvard.edu.'}]",Vaccine,['10.1016/j.vaccine.2018.04.011']
50,32270208,Invited Response on: Mastopexy with Autologous Augmentation in Women After Massive Weight Loss-A Randomized Clinical Trial.,,2020,,['Women'],['Mastopexy with Autologous Augmentation'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0191918', 'cui_str': 'Fixation of pendulous breast'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],,0.0942726,,"[{'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Ikander', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark. peder.ikander@gmail.com.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Sørensen', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Jørn B', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01697-z']
51,30988483,A low-cost information nudge increases citizenship application rates among low-income immigrants.,"We show that an information nudge increased the rate of American citizenship applications among low-income immigrants eligible for a federal fee waiver. Approximately half of the 9 million naturalization-eligible immigrants qualify for a federal programme that waives the cost of the citizenship application for low-income individuals. However, take-up of this fee waiver programme remains low 1-3 . Here we use a randomized field experiment to test the effectiveness of a low-cost intervention (a 'nudge') that informed low-income immigrants about their eligibility for the fee waiver. We find that the information nudge increased the rate of citizenship applications by about 8.6 percentage points from 24.5% in the control group to 33.1% in the treatment group (ordinary least squares regression with robust standard errors (d.f. = 933); P = 0.015; 95% confidence interval ranged from 1.7 to 15.4 percentage points). We found no evidence that the nudge was less effective for poorer or less educated immigrants. These findings contribute to the literature that addresses the incomplete take-up of public benefits by low-income populations 4-10  and suggest that lack of information is an important obstacle to citizenship among low-income immigrants who demonstrate an interest in naturalization.",2019,We find that the information nudge increased the rate of citizenship applications by about 8.6 percentage points from 24.5% in the control group to 33.1% in the treatment group (ordinary least squares regression with robust standard errors (d.f. = 933); P = 0.015; 95% confidence interval ranged from 1.7 to 15.4 percentage points).,['low-income immigrants'],"[""low-cost intervention (a 'nudge""]","['rate of American citizenship applications', 'citizenship application rates', 'rate of citizenship applications']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",,0.0319214,We find that the information nudge increased the rate of citizenship applications by about 8.6 percentage points from 24.5% in the control group to 33.1% in the treatment group (ordinary least squares regression with robust standard errors (d.f. = 933); P = 0.015; 95% confidence interval ranged from 1.7 to 15.4 percentage points).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hotard', 'Affiliation': 'Immigration Policy Laboratory, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Immigration Policy Laboratory, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Laitin', 'Affiliation': 'Immigration Policy Laboratory, Stanford University, Stanford, CA, USA. dlaitin@stanford.edu.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hainmueller', 'Affiliation': 'Immigration Policy Laboratory, Stanford University, Stanford, CA, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0572-z']
52,32272243,Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension.,"BACKGROUND & AIMS


Quantification of eosinophilic esophagitis (EoE) symptoms is crucial for assessing treatment outcomes. We aimed to explore the effect of budesonide oral suspension (BOS) on dysphagia and pain with swallowing.
METHODS


We performed a secondary analysis of data from a phase 2 multicenter, double-blind, trial (conducted from July 2012 through October 2014) of patients with EoE, 11-40 y old, who were randomly assigned to groups given placebo or BOS (2.0 mg twice daily) for 12 weeks. Symptoms were quantified using the Dysphagia Symptom Questionnaire (DSQ) from baseline to week 12 of therapy.
RESULTS


Overall, 93 patients were randomly assigned to groups; the prespecified modified intention-to-treat analysis set comprised 87 patients (38 from the placebo group and 49 from the BOS group). Improvements from baseline in least-squares mean (standard error) DSQ (Q2+Q3) scores were observed. The difference between groups was statistically significant only at week 12 (placebo vs BOS: week 4, -4.9 [1.7] vs -7.4 [1.5]; P = .265; week 8, -7.4 [2.1] vs -10.3 [1.8]; P = .288; week 12, -7.5 [1.9] vs -14.3 [1.7]; P = .01). Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5 [0.8] vs -3.3 [0.7]; P = .484; week 8, -3.0 [0.8] vs -4.9 [0.7]; P = .066; week 12, -3.1 [0.8] vs -4.9 [0.7]; P = .109). More severe DSQ and DSQ+pain scores were associated with presence of other symptoms (such as regurgitation) and physician-rated severity. Improvements in DSQ and DSQ+pain scores were greater in patients with either a histologic or endoscopic response than in patients without a response.
CONCLUSIONS


In a secondary analysis of data from a phase 2 trial of patients with EoE, we found evidence for improvements in dysphagia and pain scores in patients who received BOS (2.0 mg twice daily) vs placebo. Pain with swallowing should be considered in the clinical assessment of patients with EoE. ClinicalTrials.gov no: NCT01642212.",2020,"Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5","['9[1.7', '93 patients', 'July 2012 through October 2014) of patients with EoE', '11-40 y old']","['placebo', 'Budesonide Oral Suspension', 'placebo or BOS', 'budesonide oral suspension (BOS', 'BOS']","['least-squares mean (standard error) DSQ (Q2+Q3) scores', 'dysphagia symptom questionnaire (DSQ', 'DSQ and DSQ+pain scores', 'pain (Q4) scores', 'dysphagia and pain scores', 'dysphagia and pain with swallowing', 'severe DSQ and DSQ+pain scores', 'Dysphagia and Pain With Swallowing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",93.0,0.454328,"Similar findings were observed for pain (Q4) scores (placebo vs BOS: week 4, -2.5","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Hudgens', 'Affiliation': 'Clinical Outcome Solutions, Tucson, Arizona.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Vera-Llonch', 'Affiliation': 'Shire, a Takeda company, Lexington, Massachusetts.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.060']
53,32267724,"Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin. A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial.","Rationale:  Chronic obstructive pulmonary disease (COPD) exacerbations are prone to nonrecovery, but there are no data about the effectiveness of retreatment for these prolonged events. We examined whether further therapy with ciprofloxacin for incompletely resolved COPD exacerbations prolonged the time until the next event. Objectives:  To assess whether incompletely recovered COPD exacerbations benefit from additional treatment with ciprofloxacin, at Day 14. Methods:  In a multicenter, randomized double-blind placebo-controlled trial, we studied retreatment with oral ciprofloxacin 500 mg or matched placebo twice daily for 7 days in patients with Global Initiative for Chronic Obstructive Lung Disease stage II-IV COPD and persistent symptoms and/or serum C-reactive protein ≥8 mg/L initiated 14 (±3) days after an index COPD exacerbation. The primary outcome was the time to the next exacerbation within a 90-day period. Measurements and Main Results:  Among 826 patients screened at four centers, 144 eligible participants with incomplete recovery were randomized to receive ciprofloxacin ( n  = 72) or placebo ( n  = 72). Within 90 days of randomization, 57% of the patients in the ciprofloxacin group and 53% in the placebo group experienced one or more exacerbations. The median time to the next exacerbation was 32.5 days (interquartile range 13-50) in the placebo arm and 34 days (interquartile range 17-62) in the ciprofloxacin arm, which was not significantly different (adjusted hazard ratio, 1.07; 95% confidence interval, 0.68-1.68;  P  = 0.76). No significant differences were seen in quality-of-life scores or lung function between the treatment groups. Conclusions:  In patients with persistent symptoms and/or raised C-reactive protein 14 days after a COPD exacerbation, an additional course of ciprofloxacin resulted in no additional benefit compared with placebo. This suggests that nonrecovered exacerbations are not driven by ongoing bacterial infection and may potentially be targeted with antiinflammatory therapy.Clinical trial registered with www.clinicaltrials.gov (NCT02300220).",2020,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","['826 patients screened at 4 centres', '144 eligible participants with incomplete recovery', 'patients with GOLD stage II - IV COPD with persistent symptoms and/or serum C-reactive protein (CRP']","['oral ciprofloxacin 500mg or matched placebo', 'placebo', 'Ciprofloxacin', 'ciprofloxacin', 'Placebo']","['exacerbations', 'median time to the next exacerbation', 'COPD Exacerbations', 'time to the next exacerbation within a 90-day period', 'quality of life scores or lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1123173', 'cui_str': 'Ciprofloxacin 500 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.771152,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","[{'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Ritchie', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Brill', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Vlies', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Finney', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Alves-Moreira', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Dexter J', 'Initials': 'DJ', 'LastName': 'Wiseman', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Walker', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ""Institute of Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Elkin', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallia', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Hub for Trials Methodology Research, Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Gavin C', 'Initials': 'GC', 'LastName': 'Donaldson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-2058OC']
54,31160812,Closed-loop digital meditation improves sustained attention in young adults.,"Attention is a fundamental cognitive process that is critical for essentially all aspects of higher-order cognition and real-world activities. Younger generations have deeply embraced information technology and multitasking in their personal lives, school and the workplace, creating myriad challenges to their attention. While improving sustained attention in healthy young adults would be beneficial, enhancing this ability has proven notoriously difficult in this age group. Here we show that 6 weeks of engagement with a meditation-inspired, closed-loop software program (MediTrain) delivered on mobile devices led to gains in both sustained attention and working memory in healthy young adults. These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography. Our findings suggest the utility of delivering aspects of the ancient practice of focused-attention meditation in a modern, technology-based approach and its benefits on enhancing sustained attention.",2019,"These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography.","['healthy young adults', 'young adults']","['meditation-inspired, closed-loop software program (MediTrain) delivered on mobile devices led to gains in both sustained attention and working memory', 'Closed-loop digital meditation']",['positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0150277'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}]",,0.0377703,"These improvements were associated with positive changes in key neural signatures of attentional control (frontal theta inter-trial coherence and parietal P3b latency), as measured by electroencephalography.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ziegler', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. david.ziegler@ucsf.edu.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Simon', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Gallen', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Skinner', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Janowich', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Volponi', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Kornfield', 'Affiliation': 'Spirit Rock Meditation Center, Woodacre, CA, USA.'}, {'ForeName': 'Joaquin A', 'Initials': 'JA', 'LastName': 'Anguera', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, CA, USA. adam.gazzaley@ucsf.edu.'}]",Nature human behaviour,['10.1038/s41562-019-0611-9']
55,32279106,A comparison of endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty for repairing medium- to large-sized tympanic membrane perforation: a randomized clinical trial.,"INTRODUCTION


Endoscopic type I tympanoplasty (ETT) is currently accepted as an effective, minimally traumatic procedure for repairing tympanic membrane perforation. However, ETT requires tympanomeatal flap elevation which chorda tympani nerve injury, bleeding and wound healing are the drawbacks of this technique. Thus endoscopic transtympanic myringoplasty (ETM) without elevation of the tympanomeatal flap is commonly used as an alternative technique. This study aimed to compare the efficacy of ETM versus ETT for repairing medium- to large-sized perforation of the tympanic membrane.
METHODS


The study cohort comprised patients undergoing surgery for medium- to large-sized perforation of the tympanic membrane between February 2018 and February 2019. The patients were randomized into the ETM group and the ETT group. The main outcomes were the graft take rates and hearing results. Secondary outcomes were the operative time, visual analog scale (VAS) pain scores, and postoperative complications.
RESULTS


Forty patients who completed 6 months of follow-up were included, comprising 21 patients in the ETM group and 19 in the ETT group. The overall graft take rates for the ETM and ETT groups were 95.2% and 89.5%, respectively (P = 0.59). The graft take rates for patients in the ETM group with large-sized tympanic membrane perforation was 88.9%. There was a significantly higher rate of good hearing result in the ETM group (95.2% versus 68.4%) (P = 0.04). The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
CONCLUSION


Our results demonstrated that the surgical outcome of ETM is comparable to that of ETT. However, ETM is less invasive and has a shorter operative time than ETT, and is suitable for simple perforation repair, regardless of the perforation size.",2020,"The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
","['Forty patients who completed 6\xa0months of follow-up were included, comprising 21 patients in the ETM group and 19 in the ETT group', 'patients undergoing surgery for medium- to large-sized perforation of the tympanic membrane between February 2018 and February 2019', 'repairing medium- to large-sized tympanic membrane perforation']","['Endoscopic type I tympanoplasty (ETT', 'ETM versus ETT', 'ETM', 'endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty']","['rate of good hearing result', 'shorter operative times', 'graft take rates and hearing results', 'operative time, visual analog scale (VAS) pain scores, and postoperative complications', 'graft take rates', 'overall graft take rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",21.0,0.0648849,"The ETM group had significantly shorter operative times than the ETT group (P < 0.01).
","[{'ForeName': 'Viraporn', 'Initials': 'V', 'LastName': 'Atchariyasathian', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand. viraporn.a@psu.ac.th.'}, {'ForeName': 'Rata', 'Initials': 'R', 'LastName': 'Suwannajak', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}, {'ForeName': 'Yuvatiya', 'Initials': 'Y', 'LastName': 'Plodpai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}, {'ForeName': 'Pittayapon', 'Initials': 'P', 'LastName': 'Pitathawatchai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, 90110, Songkhla, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05955-3']
56,30934894,"Randomized Trial of Marine n-3 Polyunsaturated Fatty Acids for the Prevention of Cerebral Small Vessel Disease and Inflammation in Aging (PUFA Trial): Rationale, Design and Baseline Results.","Vascular risk factors for age-related cognitive decline are significant, and their management may ultimately prove the most successful strategy for reducing risk and sustaining cognitive health. This randomized, double-blinded, placebo-controlled trial with parallel group allocation to either marine n-3 polyunsaturated fatty acids (n-3 PUFA) or soybean oil placebo assesses the effects on the total volume of accumulation in cerebral white matter hyperintensities (WMH), a potentially modifiable neurovascular component of age-related cognitive decline. Total WMH accumulation over 3 years is the primary endpoint. The safety and efficacy of n-3 PUFA is evaluated in older adults with significant WMH and suboptimum plasma n-3 PUFA as inclusion criteria. One hundred and two non-demented older adults were enrolled with a mean age of 81.1 (±4.4) years, WMH of 19.4 (±16.1) cm³, and a plasma n-3 PUFA of 86.64 (±29.21) µg/mL. 61% were female, 28% were apolipoprotein E epsilon 4 carriers, and the mean mini-mental state exam (MMSE) was 27.9 (±1.7). This trial provides an initial evaluation of n-3 PUFA effects on WMH, a reproducible and valid risk biomarker for cognitive decline, as well as on inflammatory biomarkers thought to play a role in WMH accumulation. We present the baseline results and operational experience of enriching a study population on advanced age, blood n-3 PUFA, and magnetic resonance imaging (MRI) derived WMH with biomarker outcomes (WMH, inflammation markers) in a dementia prevention paradigm.",2019,"This trial provides an initial evaluation of n-3 PUFA effects on WMH, a reproducible and valid risk biomarker for cognitive decline, as well as on inflammatory biomarkers thought to play a role in WMH accumulation.","['older adults with significant WMH and suboptimum plasma n-3 PUFA as inclusion criteria', 'One hundred and two non-demented older adults were enrolled with a mean age of 81.1 (±4.4) years, WMH of 19.4 (±16.1) cm³, and a plasma n-3 PUFA of 86.64 (±29.21) µg/mL. 61% were female, 28% were apolipoprotein', 'cerebral white matter hyperintensities (WMH']","['marine n-3 polyunsaturated fatty acids (n-3 PUFA) or soybean oil placebo', 'n-3 PUFA', 'placebo', 'Marine n-3 Polyunsaturated Fatty Acids']","['mean mini-mental state exam (MMSE', 'Total WMH accumulation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0152295', 'cui_str': 'Cerebral white matter structure'}]","[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",102.0,0.330617,"This trial provides an initial evaluation of n-3 PUFA effects on WMH, a reproducible and valid risk biomarker for cognitive decline, as well as on inflammatory biomarkers thought to play a role in WMH accumulation.","[{'ForeName': 'Gene L', 'Initials': 'GL', 'LastName': 'Bowman', 'Affiliation': 'Interventional Studies in Aging Center, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA 02131, USA. genebowman@hsl.harvard.edu.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Silbert', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. silbertl@ohsu.edu.'}, {'ForeName': 'Hiroko H', 'Initials': 'HH', 'LastName': 'Dodge', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. dodgeh@ohsu.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lahna', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. lahnad@ohsu.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. hagenk@ohsu.edu.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Murchison', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. cfmurch@uab.edu.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Howieson', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. dbhowieson@comcast.net.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. kaye@ohsu.edu.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. quinnj@ohsu.edu.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Shinto', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97219, USA. shintol@ohsu.edu.'}]",Nutrients,['10.3390/nu11040735']
57,32139109,"Comment on ""preoperative administration of Omega-3 fatty acids on postoperative pain and acute-phase reactants in patients undergoing Roux-en-Y gastric bypass: A randomized clinical trial"".",,2020,,['patients undergoing Roux-en-Y gastric bypass'],['Omega-3 fatty acids'],['postoperative pain and acute-phase reactants'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4521952', 'cui_str': 'Acute phase reactant'}]",,0.0247879,,"[{'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Qiang', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Yuanshui', 'Affiliation': 'Department of General Surgery, Tongde Hospital of Zhejiang Province, Hangzhou, China. Electronic address: 15658827827@163.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.02.028']
58,31787421,Assessing treatment efficacy by examining relationships between age groups of children with autism spectrum disorder and clinical anxiety symptoms: Prediction by correspondence analysis.,"INTRODUCTION


Autism spectrum disorders (ASD) are neurodevelopmental in nature and are frequently accompanied by anxiety. To fully assess treatment efficacy, we examined rates of anxiety symptom change by age groups following either cognitive behavioral therapy (CBT) or treatment as usual (TAU).
METHODS


One hundred sixty-three children with ASD and ASD-related anxiety symptoms were randomly assigned to either CBT or TAU. Utilizing prediction by correspondence analysis (CA), we evaluated the age effect (defined in three groups; ages 6-9, 10-12, and 13-16) and the changes in correlations between age and anxiety severity levels over the course of treatment.
RESULTS


Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups. Of particular note, the children ages 10-12 who received CBT showed the greatest improvement compared to all other groups. Late childhood, prior to adolescence, showed the best response to CBT for anxiety in ASD.
DISCUSSION


These findings suggest that treatment programs need to more closely address developmental factors within narrower bands of age groups. The present results are limited in their generalization to the CBT efficacy for a specific age band (ages 10-12). Longitudinal investigations are recommended to confirm whether the similar age group children who receive CBT experience the greatest benefit in reducing their ASD-related anxiety symptoms.",2020,Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups.,"['One hundred sixty-three children with ASD and ASD-related anxiety symptoms', 'children with autism spectrum disorder and clinical anxiety symptoms']","['CBT or TAU', 'cognitive behavioral therapy (CBT) or treatment as usual (TAU', 'CBT']","['anxiety symptom change', 'anxiety symptom reduction']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",163.0,0.012788,Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups.,"[{'ForeName': 'Se-Kang', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Fordham University, New York City, NY, United States. Electronic address: sekim@fordham.edu.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McKay', 'Affiliation': 'Fordham University, New York City, NY, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, TX, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.107']
59,32249311,Thiopental Does Not Produce Hyperalgesia: A Laboratory Study Using Two Human Experimental Pain Models.,"OBJECTIVE


Past investigations assessing the effects of thiopental on pain are conflicting. Although several studies demonstrate hyperalgesia as a result of barbiturate administration, others show analgesia. Our objective was to assess the effects of an infusion of the GABAA agonist thiopental, compared with placebo, in healthy participants on two subjective experimental pain paradigms: noxious electrical stimulation and intradermal capsaicin.
METHODS


For electrical stimulation, the milliamps required to achieve pain threshold and tolerance were recorded, and the percent change from baseline was determined for each infusion condition. In the intradermal capsaicin condition, the area of hyperalgesia was determined by von Frey technique pre- and postinfusion, and the percent change in the area of hyperalgesia was calculated.
RESULTS


Though thiopental infusion resulted in an increase in the electrical stimulation current required to elicit pain threshold or reach pain tolerance when compared with baseline, this finding was not statistically significant. In the intradermal capsaicin condition, there was a statistically significant difference in overall pre- and postinfusion pain interpretation, as measured by the McGill Pain Questionnaire (P < 0.05), but there was no significant difference in area of hyperalgesia.
CONCLUSIONS


In this human study of thiopental's effects on two experimental pain models, our results show that thiopental does not induce hyperalgesia.",2020,"In the intradermal capsaicin condition, the area of hyperalgesia was determined by von Frey technique pre- and postinfusion, and the percent change in the area of hyperalgesia was calculated.
",['healthy participants on two subjective experimental pain paradigms'],"['thiopental', 'placebo', 'Thiopental', 'GABAA agonist thiopental', 'noxious electrical stimulation and intradermal capsaicin']","['McGill Pain Questionnaire', 'area of hyperalgesia', 'electrical stimulation current required to elicit pain threshold or reach pain tolerance', 'Hyperalgesia', 'hyperalgesia', 'overall pre- and postinfusion pain interpretation', 'pain threshold and tolerance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",2.0,0.0660682,"In the intradermal capsaicin condition, the area of hyperalgesia was determined by von Frey technique pre- and postinfusion, and the percent change in the area of hyperalgesia was calculated.
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Arout', 'Affiliation': 'Department of Psychiatry, Center for Translational Neuroscience of Alcoholism and VA Alcohol Research Center, Yale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Ismene L', 'Initials': 'IL', 'LastName': 'Petrakis', 'Affiliation': 'Department of Psychiatry, Center for Translational Neuroscience of Alcoholism and VA Alcohol Research Center, Yale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ralevski', 'Affiliation': 'Department of Psychiatry, Center for Translational Neuroscience of Alcoholism and VA Alcohol Research Center, Yale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Acampora', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Center for Addiction Medicine, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Koretski', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'DeNegre', 'Affiliation': 'Department of Psychiatry, Center for Translational Neuroscience of Alcoholism and VA Alcohol Research Center, Yale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Jenelle', 'Initials': 'J', 'LastName': 'Newcomb', 'Affiliation': 'Department of Psychiatry, Center for Translational Neuroscience of Alcoholism and VA Alcohol Research Center, Yale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Perrino', 'Affiliation': 'Department of Anesthesiology, Yale School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa037']
60,31957691,"Effects of working memory training on cognitive, affective, and biological responses to stress in major depression: A novel cognitive bias modification protocol.","BACKGROUND


Over 320 million individuals are living with Major Depressive Disorder (MDD), a leading cause of disability worldwide. Thus, there is a crucial need to identify processes that contribute to the maintenance of depressive episodes. Difficulty removing negative information from working memory (WM) is posited to exacerbate affective, cognitive, and biological dysregulation in Major Depressive Disorder (MDD), but this has not yet been tested empirically.
METHODS


In this study we examined whether training depressed individuals to remove negative information from WM (RNI training) would reduce symptoms of depression and levels of rumination, and would be associated with attenuated biological responsivity to stress. Individuals diagnosed with MDD were randomly assigned to complete Real-RNI training or Sham-RNI training for six days.
RESULTS


Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination. Furthermore, participants in the Real-RNI condition showed a more attenuated pattern of cortisol and respiratory sinus arrhythmia (RSA) responses to stress than did participants in the Sham-RNI training condition.
LIMITATIONS


We did not assess the long-term effects of training. It will be important for future research to examine whether the documented training-related effects persist across time.
CONCLUSIONS


This study is the first to examine the effects of RNI training on clinical symptoms and biological responses to stress in MDD, and it provides experimental evidence that training individuals with depression to remove negative information from WM can help to modulate the heightened biological responses to stress seen in depression.",2020,"Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination.","['320 million individuals are living with Major Depressive Disorder (MDD', 'Individuals diagnosed with MDD', 'major depression']","['training depressed individuals to remove negative information from WM (RNI training', 'complete Real-RNI training or Sham-RNI training', 'working memory training', 'RNI training']","['cognitive, affective, and biological responses', 'WM, symptoms of depression, and rumination', 'pattern of cortisol and respiratory sinus arrhythmia (RSA) responses to stress']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0349911,"Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jopling', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, BC V6T1Z4, Canada. Electronic address: ellen.jopling@psych.ubc.ca.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Gotlib', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'LeMoult', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, BC V6T1Z4, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.007']
61,32240832,Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.,"BACKGROUND & AIMS


Antibiotic treatment is the standard care for patients with uncomplicated acute diverticulitis. However, this practice is based on low-level evidence and has been challenged by findings from 2 randomized trials, which did not include a placebo group. We investigated the non-inferiority of placebo vs antibiotic treatment for the management of uncomplicated acute diverticulitis.
METHODS


In the selective treatment with antibiotics for non-complicated diverticulitis study, 180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia were randomly assigned to groups given antibiotics (n = 85) or placebo (n = 95) for 7 days. We collected demographic, clinical, and laboratory data and answers to questionnaires completed every 12 hrs for the first 48 hrs and then daily until hospital discharge. The primary endpoint was length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores at 12 and 24 hrs.
RESULTS


There was no significant difference in median time of hospital stay between the antibiotic group (40.0 hrs; 95% CI, 24.4-57.6 hrs) and the placebo group (45.8 hrs; 95% CI, 26.5-60.2 hrs) (P = .2). There were no significant differences between groups in adverse events (12% for both groups; P = 1.0), readmission to the hospital within 1 week (1% for the placebo group vs 6% for the antibiotic group; P = .1), and readmission to the hospital within 30 days (11% for the placebo group vs 6% for the antibiotic group; P = .3).
CONCLUSIONS


Foregoing antibiotic treatment did not prolong length of hospital admission. This result provides strong evidence for omission of antibiotics for selected patients with uncomplicated acute diverticulitis.
ACTRN


12615000249550.",2021,"There were no significant differences between groups in adverse events (12% for both groups; P=1.0), readmission to the hospital within 1 week (6% for the placebo group vs 1% for the antibiotic group; P=.1), and readmission to the hospital within 30 days (6% for the placebo group vs 11% for the antibiotic group; P= .3).
","['patients with uncomplicated acute diverticulitis', '180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia', 'selected patients with uncomplicated acute diverticulitis']","['Antibiotic treatment', 'placebo vs antibiotic treatment', 'placebo', 'antibiotics']","['Length of Hospital Stay', 'length of hospital admission', 'median time of hospital stay', 'adverse events', 'readmission to the hospital', 'length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0518989', 'cui_str': 'Acute diverticulitis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",180.0,0.661601,"There were no significant differences between groups in adverse events (12% for both groups; P=1.0), readmission to the hospital within 1 week (6% for the placebo group vs 1% for the antibiotic group; P=.1), and readmission to the hospital within 30 days (6% for the placebo group vs 11% for the antibiotic group; P= .3).
","[{'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Jaung', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Nisbet', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Martijn Pieter', 'Initials': 'MP', 'LastName': 'Gosselink', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Di Re', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Keane', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': ""Su'a"", 'Affiliation': 'South Auckland Clinical School, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Siraj', 'Initials': 'S', 'LastName': 'Rajaratnam', 'Affiliation': 'Colorectal Unit, Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Grahame', 'Initials': 'G', 'LastName': 'Ctercteko', 'Affiliation': 'Department of Colorectal Surgery, Westmead Hospital, Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hsee', 'Affiliation': 'Acute Surgical Unit, Department of Surgery, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rowbotham', 'Affiliation': 'Department of Gastroenterology and Hepatology, Auckland City Hospital, Auckland, New Zealand South Auckland Clinical School, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'South Auckland Clinical School, University of Auckland, Auckland, New Zealand; Department of Surgery, Counties Manukau Health, Auckland New Zealand.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Bissett', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland, New Zealand; Colorectal Unit, Department of Surgery, Auckland District Health Board, Auckland, New Zealand. Electronic address: i.bissett@auckland.ac.nz.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.049']
62,32243582,Enhanced serotonin availability amplifies fatigue perception and modulates the TMS-induced silent period during sustained low-intensity elbow flexions.,"KEY POINTS


During maximal effort contractions, intense serotonin release via the raphe-spinal pathway spills over from the somato-dendritic compartment to activate inhibitory 5-HT 1A  receptors on the axon initial segment of motoneurons to reduce motoneuronal output. We investigated whether the same mechanism of central fatigue is present for low-intensity contractions, whereby weak serotonergic drive over an extended period may cause accumulation of serotonin and exacerbate central fatigue. Enhanced availability of serotonin did not directly influence motor pathways or motor performance during prolonged submaximal contraction. However, perceptions of muscle fatigue were greater, and the fatigue-induced lengthening of the silent period elicited via motor cortical stimulation was reduced with enhanced availability of serotonin. We propose that sustained low-intensity serotonergic neurotransmission influences supraspinal processes associated with fatigue, without directly influencing the output of the motor system during submaximal exercise.
ABSTRACT


Enhanced availability of serotonin (5-HT) exacerbates central fatigue that occurs during maximal effort contractions. However, it is unknown if 5-HT release contributes to central fatigue during prolonged submaximal contractions. Hence, we assessed the effect that enhanced availability of 5-HT has on sustained low-intensity fatiguing contractions. Fifteen individuals (22.3 ± 2.1 years) ingested the 5-HT reuptake inhibitor paroxetine in a human, double-blinded, placebo-controlled, repeated-measures design. Participants performed a low-intensity isometric elbow flexion for 30 min (15% of maximal voluntary contraction, MVC). Throughout the protocol, brief MVCs were performed and muscle responses to transcranial magnetic stimulation (TMS) of the motor cortex, electrical stimulation of the brachial plexus, and motor point stimulation of the biceps were obtained. Ratings of perceived fatigue were also acquired. Paroxetine did not influence torque or voluntary activation during brief MVCs performed throughout the low-intensity contraction. However, paroxetine increased the perception of fatigue throughout the contraction (P = 0.005), and shortened the biceps silent period elicited via TMS during sustained submaximal contraction (P = 0.003) and brief MVCs (P = 0.011). Overall, it appears that prolonged low-intensity contractions do not cause intense 5-HT release onto motoneurons, and therefore, 5-HT does not activate inhibitory extra-synaptic 5-HT 1A  receptors of motoneurons to reduce their output. Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction. Thus, 5-HT affects supraspinal processes during low-intensity contractions without directly altering motor pathways projecting to the muscle.",2020,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.",['Fifteen individuals (22.3\xa0±\xa02.1\xa0yr) ingested the'],"['low-intensity isometric elbow flexion', 'serotonin (5-HT', 'Paroxetine', 'paroxetine', 'serotonin', '5-HT', '5-HT reuptake inhibitor paroxetine']","['perception of fatigue', 'Ratings of perceived fatigue', 'brief MVCs', 'muscle fatigue', 'intracortical inhibitory activity', 'torque or voluntary activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",,0.04441,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.","[{'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Thorstensen', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Murray G', 'Initials': 'MG', 'LastName': 'Tucker', 'Affiliation': 'Mental Health, Drugs and Alcohol Service, Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}]",The Journal of physiology,['10.1113/JP279347']
63,31685489,Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.,"OBJECTIVE


To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D.
RESEARCH DESIGN AND METHODS


A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE (≥30 mg/g) were assessed annually.
RESULTS


Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA 1c , TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up.
CONCLUSIONS


Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.",2020,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","['Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ', 'Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes', 'severely obese adolescents with type 2 diabetes ', 'T2D) undergoing medical or surgical treatment for T2D', 'obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies']","['Surgical Versus Medical Therapy', 'metabolic bariatric surgery (MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['Elevated UAE', 'Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE', 'diabetic kidney disease (DKD) rates']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]",,0.0493397,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","[{'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO petter.bjornstad@childrenscolorado.org.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hughan', 'Affiliation': ""University of Pittsburgh and UPMC Children's Hospital Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nehus', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mitsnefes', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}]",Diabetes care,['10.2337/dc19-0708']
64,32246238,A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated unilateral inguinal hernia.,"BACKGROUND


Routine TEP technique requires three skin incisions for placement of three trocars in the midline. Otherwise, this can be done by three-port triangular technique or two-hand technique. This study reports a randomised trial of perioperative outcomes and ergonomics characteristics of this procedure using two different techniques of port insertion.
METHODS


N = 28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval. Patient-related outcomes in terms of quality of life (QOL) and ergonomic evaluation of the technique were compared in double-blinded fashion.
RESULTS


Postoperative pain score at 24 h post surgery (5.1 ± 0.6; 95% CI 4.9-5.3 vs. 4.8 ± 0.4; 95% CI 4.6-4.9) differed, while hospital stay, time to return to routine work, tolerance to oral feeds and intraoperative complications occurrence (OR 2.1; 95% CI 0.2-24.3) were comparable in both groups. Time to return to office work (5.5 ± 0.5; 95% CI 5.4-5.7 vs. 4.0 ± 0.8; 95% CI 3.7-4.3) and immediate postoperative sensation of mesh and pain score were significantly higher in MTEP compared to TTEP. Ergonomic parameters including visualization of landmark score, spreading of mesh score and total surgeon satisfaction score (TTEP 8.4 ± 0.7; 95% CI 8.1-8.6 vs. MTEP 7.0 ± 0.8; 95% CI 6.7-7.3), mental effort quotient (SMEQ score: TTEP 50.6 ± 12.7; 95% CI 45.9-55.3 vs. MTEP 70.8 ± 12.6: 95% CI 66.1-75.4) and physical effort quotient (LEDQ scores in wrist, hand, arm and shoulders) were also superior in triangular technique of port placement.
CONCLUSION


Triangular three-port TEP hernioplasty is ergonomically feasible and enables a surgeon to perform surgery safely using basic principles of laparoscopy.",2021,"28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval.","['28 patients', 'N\u2009', ""after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval"", 'total extra-peritoneal repair of uncomplicated unilateral inguinal hernia']","['triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty', 'Triangular three-port TEP hernioplasty', 'triangular versus midline port placement']","['Postoperative pain score', 'hospital stay, time to return to routine work, tolerance to oral feeds and intraoperative complications occurrence', 'physical effort quotient (LEDQ scores', 'quality of life (QOL) and ergonomic evaluation of the technique', 'Time to return to office work', 'visualization of landmark score, spreading of mesh score and total surgeon satisfaction score', 'immediate postoperative sensation of mesh and pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",28.0,0.193308,"28 patients were randomised into two groups for triangular three-port (TTEP) versus midline three-port TEP (MTEP) hernioplasty after informed written consent in Department of Surgery, King George's Medical University UP between September 2016 and September 2017 after institutional ethical approval.","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Awanish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India. awanishkr79@gmail.com.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Pal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Agrawal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Pahwa', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Abhinav A', 'Initials': 'AA', 'LastName': 'Sonkar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}]",Surgical endoscopy,['10.1007/s00464-020-07525-4']
65,31112513,An online investigation into the impact of adding epidemiological information to imaging reports for low back pain.,"Degenerative changes commonly feature on spinal images and are often identified in the imaging reports of pain-free individuals. Many of these findings relate to ""normal"" age-related characteristics, however are frequently interpreted as implying abnormality and may adversely influence patient outcomes. The aim of this study was to investigate the impact of adding epidemiological information to lumbar imaging reports in a general adult population. This study was an online, scenario-based, randomised experiment. Participants were presented with a ""virtual patient"" scenario via an online survey and then randomly allocated to either receive a standard imaging report or a standard report with additional epidemiological information. The primary outcome was a composite ""back-related perceptions"" (BRP) score. Data from 247 participants (72% female) were included in the analysis. There was a small effect of group on BRP [F(12,444) = 6.75, p = 0.010] with participants who received the additional epidemiological information demonstrating more positive perceptions. Including epidemiological information in spinal imaging reports positively impacted ""virtual-patient"" perceptions in an online scenario-based study. This finding suggests that implementing a simple imaging reporting strategy may be reassuring and should be further considered for its potential to positively impact patient outcomes. Further research is warranted in clinical populations.",2019,"There was a small effect of group on BRP [F(12,444) = 6.75, p = 0.010] with participants who received the additional epidemiological information demonstrating more positive perceptions.","['247 participants (72% female', 'general adult population']",['standard imaging report or a standard report with additional epidemiological information'],"['composite ""back-related perceptions"" (BRP) score']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",247.0,0.215064,"There was a small effect of group on BRP [F(12,444) = 6.75, p = 0.010] with participants who received the additional epidemiological information demonstrating more positive perceptions.","[{'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Medalian', 'Affiliation': 'University of South Australia, School of Health Sciences, Adelaide, Australia.'}, {'ForeName': 'G Lorimer', 'Initials': 'GL', 'LastName': 'Moseley', 'Affiliation': 'University of South Australia, School of Health Sciences, Adelaide, Australia.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Karran', 'Affiliation': 'University of South Australia, School of Health Sciences, Adelaide, Australia.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0023']
66,32232645,A preliminary evaluation of two different meshes in minimally invasive inguinal hernia surgery.,"BACKGROUND


Many meshes are available for use in laparoscopic inguinal hernia repair. The surgeon must consider several factors when choosing a mesh for hernia repair including clinical outcomes, cost, and ease of use. The purpose of this study was to compare two different lightweight polypropylene meshes for laparoscopic and robotic inguinal hernia repairs.
METHODS


Subjects were randomized immediately before surgery. Data were reported in N (%) and median [Q1-Q3], comparisons of mesh insertion time were tested using a 2 × 2 ANOVA on the ranked times, comparisons between categorical variables were tested with Fisher's Exact, and all data were analyzed using SAS® 9.4 (SAS Institute, Inc.).
RESULTS


Between January 2015 and June 2016, 50 subjects were enrolled; two were excluded. Of 48 eligible subjects, most were Caucasian (N = 42, 88%), male (N = 37, 77%), with a median age of 63, and were randomized evenly between 3DMax™ mesh and Ultrapro® mesh. Robotic mesh placement significantly increased insertion time regardless of mesh type (p < .0001). When comparing NASA-TLX self-assessment surveys, there was no significant difference between the meshes in difficulty of placement. The type of mesh did not significantly impact the insertion time regardless of robot use (p = 0.523).
CONCLUSION


Our data demonstrate that mesh insertion times comparing two different lightweight polypropylene meshes were not significantly different. Increased insertion times associated with robotic repair are likely due to the mechanics of robotic suturing and associated learning curve. Our data suggest that these meshes can be used interchangeably based on the surgeon's preference.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01825187.",2021,"The type of mesh did not significantly impact the insertion time regardless of robot use (p = 0.523).
","['Subjects', 'minimally invasive inguinal hernia surgery', '48 eligible subjects, most were Caucasian (N\u2009=\u200942, 88%), male (N\u2009=\u200937, 77%), with a median age of 63', 'Between January 2015 and June 2016, 50 subjects were enrolled; two were excluded', 'laparoscopic inguinal hernia repair']","['3DMax™ mesh and Ultrapro® mesh', 'laparoscopic and robotic inguinal hernia repairs', 'Robotic mesh placement']","['insertion time regardless of mesh type', 'median [Q1-Q3], comparisons of mesh insertion time']","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",50.0,0.149928,"The type of mesh did not significantly impact the insertion time regardless of robot use (p = 0.523).
","[{'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Bilezikian', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, Wilmington, NC, 28402, USA.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Tenzel', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, Wilmington, NC, 28402, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Johnson', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, Wilmington, NC, 28402, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Powers', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, Wilmington, NC, 28402, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, 2131 South 17th Street, Wilmington, NC, 28402, USA. William.Hope@nhrmc.org.'}]",Surgical endoscopy,['10.1007/s00464-020-07512-9']
67,31031266,Educational interventions to improve medical students' knowledge of acute pain management: a randomized study.,"It has been consistently documented that the treatment of acute pain is inadequate. Education of medical students is an obvious strategy to improve this. We therefore conducted a study in which 217 medical students were randomized into one of three groups: a control group (no intervention) and two intervention groups (education with e-learning alone or e-learning combined with simulation-based training). We hypothesized that the combined intervention would be superior to no intervention and e-learning alone. All students completed the same multiple choice questionnaire twice with an interval of approximately 1 week. During this 1-week interval, students in the two intervention groups completed either an 45-min interactive case-based e-learning program, or the e-learning program and a simulation-based training. We showed that the theoretical knowledge about treatment of acute pain increased in both intervention groups but students who received the combined intervention felt more confident in the future handling of patients.",2019,We showed that the theoretical knowledge about treatment of acute pain increased in both intervention groups but students who received the combined intervention felt more confident in the future handling of patients.,"[""medical students' knowledge of acute pain management"", '217 medical students']","['45-min interactive case-based e-learning program, or the e-learning program and a simulation-based training', 'Educational interventions', 'control group (no intervention) and two intervention groups (education with e-learning alone or e-learning combined with simulation-based training']",['acute pain'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",217.0,0.0186166,We showed that the theoretical knowledge about treatment of acute pain increased in both intervention groups but students who received the combined intervention felt more confident in the future handling of patients.,"[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Poulsenª', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kristian Dahl', 'Initials': 'KD', 'LastName': 'Friesgaard', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Seidenfaden', 'Affiliation': 'Research and Development, Prehospital Emergency Medical Services, Central Denmark Region, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Paltved', 'Affiliation': 'Corporate HR MidtSim, Central Denmark Region, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark, E-mail: nikolajsen@dadlnet.dk.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0036']
68,32220099,Opioid-induced Euphoria Among Emergency Department Patients With Acute Severe Pain: An Analysis of Data From a Randomized Trial.,"BACKGROUND


Parenteral opioids are commonly used to treat acute severe pain. We measured pleasurable sensations in patients administered intravenous analgesics to determine if these sensations were associated with receipt of an opioid, after controlling for relief of pain. Pleasurable sensations not accounted for by relief of pain were considered opioid-induced euphoria.
METHODS


These data were from a randomized study of 1 mg of hydromorphone versus 120 mg of lidocaine for abdominal pain. To assess euphoria, participants were asked to provide a 0 to 10 response to each of these questions: 1) How good did the medication make you feel? 2) How high did the medication make you feel? and 3) How happy did the medication make you feel? Pain at baseline and 30 minutes was also measured on a 0 to 10 scale. To determine the relative importance of pain relief versus medication type, we built three linear regression models in which each euphoria question was the dependent variable and pain relief, medication type, and medication-induced side effects were the independent variables.
RESULTS


Seventy-seven patients received lidocaine and 77 hydromorphone. Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8). In the regression models, hydromorphone administration (β-coefficient = 0.16, p = 0.03) and pain relief (β-coefficient = 0.45, p < 0.01) were both associated with ""feeling good."" ""Feeling high"" and ""feeling happy"" were associated with pain improvement (p < 0.01) but not with hydromorphone administration (p = 0.07 for ""high"" and p = 0.06 for ""happy""). Medication-induced side effects were not associated with these measures of euphoria.
CONCLUSION


Among emergency department patients with acute pain, hydromorphone-induced euphoria, though measurable, was generally less important for patients than relief of pain.",2020,"Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8).","['emergency department patients with acute pain', 'Emergency Department Patients With Acute Severe Pain']","['Hydromorphone', 'Opioid-induced Euphoria', 'hydromorphone', 'lidocaine']","['pain improvement', 'feeling good', 'euphoria questions', 'pleasurable sensations', 'Pain', 'pain relief', 'euphoria']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.237047,"Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8).","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Abril Ochoa', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Farnia', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'and the, Medical College, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13946']
69,30796851,Decline of substance P levels after stress management with cognitive behaviour therapy in women with the fibromyalgia syndrome.,"Background and aims Substance P (CSF-SP) is known to be elevated in females with fibromyalgia syndrome (FMS). The aims of this study were to evaluate the effect of cognitive behaviour therapy (CBT) on plasma SP levels in women with FMS and to find possible clinical behavioural correlates to plasma SP level changes. Methods Forty-eight women with FMS were randomly allocated into two groups. Group 1 received the CBT treatment intervention over the course of 6 months while group 2 was waitlisted. CBT was given with a protocol developed to diminish stress and pain. After 6 months, group 2 was given the same CBT treatment as well. All were followed up 1 year after the start of CBT treatment. This approach allowed for two analytical designs - a randomised controlled trial (RCT) (n=24 vs. n=24) and a before-and-after treatment design (n=48). All women were repeatedly evaluated by the West Haven-Yale Multidimensional Pain Inventory (MPI) and three other psychometric questionnaires and plasma SP was analysed. Results In the RCT design, the plasma SP level was 8.79 fmol/mL in both groups at the start of the trial, after adjustment for initial differences. At the end of the RCT, the plasma SP level was 5.25 fmol/mL in the CBT intervention group compared to 8.39 fmol/mL in the control group (p=0.02). In the before-and-after design, the plasma SP was reduced by 33% (p<0.01) after CBT, but returned to the pre-treatment level at follow-up 1 year after the start of CBT treatment. Plasma SP was associated with the MPI dimensions experienced ""support from spouses or significant others"" and ""life control"". Conclusions Plasma SP might be a marker of the effect of CBT in FMS associated with better coping strategies and reduced stress rather than a biochemical marker of pain.",2019,"Plasma SP was associated with the MPI dimensions experienced ""support from spouses or significant others"" and ""life control"".","['females with fibromyalgia syndrome (FMS', 'women with the fibromyalgia syndrome', 'Methods Forty-eight women with FMS', 'women with FMS']","['cognitive behaviour therapy (CBT', 'CBT treatment intervention', 'Substance P (CSF-SP', 'CBT', 'CBT intervention', 'cognitive behaviour therapy']","['plasma SP levels', 'plasma SP', 'plasma SP level', 'stress and pain', 'West Haven-Yale Multidimensional Pain Inventory (MPI']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038585', 'cui_str': 'Euler-Gaddum Substance P'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",48.0,0.0531251,"Plasma SP was associated with the MPI dimensions experienced ""support from spouses or significant others"" and ""life control"".","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Karlsson', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala SE-751 22, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Burell', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala SE-751 22, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kristiansson', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala SE-751 22, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Björkegren', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala SE-751 22, Sweden.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Nyberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala SE-751 22, Sweden.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Svärdsudd', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala SE-751 22, Sweden.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0324']
70,32174470,Evaluation of the effects of rTMS on self-reported quality of life and disability in treatment-resistant depression: A THREE-D study.,"INTRODUCTION


Although the antidepressant efficacy of rTMS is well documented, patient reported outcomes (PROs) with rTMS are poorly characterized. The aim of the current study is to assess short and long-term changes in self-reported quality of life and disability following a 6-week course of rTMS.
METHODS


We performed a secondary analysis of data from the multi-centre THREE-D trial of 10 Hz high-frequency (HF) rTMS (n = 192) vs. intermittent theta-burst stimulation (iTBS) (n = 193) of the left dorsolateral prefrontal cortex (DLPFC). We assessed changes in the Quality of Life Enjoyment and Satisfaction Questionnaire and Sheehan Disability Scale pre-treatment, at 1-week post-rTMS treatment (Acute Follow-up), and at 12-weeks post-treatment (Long-Term Follow-Up).
RESULTS


PROs significantly improved with rTMS. There were no differences in PROs between iTBS and HF left DLPFC rTMS at either the Acute or Long-Term Follow-Up. The magnitude of the change in effect sizes seen for the PROs were significantly greater in those who achieved greater resolution their depressive symptoms, with remitters demonstrating very large effect size improvements in PROs compared to small-to-medium effect sizes in non-remitters.
CONCLUSIONS


This study is the largest in the literature exploring at the effect of rTMS on PROs. rTMS yielded acute and sustained improvements in PROs. The improvements in PROs were strongly associated with the degree of resolution of depressive symptoms. The magnitude of the change in remitters was comparable to those reported with ECT. The goal of a course of rTMS should be for full remission of depressive symptoms in order to achieve optimal functional outcomes.",2020,There were no differences in PROs between iTBS and HF left DLPFC rTMS at either the Acute or Long-Term Follow-Up.,[],"['rTMS', '10\xa0Hz high-frequency (HF) rTMS (n\xa0=\xa0192) vs. intermittent theta-burst stimulation (iTBS) ']","['degree of resolution of depressive symptoms', 'PROs between iTBS and HF left DLPFC rTMS', 'Quality of Life Enjoyment and Satisfaction Questionnaire and Sheehan Disability Scale', 'self-reported quality of life and disability', 'PROs']",[],"[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.0500473,There were no differences in PROs between iTBS and HF left DLPFC rTMS at either the Acute or Long-Term Follow-Up.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Giacobbe', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada. Electronic address: peter.giacobbe@sunnybrook.ca.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Mithani', 'Affiliation': 'Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada; Non-Invasive Neurostimulation Therapies (NINET) Laboratory, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada; MRI-Guided rTMS Clinic and Krembil Research Institute, University Health Network, Toronto, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.002']
71,32056873,A novel study design for investigating relapse prevention in major depressive disorder: Preliminary data from the open-label period of a phase 4 vortioxetine study.,"BACKGROUND


Traditional randomized withdrawal studies have assessed the efficacy of antidepressants for reducing relapse and recurrence of major depressive episodes (MDEs) but have not compared dose reduction, increase, or maintenance within the same study.
METHODS


Here we present the development, implementation, and preliminary data from the open-label period of an ongoing phase 4, non-traditional, randomized withdrawal study. Designed to evaluate the efficacy of vortioxetine across its approved dose range for relapse prevention, the study enrolled adult patients with recurrent major depressive disorder (MDD), Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 26, and history of ≥2 MDEs. After a 16-week, open-label, fixed-dose (vortioxetine 10 mg once daily) period, patients meeting response criteria (≥50% reduction in MADRS total score, Weeks 8-16) and remission criteria (MADRS total score ≤12, Weeks 14 and 16) were randomized to vortioxetine 5, 10, or 20 mg, or placebo in a 32-week double-blind treatment period.
RESULTS


Of 1106 patients enrolled, 510 completed the open-label period (mean age: 45.7 years; mean MADRS = 5.0; predominantly female, white, and never smokers) and were eligible for randomization in the ongoing double-blind period.
LIMITATIONS


Study is ongoing; only data from the open-label period are available for evaluation.
CONCLUSIONS


Preliminary analysis suggests that patient baseline characteristics were not a factor in response to and stabilization with vortioxetine during the open-label period. The lack of flexibility in dosing, however, may have reduced the number of patients qualifying for randomization. This study design may provide useful information for optimizing the long-term efficacy and tolerability of vortioxetine treatment for MDD.",2020,"CONCLUSIONS


Preliminary analysis suggests that patient baseline characteristics were not a factor in response to and stabilization with vortioxetine during the open-label period.","['1106 patients enrolled, 510 completed the open-label period (mean age: 45.7 years; mean MADRS\xa0=\xa05.0; predominantly female, white, and never smokers) and were eligible for randomization in the ongoing double-blind period', 'major depressive disorder', 'enrolled adult patients with recurrent major depressive disorder (MDD), Montgomery-Åsberg Depression Rating Scale (MADRS)\xa0≥\xa026, and history of ≥2 MDEs']","['open-label, fixed-dose (vortioxetine', 'vortioxetine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],1106.0,0.110249,"CONCLUSIONS


Preliminary analysis suggests that patient baseline characteristics were not a factor in response to and stabilization with vortioxetine during the open-label period.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Jacobsen', 'Affiliation': 'Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL 60015, USA. Electronic address: pjakes1@gmail.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL 60015, USA.'}, {'ForeName': 'Rengyi', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL 60015, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nomikos', 'Affiliation': 'Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, IL 60015, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.090']
72,32056892,Self-guided online cognitive behavioural therapy for insomnia: A naturalistic evaluation in patients with potential psychiatric comorbidities.,"BACKGROUND


Insomnia is the most prevalent sleep disorder worldwide, and regularly co-occurs with anxiety and depression. Cognitive behavioural therapy is the gold standard treatment for insomnia (CBT-I), however demand for treatment providers drastically exceeds supply. Internet-delivered programs for insomnia (iCBT-I) improve treatment access. However the effects of unguided iCBT-I for individuals with comorbidities within a naturalistic setting remains unexplored. We developed a novel unguided iCBT-I program and evaluated its impact on insomnia, psychological distress, and wellbeing when accessed by the public.
METHODS


317 participants experiencing insomnia for over 3 months enrolled in the program. The program consisted of 4 lessons delivered online with automated web support. Insomnia symptoms, psychological distress, and general wellbeing were assessed at lesson 1 and 4. Intention-to-treat linear mixed models were used to examine effects on insomnia, distress, and wellbeing.
RESULTS


Participants experienced large (g = 1.11) and significant reductions in insomnia, moderate (g = 0.55) and significant reductions in distress, and small (g = 0.37) but significant improvements in wellbeing. 65% of participants who reported pre-treatment insomnia severity at clinical levels remitted following treatment.
LIMITATIONS


To examine the program in a naturalistic setting, we did not employ a control group or follow participants beyond the completion of treatment.
CONCLUSIONS


Unguided iCBT-I is effective for individuals in the community who experience insomnia and are likely experiencing comorbid mental health problems. These effects in the absence of guided contact strengthen the utility of unguided iCBT-I as a scalable and cost-effective method of disseminating treatments for this disorder.",2020,Unguided iCBT-I is effective for individuals in the community who experience insomnia and are likely experiencing comorbid mental health problems.,"['patients with potential psychiatric comorbidities', '317 participants experiencing insomnia for over 3 months enrolled in the program', 'insomnia']","['4 lessons delivered online with automated web support', 'Unguided iCBT-I', 'unguided iCBT-I', 'Cognitive behavioural therapy', 'Self-guided online cognitive behavioural therapy']","['Insomnia symptoms, psychological distress, and general wellbeing', 'insomnia, psychological distress, and wellbeing', 'wellbeing', 'insomnia, distress, and wellbeing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}]",317.0,0.0536956,Unguided iCBT-I is effective for individuals in the community who experience insomnia and are likely experiencing comorbid mental health problems.,"[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Grierson', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW. Electronic address: ashlee.grierson@svha.org.au.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hobbs', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW.""}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Mason', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Sydney, NSW.""}]",Journal of affective disorders,['10.1016/j.jad.2020.01.143']
73,32090783,Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.,"BACKGROUND


The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates.
METHODS


Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth.
RESULTS


Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes.
LIMITATIONS


The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data.
CONCLUSIONS


This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.",2020,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","['perinatal depression delivered through peers', 'Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to', '850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up']","['THPP plus enhanced usual care (EUC) or EUC-only', 'THPP', 'Thinking Healthy Programme (THP', 'India and Pakistan', 'THP', 'Thinking Healthy Programme']","['lower symptom severity (PHQ-9 score', 'symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth', 'depression, disability and social support at 3 and 6 months post-childbirth']","[{'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0060462', 'cui_str': 'flopropione'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0217641', 'cui_str': '4-Pyrimidinecarboxylic acid, 1,4,5,6-tetrahydro-2-methyl-'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0037438'}]",850.0,0.199711,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: fiona.vanobberghen@swisstph.ch.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Faculty of Public Health and Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan; Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Ejma', 'Initials': 'E', 'LastName': 'Afonso', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ikhlaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Bilal', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Aveena', 'Initials': 'A', 'LastName': 'De Sa', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': ""D'Souza"", 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Korgaonkar', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Lazarus', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Rakshanda', 'Initials': 'R', 'LastName': 'Liaqat', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sharif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Faculty of Epidemiology and Population Health, Department of Population Health, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Shaffaq', 'Initials': 'S', 'LastName': 'Zuliqar', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.110']
74,32056945,Cognitive behavioral therapy for suicide prevention in youth admitted to hospital following an episode of self-harm: A pilot randomized controlled trial.,"BACKGROUND


Self-harm (SH) is among the strongest risk factors for eventual suicide death yet there are limited data on which interventions are most effective for treating SH in youth.
METHODS


This single-blind, pilot randomized controlled trial examined brief cognitive behavioral therapy (BCBT) for suicide prevention vs. minimally-directive supportive psychotherapy in youth (aged 16-26) hospitalized following SH. Both therapies included 10 acute sessions over 15 weeks with three booster sessions occurring at three month intervals thereafter. The primary feasibility outcome was ≥70% retention at study endpoint. Efficacy measures, including repeat SH, were secondary outcomes.
RESULTS


Twenty-four subjects were enrolled (12 per group) with one BCBT subject and two controls dropping out prior to the first therapy session. Five (45%) of the remaining BCBT subjects and seven (70%) control subjects completed all 10 acute therapy sessions. All subjects who completed five sessions went on to complete 10. There were significantly fewer instances of repeat SH in BCBT subjects (7 of 62 weeks of acute follow-up; 11%) compared to control subjects (24 of 79 weeks; 30%)(OR 0.34, 95%CI:0.13-0.92). Three subjects, all in the control condition, made a total of five suicide attempts during the study.
LIMITATIONS


This study had a modest sample size and retention rate.
CONCLUSIONS


This study failed to achieve its primary feasibility retention goal for BCBT. However, it did demonstrate that initial adherence to follow-up predicted study completion. Despite small numbers, it also found a significant reduction in repeat SH in the BCBT group, a finding which requires replication.",2020,"There were significantly fewer instances of repeat SH in BCBT subjects (7 of 62 weeks of acute follow-up; 11%) compared to control subjects (24 of 79 weeks; 30%)(OR 0.34, 95%CI:0.13-0.92).","['youth (aged 16-26) hospitalized following SH', 'youth admitted to hospital following an episode of self-harm', 'Twenty-four subjects were enrolled (12 per group) with one BCBT subject and two controls dropping out prior to the first therapy session']","['Cognitive behavioral therapy', 'suicide prevention vs. minimally-directive supportive psychotherapy', 'cognitive behavioral therapy (BCBT']",['repeat SH'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",24.0,0.0327244,"There were significantly fewer instances of repeat SH in BCBT subjects (7 of 62 weeks of acute follow-up; 11%) compared to control subjects (24 of 79 weeks; 30%)(OR 0.34, 95%CI:0.13-0.92).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sinyor', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada. Electronic address: mark.sinyor@sunnybrook.ca.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Athabasca University, Athabasca, AB, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Zaheer', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, Utah, United States; Department of Psychology, University of Utah, Utah, United States.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Westreich', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Selchen', 'Affiliation': 'Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Evaluative Clinical Sciences, Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Canada; Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Homer', 'Initials': 'H', 'LastName': 'Tien', 'Affiliation': 'Evaluative Clinical Sciences, Tory Trauma Program, Sunnybrook Research Institute, Toronto, Canada; Department of General Surgery, Faculty of Medicine, University of Toronto, Toronto, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.178']
75,32056951,Rostral anterior cingulate glutamate predicts response to subcallosal deep brain stimulation for resistant depression.,"BACKGROUND


Deep brain stimulation (DBS) of the subcallosal cingulate (SCC) provided benefit for treatment-resistant depression (TRD) in open-label studies but failed in a recent randomized sham-controlled trial. Informed patient selection, based on reliable biomarkers, is needed to optimize outcome. We investigated if rostral anterior cingulate (rACC) glutamate/glutamine concentration could serve as a potential biomarker of response.
METHODS


Sixteen adults with TRD (Major Depression; MDD = 14; Bipolar Depression; BD =2) underwent proton magnetic resonance spectroscopy using a short-echo proton spectroscopy with a voxel placed in the rACC, prior to DBS. Improvement in depression was assessed using the 17-item Hamilton Rating Scale for Depression (HDRS). Glutamate and glutamine concentrations at baseline in the rACC were examined in relation to clinical outcomes at six months.
RESULTS


Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013). Neither baseline glutamine nor glutamine/glutamate ratio significantly related to outcome or symptom improvement.
LIMITATIONS


Our study was limited by sample size, though it is large for a DBS study. We measured from a single voxel in the brain, so we cannot be certain our findings are specific to the rACC.
CONCLUSIONS


These preliminary results suggest that baseline rACC-glutamate concentration could serve as a response-predictive biomarker for SCC-DBS, particularly in patients with resistant major depression. If our findings are replicated and validated, rACC-glutamate may provide a basis to prospectively select TRD patients to improve likelihood of response to SCC-DBS.",2020,"RESULTS


Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013).","['patients with resistant major depression', 'Sixteen adults with TRD (Major Depression; MDD\xa0=\xa014; Bipolar Depression; BD =2) underwent']","['proton magnetic resonance spectroscopy using a short-echo proton spectroscopy with a voxel placed in the rACC, prior to DBS', 'rostral anterior cingulate (rACC) glutamate/glutamine concentration', 'Deep brain stimulation (DBS) of the subcallosal cingulate (SCC']","['Glutamate and glutamine concentrations', 'baseline glutamine nor glutamine/glutamate ratio', 'HDRS reduction', 'HDRS scores', '17-item Hamilton Rating Scale for Depression (HDRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}]","[{'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}]",16.0,0.0519456,"RESULTS


Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013).","[{'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: dlclark@ucalgary.ca.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'MacMaster', 'Affiliation': ""Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada; Department of Radiology, University of Calgary, Calgary, AB, Canada; Child and Adolescent Imaging Research (CAIR) Program, Alberta Children's Hospital, 2888 Shaganappi Trail NW, Calgary, Alberta, T3B 6A8 Canada. Electronic address: fmacmast@ucalgary.ca.""}, {'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Neuroscience Research Center, Berlin, Germany. Electronic address: elliot.c.brown@gmail.com.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: zkiss@ucalgary.ca.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: rramasub@ucalgary.ca.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.058']
76,32063564,"L-Carnosine combination therapy for major depressive disorder: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Evidence for antidepressant effects of L-Carnosine was shown in some experimental studies. In this study we tried to evaluate the efficacy and tolerability of L-Carnosine combination therapy in treatment of patients with major depressive disorder (MDD).
METHODS


Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks in a randomized double-blind, and placebo-controlled study. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6.
RESULTS


Fifty-two patients completed the trial. General linear model repeated measure showed significant difference for time × treatment on HAM-D score [F = 3.17, df = 2.39, p-value = 0.03]. Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6 [Ps = 0.013, 0.028 and 0.023; respectively]. Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group [Ps = 0.023 and 0.012; respectively]. There was no significant difference between the two groups in baseline parameters and frequency of side effects.
LIMITATIONS


Short follow-up period and small population size were two important limitations of this study.
CONCLUSIONS


L-Carnosine combination therapy with citalopram can effectively improve symptoms of patients with major depressive disorder. Rapid-onset antidepressant effects of L-Carnosine were also shown which need further investigation.",2020,"Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6","['Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score\xa0≥\xa019', 'major depressive disorder', 'patients with major depressive disorder (MDD', 'patients with major depressive disorder']","['L-Carnosine combination therapy', 'placebo', '400\xa0mg twice daily L-Carnosine or placebo in addition to citalopram', 'citalopram', 'L-Carnosine']","['HAM-D score', 'frequency of side effects', 'response and remission rate', 'efficacy and tolerability', 'HAM-D scale']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}]","[{'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0222045'}]",58.0,0.534727,"Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6","[{'ForeName': 'Behin', 'Initials': 'B', 'LastName': 'Araminia', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Shalbafan', 'Affiliation': 'Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shirazi', 'Affiliation': 'Mental Health Research Center, School of Behavioral Sciences and Mental Health, Tehran Institute of Psychiatry, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Salomeh', 'Initials': 'S', 'LastName': 'Ghaffari', 'Affiliation': 'School of Persian Medicine, Iran University of Medical Sciences, Research Institute for Islamic and Complementary Medicine, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran.'}, {'ForeName': 'Seyyed Hosein', 'Initials': 'SH', 'LastName': 'Mortazavi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Shariati', 'Affiliation': 'Mental Health Research Center, School of Behavioral Sciences and Mental Health, Tehran Institute of Psychiatry, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad Eftekhar', 'Initials': 'ME', 'LastName': 'Ardebili', 'Affiliation': 'Mental Health Research Center, School of Behavioral Sciences and Mental Health, Tehran Institute of Psychiatry, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, Iran. Electronic address: s.akhond@neda.net.'}]",Journal of affective disorders,['10.1016/j.jad.2020.02.020']
77,32213146,Effect of piezocision corticotomy on en-masse retraction:  A randomized controlled trial .,"OBJECTIVES


To compare the amount of en-masse retraction with or without piezocision corticotomy, to assess the type of tooth movement, to evaluate root integrity after retraction, and to record reported pain levels.
MATERIALS AND METHODS


This randomized, controlled clinical trial included 26 orthodontic patients requiring premolar extraction. The patients were divided into two groups: (1) an extraction with piezocision corticotomy group (PCG) and (2) an extraction-only group, which served as the control group (CG). Cone-beam computed tomography images were acquired before and 4 months after the initiation of en-masse retraction utilizing miniscrews. The following variables were assessed: the amount of en-masse retraction, incisor inclination, incisor and canine root resorption, and patient-reported pain.
RESULTS


Twelve and 11 participants completed the entire study in the PCG and CG, respectively. The amount of en-masse retraction was significantly greater in the PCG compared to the CG (mean = 4.8 ± 0.57 mm vs 2.4 ± 0.33 mm, respectively [ P  < .001]). There was also significantly less tipping and root resorption of incisors in the PCG ( P  < .05). The reported pain was significantly higher on the first day in the PCG compared to the CG ( P  < .001); however, it became similar between the groups after 24 hours.
CONCLUSIONS


Piezocision corticotomy enhanced the amount of en-masse retraction two times more with less root resorption. However, future studies are required to assess the long-term effects of this technique.",2020,There was also significantly less tipping and root resorption of incisors in the PCG ( P  < .05).,"['en-masse retraction', '26 orthodontic patients requiring premolar extraction']","['piezocision corticotomy', 'Piezocision corticotomy', 'en-masse retraction with or without piezocision corticotomy', 'extraction with piezocision corticotomy group (PCG) and (2) an extraction-only group, which served as the control group (CG']","['tipping and root resorption of incisors', 'amount of en-masse retraction', 'amount of en-masse retraction, incisor inclination, incisor and canine root resorption, and patient-reported pain', 'reported pain']","[{'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",26.0,0.0403627,There was also significantly less tipping and root resorption of incisors in the PCG ( P  < .05).,"[{'ForeName': 'Abdulkarim A', 'Initials': 'AA', 'LastName': 'Hatrom', 'Affiliation': ''}, {'ForeName': 'Khalid H', 'Initials': 'KH', 'LastName': 'Zawawi', 'Affiliation': ''}, {'ForeName': 'Reem M', 'Initials': 'RM', 'LastName': 'Al-Ali', 'Affiliation': ''}, {'ForeName': 'Hanadi M', 'Initials': 'HM', 'LastName': 'Sabban', 'Affiliation': ''}, {'ForeName': 'Talal M', 'Initials': 'TM', 'LastName': 'Zahid', 'Affiliation': ''}, {'ForeName': 'Ghassan A', 'Initials': 'GA', 'LastName': 'Al-Turki', 'Affiliation': ''}, {'ForeName': 'Ali H', 'Initials': 'AH', 'LastName': 'Hassan', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/092719-615.1']
78,31309333,"Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG.","PURPOSE


To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up.
METHODS


Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days.
RESULTS


Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20-1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups.
CONCLUSIONS


No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.",2019,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"['Eighty-nine patients with CLBP and type 1 MC or mixed MC', 'chronic low back pain with type 1 Modic changes', 'chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up']","['lactic acid bacteria', 'capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100\xa0days', 'placebo', 'Probiotics']","['outcomes disability and back\u2009+\u2009leg pain', 'global effect or percentage with minimal disability', 'gastrointestinal side effects', 'back pain']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1210581', 'cui_str': 'Lactic Acid Bacteria'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",89.0,0.459244,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"[{'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jensen', 'Affiliation': 'Spine Center, Research Unit, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Andersen', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'René D', 'Initials': 'RD', 'LastName': 'Østgård', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Niels T', 'Initials': 'NT', 'LastName': 'Andersen', 'Affiliation': 'Department of Biostatistics, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'DEFACTUM, Central Denmark Region, Aarhus, Denmark.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06046-6']
79,30699073,Muscle stretching - the potential role of endogenous pain inhibitory modulation on stretch tolerance.,"Background and aims The effect of stretching on joint range of motion is well documented and is primarily related to changes in the tolerance to stretch, but the mechanisms underlying this change are still largely unknown. The aim of this study was to investigate the influence of a remote, painful stimulus on stretch tolerance. Methods Thirty-four healthy male subjects were recruited and randomly assigned to an experimental pain group (n=17) or a control group (n=17). Passive knee extension range of motion, the activity of hamstring muscles and passive resistive torque were measured with subjects in a seated position. Three consecutive measures were performed with a 5-min interval between. A static stretch protocol was utilized in both groups to examine the effect of stretching and differences in stretch tolerance between groups. Following this, the pain-group performed a cold pressor test which is known to engage the endogenous pain inhibitory system after which measurements were repeated. Results A significant increase in knee extension range of motion was found in the pain group compared with controls (ANCOVA: p<0.05). No difference was found in muscle activity or passive resistive torque between groups (ANCOVA p>0.091). Conclusions Passive knee extension range of motion following stretching increased when following a distant, painful stimulus, potentially engaging the endogenous pain inhibitory systems. Current findings indicate a link between increased tolerance to stretch and endogenous pain inhibition. Implications The current findings may have implications for clinical practice as they indicate that a distant painful stimulus can influence range of motion in healthy individuals. This implies that the modulation of pain has significance for the efficacy of stretching which is important knowledge when prescribing stretching as part of rehabilitation.",2019,No difference was found in muscle activity or passive resistive torque between groups (ANCOVA p>0.091).,"['Methods Thirty-four healthy male subjects', 'healthy individuals']","['experimental pain group', 'control group']","['knee extension range of motion', 'muscle activity or passive resistive torque', 'Passive knee extension range of motion, the activity of hamstring muscles and passive resistive torque']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0584895', 'cui_str': 'Hamstring Muscles'}]",34.0,0.0251063,No difference was found in muscle activity or passive resistive torque between groups (ANCOVA p>0.091).,"[{'ForeName': 'Morten Pallisgaard', 'Initials': 'MP', 'LastName': 'Støve', 'Affiliation': 'Department of Physiotherapy, University College of Northern Denmark (UCN), Selma Lagerløfs Vej 2, 9220 Aalborg East, Denmark, Phone: 004522980862.'}, {'ForeName': 'Rogerio Pessoto', 'Initials': 'RP', 'LastName': 'Hirata', 'Affiliation': 'SMI® , Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg East, Denmark.'}, {'ForeName': 'Thorvaldur Skuli', 'Initials': 'TS', 'LastName': 'Palsson', 'Affiliation': 'SMI® , Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg East, Denmark.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0334']
80,32404389,Focus group discussions on low-flow oxygen and bubble CPAP treatments among mothers of young children in Malawi: a CPAP IMPACT substudy.,"OBJECTIVE


To determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy.
SETTING


A district hospital in Salima, Malawi.
PARTICIPANTS


We conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183).
PRIMARY AND SECONDARY OUTCOME MEASURES


FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts.
RESULTS


Community perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that 'oxygen kills babies'. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
CONCLUSION


There are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.",2020,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","['mothers of children who had received either therapy', 'We conducted eight focus group discussions (FGDs) with a total of 54 participants', 'A district hospital in Salima, Malawi', 'Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent', 'mothers of young children in Malawi']","['bubble continuous positive airway pressure (bCPAP) and low-flow oxygen', 'bCPAP', 'CPAP IMPACT', 'low-flow oxygen and bubble CPAP treatments']","[""FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP""]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205454', 'cui_str': '8'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020006', 'cui_str': 'District hospital'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",54.0,0.106875,"After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers.
","[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Sessions', 'Affiliation': 'Pediatrics, McGaw Medical Center of Northwestern University, Chicago, Illinois, United States ksessions@luriechildrens.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ruegsegger', 'Affiliation': 'Project Malawi, University of North Carolina System, Lilongwe, Malawi.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Davie', 'Initials': 'D', 'LastName': 'Kondowe', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mercy', 'Initials': 'M', 'LastName': 'Tsidya', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'Acute Respiratory Infection Unit, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Eckerle', 'Affiliation': ""Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.""}, {'ForeName': 'Andrew Gerald', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': 'Pediatric Critical Care Medicine, University of Utah, Salt Lake City, Utah, United States.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, United States.'}]",BMJ open,['10.1136/bmjopen-2019-034545']
81,32404390,Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial.,"INTRODUCTION


Adolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
METHODS AND ANALYSIS


A two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.
ETHICS AND DISSEMINATION


The study was approved by the Swedish Ethical Review Authority (no. 2019-03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.
TRIAL REGISTRATION NUMBER


24 September 2019, ISRCTN91048246; Pre-results.",2020,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","['adolescents and young adults aged 15 to 25 years', 'substance using adolescents and young adults', 'adolescents and young adults', 'adolescents and young adults with risky alcohol and other substance use', '800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble']",['automated digital brief prevention intervention'],"['binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure', 'reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0562366', 'cui_str': 'Pressured by peers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.0827623,"The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.
","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kvillemo', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden pia.kvillemo@ki.se.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Strandberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gripenberg', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Skoglund', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Tobias H', 'Initials': 'TH', 'LastName': 'Elgán', 'Affiliation': 'STAD (Stockholm Prevents Alcohol and Drug Problems), Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034894']
82,32114475,Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL).,"INTRODUCTION


There has been an interest in studying the efficacy of extreme hypofractionation in low and intermediate risk prostate cancer utilising the low alpha/beta ratio of prostate. Its role in high-risk and node-positive prostate cancer, however, is unknown. We hypothesise that a five-fraction schedule of extreme hypofractionation will be non-inferior to a moderately hypofractionated regimen over 5 weeks in efficacy and will have acceptable toxicity and quality of life while reducing the cost implications during treatment.
METHODS AND ANALYSIS


This is an ongoing, non-inferiority, multicentre, randomised trial (NCT03561961) of two schedules for National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate. The standard arm will be a schedule of 68 Gy/25# over 5 weeks while the test arm will be extremely hypofractionated radiotherapy with stereotactic body radiation therapy to 36.25 Gy/5# (7 to 10 days). The block randomisation will be stratified by nodal status (N0/N+), hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy) and centre. All patients will receive daily image-guided radiotherapy.The primary end point is 4-year biochemical failure free survival (BFFS). The power calculations assume 4-year BFFS of 80% in the moderate hypofractionation arm. With a 5% one-sided significance and 80% power, a total of 434 patients will be randomised to both arms equally (217 in each arm). The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.
DISCUSSION


The trial aims to establish a therapeutically efficacious and cost-efficient modality for high-risk and node-positive prostate cancer with an acceptable toxicity profile. Presently, this is the only trial evaluating and answering such a question in this cohort.
ETHICS AND DISSEMINATION


The trial has been approved by IEC-III of Tata Memorial Centre, Mumbai.
TRIAL REGISTRATION NUMBER


Registered with CTRI/2018/05/014054 (http://ctri.nic.in) on 24 May 2018.",2020,"The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.
","['434 patients', 'National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate']","['prostate radiotherapy', 'daily image-guided radiotherapy', 'hypofractionated radiotherapy with stereotactic body radiation therapy', 'hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy', 'CTRI/2018/05/014054 (http://ctri.nic.in']","['4-year biochemical failure free survival (BFFS', 'overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1384494', 'cui_str': 'Carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3179062', 'cui_str': 'Image-Guided Radiation Therapy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0029189', 'cui_str': 'Orchidectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C3815933', 'cui_str': 'Expenditures, Out-of-Pocket'}]",434.0,0.360152,"The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.
","[{'ForeName': 'Vedang', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India vmurthy@actrec.gov.in.'}, {'ForeName': 'Indranil', 'Initials': 'I', 'LastName': 'Mallick', 'Affiliation': 'Department of Radiation Oncology, Tata Medical Centre, Kolkata, India.'}, {'ForeName': 'Abhilash', 'Initials': 'A', 'LastName': 'Gavarraju', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Shwetabh', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Krishnatry', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Tejshri', 'Initials': 'T', 'LastName': 'Telkhade', 'Affiliation': 'Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Arunsingh', 'Initials': 'A', 'LastName': 'Moses', 'Affiliation': 'Department of Radiation Oncology, Tata Medical Centre, Kolkata, India.'}, {'ForeName': 'Sadhna', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Prakash', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Mahendra', 'Initials': 'M', 'LastName': 'Pal', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Pathology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Popat', 'Affiliation': 'Department of Radiology, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rangarajan', 'Affiliation': 'Department of Nuclear Imaging and Bio imaging, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Archi', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Nuclear Imaging and Bio imaging, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Sheetal', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Clinical Research Secretariat, Tata Memorial Centre, Mumbai, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Bakshi', 'Affiliation': 'Division of Uro-Oncology, Tata Memorial Centre, Mumbai, India.'}]",BMJ open,['10.1136/bmjopen-2019-034623']
83,32114477,"Medroxyprogesterone acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and endometrial carcinoma: trial protocol for a prospective, randomised, open, blinded-endpoint design, dose-response trial (FELICIA trial).","INTRODUCTION


Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC). However, the results of three meta-analyses revealed a high remission rate, as well as an association with a high rate of relapse. We previously conducted a phase II of medroxyprogesterone acetate (MPA) plus metformin as a fertility-sparing treatment for AEH and EC patients, and reported that metformin inhibited disease relapse after remission.
METHODS AND ANALYSIS


A randomised, open, blinded-endpoint design phase IIb dose response trial was planned to commence in July 2019. The trial aims to identify the appropriate dose of metformin to be combined with MPA therapy for fertility - sparing treatment of patients with AEH and EC. The primary endpoint of the trial is the 3-year relapse-free survival (RFS) rate. The secondary endpoints are RFS rate, the overall rate of response to MPA therapy, the conception rate after treatment, the outcome of pregnancy, toxicity evaluation and changes in insulin resistance and body mass index. A total of 120 patients will be enrolled from 15 Japanese institutions within a 2.5-year period and followed up for at least 3 years.
ETHICS AND DISSEMINATION


The protocol was approved by the institutional review board at Chiba University Hospital and boards at 14 other institutions. The trial will be conducted according to the principles of the World Medical Association's Declaration of Helsinki and in accordance with Good Clinical Practice (GCP) standards. The trial findings will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Japan Registry of Clinical Trials (jRCT2031190065).",2020,Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC).,"['patients with AEH and EC', 'patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC', 'atypical endometrial hyperplasia and endometrial carcinoma', '120 patients will be enrolled from 15 Japanese institutions within a 2.5-year period and followed up for at least 3 years']","['metformin', 'MPA therapy', 'Progestin therapy', 'Medroxyprogesterone acetate plus metformin', 'medroxyprogesterone acetate (MPA) plus metformin']","['3-year relapse-free survival (RFS) rate', 'high remission rate', 'RFS rate, the overall rate of response to MPA therapy, the conception rate after treatment, the outcome of pregnancy, toxicity evaluation and changes in insulin resistance and body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349579', 'cui_str': 'Atypical Endometrial Hyperplasia'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",120.0,0.180097,Progestin therapy is the only fertility-sparing treatment option for patients with atypical endometrial hyperplasia (AEH) and endometrial cancer (EC).,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mitsuhashi', 'Affiliation': 'Department of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan antira@faculty.chiba-u.jp.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hori', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Tadami', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hanaoka', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Shozu', 'Affiliation': 'Department of Reproductive Medicine, Chiba University Graduate School of Medicine School of Medicine, Chiba, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-035416']
84,32114479,"i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.","INTRODUCTION


There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue.
METHODS AND ANALYSIS


Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning.
ETHICS AND DISSEMINATION


This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients.
TRIAL REGISTRATION NUMBER


ACTRN12619000952145; Pre-results.",2020,The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined.,"['patients with advanced melanoma receiving', 'Thirty participants will be recruited from a specialist cancer centre between May and September, 2019', 'patients with advanced melanoma receiving immunotherapy', '30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent']","['personalised exercise intervention', 'exercise intervention', 'exercise', 'ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab', 'immunotherapy', 'personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove', 'Immunotherapy', 'iMove, or usual care (an information booklet about exercise']","['safety, adherence to and acceptability', 'Physical assessments measure physical fitness and functioning', ' fatigue, role functioning, symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0260141', 'cui_str': 'Physiologist (occupation)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",30.0,0.3676,The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined.,"[{'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Hyatt', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Gough', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Murnane', 'Affiliation': 'ONTrac at Peter Mac Victorian Adolescent and Young Adult Cancer Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Au-Yeung', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Dawson', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Haryana', 'Initials': 'H', 'LastName': 'Dhillon', 'Affiliation': 'Centre for Medical Psychology and Evidence-based Decision-making, School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Melanoma and Skin Cancer Trials Ltd, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Paton', 'Affiliation': 'Melanoma and Skin Cancer Trials Ltd, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Billett', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Traill', 'Affiliation': 'Occupational Therapy and Physiotherapy Department, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Bristol-Myers Squibb Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Beedle', 'Affiliation': 'Melanoma Patients Australia, Brisbane, Queensland, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Milne', 'Affiliation': 'Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia donna.milne@petermac.org.'}]",BMJ open,['10.1136/bmjopen-2019-036059']
85,32173259,"A comparison of acute glycaemic responses to accumulated or single bout walking exercise in apparently healthy, insufficiently active adults.","OBJECTIVES


To investigate the acute glyacaemic response to accumulated or single bout walking exercise in apparently healthy adults.
DESIGN


Three arm, randomised crossover control study.
METHODS


Ten adults (age: 50±12.6 y; BMI 29.0±5.4kgm -2 ) completed three separate trials comprising three 10-min walking bouts after breakfast, lunch, and dinner (APPW), a single 30-min walking bout after dinner only (CPPW), or a no-exercise control (NOEX). Participants walked on a treadmill at a moderate intensity of 55%-70% heart rate reserve. Two-hour postprandial glucose response was assessed using a continuous glucose monitor.
RESULTS


There was a difference in the pattern of the glucose response between the trials during the two hours following dinner (p<0.001). Postprandial dinner glucose concentrations were not different between APPW and CPPW but were up to 1.01mmolL -1  lower than NOEX (partial eta 2 =0.21, p=0.041).
CONCLUSIONS


Ten minutes of moderate intensity walking completed 30min after each meal lowers postprandial dinner glucose concentrations in comparison to no-exercise, and reduces glucose by a similar magnitude as a single 30-min bout after the evening meal. Short bouts of exercise after each meal may be recommended to minimise glucose elevations after dinner that might increase risk of cardiometabolic disease.",2020,"Ten minutes of moderate intensity walking completed 30min after each meal lowers postprandial dinner glucose concentrations in comparison to no-exercise, and reduces glucose by a similar magnitude as a single 30-min bout after the evening meal.","['Ten adults (age: 50±12.6', 'apparently healthy, insufficiently active adults', 'apparently healthy adults']","['single bout walking exercise', '10-min walking bouts after breakfast, lunch, and dinner (APPW), a single 30-min walking bout after dinner only (CPPW), or a no-exercise control (NOEX']","['glucose response', 'postprandial dinner glucose concentrations', 'postprandial glucose response', 'Postprandial dinner glucose concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1550743', 'cui_str': 'After breakfast (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C1879671', 'cui_str': 'After dinner (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",10.0,0.0939458,"Ten minutes of moderate intensity walking completed 30min after each meal lowers postprandial dinner glucose concentrations in comparison to no-exercise, and reduces glucose by a similar magnitude as a single 30-min bout after the evening meal.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Shambrook', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, Australia.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Kingsley', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'School of Allied Health, Human Services and Sport, La Trobe University, Australia.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Wundersitz', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, Australia.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wundersitz', 'Affiliation': 'Angliss Hospital Community Rehabilitation Program, Eastern Health, Australia.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Paton', 'Affiliation': 'School of Health and Sport Science, Eastern Institute of Technology, New Zealand.'}, {'ForeName': 'Brett A', 'Initials': 'BA', 'LastName': 'Gordon', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, Australia. Electronic address: b.gordon@latrobe.edu.au.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.02.015']
86,32209619,Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.,"OBJECTIVES


The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.
DESIGN


In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.
SETTING


This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.
PARTICIPANTS


368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.
INTERVENTIONS


NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.
PRIMARY AND SECONDARY OUTCOME MEASURES


Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.
RESULTS


In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.
CONCLUSIONS


NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.
TRIAL REGISTRATION NUMBERS


NCT01480362 and DRKS00003347.",2020,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","['191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes', 'Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included', '40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care', '96 participants in the NPWT arm and 72 participants in the', 'patients with diabetic foot wounds in clinical practice', '368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population']","['standard moist wound care', 'Negative pressure wound therapy', 'NPWT', 'SMWC', 'negative pressure wound therapy (NPWT', 'NPWT was compared with standard moist wound care (SMWC']","['wound closure rate', 'wound closure within 16 weeks', 'Overall, wound closure rate', 'wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months', 'diabetic foot ulcers', 'time to wound closure']","[{'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}]",368.0,0.180456,"191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes.","[{'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Seidel', 'Affiliation': 'Institut für Forschung in der Operativen Medizin (IFOM), Universität Witten/Herdecke, Köln, Germany Doerthe.Seidel@uni-wh.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Storck', 'Affiliation': 'Klinik für Gefäß- und Thoraxchirurgie, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Lawall', 'Affiliation': 'Praxis für Herzkreislauferkrankungen, Ettlingen, Germany.'}, {'ForeName': 'Gernold', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Gefäßchirurgische Klinik, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mauckner', 'Affiliation': 'Innere Medizin, St. Remigius Krankenhaus Opladen, Leverkusen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hochlenert', 'Affiliation': 'Gemeinschaftspraxis Schlotmann-Hochlenert-Zavaleta-Haberstock, Köln, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wetzel-Roth', 'Affiliation': 'Chirurgische Praxis Wetzel-Roth, Buchloe, Germany.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Sondern', 'Affiliation': 'Klinik für Innere Medizin/Diabetologie, Marien Hospital Dortmund-Hombruch, Dortmund, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Allgemein- und Viszeralchirurgie, Helfenstein Klinik, Geisslingen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Rothenaicher', 'Affiliation': 'Chirurgische Praxis Rothenaicher, München, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krönert', 'Affiliation': 'Klinik für Gefäßchirurgie, Thüringen-Kliniken ""Georgius Agricola"" GmbH, Saalfeld, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Zink', 'Affiliation': 'Diabetes Klinik, Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Neugebauer', 'Affiliation': 'Department fur Humanmedizin, Universität Witten/Herdecke, Witten, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-026345']
87,32165549,MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.,"OBJECTIVES


To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain.
DESIGN


Three arm randomised feasibility trial.
SETTING


Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing.
PARTICIPANTS


Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised.
INTERVENTIONS


Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days.
PRIMARY AND SECONDARY OUTCOME MEASURES


Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months.
RESULTS


The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1).
CONCLUSIONS


Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement.
TRIAL REGISTRATION NUMBERS


NCT02721108; ISRCTN10925965; Results.",2020,"Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control).","['women with chronic pelvic pain', 'Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up', '90 women were randomised', 'women with chronic pelvic pain presenting to gynaecology clinics', 'Women were recruited at two gynaecology clinics in the UK', 'Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6\u2009months or more, and had access to a computer or smartphone']","['smartphone app using psychological approaches', 'Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app', 'modified, pre-existing, mindfulness meditation smartphone app']","['pain acceptance scores', 'length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",90.0,0.260056,"Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control).","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Forbes', 'Affiliation': ""IoPPN, King's College London, London, UK.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Newton', 'Affiliation': 'Centre for Primary Care and Population Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cantalapiedra Calvete', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': 'Pelvic Pain Support Network, Poole, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Women's Health Research Unit, Barts and The London School of Medicine and Dentistry, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Centre for Primary Care and Population Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Department of Public Health, University of Granada, Granada, Spain.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Röhricht', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Centre for Psychiatry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ball', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK elizabeth.ball9@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2019-030164']
88,32165550,mHealth: providing a mindfulness app for women with chronic pelvic pain in gynaecology outpatient clinics: qualitative data analysis of user experience and lessons learnt.,"OBJECTIVES


To determine whether a pre-existing smartphone app to teach mindfulness meditation is acceptable to women with chronic pelvic pain (CPP) and can be integrated into clinical practice within the National Health Service (NHS) CPP pathways, and to inform the design of a potential randomised clinical trial.
DESIGN


A prestudy patient and public involvement (PPI) group to collect feedback on the acceptability of the existing app and study design was followed by a three-arm randomised feasibility trial. In addition, we undertook interviews and focus groups with patients and staff to explore app usability and acceptability. We also obtained participant comments on the research process, such as acceptability of the study questionnaires.
SETTING


Two gynaecology clinics within Barts Health NHS, London, UK.
PARTICIPANTS


Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English.
INTERVENTION


The intervention was mindfulness meditation content plus additional pain module delivered by a smartphone app. Active controls received muscle relaxation content from the same app. Passive (waiting list) controls received usual care.
MAIN OUTCOME MEASURES


Themes on user feedback, app usability and integration, and reasons for using/not using the app.
RESULTS


The use of the app was low in both active groups. Patients in the prestudy PPI group, all volunteers, were enthusiastic about the app (convenience, content, portability, flexibility, ease of use). Women contributing to the interview or focus group data (n=14), from a 'real world' clinic (some not regular app users), were less positive, citing as barriers lack of opportunities/motivation to use the app and lack of familiarity and capabilities with technology. Staff (n=7) were concerned about the potential need for extra support for them and for the patients, and considered the app needed organisational backing and peer acceptance.
CONCLUSION


The opinions of prestudy PPI volunteers meeting in their private time may not represent those of patients recruited at a routine clinic appointment. It may be more successful to codesign/codevelop an app with typical users than to adapt existing apps for use in real-world clinical populations.
TRIAL REGISTRATION NUMBER


ISRCTN10925965.",2020,The use of the app was low in both active groups.,"['Two gynaecology clinics within Barts Health NHS, London, UK', 'Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English', 'women with chronic pelvic pain (CPP', 'women with chronic pelvic pain in gynaecology outpatient clinics']","['Passive (waiting list) controls received usual care', 'public involvement (PPI) group to collect feedback', 'mindfulness meditation content plus additional pain module delivered by a smartphone app', 'pre-existing smartphone app to teach mindfulness meditation']","['user feedback, app usability and integration, and reasons for using/not using the app', 'muscle relaxation content']","[{'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.0476217,The use of the app was low in both active groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ball', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Newton', 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rohricht', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute for Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Birch', 'Affiliation': 'Pelvic Pain Support Network, Poole, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Cantalapiedra Calvete', 'Affiliation': 'Department of Obstetrics and Gynaecology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'UCL Social Research Institute, University College London, London, UK c.rivas@ucl.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-030711']
89,32066598,Randomised controlled trial to investigate the relationship between mild hypercapnia and cerebral oxygen saturation in patients undergoing major surgery.,"OBJECTIVES


The effects of hypercapnia on regional cerebral oxygen saturation (rSO 2 ) during surgery are unclear. We conducted a randomised controlled trial to investigate the relationship between mild hypercapnia and rSO 2 . We hypothesised that, compared with targeted normocapnia (TN), targeted mild hypercapnia (TMH) during major surgery would increase rSO 2 .
DESIGN


A prospective, randomised, controlled trial in adult participants undergoing elective major surgery.
SETTING


A single tertiary centre in Heidelberg, Victoria, Australia.
PARTICIPANTS


40 participants were randomised to either a TMH or TN group (20 to each).
INTERVENTIONS


TMH (partial pressure of carbon dioxide in arterial blood, PaCO 2 , 45-55 mm Hg) or TN (PaCO 2  35-40 mm Hg) was delivered via controlled ventilation throughout surgery.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary endpoint was the absolute difference between the two groups in percentage change in rSO 2  from baseline to completion of surgery. Secondary endpoints included intraoperative pH, bicarbonate concentration, base excess, serum potassium concentration, incidence of postoperative delirium and length of stay (LOS) in hospital.
RESULTS


The absolute difference between the two groups in percentage change in rSO 2  from the baseline to the completion of surgery was 19.0% higher in both hemispheres with TMH (p<0.001). On both sides, the percentage change in rSO 2  was greater in the TMH group than the TN group throughout the duration of surgery. The difference between the groups became more noticeable over time. Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02). LOS was similar between groups (5 days vs 5 days; p=0.99).
CONCLUSION


TMH was associated with a stable increase in rSO 2  from the baseline, while TN was associated with a decrease in rSO 2  in both hemispheres in patients undergoing major surgery. This resulted in a clear separation of percentage change in rSO 2  from the baseline between TMH and TN over time. Our findings provide the rationale for larger studies on TMH during surgery.
TRIAL REGISTRATION NUMBER


The Australian New Zealand Clinical Trials Registry (ACTRN12616000320459).",2020,"Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02).","['A single tertiary centre in Heidelberg, Victoria, Australia', 'patients undergoing major surgery', 'adult participants undergoing elective major surgery', '40 participants']","['TMH', 'hypercapnia', 'TMH (partial pressure of carbon dioxide in arterial blood, PaCO 2 , 45-55\u2009mm Hg) or TN (PaCO 2  35-40\u2009mm Hg) was delivered via controlled ventilation throughout surgery', 'TMH or TN']","['LOS', 'regional cerebral oxygen saturation', 'mild hypercapnia and cerebral oxygen saturation', 'intraoperative pH, bicarbonate concentration, base excess, serum potassium concentration, incidence of postoperative delirium and length of stay (LOS) in hospital', 'postoperative delirium']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201985', 'cui_str': 'Base excess - observation'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",40.0,0.425041,"Furthermore, postoperative delirium was higher in the TN group (risk difference 0.3, 95% CI 0.1 to 0.5, p=0.02).","[{'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'The Department of Medicine, Austin Health, The Univesity of Melbourne, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cowie', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Chong Oon', 'Initials': 'CO', 'LastName': 'Tan', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tremewen', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Pearce', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Param', 'Initials': 'P', 'LastName': 'Pillai', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Dharshi', 'Initials': 'D', 'LastName': 'Karalapillai', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia laurence.weinberg@austin.org.au.'}]",BMJ open,['10.1136/bmjopen-2019-029159']
90,30703062,"Risk-based targeting of adjuvant pregabalin treatment in laparoscopic cholecystectomy: a randomized, controlled trial.","Background and aims Pain is the most common reason for delayed discharge after day-case laparoscopic cholecystectomy. This study investigates a simple five-item questionnaire in evaluating the risk of postoperative pain in day-case cholecystectomy and the efficacy and safety of single-dose preoperative pregabalin on patients with multiple risk factors for pain. There are no previous studies on targeting adjuvant pain treatment based on the individual risk factors like the preoperative state of anxiety, acute or chronic pain, and the expectation of pain in day-case surgery. Methods One hundred and thirty patients scheduled for day-case laparoscopic cholecystectomy were evaluated with a five-item questionnaire assessing the risk for postoperative pain. The patients with multiple risk factors (n=60) were randomized to receive either pregabalin 150 mg or placebo, 1 h before surgery. The primary outcome was abdominal pain intensity on numerical rating scale (NRS) 1 h after surgery. Pain, analgesic consumption and adverse effects during first three postoperative days, and the length of hospital stay were also recorded. Results Pregabalin 150 mg given as an adjuvant analgesic preoperatively did not decrease postoperative abdominal pain or opioid consumption in the first hour after surgery compared to placebo in a preselected group of patients with multiple risk factors for postoperative pain (p=0.31). Preoperative anxiety assessed with a scale of 0-10 had a positive association with postoperative pain (p=0.045). Conclusions and implications This was the first trial on systematically selecting patients with a high-risk factor profile for postoperative pain as a target for a preventive adjuvant analgesic intervention. Although numerous previous studies have identified various risk factors, including those used in the current trial, it seems to be challenging to use these risk factors as predictive tools for targeting adjuvant analgesics in day-case surgery. Preoperative anxiety has a positive association with postoperative pain in day-case laparoscopic cholecystectomy, and this should be taken into account when treating these patients.",2019,Preoperative anxiety assessed with a scale of 0-10 had a positive association with postoperative pain (p=0.045).,"['patients with a high-risk factor profile for postoperative pain as a target for a preventive adjuvant analgesic intervention', 'patients with multiple risk factors (n=60', 'laparoscopic cholecystectomy', 'Methods One hundred and thirty patients scheduled for day-case', 'patients with multiple risk factors for pain']","['placebo', 'laparoscopic cholecystectomy', 'Pregabalin', 'pregabalin 150 mg or placebo', 'single-dose preoperative pregabalin']","['postoperative pain', 'length of hospital stay', 'Preoperative anxiety', 'postoperative abdominal pain or opioid consumption', 'abdominal pain intensity on numerical rating scale (NRS', 'Pain, analgesic consumption and adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1658524', 'cui_str': 'pregabalin 150 MG'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",130.0,0.0787195,Preoperative anxiety assessed with a scale of 0-10 had a positive association with postoperative pain (p=0.045).,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'von Plato', 'Affiliation': 'Helsinki University Hospital, Jorvi Hospital, P. O. Box 800, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Mattila', 'Affiliation': 'Division of Perioperative Care, Jorvi Hospital, Department of Anesthesiology and Intensive Care Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Poikola', 'Affiliation': 'Division of Perioperative Care, Jorvi Hospital, Department of Anesthesiology and Intensive Care Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Hamunen', 'Affiliation': 'Helsinki Pain Clinic, Division of Pain Medicine, Department of Anesthesiology and Intensive Care Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Kontinen', 'Affiliation': 'Division of Perioperative Care, Jorvi Hospital, Department of Anesthesiology and Intensive Care Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0330']
91,32208922,Comparison of orthodontic space closure using micro-osteoperforation and passive self-ligating appliances or conventional fixed appliances: A randomized controlled trial .,"OBJECTIVES


To examine the effect of micro-osteoperforation (MOP) on the space closure rate using passive self-ligating or conventional brackets.
MATERIALS AND METHODS


This was a two-arm parallel randomized controlled trial undertaken at the outpatient department of a dental college. There were 60 participants (30 women and 30 men) who fulfilled the inclusion criteria. Both the study and control groups were subjected to MOPs throughout the period of space closure. MOPs were repeated every 28 days. The experimental group (mean age 19.5 ± 1.66 years) was bonded with passive self-ligating brackets while the control group (mean age 19.9 ± 1.13 years) was bonded with conventional brackets. Both groups were examined and compared for rate of space closure. An evaluation was conducted for both groups until the entire extraction space was closed and confirmed by evaluation of a tight contact between the canine and the second premolar using a piece of dental floss.
RESULTS


Before the initiation of retraction, all initial criteria were similar between the two groups ( P  > .05). No difference was observed between the two groups in the rate of space closure ( P  > .05).
CONCLUSIONS


MOP in conjunction with passive self-ligation does not increase the rate of orthodontic space closure when compared with MOP used with conventional brackets.",2020,"No difference was observed between the two groups in the rate of space closure ( P  > .05).
","['60 participants (30 women and 30 men) who fulfilled the inclusion criteria', 'experimental group (mean age 19.5 ± 1.66 years) was bonded with passive self-ligating brackets while the control group (mean age 19.9 ± 1.13 years) was bonded with conventional brackets', 'outpatient department of a dental college']","['passive self-ligating or conventional brackets', 'micro-osteoperforation (MOP', 'orthodontic space closure using micro-osteoperforation and passive self-ligating appliances or conventional fixed appliances']","['rate of space closure', 'rate of orthodontic space closure']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517510', 'cui_str': '1.66 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0066823', 'cui_str': 'morpholinopropane sulfonic acid'}, {'cui': 'C0376671', 'cui_str': 'Orthodontic Space Closure'}, {'cui': 'C0243112'}, {'cui': 'C0441421', 'cui_str': 'Permanent Retainer'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0376671', 'cui_str': 'Orthodontic Space Closure'}]",60.0,0.060213,"No difference was observed between the two groups in the rate of space closure ( P  > .05).
","[{'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Mittal', 'Affiliation': ''}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Attri', 'Affiliation': ''}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Batra', 'Affiliation': ''}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Sonar', 'Affiliation': ''}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Sreevatsan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/111119-712.1']
92,32184185,Efficacy and Safety of 5-HT4 Receptor Agonist Minesapride for Irritable Bowel Syndrome with Constipation in a Randomized Controlled Trial.,"BACKGROUND & AIMS


Treatment options for irritable bowel syndrome with constipation (IBS-C) are limited-new prokinetic drugs are needed. We evaluated the efficacy and safety of minesapride (DSP-6952), a partial agonist with high affinity for 5-HT4 receptors, in patients with IBS-C in Japan.
METHODS


We performed a double-blind phase 2 study of 171 patients with Rome III-defined IBS-C at 33 centers in Japan, from December 2012 through August 2013. Patients were randomly assigned to groups given minesapride (1, 4, 12, or 40 mg) or placebo once daily for 4 weeks. The primary outcome was efficacy, defined as improvement in the weekly frequency of complete spontaneous bowel movements (CSBMs), abdominal symptoms, and IBS-C symptoms (according to the Japanese version of the IBS severity index score). For evaluation of safety, adverse events (AEs) were recorded.
RESULTS


The least squares mean change from baseline in the weekly frequency of CSBMs was greater in all minesapride groups than in the placebo group at week 4 (40 mg vs placebo, P = .040). The abdominal symptoms score improved in minesapride 40 mg group. The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P = .048 and <.001 vs placebo, respectively). The proportions of patients with treatment-emergent AEs in the pooled minesapride and placebo groups were 55.0% and 60.0%, respectively. The most common treatment-emergent AE was diarrhea (in 42.9% and 37.1% of patients in the pooled minesapride and placebo groups, respectively).
CONCLUSIONS


In a phase 2 trial of patients with IBS-C in Japan, minesapride increased stool frequency (measured by CSBMs), reduced abdominal and overall IBS-C symptoms, and was well tolerated. Japan Pharmaceutical Information Center trial no: JapicCTI-122041.",2021,"The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P=.048 and <.001 vs placebo, respectively).","['Irritable Bowel Syndrome with Constipation', 'patients with IBS-C in Japan', '171 patients with Rome III-defined IBS-C at 33 centers in Japan, from December 2012 through August 2013', 'irritable bowel syndrome with constipation (IBS-C']","['5-HT4 Receptor Agonist Minesapride', 'minesapride', 'minesapride (DSP-6952', 'placebo']","['frequency of CSBMs', 'Efficacy and Safety', 'overall IBS severity index score', 'tolerated', 'safety, adverse events (AEs', 'abdominal symptoms score', 'weekly frequency of complete spontaneous bowel movements (CSBMs), abdominal symptoms, and IBS-C symptoms (according to the Japanese version of the IBS severity index score', 'diarrhea', 'stool frequency (measured by CSBMs), reduced abdominal and overall IBS-C symptoms']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0299247', 'cui_str': 'Receptors, Serotonin, 5-HT4'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]",171.0,0.416361,"The overall IBS severity index score decreased from baseline to week 4 in all treatment groups-especially in the 12 mg and 40 mg groups (P=.048 and <.001 vs placebo, respectively).","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.019']
93,32492087,Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


Abrocitinib, an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD).
Objective


To investigate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD in an identically designed trial.
Design, Setting, and Participants


This phase 3, double-blinded, placebo-controlled, parallel-group randomized clinical trial included patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months. Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019. Data were analyzed from September 13 to October 25, 2019.
Interventions


Patients were randomly assigned (2:2:1) to receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo for 12 weeks.
Main Outcomes and Measures


The coprimary end points were the proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75) at week 12. Key secondary end points included the proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points) at week 12. Other secondary end points included the proportion of patients achieving at least 90% improvement in EASI score (EASI-90). Safety was assessed via adverse events and laboratory monitoring.
Results


A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78, placebo. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs the placebo group achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses. Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group. Decreases in platelet count (2 [1.3%]) and laboratory values indicating thrombocytopenia (5 [3.2%]) were reported in the 200-mg group.
Conclusions and Relevance


Monotherapy with once-daily oral abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03575871.",2020,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","['patients with moderate-to-severe atopic dermatitis (AD', 'adolescents and adults with moderate-to-severe AD', 'Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019', 'Patients With Moderate-to-Severe Atopic Dermatitis', 'A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78', 'adolescents and adults with moderate-to-severe AD in an identically designed trial', 'patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months']","['Abrocitinib', 'abrocitinib', 'receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo', 'placebo']","['Efficacy and Safety', 'platelet count', 'Adverse events', 'proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points', 'EASI-90', 'PP-NRS', 'thrombocytopenia', 'efficacy and safety', 'serious adverse events', 'EASI-75', 'proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75', 'proportion of patients achieving at least 90% improvement in EASI score (EASI-90', 'IGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0420210', 'cui_str': 'Medication given'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",391.0,0.644566,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, Ontario, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Chudy', 'Initials': 'C', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.1406']
94,32171647,Dietary supplementation with New Zealand blackcurrant extract enhances fat oxidation during submaximal exercise in the heat.,"OBJECTIVES


This study investigated the effect of 7 days' supplementation with New Zealand blackcurrant extract on thermoregulation and substrate metabolism during running in the heat.
DESIGN


Randomized, double-blind, cross-over study.
METHODS


Twelve men and six women (mean±SD: Age 27±6 years, height 1.76±0.10m, mass 74±12kg, V̇O 2max  53.4±7.0mLkg -1 min -1 ) completed one assessment of maximal aerobic capacity and one familiarisation trial (18°C, 40% relative humidity, RH), before ingesting 2×300mgday -1  capsules of CurraNZ™ (each containing 105mg anthocyanin) or a visually matched placebo (2×300mg microcrystalline cellulose M102) for 7 days (washout 14 days). On day 7 of each supplementation period, participants completed 60min of fasted running at 65% V̇O 2max  in hot ambient conditions (34°C and 40% relative humidity).
RESULTS


Carbohydrate oxidation was decreased in the NZBC trial [by 0.24gmin -1  (95% CI: 0.21-0.27gmin -1 )] compared to placebo (p= 0.014, d=0.46), and fat oxidation was increased in the NZBC trial [by 0.12gmin -1  (95% CI: 0.10 to 0.15gmin -1 )], compared to placebo (p=0.008, d=0.57). NZBC did not influence heart rate (p=0.963), rectal temperature (p=0.380), skin temperature (p=0.955), body temperature (p=0.214) or physiological strain index (p=0.705) during exercise.
CONCLUSIONS


Seven-days intake of 600mg NZBC extract increased fat oxidation without influencing cardiorespiratory or thermoregulatory variables during prolonged moderate intensity running in hot conditions.",2020,NZBC extract increased fat oxidation without influencing cardiorespiratory or thermoregulatory variables during prolonged moderate intensity running in hot conditions.,"['Age 27±6 years, height 1.76±0.10m, mass 74±12kg, V̇O 2max', 'Twelve men and six women (mean±SD']","['New Zealand blackcurrant extract', 'CurraNZ™ (each containing 105mg anthocyanin) or a visually matched placebo', 'placebo', 'Dietary supplementation with New Zealand blackcurrant extract', 'NZBC', 'fasted running at 65% V̇O 2max  in hot ambient conditions', 'NZBC extract']","['heart rate (p=0.963), rectal temperature (p=0.380), skin temperature (p=0.955), body temperature (p=0.214) or physiological strain index', 'Carbohydrate oxidation', 'thermoregulation and substrate metabolism', 'fat oxidation']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Black Currant'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanins'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0005905', 'cui_str': 'Thermoregulation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",12.0,0.530855,NZBC extract increased fat oxidation without influencing cardiorespiratory or thermoregulatory variables during prolonged moderate intensity running in hot conditions.,"[{'ForeName': 'Ania M', 'Initials': 'AM', 'LastName': 'Hiles', 'Affiliation': 'Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Tessa R', 'Initials': 'TR', 'LastName': 'Flood', 'Affiliation': 'Occupational Performance Research Group, Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Occupational Performance Research Group, Institute of Sport, University of Chichester, UK. Electronic address: B.Lee@chi.ac.uk.'}, {'ForeName': 'Lucy E V', 'Initials': 'LEV', 'LastName': 'Wheeler', 'Affiliation': 'Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Costello', 'Affiliation': 'Occupational Performance Research Group, Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Ella F', 'Initials': 'EF', 'LastName': 'Walker', 'Affiliation': 'Occupational Performance Research Group, Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Ashdown', 'Affiliation': 'Occupational Performance Research Group, Institute of Sport, University of Chichester, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Kuennen', 'Affiliation': 'Department of Exercise Science, High Point University, USA.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, UK.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.02.017']
95,32086350,Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial.,"INTRODUCTION


Chronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants' perceptions about the therapy.
METHODS AND ANALYSIS


The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16-24 and 25-60 will be undertaken.
ETHICS AND DISSEMINATION


This study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups.
TRIAL REGISTRATION NUMBER


NCT02232100; Pre-results.",2020,"The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit.","['Participants with chronic musculoskeletal pain', 'Patients with chronic pain demonstrate attentional biases towards pain-related information', 'participants aged 16-24 and 25-60 will be undertaken', 'chronic musculoskeletal pain']","['online attentional bias modification training versus placebo training', '10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group', 'Internet-delivered attentional bias modification training (iABMT']","['pain interference', 'pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment']","[{'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.504369,"The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Liossi', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK cliossi@soton.ac.uk.'}, {'ForeName': 'Tsampikos', 'Initials': 'T', 'LastName': 'Georgallis', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Hamilton', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Applied Statistics Group, Engineering, Design and Mathematics, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Daniel Eric', 'Initials': 'DE', 'LastName': 'Schoth', 'Affiliation': 'Pain Research Laboratory, School of Psychology, University of Southampton, Southampton, Hampshire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030607']
96,30465720,Chronic Widespread Pain in a tertiary pain clinic: classification overlap and use of a patient generated quality of life instrument.,"Background and aims This study has two main aims: (1) To explore the overlap between classification criteria in patients with Chronic Widespread Pain (CWP) and (2) To explore the use of the Patient Generated Index (PGI) as a quality of life (QoL) measure in this patient group. Methods Patients with Widespread Pain (ICD-11: pain in four or more out of five bodily regions, i.e. the four quadrants and axially) in a tertiary pain outpatient clinic were assessed according to classification criteria for Fibromyalgia [FM, American College of Rheumatology (ACR) criteria of 1990, 2010, 2011 and 2016], Chronic Fatigue Syndrome [CFS, Fukuda, Canada and International Consensus Criteria (ICC)] and Bodily Distress Syndrome (BDS). Furthermore, patients completed the PGI to assess QoL, and electronic questionnaires including demographic variables and standardised patient-reported outcome measures (PROMs). Results All patients (n=33) fulfilled the criteria for musculoskeletal type single-organ BDS, 81.8% met the 2016 modified criteria for FM, 30.3% met the Canada criteria for CFS and 24.2% met the criteria for multi-organ type BDS. There was substantial agreement between the 2016 and the 2011 and 2010 criteria sets for FM compared to the 1990 criteria (κ=0.766 and 0.673 compared to 0.279). Patients generally scored low on the PGI, indicating poor QoL (mean PGI 28.9, SD 19.8, range 0-100). Conclusions Our findings support the use of the term musculoskeletal type single-organ BDS to describe patients with CWP and the 2016 revision of the FM criteria. The PGI provides useful clinical information which is not captured by standardised PROMs. Implications The terminology of CWP has become less ambiguous as the new ICD-11 is closely related to the generalised pain criterion of the modified 2016 FM definition. Studies based on the 1990 classification criteria for FM should not be directly compared to studies based on later criteria set. The PGI may be a supplement to other measurements to portray patients' individual concerns in patients with complex symptom disorders.",2019,"Patients generally scored low on the PGI, indicating poor QoL (mean PGI 28.9, SD 19.8, range 0-100).","['Methods Patients with Widespread Pain (ICD-11: pain in four or more out of five bodily regions, i.e. the four quadrants and axially) in a tertiary pain outpatient clinic were assessed according to classification criteria for Fibromyalgia [FM, American College of Rheumatology (ACR) criteria of 1990, 2010, 2011 and 2016], Chronic Fatigue Syndrome', 'patients with Chronic Widespread Pain (CWP) and (2', 'patients with complex symptom disorders']",[],"['CFS, Fukuda, Canada and International Consensus Criteria (ICC)] and Bodily Distress Syndrome (BDS']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205391', 'cui_str': 'Widespread (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4704940', 'cui_str': 'ICD-11'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0439738', 'cui_str': 'Four quadrants (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0015674', 'cui_str': 'Systemic Exertion Intolerance Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",,0.0447681,"Patients generally scored low on the PGI, indicating poor QoL (mean PGI 28.9, SD 19.8, range 0-100).","[{'ForeName': 'Hedda', 'Initials': 'H', 'LastName': 'Tschudi-Madsen', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Linn N', 'Initials': 'LN', 'LastName': 'Rødevand', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bøymo Kaarbø', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Lars-Petter', 'Initials': 'LP', 'LastName': 'Granan', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0097']
97,32206861,Mastopexy with Autologous Augmentation in Women After Massive Weight Loss: A Randomized Clinical Trial.,,2020,,"['After Massive Weight Loss', 'Women']",['Mastopexy with Autologous Augmentation'],[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0191918', 'cui_str': 'Fixation of pendulous breast (procedure)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",[],,0.134257,,"[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China.""}, {'ForeName': 'Dali', 'Initials': 'D', 'LastName': 'Mu', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 33 Badachu Road, Shijingshan District, Beijing, 100144, People's Republic of China. doctormudali@hotmail.com.""}]",Aesthetic plastic surgery,['10.1007/s00266-020-01688-0']
98,32047010,Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial.,"INTRODUCTION


Chemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation.
METHODS AND ANALYSIS


This study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients.
ETHICS AND DISSEMINATION


This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings.
TRIAL REGISTRATION NUMBER


The ClinicalTrials.gov registry .(NCT03591848).",2020,"This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation.
","['February 2020 for a total of 186 patients', 'women with breast cancer (DECISIF', 'young survivors of breast cancer', 'Since September 2018, 52 participants have been enrolled in the study and have completed the survey', 'survivors becoming genetic mothers']",['Chemotherapy'],['decisional conflict and anxiety'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",186.0,0.159322,"This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation.
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Benoit', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Université, Caen, France alexandra.benoit@aphp.fr.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine-Béclère, Clamart, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sermondade', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Bondy, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Grandazzi', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Moutel', 'Affiliation': 'UNICAEN, Inserm U1086, ANTICIPE, Normandie Universite, Caen, France.'}]",BMJ open,['10.1136/bmjopen-2019-031739']
99,32047011,Improving depression outcomes among Australian primary care patients: protocol for a cluster randomised controlled trial.,"INTRODUCTION


Depression is a common and debilitating condition. In Australia, general practitioners (GPs) are the key providers of depression care. However, available evidence suggests that case finding for depression in primary care is poor. This study will examine whether a systematic approach to screening for depression and assessing patient preferences for depression care improves depression outcomes among primary care patients.
METHODS AND ANALYSIS


A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12). Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate. Eighty-three participants will be recruited at each clinic. Participants will be asked to complete a baseline survey administered on a touch screen computer at their GP clinic, and then a follow-up survey at 3, 6 and 12 months. Those attending usual care practices will receive standard care. GPs at intervention practices will complete an online Clinical e-Audit, and will be provided with provider and patient-directed resources for depression care. Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP. The primary analysis will compare the number of cases of depression between the intervention and control groups.
ETHICS AND DISSEMINATION


The study has been approved by the University of Newcastle Human Research Ethics Committee, and registered with Human Research Ethics Committees of the University of Wollongong, Monash University and University of New South Wales. Results will be disseminated through peer-reviewed journal publications and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12618001139268; Pre-results.",2020,A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12).,"['Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP', 'Eighty-three participants will be recruited at each clinic', 'Australian primary care patients', 'Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate', 'primary care patients']",['usual care group'],"['number of cases of depression', 'depression outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0740218', 'cui_str': 'Depression screening (procedure)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",83.0,0.122334,A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12).,"[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia Mariko.Carey@newcastle.edu.au.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Sanson-Fisher', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'School of Primary and Allied Health Care, Department of General Practice, Monash University, Notting Hill, Victoria, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Monash Health Adult Psychiatry Research, Training and Evaluation Centre, Dandenong, Victoria, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Piterman', 'Affiliation': 'School of Primary and Allied Health Care, Department of General Practice, Monash University, Notting Hill, Victoria, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Waller', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Walsh', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Deeming', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Searles', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Henskens', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'School of Medicine and Public Health, The University of Newcastle, Callaghan, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032057']
100,32034016,"Neurokinin-1 antagonist orvepitant for EGFRI-induced pruritus in patients with cancer: a randomised, placebo-controlled phase II trial.","OBJECTIVE


To evaluate the efficacy of orvepitant (10 or 30 mg given once daily, orally for 4 weeks), a neurokinin-1 receptor antagonist, compared with placebo in reducing the intensity of epidermal growth factor receptor inhibitor (EGFRI)-induced intense pruritus.
DESIGN


Randomised, double-blind, placebo-controlled clinical trial.
SETTING


15 hospitals in Italy and five hospitals in the UK.
PARTICIPANTS


44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment.
INTERVENTION


30 or 10 mg orvepitant or placebo tablets once daily for 4 weeks (randomised 1:1:1).
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary endpoint was change from baseline in mean patient-recorded numerical rating scale (NRS) score (over the last three recordings) at week 4. Secondary outcome measures were NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus.
RESULTS


The trial was terminated early because of recruitment challenges; only 44 of the planned 90 patients were randomised. All patients were analysed for efficacy and safety. Mean NRS score change from baseline to week 4 was -2.78 (SD: 2.64) points in the 30 mg group, -3.04 (SD: 3.06) points in the 10 mg group and -3.21 (SD: 1.77) points in the placebo group; the difference between orvepitant and placebo was not statistically significant. No safety signal was detected. Adverse events related to orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis) were all of mild or moderate severity.
CONCLUSIONS


Orvepitant was safe and well tolerated. No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint. A number of explanations for this outcome are possible.
TRIAL REGISTRATION NUMBER


EudraCT2013-002763-25.",2020,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"['patients with cancer', '15 hospitals in Italy and five hospitals in the UK', '44 patients aged ≥18 years receiving an EGFRI for a histologically confirmed malignant solid tumour and experiencing moderate or intense pruritus after EGFRI treatment']","['placebo', 'Neurokinin-1 antagonist orvepitant']","['mean patient-recorded numerical rating scale (NRS) score', 'orvepitant (asthenia, dizziness, dry mouth, hyperhidrosis', 'efficacy and safety', 'Mean NRS score change', 'NRS score, verbal rating scale score, Skindex-16 and Leeds Sleep Evaluation Questionnaire at each study visit (baseline, weeks 1, 4, 8); rescue medication use; EGFRI dose reduction; and study withdrawal because of intense uncontrolled pruritus', 'safe and well tolerated', 'safety signal', 'NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1698088', 'cui_str': 'Malignant solid tumour'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2983799', 'cui_str': 'orvepitant'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4274441', 'cui_str': 'Verbal Rating Scale score'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",44.0,0.759463,No difference in NRS score between the orvepitant and placebo groups was observed at the week 4 primary endpoint.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Trower', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK mike.trower@nerretherapeutics.com.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Adnovate Clinical Development Strategies, East Sussex, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Guglielmini', 'Affiliation': 'Oncology Unit, ASO SS Antonio e Biagio e C Arrigo, Alessandria, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Biometrics Division, Cromsource, Stirling, UK.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Emiliangelo', 'Initials': 'E', 'LastName': 'Ratti', 'Affiliation': 'NeRRe Therapeutics, Stevenage, UK.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tonini', 'Affiliation': 'Medical Oncology, Universita Campus Bio-Medico di Roma Facolta di Medicina e Chirurgia, Roma, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Idfac, Devon, UK.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Ständer', 'Affiliation': 'Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-030114']
101,32401286,Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.,"Importance


Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
Objective


To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
Design, Setting, and Participants


This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Interventions


Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Main Outcomes and Measures


Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Results


Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
Conclusions and Relevance


In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02314065.",2020,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"['Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50', '204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period', 'primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care', 'Health Anxiety']","['Face-to-face cognitive behavior therapy (CBT', 'internet-delivered CBT or to individual face-to-face CBT', 'Internet vs Face-to-Face Cognitive Behavior Therapy']","['initial symptom level, recruitment path, or patient treatment preference', 'health anxiety symptoms', 'net societal cost', '1-sided 95% CI upper limits', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.102247,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Björkander', 'Affiliation': 'Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0940']
102,32205221,Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.,"BACKGROUND & AIMS


The short-term efficacy of RPC4046, a monoclonal antibody against interleukin-13, has been shown in patients with eosinophilic esophagitis (EoE). We investigated the long-term efficacy and safety of RPC4046 in an open-label, long-term extension (LTE) study in adults with EoE.
METHODS


We analyzed data from 66 patients who completed the 16-week, double-blind, induction portion of a phase 2 study of RPC4046 (180 mg or 360 mg/wk) vs placebo and then completed a 52-week LTE, receiving open-label RPC4046 360 mg/wk. The study was conducted at 28 centers in 3 countries; patients were enrolled between September 2014 and January 2017. Outcomes were stratified by double-blind dose group and included esophageal eosinophil counts, EoE endoscopic reference score, EoE histologic scoring system score, symptom-based EoE activity index score, and safety.
RESULTS


By week 12 of the LTE, esophageal eosinophil mean and peak counts, total EoE endoscopic reference scores, and EoE histologic scoring system grade and stage scores did not differ considerably between patients who originally received placebo vs RPC4046. Most patients maintained responses through week 52. Symptom remission (symptom-based EoE activity index score, ≤20) increased from 14% at LTE entry to 67% at LTE week 52 in placebo‒RPC4046 patients and from 30% to 54% in RPC4046‒RPC4046 (either dose) patients. Of the 28 patients who did not have a histologic response to RPC4046 during the double-blind induction phase, 10 patients (36%) achieved response during the LTE. The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
CONCLUSIONS


One year of treatment with RPC4046 is generally well tolerated and results in continued improvement and/or maintenance of endoscopic, histologic, and clinical measures of EoE disease activity relative to baseline.
TRIAL REGISTRATION


NCT02098473.",2021,"The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
","['Patients With Eosinophilic Esophagitis', 'patients with eosinophilic esophagitis (EoE', '66 patients who completed the 16-week double-blind induction portion of a phase 2 study of', '28 centers in 3 countries; patients were enrolled between September 2014 and January 2017', 'adults with EoE']","['RPC4046', 'LTE, receiving open-label RPC4046', 'placebo']","['nasopharyngitis', 'histologic response to RPC4046', 'esophageal eosinophil mean and peak counts, total EoE endoscopic reference scores, and EoE histologic scoring system grade and stage scores', 'esophageal eosinophil counts, EoE endoscopic reference score, EoE histologic scoring system score, symptom-based EoE activity index score, and safety', 'Symptom remission (symptom-based EoE activity index score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.191745,"The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina. Electronic address: evan_dellon@med.unc.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Yehudith', 'Initials': 'Y', 'LastName': 'Assouline-Dayan', 'Affiliation': 'Department of Gastroenterology, Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Gastroenterology, Grand Teton Research Group, Idaho Falls, Idaho.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Department of Pediatrics, University of Illinois College of Medicine, Children's Hospital of Illinois, Peoria, Illinois.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Division of Gastroenterology and Hepatology, Swiss EoE Clinic, Olten, Switzerland.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventative Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Inflammation & Fibrosis, Summit, New Jersey.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Minton', 'Affiliation': 'Drug Safety, Summit, New Jersey.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Department of Biostatistics, Summit, New Jersey.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Medicine, Gastroenterology, Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.036']
103,31915178,"Recurrence of WHO-defined fast breathing pneumonia among infants, its occurrence and predictors in Pakistan: a nested case-control analysis.","OBJECTIVES


Studies in low-income and middle-income countries have shown an adverse association between environmental exposures including poverty. There is little literature from South Asia. We aimed to test the associations between housing, indoor air pollution and children's respiratory health and recurrent fast breathing pneumonia in a poor urban setting in Pakistan.
SETTING


Primary health centres in a periurban slum in Karachi, Pakistan.
METHODS


Nested matched case-control study within a non-inferiority randomised controlled trial of fast breathing pneumonia (Randomised Trial of Amoxicillin vs Placebo for Pneumonia (RETAPP)) in periurban slums of Karachi, Pakistan. Cases were children aged 2-60 months enrolled in RETAPP with fast breathing pneumonia who presented again with fast breathing between 8 weeks and 12 months after full recovery. Controls, selected in a 2:1 ratio, were age-matched participants who did not represent. Multivariable conditional logistic regression analysis was undertaken to explore associations with potentially modifiable environmental predictors including housing type, indoor air quality, exposure to tobacco smoke, outdoor pollution, household crowding, water and sanitation quality, nutritional status, immunisation completeness, breast feeding and airways hyperactivity.
RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial. Poor-quality housing of either katcha or mixed type strongly predicted recurrence with adjusted matched ORs 2.43 (95% CI 1.02 to 5.80) and 2.44 (1.11 to 5.38), respectively. Poor air quality, cooking fuel, inadequate ventilation, nutritional status, water, sanitation and hygiene (WASH) index, wheeze at first presentation and group of initial trial assignment were not independently predictive of recurrence.
CONCLUSION


Poor-quality housing independently predicted recurrence of fast breathing pneumonia.
TRIAL REGISTRATION NUMBER


NCT02372461.",2020,"RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial.","['for Pneumonia (RETAPP)) in periurban slums of Karachi, Pakistan', 'Primary health centres in a periurban slum in Karachi, Pakistan', 'Controls, selected in a 2:1 ratio, were age-matched participants who did not represent', 'Cases were children aged 2-60 months enrolled in RETAPP with fast breathing pneumonia who presented again with fast breathing between 8 weeks and 12 months after full recovery', 'Nested matched case-control study within a non-inferiority randomised controlled trial of fast breathing pneumonia', ""and children's respiratory health and recurrent fast breathing pneumonia in a poor urban setting in Pakistan""]","['housing, indoor air pollution', 'Amoxicillin vs Placebo']","['housing type, indoor air quality, exposure to tobacco smoke, outdoor pollution, household crowding, water and sanitation quality, nutritional status, immunisation completeness, breast feeding and airways hyperactivity', 'Recurrence of WHO-defined fast breathing pneumonia', 'Poor air quality, cooking fuel, inadequate ventilation, nutritional status, water, sanitation and hygiene (WASH) index, wheeze', 'recurrence']","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0007328', 'cui_str': 'Case-Referrent Studies'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0085420', 'cui_str': 'Air Pollution, Indoor'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085760', 'cui_str': 'Air Quality, Indoor'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0392355', 'cui_str': 'Pollution (event)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0556991', 'cui_str': 'Fuel (substance)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}]",,0.146635,"RESULTS


Fast breathing recurred in 151 (3.7%) of children out of the total (4003) enrolled in the trial.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': ""International Maternal and Child Health, Department of Women's and Children's Health, Uppsala University, Academiska Sjukhuset, Uppsala, 75185, Sweden nick.brown@kbh.uu.se.""}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Kerai', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Muhammad Imran', 'Initials': 'MI', 'LastName': 'Nisar', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Najeeb', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Baloch', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}, {'ForeName': 'Fyezah', 'Initials': 'F', 'LastName': 'Jehan', 'Affiliation': 'Department of Child Health, Aga Khan University Hospital, National Stadium Rd, Karachi, Sindh, 74800, Pakistan.'}]",BMJ open,['10.1136/bmjopen-2019-035277']
104,32066739,Low-frequency parietal repetitive transcranial magnetic stimulation reduces fear and anxiety.,"Anxiety disorders are the most prevalent mental disorders, with few effective neuropharmacological treatments, making treatments development critical. While noninvasive neuromodulation can successfully treat depression, few treatment targets have been identified specifically for anxiety disorders. Previously, we showed that shock threat increases excitability and connectivity of the intraparietal sulcus (IPS). Here we tested the hypothesis that inhibitory repetitive transcranial magnetic stimulation (rTMS) targeting this region would reduce induced anxiety. Subjects were exposed to neutral, predictable, and unpredictable shock threat, while receiving double-blinded, 1 Hz active or sham IPS rTMS. We used global brain connectivity and electric-field modelling to define the single-subject targets. We assessed subjective anxiety with online ratings and physiological arousal with the startle reflex. Startle stimuli (103 dB white noise) probed fear and anxiety during the predictable (fear-potentiated startle, FPS) and unpredictable (anxiety-potentiated startle, APS) conditions. Active rTMS reduced both FPS and APS relative to both the sham and no stimulation conditions. However, the online anxiety ratings showed no difference between the stimulation conditions. These results were not dependent on the laterality of the stimulation, or the subjects' perception of the stimulation (i.e. active vs. sham). Results suggest that reducing IPS excitability during shock threat is sufficient to reduce physiological arousal related to both fear and anxiety, and are consistent with our previous research showing hyperexcitability in this region during threat. By extension, these results suggest that 1 Hz parietal stimulation may be an effective treatment for clinical anxiety, warranting future work in anxiety patients.",2020,"These results were not dependent on the laterality of the stimulation, or the subjects' perception of the stimulation (i.e. active vs. sham).",[],"['Startle stimuli (103\u2009dB white noise', 'Low-frequency parietal repetitive transcranial magnetic stimulation', 'Hz active or sham IPS rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS']","['online anxiety ratings', 'subjective anxiety with online ratings and physiological arousal with the startle reflex', 'fear and anxiety during the predictable (fear-potentiated startle, FPS) and unpredictable (anxiety-potentiated startle, APS) conditions', 'IPS excitability', 'fear and anxiety', 'Anxiety disorders', 'excitability and connectivity of the intraparietal sulcus (IPS']",[],"[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0038186', 'cui_str': 'Startle Response'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0228213', 'cui_str': 'Intraparietal Sulcus'}]",,0.0550955,"These results were not dependent on the laterality of the stimulation, or the subjects' perception of the stimulation (i.e. active vs. sham).","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Goodwin', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health Bethesda, Bethesda, MD, USA.'}]",Translational psychiatry,['10.1038/s41398-020-0751-8']
105,32126576,Endoscopic ultrasonography-guided deployment of embolization coils and cyanoacrylate injection in gastric varices versus coiling alone: a randomized trial.,"BACKGROUND


Gastric variceal bleeding is a life-threating condition with challenging management. We aimed to compare the efficacy and safety of endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided coil embolization alone in the management of gastric varices.
METHODS


A single-center, parallel-randomized controlled trial involving 60 participants with gastric varices (GOV II and IGV I) who were randomly allocated to EUS-guided coil embolization and cyanoacrylate injection (n = 30) or EUS-guided coil embolization alone (n = 30). The primary end points were the technical and clinical success rates of both procedures. The secondary end points were the reappearance of gastric varices during follow-up, along with rebleeding, the need for reintervention, and complication and survival rates.
RESULTS


The technical success rate was 100 % in both groups. Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P  < 0.001). Median survival time was 16.4 months with coils and cyanoacrylate versus 14.2 months with coils alone ( P  = 0.90). Rebleeding occurred in 3.3 % of patients treated with combined treatment and 20 % of those treated with coils alone ( P  = 0.04). With combined treatment, 83.3 % of patients were free from reintervention versus 60 % with coils alone (hazard ratio 0.27; 95 % confidence interval 0.095 - 0.797;  P  = 0.01).
CONCLUSIONS


EUS-guided coil embolization with cyanoacrylate injection achieved excellent clinical success, with lower rates of rebleeding and reintervention than coil treatment alone. Multicenter studies are required to define the most appropriate technique for gastric variceal obliteration.",2020,"Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P  < 0.001).",['60 participants with gastric varices (GOV II and IGV I'],"['coils alone', 'cyanoacrylate', 'Endoscopic ultrasonography-guided deployment of embolization coils and cyanoacrylate injection', 'coiling alone', 'endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided coil embolization alone', 'EUS-guided coil embolization and cyanoacrylate injection (n\u200a=\u200a30) or EUS-guided coil embolization alone']","['Median survival time', 'efficacy and safety', 'Rebleeding', 'technical and clinical success rates of both procedures', 'technical success rate', 'reappearance of gastric varices', 'Immediate disappearance of varices', 'rebleeding and reintervention', 'excellent clinical success', 'rebleeding, the need for reintervention, and complication and survival rates']","[{'cui': 'C0017145', 'cui_str': 'Gastric Varix'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylates'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522644', 'cui_str': 'Embolization coil, device (physical object)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0017145', 'cui_str': 'Gastric Varix'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",60.0,0.0756777,"Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P  < 0.001).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Robles-Medranda', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Oleas', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Valero', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Puga-Tejada', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Baquerizo-Burgos', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Jesenia', 'Initials': 'J', 'LastName': 'Ospina', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pitanga-Lukashok', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}]",Endoscopy,['10.1055/a-1123-9054']
106,30653471,Gender bias in assessment of future work ability among pain patients - an experimental vignette study of medical students' assessment.,"Background and aims Pain is a prevalent problem in many countries. Women are more often on sick-leave for pain than men. Such gender differences have been explained through biological factors, different demands for on the job market, and home conditions. Fewer studies have focused on how gender stereotypes may bias the medical assessment of pain patients. The aim of the present research was to investigate if a gender bias in medical students' evaluations of chronic pain patients can contribute to explaining the gender differences in sick-leave due to pain. Specifically, we investigated whether medical students' estimates of a patient's accuracy of their own work ability and amount of domestic work differed between female and male patients, and how such estimates influenced the medical students' judgments of the patient's work ability. Methods Medical students (n=137; 60 women; 74 men; three unspecified) read a vignette describing a patient with pain and filled out a questionnaire. The vignette was identical and gender neutral, except for the name of the patient signaling gender. A between-subjects experimental design was used in which participants were randomly assigned to an experimental condition. Participants then judged the patient's work ability, the accuracy of the patient's self-assessed work ability, and the amount of domestic work they believed was performed by the patient. All ratings were made on seven-point items. Results The results showed that there was no main effect of gender on perceived future work ability of the patient, F (1,131)=0.867, p=0.353. However, male patients were considered to be more accurate in their self-assessed work ability than female patients F (1,131)=5.925 p=0.016 (Mfemale=4.87, SDfemale=1.22, and Mmale=5.33, SDmale=1.02). Moreover, female patients were thought to perform more domestic work, F (1,131)=25.56, p<0.001 (Mfemale=4.14, SDfemale=1.41, and Mmale=3.07, SDmale=1.16). Finally, perceived amount of domestic work moderated the effects of perceived future work ability for female but not for male patients, B=0.42, p=0.005. Hence, there was a positive effect of amount of domestic work performed on work ability judgments for women, such that the more domestic work they were assumed to perform, the more they were perceived to be able to work. Conclusions Gender stereotypes influenced assessments of future work ability in pain patients, mainly because women were assumed to perform more domestic work which had a positive effect on perceived work ability. Because domestic work should have a negative effect on recovery, expectations from the physician that domestic work is expected by female patients may in fact have the opposite effect prolonging sick-leave. Moreover, the students trusted the male patients' ability to assess their own work capacity more than women's. Implications It is important that medical students receive education about gender biases and how they may influence medical assessment during their training. Such education may alleviate the influence of gender stereotypes.",2019,"Moreover, female patients were thought to perform more domestic work, F (1,131)=25.56, p<0.001 (Mfemale=4.14, SDfemale=1.41, and Mmale=3.07, SDmale=1.16).","['Methods Medical students (n=137; 60 women; 74 men; three unspecified) read a vignette describing a patient with pain and filled out a questionnaire', 'female and male patients', 'male patients', ""medical students' evaluations of chronic pain patients"", 'pain patients', ""pain patients - an experimental vignette study of medical students' assessment""]",[],['sick-leave for pain'],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",137.0,0.0358339,"Moreover, female patients were thought to perform more domestic work, F (1,131)=25.56, p<0.001 (Mfemale=4.14, SDfemale=1.41, and Mmale=3.07, SDmale=1.16).","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Gustafsson Sendén', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Emma A', 'Initials': 'EA', 'LastName': 'Renström', 'Affiliation': 'Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0108']
107,32196110,Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study.,"OBJECTIVE


The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment.
DESIGN


Randomized, double-blind, clinical study.
METHODS


The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0-10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D).
RESULTS


There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study.
CONCLUSIONS


After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.",2020,"Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study.
","['discogenic low back pain treatment', 'Chronic Discogenic Low Back Pain Treatment']","['Discogel alone and Discogel in combination with pulsed radiofrequency', 'Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol', 'intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel']","['Efficacy', 'pain score', 'Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D', 'pain, function, quality of life, and consumption of analgesics']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C4307245', 'cui_str': 'Ethanol Injection'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.39123,"Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study.
","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Papadopoulos', 'Affiliation': '2nd Department of Anesthesiology, School of Medicine, University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Batistaki', 'Affiliation': '2nd Department of Anesthesiology, School of Medicine, University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Kostopanagiotou', 'Affiliation': '2nd Department of Anesthesiology, School of Medicine, University of Athens, Attikon University Hospital, Athens, Greece.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa025']
108,32024786,Menstrual health intervention and school attendance in Uganda (MENISCUS-2): a pilot intervention study.,"OBJECTIVES


Achieving good menstrual health and hygiene (MHH) is a public health challenge and there is little evidence to inform interventions. The aim of this study was to pilot test an intervention to improve MHH and school attendance in Uganda, in preparation for a future cluster-randomised trial.
DESIGN


Longitudinal study with pre-post evaluation of a pilot intervention.
SETTING


Two secondary schools in Entebbe, Uganda.
PARTICIPANTS


Of the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented. 369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey.
INTERVENTION


The intervention comprised training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities.
PRIMARY AND SECONDARY OUTCOME MEASURES


Feasibility and acceptability of delivering the intervention. Baseline and endline quantitative surveys were conducted, with qualitative interviews conducted at endline. School attendance was assessed using self-completed daily diaries among a nested cohort of 100 female students.
RESULTS


There were high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management). The proportion of girls reporting anxiety about next period decreased from 58.6% to 34.4%, and reported use of effective pain management increased from 76.4% to 91.4%. Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation. The diary data and qualitative data indicated a potential intervention impact on improving menstrual-related school absenteeism.
CONCLUSIONS


The pilot study showed that the multicomponent MHM intervention was acceptable and feasible to deliver, and potentially effective in improving menstruation knowledge and management. A cluster-randomised trial is needed to evaluate rigorously the intervention effects on MHM and school attendance.
TRIAL REGISTRATION NUMBER


NCT04064736; Pre-results.",2020,"Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation.","['Menstrual health intervention and school attendance in Uganda (MENISCUS-2', 'Of the 473 eligible students in secondary 2 (S2) at baseline, 450 (95.1%; 232 girls and 218 boys) consented/assented', '100 female students', 'Two secondary schools in Entebbe, Uganda', '369 students (188 girls; 81.0%; and 181 boys; 83.0%) participated in the endline survey']","['multicomponent MHM intervention', 'training teachers to improve delivery of government guidelines for puberty education, training in use of a menstrual kit and pain management, a drama skit, provision of analgesics and improvements to school water and sanitation hygiene facilities']","['School attendance', 'high levels of uptake of the individual and behavioural intervention components (puberty education, drama skit, menstrual hygiene management (MHM) kit and pain management', 'effective pain management', 'school toilet facilities', 'MHH and school attendance', 'proportion of girls reporting anxiety about next period', 'comfort managing menstruation']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C2315938', 'cui_str': 'Genus Meniscus'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013109', 'cui_str': 'Drama'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0040364', 'cui_str': 'Lavatories'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",473.0,0.0450692,"Most girls (81.4%) reported improved school toilet facilities, which improved their comfort managing menstruation.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kansiime', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hytti', 'Affiliation': 'WoMena Uganda, Kampala, Uganda.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Nalugya', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Nakuya', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Prossy', 'Initials': 'P', 'LastName': 'Namirembe', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Shamirah', 'Initials': 'S', 'LastName': 'Nakalema', 'Affiliation': 'WoMena Uganda, Kampala, Uganda.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Neema', 'Affiliation': 'College of Humanities and Social Science, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Tanton', 'Affiliation': 'Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Alezuyo', 'Affiliation': 'Palm Tree Academy Uganda, Kampala, Uganda.'}, {'ForeName': 'Saidat', 'Initials': 'S', 'LastName': 'Namuli Musoke', 'Affiliation': 'Uganda Virus Research Institute, Entebbe, Uganda.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Torondel', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Suzanna C', 'Initials': 'SC', 'LastName': 'Francis', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ross', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneve, Switzerland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Research Unit, Medical Research Council/Uganda Virus Research Institute & London School of Hygiene & Tropical Medicine Uganda, Entebbe, Uganda.'}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK helen.weiss@lshtm.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-031182']
109,32162287,Fork-tip needle biopsy versus fine-needle aspiration in endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized crossover study.,"BACKGROUND


A novel fork-tip fine-needle biopsy (FNB) needle has recently been introduced for endoscopic ultrasound (EUS)-guided sampling. The aim of this study was to compare the performance of fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology in the diagnosis of solid pancreatic masses.
METHODS


A randomized crossover study was performed in patients referred for EUS-guided sampling. Three passes were taken with each needle in a randomized order. Only samples reported as diagnostic of malignancy were considered positive. The primary end point was the sensitivity of diagnosis of malignancy. Secondary end points included the amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost.
RESULTS


108 patients were recruited. Median age was 69 years (range 30 - 87) and 57 were male; 85.2 % had a final diagnosis of malignancy. There were statistically significant differences in sensitivity (82 % [95 % confidence interval (CI) 72 % to 89 %] vs. 71 % [95 %CI 60 % to 80 %]), accuracy (84 % [95 %CI 76 % to 91 %] vs. 75 % [95 %CI 66 % to 83 %]), proportion graded as a straightforward diagnosis (69 % [95 %CI 60 % to 78 %] vs. 51 % [95 %CI 41 % to 61 %]), and median pathology viewing time (188 vs. 332 seconds) ( P  < 0.001) between FNB and FNA needles, respectively. There was no significant difference in cost between an FNB or FNA strategy.
CONCLUSION


The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.",2020,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","['Median age was 69 years (range 30\u200a-\u200a87) and 57 were male; 85.2\u200a% had a final diagnosis of malignancy', '108 patients were recruited', 'patients referred for EUS-guided sampling']","['Fork-tip needle biopsy versus fine-needle aspiration', 'endoscopic ultrasound-guided sampling of solid pancreatic masses', 'fork-tip FNB histology and standard fine-needle aspiration (FNA) cytology', 'FNA', 'novel fork-tip fine-needle biopsy ']","['amount of sample obtained, ease of diagnosis, duration of tissue sampling, pathologist viewing time, and cost', 'sensitivity of diagnosis of malignancy', 'median pathology viewing time', 'accuracy', 'sensitivity', 'straightforward diagnosis']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0546910', 'cui_str': 'Fork (physical object)'}, {'cui': 'C0005560', 'cui_str': 'Biopsy, Needle'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy (procedure)'}]","[{'cui': 'C1277697', 'cui_str': 'Sample obtained'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1272701', 'cui_str': 'Straightforward'}]",108.0,0.0843607,"The diagnostic performance of the fork-tip FNB needle was significantly better than that of FNA; it was associated with ease of diagnosis, shorter pathological viewing times, and was cost neutral.","[{'ForeName': 'Kofi W', 'Initials': 'KW', 'LastName': 'Oppong', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Noor L H', 'Initials': 'NLH', 'LastName': 'Bekkali', 'Affiliation': 'Department of Gastroenterology, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Leeds', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Manu K', 'Initials': 'MK', 'LastName': 'Nayar', 'Affiliation': 'HPB Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Darné', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Egan', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy, Amersham, United Kingdom.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Haugk', 'Affiliation': 'Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}]",Endoscopy,['10.1055/a-1114-5903']
110,31992407,Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial.,"STUDY OBJECTIVES


Sleep restriction therapy (SRT) has been shown to be comparably effective relative to cognitive behavioral therapy for insomnia (CBT-I), but with lower requirements for patient contact. As such, SRT appears to be a viable alternate treatment for those who cannot complete a full course of CBT-I. However, it is unclear whether SRT-a treatment solely focusing on restricting time in bed-increases risk for sleepiness comparably to CBT-I. The current study tested objective sleepiness as an outcome in a randomized controlled trial comparing SRT, CBT-I, and attention control in a sample of postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
METHODS


Single-site, randomized controlled trial. A total of 150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder were randomized to 3 treatment conditions: sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions). Blinded assessments were performed at pretreatment and posttreatment. Risk of excessive sleepiness was evaluated using a symmetry analysis of sleepiness measured through the Multiple Sleep Latency Test (MSLT).
RESULTS


The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy. This suggests that excessive sleepiness is not of unique concern following SRT relative to CBT-I or sleep education.
CONCLUSIONS


SRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I. Future research should characterize objective measures of excessive sleepiness immediately following sleep restriction.
CLINICAL TRAIL REGISTRATION


Registry: ClinicalTrials.gov; Name: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295.",2020,"The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy.","['insomnia', 'postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition', '150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder']","['sleep restriction therapy and cognitive behavioral therapy', 'SRT', 'Sleep restriction therapy (SRT', 'sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions']","['Risk of excessive sleepiness', 'odds ratios (ORs) of being excessively sleepy versus nonsleepy']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}]",150.0,0.0429993,"The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8164']
111,32144557,"Comparison of surgical outcomes among different methods of esophagojejunostomy in laparoscopic total gastrectomy for clinical stage I proximal gastric cancer: results of a single-arm multicenter phase II clinical trial in Korea, KLASS 03.","BACKGROUND


Laparoscopic distal gastrectomy for early gastric cancer has been widely accepted, but laparoscopic total gastrectomy has still not gained popularity because of technical difficulty and unsolved safety issue. We conducted a single-arm multicenter phase II clinical trial to evaluate the safety and the feasibility of laparoscopic total gastrectomy for clinical stage I proximal gastric cancer in terms of postoperative morbidity and mortality in Korea. The secondary endpoint of this trial was comparison of surgical outcomes among the groups that received different methods of esophagojejunostomy (EJ).
METHODS


The 160 patients of the full analysis set group were divided into three groups according to the method of EJ, the extracorporeal circular stapling group (EC; n = 45), the intracorporeal circular stapling group (IC; n = 64), and the intracorporeal linear stapling group (IL; n = 51). The clinicopathologic characteristics and the surgical outcomes were compared among these three groups.
RESULTS


There were no significant differences in the early complication rates among the three groups (26.7% vs. 18.8% vs. 17.6%, EC vs. IC vs. IL; p = 0.516). The length of mini-laparotomy incision was significantly longer in the EC group than in the IC or IL group. The anastomosis time was significantly shorter in the EC group than in the IL group. The time to first flatus was significantly shorter in the IL group than in the EC group. The long-term complication rate was not significantly different among the three groups (4.4% vs. 12.7% vs. 7.8%; EC vs. IC vs. IL; p = 0.359), however, the long-term incidence of EJ stenosis in IC group (10.9%) was significantly higher than in EC (0%) and IL (2.0%) groups (p = 0.020).
CONCLUSIONS


The extracorporeal circular stapling and the intracorporeal linear stapling were safe and feasible in laparoscopic total gastrectomy, however, intracorporeal circular stapling increased EJ stenosis.",2021,The long-term complication rate was not significantly different among the three groups (4.4% vs. 12.7% vs. 7.8%; EC vs. IC vs. IL;,"['early gastric cancer', '160 patients of the full analysis set group', 'clinical stage I proximal gastric cancer', 'Korea']","['EC', 'extracorporeal circular stapling group (EC; n\u2009=\u200945), the intracorporeal circular stapling', 'laparoscopic total gastrectomy', 'IL', 'extracorporeal circular stapling and the intracorporeal linear stapling', 'esophagojejunostomy', 'Laparoscopic distal gastrectomy', 'intracorporeal linear stapling', 'esophagojejunostomy (EJ']","['length of mini-laparotomy incision', 'long-term complication rate', 'surgical outcomes', 'time to first flatus', 'anastomosis time', 'long-term incidence of EJ stenosis', 'early complication rates']","[{'cui': 'C0349530', 'cui_str': 'Early gastric cancer (disorder)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I (finding)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C1282913', 'cui_str': 'Circular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy (procedure)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0192362', 'cui_str': 'Esophagojejunostomy (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0231243', 'cui_str': 'Early complication (finding)'}]",,0.044021,The long-term complication rate was not significantly different among the three groups (4.4% vs. 12.7% vs. 7.8%; EC vs. IC vs. IL;,"[{'ForeName': 'Han-Kwang', 'Initials': 'HK', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Hyung', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Uk', 'Initials': 'SU', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, Korea.'}, {'ForeName': 'Joong-Min', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gyu Seok', 'Initials': 'GS', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.'}, {'ForeName': 'Oh Kyoung', 'Initials': 'OK', 'LastName': 'Kwon', 'Affiliation': 'Department of Surgery, Kyungpook National University Medical Center, Daegu, Korea.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kong', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyoung-Il', 'Initials': 'HI', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuk-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.""}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Ryu', 'Affiliation': 'Department of Surgery, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Jin', 'Affiliation': 'Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Oh', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Keun Won', 'Initials': 'KW', 'LastName': 'Ryu', 'Affiliation': 'Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Min-Chan', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Hye Seong', 'Initials': 'HS', 'LastName': 'Ahn', 'Affiliation': 'Department of Surgery, Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Young Kyu', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasoon Hospital, Hwasun, Korea.'}, {'ForeName': 'Yong Ho', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun-Hwi', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Jo', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Incheon St. Mary's Hospital, The Catholic University of Korea College of Medicine, 56 Dongsuro, Bupyong-Gu, Inchon, 21431, Korea. kjj@catholic.ac.kr.""}]",Surgical endoscopy,['10.1007/s00464-020-07480-0']
112,3416079,Prevention of HLA immunization with leukocyte-poor packed red cells and platelet concentrates obtained by filtration.,"HLA immunization is a common complication of transfusion therapy in 30% to 60% of oncohematologic patients. Evidence shows that leukocytes present in cellular blood products are the main component involved in the occurrence of HLA immunization, and several studies showed that leukocyte-poor blood products are less able to induce it. However, leukocyte-poor platelet concentrates obtained by conventional techniques, ie, centrifugation, frequently have a high level of remaining leukocytes. Cotton wool filter Imugard IG 500 can be used to obtain leukocyte-poor cellular blood products. The technique is easy to perform, even in an emergency, and can be used with either packed RBCs or platelet concentrates. Means of 97%, 92%, and 76% elimination of leukocytes are obtained for packed RBCs, pooled standard platelet concentrates, and single-donor platelet concentrates, respectively. Patients were randomized to receive either standard (control group) or filtered (leukocyte-poor group) blood products. Of 112 randomized patients, 69 were evaluable, 35 in the control group and 34 in the leukocyte-poor group. Both groups are comparable according to age, diagnosis, sex ratio, previous transfusions, and pregnancies. There is a significant difference in regard to the HLA immunization rate (31.4% in the control v 11.7% in the leukocyte-poor group, P less than .05) and frequency of refractoriness to platelet transfusions (46.6% v 11.7%, P less than .05). We conclude that this filtration technique can be an efficient means to reduce the HLA immunization rate in polytransfused oncohematologic patients.",1988,"The technique is easy to perform, even in an emergency, and can be used with either packed RBCs or platelet concentrates.","['Of 112 randomized patients, 69 were evaluable, 35 in the control group and 34 in the leukocyte-poor group', 'polytransfused oncohematologic patients']","['HLA immunization', 'standard (control group) or filtered (leukocyte-poor group) blood products', 'HLA immunization with leukocyte-poor packed red cells and platelet concentrates obtained by filtration']","['HLA immunization rate', 'frequency of refractoriness to platelet transfusions']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}]","[{'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0920064', 'cui_str': 'Platelet transfusion refractoriness'}]",112.0,0.0119648,"The technique is easy to perform, even in an emergency, and can be used with either packed RBCs or platelet concentrates.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Andreu', 'Affiliation': 'Blood Bank, Paris Hotel-Dieu, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dewailly', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leberre', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Quarre', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bidet', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tardivel', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Devers', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soreau', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boccaccio', 'Affiliation': ''}]",Blood,[]
113,32151500,Effects of a preoperative neuromobilization program offered to individuals with carpal tunnel syndrome awaiting carpal tunnel decompression surgery: A pilot randomized controlled study.,"STUDY DESIGN


Pilot randomized controlled trial with parallel groups.
INTRODUCTION


Engaging individuals with carpal tunnel syndrome (CTS) awaiting carpal tunnel decompression surgery in a preoperative rehabilitation program may mitigate pain and sensorimotor impairments, enhance functional abilities before surgery, and improve postoperative outcomes.
PURPOSE OF THE STUDY


To assess the feasibility and the efficacy of a novel preoperative neuromobilization exercise program (NEP).
METHODS


Thirty individuals with CTS were randomly allocated into a four-week home-based neuromobilization exercise group or a standard care group while awaiting surgery. Outcome measures included feasibility (ie, recruitment, attrition, adherence, satisfaction, and safety) and efficacy metrics (ie, median nerve integrity and neurodynamics, tip pinch grip, pain, and upper limb functional abilities) collected before (ie, at the baseline and about four weeks later) and four weeks after surgery.
RESULTS


Thirty individuals with CTS were recruited (recruitment rate = 11.8%) and 25 completed the study (attrition rate = 16.7%). Adherence (94%) and satisfaction with the program (eg, enjoy the exercises and likeliness to repeat the NEP (≥4.2/5) were high and no serious adverse event was reported. NEP-related immediate pre- and post-surgery beneficial effects on pain interference were documented (P = .05, η 2  = .10), whereas an overall increased neurodynamics (P = .04, η 2  = .11) and decreased pain severity (P = .01, η 2  = .21) were observed.
DISCUSSION


Engaging in the proposed NEP has limited beneficial effect as a stand-alone intervention on pre- and post-surgery outcomes for individuals with CTS. Expanding the program's content and attribute by adding other components including desensitization maneuvers and novel therapies promoting corticospinal plasticity is recommended.
CONCLUSION


A preoperative NEP completed by individuals with CTS awaiting surgery is feasible, acceptable, and safe. However, given the limited beneficial effectsof the program, revision of its content and attributes is recommended before proceeding to large-scale trials.",2021,"NEP-related immediate pre- and post-surgery beneficial effects on pain interference were documented (P = .05, η 2  = .10), whereas an overall increased neurodynamics (P = .04, η 2  = .11) and decreased pain severity (P = .01, η 2  = .21) were observed.
","['individuals with carpal tunnel syndrome awaiting carpal tunnel decompression surgery', 'Thirty individuals with CTS', 'individuals with carpal tunnel syndrome (CTS) awaiting carpal tunnel decompression surgery', 'Thirty individuals with CTS were recruited (recruitment rate\xa0=\xa011.8%) and 25 completed the study (attrition rate\xa0=\xa016.7', 'individuals with CTS']","['neuromobilization exercise group or a standard care group while awaiting surgery', 'novel preoperative neuromobilization exercise program (NEP', 'preoperative neuromobilization program']","['pain severity', 'Adherence', 'pain interference', 'feasibility (ie, recruitment, attrition, adherence, satisfaction, and safety) and efficacy metrics (ie, median nerve integrity and neurodynamics, tip pinch grip, pain, and upper limb functional abilities']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0196576', 'cui_str': 'Carpal tunnel decompression'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0429273', 'cui_str': 'Tip pinch (observable entity)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",30.0,0.0349417,"NEP-related immediate pre- and post-surgery beneficial effects on pain interference were documented (P = .05, η 2  = .10), whereas an overall increased neurodynamics (P = .04, η 2  = .11) and decreased pain severity (P = .01, η 2  = .21) were observed.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Paquette', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Higgins', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Michel Alain', 'Initials': 'MA', 'LastName': 'Danino', 'Affiliation': ""Department of Surgery, Centre Hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': ""Department of Surgery, Centre Hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lamontagne', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, Centre Hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Dany H', 'Initials': 'DH', 'LastName': 'Gagnon', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Institut universitaire sur la réadaptation en déficience physique de Montréal, Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Centre-Sud-de-l'Île-de-Montréal, Montreal, Canada; School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Canada. Electronic address: dany.gagnon.2@umontreal.ca.""}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.012']
114,31720722,Physiotherapy rehabilitation for osteoporotic vertebral fracture-a randomised controlled trial and economic evaluation (PROVE trial).,"The trial compared three physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT) for people with osteoporotic vertebral fracture(s). At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
INTRODUCTION


To evaluate the clinical and cost-effectiveness of different physiotherapy approaches for people with osteoporotic vertebral fracture(s) (OVF).
METHODS


>Prospective, multicentre, adaptive, three-arm randomised controlled trial. Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated.
INTERVENTIONS


7 individual physiotherapy sessions over 12 weeks focused on either manual therapy or home exercise compared with a single session of physiotherapy education (SSPT). The co-primary outcomes were quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test at 12 months.
RESULTS


At 12 months, there were no statistically significant differences between groups. Mean QUALEFFO-41: - 1.3 (exercise), - 0.15 (manual), and - 1.2 (SSPT), a mean difference of - 0.2 (95% CI, - 3.2 to 1.6) for exercise and 1.3 (95% CI, - 1.8 to 2.9) for manual therapy. Mean TLS: 9.8 s (exercise), 13.6 s (manual), and 4.2 s (SSPT), a mean increase of 5.8 s (95% CI, - 4.8 to 20.5) for exercise and 9.7 s (95% CI, 0.1 to 24.9) for manual therapy. Exercise provided more quality-adjusted life years than SSPT but was more expensive. At 4 months, significant changes above SSPT occurred in endurance and balance in manual therapy, and in endurance for those ≤ 70 years, in balance, mobility, and walking in exercise.
CONCLUSIONS


Adherence was problematic. Benefits at 4 months did not persist and at 12 months, we found no significant differences between treatments. There is inadequate evidence a short physiotherapy intervention of either manual therapy or home exercise provides long-term benefits, but arguably short-term benefits are valuable.
TRIAL REGISTRATION


ISRCTN 49117867.",2020,"At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
","['Six hundred fifteen adults with back pain, osteoporosis, and at least 1 OVF participated', 'people with osteoporotic vertebral fracture(s', 'people with osteoporotic vertebral fracture(s) (OVF']","['physiotherapy approaches: manual or exercise therapy compared with a single session of physiotherapy education (SSPT', 'Physiotherapy rehabilitation', 'manual therapy or home exercise compared with a single session of physiotherapy education (SSPT', 'physiotherapy approaches']","['quality of life and back muscle endurance measured by the QUALEFFO-41 and timed loaded standing (TLS) test', 'balance, mobility, and walking in exercise', 'quality-adjusted life years']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0034380'}, {'cui': 'C0224334', 'cui_str': 'Back Muscles'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",615.0,0.185415,"At 1 year, there were no statistically significant differences between the groups meaning there is inadequate evidence to support manual or exercise therapy.
","[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK. karen.barker@ouh.nhs.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Lowe', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Javaid', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Noufaily', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hughes', 'Affiliation': 'Physiotherapy Research Unit, Physiotherapy Department, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Windmill Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gandhi', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05133-0']
115,32151115,The effect of vitamin D status on different neuromuscular blocker agents reverse time,"Background/aim


This study is aimed to investigate the effects of vitamin D levels on sugammadex and neostigmine reversal times.
Material and methods


Eighty patients between the ages of 18 and 65 years, with ASA I-III status who were undergoing surgery under general anesthesia were included in the study. A double blind fashion was used to randomly divide all the patients into two groups. At the end of the operation, sugammadex 2 mg/kg was administered to one group (Group sugammadex) and atropine and neostigmine was administered to the other group (Group neostigmine) intravenously. In the data analysis stage, the group was divided into two subgroups according to sugammadex and group neostigmine in itself, with vitamin D levels above and below 30 ng/mL. Statistical analysis was performed on these 4 groups (Group neostigmine and vitamin D < 30 ng/mL), (Group neostigmine and vitamin D ≥ 30 ng/mL), ( Group sugammadex and vitamin D < 30 ng/mL), (Group sugammadex and vitamin D ≥ 30 ng/mL).
When two responses to train of four (TOF) stimulation were taken, the following times were recorded until extubation phase. The time until TOF value 50%, 70%, 90%, and extubation were recorded.
Results


There were statistically significant differences between Group sugammadex and vitamin D < 30 ng/mL and Group sugammadex and vitamin D ≥ 30 ng/mL (P = 0.007) for extubation times and 50% TOF reach times (P = 0.015). However, there was no difference observed between Group neostigmine and vitamin D < 30 ng/mL and Group neostigmine and vitamin D ≥ 30 ng/mL (P = 0.999).
Conclusion


Vitamin D deficiency is important for anesthesiologists in terms of muscle strength and extubation time. Vitamin D deficiency seems to affect sugammadex reverse times but seems not to affect neostigmine reverse times. This conclusion needs further studies.",2020,"TOF reach times (p=0,015).","['Eighty patients between the ages of 18 and 65 years, with ASA I-III status who were undergoing surgery under general anaesthesia were included in the study']","['atropine and neostigmine', 'sugammadex and vitamin D', 'neostigmine and vitamin D', 'sugammadex and group neostigmine']",['time until TOF value'],"[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.166963,"TOF reach times (p=0,015).","[{'ForeName': 'Ilknur Suidiye', 'Initials': 'IS', 'LastName': 'Yorulmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Düzce University, Düzce, Turkey'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Demiraran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Medipol University Mega Hospital Complex, İstanbul, Turkey'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Özlü', 'Affiliation': 'Department of Anesthesiology and Reanimation, TOBB Economy and Technology University, Faculty of Medicine, Ankara, Turkey'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Dost', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ondokuz Mayıs University, Samsun, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-1901-115']
116,32151119,"Effects of oral/enteral nutrition alone versus plus pantoprazole on gastrointestinal bleeding in critically ill patients with low risk factor: a multicenter, randomized controlled trial","Background/aim


Critically ill patients are at risk of developing gastrointestinal (GI) bleeding due to stress causing mucosal damage. Aim of the study was to determine the effect of oral/enteral nutrition with or without concomitant pantoprazole on upper GI bleeding in low risk critically ill patients.
Materials and methods


This was a prospective, randomized, open-label, multicenter study conducted with intensive care unit (ICU) patients receiving oral/enteral nutritional support. Patients were randomly assigned into two groups including intervention group (received oral/EN plus pantoprazole) and control group (received only oral/EN).
Results


A total of 300 patients (intervention group: 152, control group: 148) participated in the study. Overall, 226 (75%) patients were fed by orally and 74 (25%) patients fed by enteral tube feeding. Median duration of nutritional support 4 (range: 2–33) days. Overt upper GI bleeding was noted only in one patient (0.65%) who was in the intervention group. The overall length of ICU stay of 4 (2–105) days, while ICU stay was significantly longer in the intervention group than in the control group (P = 0.006).
Conclusions


Our findings seems to indicate that in patients who are at low risk for GI bleeding and under oral/enteral nutritional support, the use of PPIs may not reduce the risk of bleeding, however these results are imprecise because of low event (GI bleeding) rate and limited power.",2020,"The overall length of ICU stay of 4 (2-105) days, while ICU stay was significantly longer in the intervention group than in the control group (p=0.006).
","['300 patients (intervention group: 152, control group: 148) participated in the study', 'critically ill patients with low risk factor', 'low risk critically ill patients']","['oral/enteral nutrition alone versus plus pantoprazole', 'intervention group (received oral/EN plus pantoprazole) and control group (received only oral/EN', 'intensive care unit (ICU) patients receiving oral/enteral nutritional support', 'oral/ enteral nutrition with or without concomitant pantoprazole']","['upper GI bleeding', 'Overt upper GI bleeding', 'overall length of ICU stay', 'gastrointestinal bleeding', 'ICU stay']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}]",300.0,0.0612705,"The overall length of ICU stay of 4 (2-105) days, while ICU stay was significantly longer in the intervention group than in the control group (p=0.006).
","[{'ForeName': 'Kürşat', 'Initials': 'K', 'LastName': 'Gündoğan', 'Affiliation': 'Division of Intensive Care, Department of Internal Medicine, Faculty of Medicine, Erciyes University, Kayseri, Turkey'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Karakoc', 'Affiliation': 'Division of Intensive Care, Department of Internal Medicine, Faculty of Medicine, Çukurova University, Adana, Turkey'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Teke', 'Affiliation': 'Division of Intensive Care, Department of Pulmonary Disease, Faculty of Medicine, Necmettin Erbakan University, Konya, Turkey'}, {'ForeName': 'Avşar', 'Initials': 'A', 'LastName': 'Zerman', 'Affiliation': 'Intensive Care Unit, Department of Internal Medicine, Ministry of Health Adana Numune Training and Educational Hospital, Adana, Turkey'}, {'ForeName': 'Aliye', 'Initials': 'A', 'LastName': 'Esmaoglu', 'Affiliation': 'Division of Intensive Care, Department of Anesthesiology and Reanimation, Faculty of Medicine, Erciyes University, Kayseri, Turkey'}, {'ForeName': 'Şahin', 'Initials': 'Ş', 'LastName': 'Temel', 'Affiliation': 'Division of Intensive Care, Department of Internal Medicine, Faculty of Medicine, Erciyes University, Kayseri, Turkey'}, {'ForeName': 'Muhammet', 'Initials': 'M', 'LastName': 'Güven', 'Affiliation': 'Division of Intensive Care, Department of Internal Medicine, Faculty of Medicine, Erciyes University, Kayseri, Turkey'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sungur', 'Affiliation': 'Division of Intensive Care, Department of Internal Medicine, Faculty of Medicine, Erciyes University, Kayseri, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-1911-42']
117,31922359,Late clinical outcomes of myocardial hybrid revascularization versus coronary artery bypass grafting for complex triple-vessel disease: Long-term follow-up of the randomized MERGING clinical trial.,"OBJECTIVES


This article aimed to compare the outcomes after hybrid revascularization with conventional coronary artery bypass grafting (CABG) surgery.
BACKGROUND


The concept of hybrid coronary revascularization combines the advantages of CABG and percutaneous coronary intervention to improve the treatment of patients with complex multivessel disease.
METHODS


The Myocardial hybrid revascularization versus coronary artERy bypass GraftING for complex triple-vessel disease-MERGING study is a pilot randomized trial that allocated 60 patients with complex triple-vessel disease to treatment with hybrid revascularization or conventional CABG (2:1 ratio). The primary outcome was the composite of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization at 2 years.
RESULTS


Clinical and anatomical characteristics were similar between groups. After a mean follow-up of 802 ± 500 days, the primary endpoint rate was 19.3% in the hybrid arm and 5.9% in the CABG arm (p = NS). The incidence of unplanned revascularization increased over time in both groups, reaching 14.5 versus 5.9% in the hybrid and in the CABG groups, respectively (p = .4). Of note, in the hybrid group, there were no reinterventions driven by the occurrence of stent restenosis.
CONCLUSIONS


Hybrid myocardial was feasible but associated with increasing rates of major adverse cardiovascular events during 2 years of clinical follow-up, while the control group treated with conventional surgery presented with low rates of complications during the same period. In conclusion, before more definitive data arise, hybrid revascularization should be applied with careful attention in practice, following a selective case-by-case indication.",2021,"The incidence of unplanned revascularization increased over time in both groups, reaching 14.5 versus 5.9% in the hybrid and in the CABG groups, respectively (p = .4).","['patients with complex multivessel disease', '60 patients with complex triple-vessel disease to treatment with hybrid revascularization or conventional CABG (2:1 ratio']","['hybrid revascularization with conventional coronary artery bypass grafting (CABG) surgery', 'Myocardial hybrid revascularization versus coronary artERy bypass GraftING', 'CABG and percutaneous coronary intervention', 'coronary artery bypass grafting', 'myocardial hybrid revascularization']","['rates of major adverse cardiovascular events', 'incidence of unplanned revascularization', 'composite of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization at 2\u2009years', 'primary endpoint rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0856738', 'cui_str': 'Triple vessel disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",60.0,0.0819068,"The incidence of unplanned revascularization increased over time in both groups, reaching 14.5 versus 5.9% in the hybrid and in the CABG groups, respectively (p = .4).","[{'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Esteves', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Marco A P', 'Initials': 'MAP', 'LastName': 'Oliveira', 'Affiliation': 'Division of Cardiovascular Surgery, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Fernanda S', 'Initials': 'FS', 'LastName': 'Feitosa', 'Affiliation': 'Division of Clinical Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Mariani', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Campos', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Division of Clinical Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Lisboa', 'Affiliation': 'Division of Cardiovascular Surgery, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Fabio B', 'Initials': 'FB', 'LastName': 'Jatene', 'Affiliation': 'Division of Cardiovascular Surgery, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Roberto K', 'Initials': 'RK', 'LastName': 'Filho', 'Affiliation': 'Division of Clinical Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos Neto', 'Affiliation': 'Department of Interventional Cardiology, Heart Institute - InCor, University of Sao Paulo Medical School, São Paulo, Brazil.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28710']
118,29943058,Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities.,"BACKGROUND


One-Anastomosis Gastric Bypass (OAGB) has exponentially increased in the last decade, as it is associated with very low complications, mortality, readmissions and reoperations rates, and shows excellent short- and long-term benefits of weight loss and resolution of comorbidities. The aim of this study was to compare the effect of SG, RYGB, and OAGB, on short- and long-term weight loss and comorbidities resolution.
METHODS


A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB, and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT), and dyslipidemia (DL) were assessed.
RESULTS


600 patients were included in the study, 200 in each group. Follow-up rate at 5 years postoperatively was 91% in SG group, 92% in RYGB, and 90% in OAGB. OAGB achieves significantly greater EBMIL than RYGB and SG at 1, 2, and 5 years (p < 0.001, respectively). At 5 years, OAGB achieves significantly greater remission of T2DM (p = 0.027), HT (p = 0.006), and DL (p < 0.001) than RYGB and SG. RYGB did not show significant superiority than SG in short- and long-term remission of T2DM and HT, but achieves greater remission of DL (p < 0.001).
CONCLUSION


OAGB achieves superior mid- and long-term weight loss than RYGB and SG. There are no significant differences in weight loss between SG and RYGB at 1, 2, and 5 years. OAGB achieves better short- and long-term resolution rates of DM, HT, and DL than SG and RYGB. RYGB and SG obtain similar T2DM and HT remissions, but RYGB reaches significantly greater rates of DL remission. ClinicalTrials.gov Identifier: NCT03467646.",2019,"RYGB did not show significant superiority than SG in short- and long-term remission of T2DM and HT, but achieves greater remission of DL (p < 0.001).
","['morbidly obese patients undergoing SG, RYGB, and OAGB, as primary bariatric procedures, was performed', '600 patients were included in the study, 200 in each group']","['OAGB', 'sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass']","['remission of DL', 'weight loss', 'remission of T2DM', 'BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT), and dyslipidemia (DL', 'OAGB achieves superior mid- and long-term weight loss', 'rates of DL remission', 'RYGB and SG obtain similar T2DM and HT remissions']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]",600.0,0.0248594,"RYGB did not show significant superiority than SG in short- and long-term remission of T2DM and HT, but achieves greater remission of DL (p < 0.001).
","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Carbajo', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Jimenez', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Castro', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Gonzalez', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ortiz-de-Solorzano', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Lorea', 'Initials': 'L', 'LastName': 'Zubiaga', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}]",Surgical endoscopy,['10.1007/s00464-018-6307-9']
119,31971338,A new intravascular ultrasound-guided stenting strategy compared with angiography on stent expansion and procedural outcomes in patients with positive lesion remodeling.,"OBJECTIVES


We investigated the role of a new intravascular ultrasound (IVUS)-guided stenting strategy versus angiography on optimal stent expansion (OSE) and procedural outcomes in patients with positive lesion remodeling.
BACKGROUND


There are no IVUS criteria on how to achieve OSE.
METHODS


A total of 100 patients were assigned to a new IVUS-guided stenting strategy (IVUS group) versus angiography-guided stenting (Angio group). In the IVUS group, among patients with positive lesion remodeling, defined as a remodeling ratio (RR; lesion external elastic membrane (EEM) area/distal reference EEM area) >1.05, the stent was expanded with a balloon sized to the distal reference EEM diameter. In the Angio group, the stent was expanded by visual estimation. In both groups, IVUS was performed after postdilation.
RESULTS


Minimum stent area (MSA) and stent volume index were significantly larger in the IVUS versus Angio group (7.1 ± 1.9 vs. 5.9 ± 1.5 mm 2  , and 8.7 ± 2.1 vs. 7.5 ± 1.8 mm 3  /mm, respectively; p < .01). The percentages of OSE, defined as an MSA ≥5.4 mm 2  , MSA ≥90% of distal reference lumen area (DRLA), or MSA > DRLA, were significantly higher in the IVUS versus Angio group (80 vs. 56%, 78 vs. 54%, and 71 vs. 38%, respectively; p < .01). Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05). In the IVUS group, owing to positive remodeling, there was no incidence of dissection or perforation.
CONCLUSIONS


This new strategy of IVUS-guided stenting in patients with positive lesion remodeling, compared with angiography, significantly increased stent expansion and decreased stent underexpansion, malapposition, and residual reference segment stenosis with no complications.",2021,"Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05).","['100 patients', 'patients with positive lesion remodeling']","['new IVUS-guided stenting strategy (IVUS group) versus angiography-guided stenting (Angio group', 'new intravascular ultrasound (IVUS)-guided stenting strategy versus angiography', 'IVUS-guided stenting', 'IVUS']","['incidence of dissection or perforation', 'Minimum stent area (MSA) and stent volume index', 'remodeling ratio (RR; lesion external elastic membrane (EEM) area/distal reference EEM area', 'stent expansion', 'Stent underexpansion, malapposition, and residual reference segment stenosis']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",100.0,0.0435607,"Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05).","[{'ForeName': 'Diaa', 'Initials': 'D', 'LastName': 'Hakim', 'Affiliation': 'Division of Cardiology, University of Alabama-Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Mouhamad', 'Initials': 'M', 'LastName': 'Abdallah', 'Affiliation': 'Division of Cardiology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Effat', 'Affiliation': 'Division of Cardiology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Al Solaiman', 'Affiliation': 'Division of Cardiology, University of Alabama-Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Oluseun', 'Initials': 'O', 'LastName': 'Alli', 'Affiliation': 'Division of Cardiology, University of Alabama-Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Massoud A', 'Initials': 'MA', 'LastName': 'Leesar', 'Affiliation': 'Division of Cardiology, University of Alabama-Birmingham, Birmingham, Alabama.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28727']
120,31980886,"Postoperative analgesic efficacy of perioperative intravenous lidocaine infusion in patients undergoing septorhinoplasty: a prospective, randomized, double-blind study.","PURPOSE


Intravenous lidocaine infusion has been used for postoperative analgesia in many surgical procedures in recent years. The aim of this randomized, double-blind study was to investigate the postoperative analgesic efficacy of perioperative intravenous lidocaine infusion in patients undergoing septorhinoplasty surgery.
MATERIALS AND METHODS


Forty-eight American Society of Anesthesiologists I and II patients, aged 18-40 years scheduled for septorhinoplasty surgery, were assigned into two groups. Before anesthesia induction, patients in the lidocaine group (Group L, n = 24) received an intravenous bolus infusion of 1.5 mg/kg lidocaine followed by a continuous infusion of 1.5 mg/kg/h during the operation and until the end of the first postoperative hour. Patients in the control group (Group C, n = 24) received normal saline according to the same protocol. In the postoperative period, 50 mg dexketoprofen trometamol was administered and repeated every 12 h. Postoperative pain scores, rescue analgesia, intraoperative opioid requirements, and side effects were recorded.
RESULTS


Postoperative pain scores were significantly lower in Group L than in Group C at postoperative 30 min, 1, 2, 4, 8, 12 and 24 h (p < 0.05). There was no difference between groups intraoperative remifentanil consumption (p > 0.05). Rescue analgesia use was statistically significantly higher in Group C than in Group L (12/24 versus 1/24, respectively, p  =  0.001). Postoperative nausea was statistically higher in Group C than in Group L (13/24 versus 5/24 respectively, p  =  0.017), whereas other side-effects were similar for the two groups (p > 0.05).
DISCUSSION


We recommended the use of intravenous lidocaine infusion for intraoperatively and first postoperative hours in septorhinoplasty surgery as it reduces pain scores and the need for additional opioid use.",2020,"RESULTS


Postoperative pain scores were significantly lower in Group L than in Group C at postoperative 30 min, 1, 2, 4, 8, 12 and 24 h (p < 0.05).","['patients undergoing septorhinoplasty surgery', 'Forty-eight American Society of Anesthesiologists', 'I and II patients, aged 18-40 years scheduled for septorhinoplasty surgery', 'patients undergoing septorhinoplasty']","['lidocaine', 'perioperative intravenous lidocaine infusion', 'normal saline', 'perioperative intravenous lidocaine', 'intravenous bolus infusion of 1.5\xa0mg/kg lidocaine', 'dexketoprofen trometamol']","['side-effects', 'Rescue analgesia use', 'Postoperative analgesic efficacy', 'intraoperative remifentanil consumption', 'Postoperative pain scores, rescue analgesia, intraoperative opioid requirements, and side effects', 'Postoperative nausea', 'pain scores', 'Postoperative pain scores', 'postoperative analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0765538', 'cui_str': 'dexketoprofen trometamol'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",48.0,0.272134,"RESULTS


Postoperative pain scores were significantly lower in Group L than in Group C at postoperative 30 min, 1, 2, 4, 8, 12 and 24 h (p < 0.05).","[{'ForeName': 'İrem', 'Initials': 'İ', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, 25070, Erzurum, Turkey.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, 25070, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, 25070, Erzurum, Turkey. aliahiskalioglu@hotmail.com.'}, {'ForeName': 'Elif Oral', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, 25070, Erzurum, Turkey.'}, {'ForeName': 'Zulkuf', 'Initials': 'Z', 'LastName': 'Kaya', 'Affiliation': 'Department of Otorhinolaryngology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Mustafa Sitki', 'Initials': 'MS', 'LastName': 'Gozeler', 'Affiliation': 'Department of Otorhinolaryngology, Ataturk University School of Medicine, Erzurum, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05801-6']
121,32406569,Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department.,"BACKGROUND


There is limited research on loop drainage (LD) compared to incision and drainage (I&D) for treatment of cutaneous abscesses. We investigated whether LD was noninferior to I&D for abscess resolution and whether there was any difference in repeat ED visits or complication rates between these techniques.
METHODS


We performed a prospective randomized controlled trial, using a convenience sample at an urban academic emergency department (ED). Subjects over 18 years who presented for first-time management of an abscess were eligible. Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded. Enrolled subjects were seen 2 weeks after treatment for blinded reevaluation of abscess resolution, and the electronic medical record was reviewed for return ED visits/abscess complications.
RESULTS


Of 2,889 patients screened, 238 subjects consented and were randomized to LD or I&D. Abscess resolution was achieved in 53/65 (81.5%) of patients in the I&D arm, compared to 66/75 (88%) in the LD arm. Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%, p = 0.002). Among returning subjects, there was a significant difference in mean visits per subject between LD and I&D groups (0.5 vs. 1.2, p = 0.001). There were fewer complications among LD than I&D subjects (9.3% vs. 24.6%, p = 0.01).
CONCLUSION


Our study provides evidence that LD is noninferior to I&D in achieving complete abscess resolution at 14 days and is associated with fewer return ED visits and fewer complications. This makes it an attractive alternative treatment option for abscesses.",2020,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","['convenience sample at an urban academic emergency department (ED', 'Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded', 'Subjects over 18\xa0years who presented for first-time management of an abscess were eligible', '238 subjects consented', '2,889 patients screened']","['incision and drainage (I&D', 'LD']","['repeat ED visits or complication rates', 'mean visits']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0205546', 'cui_str': 'Repeat emergency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",238.0,0.11263,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","[{'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Schechter-Perkins', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kristin H', 'Initials': 'KH', 'LastName': 'Dwyer', 'Affiliation': 'the, Department of Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'the, Department of Emergency Medicine, Kaiser Permanante Medical Center, Oakland, CA, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Tyler', 'Affiliation': 'the, Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kerrie P', 'Initials': 'KP', 'LastName': 'Nelson', 'Affiliation': 'and the, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Mitchell', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13981']
122,1378324,Molecular breakpoints and platelet counts in chronic myeloid leukemia.,,1992,,['chronic myeloid leukemia'],[],[],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]",[],[],,0.0187318,,"[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Shepherd', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bond', 'Affiliation': ''}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Allan', 'Affiliation': ''}]",Blood,[]
123,31742670,Promoting colonoscopy screening among low-income Latinos at average risk of colorectal cancer: A randomized clinical trial.,"BACKGROUND


Screening colonoscopy (SC) for colorectal cancer (CRC) is underused by Latino individuals. The current randomized clinical trial examined the impact of 3 interventions: 1) patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC. Demographic, personal and health history, and psychometric factors associated with SC also were examined.
METHODS


A total of 344 urban Latino individuals aged 50 to 85 years with no personal and/or immediate family history of CRC diagnosed before age 60 years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5 years, with insurance coverage, and with a referral for SC were consented. Participants were randomized to patient navigation (20%), patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials (40%). The completion of SC was assessed at 12 months.
RESULTS


The interventions had an overall SC rate of 82%. Counterintuitively, patients with an average income of <$10,000 were found to have higher SC rates (87%) than those with a greater income (75%).
CONCLUSIONS


The addition of standard or culturally targeted print materials did not appear to increase SC rates above those for patient navigation. Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.",2020,"Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.","['Latino individuals', '344 urban Latino individuals aged 50 to 85\xa0years with no personal and/or immediate family history of CRC diagnosed before age 60\xa0years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5\xa0years, with insurance coverage, and with a referral for SC were consented', 'low-income Latinos at average risk of colorectal cancer']","['patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials', 'Screening colonoscopy (SC', 'patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC']","['overall SC rate', 'SC rates']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0424945', 'cui_str': 'Social / personal history observable'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0568607,"Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.","[{'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'DuHamel', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villagra', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Pathu', 'Initials': 'P', 'LastName': 'Sriphanlop', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Itzkowitz', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Deborah O', 'Initials': 'DO', 'LastName': 'Erwin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Winkel', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Hayley S', 'Initials': 'HS', 'LastName': 'Thompson', 'Affiliation': 'Department of Community Outreach and Engagement, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lina H', 'Initials': 'LH', 'LastName': 'Jandorf', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}]",Cancer,['10.1002/cncr.32541']
124,31767215,A randomized controlled trial of internet-delivered cognitive behaviour therapy to prevent the development of depressive disorders in older adults with multimorbidity.,"BACKGROUND


Multimorbidity, which commonly impacts older adults is associated with higher rates of depression. We aimed to investigate whether internet delivered cognitive-behaviour therapy (iCBT) could prevent depressive disorders in older adults with multimorbidity who were not currently depressed.
METHOD


302 primary care and community participants aged 65 years and over, who had multimorbidity but did not meet criteria for a depressive disorder were randomised to an intervention group who received an eight-week, five session iCBT (n = 150) or to a control group (n = 152) who received treatment as usual. Diagnostic interviews were conducted at baseline, and three and six months after the intervention period, where indicated, and the presence of depressive disorder was the primary outcome.
RESULTS


The intention to treat, chi-square analyses indicated there were significantly fewer cases of depressive disorder in the treatment group compared to the control group by six-month follow-up (χ²(1,302) = 5.21, p = .02).
LIMITATIONS


The main limitations of this RCT are a short follow up period and low proportion of participants who developed depressive disorders. Participants were relatively well educated, with a majority having English as their first language.
CONCLUSIONS


These results indicate that depressive disorder was prevented in the first six months following iCBT with three times the number of cases of depressive disorder in the control group compared to the treatment group. Further research is required to determine whether iCBT can be effective for preventing depressive disorder in this population over a longer time period.",2020,"The intention to treat, chi-square analyses indicated there were significantly fewer cases of depressive disorder in the treatment group compared to the control group by six-month follow-up (χ²(1,302) = 5.21, p = .02).
","['Participants were relatively well educated, with a majority having English as their first language', 'older adults with multimorbidity', '302 primary care and community participants aged 65 years and over, who had multimorbidity but did not meet criteria for a depressive disorder', 'participants who developed depressive disorders', 'older adults with multimorbidity who were not currently depressed']","['intervention group who received an eight-week, five session iCBT', 'iCBT', 'internet-delivered cognitive behaviour therapy', 'internet delivered cognitive-behaviour therapy (iCBT']","['depressive disorder', 'depressive disorders']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0557073', 'cui_str': 'First language (observable entity)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",302.0,0.0939697,"The intention to treat, chi-square analyses indicated there were significantly fewer cases of depressive disorder in the treatment group compared to the control group by six-month follow-up (χ²(1,302) = 5.21, p = .02).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': 'University of Sydney, Australia. Electronic address: louise.sharpe@sydney.edu.au.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Sharpe', 'Affiliation': 'University of Sydney, Australia.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Burton', 'Affiliation': 'University of Sydney, Australia.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Arean', 'Affiliation': 'University of Washington, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'University of Washington, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McDonald', 'Affiliation': 'Macquarie University, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Macquarie University, Australia.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Gandy', 'Affiliation': 'Macquarie University, Australia.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Macquarie University, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.077']
125,31905307,"Acceptability, Feasibility, and Efficacy Potential of a Multimodal Acceptance and Commitment Therapy Intervention to Address Psychosocial and Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic Cancer.","Background:  Adults with metastatic cancer frequently report anxiety and depression symptoms, which may impact health behaviors such as advance care planning (ACP).  Objective:  The study leveraged acceptance and commitment therapy (ACT), an evidence-based approach for reducing distress and improving health behaviors, and adapted it into a multimodal intervention (M-ACT) designed to address the psychosocial and ACP needs of anxious and depressed adults with metastatic cancer. The study evaluated M-ACT's acceptability, feasibility, and efficacy potential.  Design:  The study was designed as a single-arm intervention development and pilot trial.  Setting/Subjects:  The trial enrolled 35 anxious or depressed adults with stage IV cancer in community oncology clinics, with a referred-to-enrolled rate of 69% and eligible-to-enrolled rate of 95%.  Measurements:  M-ACT alternated four in-person group sessions with three self-paced online sessions. Acceptability and feasibility were assessed through enrollment, attendance, and satisfaction ratings. Outcomes and theorized intervention mechanisms were evaluated at baseline, midintervention, postintervention, and two-month follow-up.  Results:  Participant feedback was used to refine the intervention. Of participants starting the intervention, 92% completed, reporting high satisfaction. One-quarter did not begin M-ACT due to health declines, moving, or death. Completers showed significant reductions in anxiety, depression, and fear of dying and increases in ACP and sense of life meaning. In this pilot, M-ACT showed no significant impact on pain interference. Increases in two of three mechanism measures predicted improvement on 80% of significant outcomes.  Conclusions:  The M-ACT intervention is feasible, acceptable, and shows potential for efficacy in community oncology settings; a randomized trial is warranted.",2020,"Completers showed significant reductions in anxiety, depression, and fear of dying and increases in ACP and sense of life meaning.","['anxious and depressed adults with metastatic cancer', 'Adults with metastatic cancer frequently report anxiety and depression symptoms', 'Anxious and Depressed Adults with Metastatic Cancer', '35 anxious or depressed adults with stage IV cancer in community oncology clinics, with a referred-to-enrolled rate of 69% and eligible-to-enrolled rate of 95']","['Multimodal Acceptance and Commitment Therapy Intervention', 'M-ACT intervention', 'M-ACT alternated four']","[""M-ACT's acceptability, feasibility, and efficacy potential"", 'pain interference', 'anxiety, depression, and fear of dying and increases in ACP and sense of life meaning', 'enrollment, attendance, and satisfaction ratings', 'Acceptability and feasibility', 'Acceptability, Feasibility, and Efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0522179', 'cui_str': 'Fear of death (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",35.0,0.0595659,"Completers showed significant reductions in anxiety, depression, and fear of dying and increases in ACP and sense of life meaning.","[{'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Arch', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Fishbein', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Ferris', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Mitchell', 'Affiliation': 'Department of Medical Oncology, Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Department of Psychology, Utah State University, Logan, Utah, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Slivjak', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Andorsky', 'Affiliation': 'Department of Medical Oncology, Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0398']
126,3516258,Increased red blood cell deformability due to isoxsuprine administration decreases platelet adherence in a perfusion chamber: a double-blind cross-over study in patients with intermittent claudication.,"Platelet transport towards the vessel wall is influenced by the hematocrit, red blood cell (RBC) size, and shape. Recent in vitro studies have indicated that RBC deformability may also influence platelet transport. The observation that isoxsuprine, a known vasodilating drug, caused increased RBC deformability in vitro and decreased platelet transport in vitro prompted us to study the effects of this drug in vivo. The study was performed in a double-blind cross-over study of isoxsuprine v placebo in ten patients with peripheral arterial insufficiency. RBC deformability was estimated from viscosity measurements using the blood viscosity equation of Dintenfass and expressed as T value. Platelet transport was studied in an annular perfusion chamber according to Baumgartner. Human umbilical arteries were used as blood vessels. Perfusion studies were performed with whole blood or with RBCs of the patients mixed with normal platelets and plasma at a standardized hematocrit and platelet count. An increase in RBC deformability concomitant with a decrease in platelet adherence was observed in patients on isoxsuprine with a drop in T value of approximately 0.06 (from 0.91 toward 0.86), and a concomitant decrease in platelet adherence of 20% to 40%. These observations differed significantly from the results in the placebo group and showed a significant group-period interaction at the cross-over of medication (analysis of variance). The effects on platelet adherence were observed at high vessel wall shear rate (1,800 s-1) with perfusates consisting of patients' RBCs and donor plasma and platelets at standardized hematocrit and platelet count. No differences were observed under these conditions at a shear rate of 300 s-1. When whole blood of patients was used, nonsignificant effect was observed at shear rates of 300 s-1 and 1,800 s-1. This was probably caused by the added noise due to variations in hematocrit and platelet number. These data demonstrate that isoxsuprine increases RBC deformability, and they suggest the possibility of decreasing platelet-vessel wall interaction in vivo by manipulation of RBC deformability.",1986,"An increase in RBC deformability concomitant with a decrease in platelet adherence was observed in patients on isoxsuprine with a drop in T value of approximately 0.06 (from 0.91 toward 0.86), and a concomitant decrease in platelet adherence of 20% to 40%.","['patients with intermittent claudication', 'ten patients with peripheral arterial insufficiency']","['isoxsuprine v placebo', 'placebo', 'isoxsuprine']","['RBC deformability concomitant', 'red blood cell deformability', 'Platelet transport', 'hematocrit, red blood cell (RBC) size, and shape', 'platelet adherence', 'RBC deformability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0281943', 'cui_str': 'Peripheral artery insufficiency'}]","[{'cui': 'C0022267', 'cui_str': 'Isoxsuprine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0427488', 'cui_str': 'Red blood cell size - finding'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}]",10.0,0.0384223,"An increase in RBC deformability concomitant with a decrease in platelet adherence was observed in patients on isoxsuprine with a drop in T value of approximately 0.06 (from 0.91 toward 0.86), and a concomitant decrease in platelet adherence of 20% to 40%.","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Aarts', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Banga', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'van Houwelingen', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Heethaar', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sixma', 'Affiliation': ''}]",Blood,[]
127,31614373,Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study.,"BACKGROUND


Cap-assisted colonoscopy is frequently used to facilitate adenoma detection during endoscopy. However, data on how cap assistance influences polyp resection are scarce. We aimed to evaluate the impact of cap assistance with the Endocuff vision device (EVD) on the resection time for colorectal polyps in patients undergoing colonoscopy. METHODS : A randomized, prospective study was performed in a university hospital in Germany. A total of 250 patients were randomly assigned 1:1 to undergo either colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm). The primary outcome was the average duration of polypectomy. Secondary outcomes included adenoma detection rate, cecal and ileal intubation times, and propofol dosage.
RESULTS


The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively;  P  = 0.02). This effect was strongest for polyps ≥ 6 mm. Compared with the standard group, Endocuff assistance also resulted in a shorter cecal intubation time (6 vs. 8 minutes;  P  = 0.03) and overall colonoscopy time (23 vs. 27 minutes;  P  = 0.02). In contrast, no difference in withdrawal time was observed. The polyp and adenoma detection rates did not differ significantly between the two groups.
CONCLUSION


Endocuff-assisted colonoscopy reduces the duration of polypectomy, which may be due to a more stable scope position during resection. Further studies are needed to investigate whether comparable effects will be seen for other interventions, such as clipping or biopsy sampling.",2020,"The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively;  P  = 0.02).","['university hospital in Germany', 'patients undergoing colonoscopy', 'A total of 250 patients']","['colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm', 'Endocuff-assisted colonoscopy', 'cap assistance with the Endocuff vision device (EVD', 'Endocuff vision-assisted vs. standard polyp resection']","['duration of polypectomy', 'average duration of polypectomy', 'shorter cecal intubation time', 'median polypectomy time', 'polyp and adenoma detection rates', 'adenoma detection rate, cecal and ileal intubation times, and propofol dosage', 'withdrawal time', 'overall colonoscopy time']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",250.0,0.0984559,"The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively;  P  = 0.02).","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'von Figura', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hasenöhrl', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institut für Medizinische Informatik, Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Poszler', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Ulrich', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelhafez', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Roland M', 'Initials': 'RM', 'LastName': 'Schmid', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'von Delius', 'Affiliation': 'Medizinische Klinik II, RoMed Klinikum Rosenheim, Rosenheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klare', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}]",Endoscopy,['10.1055/a-1018-1870']
128,31203685,Effect of breast milk and sucrose on pain and perfusion index during examination for retinopathy of prematurity.,"OBJECTIVE


The objective of this study is to investigate the effect of breast milk and sucrose on pain scores and perfusion index (PI) and to evaluate the alteration in pain and PI during retinopathy of prematurity (ROP) examination.
METHODS


This prospective randomized controlled study was conducted with preterm infants who were born in our hospital, hospitalized in the neonatal intensive care unit and whose gestational week was <32 weeks and birth weight was <1500 g. The preterm infants who would undergo ROP examination were allocated to three groups according to simple randomization method as follows: group 1: only local anesthetic eye drops, proparacaine HCl ophthalmic solution 0.5%, group 2: proparacaine HCl ophthalmic solution 0.5% plus breast milk, and group 3: proparacaine HCl ophthalmic solution 0.5% plus sucrose 24%. Postductal PI, transcutaneous oxygen saturation and heart rate (HR) values were measured before the eye examination (0), at the 30th, 60th, and 90th seconds (s) of the eye examination and 30 s after lasting of the examination in all infants. Pain was evaluated using Neonatal Infant Pain Scale (NIPS) during the examination.
RESULTS


Fifty-one preterm neonates were prospectively enrolled into the study. The HR was higher during and after the examination in all infants according to before the examination ( p  < .001). Transcutaneous oxygen saturation values significantly decreased during the examination in breast milk and sucrose groups ( p  = .001 and <.001, respectively). While PI was found to be lower at the 60th s compared to the 30th s of the examination in the proparacaine HCl group, no difference was found between the values before and after the examination. Perfusion index was found to significantly decrease during and after the examination compared to the values before the examination in the breast milk group. Perfusion index values were determined to significantly decrease at the 30th and 60th s of the examination in the sucrose group. The NIPS scores during the examination were determined to be higher compared to the NIPS scores before the examination in all groups ( p < .001). In the intergroup comparisons, the NIPS scores were found to be higher in the sucrose group compared to the proparacaine HCl group at the 60th s of the examination and higher than that in the breast milk group at the 90th s of the examination ( p  = .02 and  p  = .01, respectively).
CONCLUSIONS


The present study indicates that alterations may be seen in PI during the ROP examination; in other words, peripheral tissue perfusion could be affected. We consider that eye examination is a very painful procedure, and administering breast milk, sucrose or local anesthetic is not sufficient for reducing pain.",2021,"Transcutaneous oxygen saturation values significantly decreased during the examination in breast milk and sucrose groups ( p  = .001 and <.001, respectively).","['retinopathy of prematurity', 'preterm infants who were born in our hospital, hospitalized in the neonatal intensive care unit and whose gestational week was <32\xa0weeks and birth weight was <1500\u2009g. The preterm infants who would undergo ROP examination', 'Results:  Fifty-one preterm neonates']","['breast milk and sucrose', 'local anesthetic eye drops, proparacaine HCl ophthalmic solution', 'proparacaine HCl', 'proparacaine HCl ophthalmic solution 0.5% plus breast milk, and group 3: proparacaine HCl ophthalmic solution 0.5% plus sucrose 24']","['NIPS scores', 'pain scores and perfusion index (PI', 'pain and perfusion index', 'Pain', 'Postductal PI, transcutaneous oxygen saturation and heart rate (HR) values', 'Neonatal Infant Pain Scale (NIPS', 'Transcutaneous oxygen saturation values', 'Perfusion index values', 'Perfusion index']","[{'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C0740235', 'cui_str': 'Proparacaine hydrochloride'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0645782', 'cui_str': 'NIPS'}]",51.0,0.0524076,"Transcutaneous oxygen saturation values significantly decreased during the examination in breast milk and sucrose groups ( p  = .001 and <.001, respectively).","[{'ForeName': 'Ozden', 'Initials': 'O', 'LastName': 'Turan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Imren', 'Initials': 'I', 'LastName': 'Akkoyun', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Deniz Anuk', 'Initials': 'DA', 'LastName': 'Ince', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Beyza', 'Initials': 'B', 'LastName': 'Doganay', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Ankara University, Ankara, Turkey.'}, {'ForeName': 'A Ulas', 'Initials': 'AU', 'LastName': 'Tugcu', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ecevit', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Faculty of Medicine, Baskent University, Ankara, Turkey.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1628209']
129,31786030,"Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: A randomized, double-blind, non-inferiority study.","BACKGROUND


Ketamine and its enantiomers have recently been highlighted as one of the most effective therapeutic options in refractory depression. However, racemic ketamine and esketamine have not been directly compared. The aim of this study is to assess the efficacy and safety of esketamine compared to ketamine in patients with treatment-resistant depression (TRD).
METHODS


This is a randomized, double-blind, active-controlled, bicentre, non-inferiority clinical trial, with two parallel groups. Participants were randomly assigned to a 40-min single intravenous infusion of ketamine 0.5 mg/kg or esketamine 0.25 mg/kg. The primary outcome was the difference in remission rates for depression 24 h following intervention using the Montgomery-Åsberg Depression Rating Scale (MADRS), with a non-inferiority margin of 20%.
RESULTS


63 subjects were included and randomly assigned (29 to receive ketamine and 34 to receive esketamine). At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority. MADRS scores improved from 33 (SD 9.3) to 16.2 (SD 10.7) in the ketamine group and from 33 (SD 5.3) to 17.5 (SD 12.2) in the esketamine one, with a difference of -5.27% (95% CILB, -13.6). Both groups presented similar mild side effects.
CONCLUSIONS


Esketamine was non-inferior to ketamine for TRD 24 h following infusion. Both treatments were effective, safe, and well tolerated.
TRIAL REGISTRATION


Registered in Japan Primary Registries Network: UMIN000032355.",2020,"At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority.","['63 subjects', 'patients with treatment-resistant depression (TRD', 'adult treatment-resistant depression']","['racemic ketamine', 'ketamine 0.5\u202fmg/kg or esketamine 0.25\u202fmg/kg', 'Ketamine', 'ketamine', 'esketamine or racemic ketamine', 'ketamine and 34 to receive esketamine', 'esketamine']","['effective, safe, and well tolerated', 'remission rates for depression 24\xa0h following intervention using the Montgomery-Åsberg Depression Rating Scale (MADRS), with a non-inferiority margin of 20', 'efficacy and safety', 'Efficacy and safety', 'mild side effects', 'MADRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C2825616'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",63.0,0.705217,"At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority.","[{'ForeName': 'Fernanda S', 'Initials': 'FS', 'LastName': 'Correia-Melo', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil. Electronic address: lcq@ufba.br.'}, {'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Leal', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil; Division of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'Vieira', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Jesus-Nunes', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Mello', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Magnavita', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Ana Teresa', 'Initials': 'AT', 'LastName': 'Caliman-Fontes', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Mariana V F', 'Initials': 'MVF', 'LastName': 'Echegaray', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Igor D', 'Initials': 'ID', 'LastName': 'Bandeira', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Samantha S', 'Initials': 'SS', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Diogo E', 'Initials': 'DE', 'LastName': 'Cavalcanti', 'Affiliation': 'Division of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Araújo-de-Freitas', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Sarin', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Tuena', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Nakahira', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Aline S', 'Initials': 'AS', 'LastName': 'Sampaio', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Del-Porto', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Turecki', 'Affiliation': 'McGill Group for Suicide Studies, Douglas Mental Health University Institute & Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Loo', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australia; Black Dog Institute, Sydney, Australia; St George Hospital, South Eastern Sydney Health, Sydney, Australia.'}, {'ForeName': 'Acioly L T', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': 'Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil; Interdisciplinary Laboratory of Clinical Neurosciences, Federal University of São Paulo, São Paulo, Brazil; Sinapse Institute of Clinical Neurosciences, Campinas, Brazil.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Quarantini', 'Affiliation': 'Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil; Division of Psychiatry, Professor Edgard Santos University Hospital, Federal University of Bahia, Salvador, Brazil; Department of Neuroscience and Mental Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.086']
130,31780130,The effectiveness of internet-delivered cognitive behavioural therapy for health anxiety in routine care.,"INTRODUCTION


Randomised controlled trials have shown that internet-delivered cognitive behavioural treatment (iCBT) is an effective treatment for health anxiety, but the effectiveness of these programs in routine care has not been investigated. This study examined the effectiveness of iCBT for health anxiety symptoms in routine care settings in the community.
METHODS


Using an open-trial design, we investigated adherence to, and effectiveness of a 6-lesson iCBT program for health anxiety symptoms amongst individuals (n = 391, mean age 41 years, 64% female) who enrolled in the program either self-guided (n = 312) or under the supervision of community clinicians (general practitioners, psychologists and other allied health professionals) (n = 79). Primary outcome was health anxiety severity on the Short Health Anxiety Inventory (SHAI), and secondary outcomes were depression severity on the Patient Health Questionnaire 9-item (PHQ-9) (depression) and distress (Kessler-10: K-10).
RESULTS


Adherence to the iCBT program was modest (45.6% in the clinician-supervised group, 33.0% in the unguided group), but within-subjects effect sizes were large (SHAI: g = 1.66, 95%CI: 1.45-1.88; PHQ-9: g = 1.12, 95%CI: 0.92-1.32; K-10: g = 1.35, 95%CI: 1.15-1.56).
LIMITATIONS


No control group, lack of follow-up data.
CONCLUSIONS


iCBT is an effective treatment for health anxiety symptoms in routine care, but methods to increase adherence are needed to optimise benefits to participants. Randomised controlled effectiveness trials with long-term follow-up are needed.",2020,"Adherence to the iCBT program was modest (45.6% in the clinician-supervised group, 33.0% in the unguided group), but within-subjects effect sizes were large (SHAI:","['health anxiety in routine care', 'health anxiety symptoms amongst individuals (n\u202f=\u202f391, mean age 41 years, 64% female) who enrolled in the program either self-guided (n\u202f=\u202f312) or under the supervision of community clinicians (general practitioners, psychologists and other allied health professionals) (n\u202f=\u202f79']","['cognitive behavioural treatment (iCBT', '6-lesson iCBT program', 'PHQ-9', 'internet-delivered cognitive behavioural therapy', 'iCBT']","['health anxiety severity on the Short Health Anxiety Inventory (SHAI), and secondary outcomes were depression severity on the Patient Health Questionnaire 9-item', 'PHQ-9) (depression) and distress (Kessler-10: K-10']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2959402', 'cui_str': 'Short health anxiety inventory (assessment scale)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.115453,"Adherence to the iCBT program was modest (45.6% in the clinician-supervised group, 33.0% in the unguided group), but within-subjects effect sizes were large (SHAI:","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia; School of Psychology, University of New South Wales, NSW, Australia. Electronic address: j.newby@unsw.edu.au.""}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Haskelberg', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Hobbs', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia; School of Psychiatry, University of New South Wales, NSW, Australia.""}, {'ForeName': 'Alison E J', 'Initials': 'AEJ', 'LastName': 'Mahoney', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mason', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, St Vincent's Hospital, Darlinghurst, NSW, Australia; School of Psychiatry, University of New South Wales, NSW, Australia.""}]",Journal of affective disorders,['10.1016/j.jad.2019.11.087']
131,31780332,[Penile prostheses: Description of a series of implants with and without dilatation of the corpora cavernosa].,"INTRODUCTION


Penile prosthesis (PP) implantation is the treatment of choice for refractory erectile dysfunction (ED). They show a high satisfaction rate (75%-100%) and a complication rate that varies between 2.1% and 28.8%. The standard surgical technique includes dilatation of the corpora cavernosa (CC) prior to the insertion of the cylinders. This step takes time and is critical for the occurrence of complications. The aim of this study is to describe the results of a series of PP implanted using the techniques with and without dilatation of the CC.
MATERIALS AND METHODS


One-hundred and 20 patients with refractory ED in whom a PP was implanted by 2 surgeons in different centers. Comorbidities, operative characteristics, satisfaction and postoperative complications were evaluated.
RESULTS


The average age was 61±9.6 years. The most prevalent comorbidities were: history of radical prostatectomy, high-blood pressure and diabetes mellitus. Forty-two malleable and 78 hydraulic prostheses were implanted. Eleven patients had a previous PP. The median operative time was 70minutes (35-140). The satisfaction reported was 95.8%. Ten patients presented complications. In the group in which the surgery was performed without dilatation of the CC (n=80), the operative time was shorter (62.5minutes [35-105] versus 90minutes [60-140] respectively, p<0.0001). There was no difference in complications (p=0.73) or levels of satisfaction (p=0.196) when comparing the technique with and without dilatation of the CC.
CONCLUSION


In our series, a shorter operative time was observed with the technique without dilatation of the CC, but there were no differences in complications. A prospective and randomized study is required to make a stronger recommendation regarding to dilatation of the CC.",2021,"There was no difference in complications (p=0.73) or levels of satisfaction (p=0.196) when comparing the technique with and without dilatation of the CC.
CONCLUSION


","['Eleven patients had a previous PP', 'One-hundred and 20 patients with refractory ED in whom a PP was implanted by 2 surgeons in different centers', 'series of implants with and without dilatation of the corpora cavernosa', 'Forty-two malleable and 78 hydraulic prostheses were implanted']",['Penile prosthesis (PP) implantation'],"['satisfaction rate', 'operative time', 'complications', 'median operative time', 'shorter operative time', 'Comorbidities, operative characteristics, satisfaction and postoperative complications', 'complications (p=0.73) or levels of satisfaction', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0403319', 'cui_str': 'Penile Prosthesis Implantation'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0280156,"There was no difference in complications (p=0.73) or levels of satisfaction (p=0.196) when comparing the technique with and without dilatation of the CC.
CONCLUSION


","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fleck-Lavergne', 'Affiliation': 'Servicio de Urología, Hospital San José, Santiago, Región Metropolitana, Chile. Electronic address: danielafleck@gmail.com.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Marconi', 'Affiliation': 'Unidad de Andrología, Departamento de Urología, Pontificia Universidad Católica de Chile, Santiago, Región Metropolitana, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mercado-Campero', 'Affiliation': 'Servicio de Urología, Hospital Clínico Universidad de Chile, Santiago, Región Metropolitana, Chile; Departamento de Urología, Clínica Las Condes, Santiago, Región Metropolitana, Chile.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Hidalgo', 'Affiliation': 'Servicio de Urología, Hospital Clínico Universidad de Chile, Santiago, Región Metropolitana, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Marchant', 'Affiliation': 'Servicio de Urología, Hospital Clínico Universidad de Chile, Santiago, Región Metropolitana, Chile; Departamento de Urología, Clínica Las Condes, Santiago, Región Metropolitana, Chile.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Palma-Ceppi', 'Affiliation': 'Servicio de Urología, Hospital Clínico Universidad de Chile, Santiago, Región Metropolitana, Chile; Departamento de Urología, Clínica Las Condes, Santiago, Región Metropolitana, Chile.'}]",Revista internacional de andrologia,['10.1016/j.androl.2019.07.002']
132,31846901,Predictors of cognitive remediation therapy improvement in (partially) remitted unipolar depression.,"BACKGROUND


There is urgent need for development and evaluation of targeted interventions for cognitive deficits in (partially) remitted major depression. Until now the analyses of the moderators of treatment efficacy were only examined in mixed samples of patients with schizophrenia, affective spectrum and schizoaffective disorders. Thus, the aim of our study was to evaluate the predictors of cognitive remediation therapy (CRT) improvement in a sample of (partially) remitted major depressive disorder patients.
METHODS


Reliable Change Index with corrections for practice effects was calculated for each participant as an indicator for training improvement. Thirty eight patients, who were randomized within our previously conducted CRT clinical trial, were divided into ""Improvers"" and ""Nonimprovers"" in the attention domain, to compare them on sociodemographic, psychopathological, neurocognitive, psychosocial and training factors.
RESULTS


We detected 13 training participants who improved reliably in the attention domain. Illness duration was the only factor which significantly differentiated between Improvers and Nonimprovers. No significant differences between Improvers and Nonimprovers in terms of other clinical variables, sociodemographic and neuropsychological factors were found.
LIMITATIONS


Exploratory research results should be taken with caution. Focus on the attention domain could have led to a limited point of view.
CONCLUSION


Our findings represent a first analysis of the predictors of cognitive remediation training improvement in (partially) remitted unipolar depression. Much more work should be done to refine cognitive treatment approaches. An initiation of cognitive training in early stages of the disease could be beneficial for the affected patients.",2020,"No significant differences between Improvers and Nonimprovers in terms of other clinical variables, sociodemographic and neuropsychological factors were found.
","['13 training participants who improved reliably in the attention domain', 'Thirty eight patients', 'a sample of (partially) remitted major depressive disorder patients', 'patients with schizophrenia, affective spectrum and schizoaffective disorders']","['cognitive remediation therapy (CRT', 'cognitive training']",['Illness duration'],"[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",38.0,0.0306081,"No significant differences between Improvers and Nonimprovers in terms of other clinical variables, sociodemographic and neuropsychological factors were found.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Listunova', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany. Electronic address: olena.listunova@med.uni-heidelberg.de.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bartolovic', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kienzle', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jaehn', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Thea Marianne', 'Initials': 'TM', 'LastName': 'Grützner', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Robert Christian', 'Initials': 'RC', 'LastName': 'Wolf', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Cognitive Neuropsychiatry Section, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weisbrod', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany; Department of Adult Psychiatry, SRH-Klinik, Karlsbad-Langensteinbach, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Roesch-Ely', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University, Voßstraße 4, 69115 Heidelberg, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2019.12.006']
133,31873952,Changes in systemic and subcutaneous adipose tissue inflammation and oxidative stress in response to exercise training in obese black African women.,"KEY POINTS


Inflammation and oxidative stress are interrelated during obesity and contribute to the development of insulin resistance; and exercise training represents a key component in the management of these conditions. Black African women, despite high gluteal subcutaneous adipose tissue (SAT) and less visceral fat, are less insulin sensitive than their white counterparts. Exercise training improved systemic oxidative stress in obese black women, which was related to gynoid fat reduction and not insulin sensitivity. Inflammatory markers changed depot-specifically in response to exercise training, increasing in gluteal SAT without changing in abdominal SAT. The increase of inflammatory state in gluteal SAT after exercise training is suggested to result from tissue remodelling consecutive to the reduction of gynoid fat but does not contribute to the improvement of whole-body insulin sensitivity in obese black South African women.
ABSTRACT


Inflammation and oxidative stress are interrelated during obesity and contribute to the development of insulin resistance. Exercise training represents a key component in the management of obesity. We evaluated the effects of 12 weeks' combined resistance and aerobic exercise training on systemic and abdominal vs. gluteal subcutaneous adipose tissue (SAT) inflammatory and oxidative status in obese black South African women. Before and after the intervention, body composition (dual energy X-ray absorptiometry), cardio-respiratory fitness (  VO   2   peak      ), serum and SAT inflammatory and oxidative stress markers were measured from 15 (control group) and 20 (exercise group) women and insulin sensitivity (S I  ; frequently sampled intravenous glucose tolerance test) was estimated. Following the intervention,  VO   2   peak      (9.8%), body fat composition (1-3%) and S I  (9%) improved, serum thiobarbituric acid reactive substances (TBARS) decreased (6.5%), and catalase activity increased (23%) in the exercise compared to the control group (P < 0.05), without changes in circulating inflammatory markers. The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT. These changes of inflammatory profile in gluteal SAT, in addition to the reduction of circulating TBARS, correlated with the reduction of gynoid fat, but not with the improvement of S I  . The changes in systemic oxidative stress markers and gluteal SAT inflammatory genes correlated with the reduction in gynoid fat but were not directly associated with the exercise-induced improvements in S I  .",2020,"The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT.","['obese black African women', 'Black African women', 'obese black women', 'obese black South African women']","['exercise training', 'Exercise training', ""12\xa0weeks' combined resistance and aerobic exercise training""]","['gluteal SAT exercise', 'abdominal SAT', 'systemic oxidative stress markers and gluteal SAT inflammatory genes', 'systemic and abdominal vs. gluteal subcutaneous adipose tissue (SAT) inflammatory and oxidative status', 'catalase activity', 'body fat composition', 'body composition (dual energy X-ray absorptiometry), cardio-respiratory fitness (  VO   2   peak      ), serum and SAT inflammatory and oxidative stress markers', 'serum thiobarbituric acid reactive substances (TBARS', 'circulating inflammatory markers', 'systemic oxidative stress', 'insulin sensitivity (S', 'mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337824', 'cui_str': 'Black African (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0024429', 'cui_str': 'Migration Inhibition Factors, Macrophage'}]",,0.0197529,"The mRNA content of interleukin-10, tumour necrosis factor α, nuclear factor κB and macrophage migration inhibitory factor increased in the gluteal SAT exercise compared to the control group P < 0.05), with no changes in abdominal SAT.","[{'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Nono Nankam', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Melony F', 'Initials': 'MF', 'LastName': 'De Smidt', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Dheshnie', 'Initials': 'D', 'LastName': 'Keswell', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Cape Town, South Africa.'}]",The Journal of physiology,['10.1113/JP278669']
134,3516257,"A collaborative, double-blind randomized study of cetiedil citrate in sickle cell crisis.","We have recently completed a double-blind, placebo-controlled, noncrossover study, the goal of which was to determine whether cetiedil citrate (cetiedil) could affect the course of vaso-occlusive crises in sickle cell disease. Patients, who presented to the emergency room at least 4 but no more than 24 hours after the onset of a painful vasoocclusive crisis severe enough to require hospitalization, were considered candidates for the study. Each patient received either placebo or cetiedil at one of the following three dosages: 0.2, 0.3, or 0.4 mg/kg body weight. The assigned drug dosage was given as a 30 minute intravenous infusion every 8 hours for 4 consecutive days. A total of 67 patients was enrolled in the study. Cetiedil, at its highest dosage (0.4 mg/kg body weight), was found to be significantly superior to placebo both in reducing the number of painful sites present on all 4 treatment days and in shortening the total time in crisis. No serious adverse reactions were observed during the course of the study. We conclude that cetiedil, given at a dosage of 0.4 mg/kg body weight, is therapeutically advantageous for sickle cell crisis.",1986,No serious adverse reactions were observed during the course of the study.,"['sickle cell disease', 'sickle cell crisis', '67 patients was enrolled in the study']","['placebo', 'cetiedil citrate', 'cetiedil citrate (cetiedil']","['serious adverse reactions', 'number of painful sites']","[{'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0238425', 'cui_str': 'Hemoglobin SS disease with crisis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0771456', 'cui_str': 'CETIEDIL CITRATE'}, {'cui': 'C0055146', 'cui_str': 'cetiedil'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",67.0,0.187616,No serious adverse reactions were observed during the course of the study.,"[{'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Benjamin', 'Affiliation': ''}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Berkowitz', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Orringer', 'Affiliation': ''}, {'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Mankad', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Lewkow', 'Affiliation': ''}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Chillar', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': ''}]",Blood,[]
135,31846808,"Heart and brain: Cortical representation of cardiac signals is disturbed in borderline personality disorder, but unaffected by oxytocin administration.","BACKGROUND


Emotional dysregulation, a core feature of borderline personality disorder (BPD) has recently been linked to deficits in the cortical representation of bodily signals. Oxytocin modulates the salience of external social cues. However, its role in interoception is still not fully understood. The aim of the current study was to replicate reduced heartbeat-evoked potentials (HEPs) as a marker for the cortical representation of cardiac signals in BPD and to explore potential effects of oxytocin on HEP amplitude.
METHODS


Fifty-three medication-free women with a DSM-IV diagnosis of BPD and sixty healthy female controls (HCs) participated in the study. In a randomized, double-blind placebo-controlled trial, participants self-administered either 24 I.U. of oxytocin or placebo and took part in a 5-minute resting-state electrocardiogram (ECG) with parallel electroencephalogram (EEG) measurement. In addition, emotional dysregulation and BPD symptomatology were assessed with self-report questionnaires.
RESULTS


Patients with BPD had significantly lower mean HEP amplitudes than HCs. Furthermore, HEP amplitudes were negatively correlated with emotional dysregulation in the whole sample. However, oxytocin had no significant effect on HEP amplitude.
LIMITATIONS


Only female participants were investigated and no clinicial controls were included.
CONCLUSIONS


This is the first replication from an independent sample showing a reduced cortical representation of cardiac signals in BPD patients. This, together with other body-related symptoms, suggests deficits in the processing of bodily signals, which seem to be associated with emotional dysregulation. Whether oxytocin influences HEP during emotion regulation tasks needs to be investigated in future studies.",2020,"However, oxytocin had no significant effect on HEP amplitude.
","['participants self-administered either 24\xa0I.U. of', 'Heart and brain', 'Only female participants were investigated and no clinicial controls were included', 'Fifty-three medication-free women with a DSM-IV diagnosis of BPD and sixty healthy female controls (HCs) participated in the study', 'BPD patients']","['oxytocin or placebo and took part in a 5-minute resting-state electrocardiogram (ECG) with parallel electroencephalogram (EEG) measurement', 'Oxytocin', 'oxytocin', 'placebo']","['mean HEP amplitudes', 'HEP amplitude', 'HEP amplitudes', 'heartbeat-evoked potentials (HEPs', 'emotional dysregulation', 'emotional dysregulation and BPD symptomatology', 'salience of external social cues']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0015214', 'cui_str': 'Evoked Potentials'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.258029,"However, oxytocin had no significant effect on HEP amplitude.
","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Schmitz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Müller', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Institute for Health and Behavior, Research Unit INSIDE, University of Luxembourg, Luxembourg.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health Mannheim, Medical Faculty Mannheim/Heidelberg University, Germany.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Herpertz', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department of General Psychiatry, Center for Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany. Electronic address: katja.bertsch@med.uni-heidelberg.de.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.139']
136,31904304,Effect of the Serious Illness Care Program on Health Care Utilization at the End of Life for Patients with Cancer.,"Objectives:  To determine the effect of the Serious Illness Care Program on health care utilization at the end of life in oncology.  Design:  Analysis of the secondary outcome of health care utilization as part of a cluster-randomized clinical trial that ran from 2012 to 2016. Clinicians in the intervention group received training, coaching, and system supports to have discussions with patients using a Serious Illness Conversation Guide (SICG); clinicians in the control arm followed usual care.  Setting/Subject:  Patients with advanced cancer who died within two years of enrollment at the Dana-Farber Cancer Institute.  Measurement:  Health care utilization was abstracted from the electronic medical record using the National Quality Forum (NQF)-endorsed indicators of aggressive cancer care at the end of life and scored from 0 to 6 (one point for each aggressive indicator);  t  tests and chi-square tests were used to determine differences between intervention and control patients.  Results:  The charts of 159 patients who died were reviewed. Neither the main outcome of mean number of aggressive indicators (0.9 vs. 0.9,  p  = 0.84) nor the proportion of patients with any aggressive care (49% intervention [95% CI: 40-57] vs. 54% control [95% CI: 42-67]) differed between patients in the intervention and control groups.  Conclusion:  In this analysis of a secondary outcome from a randomized clinical trial of the Serious Illness Care Program, intervention and control patients had similar end-of-life health care utilization as measured by the mean number of NQF-endorsed indicators. Future research efforts should focus on studying the strategies by which communication about patients' prognosis, values, and goals leads to personalized care plans.",2020,"Clinicians in the intervention group received training, coaching, and system supports to have discussions with patients using a Serious Illness Conversation Guide (SICG); clinicians in the control arm followed usual care.  ","['159 patients who died were reviewed', 'Patients with advanced cancer who died within two years of enrollment at the Dana-Farber Cancer Institute', 'Patients with Cancer', 'ran from 2012 to 2016']","['training, coaching, and system supports to have discussions with patients using a Serious Illness Conversation Guide (SICG); clinicians in the control arm followed usual care', 'Serious Illness Care Program']","['mean number of aggressive indicators', 'proportion of patients with any aggressive care', 'National Quality Forum (NQF)-endorsed indicators of aggressive cancer care', 'Health Care Utilization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}]",159.0,0.042428,"Clinicians in the intervention group received training, coaching, and system supports to have discussions with patients using a Serious Illness Conversation Guide (SICG); clinicians in the control arm followed usual care.  ","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Koritsanszky', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Neal', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Stu', 'Initials': 'S', 'LastName': 'Lipsitz', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Fromme', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Benjamin', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.""}]",Journal of palliative medicine,['10.1089/jpm.2019.0437']
137,31256068,Walking increases pain tolerance in humans: an experimental cross-over study.,"BACKGROUND AND AIMS


Exercise is commonly used as treatment for chronic pain with positive long-term effects on pain and pain-related disability. In pain-free subjects, hypoalgesia following an acute bout of exercise compared with a control condition has consistently been demonstrated also known as exercise-induced hypoalgesia (EIH). Walking exercise, a low intensity aerobic exercise, is frequently used in clinical practice as an easily applicable intervention for patients with chronic pain. Walking exercise is furthermore recommended as an effective treatment for patients with chronic musculoskeletal pain conditions to alleviate pain and reduce disability, however, the effect of walking on pain sensitivity is currently unknown. The aims of the present study were to investigate (1) the acute effect of walking on pain sensitivity, and (2) the relative (between-subjects) and absolute (within-subject) test-retest reliability of the hypoalgesic response across two sessions separated by 1 week.
METHODS


In this randomised experimental cross-over study including two identical sessions, 35 pain-free subjects performed a standardized 6 min walking test and a duration-matched quiet rest condition in a randomized and counterbalanced order in each session. Before and after both conditions, handheld pressure pain thresholds (PPTs) were assessed at the thigh and shoulder, and pressure pain thresholds (cPPT) and pain tolerance (cPTT) were assessed with computer-controlled cuff algometry at the lower leg. Change in the pain sensitivity measures were analysed with repeated-measures ANOVAs, and test-retest reliability with intraclass correlation coefficients (ICC) and agreements in classification of EIH responders/non-responders between the two sessions.
RESULTS


All subjects completed the walking conditions in both session 1 and session 2. The perceived intensity of walking assessed with rating of perceived exertion (RPE) and walking distance did not differ significantly between session 1 (distance: 632.5 ± 75.2 meters, RPE: 10.9 ± 1.9) and session 2 (distance: 642.1 ± 80.2 meters, RPE: 11.0 ± 2.4) ( p  > 0.11). Moreover, RPE showed excellent relative reliability with an ICC value of 0.95 [95%CI: 0.90-0.97]. Walking increased pain tolerance (mean difference: 2.6 kPa [95%CI: 0.5-4.9 kPa;  p  = 0.02]), but not pain thresholds compared with rest in both sessions. Hypoalgesia after walking demonstrated fair to good relative reliability (ICC = 0.61), however the agreement in classification of EIH responders/non-responders (absolute reliability) across sessions was low and not significant (κ = 0.19,  p  = 0.30).
CONCLUSIONS


Walking consistently increased pain tolerance but not pain thresholds compared with a duration-matched control condition with fair to good relative reliability between sessions. Based on classification of EIH responders/non-responders the absolute reliability between the two sessions was low indicating individual variance in the EIH response. Future studies should investigate the hypoalgesic effect of a walking exercise in a clinical pain population.",2019,"The perceived intensity of walking assessed with rating of perceived exertion (RPE) and walking distance did not differ significantly between session 1 (distance: 632.5 ± 75.2 meters, RPE: 10.9 ± 1.9) and session 2 (distance: 642.1 ± 80.2 meters, RPE: 11.0 ± 2.4) (p > 0.11).","['patients with chronic musculoskeletal pain conditions', 'patients with chronic pain', '35 pain-free subjects performed a']","['Walking exercise, a low intensity aerobic exercise', 'standardized 6 min walking test and a duration-matched quiet rest condition', 'Walking exercise', 'walking exercise']","['handheld pressure pain thresholds (PPTs', 'perceived intensity of walking assessed with rating of perceived exertion (RPE) and walking distance', 'pain sensitivity measures', 'pressure pain thresholds (cPPT) and pain tolerance (cPTT', 'pain tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0580927,"The perceived intensity of walking assessed with rating of perceived exertion (RPE) and walking distance did not differ significantly between session 1 (distance: 632.5 ± 75.2 meters, RPE: 10.9 ± 1.9) and session 2 (distance: 642.1 ± 80.2 meters, RPE: 11.0 ± 2.4) (p > 0.11).","[{'ForeName': 'Jens-Christian Trojel', 'Initials': 'JT', 'LastName': 'Hviid', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jonas Bloch', 'Initials': 'JB', 'LastName': 'Thorlund', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Henrik Bjarke', 'Initials': 'HB', 'LastName': 'Vaegter', 'Affiliation': 'Pain Research Group, Pain Center, Odense University Hospital, Odense, Denmark.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0070']
138,31185762,Foley catheter versus cervical double balloon for labor induction: a prospective randomized study.,"OBJECTIVE


Cervical ripening by mechanical methods enhances labor induction success. We compared Cervical Ripening Double Balloon catheter (CRDB) to Foley catheter.
STUDY DESIGN


This prospective blind study randomized 85 nulliparas and 95 multiparas to labor induction by either Foley catheter or CRDB. Primary outcomes were Bishop score increment, time from catheter withdrawal to delivery, and cesarean section rate.
RESULTS


In multiparas, mean Bishop score increment between pre- and post-catheter was significantly higher in the CRDB catheter than in the Foley group (4.4 ± 1.9 and 3.4 ± 2.0, respectively,  p  = .02). Mean interval from catheter withdrawal to delivery was shorter in the CRDB catheter (14.6 ± 12.3 and 8.6 ± 5.4) than in the Foley catheter group (22.6 ± 27.2 and 13.9 ± 17.7), in both nulliparas and multiparas ( p  = .05 and  p  = .03, respectively). In nulliparas, no statistically significant differences were found in mean Bishop score increment between the two catheters, but cesarean section rate was higher in the Foley group than the CRDB group (46.5% and 20%, respectively,  p  = .02).
CONCLUSION


Bishop score increment by CRDB catheter is more effective than induction by Foley catheter in multiparas. CRDB catheter is associated with decreased time to delivery in both nulliparas and multiparas and a lower cesarean section rate in nulliparas. ClinicalTrials.gov Identifier: NCT00501033.",2021,CRDB catheter is associated with decreased time to delivery in both nulliparas and multiparas and a lower cesarean section rate in nulliparas.,"['labor induction', '85 nulliparas and 95 multiparas to labor induction by either']","['Foley catheter or CRDB', 'Cervical Ripening Double Balloon catheter (CRDB) to Foley catheter', 'CRDB catheter', 'Foley catheter versus cervical double balloon', 'CRDB']","['Bishop score increment, time from catheter withdrawal to delivery, and cesarean section rate', 'mean Bishop score increment', 'labor induction success', 'Mean interval from catheter withdrawal to delivery', 'cesarean section rate']","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C0179804'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",85.0,0.161569,CRDB catheter is associated with decreased time to delivery in both nulliparas and multiparas and a lower cesarean section rate in nulliparas.,"[{'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Solt', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Frank Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Ben-Haroush', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Kaminskyi', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Ophir', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1623776']
139,31199778,Validity of self-reported assessment of Severity of Dependence Scale in Medication-Overuse Headache.,"The interview-based Severity of Dependence Scale (SDS) predicts the outcome of withdrawal therapy in Medication-Overuse Headache (MOH). We aimed to compare the interview-based SDS with a self-administrated written version. Fifty-three MOH patients, 19 chronic headache patients without medication overuse and 25 population controls were recruited from a previous randomized controlled trial. The SDS was scored in a telephone interview by headache experts, further, the participants filled in the SDS as a part of a self-administered questionnaire. The SDS assesses scores dependence through five questions, each scored from 0 to 3. A score of ≥5 is associated with MOH. Mean SDS scores were 2.8 (SD 3.0) vs. 3.1 (SD 2.9),  p  = 0.12, for the interview vs. the self-reported questionnaire, with a correlation 0.78. There was a non-significant bias of 0.32 (95% limits of agreement of -3.6; 4.2) between the two methods in the Bland-Altman analysis. A self-reported SDS questionnaire can be used, and may yield valuable information as a screening tool prior to headache consultations or studies. The possibilities of designing web-based self-treatment tools based on SDS self-assessment and brief intervention may be a future approach for a large group of patients.",2019,The interview-based Severity of Dependence Scale (SDS) predicts the outcome of withdrawal therapy in Medication-Overuse Headache (MOH).,"['Fifty-three MOH patients, 19 chronic headache patients without medication overuse and 25 population controls']",['interview-based SDS with a self-administrated written version'],['Mean SDS scores'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151293', 'cui_str': 'Chronic Headache'}, {'cui': 'C3266697', 'cui_str': 'Prescription Drug Overutilization'}, {'cui': 'C0032662', 'cui_str': 'Population Control'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",53.0,0.0254921,The interview-based Severity of Dependence Scale (SDS) predicts the outcome of withdrawal therapy in Medication-Overuse Headache (MOH).,"[{'ForeName': 'Espen Saxhaug', 'Initials': 'ES', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jūratė Šaltytė', 'Initials': 'JŠ', 'LastName': 'Benth', 'Affiliation': 'Research Centre, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jørund', 'Initials': 'J', 'LastName': 'Straand', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Michael Bjørn', 'Initials': 'MB', 'LastName': 'Russell', 'Affiliation': 'Research Centre, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Christofer', 'Initials': 'C', 'LastName': 'Lundqvist', 'Affiliation': 'Research Centre, Akershus University Hospital, Lørenskog, Norway.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0022']
140,11877270,A randomized comparison of native Escherichia coli asparaginase and polyethylene glycol conjugated asparaginase for treatment of children with newly diagnosed standard-risk acute lymphoblastic leukemia: a Children's Cancer Group study.,"For this study, 118 children with standard-risk acute lymphoblastic leukemia (ALL) were given randomized assignments to receive native or pegylated Escherichia coli asparaginase as part of induction and 2 delayed intensification phases. Patients treated with pegaspargase had more rapid clearance of lymphoblasts from day 7 and day 14 bone marrow aspirates and more prolonged asparaginase activity than those treated with native asparaginase. In the first delayed intensification phase, 26% of native asparaginase patients had high-titer antibodies, whereas 2% of pegaspargase patients had those levels. High-titer antibodies were associated with low asparaginase activity in the native arm, but not in the pegaspargase arm. Adverse events, infections, and hospitalization were similar between arms. Event-free survival at 3 years was 82%. A population pharmacodynamic model using the nonlinear mixed effects model (NONMEM) program was developed that closely fit the measured enzyme activity and asparagine concentrations. Half-lives of asparaginase were 5.5 days and 26 hours for pegaspargase and native asparaginase, respectively. There was correlation between asparaginase enzymatic activity and depletion of asparagine or glutamine in serum. In cerebrospinal fluid asparagine, depletion was similar with both enzyme preparations. Intensive pegaspargase for newly diagnosed ALL should be tested further in a larger population.",2002,"High-titer antibodies were associated with low asparaginase activity in the native arm, but not in the pegaspargase arm.","['118 children with standard-risk acute lymphoblastic leukemia (ALL', 'children with newly diagnosed standard-risk acute lymphoblastic leukemia']","['native Escherichia coli asparaginase and polyethylene glycol conjugated asparaginase', 'native asparaginase', 'native or pegylated Escherichia coli asparaginase']","['high-titer antibodies', 'Adverse events, infections, and hospitalization', 'prolonged asparaginase activity', 'rapid clearance of lymphoblasts', 'Event-free survival', 'asparaginase enzymatic activity and depletion of asparagine or glutamine in serum', 'low asparaginase activity']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C1269691', 'cui_str': 'Escherichia coli asparaginase'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0229613', 'cui_str': 'Lymphoblast (cell)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0003995', 'cui_str': 'L-asparagine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",118.0,0.0646757,"High-titer antibodies were associated with low asparaginase activity in the native arm, but not in the pegaspargase arm.","[{'ForeName': 'Vassilios I', 'Initials': 'VI', 'LastName': 'Avramis', 'Affiliation': ""Children's Hospital, Los Angeles, CA, USA. vavramis@chla.usc.edu""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sencer', 'Affiliation': ''}, {'ForeName': 'Antonia P', 'Initials': 'AP', 'LastName': 'Periclou', 'Affiliation': ''}, {'ForeName': 'Harland', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ''}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Bostrom', 'Affiliation': ''}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alice G', 'Initials': 'AG', 'LastName': 'Ettinger', 'Affiliation': ''}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Ettinger', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': ''}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ''}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Hilden', 'Affiliation': ''}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Fataneh', 'Initials': 'F', 'LastName': 'Majlessipour', 'Affiliation': ''}, {'ForeName': 'Pracad', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Needle', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Neglia', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reaman', 'Affiliation': ''}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Holcenberg', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stork', 'Affiliation': ''}]",Blood,[]
141,11877261,Does treatment with intermittent infusions of intravenous anti-D allow a proportion of adults with recently diagnosed immune thrombocytopenic purpura to avoid splenectomy?,"This study explored whether repeated infusions of intravenous anti-D could allow adults with recently diagnosed immune thrombocytopenic purpura (ITP) who had failed an initial steroid course to postpone and ultimately avoid splenectomy. Twenty-eight Rh(+), nonsplenectomized adults with ITP diagnosed within 1 to 11 months and platelet counts 30 x 10(9)/L (30 000/microL) or below were enrolled. Anti-D was infused whenever the platelet count decreased to 30 x 10(9)/L (30 000/microL) or below. ""Response"" was defined as a platelet increase of more than 20 x 10(9)/L (20 000/microL) to more than 30 x 10(9)/L (30 000/microL) within 7 days of treatment. Patients were a median 3.5 months from ITP diagnosis at enrollment and had received a median of 2 previous therapies, including prednisone in 26 of 28 cases. They were followed for a median 26 months. A total of 93% responded to their initial infusion of anti-D, and 68% repeatedly responded with counts maintained above 30 x 10(9)/L (30 000/microL) using anti-D alone. Currently, 12 (43%) of 28 patients have been off all treatment for more than 6 months without undergoing splenectomy, 6 maintaining counts above 100 x 10(9)/L (100 000/microL). Seven continue on treatment, 8 underwent splenectomy, and 1 was lost to follow-up at 10 months. One patient discontinued anti-D because of toxicity. Patients with platelet counts at least 14 x 10(9)/L (14 000/microL) at enrollment were more likely to discontinue treatment (P <.05). Anti-D was an effective maintenance treatment for two thirds of Rh(+), nonsplenectomized adults with ITP who had failed an initial steroid course. Intermittent infusions of intravenous anti-D allowed more than 40% of these adults to avoid splenectomy and to achieve stable platelet counts off all therapy, even after many months of treatment. Platelet count at study entry was the primary predictor of outcome.",2002,"Anti-D was an effective maintenance treatment for two thirds of Rh(+), nonsplenectomized adults with ITP who had failed an initial steroid course.","['Twenty-eight Rh(+), nonsplenectomized adults with ITP diagnosed within 1 to 11 months and platelet counts 30 x 10(9)/L (30 000/microL) or below were enrolled', 'two thirds of Rh(+), nonsplenectomized adults with ITP who had failed an initial steroid course', 'adults with recently diagnosed immune thrombocytopenic purpura (ITP) who had failed an initial steroid course to postpone and ultimately avoid splenectomy']","['intravenous anti-D', 'prednisone']","['platelet count', 'Platelet count', 'platelet counts', 'toxicity']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0398650', 'cui_str': 'Autoimmune Thrombocytopenia'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0140430', 'cui_str': 'RHO(D) antibody'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0352952,"Anti-D was an effective maintenance treatment for two thirds of Rh(+), nonsplenectomized adults with ITP who had failed an initial steroid course.","[{'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Cooper', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, New York Presbyterian Hospital-Weill Medical College of Cornell University, 525 East 68th Street, New York, NY 10021, USA. nicholacooper@yahoo.com'}, {'ForeName': 'B Michael R', 'Initials': 'BM', 'LastName': 'Woloski', 'Affiliation': ''}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Fodero', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Novoa', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Leber', 'Affiliation': ''}, {'ForeName': 'Juerg H', 'Initials': 'JH', 'LastName': 'Beer', 'Affiliation': ''}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Bussel', 'Affiliation': ''}]",Blood,[]
142,11877267,Randomized trial of different regimens of heparins and in vivo thrombin generation in acute deep vein thrombosis.,"Low-molecular-weight and unfractionated heparins are frequently used to treat venous thromboembolism, but it is not known whether they are equally effective in inhibiting in vivo generation of thrombin. In this multicenter trial, 1048 patients were randomized to intravenous unfractionated heparin (group A), twice daily low-molecular-weight heparin (reviparin) for 1 week (group B), or once daily reviparin for 4 weeks (group C). All patients received vitamin K antagonists. Blood samples withdrawn at the baseline and at weeks 1 and 3 were analyzed using markers of in vivo thrombin generation and other coagulation parameters. During the first 3 weeks symptomatic recurrent deep vein thrombosis-pulmonary embolism (DVT/PE) occurred in 17 (4.5%) of 375 patients in group A compared with 4 (1.0%) of 388 patients in group B, and 9 (2.4%) of 374 patients in group C. Forty percent of patients in group A, 53.4% in group B, and 53.5% in group C showed 30% or greater reduction in thrombus size assessed by venography. Patients in group B had significantly greater reduction in D-dimer, prothrombin fragments 1 and 2 (F1 + 2), endogenous thrombin potential (ETP), and thrombin-antithrombin (TAT) complexes compared to groups A and C. Greater release of tissue factor pathway inhibitor (TFPI) and reduction in levels of thrombin activatable fibrinolysis inhibitor (TAFI) and fibrinogen were significantly more pronounced in group C patients. Reviparin administered twice daily plus vitamin K antagonist is more effective in inhibiting in vivo thrombin generation compared to intravenous unfractionated heparin plus vitamin K antagonist, and reviparin once daily produced significantly higher TFPI release and greater reduction in TAFI and fibrinogen levels.",2002,"Patients in group B had significantly greater reduction in D-dimer, prothrombin fragments 1 and 2 (F1 + 2), endogenous thrombin potential (ETP), and thrombin-antithrombin (TAT) complexes compared to groups A and C. Greater release of tissue factor pathway inhibitor (TFPI) and reduction in levels of thrombin activatable fibrinolysis inhibitor (TAFI) and fibrinogen were significantly more pronounced in group C patients.","['acute deep vein thrombosis', '1048 patients']","['intravenous unfractionated heparin', 'twice daily low-molecular-weight heparin (reviparin', 'Reviparin administered twice daily plus vitamin K antagonist', 'heparins and in vivo thrombin generation', 'vitamin K antagonists']","['TFPI release', 'TAFI and fibrinogen levels', 'symptomatic recurrent deep vein thrombosis-pulmonary embolism (DVT/PE', 'tissue factor pathway inhibitor (TFPI) and reduction in levels of thrombin activatable fibrinolysis inhibitor (TAFI) and fibrinogen', 'reduction in D-dimer, prothrombin fragments 1 and 2 (F1 + 2), endogenous thrombin potential (ETP), and thrombin-antithrombin (TAT) complexes', 'thrombus size']","[{'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0254215', 'cui_str': 'reviparin'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0164707', 'cui_str': 'TFPI'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1735901', 'cui_str': 'Recurrent deep vein thrombosis (disorder)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0255161', 'cui_str': 'Thrombin-Activatable Fibrinolysis Inhibitor (TAFI)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",1048.0,0.0343089,"Patients in group B had significantly greater reduction in D-dimer, prothrombin fragments 1 and 2 (F1 + 2), endogenous thrombin potential (ETP), and thrombin-antithrombin (TAT) complexes compared to groups A and C. Greater release of tissue factor pathway inhibitor (TFPI) and reduction in levels of thrombin activatable fibrinolysis inhibitor (TAFI) and fibrinogen were significantly more pronounced in group C patients.","[{'ForeName': 'Vijay V', 'Initials': 'VV', 'LastName': 'Kakkar', 'Affiliation': 'Thrombosis Research Institute, Emmanuel Kaye Building, Manresa Road, Chelsea, London SW3 6LR, UK. director@tri-london.ac.uk'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Hoppenstead', 'Affiliation': ''}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': ''}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Kadziola', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': ''}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': ''}, {'ForeName': 'Hans K', 'Initials': 'HK', 'LastName': 'Breddin', 'Affiliation': ''}]",Blood,[]
143,11392326,Long-term follow-up of a randomized trial comparing the combination of cyclophosphamide with total body irradiation or busulfan as conditioning regimen for patients receiving HLA-identical marrow grafts for acute myeloblastic leukemia in first complete remission.,,2001,,['patients receiving HLA-identical marrow grafts for acute myeloblastic leukemia in first complete remission'],['cyclophosphamide with total body irradiation or busulfan'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]",[],,0.0277738,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maraninchi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michallet', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiffers', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Jouet', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Milpied', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Devergie', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sotto', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kuentz', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dauriac', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bordigoni', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gratecos', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guilhot', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guyotat', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gluckman', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Vernant', 'Affiliation': ''}]",Blood,[]
144,11721685,Increased risk of leukemia relapse with high dose cyclosporine after allogeneic marrow transplantation for acute leukemia: 10 year follow-up of a randomized study.,,2001,,[],"['cyclosporine', 'allogeneic marrow transplantation']",['Increased risk of leukemia relapse'],[],"[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0920028', 'cui_str': 'Leukaemia recurrent'}]",,0.0418115,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bicigalupo', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lamparelli', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gualandi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bregante', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Raiola', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'di Grazia', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dominietto', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Romagnani', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Occhini', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Frassoni', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'van Lint', 'Affiliation': ''}]",Blood,[]
145,11929760,Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European Organisation for Research and Treatment of Cancer-Children's Leukemia Group phase 3 trial.,"Asparaginase is an enzyme used in the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in children. It has minimal bone marrow toxicity. Its major side effects are anaphylaxis, pancreatitis, diabetes, coagulation abnormalities, and thrombosis, especially intracranial. It is derived from 2 different sources: Escherichia coli and Erwinia chrysanthemi. Nonrandomized clinical studies have suggested a similar efficacy of these 2 types of asparaginases and a lower toxicity for Erwinia-asparaginase. The European Organisation for Research and Treatment of Cancer-Children's Leukemia Group (EORTC-CLG) 58881 trial randomized 700 children with acute lymphoblastic leukemia or lymphoblastic lymphoma to either E coli- or Erwinia-asparaginase at the same dosage of 10 000 IU/m(2) twice weekly to compare toxicity and efficacy. Coagulation abnormalities were more frequent in the E coli-asparaginase than in the Erwinia-asparaginase arm of the study (30.2% versus 11.9%, P <.0001). The incidence of other toxicity was not significantly different. In the Erwinia-asparaginase arm, more patients failed to achieve complete remission (4.9% versus 2.0%; P =.038) and the relapse rate was higher, leading to shorter event-free survival (hazard ratio,1.59; 95% CI, 1.23-2.06; P =.0004). The estimate of event-free survival rate (SE) at 6 years was 59.8% (2.6%) versus 73.4% (2.4%). Overall survival rate at 6 years was also lower in the Erwinia-asparaginase arm at 75.1% (2.3%) versus 83.9% (2.0%), P =.002. With the dose scheduling used in this protocol, E coli-asparaginase induced more coagulation abnormalities but was superior to Erwinia-asparaginase for the treatment of childhood lymphoid malignancies.",2002,"With the dose scheduling used in this protocol, E coli-asparaginase induced more coagulation abnormalities but was superior to Erwinia-asparaginase for the treatment of childhood lymphoid malignancies.","[""Cancer-Children's Leukemia Group (EORTC-CLG"", 'childhood lymphoid malignancies', ""Cancer-Children's Leukemia Group"", '58881 trial randomized 700 children with acute lymphoblastic leukemia or lymphoblastic lymphoma to either E coli- or Erwinia-asparaginase at the same dosage of 10 000 IU/m(2', 'acute lymphoblastic leukemia and lymphoblastic lymphoma in children']","['Asparaginase', 'Escherichia coli-asparaginase with Erwinia-asparaginase']","['Coagulation abnormalities', 'relapse rate', 'estimate of event-free survival rate (SE', 'Overall survival rate', 'complete remission', 'incidence of other toxicity', 'toxicity and efficacy', 'minimal bone marrow toxicity', 'coagulation abnormalities']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0771210', 'cui_str': 'Erwinia asparaginase'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]","[{'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C1269691', 'cui_str': 'Escherichia coli asparaginase'}, {'cui': 'C0771210', 'cui_str': 'Erwinia asparaginase'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0948168', 'cui_str': 'Bone marrow toxicity'}]",700.0,0.0464246,"With the dose scheduling used in this protocol, E coli-asparaginase induced more coagulation abnormalities but was superior to Erwinia-asparaginase for the treatment of childhood lymphoid malignancies.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Duval', 'Affiliation': ""Service d'Hémato-Immunologie, Hôpital Robert-Debré, Paris, France. michel.duval@umontreal.ca""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': ''}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': ''}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rialland', 'Affiliation': ''}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Nelken', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lutz', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Benoit', 'Affiliation': ''}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Manel', 'Affiliation': ''}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Vilmer', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Otten', 'Affiliation': ''}, {'ForeName': 'Noël', 'Initials': 'N', 'LastName': 'Philippe', 'Affiliation': ''}]",Blood,[]
146,11435293,Survival of transfused donor white blood cells in HIV-infected recipients.,"The appearance and expansion of donor white blood cells in a recipient after transfusion has many potential biologic ramifications. Although patients with HIV infection are ostensibly at high risk for microchimerism, transfusion-associated graft-versus-host disease (TA-GVHD) is rare. The purpose of this study was to search for sustained microchimerism in such patients. Blood samples were collected from 93 HIV-infected women (a subset from the Viral Activation Transfusion Study, an NHLBI multicenter randomized trial comparing leukoreduced versus unmodified red blood cell [RBC] transfusions) before and after transfusions from male donors. Donor lymphocytes were detected in posttransfusion specimens using a quantitative Y-chromosome-specific polymerase chain reaction (PCR) assay, and donor-specific human leukocyte antigen (HLA) alleles were identified with allele-specific PCR primers and probes. Five of 47 subjects randomized to receive nonleukoreduced RBCs had detectable male lymphocytes 1 to 2 weeks after transfusion, but no subject had detectable male cells more than 4 weeks after a transfusion. In 4 subjects studied, donor-specific HLA haplotypes were detected in posttransfusion specimens, consistent with one or more donors' cells. None of 46 subjects randomized to receive leukoreduced RBCs had detectable male lymphocytes in the month after transfusion. Development of sustained microchimerism after transfusion in HIV-infected patients is rare; HIV-infected patients do not appear to be at risk for TA-GVHD.",2001,"Five of 47 subjects randomized to receive nonleukoreduced RBCs had detectable male lymphocytes 1 to 2 weeks after transfusion, but no subject had detectable male cells more than 4 weeks after a transfusion.","['46 subjects randomized to receive', 'HIV-infected recipients', 'male donors', '93 HIV-infected women (a subset from the Viral Activation Transfusion Study, an NHLBI multicenter randomized trial comparing']","['leukoreduced RBCs', 'nonleukoreduced RBCs', 'leukoreduced versus unmodified red blood cell [RBC] transfusions']",['Survival of transfused donor white blood cells'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042767', 'cui_str': 'Viral Activation'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1955970', 'cui_str': 'National Heart, Lung, and Blood Institute'}]","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}]",93.0,0.034737,"Five of 47 subjects randomized to receive nonleukoreduced RBCs had detectable male lymphocytes 1 to 2 weeks after transfusion, but no subject had detectable male cells more than 4 weeks after a transfusion.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kruskall', 'Affiliation': 'Departments of Pathology and Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Assmann', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laycock', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Kalish', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Lederman', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Busch', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
147,11567990,Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation.,"Peripheral blood cell (PBC) rescue has become the mainstay for autologous transplantation in patients with lymphoma, multiple myeloma, and solid tumors. Different methods of hematopoietic progenitor cell (HPC) mobilization are in use without an established standard. Forty-seven patients with relapsed or refractory lymphoma received salvage chemotherapy and were randomized to have HPC mobilization using filgrastim [granulocyte-colony-stimulating factor (G-CSF)] alone for 4 days at 10 microg/kg per day (arm A) or cyclophosphamide (5 g/m(2)) and G-CSF at 10 microg/kg per day until hematologic recovery (arm B). Engraftment and ease of PBC collection were primary outcomes. All patients underwent the same high-dose chemotherapy followed by reinfusion of PBCs. There were no differences in median time to neutrophil engraftment (11 days in both arms; P =.5) or platelet engraftment (14 days in arm A, 13 days in arm B; P =.35). Combined chemotherapy and G-CSF resulted in higher CD34(+) cell collection than G-CSF alone (median, 7.2 vs 2.5 x 10(6) cells/kg; P =.004), but this did not impact engraftment. No differences were found in other PBC harvest outcomes or resource utilization measures. A high degree of tumor contamination, as studied by consensus CDR3 polymerase chain reaction of the mobilized PBCs, was present in both arms (92% in arm A vs 90% in arm B; P = 1). No differences were found in overall survival or progression-free survival at a median follow-up of 21 months. This randomized trial provides clinical evidence that the use of G-CSF alone is adequate for HPC mobilization, even in heavily pretreated patients with relapsed lymphoma.",2001,"There were no differences in median time to neutrophil engraftment (11 days in both arms; P =.5) or platelet engraftment (14 days in arm A, 13 days in arm B; P =.35).","['Forty-seven patients with relapsed or refractory lymphoma received', 'patients with lymphoma, multiple myeloma, and solid tumors', 'autologous transplantation', 'heavily pretreated patients with relapsed lymphoma']","['G-CSF', 'Combined chemotherapy and G-CSF', 'cyclophosphamide', 'HPC mobilization using filgrastim [granulocyte-colony-stimulating factor (G-CSF', 'salvage chemotherapy', 'filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells', 'hematopoietic progenitor cell (HPC) mobilization']","['Peripheral blood cell (PBC) rescue', 'platelet engraftment', 'median time to neutrophil engraftment', 'overall survival or progression-free survival', 'higher CD34(+) cell collection', 'PBC harvest outcomes or resource utilization measures', 'Engraftment and ease of PBC collection']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0768635', 'cui_str': 'HPC(III)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",47.0,0.0717288,"There were no differences in median time to neutrophil engraftment (11 days in both arms; P =.5) or platelet engraftment (14 days in arm A, 13 days in arm B; P =.35).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Narayanasami', 'Affiliation': 'Division of Hematology-Oncology, Cancer Center and Tupper Research Institute, New England Medical Center, Boston, MA 02111, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kanteti', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Klekar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Al-Olama', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Keating', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Berkman', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Erban', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Sprague', 'Affiliation': ''}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Schenkein', 'Affiliation': ''}]",Blood,[]
148,11698275,Antithymocyte globulin for graft-versus-host disease prophylaxis in transplants from unrelated donors: 2 randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO).,"One hundred nine patients with hematologic malignancies, undergoing bone marrow transplants (BMT) from unrelated donors, were randomized in 2 consecutive trials to receive or not to receive antithymocyte globulin (ATG) in the conditioning regimen, as follows: (A) 54 patients (median age, 28 years; 39% with advanced disease) were randomized to no ATG (n = 25) versus 7.5 mg/kg rabbit ATG (Thymoglobulin; Sangstat, Lyon, France) (n = 29); (B) 55 patients (median age, 31 years, 71% with advanced disease) were randomized to no ATG (n = 28) versus 15 mg/kg rabbit ATG (n = 27). Grade III-IV graft-versus-host disease (GVHD) was diagnosed in 36% versus 41% (P =.8) in the first and in 50% versus 11% (P =.001) in the second trial. Transplant-related mortality (TRM), relapse, and actuarial 3-year survival rates were comparable in both trials. In fact, despite the reduction of GVHD in the second trial, a higher risk for lethal infections (30% vs 7%; P =.02) was seen in the arm given 15 mg/kg ATG. Extensive chronic GVHD developed overall more frequently in patients given no ATG (62% vs 39%; P =.04), as confirmed by multivariate analysis (P =.03). Time to 50 x 10(9)/L platelets was comparable in the first trial (21 vs 24 days; P =.3) and delayed in the ATG arm in the second trial (23 vs 38 days; P =.02). These trials suggest that (1) 15 mg/kg ATG before BMT significantly reduces the risk for grade III-IV acute GVHD, (2) this does not translate to a reduction in TRM because of the increased risk for infections, and (3) though survival is unchanged, extensive chronic GVHD is significantly reduced in patients receiving ATG.",2001,"Extensive chronic GVHD developed overall more frequently in patients given no ATG (62% vs 39%; P =.04), as confirmed by multivariate analysis (P =.03).","['transplants from unrelated donors', 'A) 54 patients (median age, 28 years; 39% with advanced disease', '55 patients (median age, 31 years, 71% with advanced disease', 'One hundred nine patients with hematologic malignancies, undergoing bone marrow transplants (BMT) from unrelated donors']","['no ATG', 'antithymocyte globulin (ATG', 'Antithymocyte globulin']","['lethal infections', 'Extensive chronic GVHD', 'Grade III-IV graft-versus-host disease (GVHD', 'x 10(9)/L platelets', 'Transplant-related mortality (TRM), relapse, and actuarial 3-year survival rates']","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",109.0,0.18067,"Extensive chronic GVHD developed overall more frequently in patients given no ATG (62% vs 39%; P =.04), as confirmed by multivariate analysis (P =.03).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': 'Ospedale San Martino, Genova, Italy. apbacigalupo@smartino.ge.it'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lamparelli', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Guidi', 'Affiliation': ''}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Alessandrino', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'di Bartolomeo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Oneto', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bruno', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbanti', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sacchi', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Van Lint', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': ''}]",Blood,[]
149,11719356,Benefit of cyclosporine modulation of drug resistance in patients with poor-risk acute myeloid leukemia: a Southwest Oncology Group study.,"Cyclosporine A (CsA) inhibits P-glycoprotein (Pgp)-mediated cellular export of anthracyclines at clinically achievable concentrations. This randomized controlled trial was performed to test the benefit of CsA addition to treatment with cytarabine and daunorubicin (DNR) in patients with poor-risk acute myeloid leukemia (AML). A total of 226 patients were randomly assigned to sequential treatment with cytarabine and infusional DNR with or without intravenous CsA. Remitting patients received one course of consolidation chemotherapy that included DNR with or without CsA as assigned during induction. Addition of CsA significantly reduced the frequency of resistance to induction chemotherapy (31% versus 47%, P =.0077). Whereas the rate of complete remission was not significantly improved (39% versus 33%, P =.14), relapse-free survival (34% versus 9% at 2 years, P =.031) and overall survival (22% versus 12%, P =.046) were significantly increased with CsA. The effect of CsA on survival was greatest in patients with moderate or bright Pgp expression (median 12 months with CsA versus 4 months for controls) compared to patients with absent or low Pgp expression (median 6 months in both arms). The frequency of induction deaths was 15% with CsA and 18% in controls. Steady-state serum concentrations of DNR (P =.0089) and daunorubicinol (P <.0001) were significantly higher in CsA-treated patients. Survival (P =.0003) and induction response (P =.028) improved with increasing DNR concentration in CsA-treated patients but not in controls, suggesting a targeted interaction by CsA to enhance anthracycline cytotoxicity. These results indicate that addition of CsA to an induction and consolidation regimen containing infusional DNR significantly reduces resistance to DNR, prolongs the duration of remission, and improves overall survival in patients with poor-risk AML.",2001,Steady-state serum concentrations of DNR (P =.0089) and daunorubicinol (P <.0001) were significantly higher in CsA-treated patients.,"['patients with poor-risk AML', 'patients with poor-risk acute myeloid leukemia', 'patients with poor-risk acute myeloid leukemia (AML', 'A total of 226 patients', 'patients with moderate or bright Pgp expression ']","['cyclosporine', 'CsA', 'Cyclosporine A (CsA) inhibits', 'cytarabine and infusional DNR with or without intravenous CsA. Remitting patients received one course of consolidation chemotherapy that included DNR with or without CsA', 'cytarabine and daunorubicin (DNR']","['Steady-state serum concentrations of DNR', 'survival', 'Survival', 'frequency of resistance to induction chemotherapy', 'relapse-free survival', 'frequency of induction deaths', 'induction response', 'rate of complete remission', 'DNR concentration', 'overall survival', 'resistance to DNR, prolongs the duration of remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",226.0,0.0653608,Steady-state serum concentrations of DNR (P =.0089) and daunorubicinol (P <.0001) were significantly higher in CsA-treated patients.,"[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'List', 'Affiliation': 'Southwest Oncology Group, Operations Office, 14980 Omicron Dr, San Antonio, TX, USA. alist@azcc.arizona.edu'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Persons', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Slovak', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dorr', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Karanes', 'Affiliation': ''}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hynes', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Doroshow', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shurafa', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
150,11588025,"Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients.","To comparatively assess first-line treatment with fludarabine and 2 anthracycline-containing regimens, namely CAP (cyclophosphamide, doxorubicin plus prednisone) and ChOP (cyclophosphamide, vincristine, prednisone plus doxorubicin), in advanced stages of chronic lymphocytic leukemia (CLL), previously untreated patients with stage B or C CLL were randomly allocated to receive 6 monthly courses of either ChOP, CAP, or fludarabine (FAMP), stratified based on the Binet stages. End points were overall survival, treatment response, and tolerance. From June 1, 1990 to April 15, 1998, 938 patients (651 stage B and 287 stage C) were randomized in 73 centers. Compared to ChOP and FAMP, CAP induced lower overall remission rates (58.2%; ChOP, 71.5%; FAMP; 71.1%; P <.0001 for each), including lower clinical remission rates (CAP, 15.2%; ChOP, 29.6%; FAMP, 40.1%; P =.003). By contrast, median survival time did not differ significantly according to randomization (67, 70, and 69 months in the ChOP, CAP, and FAMP groups, respectively). Incidences of infections (< 5%) and autoimmune hemolytic anemia (< 2%) during the 6 courses were similar in the randomized groups, whereas fludarabine induced, compared to ChOP and CAP, more frequent protracted thrombocytopenia (P =.003) and less frequent nausea-vomiting (P =.003) and hair loss (P <.0001). For patients with stage B and C CLL first-line fludarabine and ChOP regimens both provided similar overall survival and close response rates, and better results than CAP. However, there was an increase in clinical remission rate and a trend toward a better tolerance of fludarabine over ChOP that may influence the choice between these regimens as front-line treatments in patients with CLL.",2001,"Compared to ChOP and FAMP, CAP induced lower overall remission rates (58.2%; ChOP, 71.5%; FAMP; 71.1%; P <.0001 for each), including lower clinical remission rates (CAP, 15.2%; ChOP, 29.6%; FAMP, 40.1%; P =.003).","['From June 1, 1990 to April 15, 1998, 938 patients (651 stage B and 287 stage C', 'patients with CLL', '938 previously untreated stage B and C chronic lymphocytic leukemia patients', 'advanced stages of chronic lymphocytic leukemia (CLL), previously untreated patients with stage B or C CLL']","['ChOP and FAMP, CAP', 'fludarabine', 'ChOP, CAP, or fludarabine (FAMP', 'fludarabine, CAP, and ChOP', 'fludarabine and 2 anthracycline-containing regimens, namely CAP (cyclophosphamide, doxorubicin plus prednisone) and ChOP (cyclophosphamide, vincristine, prednisone plus doxorubicin']","['overall survival and close response rates', 'frequent nausea-vomiting', 'hair loss', 'median survival time', 'autoimmune hemolytic anemia', 'Incidences of infections', 'clinical remission rate', 'overall remission rates', 'overall survival, treatment response, and tolerance', 'lower clinical remission rates', 'protracted thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441781', 'cui_str': 'Stage B (qualifier value)'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0441785', 'cui_str': 'Stage C (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0002880', 'cui_str': 'Autoimmune hemolytic anemia (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.183796,"Compared to ChOP and FAMP, CAP induced lower overall remission rates (58.2%; ChOP, 71.5%; FAMP; 71.1%; P <.0001 for each), including lower clinical remission rates (CAP, 15.2%; ChOP, 29.6%; FAMP, 40.1%; P =.003).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leporrier', 'Affiliation': ""Service d'Hématologie, CHU Caen, France. leporrier-m@chu-caen.fr""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Boudjerra', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rapp', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jaubert', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Autrand', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Divine', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Maloum', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Travade', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dighiero', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Binet', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chastang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
151,11520775,Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: the results of the United Kingdom Medical Research Council AML11 trial.,"In an attempt to improve induction chemotherapy for older patients with acute myeloid leukemia (AML),1314 patients were randomized to 1 of 3 induction treatments for 2 courses of DAT (daunorubicin, cytarabine, and thioguanine) 3 + 10, ADE (daunorubicin, cytarabine, and etoposide) 10 + 3 + 5, or MAC (mitoxantrone-cytarabine). The remission rate in the DAT arm was significantly better than ADE (62% vs 50%; P =.002) or MAC (62% vs 55%; P =.04). This benefit was seen in patients younger and older than 70 years. There were no differences between the induction schedules with respect to overall survival at 5 years (12% vs 8% vs 10%). A total of 226 patients were randomized to receive granulocyte colony-stimulating factor (G-CSF) or placebo as supportive care from day 8 after the end of treatment course 1. The remission rate or survival were not improved by G-CSF, although the median number of days to recover neutrophils to 1.0 x 10(9)/L was reduced by 5 days. Patients who entered remission (n = 371) were randomized to stop after a third course (DAT 2 + 7) or after 6 courses, ie, a subsequent COAP (cyclophosphamide, vincristine, cytarabine, and prednisolone), DAT 2 + 5, and COAP. The relapse risk (81% vs 73%), disease-free survival (16% vs 23%), and overall survival at 5 years (23% vs 22%) did not differ between the 3-course or 6-course arms. In addition to a treatment duration randomization, 362 patients were randomized to receive 12-month maintenance treatment with low-dose interferon, but no benefit was seen with respect to relapse risk, disease-free survival, or overall survival.",2001,There were no differences between the induction schedules with respect to overall survival at 5 years (12% vs 8% vs 10%).,"['226 patients', 'older patients with acute myeloid leukemia (AML),1314 patients', 'Patients who entered remission (n = 371', 'patients younger and older than 70 years', '362 patients', 'acute myeloid leukemia (AML) in older patients']","['DAT (daunorubicin, cytarabine, and thioguanine) 3 + 10, ADE (daunorubicin, cytarabine, and etoposide) 10 + 3 + 5, or MAC (mitoxantrone-cytarabine', 'COAP (cyclophosphamide, vincristine, cytarabine, and prednisolone), DAT 2 + 5, and COAP', 'granulocyte colony-stimulating factor (G-CSF) or placebo', 'induction chemotherapy']","['relapse risk', 'remission rate', 'disease-free survival', 'median number of days to recover neutrophils', 'remission rate or survival', 'overall survival', 'relapse risk, disease-free survival, or overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",371.0,0.122753,There were no differences between the induction schedules with respect to overall survival at 5 years (12% vs 8% vs 10%).,"[{'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Goldstone', 'Affiliation': 'Department of Haematology, University College Hospital, London, United Kingdom.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Hutchinson', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
152,11739158,Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies.,"In the early 1990s, 4 randomized studies compared conditioning regimens before transplantation for leukemia with either cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan (Bu) and CY. This study analyzed the long-term outcomes for 316 patients with chronic myeloid leukemia (CML) and 172 patients with acute myeloid leukemia (AML) who participated in these 4 trials, now with a mean follow-up of more than 7 years. Among patients with CML, no statistically significant difference in survival or disease-free survival emerged from testing the 2 regimens. The projected 10-year survival estimates were 65% and 63% with Bu-CY versus CY-TBI, respectively. Among patients with AML, the projected 10-year survival estimates were 51% and 63% (95% CI, 52%-74%) with Bu-CY versus CY-TBI, respectively. At last follow-up, most surviving patients had unimpaired health and had returned to work, regardless of the conditioning regimen. Late complications were analyzed after adjustment for patient age and for acute and chronic graft-versus-host disease (GVHD). CML patients who received CY-TBI had an increased risk of cataract formation, and patients treated with Bu-CY had an increased risk of irreversible alopecia. Chronic GVHD was the primary risk factor for late pulmonary disease and avascular osteonecrosis. Thus, Bu-CY and CY-TBI provided similar probabilities of cure for patients with CML. In patients with AML, a nonsignificant 10% lower survival rate was observed after Bu-CY. Late complications occurred equally after both conditioning regimens (except for increased risk of cataract after CY-TBI and of alopecia with Bu-CY).",2001,Late complications occurred equally after both conditioning regimens (except for increased risk of cataract after CY-TBI and of alopecia with Bu-CY).,"['316 patients with chronic myeloid leukemia (CML) and 172 patients with acute myeloid leukemia (AML) who participated in these 4 trials, now with a mean follow-up of more than 7 years', 'patients with CML', 'before marrow transplantation for myeloid leukemia']","['Bu-CY', 'cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan (Bu) and CY', 'total-body irradiation plus cyclophosphamide', 'Busulfan plus cyclophosphamide']","['survival rate', 'risk of irreversible alopecia', 'survival or disease-free survival', 'risk of cataract formation', '10-year survival estimates', 'Late complications']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0023470', 'cui_str': 'Myelogenous Leukemia'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",316.0,0.0574988,Late complications occurred equally after both conditioning regimens (except for increased risk of cataract after CY-TBI and of alopecia with Bu-CY).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': ""Service d'Hématologie Greffe de Moelle and Département de Bio-Informatique, Hôpital Saint Louis, Paris, France. gsocie@chu-stlouis.fr""}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Devergie', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ringden', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruutu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michallet', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': ''}]",Blood,[]
153,11739159,"Comparison of idarubicin + ara-C-, fludarabine + ara-C-, and topotecan + ara-C-based regimens in treatment of newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts.","It has been unclear whether regimens containing topotecan + ara-C (TA) or fludarabine + ara-C (FA) +/- idarubicin are superior to regimens containing idarubicin + ara-C (IA) without either fludarabine or topotecan for treatment of newly diagnosed acute myeloid leukemia (AML), refractory anemia with excess blasts in transformation (RAEB-t), or RAEB. Of 1279 patients treated here for these diagnoses between 1991 and 1999, 322 received IA regimens, 600 FA regimens, and 357 TA regimens. All regimens used ara-C doses of 1 to 2 gm/m(2)/d, given by continuous infusion in IA, and over 2 to 4 hours in FA and TA. Complete remission (CR) rates were lower with FA (55%) and TA (59%) than with IA (77%). Both event-free survival (EFS) in CR and survival were shorter: median EFS in CR (95% confidence interval) was 63 weeks (range, 55-76 weeks) for IA, 40 (range, 31-46 weeks) for FA, and 36 (range, 27-44 weeks) for TA; median survival was 77 weeks (range, 57-88 weeks) for IA, 30 (range, 27-35 weeks) for FA, and 41 (range, 35-50 weeks) for TA. These trials were not randomized, and patients with worse prognoses were disproportionately given the FA and TA regimens. Nonetheless, after accounting for prognosis the FA and TA regimens remained highly significantly associated with lower CR rates, shorter EFS in CR, and shorter survival. Accounting for possible effects of individual trials within each of the IA, FA, and TA groups did not alter these findings. It is unlikely that, as given here, either FA or TA is, in general, superior to IA, highlighting the need for new treatments.",2001,Complete remission (CR) rates were lower with FA (55%) and TA (59%) than with IA (77%).,"['1279 patients treated here for these diagnoses between 1991 and 1999, 322 received IA regimens, 600 FA regimens, and 357 TA regimens', 'newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts in transformation, or refractory anemia with excess blasts']","['idarubicin + ara-C (IA) without either fludarabine or topotecan', 'topotecan + ara-C (TA) or fludarabine + ara-C (FA) ', 'idarubicin + ara-C-, fludarabine + ara-C-, and topotecan + ara-C-based regimens', 'idarubicin']","['lower CR rates, shorter EFS in CR, and shorter survival', 'Complete remission (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0280028', 'cui_str': 'Refractory anemia with excess blasts in transformation (morphologic abnormality)'}, {'cui': 'C0002894', 'cui_str': 'RAEB'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.103403,Complete remission (CR) rates were lower with FA (55%) and TA (59%) than with IA (77%).,"[{'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Estey', 'Affiliation': 'Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. eestey@mdanderson.org'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': ''}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Giles', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beran', 'Affiliation': ''}]",Blood,[]
154,11313239,Experiences of donors enrolled in a randomized study of allogeneic bone marrow or peripheral blood stem cell transplantation.,"The experiences of 69 (38 marrow and 31 peripheral blood stem cell [PBSC]) donors participating in a randomized trial comparing allogeneic bone marrow with PBSC transplantation were studied. Marrow was collected by means of standard harvest techniques and general or regional anesthesia. PBSC donors were treated with 5 to 7 days of filgrastim at a dose of 16 microg/kg/d and underwent 1 to 3 days of apheresis to obtain 5 x 10(6) CD34(+) cells per kilogram recipient weight. Donors completed questionnaires describing their health experiences before, during, and then weekly after donation until return to baseline status. Both marrow and PBSC donors reported minimal fluctuation in symptoms measuring emotional status. In contrast, both groups of donors reported deterioration in physical status starting with administration of filgrastim (PBSC donors) or after the marrow collection procedure. The symptom burden reported was similar, with pain a prominent symptom for both groups. Equivalent mean levels of maximal pain, average pain, and pain duration through the day were reported, although toxicity peaks occurred at different time points during the harvest procedures. All PBSC donors but only 79% of marrow donors reported good physical status by 14 days after the harvest procedures. These data demonstrate similar levels of physical discomfort for hematopoietic stem cell donors regardless of the collection procedure used, but a quicker resolution of symptoms for PBSC donors.",2001,"Equivalent mean levels of maximal pain, average pain, and pain duration through the day were reported, although toxicity peaks occurred at different time points during the harvest procedures.",['69 (38 marrow and 31 peripheral blood stem cell [PBSC]) donors participating in a randomized trial comparing allogeneic bone marrow with PBSC transplantation were studied'],"['filgrastim', 'allogeneic bone marrow or peripheral blood stem cell transplantation']","['good physical status', 'Equivalent mean levels of maximal pain, average pain, and pain duration', 'toxicity peaks']","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",,0.0263836,"Equivalent mean levels of maximal pain, average pain, and pain duration through the day were reported, although toxicity peaks occurred at different time points during the harvest procedures.","[{'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Rowley', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. srowley@humed.com'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Donaldson', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lilleby', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
155,11313245,Influence of the hematopoietic stem cell source on early immunohematologic reconstitution after allogeneic transplantation.,"Several acute hemolysis episodes, sometimes lethal, have been recently described after transplantation of allogeneic peripheral blood hematopoietic stem cells (PBHSCs). Hemolysis resulted from the production of donor-derived antibodies (Abs) directed at ABO antigens (Ags) present on recipient red blood cells (RBCs). A multicenter randomized phase III clinical study comparing allogeneic PBHSC transplantation (PBHSCT) versus bone marrow hematopoietic stem cell transplantation (BMHSCT) has been conducted in France. In the course of this study, serum anti-A and/or anti-B Ab titers were compared before the conditioning regimen and on day +30 after transplantation in 49 consecutive evaluable PBHSCT (n = 21) or BMHSCT (n = 28) recipients. PBHSCT resulted in a higher frequency of increased anti-A and/or anti-B Ab titers 30 days after transplantation as compared to BMHSCT: 8 (38%) of 21 versus 3 (11%) of 28 (P =.04). In PBHSCT recipients, increased titers were observed mostly after receiving a minor ABO mismatch transplant: 5 of 7 versus 3 of 14 in the absence of any minor ABO mismatch (P =.05), whereas this was not the case after BMHSCT: 1 of 8 versus 2 of 20. Anti-A and/or anti-B serum Abs detectable at day +30 after PBHSCT were always directed against A and/or B Ags absent both on donor and recipient RBCs. Finally, 3 of 21 PBHSCT versus 0 of 28 BMHSCT recipients developed anti-allogeneic RBC Abs other than ABO (P =.07). Overall, the data strongly suggest that immunohematologic reconstitution differs significantly after granulocyte colony-stimulating factor-mobilized PBHSCT when compared to BMHSCT. Such a difference could contribute to the acute hemolysis described after PBHSCT as well as to distinct alloreactivity after PBHSCT.",2001,PBHSCT resulted in a higher frequency of increased anti-A and/or anti-B Ab titers 30 days after transplantation as compared to BMHSCT: 8 (38%) of 21 versus 3 (11%) of 28 (P =.04).,['early immunohematologic reconstitution after allogeneic transplantation'],"['BMHSCT', 'allogeneic PBHSC transplantation (PBHSCT) versus bone marrow hematopoietic stem cell transplantation (BMHSCT', 'hematopoietic stem cell source']","['higher frequency of increased anti-A and/or anti-B Ab titers', 'anti-allogeneic RBC', 'recipient red blood cells (RBCs', 'production of donor-derived antibodies (Abs) directed at ABO antigens (Ags']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0432616', 'cui_str': 'Blood group antibody A (substance)'}, {'cui': 'C0432618', 'cui_str': 'Blood group antibody B (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0033268'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}]",28.0,0.0271995,PBHSCT resulted in a higher frequency of increased anti-A and/or anti-B Ab titers 30 days after transplantation as compared to BMHSCT: 8 (38%) of 21 versus 3 (11%) of 28 (P =.04).,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lapierre', 'Affiliation': ""Unité de Médecine Transfusionnelle et d'Hémovigilance, the Comité de Sécurité Transfusionnelle et d'Hémovigilance, and the Service d'Epidémiologie et de Biostatistique, Institut Gustave Roussy, Villejuif, France. lapierre@igr.fr""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Oubouzar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tramalloni', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tayebi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Robinet', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kuentz', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hartmann', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hervé', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Tiberghien', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
156,11535502,"Relationships between age at diagnosis, clinical features, and outcome of therapy in children treated in the Medical Research Council AML 10 and 12 trials for acute myeloid leukemia.","Between May 1988 and June 2000, 698 children were treated in the Medical Research Council acute myeloid leukemia 10 and 12 trials. The presenting features and outcomes of therapy in these children were compared by age. Although there was no single cutoff in age, younger children were more likely to have intermediate risk and less likely to have favorable cytogenetics (P <.001), and they had a higher incidence of translocations involving chromosome 11q23 (P <.001). The distribution of French-American-British (FAB) types also varied with age; FAB types M5 (P <.001) and M7 (P <.001) were more common in early childhood, whereas older children were more likely to have FAB types M0 (P =.03), M1 (P =.04), M2 (P =.005), and M3 (P <.001). Involvement of the central nervous system at diagnosis was also more common in the youngest children (P =.01). Younger children had more severe diarrhea (P =.002), whereas older children had worse nausea and vomiting (P =.01) after chemotherapy. When adjusted for other important factors, complete remission rates were similar (P =.5) and although there was less resistant disease in younger children (P =.003), this was partially balanced by a slight increase in deaths during induction therapy in younger patients (P =.06). On multivariate analysis overall survival (P =.02), event-free survival (P =.02), and disease-free survival were better (P =.06) in younger children due to a lower relapse rate (P =.02) especially in the bone marrow (P =.02).",2001,"On multivariate analysis overall survival (P =.02), event-free survival (P =.02), and disease-free survival were better (P =.06) in younger children due to a lower relapse rate (P =.02) especially in the bone marrow (P =.02).","['Between May 1988 and June 2000, 698 children were treated in the Medical Research Council acute myeloid leukemia 10 and 12 trials']",[],"['nausea and vomiting', 'relapse rate', 'disease-free survival', 'severe diarrhea', 'event-free survival', 'deaths', 'complete remission rates']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]",[],"[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",698.0,0.189363,"On multivariate analysis overall survival (P =.02), event-free survival (P =.02), and disease-free survival were better (P =.06) in younger children due to a lower relapse rate (P =.02) especially in the bone marrow (P =.02).","[{'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Webb', 'Affiliation': 'Great Ormond Street Hospital for Children, London, United Kingdom. david.webb@gosh-tr.nthames.nhs.uk'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Gibson', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Hann', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
157,11830461,Randomized multicenter trial of foscarnet versus ganciclovir for preemptive therapy of cytomegalovirus infection after allogeneic stem cell transplantation.,"The present study compared foscarnet with ganciclovir for preemptive therapy of cytomegalovirus (CMV) infection after allogeneic blood or marrow stem cell transplantation (SCT). Patients with CMV infection, as detected by weekly antigenemia or polymerase chain reaction (PCR) in blood leukocytes, were randomized to intravenous therapy for 2 weeks with either foscarnet at 60 mg/kg or ganciclovir at 5 mg/kg administered every 12 hours; if CMV infection remained detectable, patients received an additional 2 weeks of intravenous foscarnet at 90 mg/kg or ganciclovir at 6 mg/kg given once daily for 5 days per week, after which therapy was stopped. Primary efficacy endpoint was the occurrence of CMV disease or death from any cause within 180 days after SCT. A total of 213 patients were treated with either foscarnet (n = 110) or ganciclovir (n = 103). Kaplan-Meier estimates of event-free survival within 180 days after SCT were similar in the 2 treatment groups (P =.6). During study treatment, severe neutropenia (< 0.5 x 10(9)/L) occurred in 11 (11%) patients on ganciclovir versus 4 (4%) patients on foscarnet (P =.04), and impaired renal function was observed in 5 (5%) patients on foscarnet versus 2 (2%) patients on ganciclovir (P =.4). Neutropenia or thrombocytopenia required discontinuation of ganciclovir in 6 (6%) patients but in no foscarnet-treated patient (P =.03). After allogeneic SCT, preemptive therapy of CMV infection with foscarnet shows similar efficacy as with ganciclovir, but is associated with a lower proportion of patients who develop severe neutropenia and who require discontinuation of antiviral therapy due to hematotoxicity.",2002,Kaplan-Meier estimates of event-free survival within 180 days after SCT were similar in the 2 treatment groups (P =.6).,"['cytomegalovirus (CMV) infection after allogeneic blood or marrow stem cell transplantation (SCT', 'cytomegalovirus infection after allogeneic stem cell transplantation', '213 patients', 'Patients with CMV infection, as detected by weekly antigenemia or polymerase chain reaction (PCR) in blood leukocytes']","['ganciclovir', 'foscarnet at 60 mg/kg or ganciclovir', 'foscarnet with ganciclovir', 'foscarnet', 'intravenous foscarnet at 90 mg/kg or ganciclovir']","['occurrence of CMV disease or death', 'severe neutropenia', 'Neutropenia or thrombocytopenia required discontinuation of ganciclovir', 'Kaplan-Meier estimates of event-free survival', 'renal function']","[{'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0005768'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}]","[{'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0070895', 'cui_str': 'Foscarnet'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",213.0,0.0269194,Kaplan-Meier estimates of event-free survival within 180 days after SCT were similar in the 2 treatment groups (P =.6).,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Reusser', 'Affiliation': 'Medizinische Klinik A, University Hospital, Basel, Switzerland. pierre.reusser@cgh.ch'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Rovira', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Engelhard', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Finke', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': ''}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
158,11535506,"No difference in graft-versus-host disease, relapse, and survival comparing peripheral stem cells to bone marrow using unrelated donors.","The clinical results in 107 patients receiving a peripheral blood stem cell (PBSC) graft mobilized by granulocyte colony-stimulating factor (G-CSF) from HLA-A, -B, and -DR-compatible unrelated donors were compared to 107 matched controls receiving unrelated bone marrow (BM) transplants. Engraftment was achieved in 94% of the patients in both groups. The PBSC graft contained significantly more nucleated cells, CD34(+), CD3(+), and CD56(+) cells (P <.001), and resulted in a significantly shorter time-to-neutrophil (15 versus 19 days) and platelet engraftment (20 versus 27 days), compared to the BM control group (P <.001). Probabilities of acute graft-versus-host disease (GVHD) grades II to IV were 35% and 32% (not significant [NS]) and of chronic GVHD 61% and 76% (NS) in the PBSC and BM groups, respectively. There was no difference between the 2 groups in bacteremia, cytomegalovirus reactivation or disease, and fungal infection. The 3-year transplant-related mortality (TRM) rates were 42% in the PBSC group and 31% in the BM controls (P =.7) and the survival rates were 46% and 51%, respectively. The probability of relapse was 25% and 31% in both groups (NS), resulting in disease-free survival rates of 43% in the PBSC group and 46% in the BM controls (NS). In the multivariate analysis, early disease, acute GVHD grade 0 to I, and presence of chronic GVHD were independent factors associated with a better disease-free survival in this study. PBSC from HLA-compatible unrelated donors can be used safely as an alternative to BM for stem cell transplantation.",2001,"There was no difference between the 2 groups in bacteremia, cytomegalovirus reactivation or disease, and fungal infection.","['107 patients receiving a peripheral blood stem cell (PBSC) graft mobilized by granulocyte colony-stimulating factor (G-CSF) from HLA-A, -B, and -DR-compatible unrelated donors were compared to 107 matched controls receiving unrelated bone marrow (BM) transplants']",[],"['shorter time-to-neutrophil', 'survival rates', '3-year transplant-related mortality (TRM) rates', 'probability of relapse', 'platelet engraftment', 'Engraftment', 'bacteremia, cytomegalovirus reactivation or disease, and fungal infection', 'disease-free survival rates', 'nucleated cells, CD34(+), CD3(+), and CD56(+) cells', 'graft-versus-host disease, relapse, and survival']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0019728', 'cui_str': 'HLA-A'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026946', 'cui_str': 'Fungal Infections'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",107.0,0.0235094,"There was no difference between the 2 groups in bacteremia, cytomegalovirus reactivation or disease, and fungal infection.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': 'Centre for Allogeneic Stem Cell Transplantation and Department of Clinical Immunology, Huddinge University Hospital, Stockholm, Sweden. mats.remberger@impi.ki.se'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ringdén', 'Affiliation': ''}, {'ForeName': 'I W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ottinger', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kremens', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Kiehl', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aschan', 'Affiliation': ''}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Beelen', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Basara', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kumlien', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fauser', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Runde', 'Affiliation': ''}]",Blood,[]
159,11535508,The presence of a FLT3 internal tandem duplication in patients with acute myeloid leukemia (AML) adds important prognostic information to cytogenetic risk group and response to the first cycle of chemotherapy: analysis of 854 patients from the United Kingdom Medical Research Council AML 10 and 12 trials.,"In acute myeloid leukemia (AML), further prognostic determinants are required in addition to cytogenetics to predict patients at increased risk of relapse. Recent studies have indicated that an internal tandem duplication (ITD) in the FLT3 gene may adversely affect clinical outcome. This study evaluated the impact of a FLT3/ITD mutation on outcome in 854 patients, mostly 60 years of age or younger, treated in the United Kingdom Medical Research Council (MRC) AML trials. An FLT3/ITD mutation was present in 27% of the patients and was associated with leukocytosis and a high percentage of bone marrow blast cells (P <.001 for both). It had a borderline association with a lower complete remission rate (P =.05) and a higher induction death rate (P =.04), and was associated with increased relapse risk (RR), adverse disease-free survival (DFS), event-free survival (EFS), and overall survival (OS) (P <.001 for all). In multivariate analysis, presence of a mutation was the most significant prognostic factor predicting RR and DFS (P <.0001) and was still significant for OS (P =.009) and EFS (P =.002). There was no evidence that the relative effect of a FLT3/ITD differed between the cytogenetic risk groups. More than one mutation was detected in 23% of FLT3/ITD(+) patients and was associated with worse OS (P =.04) and EFS (P =.07). Biallelic disease or partial/complete loss of wild-type alleles was present in 10% of FLT3/ITD(+) patients. The suggestion is made that detection of a FLT3/ITD should be included as a routine test at diagnosis and evaluated for therapeutic management.",2001,"It had a borderline association with a lower complete remission rate (P =.05) and a higher induction death rate (P =.04), and was associated with increased relapse risk (RR), adverse disease-free survival (DFS), event-free survival (EFS), and overall survival (OS) (P <.001 for all).","['854 patients, mostly 60 years of age or younger, treated in the United Kingdom Medical Research Council (MRC) AML trials', 'patients with acute myeloid leukemia (AML', '854 patients from the United Kingdom Medical Research Council AML 10 and 12 trials']","['FLT3/ITD mutation', 'FLT3/ITD', 'FLT3 internal tandem duplication']","['complete remission rate', 'leukocytosis', 'worse OS', 'induction death rate', 'relapse risk (RR), adverse disease-free survival (DFS), event-free survival (EFS), and overall survival (OS', 'bone marrow blast cells', 'Biallelic disease or partial/complete loss of wild-type alleles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0368761', 'cui_str': 'Blast cell (cell)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}]",854.0,0.0992308,"It had a borderline association with a lower complete remission rate (P =.05) and a higher induction death rate (P =.04), and was associated with increased relapse risk (RR), adverse disease-free survival (DFS), event-free survival (EFS), and overall survival (OS) (P <.001 for all).","[{'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Kottaridis', 'Affiliation': 'Department of Haematology, University College London, London, United Kingdom. p.kottaridis@ucl.ac.uk'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Gale', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Frew', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Langabeer', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Belton', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Bowen', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Goldstone', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Linch', 'Affiliation': ''}]",Blood,[]
160,11369627,Immune reconstitution after allogeneic marrow transplantation compared with blood stem cell transplantation.,"Allogeneic peripheral blood stem cell grafts contain about 10 times more T and B cells than marrow grafts. Because these cells may survive in transplant recipients for a long time, recipients of blood stem cells may be less immunocompromised than recipients of marrow. Immune reconstitution was studied in 115 patients randomly assigned to receive either allogeneic marrow or filgrastim-mobilized blood stem cell transplantation. Between day 30 and 365 after transplantation, counts of most lymphocyte subsets were higher in the blood stem cell recipients. The difference was most striking for CD4 T cells (about 4-fold higher counts for CD45RA(high) CD4 T cells and about 2-fold higher counts for CD45RA(low/-)CD4 T cells; P <.05). On assessment using phytohemagglutinin and herpesvirus antigen-stimulated proliferation, T cells in the 2 groups of patients appeared equally functional. Median serum IgG levels were similar in the 2 groups. The rate of definite infections after engraftment was 1.7-fold higher in marrow recipients (P =.001). The rate of severe (inpatient treatment required) definite infections after engraftment was 2.4-fold higher in marrow recipients (P =.002). The difference in the rates of definite infections was greatest for fungal infections, intermediate for bacterial infections, and lowest for viral infections. Death associated with a fungal or bacterial infection occurred between day 30 and day 365 after transplantation in 9 marrow recipients and no blood stem cell recipients (P =.008). In conclusion, blood stem cell recipients have higher lymphocyte-subset counts and this appears to result in fewer infections. (Blood. 2001;97:3380-3389)",2001,The rate of definite infections after engraftment was 1.7-fold higher in marrow recipients (P =.001).,['115 patients randomly assigned to receive either'],"['allogeneic marrow or filgrastim-mobilized blood stem cell transplantation', 'blood stem cell transplantation', 'Allogeneic peripheral blood stem cell grafts', 'allogeneic marrow transplantation']","['Immune reconstitution', 'Median serum IgG levels', 'CD45RA(high) CD4 T cells', 'Death associated with a fungal or bacterial infection', 'CD4 T cells', 'rates of definite infections', 'counts of most lymphocyte subsets', 'rate of severe (inpatient treatment required) definite infections after engraftment', 'rate of definite infections after engraftment']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}]",115.0,0.0376959,The rate of definite infections after engraftment was 1.7-fold higher in marrow recipients (P =.001).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Storek', 'Affiliation': 'Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA. jstorek@fhcrc.org'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Storer', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Stevens-Ayers', 'Affiliation': ''}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Maloney', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Marr', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': ''}]",Blood,[]
161,11806971,Comparison of 200 mg/m(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial.,"High-dose therapy has become a common treatment for myeloma. The objective of this study (Intergroupe Francophone du Myélome [IFM] 9502 trial) was to compare in a prospective and randomized trial the 2 most widely used conditioning regimens before autologous stem cell transplantation in newly diagnosed symptomatic patients younger than 65 years old: 8 Gy total body irradiation plus 140 mg/m(2) melphalan (arm A) versus 200 mg/m(2) melphalan (arm B). A total of 282 evaluable patients were compared--140 in arm A and 142 in arm B. Baseline characteristics and disease response to 4 cycles of the VAD regimen performed before randomization and autologous stem cell transplantation were identical in the 2 treatment arms. In arm B, hematologic recovery was significantly faster for both the duration of neutropenia and thrombocytopenia, transfusion requirements were also significantly lower, and the median duration of hospitalization was significantly shorter. In arm A, the incidence of severe mucositis was significantly increased. The median duration of event-free survival was similar in both arms (21 vs 20.5 months, P =.6), but the 45-month survival was 65.8% in arm B versus 45.5% in arm A (P =.05). This difference might be attributed in part to better salvage regimens after relapse in arm B compared with arm A. We conclude that 200 mg/m(2) melphalan is a less toxic and at least as effective conditioning regimen when compared with 8 Gy total body irradiation with 140 mg/m(2) melphalan. This regimen should be considered as the standard of care before autologous stem cell transplantation in multiple myeloma.",2002,"In arm B, hematologic recovery was significantly faster for both the duration of neutropenia and thrombocytopenia, transfusion requirements were also significantly lower, and the median duration of hospitalization was significantly shorter.","['282 evaluable patients were compared--140 in arm A and 142 in arm B. Baseline characteristics and disease response to 4 cycles of the VAD regimen performed before randomization and autologous stem cell transplantation', 'patients with newly diagnosed multiple myeloma', 'newly diagnosed symptomatic patients younger than 65 years old']","['melphalan', 'm(2) melphalan', 'autologous stem cell transplantation', 'Gy total body irradiation plus 140 mg/m(2) melphalan (arm A) versus 200 mg/m(2) melphalan', 'Francophone du Myélome [IFM', 'm(2) melphalan and 8 Gy total body irradiation plus 140 mg/m(2) melphalan']","['45-month survival', 'median duration of hospitalization', 'incidence of severe mucositis', 'median duration of event-free survival', 'neutropenia and thrombocytopenia, transfusion requirements', 'hematologic recovery']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",282.0,0.0459519,"In arm B, hematologic recovery was significantly faster for both the duration of neutropenia and thrombocytopenia, transfusion requirements were also significantly lower, and the median duration of hospitalization was significantly shorter.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': ""Service d'Hématologie, University Hospital Hôtel-Dieu, Place Alexis Recordeau, 44093 Nantes cedex 01, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': ''}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': ''}, {'ForeName': 'Mauricette', 'Initials': 'M', 'LastName': 'Michallet', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Maloisel', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Sotto', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Guilhot', 'Affiliation': ''}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Marit', 'Affiliation': ''}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Doyen', 'Affiliation': ''}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Jaubert', 'Affiliation': ''}, {'ForeName': 'Jean-Gabriel', 'Initials': 'JG', 'LastName': 'Fuzibet', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'François', 'Affiliation': ''}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ''}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Monconduit', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Voillat', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Berthou', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Pignon', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Rio', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Matthes', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Casassus', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Najman', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Grosbois', 'Affiliation': ''}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Bataille', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
162,11806983,Double-delayed intensification improves event-free survival for children with intermediate-risk acute lymphoblastic leukemia: a report from the Children's Cancer Group.,"Addition of a delayed-intensification (DI) phase after standard induction/consolidation therapy was previously shown to improve outcome for patients younger than 10 years of age with intermediate-risk acute lymphoblastic leukemia (ALL). The current trial randomized 1204 patients to regimens containing a single DI phase (405 patients), 2 DI phases (DDI) (402 patients), or a single DI phase in conjunction with increased vincristine and prednisone pulses during maintenance (DIVPI) (397 patients). Estimates of event-free survival (EFS) and survival at 6 years are 79% +/- 1% and 89% +/- 1%, respectively. EFS was improved on DDI compared with either DI (log-rank P =.04; Kaplan-Meier [KM] P =.04; relative risk [RR] = 1.38) or DIVPI (log-rank P =.04; KM P =.01; RR = 1.39). There was no difference in EFS for the DI and DIVPI regimens (log-rank P =.96; KM P =.75). Survival estimates at 6 years were 87% (SD = 2%) for DI; 91% (SD = 2%) for DDI; and 90% (SD = 2%) for DIVPI (P =.17). Significant univariate risk factors for the overall cohort included poor day-7 marrow response, black race, and age of at least 5 years. These data demonstrate that DDI improves EFS of patients younger than 10 years of age with intermediate-risk ALL.",2002,There was no difference in EFS for the DI and DIVPI regimens (log-rank P =.96; KM P =.75).,"['patients younger than 10 years of age with intermediate-risk ALL', '1204 patients to regimens containing a single DI phase (405 patients), 2 DI phases (DDI) (402 patients), or a', 'patients younger than 10 years of age with intermediate-risk acute lymphoblastic leukemia (ALL', 'children with intermediate-risk acute lymphoblastic leukemia', '397 patients']","['single DI phase in conjunction with increased vincristine and prednisone pulses during maintenance (DIVPI', 'Double-delayed intensification', 'delayed-intensification (DI) phase after standard induction/consolidation therapy']","['Estimates of event-free survival (EFS) and survival', 'Survival estimates', 'EFS', 'DDI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012133', 'cui_str': 'Didanosine'}]",1204.0,0.0314862,There was no difference in EFS for the DI and DIVPI regimens (log-rank P =.96; KM P =.75).,"[{'ForeName': 'Beverly J', 'Initials': 'BJ', 'LastName': 'Lange', 'Affiliation': ""Division of Oncology, Children's Hospital of Philadelphia, PA, USA. lange@email.chop.edu""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Bostrom', 'Affiliation': ''}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Cherlow', 'Affiliation': ''}, {'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Sensel', 'Affiliation': ''}, {'ForeName': 'Mei K L', 'Initials': 'MK', 'LastName': 'La', 'Affiliation': ''}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Rackoff', 'Affiliation': ''}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': ''}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Wimmer', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trigg', 'Affiliation': ''}, {'ForeName': 'Harland N', 'Initials': 'HN', 'LastName': 'Sather', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
163,11806988,Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study.,"The GIMEMA ALL 0288 trial was designed to evaluate the impact of a 7-day prednisone (PDN) pretreatment on complete remission (CR) achievement and length, the influence of the addition of cyclophosphamide (random I) to a conventional 4-drug induction on CR rate and duration, and whether an early post-CR intensification (random II) by an 8-drug consolidation could improve CR duration. Median follow-up of this study was 7.3 years. From January 1988 to April 1994, among 794 adult (> 12 but < 60 years) patients registered, 778 were eligible. Their median age was 27.5 years; 73% had B-lineage acute lymphoblastic leukemia (ALL) and 22% had T-lineage disease; 18% showed associated myeloid markers; 47 of 216 analyzed patients (22%) had Philadelphia chromosome-positive ALL. Response to PDN pretreatment was observed in 65% of cases. CR was achieved in 627 patients (82%). Resistant patients and induction death rates were 11% and 7%, respectively. Random II was applied to 388 patients with CR; 201 had maintenance alone and 187 had consolidation followed by maintenance. The relapse rate was 60%; isolated central nervous system relapses were 8% of all CRs and 13% of all relapses. Median survival (overall survival [OS]), continuous complete remission (CCR), and disease-free survival (DFS) were 2.2, 2.4, and 2 years, respectively. PDN pretreatment response resulted the main independent factor influencing CR achievement, OS, CCR, and DFS; the addition of cyclophosphamide in induction significantly influenced CR achievement in a multivariate analysis. Neither induction intensification nor early consolidation appeared to influence CCR and DFS duration. For the first time PDN pretreatment response proved to be a powerful factor predicting disease outcome in adult ALL patients.",2002,Neither induction intensification nor early consolidation appeared to influence CCR and DFS duration.,"['adult acute lymphoblastic leukemia (ALL', 'From January 1988 to April 1994, among 794 adult (> 12 but < 60 years) patients registered, 778 were eligible', 'adult ALL patients', '388 patients with CR; 201 had maintenance alone and 187 had consolidation followed by maintenance', '47 of 216 analyzed patients (22%) had Philadelphia chromosome-positive ALL']","['cyclophosphamide', '7-day prednisone (PDN']","['relapse rate', 'myeloid markers', 'CR duration', 'CCR and DFS duration', 'CR', 'induction death rates', 'CR achievement, OS, CCR, and DFS', 'isolated central nervous system relapses', 'complete remission (CR) achievement and length', 'Median survival (overall survival [OS]), continuous complete remission (CCR), and disease-free survival (DFS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",388.0,0.0485581,Neither induction intensification nor early consolidation appeared to influence CCR and DFS duration.,"[{'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Annino', 'Affiliation': 'Department of Cellular Biotechnology and Hematology, Università degli Studi La Sapienza, Via Benevento, 6-00161, Rome, Italy.'}, {'ForeName': 'Maria Luce', 'Initials': 'ML', 'LastName': 'Vegna', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Camera', 'Affiliation': ''}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Visani', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Fioritoni', 'Affiliation': ''}, {'ForeName': 'Felicetto', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Peta', 'Affiliation': ''}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ciolli', 'Affiliation': ''}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Deplano', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fabbiano', 'Affiliation': ''}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sica', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Cascavilla', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tabilio', 'Affiliation': ''}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': ''}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Invernizzi', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rotoli', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
164,11342422,Mitoxantrone is superior to doxorubicin in a multiagent weekly regimen for patients older than 60 with high-grade lymphoma: results of a BNLI randomized trial of PAdriaCEBO versus PMitCEBO.,"A prospective, multicenter, randomized trial was undertaken to compare the efficacy and toxicity of adriamycin with mitoxantrone within a 6-drug combination chemotherapy regimen for elderly patients (older than 60 years) with high-grade non-Hodgkin lymphoma (HGL) given for a minimum of 8 weeks. A total of 516 previously untreated patients aged older than 60 years were randomized to receive 1 of 2 anthracycline-containing regimens: adriamycin, 35 mg/m(2) intravenously (IV) on day 1 (n = 259), or mitoxantrone, 7 mg/m(2) IV on day 1 (n = 257); with prednisolone, 50 mg orally on days 1 to 14; cyclophosphamide, 300 mg/m(2) IV on day 1; etoposide, 150 mg/m(2) IV on day 1; vincristine, 1.4 mg/m(2) IV on day 8; and bleomycin, 10 mg/m(2) IV on day 8. Each 2-week cycle was administered for a minimum of 8 weeks in the absence of progression. Forty-three patients were ineligible for analysis. The overall and complete remission rates were 78% and 60% for patients receiving PMitCEBO and 69% and 52% for patients receiving PAdriaCEBO (P =.05, P =.12, respectively). Overall survival was significantly better with PMitCEBO than PAdriaCEBO (P =.0067). However, relapse-free survival was not significantly different (P =.16). At 4 years, 28% of PAdriaCEBO patients and 50% of PMitCEBO patients were alive (P =.0001). Ann Arbor stage III/IV, World Health Organization performance status 2-4, and elevated lactate dehydrogenase negatively influenced overall survival from diagnosis. In conclusion, the PMitCEBO 8-week combination chemotherapy regimen offers high response rates, durable remissions, and acceptable toxicity in elderly patients with HGL.",2001,"However, relapse-free survival was not significantly different (P =.16).","['elderly patients (older than 60 years) with high-grade non-Hodgkin lymphoma (HGL) given for a minimum of 8 weeks', 'elderly patients with HGL', '516 previously untreated patients aged older than 60 years', 'Forty-three patients were ineligible for analysis', 'patients older than 60 with high-grade lymphoma']","['cyclophosphamide, 300 mg/m(2) IV on day 1; etoposide, 150 mg/m(2) IV on day 1; vincristine, 1.4 mg/m(2) IV on day 8; and bleomycin', 'mitoxantrone', 'adriamycin with mitoxantrone', 'Mitoxantrone', 'doxorubicin', 'prednisolone', 'anthracycline-containing regimens: adriamycin']","['response rates, durable remissions, and acceptable toxicity', 'Overall survival', 'relapse-free survival', 'efficacy and toxicity', 'overall and complete remission rates']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",516.0,0.0804526,"However, relapse-free survival was not significantly different (P =.16).","[{'ForeName': 'P N', 'Initials': 'PN', 'LastName': 'Mainwaring', 'Affiliation': 'Lymphoma Trials Office at the CRC and UCL Cancer Trials Office, London, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hoskin', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Norton', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'MacLennan', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Hudson', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Linch', 'Affiliation': ''}]",Blood,[]
165,11342423,A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis.,"Standard therapy in the United States for malignancy-associated hyperuricemia consists of hydration, alkalinization, and allopurinol. Urate oxidase catalyzes the enzymatic oxidation of uric acid to a 5 times increased urine soluble product, allantoin. Rasburicase is a new recombinant form of urate oxidase available for clinical evaluation. This multicenter randomized trial compared allopurinol to rasburicase in pediatric patients with leukemia or lymphoma at high risk for tumor lysis. Patients received the assigned uric acid-lowering agent for 5 to 7 days during induction chemotherapy. The primary efficacy end point was to compare the area under the serial plasma uric acid concentration curves during the first 96 hours of therapy (AUC(0-96)). Fifty-two patients were randomized at 6 sites. In an intent-to-treat analysis, the mean uric acid AUC(0-96) was 128 +/- 70 mg/dL.hour for the rasburicase group and 329 +/- 129 mg/dL.hour for the allopurinol group (P <.0001). The rasburicase versus allopurinol group experienced a 2.6-fold (95% CI: 2.0-3.4) less exposure to uric acid. Four hours after the first dose, patients randomized to rasburicase compared to allopurinol achieved an 86% versus 12% reduction (P <.0001) of initial plasma uric acid levels. No antirasburicase antibodies were detected at day 14. This randomized study demonstrated more rapid control and lower levels of plasma uric acid in patients at high risk for tumor lysis who received rasburicase compared to allopurinol. For pediatric patients with advanced stage lymphoma or high tumor burden leukemia, rasburicase is a safe and effective alternative to allopurinol during initial chemotherapy.",2001,"For pediatric patients with advanced stage lymphoma or high tumor burden leukemia, rasburicase is a safe and effective alternative to allopurinol during initial chemotherapy.","['children with lymphoma or leukemia at high risk for tumor lysis', 'pediatric patients with advanced stage lymphoma or high tumor burden leukemia', 'pediatric patients with leukemia or lymphoma at high risk for tumor lysis', 'patients at high risk for tumor lysis who received rasburicase compared to']","['uric acid-lowering agent for 5 to 7 days during induction chemotherapy', 'allopurinol', 'rasburicase and allopurinol']","['area under the serial plasma uric acid concentration curves', 'initial plasma uric acid levels', 'antirasburicase antibodies']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0937932', 'cui_str': 'Rasburicase'}]","[{'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0937932', 'cui_str': 'Rasburicase'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",52.0,0.0934235,"For pediatric patients with advanced stage lymphoma or high tumor burden leukemia, rasburicase is a safe and effective alternative to allopurinol during initial chemotherapy.","[{'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Goldman', 'Affiliation': 'Department of Pediatric Hematology/Oncology at North Texas Hospital for Children at Medical City, Dallas, TX, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Holcenberg', 'Affiliation': ''}, {'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Finklestein', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hutchinson', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kreissman', 'Affiliation': ''}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cairo', 'Affiliation': ''}]",Blood,[]
166,11719353,Granulocyte-colony-stimulating factor (G-CSF)-primed allogeneic bone marrow: significantly less graft-versus-host disease and comparable engraftment to G-CSF-mobilized peripheral blood stem cells.,"Prospective studies have shown rapid engraftment using granulocyte-colony-stimulating factor-mobilized peripheral blood stem cells (G-PBSCs) for allogeneic transplantation, though the risks for graft-versus-host disease (GVHD) may be increased. It was hypothesized that the use of G-CSF to prime bone marrow (G-BM) would allow rapid engraftment without increased risk for GVHD compared with G-PBSC. Patients were randomized to receive G-BM or G-PBSCs for allogeneic stem cell transplantation. The study was designed (beta <.8) to detect a difference in the incidence of chronic GVHD of 33% (alpha <.05). The plan was to recruit 100 patients and to conduct an interim analysis when the 6-month follow-up point was reached for the first 50 patients. Fifty-seven consecutive patients were recruited (G-BM, n = 28; G-PBSC, n = 29). Patients in the G-PBSC group received 3-fold more CD34(+) and 9-fold more CD3(+) cells. Median times to neutrophil (G-BM, 16 days; G-PBSC, 14 days; P <.1) and platelet engraftment (G-BM, 14 days; G-PBSC, 12 days; P <.1) were similar. The use of G-PBSC was associated with steroid refractory acute GVHD (G-BM, 0%; G-PBSC, 32%; P <.001), chronic GVHD (G-BM, 22%; G-PBSC, 80%; P <.02), and prolonged requirement for immunosuppressive therapy (G-BM, 173 days; G-PBSC, 680 days; P <.009). Survival was similar for the 2 groups. Compared with G-PBSC, the use of G-BM resulted in comparable engraftment, reduced severity of acute GVHD, and less subsequent chronic GVHD.",2001,"; G-PBSC, 14 days; P <.1) and platelet engraftment (G-BM, 14 days; G-PBSC, 12 days; P <.1) were similar.","['Fifty-seven consecutive patients were recruited (G-BM, n = 28; G-PBSC, n = 29']","['G-BM or G-PBSCs for allogeneic stem cell transplantation', 'Granulocyte-colony-stimulating factor (G-CSF)-primed allogeneic bone marrow', 'granulocyte-colony-stimulating factor-mobilized peripheral blood stem cells (G-PBSCs']","['severity of acute GVHD, and less subsequent chronic GVHD', 'Median times to neutrophil', 'chronic GVHD', 'Survival', 'platelet engraftment', 'incidence of chronic GVHD', 'CD34(+) and 9-fold more CD3(+) cells']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",57.0,0.0174112,"; G-PBSC, 14 days; P <.1) and platelet engraftment (G-BM, 14 days; G-PBSC, 12 days; P <.1) were similar.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Morton', 'Affiliation': 'Bone Marrow Transplant Unit, Royal Brisbane Hospital, Herston, Australia. james_morton@health.qld.gov.au'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hutchins', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Durrant', 'Affiliation': ''}]",Blood,[]
167,6946847,Treatment of acute myelocytic leukemia: a study by cancer and leukemia group B.,,1981,,['acute myelocytic leukemia'],[],[],"[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]",[],[],,0.0126508,,"[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'O J', 'Initials': 'OJ', 'LastName': 'Glidewell', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Weinberg', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brunner', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Obrecht', 'Affiliation': ''}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Preisler', 'Affiliation': ''}, {'ForeName': 'I W', 'Initials': 'IW', 'LastName': 'Nawabi', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Prager', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Carey', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Haurani', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Falkson', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wiernik', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Hoagland', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': ''}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Ramanan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Blom', 'Affiliation': ''}, {'ForeName': 'N I', 'Initials': 'NI', 'LastName': 'Nissen', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bank', 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Ellison', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kung', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'O R', 'Initials': 'OR', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kaan', 'Affiliation': ''}]",Blood,[]
168,2508791,DDAVP shortens the prolonged bleeding times of patients with severe von Willebrand disease treated with cryoprecipitate. Evidence for a mechanism of action independent of released von Willebrand factor.,"After infusion of cryoprecipitate, the very prolonged bleeding time of patients with severe von Willebrand disease (vWD) is shortened but not always normalized in spite of normalization of plasma von Willebrand factor (vWF) levels. Therefore treatments that further improve primary hemostasis in severe vWD patients are needed. Since DDAVP shortens the bleeding time in a variety of bleeding disorders, we investigated in a double-blind, placebo-controlled crossover study the effects of the intravenous (IV) infusion of DDAVP (0.3 microgram/kg) on the bleeding times of 10 patients with severe vWD treated with cryoprecipitate. Their very prolonged bleeding times (greater than 30 minutes), partially corrected by the infusion of cryoprecipitate (14 +/- 2 minutes, mean +/- SEM), were further shortened by the administration of DDAVP (9 +/- 2 minutes, P less than .01) but not of saline (15 +/- 3 minutes, ns). Plasma vWF levels, raised from unmeasurable to normal values by cryoprecipitate, were not changed after DDAVP or saline. The defective deposition of platelets from eight patients onto human umbilical artery subendothelium was increased but not normalized by cryoprecipitate and was not significantly affected by DDAVP or saline. Therefore the infusion of DDAVP after cryoprecipitate may be of clinical benefit for management of bleeding episodes in severe vWD patients. Since severe vWD patients do not have releasable tissue stores of vWF, DDAVP must shorten their prolonged bleeding times independently of released vWF.",1989,"Plasma vWF levels, raised from unmeasurable to normal values by cryoprecipitate, were not changed after DDAVP or saline.","['severe vWD patients', 'patients with severe von Willebrand disease (vWD', 'patients with severe von Willebrand disease treated with cryoprecipitate', '10 patients with severe vWD treated with cryoprecipitate']","['DDAVP', 'placebo']","['defective deposition of platelets', 'bleeding times', 'human umbilical artery subendothelium', 'bleeding time', 'Plasma vWF levels', 'prolonged bleeding times', 'plasma von Willebrand factor (vWF) levels']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042974', 'cui_str': ""Von Willebrand's Factor Deficiency""}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate (product)'}]","[{'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}]",10.0,0.0207097,"Plasma vWF levels, raised from unmeasurable to normal values by cryoprecipitate, were not changed after DDAVP or saline.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'A. Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moia', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Delle Valle', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Castellana', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ''}]",Blood,[]
169,31743151,"The Effects of a Tripod Approach for Cancer Patients on Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience.","BACKGROUND


Health-related exercise and education program for cancer patients are necessary to provide physical and emotional support to enable efficient and appropriate self-management at home.
OBJECTIVE


This study aimed to investigate the effects of a tripod approach including physical exercise, education, and emotional support program on illness stress, health promotion lifestyle, hope, and resilience in cancer patients.
INTERVENTIONS/METHODS


This was a quasi-experimental repeated-measures study using a pre-post design with a nonhomogeneous control group. A total of 72 cancer patients (experimental group = 37, control group = 35) who were currently receiving treatment and staying at home were enrolled.
RESULTS


The experimental group showed significantly lower illness stress scores (F = 17.35, P < .001) and increase in health promotion lifestyle scores (F = 4.05, P = .048) compared with the control group, especially social relationships (t = 1.85, P = .073) and stress management (t = 2.30, P = .027). However, there were no effects on hope and resilience. Also, illness stress showed significant changes after 6 weeks (t = -3.35, P = .001) and after 10 weeks (t = -5.04, P < .001). Overall health promotion lifestyle showed changes after 10 weeks (t = 2.25, P = .030), with meaning of life (t = 2.57, P = .014), stress management (t = 2.30, P = .027), and medical behaviors (t = 2.46, P = .019) especially showing significant changes.
CONCLUSIONS


The results showed that the tripod approach had positive effects on illness stress and health promotion lifestyle of cancer patients staying at home. Further study to improve positive emotions such as hope and resilience is needed.
IMPLICATIONS FOR PRACTICE


Based on our findings, combining nursing intervention with physical exercise, education, and emotional support could be incorporated into cancer patients in community and early survivorship care plans in clinical practice.",2021,"The experimental group showed significantly lower illness stress scores (F = 17.35, P < .001) and increase in health promotion lifestyle scores (F = 4.05, P = .048) compared with the control group, especially social relationships (t = 1.85, P = .073) and stress management (t = 2.30, P = .027).","['cancer patients', 'Cancer Patients on', 'cancer patients in community and early survivorship care plans in clinical practice', '72 cancer patients (experimental group = 37, control group = 35) who were currently receiving treatment and staying at home were enrolled']","['tripod approach including physical exercise, education, and emotional support program', 'Tripod Approach', 'Health-related exercise and education program']","['Overall health promotion lifestyle', 'stress management', 'meaning of life', 'illness stress and health promotion lifestyle of cancer patients staying at home', 'medical behaviors', 'illness stress scores', 'health promotion lifestyle scores', 'social relationships', 'Illness Stress, Health-Promoting Lifestyle, Hope, and Resilience']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0454273', 'cui_str': 'Tripod (physical object)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392347', 'cui_str': 'Hope'}]",,0.0419048,"The experimental group showed significantly lower illness stress scores (F = 17.35, P < .001) and increase in health promotion lifestyle scores (F = 4.05, P = .048) compared with the control group, especially social relationships (t = 1.85, P = .073) and stress management (t = 2.30, P = .027).","[{'ForeName': 'Kyung Mi', 'Initials': 'KM', 'LastName': 'Sung', 'Affiliation': 'Author affiliations: College of Nursing, Institute of Health Sciences, Gyeongsang National University, Jinju-si, Republic of Korea.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Young Sil', 'Initials': 'YS', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Mee Ock', 'Initials': 'MO', 'LastName': 'Gu', 'Affiliation': ''}, {'ForeName': 'Myun Sook', 'Initials': 'MS', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Eun', 'Affiliation': ''}, {'ForeName': 'Mi Yang', 'Initials': 'MY', 'LastName': 'Jeon', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000746']
170,31077093,Improving Education About Breast Cancer for Medical Students in China.,"In traditional medical school curriculum of cancer education in China, there is a very limited amount of teaching about breast cancer. The current situation may result in indifference to breast cancer education among medical students. Case-based learning (CBL) is a popular teaching method based on clinical cases. To date, there are few research reports about the application and research of CBL in breast cancer education. The aim of this study is to explore the teaching effect about CBL combined with lecture-based learning (LBL) in breast cancer education. Questions of breast cancer in National Medical Licensing Examination (NMLE) from 2011 to 2018 were analyzed. The questions about breast cancer were used as the evaluation criteria for this study. In this pilot study, a total of 140 students were randomly divided into a lecture only group (control group) and a lecture plus CBL group (observation group). The students in the observation group had better academic performances and abilities of memory, understanding, and application. They also had higher favorable impressions of the learning experience. In conclusion, more active approaches yield more learning and are viewed more favorably. CBL plus lecture can significantly improve education about breast cancer among medical students, which may be an important message for the evolution of curriculum in Chinese medical schools.",2020,"The students in the observation group had better academic performances and abilities of memory, understanding, and application.","['breast cancer in National Medical Licensing Examination (NMLE) from 2011 to 2018 were analyzed', 'breast cancer education', 'Medical Students in China', '140 students']","['CBL plus lecture', 'Case-based learning (CBL', 'lecture only group (control group) and a lecture plus CBL', 'CBL combined with lecture-based learning (LBL']","['academic performances and abilities of memory, understanding, and application']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0242373', 'cui_str': 'Licensing'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",140.0,0.0127199,"The students in the observation group had better academic performances and abilities of memory, understanding, and application.","[{'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Xinmiao', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Jinfei', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Breast Surgery, the First Affiliated Hospital of China Medical University, China Medical University, No. 155 Nanjing Road, Heping Districrt, Shenyang, Liaoning Province, People's Republic of China. jinfeng@cmu.edu.cn.""}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01536-z']
171,1912556,A randomized controlled trial of recombinant interferon-alpha in chronic hepatitis C in hemophiliacs.,"Chronic liver disease associated with hepatitis C virus (HCV) is an important cause of morbidity and mortality in hemophilia. We have used recombinant interferon alpha-2b (IFN alpha-2b) in a randomized controlled liver biopsy trial to treat hemophiliacs with chronic hepatitis. Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV. All underwent liver biopsy at entry and were randomized to either treatment with self-administered IFN alpha-2b, 3 million units subcutaneously thrice weekly (n = 10) or no treatment (control group) (n = 8). Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis. Twelve months after entry into the study 17 patients underwent a second liver biopsy. All biopsies were coded, assessed, and scored according to the histologic severity of the liver disease. Ten patients were administered IFN for 1 year, and in four patients normalization of alanine aminotransferase (ALT) occurred compared with none in the untreated group. After the second liver biopsy, six of the eight initial no-treatment patients were treated with interferon 3 million units thrice weekly for 6 months, and normalization of ALT was seen in five patients. Biochemical relapse within 4 months of stopping IFN occurred in one of four patients treated for 1 year and in four of five patients treated for 6 months. IFN treatment was well tolerated. Although the histologic scores of the two groups were similar at entry into the study, after 12 months the biopsy appearances in the treated group were significantly improved compared with the controls (P less than .01). Histologic improvement was noted in the three interferon-treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response. We conclude that low-dose recombinant IFN alpha is effective in normalizing transaminases and improving the histologic appearances in at least 50% of hemophiliacs with chronic hepatitis C.",1991,Histologic improvement was noted in the three interferon-treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response.,"['hemophiliacs with chronic hepatitis', 'hemophilia', 'Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV', 'Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis', 'Chronic liver disease associated with hepatitis C virus (HCV', '17 patients underwent a second liver biopsy', 'chronic hepatitis C in hemophiliacs']","['self-administered IFN alpha-2b', 'interferon', 'recombinant IFN alpha', 'recombinant interferon-alpha', 'recombinant interferon alpha-2b (IFN alpha-2b', 'IFN']","['histologic scores', 'histologic appearances', 'alanine aminotransferase (ALT', 'histologic severity of the liver disease', 'tolerated', 'biopsy appearances', 'Biochemical relapse', 'Histologic improvement']","[{'cui': 'C0019189', 'cui_str': 'Hepatitis, Chronic'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0520463', 'cui_str': 'Chronic active hepatitis (disorder)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0149519', 'cui_str': 'Chronic Persistent Hepatitis'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",10.0,0.0436494,Histologic improvement was noted in the three interferon-treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makris', 'Affiliation': 'Department of Hematology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Preston', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Triger', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Underwood', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Westlake', 'Affiliation': ''}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Adelman', 'Affiliation': ''}]",Blood,[]
172,31119709,An Evaluation of the Influence of Web-Based Patient Education on the Anxiety and Life Quality of Patients Who Have Undergone Mammaplasty: a Randomized Controlled Study.,"The aim of this study is to evaluate the influence of web-based education on the anxiety and quality of life of patients who were hospitalized and underwent breast surgery (modified radical mastectomy or breast-conserving surgery) with axilla lymph node dissection. The patients were divided into three groups by the block randomization method as follows: web-based education group, brochure group, and control group (total N = 75). To obtain the study data, the Risk Factors for Breast Cancer and Data Collection Form for the Disease, SF 36 Quality of Life Scale, State-Trait Anxiety Inventory, and Website Usability Scale were used. The learning content was patient education associated with the pre-operative and post-operative periods. The differences in the state of anxiety scores 1 day before surgery, the 2nd day after surgery, and 1 month after surgery were statistically lower in the web-based education group than in the other two groups. The mean difference in the trait anxiety scores after 1 month was higher in the control group than in the other two groups. Web-based patient education was identified as a more effective method than the brochure and control groups in terms of patients' physical and emotional well-being, vitality/fatigue, and role limitations emotional and general health perception. Web-based patient education is effective in decreasing the anxiety of patients and improving their quality of life.",2020,The mean difference in the trait anxiety scores after 1 month was higher in the control group than in the other two groups.,"['patients who were hospitalized and underwent', 'Patients']","['Web-Based Patient Education', 'Undergone Mammaplasty', 'breast surgery (modified radical mastectomy or breast-conserving surgery) with axilla lymph node dissection', 'web-based education']","['Disease, SF 36 Quality of Life Scale, State-Trait Anxiety Inventory, and Website Usability Scale', 'anxiety and quality of life', 'trait anxiety scores', 'state of anxiety scores', 'Anxiety and Life Quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0024883', 'cui_str': 'Modified Mastectomy'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0431699,The mean difference in the trait anxiety scores after 1 month was higher in the control group than in the other two groups.,"[{'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Korkmaz', 'Affiliation': 'Gülhane Training and Research Hospital, Department of General Surgery, University of Health Sciences, Ankara, Turkey. serapkorkmaz2012@hotmail.com.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Iyigun', 'Affiliation': 'Gulhane Faculty of Nursing, Department of Surgical Nursing, University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Sevinc', 'Initials': 'S', 'LastName': 'Tastan', 'Affiliation': 'Health Science Faculty, Nursing Department, Eastern Mediterranean University, Via Mersin 10, Famagusta, North Cyprus, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01542-1']
173,31112605,Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention.,"BACKGROUND AND OBJECTIVES


Social isolation is associated with a higher risk of dementia. We previously conducted and showed the efficacy of an intervention which uses conversation (the core component of social interactions) as a tool to enhance cognitive function. We now explore whether cognitive improvements through conversation-based intervention depend on an individual's personality.
RESEARCH DESIGN AND METHODS


We reexamined data from a 6-week randomized controlled trial (ClinicalTrials.gov Number: NCT01571427) to determine whether conversation-based intervention effects were moderated by personality traits in 83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment). The intervention group participated in daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks. At baseline, psychosocial questionnaires and a neuropsychological battery were completed.
RESULTS


Intervention group participants with high agreeableness, conscientiousness, and extraversion exhibited significant improvements in language-based executive function tasks beyond changes in the control group (ps < .05). An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
DISCUSSION AND IMPLICATIONS


Our exploratory findings suggest the adaptive role of personality traits in conversation-based cognitive interventions may be limited to tasks incorporating a language component, and offer initial evidence for personalized approaches to cognitive health in late life.",2020,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","['83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment']",['daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks'],"['language-based executive function tasks', 'Cognitive Function', 'delayed recall memory and working memory tasks']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",83.0,0.0918085,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Cerino', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hooker', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Goodrich', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}, {'ForeName': 'Hiroko H', 'Initials': 'HH', 'LastName': 'Dodge', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}]",The Gerontologist,['10.1093/geront/gnz063']
174,31070072,An Optimal Uterine Closure Technique for Better Scar Healing and Avoiding Isthmocele in Cesarean Section: A Randomized Controlled Study.,"Objective:  The aim of this study is to compare the effects of two different uterine closure techniques, used during cesarean section (CS) operations on isthmocele formation.  Material and Methods:  This prospective, randomized, controlled study was performed on 138 patients in a university hospital between the dates December 2016 and August 2017. Uterine closures were performed using the double-layer, far-far-near-near (FFNN) unlocked technique, in the study group ( n  = 70) and using a single-layer continuous locked (SLL) technique in the control group ( n  = 68). The presence of isthmocele, residual myometrial thickness (RMT), postmenstrual spotting, dysmenorrhea, chronic pelvic pain and uterus position were evaluated in postoperative sixth month.  Results : Isthmocele formation was less frequent and RMT was greater in the study group when compared to the control group ( p  < 0.001 and  p  < 0.001, respectively). Duration of operation, amount of blood loss and additional hemostatic suture requirement were not significantly different between the two groups ( p  = 0.221,  p  = 0.520 and  p  = 0.930, respectively). Postmenstrual spotting was less common in FFNN group, while the rates of chronic pelvic pain and dysmenorrhea were not significantly different between the groups ( p  = 0.002,  p  = 0.205 and  p  = 0.490, respectively).  Conclusion : The findings of the present study demonstrate that uterine closure using the FFNN technique is beneficial in terms of providing protection from isthmocele formation and ensuring sufficient RMT. This method has the potential to become the optimal uterine closure technique, but the findings of the present study should be supported by large-scale studies in the future.",2021,"Isthmocele formation was less frequent and RMT was greater in the study group when compared to the control group (p < 0.001 and p < 0.001, respectively).","['138 patients in a university hospital between the dates December 2016 and August 2017', 'Cesarean Section']","['cesarean section (CS) operations', 'single-layer continuous locked (SLL) technique']","['rates of chronic pelvic pain and dysmenorrhea', 'Isthmocele formation', 'RMT', 'presence of isthmocele, residual myometrial thickness (RMT), postmenstrual spotting, dysmenorrhea, chronic pelvic pain and uterus position', 'Duration of operation, amount of blood loss and additional hemostatic suture requirement', 'Postmenstrual spotting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1275590', 'cui_str': 'Thickness of myometrium'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",138.0,0.0359734,"Isthmocele formation was less frequent and RMT was greater in the study group when compared to the control group (p < 0.001 and p < 0.001, respectively).","[{'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kalem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gurgan Clinic IVF and Women Health Center, Ankara, Turkey.'}, {'ForeName': 'Aski Ellibes', 'Initials': 'AE', 'LastName': 'Kaya', 'Affiliation': 'Department of Obstetrics and Gynecology, Duzce University, Duzce, Turkey.'}, {'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Bakırarar', 'Affiliation': 'Department of Biostatistics, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Basbug', 'Affiliation': 'Department of Obstetrics and Gynecology, Duzce University, Duzce, Turkey.'}, {'ForeName': 'Müberra Namlı', 'Initials': 'MN', 'LastName': 'Kalem', 'Affiliation': 'Department of Obstetrics and Gynecology, Liv Hospital Ankara, Ankara, Turkey.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2019.1610530']
175,1912554,Pharmacologic doses of recombinant human erythropoietin in the treatment of myelodysplastic syndromes.,"Twenty patients with myelodysplastic syndromes (MDS) entered a randomized, placebo-controlled, double-blind trial designed to evaluate the efficacy and toxicity of high doses of recombinant human erythropoietin (rhEPO). Patients completing the trial were eligible to receive rhEPO as part of an open-label study. Eighteen patients were transfusion dependent; 10 had refractory anemia (RA), and 10 had refractory anemia with ringed sideroblasts (RARS). A response to rhEPO was defined as an increase in hematocrit of 4 percentage points or more over baseline, or the elimination of all transfusions with the hematocrit stable at the baseline level. In the double-blind trial, 1 patient (12.5%) receiving rhEPO responded, as compared with no responses in the placebo group. Overall, responses occurred in 4 of 17 patients (24%) receiving rhEPO at a dose of 1,200 to 1,600 U/kg intravenously (IV) twice weekly. Changes in granulocyte or platelet counts were not observed. Despite the administration of high doses of rhEPO, toxicity attributable to rhEPO was not observed in either the double-blind or open-label study. Response to rhEPO was not significantly related to age, gender, type of MDS, time since diagnosis, time since initiation of transfusion therapy, or baseline serum EPO. These studies indicate that rhEPO can be administered safely in very high doses to patients with MDS and that 24% of these patients will respond with increased erythropoiesis.",1991,Changes in granulocyte or platelet counts were not observed.,"['myelodysplastic syndromes', 'Eighteen patients were transfusion dependent; 10 had refractory anemia (RA), and 10 had refractory anemia with ringed sideroblasts (RARS', 'Twenty patients with myelodysplastic syndromes (MDS']","['recombinant human erythropoietin (rhEPO', 'rhEPO', 'placebo', 'recombinant human erythropoietin']","['Changes in granulocyte or platelet counts', 'efficacy and toxicity', 'hematocrit']","[{'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2981142', 'cui_str': 'Refractory anemia (clinical)'}, {'cui': 'C0229630', 'cui_str': 'Sideroblast (cell)'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}]",18.0,0.203833,Changes in granulocyte or platelet counts were not observed.,"[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Stein', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Abels', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Krantz', 'Affiliation': ''}]",Blood,[]
176,31714266,Impact of an Animation Education Program on Promoting Compliance With Active Respiratory Rehabilitation in Postsurgical Lung Cancer Patients: A Randomized Clinical Trial.,"BACKGROUND


Non-small cell lung cancer is the most common type of lung cancer. Lung resection is proven to be the most effective curative treatment for early-stage non-small cell lung cancer (stages I-IIIA). Studies show evidence-based pulmonary rehabilitation is critical for improving exercise capacity and pulmonary function, reducing burden of cancer-related symptoms, and facilitating quality of life following a lung resection.
OBJECTIVE


To explore the effectiveness of an animation education program to promote respiratory rehabilitation outcomes for postsurgical lung cancer patients.
INTERVENTIONS/METHODS


Eighty lung cancer patients who had undergone lung resection were equally randomized to 2 groups with 40 participants in each group. The intervention group received animation education. The control group received traditional face-to-face education. The training-related knowledge and exercise compliance were evaluated at baseline, 3 days after education, and the day of discharge, along with related pulmonary functional indicators.
RESULTS


Eighty of 99 eligible participants were enrolled (80.8%). Mean scores of training-related knowledge and exercise compliance in the intervention group were higher than those of the control group. Occurrences of postoperative pulmonary complications and the indwelling time of thoracic drainage tube were lower, and 6-minute walk distance was longer compared with the control group. No statistical differences in other pulmonary functional indicators were found.
CONCLUSIONS


Educational animation is effective for promoting training-related knowledge and exercise compliance with active respiratory rehabilitation in postsurgical lung cancer patients.
IMPLICATIONS FOR PRACTICE


Oncology nurses can implement animation as an innovative educational method for improving cancer patients' uptake and compliance on health education.",2021,"Occurrences of postoperative pulmonary complications and the indwelling time of thoracic drainage tube were lower, and 6-minute walk distance was longer compared with the control group.","['Eighty lung cancer patients who had undergone lung resection were equally randomized to 2 groups with 40 participants in each group', 'early-stage non-small cell lung cancer (stages', 'Postsurgical Lung Cancer Patients', 'Eighty of 99 eligible participants were enrolled (80.8', 'postsurgical lung cancer patients']","['Lung resection', 'traditional face-to-face education', 'animation education program', 'animation education', 'Animation Education Program']","['Mean scores of training-related knowledge and exercise compliance', '6-minute walk distance']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376650', 'cui_str': 'Animation'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",99.0,0.0818867,"Occurrences of postoperative pulmonary complications and the indwelling time of thoracic drainage tube were lower, and 6-minute walk distance was longer compared with the control group.","[{'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Author Affiliations: Departments of Thoracic Surgery (Drs Li and Ye and Ms Li), Cardiology (Dr Huang), and Clinical Nursing Teaching and Research Section (Dr Li and Ms Li), Second Xiangya Hospital of Central South University, Changsha, Hunan, China; and Yale University School of Nursing, Orange, Connecticut (Dr Davies).'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Yingxia', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Lezhi', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000758']
177,31935116,Effect of platelet-rich plasma on the rate of orthodontic tooth movement:  A split-mouth randomized trial .,"OBJECTIVE


To investigate the effect of local injection of platelet-rich plasma (PRP) on the rate of orthodontic tooth movement.
MATERIALS AND METHODS


Sixteen female patients were randomly allocated in a split-mouth study design to receive PRP injections with CaCl 2  activating solution on one side (intervention side) while the other side received CaCl 2  injection only (control side). Canine retraction was performed on 0.017 × 0.025-inch stainless steel archwire applying 1.5 N retraction force. PRP and CaCl 2  injections were done at 0, 3, and 6 weeks. The duration of the study was 4 months. Data were collected from digitized models. Assessment of pain accompanying the procedure was done using a visual analogue scale.
RESULTS


The rate of canine retraction was faster on the intervention side in the first 2 months, with a statistically significant difference in the first month ( P  = .049). On the other hand, the rate was statistically significantly slower on the intervention side in the third month following cessation of PRP injections ( P  = .02). Pain increased following injections on both sides.
CONCLUSIONS


PRP showed a positive potential to accelerate the rate of tooth movement when injected in the first 2 months. Repeated injections of PRP to maintain a steady rate of accelerated tooth movement warrant further investigation.",2020,"The rate of canine retraction was faster on the intervention side in the first 2 months, with a statistically significant difference in the first month ( P  = .049).",['Sixteen female patients'],"['platelet-rich plasma (PRP', 'PRP', 'PRP injections with CaCl 2  activating solution on one side (intervention side) while the other side received CaCl 2  injection only (control side', 'platelet-rich plasma']","['rate of canine retraction', 'Pain', 'rate of orthodontic tooth movement', 'rate of tooth movement', 'Canine retraction']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040446', 'cui_str': 'Tooth Movement Techniques'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",16.0,0.0450564,"The rate of canine retraction was faster on the intervention side in the first 2 months, with a statistically significant difference in the first month ( P  = .049).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Timamy', 'Affiliation': ''}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'El Sharaby', 'Affiliation': ''}, {'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Eid', 'Affiliation': ''}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'El Dakroury', 'Affiliation': ''}, {'ForeName': 'Yehya', 'Initials': 'Y', 'LastName': 'Mostafa', 'Affiliation': ''}, {'ForeName': 'Olfat', 'Initials': 'O', 'LastName': 'Shakr', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/072119-483.1']
178,30885760,"Comparison of a picosecond alexandrite laser versus a Q-switched alexandrite laser for the treatment of nevus of Ota: A randomized, split-lesion, controlled trial.","BACKGROUND


Novel picosecond lasers have been available for various pigmentary disorders. However, there are limited data directly comparing picosecond lasers and Q-switched lasers for treatment of nevus of Ota.
OBJECTIVE


To compare the efficacy and safety of a picosecond alexandrite laser (PSAL) with a Q-switched alexandrite laser (QSAL) for the treatment of nevus of Ota.
METHODS


Each lesion of 56 enrolled participants was split into 2 parts and randomly assigned to either the PSAL or QSAL treatment arm. Each lesion was treated in up to 6 sessions in 12-week intervals. Efficacy and safety were determined using blinded visual evaluation and self-report at each follow-up visit.
RESULTS


The PSAL arm achieved a significantly better clearance (5-point scale, PSAL 4.53 vs QSAL 4.0) with fewer sessions (PSAL 5.26 vs QSAL 5.87) and less severe pain (Visual Analog Scale, PSAL 5.61 vs QSAL 6.40). Patients were more satisfied with PSAL than QSAL (Likert scale, 4.5 vs 4.0). Occurrences of postinflammatory hyperpigmentation (PSAL 26% vs QSAL 34%) and hypopigmentation (PSAL 21% vs QSAL 47%) were also lower in PSAL than QSAL arm.
LIMITATIONS


Lack of objective assessments and outcome measures.
CONCLUSION


PSAL demonstrated better clinical results and fewer adverse events than QSAL for the treatment of nevus of Ota.",2020,"RESULTS


PSAL arm achieved a significantly better clearance (4.53 vs 4.0) with fewer sessions (5.26 vs 5.87) and less severe pain (5.61 vs 6.40).","['nevus of Ota', '56 participants enrolled was split into two parts']","['Q-switched alexandrite laser (QSAL', 'QSAL', 'picosecond alexandrite laser (PSAL', 'picosecond alexandrite laser versus a Q-switched alexandrite laser', 'PASL or QSAL']","['clearance', 'adverse events', 'Occurrences of post inflammatory hyperpigmentation', 'efficacy and safety', 'severe pain']","[{'cui': 'C0027961', 'cui_str': 'Nevus of Ota'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}]","[{'cui': 'C0392245', 'cui_str': 'Alexandrite Lasers'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",56.0,0.0503462,"RESULTS


PSAL arm achieved a significantly better clearance (4.53 vs 4.0) with fewer sessions (5.26 vs 5.87) and less severe pain (5.61 vs 6.40).","[{'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Mengli', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Qiuju', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zeng', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Huizhen', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Gaorong', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Hualing', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Cosmetic Laser Surgery, Hospital for Skin Disease and Institute of Dermatology, Peking Union Medical College and Chinese Academy of Medical Sciences, Nanjing, China. Electronic address: ddlin@hotmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.03.016']
179,30604373,Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.,"INTRODUCTION


Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes.
METHODS


We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W).
RESULTS


Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
CONCLUSIONS


Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.",2020,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
",['222 adults with IBD who had experienced an IBD flare within 2\xa0years prior to the trial'],"['control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W', 'TELEmedicine']","['Patient activation scores', 'Patient Activation and Self-Efficacy', 'self-efficacy or patient activation', 'patient activation and general self-efficacy', 'self-efficacy scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",222.0,0.0406776,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).
","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Bilgrami', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Abutaleb', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Kenechukwu', 'Initials': 'K', 'LastName': 'Chudy-Onwugaje', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Langenberg', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Regueiro', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'J Kathleen', 'Initials': 'JK', 'LastName': 'Tracy', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Patil', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Quezada', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Russman', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Charlene C', 'Initials': 'CC', 'LastName': 'Quinn', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Guruprasad', 'Initials': 'G', 'LastName': 'Jambaulikar', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Horst', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Raymond K', 'Initials': 'RK', 'LastName': 'Cross', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA. rcross@som.umaryland.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-018-5433-5']
180,31618768,A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett's surveillance: the ABBA trial.,"BACKGROUND


The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett's surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique.
METHODS


This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett's surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies.
RESULTS


200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients.
CONCLUSIONS


We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett's surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.",2020,"The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.","['A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm', '200 patients were recruited from 6 centers, and 174 (87.0\u200a%) underwent both procedures', ""Patients under Barrett's surveillance with no history of neoplasia were included"", '2828 patients']","['Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies', 'nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol']","['neoplasia detection rates', 'cost savings', 'recruitment and retention rates, neoplasia yield, and number of biopsies', 'High grade dysplasia and cancer', 'Neoplasia prevalence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",2828.0,0.179255,"The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.","[{'ForeName': 'Gaius', 'Initials': 'G', 'LastName': 'Longcroft-Wheaton', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fogg', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Chedgy', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Kandiah', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dewey', 'Affiliation': 'School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Barr', 'Affiliation': 'Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Higgins', 'Affiliation': 'Department of Mathematics, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Poller', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Jankowski', 'Affiliation': 'Gastroenterology, University Hospitals of Morcambe Bay NHS Foundation Trust, Lancaster, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeCaestecker', 'Affiliation': 'University Hospitals of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endoscopy,['10.1055/a-1015-6653']
181,30789827,"Symptom reduction and improved function in chronic CRPS type 1 after 12-week integrated, interdisciplinary therapy.","Background and aims Complex Regional Pain Syndrome (CRPS) often recovers spontaneously within the first year, but when it becomes chronic, available rehabilitative therapies (pharmacological management, physiotherapy, and psychological intervention) have limited effectiveness. This study examined the effect of a 12-week intensive outpatient rehabilitation on pain relief and function in chronic CRPS patients. Rehabilitation program included memantine and morphine treatment (added to patient's prior pain medication) and concurrent psychological and physiotherapeutic intervention. Primary outcome measure was a change in CRPS symptom count and secondary outcomes were motor performance, psychological factors, pain intensity, and quality of life. Methods Ten patients with chronic upper limb CRPS I (median 2.9 years, range 8 months to 12 years) were recruited to the study and were assessed before and after the intervention. Hand motor function of the patients was evaluated by an independent physiotherapist. There were standardized questionnaires for depression, pain anxiety, pain acceptance, quality of life, and CRPS symptom count. In addition, psychological factors were evaluated by a semi-structured interview. Severity of experienced pain was rated at movement and at rest. In addition, a video experiment of a hand action observation was conducted pre- and post-intervention to study possible change in neuronal maladaptation. Intervention consisted of pharmacological, psychological and physiotherapeutic treatment. First, 10 mg daily morphine was started and increased gradually to 30 mg daily, if tolerated. After 30 mg/day or tolerated dose of morphine was achieved, 5 mg daily memantine was started and increased gradually to 40 mg, if tolerated. Psychological intervention consisted of weekly group sessions, using cognitive and behavioral methods (relaxation, behavioral activation, and exposure) and acceptance and commitment therapy (ACT) and daily home practice. Physiotherapeutic intervention consisted of graded motor imagery and physiotherapy exercises with weekly group sessions and/or individual guidance by the physiotherapist, and individual exercise of the affected upper limb. Results Multimodal intensive intervention resulted in significant decrease in CRPS symptom count. The effect was strongest in motor and trophic symptoms (19% decrease after intervention) and in sensory symptoms (18% decrease). Additionally, improvement was seen in some, but not all, secondary outcomes (movement pain, motor symptoms, change in perceptions during video experiment of hand actions, and summary index with motor functioning, pain, and psychological factors). There were no dropouts. Conclusions Intensive 12-week multimodal intervention reduced some CRPS symptoms but was not sufficient to alter patients' rest pain, distress, or quality of life. Implications These results support the efficacy of an interdisciplinary rehabilitation program for pain and function in chronic CRPS patients. After intervention, some CRPS symptoms reduced and function improved, but distress and quality of life were unchanged. This may be due to the relatively short duration of this program; to delayed effects; to particular cognitive problems of CPRS patients; and/or to low distress levels at baseline that make statistically significant reduction less likely.",2019,"Conclusions Intensive 12-week multimodal intervention reduced some CRPS symptoms but was not sufficient to alter patients' rest pain, distress, or quality of life.","['patients with chronic upper limb', 'chronic CRPS patients']","['morphine', ""memantine and morphine treatment (added to patient's prior pain medication) and concurrent psychological and physiotherapeutic intervention"", 'memantine', 'interdisciplinary rehabilitation program', 'intensive outpatient rehabilitation', 'pharmacological, psychological and physiotherapeutic treatment', 'Psychological intervention consisted of weekly group sessions, using cognitive and behavioral methods (relaxation, behavioral activation, and exposure) and acceptance and commitment therapy (ACT) and daily home practice', 'Physiotherapeutic intervention consisted of graded motor imagery and physiotherapy exercises with weekly group sessions and/or individual guidance by the physiotherapist, and individual exercise of the affected upper limb']","['tolerated', 'CRPS symptoms reduced and function improved, but distress and quality of life', 'Severity of experienced pain', 'standardized questionnaires for depression, pain anxiety, pain acceptance, quality of life, and CRPS symptom count', 'motor and trophic symptoms', 'change in CRPS symptom count and secondary outcomes were motor performance, psychological factors, pain intensity, and quality of life', 'CRPS symptoms', 'secondary outcomes (movement pain, motor symptoms, change in perceptions during video experiment of hand actions, and summary index with motor functioning, pain, and psychological factors', 'sensory symptoms', 'pain relief and function', ""patients' rest pain, distress, or quality of life"", 'CRPS symptom count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises (regime/therapy)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0033898', 'cui_str': 'Psychological Factors'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms (finding)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}]",10.0,0.0258964,"Conclusions Intensive 12-week multimodal intervention reduced some CRPS symptoms but was not sufficient to alter patients' rest pain, distress, or quality of life.","[{'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Elomaa', 'Affiliation': 'Pain Clinic, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Hotta', 'Affiliation': 'Clinical Neurosciences, Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'de C Williams', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Forss', 'Affiliation': 'Clinical Neurosciences, Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Äyräpää', 'Affiliation': 'Pain Clinic, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Eija', 'Initials': 'E', 'LastName': 'Kalso', 'Affiliation': 'Pain Clinic, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Harno', 'Affiliation': 'Pain Clinic, Department of Anaesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}]",Scandinavian journal of pain,['10.1515/sjpain-2018-0098']
182,15002680,Adolescents with substance diagnoses in an HMO: factors associated with medical provider referrals to substance abuse and mental health treatment.,"This study examines the factors related to referrals of adolescents with substance use disorders to substance abuse or mental health treatment by their medical providers. Administrative and chart review data from the membership of a large private health maintenance organization (HMO) were collected from a probability sample of 400 adolescents, ages 13-18, who were diagnosed with a substance use disorder in 1999. Logistic regression analyses examined referral to substance abuse treatment and referral to mental health treatment in the aggregate and stratified by gender. Documented use of both alcohol and another illicit drug, and legal problems increased likelihood of referral to substance abuse and mental health treatment, whereas diagnoses of alcohol and marijuana use disorders decreased likelihood of referral to substance abuse treatment. Mental health diagnoses played a limited role in both types of referrals, although specific psychosocial problems were associated with increased likelihood of referrals. Treatment history and location of first mention of problem were significant predictors of referral. There were no gender differences in referral rates to either substance abuse or mental health treatment; however predictors of referral differed by gender. These findings extend our knowledge about factors that influence clinicians' treatment referrals of adolescents with substance abuse diagnoses and have implications for influencing clinician referral behavior within health plans.",2004,There were no gender differences in referral rates to either substance abuse or mental health treatment; however predictors of referral differed by gender.,"['adolescents with substance abuse diagnoses', '400 adolescents, ages 13-18, who were diagnosed with a substance use disorder in 1999', 'adolescents with substance use disorders to substance abuse or mental health treatment by their medical providers', 'Adolescents with substance diagnoses in an HMO: factors associated with medical provider referrals to substance abuse and mental health treatment']",[],['referral rates'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0018720', 'cui_str': 'Prepaid Group Health Organizations'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}]",[],"[{'cui': 'C0034927', 'cui_str': 'Referral'}]",,0.0190959,There were no gender differences in referral rates to either substance abuse or mental health treatment; however predictors of referral differed by gender.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Columbia University College of Physicans and Surgeons New York, New York 10032, USA. scottm@childpsych.columbia.edu'}, {'ForeName': 'Sujaya', 'Initials': 'S', 'LastName': 'Parthasarathy', 'Affiliation': ''}, {'ForeName': 'Carolynn', 'Initials': 'C', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Hinman', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sterling', 'Affiliation': ''}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Weisner', 'Affiliation': ''}]",Mental health services research,[]
183,31657590,ENHANCE: Evidence for the efficacy of a comprehensive intervention program to promote subjective well-being.,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time. In a randomized controlled trial, participants (N = 155; 55 using the in-person format, 100 online format) were randomly assigned to participate in ENHANCE or to a waitlist control condition. All participants completed assessments of SWB, including non-self-report measures, and process variables at baseline, posttest, and follow-up (3 months). We found evidence supporting the efficacy of ENHANCE for increasing SWB, whether administered in-person or online. Furthermore, development of the skills targeted in the program (e.g., gratitude, mindfulness) accounted for SWB improvements. This study provides initial evidence that ENHANCE can promote SWB and offers insights regarding the processes involved in these changes. To bolster these findings, we present additional data (n = 74) from a fourth assessment showing within-person maintenance of SWB gains over 6 months in the original treatment condition (n = 39) and a replication of the immediate ENHANCE treatment effects in the waitlist condition (n = 36). We discuss potential avenues for the utilization of ENHANCE in basic research and applied disseminations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time.","['participants (N = 155; 55 using the in-person format, 100 online format']","['comprehensive intervention program', 'waitlist control condition']",[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],2019.0,0.0323261,"Building from the growing empirical science of happiness, or subjective well-being (SWB), we have developed a 12-week comprehensive intervention program-Enduring Happiness and Continued Self-Enhancement (ENHANCE)-to increase SWB and enable a thorough examination of the mechanistic processes of program content and administrative structure for SWB change over time.","[{'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Heintzelman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kostadin', 'Initials': 'K', 'LastName': 'Kushlev', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lesley D', 'Initials': 'LD', 'LastName': 'Lutes', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Wirtz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Kanippayoor', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Leitner', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Oishi', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000254']
184,32408361,22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy.,"BACKGROUND : Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has been suggested for obtaining high quality tissue samples from pancreatic tumors. We performed a multicenter randomized crossover trial comparing EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle. The aims were to compare the quantity of targeted tissue (pancreas) and diagnostic accuracy for the two needles. METHODS : 60 patients admitted for EUS-FNB in three endoscopy units were included. One pass was performed consecutively with each needle, in a randomized order. Histologic material was studied in a blinded manner with respect to the needle. The primary end point was mean cumulative length of tissue core biopsies per needle pass. RESULTS : Final diagnosis was adenocarcinoma (n = 46; 77 %), neuroendocrine neoplasm (n = 11; 18 %), autoimmune pancreatitis (n = 2), and mass-forming chronic pancreatitis (n = 1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22G Acquire needle at 11.4 mm (95 % confidence interval [CI] 9.0 - 13.8] vs. 5.4 mm (95 %CI 3.8 - 7.0) for the 20G Procore needle ( P  < 0.001), as was the mean surface area (3.5 mm 2  [95 %CI 2.7 - 4.3] vs. 1.8 mm 2  [95 %CI 1.2 - 2.3];  P  < 0.001). Diagnostic adequacy and accuracy were 100 % and 87 % with the 22G Acquire needle, and 82 % and 67 % with the 20G Procore needle ( P  = 0.001 and  P  = 0.02, respectively). CONCLUSIONS : EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.",2020,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,['60 patients admitted for EUS-FNB in three endoscopy units were included'],"['Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB', '22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses', 'EUS-FNB with a 20G Procore needle vs. a 22G Acquire needle']","['quantity of targeted tissue (pancreas) and diagnostic accuracy', 'Diagnostic adequacy and accuracy', 'autoimmune pancreatitis', 'mean cumulative length of tissue core biopsies per needle pass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0877425', 'cui_str': 'Mass of pancreas'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C2609129', 'cui_str': 'Autoimmune pancreatitis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]",60.0,0.0430272,EUS-guided biopsy of pancreatic masses with the 22G Acquire needle provided more tissue for histologic evaluation and better diagnostic accuracy than the 20G Procore needle.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Karsenti', 'Affiliation': 'Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Paris-Bercy, Charenton-le-Pont, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Palazzo', 'Affiliation': 'Digestive Endoscopy Unit, Clinique du Trocadéro, Paris, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Perrot', 'Affiliation': 'UMR1246_SPHERE Methods for Patient-Centered Outcomes and Health Research, Nantes University, France.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Zago', 'Affiliation': 'Pathology Department, 29 rue du Colisée, Paris, France.'}, {'ForeName': 'Anne-Isabelle', 'Initials': 'AI', 'LastName': 'Lemaistre', 'Affiliation': 'Department of Pathology, Eurofins Biomnis, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon Hospital, Pathology Department, Université de Paris, INSERM U1149, Clichy, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Napoléon', 'Affiliation': 'Digestive Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France.'}]",Endoscopy,['10.1055/a-1160-5485']
185,31691253,"Evaluating NeuroSENSE for assessing depth of hypnosis during desflurane anesthesia: an adaptive, randomized-controlled trial.","PURPOSE


Processed electroencephalography (EEG) monitors support depth-of-hypnosis assessment during anesthesia. This randomized-controlled trial investigated the performance of the NeuroSENSE electroencephalography (EEG) monitor to determine whether its wavelet anesthetic value for central nervous system (WAV CNS ) index distinguishes consciousness from unconsciousness during induction of anesthesia (as assessed by the anesthesiologist) and emergence from anesthesia (indicated by patient responsiveness), and whether it correlates with changes in desflurane minimum alveolar concentration (MAC) during maintenance of anesthesia.
METHODS


EEG was collected using a fronto-temporal bilateral montage. The WAV CNS  was continuously recorded by the NeuroSENSE monitor, to which the anesthesiologist was blinded. Anesthesia was induced with propofol/remifentanil and maintained with desflurane, with randomized changes of -0.4, 0, or +0.4 MAC every 7.5 min within the 0.8-1.6 MAC range, if clinically acceptable to the anesthesiologist. During emergence from anesthesia, desflurane was stepped down by 0.2 MAC every five minutes.
RESULTS


Data from 75 patients with a median [interquartile range] age of 41[35-52] yr were obtained. The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness. Bilateral WAV CNS  changes correlated with desflurane concentrations, with -8.0 and -8.6 WAV CNS  units, respectively, per 1 MAC change in the 0.8-1.6 MAC range during maintenance of anesthesia and -10.0 and -10.5 WAV CNS  units, respectively, in the 0.4-1.6 MAC range including emergence from anesthesia.
CONCLUSION


The NeuroSENSE monitor can reliably discriminate between consciousness and unconsciousness, as assessed by the anesthesiologist, during induction of anesthesia and with a lower level of reliability during emergence from anesthesia. The WAV CNS  correlates with desflurane concentration but plateaus at higher concentrations, similar to other EEG monitors, which suggests limited utility to titrate higher concentrations of anesthetic vapour.
TRIAL REGISTRATION


clinicaltrials.gov, NCT02088671; registered 17 March, 2014.",2020,"The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness.",['75 patients with a median [interquartile range] age of 41[35-52] yr were obtained'],"['propofol/remifentanil', 'NeuroSENSE electroencephalography (EEG', 'desflurane', 'desflurane anesthesia']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]",[],,0.151689,"The WAV CNS  distinguished consciousness from unconsciousness as assessed by the anesthesiologist, with area under the receiver operating characteristic curve of 99.5% (95% confidence interval [CI], 98.5 to 100.0) at loss of consciousness and 99.4% (95% CI, 98.5 to 100.0) at return of consciousness.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Görges', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada. mgorges@bcchr.ca.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'West', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Cooke', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Pi', 'Affiliation': 'Department of Statistics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Rollin F', 'Initials': 'RF', 'LastName': 'Brant', 'Affiliation': ""BC Children's Hospital Research Institute, 950 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada.""}, {'ForeName': 'Guy A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': ""BC Children's Hospital Research Institute, 950 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada.""}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Ansermino', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Merchant', 'Affiliation': 'Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Vancouver, BC, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-019-01522-5']
186,30325791,"Effects of Prolonging Eccentric Phase Duration in Parallel Back-Squat Training to Momentary Failure on Muscle Cross-Sectional Area, Squat One Repetition Maximum, and Performance Tests in University Soccer Players.","ABSTRACT


Shibata, K, Takizawa, K, Nosaka, K, and Mizuno, M. Effects of prolonging eccentric phase duration in parallel back-squat training to momentary failure on muscle cross sectional area, squat one repetition maximum, and performance tests in university soccer players. J Strength Cond Res 35(3): 668-674, 2021-This study aimed to compare 2 squat training programs repeated until momentary failure with different eccentric phase duration (2 seconds vs. 4 seconds) on the changes in muscle cross-sectional area, squat 1 repetition maximum (1RM), squat jump (SJ), and countermovement jump (CMJ) height, agility (T-test), and Yo-Yo intermittent recovery test (YY-IR2). Male university soccer players (19.9 ± 0.9 years, 172.2 ± 3.8 cm, 66.1 ± 6.6 kg) were randomly assigned to one of the 2 groups; CON for 2 seconds and ECC for 4 seconds (C2/E4, n = 11) or CON for 2 seconds and ECC for 2 seconds (C2/E2, n = 11). They performed parallel back-squat exercises twice a week for 6 weeks using 75% 1RM weight to momentary failure in each set for 3 sets with each protocol. Outcome measurements were taken before (Pre) and after 3 (Mid; 1RM, SJ, and CMJ only), and at 6 weeks (Post). One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively). Cross-sectional area (50% of the thigh length: 3.5 ± 2.8%), SJ (6.7 ± 8.9%) and CMJ height (6.3 ± 8.6%) increased similarly between C2/E2 and C2/E4, but no significant changes in T-test or YY-IR2 were evident in either group. These results suggest that increasing the ECC phase duration during squat exercises does not produce greater training effects when compared with a shorter ECC phase-duration program with momentary failure.",2021,"One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively).","['university soccer players', 'Male university soccer players (19.9 ± 0.9 years, 172.2 ± 3.8 cm, 66.1 ± 6.6 kg', 'University Soccer Players']","['J Strength Cond Res XX(X', 'CON', 'squat training programs repeated until momentary failure with different eccentric phase duration', 'CON for 2 seconds and ECC']","['Shibata, K, Takizawa, K, Nosaka, K, and Mizuno, M. Effects', 'T-test or YY-IR2', 'changes in muscle cross-sectional area, squat 1 repetition maximum (1RM), squat jump (SJ), and countermovement jump (CMJ) height, agility (T-test), and Yo-Yo intermittent recovery test (YY-IR2', 'Muscle Cross-Sectional Area, Squat One Repetition Maximum, and Performance Tests', 'CMJ height']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4076913', 'cui_str': ""bis(2-(2'-benzothienyl)pyridinato-N,C3')iridium(III) (acetylacetonate)""}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]",,0.0384999,"One repetition maximum increased more (p < 0.05) for C2/E2 (Pre: 95.9 ± 12.2 kg, Mid: 108.2 ± 15.4 kg, Post: 113.6 ± 14.8 kg) than C2/E4 (95.5 ± 12.9 kg, 102.7 ± 15.6 kg, 105.5 ± 14.9 kg, respectively).","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Shibata', 'Affiliation': 'Strength and Conditioning Laboratory, Department of Sustainable Agriculture, College of Agriculture, Food and Environment Sciences, Rakuno Gakuen University, Ebetsu, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Takizawa', 'Affiliation': 'Institute of Physical Development Research, Sapporo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'School of Exercise and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia; and.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Mizuno', 'Affiliation': 'Department of Human Developmental Sciences, Faculty of Education, Hokkaido University, Sapporo, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002838']
187,29589111,Effects of resistance training on MRI-derived epicardial fat volume and arterial stiffness in women with obesity: a randomized pilot study.,"AIM


To date, few studies have analyzed the effects of exercise on cardiac adipose tissue. Overall, exercise programs did not meet the recommendations for significant weight loss, the utilization of resistance training was minimal, and the conclusions derived from these studies have diminished exercise as a strategy for cardiac fat loss.
PURPOSE


The objective of this pilot study was to analyze the effects of 3-week high-intensity, moderate-volume muscular endurance resistance training (RT) on cardiac fat and arterial stiffness.
METHODS


A total of 11 young females with obesity, BMI = 34.13 (± 3.16) kg/m 2  (n = 5 control, n = 6 intervention) completed the study. Absolute strength was assessed using one repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength was calculated using body weight (BW) as BP-to-BW and LP-to-BW ratio. Magnetic resonance was used to quantify epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry was used to assess arterial stiffness by estimating pulse wave velocity (PWV).
RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group. In addition, strength was significantly improved, including BP (p = 0.003), LP (p = 0.001), BP-to-BW ratio (p = 0.001), and LP-to-BW ratio (p = 0.002), while no changes were found in PWV.
CONCLUSIONS


High-intensity, moderate-volume RT, designed to enhance muscular endurance following the recommendations reduces EAT and PAT volumes, improves physical fitness in females with obesity, and has no negative effects on arterial stiffness.",2018,"RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","['females with obesity', '11 young females with obesity, BMI\u2009=\u200934.13 (±\u20093.16) kg/m 2  (n\u2009=\u20095 control, n\u2009=\u20096 intervention) completed the study', 'women with obesity']","['resistance training', '3-week high-intensity, moderate-volume muscular endurance resistance training (RT', 'Magnetic resonance']","['cardiac fat and arterial stiffness', 'physical fitness', 'Absolute strength', 'interaction effects', 'repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength', 'BP', 'epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry', 'LP', 'BP-to-BW ratio']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",11.0,0.0316204,"RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fernandez-del-Valle', 'Affiliation': 'Department of Applied Health, Southern Illinois University Edwardsville, Vadalabene Center, Edwardsville, IL, 62026, USA. marfern@siue.edu.'}, {'ForeName': 'Joaquin U', 'Initials': 'JU', 'LastName': 'Gonzales', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kloiber', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Sunanda', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Department of Electrical and Computer Engineering, Texas Tech University, 1012 Boston Ave, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Klingensmith', 'Affiliation': 'Department of Electrical and Computer Engineering, Southern Illinois University Edwardsville, 30 Circle Drive, Edwardsville, IL, 62026, USA.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX, 79430, USA.'}]",European journal of applied physiology,['10.1007/s00421-018-3852-9']
188,29985223,Jump Training in Rugby Union Players: Barbell or Hexagonal Bar?,"ABSTRACT


Weakley, JJS, Till, K, Read, DB, Leduc, C, Roe, GAB, Phibbs, PJ, Darrall-Jones, J, and Jones, B. Jump training in rugby union players: barbell or hexagonal bar?. J Strength Cond Res 35(3): 754-761, 2021-The countermovement jump (CMJ) is an exercise that can develop athletic performance. Using the conventional barbell (BAR) and hexagonal barbell (HEX) while jumping, the intensity can be increased. However, the bar that provides greater adaptations is unknown. Therefore, this study aimed to assess changes in loaded and unloaded CMJ with either a BAR or HEX across a 4-week mesocycle in rugby union players. Twenty-nine subjects were strength-matched and randomized into 2 groups. Subjects completed 3 sets of CMJ at 20% of 1 repetition maximum back squat, 3 times per week for 4 weeks, using either a BAR or HEX. Subjects completed an unloaded CMJ on a force plate before and after, whereas the highest peak concentric velocity during the jump squat was recorded in the first and last training sessions using a linear position transducer. Magnitude-based inferences assessed meaningful changes within- and between-groups. Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36). In addition, likely to very likely greater improvements were observed in the HEX group in peak velocity (0.33 ± 0.27), relative mean power (0.53 ± 0.30), mean force (0.47 ± 0.27), and 100-ms impulse (0.60 ± 0.48). Similar raw changes in jump squat peak velocity occurred (0.20-0.25 m·s-1), despite the likely greater ES occurring with the BAR (0.32 ± 0.26). These results indicate that training with the HEX leads to superior unloaded CMJ adaptations. In addition, practitioners should use either the HEX or BAR when aiming to enhance loaded jump ability.",2021,"Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36).","['rugby union players', 'Twenty-nine subjects were strength-matched and randomized into 2 groups']","['HEX', 'J Strength Cond Res XX(X', '2018-The countermovement jump (CMJ', 'unloaded CMJ', 'BAR or HEX', 'Jump Training', 'conventional barbell (BAR) and hexagonal barbell (HEX']","['Weakley, JJS, Till, K, Read, DB, Leduc, C, Roe, GAB, Phibbs, PJ, Darrall-Jones, J, and Jones, B. Jump training', 'jump squat peak velocity', 'highest peak concentric velocity', 'unloaded CMJ']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}]",29.0,0.0161079,"Possibly greater improvements in unloaded CMJ were found in the HEX group in jump height (effect size ± 90% confidence intervals: 0.27 ± 0.27), relative peak (0.21 ± 0.23), and mean power (0.32 ± 0.36).","[{'ForeName': 'Jonathon J S', 'Initials': 'JJS', 'LastName': 'Weakley', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Till', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Dale B', 'Initials': 'DB', 'LastName': 'Read', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Leduc', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Gregory A B', 'Initials': 'GAB', 'LastName': 'Roe', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Padraic J', 'Initials': 'PJ', 'LastName': 'Phibbs', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Darrall-Jones', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds, West Yorkshire, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002742']
189,30024484,Prior Knowledge of the Grading Criteria Increases Functional Movement Screen Scores in Youth Soccer Players.,"ABSTRACT


Bryson, A, Arthur, R, and Easton, C. Prior knowledge of the grading criteria increases Functional Movement Screen scores in youth soccer players. J Strength Cond Res 35(3): 762-768, 2021-We sought to determine whether familiarity with the grading criteria of the Functional Movement Screen (FMS) impacted the outcome score in elite youth soccer players. Thirty-two trained male youth soccer players (aged 17 ± 1 years) participated in a randomized control trial. Subjects were randomly assigned to evenly sized control and experimental groups, who each completed the FMS on 2 separate occasions. Subjects in the experimental group were provided the FMS grading criteria between their first and second screens. Time-synchronized video footage was used to grade the FMS using standardized criteria. Structured interviews were then conducted with selected subjects (n = 4) in the experimental group to establish athletes' perception of the FMS. The experimental group had a large increase in overall FMS score from the first to the second screen in comparison with the control group (Δ2.0 ± 1.0, p < 0.001, d = 1.3). Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05). Thematic analysis of the interview data suggested that the subjects in the experimental group improved their understanding between good and poor technique during the FMS. These findings support the notion that FMS scores are influenced by awareness of the grading criteria. As a consequence, the FMS may not be suitable for objectively predicting injury in youth soccer players.",2021,"Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05).","['youth soccer players', 'Youth Soccer Players', 'elite youth soccer players', 'Thirty-two trained male youth soccer players (aged 17 ± 1 years']","['J Strength Cond Res XX(X', 'Functional Movement Screen (FMS']","['overall FMS score', 'Functional Movement Screen scores', 'deep squat, hurdle step, and rotary stability tests components of the FMS']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",32.0,0.0176392,"Scores for the deep squat, hurdle step, and rotary stability tests components of the FMS all increased in the experimental group in comparison with the control group (p < 0.05).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bryson', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Arthur', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Easton', 'Affiliation': 'Institute for Clinical Exercise and Health Science, University of the West of Scotland, Hamilton, United Kingdom; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002724']
190,30161088,"Effects of 6-Week Static Stretching of Knee Extensors on Flexibility, Muscle Strength, Jump Performance, and Muscle Endurance.","ABSTRACT


Ikeda, N and Ryushi, T. Effects of 6-week static stretching of knee extensors on flexibility, muscle strength, jump performance, and muscle endurance. J Strength Cond Res 35(3): 715-723, 2021-The purpose of this study was to evaluate the changes in flexibility and muscular performance after stretching training for 6 weeks. Twelve healthy young men were assigned to a stretching group and 13 to a control group. The subjects of the stretching group performed static stretching of knee extensors for 6 weeks. Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions. In the stretching group, KFROM significantly increased from 145.2 ± 17.3 to 158.7 ± 6.3° (p < 0.05), whereas RFD significantly improved from 10,173 ± 2,401 to 11,883 ± 2,494 N·s-1 (p < 0.05). By contrast, leg extension strength and jump performance of each jump type did not improve significantly. Furthermore, muscle endurance decreased significantly. All variables remained unchanged in the control group. In conclusion, 6 weeks of stretching training of knee extensors improved KFROM and RFD in leg extension, but not leg extension strength and jump performance; moreover, muscle endurance decreased. These findings indicate that this stretching training protocol can be used by athletes in sports who require high flexibility and those who require high-power exertion.",2021,"Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions.",['Twelve healthy young men'],"['J Strength Cond Res XX(X', '6-Week Static Stretching of Knee Extensors', 'stretching group performed static stretching of knee extensors']","['Flexibility, Muscle Strength, Jump Performance, and Muscle Endurance', 'KFROM', 'flexibility and muscular performance', 'flexibility, muscle strength, jump performance, and muscle endurance', 'leg extension strength and jump performance', 'KFROM and RFD in leg extension, but not leg extension strength and jump performance', 'Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance', 'RFD', 'muscle endurance']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",12.0,0.0145259,"Knee flexion range of motion (KFROM), leg extension strength, rate of force development (RFD) in leg extension, jump performance (squat and countermovement jump height, and index of rebound jump), and strength decrement index of 50 repetitions of isokinetic knee extension (muscle endurance) were measured before and after the interventions.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan; and.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Ryushi', 'Affiliation': 'Faculty of Sports & Health Sciences, Daito Bunka University, Higashi-matsuyama, Saitama, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002819']
191,30289873,Examination of Physical Fitness Parameters Between Professional and Amateur Greek Soccer Players During the Transition Period.,"ABSTRACT


Bekris, E, Pidoulas, G, Pidoulas, P, Gissis, I, Katis, A, and Komsis, S. Examination of physical fitness parameters between professional and amateur Greek soccer players during the transition period. J Strength Cond Res 35(3): 776-781, 2021-The aim of the study was to compare physical fitness parameters between professional and amateur soccer players of different levels. The sample consisted of 381 soccer players divided in 4 experimental groups: first division professional players (n = 115), second division professional players (n = 70), third division semiprofessional players (n = 93), and amateur soccer players (n = 103). Players were tested for several physiological parameters at the end of the transition period. Analysis of variance showed significantly lower body fat and increased maximum oxygen consumption (V̇o2max) and velocity of maximum oxygen consumption (vV̇o2max) values for first division professional players compared with the other experimental groups (p < 0.05). Similarly, first division professional players showed higher performance during squat jump and countermovement jump test compared with the other experimental groups (p < 0.05). Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05). The results of the study indicated that Greek soccer players at the highest level overcome in almost all the underexamination physiological parameters probably because of less absence from training and better implementation of training programs during the transition period.",2021,Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05).,"['first division professional players', 'professional and amateur soccer players of different levels', '381 soccer players divided in 4 experimental groups: first division professional players (n = 115), second division professional players (n = 70), third division semiprofessional players (n = 93), and amateur soccer players (n = 103']","['J Strength Cond Res XX(X', 'V[Combining']","['Dot Above]O2max) and velocity of maximum oxygen consumption (vV[Combining Dot Above]O2max) values', 'maximum oxygen consumption', 'flexibility test', 'higher performance during squat jump and countermovement jump test', 'Bekris, E, Pidoulas, G, Pidoulas, P, Gissis, I, Katis, A, and Komsis, S. Examination of physical fitness parameters']","[{'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]",[],"[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0202038,Significant differences on flexibility test were observed between amateur players and the other group (p < 0.05).,"[{'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bekris', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Pidoulas', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Pidoulas', 'Affiliation': 'Department of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece; and.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Gissis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Katis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stergios', 'Initials': 'S', 'LastName': 'Komsis', 'Affiliation': 'Neuromechanics Laboratory, Department of Physical Education and Sport Science, Serres, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002770']
192,29939900,High-Intensity Interval vs. Continuous Endurance Training: Preventive Effects on Hormonal Changes and Physiological Adaptations in Prediabetes Patients.,"ABSTRACT


Safarimosavi, S, Mohebbi, H, and Rohani, H. High-intensity interval vs. continuous endurance training: Preventive effects on hormonal changes and physiological adaptations in prediabetes patients. J Strength Cond Res 35(3): 731-738, 2021-The aim of this study was to examine the effects of a 12-week high-intensity interval training (HIIT) intervention, or an isocaloric continuous endurance training (CET) intervention on insulin resistance indices and change in irisin and preptin in patients with prediabetes. Thirty-two prediabetic male patients (age = 38.7 ± 4; body mass index = 26.9 ± 1.4 kg·m-2; and V̇o2peak = 2.49 ± 0.22 L·min-1) were randomly assigned into 3 training groups (N = 8). These groups were matched based on the required energy expenditure (EE) for completing each protocol: (a) HIIT (10 × 60 seconds at 90% peak oxygen uptake [V̇o2peak], 1: 1 work to recovery at 50 W), (b) CET at an intensity equivalent to maximal fat oxidation (Fatmax) (CETFAT) (pedaling for a duration that expends an equivalent EE to an HIIT session [E ≈ HIIT]), (c) CET at an intensity equivalent to anaerobic threshold (CETAT) (E ≈ HIIT), and (d) the control group (CON): continued to perform their daily activities. After intervention, blood glucose levels were significantly (p < 0.05) lower in the HIIT group compared with CETAT group. Exercise training improved the insulin resistance index by 35, 28, and 37% in CETFAT, CETAT, and HIIT groups, respectively. Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values. Also, HIIT and CETFAT resulted in significant (p < 0.05) changes in preptin concentration compared with baseline. This study demonstrated that both HIIT and CETFAT protocols had similar effects on the insulin resistance index of prediabetic patients. Also, the intensity and type of exercise were effective factors in changing irisin and preptin concentrations.",2021,Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values.,"['patients with prediabetes', 'Thirty-two prediabetic male patients (age = 38.7 ± 4; body mass index = 26.9 ± 1.4 kg·m; and V[Combining Dot Above]O2peak = 2.49 ± 0.22 L·min', 'prediabetic patients', 'Prediabetes Patients', 'prediabetes patients']","['High-Intensity Interval vs. Continuous Endurance Training', 'V[Combining', 'J Strength Cond Res XX(X', 'anaerobic threshold (CETAT', 'HIIT and CETFAT', 'Exercise training', 'Dot Above]O2peak', 'isocaloric continuous endurance training (CET) intervention', 'high-intensity interval training (HIIT) intervention']","['Hormonal Changes and Physiological Adaptations', 'preptin concentration', 'insulin resistance indices and change in irisin and preptin', 'Irisin concentrations', 'Safarimosavi, S, Mohebbi, H, and Rohani, H. High-intensity interval', 'blood glucose levels', 'insulin resistance index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C4708661', 'cui_str': '2.49'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0001400', 'cui_str': 'Adaptations, Physiologic'}, {'cui': 'C1100366', 'cui_str': 'proinsulin-like growth factor II E-peptide (69-102)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",32.0,0.0278581,Irisin concentrations in the HIIT and CETAT groups was significantly (p < 0.05) decreased compared with the pre-training values.,"[{'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Safarimosavi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Exercise Physiology, University of Guilan, Rasht, Iran; and.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Mohebbi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Exercise Physiology, University of Guilan, Rasht, Iran; and.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Rohani', 'Affiliation': 'Department of Exercise Physiology, Sport Sciences Research Institute, Tehran, Iran.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002709']
193,31569180,The Experience of Complex Pain Dynamics in Oncology Outpatients: A Longitudinal Qualitative Analysis.,"BACKGROUND


Few qualitative studies of cancer patients' everyday experiences with pain exist within the large body of cancer pain research. Longitudinal qualitative studies are particularly sparse, and no studies have qualitatively described patients' pain experience over time during participation in a self-management intervention.
OBJECTIVE


To longitudinally describe patients' pain experiences during a 10-week pain self-management intervention.
METHODS


This qualitative study was embedded in a randomized controlled trial of a psychoeducational pain management intervention. The data consisted of transcribed audio recordings of each intervention session. An emergent, interpretive approach was used in this longitudinal qualitative analysis.
RESULTS


Forty-two adult patients were included. The analysis revealed the strikingly dynamic nature of individual patient's pain experiences. Multiple facets of pain contributed to its dynamic nature, including pain in changing locations, co-occurring sources of pain, and varying patterns of pain intensity over time. For individual patients, the cumulative effect of these multiple facets resulted in a phenomenon we termed ""complex pain dynamics.""
CONCLUSION


The results contribute to knowledge about the dynamic nature of cancer patients' pain experiences over a relatively short period. They suggest the need for a new paradigm for management of pain in cancer patients and raise questions about the interpretation of randomized controlled trial results in the absence of qualitative data.
IMPLICATIONS FOR PRACTICE


Frequent assessments and reassessments of pain are needed in cancer patients with the ongoing development of highly individualized self-management strategies. A large repertoire of interventions is needed to effectively manage pain in cancer patients over time.",2021,"Multiple facets of pain contributed to its dynamic nature, including pain in changing locations, co-occurring sources of pain, and varying patterns of pain intensity over time.","['cancer patients with the ongoing development of highly individualized self-management strategies', 'Forty-two adult patients were included', 'cancer patients', ""patients' pain experiences during a 10-week pain self-management intervention"", 'Oncology Outpatients', ""cancer patients' everyday experiences with pain exist within the large body of cancer pain research""]",['psychoeducational pain management intervention'],[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0035168'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",[],42.0,0.0298888,"Multiple facets of pain contributed to its dynamic nature, including pain in changing locations, co-occurring sources of pain, and varying patterns of pain intensity over time.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Schumacher', 'Affiliation': 'Author Affiliations: Schools of Nursing (Drs Schumacher, Paul, and Miaskowski) and Medicine (Dr Rabow), University of California San Francisco; and School of Education, University of Cincinnati, Ohio (Dr Plano Clark).'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Plano Clark', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rabow', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Paul', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Miaskowski', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000747']
194,31599627,Duluth versus cognitive behavioral therapy: A natural field experiment on intimate partner violence diversion programs.,"We used data from a 3-year natural field experiment to study rates of recidivism in 2 types of diversion programs designed to reduce intimate partner violence (IPV) among heterosexual partners. In one program (Duluth), efforts are focused on protecting women from male aggression through a psychoeducational program, regardless of the offender's sex. In the other program (cognitive behavioral therapy [CBT]), efforts are focused on improving intrahousehold behaviors and communication skills through counseling. Our experimental results found that the IPV recidivism rate, measured as reconvictions for IPV, was 11 percentage points higher for offenders randomly assigned to a Duluth treatment program (14 percentage points higher among males). This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT. In an attempt to explain the observed difference of IPV recidivism between these programs, we discuss theories for plausible psychological, sociological, psychophysiological, and neurological mechanisms responsible for this outcome. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT.","['intimate partner violence diversion programs', 'heterosexual partners']","['program (cognitive behavioral therapy [CBT', 'Duluth versus cognitive behavioral therapy']","['IPV recidivism rate', 'recidivism rates', 'intimate partner violence (IPV']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",2019.0,0.0164288,"This outcome is statistically and practically significant, suggesting that the Duluth approach corresponds to meaningfully higher recidivism rates compared with CBT.","[{'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Cotti', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'M Ryan', 'Initials': 'MR', 'LastName': 'Haley', 'Affiliation': 'Department of Economics.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Rawski', 'Affiliation': 'Department of Management and Human Resources.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000249']
195,29177979,Photobiomodulation effect on children's scars.,"The management of burn scars has become one of the major clinical challenges in the developing countries which involve enormous treatment cost; this needs new methods for better cost benefit relationship. The objective of the study is to analyze the effectiveness of low-level laser therapy on post-burn scar tissue in children. A randomized controlled study included 15 children, ranging from 2 to 10 years of age, presenting with burn scars. They received diode laser and topical treatment. Each scar was divided into two halves. One half was treated with laser therapy and topical treatment (study area), and the other half was treated with topical treatment only (control area). The children were evaluated before and after 3 months of the study by Vancouver Scar Scale (VSS), ultrasonography (U/S), and laser Doppler perfusion imaging. Significant improvement was reported in the studied area compared to the control area for patients with P values (P = 0.005) and (P = 0.0001) for VSS and U/S scores, respectively. No difference was detected for blood perfusion to the scar between both areas (P = 0.18). In addition, no adverse effect was reported. Photobiomodulation is an efficient and safe therapeutic modality for post-burn hypertrophic scars in children and should be considered a part of combination therapy for better results.",2018,"Significant improvement was reported in the studied area compared to the control area for patients with P values (P = 0.005) and (P = 0.0001) for VSS and U/S scores, respectively.","['children', '15 children, ranging from 2 to 10\xa0years of age, presenting with burn scars', ""children's scars""]","['Photobiomodulation', 'low-level laser therapy', 'laser therapy and topical treatment', 'diode laser and topical treatment']","['Vancouver Scar Scale (VSS), ultrasonography (U/S), and laser Doppler perfusion imaging', 'blood perfusion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0036280', 'cui_str': 'Burn scar (morphologic abnormality)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",15.0,0.0240771,"Significant improvement was reported in the studied area compared to the control area for patients with P values (P = 0.005) and (P = 0.0001) for VSS and U/S scores, respectively.","[{'ForeName': 'Jehan', 'Initials': 'J', 'LastName': 'Alsharnoubi', 'Affiliation': 'Pediatrics Department, National Institute of Laser Enhanced Sciences (N.I.L.E.S), Cairo University, House 2 Street 6 Zahraa Helwan, Cairo, Egypt. broncojena@gmail.com.'}, {'ForeName': 'Omnia', 'Initials': 'O', 'LastName': 'Mohamed', 'Affiliation': 'Pediatrics Department, Aboelreesh Hospital, Cairo, Egypt.'}]",Lasers in medical science,['10.1007/s10103-017-2387-3']
196,31592887,The Impact of Exposure Therapy on Resting Heart Rate and Heart Rate Reactivity among Active Duty Soldiers with PTSD.,"OBJECTIVE


Posttraumatic stress disorder (PTSD) is linked to poor health, including cardiovascular disease (CVD). These effects may be a result of increased tonic cardiovascular function and cardiovascular reactivity (CVR). Despite PTSD's negative health burden, relatively little is known about whether frontline treatments for PTSD may alleviate cardiovascular risk.
METHODS


The current study was a secondary analysis of a larger intervention study of active duty soldiers with PTSD (N = 104; mean age = 30.6 years, SD = 6.7; 6% women) randomized to an exposure therapy-either prolonged exposure (PE) or virtual reality exposure (VRE)-or a waitlist control condition. We examined change in participants' resting heart rate (HR) and HR reactivity from baseline (prior to randomization) to mid- and post-treatment using residualized change regression models.
RESULTS


The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist. Exploratory analyses found that change in resting HR and HR reactivity were not significantly correlated with either self-reported or clinician-rated PTSD symptom change.
CONCLUSIONS


These results suggest that PE and VRE for PTSD may alleviate some cardiovascular health risk associated with PTSD improving cardiovascular functioning.RCT Registration: The study was registered at ClinicalTrials.gov (identifier: NCT01193725).",2019,"The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist.","['active duty soldiers with PTSD (N = 104; mean age = 30.6 years, SD = 6.7; 6% women', 'Active Duty Soldiers with PTSD', 'Posttraumatic stress disorder (PTSD']","['RCT Registration', 'Exposure Therapy', 'exposure therapy-either prolonged exposure (PE) or virtual reality exposure (VRE)-or a waitlist control condition']","['resting HR', 'resting HR and HR reactivity', 'Resting Heart Rate and Heart Rate Reactivity', 'tonic cardiovascular function and cardiovascular reactivity (CVR', 'HR reactivity', 'heart rate (HR) and HR reactivity']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}]",,0.0344269,"The results of the study demonstrated decreased resting HR (B = -5.06, p = .024) and HR reactivity (B = -2.46, p = .005) from baseline to post-treatment for PE and VRE relative to waitlist.","[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Bourassa', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Katz', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine.'}, {'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'VA Puget Sound Healthcare System.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Norr', 'Affiliation': 'University of Washington School of Medicine.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000758']
197,31570825,Transcutaneous functional electrical stimulation-a novel therapy for premature ejaculation: results of a proof of concept study.,"Premature Ejaculation (PE) is a very common and disturbing sexual dysfunction in men. Currently available treatment modalities are associated with limited efficacy and low treatment adherence. In this prospective, single-blinded, self-controlled study, we evaluated the efficacy and safety of transcutaneous electrical stimulation (TES) for the treatment of (PE). We included 23 patients aged 20-60 (mean: 38.7) with lifelong PE. On the first visit, we delivered either TES or sham treatment to the perineum, based on the enrollment order. For stimulation, we used a commercial neuromuscular electrical stimulation device. The patients were invited for the second visit after at least 7 days for receiving the alternating treatment. During the treatment sessions, the patients were left alone in a privet silent room to masturbate and a stopwatch was used to measure their masturbation ejaculatory latency time (MELT). The patients also filled-out safety questionnaires after each visit and on each of the 3 following days. Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment. Mean MELT values increased 3.5-folds under TES (p = 0.0009). We demonstrated a significant increase in MELT in lifelong PE patients using TES. This therapeutic option may have the potential to become an on-demand treatment option for PE. Future studies with wireless devices are needed to confirm the efficacy and safety of this treatment concept during intercourse.",2020,"Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment.","['23 patients aged 20-60 (mean: 38.7) with lifelong PE', 'premature ejaculation']","['Transcutaneous functional electrical stimulation-a novel therapy', 'TES', 'transcutaneous electrical stimulation (TES']","['masturbation ejaculatory latency time (MELT', 'prolonged MELT under TES', 'Mean MELT values', 'MELT', 'Premature Ejaculation (PE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C0024906', 'cui_str': 'Masturbation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0599882', 'cui_str': 'Melting'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]",,0.0182798,"Of the 20 patients who completed the study, 17 (85%) experienced prolonged MELT under TES compared with the sham treatment.","[{'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel. arikshec@gmail.com.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Serefoglu', 'Affiliation': 'Department of Urology, Biruni University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Gollan', 'Affiliation': 'Virility Medical Ltd., Nazareth, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Springer', 'Affiliation': 'Physical Therapy Department, Faculty of Health Sciences Ariel University, Ariel, Israel.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Meiry', 'Affiliation': 'Virility Medical Ltd., Nazareth, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Appel', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Gruenwald', 'Affiliation': 'Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel.'}]",International journal of impotence research,['10.1038/s41443-019-0207-y']
198,2364165,Poor prognosis of children with pre-B acute lymphoblastic leukemia is associated with the t(1;19)(q23;p13): a Pediatric Oncology Group study.,"The prognostic significance of chromosomal translocations, particularly t(1;19) (q23;p13), was evaluated in children with pre-B and early pre-B acute lymphoblastic leukemia (ALL). Patients were treated on a risk-based protocol of the Pediatric Oncology Group (POG) between February 1986 and May 1989. An abnormal clone was detected in 46% (130 of 285) of pre-B cases and 56% (380 of 679) of early pre-B cases. Translocation of any type was associated with a worse treatment outcome than other karyotypic abnormalities: 15 of 66 versus 3 of 64 failed therapy in the pre-B group (P = .001), and 37 of 141 versus 23 of 239 failed in the early pre-B group (P less than .001). The t(1;19) (q23;p13) occurred significantly more often in cases of pre-B ALL with a clonal abnormality than in early pre-B ALL cases (29 of 130 v 5 of 380, P less than .001). Among the 285 pre-B cases in which bone marrow was studied cytogenetically, those with t(1;19) had a significantly worse treatment outcome than all others (11 of 29 v 27 of 256 have failed therapy, P less than .001). This difference is significant (P less than .001) after adjustment for leukocyte count, age, and other relevant features. Cases with the t(1;19) also had a worse prognosis than pre-B patients with other translocations (4 of 37 have failed, P less than .01) or with any other karyotypic abnormality (7 of 101 have failed, P less than .001). We conclude that chromosomal translocations confer a worse prognosis for non-T, non-B-cell childhood ALL, and that the t(1;19) is largely responsible for the poor prognosis of the pre-B subgroup.",1990,"Cases with the t(1;19) also had a worse prognosis than pre-B patients with other translocations (4 of 37 have failed, P less than .01) or with any other karyotypic abnormality (7 of 101 have failed, P less than .001).","['children with pre-B acute lymphoblastic leukemia', 'children with pre-B and early pre-B acute lymphoblastic leukemia (ALL', 'Patients were treated on a risk-based protocol of the Pediatric Oncology Group (POG) between February 1986 and May 1989']",[],['abnormal clone'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009013', 'cui_str': 'Clones'}]",,0.0571791,"Cases with the t(1;19) also had a worse prognosis than pre-B patients with other translocations (4 of 37 have failed, P less than .01) or with any other karyotypic abnormality (7 of 101 have failed, P less than .001).","[{'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Crist', 'Affiliation': ""St Jude Children's Research Hospital.""}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Shuster', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Behm', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whitehead', 'Affiliation': ''}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Vietti', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Look', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Pullen', 'Affiliation': ''}]",Blood,[]
199,26627878,Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.,"BACKGROUND


Patients with atrial fibrillation (AF) and hypertension are at high risk for stroke. Previous studies have shown elevated risk of stroke in patients with AF who have a history of hypertension (regardless of blood pressure [BP] control) and in patients with elevated BP. We assessed the association of hypertension and BP control on clinical outcomes.
METHODS AND RESULTS


In ARISTOTLE (n=18 201), BP was evaluated as history of hypertension requiring treatment and elevated BP (systolic ≥140 and/or diastolic ≥90 mm Hg) at study entry and any point during the trial. Hazard ratios (HRs) were derived from Cox proportional hazards models including BP as a time-dependent covariate. A total of 15 916 (87.5%) patients had a history of hypertension requiring treatment. In patients with elevated BP measurement at any point during the trial, the rate of stroke or systemic embolism was significantly higher (HR, 1.53; 95% confidence interval [CI], 1.25-1.86), as was hemorrhagic stroke (HR 1.85; 95% CI, 1.26-2.72) and ischemic stroke (HR, 1.50; 95% CI, 1.18-1.90). Rates of major bleeding were lower in patients with a history of hypertension (HR, 0.80; 95% CI, 0.66-0.98) and nonsignificantly lower in patients with elevated BP at study entry (HR, 0.89; 95% CI, 0.77-1.03). The benefit of apixaban versus warfarin on preventing stroke or systemic embolism was consistent among patients with and without a history of hypertension (P interaction=0.27), BP control at baseline (P interaction=0.43), and BP control during the trial (P interaction=0.97).
CONCLUSIONS


High BP measurement at any point during the trial was independently associated with a substantially higher risk of stroke or systemic embolism. These results strongly support efforts to treat elevated BP as an important strategy to optimally lower risk of stroke in patients with AF.
CLINICAL TRIAL REGISTRATION


URL: https://ClinicalTrials.gov/. Unique identifier: NCT00412984.",2015,"In patients with elevated BP measurement at any point during the trial, the rate of stroke or systemic embolism was significantly higher (HR, 1.53; 95% confidence interval [CI], 1.25-1.86), as was hemorrhagic stroke (HR 1.85; 95% CI, 1.26-2.72) and ischemic stroke (HR, 1.50; 95% CI, 1.18-1.90).","['patients with AF who have a history of hypertension (regardless of blood pressure [BP] control) and in patients with elevated BP', 'patients with AF', 'Patients With Atrial Fibrillation', 'A total of 15 916 (87.5%) patients had a history of hypertension requiring treatment', 'Patients with atrial fibrillation (AF) and hypertension are at high risk for stroke']",['apixaban versus warfarin'],"['Blood Pressure Control and Risk of Stroke or Systemic Embolism', 'stroke or systemic embolism', 'ischemic stroke', 'risk of stroke or systemic embolism', 'rate of stroke or systemic embolism', 'hemorrhagic stroke', 'Hazard ratios (HRs', 'Rates of major bleeding', 'High BP measurement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.339656,"In patients with elevated BP measurement at any point during the trial, the rate of stroke or systemic embolism was significantly higher (HR, 1.53; 95% confidence interval [CI], 1.25-1.86), as was hemorrhagic stroke (HR 1.85; 95% CI, 1.26-2.72) and ischemic stroke (HR, 1.50; 95% CI, 1.18-1.90).","[{'ForeName': 'Meena P', 'Initials': 'MP', 'LastName': 'Rao', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Oslo University Hospital, Oslo, Norway (S.H.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hylek', 'Affiliation': 'Boston University Medical Center, Boston, MA (E.M.H.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ (M.H.).'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Bahit', 'Affiliation': 'INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina (C.B.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': ""G. D'Annunzio Universita-Chieti and Fondazione Toscana G. Monasterio, Pisa, Italy (R.D.C.).""}, {'ForeName': 'Cetin', 'Initials': 'C', 'LastName': 'Erol', 'Affiliation': 'Ankara University, Ankara, Turkey (C.E.).'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Tokai University School of Medicine, Isehara, Japan (S.G.).'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de La Frontera, Temuco, Chile (F.L.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-IIT, Haifa, Israel (B.S.L.).'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Husted', 'Affiliation': 'Hospital UnitWest, Herning/Holstbro, Denmark (S.H.).'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN (B.J.G.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.P.R., D.W., L.T., J.H.A., R.D.L., C.B.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.115.002015']
200,32091269,Esthetic perception of facial profile changes in Class II patients treated with Herbst or Forsus appliances.,"OBJECTIVE


To evaluate the esthetic perceptions of orthodontists and laypersons for facial profile changes after orthodontic treatment using Herbst or Forsus appliances.
MATERIALS AND METHODS


Pre- and posttreatment facial profile contour images of 20 Class II patients treated with Herbst (group H; n = 10) and Forsus (group F; n = 10) appliances were analyzed by 30 orthodontists and 30 laypersons, who graded them from 1 (unattractive) to 10 (very attractive) using a visual analog scale. Two assessments were carried out with a 15 day-interval. In the first evaluation, 40 images were presented in a random sequence. In the second evaluation, initial and final facial profile images of each patient were randomly presented side by side. To compare groups in relation to treatment method, Mann-Whitney tests were used. To evaluate differences between time points, Wilcoxon tests were used.
RESULTS


In the first evaluation, there was a significant difference between initial and final images only for group H, for both laypersons ( P  = .017) and orthodontists ( P  = .037). There was also a significant difference between laypersons and orthodontists in their ratings of posttreatment Herbst appliance profiles ( P  = .028). There was no significant difference between initial and final facial profile images for group F and no significant differences between or within evaluator groups in their ratings of initial or final Forsus appliance profiles. In the second evaluation, there was a significant difference between appliance groups only for laypersons, who considered cases treated with the Herbst appliance more attractive than those treated with the Forsus ( P  = .031). Laypersons also considered Herbst profiles more attractive than did orthodontists ( P  = .047).
CONCLUSIONS


Class II malocclusion treatment using the Herbst appliance may produce a more esthetically improved facial profile silhouette compared with Forsus appliances. The magnitude of perceived changes may not be considered clinically relevant.",2020,There was no significant difference between initial and final facial profile images for group F and no significant differences between or within evaluator groups in their ratings of initial or final Forsus appliance profiles.,"['Class II patients treated with Herbst or Forsus appliances', 'Pre- and posttreatment facial profile contour images of 20 Class II patients treated with Herbst (group H; n = 10) and Forsus (group F; n = 10) appliances were analyzed by 30 orthodontists and 30 laypersons, who graded them from 1 (unattractive) to 10 (very attractive) using a visual analog scale']",[],"['Esthetic perception of facial profile changes', 'facial profile silhouette', 'initial and final facial profile images']","[{'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243112'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0424476', 'cui_str': 'Facial profile (observable entity)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441842', 'cui_str': 'Group H (qualifier value)'}, {'cui': 'C0441840', 'cui_str': 'Group F (qualifier value)'}, {'cui': 'C0260083', 'cui_str': 'Orthodontist'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442824', 'cui_str': 'Very (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",[],"[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424476', 'cui_str': 'Facial profile (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",40.0,0.0211076,There was no significant difference between initial and final facial profile images for group F and no significant differences between or within evaluator groups in their ratings of initial or final Forsus appliance profiles.,"[{'ForeName': 'Alexa Helena Kohler', 'Initials': 'AHK', 'LastName': 'Moresca', 'Affiliation': ''}, {'ForeName': 'Nathaly Dias', 'Initials': 'ND', 'LastName': 'de Moraes', 'Affiliation': ''}, {'ForeName': 'Francielle', 'Initials': 'F', 'LastName': 'Topolski', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Flores-Mir', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Moro', 'Affiliation': ''}, {'ForeName': 'Ricardo Cesar', 'Initials': 'RC', 'LastName': 'Moresca', 'Affiliation': ''}, {'ForeName': 'Gisele Maria', 'Initials': 'GM', 'LastName': 'Correr', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/052719-362.1']
201,32413915,Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial.,"BACKGROUND


The optimal sampling techniques for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) remain unclear and have not been standardized. The aim of this study was to compare the wet-suction and dry-suction techniques for sampling solid lesions in the pancreas, mediastinum, and abdomen.
METHODS


This was a multicenter, crossover, randomized controlled trial with randomized order of sampling techniques. The 296 consecutive patients underwent EUS-FNA with 22G needles and were randomized in a ratio of 1:1 into two separate groups that received the dry-suction and wet-suction techniques in a different order. The primary outcome was to compare the histological diagnostic accuracy of dry suction and wet suction for malignancy. The secondary outcomes were to compare the cytological diagnostic accuracy and specimen quality.
RESULTS


Among the 269 patients with pancreatic (n = 161) and non-pancreatic (n = 108) lesions analyzed, the wet-suction technique had a significantly better histological diagnostic accuracy (84.9 % [95 % confidence interval (CI) 79.9 % - 89.0 %] vs. 73.2 % [95 %CI 67.1 % - 78.7 %];  P  = 0.001), higher specimen adequacy (94.8 % vs. 78.8 %;  P  < 0.001), and less blood contamination ( P  < 0.001) than the dry-suction technique. In addition, sampling non-pancreatic lesions with two passes of wet suction provided a histological diagnostic accuracy of 91.6 %.
CONCLUSIONS


The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. Furthermore, sampling non-pancreatic lesions with two passes of EUS-FNA with wet suction may provide a definitive histological diagnosis when rapid on-site evaluation is not routinely available.",2020,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"['296 consecutive patients underwent EUS-FNA with 22G needles', '269 patients with pancreatic (n\u200a=\u200a161) and non-pancreatic (n\u200a=\u200a108) lesions']","['endoscopic ultrasound-guided fine-needle aspiration', 'endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA', 'dry-suction techniques', 'dry-suction and wet-suction techniques', 'wet-suction and dry-suction techniques']","['blood contamination', 'histological diagnostic accuracy and specimen quality', 'histological diagnostic accuracy of dry suction and wet suction for malignancy', 'higher specimen adequacy', 'histological diagnostic accuracy', 'cytological diagnostic accuracy and specimen quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205381', 'cui_str': 'Wet'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}]",296.0,0.146063,The wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique.,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Rong-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shi-Yun', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ya-Qi', 'Initials': 'YQ', 'LastName': 'Duan', 'Affiliation': 'Institute of Pathology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang-Ru', 'Initials': 'LR', 'LastName': 'Zhu', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ji-Wang', 'Initials': 'JW', 'LastName': 'Cao', 'Affiliation': 'Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yu-Chong', 'Initials': 'YC', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shou-Jiang', 'Initials': 'SJ', 'LastName': 'Tang', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cheng', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Endoscopy,['10.1055/a-1167-2214']
202,32090788,Antidepressants effects of Rhodiola capsule combined with sertraline for major depressive disorder: A randomized double-blind placebo-controlled clinical trial.,"BACKGROUND


We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola Capsule for mild to moderate major depressive disorder(MDD).
METHODS


It is a randomized double-blind placebo-controlled clinical trial which 100 patients were randomized to 12 weeks into three groups. One of which (group A: 33 patients) received one sertraline and two placebos(0.6 g/day) tablets daily, a second (group B: 33 patients) received one sertraline and two Rhodiola capsules (0.6 g/day) daily, and a third (group C: 34 patients) received one sertraline,one placebo tablet and one tablet of Rhodiola capsule (0.3 g/day)daily. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores were examined. Significant post-treatment improvements were observed for both groups (Rhodiola Capsule) in HAMD, BDI, and CGI scores. The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
RESULTS


Statistically significant reductions were observed for HAM-D, BDI, and CGI scores for all treatment conditions with significant difference between groups. The decline in HAM-D, BDI, and CGI scores was greater for group B versus group C and A.
CONCLUSIONS


It is concluded that the Rhodiola capsule shows anti-depressive potency in patients with depression disorder when administered in dosages of either 0.3 or 0.6 g/day over a 12-week period.Rhodiola capsule can improve the quality of life and clinical symptoms.The high doses of Rhodiola capsule are better than the lower doses.",2020,"The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
","['mild to moderate major depressive disorder(MDD', 'patients with depression disorder', 'major depressive disorder', '100 patients']","['Rhodiola capsule combined with sertraline', 'sertraline and two placebos(0.6', 'placebo', 'sertraline and two Rhodiola capsules', 'Rhodiola Capsule', 'sertraline,one placebo tablet and one tablet of Rhodiola capsule']","['Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores', 'HAM-D, BDI, and CGI scores', 'HAMD, BDI, and CGI scores', 'quality of life and clinical symptoms']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0950013', 'cui_str': 'Rhodiola'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.505305,"The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
","[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China. Electronic address: gaolilidexingfu@163.com.'}, {'ForeName': 'Chenghan', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Jinmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.065']
203,2180492,Effects of chlorambucil and therapeutic decision in initial forms of chronic lymphocytic leukemia (stage A): results of a randomized clinical trial on 612 patients. The French Cooperative Group on Chronic Lymphocytic Leukemia.,"In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which 612 good prognosis patients (stage A) received either no treatment (309 patients) or an indefinite course of chlorambucil at the daily dose of 0.1 mg/kg (303 patients). Overall survival appeared to be better in the untreated group (50 deceased patients compared with 62 in the chlorambucil group), but the difference was not significant (P = .21) even after adjusting for both prognostic and imbalanced factors (P = .09). The crude 5-year survival rates were 82% in the untreated group and 75% in the chlorambucil group. The action of chlorambucil appeared to be a complex phenomenon associating beneficial effects consisting in slowing down disease progression to stage B or C (P less than .01), and favoring disease remission with harmful effects given by a short survival after disease progression to stage B or C in the chlorambucil group and an increased incidence of epithelial cancers (33 v 19), as well as an excess of epithelial cancer deaths (13 v 3), in the chlorambucil group. As these results suggested an overall harmful effect of chlorambucil, we tried to define, within stage A patients, a group of patients with a low probability of disease progression. We showed that stage A patients with hemoglobin greater than or equal to 120 g/L and lymphocyte count less than 30 x 10(9)/L had a survival that was not significantly different (P = .46) from that of the age- and sex-matched French population. These patients, accounting for about 50% of all chronic lymphocytic leukemia patients, should not be treated unless disease progression is observed.",1990,The crude 5-year survival rates were 82% in the untreated group and 75% in the chlorambucil group.,"['612 patients', 'chronic lymphocytic leukemia (stage A', '612 good prognosis patients (stage A) received either no treatment (309 patients) or an']","['chlorambucil and therapeutic decision', 'chlorambucil', 'indefinite course of chlorambucil']","['crude 5-year survival rates', 'epithelial cancer deaths', 'Chronic Lymphocytic Leukemia', 'incidence of epithelial cancers', 'survival', 'Overall survival']","[{'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0441778', 'cui_str': 'Stage A (qualifier value)'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0868337,The crude 5-year survival rates were 82% in the untreated group and 75% in the chlorambucil group.,[],Blood,[]
204,32421171,Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up.,"BACKGROUND


Neurofibromatosis (NF) is a rare genetic disorder associated with substantial deficits in quality of life (QoL). We have previously shown that in this population the Relaxation Response Resiliency Program for NF (3RP-NF) delivered via live videoconferencing is associated with sustained improvement in QoL from baseline through 6-month follow-up over and above an attention placebo control..
PURPOSE


To examine between- and within-group changes in QoL domains from baseline to 1-year follow-up and 6-month to 1-year follow-up.
METHODS


We enrolled and randomized 63 adults with NF. Of these, 52 completed the 6-month follow-up and 53 completed 1-year follow-up. We assessed QoL with the World Health Organization Quality of Life-Brief.
RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes). Participants in the 3RP-NF improved from baseline to 1 year in psychological (8.16; 95% CI: 1.17 to 15.14; p =.023) and social relations QoL (9.93; 95% CI: 1.10 to 18.77; p = .028; within-group changes). There were no other significant differences between or within groups from baseline/6 months to 1 year.
CONCLUSIONS


The live video 3RP-NF shows promise in improving QoL dimensions over the course of 1 year. Results should be replicated in a fully powered randomized controlled trial.
CLINICAL TRIAL INFORMATION


ClinicalTrials.gov NCT03406208.",2021,"RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes).","['Patients With Neurofibromatosis', 'We enrolled and randomized 63 adults with NF']",['Mind-Body Therapy via Videoconferencing'],"['social relations QoL', 'QoL dimensions', 'QoL with the World Health Organization Quality of Life-Brief', 'QoL domains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0260173', 'cui_str': 'Mind-Body Therapies'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",63.0,0.181463,"RESULTS


Participation in the 3RP-NF was associated with sustained improvement from baseline to 1 year in physical health QoL (12.68; 95% confidence interval [CI]: 1.76 to 23.59; p =.024) and social relations QoL (16.81; 95% CI: 3.03 to 30.59; p =.018) but not psychological and environmental QoL, over and above the control (between group changes).","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa030']
205,31915175,Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol.,"​INTRODUCTION: Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group. ​METHODS AND ANALYSIS: The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL ('optimised' standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients' palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival. ​ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences. TRIAL REGISTRATION NUMBER: German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.",2020,"Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life.","['GBM patients (n=214) and their caregivers', 'patients with glioblastoma (EPCOG', 'patients suffering from glioblastoma multiforme (GBM']","['early palliative care', 'intervention group (receiving proactive EIPC', 'palliative care (EIPC', 'EIPC', ""control group (receiving treatment according to international standards and additional, regular assessment of QoL ('optimised' standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br""]","['changes in QoL', ""full FACT-Br scale, patients' palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival""]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C1621958', 'cui_str': 'Glioblastoma Multiforme'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.183488,"Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients' quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life.","[{'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Golla', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany heidrun.golla@uk-koeln.de.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Nettekoven', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bausewein', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jörg-Christian', 'Initials': 'JC', 'LastName': 'Tonn', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Thon', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Feddersen', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Böhlke', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Becker', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Rolke', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Clusmann', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Herrlinger', 'Affiliation': 'Division of Clinical Neurooncology, Department of Neurology, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Radbruch', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Vatter', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Güresir', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Stock', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Civello', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Papachristou', 'Affiliation': 'Faculty of Medicine and University Hospital, Center for Clinical Studies (ZKS), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Faculty of Medicine and University Hospital, Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Voltz', 'Affiliation': 'Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goldbrunner', 'Affiliation': 'Department of General Neurosurgery, Faculty of Medicine and University Hospital, Center for Neurosurgery, University of Cologne, Cologne, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034378']
206,25605582,Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.,"BACKGROUND


Accelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC.
METHODS


This study was performed at the University of Florence (Florence, Italy). Women aged more than 40years affected by early BC, with a maximum pathological tumour size of 25mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50Gy in 25 fractions, followed by a boost on the tumour bed of 10Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02104895.
FINDINGS


A total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4-7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1-3.0) and in the WBI group (three cases; 95% CI 0.0-2.8). No significant difference emerged between the two groups (log rank test p=0.86). We identified seven deaths in the WBI group and only one in the APBI group (p=0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045).
INTERPRETATION


To our knowledge, this is the first randomised study using the IMRT technique for APBI delivery. No significant difference in terms of IBTR and overall survival was observed between the two arms. APBI displayed a significantly better toxicity profile.",2015,"The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045).
","['520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013', 'University of Florence (Florence, Italy', 'selected patients with early stage breast cancer (BC', 'Women aged more than 40years affected by early BC, with a maximum pathological tumour size of 25mm']","['WBI or APBI using IMRT', 'Accelerated partial breast irradiation (APBI', 'Intensity-modulated radiotherapy (IMRT', 'Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation', 'IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI']","['occurrence of ipsilateral breast tumour recurrences (IBTRs', 'cosmetic outcome', 'toxicity profile', 'IBTR and overall survival', 'IBTR rate', 'local recurrence and survival of APBI', '5-year overall survival']","[{'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1458155', 'cui_str': 'Breast Tumors'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",520.0,0.32349,"The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045).
","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Livi', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Icro', 'Initials': 'I', 'LastName': 'Meattini', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy. Electronic address: icro.meattini@unifi.it.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Marrazzo', 'Affiliation': 'Medical Physics Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Simontacchi', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pallotta', 'Affiliation': 'Medical Physics Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Calogero', 'Initials': 'C', 'LastName': 'Saieva', 'Affiliation': 'Molecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), University of Florence, Florence, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Paiar', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Vieri', 'Initials': 'V', 'LastName': 'Scotti', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'De Luca Cardillo', 'Affiliation': 'Department of Radiation Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bastiani', 'Affiliation': 'Radiotherapy Unit, Azienda Sanitaria 10, University of Florence, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orzalesi', 'Affiliation': 'Department of Surgery, University of Florence, Florence, Italy.'}, {'ForeName': 'Donato', 'Initials': 'D', 'LastName': 'Casella', 'Affiliation': 'Department of Surgery, University of Florence, Florence, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'Department of Surgery, University of Florence, Florence, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Nori', 'Affiliation': 'Diagnostic Senology Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fambrini', 'Affiliation': 'Gynecologic and Obstetrics Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Bianchi', 'Affiliation': 'Division of Pathological Anatomy, Department of Medical and Surgical Critical Care, University of Florence, Florence, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2014.12.013']
207,5321112,The effectiveness of combinations of antileukemic agents in inducing and maintaining remission in children with acute leukemia.,,1965,,['children with acute leukemia'],['antileukemic agents'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}]","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",[],,0.0160239,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Frei', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karon', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Levin', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Freireich', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hananian', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Selawry', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoogstraten', 'Affiliation': ''}, {'ForeName': 'I J', 'Initials': 'IJ', 'LastName': 'Wolman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Abir', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sawitsky', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Burgert', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Spurr', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Ebaugh', 'Affiliation': ''}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': ''}]",Blood,[]
208,32421593,Familial severe psychiatric history in bipolar disorder and correlation with disease severity and treatment response.,"BACKGROUND


Bipolar disorder is a heritable disorder, and we aimed to assess the impact of family history of mental disorders in first-degree relatives on the severity and course of bipolar disorder.
METHODS


The Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium) comparative effectiveness studies were similar trials among bipolar disorder outpatients studying four different randomized treatment arms for 24 weeks. Patients self-reported on six severe mental disorders among first-degree relatives. We performed ANOVA and linear regression regarding disease severity measures, sociodemographic and cardiometabolic markers and mixed effects linear regression to evaluate treatment response.
RESULTS


Among 757 patients, 644 (85.1%) reported at least one first-degree relative with a severe mental disorder (mean=2.8; standard deviation=2.2; range=0-13). Depression (67.1%), alcohol abuse (51.0%) and bipolar disorder (47.0%) were the most frequently reported disorders. Familial psychiatric history correlated with several disease severity measures (hospitalizations, suicide attempts, and earlier onset) and sociodemographic markers (lower education and household income) but not with cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score. Patients with familial psychiatric history tended to require more psychopharmacological treatment (p=0.054) but responded similarly (all p>0.1) to all four treatment arms.
CONCLUSIONS


Our findings indicate that familial psychiatric history is common among outpatients with bipolar disorder and correlates with disease severity and sociodemographic measures. Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.",2020,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"['Patients with familial psychiatric history', 'bipolar disorder outpatients', 'outpatients with bipolar disorder']",['Bipolar CHOICE (lithium versus quetiapine) and LiTMUS (optimized treatment with versus without lithium'],"['severe mental disorder', 'Depression', 'cardiometabolic markers (e.g. cholesterol or waist circumference) or cardiovascular risk scores, e.g. the Framingham risk score', 'bipolar disorder', 'alcohol abuse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse'}]",757.0,0.044469,Patients with a greater familial psychiatric load required more intense treatment but achieved similar treatment responses compared to patients without familial psychiatric history.,"[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit, Aarhus University Hospital Psychiatry, Denmark; Department of Clinical Medicin, Aarhus University, Aarhus, Denmark; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: karkoe@rm.dk.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Ruberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Kuperberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alec P', 'Initials': 'AP', 'LastName': 'Shannon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Fung', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital; Department of Medicine, Harvard Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Overhage', 'Affiliation': 'Mongan Institute, Massachusetts General Hospital.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico Health Science Center, Albuquerque, NM, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Friedman', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McElroy', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH and Lindner Center of HOPE, Mason, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ostacher', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.157']
209,1586706,Multicenter randomized study comparing cyclosporine-A alone and antithymocyte globulin with prednisone for treatment of severe aplastic anemia.,"We report the results of a randomized multicenter study comparing the efficacy of antithymocyte globulin (ATG) with that of cyclosporin A (CsA) as first-line therapy for severe aplastic anemia (SAA). Patients were randomized to receive ATG and prednisone (PDN) or CsA; hematologic response and toxicity were compared. At 3-month evaluation, patients who had no or minimal response received the alternative therapy to assess the value of a sequential immunosuppressive therapy for treatment of severe aplastic anemia. One hundred nineteen patients were randomized; 25 were excluded, of whom 3 were misdiagnosed and 22 did not follow the cross-over protocol. Ninety-four patients were analyzed; 46 received CsA, and 48 received ATG-PDN. The actuarial survival was 66.7%, with a median follow-up time of 19 months. There was no significant difference in survival between the groups with, at 3 months, an actuarial survival of 88% in the CsA group and 75% in the ATG group (NS); at 12 months, it was 70% in the CsA group and 64% in the ATG group (NS). The percentage of complete and partial response was 11.6% and 16%, respectively, at 3 months, and 31.6% and 30%, respectively, at 12 months (NS). The main prognostic factor was the absolute neutrophil count (ANC) at entry: Patients with ANC less than 0.2 x 10(9)/L had a significantly lower survival as compared with patients with more than 0.2 x 10(9)/L ANC (P = .0001). At 12 months, 62 evaluable patients were alive, with a complete or partial response in 36 patients. Patients who had responded to the first treatment had a better recovery of bone marrow failure than those who had sequential immunosuppression. The main complication was infection, which was more often observed and more often lethal during ATG and PDN therapy. In this study, initial treatment of SAA with either CsA or ATG-PDN followed by cross-over therapy for nonresponders produced comparable response and survival rates.",1992,"There was no significant difference in survival between the groups with, at 3 months, an actuarial survival of 88% in the CsA group and 75% in the ATG group (NS); at 12 months, it was 70% in the CsA group and 64% in the ATG group (NS).","['62 evaluable patients were alive, with a complete or partial response in 36 patients', 'Ninety-four patients were analyzed; 46 received CsA, and 48 received ATG-PDN', 'severe aplastic anemia (SAA', 'One hundred nineteen patients were randomized; 25 were excluded, of whom 3 were misdiagnosed and 22 did not follow the cross-over protocol', 'patients who had no or minimal response received the']","['cyclosporine-A alone and antithymocyte globulin with prednisone', 'immunosuppressive therapy', 'antithymocyte globulin (ATG', 'ATG and prednisone (PDN) or CsA', 'cyclosporin A (CsA', 'alternative therapy']","['actuarial survival', 'severe aplastic anemia', 'recovery of bone marrow failure', 'response and survival rates', 'percentage of complete and partial response', 'survival', 'absolute neutrophil count (ANC', 'hematologic response and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0949216', 'cui_str': 'Alternative Therapies'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C1855710', 'cui_str': 'Bone marrow failure'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",119.0,0.127395,"There was no significant difference in survival between the groups with, at 3 months, an actuarial survival of 88% in the CsA group and 75% in the ATG group (NS); at 12 months, it was 70% in the CsA group and 64% in the ATG group (NS).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gluckman', 'Affiliation': 'Bone Marrow Transplant Unit, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Esperou-Bourdeau', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baruchel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boogaerts', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Donadio', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Leverger', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leporrier', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiffers', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Janvier', 'Affiliation': ''}]",Blood,[]
210,1536941,Intensive combined therapy for previously untreated aggressive myeloma.,"A trial was initiated to determine the feasibility and efficacy of a three-phase treatment including: (1) induction chemotherapy (IC); (2) high-dose melphalan with total body irradiation supported by unpurged autologous bone marrow transplantation (ABMT); and (3) interferon (IFN) alpha maintenance treatment, in previously untreated aggressive myeloma. Thirty-five consecutive patients, ages under 65 years, were enrolled. Initial induction therapy was randomized between the VAD regimen (vincristine, doxorubicin, dexamethasone) or the VMCP regimen (vincristine, melphalan, cyclophosphamide, prednisone) that were found to give similar results as IC. Thirty-one of 35 (89%) patients, with good performance status and normal renal function after IC, received ABMT. IFN alpha was started soon after ABMT and was well tolerated. Fifteen of 35 (43%) patients achieved complete response (CR) and 14 of 35 (40%) achieved partial response (PR). Low pretreatment beta 2 microglobulin was the only predictive factor for accomplishing CR. The duration of response was significantly affected by the magnitude of response. The 33-month, post-ABMT probability of progression-free survival was 85% for patients in CR versus 24% for patients in PR. The 42-month, post-diagnosis probability of survival was 81%. This overall strategy may represent an advance in the management of multiple myeloma. Furthermore, the high rate and long duration of CR that we observed in patients with low beta 2 microglobulin suggest that such patients may preferentially benefit from this strategy.",1992,"The 33-month, post-ABMT probability of progression-free survival was 85% for patients in CR versus 24% for patients in PR.","['Thirty-one of 35 (89%) patients, with good performance status and normal renal function after IC, received', 'Thirty-five consecutive patients, ages under 65 years, were enrolled', 'previously untreated aggressive myeloma']","['ABMT', 'VAD regimen (vincristine, doxorubicin, dexamethasone', 'VMCP regimen (vincristine, melphalan, cyclophosphamide, prednisone', 'induction chemotherapy (IC); (2) high-dose melphalan with total body irradiation supported by unpurged autologous bone marrow transplantation (ABMT); and (3) interferon (IFN) alpha maintenance treatment', 'Intensive combined therapy']","['ABMT probability of progression-free survival', 'tolerated', 'partial response (PR', 'feasibility and efficacy', 'complete response (CR', 'duration of response']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",35.0,0.0396244,"The 33-month, post-ABMT probability of progression-free survival was 85% for patients in CR versus 24% for patients in PR.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Department of Hematology, CHU Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schlaifer', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Payen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laroche', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fournie', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mazieres', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pris', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Laurent', 'Affiliation': ''}]",Blood,[]
211,31551577,Transcutaneous electric nerve stimulation to treat patients with premature ejaculation: phase II clinical trial.,"A phase II single-arm trial was conducted from June 2017 to October 2018 to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for premature ejaculation (PE) treatment. Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome. TPTNS consisted of 30-min sessions of the application of 20 Hz with a pulse amplitude of 200 µsec. The intensity was adjusted based on individual sensibility. The participants received 3 weekly sessions for 12 consecutive weeks. Follow-up continued for 9 months after therapy completion. The main outcome was a threefold increase in the intravaginal ejaculation latency time (IELT) at week 12. Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12. The IELT increased 4.8-fold, 6.8-fold, and 5.4-fold at weeks 12, 24, and 48, respectively. One episode of constipation was reported, and one patient reported a sensation of heat in the leg during one therapy session. The findings suggest that TPTNS therapy delays ejaculation in patients with lifelong premature ejaculation, with no serious secondary effects. Controlled trials with larger sample sizes are needed to verify these results.",2020,"Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12.","['patients with lifelong premature ejaculation', 'Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome', 'premature ejaculation (PE) treatment', 'patients with premature ejaculation']","['Transcutaneous electric nerve stimulation', 'transcutaneous posterior tibial nerve stimulation (TPTNS']","['intravaginal ejaculation latency time (IELT', 'tripled baseline IELT scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0410765,"Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12.","[{'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Uribe', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Sandoval-Salinas', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Hector A', 'Initials': 'HA', 'LastName': 'Corredor', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Martínez', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Saffon', 'Affiliation': 'Boston Medical Group, Bogotá, Colombia. jsaffon@bostonmedical.com.co.'}]",International journal of impotence research,['10.1038/s41443-019-0196-x']
212,32421163,The Effects of Aerobic Exercise on Psychological Functioning in Family Caregivers: Secondary Analyses of a Randomized Controlled Trial.,"BACKGROUND


The responsibility and stress of being a family caregiver are associated with reduced physical and mental health.
PURPOSE


To examine whether a 24-week aerobic exercise program improves multiple aspects of psychological functioning in family caregivers.
METHODS


Family caregivers of patients with Alzheimer's disease and other dementias (n = 68) were recruited and randomized into either an aerobic exercise group (n = 34) or a waitlist control group (n = 34). The exercise group was assigned a 24-week aerobic training program that incrementally increased the intensity, duration, and frequency of the exercise program until 150 min of moderate to vigorous activity were completed per week by the ninth week. Twelve measures of psychological functioning were administered at baseline and compared with responses completed following the intervention.
RESULTS


Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] = [-8.82, -0.38], RLMM2 = 0.11) and depression (β = -2.59, 95% CI = [-4.79, -0.38], RLMM2 = 0.13), as well as increases in mastery (β = 1.78, 95% CI = [0.09, 3.46], RLMM2 = .04) in the exercise intervention group compared to the control group.
CONCLUSION


Family caregivers report high levels of depression and caregiver burden. Engagement in a 24-week exercise intervention can ameliorate the perceived burden of caregiving, symptoms of depression, and their sense of mastery.",2021,"Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] =","['family caregivers', ""Family caregivers of patients with Alzheimer's disease and other dementias (n = 68"", 'Family Caregivers']","['aerobic exercise program', 'exercise intervention', 'Aerobic Exercise', 'waitlist control group', 'aerobic training program', 'aerobic exercise']","['caregiver burden', 'psychological functioning', 'RLMM2 = 0.11) and depression', 'perceived burden of caregiving, symptoms of depression, and their sense of mastery', 'Psychological Functioning']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C4517425', 'cui_str': '0.11'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",68.0,0.0947633,"Multilevel modeling revealed significant decreases in caregiver burden (β = -4.60, 95% confidence interval [CI] =","[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Hives', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}, {'ForeName': 'E Jean', 'Initials': 'EJ', 'LastName': 'Buckler', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Population Studies Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schilf', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Department of Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'School of Kinesiology, University of British Columbia, University Boulevard, Vancouver, BC, Canada.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa031']
213,31786163,Phase I/II open-label trial of intravenous allogeneic mesenchymal stromal cell therapy in adults with recessive dystrophic epidermolysis bullosa.,"BACKGROUND


Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary blistering disorder due to a lack of type VII collagen. At present, treatment is mainly supportive.
OBJECTIVES


To determine whether intravenous allogeneic bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs) are safe in RDEB adults and if the cells improve wound healing and quality of life.
METHODS


We conducted a prospective, phase I/II, open-label study recruiting 10 RDEB adults to receive 2 intravenous infusions of BM-MSCs (on day 0 and day 14; each dose 2-4 × 10 6  cells/kg).
RESULTS


BM-MSCs were well tolerated with no serious adverse events to 12 months. Regarding efficacy, there was a transient reduction in disease activity scores (8/10 subjects) and a significant reduction in itch. One individual showed a transient increase in type VII collagen.
LIMITATIONS


Open-label trial with no placebo.
CONCLUSIONS


MSC infusion is safe in RDEB adults and can have clinical benefits for at least 2 months.",2020,"Regarding efficacy, there was transient reduction in disease activity scores (8 of 10 subjects) and significant reduction in itch.","['10 RDEB adults', 'adults with recessive dystrophic epidermolysis bullosa']","['intravenous allogeneic mesenchymal stromal cell therapy', 'intravenous infusions of BM-MSCs', 'placebo', 'intravenous allogeneic bone marrow-derived mesenchymal stromal/stem cells (BM-MSC', 'MSC infusion']","['disease activity scores', 'transient increase in C7', 'wound healing and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079474', 'cui_str': 'Hallopeau-Siemens Disease'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0034380'}]",,0.0278886,"Regarding efficacy, there was transient reduction in disease activity scores (8 of 10 subjects) and significant reduction in itch.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Rashidghamat', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Tendai', 'Initials': 'T', 'LastName': 'Kadiyirire', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Ayis', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Petrof', 'Affiliation': 'Department of Dermatology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Pullabhatla', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Chrysanthi', 'Initials': 'C', 'LastName': 'Ainali', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK; Dignosis Ltd, London, UK.""}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Guy', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Aristodemou', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McMillan', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ozoemena', 'Affiliation': ""The Robin Eady National Diagnostic Epidermolysis Bullosa Laboratory, Viapath, Guy's Hospital, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mee', 'Affiliation': ""Immunodermatology Laboratory, Viapath, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Rashida', 'Initials': 'R', 'LastName': 'Pramanik', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Alka', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rosamund', 'Initials': 'R', 'LastName': 'Nuamah', 'Affiliation': ""UK NIHR GSTFT/KCL Comprehensive Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'de Rinaldis', 'Affiliation': 'I&I Precision Immunology, Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Serrano', 'Affiliation': ""Clinical Trial Management Research Platform, NIHR Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Maurin', 'Affiliation': ""Clinical Trial Management Research Platform, NIHR Biomedical Research Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Martinez-Queipo', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Su M', 'Initials': 'SM', 'LastName': 'Lwin', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Dusko', 'Initials': 'D', 'LastName': 'Ilic', 'Affiliation': ""Stem Cell Laboratories, Guy's Assisted Conception Unit, Department of Women & Children's Health, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Department of Dermatology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Dazzi', 'Affiliation': ""Department of Haematological Medicine, The Rayne Institute, King's College London, London, UK.""}, {'ForeName': 'Ineke', 'Initials': 'I', 'LastName': 'Slaper-Cortenbach', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Westinga', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Zeddies', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van den Broek', 'Affiliation': 'Cell Therapy Facility, Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Onoufriadis', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Jemima E', 'Initials': 'JE', 'LastName': 'Mellerio', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'McGrath', 'Affiliation': ""St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK. Electronic address: john.mcgrath@kcl.ac.uk.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.11.038']
214,1688495,Prognostic factors in childhood T-cell acute lymphoblastic leukemia: a Pediatric Oncology Group study.,"Two hundred fifty-three children with newly diagnosed T-cell acute lymphoblastic leukemia (ALL), who were treated uniformly with modified LSA2L2 therapy, were evaluated using univariate and recursive partition analyses to define clinical or biologic features associated with risk of treatment failure. Overall event-free survival (EFS) at 4 years was 43% (SE = 4%). Factors examined included white blood cell (WBC) level, age, gender, race (black v other), presence of a mediastinal mass, hepatomegaly, splenomegaly, marked lymphadenopathy, hemoglobin level, platelet count, blast cell expression of antigens such as the common acute lymphoblastic leukemia antigen (CALLA, CD10), HLA-DR, and T-cell-associated antigens (CD3, CD4, CD8, CD7, CD5, and THY). Univariate analysis showed that age less than or equal to 5 or less than or equal to 7 years, WBC level less than 10, less than 25, less than 50 or less than 100 x 10(3)/microL, and blast cell expression of CD4, CD8, or CALLA were associated with significantly better EFS, while hepatomegaly and splenomegaly were associated with worse EFS. Recursive partitioning analysis showed that the most important single favorable prognostic factor was a WBC level less than 50 x 10(3)/microL and, for patients with WBC counts below this level, the most important predictor of EFS was blast cell expression of the pan-T antigen defined by the monoclonal antibody (MoAb), L17F12 (CD5). For patients with higher WBC levels, the most important predictor of EFS was blast cell expression of THY antigen. The recursive partitioning analysis defined three groups of patients with widely varied prognoses identified as follows: (1) those with a WBC count less than 50 x 10(3)/microL who lacked massive splenomegaly and had blasts expressing CD5 had the best prognosis (66%, SE = 7%, EFS 4 years, n = 84); (2) those with (b1) WBC counts less than 50 x 10(3)/microL with either massive splenomegaly or who had blasts lacking CD5 expression, or (b2) WBC counts greater than 50 x 10(3)/microL with expression of the THY antigen had an intermediate prognosis (39%, SE = 7% EFS at 4 years, n = 94); (3) those with WBC counts greater than 50 x 10(3)/microL and whose blasts lacked expression of THY antigen had the poorest outcome (EFS = 19% at 4 years, SE = 8%, n = 63). A three-way comparison of EFS according to these groupings showed significant differences among the three patient groups (P less than .001). The recursive partitioning was able to classify 241 (95%) of the patients.(ABSTRACT TRUNCATED AT 400 WORDS)",1990,Overall event-free survival (EFS) at 4 years was 43% (SE = 4%).,"['Two hundred fifty-three children with newly diagnosed T-cell acute lymphoblastic leukemia (ALL', 'childhood T-cell acute lymphoblastic leukemia', 'patients with widely varied prognoses identified as follows: (1) those with a WBC count less than 50']",['modified LSA2L2 therapy'],"['blast cell expression of CD4, CD8, or CALLA', 'WBC counts', 'white blood cell (WBC) level, age, gender, race (black v other), presence of a mediastinal mass, hepatomegaly, splenomegaly, marked lymphadenopathy, hemoglobin level, platelet count, blast cell expression of antigens such as the common acute lymphoblastic leukemia antigen (CALLA, CD10), HLA-DR', 'Overall event-free survival (EFS', 'WBC level']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961099', 'cui_str': 'Leukemia, Lymphocytic, Acute, T-Cell'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0368761', 'cui_str': 'Blast cell (cell)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0331463', 'cui_str': 'Calla Plant'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0240318', 'cui_str': 'Mediastinal mass'}, {'cui': 'C0019209', 'cui_str': 'Enlarged Liver'}, {'cui': 'C0038002', 'cui_str': 'Enlarged Spleen'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0497156', 'cui_str': 'Adenopathy'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",253.0,0.0172623,Overall event-free survival (EFS) at 4 years was 43% (SE = 4%).,"[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Shuster', 'Affiliation': 'University of Florida, POG Statistical Office, Gainesville.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Falletta', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Pullen', 'Affiliation': ''}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Crist', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Dowell', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Wharam', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borowitz', 'Affiliation': ''}]",Blood,[]
215,3742049,"Effect of danazol on clotting factor levels, bleeding incidence, factor infusion requirements, and immune parameters in hemophilia.","Several recent studies have reported conflicting results on the effectiveness of danazol, an attenuated androgen, in raising plasma levels of clotting factors VIII and IX in patients with hemophilia. We undertook a randomized, double-blind cross-over trial using 8 weeks' administration of danazol (D), 600 mg/d, and 8 weeks' administration of placebo (P) separated by 2 weeks of rest in 12 patients with hemophilia A and four patients with hemophilia B. Plasma factor VIII and IX levels, frequency and type of bleeding episodes, amount of factor concentrate infused, fibrinogen, fibrinolysis assays, antithrombin III, liver function, and immune parameters were followed. During the danazol phase a minimal increase was noted in the average clotting factor levels, an increase that, although statistically significant, was of hemostatically marginal magnitude. Significant increases in protein C and plasminogen levels, however, were observed during the danazol period, suggestive of danazol-mediated enhanced fibrinolysis. Clinically, bleeding frequency was significantly increased, and more clotting factor was consumed during the danazol period. Furthermore, eight episodes of hematuria and oral mucosal bleeding was reported during the danazol phase in contrast to only one episode of hematuria during the placebo phase, consistent with an enhancement of fibrinolytic activity with danazol. We conclude that danazol does not have a hemostatically significant effect on plasma levels of factor VIII and IX but may be associated with enhancement of fibrinolytic activity, resulting in increased bleeding frequency and requiring more clotting factor infusions. Therefore, danazol is not a viable alternative in the treatment of hemophilia.",1986,"We conclude that danazol does not have a hemostatically significant effect on plasma levels of factor VIII and IX but may be associated with enhancement of fibrinolytic activity, resulting in increased bleeding frequency and requiring more clotting factor infusions.","['12 patients with hemophilia A and four patients with hemophilia B. Plasma factor VIII and IX levels, frequency and type of bleeding episodes', 'patients with hemophilia', 'hemophilia']","['danazol (D', 'placebo', 'danazol']","['fibrinolytic activity', 'plasma levels of factor VIII and IX', 'protein C and plasminogen levels', 'bleeding frequency', 'clotting factor', 'fibrinogen, fibrinolysis assays, antithrombin III, liver function, and immune parameters', 'hematuria and oral mucosal bleeding', 'average clotting factor levels', 'clotting factor levels, bleeding incidence, factor infusion requirements, and immune parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019069', 'cui_str': 'Classic Hemophilia'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]","[{'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0611128', 'cui_str': 'protein C (synaptosomal)'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005789', 'cui_str': 'Clotting Factors'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2748540', 'cui_str': 'Mucosal bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]",12.0,0.0356688,"We conclude that danazol does not have a hemostatically significant effect on plasma levels of factor VIII and IX but may be associated with enhancement of fibrinolytic activity, resulting in increased bleeding frequency and requiring more clotting factor infusions.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Saidi', 'Affiliation': ''}, {'ForeName': 'B Z', 'Initials': 'BZ', 'LastName': 'Lega', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Raska', 'Affiliation': ''}]",Blood,[]
216,25616647,"A randomised, open label phase III trial with nimotuzumab, an anti-epidermal growth factor receptor monoclonal antibody in the treatment of newly diagnosed adult glioblastoma.","PURPOSE


A randomised, open label phase III trial was conducted to evaluate efficacy of nimotuzumab, a monoclonal antibody against epidermal growth factor receptor (EGF-R) added to standard therapy for newly diagnosed glioblastoma.
PATIENTS AND METHODS


149 glioblastoma patients stratified as with or without residual tumour were randomly assigned to receive either intravenous nimotuzumab 400mg weekly added to standard radiochemotherapy followed by 400mg biweekly after twelve weeks or standard radiochemotherapy. Progression status after 52 weeks (12moPFS) and progression-free survival (PFS) based on Macdonald criteria were co-primary and overall survival (OS), toxicity and quality of life secondary end-points.
RESULTS


142 patients were evaluated for efficacy (per protocol cohort). 12 moPFS was 25.6% in the experimental arm and 20.3% in the control group. In residual tumour patients (n=81) median PFS was 5.6 versus 4.0 months, (hazard ratio (HR), 0.87; 95% confidence interval (CI), 0.55-1.37), for patients without residual tumour (n=61) it was 10.6 versus 9.9 months, (HR, 1.01; 95% CI, 0.57-1.77). Median OS in patients with residual tumour was 19.5 versus 16.7 months, (HR, 0.90; 95% CI, 0.52-1.57; P=0.7061), for patients without 23.3 versus 21.0 months (HR, 0.77; 95% CI, 0.41-1.44; P=0.4068). A small cohort of MGMT non-methylated patients with residual tumour showed PFS of 6.2 versus 4.0 months (HR, 0.77; 95% CI, 0.35-1.67; P=0.4997) and OS of 19.0 versus 13.8 months (HR, 0.66; 95% CI, 0.27-1.64; P=0.3648). EGF-R amplification did not correlate with clinical efficacy of nimotuzumab. Nimotuzumab was well tolerated.
CONCLUSION


This study, albeit negative, contains hypothesis generating signals supporting evaluation of correlative, efficacy-predicting tumour parameters for nimotuzumab in the treatment of glioblastoma.",2015,"Median OS in patients with residual tumour was 19.5 versus 16.7 months, (HR, 0.90; 95% CI, 0.52-1.57; P=0.7061), for patients without 23.3 versus 21.0 months (HR, 0.77; 95% CI, 0.41-1.44; P=0.4068).","['newly diagnosed adult glioblastoma', '149 glioblastoma patients stratified as with or without residual tumour', 'newly diagnosed glioblastoma', '142 patients', 'patients without residual tumour (n=61']","['intravenous nimotuzumab 400mg weekly added to standard radiochemotherapy followed by 400mg biweekly after twelve weeks or standard radiochemotherapy', 'nimotuzumab, an anti-epidermal growth factor receptor monoclonal antibody', 'Nimotuzumab', 'nimotuzumab, a monoclonal antibody against epidermal growth factor receptor (EGF-R']","['median PFS', 'tolerated', 'Median OS', 'overall survival (OS), toxicity and quality of life secondary end-points', 'progression-free survival (PFS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumor'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1570308', 'cui_str': 'nimotuzumab'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",142.0,0.155694,"Median OS in patients with residual tumour was 19.5 versus 16.7 months, (HR, 0.90; 95% CI, 0.52-1.57; P=0.7061), for patients without 23.3 versus 21.0 months (HR, 0.77; 95% CI, 0.41-1.44; P=0.4068).","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Westphal', 'Affiliation': 'Department of Neurosurgery, University Hospital Hamburg Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: westphal@uke.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Heese', 'Affiliation': 'Department of Neurosurgery, University Hospital Hamburg Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany. Electronic address: oliver.heese@helios-kliniken.de.'}, {'ForeName': 'Joachim P', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Schleusenweg 2-16, 60528 Frankfurt am Main, Germany. Electronic address: joachim.steinbach@med.uni-frankfurt.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Department of Neurosurgery, Ludwig Maximilian University München-Grosshadern, Marchioninistrasse 15, 81377 München, Germany. Electronic address: oliver.schnell@med.uni-muenchen.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schackert', 'Affiliation': 'Department of Neurosurgery, Carus University Dresden, Fetscherstrasse 74, 01307 Dresden, Germany. Electronic address: gabriele.schackert@uniklinikum-dresden.de.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Mehdorn', 'Affiliation': 'Department of Neurosurgery, Christian Albrecht Universität Kiel, Schittenhelmstrasse 10, 24106 Kiel, Germany. Electronic address: maximilian.mehdorn@uksh.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schulz', 'Affiliation': 'Department of Neurosurgery, Justus Liebig University Giessen, Klinikstrasse 33, 35392 Gießen, Germany. Electronic address: dirk.schulz@neuro.med.uni-giessen.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, University Hospital Bonn, Sigmund-Freud Strasse 25, 53105 Bonn, Germany. Electronic address: matthias.simon@ukb.uni-bonn.de.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schlegel', 'Affiliation': 'Department of Neurology, Ruhr Universität Bochum, In der Schornau 23-25, 44892 Bochum, Germany. Electronic address: uwe.schlegel@kk-bochum.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Senft', 'Affiliation': 'Department of Neurosurgery, University Hospital Frankfurt, Schleusenweg 2-16 (Haus 95), 60528 Frankfurt am Main, Germany. Electronic address: c.senft@med.uni-frankfurt.de.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Geletneky', 'Affiliation': 'Department of Neurosurgery, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany. Electronic address: karsten.geletneky@med.uni-heidelberg.de.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Braun', 'Affiliation': 'Department of Neurology, University Hospital Tübingen, Hoppe-Seyler-Strasse 3, 72076 Tübingen, Germany. Electronic address: christian.braun@medizin.uni-tuebingen.de.'}, {'ForeName': 'Joachim G', 'Initials': 'JG', 'LastName': 'Hartung', 'Affiliation': 'Universität Dortmund, Fachbereich Statistik, 44221 Dortmund, Germany. Electronic address: jghartung@aol.com.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Reuter', 'Affiliation': 'Oncoscience AG, Wedel, Hafenstrasse 32, 22880 Wedel, Germany. Electronic address: d.reuter@oncoscience-ag.de.'}, {'ForeName': 'Monika Warmuth', 'Initials': 'MW', 'LastName': 'Metz', 'Affiliation': 'Department of Neuroradiology, University Hospital Würzburg, Josef-Schneiderstrasse 11, 97080 Würzburg, Germany. Electronic address: warmuth-metz@neuroradiologie.uni-wuerzburg.de.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Bach', 'Affiliation': 'Oncoscience AG, Wedel, Hafenstrasse 32, 22880 Wedel, Germany. Electronic address: f.bach@oncoscience-ag.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Pietsch', 'Affiliation': 'Institute for Neuropathology, University Hospital Bonn, Sigmund-Freud Strasse 25, 53105 Bonn, Germany. Electronic address: t-pietsch@uni-bonn.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2014.12.019']
217,31289879,"Comments on ""Photobiomodulation Improved the First Stages of Wound Healing Process After Abdominoplasty: An Experimental, Double-Blinded, Non-randomized Clinical Trial"".",,2021,,[],[],[],[],[],[],,0.47501,,"[{'ForeName': 'Dong-Xiao', 'Initials': 'DX', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound Diagnosis, The Affiliated Hospital of Jiangnan University, Wuxi, 214041, China.'}, {'ForeName': 'Feng-Lai', 'Initials': 'FL', 'LastName': 'Yuan', 'Affiliation': 'Department of Ultrasound Diagnosis, The Affiliated Hospital of Jiangnan University, Wuxi, 214041, China. bjjq88@163.com.'}, {'ForeName': 'Zi-Li', 'Initials': 'ZL', 'LastName': 'Sun', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing, 210023, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Yangzhou University, Yangzhou, 225000, Jiangsu, China.'}, {'ForeName': 'Si-Yu', 'Initials': 'SY', 'LastName': 'Liu', 'Affiliation': 'Nanjing University of Chinese Medicine, Nanjing, 210023, Jiangsu, China.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01438-x']
218,32421193,Ethnic Differences in Experimental Pain Responses Following a Paired Verbal Suggestion With Saline Infusion: A Quasiexperimental Study.,"BACKGROUND


Ethnic differences in placebo and nocebo responses are an important, yet underresearched, patient factor that might contribute to treatment disparities.
PURPOSE


The purpose of this study was to examine ethnic differences in pain trajectories following a verbal suggestion paired with a masked, inert substance (i.e., saline).
METHODS


Using a quasiexperimental design, we examined differences between 21 non-Hispanic Black (NHB) participants and 20 non-Hispanic White (NHW) participants in capsaicin-related pain rating trajectories following a nondirectional verbal suggestion + saline infusion. All participants were told that the substance would ""either increase pain sensation, decrease it, or leave it unchanged."" A spline mixed model was used to quantify the interaction of ethnicity and time on ratings.
RESULTS


There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion. Sensitivity analyses showed no change in primary results based on differences in education level, general pain sensitivity, or condition order.
CONCLUSIONS


The present results showed ethnic differences in pain response trajectories following a verbal suggestion + saline infusion and suggest that future research rigorously examining possible ethnic differences in placebo/nocebo responses is warranted.",2021,"There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion.",['21 non-Hispanic Black (NHB) participants and 20 non-Hispanic White (NHW) participants in capsaicin-related pain rating trajectories following a'],"['nondirectional verbal suggestion + saline infusion', 'verbal suggestion paired with a masked, inert substance (i.e., saline', 'placebo']","['Experimental Pain Responses', 'pain response trajectories', 'pain sensation', 'pain', 'education level, general pain sensitivity, or condition order', 'pain trajectories']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",,0.251549,"There was a significant Ethnicity × Time interaction effect (β = -0.28, p = .002); NHB individuals reported significantly greater increases in pain following, but not before, the verbal suggestion + saline infusion.","[{'ForeName': 'Janelle E', 'Initials': 'JE', 'LastName': 'Letzen', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}, {'ForeName': 'Troy C', 'Initials': 'TC', 'LastName': 'Dildine', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Chung Jung', 'Initials': 'CJ', 'LastName': 'Mun', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Nathan Shock Drive, Suite, Baltimore, MD, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa032']
219,32418143,"Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Dual antiplatelet therapy, aspirin and a P2Y 12  inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.
METHODS


This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix ®  (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel were calculated.
RESULTS


In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD W ) was at least 0.294 for acetylsalicylic acid C max , AUC last , and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
CONCLUSION


Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.
TRIAL REGISTRATION


CTR20181695.",2020,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","['171 healthy subjects', 'Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study', 'healthy Chinese subjects under fasting conditions', 'Chinese Subjects Under Fasting Conditions', 'healthy Chinese volunteers', 'Chinese male and female healthy volunteers']","['Clopidogrel plus acetylsalicylic acid combination', 'acetylsalicylic acid and 75\xa0mg clopidogrel', 'acetylsalicylic acid', 'acetylsalicylic acid and clopidogrel', 'aspirin', 'Clopidogrel Versus Enteric Aspirin', 'Co-Plavix ®  (test formulation- fixed-dose combination of 100\xa0mg acetylsalicylic acid and 75\xa0mg clopidogrel', 'Clopidogrel\u2009+\u2009acetylsalicylic acid']","['Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel', 'geometric mean ratios of clopidogrel C max , AUC last , and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0504812,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China. jie.hou@estartpoc.com.'}]",Advances in therapy,['10.1007/s12325-020-01369-z']
220,1688499,"A randomized, placebo-controlled trial of intravenous gammaglobulin in alloimmunized thrombocytopenic patients.","In a placebo-controlled, randomized blinded study, we evaluated the efficacy of intravenous gammaglobulin (IV-IgG) in alloimmunized thrombocytopenic patients. IV-IgG was administered at a dose of 400 mg/kg for 5 days. An incompatible platelet transfusion from the same donor was used before and after treatment. Seven patients received IV-IgG and five patients received placebo. Although platelet recovery in 1 to 6 hours was satisfactory in five patients after IV-IgG treatment, 24-hour survival was not improved in most patients. None of the patients receiving the placebo achieved satisfactory 1-hour platelet-corrected count increments (CCIs). By t test, the posttreatment mean values 1 hour after transfusion CCIs in the IV-IgG group were significantly greater than in the control group (8,413 v 1,050, P less than .007). Using a regression model to adjust for any distributional assumptions of the study population, the parameter estimate for IV-IgG treatment was positive, indicating that IV-IgG treatment is associated with higher CCIs. Although IV-IgG may improve 1-hour platelet recovery, clinical benefit was not demonstrated since 24-hour survival was not improved. IV-IgG treatment before unmatched platelet transfusions should not be considered as a replacement for HLA-compatible platelets in alloimmunized patients.",1990,None of the patients receiving the placebo achieved satisfactory 1-hour platelet-corrected count increments (CCIs).,['alloimmunized thrombocytopenic patients'],"['intravenous gammaglobulin', 'placebo', 'intravenous gammaglobulin (IV-IgG']","['platelet recovery', '24-hour survival', 'satisfactory 1-hour platelet-corrected count increments (CCIs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.251118,None of the patients receiving the placebo achieved satisfactory 1-hour platelet-corrected count increments (CCIs).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kickler', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD 21205.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Braine', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piantadosi', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Ness', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Herman', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rothko', 'Affiliation': ''}]",Blood,[]
221,32421603,Efficacy and cost-effectiveness of intensive short-term dynamic psychotherapy for treatment resistant depression: 18-Month follow-up of the Halifax depression trial.,"BACKGROUND


Depressed patients with chronic and complex health issues commonly relapse; therefore, examining longer-term outcomes is an important consideration. For treatment resistant depression (TRD), the post-treatment efficacy of time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP) has been demonstrated but longer-term outcomes and cost-effectiveness are unclear.
METHOD


In this superiority trial, 60 patients referred to Community Mental Health Teams (CMHT) were randomised to 2 groups (ISTDP=30 and CMHT=30). The primary outcome was Hamilton Depression Rating scale (HAM-D) scores at 18 months. Secondary outcomes included Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission. A health economic evaluation examined mental health costs with quality-adjusted life years (QALYs).
RESULTS


Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up. Group differences in depression were in the moderate to large range on both the observer rated (Cohen's d = .64) and self-report measures (Cohen's d = .70). At 18 months follow-up the remission rate in ISTDP patients was 40.0%, and 23.4% had discontinued antidepressants. Health economic analysis suggests that ISTDP was more cost-effective than CMHT at 18 months. Probabilistic analysis suggests that there is a 64.5% probability of ISTDP being cost-effective at a willingness to pay for a QALY of $25,000 compared to CMHT at 18 months.
LIMITATIONS


Replication of these findings is necessary in larger samples and future cost analyses should also consider indirect costs.
CONCLUSIONS


ISTDP demonstrates long-term efficacy and cost-effectiveness in TRD.",2020,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,['60 patients referred to Community Mental Health Teams (CMHT'],"['ISTDP', 'intensive short-term dynamic psychotherapy', 'time-limited Intensive Short-Term Dynamic Psychotherapy (ISTDP']","['Hamilton Depression Rating scale (HAM-D) scores', 'Efficacy and cost-effectiveness', 'Patient Health Questionnaire (PHQ-9) depression scores and dichotomous measure remission', 'remission rate', 'depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",60.0,0.0697056,Statistically significant treatment differences in depression previously found at 6 months favouring ISTDP were maintained at 18-month follow-up.,"[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada. Electronic address: joel.town@dal.ca.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'The Institute of Work Psychology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry & Faculty of Computer Science, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Bernier', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berrigan', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.04.035']
222,32421612,Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.,"INTRODUCTION


Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up.
METHODS


Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period.
RESULTS


Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms.
LIMITATIONS


As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors.
CONCLUSION


MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.",2020,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","['patients with recurrent or chronic depression', 'recurrent depression', 'recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up', 'Patients were recruited between July 2013 and December 2014 (N\xa0=\xa0122']","['MBCL', 'TAU', 'mindfulness-based compassionate living (MBCL', 'intervention', 'Mindfulness-Based Cognitive Therapy (MBCT', 'mindfulness-based compassionate living compared with treatment-as-usual']","['depressive symptoms', 'severity of depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0570495,"MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61).","[{'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Schuling', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands. Electronic address: rhoda.schuling@radboudumc.nl.'}, {'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hiske', 'Initials': 'H', 'LastName': 'van Ravesteijn', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Health Technology Assessment, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cillessen', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kuyken', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Speckens', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.182']
223,2224121,Pharmacokinetics and effects of recombinant human erythropoietin after intravenous and subcutaneous injections in healthy volunteers.,"A double-blind, placebo-controlled study of the pharmacokinetics and safety of multiple doses of recombinant human erythropoietin [rHuEPO 150 or 300 U/kg either by intravenous (IV) bolus or subcutaneously (SC)] in normal male subjects demonstrated that rHuEPO had a dose-related effect on the hematocrit independent of the route of administration and that multiple doses of rHuEPO had no direct pressor effects. When rHuEPO was injected IV, a monoexponential decrease in serum EPO level was evident for 18 to 24 hours postdose. Absorption of SC injected rHuEPO occurred more slowly, with relatively low serum EPO levels being maintained for 48 hours. All rHuEPO antibody titer determinations were negative. With the exception of significant increases in hemoglobin and hematocrit, no clinically significant changes occurred. No hypertensive, convulsive, or thrombotic events were observed. Of the adverse experiences observed in 10 subjects, none was considered clinically significant, and none of the subjects dropped out because of adverse experiences.",1990,"With the exception of significant increases in hemoglobin and hematocrit, no clinically significant changes occurred.","['normal male subjects', 'healthy volunteers']","['placebo', 'recombinant human erythropoietin', 'recombinant human erythropoietin [rHuEPO 150 or 300 U/kg either by intravenous (IV) bolus or subcutaneously (SC']","['Absorption of SC injected rHuEPO', 'low serum EPO levels', 'hemoglobin and hematocrit', 'serum EPO level', 'hypertensive, convulsive, or thrombotic events']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.065401,"With the exception of significant increases in hemoglobin and hematocrit, no clinically significant changes occurred.","[{'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'McMahon', 'Affiliation': 'Clinical Research Center, New Orleans, LA 70112.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vargas', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': ''}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Abels', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Perry', 'Affiliation': ''}, {'ForeName': 'I L', 'Initials': 'IL', 'LastName': 'Smith', 'Affiliation': ''}]",Blood,[]
224,1586708,"Immunosuppressive therapy of aplastic anemia: results of a prospective, randomized trial of antithymocyte globulin (ATG), methylprednisolone, and oxymetholone to ATG, very high-dose methylprednisolone, and oxymetholone.","Sixty-eight patients with moderate (n = 15) or severe (n = 53) aplastic anemia were entered into a prospective, randomized, two-arm treatment study comparing antihuman thymocyte globulin (ATG), lower-dose methylprednisolone (LDM) and oxymetholone to ATG, higher-dose methylprednisolone (HDM), and oxymetholone. There were no differences between the two groups when comparing age, sex, etiology of aplasia, disease duration, severity of aplasia, or pretherapy granulocyte counts. Side effects of LDM and HDM were similar. Of the 64 patients evaluable for response to therapy, 12 of 33 (36%) who received LDM had complete, partial, or minimal responses compared with 15 of 31 patients (48%) who received HDM (P = .33). Actuarial survival at 4 years is 43% for patients in the LDM group and 47% for patients in the HDM group (P = .99). Causes of death included hemorrhage, infection, evolution to acute leukemia, and complications of subsequent bone marrow transplantation. Long-term complications included paroxysmal nocturnal hemoglobinuria (n = 3), evolution to myelodysplasia or acute leukemia (n = 6), and recurrent aplasia (n = 6). We were unable to show a significant difference in toxicity, response rate, or survival for patients treated with ATG, oxymetholone, and LDM compared with patients who received ATG, oxymetholone, and HDM.",1992,"There were no differences between the two groups when comparing age, sex, etiology of aplasia, disease duration, severity of aplasia, or pretherapy granulocyte counts.","['aplastic anemia', 'Sixty-eight patients with moderate (n = 15) or severe (n = 53) aplastic anemia']","['methylprednisolone, and oxymetholone', 'antithymocyte globulin (ATG), methylprednisolone, and oxymetholone to ATG', 'antihuman thymocyte globulin (ATG), lower-dose methylprednisolone (LDM) and oxymetholone to ATG, higher-dose methylprednisolone (HDM), and oxymetholone', 'LDM', 'Immunosuppressive therapy']","['sex, etiology of aplasia, disease duration, severity of aplasia, or pretherapy granulocyte counts', 'Actuarial survival', 'paroxysmal nocturnal hemoglobinuria (n = 3), evolution to myelodysplasia or acute leukemia', 'toxicity, response rate, or survival', 'hemorrhage, infection, evolution to acute leukemia, and complications of subsequent bone marrow transplantation']","[{'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0814999', 'cui_str': 'Thymic lymphocyte (cell)'}, {'cui': 'C0017649', 'cui_str': 'Globulins'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count (procedure)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]",68.0,0.109772,"There were no differences between the two groups when comparing age, sex, etiology of aplasia, disease duration, severity of aplasia, or pretherapy granulocyte counts.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA 98104.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pepe', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': ''}]",Blood,[]
225,1536959,Recombinant human granulocyte-macrophage colony-stimulating factor accelerates neutrophil and monocyte recovery after allogeneic T-cell-depleted bone marrow transplantation.,"In a prospective randomized study, five European transplant centers compared recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; mammalian glycosylated) with placebo. rhGM-CSF was administered in a dose of 8 micrograms glycoprotein (5.5 micrograms protein)/kg/d, as a continuous intravenous (IV) infusion for 14 days, starting 3 hours after bone marrow infusion. Fifty-seven patients entered and completed the study. Median age of the recipients was 34 years (range, 17 to 51 y). All donors were HLA-identical, MLC-nonreactive siblings. Marrow grafts were depleted of T lymphocytes either by counterflow centrifugation (n = 42) or by immunological methods (n = 15). Twenty-nine patients received rhGM-CSF and 28 patients placebo. The leukocyte count and the absolute neutrophil count were significantly higher in the rhGM-CSF-treated group from day +9 to day +14 after bone marrow transplantation (BMT). This was also true for the monocyte count from day +12 to day +21. Early neutrophil (greater than 0.1 and greater than 0.3 x 10(9)/L) and early leukocyte (greater than 0.3 and greater than 0.5 x 10(9)/L) recovery was significantly faster for the patients given GM-CSF. The incidences of graft-versus-host disease (GVHD) and transplant-related mortality were not different in both groups. However, the number of bronchopneumonias was significantly lower in the rhGM-CSF-treated group (P = .03). Long-term follow-up showed a trend to better overall disease-free survival at 2 years and a trend to a lower relapse risk in patients treated with rhGM-CSF. This study shows that rhGM-CSF significantly increases neutrophil and monocyte counts during periods of 6 to 10 days in the second and third week after BMT. This shortened period until myeloid cell recovery after transplantation resulted in a decreased number of pneumonias, without an increase in incidence of GVHD or relapse.",1992,The incidences of graft-versus-host disease (GVHD) and transplant-related mortality were not different in both groups.,"['Median age of the recipients was 34 years (range, 17 to 51 y', 'Fifty-seven patients entered and completed the study']","['rhGM-CSF', 'placebo', 'recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; mammalian glycosylated) with placebo', 'glycoprotein', 'counterflow centrifugation', 'allogeneic T-cell-depleted bone marrow transplantation', 'Recombinant human granulocyte-macrophage colony-stimulating factor']","['leukocyte count and the absolute neutrophil count', 'early leukocyte', 'overall disease-free survival', 'Early neutrophil', 'incidence of GVHD or relapse', 'incidences of graft-versus-host disease (GVHD) and transplant-related mortality', 'number of bronchopneumonias', 'neutrophil and monocyte counts']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}]",5.0,0.0245622,The incidences of graft-versus-host disease (GVHD) and transplant-related mortality were not different in both groups.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'De Witte', 'Affiliation': 'Department of Internal Medicine, University Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Van Der Lely', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': ''}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Stern', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Speck', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schattenberg', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nissen', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gluckman', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Fibbe', 'Affiliation': ''}]",Blood,[]
226,32066599,Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study.,"INTRODUCTION


Type II endoleak (EL) is frequently seen after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) and is often considered responsible for aneurysm sac enlargement if it persists. In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres. At present, there is a lack of robust evidence to support the efficacy of pre-emptive embolisation of IMA on reduction of persistent type II EL with subsequent sac shrinkage.
METHOD AND ANALYSIS


This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation.
ETHICS AND DISSEMINATION


The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page.
TRIAL REGISTRATION NUMBER


UMIN000035502.",2020,"In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres.","['200 patients who have fusiform AAA ≥50\u2009mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a', 'Nara Medical University']","['pre-emptive inferior mesenteric artery embolisation', 'endovascular aneurysm repair (EVAR', 'endovascular aortic aneurysm repair', 'pre-emptive IMA embolisation group or non-embolisation control']","['freedom from sac enlargement', 'change of aneurysm sac volume', 'difference of aneurysm sac volume change assessed by CT scans', 'CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0162860', 'cui_str': 'Mesenteric Artery, Inferior'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0397942', 'cui_str': 'Aortic aneurysm repair (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",200.0,0.126967,"In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres.","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Ichihashi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan shigeoichivasc@gmail.com.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fujimura', 'Affiliation': 'Vascular Surgery, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Nagatomi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwakoshi', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bolstad', 'Affiliation': 'Clinical English, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Kimihiko', 'Initials': 'K', 'LastName': 'Kichikawa', 'Affiliation': 'Radiology, Nara Medical University, Kashihara, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-031758']
227,32127657,Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC).,"This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF ± chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 µg/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 µg/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.",2020,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"['children with cancer', 'pediatric patients with solid tumors eligible for autologous transplants', 'pediatric cancer patients']","['Plerixafor combined with standard regimens', 'Plerixafor', 'plerixafor']","['successful mobilization', 'successful mobilization (doubling of peripheral blood CD34+ cell count', 'Adverse events', 'dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor\u2009+\u2009standard mobilization', 'tolerated and efficacious']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",45.0,0.045626,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women's and Children's Hospital, Birmingham, UK. bruce.morland@nhs.net.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kepak', 'Affiliation': 'University Hospital Brno and ICRC/St. Anna University Hospital, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Dallorso', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sevilla', 'Affiliation': 'Hospital Infantil Universitario Niño Jesus, FIB HIUNJ, CIBERER, Madrid, Spain.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Royal Hospital for Children, Glasgow, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luksch', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Yaniv', 'Affiliation': ""Schneider Children's Medical Center of Israel, Tel Aviv University, Petah Tikva, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Universitätsklinikum Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Rößler', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Department for Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Maecker-Kolhoff', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'C Michel', 'Initials': 'CM', 'LastName': 'Zwaan', 'Affiliation': ""Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sumerauer', 'Affiliation': 'Faculty Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Kriván', 'Affiliation': 'United St Istvan and St Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bernard', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Doyle', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ""IRCCS Bambino Gesù Children's Hospital, Rome, Italy.""}]",Bone marrow transplantation,['10.1038/s41409-020-0836-2']
228,31934777,"Combined effect of Er,Cr:YSGG laser and casein phosphopeptide amorphous calcium phosphate on the prevention of enamel demineralization:  An in-vitro study .","OBJECTIVES


To compare the effect of use of laser, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), and their combination on prevention of enamel demineralization using polarized light microscopy to assess lesion depth.
MATERIALS AND METHODS


Eighty premolars were randomly allocated to four equal groups (n = 20): Group I: Control group, no preventive measures. Group II: CPP-ACP. Group III: Er,Cr:YSGG laser. Group IV: Er,Cr:YSGG laser followed by CPP-ACP. Specimens were subjected to thermocycling and brushing protocols equivalent to 1 year intraorally. Then, all teeth were subjected to acid challenge. Teeth were then sectioned longitudinally and examined under a polarized light microscope and lesion depth was measured.
RESULTS


Group IV resulted in the least lesion depth with a significant difference between it and all other groups. CPP-ACP alone and laser alone also showed a significant difference in white spot lesion (WSL) depth compared to the control group; however, no significant difference was found between them.
CONCLUSIONS


The combined use of laser and CPP-ACP showed the best prevention against WSL development. The use of CPP-ACP or laser alone also resulted in a significant reduction in lesion depth but was significantly less than their combined use, with no significant difference between them.",2020,"CPP-ACP alone and laser alone also showed a significant difference in white spot lesion (WSL) depth compared to the control group; however, no significant difference was found between them.
",['Eighty premolars'],"['Er,Cr:YSGG laser and casein phosphopeptide amorphous calcium phosphate', 'CPP-ACP alone and laser alone', 'laser, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP', 'laser and CPP-ACP', 'CPP-ACP or laser alone', 'Control group, no preventive measures', 'Er,Cr:YSGG laser followed by CPP-ACP', 'CPP-ACP']","['least lesion depth', 'white spot lesion (WSL) depth', 'lesion depth']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}]",,0.0264535,"CPP-ACP alone and laser alone also showed a significant difference in white spot lesion (WSL) depth compared to the control group; however, no significant difference was found between them.
","[{'ForeName': 'Samar M', 'Initials': 'SM', 'LastName': 'Adel', 'Affiliation': ''}, {'ForeName': 'Eiman S', 'Initials': 'ES', 'LastName': 'Marzouk', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'El-Harouni', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/032819-238']
229,3555650,A randomized prospective comparison of chemotherapy to total body irradiation as initial treatment for the indolent lymphoproliferative diseases.,"One hundred eight consecutive patients with indolent lymphoproliferative diseases were stratified into chronic lymphocytic leukemia (CLL), stage III and IV well-differentiated lymphocytic lymphoma (WDLL), and stage III and IV follicular lymphoma (FL). Within each stratum, patients were prospectively and randomly assigned to receive chemotherapy with chlorambucil and prednisone (CP) or fractionated total body irradiation (TBI). Morbidity from both regimens was negligible. Complete response (CR) was defined as the resolution of organ enlargement and the return of blood count to normal. The CR rate for the entire CP group (n = 54) was 59% and that for the TBI group (n = 54), 52%; median survivals were 53 and 57 months respectively. In the 41 patients with CLL the CR rate for CP (n = 17) was 47% and that for TBI (n = 24), 50%; the median survival for CP was 48 months, and for TBI it was 51 months. In the 21 patients with WDLL the CR rate for CP (n = 15) was 53% and that for TBI (n = 6), 67%; the median survival for CP was 42 months and has not yet been reached for TBI. For the 46 patients with FL the CR rate for CP (n = 22) was 72% and that for TBI (n = 24), 50%; the median survival was 55 months, and for TBI it was 56 months. None of the differences in CR or survival are statistically significant (P greater than .05). In these indolent lymphoproliferative diseases, CP and TBI are equally effective forms of initial treatment irrespective of the end point being defined as CR or survival.",1987,None of the differences in CR or survival are statistically significant (P greater than .05).,"['One hundred eight consecutive patients with indolent lymphoproliferative diseases were stratified into chronic lymphocytic leukemia (CLL), stage III and IV well-differentiated lymphocytic lymphoma (WDLL), and stage III and IV follicular lymphoma (FL', 'indolent lymphoproliferative diseases']","['chemotherapy to total body irradiation', 'chemotherapy with chlorambucil and prednisone (CP) or fractionated total body irradiation (TBI']","['median survival for CP', 'median survival', 'CR rate for CP', 'Complete response (CR', 'CR rate', 'CR or survival', 'Morbidity', 'median survivals']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024314', 'cui_str': 'Lymphoproliferative Disorders'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",108.0,0.0176528,None of the differences in CR or survival are statistically significant (P greater than .05).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'King', 'Affiliation': ''}]",Blood,[]
230,3165298,Interferon alpha-2b as therapy for Ph'-positive chronic myelogenous leukemia: a study of 82 patients treated with intermittent or daily administration.,"The authors treated a total of 82 patients with Ph'-positive chronic myelogenous leukemia (CML) with recombinant interferon alpha-2b (IFN alpha-2b). Sixty-five patients in chronic phase (CP), 28 of whom were untreated and 37 pretreated, and nine patients in accelerated phase (AP), were started on IFN three times a week. Patients in CP were randomized to receive 2 or 5 X 10(6) IU/m2, while patients in AP were all given the dose of 5 X 10(6) IU/m2, in addition to concomitant chemotherapy. Patients in CP who were unresponsive to the lower dose were crossed to the higher dose. Of 63 evaluable patients in CP, 43 (68%) responded, 29 (46%) achieved complete hematologic response (CHR), and 14 (22%) achieved partial hematologic response (PHR). The response rate appeared to be significantly influenced by the IFN dose in pretreated patients. Of the nine patients in AP, two attained PHR and one CHR. More recently, eight previously untreated CP cases were submitted to daily IFN administration at doses from 2 to 5 X 10(6) IU/m2. This daily schedule was also applied to patients who had obtained, with the intermittent treatment, a PHR persisting unmodified for six months (nine patients) or an unstable CHR (five patients). Seven of the eight previously untreated patients, and five of the nine PHR patients crossed to daily IFN reached CHR. In the total series of previously untreated patients, the response rate proved to be significantly influenced by the initial risk status. Cytogenetic improvement was seen in 37 of 53 responders (70%) treated for more than 3 months, the median of Ph'-positive cells declining from 100% to 65% (range 0% to 95%). Complete suppression of Ph' chromosome was observed in one case. The cytogenetic response was persistent for over 6 months in 21 patients, but the lowest value of Ph' positivity was usually unstable. At a median follow-up of 56 weeks, 23 of 36 (64%) CHR patients remain in continued disease control with IFN. A blastic transformation (BT) occurred in seven of 21 unresponsive patients and in one of the 36 CHR patients. The authors' data confirm that IFN alpha-2b, especially at daily doses, is effective in inducing clinical and cytogenetic response in a good proportion of patients with CML in the benign phase. Longer follow-ups will define the exact influence of this agent on the natural course of the disease.",1988,"Cytogenetic improvement was seen in 37 of 53 responders (70%) treated for more than 3 months, the median of Ph'-positive cells declining from 100% to 65% (range 0% to 95%).","['82 patients treated with intermittent or daily administration', 'Patients in CP', ""Ph'-positive chronic myelogenous leukemia"", ""82 patients with Ph'-positive chronic myelogenous leukemia (CML) with"", 'Sixty-five patients in chronic phase (CP), 28 of whom were untreated and 37 pretreated, and nine patients in accelerated phase (AP', 'patients who had obtained, with the intermittent treatment, a PHR persisting unmodified for six months (nine patients) or an unstable CHR (five patients']","['Interferon alpha-2b', 'recombinant interferon alpha-2b (IFN alpha-2b']","['complete hematologic response (CHR', 'response rate', 'partial hematologic response (PHR', 'daily IFN reached CHR', 'blastic transformation (BT', ""Complete suppression of Ph' chromosome"", 'cytogenetic response', 'Cytogenetic improvement', ""median of Ph'-positive cells""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0008633', 'cui_str': 'Chromosomes'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",82.0,0.0545067,"Cytogenetic improvement was seen in 37 of 53 responders (70%) treated for more than 3 months, the median of Ph'-positive cells declining from 100% to 65% (range 0% to 95%).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alimena', 'Affiliation': 'Department of Human Biopathology, University La Sapienza, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lazzarino', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Montefusco', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Inverardi', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bernasconi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Donti', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Grignani', 'Affiliation': ''}]",Blood,[]
231,32435908,Mechanical transnasal endoscopic dacryocystorhinostomy versus transcanalicular multidiode laser dacryocystorhinostomy: long-term results of a prospective study.,"The purpose of this study is to compare two dacryocystorhinostomy (DCR) techniques in epiphora treatment. This study is a prospective randomized trial. Twenty-nine patients presenting persistent epiphora due to primary acquired nasolacrimal duct obstruction (PANDO) were included in the study. Two groups each consisting of 15 eyes were formed. Mechanical transnasal endoscopic DCR (MTE-DCR) was applied to the first group, while transcanalicular dacryocystorhinostomy with multidiode laser (TCML-DCR) techniques is employed in the second group. Follow-up is conducted in the first day, first week, and first month of the dacryocystorhinostomy which is followed by 4-month follow-up period, and results were compared using statistical methods. The main outcome measures were the elimination of epiphora and unrestricted flow of irrigated saline to the nose. Seven patients were male, 22 were female, and the mean age was 39.3 ± 12.5 years. Mean follow-up times were 111.3 ± 10.5 months and 93 ± 2.9 months in group 1 and group 2, respectively. Complete resolution is achieved in group 1, whereas failures stemming from canalicular stenosis and fibrosis at osteotomy site are recorded in two cases in group 2. Occlusion occurred in the fifth month in both cases. Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483). MTE-DCR is a strong substitute for external DCR. Although TCML-DCR shows promising results, it is far away from becoming the gold standard technique in epiphora treatment.",2021,"Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483).","['epiphora treatment', 'Twenty-nine patients presenting persistent epiphora due to primary acquired nasolacrimal duct obstruction (PANDO) were included in the study', 'Seven patients were male, 22 were female, and the mean age was 39.3\u2009±\u200912.5\xa0years']","['Mechanical transnasal endoscopic dacryocystorhinostomy versus transcanalicular multidiode laser dacryocystorhinostomy', 'dacryocystorhinostomy with multidiode laser (TCML-DCR) techniques', 'TCML-DCR', 'Mechanical transnasal endoscopic DCR (MTE-DCR']","['long-term success rates', 'elimination of epiphora and unrestricted flow of irrigated saline to the nose', 'Occlusion', 'Complete resolution']","[{'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1282418', 'cui_str': 'Primary acquired nasolacrimal duct obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",29.0,0.0141454,"Thus, long-term success rates were 100% in the first and 86.6% in the second group (P = 0.483).","[{'ForeName': 'Hanife Tuba', 'Initials': 'HT', 'LastName': 'Akcam', 'Affiliation': 'Ophthalmology Department, Duzce University School of Medicine, 81620, Duzce, Turkey. hanifetuba@hotmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Konuk', 'Affiliation': 'Ophthalmology Department, Gazi University School of Medicine, Ankara, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-03038-7']
232,2153424,"R68070, a combined thromboxane/endoperoxide receptor antagonist and thromboxane synthase inhibitor, inhibits human platelet activation in vitro and in vivo: a comparison with aspirin.","We have investigated the effects of R68070 on platelet function in vitro and in vivo. The drug inhibits U46619-induced aggregation (IC50 = 1.2 x 10(-6) mol/L), blocks serum thromboxane formation (IC50 = 1 x 10(-7) mol/L), and increases serum prostaglandin (PG)E2 and 6-keto-PGF1 alpha levels, indicating that it combines thromboxane receptor blocking and thromboxane synthase inhibiting properties. The thromboxane-dependent aggregation of blood platelets is blocked by R68070, whereas no inhibition of thromboxane independent pathways occurs. A double-blind, randomized, cross-over study was performed on nine volunteers, comparing 400 mg placebo, 400 mg aspirin, and 400 mg R68070. Thromboxane-dependent aggregations were significantly inhibited by R68070 and by aspirin, the latter still having the most pronounced action. However, R68070 was clearly more powerful than aspirin (P less than .0005) in prolonging the bleeding time. Serum TxB2 formation was completely inhibited with both treatments, whereas serum 6-keto-PGF1 alpha and PGE2 and intralesional 6-keto-PGF1 alpha were inhibited after aspirin and stimulated after R68070. We conclude that R68070 inhibits platelet thromboxane synthase and its thromboxane receptor both in vitro and in vivo; local reorientation of cyclic endoperoxide metabolism toward prostacyclin induces a stronger inhibition of hemostasis than that produced by aspirin.",1990,"However, R68070 was clearly more powerful than aspirin (P less than .0005) in prolonging the bleeding time.",[],"['placebo', 'aspirin', 'thromboxane/endoperoxide receptor antagonist and thromboxane synthase inhibitor', 'aspirin, and 400 mg R68070']","['Serum TxB2 formation', 'blocks serum thromboxane formation', 'bleeding time', 'serum 6-keto-PGF1 alpha and PGE2 and intralesional 6-keto-PGF1 alpha', 'serum prostaglandin (PG)E2 and 6-keto-PGF1 alpha levels', 'Thromboxane-dependent aggregations']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0040060', 'cui_str': 'Thromboxane Synthetase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040059', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}, {'cui': 'C0000617', 'cui_str': '6-Oxoprostaglandin F1 alpha'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}]",9.0,0.0495272,"However, R68070 was clearly more powerful than aspirin (P less than .0005) in prolonging the bleeding time.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoet', 'Affiliation': 'Center for Thrombosis and Vascular Research, University of Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falcon', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'De Reys', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arnout', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Deckmyn', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vermylen', 'Affiliation': ''}]",Blood,[]
233,31785594,Neonatal encephalopathy therapy optimization for better neuroprotection with inhalation of CO 2 : the HENRIC feasibility and safety trial.,"BACKGROUND


There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO 2  and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia.
METHODS


Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO 2  and 95% air was administered through patient circuits if the temperature-corrected PCO 2  ≤40 mm Hg. The CO 2  inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased <5 mmol/L. Follow-up was performed using Bayley Scales of Infant Development II.
RESULTS


The patients spent a median 95.1% (range 44.6-98.5%) of time in the desired PCO 2  range (40-60 mm Hg) during the inhalation. All PCO 2  values were >40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%.
CONCLUSIONS


Our results suggest that inhaled 5% CO 2  administration is a feasible and safe intervention for correcting hypocapnia.",2020,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","['mechanically ventilated infants with NE undergoing therapeutic hypothermia', 'infants with neonatal encephalopathy (NE']",[],"['rate of moderate disabilities and normal outcome', 'safety and feasibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy (disorder)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.143105,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","[{'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Kovacs', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Unoke', 'Initials': 'U', 'LastName': 'Meder', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Bokodi', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Andorka', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lakatos', 'Affiliation': 'MR Research Centre, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Attila J', 'Initials': 'AJ', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jermendy', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary. jermendy.agnes@med.semmelweis-univ.hu.'}]",Pediatric research,['10.1038/s41390-019-0697-9']
234,3552076,Comparison of three remission induction regimens and two postinduction strategies for the treatment of acute nonlymphocytic leukemia: a cancer and leukemia group B study.,"Patients with acute nonlymphocytic leukemia were randomized to receive remission induction therapy consisting of seven days of cytosine arabinoside and three days of daunorubicin (""7 + 3"") or to receive the same regimen intensified by either the addition of 6-thioguanine or by extension of the administration of cytosine arabinoside to ten days. Additionally, all patients were randomized to receive or not to receive cotrimoxazole antibacterial prophylaxis during the remission induction phase. Neither an increase in intensity of chemotherapy nor the antibacterial prophylaxis increased the remission rate above the 53% for patients treated with the standard ""7 + 3"" regimen. The second part of this study addressed the issue of the utility of long-term maintenance chemotherapy. To this end, patients were randomized to discontinue all treatment after 8 months of maintenance chemotherapy or to continue maintenance therapy for a total of 3 years. Although there was a transient increase in the relapse rate for patients who discontinued therapy, the proportion of long-term remitters was identical in the two patient groups. Additionally, there is a suggestion of a survival advantage for patients randomized to discontinue all therapy at 8 months.",1987,"Neither an increase in intensity of chemotherapy nor the antibacterial prophylaxis increased the remission rate above the 53% for patients treated with the standard ""7 + 3"" regimen.","['Patients with acute nonlymphocytic leukemia', 'acute nonlymphocytic leukemia']","['cytosine arabinoside and three days of daunorubicin', 'cotrimoxazole antibacterial prophylaxis', '6-thioguanine or by extension of the administration of cytosine arabinoside', 'maintenance chemotherapy']","['relapse rate', 'remission rate', 'intensity of chemotherapy', 'proportion of long-term remitters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0877426', 'cui_str': 'Antibacterial prophylaxis'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0232532,"Neither an increase in intensity of chemotherapy nor the antibacterial prophylaxis increased the remission rate above the 53% for patients treated with the standard ""7 + 3"" regimen.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Preisler', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kirshner', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dupre', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Hoagland', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kopel', 'Affiliation': ''}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Carey', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schulman', 'Affiliation': ''}]",Blood,[]
235,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
236,12176916,Cyclosporine inhibition of P-glycoprotein in chronic myeloid leukemia blast phase.,"Chronic myeloid leukemia blast phase (CML-BP) cells commonly express the multidrug transporter, P-glycoprotein (Pgp). To determine whether Pgp inhibition improves treatment outcome in CML-BP, the Southwest Oncology Group performed a randomized, controlled trial testing the benefit of the Pgp modulator, cyclosporin A (CsA). Seventy-three eligible patients were assigned to treatment with cytarabine and infusional daunorubicin with or without intravenous CsA. Treatment with CsA yielded no improvement in treatment outcome as measured by the frequency of induction resistance (68% vs 53%), rate of complete remission or restored chronic phase (CR/CP, 8% vs 30%), and survival (3 vs 5 months). Blast expression of Pgp (63%) and LRP (71%) was common, whereas only Pgp adversely impacted the rate of CR/CP (P =.025). We conclude that Pgp has prognostic relevance in CML-BP but that the modulation of Pgp function with CsA as applied in this trial is ineffective.",2002,"Blast expression of Pgp (63%) and LRP (71%) was common, whereas only Pgp adversely impacted the rate of CR/CP (P =.025).","['chronic myeloid leukemia blast phase', 'Seventy-three eligible patients']","['cytarabine and infusional daunorubicin', 'Cyclosporine inhibition of P-glycoprotein', 'Pgp inhibition', 'Pgp modulator, cyclosporin A (CsA']","['Blast expression of Pgp', 'survival', 'rate of complete remission or restored chronic phase', 'frequency of induction resistance', 'rate of CR/CP']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0005699', 'cui_str': 'Blast Phase'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}]","[{'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",73.0,0.0513904,"Blast expression of Pgp (63%) and LRP (71%) was common, whereas only Pgp adversely impacted the rate of CR/CP (P =.025).","[{'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'List', 'Affiliation': 'Arizona Cancer Center, Tucson, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Slovak', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Douer', 'Affiliation': ''}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': ''}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
237,30995665,Blood Chromogranin A Is Not Effective as a Biomarker for Diagnosis or Management of Bronchopulmonary Neuroendocrine Tumors/Neoplasms.,"BACKGROUND


Identification of circulating tumor markers for clinical management in bronchopulmonary (BP) neuroendocrine tumors/neoplasms (NET/NEN) is of considerable clinical interest. Chromogranin A (CgA), a ""universal"" NET biomarker, is considered controversial as a circulating biomarker of BPNEN.
AIM


Assess utility of CgA in the diagnosis and management of BPNEN in a multicentric study.
MATERIAL AND METHODS


CgA diagnostic metrics were assessed in lung NET/NENs (n = 200) and controls (n = 140), randomly assigned to a Training and Test set (100 BPC and 70 controls in each). Assay specificity was evaluated in neoplastic lung disease (n = 137) and nonneoplastic lung disease (n = 77). CgA efficacy in predicting clinical status was evaluated in the combined set of 200 NET/NENs. CgA levels in bronchopulmonary neuroendocrine tumor (BPNET) subtypes (atypical [AC] vs. typical [TC]) and grade was examined. The clinical utility of an alteration of CgA levels (±25%) was evaluated in a subset of 49 BPNET over 12 months. CgA measurement was by NEOLISATM kit (EuroDiagnostica).
RESULTS


Sensitivity and specificity in the training set were 41/98%, respectively. Test set data were 42/87%. Training set area under receiver operator characteristic analysis differentiated BPC from control area under the curve (AUC) 0.61 ± 0.05 p = 0.015. Test set the data were AUC 0.58 ± 0.05, p = 0.076. In the combined set (n = 200), 67% BPNET/NEN (n = 134) had normal CgA levels. CgA levels did not distinguish histological subtypes (TC vs. AC, AUC 0.56 ± 0.04, p = 0.21), grade (p = 0.45-0.72), or progressive from stable disease (AUC 0.53 ± 0.05 p = 0.47). There was no correlation of CgA with Ki-67 index (Pearson r = 0.143, p = 0.14). For nonneoplastic diseases (chronic obstructive pulmonary disorder and idiopathic pulmonary fibrosis), CgA was elevated in 26-37%. For neoplastic disease (NSCLC, squamous cell carcinoma), CgA was elevated in 11-16%. The neuroendocrine SCLC also exhibited elevated CgA (50%). Elevated CgA was not useful for differentiating BPNET/NEN from these other pathologies. Monitoring BPNET/NEN over a 12-month period identified neither CgA levels per se nor changes in CgA were reflective of somatostatin analog treatment outcome/efficacy or the natural history of the disease (progression).
CONCLUSIONS


Blood CgA levels are not clinically useful as a biomarker for lung BPNET/NEN. The low specificity and elevations in both nonneoplastic as well as other common neoplastic lung diseases identified limited clinical utility for this biomarker.",2020,"CgA levels did not distinguish histological subtypes (TC vs. AC, AUC: 0.56±0.04, p=0.21), grade (p=0.45-0.72) or progressive from stable disease (AUC: 0.53±0.05 p=0.47).","['neoplastic lung disease (n=137) and non-neoplastic lung disease (n=77', 'bronchopulmonary (BP) neuroendocrine tumors/neoplasms (NET/NEN', 'CgA diagnostic metrics were assessed in lung NET/NENs (n=200) and controls (n=140']","['NEN', 'CgA', 'Monitoring BPNET', 'Chromogranin A (CgA']","['normal CgA levels', 'Sensitivity and specificity', 'CgA levels', 'CgA efficacy', 'Assay specificity', 'CgA with Ki-67 index']","[{'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine Tumors'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0055633', 'cui_str': 'Secretory Protein I, Parathyroid Gland'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0373385,"CgA levels did not distinguish histological subtypes (TC vs. AC, AUC: 0.56±0.04, p=0.21), grade (p=0.45-0.72) or progressive from stable disease (AUC: 0.53±0.05 p=0.47).","[{'ForeName': 'Somer', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Malczewska', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Oberg', 'Affiliation': 'Department of Endocrine Oncology, University Hospital, Uppsala, Sweden, kjell.oberg@medsci.uu.se.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bodei', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Centre, New York, New York, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Aslanian', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lewczuk-Myślicka', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Filosso', 'Affiliation': 'Department of Thoracic Surgery, University of Turin, Turin, Italy.'}, {'ForeName': 'Alejandro L', 'Initials': 'AL', 'LastName': 'Suarez', 'Affiliation': 'Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kolasińska-Ćwikła', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Roffinella', 'Affiliation': 'Department of Thoracic Surgery, University of Turin, Turin, Italy.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Kos-Kudła', 'Affiliation': 'Department of Endocrinology and Neuroendocrine Tumors, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Jarosław B', 'Initials': 'JB', 'LastName': 'Ćwikła', 'Affiliation': 'Department of Radiology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Ignat A', 'Initials': 'IA', 'LastName': 'Drozdov', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kidd', 'Affiliation': 'Wren Laboratories, Branford, Connecticut, USA.'}, {'ForeName': 'Irvin M', 'Initials': 'IM', 'LastName': 'Modlin', 'Affiliation': 'Gastroenterological and Endoscopic Surgery, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Neuroendocrinology,['10.1159/000500202']
238,31439532,Postural control at posturography with virtual reality in the intercritical period of vestibular migraine.,"INTRODUCTION


Vestibular migraine is a condition that associates headache and vestibular symptoms.
OBJECTIVE


To evaluate body-balance with virtual reality posturography in vestibular migraine.
METHODS


A total of 26 patients in the intercritical period of vestibular migraine were compared by means of the Balance Rehabilitation Unit MT  (Medical/Interacoustics) posturography with 30 controls, paired for age and gender.
RESULTS


There was no significant statistical difference (p = 0.121) in the limit of stability area (cm 2 ) between the experimental group and the control group values. There were significant differences (p < 0.05) in the values of sway velocity (cm/s) in nine of ten evaluated sensory conditions and in the pressure center displacement area (cm 2 ) values in eight of those ten sensory conditions in the comparison between the control group and the experimental group.
CONCLUSION


Posturography with virtual reality can identify changes in the sway velocity and the pressure center displacement area, characterizing the inability to maintain postural control with and without visual deprivation in situations of visual conflict and vestibulovisual interaction,in the intercritical period of the vestibular migraine.",2021,"There were significant differences (p < 0.05) in the values of sway velocity (cm/s) in nine of ten evaluated sensory conditions and in the pressure center displacement area (cm 2 ) values in eight of those ten sensory conditions in the comparison between the control group and the experimental group.
","['26 patients in the intercritical period of vestibular migraine were compared by means of the Balance Rehabilitation Unit MT  (Medical/Interacoustics) posturography with 30 controls, paired for age and gender']","['Posturography with virtual reality', 'virtual reality-posturography', 'Postural control at posturography with virtual reality']",['values of sway velocity'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0395920', 'cui_str': 'Migrainous vertigo (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",,0.0222495,"There were significant differences (p < 0.05) in the values of sway velocity (cm/s) in nine of ten evaluated sensory conditions and in the pressure center displacement area (cm 2 ) values in eight of those ten sensory conditions in the comparison between the control group and the experimental group.
","[{'ForeName': 'Suelen', 'Initials': 'S', 'LastName': 'Cesaroni', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina (EPM), Programa de Pós-Graduação em Distúrbios da Comunicação Humana, São Paulo, SP, Brazil. Electronic address: suelen.cesaroni@gmail.com.'}, {'ForeName': 'Adriana Marques da', 'Initials': 'AMD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina (EPM), Programa de Pós-Graduação em Distúrbios da Comunicação Humana, São Paulo, SP, Brazil.'}, {'ForeName': 'Maurício Malavasi', 'Initials': 'MM', 'LastName': 'Ganança', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina (EPM), São Paulo, SP, Brazil.'}, {'ForeName': 'Heloisa Helena', 'Initials': 'HH', 'LastName': 'Caovilla', 'Affiliation': 'Universidade Federal de São Paulo (Unifesp), Escola Paulista de Medicina (EPM), Disciplina de Otologia e Otoneurologia, São Paulo, SP, Brazil.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.06.015']
239,2070058,Effective natural interferon-alpha therapy in recombinant interferon-alpha-resistant patients with hairy cell leukemia.,"To explore the relationship between anti-interferon-alpha (anti-IFN-alpha) antibodies and loss of clinical responsiveness to IFN-alpha treatment, we examined sera from 59 patients with hairy cell leukemia who responded to therapy with recombinant IFN-alpha-2a (rIFN-alpha-2a). During the first 2 years of therapy, 10 patients developed rIFN-alpha-2a-neutralizing and 15 rIFN-alpha-2a-binding antibodies. Nine of the 59 initially responding patients became resistant to rIFN-alpha-2a and suffered a relapse of the disease at 7 to 24 months of treatment. All nine relapsing patients tested positive for both neutralizing and binding antibodies with titers above 400 INU/mL, while none of the antibody-negative patients relapsed. Six patients with detectable binding antibody titers below 400 INU/mL continued to respond to treatment. By measuring the IFN kinetics and the levels of the IFN-induced Mx-homologous protein in mononuclear cells after a single injection each of rIFN-alpha-2a and nIFN-alpha the IFN antibodies of eight of the nine resistant rIFN-alpha patients were found to be highly specific for rIFN-alpha-2a. Therefore, these eight patients were switched to natural IFN-alpha (nIFN-alpha) therapy at doses of 3 million IU, three times a week. All eight patients responded to treatment with nIFN-alpha, achieving durable objective responses similar to those obtained previously with rIFN-alpha-2a. These data clearly demonstrate that rIFN-alpha antibody-positive patients can effectively be treated with nIFN-alpha.",1991,"All eight patients responded to treatment with nIFN-alpha, achieving durable objective responses similar to those obtained previously with rIFN-alpha-2a.","['59 patients with hairy cell leukemia who responded to therapy with', 'recombinant interferon-alpha-resistant patients with hairy cell leukemia']","['anti-interferon-alpha (anti-IFN-alpha) antibodies', 'natural IFN-alpha (nIFN-alpha) therapy', 'interferon-alpha therapy', 'rIFN-alpha-2a-neutralizing and 15 rIFN-alpha-2a-binding antibodies', 'rIFN-alpha-2a', 'recombinant IFN-alpha-2a (rIFN-alpha-2a']",['resistant to rIFN-alpha-2a and suffered a relapse of the disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023443', 'cui_str': 'Reticuloendotheliosis, Leukemic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}]","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",6.0,0.033867,"All eight patients responded to treatment with nIFN-alpha, achieving durable objective responses similar to those obtained previously with rIFN-alpha-2a.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'von Wussow', 'Affiliation': 'Department of Immunology, Medical School of Hanover, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pralle', 'Affiliation': ''}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Hochkeppel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jakschies', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sonnen', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Müller-Rosenau', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Franke', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haferlach', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zwingers', 'Affiliation': ''}]",Blood,[]
240,31505970,Predictors for Blood Pressure Reduction in American Latinos: Secondary Analysis of the Adelgaza Program Data.,"Little is known about factors that predict blood pressure (BP) reduction in overweight American Latinos. The aim of this secondary analysis was to explore predictors of changes in mean systolic and diastolic BPs over an 8-week weight loss intervention period in a sample of 54 overweight American Latinos using data collected during the Adelgaza trial. Baseline BP, exercise energy use (in units of metabolic equivalent of task), weight change, average daily intake of calories from beverages, average daily intake of calories from fat, age, and gender were considered as potential predictors of reductions in BP, as measured at baseline, 3, and 8 weeks. Baseline characteristics were as follows: mean age 45.3 ( SD  = 10.8) years, 31.5% male, 61.1% born in the United States. Mean baseline systolic and diastolic BPs were 122.1 ( SD  = 14.4) mmHg and 76.6 ( SD  = 9.8) mmHg, respectively. Both baseline systolic and diastolic BPs predicted reductions in systolic BP after adjusting for other factors ( p  < .001). None of the nine variables predicted reductions in diastolic BP ( p  > .05). This finding suggests that overweight American Latinos with higher baseline systolic or diastolic BP should be identified and provided with early intervention education to achieve better hypertension management or prevention.",2020,Both baseline systolic and diastolic BPs predicted reductions in systolic BP after adjusting for other factors ( p  < .001).,"['54 overweight American Latinos using data collected during the Adelgaza trial', 'mean age 45.3 ( SD  = 10.8) years, 31.5% male, 61.1% born in the United States', 'American Latinos']",[],"['Baseline BP, exercise energy use (in units of metabolic equivalent of task), weight change, average daily intake of calories from beverages, average daily intake of calories from fat, age, and gender', 'mean systolic and diastolic BPs', 'Mean baseline systolic and diastolic BPs', 'diastolic BP', 'blood pressure (BP) reduction', 'systolic BP']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C2983100', 'cui_str': 'MET - metabolic equivalent of task'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",54.0,0.0559628,Both baseline systolic and diastolic BPs predicted reductions in systolic BP after adjusting for other factors ( p  < .001).,"[{'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Li', 'Affiliation': 'San Francisco State University, San Francisco CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Fukuoka', 'Affiliation': 'University of California, San Francisco, CA, USA.'}]",Hispanic health care international : the official journal of the National Association of Hispanic Nurses,['10.1177/1540415319869936']
241,12149202,Phase 3 study of the multidrug resistance modulator PSC-833 in previously untreated patients 60 years of age and older with acute myeloid leukemia: Cancer and Leukemia Group B Study 9720.,"The Cancer and Leukemia Group B conducted a phase 3 trial of the P-glycoprotein modulator PSC-833 in untreated acute myeloid leukemia patients aged 60 years and older. Patients were randomized to 1 of 2 regimens, with doses determined in a prior phase 1 study, consisting of cytarabine 100 mg/m(2)/d by 7-day infusion, with daunorubicin 60 mg/m(2) and etoposide 100 mg/m(2) daily for 3 days (ADE), or daunorubicin 40 mg/m(2) and etoposide 60 mg/m(2) for 3 days with PSC-833, 2.8 mg/kg over 2 hours, and then 10 mg/kg/d by 3-day infusion (ADEP). The ADEP arm was closed after randomization of 120 patients (61 to ADE and 59 to ADEP) because of excessive early mortality. Rates of complete remission, nonresponse, and death were 46%, 34%, and 20% for ADE, versus 39%, 17%, and 44% for ADEP (P =.008). Nevertheless, disease-free survival (median 7 vs 8 months; P =.38) and overall survival (approximately 33% alive at 1 year) did not differ and were similar to historical results. Although the number of patients was limited, ADE patients whose pretreatment cells exhibited PSC-833-modulated dye efflux in vitro (n = 22) had worse outcomes than those without efflux (n = 11) (complete remission, nonresponse, and death rates of 41%, 41%, and 18%, compared with 91%, 9%, and 0%; P =.03), but with ADEP outcomes were nearly identical. Moreover, for patients with PSC-833-modulated efflux, median disease-free survival was 5 months with ADE and 14 months with ADEP (P =.07). Further modulation trials in older patients must await the design of less-toxic regimens.",2002,"Nevertheless, disease-free survival (median 7 vs 8 months; P =.38) and overall survival (approximately 33% alive at 1 year) did not differ and were similar to historical results.","['untreated acute myeloid leukemia patients aged 60 years and older', 'older patients', 'previously untreated patients 60 years of age and older with acute myeloid leukemia: Cancer and Leukemia Group B Study 9720']","['ADEP', 'cytarabine 100 mg/m(2)/d by 7-day infusion, with daunorubicin 60 mg/m(2) and etoposide 100 mg/m(2) daily for 3 days (ADE), or daunorubicin 40 mg/m(2) and etoposide 60 mg/m(2) for 3 days with PSC-833', 'multidrug resistance modulator PSC-833', 'P-glycoprotein modulator PSC-833']","['excessive early mortality', 'overall survival', 'disease-free survival', 'complete remission, nonresponse, and death rates', 'Rates of complete remission, nonresponse, and death', 'median disease-free survival']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C4080399', 'cui_str': 'Etoposide 100 MG [Etopophos]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0139121', 'cui_str': 'PSC833'}, {'cui': 'C0242640', 'cui_str': 'Multi-Drug Resistance'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",120.0,0.130645,"Nevertheless, disease-free survival (median 7 vs 8 months; P =.38) and overall survival (approximately 33% alive at 1 year) did not differ and were similar to historical results.","[{'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Baer', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY 14263, USA. maria.baer@roswellpark.org'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Dodge', 'Affiliation': ''}, {'ForeName': 'Kieran L', 'Initials': 'KL', 'LastName': ""O'Loughlin"", 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Minderman', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Caligiuri', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anastasi', 'Affiliation': ''}, {'ForeName': 'Bayard L', 'Initials': 'BL', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Kolitz', 'Affiliation': ''}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}, {'ForeName': 'Clara D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': ''}]",Blood,[]
242,12091332,Acute myeloid leukemia and myelodysplastic syndrome in children treated for cancer: comparison with primary presentation.,"There has not been a reported series of children with therapy-induced myelodysplastic syndrome/acute myeloid leukemia (tMDS/tAML) who were treated systematically. This paper describes 24 children with tMDS/tAML who were assigned randomly to standard- or intensive-timing induction on protocol CCG 2891. Presenting features and outcomes of those children were compared with those of 960 patients with de novo MDS (62 patients) or AML (898 patients). Children with tMDS/tAML were older at presentation (P =.015), had lower white blood cell counts (P =.01), and were more likely to have MDS (21% vs 7%) (P =.02) and trisomy 8 (P =.06). Fewer had hepatomegaly (P =.02), splenomegaly (P =.03), hepatosplenomegaly (P =.02), or classic AML translocations [t(8;21), t(15;17), 16q22; P =.02]. They had a poorer induction rate (50% vs 72%, P =.016), overall survival (26% vs 47% at 3 years, P =.007), and event-free survival (21% vs 39% at 3 years, P =.023). Disease-free survival after achieving remission was similar (45% vs 53%, P =.868). Children with tMDS/tAML who received intensive-timing induction had better outcomes than those who received standard-timing induction (overall survival 32% vs 0%, P =.54). In this study, the latency period to development of tMDS/tAML was the same for presumed alkylator-induced as for topoisomerase-induced myeloid leukemia. The findings of this study confirm that most children with tMDS/tAML have disease resistant to current therapies. Standard-timing induction appears less effective for this population.",2002,"Fewer had hepatomegaly (P =.02), splenomegaly (P =.03), hepatosplenomegaly (P =.02), or classic AML translocations [t(8;21), t(15;17), 16q22; P =.02].","['children treated for cancer', '24 children with tMDS/tAML', '960 patients with de novo MDS (62 patients) or AML (898 patients', 'children with therapy-induced myelodysplastic syndrome/acute myeloid leukemia (tMDS/tAML']",['standard- or intensive-timing induction on protocol CCG 2891'],"['Acute myeloid leukemia and myelodysplastic syndrome', 'MDS', 'poorer induction rate', 'overall survival', 'Disease-free survival', 'event-free survival', 'splenomegaly', 'white blood cell counts']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517908', 'cui_str': '960 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0038002', 'cui_str': 'Enlarged Spleen'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",24.0,0.087437,"Fewer had hepatomegaly (P =.02), splenomegaly (P =.03), hepatosplenomegaly (P =.02), or classic AML translocations [t(8;21), t(15;17), 16q22; P =.02].","[{'ForeName': 'Dorothy R', 'Initials': 'DR', 'LastName': 'Barnard', 'Affiliation': 'Dalhousie University, Halifax, NS. dorothy.barnard@iwk.nshealth.ca'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Alonzo', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Buckley', 'Affiliation': ''}, {'ForeName': 'J Nathan', 'Initials': 'JN', 'LastName': 'Kobrinsky', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Neudorf', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Burden', 'Affiliation': ''}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Woods', 'Affiliation': ''}]",Blood,[]
243,1984797,"Use of leukocyte-depleted platelet concentrates for the prevention of refractoriness and primary HLA alloimmunization: a prospective, randomized trial.","Compared with conventional transfusion regimes a strong reduction in HLA alloimmunization and refractoriness to platelet transfusions is obtained when both red blood cell concentrates (RBCs) and platelet concentrates (PCs) are depleted of leukocytes by filtration. Because most of the leukocyte contamination is introduced by transfusion of RBCs, filtration of RBCs appears rational, but uncertainty exists regarding the degree of leukocyte-depletion of PCs needed for the prevention of HLA alloimmunization and refractoriness. We conducted a prospective trial and randomized patients with acute leukemia to receive leukocyte-depleted PCs prepared either by centrifugation (mean leukocyte count 35 x 10(6)/PC of 6 U) or by filtration (mean leukocyte count less than 5 x 10(6)/PC of 6 U). Both groups received RBCs that were filtered after prior removal of the buffy coat. Clinical refractoriness occurred in 46% (12 of 26) of the evaluable patients that were transfused with centrifuged PCs and only in 11% (3 of 27) in the filtered group (P less than .005). De novo anti-HLA antibodies were detected in 42% (11 of 26) patients in the centrifuged group and only in 7% (2 of 27) of the patients receiving filtered PCs (P less than .004). In 8 of 11 alloimmunized patients in the centrifuged group antibodies were detected in the first 4 weeks of transfusion therapy while none of the patients in the filtered group became immunized against HLA antigens during that period. We conclude that for the prevention of HLA alloimmunization and refractoriness to platelet transfusions from random donors, both RBCs and PCs have to be leukocyte-depleted by filtration.",1991,Compared with conventional transfusion regimes a strong reduction in HLA alloimmunization and refractoriness to platelet transfusions is obtained when both red blood cell concentrates (RBCs) and platelet concentrates (PCs) are depleted of leukocytes by filtration.,['patients with acute leukemia to receive'],"['leukocyte-depleted platelet concentrates', 'leukocyte-depleted PCs prepared either by centrifugation (mean leukocyte count 35 x 10(6)/PC of 6 U) or by filtration']","['Clinical refractoriness', 'De novo anti-HLA antibodies', 'centrifuged group antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.0139885,Compared with conventional transfusion regimes a strong reduction in HLA alloimmunization and refractoriness to platelet transfusions is obtained when both red blood cell concentrates (RBCs) and platelet concentrates (PCs) are depleted of leukocytes by filtration.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Immuno-Hematology, University Hospital Utrecht, The Netherlands.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'van Prooijen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moes', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bosma-Stants', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Akkerman', 'Affiliation': ''}]",Blood,[]
244,11719362,Genetic variation in glycoprotein IIb/IIIa (GPIIb/IIIa) as a determinant of the responses to an oral GPIIb/IIIa antagonist in patients with unstable coronary syndromes.,"This study examined the influence of the Pl(A) polymorphism of glycoprotein IIIa (GPIIIa) in determining the response to an oral GPIIb/IIIa antagonist, orbofiban, in patients with unstable coronary syndromes. Genotyping for the Pl(A) polymorphism was performed in 1014 patients recruited into the OPUS-TIMI-16 (orbofiban in patients with unstable coronary syndromes-thrombolysis in myocardial infarction 16) trial, in which patients were randomized to low- or high-dose orbofiban or placebo for 1 year. The primary end point (n = 165) was a composite of death, myocardial infarction (MI), recurrent ischemia requiring rehospitalization, urgent revascularization, and stroke. Overall, orbofiban failed to reduce ischemic events when compared with placebo, but increased the rate of bleeding. In the whole population, Pl(A2) carriers had a significant increase in MI (n = 33) during follow up, with a relative risk (RR) of 2.71 (95% CI, 1.37 to 5.38; P =.004). There was a significant interaction between treatment (placebo and orbofiban) and the Pl(A) polymorphism for bleeding (n = 187; P =.05). Thus, while orbofiban increased bleeding in noncarriers (RR = 1.87, 1.29 to 2.71; P <.001) in a dose-dependent fashion, it did not increase bleeding events in Pl(A2) carriers (RR = 0.87, 0.46 to 1.64). There was no interaction between treatment (placebo and orbofiban) and the Pl(A) polymorphism for the primary end point (P =.10). However, in the patients receiving orbifiban there was a higher risk of a primary event (RR = 1.55, 1.03 to 2.34; P =.04) and MI (RR 4.27, 1.82 to 10.03; P <.001) in Pl(A2) carriers compared with noncarriers. In contrast, there was no evidence that Pl(A2) influenced the rate of recurrent events in placebo-treated patients. In patients presenting with an acute coronary syndrome, the Pl(A) polymorphism of GPIIb/IIIa may explain some of the variance in the response to an oral GPIIb/IIIa antagonist.",2001,There was a significant interaction between treatment (placebo and orbofiban) and the Pl(A) polymorphism for bleeding (n = 187; P =.05).,"['1014 patients recruited into the OPUS-TIMI-16 (orbofiban in patients with unstable coronary syndromes-thrombolysis in myocardial infarction 16) trial', 'patients with unstable coronary syndromes', 'patients presenting with an acute coronary syndrome, the Pl(A) polymorphism of GPIIb/IIIa']","['glycoprotein IIIa (GPIIIa', 'placebo', 'low- or high-dose orbofiban or placebo']","['rate of recurrent events', 'rate of bleeding', 'composite of death, myocardial infarction (MI), recurrent ischemia requiring rehospitalization, urgent revascularization, and stroke', 'Pl(A) polymorphism for bleeding', 'bleeding', 'ischemic events', 'MI', 'bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0769787', 'cui_str': 'orofiban'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0245726', 'cui_str': 'Platelet Glycoprotein IIIa'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0769787', 'cui_str': 'orofiban'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",1014.0,0.149193,There was a significant interaction between treatment (placebo and orbofiban) and the Pl(A) polymorphism for bleeding (n = 187; P =.05).,"[{'ForeName': 'F F', 'Initials': 'FF', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Clinical Pharmacology, and Surgen Ltd, Royal College of Surgeons in Ireland.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Shields', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fitzgerald', 'Affiliation': ''}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Fitzgerald', 'Affiliation': ''}]",Blood,[]
245,12070007,Therapy for chronic graft-versus-host disease: a randomized trial comparing cyclosporine plus prednisone versus prednisone alone.,"Results of previous studies have suggested that transplantation-related mortality among patients with chronic graft-versus-host disease (GVHD) may be reduced by combined treatment with cyclosporine (CSP) and prednisone rather than by prednisone alone. In a randomized trial, we assessed the efficacy of cyclosporine plus prednisone versus prednisone alone as initial therapy for chronic GHVD among patients whose platelet counts were higher than 100,000/microL. Prednisone was administered initially at a dose of 1.0 mg/kg per day orally, followed by a prolonged taper, and cyclosporine was administered at 6 mg/kg orally twice daily every other day. The cumulative incidence of transplantation-related mortality at 5 years from enrollment was 17% (95% CI, 0.11-0.23) in the CSP plus prednisone arm and 13% (95% CI, 0.08-0.19) in the prednisone arm. The hazards of transplantation-related mortality, overall mortality, recurrent malignancy, secondary therapy, and discontinuation of all immunosuppressive therapy were not significantly different between the 2 arms, but survival without recurrent malignancy was lower in the 2-drug arm (P =.03). Avascular necrosis developed in 18 (13%) of the 142 patients in the CSP plus prednisone arm and in 32 (22%) of the 145 patients in the prednisone arm (P =.04). Treatment with CSP plus prednisone may reduce the risk for steroid-related toxicity, but results of the current study do not substantiate the hypothesis that the administration of CSP reduces transplantation-related mortality among patients with chronic GVHD.",2002,Avascular necrosis developed in 18 (13%) of the 142 patients in the CSP plus prednisone arm and in 32 (22%) of the 145 patients in the prednisone arm (P =.04).,"['chronic graft-versus-host disease', 'patients with chronic GVHD']","['cyclosporine plus prednisone', 'CSP', 'Prednisone', 'prednisone', 'cyclosporine', 'cyclosporine (CSP) and prednisone', 'prednisone alone', 'CSP plus prednisone']","['survival without recurrent malignancy', 'Avascular necrosis', 'hazards of transplantation-related mortality, overall mortality, recurrent malignancy, secondary therapy, and discontinuation of all immunosuppressive therapy', 'cumulative incidence of transplantation-related mortality']","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3887513', 'cui_str': 'Avascular necrosis (morphologic abnormality)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",145.0,0.0962624,Avascular necrosis developed in 18 (13%) of the 142 patients in the CSP plus prednisone arm and in 32 (22%) of the 145 patients in the prednisone arm (P =.04).,"[{'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Koc', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': ''}, {'ForeName': 'Mary E D', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'H Joachim', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'Frederick R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': ''}]",Blood,[]
246,11861264,A randomized study of interferon-alpha versus interferon-alpha and low-dose arabinosyl cytosine in chronic myeloid leukemia.,"Interferon-alpha (IFN-alpha) has significantly prolonged survival in chronic myeloid leukemia (CML), but some patients do not respond and many responses are not durable. To improve the results, IFN-alpha has been combined with other treatments, but so far only the association with low-dose arabinosyl cytosine (LDAC) has been shown to increase the response rate and to prolong survival. Here are reported the results of a study of 538 Philadelphia chromosome-positive CML patients who were assigned at random to treatment with IFN-alpha 2a alone or in combination with LDAC. The scheduled dose of IFN-alpha 2a was 5(6) IU/m(2)/d. The scheduled dose of AC was 40 mg/d for the first 10 days of each month of treatment. The efficacy endpoints were a complete hematologic response rate at 6 months (62% in the IFN-alpha-plus-LDAC arm versus 55% in the IFN-alpha arm; P =.11), major cytogenetic response (MCgR) rate at 24 months (28% versus 18%; P =.003), and overall survival (5-year survival, 68% versus 65%; P =.77). Treatment did not affect overall survival within different prognostic risk groups: low, intermediate, or high. Also the duration of MCgR was identical. The results of this study confirm the results of a similar French study only for the response rate, not for survival, suggesting that the relationship between cytogenetic response and survival may be extremely variable and that a meta-analysis of these and other studies of IFN-alpha versus IFN-alpha plus LDAC is required to settle the issue of the role of LDAC in the treatment of CML.",2002,"Treatment did not affect overall survival within different prognostic risk groups: low, intermediate, or high.","['chronic myeloid leukemia (CML', 'chronic myeloid leukemia', '538 Philadelphia chromosome-positive CML patients']","['IFN-alpha 2a alone or in combination with LDAC', 'AC', 'Interferon-alpha (IFN-alpha', 'arabinosyl cytosine (LDAC', 'interferon-alpha versus interferon-alpha and low-dose arabinosyl cytosine']","['complete hematologic response rate', 'response rate', 'overall survival', 'major cytogenetic response (MCgR) rate', 'overall survival (5-year survival', 'duration of MCgR']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",538.0,0.107073,"Treatment did not affect overall survival within different prognostic risk groups: low, intermediate, or high.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'L. and A. Seràgnoli Institute of Hematology and Medical Oncology, S. Orsola Hospital, University of Bologna, Italy. baccarani@med.unibo.it'}, {'ForeName': 'Gianantonio', 'Initials': 'G', 'LastName': 'Rosti', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'de Vivo', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bonifazi', 'Affiliation': ''}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Russo', 'Affiliation': ''}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': ''}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Testoni', 'Affiliation': ''}, {'ForeName': 'Marilina', 'Initials': 'M', 'LastName': 'Amabile', 'Affiliation': ''}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Fiacchini', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Montefusco', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': ''}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Tura', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
247,11861267,Effect of N-acetyl-cysteine on the hypoxic ventilatory response and erythropoietin production: linkage between plasma thiol redox state and O(2) chemosensitivity.,"Oxygen-sensing chemoreceptors contribute significantly to the regulation of the respiratory drive and arterial PO(2) levels. The hypoxic ventilatory response (HVR) decreases strongly with age and is modulated by prolonged hypoxia and physical exercise. Several earlier studies indicated that the regulation of the ventilatory response and erythropoietin (EPO) production by the respective oxygen sensors involves redox-sensitive signaling pathways, which are triggered by the O(2)-dependent production of reactive oxygen species. The hypothesis that HVR and EPO production are modulated by thiol compounds or changes in the plasma thiol-disulfide redox state (REDST) was investigated. It was demonstrated that both responses are enhanced by oral treatment with N-acetyl-cysteine (NAC) and that HVR is correlated with plasma thiol level and REDST. Results suggest the possibility that age-related changes in plasma REDST may account for the age-related changes in HVR.",2002,Results suggest the possibility that age-related changes in plasma REDST may account for the age-related changes in HVR.,[],['N-acetyl-cysteine'],"['hypoxic ventilatory response (HVR', 'ventilatory response and erythropoietin (EPO) production', 'plasma thiol-disulfide redox state (REDST']",[],"[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0033268'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0038734', 'cui_str': 'Mercaptans'}, {'cui': 'C0012771', 'cui_str': 'Disulfides'}, {'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0148668,Results suggest the possibility that age-related changes in plasma REDST may account for the age-related changes in HVR.,"[{'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Immunochemistry, Deutsches Krebsforschungszentrum, Heidelberg, Germany.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bärtsch', 'Affiliation': ''}, {'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Dröge', 'Affiliation': ''}]",Blood,[]
248,12036860,"Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside.","We investigated treatment with gemtuzumab ozogamicin (GO) in 51 patients aged 65 years or older with newly diagnosed acute myeloid leukemia (AML), refectory anemia (RA) with excess of blasts in transformation, or RA with excess blasts. GO was given in doses of 9 mg/m(2) of body-surface area on days 1 and 8 or, therapeutically equivalently, on days 1 and 15, with or without interleukin 11 (IL-11; 15 microg/kg per day on days 3 to 28), with assignment to IL-11 treatment made randomly. Complete remission (CR) rates were 2 of 26 (8%) for GO without IL-11 and 9 of 25 (36%) for GO with IL-11. Regression analyses indicated that IL-11 was independently predictive of CR but not survival. We compared GO with or without IL-11 with idarubicin plus cytosine arabinoside (IA), as previously administered, in similar patients. The CR rate with IA was 15 of 31 (48%), and survival was superior with IA compared with GO with or without IL-11 (P =.03). Besides accounting for possible covariate effects on outcome, we also accounted for possible trial effects (TEs) arising because IA and GO with or without IL-11 were not arms of a randomized trial. Bayesian posterior probabilities that GO with or without IL-11 produced longer survival than IA, after accounting for covariates and TEs, were less than 0.01 in patients with abnormal cytogenetic findings (AC) and less than 0.15 in patients with normal cytogenetic findings (NC). Regarding CR, the analogous probabilities were less than 0.02 for GO without IL-11 (all cytogenetic groups), and for GO with IL-11, less than 0.25 for AC groups and about 0.50 for NC groups. TEs 2 to 5 times the magnitude of those previously observed would be needed to conclude that survival with GO with or without IL-11 is likely longer than with IA. Thus, there is little evidence to suggest that GO with or without IL-11 should be used instead of IA in older patients with newly diagnosed AML or myelodysplastic syndrome.",2002,"Regarding CR, the analogous probabilities were less than 0.02 for GO without IL-11 (all cytogenetic groups), and for GO with IL-11, less than 0.25 for AC groups and about 0.50 for NC groups.","['older patients with newly diagnosed AML or myelodysplastic syndrome', '51 patients aged 65 years or older with newly diagnosed acute myeloid leukemia (AML), refectory anemia (RA) with excess of blasts in transformation, or RA with excess blasts', 'patients with abnormal cytogenetic findings (AC) and less than 0.15 in patients with normal cytogenetic findings (NC', 'patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome']","['gemtuzumab ozogamicin (GO', 'GO with or without IL-11 with idarubicin plus cytosine arabinoside (IA', 'Gemtuzumab ozogamicin with or without interleukin', 'idarubicin plus continuous-infusion, high-dose cytosine arabinoside']","['longer survival', 'survival', 'CR rate with IA', 'Complete remission (CR) rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1533699', 'cui_str': 'Gemtuzumab ozogamicin'}, {'cui': 'C0083031', 'cui_str': 'Interleukin-11'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",51.0,0.182888,"Regarding CR, the analogous probabilities were less than 0.02 for GO without IL-11 (all cytogenetic groups), and for GO with IL-11, less than 0.25 for AC groups and about 0.50 for NC groups.","[{'ForeName': 'Elihu H', 'Initials': 'EH', 'LastName': 'Estey', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. ehestley@mdanderson.org'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Giles', 'Affiliation': ''}, {'ForeName': 'Xue-Mei', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': ''}, {'ForeName': 'Miloslav', 'Initials': 'M', 'LastName': 'Beran', 'Affiliation': ''}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': ''}]",Blood,[]
249,11675332,"Multicenter, randomized comparative trial of fludarabine and the combination of cyclophosphamide-doxorubicin-prednisone in 92 patients with Waldenström macroglobulinemia in first relapse or with primary refractory disease.","Few reports are available on the treatment of patients with Waldenström macroglobulinemia (WM) and primary or secondary resistance to alkylating-agent-based regimens. From December 1993 through December 1997, 92 patients with WM resistant to first-line therapy (42) or with first relapse (50) after alkylating-agent therapy were randomly assigned to receive fludarabine (25 mg/m(2) of body-surface area on days 1-5) or cyclophosphamide, doxorubicin (Adriamycin), and prednisone (CAP; 750 mg/m(2) cyclophosphamide and 25 mg/m(2) doxorubicin on day 1 and 40 mg/m(2) prednisone on days 1-5). The first end point evaluated was the response rate after 6 treatment courses. Forty-five patients received CAP and 45 received fludarabine. Two patients died before the first course of chemotherapy. No statistical differences were observed between the 2 treatment arms with respect to hematologic toxicity or infections. Mucositis and alopecia occurred significantly more often in patients treated with CAP. Partial responses were obtained in 14 patients (30%) treated with fludarabine and 5 patients (11%) treated with CAP (P =.019). Responses were more durable in patients treated with fludarabine (19 months versus 3 months), and the event-free survival rate was significantly higher in this group (P <.01). Forty-four patients died, 22 in the fludarabine group and 22 in the CAP group. There was no statistical difference in the median overall survival time in the 2 study arms. Fludarabine was thus more active than CAP in salvage therapy of WM and should be tested as first-line therapy in a randomized comparison with alkylating agents.",2001,No statistical differences were observed between the 2 treatment arms with respect to hematologic toxicity or infections.,"['92 patients with Waldenström macroglobulinemia in first relapse or with primary refractory disease', 'group and 22 in the CAP group', 'From December 1993 through December 1997, 92 patients with WM resistant to first-line therapy (42) or with first relapse (50) after alkylating-agent therapy', 'patients with Waldenström macroglobulinemia (WM) and primary or secondary resistance to alkylating-agent-based regimens']","['cyclophosphamide, doxorubicin (Adriamycin), and prednisone (CAP; 750 mg/m(2) cyclophosphamide and 25 mg/m(2) doxorubicin on day 1 and 40 mg/m(2) prednisone', 'cyclophosphamide-doxorubicin-prednisone', 'Fludarabine', 'fludarabine', 'CAP']","['Partial responses', 'hematologic toxicity or infections', 'response rate', 'event-free survival rate', 'Mucositis and alopecia', 'median overall survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024419', 'cui_str': 'Primary Macroglobulinemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",92.0,0.0257018,No statistical differences were observed between the 2 treatment arms with respect to hematologic toxicity or infections.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': ""Département d'hématologie, Hôpital Pitié-Salpétrière, AP-HP, Paris, France. veronique.leblond@psl.ap-hop-paris.fr""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lévy', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maloisel', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Fermand', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Remenieras', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gardembas', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marit', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deconinck', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guilhot', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Philippe', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Guibon', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
250,11964279,Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients.,"The role of maintenance therapy in multiple myeloma is controversial. Recent studies have shown an improvement in both progression-free and overall survival for patients receiving maintenance treatment with a combination of interferon and glucocorticoids, compared with interferon alone. The role of glucocorticoids alone as maintenance therapy has not been previously addressed. We compared alternate-day, oral prednisone at 2 different dose levels (10 mg versus 50 mg) for remission maintenance among previously untreated myeloma patients following a response to induction with standard-dose vincristine, doxorubicin, and dexamethasone with prednisone (VAD-P) or VAD-P plus quinine (VAD-P/Q). There were 250 eligible patients registered on Southwest Oncology Group study 9210 and randomized to receive VAD-P or VAD-P/Q. There were 125 patients achieving at least a 25% tumor reduction following induction therapy who were randomized to either physiologic (10 mg) or pharmacologic (50 mg) doses of alternate-day, oral prednisone until disease progression. At the time of study entry, patient characteristics were similar in VAD-P and VAD-P/Q patients and in the 2 arms randomized to maintenance therapy. After a median follow-up of 53 months, there was no difference in either progression-free or overall survival between the 2 induction regimens. However, from the time of maintenance randomization, both progression-free (14 versus 5 months; P =.003) and overall survival (37 versus 26 months; P =.05) were significantly improved in patients receiving 50 mg as compared with 10 mg alternate-day prednisone. There was no difference in treatment-related adverse events between the groups. Thus, 50 mg, oral, alternate-day prednisone is effective maintenance treatment for multiple myeloma patients who achieve a response to induction chemotherapy. (Blood. 2002;99:3163-3168)",2002,"After a median follow-up of 53 months, there was no difference in either progression-free or overall survival between the 2 induction regimens.","['multiple myeloma patients who achieve a response to induction chemotherapy', '250 eligible patients registered on Southwest Oncology Group study 9210 and randomized to receive', 'multiple myeloma patients', '125 patients achieving at least a 25% tumor reduction following induction therapy']","['interferon alone', 'oral prednisone', 'prednisone', 'vincristine, doxorubicin, and dexamethasone with prednisone (VAD-P) or VAD-P plus quinine (VAD-P/Q', 'glucocorticoids', 'physiologic (10 mg) or pharmacologic', 'VAD-P or VAD-P/Q', 'Maintenance therapy with alternate-day prednisone', 'interferon and glucocorticoids']","['progression-free', 'overall survival', 'progression-free and overall survival', 'survival', 'treatment-related adverse events', 'progression-free or overall survival']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",250.0,0.0788774,"After a median follow-up of 53 months, there was no difference in either progression-free or overall survival between the 2 induction regimens.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Berenson', 'Affiliation': 'Cedars Sinai Medical Center and the Jonsson Comprehensive Cancer Center, University of California-Los Angeles, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Crowley', 'Affiliation': ''}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Grogan', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zangmeister', 'Affiliation': ''}, {'ForeName': 'Adrienne D', 'Initials': 'AD', 'LastName': 'Briggs', 'Affiliation': ''}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Mills', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Barlogie', 'Affiliation': ''}, {'ForeName': 'Sydney E', 'Initials': 'SE', 'LastName': 'Salmon', 'Affiliation': ''}]",Blood,[]
251,11929799,Randomized study of valacyclovir as prophylaxis against cytomegalovirus reactivation in recipients of allogeneic bone marrow transplants.,"Oral valacyclovir for cytomegalovirus (CMV) prophylaxis in bone marrow transplantation (BMT) was investigated in a randomized, double-blind, acyclovir-controlled, multicenter clinical trial in recipients of allogeneic BMT who were CMV seropositive (or donor positive) before transplantation and were aged 13 years or older. Patients were randomized before BMT. All initially received intravenous acyclovir (500 mg/m(2)) 3 times daily until day 28 after transplantation or after discharge, then oral valacyclovir (2 g) or acyclovir (800 mg) 4 times daily until week 18 after transplantation. Evidence of CMV infection, CMV disease, and death were documented for 22 weeks. Primary end points were time to CMV infection (detection of CMV in blood, broncho-alveolar lavage) or CMV disease and survival. Preemptive CMV therapy was permitted. Seven hundred twenty-seven patients were evaluable for efficacy. After the administration of intravenous acyclovir, valacyclovir was significantly more effective than oral acyclovir in reducing the incidence of CMV infection. CMV infection or disease developed in 102 (28%) valacyclovir patients, compared with 143 (40%) acyclovir patients (HR, 0.59; 95% CI, 0.46-0.76; P <.0001). Survival did not differ between treatments (76% and 75% in the valacyclovir and acyclovir groups, respectively). The safety of oral valacyclovir was similar to that of high-dose oral acyclovir. Valacyclovir was more effective than acyclovir in preventing CMV reactivation in BMT recipients and showed a similar safety profile. CMV disease incidence was low, and no differences were observed between oral valacyclovir and acyclovir. Survival was similar in each group. Valacyclovir prophylaxis provides a clinically valuable intervention but must be part of an overall strategy for CMV prevention in BMT.",2002,Valacyclovir was more effective than acyclovir in preventing CMV reactivation in BMT recipients and showed a similar safety profile.,"['Seven hundred twenty-seven patients were evaluable for efficacy', 'bone marrow transplantation (BMT', 'recipients of allogeneic bone marrow transplants', 'recipients of allogeneic BMT who were CMV seropositive (or donor positive) before transplantation and were aged 13 years or older']","['oral acyclovir', 'intravenous acyclovir', 'Preemptive CMV therapy', 'acyclovir', 'valacyclovir', 'intravenous acyclovir, valacyclovir', 'valacyclovir and acyclovir', 'Valacyclovir prophylaxis', 'Oral valacyclovir', 'Valacyclovir']","['CMV infection or disease', 'CMV reactivation', 'Survival', 'CMV disease incidence', 'CMV infection, CMV disease, and death', 'incidence of CMV infection', 'time to CMV infection (detection of CMV in blood, broncho-alveolar lavage) or CMV disease and survival']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]",727.0,0.195366,Valacyclovir was more effective than acyclovir in preventing CMV reactivation in BMT recipients and showed a similar safety profile.,"[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': 'Department of Haematology, Huddinge University Hospital, Stockholm, Sweden. per.ljungman@medhs.ki.se'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de La Camara', 'Affiliation': ''}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Milpied', 'Affiliation': ''}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': ''}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Russell', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Crisp', 'Affiliation': ''}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Webster', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
252,11739201,Administration of cyclosporine for 24 months compared with 6 months for prevention of chronic graft-versus-host disease: a prospective randomized clinical trial.,"This study compared the incidence of clinical extensive chronic graft-versus-host disease (GVHD), transplantation-related mortality, survival, and relapse-free survival among recipients randomly assigned to receive a 24-month or a 6-month course of cyclosporine prophylaxis after transplantation of allogeneic marrow from an HLA-identical sibling or alternative donor. Patients who did not have clinical manifestations of chronic GVHD on day 80 after transplantation were eligible for the study if they previously had acute GVHD or if a skin biopsy showed histologic evidence of chronic GVHD. Clinical extensive chronic GVHD developed in 35 of the 89 patients (39%) in the 24-month group and 37 of the 73 patients (51%) in the 6-month group. The hazard of developing chronic GVHD was not significantly different in the 2 groups (hazard ratio = 0.76; 95% confidence interval, 0.48-1.21; P =.25). In addition, there were no significant differences between the 2 groups in transplantation-related mortality, survival, or disease-free survival.",2001,The hazard of developing chronic GVHD was not significantly different in the 2 groups (hazard ratio = 0.76,['Patients who did not have clinical manifestations of chronic GVHD on day 80 after transplantation were eligible for the study if they previously had acute GVHD or if a skin biopsy showed histologic evidence of chronic GVHD'],"['cyclosporine', 'cyclosporine prophylaxis after transplantation of allogeneic marrow from an HLA-identical sibling or alternative donor']","['hazard of developing chronic GVHD', 'clinical extensive chronic graft-versus-host disease (GVHD), transplantation-related mortality, survival, and relapse-free survival', 'transplantation-related mortality, survival, or disease-free survival', 'Clinical extensive chronic GVHD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1280464', 'cui_str': 'Manifestation of (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.154301,The hazard of developing chronic GVHD was not significantly different in the 2 groups (hazard ratio = 0.76,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kansu', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gooley', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': ''}]",Blood,[]
253,11468148,Postremission therapy in older patients with de novo acute myeloid leukemia: a randomized trial comparing mitoxantrone and intermediate-dose cytarabine with standard-dose cytarabine.,"The treatment of older patients with acute myeloid leukemia (AML) remains unsatisfactory, with complete remission (CR) achieved in only approximately 50% and long-term disease-free survival in 10% to 20%. Three hundred eighty-eight patients (60 years of age and older) with newly diagnosed de novo AML were randomly assigned to receive placebo (P) or granulocyte-macrophage colony-stimulating factor (GM-CSF) or GM in a double-blind manner, beginning 1 day after the completion of 3 days of daunorubicin and 7 days of cytarabine therapy. No differences were found in the rates of leukemic regrowth, CR, or infectious complications in either arm. Of 205 patients who achieved CR, 169 were medically well and were randomized to receive cytarabine alone or a combination of cytarabine and mitoxantrone. With a median follow-up of 7.7 years, the median disease-free survival times were 11 months and 10 months for those randomized to cytarabine or cytarabine/mitoxantrone, respectively. Rates of relapse, excluding deaths in CR, were 77% for cytarabine and 82% for cytarabine/mitoxantrone. Induction randomization had no effect on leukemic relapse rate or remission duration in either postremission arm. Because cytarabine/mitoxantrone was more toxic and no more effective than cytarabine, it was concluded that this higher-dose therapy had no benefit in the postremission management of older patients with de novo AML. These results suggest the need to develop novel therapeutic strategies for these patients. (Blood. 2001;98:548-553)",2001,"Rates of relapse, excluding deaths in CR, were 77% for cytarabine and 82% for cytarabine/mitoxantrone.","['Three hundred eighty-eight patients (60 years of age and older) with newly diagnosed de novo AML', 'older patients with acute myeloid leukemia (AML', 'older patients with de novo acute myeloid leukemia', 'older patients with de novo AML', '205 patients who achieved CR, 169 were medically well']","['cytarabine/mitoxantrone', 'Postremission therapy', 'cytarabine', 'cytarabine alone or a combination of cytarabine and mitoxantrone', 'placebo (P) or granulocyte-macrophage colony-stimulating factor (GM-CSF) or GM', 'mitoxantrone and intermediate-dose cytarabine with standard-dose cytarabine', 'cytarabine or cytarabine/mitoxantrone', 'daunorubicin and 7 days of cytarabine therapy']","['median disease-free survival times', 'Rates of relapse, excluding deaths in CR', 'complete remission (CR', 'leukemic relapse rate or remission duration', 'rates of leukemic regrowth, CR, or infectious complications']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.197667,"Rates of relapse, excluding deaths in CR, were 77% for cytarabine and 82% for cytarabine/mitoxantrone.","[{'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. rstone@partners.org'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Berg', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Dodge', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Paciucci', 'Affiliation': ''}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Schulman', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Baer', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}]",Blood,[]
254,4005428,Do androgens enhance the response to antithymocyte globulin in patients with aplastic anemia? A prospective randomized trial.,"We analyzed the effect of antithymocyte globulin (ATG) with or without androgens in 121 patients with aplastic anemia. Fifty-three patients with moderate to severe aplastic anemia were prospectively randomized to receive ATG with or without oral androgens. Eleven of 26 patients (42%) receiving ATG plus androgen responded, including three complete and eight partial responses. Twelve of 27 patients (44%) receiving ATG plus placebo responded, including five complete and seven partial responses. The difference in response rates was not significant (P greater than .9). Survival was also comparable in the two groups; for patients with severe aplastic anemia, actuarial survival at two years was 55% +/- 24% (95% confidence interval) in patients receiving ATG plus androgen compared with 50% +/- 24% in the ATG plus placebo group (P = .65). Furthermore, results in both groups were indistinguishable from those obtained in 68 historical controls receiving ATG without androgens. These data indicate that androgens are not required in order to respond to antithymocyte globulin and the addition of androgens, as used in this trial, did not significantly improve response rates to ATG treatment.",1985,"Survival was also comparable in the two groups; for patients with severe aplastic anemia, actuarial survival at two years was 55% +/-","['121 patients with aplastic anemia', 'Fifty-three patients with moderate to severe aplastic anemia', 'Twelve of 27 patients (44%) receiving', 'patients with aplastic anemia', '68 historical controls receiving ATG without androgens']","['ATG plus placebo', 'placebo', 'ATG with or without oral androgens', 'antithymocyte globulin (ATG', 'antithymocyte globulin']","['response rates', 'severe aplastic anemia, actuarial survival', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",121.0,0.456294,"Survival was also comparable in the two groups; for patients with severe aplastic anemia, actuarial survival at two years was 55% +/-","[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Champlin', 'Affiliation': ''}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Feig', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lenarsky', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': ''}]",Blood,[]
255,11520780,Thrombopoietin therapy increases platelet yields in healthy platelet donors.,"The recombinant thrombopoietins have been shown to be effective stimulators of platelet production in cancer patients. It was therefore of interest to determine if one of these, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), could be used to increase platelet counts and consequently platelet yields from apheresis in healthy platelet donors. In a blinded, 2-cycle, crossover study, 59 platelet donors were randomized to receive a single subcutaneous injection of PEG-rHuMGDF (1 microg/kg or 3 microg/kg) or placebo and 15 days later undergo platelet apheresis. Donors treated with placebo had a median peak platelet count after PEG-rHuMGDF injection of 248 x 10(9)/L compared with 366 x 10(9)/L in donors treated with 1 microg/kg PEG-rHuMGDF and 602 x 10(9)/L in donors treated with 3 microg/kg PEG-rHuMGDF. The median maximum percentage that platelet counts increased from baseline was 10% in donors who received placebo compared with 70% in donors who received 1 microg/kg and 167% in donors who received 3 microg/kg PEG-rHuMGDF. There was a direct relationship between the platelet yield and the preapheresis platelet count: Placebo-treated donors provided 3.8 x 10(11) (range 1.3 x 10(11)-7.9 x 10(11)) platelets compared with 5.6 x 10(11) (range 2.6 x 10(11)-12.5 x 10(11)) or 11.0 x 10(11) (range 7.1 x 10(11)-18.3 x 10(11)) in donors treated with 1 microg/kg or 3 microg/kg PEG-rHuMGDF, respectively. Substandard collections (<3 x 10(11) platelets) were obtained from 26%, 4%, and 0% of the placebo, 1 microg/kg, and 3 microg/kg donors, respectively. No serious adverse events were reported; nor were there events that met the criteria for dose-limiting toxicity. Thrombopoietin therapy can increase platelet counts in healthy donors to provide a median 3-fold more apheresis platelets compared with untreated donors.",2001,There was a direct relationship between the platelet yield and the preapheresis platelet count: Placebo-treated donors provided 3.8 x 10(11) (range 1.3 x 10(11)-7.9 x 10(11)),"['healthy platelet donors', '59 platelet donors', 'cancer patients', 'healthy donors']","['PEG-rHuMGDF', 'placebo', 'Thrombopoietin therapy']","['platelet yields', 'serious adverse events', 'median peak platelet count', 'platelet counts', 'median maximum percentage that platelet counts']","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",,0.106838,There was a direct relationship between the platelet yield and the preapheresis platelet count: Placebo-treated donors provided 3.8 x 10(11) (range 1.3 x 10(11)-7.9 x 10(11)),"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': 'Hematology/Oncology Unit, Massachusetts General Hospital, Boston 02114, USA. kuter.david@mgh.harvard.edu'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Goodnough', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Romo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'DiPersio', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tomita', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sheridan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': ''}]",Blood,[]
256,11520781,Prophylactic platelet transfusions from healthy apheresis platelet donors undergoing treatment with thrombopoietin.,"Many patients receiving dose-intensive chemotherapy acquire thrombocytopenia and need platelet transfusions. A study was conducted to determine whether platelets harvested from healthy donors treated with thrombopoietin could provide larger increases in platelet counts and thereby delay time to next platelet transfusion compared to routinely available platelets given to thrombocytopenic patients. Community platelet donors received either 1 or 3 microg/kg pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo and then donated platelets 10 to 15 days later. One hundred sixty-six of these platelet concentrates were then transfused to 120 patients with platelets counts 25 x 10(9)/L or lower. Pretransfusion platelet counts (11 x 10(9)/L) were similar for recipients of placebo-derived and PEG-rHuMGDF-derived platelets. Early after transfusion, the median platelet count increment was higher in patients receiving PEG-rHuMGDF-derived platelets: 19 (range, -12-66) x 10(9)/L, 41 (range, 5-133) x 10(9)/L, and 82 (range, -4-188) x 10(9)/L for placebo-, 1-microg/kg-, and 3-micro/kg-derived platelets, respectively. This difference was maintained 18 to 24 hours after transfusion. Transfusion-free intervals were 1.72, 2.64, and 3.80 days for the recipients of the placebo-, 1-microg/kg-, and 3-micro/kg-derived platelets, respectively. The rate of transfusion-related adverse events was not different in recipients of placebo-derived and PEG-rHuMGDF-derived platelets. Therefore, when transfused into patients with thrombocytopenia, platelets collected from healthy donors undergoing thrombopoietin therapy were safe and resulted in significantly greater platelet count increments and longer transfusion-free intervals than platelets obtained from donors treated with placebo.",2001,"Early after transfusion, the median platelet count increment was higher in patients receiving PEG-rHuMGDF-derived platelets: 19 (range, -12-66)","['healthy apheresis platelet donors undergoing treatment with thrombopoietin', 'Many patients receiving dose-intensive chemotherapy acquire thrombocytopenia and need platelet transfusions', 'healthy donors treated with', 'One hundred sixty-six of these platelet concentrates were then transfused to 120 patients with platelets counts 25 x 10(9)/L or lower']","['placebo', 'Prophylactic platelet transfusions', 'thrombopoietin', '1 or 3 microg/kg pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo', 'thrombopoietin therapy']","['Transfusion-free intervals', 'platelet count increments and longer transfusion-free intervals', 'platelet counts', 'Pretransfusion platelet counts', 'median platelet count increment', 'rate of transfusion-related adverse events']","[{'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0154301', 'cui_str': 'Acquired thrombocytopenia (disorder)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.124424,"Early after transfusion, the median platelet count increment was higher in patients receiving PEG-rHuMGDF-derived platelets: 19 (range, -12-66)","[{'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Goodnough', 'Affiliation': 'Department of Medicine, Washington University, St Louis, MO 63110-1093, USA. goodnough@labmed.wustl.edu'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Slichter', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'DiPersio', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Romo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Peterson', 'Affiliation': ''}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Raife', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tomita', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Armstrong', 'Affiliation': ''}]",Blood,[]
257,11520815,Increased risk of deep-vein thrombosis in patients with multiple myeloma receiving thalidomide and chemotherapy.,"The occurrence of deep-vein thrombosis (DVT) in patients with newly diagnosed multiple myeloma, who were randomly assigned to receive identical induction chemotherapy with or without thalidomide, are reported in this study. The 2 study arms were comparable with respect to key myeloma prognostic factors and known risk factors for DVT. One hundred patients received induction chemotherapy including 4 cycles of continuous infusion of combinations of dexamethasone, vincristine, doxorubicin, cyclophosphamide, etoposide, and cisplatin, and each patient completed at least one induction cycle. DVT developed in 14 of 50 patients (28%) randomly assigned to receive thalidomide but in only 2 of 50 patients (4%) not given the agent (P =.002). All episodes of DVT occurred during the first 3 cycles of induction. Administration of thalidomide was resumed safely in 75% of patients receiving anticoagulation therapy. Thus, thalidomide given in combination with multiagent chemotherapy and dexamethasone is associated with a significantly increased risk of DVT, which appears to be safely treated with anticoagulation and does not necessarily warrant discontinuation of thalidomide.",2001,DVT developed in 14 of 50 patients (28%) randomly assigned to receive thalidomide but in only 2 of 50 patients (4%) not given the agent (P =.002).,"['patients with multiple myeloma receiving', 'One hundred patients received', 'patients with newly diagnosed multiple myeloma']","['thalidomide', 'identical induction chemotherapy with or without thalidomide', 'dexamethasone', 'induction chemotherapy', 'dexamethasone, vincristine, doxorubicin, cyclophosphamide, etoposide, and cisplatin', 'thalidomide and chemotherapy']","['DVT', 'Increased risk of deep-vein thrombosis', 'risk of DVT', 'occurrence of deep-vein thrombosis (DVT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",100.0,0.0331805,DVT developed in 14 of 50 patients (28%) randomly assigned to receive thalidomide but in only 2 of 50 patients (4%) not given the agent (P =.002).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zangari', 'Affiliation': 'Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences, Little Rock, AR, USA. zangarimaurizio@uams.edu'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Anaissie', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Barlogie', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Badros', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Desikan', 'Affiliation': ''}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Gopal', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Toor', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tricot', 'Affiliation': ''}]",Blood,[]
258,11520776,The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): analysis of 1065 patients entered into the United Kingdom Medical Research Council AML11 trial.,"Acute myeloid leukemia (AML) in older adults carries a poor prognosis, and the optimum treatment remains to be determined. In younger patients, treatment stratification is frequently based upon diagnostic karyotype, which was the most important prognostic factor in the UK Medical Research Council (MRC) AML10 trial. Considered here is whether karyotype is also predictive in older adults; this is done by studying 1065 cases from MRC AML11 (median age, 66 years). Three prognostic groups were distinguished on the basis of response to induction therapy and overall survival (OS). Those with t(15;17), t(8;21), or inv(16) composed the favorable risk group. Overall, these abnormalities predicted a superior complete remission (CR) rate (72%), reflecting relatively low levels of resistant disease (RD) (8%), and lower relapse risk (RR) (56%) associated with superior OS (34% at 5 years). Normal karyotype (CR, 63%; RD, 17%; RR, 78%; OS, 15%) and other noncomplex abnormalities (CR, 53%; RD, 32%; RR, 85%; OS, 10%) composed the intermediate group; while complex karyotype predicted an extremely poor prognosis (CR, 26%; RD, 56%; RR, 91%; OS, 2%). Combining MRC AML10 and AML11 (n = 2677) revealed that the most favorable changes were rarer in older patients (younger than 55 years, 24%; 55 years or older, 7%), while complex abnormalities were more common (6% vs 13%). This study suggests that hierarchical cytogenetic classification identifies biologically distinct subsets of AML that are represented in all age groups. Furthermore, it highlights the importance of karyotype as a critical independent determinant of outcome in older patients with AML, providing a potential framework for stratified treatment approaches.",2001,Three prognostic groups were distinguished on the basis of response to induction therapy and overall survival (OS).,"['Acute myeloid leukemia (AML) in older adults', '1065 cases from MRC AML11 (median age, 66 years', 'older patients with AML', 'older adults', '1065 patients entered into the United Kingdom Medical Research Council AML11 trial', 'older adults with acute myeloid leukemia (AML']",[],"['lower relapse risk (RR', 'noncomplex abnormalities', 'overall survival (OS', 'superior complete remission (CR) rate']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0431914,Three prognostic groups were distinguished on the basis of response to induction therapy and overall survival (OS).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Grimwade', 'Affiliation': 'Department of Haematology, University College London Hospitals and Medical School, London, United Kingdom.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oliver', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chatters', 'Affiliation': ''}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Goldstone', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
259,11418458,Blood levels of immune cells predict survival in myeloma patients: results of an Eastern Cooperative Oncology Group phase 3 trial for newly diagnosed multiple myeloma patients.,"Previously, it was reported that patients with multiple myeloma (MM) who have higher baseline levels of blood CD4(+) or CD19(+) cells have longer survival. This article extends the analysis of immune cell levels and survival in a large cohort (N = 504) of patients with MM entered on Eastern Cooperative Oncology Group (ECOG) phase 3 trial (9486). Newly diagnosed patients with MM received 2 cycles of vincristine, bischloroethylnitrosourea, melphalan, cytoxan, prednisone (VBMCP) and were treated on one of 3 randomized arms: VBMCP with either interferon or high-dose cyclophosphamide, or VBMCP alone. Blood immune cell levels were studied at trial entry (baseline), after 2 cycles of chemotherapy, after 2 years of therapy, and at relapse. Baseline CD3(+), CD4(+), CD8(+), CD19(+), and CD4(+) subset cell levels were all positively associated with survival (P =.0087 to P <.0001). A multivariate analysis incorporating CD4(+) and CD19(+) cell levels defined 3 separate groups of patients with MM to survival outcome. Higher CD19(+) blood levels were positively associated with MM-patient survival at entry to the study, at year 2, and at relapse (P <.0001 at all 3 timepoints). Patients with MM had evidence of immune cell reconstitution after 2 years of therapy, but the rate and extent of recovery was greater for CD8(+), which was greater than CD4(+), which was greater than CD19(+). This latter data affirms the positive relationship between the quantitative status of the blood immune system in MM and survival. In addition, the importance of the CD19(+) blood cells to survival is evident throughout the course of MM. Therapeutic efforts to maintain an intact immune system may be crucial in maximizing chemotherapeutic and/or immunotherapy efforts in this disease.",2001,"Higher CD19(+) blood levels were positively associated with MM-patient survival at entry to the study, at year 2, and at relapse (P <.0001 at all 3 timepoints).","['Newly diagnosed patients with MM', 'newly diagnosed multiple myeloma patients', 'myeloma patients', 'patients with multiple myeloma (MM', 'large cohort (N = 504) of patients with MM entered on Eastern Cooperative Oncology Group (ECOG) phase 3 trial (9486']","['vincristine, bischloroethylnitrosourea, melphalan, cytoxan, prednisone (VBMCP', 'VBMCP with either interferon or high-dose cyclophosphamide, or VBMCP alone']","['MM-patient survival', 'Blood immune cell levels', 'Baseline CD3(+), CD4(+), CD8(+), CD19(+), and CD4(+) subset cell levels', 'immune cell reconstitution', 'Higher CD19(+) blood levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0699319', 'cui_str': 'Cytoxan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005768'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",9486.0,0.227522,"Higher CD19(+) blood levels were positively associated with MM-patient survival at entry to the study, at year 2, and at relapse (P <.0001 at all 3 timepoints).","[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Kay', 'Affiliation': 'Mayo Clinic, Rochester, MN 55905, USA. kay.neil@mayo.edu'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Leong', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bone', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Vesole', 'Affiliation': ''}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Greipp', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Van Ness', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Oken', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Kyle', 'Affiliation': ''}]",Blood,[]
260,11369630,Controlled trial of filgrastim for acceleration of neutrophil recovery after allogeneic blood stem cell transplantation from human leukocyte antigen-matched related donors.,"The rapid recovery of hematopoiesis after allogeneic blood stem cell transplantation has been attributed to the quality and quantity of hematopoietic progenitors in the blood stem cell grafts from filgrastim-stimulated donors. To determine whether further stimulation with filgrastim after transplantation would affect hematopoietic recovery, a prospective, randomized, controlled study was performed. Forty-two adult recipients of allogeneic blood stem cells from human leukocyte antigen-matched related donors were randomized to receive 10 microg/kg per day filgrastim subcutaneously from day 1 through neutrophil recovery or no growth factor support after transplantation. There was no significant difference between the 2 groups in the number of CD34(+) cells infused (median, 4.8 vs 4.3 x 10(6)/kg). Graft-versus-host (GVHD) disease prophylaxis consisted of tacrolimus and steroids for 9 patients and tacrolimus and minimethotrexate for 33 patients. The group receiving filgrastim had a shorter time to neutrophil levels greater than 0.5 x 10(9)/L (day 12 vs day 15, P =.002) and to neutrophil levels greater than 1.0 x 10(9)/L (day 12 vs day 16, P =.01). The filgrastim group also had a trend for earlier discharge (day 16 vs 20, P =.05). There was no significant difference between the groups in time to platelet recovery, number of transfusions, regimen-related toxicity, infection, incidence of GVHD, relapse, survival, or hospital charges. It can be concluded that the administration of filgrastim after allogeneic blood stem cell transplantation shortens the time to neutrophil recovery. (Blood. 2001;97:3405-3410)",2001,"There was no significant difference between the groups in time to platelet recovery, number of transfusions, regimen-related toxicity, infection, incidence of GVHD, relapse, survival, or hospital charges.","['after allogeneic blood stem cell transplantation from human leukocyte antigen-matched related donors', '9 patients and tacrolimus and minimethotrexate for 33 patients', 'Forty-two adult recipients of allogeneic blood stem cells from human leukocyte antigen-matched related donors']","['tacrolimus and steroids', 'filgrastim subcutaneously from day 1 through neutrophil recovery or no growth factor support after transplantation', 'filgrastim', 'allogeneic blood stem cell transplantation']","['shorter time to neutrophil levels', 'time to platelet recovery, number of transfusions, regimen-related toxicity, infection, incidence of GVHD, relapse, survival, or hospital charges', 'earlier discharge', 'neutrophil recovery', 'number of CD34', 'neutrophil levels']","[{'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0445119', 'cui_str': 'No growth (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0206175', 'cui_str': 'Hospital Charges'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}]",42.0,0.0447432,"There was no significant difference between the groups in time to platelet recovery, number of transfusions, regimen-related toxicity, infection, incidence of GVHD, relapse, survival, or hospital charges.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': 'Baylor College of Medicine, Center for Cell and Gene Therapy, The University of Texas M. D. Anderson Cancer Center, 6565 Fannin Street, Houston, TX 77030, USA. donnap@bcm.tmc.edu'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Folloder', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Anderlini', 'Affiliation': ''}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Körbling', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lichtiger', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Norfleet', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Champlin', 'Affiliation': ''}]",Blood,[]
261,11023504,"Cladribine with prednisone versus chlorambucil with prednisone as first-line therapy in chronic lymphocytic leukemia: report of a prospective, randomized, multicenter trial.","The efficacy and toxicity of cladribine (2-CdA) + prednisone (P) versus chlorambucil (Chl) + P were compared in previously untreated patients with progressive or symptomatic chronic lymphocytic leukemia (CLL) in a randomized, multicenter prospective trial. Eligible patients were assigned to either 2-CdA 0.12 mg/kg per day in 2-hour infusions and P 30 mg/m(2) per day for 5 consecutive days or Chl 12 mg/m(2) per day and P 30 mg/m(2) per day for 7 consecutive days. Three courses were administered at 28-day intervals or longer if myelosuppression developed. The therapy was finished if complete response (CR) was achieved. Of 229 available patients 126 received 2-CdA+P and 103 received Chl+P as a first-line treatment. CR and overall response rates were significantly higher in the patients treated with 2-CdA+P (47% and 87%, respectively) than in the patients treated with Chl+P (12% and 57%, respectively) (P = .001). Progression-free survival was significantly longer in the 2-CdA-treated group (P = .01), but event-free survival was not statistically different. Thirteen percent of patients were refractory to 2-CdA+P and 43% to Chl+P (P = .001). Drug-induced neutropenia was more frequently observed during 2-CdA+P (23%) than Chl+P therapy (11%) (P = .02), but thrombocytopenia occurred with similar frequency in both groups (36% and 27%, respectively). Infections were seen more frequently in the 2-CdA+P-treated group (56%) than in the Chl+P-treated group (40%; P = .02). Death rates have so far been similar in patients treated with 2-CdA (20%) and with Chl (17%). The probability of overall survival calculated from Kaplan-Meier curves at 24 months was also similar for both groups (78% and 82%, respectively). (Blood. 2000;96:2723-2729)",2000,"Progression-free survival was significantly longer in the 2-CdA-treated group (P = .01), but event-free survival was not statistically different.","['chronic lymphocytic leukemia', 'previously untreated patients with progressive or symptomatic chronic lymphocytic leukemia (CLL', 'Eligible patients']","['2-CdA+P', 'cladribine (2-CdA) + prednisone (P) versus chlorambucil (Chl) + P', 'Cladribine with prednisone versus chlorambucil with prednisone', '2-CdA', 'Chl+P']","['Drug-induced neutropenia', 'Progression-free survival', 'Infections', 'thrombocytopenia', 'Death rates', 'probability of overall survival', 'CR and overall response rates', 'event-free survival', 'efficacy and toxicity']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0002876', 'cui_str': 'Congenital dyserythropoietic anemia (disorder)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}]","[{'cui': 'C0272178', 'cui_str': 'Idiosyncratic neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0778431,"Progression-free survival was significantly longer in the 2-CdA-treated group (P = .01), but event-free survival was not statistically different.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Medical University of Lodz, Poland. robaktad@psk2.am.lodz.pl'}, {'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Bloński', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kasznicki', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blasińska-Morawiec', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Krykowski', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dmoszyńska', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mrugala-Spiewak', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Skotnicki', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Konopka', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ceglarek', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maj', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dwilewicz-Trojaczek', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hellmann', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Urasiński', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zdziarska', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kotlarek-Haus', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Potoczek', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Grieb', 'Affiliation': ''}]",Blood,[]
262,11222362,Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01.,"The Dana-Farber Cancer Institute (DFCI) acute lymphoblastic leukemia (ALL) Consortium Protocol 91-01 was designed to improve the outcome of children with newly diagnosed ALL while minimizing toxicity. Compared with prior protocols, post-remission therapy was intensified by substituting dexamethasone for prednisone and prolonging the asparaginase intensification from 20 to 30 weeks. Between 1991 and 1995, 377 patients (age, 0-18 years) were enrolled; 137 patients were considered standard risk (SR), and 240 patients were high risk (HR). Following a 5.0-year median follow-up, the estimated 5-year event-free survival (EFS) +/- SE for all patients was 83% +/- 2%, which is superior to prior DFCI ALL Consortium protocols conducted between 1981 and 1991 (P =.03). There was no significant difference in 5-year EFS based upon risk group (87% +/- 3% for SR and 81% +/- 3% for HR, P =.24). Age at diagnosis was a statistically significant prognostic factor (P =.03), with inferior outcomes observed in infants and children 9 years or older. Patients who tolerated 25 or fewer weeks of asparaginase had a significantly worse outcome than those who received at least 26 weeks of asparaginase (P <.01, both univariate and multivariate). Older children (at least 9 years of age) were significantly more likely to have tolerated 25 or fewer weeks of asparaginase (P <.01). Treatment on Protocol 91-01 significantly improved the outcome of children with ALL, perhaps due to the prolonged asparaginase intensification and/or the use of dexamethasone. The inferior outcome of older children may be due, in part, to increased intolerance of intensive therapy.",2001,"Age at diagnosis was a statistically significant prognostic factor (P =.03), with inferior outcomes observed in infants and children 9 years or older.","['older children', 'Between 1991 and 1995, 377 patients (age, 0-18 years) were enrolled; 137 patients were considered standard risk (SR), and 240 patients were high risk (HR', 'children with newly diagnosed ALL while minimizing toxicity', 'children with acute lymphoblastic leukemia', 'Older children (at least 9 years of age']","['dexamethasone for prednisone', 'dexamethasone']","['5-year EFS', 'estimated 5-year event-free survival (EFS) ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",137.0,0.026506,"Age at diagnosis was a statistically significant prognostic factor (P =.03), with inferior outcomes observed in infants and children 9 years or older.","[{'ForeName': 'L B', 'Initials': 'LB', 'LastName': 'Silverman', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber Cancer Institute, the Division of Hematology/Oncology, Children's Hospital, Harvard Medical School, Boston, MA 02215, USA. lewis_silverman@dfci.harvard.edu""}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': ''}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Asselin', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Barr', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Clavell', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Hurwitz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moghrabi', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Schorin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arkin', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Declerck', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Sallan', 'Affiliation': ''}]",Blood,[]
263,11090092,Thalidomide for treatment of patients with chronic graft-versus-host disease.,"In a randomized, placebo-controlled, double-blind trial, thalidomide or placebo together with glucocorticoids and either cyclosporine or tacrolimus was administered as initial therapy for clinical extensive chronic graft-versus-host disease (cGVHD). All patients had thrombocytopenia or cGVHD that evolved directly from acute GVHD as an indicator of a poor prognosis. The study drug (thalidomide or placebo) was administered initially at a dose of 200 mg orally per day, followed by a gradual increase to 800 mg/d if side effects were tolerable. Treatment with the study drug was discontinued before resolution of cGVHD in 23 (92%) of the 25 patients who received thalidomide and in 17 (65%) of the 26 patients who received placebo (P =.02). Neutropenia and neurologic symptoms were the most frequent reasons for early discontinuation of treatment with thalidomide. The duration of treatment with thalidomide was too short to assess its efficacy in controlling cGVHD. (Blood. 2000;96:3995-3996)",2000,Treatment with the study drug was discontinued before resolution of cGVHD in 23 (92%) of the 25 patients who received thalidomide and in 17 (65%) of the 26 patients who received placebo (P =.02).,"['patients with chronic graft-versus-host disease', 'clinical extensive chronic graft-versus-host disease (cGVHD']","['thalidomide or placebo', 'Thalidomide', 'placebo', 'thalidomide', 'glucocorticoids and either cyclosporine or tacrolimus']","['Neutropenia and neurologic symptoms', 'thrombocytopenia or cGVHD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}]","[{'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}]",,0.41637,Treatment with the study drug was discontinued before resolution of cGVHD in 23 (92%) of the 25 patients who received thalidomide and in 17 (65%) of the 26 patients who received placebo (P =.02).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koc', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': ''}]",Blood,[]
264,11133742,"A comparison of allogeneic bone marrow transplantation, autologous bone marrow transplantation, and aggressive chemotherapy in children with acute myeloid leukemia in remission.","Intensive, myelosuppressive therapy is necessary to maximize outcomes for patients with acute myeloid leukemia (AML). A comparison was made of 3 aggressive postremission approaches for children and adolescents with AML in a randomized trial, CCG-2891. A total of 652 children and adolescents with AML who achieved remission on 2 induction regimens using identical drugs and doses (standard and intensive timing) were eligible for allocation to allogeneic bone marrow transplantation (BMT) based on matched related donor status (n = 181) or randomization to autologous BMT (n = 177) or to aggressive high-dose cytarabine-based chemotherapy (n = 179). Only 115 patients (18%) refused to participate in the postremission phase of this study. Overall compliance with the 3 allocated regimens was 90%. At 8 years actuarial, 54% +/- 4% (95% confidence interval) of all remission patients remain alive. Survival by assigned regimen (""intent to treat"") is as follows: allogeneic BMT, 60% +/- 9%; autologous BMT, 48% +/- 8%; and chemotherapy, 53% +/- 8%. Survival in the allogeneic BMT group is significantly superior to autologous BMT (P =.002) and chemotherapy (P =.05); differences between chemotherapy and autologous BMT are not significant (P =.21). No potential confounding factors affected results. Patients receiving intensive-timing induction therapy had superior long-term survival irrespective of postremission regimen received (allogeneic BMT, 70% +/- 9%; autologous BMT, 54% +/- 9%; chemotherapy, 57% +/- 10%). Allogeneic BMT remains the treatment of choice for children and adolescents with AML in remission, when a matched related donor is available. For all others, there is no advantage to autologous BMT; hence, aggressive nonablative chemotherapy should be used.",2001,Survival in the allogeneic BMT group is significantly superior to autologous BMT (P =.002) and chemotherapy (P =.05); differences between chemotherapy and autologous BMT are not significant (P =.21).,"['652 children and adolescents with AML who achieved remission on 2 induction regimens using identical drugs and doses (standard and intensive timing) were eligible for allocation to allogeneic bone marrow transplantation (BMT) based on matched related donor status (n = 181) or randomization to autologous BMT (n = 177) or to', 'patients with acute myeloid leukemia (AML', 'Patients receiving intensive-timing induction therapy had superior long-term survival irrespective of postremission regimen received (allogeneic BMT, 70% ', 'children with acute myeloid leukemia in remission', 'children and adolescents with AML']","['aggressive high-dose cytarabine-based chemotherapy', 'autologous BMT', 'Intensive, myelosuppressive therapy', 'allogeneic bone marrow transplantation, autologous bone marrow transplantation, and aggressive chemotherapy', 'Allogeneic BMT']","['Survival', 'Overall compliance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0481508', 'cui_str': 'Donor status (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0153886', 'cui_str': 'Acute myeloid leukemia in remission (disorder)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",652.0,0.165098,Survival in the allogeneic BMT group is significantly superior to autologous BMT (P =.002) and chemotherapy (P =.05); differences between chemotherapy and autologous BMT are not significant (P =.21).,"[{'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Woods', 'Affiliation': 'South Carolina Cancer Center, Columbia, SC, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Neudorf', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Barnard', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dusenbery', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'DeSwarte', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Arthur', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Kobrinsky', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood,[]
265,11264156,A prospective randomized phase II trial of GM-CSF priming to prevent topotecan-induced neutropenia in chemotherapy-naive patients with malignant melanoma or renal cell carcinoma.,"We conducted a phase II randomized trial of recombinant granculocyte-macrophage colony-stimulating factor (GM-CSF) administered before topotecan chemotherapy to determine whether it could prevent myelosuppression and to determine the antitumor activity of this topoisomerase I inhibitor in 53 patients with metastatic malignant melanoma and renal cell cancer. All patients received GM-CSF after topotecan at a dose of 250 microg/m(2) daily for at least 8 days. Patients randomly assigned to receive GM-CSF priming were treated with GM-CSF at 250 microg/m(2) twice daily for 5 days before treatment. Twenty-five patients were randomly assigned to receive GM-CSF priming and 28 to receive topotecan without priming. The primary analysis was restricted to the protective effects seen during the first cycle of therapy. Grade 4 neutropenia occurred in 8 of 23 patients (35%) and grade 3 neutropenia in 5 of 23 patients (22%) randomized to GM-CSF priming, whereas 18 of 26 (69%) and 5 of 26 (19%) patients experienced grade 4 or 3 neutropenia, respectively, without GM-CSF priming (P =.0074). The mean duration of neutropenia was reduced by GM-CSF priming: grade 3 neutropenia from 5.2 +/- 0.7 to 2.8 +/- 0.7 days (P =.0232) and grade 4 neutropenia from 2.7 +/- 0.6 to 1.1 +/- 0.4 days (P = 0.0332). The protective effects of GM-CSF extended to the second cycle of treatment. The incidence of febrile neutropenia was also reduced. Chemotherapy-induced anemia and thrombocytopenia were similar in both groups. One partial response was seen in a patient with melanoma, and one patient with renal cell cancer had complete regression of pulmonary metastases and was rendered disease-free by nephrectomy. (Blood. 2001;97:1942-1946)",2001,Chemotherapy-induced anemia and thrombocytopenia were similar in both groups.,"['53 patients with metastatic malignant melanoma and renal cell cancer', 'chemotherapy-naive patients with malignant melanoma or renal cell carcinoma', 'Twenty-five patients']","['recombinant granculocyte-macrophage colony-stimulating factor (GM-CSF', 'GM-CSF after topotecan', 'GM-CSF', 'GM-CSF priming and 28 to receive topotecan without priming']","['febrile neutropenia', 'Grade 4 neutropenia', 'grade 3 neutropenia', 'neutropenia', 'anemia and thrombocytopenia', 'grade 4 neutropenia', 'mean duration of neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860594', 'cui_str': 'Malignant melanoma, metastatic'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0079784', 'cui_str': 'CSF-1'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",25.0,0.0646078,Chemotherapy-induced anemia and thrombocytopenia were similar in both groups.,"[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Janik', 'Affiliation': 'Frederick Cancer Research and Development Center, Biological Response Modifiers Program, National Cancer Institute, National Institutes of Health, Frederick, MD, USA. janikj@mail.nih.gov'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Korn', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Curti', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sznol', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Conlon', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sharfman', 'Affiliation': ''}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Urba', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Gause', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Longo', 'Affiliation': ''}]",Blood,[]
266,11110676,Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group Study.,"The associations of cytogenetics with complete remission (CR) rates, overall survival (OS), and outcomes after CR were studied in 609 previously untreated AML patients younger than 56 years old in a clinical trial comparing 3 intensive postremission therapies: intensive chemotherapy, autologous transplantation (ABMT), or allogeneic bone marrow transplantation (alloBMT) from matched related donors. Patients were categorized into favorable, intermediate, unfavorable, and unknown cytogenetic risk groups based on pretreatment karyotypes. CR rates varied significantly (P <.0001) among the 4 groups: favorable, 84% (95% confidence interval [CI], 77%-90%); intermediate, 76% (CI, 71%-81%); unfavorable, 55% (CI, 48%-63%); and unknown, 54% (CI, 33%-74%). There was similar significant heterogeneity of OS (P <.0001), with the estimated relative risk of death from any cause being 1.50 (CI, 1.10-2.05), 3. 33 (CI, 2.43-4.55), and 2.66 (CI, 1.59-4.45) for the intermediate, unfavorable, and unknown risk groups, respectively, compared with the favorable group. In multivariate analyses, the effects of cytogenetic risk status on CR rate and OS could not be explained by other patient or disease characteristics. Among postremission patients, survival from CR varied significantly among favorable, intermediate, and unfavorable groups (P =.0003), with significant evidence of interaction (P =.017) between the effects of treatment and cytogenetic risk status on survival. Patients with favorable cytogenetics did significantly better following ABMT and alloBMT than with chemotherapy alone, whereas patients with unfavorable cytogenetics did better with alloBMT. Cytogenetic risk status is a significant factor in predicting response of AML patients to therapy; however, to tighten treatment correlates within genetically defined AML subsets, a significantly larger leukemia cytogenetic database is warranted.",2000,"CR rates varied significantly (P <.0001) among the 4 groups: favorable, 84% (95% confidence interval [CI], 77%-90%); intermediate, 76% (CI, 71%-81%); unfavorable, 55% (CI, 48%-63%); and unknown, 54% (CI, 33%-74%).","['adult acute myeloid leukemia', '609 previously untreated AML patients younger than 56 years old']","['preremission and postremission therapy', 'intensive postremission therapies: intensive chemotherapy, autologous transplantation (ABMT), or allogeneic bone marrow transplantation (alloBMT']","['survival from CR', 'cytogenetic risk status on survival', 'complete remission (CR) rates, overall survival (OS), and outcomes after CR', 'CR rate and OS', 'heterogeneity of OS', 'relative risk of death', 'ABMT and alloBMT', 'CR rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",609.0,0.0881178,"CR rates varied significantly (P <.0001) among the 4 groups: favorable, 84% (95% confidence interval [CI], 77%-90%); intermediate, 76% (CI, 71%-81%); unfavorable, 55% (CI, 48%-63%); and unknown, 54% (CI, 33%-74%).","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Slovak', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Cassileth', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Theil', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rowe', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Forman', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
267,10979946,"Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-stimulating factor in children with acquired aplastic anemia.","A prospective multicenter trial of 119 children 1 to 18 years of age with newly diagnosed aplastic anemia (AA) was conducted, comparing treatment using antithymocyte globulin (ATG), cyclosporine (CyA), and danazol (DAN) with or without rhG-CSF (400 microg/m(2), day on days 1-90). All children with very severe AA received rhG-CSF (VSAA group, n = 50). The other children were randomized to receive ATG, CyA, DAN, and rhG-CSF (G-CSF+ group, n = 35) or ATG, CyA, and DAN without rhG-CSF (G-CSF- group, n = 34). After 6 months, the hematologic response rate was 71%, 55%, and 77% in the VSAA group, G-CSF+ group, and G-CSF- group, respectively. There was no difference in the incidence of febrile episodes and documented infections between the G-CSF+ and G-CSF- groups. Bone marrow transplantation (BMT) was attempted in 22 patients in whom initial immunosuppressive therapy (IST; n = 18) failed or in whom a relapse occurred after an initial response (n = 4). Nineteen of the 22 patients are alive and well after a median follow-up of 18 months (range, 3 to 66 months) since BMT. The probability of survival at 4 years was 83% +/- 7% in the VSAA group, 91% +/- 5% in the G-CSF+ group, and 93% +/- 6% in the G-CSF- group. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) developed in one patient in each of the three groups; the overall risk for MDS/AML was 3% +/- 2% at 4 years. Because the results of IST were encouraging, it is suggested that children with AA receive IST as first-line therapy if there is no human leukocyte antigen-matched sibling donor.",2000,There was no difference in the incidence of febrile episodes and documented infections between the G-CSF+ and G-CSF- groups.,"['119 children 1 to 18 years of age with newly diagnosed aplastic anemia (AA', '22 patients in whom initial immunosuppressive therapy (IST; n = 18) failed or in whom a relapse occurred after an initial response (n = 4', 'All children with very severe AA', 'children with acquired aplastic anemia']","['Bone marrow transplantation (BMT', 'ATG, CyA, and DAN without rhG-CSF', 'VSAA', 'G-CSF', 'IST', 'antithymocyte globulin (ATG), cyclosporine (CyA), and danazol (DAN) with or without rhG-CSF', 'Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-stimulating factor', 'ATG, CyA, DAN, and rhG-CSF', 'rhG-CSF (VSAA']","['Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML', 'hematologic response rate', 'probability of survival', 'overall risk for MDS/AML', 'incidence of febrile episodes and documented infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0271907', 'cui_str': 'Idiopathic acquired aplastic anemia'}]","[{'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0023470', 'cui_str': 'Myelogenous Leukemia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0269055,There was no difference in the incidence of febrile episodes and documented infections between the G-CSF+ and G-CSF- groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Japan Childhood Aplastic Anemia Study Group, Nagoya, Japan. kojimas@med.nagoya-u.ac.jp'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hibi', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kosaka', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tsuchida', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mugishima', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sugita', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohara', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tsukimoto', 'Affiliation': ''}]",Blood,[]
268,10979947,"Prolonged fluconazole prophylaxis is associated with persistent protection against candidiasis-related death in allogeneic marrow transplant recipients: long-term follow-up of a randomized, placebo-controlled trial.","Two randomized, placebo-controlled trials previously showed that fluconazole (400 mg/d) administered prophylactically decreases the incidence of candidiasis in blood and marrow transplant (BMT) recipients. However, there exists conflicting data regarding the optimal duration of fluconazole administration, specifically whether prophylaxis through acute graft-versus-host disease (GVHD) results in improved survival in allograft recipients. Reported here are the results of long-term follow-up and a detailed analysis of invasive candidiasis and candidiasis-related death in 300 patients who received fluconazole (400 mg/d) or placebo for 75 days after BMT at the Fred Hutchinson Cancer Research Center. Patients in both treatment arms were compared for survival, causes of death, and the incidence of invasive fungal infections early (less than 110 days) and late (more than 110 days) after BMT. After 8 years of follow-up, survival is significantly better in fluconazole recipients compared with placebo recipients (68 of 152 vs 41 of 148, P =.0001). The overall incidence of invasive candidiasis was increased in patients who received placebo compared with fluconazole (30 of 148 vs 4 of 152, P <.001). More patients who received placebo died with candidiasis early (13 of 148 vs 1 of 152, P =.001) and late (8 of 96 vs 1 of 121, P =.0068) after BMT. The incidence of severe GVHD involving the gut was higher in patients who did not receive fluconazole (20 of 143 vs 8 of 145, P =.02), and fewer patients who received fluconazole died with this complication. Thus, administration of fluconazole (400 mg/d) for 75 days after BMT appears to be associated with decreased gut GVHD, a persistent protection against disseminated candidal infections and candidiasis-related death, resulting in an overall survival benefit in allogeneic BMT recipients.",2000,"The overall incidence of invasive candidiasis was increased in patients who received placebo compared with fluconazole (30 of 148 vs 4 of 152, P <.001).","['allogeneic marrow transplant recipients', 'allogeneic BMT recipients', '300 patients who received']","['fluconazole', 'placebo', 'fluconazole prophylaxis']","['overall incidence of invasive candidiasis', 'survival, causes of death, and the incidence of invasive fungal infections', 'gut GVHD', 'survival', 'overall survival benefit', 'incidence of candidiasis in blood and marrow transplant (BMT) recipients', 'incidence of severe GVHD']","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0005768'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.5062,"The overall incidence of invasive candidiasis was increased in patients who received placebo compared with fluconazole (30 of 148 vs 4 of 152, P <.001).","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Marr', 'Affiliation': 'Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, WA 98109-1024, USA. kmarr@fhcrc.org'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seidel', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Slavin', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bowden', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Schoch', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': ''}]",Blood,[]
269,11049974,"Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin.","The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment. Long-term data on duration of overall survival and relapse-free survival and incidence of subsequent malignancies with this agent are lacking. Patients completing the treatment phase of a randomized, intergroup study who received pentostatin as an initial treatment or who crossed over after failure of interferon alpha were followed for survival, relapse, and diagnosis of subsequent malignancies. Two hundred forty-one patients treated with pentostatin as initial therapy (n = 154) or who crossed over after failure of interferon alpha (n = 87) were followed for a median duration of 9.3 years. Estimated 5- and 10-year survival rates (95% confidence interval) for all patients combined were 90% (87%-94%) and 81% (75%-86%), respectively. In the 173 patients with a confirmed complete response to pentostatin treatment, 5- and 10-year relapse-free survival rates were 85% (80%-91%) and 67% (58%-76%), respectively. Survival curves for patients initially treated with pentostatin and those crossed over were similar. Only 2 of 40 deaths were attributed to hairy cell leukemia. The mortality rate and incidence of subsequent malignancies were not higher than expected in the general population. Pentostatin is a highly effective regimen for hairy cell leukemia that produces durable complete responses. Subsequent malignancies do not appear to be increased with pentostatin treatment.",2000,"The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment.","['173 patients with a confirmed complete response to', 'patients with hairy cell leukemia', 'hairy cell leukemia patients treated with', 'Two hundred forty-one patients treated with pentostatin as initial therapy (n = 154) or who crossed over after failure of interferon alpha (n = 87']","['pentostatin', 'Pentostatin']","['10-year survival rates', '10-year relapse-free survival rates', 'Survival curves', 'duration of overall survival and relapse-free survival and incidence of subsequent malignancies', 'hairy cell leukemia', 'mortality rate and incidence of subsequent malignancies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0023443', 'cui_str': 'Reticuloendotheliosis, Leukemic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030896', 'cui_str': 'Pentostatin'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0030896', 'cui_str': 'Pentostatin'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023443', 'cui_str': 'Reticuloendotheliosis, Leukemic'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",87.0,0.0564758,"The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment.","[{'ForeName': 'I W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Foucar', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Corbett', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cassileth', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Habermann', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Golomb', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Eisenhauer', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cheson', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Grever', 'Affiliation': ''}]",Blood,[]
270,10979948,Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors.,"After the transplantation of unmodified marrow from human leukocyte antigen-matched unrelated donors receiving cyclosporine (CSP) and methotrexate (MTX), the incidence of acute graft-versus-host disease (GVHD) is greater than 75%. Tacrolimus is a macrolide compound that, in previous preclinical and clinical studies, was effective in combination with MTX for the prevention of acute GVHD. Between March 1995 and September 1996, 180 patients were randomized in a phase 3, open-label, multicenter study to determine whether tacrolimus combined with a short course of MTX (n = 90), more than CSP and a short course of MTX (n = 90), would reduce the incidence of acute GVHD after marrow transplantation from unrelated donors. There was a significant trend toward decreased severity of acute GVHD across all grades (P =.005). Based on the Kaplan-Meier estimate, the probability of grade II-IV acute GVHD in the tacrolimus group (56%) was significantly lower than in the CSP group (74%; P =.0002). Use of glucocorticoids for the management of GVHD was significantly lower with tacrolimus than with CSP (65% vs 81%, respectively; P =. 019). The number of patients requiring dialysis in the first 100 days was similar (tacrolimus, 9; CSP, 8). Overall and relapse-free survival rates for the tacrolimus and CSP arms at 2 years was 54% versus 50% (P =.46) and 47% versus 42% (P =.58), respectively. The combination of tacrolimus and MTX after unrelated donor marrow transplantation significantly decreased the risk for acute GVHD than did the combination of CSP and MTX, with no significant increase in toxicity, infections, or leukemia relapse.",2000,"Overall and relapse-free survival rates for the tacrolimus and CSP arms at 2 years was 54% versus 50% (P =.46) and 47% versus 42% (P =.58), respectively.","['prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors', 'Between March 1995 and September 1996, 180 patients']","['methotrexate and tacrolimus with methotrexate and cyclosporine', 'CSP', 'tacrolimus combined with a short course of MTX', 'MTX', 'cyclosporine (CSP) and methotrexate (MTX', 'tacrolimus and MTX', 'glucocorticoids', 'tacrolimus', 'Tacrolimus']","['Overall and relapse-free survival rates', 'GVHD', 'number of patients requiring dialysis', 'risk for acute GVHD', 'toxicity, infections, or leukemia relapse', 'probability of grade II-IV acute GVHD', 'severity of acute GVHD']","[{'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0920028', 'cui_str': 'Leukaemia recurrent'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",180.0,0.0400833,"Overall and relapse-free survival rates for the tacrolimus and CSP arms at 2 years was 54% versus 50% (P =.46) and 47% versus 42% (P =.58), respectively.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, and the Department of Medicine, University of Washington, Seattle, WA, USA. rnash@fhcrc.org'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Karanes', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Fay', 'Affiliation': ''}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Avalos', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Yeager', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bartels', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Buell', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fitzsimmons', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ratanatharathorn', 'Affiliation': ''}]",Blood,[]
271,10960240,Cyclosporine (CSP)or CSP plus methylprednisolone for graft-versus-host disease prophylaxis in patients with high-risk lymphohemopoietic malignancies: long-term follow-up of a randomized trial.,,2000,,['patients with high-risk lymphohemopoietic malignancies'],['Cyclosporine (CSP)or CSP plus methylprednisolone'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],,0.0346966,,"[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Storb', 'Affiliation': ''}]",Blood,[]
272,11001892,Bone marrow transplantation versus chemotherapy in the treatment of very high-risk childhood acute lymphoblastic leukemia in first remission: results from Medical Research Council UKALL X and XI.,"The role of bone marrow transplantation (BMT) in first remission of children with high-risk acute lymphoblastic leukemia (ALL) remains unclear. There were 3676 patients (aged 1 to 15 years) entered into the United Kingdom (UK) Medical Research Council (MRC) trials UKALL X and XI from 1985 to 1997. Of these patients, 473 patients (13%) were classified as very high (VH) risk and were eligible for a transplantation from a matched histocompatible sibling donor (MSD). We tissue-typed 286 patients; 99 patients had a matched related donor, and 76 patients received transplantations. Additionally, 25 children received transplantations from a matched unrelated donor (MUD) despite trial guidelines for MSD transplantations only. The median time to transplantation was 5 months (range, 2 to 19 months), and the median follow-up was 8 years. The 10-year event-free survival (EFS) adjusted for the time to transplantation, diagnostic white blood cell (WBC) count, Ph chromosome status, and ploidy was 6. 0% higher (95% confidence interval (CI), -10.5% to 22.5%) for 101 patients who received a first-remission transplantation (MSD and MUD) than for the 351 patients treated with chemotherapy (transplantation, 45.3%, vs chemotherapy, 39.3%). The transplantation group had fewer relapses (31%) compared to relapses in the chemotherapy group (55%); however, the transplantation group had more remission deaths (18%) compared to remission deaths in the chemotherapy group (3%). In contrast the adjusted 10-year EFS was 10. 7% higher (95% CI, -2.6% to 24.0%) for patients without a human leukocyte antigen (HLA)-matched donor than for those patients with a donor (no donor, 50.4%, vs donor, 39.7%). In conclusion, for the majority of children with VH-risk ALL, the first-remission transplantation has not improved EFS.",2000,"The transplantation group had fewer relapses (31%) compared to relapses in the chemotherapy group (55%); however, the transplantation group had more remission deaths (18%) compared to remission deaths in the chemotherapy group (3%).","['25 children received transplantations from a matched unrelated donor (MUD) despite trial guidelines for MSD transplantations only', '473 patients (13%) were classified as very high (VH) risk and were eligible for a transplantation from a matched histocompatible sibling donor (MSD', 'very high-risk childhood acute lymphoblastic leukemia in first remission', 'children with high-risk acute lymphoblastic leukemia (ALL', '3676 patients (aged 1 to 15 years) entered into the United Kingdom (UK) Medical Research Council (MRC) trials UKALL X and XI from 1985 to 1997', '286 patients; 99 patients had a matched related donor, and 76 patients received transplantations']","['bone marrow transplantation (BMT', 'Bone marrow transplantation versus chemotherapy']","['relapses', '10-year event-free survival (EFS) adjusted for the time to transplantation, diagnostic white blood cell (WBC) count, Ph chromosome status, and ploidy', 'adjusted 10-year EFS', 'median time to transplantation', 'remission deaths']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0008633', 'cui_str': 'Chromosomes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032246', 'cui_str': 'Ploidies'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3676.0,0.0464408,"The transplantation group had fewer relapses (31%) compared to relapses in the chemotherapy group (55%); however, the transplantation group had more remission deaths (18%) compared to remission deaths in the chemotherapy group (3%).","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Wheeler', 'Affiliation': 'John Radcliffe Hospital, Headington, Oxford, England. kate.wheeler@paediatrics.oxford.ac.uk'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gibson', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Hann', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Chessells', 'Affiliation': ''}]",Blood,[]
273,11001889,"Cyclosporine, methotrexate, and methylprednisolone compared with cyclosporine and methotrexate for the prevention of graft-versus-host disease in bone marrow transplantation from HLA-identical sibling donor: a prospective randomized study.","The role of corticosteroids in the prophylaxis of graft-versus-host disease (GVHD) is not well established. We have conducted a prospective, randomized, open-label, single-center study about the effect of adding methylprednisolone (MP) to the widely used prophylactic regimen consisting of cyclosporine A and methotrexate. A total of 108 consecutive patients treated with allogeneic bone marrow transplantation from an HLA-identical sibling donor for malignant blood disease were entered into the study; 53 patients were randomized to receive and 55 were randomized not to receive prophylactic MP. The dose of MP was 0.5 mg/kg on days 14 to 20, 1 mg/kg on days 21 to 34, 0.5 mg/kg on days 35 to 48, and thereafter the dose was slowly tapered and the administration discontinued on day 110. In the group given prophylactic MP, the incidence of acute GVHD was lower (19% vs 56%, P =.0001), there was a trend toward a lower incidence of chronic GVHD among low-risk patients (P =.06), and during the first 4 months the time spent at hospital was shorter and there were fewer infections. The total amount of MP given was similar in the study groups because of a higher incidence of acute GVHD and its treatment in the group of patients not given prophylactic MP. There were no significant differences between the study groups in relapse rate or survival. In conclusion, the addition of MP to the combination of cyclosporine and methotrexate markedly reduced the incidence of acute GVHD without causing untoward effects. The timing of corticosteroid administration is probably important for the efficacy.",2000,The total amount of MP given was similar in the study groups because of a higher incidence of acute GVHD and its treatment in the group of patients not given prophylactic MP.,"['bone marrow transplantation from HLA-identical sibling donor', '108 consecutive patients treated with allogeneic bone marrow transplantation from an HLA-identical sibling donor for malignant blood disease were entered into the study; 53 patients']","['cyclosporine and methotrexate', 'prophylactic MP', 'methylprednisolone (MP', 'corticosteroids', 'cyclosporine A and methotrexate', 'MP', 'Cyclosporine, methotrexate, and methylprednisolone']","['total amount of MP', 'chronic GVHD', 'time spent at hospital', 'incidence of acute GVHD', 'relapse rate or survival']","[{'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C1533163', 'cui_str': 'Blood disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",53.0,0.0574711,The total amount of MP given was similar in the study groups because of a higher incidence of acute GVHD and its treatment in the group of patients not given prophylactic MP.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruutu', 'Affiliation': 'Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parkkali', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Juvonen', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Elonen', 'Affiliation': ''}]",Blood,[]
274,10961865,Cyclosporin A and short-term methotrexate versus cyclosporin A as graft versus host disease prophylaxis in patients with severe aplastic anemia given allogeneic bone marrow transplantation from an HLA-identical sibling: results of a GITMO/EBMT randomized trial.,"A randomized trial was carried out comparing cyclosporin A (CsA) and short-term methotrexate (MTX) versus CsA alone for graft versus host disease (GVHD) prophylaxis in patients with severe aplastic anemia (SAA) undergoing allogeneic bone marrow transplantation (BMT) from a compatible sibling. Seventy-one patients (median age, 19 years; range, 4-46 years) were randomized to receive either CsA and MTX or CsA alone for the first 3 weeks after BMT. Subsequently, both groups received CsA orally, with gradual drug reduction until discontinuation 8 to 12 months after BMT. Patients randomized in both arms had comparable characteristics and received the same preparative regimen (ie, cyclophosphamide 200 mg/kg over 4 days). The median time for neutrophil engraftment was 17 days (range, 11-31 days) and 12 days (range, 4-45 days) for patients in the CsA/MTX group and the CsA alone group, respectively (P =.01). No significant difference was observed in the probability of either grade 2, grade 3, or grade 4 acute GVHD or chronic GVHD developing in the 2 groups. The Kaplan-Meier estimates of 1-year transplantation-related mortality rates for patients given either CsA/MTX or CsA alone were 3% and 15%, respectively (P =.07). With a median follow-up of 48 months from BMT, the 5-year survival probability is 94% for patients in the CsA/MTX group and 78% for those in the CsA alone group (P =. 05). These data indicate that the use of CsA with MTX is associated with improved survival in patients with SAA who receive transplants from compatible siblings. (Blood. 2000;96:1690-1697)",2000,"No significant difference was observed in the probability of either grade 2, grade 3, or grade 4 acute GVHD or chronic GVHD developing in the 2 groups.","['patients with SAA who receive transplants from compatible siblings', 'Seventy-one patients (median age, 19 years; range, 4-46 years', 'patients with severe aplastic anemia given allogeneic bone marrow transplantation from an HLA-identical sibling', 'patients with severe aplastic anemia (SAA) undergoing allogeneic bone marrow transplantation (BMT) from a compatible sibling']","['cyclophosphamide', 'CsA/MTX', 'MTX', 'CsA and MTX or CsA alone', 'Cyclosporin A and short-term methotrexate versus cyclosporin', 'cyclosporin A (CsA) and short-term methotrexate (MTX) versus CsA alone']","['5-year survival probability', 'survival', '1-year transplantation-related mortality rates', 'probability of either grade 2, grade 3, or grade 4 acute GVHD or chronic GVHD', 'median time for neutrophil engraftment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}]",,0.0568699,"No significant difference was observed in the probability of either grade 2, grade 3, or grade 4 acute GVHD or chronic GVHD developing in the 2 groups.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Dipartimento di Scienze Pediatriche, Università di Pavia, IRCCS Policlinico San Matteo, Pavia, Italy. f.locatelli@smatteo.pv.it'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bruno', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zecca', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Van-Lint', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCann', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Arcese', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dallorso', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Di Bartolomeo', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Fagioli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Locasciulli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lawler', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': ''}]",Blood,[]
275,10666187,Effect of recombinant human erythropoietin combined with granulocyte/ macrophage colony-stimulating factor in the treatment of patients with myelodysplastic syndrome. GM/EPO MDS Study Group.,"This randomized, placebo-controlled trial was designed to assess the efficacy and safety of therapy with granulocyte-macrophage colony-stimulating factor (GM-CSF) and erythropoietin (epoetin alfa) in anemic, neutropenic patients with myelodysplastic syndrome. Sixty-six patients were enrolled according to the following French-American-British classification: refractory anemia (20), refractory anemia with excess blasts (35), refractory anemia with ringed sideroblasts (9), and refractory anemia with excess blasts in transformation (2). Patients were stratified by their serum erythropoietin levels (less than or equal to 500 mU/mL, n = 37; greater than 500 mU/mL, n = 29) and randomized, in a 2:1 ratio, to either GM-CSF (0.3-5.0 microg/kg.d) + epoetin alfa (150 IU/kg 3 times/wk) or GM-CSF (0.3-5.0 microg/kg.d) + placebo (3 times/wk). The mean neutrophil count rose from 948 to 3831 during treatment with GM-CSF +/- epoetin alfa. Hemoglobin response (increase greater than or equal to 2 g/dL, unrelated to transfusion) occurred in 4 of 45 (9%) patients in the GM-CSF + epoetin alfa group compared with 1 of 21 (5%) patients with GM-CSF + placebo group (P = NS). Percentages of patients in the epoetin alfa and the placebo groups requiring transfusions of red blood cells were 60% and 92%, respectively, for the low-endogenous erythropoietin patients and 95% and 89% for the high-endogenous erythropoietin patients (P = NS). Similarly, the average numbers of units of red blood cells transfused during the 12-week study in the epoetin alfa and the placebo groups were 5.9 and 9.5, respectively, in the low-endogenous erythropoietin patients and 9.7 and 8.6 in the high-endogenous erythropoietin patients (P = NS). GM-CSF +/- epoetin alfa had no effect on mean platelet count. Treatment was well tolerated in most patients, though 10 withdrew from the study for reasons related predominantly to GM-CSF toxicity. (Blood. 2000;95:1175-1179)",2000,"Hemoglobin response (increase greater than or equal to 2 g/dL, unrelated to transfusion) occurred in 4 of 45 (9%) patients in the GM-CSF + epoetin alfa group compared with 1 of 21 (5%) patients with GM-CSF + placebo group (P = NS).","['anemic, neutropenic patients with myelodysplastic syndrome', 'Patients were stratified by their serum erythropoietin levels (less than or equal to 500 mU/mL, n = 37; greater than 500 mU/mL, n = 29', 'Sixty-six patients were enrolled according to the following French-American-British classification: refractory anemia (20), refractory anemia with excess blasts (35), refractory anemia with ringed sideroblasts (9), and refractory anemia with excess blasts in transformation (2', 'patients with myelodysplastic syndrome']","['recombinant human erythropoietin combined with granulocyte/ macrophage colony-stimulating factor', 'placebo', 'GM-CSF ', 'GM-CSF (0.3-5.0 microg/kg.d) + epoetin alfa', 'epoetin alfa', 'GM-CSF', 'granulocyte-macrophage colony-stimulating factor (GM-CSF) and erythropoietin (epoetin alfa', 'CSF + placebo']","['mean neutrophil count', 'transfusions of red blood cells', 'efficacy and safety', 'mean platelet count', 'average numbers of units of red blood cells transfused', 'tolerated', 'Hemoglobin response']","[{'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement (procedure)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C2981142', 'cui_str': 'Refractory anemia (clinical)'}, {'cui': 'C0002894', 'cui_str': 'RAEB'}, {'cui': 'C0229630', 'cui_str': 'Sideroblast (cell)'}, {'cui': 'C0280028', 'cui_str': 'Refractory anemia with excess blasts in transformation (morphologic abnormality)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0079784', 'cui_str': 'CSF-1'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0449961', 'cui_str': 'Number of units (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",66.0,0.173643,"Hemoglobin response (increase greater than or equal to 2 g/dL, unrelated to transfusion) occurred in 4 of 45 (9%) patients in the GM-CSF + epoetin alfa group compared with 1 of 21 (5%) patients with GM-CSF + placebo group (P = NS).","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Thompson', 'Affiliation': 'Division of Oncology, University of Washington, Seattle, WA 98195-6043, USA. jat@u.washington.edu'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Gilliland', 'Affiliation': ''}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Prchal', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Larholt', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Rose', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Dugan', 'Affiliation': ''}]",Blood,[]
276,10688810,Graft versus host disease prophylaxis with low-dose cyclosporine-A reduces the risk of relapse in children with acute leukemia given HLA-identical sibling bone marrow transplantation: results of a randomized trial.,"Leukemia relapse is a major cause of treatment failure for patients with acute leukemia given allogeneic bone marrow transplantation (BMT). This study evaluated whether a reduction of the dosage of cyclosporine-A (Cs-A) used for graft versus host disease (GVHD) prophylaxis could reduce relapse rate (RR) in children with acute leukemia given BMT. Fifty-nine children who had transplantation from HLA-identical siblings were randomized to receive Cs-A intravenously at a dosage of 1 mg/kg/d (Cs-A1) or of 3 mg/kg/d (Cs-A3) until patients were able to tolerate oral intake. Subsequently, both groups received Cs-A orally at a dosage of 6 mg/kg/d, with discontinuation 5 months after BMT. The probability of developing grade II-IV acute GVHD was 57% for the Cs-A1 group versus 38% for the Cs-A3 group (P =.06); the probability of developing chronic GVHD was 30% for the Cs-A1 group and 26% for the Cs-A3 group (P = NS). Three patients died of grade IV acute GVHD: 2 were in the Cs-A1 and the third in the Cs-A3 group. The RR was 15% for the Cs-A1 group and 41% for the Cs-A3 group (P =.034); 1-year transplant-related mortality estimates were 17% and 7%, respectively (P = NS). With a median observation time of 44 months from BMT, the 5-year event-free survival for children belonging to Cs-A1 and Cs-A3 groups was 70% and 51%, respectively (P =.15). Our data demonstrate that the use of low Cs-A doses is associated with a statistically significant reduction of leukemia relapse, probably due to an increased graft versus leukemia effect. (Blood. 2000;95:1572-1579)",2000,The probability of developing grade II-IV acute GVHD was 57% for the Cs-A1 group versus 38% for the Cs-A3 group (P =.06); the probability of developing chronic GVHD was 30% for the Cs-A1 group and 26% for the Cs-A3 group (P = NS).,"['children with acute leukemia given HLA-identical sibling bone marrow transplantation', 'patients with acute leukemia given allogeneic bone marrow transplantation (BMT', 'children with acute leukemia given BMT', '2000;95:1572-1579', 'Fifty-nine children who had transplantation from HLA-identical siblings']","['cyclosporine-A (Cs-A) used for graft versus host disease (GVHD) prophylaxis', 'cyclosporine-A']","['Leukemia relapse', '5-year event-free survival', 'relapse rate (RR', 'RR', 'leukemia relapse', 'risk of relapse', 'probability of developing grade II-IV acute GVHD', 'died of grade IV acute GVHD', '1-year transplant-related mortality estimates', 'probability of developing chronic GVHD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0920028', 'cui_str': 'Leukaemia recurrent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",59.0,0.0627748,The probability of developing grade II-IV acute GVHD was 57% for the Cs-A1 group versus 38% for the Cs-A3 group (P =.06); the probability of developing chronic GVHD was 30% for the Cs-A1 group and 26% for the Cs-A3 group (P = NS).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Department of Pediatrics, University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy. f.locatelli@smatteo.pv.it'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zecca', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rondelli', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonetti', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dini', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prete', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Messina', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uderzo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ripaldi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Porta', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Giorgiani', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Giraldi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pession', 'Affiliation': ''}]",Blood,[]
277,10688831,Lepirudin blunts endotoxin-induced coagulation activation.,"During sepsis, lipopolysaccharide (LPS) triggers the development of disseminated intravascular coagulation (DIC) via the tissue factor-dependent pathway of coagulation resulting in massive thrombin generation and fibrin polymerization. Recently, animal studies demonstrated that hirudin reduced fibrin deposition in liver and kidney and decreased mortality in LPS-induced DIC. Accordingly, the effects of recombinant hirudin (lepirudin) was compared with those caused by placebo on LPS-induced coagulation in humans. Twenty-four healthy male subjects participated in this randomized, double-blind, placebo-controlled, parallel group study. Volunteers received 2 ng/kg LPS intravenously, followed by a bolus-primed continuous infusion of placebo or lepirudin (Refludan, bolus: 0.1 mg/kg, infusion: 0.1 mg/kg/h for 5 hours) to achieve a 2-fold prolongation of the activated partial thromboplastin time (aPTT). LPS infusion enhanced thrombin activity as evidenced by a 20-fold increase of thrombin-antithrombin complexes (TAT), a 6-fold increase of polymerized soluble fibrin, termed thrombus precursor protein (TpP), and a 4-fold increase in D-dimer. In the lepirudin group, TAT increased only 5-fold, TpP increased by only 50%, and D-dimer only slightly exceeded baseline values (P <.01 versus placebo). Concomitantly, lepirudin also blunted thrombin generation evidenced by an attenuated rise in prothrombin fragment levels (F(1 + 2), P <. 01 versus placebo) and blunted the expression of tissue factor on circulating monocytes. This experimental model proved the anticoagulatory potency of lepirudin in LPS-induced coagulation activation. Results from this trial provide a rationale for a randomized clinical trial on the efficacy of lepirudin in DIC. (Blood. 2000;95:1729-1734)",2000,"Concomitantly, lepirudin also blunted thrombin generation evidenced by an attenuated rise in prothrombin fragment levels (F(1 + 2), P <.",['Twenty-four healthy male subjects'],"['placebo', 'placebo or lepirudin (Refludan, bolus: 0.1 mg/kg, infusion: 0.1 mg/kg/h for 5 hours) to achieve a 2-fold prolongation of the activated partial thromboplastin time (aPTT', 'recombinant hirudin (lepirudin', 'TAT', 'LPS']","['thrombin activity', 'TpP', 'expression of tissue factor on circulating monocytes', 'fibrin deposition', 'thrombin-antithrombin complexes (TAT', 'prothrombin fragment levels']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0772394', 'cui_str': 'lepirudin'}, {'cui': 'C0661608', 'cui_str': 'Refludan'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1442467', 'cui_str': '5 hours (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C1451270', 'cui_str': 'Hirudins'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}]","[{'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1259980', 'cui_str': 'disulfonated meso-tetraphenylporphine'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0040048', 'cui_str': 'Prothrombinase'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0333565', 'cui_str': 'Fibrin deposition (morphologic abnormality)'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",24.0,0.185554,"Concomitantly, lepirudin also blunted thrombin generation evidenced by an attenuated rise in prothrombin fragment levels (F(1 + 2), P <.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pernerstorfer', 'Affiliation': 'Department of Clinical Pharmacology-TARGET, Vienna General Hospital, Wien, Austria. thomas.pernerstorfer@univie.ac.at'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Hollenstein', 'Affiliation': ''}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stohlawetz', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Eichler', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Handler', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Speiser', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': ''}]",Blood,[]
278,10887107,Long-term in vivo survival of receptor-modified syngeneic T cells in patients with human immunodeficiency virus infection.,"To study human immunodeficiency virus (HIV)-specific cellular immunity in vivo, we transferred syngeneic lymphocytes after ex vivo expansion and transduction with a chimeric receptor gene (CD4/CD3-zeta) between identical twins discordant for HIV infection. Single and multiple infusions of 10(10) genetically modified CD8(+) T cells resulted in peak fractions in the circulation of approximately 10(4) to 10(5) modified cells/10(6) mononuclear cells at 24 to 48 hours, followed by 2- to 3-log declines by 8 weeks. In an effort to provide longer high-level persistence of the transferred cells and possibly enhance anti-HIV activity, we administered a second series of infusions in which both CD4(+ )and CD8(+) T cells were engineered to express the chimeric receptor and were costimulated ex vivo with beads coated with anti-CD3 and anti-CD28. Sustained fractions of approximately 10(3) to 10(4) modified cells/10(6) total CD4(+) or CD8(+) cells persisted for at least 1 year. Assessment of in vivo trafficking of the transferred cells by lymphoid tissue biopsies revealed the presence of modified cells in proportions equivalent to or below those in the circulation. The cell infusions were well tolerated and were not associated with substantive immunologic or virologic changes. Thus, adoptive transfer of genetically modified HIV-antigen-specific T cells was safe. Sustained survival in the circulation was achieved when modified CD4(+ )and CD8(+) T cells were infused together after ex vivo costimulation, indicating the important role played by antigen-specific CD4(+) T cells in providing ""help"" to cytotoxic effectors. (Blood. 2000;96:467-474)",2000,"Sustained survival in the circulation was achieved when modified CD4(+ )and CD8(+) T cells were infused together after ex vivo costimulation, indicating the important role played by antigen-specific CD4(+)","['10(10', 'patients with human immunodeficiency virus infection']","['receptor-modified syngeneic T cells', 'genetically modified CD8']","['Sustained survival', 'substantive immunologic or virologic changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]","[{'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0283783,"Sustained survival in the circulation was achieved when modified CD4(+ )and CD8(+) T cells were infused together after ex vivo costimulation, indicating the important role played by antigen-specific CD4(+)","[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Walker', 'Affiliation': 'Clinical and Molecular Retrovirology Section, Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Clinical Gene Therapy Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Bechtel', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Natarajan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baseler', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Hege', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Metcalf', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hazen', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Blaese', 'Affiliation': ''}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Leitman', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Palensky', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Davey', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Falloon', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Polis', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kovacs', 'Affiliation': ''}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Broad', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Masur', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': ''}]",Blood,[]
279,10779449,Effects of erythropoietin on platelet reactivity and thrombopoiesis in humans.,"A recent study in dogs suggested that erythropoietin (EPO) not only promotes the synthesis of increased numbers of reticulated platelets but that these newly produced platelets are hyperreactive compared with controls. Because of the increasing use of EPO in the perioperative setting, we characterized the effects of EPO on platelet reactivity in healthy human volunteers. In a randomized, controlled trial, we studied the effects of EPO on platelet reactivity, thrombopoiesis, and endothelial activation in circumstances similar to those of autologous blood donation. Thirty healthy male volunteers received placebo or EPO (100 or 500 U/kg of body weight given intravenously) three times a week for 2 weeks and underwent phlebotomy on days 8 and 15. Thrombin receptor-activating peptide induced expression of P-selectin, and CD63 increased 2- to 3-fold during EPO treatment. The enhanced platelet reactivity was also reflected by a 50% increase in soluble P-selectin in plasma. Plasma E-selectin levels increased in a dose-dependent fashion by more than 100% during EPO treatment, indicating substantial activation of endothelial cells. A 10% to 20% increase in platelet counts was observed in both EPO groups on day 5. In the placebo group, platelets increased only several days after the first phlebotomy. The increase in platelet counts was not reflected by changes in the amounts of reticulated platelets or circulating progenitor cells. In summary, we found that EPO markedly enhances endothelial activation and platelet reactivity, which may adversely affect patients at cardiovascular risk. However, the increased platelet reactivity could be exploited in patients with platelet dysfunction. (Blood. 2000;95:2983-2989)",2000,"Thrombin receptor-activating peptide induced expression of P-selectin, and CD63 increased 2- to 3-fold during EPO treatment.","['patients with platelet dysfunction', 'healthy human volunteers', 'Thirty healthy male volunteers', 'humans']","['erythropoietin', 'placebo', 'EPO', 'placebo or EPO', 'erythropoietin (EPO']","['endothelial activation and platelet reactivity', 'platelet counts', 'enhanced platelet reactivity', 'substantial activation of endothelial cells', 'Plasma E-selectin levels', 'platelet reactivity', 'expression of P-selectin, and CD63', 'platelet reactivity, thrombopoiesis, and endothelial activation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0679429', 'cui_str': 'Platelet dysfunction'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C0221145', 'cui_str': 'Thrombocytopoiesis'}]",30.0,0.0259722,"Thrombin receptor-activating peptide induced expression of P-selectin, and CD63 increased 2- to 3-fold during EPO treatment.","[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Stohlawetz', 'Affiliation': 'Department of Clinical Pharmacology-The Adhesion Research Group Elaborating Therapeutics (TARGET), Vienna University School of Medicine, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dzirlo', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hergovich', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lackner', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mensik', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Eichler', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kabrna', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Geissler', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jilma', 'Affiliation': ''}]",Blood,[]
280,10733492,Comparison of chemotherapy to radiotherapy as consolidation of complete or good partial response after six cycles of chemotherapy for patients with advanced Hodgkin's disease: results of the groupe d'études des lymphomes de l'Adulte H89 trial.,"The treatment of advanced Hodgkin's disease (HD) with chemotherapy (CTx) alone or combined modality treatments has been controversial. In 1989, we designed a randomized study to compare 2 cycles of CTx to (sub)total nodal irradiation (RTx) as consolidation treatments for patients with stage IIIB/IV HD in complete remission (CR) or good partial response after 6 cycles of CTx. A total of 559 patients were randomized to receive 6 cycles of MOPP/ABV (mechlorethamine, vincristine, procarbazine, prednisone/Adriamycin [doxorubicin], bleomycin, vinblastine) hybrid (n = 266) or ABVPP (n = 267). After induction treatment, 418 patients could be evaluated for the consolidation phase. With a median follow-up of 48 months, the 5-year disease-free survival estimates were 80% for 8 cycles of MOPP/ABV, 82% for 6 cycles of MOPP/ABV plus RTx, 68% for 8 cycles of ABVPP, and 75% for 6 cycles of ABVPP plus RTx (P =.01). The 5-year disease-free survival estimates did not differ between CTx and RTx, 74% and 79%, respectively (P =.07). After MOPP/ABV, the 5-year overall survival estimates did not differ between CTx and RTx, 85% and 88%, respectively (P =.2). After ABVPP, the 5-year survival estimates were 94% for CTx and 78% for RTx (P =.002). These results showed that RTx was not superior to CTx consolidation after doxorubicin-induced CR for patients with advanced HD. Because of the uncertainty of obtaining a prolonged second remission for patients relapsing after CTx and RTx and the possible long-term effects of RTx, we prefer 8 cycles of CTx as standard treatment when a CR has been achieved after 6 cycles.",2000,"After MOPP/ABV, the 5-year overall survival estimates did not differ between CTx and RTx, 85% and 88%, respectively (P =.2).","['patients with stage IIIB/IV HD in complete remission (CR) or good partial response after 6 cycles of CTx', 'patients with advanced HD', '418 patients could be evaluated for the consolidation phase', 'A total of 559 patients', ""patients with advanced Hodgkin's disease"", ""advanced Hodgkin's disease (HD) with""]","['doxorubicin-induced CR', 'chemotherapy (CTx) alone or combined modality treatments', 'MOPP/ABV (mechlorethamine, vincristine, procarbazine, prednisone/Adriamycin [doxorubicin], bleomycin, vinblastine) hybrid (n = 266) or ABVPP', 'CTx to (sub)total nodal irradiation (RTx', 'chemotherapy', 'chemotherapy to radiotherapy']","['5-year survival estimates', '5-year disease-free survival estimates', '5-year overall survival estimates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0677874', 'cui_str': 'In full remission (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025033', 'cui_str': 'chlormethine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",559.0,0.141611,"After MOPP/ABV, the 5-year overall survival estimates did not differ between CTx and RTx, 85% and 88%, respectively (P =.2).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fermé', 'Affiliation': ""Groupe d'études des Lymphomes de l'Adulte, Hôpital Saint-Louis, Paris, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hennequin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diviné', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lederlin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gabarre', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferrant', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bordessoule', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Moullet', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lepage', 'Affiliation': ''}]",Blood,[]
281,10753831,"A double-blind, placebo-controlled trial of pegylated recombinant human megakaryocyte growth and development factor as an adjunct to induction and consolidation therapy for patients with acute myeloid leukemia.","Newly diagnosed patients with acute myeloid leukemia (AML) were randomized to receive either 2.5 or 5 microg/kg/day of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or a placebo administered subcutaneously after completion of chemotherapy. The study evaluated the toxicity of PEG-rHuMGDF and any effect on the duration of thrombocytopenia. Each of 35 patients under 60 years of age received the following therapy: 45 mg/m(2) daunorubicin on days 1-3, 100 mg/m(2) cytarabine (ARA-C) for 7 days, and 2 gm/m(2) high-dose ARA-C (HIDAC) for 6 doses on days 8-10. The 22 patients 60 years or older received standard daunorubicin and ARA-C without HIDAC. PEG-rHuMGDF was well tolerated, and no specific toxicities could be attributed to its use. There was no difference in the time to achieve a platelet count of at least 20 x 10(9)/L among the 3 groups (median 28-30 days for patients less than 60 years old and 21-23 days for patients 60 years or older). Patients receiving PEG-rHuMGDF achieved higher platelet counts after remission. However there was no significant difference in the number of days on which platelet transfusions were administered among the 3 groups. The complete remission rate was 71% for patients less than 60 years and 64% for those 60 years or older, with no significant difference among the 3 groups. Postremission consolidation chemotherapy with either placebo or PEG-rHuMGDF was given to 28 patients beginning the day after completion of chemotherapy. There was no apparent difference in the time that was necessary to reach a platelet count of at least 20 or 50 x 10(9)/L or more platelets or in the number of platelet transfusions received. In summary, PEG-rHuMGDF was well tolerated by patients receiving induction and consolidation therapy for AML; however, there was no effect on the duration of severe thrombocytopenia or the platelet transfusion requirement. (Blood. 2000;95:2530-2535)",2000,There was no difference in the time to achieve a platelet count of at least 20 x 10(9)/L among the 3 groups (median 28-30 days for patients less than 60 years old and 21-23 days for patients 60 years or older).,"['22 patients 60 years or older received', 'Newly diagnosed patients with acute myeloid leukemia (AML', 'patients with acute myeloid leukemia', '35 patients under 60 years of age received the following']","['PEG-rHuMGDF', 'placebo or PEG-rHuMGDF', 'placebo', 'therapy: 45 mg/m(2) daunorubicin', 'cytarabine (ARA-C', 'pegylated recombinant human megakaryocyte growth', 'standard daunorubicin and ARA-C without HIDAC', 'pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) or a placebo']","['complete remission rate', 'platelet count', 'number of days on which platelet transfusions', 'platelet counts', 'duration of thrombocytopenia', 'duration of severe thrombocytopenia', 'toxicity of PEG-rHuMGDF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025166', 'cui_str': 'Megakaryocytes'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}]",,0.0375737,There was no difference in the time to achieve a platelet count of at least 20 x 10(9)/L among the 3 groups (median 28-30 days for patients less than 60 years old and 21-23 days for patients 60 years or older).,"[{'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA. schiffer@karmanos.org'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Amrein', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': ''}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Zani', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': ''}]",Blood,[]
282,10666180,Tissue factor pathway inhibitor dose-dependently inhibits coagulation activation without influencing the fibrinolytic and cytokine response during human endotoxemia.,"Inhibition of the tissue factor pathway has been shown to attenuate the activation of coagulation and to prevent death in a gram-negative bacteremia primate model of sepsis. It has been suggested that tissue factor influences inflammatory cascades other than the coagulation system. The authors sought to determine the effects of 2 different doses of recombinant tissue factor pathway inhibitor (TFPI) on endotoxin-induced coagulant, fibrinolytic, and cytokine responses in healthy humans. Two groups, each consisting of 8 healthy men, were studied in a double-blind, randomized, placebo-controlled crossover study. Subjects were studied on 2 different occasions. They received a bolus intravenous injection of 4 ng/kg endotoxin, which was followed by a 6-hour continuous infusion of TFPI or placebo. Eight subjects received 0.05 mg/kg per hour TFPI after a bolus of 0.0125 mg/kg (low-dose group), and 8 subjects received 0.2 mg/kg per hour after a bolus of 0.05 mg/kg (high-dose group). Endotoxin injection induced the activation of coagulation, the activation and subsequent inhibition of fibrinolysis, and the release of proinflammatory and antiinflammatory cytokines. TFPI infusion induced a dose-dependent attenuation of thrombin generation, as measured by plasma F1 + 2 and thrombin-antithrombin complexes, with a complete blockade of coagulation activation after high-dose TFPI. Endotoxin-induced changes in the fibrinolytic system and cytokine levels were not altered by either low-dose or high-dose TFPI. The authors concluded that TFPI effectively and dose-dependently attenuates the endotoxin-induced coagulation activation in humans without influencing the fibrinolytic and cytokine response. (Blood. 2000;95:1124-1129)",2000,"TFPI infusion induced a dose-dependent attenuation of thrombin generation, as measured by plasma F1 + 2 and thrombin-antithrombin complexes, with a complete blockade of coagulation activation after high-dose TFPI.","['8 healthy men', 'healthy humans']","['placebo', 'TFPI', 'Endotoxin injection', 'recombinant tissue factor pathway inhibitor (TFPI', 'TFPI or placebo']","['endotoxin-induced coagulant, fibrinolytic, and cytokine responses', 'activation of coagulation, the activation and subsequent inhibition of fibrinolysis, and the release of proinflammatory and antiinflammatory cytokines', 'fibrinolytic system and cytokine levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0164707', 'cui_str': 'TFPI'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009117', 'cui_str': 'Coagulants'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",8.0,0.16897,"TFPI infusion induced a dose-dependent attenuation of thrombin generation, as measured by plasma F1 + 2 and thrombin-antithrombin complexes, with a complete blockade of coagulation activation after high-dose TFPI.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jonge', 'Affiliation': 'Department of Intensive Care, Laboratory of Experimental Internal Medicine, Academic Medical Center, University of Amsterdam, Central Laboratory of the Red Cross Blood Transfusion Service, Amsterdam, The Netherlands.'}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Dekkers', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Creasey', 'Affiliation': ''}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Hack', 'Affiliation': ''}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Paulson', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karim', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kesecioglu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'van Deventer', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van Der Poll', 'Affiliation': ''}]",Blood,[]
283,10828010,Improved outcome in childhood acute lymphoblastic leukemia despite reduced use of anthracyclines and cranial radiotherapy: results of trial ALL-BFM 90. German-Austrian-Swiss ALL-BFM Study Group.,"Trial ALL-BFM 90 was designed to improve outcome in patients with childhood acute lymphoblastic leukemia (ALL) by using a reduced treatment regimen. Patients were stratified into a standard-risk group (SRG), a medium-risk group (MRG), both defined by adequate early treatment response; and a high-risk group (HRG), defined by inadequate response to the cytoreductive prednisone prephase, induction failure, or Philadelphia-chromosome-positive ALL. Four treatment modifications were evaluated: dose intensification in induction by a more rapid drug sequence; administration of L-asparaginase during consolidation therapy in the MRG (randomized); enforced consolidation by rotational elements in the HRG; and reduction in the dose of anthracyclines and use of only 12-Gy preventive cranial radiotherapy in the MRG and HRG, with the aim of avoiding toxicity. Among all 2178 patients (</= 18 years of age), the 6-year event-free survival (EFS) rate (+/- SE) was 78% +/- 1%, with a median observation time of 4.8 years. EFS was 85% +/- 2% in the SRG (n = 636) and 82% +/- 1% in the MRG (n = 1299). L-asparaginase did not improve outcome in the MRG: the event-free interval was 83% +/- 2% with L-asparaginase (n = 528) and 81% +/- 2% without it (n = 557). Because there were more systemic relapses in the HRG (n = 243), EFS was 34% +/- 3%, an outcome inferior to that in the HRG in a previous trial, ALL-BFM 86, in which EFS was 47% +/- 5% (P =.04). The rates of isolated central nervous system relapse in the MRG and HRG were 0.8% and 1.6%, respectively; thus, the 12-Gy preventive cranial radiotherapy regimen apparently provided sufficient central nervous system prophylaxis. The overall improvement over the results in ALL-BFM 86 (6-year EFS, 72%; P =. 001) was based on fewer recurrences among patients in the MRG with B-cell-precursor ALL, indicating an advantage of more condensed induction therapy. In multivariate analysis, inadequate in vivo response emerged as the strongest adverse prognostic variable.",2000,L-asparaginase did not improve outcome in the MRG: the event-free interval was 83% +/-,"['2178 patients (</= 18 years of age', 'Patients were stratified into a standard-risk group (SRG), a medium-risk group (MRG), both defined by adequate early treatment response; and a high-risk group (HRG), defined by inadequate response to the cytoreductive prednisone prephase, induction failure, or Philadelphia-chromosome-positive ALL', 'patients with childhood acute lymphoblastic leukemia (ALL']","['anthracyclines and cranial radiotherapy', 'SRG', 'anthracyclines and use of only 12-Gy preventive cranial radiotherapy', 'MRG', 'L-asparaginase']","['6-year event-free survival (EFS) rate', 'systemic relapses', 'rates of isolated central nervous system relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]",2178.0,0.0364564,L-asparaginase did not improve outcome in the MRG: the event-free interval was 83% +/-,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Medizinische Hochschule Hannover, Federal Republic of Germany (FRG). schrappe.martin@mh-hannover.de'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Harbott', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Niemeyer', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Henze', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feldges', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zintl', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kornhuber', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Welte', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gadner', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riehm', 'Affiliation': ''}]",Blood,[]
284,10607690,Clinical description of 44 patients with acute promyelocytic leukemia who developed the retinoic acid syndrome.,"We examined the incidence, clinical course, and outcome of patients with newly diagnosed acute promyelocytic leukemia (APL) who developed the retinoic acid syndrome (RAS) treated on the Intergroup Protocol 0129, which prospectively evaluated the role of alltrans retinoic acid (ATRA) alone during induction and as maintenance therapy. Forty-four of 167 (26%) patients receiving ATRA for induction developed the syndrome at a median of 11 days of ATRA (range, 2-47). The median white blood cell (WBC) count was 1,450/microL at diagnosis and was 31,000/microL (range, 6,800-72,000/microL) at the time the syndrome developed. ATRA was discontinued in 36 of the 44 patients (82%) and continued in 8 patients (18%), with subsequent resolution of the syndrome in 7 of the 8. ATRA was resumed in 19 of the 36 patients (53%) in whom ATRA was stopped and not in 17 (47%). The syndrome recurred in 3 of those 19 patients, with 1 death attributable to resumption of the drug. Ten of these 36 patients received chemotherapy without further ATRA, and 8 achieved complete remission (CR). Among 7 patients in whom ATRA was not restarted and were not treated with chemotherapy, 5 achieved CR and 2 died. Two deaths were definitely attributable to the syndrome. No patient receiving ATRA as maintenance developed the syndrome. (Blood. 2000;95:90-95)",2000,"ATRA was discontinued in 36 of the 44 patients (82%) and continued in 8 patients (18%), with subsequent resolution of the syndrome in 7 of the 8.","['44 patients with acute promyelocytic leukemia who developed the retinoic acid syndrome', 'patients with newly diagnosed acute promyelocytic leukemia (APL) who developed the retinoic acid syndrome (RAS) treated on the Intergroup Protocol 0129, which prospectively evaluated the role of alltrans retinoic acid (ATRA) alone during induction and as maintenance therapy', 'Forty-four of 167 (26%) patients receiving']","['chemotherapy without further ATRA', 'ATRA']","['complete remission (CR', 'ATRA', 'median white blood cell (WBC) count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0860564', 'cui_str': 'Differentiation syndrome'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",,0.0384709,"ATRA was discontinued in 36 of the 44 patients (82%) and continued in 8 patients (18%), with subsequent resolution of the syndrome in 7 of the 8.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': 'Eastern Cooperative Oncology Group, Northwestern University Medical School, Robert H. Lurie Comprehensive Cancer Center, Chicago IL 60611, USA. m-tallman@nwu.edu'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Feusner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ogden', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rowe', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'François', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Larson', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}]",Blood,[]
285,10607712,Human monocytes express functional receptors for granulocyte colony-stimulating factor that mediate suppression of monokines and interferon-gamma.,"In a double-blind, placebo-controlled, randomized study, 10 healthy men received either a single dose of 480 microg granulocyte colony-stimulating factor (G-CSF) or saline. Blood taken from the volunteers was stimulated with 10 microg/mL endotoxin and released cytokines were measured by enzyme-linked immunosorbent assay. Expression of G-CSF receptors on leukocytes was examined by flow cytometry and reverse transcriptase-polymerase chain reaction. Functional activity of these receptors was tested by challenging isolated leukocyte populations to release cytokines with endotoxin in the presence of G-CSF. The G-CSF treatment attenuated the release of the proinflammatory cytokines tumor necrosis factor (TNF)-alpha, interleukin (IL)-12, IL-1beta, and interferon (IFN)-gamma in ex vivo lipopolysaccharide (LPS)-stimulated whole blood. In blood from untreated volunteers the presence of G-CSF in vitro also attenuated the LPS-stimulated release of these cytokines. G-CSF in vitro also attenuated TNF-alpha release from elutriation-purified monocytes. In the presence of 10 ng/mL recombinant TNF-alpha, the attenuation of LPS-inducible IFN-gamma release by G-CSF was blunted in whole blood. However, G-CSF had no such effect on IFN-gamma release from isolated lymphocytes stimulated with anti-CD3 or a combination of TNF-alpha and IL-12. G-CSF receptor expression was detected in human neutrophils and monocytes but not in lymphocytes by means of RT-PCR as well as flow cytometry. These results indicate that G-CSF receptors expressed on monocytes are functional in modulating monokine release. We conclude that the attenuation of IFN-gamma release from lymphocytes is not a direct effect of G-CSF on these cells but is rather due to the inhibition of monocytic IL-12 and TNF-alpha release by G-CSF. (Blood. 2000;95:270-276)",2000,"However, G-CSF had no such effect on IFN-gamma release from isolated lymphocytes stimulated with anti-CD3 or a combination of TNF-alpha and IL-12. G-CSF receptor expression was detected in human neutrophils and monocytes but not in lymphocytes by means of RT-PCR as well as flow cytometry.",['10 healthy men'],"['placebo', 'granulocyte colony-stimulating factor (G-CSF) or saline']","['IFN-gamma release', 'proinflammatory cytokines tumor necrosis factor (TNF)-alpha, interleukin (IL)-12, IL-1beta, and interferon (IFN)-gamma in ex vivo lipopolysaccharide (LPS)-stimulated whole blood']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}]",10.0,0.0254926,"However, G-CSF had no such effect on IFN-gamma release from isolated lymphocytes stimulated with anti-CD3 or a combination of TNF-alpha and IL-12. G-CSF receptor expression was detected in human neutrophils and monocytes but not in lymphocytes by means of RT-PCR as well as flow cytometry.","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Boneberg', 'Affiliation': 'University of Konstanz, Biochemical Pharmacology, Konstanz, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hareng', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gantner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendel', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hartung', 'Affiliation': ''}]",Blood,[]
286,10910888,Prolonged survival and tissue trafficking following adoptive transfer of CD4zeta gene-modified autologous CD4(+) and CD8(+) T cells in human immunodeficiency virus-infected subjects.,"We have genetically engineered CD4(+) and CD8(+) T cells with human immunodeficiency virus (HIV) specificity by inserting a gene, CD4zeta, containing the extracellular domain of human CD4 (which binds HIV env) linked to the zeta (zeta) chain of the T-cell receptor (which mediates T-cell activation). Twenty-four HIV-positive subjects received a single infusion of 2 to 3 x 10(10) autologous CD4zeta-modified CD4(+) and CD8(+) T cells administered with (n = 11) or without (n = 13) interleukin-2 (IL-2). Subjects had CD4 counts greater than 50/microL and viral loads of at least 1000 copies/mL at entry. T cells were costimulated ex vivo through CD3 and CD28 and expanded for approximately 2 weeks. CD4zeta was detected in 1% to 3% of blood mononuclear cells at 8 weeks and 0.1% at 1 year after infusion, and survival was not enhanced by IL-2. Trafficking of gene-modified T cells to bulk rectal tissue and/or isolated lamina propria lymphocytes was documented in a subset of 5 of 5 patients at 14 days and 2 of 3 at 1 year. A greater than 0.5 log mean decrease in rectal tissue-associated HIV RNA was observed for at least 14 days, suggesting compartmental antiviral activity of CD4zeta T cells. CD4(+) counts increased by 73/microL at 8 weeks in the group receiving IL-2. There was no significant mean change in plasma HIV RNA or blood proviral DNA in either treatment arm. This sustained, high-level persistence of gene-modified T cells demonstrates the feasibility of ex vivo T-cell gene therapy in HIV-infected adults and suggests the importance of providing HIV-specific T-helper function.",2000,"A greater than 0.5 log mean decrease in rectal tissue-associated HIV RNA was observed for at least 14 days, suggesting compartmental antiviral activity of CD4zeta T cells.","['human immunodeficiency virus-infected subjects', 'Twenty-four HIV-positive subjects', 'HIV-infected adults']","['CD4', 'ex vivo T-cell gene therapy', 'CD4zeta gene-modified autologous CD4(+) and CD8(+) T cells', 'single infusion of 2 to 3 x 10(10) autologous CD4zeta-modified CD4(+) and CD8(+) T cells administered with (n = 11) or without (n = 13) interleukin-2 (IL-2']","['plasma HIV RNA or blood proviral DNA', 'blood mononuclear cells', 'compartmental antiviral activity of CD4zeta T cells', 'CD4zeta', 'survival', 'CD4 counts', 'Prolonged survival and tissue trafficking', 'rectal tissue-associated HIV RNA']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0005768'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}]",,0.13002,"A greater than 0.5 log mean decrease in rectal tissue-associated HIV RNA was observed for at least 14 days, suggesting compartmental antiviral activity of CD4zeta T cells.","[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Mitsuyasu', 'Affiliation': 'University of California, Los Angeles, USA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Anton', 'Affiliation': ''}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Deeks', 'Affiliation': ''}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Scadden', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Connick', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Downs', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bakker', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Roberts', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'June', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jalali', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pennathur-Das', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Hege', 'Affiliation': ''}]",Blood,[]
287,10891434,"A randomized, double-blind trial of filgrastim (granulocyte colony-stimulating factor) versus placebo following allogeneic blood stem cell transplantation.","Blood stem cell transplantation (BSCT) results in rapid hematopoietic recovery in both the allogeneic and autologous transplant settings. Because of the large numbers of progenitor cells in mobilized blood, the administration of growth factors after transplantation may not provide further acceleration of hematopoietic recovery. A randomized, double-blind, placebo-controlled study was performed to determine the effects of filgrastim (granulocyte colony-stimulating factor; G-CSF) administration on hematopoietic recovery after allogeneic BSCT. Fifty-four patients with hematologic malignancies undergoing a related, HLA-matched allogeneic BSCT were randomly assigned to receive daily filgrastim at 10 microg/kg or placebo starting on the day of transplantation. A minimum of 3 x 10(6) CD34(+) cells/kg in the allograft was required for transplantation. All patients received a standard preparative regimen and a standard regimen for the prevention of graft-versus-host disease (GVHD). The median time to achieve an absolute neutrophil count greater than 0.5 x 10(9)/L was 11 days (range, 9-20 days) for patients who received filgrastim compared with 15 days (range, 10-22 days) for patients who received placebo (P =.0082). The median time to achieve a platelet count greater than 20 x 10(9)/L was 13 days (range, 8-35 days) for patients who received filgrastim compared with 15.5 days (range, 8-42 days) for patients who received placebo (P =.79). There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups. The administration of filgrastim appears to be a safe and effective supportive-care measure following allogeneic BSCT.",2000,"There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups.","['hematopoietic recovery after allogeneic BSCT', 'allogeneic blood stem cell transplantation', 'Fifty-four patients with hematologic malignancies undergoing a related, HLA-matched allogeneic BSCT']","['daily filgrastim at 10 microg/kg or placebo', 'placebo', 'filgrastim', 'filgrastim (granulocyte colony-stimulating factor; G-CSF', 'filgrastim (granulocyte colony-stimulating factor', 'Blood stem cell transplantation (BSCT']","['median time to achieve an absolute neutrophil count', 'median time to achieve a platelet count', 'red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality']","[{'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",54.0,0.413337,"There were no significant differences for red blood cell transfusion independence, the incidence of acute GVHD, or 100-day mortality between the groups.","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Bishop', 'Affiliation': 'Department of Medicine, University of Nebraska Medical Center, Omaha, NE, USA. mbishopmail.nih.gov'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Tarantolo', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Geller', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Lynch', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Bierman', 'Affiliation': ''}, {'ForeName': 'Z S', 'Initials': 'ZS', 'LastName': 'Pavletic', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Vose', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kruse', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Dix', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Armitage', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kessinger', 'Affiliation': ''}]",Blood,[]
288,10753829,"Effects of megakaryocyte growth and development factor on platelet production, platelet life span, and platelet function in healthy human volunteers.","The effects of thrombopoietic stimulation on megakaryocytopoiesis, platelet production, and platelet viability and function were examined in normal volunteers randomized to receive single bolus subcutaneous injections of 3 microg/kg pegylated recombinant megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo in a 3:1 ratio. PEG-rHuMGDF transiently doubled circulating platelet counts, from 237 +/- 41 x 10(3)/microL to 522 +/- 90 x 10(3)/microL (P <.0001), peaking on day 12. Baseline and day-12 samples showed no differences in responsiveness of platelets to adenosine diphosphate or thrombin receptor agonist peptide (P >.4 in all cases); expression of platelet ligand-induced binding sites or annexin V binding sites (P >.6 in both cases); or density of platelet TPO-receptors (P >.5). Platelet counts normalized by day 28. The life span of autologous (111)In-labeled platelets increased from 205 +/- 18 hours (baseline) to 226 +/- 22 hours (P <.01) on day 8. Platelet life span decreased from 226 +/- 22 hours (day 8) to 178 +/- 53 hours (P <.05) on day 18. The theoretical basis for senescent changes in mean platelet life span was illustrated by biomathematical modeling. Platelet turnover increased from 43.9 +/- 11.9 x 10(3) platelets/microL/d (baseline) to 101 +/- 27.6 x 10(3) platelets/microL/d (P =.0009), and marrow megakaryocyte mass expanded from 37.4 +/- 18.5 fL/kg to 62 +/- 17 x 10(10) fL/kg (P =. 015). Although PEG-rHuMGDF initially increased megakaryocyte volume and ploidy, subsequently ploidy showed a transient reciprocal decrease when the platelet counts exceeded placebo values. In healthy human volunteers PEG-rHuMGDF transiently increases megakaryocytopoiesis 2-fold. Additionally, peripheral platelets expand correspondingly and exhibit normal function and viability during the ensuing 10 days. The induced perturbation in steady state thrombopoiesis resolves by 4 weeks. (Blood. 2000;95:2514-2522)",2000,Baseline and day-12 samples showed no differences in responsiveness of platelets to adenosine diphosphate or thrombin receptor agonist peptide (P >.4 in all cases); expression of platelet ligand-induced binding sites or annexin V binding sites (P >.6 in both cases); or density of platelet TPO-receptors (P >.5).,"['healthy human volunteers PEG', 'healthy human volunteers', '41', 'normal volunteers', '17']","['PEG-rHuMGDF', 'megakaryocyte growth and development factor', 'thrombopoietic stimulation', 'rHuMGDF', 'single bolus subcutaneous injections of 3 microg/kg pegylated recombinant megakaryocyte growth and development factor (PEG-rHuMGDF) or placebo']","['Platelet counts', 'Platelet life span', 'marrow megakaryocyte mass', 'platelet production, platelet life span, and platelet function', 'megakaryocyte volume and ploidy', 'responsiveness of platelets to adenosine diphosphate or thrombin receptor agonist peptide', 'life span of autologous (111)In-labeled platelets', 'Platelet turnover', 'megakaryocytopoiesis, platelet production, and platelet viability and function']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C3661466', 'cui_str': 'Normal Volunteers'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301654', 'cui_str': 'Single bolus (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0302034', 'cui_str': 'Platelet life span, function (observable entity)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0025166', 'cui_str': 'Megakaryocytes'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0221145', 'cui_str': 'Thrombocytopoiesis'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032246', 'cui_str': 'Ploidies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0076552', 'cui_str': 'Thrombin Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0522310', 'cui_str': 'Megakaryocytopoiesis'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0208463,Baseline and day-12 samples showed no differences in responsiveness of platelets to adenosine diphosphate or thrombin receptor agonist peptide (P >.4 in all cases); expression of platelet ligand-induced binding sites or annexin V binding sites (P >.6 in both cases); or density of platelet TPO-receptors (P >.5).,"[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Harker', 'Affiliation': 'Division of Hematology and Oncology, Emory University School of Medicine, Atlanta, GA 30322, USA.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Roskos', 'Affiliation': ''}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Marzec', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Cherry', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sundell', 'Affiliation': ''}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Terry', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sheridan', 'Affiliation': ''}]",Blood,[]
289,10627441,Molecular analysis and clinical outcome of adult APL patients with the type V PML-RARalpha isoform: results from intergroup protocol 0129.,"The type V (for variable) promyelocytic leukemia retinoic acid receptor (PML-RAR)alpha transcript, found in approximately 8% of adult patients with acute promyelocytic leukemia (APL), is defined molecularly by truncation of PML exon 6 and frequent insertion of genetic material from RARalpha intron 2. To more fully characterize the molecular features of PML-RARalpha V-type transcripts and to determine whether V-form APL patients have a distinct clinical presentation or prognosis, we analyzed 18 adult V-form APL patients enrolled on Intergroup protocol 0129 (INT-0129). Truncations in PML exon 6 ranged from 8 to 146 nucleotides, and 3 to 127 extra nucleotides (1 to 42 extra amino acids) were inserted at the PML exon 6/RARalpha exon 3 junction in 13 cases. No distinguishing morphologic, cytogenetic, or immunophenotypic features of V-form blasts were identified. A total of 5 of 7 patients induced with ATRA and 8 of 11 patients who received chemotherapy for induction achieved complete remission (CR). Six patients have relapsed, 4 after chemotherapy induction and 2 after ATRA. Nine patients (50%) are alive, 6 in continuous CR, 2 after salvage therapy for relapsed or refractory disease, and 1 after alternative treatment following early removal from protocol. Although the failure rate for V-form APL patients was high (61%), the low power of the current study to detect clinically significant differences precludes a meaningful comparison of clinical outcomes between the 18 V-form cases and non-V-form adult APL patients enrolled on INT-0129. (Blood. 2000;95:398-403)",2000,"No distinguishing morphologic, cytogenetic, or immunophenotypic features of V-form blasts were identified.","['Six patients have relapsed, 4 after chemotherapy induction and 2 after ATRA', 'adult APL patients with the type V PML-RARalpha isoform', '18 adult V-form APL patients enrolled on Intergroup protocol 0129', 'adult patients with acute promyelocytic leukemia (APL']","['PML', 'exon 6/RARalpha', 'chemotherapy']","['complete remission (CR', 'failure rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0297323', 'cui_str': 'promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0422742,"No distinguishing morphologic, cytogenetic, or immunophenotypic features of V-form blasts were identified.","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Slack', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. james.slack@roswellpark.org'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Viswanatha', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Gallagher', 'Affiliation': ''}]",Blood,[]
290,10845898,Quality of life-adjusted survival analysis of high-dose therapy with autologous bone marrow transplantation versus sequential chemotherapy for patients with aggressive lymphoma in first complete remission. Groupe d'Etude les Lymphomes de l'Adulte (GELA).,"Evaluating high-dose therapy (HDT) with autologous stem cell transplantation (ASCT) in term of both duration and quality of life (QOL) presents major interests for patients with non-Hodgkin lymphoma. The quality-adjusted time without symptom and toxicity (Q-TWiST) methodology was applied to the LNH87-2 trial comparing HDT with ASCT versus sequential chemotherapy in 541 patients in first complete remission (CR). Overall survival (OS) and disease-free survival (DFS) curves were used to estimate duration of 4 health states: acute short-term toxicity (Tox1), secondary toxicity (Tox2), time without symptom and toxicity (TWiST), and relapse (Rel). Areas under survival curves (AUC) were retrospectively weighted according to QOL coefficients. HDT increased, but not significantly, TWiST (+2. 4 months in AUC, P =.17) and decreased Rel (-3 months, P <.01). Survival estimates did not differ between the 2 treatments (AUC 47.7 months for OS, 39.7 months for DFS). High-risk patients treated by HDT versus chemotherapy had a significant benefit in DFS (AUC 28.8 versus 24.9 months, P <.01) but not in OS (AUC 37.3 versus 36 months, P =.27). Sensitivity analysis, performed by varying QOL coefficients, demonstrated significant quality-adjusted survival gain in high-risk patients treated by HDT. In low-risk patients, a diagram provided an aid to clinical decision-making. This analysis supports the use of HDT in these patients with adverse prognostic factors in the first CR, even after adjusting for QOL using the Q-TWiST method. (Blood. 2000;95:3687-3692)",2000,"HDT increased, but not significantly, TWiST (","['2000;95:3687-3692', '541 patients in first complete remission (CR', 'patients with non-Hodgkin lymphoma', 'patients with aggressive lymphoma in first complete remission']","['HDT versus chemotherapy', 'Evaluating high-dose therapy (HDT) with autologous stem cell transplantation (ASCT', 'TWiST ', 'autologous bone marrow transplantation versus sequential chemotherapy', 'ASCT']","['HDT', 'quality-adjusted survival gain', 'quality-adjusted time without symptom and toxicity', 'Survival estimates', 'Rel', 'duration and quality of life (QOL', 'Areas under survival curves (AUC', 'Overall survival (OS) and disease-free survival (DFS) curves', 'Quality of life-adjusted survival analysis', 'DFS', 'duration of 4 health states: acute short-term toxicity (Tox1), secondary toxicity (Tox2), time without symptom and toxicity (TWiST), and relapse (Rel']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0034380'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0476288,"HDT increased, but not significantly, TWiST (","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mounier', 'Affiliation': ""Département d'information hospitalier and Service d'hématologie clinique Hôpital Henri Mondor, AP-HP, Créteil, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': ''}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gisselbrecht', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marit', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ravoet', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Reyes', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lepage', 'Affiliation': ''}]",Blood,[]
291,10627439,Serum syndecan-1: a new independent prognostic marker in multiple myeloma.,"Serum samples drawn at diagnosis from 174 myeloma patients were analyzed for the presence of the heparan [corrected] sulfate proteoglycan, syndecan-1. Syndecan-1 was elevated in 79% of patients (median, 643 units/mL) compared with 40 healthy controls (median, 128 units/mL), P <.0001. Serum syndecan-1 correlated with the following: serum creatinine, secretion of urine M-component over the course of 24 hours, soluble interleukin-6 (IL-6) receptor, C-terminal telopeptide of type I collagen, beta(2)-microglobulin, percentage of plasma cells in the bone marrow, disease stage, and serum M-component concentration. In order to evaluate syndecan-1 as a prognostic marker in multiple myeloma, it was entered into a multivariate Cox regression model. Data from 138 patients were available for this analysis. As a continuous variable, syndecan-1 was an independent prognostic parameter in addition to serum beta(2)-microglobulin and World Health Organization performance status. When syndecan-1 was dichotomized by the best cutoff (66th percentile, 1170 units/mL), the survival difference between the groups was highly significant: ""high"" syndecan-1 group had a median survival of 20 months, and the ""low"" syndecan-1 group had a median of 44 months (P <.0001). We conclude that syndecan-1 is a new independent prognostic parameter in multiple myeloma, and its role in prognostic classification systems should be further investigated. (Blood. 2000;95:388-392)",2000,"Syndecan-1 was elevated in 79% of patients (median, 643 units/mL) compared with 40 healthy controls (median, 128 units/mL), P <.0001.","['138 patients were available for this analysis', '174 myeloma patients']",[],"['median survival', 'I collagen, beta(2)-microglobulin, percentage of plasma cells in the bone marrow, disease stage, and serum M-component concentration', 'survival difference', 'Serum syndecan-1', 'serum creatinine, secretion of urine M-component over the course of 24 hours, soluble interleukin-6 (IL-6) receptor, C-terminal telopeptide of type']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0032112', 'cui_str': 'Plasmacytes'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027015', 'cui_str': 'M Components'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609943', 'cui_str': 'CD138 Antigens'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0042037'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",138.0,0.032882,"Syndecan-1 was elevated in 79% of patients (median, 643 units/mL) compared with 40 healthy controls (median, 128 units/mL), P <.0001.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Seidel', 'Affiliation': 'Institute of Cancer Research and Molecular Biology and the Section of Hematology, University Hospital, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sundan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hjorth', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Turesson', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Dahl', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Abildgaard', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Waage', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borset', 'Affiliation': ''}]",Blood,[]
292,10438709,"Stem cell factor in combination with filgrastim after chemotherapy improves peripheral blood progenitor cell yield and reduces apheresis requirements in multiple myeloma patients: a randomized, controlled trial.","Stem cell factor (SCF) has been shown to synergize with filgrastim to mobilize CD34(+) cells into the peripheral blood. To determine if addition of SCF to chemotherapy and filgrastim reduces the number of leukaphereses required to achieve a target yield of 5 x 10(6) CD34(+) cells/kg, 102 patients with multiple myeloma were randomized to receive mobilization chemotherapy with cyclophosphamide (4 g/m(2)) and either SCF (20 micrograms/kg/d) combined with filgrastim (5 micrograms/kg/d) or filgrastim alone (5 micrograms/kg/d), administered daily until leukaphereses were completed. After collection, patients were treated with myeloablative therapy supported by autologous peripheral blood progenitor cell (PBPC) infusion and filgrastim (5 micrograms/kg/d). There was a significant difference between the treatment groups in the number of leukaphereses required to collect 5 x 10(6) CD34(+) cells/kg (median of 1 v 2 for SCF + filgrastim and filgrastim alone, respectively, P =.008). Patients receiving the combination of SCF plus filgrastim had a 3-fold greater chance of reaching 5 x 10(6) CD34(+) cells/kg in a single leukapheresis compared with patients mobilized with filgrastim alone. The median CD34(+) cell yield was significantly increased for the SCF group in the first leukapheresis (11.3 v 4.0 x 10(6)/kg, P =.003) and all leukaphereses (12.4 v 8.2 x 10(6)/kg, P =.007). Total colony-forming unit-granulocyte-macrophage (CFU-GM) and mononuclear cell counts were also significantly higher in the SCF group in the first leukapheresis and in all leukaphereses. As expected for patients mobilized to an optimal CD34(+) cell yield, the time to engraftment was similar between the 2 treatment groups. Cells mobilized with the combination of SCF plus filgrastim were thus considered effective and safe for achieving rapid engraftment. Treatment with SCF plus filgrastim was well tolerated, with mild to moderate injection site reactions being the most frequently reported adverse events. There were no serious allergic-like reactions to SCF. The addition of SCF to filgrastim after cyclophosphamide for PBPC mobilization resulted in a significant increase in CD34(+) cell yield and a concomitant reduction in the number of leukaphereses required to collect an optimal harvest of 5 x 10(6) CD34(+) cells/kg.",1999,Total colony-forming unit-granulocyte-macrophage (CFU-GM) and mononuclear cell counts were also significantly higher in the SCF group in the first leukapheresis and in all leukaphereses.,"['multiple myeloma patients', '102 patients with multiple myeloma']","['filgrastim alone', 'SCF plus filgrastim', 'cyclophosphamide', 'mobilization chemotherapy with cyclophosphamide', 'filgrastim', 'myeloablative therapy supported by autologous peripheral blood progenitor cell (PBPC) infusion and filgrastim', 'SCF to chemotherapy and filgrastim', 'SCF', 'Stem cell factor (SCF']","['apheresis requirements', 'serious allergic-like reactions', 'median CD34(+) cell yield', 'CD34(+) cell yield', 'number of leukaphereses required to collect 5 x 10(6) CD34(+) cells/kg', 'Total colony-forming unit-granulocyte-macrophage (CFU-GM) and mononuclear cell counts', 'time to engraftment']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}]","[{'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0023416', 'cui_str': 'Leukocytapheresis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C2919236', 'cui_str': 'Colony-forming unit of granulocytic-monocytic lineage (cell)'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}]",102.0,0.0436311,Total colony-forming unit-granulocyte-macrophage (CFU-GM) and mononuclear cell counts were also significantly higher in the SCF group in the first leukapheresis and in all leukaphereses.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Department of Hematology, Service des Maladies du Sang,Hôpital Claude Huriez, 59037 Lille Cedex, France. tfalcon.lille@invivo.edu'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maloisel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Odriozola', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alegre', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schroyens', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schots', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marin', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guilhot', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Granena', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Waele', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pigneux', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Méresse', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiffers', 'Affiliation': ''}]",Blood,[]
293,10438706,A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia. The European APL Group.,"All transretinoic acid (ATRA) followed by daunorubicin (DNR)-AraC chemotherapy (CT) has improved the outcome of acute promyelocytic leukemia (APL) by comparison to CT alone. In a randomized trial, (1) we compared 2 induction schedules (ATRA followed by CT [ATRA-->CT] and ATRA plus CT [ATRA+CT, with CT added on day 3 of ATRA treatment]) and (2) we assessed the role of maintenance treatment. Four hundred thirteen patients </=75 years of age and with newly diagnosed APL were included. Induction treatment was stratified on white blood cell (WBC) count and age: patients </=65 years of age and with an initial WBC count of </=5,000/microL (n = 208) were randomized between ATRA-->CT and ATRA+CT (initially randomized patients); patients with a WBC count greater than (high WBC count group, n = 163) and patients 66 to 75 years of age with a WBC count greater than 5,000/microL (elderly group, n = 42) were not initially randomized and received ATRA+CT from day 1 and ATRA -->CT, respectively. All patients achieving CR received 2 additional DNR-AraC courses (only 1 in patients 66 to 75 years of age) and were then randomized for maintenance between no treatment, intermittent ATRA (15 days every 3 months) for 2 years, continuous low-dose CT (6 mercaptopurine + methotrexate) for 2 years, or both, using a 2-by-2 factorial design. Overall, 381 (92%) of the patients achieved complete remission (CR), 31 (7%) suffered an early death, and only 1 patient had leukemic resistance. ATRA syndrome occurred in 64 patients (15%) and was fatal in 5 cases. The CR rate was similar in all induction treatment groups. Event-free survival (EFS) was significantly lower in the high WBC group (P =.0002) and close to significance in the elderly group (P =.086) as compared with initially randomized patients. Relapse at 2 years was estimated at 6% in the ATRA+CT group, versus 16% in the ATRA-->CT group (P =.04, relative risk [RR] =.41). EFS at 2 years was estimated at 84% in the ATRA+CT group, versus 77% in the ATRA-->CT group (P =.1, RR =.62). Two hundred eighty-nine patients were randomized for maintenance. The 2-year relapse rate was 11% in patients randomized to continuous maintenance CT and 27% in patients randomized to no CT (P =.0002) and 13% in patients randomized to intermittent ATRA and 25% in patients randomized to no ATRA (P =.02). An additive effect of continuous maintenance CT and intermittent ATRA was seen, and only 6 of the 74 patients who received both maintenance treatments had relapsed. Overall survival was improved in patients who received maintenance CT (P =.01), and there was a trend for better survival in patients who received maintenance ATRA (P =.22). Our findings strongly suggest that early addition of chemotherapy to ATRA and maintenance therapy combining continuous CT and intermittent ATRA can reduce the incidence of relapse in APL. This effect already translates into significantly better survival for maintenance treatment with continuous CT.",1999,Event-free survival (EFS) was significantly lower in the high WBC group (P =.0002) and close to significance in the elderly group (P =.086) as compared with initially randomized patients.,"['newly diagnosed acute promyelocytic leukemia', 'Two hundred eighty-nine patients', 'Four hundred thirteen patients ', '65 years of age and with an initial WBC count of </=5,000/microL', 'n = 208', '75 years of age and with newly diagnosed APL were included', 'initially randomized patients); patients with a WBC count greater than (high WBC count group, n = 163) and patients 66 to 75 years of age with a WBC count greater than 5,000/microL (elderly group, n = 42', '74 patients who received both maintenance treatments had relapsed']","['chemotherapy and ATRA plus chemotherapy', 'continuous low-dose CT (6 mercaptopurine + methotrexate', '2 induction schedules (ATRA followed by CT [ATRA-->CT] and ATRA plus CT [ATRA+CT, with CT', 'ATRA+CT', 'ATRA-->CT', 'ATRA-->CT and ATRA+CT', 'transretinoic acid (ATRA', 'continuous maintenance CT and intermittent ATRA', 'continuous CT', 'All transretinoic acid (ATRA) followed by daunorubicin (DNR)-AraC chemotherapy (CT']","['Relapse', 'early death', 'white blood cell (WBC) count and age: patients', 'leukemic resistance', '2-year relapse rate', 'better survival', 'survival', 'complete remission (CR', 'ATRA syndrome', 'CR rate', 'Overall survival', 'Event-free survival (EFS']","[{'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1739128', 'cui_str': 'ATRA syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",208.0,0.0500673,Event-free survival (EFS) was significantly lower in the high WBC group (P =.0002) and close to significance in the elderly group (P =.086) as compared with initially randomized patients.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': 'European APL Group, Service des Maladies pour la Recherche contre le Cancer.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chastang', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Archimbaud', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fey', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rayon', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sotto', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Makhoul', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Travade', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Solary', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fegueux', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bordessoule', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Miguel', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deconinck', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maloisel', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Castaigne', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Preudhomme', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Degos', 'Affiliation': ''}]",Blood,[]
294,10498596,The effect of a metalloproteinase inhibitor (GI5402) on tumor necrosis factor-alpha (TNF-alpha) and TNF-alpha receptors during human endotoxemia.,"Tumor necrosis factor-alpha (TNF-alpha) is released from the cell surface by cleavage of pro-TNF-alpha by metalloproteinases (MPs). In cell cultures, inhibition of MPs has been found not only to reduce the release of TNF-alpha, but also to enhance the surface expression of TNF-alpha and TNF-alpha receptors, which might lead to a proinflammatory effect. To determine the effect of MP inhibition during inflammation in humans, 7 healthy subjects were studied after intravenous injection of lipopolysaccharide (LPS; 4 ng/kg) preceded (-20 minutes) by an oral dose of the MP inhibitor GI5402 (100 mg) or matching placebo. GI5402 strongly reduced LPS-induced TNF-alpha release (P <.001), but did not influence the increase in monocyte-bound TNF-alpha. In addition, GI5402 attenuated the rise in plasma-soluble TNF-alpha receptors types I and II after LPS injection (both P <.001), but did not change the LPS-induced decreases in granulocyte and monocyte TNF-alpha receptor expression. These data suggest that MP inhibitors may be useful as a treatment modality in diseases in which excessive production of TNF-alpha is considered to play an important role. Furthermore, unlike in vitro, no evidence has been found in vivo with MP inhibition for a potential proinflammatory effect due to increases in membrane-bound TNF-alpha and TNF-alpha receptor number.",1999,"GI5402 strongly reduced LPS-induced TNF-alpha release (P <.001), but did not influence the increase in monocyte-bound TNF-alpha.","['humans, 7 healthy subjects']","['metalloproteinase inhibitor (GI5402', 'MP inhibition', 'MP inhibitor GI5402 (100 mg) or matching placebo', 'lipopolysaccharide (LPS']","['LPS-induced TNF-alpha release', 'Tumor necrosis factor-alpha (TNF-alpha', 'tumor necrosis factor-alpha (TNF-alpha) and TNF-alpha receptors', 'monocyte-bound TNF-alpha', 'rise in plasma-soluble TNF-alpha receptors', 'granulocyte and monocyte TNF-alpha receptor expression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025543', 'cui_str': 'Metalloproteases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",7.0,0.0358542,"GI5402 strongly reduced LPS-induced TNF-alpha release (P <.001), but did not influence the increase in monocyte-bound TNF-alpha.","[{'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Dekkers', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Laboratory of Experimental Internal Medicine, Amsterdam, The Netherlands. P.E.Dekkers@AMC.UVA.NL'}, {'ForeName': 'F N', 'Initials': 'FN', 'LastName': 'Lauw', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'ten Hove', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'te Velde', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lumley', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Becherer', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'van Deventer', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': ''}]",Blood,[]
295,10572078,"Interferon-alpha before allogeneic bone marrow transplantation in chronic myelogenous leukemia does not affect outcome adversely, provided it is discontinued at least 90 days before the procedure.","The influence of interferon-alpha (IFN) pretreatment on the outcome after allogeneic bone marrow transplantation (BMT) in chronic myelogenous leukemia (CML) is controversial. One goal of the German randomized CML Studies I and II, which compare IFN +/- chemotherapy versus chemotherapy alone, was the analysis of whether treatment with IFN as compared to chemotherapy had an influence on the outcome after BMT. One hundred ninety-seven (23%) of 856 Ph/bcr-abl-positive CML patients were transplanted. One hundred fifty-two patients transplanted in first chronic phase were analyzed: 86 had received IFN, 46 hydroxyurea, and 20 busulfan. Forty-eight patients (32%) had received transplants from unrelated donors. Median observation time after BMT was 4.7 (0.7 to 13.5) years. IFN and chemotherapy cohorts were compared with regard to transplantation risks, duration of treatments, interval from discontinuation of pretransplant treatment to BMT, conditioning therapy, graft-versus-host disease prophylaxis and risk profiles at diagnosis and transplantation, and IFN cohorts also with regard to performance and resistance to IFN. Outcome of patients receiving related or unrelated transplants pretreated with IFN, hydroxyurea, or busulfan was not significantly different. Five-year survival after transplantation was 58% for all patients (57% for IFN, 60% for hydroxyurea and busulfan patients). The outcome within the IFN group was not different by duration of prior IFN therapy more or less than 5 months, 1 year, or 2 years. In contrast, a different impact was observed in IFN-pretreated patients depending on the time of discontinuation of IFN before transplantation. Five-year survival was 46% for the 50 patients who received IFN within the last 90 days before BMT and 71% for the 36 patients who did not (P =.0057). Total IFN dosage had no impact on survival after BMT. We conclude that outcome after BMT is not compromised by pretreatment with IFN if it is discontinued at least 3 months before transplantation. Clear candidates for early transplantation should not be pretreated with IFN.",1999,"Five-year survival after transplantation was 58% for all patients (57% for IFN, 60% for hydroxyurea and busulfan patients).","['One hundred fifty-two patients transplanted in first chronic phase were analyzed: 86 had received', 'One hundred ninety-seven (23%) of 856 Ph/bcr-abl-positive CML patients were transplanted', 'patients receiving related or unrelated transplants pretreated with', 'Forty-eight patients (32%) had received transplants from unrelated donors', 'chronic myelogenous leukemia', 'chronic myelogenous leukemia (CML']","['Interferon-alpha before allogeneic bone marrow transplantation', 'allogeneic bone marrow transplantation (BMT', 'chemotherapy versus chemotherapy', 'IFN ', 'interferon-alpha (IFN', 'IFN, hydroxyurea, or busulfan', 'IFN and chemotherapy', 'IFN, 46 hydroxyurea, and 20 busulfan']","['Median observation time', 'Five-year survival', 'survival']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C4517894', 'cui_str': '856 (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0570239,"Five-year survival after transplantation was 58% for all patients (57% for IFN, 60% for hydroxyurea and busulfan patients).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'III. Medizinische Universitätsklinik, Klinikum Mannheim, Universität Heidelberg, Heidelberg, Germany. R.Hehlmann@urz.uni-heidelberg.de'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Heimpel', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Siegert', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Finke', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holler', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Berger', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muth', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zander', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fauser', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Heyll', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Löffler', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pralle', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Queisser', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tobler', 'Affiliation': ''}]",Blood,[]
296,10572081,"A randomized, double-blind, placebo-controlled study with pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) as an adjunct to chemotherapy for adults with de novo acute myeloid leukemia.","To determine the safety, biologic, and clinical benefits of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF; Amgen, Thousand Oaks, CA) after myelosuppressive chemotherapy in acute myeloid leukemia (AML), 108 adult patients with de novo AML were randomized to receive either PEG-rHuMGDF (2.5 microg/kg/d or 5 microg/kg/d) for up to 21 doses (group A), a single dose of 2.5 microg/kg PEG-rHuMGDF, 7 daily doses of 2.5 microg/kg PEG-rHuMGDF (group B), or placebo. The greatest biologic activity was seen in group A with a median peak platelet count of 1,084 x 10(9)/L, occurring at a median 9 days after the last dose of study drug, compared with 517 x 10(9)/L and 390 x 10(9)/L in group B and placebo group, respectively. Thrombocytosis (platelets >1,000 x 10(9)/L) was seen at rates of 52%, 8%, and 9% in groups A, B, and placebo, respectively, but were not associated with any adverse event. There was no effect on median time to transfusion independent platelet recovery (> or = 20 x 10(9)/L). The median time to neutrophil recovery (> or = 500/microL) and red blood cell transfusion requirements were similar in all groups, and there was no apparent stimulation of leukemia. PEG-rHuMGDF was biologically active and well tolerated. Further investigation of dose and scheduling is required, specifically earlier dosing before and during chemotherapy.",1999,"The median time to neutrophil recovery (> or = 500/microL) and red blood cell transfusion requirements were similar in all groups, and there was no apparent stimulation of leukemia.","['acute myeloid leukemia (AML), 108 adult patients with de novo AML', 'adults with de novo acute myeloid leukemia']","['PEG-rHuMGDF', 'myelosuppressive chemotherapy', 'placebo', 'PEG-rHuMGDF, 7 daily doses of 2.5 microg/kg PEG-rHuMGDF', 'pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF']","['median time to transfusion independent platelet recovery', 'Thrombocytosis', 'red blood cell transfusion requirements', 'greatest biologic activity', 'median time to neutrophil recovery']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0836924', 'cui_str': 'Thrombocythemia'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}]",108.0,0.166698,"The median time to neutrophil recovery (> or = 500/microL) and red blood cell transfusion requirements were similar in all groups, and there was no apparent stimulation of leukemia.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Archimbaud', 'Affiliation': 'Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Ottmann', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Brugger', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barge', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""O'Brien-Ewen"", 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matcham', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoelzer', 'Affiliation': ''}]",Blood,[]
297,10438710,Intensive treatment of children with acute lymphoblastic leukemia according to ALL-BFM-86 without cranial radiotherapy: results of Dutch Childhood Leukemia Study Group Protocol ALL-7 (1988-1991).,"In The Netherlands from July 1988 to October 1991, children (0 to 16 years of age) with de novo acute lymphoblastic leukemia (ALL) were treated according to protocol ALL-7 of the Dutch Childhood Leukemia Study Group (DCLSG). In this protocol, chemotherapy and treatment stratification were identical to the ALL-BFM-86 protocol (Reiter et al, Blood 84:3122, 1994), but cranial irradiation was restricted to patients with initial central nervous system (CNS) involvement. Patients were stratified into 3 risk groups, based on leukemia cell mass and response to initial treatment: standard-risk group (SRG), risk group (RG), and experimental group (EG). As in ALL-BFM-86, a randomized study on late intensification (protocol S) was performed in RG patients, and during the study (since October 1990), early reinduction treatment (protocol II) was introduced for SRG patients. Treatment duration for all patients was 18 months. Two hundred eighteen children entered the study: 74 SRG, 127 RG, and 17 EG patients. The overall complete remission (CR) rate was 98%. The 5-year event-free survival (EFS) for all DCLSG ALL-7 patients was 65. 3% (standard error [SE] 3.2%), which was significantly different from the 73% (SE 1%) 5-year EFS achieved in the ALL-BFM-86 study (P =.02, Z-test). However, restricting the analysis to SRG patients receiving protocol II with a total duration of treatment of 18 months, the 5-year EFS rates were 64.6% (SE 4.0%) and 67% (SE 4%), respectively, and no significant difference could be established (P =.67, Z-test). The 5-year EFS rates for SRG, RG, and EG patients were 63.5% (SE 5.6%), 66.6% (SE 4.2%), and 63.3% (SE 12.0%), respectively. SRG patients receiving protocol II fared better than patients not receiving protocol II (5-year EFS 76.7% [SE 7.7] and 54. 5% [SE 7.5], respectively). No difference in 5-year EFS was observed in RG patients randomized to receive or not to receive late intensification with protocol S. The overall CNS relapse rate at 5 years was 5.5%. The incidence rate at 5 years was 11.4% in SRG patients not receiving protocol II, whereas no CNS relapses occurred in SRG patients receiving protocol II. Six children died in first complete remission and 2 children developed a second malignancy (thyroid carcinoma and acute nonlymphoblastic leukemia). Systemic high-dose methotrexate (MTX) and intrathecal chemotherapy is a safe and effective method of CNS prophylaxis in the context of BFM-oriented treatment for all children with ALL, regardless of the risk group (with the possible exception of T-ALL patients with high white blood cell counts). The results of the DCLSG ALL-7 study confirm those of the ALL-BFM-86 study showing that early reinduction with protocol II is essential in the treatment of SRG patients and that late intensification with protocol S does not improve the prognosis for RG patients.",1999,No difference in 5-year EFS was observed in RG patients randomized to receive or not to receive late intensification with protocol S.,"['Patients were stratified into 3 risk groups, based on leukemia cell mass and response to initial treatment: standard-risk group (SRG), risk group (RG), and experimental group (EG', 'In The Netherlands from July 1988 to October 1991, children (0 to 16 years of age) with de novo acute lymphoblastic leukemia (ALL', 'children with acute lymphoblastic leukemia according to ALL-BFM-86 without cranial radiotherapy', 'Two hundred eighteen children entered the study: 74 SRG, 127 RG, and 17 EG patients']",['Systemic high-dose methotrexate (MTX) and intrathecal chemotherapy'],"['5-year event-free survival (EFS', 'CNS relapses', '5-year EFS rates', '5-year EFS', 'second malignancy (thyroid carcinoma and acute nonlymphoblastic leukemia', 'incidence rate', 'overall complete remission (CR) rate', 'overall CNS relapse rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0085183', 'cui_str': 'Neoplasms, Metachronous Second Primary'}, {'cui': 'C0549473', 'cui_str': 'Thyroid Cancer'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",218.0,0.0238309,No difference in 5-year EFS was observed in RG patients randomized to receive or not to receive late intensification with protocol S.,"[{'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Kamps', 'Affiliation': 'Dutch Childhood Leukemia Study Group (DCLSG), The Hague, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Bökkerink', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hählen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hermans', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riehm', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gadner', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Slater', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'van den Berg-de Ruiter', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Smets', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'de Vaan', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Weening', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'van Weerden', 'Affiliation': ''}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'van Wering', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'den der Does-van den Berg', 'Affiliation': ''}]",Blood,[]
298,10419902,"Frequency and clinical significance of the expression of the multidrug resistance proteins MDR1/P-glycoprotein, MRP1, and LRP in acute myeloid leukemia: a Southwest Oncology Group Study.","Therapeutic resistance is a major obstacle in the treatment of acute myeloid leukemia (AML). Such resistance has been associated with rapid drug efflux mediated by the multidrug resistance gene 1 (MDR1; encoding P-glycoprotein) and more recently with expression of other novel proteins conferring multidrug resistance such as MRP1 (multidrug resistance-associated protein 1) and LRP (lung resistance protein). To determine the frequency and clinical significance of MDR1, MRP1, and LRP in younger AML patients, we developed multiparameter flow cytometric assays to quantify expression of these proteins in pretreatment leukemic blasts from 352 newly diagnosed AML patients (median age, 44 years) registered to a single clinical trial (SWOG 8600). Protein expression was further correlated with functional efflux by leukemic blasts [assessed using two substrates: Di(OC)(2) and Rhodamine 123] and with the ability of MDR-reversing agents to inhibit efflux in vitro. MDR1/P-glycoprotein expression, which was highly correlated with cyclosporine-inhibited efflux, was noted in only 35% of these younger AML patients, distinctly lower than the frequency of 71% we previously reported in AML in the elderly (Blood 89:3323, 1997). Interestingly, MDR1 expression and functional drug efflux increased with patient age, from a frequency of only 17% in patients less than 35 years old to 39% in patients aged 50 years (P =.010). In contrast, MRP1 was expressed in only 10% of cases and decreased with patient age (P =. 024). LRP was detected in 43% of cases and increased significantly with increasing white blood cell counts (P =.0015). LRP was also marginally associated with favorable cytogenetics (P =.012) and French-American-British (FAB) AML FAB subtypes (P =.013), being particularly frequent in M4/M5 cases. Only MDR1/P-glycoprotein expression and cyclosporine-inhibited efflux were significantly associated with complete remission (CR) rate (P(MDR1) =.012; P(efflux) =.039) and resistant disease (RD; P(MDR1) =.0007; P(efflux) =.0092). No such correlations were observed for MRP1 (P(CR) =.93; P(RD) =.55) or LRP (P(CR) =.50; P(RD) =.53). None of these parameters were associated with overall or relapse-free survival. Unexpectedly, a distinct and nonoverlapping phenotype was detected in 18% of these cases: cyclosporine-resistant efflux not associated with MDR1, MRP1, or LRP expression, implying the existence of other as yet undefined efflux mechanisms in AML. In summary, MDR1 is less frequent in younger AML patients, which may in part explain their better response to therapy. Neither MRP1 nor LRP are significant predictors of outcome in this patient group. Thus, inclusion of MDR1-modulators alone may benefit younger AML patients with MDR1(+) disease.",1999,Only MDR1/P-glycoprotein expression and cyclosporine-inhibited efflux were significantly associated with complete remission (CR) rate (P(MDR1) =.012; P(efflux) =.039) and resistant disease (RD; P(MDR1) =.0007; P(efflux) =.0092).,"['acute myeloid leukemia (AML', 'younger AML patients', '352 newly diagnosed AML patients (median age, 44 years) registered to a single clinical trial (SWOG 8600', 'acute myeloid leukemia']",['cyclosporine'],"['AML FAB subtypes', 'MDR1, MRP1, or LRP expression', 'complete remission (CR) rate', 'Protein expression', 'MDR1/P-glycoprotein expression', 'MRP1', 'LRP', 'MDR1 expression and functional drug efflux', 'French-American-British (FAB', 'white blood cell counts', 'overall or relapse-free survival']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0906368', 'cui_str': 'MRP-1'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0282306,Only MDR1/P-glycoprotein expression and cyclosporine-inhibited efflux were significantly associated with complete remission (CR) rate (P(MDR1) =.012; P(efflux) =.039) and resistant disease (RD; P(MDR1) =.0007; P(efflux) =.0092).,"[{'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Leith', 'Affiliation': 'Department of Pathology and the Cancer Center, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eijdems', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Slovak', 'Affiliation': ''}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'McConnell', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weick', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Grever', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}]",Blood,[]
299,9694705,Leukemic cellular retinoic acid resistance and missense mutations in the PML-RARalpha fusion gene after relapse of acute promyelocytic leukemia from treatment with all-trans retinoic acid and intensive chemotherapy.,"This study evaluated whether relapse of acute promyelocytic leukemia (APL) patients from clinical remissions achieved and/or maintained with all-trans retinoic acid (RA) in combination with intensive chemotherapy is associated with leukemic cellular resistance to RA and with alterations in the PML-RARalpha fusion gene. We studied matched pretreatment and relapse specimens from 12 patients who received variable amounts of RA, primarily in nonconcurrent combination with daunorubicin and cytarabine (DA) on Eastern Cooperative Oncology Group (ECOG) protocol E2491, and from 8 patients who received DA only on protocol E2491. Of 10 RA-treated patients evaluable for a change in APL cell sensitivity to RA-induced differentiation in vitro, 8 showed diminished sensitivity at relapse, whereas, of 6 evaluable patients treated with DA alone, only 1 had marginally reduced sensitivity. From analysis of sequences encoding the principal functional domains of the PML and RARalpha portions of PML-RARalpha, we found missense mutations in relapse specimens from 3 of 12 RA-treated patients and 0 of 8 DA-treated patients. All 3 mutations were located in the ligand binding domain (LBD) of the RARalpha region of PML-RARalpha. Relative to normal RARalpha1, the mutations were Leu290Val, Arg394Trp, and Met413Thr. All pretreatment analyses were normal except for a C to T base change in the 3'-untranslated (UT) region of 1 patient that was also present after relapse from DA therapy. No mutations were detected in the corresponding sequences of the normal RARalpha or PML (partial) alleles. Minor additional PML-RARalpha isoforms encoding truncated PML proteins were detected in 2 cases. We conclude that APL cellular resistance occurs with high incidence after relapse from RA + DA therapy administered in a nonconcurrent manner and that mutations in the RARalpha region of the PML-RARalpha gene are present in and likely mechanistically involved in RA resistance in a subset of these cases.",1998,All pretreatment analyses were normal except for a C to T base change in the 3'-untranslated (UT) region of 1 patient that was also present after relapse from DA therapy.,"['12 patients who received variable amounts of RA, primarily in nonconcurrent combination with', 'acute promyelocytic leukemia (APL) patients', 'on Eastern Cooperative Oncology Group (ECOG) protocol E2491, and from 8 patients who received DA only on protocol E2491']","['trans retinoic acid (RA', 'daunorubicin and cytarabine (DA', 'RA + DA therapy']","['sensitivity', 'sensitivity at relapse', 'normal RARalpha or PML (partial) alleles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}]",12.0,0.0527938,All pretreatment analyses were normal except for a C to T base change in the 3'-untranslated (UT) region of 1 patient that was also present after relapse from DA therapy.,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Ding', 'Affiliation': 'Montefiore Medical Center and Albert Einstein Cancer Center, Bronx, NY 10467, USA.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Nobile', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grills', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Carrera', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Gallagher', 'Affiliation': ''}]",Blood,[]
300,10339471,Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial.,"We performed a prospective, randomized, multicenter trial to evaluate the effectiveness of prophylactic inhalations with aerosolized amphotericin B (aeroAmB) to reduce the incidence of invasive aspergillus (IA) infections in patients after chemotherapy or autologous bone marrow transplantation and an expected duration of neutropenia of at least 10 days. From March 1993 until April 1996, 382 patients with leukemias, relapsed high-grade non-Hodgkin lymphomas, or solid tumors were randomized with a 13:10 ratio to receive either prophylactic aeroAmB inhalations at a dose of 10 mg twice daily or no inhalation prophylaxis in an unblinded fashion. The incidence of proven, probable, or possible IA infections was 10 of 227 (4%) in patients who received prophylactic aeroAmB. This did not differ significantly from the 11 of 155 (7%) incidence in patients who received no inhalation prophylaxis (P =.37). Moreover, no differences in the overall mortality (13% v 10%; P =.37) or in the infection-related mortality (8% v 7%; P =.79) were found. In contrast to other nonrandomized trials, we observed no benefit from prophylactic aeroAmB inhalations, but the overall incidence of IA infections was low.",1999,"Moreover, no differences in the overall mortality (13% v 10%; P =.37) or in the infection-related mortality (8% v 7%; P =.79) were found.","['invasive aspergillus infections during prolonged neutropenia', 'patients after chemotherapy or autologous bone marrow transplantation and an expected duration of neutropenia of at least 10 days', 'From March 1993 until April 1996, 382 patients with leukemias, relapsed high-grade non-Hodgkin lymphomas, or solid tumors']","['prophylactic aeroAmB inhalations at a dose of 10 mg twice daily or no inhalation prophylaxis', 'aerosolized amphotericin B (aeroAmB', 'Aerosolized amphotericin B inhalations']","['incidence of invasive aspergillus (IA) infections', 'incidence of proven, probable, or possible IA infections', 'infection-related mortality', 'overall incidence of IA infections', 'overall mortality']","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0004030', 'cui_str': 'Aspergillus Infection'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0004030', 'cui_str': 'Aspergillus Infection'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",382.0,0.0376251,"Moreover, no differences in the overall mortality (13% v 10%; P =.37) or in the infection-related mortality (8% v 7%; P =.79) were found.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Hematology and Oncology, Universitätsklinikum Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Behre', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wandt', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schilling', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arning', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Trittin', 'Affiliation': ''}, {'ForeName': 'W V', 'Initials': 'WV', 'LastName': 'Kern', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Boenisch', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bosse', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lenz', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Siegert', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beyer', 'Affiliation': ''}]",Blood,[]
301,10361108,Double induction strategy for acute myeloid leukemia: the effect of high-dose cytarabine with mitoxantrone instead of standard-dose cytarabine with daunorubicin and 6-thioguanine: a randomized trial by the German AML Cooperative Group.,"Early intensification of chemotherapy with high-dose cytarabine either in the postremission or remission induction phase has recently been shown to improve long-term relapse-free survival (RFS) in patients with acute myeloid leukemia (AML). Comparable results have been produced with the double induction strategy. The present trial evaluated the contribution of high-dose versus standard-dose cytarabine to this strategy. Between March 1985 and November 1992, 725 eligible patients 16 to 60 years of age with newly diagnosed primary AML entered the trial. Before treatment started, patients were randomized between two versions of double induction: 2 courses of standard-dose cytarabine (ara-C) with daunorubicin and 6-thioguanine (TAD) were compared with 1 course of TAD followed by high-dose cytarabine (3 g/m2 every 12 hours for 6 times) with mitoxantrone (HAM). Second courses started on day 21 before remission criteria were reached, regardless of the presence or absence of blast cells in the bone marrow. Patients in remission received consolidation by TAD and monthly maintenance with reduced TAD courses for 3 years. The complete remission (CR) rate in the TAD-TAD compared with the TAD-HAM arm was 65% versus 71% (not significant [NS]), and the early and hypoplastic death rate was 18% versus 14% (NS). The corresponding RFS after 5 years was 29% versus 35% (NS). An explorative analysis identified a subgroup of 286 patients with a poor prognosis representing 39% of the entire population; they included patients with more than 40% residual blasts in the day-16 bone marrow, patients with unfavorable karyotype, and those with high levels of serum lactate dehydrogenase. Their CR rate was 65% versus 49% (p =.004) in favor of TAD-HAM and was associated with a superior event-free survival (median, 7 v 3 months; 5 years, 17% v 12%; P =.012) and overall survival (median, 13 v 8 months; 5 years, 24% v 18%; P =.009). This suggests that the incorporation of high-dose cytarabine with mitoxantrone may contribute a specific benefit to poor-risk patients that, however, requires further substantiation. Double induction, followed by consolidation and maintenance, proved a safe and effective strategy and a new way of delivering early intensification treatment for AML.",1999,"Their CR rate was 65% versus 49% (p =.004) in favor of TAD-HAM and was associated with a superior event-free survival (median, 7 v 3 months; 5 years, 17% v 12%; P =.012) and overall survival (median, 13 v 8 months; 5 years, 24% v 18%; P =.009).","['Between March 1985 and November 1992, 725 eligible patients 16 to 60 years of age with newly diagnosed primary AML entered the trial', 'patients with acute myeloid leukemia (AML', 'acute myeloid leukemia', '286 patients with a poor prognosis representing 39% of the entire population; they included patients with more than 40% residual blasts in the day-16 bone marrow, patients with unfavorable karyotype, and those with high levels of serum lactate dehydrogenase']","['TAD followed by high-dose cytarabine', 'cytarabine with daunorubicin and 6-thioguanine', 'standard-dose cytarabine (ara-C) with daunorubicin and 6-thioguanine (TAD', 'chemotherapy with high-dose cytarabine', 'cytarabine with mitoxantrone', 'cytarabine', 'mitoxantrone (HAM']","['CR rate', 'early and hypoplastic death rate', 'overall survival', 'superior event-free survival', 'complete remission (CR) rate']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1261273', 'cui_str': 'Karyotype'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",725.0,0.115939,"Their CR rate was 65% versus 49% (p =.004) in favor of TAD-HAM and was associated with a superior event-free survival (median, 7 v 3 months; 5 years, 17% v 12%; P =.012) and overall survival (median, 13 v 8 months; 5 years, 24% v 18%; P =.009).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Büchner', 'Affiliation': 'Departments of Hematology/Oncology and of Biostatistics, University of Münster, Münster, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wörmann', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Löffler', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gassmann', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Haferlach', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fonatsch', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haase', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schoch', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hossfeld', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lengfelder', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Aul', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Heyll', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Sauerland', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Heinecke', 'Affiliation': ''}]",Blood,[]
302,10361110,Presenting white blood cell count and kinetics of molecular remission predict prognosis in acute promyelocytic leukemia treated with all-trans retinoic acid: result of the Randomized MRC Trial.,"All-trans retinoic acid (ATRA) is an essential component of the treatment of acute promyelocytic leukemia (APL), but the optimal timing and duration remain to be determined. Molecular characterization of this disease can refine the diagnosis and could be potentially useful in monitoring response to treatment. Patients defined morphologically to have APL were randomized to receive a 5-day course of ATRA before commencing chemotherapy or to receive daily ATRA commencing with chemotherapy and continuing until complete remission (CR). The chemotherapy was that used in current MRC Leukaemia Trials. Outcome comparisons were by intention to treat with additional analysis for relevant risk factors. Patients were characterized by molecular techniques for the fusion products of the t(15;17) and monitored by reverse transcriptase-polymerase chain reaction (RT-PCR) during and after treatment. Two hundred thirty-nine patients were randomized. Treatment with extended ATRA resulted in a superior remission rate (87% v 70%, P <.001), due to fewer early and induction deaths (12% v 23%, P =.02), and less resistant disease (2% v 7%, P =.03), which was associated with a significantly more rapid recovery of neutrophils and platelets. Extended ATRA reduced relapse risk (20% v 36% at 4 years, P =.04) and resulted in superior survival (71% v 52% at 4 years, P =.005). Presenting white blood cell count (WBC) was a key determinant of outcome. The 70% of patients who presented with a WBC less than 10 x 10(9)/L had a better CR (85% v 62%, P =.0001) and reduced relapse risk (22% v 42%, P =.002) and superior survival (69% v 43%, P <. 0001). Within the low count group, extended ATRA resulted in a better CR (94% v 76%, P =.001), reduced relapse risk (13% v 35%, P =. 04), and improved survival (80% v 57%, P =.0009). There was no evidence of benefit in patients presenting with a higher WBC (>10 x 10(9)/L). Molecular monitoring after the third chemotherapy course had a correlation with risk of relapse. The relapse risk was 57% if the RT-PCR was positive versus 27% if the RT-PCR was negative (P =. 006). APL patients who present with a low WBC derive substantial benefit from combining ATRA with induction chemotherapy until remission is achieved, whereas patients with a higher WBC did not benefit. Molecular characterization of disease can improve diagnostic precision and a positive RT-PCR after consolidation identifies patients at a higher risk of relapse.",1999,"Treatment with extended ATRA resulted in a superior remission rate (87% v 70%, P <.001), due to fewer early and induction deaths (12% v 23%, P =.02), and less resistant disease (2% v 7%, P =.03), which was associated with a significantly more rapid recovery of neutrophils and platelets.","['Patients defined morphologically to have APL', 'patients presenting with a higher WBC ', 'Two hundred thirty-nine patients were randomized', 'acute promyelocytic leukemia treated with all-trans retinoic acid', 'acute promyelocytic leukemia (APL']","['All-trans retinoic acid (ATRA', 'extended ATRA']","['Presenting white blood cell count (WBC', 'induction deaths', 'reduced relapse risk', 'superior remission rate', 'relapse risk', 'reverse transcriptase-polymerase chain reaction (RT-PCR', 'risk of relapse', 'survival', 'rapid recovery of neutrophils and platelets', 'resistant disease', 'superior survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0599161', 'cui_str': 'Reverse Transcriptase PCR'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",239.0,0.25141,"Treatment with extended ATRA resulted in a superior remission rate (87% v 70%, P <.001), due to fewer early and induction deaths (12% v 23%, P =.02), and less resistant disease (2% v 7%, P =.03), which was associated with a significantly more rapid recovery of neutrophils and platelets.","[{'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': 'Department of Haematology, University of Wales College of Medicine, Cardiff, UK. burnettAK@Cardiff.ac.UK'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Grimwade', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Solomon', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Goldstone', 'Affiliation': ''}]",Blood,[]
303,10361111,Serum hyaluronan in patients with multiple myeloma: correlation with survival and Ig concentration.,"Serum from 386 myeloma patients were analyzed for serum hyaluronan (HYA) at diagnosis. Median age was 68 years (range, 32 to 87 years). The distribution of Ig classes was typical (58% IgG, 21% IgA, 1% IgD, and 20% light chain disease). The patients comprised 58% in stage III, 33% in stage II, and 9% in stage I. The majority (82%) had HYA values within an intermediate range (10 to 120 micrograms/L), 13% had high values (>120 micrograms/L), and 5% had abnormally low values (0 to 9 micrograms/L). For the first time, a patient group with abnormally low HYA serum values is reported. An inverse correlation between survival and HYA serum level was found (P =.015). When tested separately, patients with abnormally low or high HYA values had significantly shorter median survival (21.1 and 19.7 months, respectively) than those with an intermediate HYA concentration (32. 6 months; P =.005). Patients with abnormally low or high HYA levels had more advanced disease as judged by staging and biochemical markers. Interestingly, there was an inverse correlation between the HYA value and the M-component concentration in serum. Fifty percent of patients with abnormally low HYA values had IgA myelomas. In conclusion, the serum concentration of HYA may be of prognostic value in selected cases of multiple myeloma. Further studies will be performed to elucidate possible explanations for our findings, especially those related to the HYA cell surface binding proteins.",1999,"When tested separately, patients with abnormally low or high HYA values had significantly shorter median survival (21.1 and 19.7 months, respectively) than those with an intermediate HYA concentration (32. 6 months; P =.005).","['386 myeloma patients were analyzed for serum hyaluronan (HYA) at diagnosis', 'patients with multiple myeloma', 'Median age was 68 years (range, 32 to 87 years']",[],"['median survival', 'survival and HYA serum level', 'Serum hyaluronan']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0813622', 'cui_str': 'Hyaluronan'}]",,0.019568,"When tested separately, patients with abnormally low or high HYA values had significantly shorter median survival (21.1 and 19.7 months, respectively) than those with an intermediate HYA concentration (32. 6 months; P =.005).","[{'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Dahl', 'Affiliation': 'Section of Hematology, University Hospital, Tromso, Norway.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Turesson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lilja', 'Affiliation': ''}]",Blood,[]
304,10090926,Prospective randomized multicenter study comparing cyclosporin alone versus the combination of antithymocyte globulin and cyclosporin for treatment of patients with nonsevere aplastic anemia: a report from the European Blood and Marrow Transplant (EBMT) Severe Aplastic Anaemia Working Party.,"We report the results of the first prospective randomized multicenter study of immunosuppressive treatment in patients with previously untreated nonsevere aplastic anemia (AA) as defined by a neutrophil count of at least 0.5 x 10(9)/L and transfusion dependence. Patients were randomized to receive cyclosporin (CSA) alone or the combination of horse antithymocyte globulin ([ATG] Lymphoglobuline; Merieux, Lyon, France) and CSA. The endpoint of the study was the hematologic response at 6 months. One hundred fifteen patients were randomized and assessable with a median follow-up period of 36 months; 61 received CSA and 54 ATG and CSA. In the CSA group, the percentage of complete and partial responders was 23% and 23%, respectively, for an overall response rate of 46%. A significantly higher overall response rate of 74% was found in the ATG and CSA group, with 57% complete and 17% partial responders (P =. 02). Compared with CSA alone, the combination of ATG and CSA resulted in a significantly higher median hemoglobin level and platelet count at 6 months. Fewer patients required a second course of treatment before 6 months due to a nonresponse. In the CSA group, 15 of 61 (25%) patients required a course of ATG before 6 months because of disease progression, compared with only 3 of 54 (6%) in the ATG and CSA group. The survival probabilities for the two groups were comparable, 93% (CSA group) and 91% (ATG and CSA group), but at 180 days, the prevalence of patients surviving free of transfusions, which excluded patients requiring second treatment because of nonresponse, death, disease progression, or relapse, was 67% in the CSA group and 90% in the ATG and CSA group (P =.001). We conclude that the combination of ATG and CSA is superior to CSA alone in terms of the hematologic response, the quality of response, and early mortality, and a second course of immunosuppression is less frequently required.",1999,"The survival probabilities for the two groups were comparable, 93% (CSA group) and 91% (ATG and CSA group), but at 180 days, the prevalence of patients surviving free of transfusions, which excluded patients requiring second treatment because of nonresponse, death, disease progression, or relapse, was 67% in the CSA group and 90% in the ATG and CSA group (P =.001).","['patients with nonsevere aplastic anemia', 'patients with previously untreated nonsevere aplastic anemia (AA) as defined by a neutrophil count of at least 0.5 x 10(9)/L and transfusion dependence', 'One hundred fifteen patients']","['CSA', 'cyclosporin', 'CSA and 54 ATG and CSA', 'cyclosporin (CSA) alone or the combination of horse antithymocyte globulin ([ATG] Lymphoglobuline; Merieux, Lyon, France) and CSA', 'immunosuppressive', 'antithymocyte globulin and cyclosporin']","['hematologic response', 'survival probabilities', 'percentage of complete and partial responders', 'prevalence of patients surviving free of transfusions', 'median hemoglobin level and platelet count', 'hematologic response, the quality of response, and early mortality', 'nonresponse, death, disease progression, or relapse', 'overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0242616', 'cui_str': 'Equidae'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0591747', 'cui_str': 'lymphoglobuline'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",115.0,0.0590576,"The survival probabilities for the two groups were comparable, 93% (CSA group) and 91% (ATG and CSA group), but at 180 days, the prevalence of patients surviving free of transfusions, which excluded patients requiring second treatment because of nonresponse, death, disease progression, or relapse, was 67% in the CSA group and 90% in the ATG and CSA group (P =.001).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Marsh', 'Affiliation': ""Department of Haematology, St George's Hospital Medical School, London, UK. jmarsh@sghms.ac.uk""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schrezenmeier', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marin', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ilhan', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McCann', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Socie', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tichelli', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Passweg', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hows', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Raghavachar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Locasciulli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': ''}]",Blood,[]
305,10090927,"Increased risk of chronic graft-versus-host disease, obstructive bronchiolitis, and alopecia with busulfan versus total body irradiation: long-term results of a randomized trial in allogeneic marrow recipients with leukemia. Nordic Bone Marrow Transplantation Group.","Leukemic patients receiving marrow from HLA-identical sibling donors were randomized to treatment with either busulfan 16 mg/kg (n = 88) or total body irradiation ([TBI] n = 79) in addition to cyclophosphamide 120 mg/kg. The patients were observed for a period of 5 to 9 years. Busulfan-treated patients had an increased risk of veno-occlusive disease (VOD) of the liver (12% v 1%, P =.01) and hemorrhagic cystitis (32% v 10%, P =.003). Acute graft-versus-host disease (GVHD) was similar in the two groups, but the 7-year cumulative incidence of chronic GVHD was 59% in the busulfan-treated group versus 47% in the TBI group (P =.05). Death from GVHD was more common in the busulfan group (22% v 3%, P <.001). Obstructive bronchiolitis occurred in 26% of the busulfan patients but in only 5% of the TBI patients (P <.01). Complete alopecia developed in 8 busulfan patients and partial alopecia in 17, versus five with partial alopecia in the TBI group (P <.001). Cataracts occurred in 5 busulfan-treated patients and 16 TBI patients (P =.02). The incidence of relapse after 7 years was 29% in both groups. Seven-year transplant-related mortality (TRM) in patients with early disease was 21% in the busulfan group and 12% in the TBI group. In patients with more advanced disease, the corresponding figures were 64% and 22%, respectively (P =.004). Leukemia-free survival (LFS) in patients with early disease was 68% in busulfan-treated patients and 66% in TBI patients. However, 7-year LFS in patients with more advanced disease was 17% in the busulfan group versus 49% in the TBI group (P <.01). In patients with chronic myeloid leukemia (CML) in first chronic phase, 7-year LFS was 72% and 83% in the two groups, respectively.",1999,"Death from GVHD was more common in the busulfan group (22% v 3%, P <.001).","['allogeneic marrow recipients with leukemia', 'patients with early disease was 68% in busulfan-treated patients and 66% in TBI patients', 'patients with chronic myeloid leukemia (CML', 'Leukemic patients receiving marrow from HLA-identical sibling donors']","['Nordic Bone Marrow Transplantation Group', 'total body irradiation ([TBI] n = 79) in addition to cyclophosphamide', 'Busulfan', 'busulfan']","['Complete alopecia', 'Cataracts', 'risk of veno-occlusive disease (VOD) of the liver', '7-year LFS', '7-year cumulative incidence of chronic GVHD', 'Death from GVHD', 'Obstructive bronchiolitis', 'Acute graft-versus-host disease (GVHD', 'advanced disease', 'partial alopecia', 'mortality (TRM', 'Leukemia-free survival (LFS', 'incidence of relapse', 'hemorrhagic cystitis']","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019156', 'cui_str': 'Sinusoidal Obstruction Syndrome'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0085692', 'cui_str': 'Hemorrhagic cystitis (disorder)'}]",,0.030196,"Death from GVHD was more common in the busulfan group (22% v 3%, P <.001).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ringdén', 'Affiliation': 'Centre for Allogeneic Stem Cell Transplantation, and the Department of Hematology, Karolinska Institute, Huddinge Hospital, Huddinge, Sweden. olle.ringden@immunlab.hs.sll.se'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruutu', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nikoskelainen', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vindeløv', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parkkali', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lenhoff', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sallerfors', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mellander', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jacobsen', 'Affiliation': ''}]",Blood,[]
306,10029593,Reduced folate carrier expression in acute lymphoblastic leukemia: a mechanism for ploidy but not lineage differences in methotrexate accumulation.,"Methotrexate (MTX) is one of the most active and widely used agents for the treatment of acute lymphoblastic leukemia (ALL). To elucidate the mechanism for higher accumulation of MTX polyglutamates (MTX-PG) in hyperdiploid ALL and lower accumulation in T-lineage ALL, expression of the reduced folate carrier (RFC) was assessed by reverse transcription-polymerase chain reaction in ALL blasts isolated from newly diagnosed patients. RFC expression exhibited a 60-fold range among 29 children, with significantly higher expression in hyperdiploid B-lineage ALL (median, 11.3) compared with nonhyperdiploid ALL (median, 2.1; P <.0006), but no significant difference between nonhyperdiploid B-lineage and T-lineage ALL. Furthermore, mRNA levels of RFC (mapped by FISH to chromosome 21) were significantly related to chromosome 21 copy number (P =.0013), with the highest expression in hyperdiploid ALL blasts with 4 copies of chromosome 21. To assess the functional significance of gene copy number, MTX-PG accumulation was compared in ALL blasts isolated from 121 patients treated with either low-dose MTX (LDMTX; n = 60) or high-dose MTX (HDMTX; n = 61). After LDMTX, MTX-PG accumulation was highest in hyperdiploid B-lineage ALL with 4 copies of chromosome 21 (P =.011), but MTX-PG accumulation was not significantly related to chromosome 21 copy number after HDMTX (P =.24). These data show higher RFC expression as a mechanism for greater MTX accumulation in hyperdiploid B-lineage ALL and indicate that lineage differences in MTX-PG accumulation are not due to lower RFC expression in T-lineage ALL.",1999,"Furthermore, mRNA levels of RFC (mapped by FISH to chromosome 21) were significantly related to chromosome 21 copy number (P =.0013), with the highest expression in hyperdiploid ALL blasts with 4 copies of chromosome 21.","['acute lymphoblastic leukemia (ALL', 'acute lymphoblastic leukemia']","['MTX (LDMTX', 'Methotrexate (MTX']","['Furthermore, mRNA levels of RFC', 'functional significance of gene copy number, MTX-PG accumulation', 'RFC expression', 'MTX-PG accumulation', 'folate carrier expression']","[{'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0178655', 'cui_str': 'Gene Copy Number'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}]",121.0,0.0264708,"Furthermore, mRNA levels of RFC (mapped by FISH to chromosome 21) were significantly related to chromosome 21 copy number (P =.0013), with the highest expression in hyperdiploid ALL blasts with 4 copies of chromosome 21.","[{'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Belkov', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, TN; and the University of Tennessee, Memphis, TN, USA.""}, {'ForeName': 'E Y', 'Initials': 'EY', 'LastName': 'Krynetski', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schuetz', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yanishevski', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Masson', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': ''}]",Blood,[]
307,9834207,Marginal benefit/disadvantage of granulocyte colony-stimulating factor therapy after autologous blood stem cell transplantation in children: results of a prospective randomized trial. The Japanese Cooperative Study Group of PBSCT.,"In this prospective trial, a total of 74 children who were scheduled to undergo high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation (PBSCT) were prospectively randomized at diagnosis to evaluate the effectiveness of exogenous granulocyte colony-stimulating factor (G-CSF) treatment in accelerating hematopoietic recovery after PBSCT. The diagnosis included acute lymphoblastic leukemia (ALL) (n = 27), neuroblastoma (n = 29), and miscellaneous solid tumors (n = 18). Eligibility criteria included (1) primary PBSCT, (2) chemotherapy-responsive disease, and (3) collected cell number >1 x 10(5) colony-forming unit-granulocyte-macrophage (CFU-GM)/kg and >1 x 10(6) CD34(+) cells/kg patient's body weight. After applying the above criteria, 11 patients were excluded due to disease progression before PBSCT (n = 6) or a low number of harvested cells (n = 5), leaving 63 patients for analysis; 32 patients in the treatment group (300 microg/m2 of G-CSF intravenously over 1 hour from day 1 of PBSCT) and 31 in the control group without treatment. Two distinct disease-oriented high-dose regimens without total body irradiation consisted of the MCVAC regimen using ranimustine (MCNU, 450 mg/m2), cytosine arabinoside (16 g/m2), etoposide (1.6 g/m2), and cyclophosphamide (100 mg/kg) for patients with ALL, and the Hi-MEC regimen using melphalan (180 mg/m2), etoposide (1.6 g/m2), and carboplatinum (1.6 g/m2) for those with solid tumors. Five patients (two in the treatment group and three in the control group) were subsequently removed due to protocol violations. All patients survived PBSCT. The median numbers of transfused mononuclear cells (MNC), CD34(+) cells, and CFU-GM were, respectively, 4.5 (range, 1 to 19) x 10(8)/kg, 8.0 (1.1 to 25) x 10(6)/kg, and 3.7 (1.2 to 23) x 10(5)/kg in the treatment group (n = 30) and 2.9 (0.8 to 21) x 10(8)/kg, 6.3 (1.1 to 34) x 10(6)/kg, and 5.5 (1.3 to 37) x 10(5)/kg, respectively, in the control group (n = 28), with no significant difference. After PBSCT, the time to achieve an absolute neutrophil count (ANC) of >0.5 x 10(9)/L in the treatment group was less than that in the control group (median, 11 v 12 days; the log-rank test, P =.046), although the last day of red blood cell (RBC) transfusion (day 11 v day 10) and the duration of febrile days (>38 degrees C) after PBSCT (4 v 4 days) were identical in both groups. However, platelet recovery to >20 x 10(9)/L was significantly longer in treatment group than control group (26 v 16 days; P =.009) and >50 x 10(9)/L tended to take longer in the treatment group (29 v 26 days; P =.126), with significantly more platelet transfusion-dependent days (27 v 13 days; t-test, P =.037). When patients were divided into two different disease cohorts, ALL patients showed no difference in engraftment kinetics between the G-CSF treatment and control groups, while differences were seen in those with solid tumors. We concluded that the marginal clinical benefit of 1 day earlier recovery of granulocytes could be offset by the delayed recovery of platelets. We recommend that the routine application of costly G-CSF therapy in children undergoing PBSCT should be seriously reconsidered.",1998,"However, platelet recovery to >20 x 10(9)/L was significantly longer in treatment group than control group (26 v 16 days; P =.009) and >50 x 10(9)/L tended to take longer in the treatment group (29 v 26 days; P =.126), with significantly more platelet transfusion-dependent days (27 v 13 days; t-test, P =.037).","['11 patients were excluded due to disease progression before PBSCT (n = 6) or a low number of harvested cells (n = 5), leaving 63 patients for analysis; 32 patients', 'children undergoing PBSCT', 'children', ""Eligibility criteria included (1) primary PBSCT, (2) chemotherapy-responsive disease, and (3) collected cell number >1 x 10(5) colony-forming unit-granulocyte-macrophage (CFU-GM)/kg and >1 x 10(6) CD34(+) cells/kg patient's body weight"", '74 children who were scheduled to undergo high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation (PBSCT', 'acute lymphoblastic leukemia (ALL) (n = 27), neuroblastoma (n = 29), and miscellaneous solid tumors (n = 18']","['MCVAC regimen using ranimustine (MCNU, 450 mg/m2), cytosine arabinoside', 'carboplatinum', 'cyclophosphamide', 'autologous blood stem cell transplantation', 'etoposide', 'melphalan', 'costly G-CSF therapy', 'exogenous granulocyte colony-stimulating factor (G-CSF', 'granulocyte colony-stimulating factor therapy']","['red blood cell (RBC) transfusion', 'median numbers of transfused mononuclear cells (MNC), CD34(+) cells, and CFU-GM', 'duration of febrile days', 'time to achieve an absolute neutrophil count (ANC', 'platelet transfusion', 'platelet recovery', 'engraftment kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0243666', 'cui_str': 'ranimustine'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0860380', 'cui_str': 'G-CSF therapy'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2919236', 'cui_str': 'Colony-forming unit of granulocytic-monocytic lineage (cell)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}]",74.0,0.0549287,"However, platelet recovery to >20 x 10(9)/L was significantly longer in treatment group than control group (26 v 16 days; P =.009) and >50 x 10(9)/L tended to take longer in the treatment group (29 v 26 days; P =.126), with significantly more platelet transfusion-dependent days (27 v 13 days; t-test, P =.037).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kawano', 'Affiliation': 'Department of Pediatrics, University Hospital of Tokushima, Tokushima; Stem Cell Transplant Unit, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Takaue', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mimaya', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Horikoshi', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kikuta', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Iwai', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ito', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kodani', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ohta', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gushi', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Azuma', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hattori', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kuroda', 'Affiliation': ''}]",Blood,[]
308,9763554,"Incidence, clinical features, and outcome of all trans-retinoic acid syndrome in 413 cases of newly diagnosed acute promyelocytic leukemia. The European APL Group.","All trans-retinoic acid (ATRA) syndrome is a life-threatening complication of uncertain pathogenesis that can occur during the treatment of acute promyelocytic leukemia (APL) by ATRA. Since its initial description, however, no large series of ATRA syndrome has been reported in detail. We analyzed cases of ATRA syndrome observed in an ongoing European trial of treatment of newly diagnosed APL. In this trial, patients 65 years of age or less with an initial white blood cell count (WBC) less than 5,000/microL were initially randomized between ATRA followed by chemotherapy (CT) (ATRA-->CT group) or ATRA with CT started on day 3; patients with WBC greater than 5,000/microL received ATRA and CT from day 1; patients aged 66 to 75 received ATRA-->CT. In patients with initial WBC less than 5, 000/microL and allocated to ATRA-->CT, CT was rapidly added if WBC was greater than 6,000, 10,000, 15,000/microL by days 5, 10, and 15 of ATRA treatment. A total of 64 (15%) of the 413 patients included in this trial experienced ATRA syndrome during induction treatment. Clinical signs developed after a median of 7 days (range, 0 to 35 days). In two of them, they were in fact present before the onset of ATRA. In 11 patients, they occurred upon recovery from the phase of aplasia due to the addition of CT. Respiratory distress (89% of the patients), fever (81%), pulmonary infiltrates (81%), weight gain (50%), pleural effusion (47%), renal failure (39%), pericardial effusion (19%), cardiac failure (17%), and hypotension (12%) were the main clinical signs, and 63 of the 64 patients had at least three of them. Thirteen patients required mechanical ventilation and two dialysis. A total of 60 patients received CT in addition to ATRA as per protocol or based on increasing WBC; 58 also received high dose dexamethasone (DXM); ATRA was stopped when clinical signs developed in 30 patients. A total of 55 patients (86%) who experienced ATRA syndrome achieved complete remission (CR), as compared with 94% of patients who had no ATRA syndrome (P = .07) and nine (14%) died of ATRA syndrome (5 cases), sepsis (2 cases), leukemic resistance (1 patient), and central nervous system (CNS) bleeding (1 patient). None of the patients who achieved CR and received ATRA for maintenance had ATRA syndrome recurrence. No significant predictive factors of ATRA syndrome, including pretreatment WBC, could be found. Kaplan Meier estimates of relapse, event-free survival (EFS), and survival at 2 years were 32% +/- 10%, 63% +/- 8%, and 68% +/- 7% in patients who had ATRA syndrome as compared with 15% +/- 3%, 77% +/- 2%, and 80% +/- 2% in patients who had no ATRA syndrome (P = .05, P = .003, and P = .03), respectively. In a stepwise Cox model that also included pretreatment prognostic variables, ATRA syndrome remained predictive for EFS and survival. In conclusion, in this multicenter trial where CT was rapidly added to ATRA in case of high or increasing WBC counts and DXM generally also used at the earliest clinical sign, the incidence of ATRA syndrome was 15%, but ATRA syndrome was responsible for death in only 1.2% of the total number of patients treated. However, occurrence of ATRA syndrome was associated with lower EFS and survival.",1998,"2% in patients who had no ATRA syndrome (P = .05, P = .003, and P = .03), respectively.","['patients 65 years of age or less with an initial white blood cell count (WBC) less than 5,000/microL were initially randomized between', 'Thirteen patients required mechanical ventilation and two dialysis', 'A total of 64 (15%) of the 413 patients included in this trial experienced ATRA syndrome during induction treatment', '60 patients received', '413 cases of newly diagnosed acute promyelocytic leukemia']","['dexamethasone (DXM); ATRA', 'ATRA followed by chemotherapy (CT) (ATRA-->CT group) or ATRA with CT', 'ATRA-->CT', 'CT', 'ATRA and CT', 'ATRA-->CT, CT', 'ATRA']","['renal failure', 'pleural effusion', 'cardiac failure', 'Respiratory distress', 'pericardial effusion', 'fever', 'hypotension', 'weight gain', 'Incidence, clinical features, and outcome of all trans-retinoic acid syndrome', 'pulmonary infiltrates', 'relapse, event-free survival (EFS), and survival', 'complete remission (CR', 'leukemic resistance (1 patient), and central nervous system (CNS) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1739128', 'cui_str': 'ATRA syndrome'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0349077', 'cui_str': 'Pericardial effusion - noninflammatory (disorder)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0860564', 'cui_str': 'Differentiation syndrome'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",55.0,0.0825076,"2% in patients who had no ATRA syndrome (P = .05, P = .003, and P = .03), respectively.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'De Botton', 'Affiliation': ""Service d'Hematologie of the Centre Hospitalier Universitaire (CHU) of Lille, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Miguel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zittoun', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gardembas', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stamatoulas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Condé', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerci', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gardin', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Geiser', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Makhoul', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Reman', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de la Serna', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lefrere', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chomienne', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chastang', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Degos', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ''}]",Blood,[]
309,9763593,Questions raised by the Benelux CML Study Group: results from the randomized study with hydroxyurea alone versus hydroxyurea combined with low-dose interferon-alpha2b for chronic myeloid leukemia.,,1998,,['chronic myeloid leukemia'],['hydroxyurea alone versus hydroxyurea combined with low-dose interferon-alpha2b'],[],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4307370', 'cui_str': 'IFN-alpha2b'}]",[],,0.0305781,,"[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Talpaz', 'Affiliation': ''}]",Blood,[]
310,10194425,Randomized phase II study of fludarabine + cytosine arabinoside + idarubicin +/- all-trans retinoic acid +/- granulocyte colony-stimulating factor in poor prognosis newly diagnosed acute myeloid leukemia and myelodysplastic syndrome.,"Preclinical data suggest that retinoids, eg, all-trans retinoic acid (ATRA), lower concentrations of antiapoptotic proteins such as bcl-2, possibly thereby improving the outcome of anti-acute myeloid leukemia (AML) chemotherapy. Granulocyte colony-stimulating factor (G-CSF) has been considered to be potentially synergistic with ATRA in this regard. Accordingly, we randomized 215 patients with newly diagnosed AML (153 patients) or high-risk myelodysplastic syndrome (MDS) (refractory anemia with excess blasts [RAEB] or RAEB-t, 62 patients) to receive fludarabine + ara-C + idarubicin (FAI) alone, FAI + ATRA, FAI + G-CSF, or FAI + ATRA + G-CSF. Eligibility required one of the following: age over 71 years, a history of abnormal blood counts before M.D. Anderson (MDA) presentation, secondary AML/MDS, failure to respond to one prior course of chemotherapy given outside MDA, or abnormal renal or hepatic function. For the two treatment arms containing ATRA, ATRA was given 2 days (day-2) before beginning and continued for 3 days after completion of FAI. For the two treatment arms including G-CSF, G-CSF began on day-1 and continued until neutrophil recovery. Patients with white blood cell (WBC) counts >50,000/microL began ATRA on day 1 and G-CSF on day 2. Events (death, failure to achieve complete remission [CR], or relapse from CR) have occurred in 77% of the 215 patients. Reflecting the poor prognosis of the patients entered, the CR rate was only 51%, median event-free survival (EFS) time once in CR was 36 weeks, and median survival time was 28 weeks. A Cox regression analysis indicated that, after accounting for patient prognostic variables, none of the three adjuvant treatment combinations (FAI + ATRA, FAI + G, FAI + ATRA + G) affected survival, EFS, or EFS once in CR compared with FAI. Similarly, there were no significant effects of either ATRA ignoring G-CSF, or of G-CSF ignoring ATRA. As previously found, a diagnosis of RAEB or RAEB-t rather than AML was insignificant. There were no indications that the effect of ATRA differed according to cytogenetic group, diagnosis (AML or MDS), or treatment schedule. Logistic regression analysis indicated that, after accounting for prognosis, addition of G-CSF +/- ATRA to FAI improved CR rate versus either FAI or FAI + ATRA, but G-CSF had no effect on the other outcomes. We conclude that addition of ATRA +/- G-CSF to FAI had no effect on CR rate, survival, EFS, or EFS in CR in poor prognosis, newly diagnosed AML or high-risk MDS.",1999,"G-CSF to FAI had no effect on CR rate, survival, EFS, or EFS in CR in poor prognosis, newly diagnosed AML or high-risk MDS.","['Patients with white blood cell (WBC) counts ', 'Eligibility required one of the following: age over 71 years, a history of abnormal blood counts before M.D. Anderson (MDA) presentation, secondary AML/MDS, failure to respond to one prior course of chemotherapy given outside MDA, or abnormal renal or hepatic function', '215 patients with newly diagnosed AML (153 patients) or high-risk myelodysplastic syndrome (MDS) (refractory anemia with excess blasts [RAEB] or RAEB-t, 62 patients) to receive', 'poor prognosis newly diagnosed acute myeloid leukemia and myelodysplastic syndrome']","['ATRA, ATRA', 'fludarabine + ara-C + idarubicin (FAI) alone, FAI + ATRA, FAI + G-CSF, or FAI + ATRA + G-CSF', 'fludarabine + cytosine arabinoside + idarubicin ', 'retinoic acid ', 'ATRA ', 'granulocyte colony-stimulating factor', 'Granulocyte colony-stimulating factor (G-CSF']","['Events (death, failure to achieve complete remission [CR], or relapse from CR', 'median event-free survival (EFS) time', 'median survival time', 'CR rate, survival, EFS, or EFS', 'CR rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0002894', 'cui_str': 'RAEB'}, {'cui': 'C0280028', 'cui_str': 'Refractory anemia with excess blasts in transformation (morphologic abnormality)'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",215.0,0.0712186,"G-CSF to FAI had no effect on CR rate, survival, EFS, or EFS in CR in poor prognosis, newly diagnosed AML or high-risk MDS.","[{'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Estey', 'Affiliation': 'Department of Leukemia, Division of Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. eestey@odin.mdacc.tmc.edu'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Thall', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pierce', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beran', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Keating', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Freireich', 'Affiliation': ''}]",Blood,[]
311,10194427,A randomized phase 3 study of peripheral blood progenitor cell mobilization with stem cell factor and filgrastim in high-risk breast cancer patients.,"This randomized study compared the number of leukaphereses required to collect an optimal target yield of 5 x 10(6) CD34(+) peripheral blood progenitor cells/kg, using either stem cell factor (SCF) at 20 micrograms/kg/d in combination with Filgrastim at 10 micrograms/kg/d or Filgrastim alone at 10 micrograms/kg/d, from 203 patients with high-risk stage II, III, or IV breast cancer. Leukapheresis began on day 5 of cytokine administration and continued daily until the target yield of CD34(+) cells had been reached or a maximum of 5 leukaphereses performed. By day 5 of leukapheresis, 63% of the patients treated with SCF plus Filgrastim (n = 100) compared with 47% of those receiving Filgrastim alone (n = 103) reached the CD34(+) cell target yield. There was a clinically and statistically significant reduction (P <.05) in the number of leukaphereses required to reach the target yield for the patients receiving SCF plus Filgrastim (median, 4 leukaphereses) compared with patients receiving Filgrastim alone (median, 6 or more leukapherses; ie, <50% of patients reached the target in 5 leukaphereses). All patients receiving SCF were premedicated with antihistamines, albuterol, and pseudoephedrine. Treatment was safe, generally well tolerated, and not associated with life-threatening or fatal toxicity. In conclusion, SCF plus Filgrastim is a more effective peripheral blood progenitor cell (PBPC)-mobilization regimen than Filgrastim alone. In addition to the potential for reduced leukapheresis-related morbidity and costs, SCF offers additional options for obtaining cells for further graft manipulation.",1999,"There was a clinically and statistically significant reduction (P <.05) in the number of leukaphereses required to reach the target yield for the patients receiving SCF plus Filgrastim (median, 4 leukaphereses) compared with patients receiving Filgrastim alone (median, 6 or more leukapherses; ie, <50% of patients reached the target in 5 leukaphereses).","['high-risk breast cancer patients', '203 patients with high-risk stage II, III, or IV breast cancer']","['peripheral blood progenitor cell mobilization with stem cell factor and filgrastim', 'Filgrastim alone', 'SCF plus Filgrastim', '5 x 10(6) CD34(+) peripheral blood progenitor cells/kg, using either stem cell factor (SCF) at 20 micrograms/kg/d in combination with Filgrastim', 'Filgrastim', 'SCF', 'antihistamines, albuterol, and pseudoephedrine']","['effective peripheral blood progenitor cell', 'life-threatening or fatal toxicity']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",203.0,0.0331272,"There was a clinically and statistically significant reduction (P <.05) in the number of leukaphereses required to reach the target yield for the patients receiving SCF plus Filgrastim (median, 4 leukaphereses) compared with patients receiving Filgrastim alone (median, 6 or more leukapherses; ie, <50% of patients reached the target in 5 leukaphereses).","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Bone Marrow Transplant Programs, University of Colorado Health Sciences Center, Denver, CO, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yanovich', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Pecora', 'Affiliation': ''}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': ''}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Mangan', 'Affiliation': ''}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'LeMaistre', 'Affiliation': ''}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Murphy-Filkins', 'Affiliation': ''}, {'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Glaspy', 'Affiliation': ''}]",Blood,[]
312,10381531,Incidence of tumor-cell contamination in leukapheresis products of breast cancer patients mobilized with stem cell factor and granulocyte colony-stimulating factor (G-CSF) or with G-CSF alone.,"We have assessed tumor contamination of peripheral blood progenitor cells (PBPC) in 203 high-risk breast cancer patients who were prospectively randomized to mobilization with stem cell factor (SCF) plus granulocyte colony-stimulating factor (G-CSF) versus G-CSF alone. The patients then received high-dose cyclophosphamide, cisplatin, and carmustine (BCNU) with PBPC support. One bone marrow aspirate obtained before treatment, one whole blood specimen obtained before cytokine infusion, and one to five leukapheresis products were tested for the presence of tumor cells by an alkaline phosphatase immunocytochemical technique with a targeted sensitivity of 1.7 tumor cells per 10(6) hematopoietic cells. Tumor cells were detected in the bone marrow, peripheral blood, and/or PBPC of 21 patients (10%). In 14 patients, bone marrow specimens were tumor-positive; in seven patients, premobilization whole blood specimens were tumor-positive, and in eight patients, leukapheresis products were tumor-positive. In five patients, repetitive or multiple specimens were tumor-positive, and in three cases, marrow, peripheral blood, and PBPC products were all tumor-positive. Nine of the patients in whom tumor cells were found in marrow or peripheral blood were clinical stage II to III and 12 were clinical stage IV. Nine of the tumor-positive patients were in the SCF + G-CSF arm and 12 were in the G-CSF arm. Tumor cells were detected in leukapheresis products of eight patients: three in the G-CSF + SCF arm and five in the G-CSF arm. We conclude that detectable tumor-cell contamination of bone marrow, peripheral blood, and/or PBPC occurred in approximately 10% of patients in this trial and was observed in stage II to III patients, as well as in stage IV patients. No significant difference could be found in the rate of PBPC tumor-cell contamination between patients who received SCF + G-CSF compared with those who received G-CSF alone. Neither mobilization regimen was found to increase the rate of tumor-cell contamination when control premobilization blood samples were compared with leukapheresis products.",1999,Neither mobilization regimen was found to increase the rate of tumor-cell contamination when control premobilization blood samples were compared with leukapheresis products.,"['203 high-risk breast cancer patients', 'breast cancer patients mobilized with stem cell factor and']","['SCF + G-CSF', 'granulocyte colony-stimulating factor (G-CSF) or with G-CSF alone', 'mobilization with stem cell factor (SCF) plus granulocyte colony-stimulating factor (G-CSF) versus G-CSF alone', 'cyclophosphamide, cisplatin, and carmustine (BCNU) with PBPC support']","['Tumor cells', 'rate of tumor-cell contamination', 'detectable tumor-cell contamination of bone marrow, peripheral blood, and/or PBPC', 'rate of PBPC tumor-cell contamination', 'marrow or peripheral blood']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}]","[{'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}]",203.0,0.0236707,Neither mobilization regimen was found to increase the rate of tumor-cell contamination when control premobilization blood samples were compared with leukapheresis products.,"[{'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Franklin', 'Affiliation': 'Bone Marrow Transplant Unit and Department of Pathology, University of Colorado Health Science Center, Denver, CO 80262, USA. wilbur.franklin@uchsc.edu'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Pflaumer', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hami', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': ''}]",Blood,[]
313,10216104,Prognostic implication of FLT3 and N-RAS gene mutations in acute myeloid leukemia.,"Internal tandem duplication of the FLT3 gene and point mutations of the N-RAS gene are the most frequent somatic mutations causing aberrant signal-transduction in acute myeloid leukemia (AML). However, their prognostic importance is unclear. In this study, their prognostic significance was analyzed in 201 newly diagnosed patients with de novo AML except acute promyelocytic leukemia. Three patients had mutations in both genes, 43 had only the FLT3 gene mutation, 25 had only the N-RAS gene mutation, and 130 had neither. These mutations seemed to occur independently. Both mutations were related to high peripheral white blood cell counts, and the FLT3 gene mutation was infrequently observed in the French-American-British (FAB)-M2 type. AML cases with wild FLT3/mutant N-RAS had a lower complete remission (CR) rate than those with wild FLT3/wild N-RAS, whereas the presence of mutant FLT3 did not affect the CR rate. Univariate analysis showed that unfavorable prognostic factors for overall survival were age 60 years or older (P =.0002), cytogenetic data (P =.002), FAB types other than M2 (P =.002), leukocytosis over 100 +/- 10(9)/L (P =.003), and the FLT3 gene mutation (P =.004). However, the N-RAS gene mutation was only a marginal prognostic factor (P =.06). For the subjects under 60 years old, multivariate analysis showed that the FLT3 gene mutation was the strongest prognostic factor (P =.008) for overall survival. The FLT3 gene mutation, whose presence is detectable only by genomic polymerase chain reaction amplification and gel electrophoresis, might serve as an important molecular marker to predict the prognosis of patients with AML.",1999,"Univariate analysis showed that unfavorable prognostic factors for overall survival were age 60 years or older (P =.0002), cytogenetic data (P =.002), FAB types other than M2 (P =.002), leukocytosis over 100 +/-","['acute myeloid leukemia', '201 newly diagnosed patients with de novo AML except acute promyelocytic leukemia']",['FLT3'],"['leukocytosis', 'cytogenetic data', 'overall survival', 'CR rate', 'complete remission (CR) rate']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]",[],"[{'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",201.0,0.0626902,"Univariate analysis showed that unfavorable prognostic factors for overall survival were age 60 years or older (P =.0002), cytogenetic data (P =.002), FAB types other than M2 (P =.002), leukocytosis over 100 +/-","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kiyoi', 'Affiliation': 'Department of Infectious Diseases, Nagoya University School of Medicine, Nagoya, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Naoe', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yokota', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Minami', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Miyawaki', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Asou', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kuriyama', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jinnai', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Shimazaki', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Akiyama', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Motoji', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Omoto', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ohno', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ueda', 'Affiliation': ''}]",Blood,[]
314,10068658,Multicenter phase III trial to evaluate CD34(+) selected versus unselected autologous peripheral blood progenitor cell transplantation in multiple myeloma.,"High-dose chemotherapy followed by autologous transplantation has been shown to improve response rates and survival in multiple myeloma and other malignancies. However, autografts frequently contain detectable tumor cells. Enrichment for stem cells using anti-CD34 antibodies has been shown to reduce autograft tumor contamination in phase I/II studies. To more definitively assess the safety and efficacy of CD34 selection, a phase III study was completed in 131 multiple myeloma patients randomized to receive an autologous transplant with either CD34-selected or unselected peripheral blood progenitor cells after myeloablative therapy. Tumor contamination in the autografts was assessed by a quantitative polymerase chain reaction detection assay using patient-specific, complementarity-determining region (CDR) Ig gene primers before and after CD34 selection. A median 3.1 log reduction in contaminating tumor cells was achieved in the CD34 selected product using the CEPRATE SC System (CellPro, Inc, Bothell, WA). Successful neutrophil engraftment was achieved in all patients by day 15 and no significant between-arm difference for time to platelet engraftment occurred in patients who received an infused dose of at least 2.0 x 10(6) CD34(+) cells/kg. In conclusion, this phase III trial demonstrates that CD34-selection of peripheral blood progenitor cells significantly reduces tumor cell contamination yet provides safe and rapid hematologic recovery for patients receiving myeloablative therapy.",1999,Successful neutrophil engraftment was achieved in all patients by day 15 and no significant between-arm difference for time to platelet engraftment occurred in patients who received an infused dose of at least 2.0 x 10(6) CD34(+) cells/kg.,"['131 multiple myeloma patients', 'patients receiving myeloablative therapy', 'multiple myeloma']","['autologous transplant with either CD34-selected or unselected peripheral blood progenitor cells after myeloablative therapy', 'CD34', 'autologous peripheral blood progenitor cell transplantation']","['time to platelet engraftment', 'complementarity-determining region (CDR', 'Successful neutrophil engraftment']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0021024', 'cui_str': 'Hypervariable Region, Immunoglobulin'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}]",,0.0230885,Successful neutrophil engraftment was achieved in all patients by day 15 and no significant between-arm difference for time to platelet engraftment occurred in patients who received an infused dose of at least 2.0 x 10(6) CD34(+) cells/kg.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vescio', 'Affiliation': 'West LA VAMC/University of California, Los Angeles, Los Angeles, CA; The Toronto Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schiller', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ballester', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noga', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Freytes', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tarantolo', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sahebi', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiff', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meharchard', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schlossman', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tully', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Benyunes', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Berenson', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'DiPersio', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berenson', 'Affiliation': ''}]",Blood,[]
315,9787142,Beneficial effect of intravenous dexamethasone in children with mild to moderately severe acute chest syndrome complicating sickle cell disease.,"Acute chest syndrome (ACS) in patients with sickle cell disease (SCD) has historically been managed with oxygen, antibiotics, and blood transfusions. Recently high-dose corticosteroid therapy was shown to reduce the duration of hospitalization in children with SCD and vaso-occlusive crisis. Therefore, we chose to assess the use of glucocorticoids in ACS. We conducted a randomized, double-blind placebo-controlled trial to evaluate the efficacy and toxicity of intravenous dexamethasone (0.3 mg/kg every 12 hours x 4 doses) in children with SCD hospitalized with mild to moderately severe ACS. Forty-three evaluable episodes of ACS occurred in 38 children (median age, 6.7 years). Twenty-two patients received dexamethasone and 21 patients received placebo. There were no statistically significant differences in demographic, clinical, or laboratory characteristics between the two groups. Mean hospital stay was shorter in the dexamethasone-treated group (47 hours v 80 hours; P = .005). Dexamethasone therapy prevented clinical deterioration and reduced the need for blood transfusions (P < .001 and = .013, respectively). Mean duration of oxygen and analgesic therapy, number of opioid doses, and the duration of fever was also significantly reduced in the dexamethasone-treated patients. Of seven patients readmitted within 72 hours after discharge (six after dexamethasone; P = .095), only one had respiratory complications (P = 1.00). No side effects clearly related to dexamethasone were observed. In a stepwise multiple linear regression analysis, gender and previous episodes of ACS were the only variables that appeared to predict response to dexamethasone, as measured by lengh of hospital stay. Intravenous dexamethasone has a beneficial effect in children with SCD hospitalized with mild to moderately severe acute chest syndrome. Further study of this therapeutic modality is indicated.",1998,"Dexamethasone therapy prevented clinical deterioration and reduced the need for blood transfusions (P < .001 and = .013, respectively).","['children with SCD hospitalized with mild to moderately severe acute chest syndrome', 'patients with sickle cell disease', 'children with SCD hospitalized with mild to moderately severe ACS', 'children with SCD and vaso-occlusive crisis', 'children with mild to moderately severe acute chest syndrome complicating sickle cell disease']","['placebo', 'dexamethasone', 'intravenous dexamethasone', 'Intravenous dexamethasone', 'Dexamethasone']","['Acute chest syndrome (ACS', 'demographic, clinical, or laboratory characteristics', 'duration of hospitalization', 'respiratory complications', 'clinical deterioration', 'Mean hospital stay', 'Mean duration of oxygen and analgesic therapy, number of opioid doses, and the duration of fever', 'efficacy and toxicity', 'need for blood transfusions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0742343', 'cui_str': 'Acute Chest Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0750151'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0742343', 'cui_str': 'Acute Chest Syndrome'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",,0.254606,"Dexamethasone therapy prevented clinical deterioration and reduced the need for blood transfusions (P < .001 and = .013, respectively).","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Bernini', 'Affiliation': ""Department of Pediatrics and Academic Computing Service, The University of Texas Southwestern Medical Center at Dallas and Center for Cancer and Blood Disorders, Children's Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Z R', 'Initials': 'ZR', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Sandler', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Reisch', 'Affiliation': ''}, {'ForeName': 'C T', 'Initials': 'CT', 'LastName': 'Quinn', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Buchanan', 'Affiliation': ''}]",Blood,[]
316,9787148,High-dose therapy and autologous peripheral blood stem cell transplantation in multiple myeloma: up-front or rescue treatment? Results of a multicenter sequential randomized clinical trial.,"Results to date indicate that high-dose therapy (HDT) with autologous stem cell support improves survival of patients with symptomatic multiple myeloma (MM). We performed a multicenter, sequential, randomized trial designed to assess the optimal timing of HDT and autotransplantation. Among 202 enrolled patients who were up to 56 years old, 185 were randomly assigned to receive HDT and peripheral blood stem cell (PBSC) autotransplantation (early HDT group, n = 91) or a conventional-dose chemotherapy (CCT) regimen (late HDT group, n = 94). In the late HDT group, HDT and transplantation were performed as rescue treament, in case of primary resistance to CCT or at relapse in responders. PBSC were collected before randomization, after mobilization by chemotherapy, and, in the two groups, HDT was preceded by three or four treatments with vincristine, doxorubicin, and methylprednisolone. Data were analyzed on an intent-to-treat basis using a sequential design. Within a median follow-up of 58 months, estimated median overall survival (OS) was 64.6 months in the early HDT group and 64 months in the late group. Survival curves were not different (P = .92, log-rank test). Median event-free survival (EFS) was 39 months in the early HDT group whereas median time between randomization and CCT failure was 13 months in the late group. Average time without symptoms, treatment, and treatment toxicity (TWiSTT) were 27.8 months (95% confidence interval [CI]; range, 23.8 to 31.8) and 22.3 months (range, 16.0 to 28.6) in the two groups, respectively. HDT with PBSC transplantation obtained a median OS exceeding 5 years in young patients with symptomatic MM, whether performed early, as first-line therapy, or late, as rescue treatment. Early HDT may be preferred because it is associated with a shorter period of chemotherapy.",1998,"HDT with PBSC transplantation obtained a median OS exceeding 5 years in young patients with symptomatic MM, whether performed early, as first-line therapy, or late, as rescue treatment.","['patients with symptomatic multiple myeloma (MM', '202 enrolled patients who were up to 56 years old, 185', 'multiple myeloma']","['autologous peripheral blood stem cell transplantation', 'HDT and autotransplantation', 'high-dose therapy (HDT) with autologous stem cell support', 'vincristine, doxorubicin, and methylprednisolone', 'HDT and peripheral blood stem cell (PBSC) autotransplantation (early HDT group, n = 91) or a conventional-dose chemotherapy (CCT) regimen (late HDT']","['Average time without symptoms, treatment, and treatment toxicity (TWiSTT', 'Median event-free survival (EFS', 'survival', 'Survival curves', 'median overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1518999', 'cui_str': 'Peripheral Stem Cells'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",202.0,0.0508732,"HDT with PBSC transplantation obtained a median OS exceeding 5 years in young patients with symptomatic MM, whether performed early, as first-line therapy, or late, as rescue treatment.","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Fermand', 'Affiliation': 'Immuno-Haematology Unit and the Department of Biostatistics, Hôpital Saint Louis, Paris; The Rheumatology and Haematology Units, Hôpital Cochin, Paris.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chevret', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Divine', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Belanger', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Macro', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pertuiset', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dreyfus', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boccacio', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Brouet', 'Affiliation': ''}]",Blood,[]
317,9787199,Randomized trial of autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation in lymphoma patients.,,1998,,['lymphoma patients'],['autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation'],[],"[{'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}]",[],,0.0253567,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gyger', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sahovic', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': ''}]",Blood,[]
318,9746768,"Phase III study comparing methotrexate and tacrolimus (prograf, FK506) with methotrexate and cyclosporine for graft-versus-host disease prophylaxis after HLA-identical sibling bone marrow transplantation.","We report the results of a phase III open-label, randomized, multicenter trial comparing tacrolimus/methotrexate to cyclosporine/methotrexate for graft-versus-host disease (GVHD) prophylaxis after HLA-identical sibling marrow transplantation in patients with hematologic malignancy. The primary objective of this study was to compare the incidence of moderate to severe (grade II-IV) acute GVHD. Secondary objectives were to compare the relapse rate, disease-free survival, overall survival, and the incidence of chronic GVHD. Patients were stratified according to age (<40 v >/=40) and for male recipients of a marrow graft from an alloimmunized female. There was a significantly greater proportion of patients with advanced disease randomized to tacrolimus arm (P = . 02). The incidence of grade II-IV acute GVHD was significantly lower in patients who received tacrolimus than patients in the cyclosporine group (31.9% and 44.4%, respectively; P = .01). The incidence of grade III-IV acute GVHD was similar, 17.1% in cyclosporine group and 13.3% in the tacrolimus group. There was no difference in the incidence of chronic GVHD between the tacrolimus and the cyclosporine group (55.9% and 49.4%, respectively; P = .8). However, there was a significantly higher proportion of patients in the cyclosporine group who had clinical extensive chronic GVHD (P = . 03). The relapse rates of the two groups were similar. The patients in the cyclosporine arm had a significantly better 2-year disease-free survival and overall survival than patients in the tacrolimus arm, 50.4% versus 40.5% (P = .01) and 57.2% versus 46.9% (P = .02), respectively. The significant difference in the overall and disease-free survival was largely the result of the patients with advanced disease, 24.8% with tacrolimus versus 41.7% with cyclosporine (P = .006) and 20.4% with tacrolimus versus 28% with cyclosporine (P = .007), respectively. There was a higher frequency of deaths from regimen-related toxicity in patients with advanced disease who received tacrolimus. There was no difference in the disease-free and overall survival in patients with nonadvanced disease. These results show the superiority of tacrolimus/methotrexate over cyclosporine/methotrexate in the prevention of grade II-IV acute GVHD with no difference in disease-free or overall survival in patients with nonadvanced disease. The survival disadvantage in advanced disease patients receiving tacrolimus warrants further investigation.",1998,"The incidence of grade II-IV acute GVHD was significantly lower in patients who received tacrolimus than patients in the cyclosporine group (31.9% and 44.4%, respectively; P = .01).","['patients with nonadvanced disease', 'patients with advanced disease who received', 'patients with hematologic malignancy', 'graft-versus-host disease prophylaxis after HLA-identical sibling bone marrow transplantation', 'Patients were stratified according to age (<40 v >/=40) and for male recipients of a marrow graft from an alloimmunized female', 'advanced disease patients receiving']","['HLA-identical sibling marrow transplantation', 'tacrolimus/methotrexate', 'methotrexate and tacrolimus (prograf, FK506) with methotrexate and cyclosporine', 'tacrolimus', 'cyclosporine', 'tacrolimus/methotrexate to cyclosporine/methotrexate', 'cyclosporine/methotrexate']","['disease-free or overall survival', 'disease-free and overall survival', 'incidence of grade III-IV acute GVHD', 'incidence of grade II-IV acute GVHD', 'survival disadvantage', '2-year disease-free survival and overall survival', 'relapse rates', 'overall and disease-free survival', 'relapse rate, disease-free survival, overall survival, and the incidence of chronic GVHD', 'clinical extensive chronic GVHD', 'frequency of deaths', 'incidence of moderate to severe (grade II-IV) acute GVHD', 'incidence of chronic GVHD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0678125', 'cui_str': 'Prograf'}, {'cui': 'C0729218', 'cui_str': 'FK506'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",,0.128118,"The incidence of grade II-IV acute GVHD was significantly lower in patients who received tacrolimus than patients in the cyclosporine group (31.9% and 44.4%, respectively; P = .01).","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ratanatharathorn', 'Affiliation': 'University of Michigan, Ann Arbor; Fred Hutchinson Cancer Research Center, Seattle, WA, USA. vratanat@umich.edu'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Devine', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Fay', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': ''}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Christiansen', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van der Jagt', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Herzig', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Litzow', 'Affiliation': ''}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'W L', 'Initials': 'WL', 'LastName': 'Longo', 'Affiliation': ''}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Karanes', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Avalos', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Buell', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Maher', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Fitzsimmons', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Wingard', 'Affiliation': ''}]",Blood,[]
319,9716578,A double-blind randomized comparison of combined aspirin and ticlopidine therapy versus aspirin or ticlopidine alone on experimental arterial thrombogenesis in humans.,"No randomized study comparing the effect of combined ticlopidine and aspirin therapy versus each drug alone in reducing poststenting thrombotic complications has been performed. To compare these three antiplatelet regimens versus placebo, we conducted a double-blind randomized study using an ex vivo model of thrombosis. Sixteen healthy male volunteers were assigned to receive for 8 days the following four regimens separated by a 1-month period: aspirin 325 mg/d, ticlopidine 500 mg/d, aspirin 325 mg/d + ticlopidine 500 mg/d, and placebo. At the end of each treatment period, native nonanticoagulated blood was drawn directly from an antecubital vein over collagen- or tissue factor (TF)-coated coverslips positioned in a parallel-plate perfusion chamber at an arterial wall shear rate (2, 600 s-1 ) for 3 minutes. Thrombus, which formed on collagen in volunteers treated by placebo, were rich in platelets and poor in fibrin. As compared with placebo, aspirin and ticlopidine alone reduced platelet thrombus formation by only 29% and 15%, respectively (P > .2). In contrast, platelet thrombus formation was blocked by more than 90% in volunteers treated by aspirin + ticlopidine (P < .01 v placebo or each treatment alone). Furthermore, the effect of the drug combination therapy was significantly larger than the sum of the two active treatments (P < .05). Thrombus, which formed on TF-coated coverslips in volunteers treated by placebo, were rich in fibrin and platelets. Neither of the three antiplatelet treatments significantly inhibited fibrin deposition and platelet thrombus formation on this surface (P > .2). Thus, the present study shows that combined aspirin and ticlopidine therapy dramatically potentiates the antithrombotic effect of each drug alone, but that the antithrombotic effect of the combined treatment depends on the nature of the thrombogenic surface.",1998,Neither of the three antiplatelet treatments significantly inhibited fibrin deposition and platelet thrombus formation on this surface (P > .2).,"['Sixteen healthy male volunteers', 'humans']","['ticlopidine and aspirin therapy', 'placebo', 'ticlopidine', 'placebo, aspirin and ticlopidine', 'aspirin', 'combined aspirin and ticlopidine therapy versus aspirin or ticlopidine alone', 'aspirin + ticlopidine', 'aspirin 325 mg/d, ticlopidine 500 mg/d, aspirin 325 mg/d + ticlopidine']","['antithrombotic effect', 'poststenting thrombotic complications', 'platelet thrombus formation', 'fibrin deposition and platelet thrombus formation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0040207', 'cui_str': 'Ticlopidine'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1606590', 'cui_str': 'Aspirin 325 MG [Ecotrin]'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0333209', 'cui_str': 'Platelet thrombus (morphologic abnormality)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0333565', 'cui_str': 'Fibrin deposition (morphologic abnormality)'}]",16.0,0.132689,Neither of the three antiplatelet treatments significantly inhibited fibrin deposition and platelet thrombus formation on this surface (P > .2).,"[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Bossavy', 'Affiliation': ""Laboratoire de Recherche sur l'Hémostase et la Thrombose, Pavillon Lefèbvre, CHU Purpan, Toulouse CEDEX, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thalamas', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sagnard', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barret', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sakariassen', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Boneu', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cadroy', 'Affiliation': ''}]",Blood,[]
320,9716580,"A randomized phase-II study of BB-10010 (macrophage inflammatory protein- 1alpha) in patients with advanced breast cancer receiving 5-fluorouracil, adriamycin, and cyclophosphamide chemotherapy.","BB-10010 is a variant of the human form of macrophage inflammatory protein-1alpha (MIP-1alpha), which has been shown in mice to block the entry of hematopoietic stem cells into S-phase and to increase their self-renewal capacity during recovery from cytotoxic damage. Its use may constitute a novel approach for protecting the quality of the stem cell population and its capacity to regenerate after periods of cytotoxic treatment. Thirty patients with locally advanced or metastatic breast cancer were entered into the first randomized, parallel group controlled phase II study. This was designed to evaluate the potential myeloprotective effects of a 7-day regimen of BB-10010 administered to patients receiving six cycles of 5-fluorouracil (5-FU), adriamycin, and cyclophosphamide (FAC) chemotherapy. Patients were randomized, 10 receiving 100 microgram/kg BB-10010, 11 receiving 30 microgram/kg BB-10010, and nine control patients receiving no BB-10010. BB-10010 was well-tolerated in all patients with no severe adverse events related to the drug. Episodes of febrile neutropenia complicated only 4% of the treatment cycles and there was no difference in incidence between the treated and nontreated groups. Studies to assess the generation of progenitor cells in long-term bone marrow cultures were performed immediately preceding chemotherapy and at the end of six dosing cycles in 18 patients. Circulating neutrophils, platelets, CD 34(+) cells, and granulocyte/macrophage colony-forming cell (GM-CFC) levels were determined at serial time points in cycles 1, 3, and 6. The results showed similar hemoglobin and platelet kinetics in all three groups. On completion of the six treatment cycles, the average pretreatment neutrophil levels were reduced from 5.3 to 1.7 x 10(9)/L in the control patients and from 4.3 to 1.9 and 4.5 to 2.5 x 10(9)/L in the 30/100 microgram/kg BB-10010 groups, respectively. Relative to their pretreatment values, 50% of the patients receiving BB-10010 completed the treatment with neutrophil values significantly higher than any of the controls (P = .02). Mobilization of GM-CFC was enhanced by BB-10010 with an additional fivefold increase over that generated by chemotherapy alone, giving a maximal 25-fold increase over pretreatment values. Bone marrow progenitor assays before and after this standard regimen of chemotherapy indicated little long-term cumulative impairment to recovery from chemotherapy. Despite the limited cumulative damage to the bone marrow, which may have minimized the protective value of BB-10010 during this regimen of chemotherapy, better recovery of neutrophils in the later treatment cycles with BB-10010 was indicated in a number of patients.",1998,Bone marrow progenitor assays before and after this standard regimen of chemotherapy indicated little long-term cumulative impairment to recovery from chemotherapy.,"['patients with advanced breast cancer receiving', 'Thirty patients with locally advanced or metastatic breast cancer', '18 patients']","['5-fluorouracil (5-FU), adriamycin, and cyclophosphamide (FAC) chemotherapy', '5-fluorouracil, adriamycin, and cyclophosphamide chemotherapy', 'BB-10010 (macrophage inflammatory protein- 1alpha', 'nine control patients receiving no BB-10010']","['hemoglobin and platelet kinetics', 'Circulating neutrophils, platelets, CD 34(+) cells, and granulocyte/macrophage colony-forming cell (GM-CFC) levels', 'Mobilization of GM-CFC', 'Episodes of febrile neutropenia', 'average pretreatment neutrophil levels', 'neutrophil values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0286385', 'cui_str': 'BB-10010'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0193319,Bone marrow progenitor assays before and after this standard regimen of chemotherapy indicated little long-term cumulative impairment to recovery from chemotherapy.,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Clemons', 'Affiliation': ""CRC Department of Medical Oncology and Paterson Institute for Cancer Research, Christie Hospital, Manchester; ICRF Clinical Oncology Unit, Guy's Hospital, London.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dürig', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kiernan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Griffiths', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Towlson', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'DeTakats', 'Affiliation': ''}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dougal', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Hunter', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Czaplewski', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Millar', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Dexter', 'Affiliation': ''}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Lord', 'Affiliation': ''}]",Blood,[]
321,9716581,Long-term follow-Up of the italian trial of interferon-alpha versus conventional chemotherapy in chronic myeloid leukemia. The Italian Cooperative Study Group on Chronic Myeloid Leukemia.,"Several prospective randomized studies have shown that the treatment of chronic myeloid leukemia with interferon-alpha (IFN-alpha) prolongs the survival by comparison with conventional chemotherapy. However, although IFN-alpha can induce cytogenetic responses, true complete remissions are rarely achieved and information on the long-term effects of IFN-alpha treatment is limited. For that purpose, we updated and analyzed a prospective comparative trial of IFN-alpha and conventional chemotherapy that was initiated in 1986. The first analysis of the trial was already published, and showed a survival advantage for IFN-alpha (N Engl J Med 12:820, 1994). The observation period of living patients now ranges between 95 and 129 months and we examined the long-term effects of IFN-alpha treatment, always by comparison with conventional chemotherapy and according to the intention-to-treat principle. The patients who were submitted to allogeneic bone marrow transplantation (BMT) in chronic phase (38 of 322 or 12%) were censored at the date of BMT. Seventy-three of the original 284 nontransplanted patients were alive, 56 (30%) in the IFN-alpha arm and 17 (18%) in the chemotherapy arm. Forty-one patients overall (14%) were still receiving IFN-alpha. In the IFN-alpha arm 9 patients were in continuous complete cytogenetic remission and 11 were in major or minor cytogenetic remission. Median and 10-year survival of low-risk patients were 104 months (95% CI, 85 to 127 months) and 47% (95% CI, 36% to 59%) in IFN-alpha arm versus 64 months (95% CI, 49 to 98 months) and 30% (95% CI, 16% to 44%) in chemotherapy arm (P = .03). Median and ten-year survival of non-low-risk patients were 69 months (95% CI, 56 to 76 months) and 16% (95% CI, 8% to 24%) in IFN-alpha arm versus 46 months (95% CI, 39 to 61 months) and 5% (95% CI, 0% to 11%) in chemotherapy arm (P = .006). A low Sokal's risk, hematologic response, and cytogenetic response were associated with a longer survival. No major or unusual side effects were recorded after the 5th year of IFN-alpha treatment. Fourteen patients died in chronic phase, 9 (4%) in IFN-alpha arm and 5 (5%) in chemotherapy arm, mainly of cardiovascular accidents (6 cases) and of other cancers (5 cases). We conclude that a policy of chronic treatment with IFN-alpha maintained a significant survival advantage over conventional chemotherapy on a long-term basis and irrespective of the risk. However, the great majority of the long-term survivors were in the low-risk group. The question of treatment discontinuation was not addressed in this study.",1998,"Median and 10-year survival of low-risk patients were 104 months (95% CI, 85 to 127 months) and 47% (95% CI, 36% to 59%) in IFN-alpha arm versus 64 months (95% CI, 49 to 98 months) and 30% (95% CI, 16% to 44%) in chemotherapy arm (P = .03).","['Seventy-three of the original 284 nontransplanted patients were alive, 56 (30%) in the IFN-alpha arm and 17 (18%) in the chemotherapy arm', 'chronic myeloid leukemia', 'Fourteen patients died in chronic phase, 9 (4%) in IFN-alpha arm and 5 (5%) in chemotherapy arm, mainly of cardiovascular accidents (6 cases) and of other cancers (5 cases']","['allogeneic bone marrow transplantation (BMT', 'interferon-alpha versus conventional chemotherapy', 'IFN-alpha and conventional chemotherapy', 'conventional chemotherapy', 'interferon-alpha (IFN-alpha']","['hematologic response, and cytogenetic response', 'unusual side effects', 'survival advantage', 'cytogenetic remission', 'Median and 10-year survival', 'cytogenetic responses']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",284.0,0.10654,"Median and 10-year survival of low-risk patients were 104 months (95% CI, 85 to 127 months) and 47% (95% CI, 36% to 59%) in IFN-alpha arm versus 64 months (95% CI, 49 to 98 months) and 30% (95% CI, 16% to 44%) in chemotherapy arm (P = .03).",[],Blood,[]
322,9716583,A randomized controlled trial of filgrastim during remission induction and consolidation chemotherapy for adults with acute lymphoblastic leukemia: CALGB study 9111.,"Recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim) shortens the time to neutrophil recovery after intensive chemotherapy, but its role in the treatment of adults with acute lymphoblastic leukemia (ALL) is uncertain. We randomly assigned 198 adults with untreated ALL (median age, 35 years; range, 16 to 83) to receive either placebo or G-CSF (5 microgram/kg/d) subcutaneously, beginning 4 days after starting intensive remission induction chemotherapy and continuing until the neutrophil count was >/=1, 000/microL for 2 days. The study assignment was unblinded as individual patients achieved a complete remission (CR). Patients initially assigned to G-CSF then continued to receive G-CSF through 2 monthly courses of consolidation therapy. Patients assigned to placebo received no further study drug. The median time to recover neutrophils >/=1,000/microL during the remission induction course was 16 days (interquartile range [IQR], 15 to 18 days) for the patients assigned to receive G-CSF and 22 days (IQR, 19 to 29 days) for the patients assigned to placebo (P < .001). Patients in the G-CSF group had significantly shorter durations of neutropenia (<1, 000/microL) and thrombocytopenia (<50,000/microL) and fewer days in the hospital (median, 22 days v 28 days; P = .02) compared with patients receiving placebo. The patients assigned to receive G-CSF had a higher CR rate and fewer deaths during remission induction than did those receiving placebo (P = .04 by the chi-square test for trend). During Courses IIA and IIB of consolidation treatment, patients in the G-CSF group had significantly more rapid recovery of neutrophils >/=1,000/microL than did the control group by approximately 6 to 9 days. However, the patients in the G-CSF group did not complete the planned first 3 months of chemotherapy any more rapidly than did the patients in the placebo group. Overall toxicity was not lessened by the use of G-CSF. After a median follow-up of 4. 7 years, there were no significant differences in either the disease-free survival (P = .53) or the overall survival (P = .25) for the patients assigned to G-CSF (medians, 2.3 years and 2.4 years, respectively) compared with those assigned to placebo (medians, 1.7 and 1.8 years, respectively). Adults who received intensive chemotherapy for ALL benefited from G-CSF treatment, but its use did not markedly affect the ultimate outcome.",1998,"During Courses IIA and IIB of consolidation treatment, patients in the G-CSF group had significantly more rapid recovery of neutrophils >","['198 adults with untreated ALL (median age, 35 years; range, 16 to 83) to receive either', 'adults with acute lymphoblastic leukemia (ALL', 'adults with acute lymphoblastic leukemia']","['Recombinant human granulocyte colony-stimulating factor (G-CSF; filgrastim', 'placebo', 'G-CSF', 'intensive chemotherapy', 'filgrastim', 'consolidation chemotherapy', 'placebo or G-CSF']","['rapid recovery of neutrophils ', 'CR rate and fewer deaths during remission induction', 'Overall toxicity', 'thrombocytopenia', 'median time to recover neutrophils >/=1,000/microL', 'overall survival', 'disease-free survival', 'shorter durations of neutropenia', 'complete remission (CR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",198.0,0.24127,"During Courses IIA and IIB of consolidation treatment, patients in the G-CSF group had significantly more rapid recovery of neutrophils >","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL 60637-1470, USA. ralarson@mcis.bsd.uchicago.edu'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Dodge', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Linker', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': ''}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Powell', 'Affiliation': ''}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schulman', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Davey', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Frankel', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'George', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}]",Blood,[]
323,9680346,Anaplastic large cell lymphoma Hodgkin's-like: a randomized trial of ABVD versus MACOP-B with and without radiation therapy.,"During the last few years, morphological, immunohistochemical, and genetic findings have placed anaplastic large cell lymphoma (ALCL) as a distinct clinicopathologic entity, and several reports have focused on the existence of different subtypes of the tumor. Particular attention has been paid to the ALCL-Hodgkin's-like (HL) subtype, which seems to be on the border between Hodgkin's disease (HD) and high-grade non-Hodgkin's lymphoma (HG-NHL). From September 1994 to July 1997, during the course of an Italian multicentric trial, 40 ALCL-HLs were randomized to receive as front-line chemotherapy MACOP-B (methotrexate with leucovorin, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin-a third-generation HG-NHL regimen) or ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine-a scheme specific for HD). All patients with bulky disease in the mediastinum at diagnosis underwent local radiotherapy after the chemotherapeutic program. Complete response (CR) was achieved in 17 of the 19 (90%) patients who were treated with MACOP-B, and in 19 of the 21 (91%) patients who were administered ABVD. The probability of relapse-free survival, projected at 32 months, was 94% for the MACOP-B subset and 91% for the ABVD subset. The majority of patients with mediastinal bulky disease obtained CR (evaluated with 67Ga single photon emission computed tomography [SPECT]) after their radiotherapy. The present study suggests that ALCL-HL, in line with its borderline status, responds in an equivalent way to third-generation chemotherapy for HG-NHL and to conventional HD treatment in terms of both CR and relapse-free survival rates. However, as to the latter, a longer follow-up period may be needed before stating the absolute equivalence of the two regimens used.",1998,"The probability of relapse-free survival, projected at 32 months, was 94% for the MACOP-B subset and 91% for the ABVD subset.","['From September 1994 to July 1997, during the course of an Italian multicentric trial, 40 ALCL-HLs', 'All patients with bulky disease in the mediastinum at diagnosis underwent', ""Anaplastic large cell lymphoma Hodgkin's-like""]","['67Ga single photon emission computed tomography [SPECT', 'front-line chemotherapy MACOP-B (methotrexate with leucovorin, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin-a third-generation HG-NHL regimen) or ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine-a scheme specific for HD', 'local radiotherapy', 'MACOP-B with and without radiation therapy']","['Complete response (CR', 'probability of relapse-free survival']","[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439743', 'cui_str': 'Multicentric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0206180', 'cui_str': 'CD30+ Anaplastic Large-Cell Lymphoma'}, {'cui': 'C0235598', 'cui_str': ""Hodgkin's-like""}]","[{'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005736', 'cui_str': 'Bleomycin A(2)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0199448,"The probability of relapse-free survival, projected at 32 months, was 94% for the MACOP-B subset and 91% for the ABVD subset.","[{'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology and Medical Oncology ""Seràgnoli,"" University of Bologna, Bologna, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Martelli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Magagnoli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaccaria', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ronconi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantonetti', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bocchia', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marra', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gobbi', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Falini', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gherlinzoni', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moretti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Renzo', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mazza', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pavone', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sabattini', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bendandi', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Pileri', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tura', 'Affiliation': ''}]",Blood,[]
324,9845521,"Moderate dose escalation for advanced stage Hodgkin's disease using the bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone scheme and adjuvant radiotherapy: a study of the German Hodgkin's Lymphoma Study Group.","The BEACOPP (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) regimen, a rearranged and accelerated version of the standard COPP/adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy, has been shown to be effective and safe in a previous pilot study for advanced stage Hodgkin's disease (HD). The present study aimed to determine a maximum practicable dose of three drugs, ie, etoposide, adriamycin, and cyclophosphamide, for which acute toxicities were acceptable and to assess the feasibility of the escalated scheme. Sixty untreated patients with advanced stage HD were enrolled in this study. Radiotherapy was given in 44 patients (73%) after chemotherapy to initial bulk lesions and residual disease. Granulocyte-colony stimulating factor (G-CSF) was given from day 8 to prevent prolonged neutrocytopenia and severe infections. The intended doses of adriamycin, etoposide, and cyclophosphamide in the BEACOPP schedule could be substantially escalated: adriamycin from 25 to 35, cyclophosphamide from 650 to 1,200, and etoposide from 100 to 200 mg/m2. The major toxicities were leukocytopenia and thrombocytopenia with considerable heterogeneity between individual patients. Of 60 patients, 56 (93%) achieved a complete remission (CR). At a median observation of 32 months, the rates of survival and freedom from treatment failure (FFTF) were estimated to be 91% (95% confidence interval 83% to 99%) and 90% (82% to 98%). These results show that a moderate dose escalation of adriamycin, cyclophosphamide, and etoposide of the baseline BEACOPP regimen is feasible. The escalated BEACOPP regimen shows very encouraging results in advanced stage HD and is now being compared in a randomized phase III study with BEACOPP at baseline dose level.",1998,"At a median observation of 32 months, the rates of survival and freedom from treatment failure (FFTF) were estimated to be 91% (95% confidence interval 83% to 99%) and 90% (82% to 98%).","[""German Hodgkin's Lymphoma Study Group"", ""advanced stage Hodgkin's disease (HD"", 'Sixty untreated patients with advanced stage HD', ""advanced stage Hodgkin's disease""]","['Radiotherapy', 'Granulocyte-colony stimulating factor (G-CSF', 'cyclophosphamide', 'BEACOPP', 'bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone scheme and adjuvant radiotherapy', 'adriamycin, etoposide, and cyclophosphamide', 'etoposide, adriamycin, and cyclophosphamide', 'adriamycin', 'BEACOPP (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone', 'adriamycin, cyclophosphamide, and etoposide of the baseline BEACOPP', 'COPP/adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy']","['complete remission (CR', 'leukocytopenia and thrombocytopenia', 'rates of survival and freedom from treatment failure (FFTF']","[{'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023530', 'cui_str': 'Leukocytopenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0162643'}]",60.0,0.0389938,"At a median observation of 32 months, the rates of survival and freedom from treatment failure (FFTF) were estimated to be 91% (95% confidence interval 83% to 99%) and 90% (82% to 98%).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Klinik I für Innere Medizin, Universität Köln, Köln, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lathan', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sieber', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rüffer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pfreundschuh', 'Affiliation': ''}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Schalk', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schwieder', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dölken', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Worst', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koch', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bruntsch', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tirier', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Loeffler', 'Affiliation': ''}]",Blood,[]
325,9808548,The International Prognostic Index correlates to survival in patients with aggressive lymphoma in relapse: analysis of the PARMA trial. Parma Group.,"The objectives of the present study were to investigate the prognostic value of the International Prognostic Index (IPI) at relapse in the 215 patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) included in the PARMA trial. The IPI at relapse was available in 204 (95%) of these patients. Response rates to 2 courses of DHAP were 77%, 54%, 55%, and 42% in patients with an IPI of 0, 1, 2 and 3, respectively (P <.02), whereas complete response (CR) rates were 33%, 29%, 20%, and 0% in the same groups of patients (P <.03). With a median follow-up period of 79 months, overall survival (OS) at 5 years was 46%, 25%, 25%, and 11% in these four groups (P <.001). One hundred nine patients responding to 2 courses of DHAP were randomized to receive either BEAC (carmustine, etoposide, cytarabine, cyclophosphamide and mesna) followed by autologous bone marrow transplantation (ABMT) or 4 additional courses of DHAP: IPI at relapse was found highly correlated to OS in patients treated in the DHAP arm (5-year OS: 48%, 21%, 33%, and 0% for IPI 0, 1, 2, and 3, respectively; P =.006), but not in the BEAC arm (5-year OS: 51%, 47%, 50%, and 50% for IPI 0, 1, 2, and 3, respectively; P =.90). OS was significantly superior in the BEAC arm as compared with the DHAP arm in patients with an IPI >0 (P <.05), but not in patients with an IPI of 0. In conclusion, these results show that IPI correlates to response and overall survival in patients with aggressive NHL in relapse and enables us to identify patients with a significantly different outcome among those treated with conventional chemotherapy alone.",1998,OS was significantly superior in the BEAC arm as compared with the DHAP arm in patients with an IPI >0,"['patients with aggressive lymphoma in relapse', ""215 patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) included in the PARMA trial"", 'One hundred nine patients responding to 2 courses of DHAP', 'patients with an IPI >0']","['BEAC', 'conventional chemotherapy', 'DHAP', 'BEAC (carmustine, etoposide, cytarabine, cyclophosphamide and mesna) followed by autologous bone marrow transplantation (ABMT']","['overall survival (OS', 'IPI at relapse', 'IPI correlates to response and overall survival', 'complete response (CR) rates', 'Response rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0668760', 'cui_str': ""P(1),P(5)-di(inosine-5')pentaphosphate""}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0668760', 'cui_str': ""P(1),P(5)-di(inosine-5')pentaphosphate""}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",215.0,0.0641108,OS was significantly superior in the BEAC arm as compared with the DHAP arm in patients with an IPI >0,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Blay', 'Affiliation': 'PARMA Cooperative Group (with Fédération Nationale des Centres de Lutte Contre le Cancer [FNCLCC], Dutch Haemato-Oncology Working Party [HOVON], European Organization for Research and Treatment of Cancer [EORTC], Lyon, France. blay@lyon.fnclcc.fr'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Biron', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Guglielmi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hagenbeek', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Somers', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chauvin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Philip', 'Affiliation': ''}]",Blood,[]
326,9808550,Prospective randomized multicenter clinical trial on the use of interferon -2a plus acitretin versus interferon -2a plus PUVA in patients with cutaneous T-cell lymphoma stages I and II.,"Cutaneous T-cell lymphoma (CTCL) constitutes a malignant proliferative disease involving mostly CD4(+) T cells arising in the skin. Because of the lack of curative treatment options, interferons (IFN) have been introduced into the therapy of CTCL. Although effective even in advanced disease, response rates were about 50% and the duration of response was short. To improve the results of interferon monotherapy, combinations of IFN with oral photochemotherapy (PUVA) or retinoids were investigated in nonrandomized trials showing higher response rates. We have therefore conducted this prospective randomized multicenter trial to compare these two combination therapies, ie, IFN plus PUVA and IFN plus acitretin. IFN -2a was administered at 9 MU three times weekly subcutaneously in both groups, with lower increasing doses during the first week. Photochemotherapy was applied after oral intake of 8-methoxypsoralen (0.6 mg/kg body weight) 5x weekly during the first 4 weeks, 3x weekly from weeks 5 through 23, and 2x weekly from weeks 24 through 48, with escalating doses beginning with 0.25 J/cm2. Twenty-five milligrams of acitretin was administered daily during the first week, and 50 mg was administered from weeks 2 through 48. Of 98 patients randomized in this study, 82 stage I and II patients were evaluable: 40 in the IFN+PUVA group and 42 in the IFN+acitretin group. With 70% complete remissions in the IFN+PUVA group, this treatment was significantly superior to the IFN+acitretin group with only 38.1% complete remissions. Time to response was significantly shorter in the IFN+PUVA group, with 18.6 weeks compared with 21.8 weeks in the IFN+acitretin group. Side effects were mostly mild to moderate and did not differ significantly in both treatment groups. However, there were more adverse events leading to study discontinuation in the IFN+acitretin group. Based on these findings, we conclude that IFN plus oral photochemotherapy is superior to IFN plus acitretin, inducing more complete remissions in patients with CTCL stages I and II.",1998,Side effects were mostly mild to moderate and did not differ significantly in both treatment groups.,"['patients with CTCL stages', 'malignant proliferative disease involving mostly CD4', 'patients with cutaneous T-cell lymphoma stages I and II', '98 patients randomized in this study, 82 stage I and II patients were evaluable: 40 in the IFN+PUVA group and 42 in the IFN+acitretin group']","['IFN plus PUVA and IFN plus acitretin', 'IFN with oral photochemotherapy (PUVA', '8-methoxypsoralen', 'acitretin', 'IFN+PUVA', 'IFN plus oral photochemotherapy', 'Photochemotherapy', 'IFN+acitretin', 'interferon -2a plus acitretin versus interferon -2a plus PUVA']","['response rates', 'Side effects', 'Time to response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0278566', 'cui_str': 'Cutaneous T-cell lymphoma stage I'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0853073', 'cui_str': 'PUVA'}, {'cui': 'C0050559', 'cui_str': 'Acitretin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0025684', 'cui_str': 'Methoxsalen'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",98.0,0.0519259,Side effects were mostly mild to moderate and did not differ significantly in both treatment groups.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stadler', 'Affiliation': 'Department of Dermatology, University of Ulm, Ulm, Germany, USA.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Otte', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Luger', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Henz', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kühl', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zwingers', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Sterry', 'Affiliation': ''}]",Blood,[]
327,9731049,Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study.,"Rituximab, a chimeric monoclonal antibody that binds specifically to the CD20 antigen, induced objective responses in 50% of patients with low-grade or follicular B-cell lymphoma. Because most nonfollicular B-cell lymphomas also express the CD20 antigen, we conducted a phase II study to evaluate the efficacy and tolerability of this new agent in patients with more aggressive types of lymphoma. Patients with diffuse large B-cell lymphoma (DLCL), mantle cell lymphoma (MCL), or other intermediate- or high-grade B-cell lymphomas according to the Working Formulation were included in this prospective randomized phase II study if they were in first or second relapse, if they were refractory to initial therapy, if they progressed after a partial response to initial therapy, or if they were elderly (age >60 years) and not previously treated. The patients received 8 weekly infusions of rituximab at the dose of 375 mg/m2 in arm A or one infusion of 375 mg/m2 followed by 7 weekly infusions of 500 mg/m2 in arm B. Patients were evaluated 2 months after the last rituximab infusion. Fifty-four patients were randomized from 9 centers in Europe and Australia (28 in arm A and 26 in arm B). A total of 5 complete responses (CR) and 12 partial responses (PR) were observed among the 54 enrolled patients, with no difference between the two doses. In an intent-to-treat analysis, the CR rate was 9% (CI95%, 3% to 20%) and the PR rate was 22% (CI95%, 12% to 36%), for an overall response rate of 31% (CI95%, 20% to 46%). An analysis of prognostic factors showed that response rates were lower in patients with refractory disease, patients with lymphoma not classified as DLCL, and patients with a tumor larger than 5 cm in diameter. DLCL and MCL patients had response rates of 37% and 33%, respectively. The median time to progression exceeded 246 days for the 17 responding patients. The most frequently reported adverse events were related to an infusion syndrome and were mild: 19% of the patients had a grade 3 related adverse event, slightly more in arm B, and only 1 patient had a grade 4 related adverse event in arm A. Two patients (3.7%) withdrew from treatment because of severe adverse events, one patient in each arm. In this first trial of rituximab in DLCL and MCL, patients experienced a significant clinical activity with a low toxicity. Rituximab has significant activity in DLCL and MCL patients and should be tested in combination with chemotherapy in such patients.",1998,"Rituximab, a chimeric monoclonal antibody that binds specifically to the CD20 antigen, induced objective responses in 50% of patients with low-grade or follicular B-cell lymphoma.","['Fifty-four patients were randomized from 9 centers in Europe and Australia (28 in arm A and 26 in arm B', 'patients with relapsing or refractory aggressive lymphoma', 'Patients with diffuse large B-cell lymphoma (DLCL), mantle cell lymphoma (MCL), or other intermediate- or high-grade B-cell lymphomas according to the Working Formulation were included in this prospective randomized phase II study if they were in first or second relapse, if they were refractory to initial therapy, if they progressed after a partial response to initial therapy, or if they were elderly (age >60 years) and not previously treated', 'patients with more aggressive types of lymphoma']","['Rituximab', 'Rituximab (anti-CD20 monoclonal antibody', 'DLCL and MCL', 'rituximab']","['adverse event', 'PR rate', 'response rates', 'complete responses (CR) and 12 partial responses (PR', 'median time to progression', 'adverse events', 'efficacy and tolerability', 'CR rate', 'overall response rate']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",54.0,0.0339023,"Rituximab, a chimeric monoclonal antibody that binds specifically to the CD20 antigen, induced objective responses in 50% of patients with low-grade or follicular B-cell lymphoma.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': ""Service d'Hématologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; the Service d'Hématologie, Hôpital Henri-Mondor, Créteil, France; the Klinik 1 fur Innere Medezin, Universität zu Köln, Köln, Germany. coiffer@hematologie.univ-lyon1.fr""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ketterer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lister', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Feuring-Buske', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Radford', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Capdeville', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Reyes', 'Affiliation': ''}]",Blood,[]
328,10233878,Influence of intestinal bacterial decontamination using metronidazole and ciprofloxacin or ciprofloxacin alone on the development of acute graft-versus-host disease after marrow transplantation in patients with hematologic malignancies: final results and long-term follow-up of an open-label prospective randomized trial.,"In a single-center open-label prospective study, a total of 134 marrow transplant recipients with hematologic malignancies were randomly assigned to a bacterial decontamination medication using metronidazole and ciprofloxacin (n = 68) or ciprofloxacin alone (n = 66) during 5 weeks posttransplant. The development of grades II to IV acute graft-versus-host disease (GVHD) was defined as the primary study endpoint. According to the intention-to-treat, 17 patients (25%) randomized to the combined decontamination medication and 33 patients (50%) randomized to ciprofloxacin alone developed grades II to IV GVHD (P <.002). The higher frequency of grades II to IV acute GVHD in patients randomized to ciprofloxacin alone resulted from a more than twofold increased number of patients developing liver or intestinal involvement with acute GVHD compared with patients randomized to the combined decontamination medication (P <.003). The influence of the study medication on grades II to IV acute GVHD was significant only in recipients of transplants from genotypically HLA-identical sibling donors (n = 80), whereas in recipients of transplants from donors other than HLA-identical siblings (n = 54), grades II to IV acute GVHD frequencies between the study arms were not significantly different. The combined decontamination was associated with a significant reduction of culture growth of intestinal anaerobic bacteria during 5 weeks posttransplant (P <. 00001). In addition, the number of cultures with growth of anaerobic bacteria (P <.005) as well as the median concentrations of anaerobic bacteria in the posttransplant period (P <.0001) were higher in patients contracting grades II to IV acute GVHD. Neither chronic GVHD nor overall survival was significantly different between the two study arms. In patients with HLA-identical sibling donors who were treated in early disease stages, the 5-year survival estimate was slightly, but not significant, higher after the combined decontamination medication (60% +/- 11%) compared with ciprofloxacin alone (46% +/- 9%). In conclusion, the present study provides evidence that antimicrobial chemotherapy targeted to intestinal anaerobic bacteria in marrow transplant recipients significantly reduces the severity of acute GVHD and supports the theory that the intestinal anaerobic bacterial microflora plays a role in the pathogenesis of acute GVHD after human marrow transplantation.",1999,The combined decontamination was associated with a significant reduction of culture growth of intestinal anaerobic bacteria during 5 weeks posttransplant (P <.,"['marrow transplant recipients', 'acute graft-versus-host disease after marrow transplantation in patients with hematologic malignancies', '134 marrow transplant recipients with hematologic malignancies']","['bacterial decontamination medication using metronidazole and ciprofloxacin', 'metronidazole and ciprofloxacin or ciprofloxacin alone', 'ciprofloxacin', 'antimicrobial chemotherapy', 'ciprofloxacin alone']","['culture growth of intestinal anaerobic bacteria', 'chronic GVHD nor overall survival', 'grades II to IV acute GVHD frequencies', 'grades II to IV acute GVHD', 'median concentrations of anaerobic bacteria', 'number of patients developing liver or intestinal involvement with acute GVHD', 'number of cultures with growth of anaerobic bacteria', '5-year survival estimate']","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}]","[{'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0004613', 'cui_str': 'Bacteria, Anaerobic'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",134.0,0.0253642,The combined decontamination was associated with a significant reduction of culture growth of intestinal anaerobic bacteria during 5 weeks posttransplant (P <.,"[{'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Beelen', 'Affiliation': 'Departments of Bone Marrow Transplantation, Medical Microbiology, and Medical Informatics, Biometry and Epidemiology, University Hospital of Essen, Germany. dietrich.beelen@uni-essen.de'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elmaagacli', 'Affiliation': ''}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hirche', 'Affiliation': ''}, {'ForeName': 'U W', 'Initials': 'UW', 'LastName': 'Schaefer', 'Affiliation': ''}]",Blood,[]
329,9746766,Early treatment of acute graft-versus-host disease with high- or low-dose 6-methylprednisolone: a multicenter randomized trial from the Italian Group for Bone Marrow Transplantation.,"Ninety-five patients undergoing an allogeneic bone marrow transplant (BMT) and developing acute graft-versus-host disease (aGvHD) were randomized to receive low-dose intravenous 6-methylprednisolone (6MPred; 2 mg/kg /d; n = 47) or high-dose 6MPred (10 mg/kg/d; n = 48) for 5 days, with subsequent tapering doses. On day 5 patients not responding or progressing on low-dose 6MPred could be switched to high-dose 6MPred. All patients, aged 1 to 55 years, were recipients of unmanipulated BMT from HLA identical sibling donors. Patients were stratified at randomization for age (</>/= 20 years), disease (acute leukemia, chronic myeloid leukemia [CML], nonneoplastic disease), disease status (early/advanced), and GvHD prophylaxis (cyclosporin/cyclosporin + methotrexate). Primary endpoints were response to treatment and evolution of aGvHD to grade III-IV. Secondary endpoints were cytomegalovirus (CMV) infections, transplant-related mortality (TRM), and relapse. The median interval between BMT and treatment was 12 days (6 to 43). Results in the two groups (2 v 10 mg/kg) were as follows: response of aGvHD 68% versus 71% (P = .9), evolution to aGvHD grade III-IV 17% versus 20% (P = . 6), CMV infections 55% versus 60% (P = .7), 3-year actuarial TRM 28% versus 32% (P = .7), relapse 17% versus 7% (P = .1). The actuarial survival at 3 years was 63% versus 62% (P = .9) with a median follow up of 580 and 778 days. On day 5 of therapy, 26 patients assigned to low-dose (2 mg/kg) 6MPred were switched to a higher dose of 6MPred because of no response or progression. Their actuarial TRM was 46%, which is significantly higher than TRM of patients who responded on 2 mg/kg and continued with tapering doses (TRM = 16%, P = .007). In conclusion, early treatment of acute GvHD with 6MPred 10 mg/kg/d does not improve the response rate as compared with 2 mg/kg/d, nor does it prevent evolution to aGvHD grade III-IV. CMV infections, TRM, and survival were also comparable. A group of patients at high risk of TRM can be identified after 5 days of treatment with 6MPred 2 mg/kg and could be eligible for alternative forms of therapy.",1998,The actuarial survival at 3 years was 63% versus 62% (P = .9) with a median follow up of 580 and 778 days.,"['Ninety-five patients undergoing an allogeneic bone marrow transplant (BMT) and developing acute graft-versus-host disease (aGvHD', 'Italian Group for Bone Marrow Transplantation', 'All patients, aged 1 to 55 years, were recipients of unmanipulated BMT from HLA identical sibling donors', 'Patients were stratified at randomization for age (</>/= 20 years), disease (acute leukemia, chronic myeloid leukemia [CML], nonneoplastic disease), disease status (early/advanced), and GvHD prophylaxis ']","['low-dose intravenous 6-methylprednisolone', 'high-dose 6MPred', 'cyclosporin/cyclosporin + methotrexate', 'high- or low-dose 6-methylprednisolone']","['median interval', 'CMV infections', 'actuarial survival', 'cytomegalovirus (CMV) infections, transplant-related mortality (TRM), and relapse', 'response rate', 'actuarial TRM', 'response to treatment and evolution of aGvHD to grade III-IV', 'CMV infections, TRM, and survival', '3-year actuarial TRM']","[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",95.0,0.0426878,The actuarial survival at 3 years was 63% versus 62% (P = .9) with a median follow up of 580 and 778 days.,"[{'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Van Lint', 'Affiliation': 'Divisione Ematologial, Ospedale San Martino, Genova; Clinica Pediatrica, Milano, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uderzo', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Locasciulli', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Majolino', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Scimé', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Giorgiani', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Arcese', 'Affiliation': ''}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Iori', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Falda', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Miniero', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Alessandrino', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dini', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rotoli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': ''}]",Blood,[]
330,9639500,The redox state as a correlate of senescence and wasting and as a target for therapeutic intervention.,"The loss of body cell mass (bcm) in senescence and wasting is poorly understood. We now show that the plasma cystine/acid soluble thiol ratio, ie, an indicator of the redox state, is increased in old age and cancer patients and correlated with a decrease in bcm and plasma albumin. A cause/effect relationship was suggested by two independent studies with N-acetyl-cysteine (NAC). NAC caused an increase in the bcm of healthy persons with high plasma cystine/thiol ratios, and treatment of cancer patients with NAC plus interleukin-2 caused an increase in bcm, plasma albumin, and functional capacity. Albumin levels below 680 micromol/L were associated with an increase in body water. Our studies suggest that the shift in the redox state may contribute to the loss of bcm and may provide a quantitative guideline for therapeutic intervention. Treatment of cancer patients with thiol-containing antioxidants may improve the quality of life.",1998,"NAC caused an increase in the bcm of healthy persons with high plasma cystine/thiol ratios, and treatment of cancer patients with NAC plus interleukin-2 caused an increase in bcm, plasma albumin, and functional capacity.","['cancer patients with', 'healthy persons']","['NAC', 'thiol-containing antioxidants']","['loss of body cell mass', 'Albumin levels', 'bcm, plasma albumin, and functional capacity', 'quality of life']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0038734', 'cui_str': 'Mercaptans'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C1260311', 'cui_str': 'Plasma Albumin'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}]",,0.0318328,"NAC caused an increase in the bcm of healthy persons with high plasma cystine/thiol ratios, and treatment of cancer patients with NAC plus interleukin-2 caused an increase in bcm, plasma albumin, and functional capacity.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hack', 'Affiliation': 'Division of Immunochemistry, Deutsches Krebsforschungszentrum, Heidelberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Breitkreutz', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kinscherf', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Röhrer', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bärtsch', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Taut', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Dröge', 'Affiliation': ''}]",Blood,[]
331,9639501,Treatment of anemia in myelodysplastic syndromes with granulocyte colony-stimulating factor plus erythropoietin: results from a randomized phase II study and long-term follow-up of 71 patients.,"Treatment with erythropoietin (epo) may improve the anemia of myelodysplastic syndromes (MDS) in approximately 20% of patients. Previous studies have suggested that treatment with the combination of granulocyte colony-stimulating factor (G-CSF) and epo may increase this response rate. In the present phase II study, patients with MDS and anemia were randomized to treatment with G-CSF + epo according to one of two alternatives; arm A starting with G-CSF for 4 weeks followed by the combination for 12 weeks, and arm B starting with epo for 8 weeks followed by the combination for 10 weeks. Fifty evaluable patients (10 refractory anemia [RA], 13 refractory anemia with ring sideroblasts [RARS], and 27 refractory anemia with excess blasts [RAEB]) were included in the study, three were evaluable only for epo as monotherapy and 47 for the combined treatment. The overall response rate to G-CSF + epo was 38%, which is identical to that in our previous study. The response rates for patients with RA, RARS, and RAEB were 20%, 46%, and 37%, respectively. Response rates were identical in the two treatment groups indicating that an initial treatment with G-CSF was not neccessary for a response to the combination. Nine patients in arm B showed a response to the combined treatment, but only three of these responded to epo alone. This suggests a synergistic effect in vivo by G-CSF + epo. A long-term follow-up was made on 71 evaluable patients from both the present and the preceding Scandinavian study on G-CSF + epo. Median survival was 26 months, and the overall risk of leukemic transformation during a median follow-up of 43 months was 28%. Twenty patients entered long-term maintenance treatment and showed a median duration of response of 24 months. The international prognostic scoring system (IPSS) was effective to predict survival, leukemic transformation, and to a lesser extent, duration of response, but had no impact on primary response rates.",1998,Response rates were identical in the two treatment groups indicating that an initial treatment with G-CSF was not neccessary for a response to the combination.,"['patients with MDS and anemia', '71 patients', '71 evaluable patients from both the present and the preceding Scandinavian study on G-CSF + epo', 'Fifty evaluable patients (10 refractory anemia [RA], 13 refractory anemia with ring sideroblasts [RARS], and 27 refractory anemia with excess blasts [RAEB']","['G-CSF + epo', 'granulocyte colony-stimulating factor plus erythropoietin', 'erythropoietin (epo']","['response rates', 'Median survival', 'anemia of myelodysplastic syndromes (MDS', 'median duration of response of 24 months', 'Response rates', 'overall response rate', 'overall risk of leukemic transformation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0240951', 'cui_str': 'Scandinavian'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C2981142', 'cui_str': 'Refractory anemia (clinical)'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0002894', 'cui_str': 'RAEB'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}]",71.0,0.0398851,Response rates were identical in the two treatment groups indicating that an initial treatment with G-CSF was not neccessary for a response to the combination.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hellström-Lindberg', 'Affiliation': 'Department of Hematology, Huddinge University Hospital, Huddinge, Sweden. Eva.Hellstrom-Lindberg@medhs.ki.se'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ahlgren', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Beguin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Carlsson', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carneskog', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Dahl', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Dybedal', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grimfors', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kanter-Lewensohn', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Linder', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Luthman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Löfvenberg', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nilsson-Ehle', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Samuelsson', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Tangen', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Winqvist', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Oberg', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Osterborg', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ost', 'Affiliation': ''}]",Blood,[]
332,9572995,A double-blind placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: a Southwest oncology group study (9031).,"Older age is a poor prognosis factor in acute myeloid leukemia (AML). This double-blind trial was designed to test the hypothesis that granulocyte colony-stimulating factor (G-CSF) used as supportive care could improve the treatment of elderly AML patients. Two hundred thirty-four patients 55 or more years of age with a morphologic diagnosis of de novo or secondary AML, French-American-British (FAB) M0-M7, excluding M3, were randomly assigned to a standard induction regimen (daunorubicin at 45 mg/m2 intravenously [IV] on days 1 through 3 and Ara-C at 200 mg/m2 IV continuous infusion on days 1 through 7) plus either placebo or G-CSF (400 microg/m2 IV over 30 minutes once daily). Results are reported here for 211 centrally confirmed cases of non-M3 AML. The two groups were well balanced in demographic, clinical, and hematological parameters, with median ages of 68 years in the G-CSF and 67 years in the placebo groups. The complete response (CR) rate was not significantly better in the G-CSF group: 50% in the placebo and 41% in the G-CSF group (one-tailed P = .89). Median overall survival was also similar, 9 months (95% confidence interval [CI], 7 to 10 months) in the placebo and 6 months (95% CI, 3 to 8 months) in the G-CSF arms (P = .71). We found a significant 15% reduction in the time to neutrophil recovery in the G-CSF group (P = .014). G-CSF had no impact on recovery from thrombocytopenia (P = .80) or duration of first hospitalization (P = .27). When infection complications were evaluated, G-CSF had a beneficial effect on the duration but not on incidence of infection. G-CSF patients had fewer days with fever and shorter duration of antibiotic use. However, there was no difference in the frequency of total documented infections or in the number of fatal infections (19% placebo v 20% G-CSF). In this study of elderly AML patients, G-CSF improved clinical parameters of duration of neutropenia and antibiotic use, but did not change CR rate or survival or shorten hospitalization.",1998,The complete response (CR) rate was not significantly better in the G-CSF group: 50% in the placebo and 41% in the G-CSF group (one-tailed P = .89).,"['elderly patients with previously untreated acute myeloid leukemia', 'elderly AML patients', 'Two hundred thirty-four patients 55 or more years of age with a morphologic diagnosis of de novo or secondary AML, French-American-British (FAB) M0-M7, excluding M3', 'median ages of 68 years in the G-CSF and 67 years in the placebo groups']","['standard induction regimen (daunorubicin', 'placebo', 'granulocyte colony-stimulating factor (G-CSF', 'granulocyte colony-stimulating factor', 'placebo or G-CSF']","['recovery from thrombocytopenia', 'complete response (CR) rate', 'duration of first hospitalization', 'number of fatal infections', 'Median overall survival', 'fever and shorter duration of antibiotic use', 'time to neutrophil recovery', 'CR rate or survival or shorten hospitalization', 'frequency of total documented infections']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839409', 'cui_str': 'Morphologic diagnosis (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",,0.223725,The complete response (CR) rate was not significantly better in the G-CSF group: 50% in the placebo and 41% in the G-CSF group (one-tailed P = .89).,"[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Godwin', 'Affiliation': 'Loyola University Chicago, Maywood, IL, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Leith', 'Affiliation': ''}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hynes', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Balcerzak', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
333,9558411,Low transplant mortality in allogeneic bone marrow transplantation for acute myeloid leukemia: a randomized study of low-dose cyclosporin versus low-dose cyclosporin and low-dose methotrexate.,"Sixty patients undergoing allogeneic bone marrow transplant for acute myeloid leukemia (AML) in first remission (CR1; n = 49) or more advanced phase (n = 11) were entered in a prospective trial of graft-versus-host disease (GvHD) prophylaxis: low-dose cyclosporin A (IdCSA; 1 mg/kg/d from day -1 to +20 day; n = 28) or IdCSA plus low-dose methotrexate (IdMTX; 10 mg/m2 for day +1, 8 mg/m2 for days +3, +6, and +11; n = 32). Primary end points were acute GvHD (aGvHD) and transplant-related mortality (TRM); secondary end points were relapse and survival. The conditioning regimen consisted of cyclophosphamide (120 mg/kg) and fractionated total body irradiation (3.3 Gy/d for 3 consecutive days). The actuarial risk of developing aGvHD grade II-III was 61% for IdCSA alone and 34% for IdCSA + IdMTX (P = .02). The actuarial risk of TRM at 1 year was 11% versus 13%, respectively, and older patients (>/= 29 years) had higher TRM than younger patients (22% v 5%, P = .01). The age effect was significant in the IdCSA group (P = .04) but not in the IdCSA + IdMTX group (P = .1). The median follow-up is 4.4 years, with an overall actuarial survival of 78% for CR1 patients and 36% for patients with advanced disease. For patients in CR1 the outcome of the two regimens was as follows: survival 77% versus 80% (P = .6), relapse 20% versus 9% (P = .1), and TRM 13% versus 17% (P = .6). This study suggests that TRM can be reduced in AML patients undergoing allogeneic marrow transplants with a mild conditioning regimen and low-dose immunosuppression, and this translates in a 78% 5-year survival for CR1 patients. Beyond CR1 the major obstacle remains leukemia relapse, which is not prevented by low-dose in vivo immunosuppression.",1998,The age effect was significant in the IdCSA group (P = .04) but not in the IdCSA + IdMTX group (P = .1).,"['AML patients undergoing allogeneic marrow transplants', 'acute myeloid leukemia', 'Sixty patients undergoing allogeneic bone marrow transplant for acute myeloid leukemia (AML) in first remission (CR1; n = 49) or more advanced phase (n = 11']","['IdCSA + IdMTX', 'graft-versus-host disease (GvHD) prophylaxis: low-dose cyclosporin A (IdCSA', 'cyclosporin', 'cyclophosphamide', 'fractionated total body irradiation', 'allogeneic bone marrow transplantation', 'IdCSA', 'cyclosporin and low-dose methotrexate', 'TRM', 'IdCSA plus low-dose methotrexate (IdMTX']","['overall actuarial survival', '5-year survival', 'Low transplant mortality', 'actuarial risk of TRM', 'acute GvHD (aGvHD) and transplant-related mortality (TRM); secondary end points were relapse and survival', 'actuarial risk of developing aGvHD grade II-III', 'survival', 'TRM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0056182', 'cui_str': 'CD35 Antigens'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",11.0,0.0560834,The age effect was significant in the IdCSA group (P = .04) but not in the IdCSA + IdMTX group (P = .1).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zikos', 'Affiliation': 'Divisione Ematologia II Ospedale San Martino, Istituto Medicina Legale, Universitá, Servizio Radioterapia Istituto Tumori, Genova, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Van Lint', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Frassoni', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lamparelli', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gualandi', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Occhini', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mordini', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berisso', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bregante', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'De Stefano', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Soracco', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vitale', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': ''}]",Blood,[]
334,9694707,Effective treatment of cobalamin deficiency with oral cobalamin.,"Because cobalamin deficiency is routinely treated with parenteral cobalamin, we investigated the efficacy of oral therapy. We randomly assigned 38 newly diagnosed cobalamin deficient patients to receive cyanocobalamin as either 1 mg intramuscularly on days 1, 3, 7, 10, 14, 21, 30, 60, and 90 or 2 mg orally on a daily basis for 120 days. Therapeutic effectiveness was evaluated by measuring hematologic and neurologic improvement and changes in serum levels of cobalamin (normal, 200 to 900 pg/mL) methylmalonic acid (normal, 73 to 271 nmol/L), and homocysteine (normal, 5.1 to 13.9 micromol/L). Five patients were subsequently found to have folate deficiency, which left 18 evaluable patients in the oral group and 15 in the parenteral group. Correction of hematologic and neurologic abnormalities was prompt and indistinguishable between the 2 groups. The mean pretreatment values for serum cobalamin, methylmalonic acid, and homocysteine were, respectively, 93 pg/mL, 3,850 nmol/L, and 37. 2 micromol/L in the oral group and 95 pg/mL, 3,630 nmol/L, and 40.0 micromol/L in the parenteral therapy group. After 4 months of therapy, the respective mean values were 1,005 pg/mL, 169 nmol/L, and 10.6 micromol/L in the oral group and 325 pg/mL, 265 nmol/L, and 12.2 micromol/L in the parenteral group. The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant, with P < .0005 and P < .05, respectively. In cobalamin deficiency, 2 mg of cyanocobalamin administered orally on a daily basis was as effective as 1 mg administered intramuscularly on a monthly basis and may be superior.",1998,"The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant, with P < .0005 and P < .05, respectively.","['38 newly diagnosed cobalamin deficient patients to receive', 'Five patients were subsequently found to have folate deficiency, which left 18 evaluable patients in the oral group and 15 in the parenteral group']","['cyanocobalamin', 'cobalamin deficiency with oral cobalamin']","['hematologic and neurologic improvement and changes in serum levels of cobalamin', 'Correction of hematologic and neurologic abnormalities', 'higher serum cobalamin and lower serum methylmalonic acid levels', 'Therapeutic effectiveness', 'mean pretreatment values for serum cobalamin, methylmalonic acid, and homocysteine']","[{'cui': 'C0086024', 'cui_str': 'Cobalamins'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016412', 'cui_str': 'Folic Acid Deficiency'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}]","[{'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0042847', 'cui_str': 'Deficiency, Vitamin B12'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086024', 'cui_str': 'Cobalamins'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086024', 'cui_str': 'Cobalamins'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1318671', 'cui_str': 'Serum methylmalonic acid measurement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025787', 'cui_str': 'Propanedioic acid, methyl-'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",38.0,0.0437544,"The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant, with P < .0005 and P < .05, respectively.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Kuzminski', 'Affiliation': 'Division of General Internal Medicine, Bassett Healthcare, Cooperstown, NY, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Del Giacco', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Stabler', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindenbaum', 'Affiliation': ''}]",Blood,[]
335,9373242,A prospective randomized trial of buffy coat versus CD34-selected autologous bone marrow support in high-risk breast cancer patients receiving high-dose chemotherapy.,"High-dose chemotherapy with hematopoietic progenitor cell support is administered increasingly to selected categories of patients with high-risk malignancies. Bone marrow and/or peripheral blood progenitor cells (PBPCs) are commonly cryopreserved with the cryoprotectant dimethyl sulfoxide (DMSO), which can cause a variety of systemic side effects when the graft is thawed and infused. The progenitor cells thought to be responsible for hematopoietic recovery express the CD34 antigen and constitute 1% to 3% of the marrow cells and 0.5% of the PBPC fraction. Transplantation of a CD34(+) graft would markedly reduce the volume and thus the amount of DMSO required, thereby decreasing the infusion-related toxicities. In this study, 89 high-risk breast cancer patients received high-dose therapy and were randomized to receive an autologous CD34(+) marrow graft (Arm A) versus a standard buffy coat fraction (Arm B). After marrow infusion, significant increases in diastolic and systolic blood pressure, as well as significant decreases in heart rate, were documented in Arm B compared to Arm A patients (P < .001). None of the patients in Arm A experienced any clinically serious adverse events associated with the marrow infusion compared to 6% of the Arm B patients. The median time to neutrophil engraftment was 13 days for Arm A and 11 days for Arm B patients (P = .218). The median time to platelet engraftment was 27 days for Arm A and 20 days for Arm B patients (0.051). There were no other significant differences between the two arms of the study with respect to thrombocytopenia-related complications or immune function reconstitution. Additionally, patients on Arm A who received >/=1.2 x 10(6) CD34(+) cells/kg had no delay in platelet recovery (22 days), compared to patients on Arm B, who also received greater than 1.2 x 10(6) CD34(+) cells/kg (20 days) (P = .604). In conclusion, this prospective randomized study demonstrates that breast cancer patients who receive high-dose therapy with autologous CD34(+) marrow support have reduced marrow infusion-related toxicity, comparable time to neutrophil engraftment and immune function recovery posttransplant, and for those who receive <1.2 x 10(6) CD34(+) cells/kg, comparable time to platelet engraftment compared to women who receive buffy coat fractions of marrow.",1997,There were no other significant differences between the two arms of the study with respect to thrombocytopenia-related complications or immune function reconstitution.,"['89 high-risk breast cancer patients', 'high-risk breast cancer patients receiving high-dose chemotherapy', 'breast cancer patients who receive high-dose therapy with', 'patients with high-risk malignancies']","['CD34-selected autologous bone marrow support', 'autologous CD34(+) marrow graft (Arm A) versus a standard buffy coat fraction (Arm B', 'Bone marrow and/or peripheral blood progenitor cells (PBPCs', 'cryoprotectant dimethyl sulfoxide (DMSO', 'autologous CD34', 'x 10(6) CD34']","['median time to platelet engraftment', 'heart rate', 'thrombocytopenia-related complications or immune function reconstitution', 'clinically serious adverse events', 'diastolic and systolic blood pressure', 'platelet recovery', 'median time to neutrophil engraftment']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443089', 'cui_str': 'Leukocyte buffy coat (product)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0012403', 'cui_str': 'Dimethyl Sulfoxide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}]",89.0,0.0400449,There were no other significant differences between the two arms of the study with respect to thrombocytopenia-related complications or immune function reconstitution.,"[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'University of Colorado, Denver, CO 80262, USA.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'LeMaistre', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Saral', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Heimfeld', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Berenson', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Champlin', 'Affiliation': ''}]",Blood,[]
336,9531580,Randomized study on hydroxyurea alone versus hydroxyurea combined with low-dose interferon-alpha 2b for chronic myeloid leukemia. The Benelux CML Study Group.,"Interferon-alpha (IFN-alpha) is considered the standard therapy for chronic myeloid leukemia (CML) patients not suitable for allogeneic stem cell transplantation. From 1987 through 1992, 195 patients in the Benelux with recent untreated CML were randomized between low-dose IFN-alpha2b (3 MIU, 5 days/wk) or hydroxyurea alone (control group). The white blood cell count had to be kept less than 10 x 10(9)/L in both arms; to this end, the IFN group received additional hydroxyurea, if necessary. The complete hematologic responses at 6 months in the IFN group were 62%, versus 38% in the control group. In the IFN group, a complete hematologic response at 6 months predicted a better survival (P = .001), but such a tendency was also seen in the control group (P = .07). Cytogenetic responses in the IFN group yielded 9% complete responders, 7% partial responders (<35% Ph+), and 24% minor responders (36% to 95% Ph+). The quality of cytogenetic response within the first 24 months was highly predictive for survival (P = .002). Twenty-four patients discontinued IFN-alpha because of side effects, but they did this at a long median interval of 17.6 months; the remaining patients did not require dose adaptations. Although the hematologic and cytogenetic responses in the IFN group were higher than in the control group, the duration of chronic phase from randomization was not statistically different with 53 and 44 months in the IFN and control group, respectively. Also, no advantage for survival calculated from diagnosis was seen for the IFN group (median, 64 months) compared with the control group (median, 68 months).",1998,"In the IFN group, a complete hematologic response at 6 months predicted a better survival (P = .001), but such a tendency was also seen in the control group (P = .07).","['chronic myeloid leukemia', 'From 1987 through 1992, 195 patients in the Benelux with recent untreated CML', 'chronic myeloid leukemia (CML) patients not suitable for allogeneic stem cell transplantation']","['hydroxyurea alone versus hydroxyurea combined with low-dose interferon-alpha 2b', 'hydroxyurea alone (control group', 'Interferon-alpha (IFN-alpha', 'hydroxyurea']","['hematologic and cytogenetic responses', 'duration of chronic phase', 'better survival', 'complete hematologic responses', 'white blood cell count', 'Cytogenetic responses', 'complete hematologic response', 'quality of cytogenetic response']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.049863,"In the IFN group, a complete hematologic response at 6 months predicted a better survival (P = .001), but such a tendency was also seen in the control group (P = .07).",[],Blood,[]
337,9531581,A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucémies Aiguës Myéloblastiques (GOELAM).,"The complete remission (CR) rate after intensive chemotherapy for acute myelogenous leukemia (AML) remains low in elderly patients, mainly because of a higher infectious mortality rate related to neutropenia and an increased incidence of adverse prognostic factors. Granulocyte-macrophage colony-stimulating factor (GM-CSF) has been shown to potentially recruit leukemic blasts into cell cycle and improve cytotoxic effects when given during chemotherapy, and to shorten the duration of neutropenia when administered after chemotherapy. Two hundred forty patients aged 55 to 75 years who had newly diagnosed AML were randomly assigned to receive placebo or Escherichia coli-derived GM-CSF (5 micrograms/kg/d by 6-hour intravenous infusion) starting during induction chemotherapy on day 1 and continued through and after chemotherapy until recovery of neutrophils, or evidence of regrowth of leukemia, or up to day 28. Induction chemotherapy consisted of idarubicin (8 mg/m2/d on days 1 to 5) and cytarabine (100 mg/m2/d on days 1 to 7). The study drug was not administered subsequent to the induction course. Patients who achieved a CR received continuous maintenance therapy for 1 year with four quarterly reinduction courses; in the 55- to 64-year age subgroup, patients were randomly assigned to receive or not a consolidation course before maintenance therapy. The CR rate was similar in the GM-CSF and placebo groups (63% and 60.5%, respectively; P = .79). The mortality, rate of resistant disease, and rate of regrowth of leukemia were also similar in both groups. The time to neutrophil recovery was shorter in patients who received GM-CSF (24 v 29 days; P = .0001), but the incidence and characteristics of infectious events were not different. The 2-year disease-free survival (DFS) rate was significantly improved in the GM-CSF group (48% v 21% in the placebo group; P = .003). This effect was highly significant in the cohort of patients aged 55 to 64, but only marginal in patients >/=65 years of age. There was a trend toward a longer overall survival (OS) in the GM-CSF group (P = .082). In summary, the administration of GM-CSF, concomitantly with chemotherapy and thereafter during induction course in AML, shortened the time to neutrophil recovery, but did not improve the CR rate in patients aged 55 to 75. Nonetheless, DFS and OS were significantly prolonged in patients aged 55 to 64 treated with GM-CSF. These results are promising and further evaluation of myeloid growth factors in AML is warranted.",1998,There was a trend toward a longer overall survival (OS) in the GM-CSF group (P = .082).,"['65 years of age', 'patients aged 55 to 75', 'de novo acute myelogenous leukemia in elderly patients', 'Two hundred forty patients aged 55 to 75 years who had newly diagnosed AML']","['continuous maintenance therapy', 'placebo', 'placebo or Escherichia coli-derived GM-CSF', 'GM-CSF', 'Granulocyte-macrophage colony-stimulating factor (GM-CSF', 'recombinant human granulocyte-macrophage colony-stimulating factor', 'cytarabine', 'idarubicin']","['cytotoxic effects', 'mortality, rate of resistant disease, and rate of regrowth of leukemia', 'overall survival (OS', 'DFS and OS', 'time to neutrophil recovery', 'incidence and characteristics of infectious events', '2-year disease-free survival (DFS) rate', 'CR rate', 'complete remission (CR) rate']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}]","[{'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",240.0,0.177356,There was a trend toward a longer overall survival (OS) in the GM-CSF group (P = .082).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Witz', 'Affiliation': 'Clinical Hematology Units of Centre Hospitalier Universitaire de Nancy, Nancy, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadoun', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Perrin', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berthou', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brière', 'Affiliation': ''}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Cahn', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lioure', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Witz', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'François', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pignon', 'Affiliation': ''}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Le Prisé', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Audhuy', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Casassus', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delain', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Christian', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tellier', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Polin', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hurteloup', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}]",Blood,[]
338,9292541,RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: a pilot study.,"RheothRx (Glaxo Wellcome Inc, Research Triangle Park, NC; poloxamer 188) Injection is a nonionic surfactant with hemorrheologic properties that suggest it may be useful in treating acute painful episodes (vasoocclusive crises) of sickle cell disease (SCD). We conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the safety and efficacy of poloxamer, formulated as RheothRx Injection, in 50 patients with SCD. Patients with moderate to severe painful episodes requiring parenteral analgesics were randomized to receive a 48-hour infusion of either RheothRx or placebo. Pain was assessed every 4 hours. Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores. Three subgroups of patients were considered for efficacy analyses based on the actual duration of the study drug infusion and the completeness of pain score data collection. Compared with placebo and depending on the subgroup, RheothRx-treated patients showed a 16% to 45% decrease in duration of painful episodes, a 1- to 2-day reduction in hospital stay, a threefold to fivefold reduction in analgesic requirements, and a 1-point reduction (using a 5-point scale) in average pain intensity scores at 72 hours. RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures. In addition, there were no differences between treatment groups in the incidence of recurrent painful episodes. In this study, RheothRx significantly reduced total analgesic use and pain intensity and showed trends to shorter duration of painful episodes and total days of hospitalization. In patients with moderate to severe vasoocclusive pain, RheothRx was safe and may offer a therapeutic benefit.",1997,RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures.,"['acute painful episode of sickle cell disease', '50 patients with SCD', 'Patients with moderate to severe painful episodes requiring parenteral analgesics']","['poloxamer, formulated as RheothRx Injection', 'placebo', 'RheothRx', 'RheothRx or placebo', 'RheothRx (poloxamer 188) injection']","['incidence of recurrent painful episodes', 'average pain intensity scores', 'total analgesic use and pain intensity', 'shorter duration of painful episodes and total days of hospitalization', 'tolerated', 'Pain', 'duration of painful episodes', 'safety and efficacy', 'hospital stay', 'Efficacy endpoints included: (1) painful episode duration, (2) days of hospitalization, (3) quantity of analgesics used, and (4) pain intensity scores']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]","[{'cui': 'C0086827', 'cui_str': 'Poloxamers'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600611', 'cui_str': 'Poloxamer 188'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",50.0,0.122653,RheothRx was well tolerated; no clinically significant differences were observed between treatments with respect to adverse experiences or other safety measures.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Adams-Graves', 'Affiliation': 'University of Tennessee, Memphis 38163, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koshy', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Steinberg', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Veith', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Crawford', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bustrack', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Emanuele', 'Affiliation': ''}]",Blood,[]
339,9473217,A bioavailability and pharmacokinetic study of oral and intravenous hydroxyurea.,"Despite the widespread usage of hydroxyurea in the treatment of both malignant and nonmalignant diseases and a recent expansion in the recognition of its potential therapeutic applications, there have been few detailed studies of hydroxyurea's pharmacokinetic (PK) behavior and oral bioavailability. Parenteral administration schedules have been evaluated because of concerns about the possibility for significant interindividual variability in the PK behavior and bioavailability of hydroxyurea after oral administration. In this PK and bioavailability study, 29 patients with advanced solid malignancies were randomized to treatment with 2, 000 mg hydroxyurea administered either orally or as a 30-minute intravenous (IV) infusion accompanied by extensive plasma and urine sampling for PK studies. After 3 weeks of treatment with hydroxyurea (80 mg/kg orally every 3 days followed by a 1-week washout period), patients were crossed over to the alternate route of administration, at which time extensive PK studies were repeated. Three days later, patients continued treatment with 80 mg/kg hydroxyurea orally every 3 days for 3 weeks, followed by a 1-week rest period. Thereafter, 80 mg/kg hydroxyurea was administered orally every 3 days. Twenty-two of 29 patients had extensive plasma and urine sampling performed after treatment with both oral and IV hydroxyurea. Oral bioavailability (F) averaged 108%. Moreover, interindividual variability in F was low, as indicated by 19 of 22 individual F values within a narrow range of 85% to 127% and a modest coefficient of variation of 17%. The time in which maximum plasma concentrations (Cmax) were achieved averaged 1.22 hours with an average lag time of 0.22 hours after oral administration. Except for Cmax, which was 19. 5% higher after IV drug administration, the PK profiles of oral and IV hydroxyurea were very similar. The plasma disposition of hydroxyurea was well described by a linear two-compartment model. The initial harmonic mean half-lives for oral and IV hydroxyurea were 1.78 and 0.63 hours, respectively, and the harmonic mean terminal half-lives were 3.32 and 3.39 hours, respectively. For IV hydroxyurea, systemic clearance averaged 76.16 mL/min/m2 and the mean volume of distribution at steady-state was 19.71 L/m2, whereas Cloral/F and Voral/F averaged 73.16 mL/min/m2 and 19.65 L/m2, respectively, after oral administration. The percentage of the administered dose of hydroxyurea that was excreted unchanged into the urine was nearly identical after oral and IV administration-36. 84% and 35.82%, respectively. Additionally, the acute toxic effects of hydroxyurea after treatment on both routes were similar. Relationships between pertinent PK parameters and the principal toxicity, neutropenia, were sought, but no pharmacodynamic relationships were evident. From PK, bioavailability, and toxicologic standpoints, these results indicate that there are no clear advantages for administering hydroxyurea by the IV route except in situations when oral administration is not possible and/or in the case of severe gastrointestinal impairment.",1998,"For IV hydroxyurea, systemic clearance averaged 76.16 mL/min/m2 and the mean volume of distribution at steady-state was 19.71 L/m2, whereas Cloral/F and Voral/F averaged 73.16 mL/min/m2 and 19.65 L/m2, respectively, after oral administration.",['29 patients with advanced solid malignancies'],"['oral and intravenous hydroxyurea', 'hydroxyurea']","['principal toxicity, neutropenia', 'initial harmonic mean half-lives for oral and IV hydroxyurea', 'acute toxic effects', 'time in which maximum plasma concentrations (Cmax', 'PK profiles of oral and IV hydroxyurea', 'harmonic mean terminal half-lives', 'Oral bioavailability', 'plasma disposition of hydroxyurea', 'extensive plasma and urine sampling']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0042037'}]",29.0,0.0726365,"For IV hydroxyurea, systemic clearance averaged 76.16 mL/min/m2 and the mean volume of distribution at steady-state was 19.71 L/m2, whereas Cloral/F and Voral/F averaged 73.16 mL/min/m2 and 19.65 L/m2, respectively, after oral administration.","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Rodriguez', 'Affiliation': 'Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, TX 78229, USA.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Kuhn', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Hilsenbeck', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Eckardt', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Thurman', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Rinaldi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hodges', 'Affiliation': ''}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Von Hoff', 'Affiliation': ''}, {'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Rowinsky', 'Affiliation': ''}]",Blood,[]
340,9473250,Survival with bone marrow transplantation versus hydroxyurea or interferon for chronic myelogenous leukemia. The German CML Study Group.,"Hydroxyurea, interferon, and HLA-identical sibling bone marrow transplantation are common therapies for chronic myelogenous leukemia (CML) in chronic phase. Which is best is controversial. The purpose of this study was to compare survival of patients with CML receiving HLA-identical sibling transplants versus hydroxyurea or interferon. The transplant cohort included 548 recipients of HLA-identical sibling transplants, reported to the International Bone Marrow Transplant Registry. The nontransplant cohort included 196 patients receiving hydroxyurea (n = 121) or interferon (n = 75) on a randomized trial of the German CML Study Group. Survivals were compared using proportional hazards regression with fixed and time-dependent variables to adjust for patient differences and changing risks over time. For the first 18 months after diagnosis, mortality was higher in the transplant than the nontransplant cohort (relative risk [RR], 5.85; P < .0001). From 18 to 56 months, mortality was similar (RR, 0.80; P = .38). After 56 months, mortality was lower in the transplant cohort (RR, 0.16; P < .0001). Seven-year survival probabilities (95% confidence interval) were 58% (50% to 66%) with transplant and 32% (22% to 41%) with hydroxyurea or interferon. There was a significant survival advantage for hydroxyurea or interferon in the first 4 years after diagnosis and for transplants starting 5.5 years after diagnosis. For transplants done within 1 year of diagnosis, the survival advantage for transplantation began earlier. Survival advantage for transplants was greater and occurred earlier in patients with intermediate- and high-risk prognostic features than in those with low-risk features. This study confirms higher early mortality, but a long-term survival advantage for HLA-identical sibling transplants over hydroxyurea or interferon in CML.",1998,"After 56 months, mortality was lower in the transplant cohort (RR, 0.16; P < .0001).","['n = 121) or', '548 recipients of HLA-identical sibling transplants, reported to the International Bone Marrow Transplant Registry', 'chronic myelogenous leukemia', 'patients with CML receiving HLA-identical sibling transplants versus', '196 patients receiving', 'chronic myelogenous leukemia (CML) in chronic phase']","['Hydroxyurea, interferon, and HLA-identical sibling bone marrow transplantation', 'hydroxyurea or interferon', 'interferon', 'hydroxyurea', 'bone marrow transplantation versus hydroxyurea or interferon']","['Seven-year survival probabilities', 'Survival advantage', 'Survivals', 'survival advantage', 'mortality', 'Survival']","[{'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",548.0,0.0649678,"After 56 months, mortality was lower in the transplant cohort (RR, 0.16; P < .0001).","[{'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': 'International Bone Marrow Transplant Registry, Health Policy Institute, Medical College of Wisconsin, Milwaukee, WI 53226, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Goldman', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Heimpel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'McGlave', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Passweg', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Rowlings', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Sobocinski', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Horowitz', 'Affiliation': ''}]",Blood,[]
341,9427706,Evidence of a local mechanism for desmopressin-induced tissue-type plasminogen activator release in human forearm.,"Systemic administration of desmopressin (DDAVP) induces increased plasma levels of tissue-type plasminogen activator (t-PA), coagulation factor VIII, and von Willebrand factor (vWF). However, the mechanisms behind these responses are not known. We tested the hypothesis that DDAVP acts as a local stimulator of acute endothelial release of t-PA and vWF independently of central pathways. Healthy, young, nonsmoking male volunteers were studied. In a first study (n = 7), DDAVP and placebo were administered as randomized single-blind stepwise intrabrachial artery infusions (0.7, 7.0, and 70 ng/min). In a another subset of subjects (n = 4), a constant-rate DDAVP infusion of 70 ng/min was administered for 20 minutes in the brachial artery of the nondominant arm with the dominant arm as control. To rule out that the observed t-PA release was flow-dependent, 4 additional subjects received stepwise intra-arterial infusions of both DDAVP (7.0, 21, and 70 ng/min) and sodium nitroprusside (SNP; 0.5, 2.5, and 10 micrograms/min). Brachial venoarterial plasma concentration gradients and forearm plasma flow were used to determine net release/uptake rates of t-PA and vWF. At baseline, the average net release rate of t-PA was 6.7 ng/min across the whole forearm vascular bed, whereas there was no detectable basal release of vWF. Stepwise infusion of DDAVP induced a massive regulated release of t-PA with a peak after 15 minutes on the highest dose-step (ANOVA; P < .0001). The average maximum net release rate was 178 ng/min, and the total amount of t-PA released was, on the average, 3,000 ng. The majority was released in its active form. Constant-rate DDAVP infusion again markedly increased t-PA release in the infusion arm but had no effect whatsoever in the control arm. In contrast, DDAVP did not stimulate a local release of vWF in either study. Central hemodynamics were unchanged during infusions despite a local vasodilatory response with DDAVP. Endothelium-independent flow stimulation by SNP did not elicit any local t-PA release. We conclude that DDAVP induces a massive acute flow-independent release of t-PA, without the simultaneous release of vWF, in the human forearm vascular bed. The lack of a t-PA response in the control arm, as well as the unaltered central hemodynamics with DDAVP, confirms that the observed regulated t-PA release is local and independent of central mechanisms.",1998,"Systemic administration of desmopressin (DDAVP) induces increased plasma levels of tissue-type plasminogen activator (t-PA), coagulation factor VIII, and von Willebrand factor (vWF).","['human forearm', 'Healthy, young, nonsmoking male volunteers']","['sodium nitroprusside (SNP', 'DDAVP and placebo', 'DDAVP', 'desmopressin (DDAVP']","['t-PA release', 'Central hemodynamics', 'basal release of vWF', 'Constant-rate DDAVP infusion', 'average maximum net release rate', 'plasma levels of tissue-type plasminogen activator (t-PA), coagulation factor VIII, and von Willebrand factor (vWF', 'Brachial venoarterial plasma concentration gradients and forearm plasma flow', 't-PA response']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0037533', 'cui_str': 'Sodium Nitroprusside'}, {'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0450124', 'cui_str': 'Venoarterial (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}]",,0.0258975,"Systemic administration of desmopressin (DDAVP) induces increased plasma levels of tissue-type plasminogen activator (t-PA), coagulation factor VIII, and von Willebrand factor (vWF).","[{'ForeName': 'U', 'Initials': 'U', 'LastName': 'Wall', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital/Ostra, Göteborg, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jern', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tengborn', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jern', 'Affiliation': ''}]",Blood,[]
342,9345021,Effects of aerobic exercise on the physical performance and incidence of treatment-related complications after high-dose chemotherapy.,"Loss of physical performance is a universal problem of cancer patients undergoing chemotherapy. We postulated that this impairment can be partially prevented by aerobic exercise. In a randomized study, 33 cancer patients receiving high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation (training group, T) performed an exercise program consisting of biking on an ergometer in the supine position after an interval-training pattern for 30 minutes daily during hospitalization. Patients in the control group (C, n = 37) did not train. Maximal physical performance was assessed with a treadmill test by admission and discharge. Physical performance of the two groups was not different on admission. The decrement in performance during hospitalization was 27% greater in the control group than in the training group (P = .05); this resulted in a significantly higher maximal physical performance at discharge in the trained patients (P = .04). Duration of neutropenia (P = .01) and thrombopenia (P = .06), severity of diarrhea (P = .04), severity of pain (P = .01), and duration of hospitalization (P = . 03) were reduced in the training group. We conclude that aerobic exercise can be safely carried out immediately after high-dose chemotherapy and can partially prevent loss of physical performance. Based on the potential significance of the observed outcomes, further studies are warranted to confirm our results.",1997,"Duration of neutropenia (P = .01) and thrombopenia (P = .06), severity of diarrhea (P = .04), severity of pain (P = .01), and duration of hospitalization (P = .","['33 cancer patients receiving', 'cancer patients undergoing chemotherapy']","['high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation (training group, T) performed an exercise program consisting of biking on an ergometer in the supine position after an interval-training pattern', 'aerobic exercise']","['severity of diarrhea', 'duration of hospitalization', 'severity of pain', 'performance during hospitalization', 'Physical performance', 'physical performance and incidence of treatment-related complications', 'maximal physical performance', 'Duration of neutropenia', 'Maximal physical performance']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2607857'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",33.0,0.0329706,"Duration of neutropenia (P = .01) and thrombopenia (P = .06), severity of diarrhea (P = .04), severity of pain (P = .01), and duration of hospitalization (P = .","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dimeo', 'Affiliation': 'Department of Rehabilitation, Prevention and Sports Medicine, Freiburg University Medical Center, Freiburg in Breisgau, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fetscher', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lange', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mertelsmann', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Keul', 'Affiliation': ''}]",Blood,[]
343,9345019,Treatment of polycythemia vera: the use of hydroxyurea and pipobroman in 292 patients under the age of 65 years.,"Nonradiomimetic drugs, hydroxyurea (HU) and pipobroman (Pi), were administred to relatively young subjects with polycythemia vera (PV) in an attempt to decrease the leukemogenic risk observed in patients treated with 32P. Clinical safety, hematological efficacy, risk of carcinoma or leukemia, and frequency of progression to myelofibrosis have not yet been defined in long-term studies, and no comparative studies of HU and Pi have been conducted. Since 1980, 292 patients with PV diagnosed before the age of 65 years were randomized to receive treatment with HU (25 mg/kg/d, followed by low-dose maintenance) or Pi (1.2 mg/kg/d, followed by low-dose maintenance). Patients were followed until death or until May 1997. Drug tolerance was often poor; leg ulcers and buccal aphthous ulcers (with HU) and gastric pain and diarrhea (with Pi) sometimes required treatment change, mainly in the HU arm. Hematological stability, especially in terms of platelet count, was very often insufficient with HU (45% of cases), but the risk of thrombo-embolic event was similar in both arms. Actuarial survival was similar in the two arms and shorter than that of the reference population. The risk of leukemia was approximately 10% at the 13th year, with no significant difference between the two arms. The risk of carcinoma (when excluding the skin cancers) was similar in both groups. There was a high risk of progression to myelofibrosis in the patients treated by HU, which was significantly higher than with Pi.",1997,"Hematological stability, especially in terms of platelet count, was very often insufficient with HU (45% of cases), but the risk of thrombo-embolic event was similar in both arms.","['polycythemia vera', '292 patients with PV diagnosed before the age of 65 years', '292 patients under the age of 65 years', 'young subjects with polycythemia vera (PV']","['Nonradiomimetic drugs, hydroxyurea (HU) and pipobroman (Pi', 'hydroxyurea and pipobroman', 'HU']","['risk of leukemia', 'leg ulcers and buccal aphthous ulcers (with HU) and gastric pain and diarrhea', 'risk of thrombo-embolic event', 'Actuarial survival', 'high risk of progression to myelofibrosis', 'Hematological stability']","[{'cui': 'C0032463', 'cui_str': 'Primary Polycythemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0031965', 'cui_str': 'Pipobroman'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0038363', 'cui_str': 'Ulcer, Aphthous'}, {'cui': 'C0221512', 'cui_str': 'Stomach ache (finding)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}]",292.0,0.0406613,"Hematological stability, especially in terms of platelet count, was very often insufficient with HU (45% of cases), but the risk of thrombo-embolic event was similar in both arms.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Najean', 'Affiliation': 'Department of Nuclear Medicine, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Rain', 'Affiliation': ''}]",Blood,[]
344,9345020,Enhanced levels and enhanced clonogenic capacity of blood progenitor cells following administration of stem cell factor plus granulocyte colony-stimulating factor to humans.,"Administration of hematopoietic growth factors is being used increasingly to obtain populations of blood progenitor/stem cells (PBPC) for clinical transplantation. Here we examined the effect of combining stem cell factor (SCF ) and granulocyte colony-stimulating factor (G-CSF ) versus G-CSF alone in a randomized clinical study involving 62 women with early-stage breast cancer. In the first patient cohorts, escalating doses of SCF were administered for 7 days with concurrent G-CSF administration. At baseline, levels of progenitor cells in the bone marrow or blood were comparable in the different patient groups. As with administration of G-CSF alone, the combination of SCF plus G-CSF did not alter the wide variation in levels of PBPC observed between individuals and did not alter the selective nature of PBPC release, with preferential release of day-14 granulocyte-macrophage colony-stimulating factor (GM-CFC) versus day-7 GM-CFC. However, SCF acted to sustain the levels of PBPC after cessation of growth factor treatment; levels of PBPC were elevated 100-fold at later timepoints compared with G-CSF alone. In addition, the maximum levels of PBPC observed were increased approximately fivefold at day 5 of growth-factor administration. The increased levels of PBPC resulted in significantly increased levels of PBPC obtained by leukapheresis. In a subsequent patient cohort, 3-days pretreatment with SCF was introduced and followed by 7 days concurrent SCF plus G-CSF. The 3-days pretreatment with SCF resulted in an earlier wave of PBPC release in response to commencement of G-CSF. In addition, maximum PBPC levels in blood and PBPC yield in leukapheresis products were further increased. Unexpectedly however, SCF pretreatment resulted in progenitor cells with enhanced self-generation potential. Recloning assays documented the ability of approximately 30% of primary granulocyte-macrophage (GM) colonies from control cell populations to generate secondary GM colonies (n = 1,106 primary colonies examined). In contrast approximately 90% of GM colonies from PBPC after SCF pretreatment generated secondary clones and 65% generated secondary colonies. The action of SCF was not explicable in terms of altered SCF, GM-CSF, or G-CSF responsiveness, but SCF pretreatment was associated with maximum serum SCF levels at the time G-CSF was commenced. These results show that PBPC populations mobilized by different growth factor regimens can differ in their functional properties and caution against solely considering number of harvested progenitor cells without regard to their function.",1997,"The action of SCF was not explicable in terms of altered SCF, GM-CSF, or G-CSF responsiveness, but SCF pretreatment was associated with maximum serum SCF levels at the time G-CSF was commenced.",['62 women with early-stage breast cancer'],"['combining stem cell factor (SCF ) and granulocyte colony-stimulating factor (G-CSF ) versus G-CSF alone', 'SCF', 'G-CSF']","['PBPC', 'maximum PBPC levels in blood and PBPC yield', 'levels of PBPC', 'maximum serum SCF levels', 'levels of progenitor cells in the bone marrow or blood', 'maximum levels of PBPC', 'Enhanced levels and enhanced clonogenic capacity of blood progenitor cells']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}]",62.0,0.0315756,"The action of SCF was not explicable in terms of altered SCF, GM-CSF, or G-CSF responsiveness, but SCF pretreatment was associated with maximum serum SCF levels at the time G-CSF was commenced.","[{'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Begley', 'Affiliation': 'The Walter and Eliza Hall Institute of Medical Research, PO Royal Melbourne Hospital, Victoria, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Basser', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mansfield', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thomson', 'Affiliation': ''}, {'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Layton', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'To', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cebon', 'Affiliation': ''}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Sheridan', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Green', 'Affiliation': ''}]",Blood,[]
345,9389686,"A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia. The International Acute Myeloid Leukemia Study Group.","The safety and efficacy of filgrastim as an adjunct to acute myeloid leukemia (AML) induction and consolidation therapy was assessed in this prospective double-blind, randomized, placebo-controlled, multicenter trial. A total of 521 consecutive de novo AML patients aged 16 or more years were randomized to receive filgrastim (5 microg/kg/d subcutaneously) or placebo after standard induction as well as consolidation chemotherapy. Blinded study drug was given from 24 hours after chemotherapy until the absolute neutrophil count was >/=1.0 x 10(9)/L for 3 consecutive days. The overall complete remission rate was 68%. After a median follow-up of 24 months (range 5 to 40) the median disease-free survival was 10 months (95% confidence interval [CI], 8.7 to 10.8) and the median overall survival was 13 months (95%CI, 12.2 to 14.6). These did not differ between treatment groups. Patients receiving filgrastim experienced neutrophil recovery 5 days earlier after induction 1 than those receiving placebo (P < .0001). This was accompanied by reductions in the duration of fever (7 v 8.5 days; P = .009), parenteral antibiotic use (15 v 18.5 days; P = .0001), and hospitalization (20 v 25 days; P = .0001). Similar reductions were seen after induction 2 and the consolidation courses. There was a significant reduction in the number of patients requiring systemic antifungal therapy in the filgrastim group during induction treatment (34% v 43%; P = .04). In conclusion, filgrastim is safe in that it had no negative impact on the prognosis of the AML patients. In addition, it effectively reduced the duration of neutropenia, leading to significant clinical benefits by reducing the duration of fever; requirement for parenteral anti-infectives, specifically amphotericin B; and the duration of hospitalization.",1997,There was a significant reduction in the number of patients requiring systemic antifungal therapy in the filgrastim group during induction treatment (34% v 43%; P = .04).,"['A total of 521 consecutive de novo AML patients aged 16 or more years', 'adults with de novo acute myeloid leukemia']","['placebo', 'filgrastim']","['parenteral antibiotic use', 'median overall survival', 'overall complete remission rate', 'duration of hospitalization', 'neutrophil recovery', 'number of patients requiring systemic antifungal therapy', 'safety and efficacy', 'duration of neutropenia', 'duration of fever', 'hospitalization', 'median disease-free survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",521.0,0.637046,There was a significant reduction in the number of patients requiring systemic antifungal therapy in the filgrastim group during induction treatment (34% v 43%; P = .04).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoelzer', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sanz', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Liu Yin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Noens', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matcham', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barge', 'Affiliation': ''}]",Blood,[]
346,9269759,Modulation of cytokine release and neutrophil function by granulocyte colony-stimulating factor during endotoxemia in humans.,"In this double-blind, cross-over, placebo-controlled, randomized study, two groups of eight healthy male volunteers were challenged with endotoxin (4 ng/kg) on two occasions, once in conjunction with placebo and once with granulocyte colony-stimulating factor (G-CSF; 5 microg/kg). In group 1, G-CSF was administered intravenously 2 hours before endotoxin challenge; in group 2, G-CSF was administered subcutaneously 24 hours before endotoxin challenge. In group 1, G-CSF significantly enhanced the release of tumor necrosis factor (TNF), interleukin-6 (IL-6), IL-8, IL-1 receptor antagonist (IL-1ra), and soluble TNF receptors. In group 2, G-CSF significantly reduced IL-8 concentrations and modestly attenuated TNF and IL-6 levels. In this group, IL-1ra and soluble TNF receptors were enhanced by G-CSF pretreatment and lipopolysaccharide (LPS)-induced soluble TNF receptor release was further augmented, whereas LPS-induced IL-1ra concentrations remained unaltered. Both pretreatments with G-CSF increased LPS-induced peripheral neutrophilia; the expression of CD11b, CD18, and CD67; and the release of elastase and lactoferrin. Both pretreatments also down-regulated neutrophil L-selectin expression and prevented the endotoxin-induced pulmonary neutrophil accumulation during the first 2 hours after endotoxin challenge. These data indicate that two different pretreatments with G-CSF result in differential effects on LPS-induced cytokine release but similar effects on LPS-induced neutrophil activation and changes in expression of cell surface molecules. Finally, regardless of the effects of G-CSF on LPS-induced cytokine release, G-CSF blocks LPS-induced pulmonary granulocyte accumulation.",1997,"In group 2, G-CSF significantly reduced IL-8 concentrations and modestly attenuated TNF and IL-6 levels.","['eight healthy male volunteers', 'humans']","['placebo', 'G-CSF', 'placebo and once with granulocyte colony-stimulating factor (G-CSF', 'granulocyte colony-stimulating factor', 'endotoxin']","['IL-8 concentrations', 'TNF and IL-6 levels', 'IL-1ra and soluble TNF receptors', 'pulmonary neutrophil accumulation', 'LPS-induced IL-1ra concentrations', 'release of tumor necrosis factor (TNF), interleukin-6 (IL-6), IL-8, IL-1 receptor antagonist (IL-1ra), and soluble TNF receptors']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0147226', 'cui_str': 'tumor necrosis factor receptor type I, P55 soluble fragment'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]",8.0,0.0432219,"In group 2, G-CSF significantly reduced IL-8 concentrations and modestly attenuated TNF and IL-6 levels.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pajkrt', 'Affiliation': 'Department of Nuclear Medicine, and Center for Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Academic Medical Center, University of Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manten', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Tiel-van Buul', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wouter ten Cate', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'van Deventer', 'Affiliation': ''}]",Blood,[]
347,9376575,"Use of recombinant GM-CSF during and after remission induction chemotherapy in patients aged 61 years and older with acute myeloid leukemia: final report of AML-11, a phase III randomized study of the Leukemia Cooperative Group of European Organisation for the Research and Treatment of Cancer and the Dutch Belgian Hemato-Oncology Cooperative Group.","We conducted a prospective randomized multicenter clinical trial comparing the effects of granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjunct to intensive chemotherapy in patients of 61 years and older with untreated newly diagnosed acute myeloid leukemia (AML). Patients were randomized to either receive daunomycin-cytosine arabinoside with GM-CSF or daunomycin-cytosine arabinoside (control arm). Based on the rationale that GM-CSF might sensitize the leukemic cells to the cytotoxicity of chemotherapy as well as enhance white blood cell regeneration, GM-CSF was given during chemotherapy as well as after chemotherapy. Patients were treated with one, and in case of a partial response, with two remission induction cycles. When a complete remission was attained they received one additional cycle of consolidation therapy. Of 318 evaluable patients with a median age of 68 years, 157 were randomized to receive GM-CSF and 161 were assigned to control therapy. The effect of GM-CSF on treatment was evaluated according to intention-to-treat. Complete remission was achieved in 56% of the patients in the GM-CSF group and 55% of the control patients (P = .98). Recovery of neutrophils was significantly faster in GM-CSF-treated patients. The median time of recovery of neutrophils towards 0.5 x 10(9)/L was 23 days in the GM-CSF group versus 25 days in the control group (P = .0002) with the percentages of patients who recovered being 81% and 71%, respectively. With a median follow-up of 36 months, the probabilities of survival at 2 years after randomization were estimated at 22% for individuals assigned to the GM-CSF treatment as well as for control patients (P = .55). Disease-free survival at 2 years compared 15% and 19% for the two treatment groups (P = .69). The number of nights spent in the hospital, number of transfusions, and frequencies and types of hemorrhages and infections did not differ either. The cytogenetic results at diagnosis of this study in elderly AML shows that there is a relatively high numerical representation of patients with abnormal cytogenetics (55% of documented cases), who showed significantly inferior response rates and survival duration. We conclude that, except for a faster neutrophil recovery, GM-CSF during and after induction chemotherapy does not improve the clinical outcome of elderly patients with AML.",1997,Disease-free survival at 2 years compared 15% and 19% for the two treatment groups (P = .69).,"['patients aged 61 years and older with acute myeloid leukemia', 'elderly patients with AML', 'patients of 61 years and older with untreated newly diagnosed acute myeloid leukemia (AML', '318 evaluable patients with a median age of 68 years']","['granulocyte-macrophage colony-stimulating factor (GM-CSF', 'recombinant GM-CSF', 'intensive chemotherapy', 'GM-CSF', 'control therapy', 'daunomycin-cytosine arabinoside with GM-CSF or daunomycin-cytosine arabinoside (control arm']","['probabilities of survival', 'Disease-free survival', 'inferior response rates and survival duration', 'Recovery of neutrophils', 'Complete remission', 'number of nights spent in the hospital, number of transfusions, and frequencies and types of hemorrhages and infections', 'median time of recovery of neutrophils']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",318.0,0.0699323,Disease-free survival at 2 years compared 15% and 19% for the two treatment groups (P = .69).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Archimbaud', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ossenkoppele', 'Affiliation': ''}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Verhoef', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vellenga', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wijermans', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Berneman', 'Affiliation': ''}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Dekker', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stryckmans', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Schouten', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Jehn', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Muus', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dardenne', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zittoun', 'Affiliation': ''}]",Blood,[]
348,9376578,Comparison of autologous bone marrow transplantation and intensive chemotherapy as postremission therapy in adult acute myeloid leukemia. The Groupe Ouest Est Leucémies Aiguës Myéloblastiques (GOELAM).,"Three intensive consolidation strategies are currently proposed to younger adults with acute myeloid leukemia (AML) in first complete remission (CR): allogeneic or autologous bone marrow transplantation (BMT) and intensive consolidation chemotherapy (ICC). Patients aged 15 to 50 years with de novo AML received an induction treatment with 7 days of cytarabine and either idarubicin or rubidazone. After achievement of a CR, patients up to the age of 40 and having an HLA-identical sibling were assigned to undergo an allogeneic BMT. All the other patients received a first course of ICC with high-dose cytarabine and the same anthracycline as for induction. They were then randomly assigned to either receive a second course of ICC with amsacrine and etoposide or a combination of busulfan and cyclosphosphamide followed by an unpurged autologous BMT. Of 517 eligible patients, 367 had a CR, but only 219 (59.5%) actually received the planned intensive postremission treatment (73 allogeneic BMT, 75 autologous BMT, and 71 ICC). With a median follow-up of 62 months, the 4-year disease-free survival (DFS) of the 367 patients in CR was 39.5%. The 4-year overall survival (OS) of the 517 eligible patients was 40.5%. In multivariate analysis, DFS and OS were influenced only by the initial white blood cell count and by the French-American-British classification. The type of postremission therapy had no significant impact on the outcome. There was no difference in the 4-year DFS and OS between 88 patients for whom an allogeneic BMT was scheduled (respectively, 44% and 53%) and 134 patients of the same age category and without an HLA-identical sibling (respectively, 38% and 53%). Similarly, there was no difference in the outcome between autologous BMT and ICC. The 4-year DFS was 44% for the 86 patients randomly assigned to autologous BMT and 40% for the 78 patients assigned to ICC (P = .41). The 4-year OS was similar in the two groups (50% v 54.5%, P = .72). The median duration of hospitalization and thrombocytopenia were longer after autologous BMT (39 v 32 days, P = .006, and 109.5 v 18.5 days, P = .0001, respectively). After a first course of ICC, a second course of chemotherapy is less myelotoxic than an unpurged autologous BMT but yields comparable DFS and OS rates.",1997,"There was no difference in the 4-year DFS and OS between 88 patients for whom an allogeneic BMT was scheduled (respectively, 44% and 53%) and 134 patients of the same age category and without an HLA-identical sibling (respectively, 38% and 53%).","['adult acute myeloid leukemia', '517 eligible patients was 40.5', 'Patients aged 15 to 50 years with de novo AML', '517 eligible patients, 367 had a CR, but only 219 (59.5%) actually received the planned intensive postremission treatment (73 allogeneic BMT, 75 autologous BMT, and 71 ICC', 'younger adults with acute myeloid leukemia (AML) in first complete remission (CR']","['ICC with high-dose cytarabine', 'allogeneic or autologous bone marrow transplantation (BMT) and intensive consolidation chemotherapy (ICC', 'autologous bone marrow transplantation and intensive chemotherapy', 'autologous BMT', 'cytarabine and either idarubicin or rubidazone', 'ICC with amsacrine and etoposide or a combination of busulfan and cyclosphosphamide followed by an unpurged autologous BMT']","['4-year disease-free survival (DFS', 'autologous BMT and ICC', '4-year DFS', '4-year DFS and OS', '4-year overall survival (OS', 'median duration of hospitalization and thrombocytopenia', '4-year OS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0073688', 'cui_str': 'Rubidazone'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",517.0,0.0955988,"There was no difference in the 4-year DFS and OS between 88 patients for whom an allogeneic BMT was scheduled (respectively, 44% and 53%) and 134 patients of the same age category and without an HLA-identical sibling (respectively, 38% and 53%).","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': 'Department of Hematology of Centre Hospitalier Universitaire de Nantes, France.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Cahn', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pignon', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Witz', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Milpied', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delain', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lioure', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guilhot', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Abgrall', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Francois', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guyotat', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Casassus', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Audhuy', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tellier', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hurteloup', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herve', 'Affiliation': ''}]",Blood,[]
349,9269788,Downregulation of the proinflammatory cytokine response to endotoxin by pretreatment with the nontoxic lipid A analog SDZ MRL 953 in cancer patients.,"Interfering with the endotoxin-mediated cytokine cascade is thought to be a promising approach to prevent septic complications in gram-negative infections. The synthetic lipid A analog SDZ MRL 953 has been shown to be protective against endotoxic shock and bacterial infection in preclinical in vivo models. As part of a trial of unspecific immunostimulation in cancer patients, we conducted a double-blind, randomized, vehicle-controlled phase I trial of SDZ MRL 953 to investigate, first, its biologic effects and safety of administration in humans and, second, its influence on reactions to a subsequent challenge of endotoxin (Salmonella abortus equi). Twenty patients were treated intravenously with escalating doses of SDZ MRL 953 or vehicle control, followed by an intravenous application of endotoxin (2 ng/kg of body weight [BW]). Administration of SDZ MRL 953 was safe and well-tolerated. SDZ MRL 953 itself increased granulocyte counts and serum levels of granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6), but not of the proinflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), IL-1beta, and IL-8. Compared with vehicle control, pretreatment with SDZ MRL 953 markedly reduced the release of TNF-alpha, IL-1beta, IL-8, IL-6, and G-CSF, but augmented the increase in granulocyte counts to endotoxin. Induction of tolerance to the endotoxin-mediated cascade of proinflammatory cytokines by pretreatment with SDZ MRL 953 in patients at risk may help to prevent complications of gram-negative sepsis.",1997,"SDZ MRL 953 itself increased granulocyte counts and serum levels of granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6), but not of the proinflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), IL-1beta, and IL-8.","['Twenty patients', 'cancer patients', '953 in cancer patients']","['endotoxin', 'nontoxic lipid A analog SDZ MRL', 'SDZ MRL 953 or vehicle control, followed by an intravenous application of endotoxin', 'SDZ MRL']","['safe and well-tolerated', 'granulocyte counts to endotoxin', 'release of TNF-alpha, IL-1beta, IL-8, IL-6, and G-CSF', 'granulocyte counts and serum levels of granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6', 'proinflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), IL-1beta, and IL-8']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0023767', 'cui_str': 'Lipid A'}, {'cui': 'C0141826', 'cui_str': 'SDZ MRL 953'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0857490', 'cui_str': 'Granulocyte count (procedure)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]",20.0,0.0982961,"SDZ MRL 953 itself increased granulocyte counts and serum levels of granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6), but not of the proinflammatory cytokines tumor necrosis factor-alpha (TNF-alpha), IL-1beta, and IL-8.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kiani', 'Affiliation': 'Department of Internal Medicine I, University Hospital of Freiburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tschiersch', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaboriau', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Otto', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Seiz', 'Affiliation': ''}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Knopf', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stütz', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Färber', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Haus', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Galanos', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mertelsmann', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Engelhardt', 'Affiliation': ''}]",Blood,[]
350,9207435,Randomized trial of autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation in lymphoma patients.,"Although a large amount of data is available on the effects of filgrastim (granulocyte colony-stimulating factor [G-CSF]) on the mobilization of stem cells in the circulation, data concerning its effects on bone marrow (BM) harvesting is scarce and controversial. We have designed a randomized trial comparing filgrastim-mobilized peripheral blood stem cell (PBSC) transplantation with filgrastim-primed autologous bone marrow transplantation (ABMT). Fifty-five patients affected by non-Hodgkin's (n = 38) or Hodgkin's (n = 17) lymphoma, selected for autologous transplantation over a 12-month period in a single institution, were randomized 2:1 to undergo BM or PB harvest/collection after priming for 3 days with filgrastim, 16 microg/kg body weight daily subcutaneously. BM priming with G-CSF allowed the harvest of a significantly higher number of mononuclear cells (MNC) (0.53 x 10(8)/kg, range, 0.32 to 1.40), as compared with a historical control of unprimed BM harvests (0.43 x 10(8) MNC/kg, range, 0.15 to 0.72, P = .001). After high-dose ablative therapy, median time to neutrophil recovery above 0.5 x 10(9)/L was 12 days for BM and 11 days for PB (P = .219); median time to platelet recovery above 20 x 10(9)/L was 13 days for BM and 11 days for PB (P = .242). The same number of red blood cells, platelet transfusions, and posttransplant G-CSF doses were required in the two groups of patients. Less patients (50% v 70%) became febrile in the group transplanted with mobilized PB, but days of fever/patient and days on antibiotics were overlapping. The median time spent in the hospital after reinfusion was 16.5 and 15.5 days after primed BM and primed PB, respectively (P = .134). These data suggest that in patients with lymphoma submitted to autologous transplantation, the reinfusion of filgrastim-primed BM or filgrastim-mobilized PB leads to similar results, with an advantage of only 1 day in the neutrophil recovery and 1 day on the time spent in the hospital in favor of primed PB. Either option can be chosen on the basis of the availability of a surgery room or cell separator facilities and considering the patients' characteristics and wishes.",1997,"BM priming with G-CSF allowed the harvest of a significantly higher number of mononuclear cells (MNC) (0.53 x 10(8)/kg, range, 0.32 to 1.40), as compared with a historical control of unprimed BM harvests (0.43 x 10(8) MNC/kg, range, 0.15 to 0.72, P = .001).","['patients with lymphoma submitted to autologous transplantation', 'lymphoma patients', ""Fifty-five patients affected by non-Hodgkin's (n = 38) or Hodgkin's (n = 17) lymphoma, selected for autologous transplantation over a 12-month period in a single institution""]","['autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation', 'filgrastim (granulocyte colony-stimulating factor [G-CSF', 'filgrastim-mobilized peripheral blood stem cell (PBSC) transplantation with filgrastim-primed autologous bone marrow transplantation (ABMT']","['red blood cells, platelet transfusions, and posttransplant G-CSF doses', 'number of mononuclear cells (MNC', 'median time spent', 'median time to neutrophil recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0242602', 'cui_str': 'Peripheral Stem Cell Transplantation'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}]",55.0,0.0325251,"BM priming with G-CSF allowed the harvest of a significantly higher number of mononuclear cells (MNC) (0.53 x 10(8)/kg, range, 0.32 to 1.40), as compared with a historical control of unprimed BM harvests (0.43 x 10(8) MNC/kg, range, 0.15 to 0.72, P = .001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Damiani', 'Affiliation': 'Department of Bone Marrow Transplantation, University Hospital, Udine, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fanin', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Silvestri', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grimaz', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Infanti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Geromin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cerno', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michieli', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rinaldi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Savignano', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Trani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fiacchini', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': ''}]",Blood,[]
351,9207470,Circulating blood B cells in multiple myeloma: analysis and relationship to circulating clonal cells and clinical parameters in a cohort of patients entered on the Eastern Cooperative Oncology Group phase III E9486 clinical trial.,"Recent analyses of circulating blood B cells in myeloma have generated controversy concerning the exact levels of these cells and whether they may represent circulating clonal tumor B cells. Previous reports suggested that CD19+ B cells are markedly increased in myeloma patients and that this population shares clonotypic rearrangements with the malignant plasma cell. We studied the numbers of CD19+ B cells by flow cytometry in previously untreated newly diagnosed myeloma patients in Eastern Cooperative Oncology Group (ECOG) phase III trial E9486. There were 628 patients who were eligible for the clinical protocol E9486, but of these 521 were also entered on the companion laboratory study (E9487) and had CD19 data. In comparison with normal controls, the myeloma patients exhibited a marked heterogeneity in the number of circulating CD19+ B cells as detected by flow cytometry. Approximately 20% of patients had significantly increased levels of circulating CD19+ B cells. However, the total CD19+ blood population from myeloma was not significantly different from the median of age-matched, normal controls. Analysis of CD19+ blood cells in relationship to circulating clonal cells was done in 13 myeloma patients using a clonotypic, quantitative allele-specific oligonucleotide-polymerase chain reaction (PCR) assay. No correlation was found between the numbers of CD19+ B cells (range, 5% to 51%) and PCR estimates of the number of clonal cells in the peripheral blood (range, .009% to 3.6%). Low CD19+ B-cell level (<125 microL) was associated with clinical stage III (P = .033). A significant relationship exists between higher levels (> or = 125/microL) of CD19 cells and longer overall survival (P < .0001). In addition, high CD19 levels also predicted a clinical response and longer event-free survival. There was a strong inverse association between the level of CD19 values at diagnosis and infections within the first 2 months of diagnosis. Importantly, the number of deaths related to infections was significantly greater in the low versus high CD19 group (P < .0202). Also, CD19 is an independent prognostic factor in addition to plasma cell labeling indices, beta2-microglobulin, hemoglobin, and plasmablastic morphology. Patients with infections were more likely to have low levels of CD19+ cells. In summary, higher CD19+ cell levels are a favorable prognostic sign with no apparent relationship to circulating tumor cells. In addition, this analysis strongly suggests that low peripheral blood levels of CD19+ cells are an adverse prognostic sign in myeloma. The CD19+ cell levels in myeloma patients is an important parameter in the overall assessment of these patients.",1997,A significant relationship exists between higher levels (> or = 125/microL) of CD19 cells and longer overall survival (P < .0001).,"['13 myeloma patients', 'previously untreated newly diagnosed myeloma patients in Eastern Cooperative Oncology Group (ECOG) phase III trial E9486', 'myeloma patients', '628 patients who were eligible for the clinical protocol E9486, but of these 521 were also entered on the companion laboratory study (E9487) and had CD19 data', 'patients entered on the Eastern Cooperative Oncology Group phase III E9486 clinical trial']",[],"['CD19+ cell levels', 'Low CD19+ B-cell level', 'total CD19+ blood population from myeloma', 'clinical response and longer event-free survival', 'higher CD19+ cell levels', 'levels of circulating CD19+ B cells', 'overall survival', 'numbers of CD19+ B cells', 'number of circulating CD19+ B cells', 'number of deaths related to infections', 'low levels of CD19+ cells']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008971', 'cui_str': 'Clinical Protocols'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C0882808', 'cui_str': 'CD19+ cell'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",628.0,0.0965418,A significant relationship exists between higher levels (> or = 125/microL) of CD19 cells and longer overall survival (P < .0001).,"[{'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Kay', 'Affiliation': 'Department of Medicine, University of Kentucky Medical Center, Lexington 40536-0093, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Leong', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Greipp', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Billadeau', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Van Ness', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bone', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Oken', 'Affiliation': ''}]",Blood,[]
352,9129014,"Randomized, blinded, placebo-controlled phase I trial of pegylated recombinant human megakaryocyte growth and development factor with filgrastim after dose-intensive chemotherapy in patients with advanced cancer.","Thrombocytopenia caused by chemotherapy is an important cause of morbidity and mortality in the treatment of malignant disease. Recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) is a potent stimulator of megakaryocytopoiesis and prevents chemotherapy-induced thrombocytopenia in preclinical studies. We administered PEG-rHuMGDF with filgrastim after dose-intensive chemotherapy to 41 patients with advanced cancers to determine its safety and effects on hematologic recovery. Carboplatin 600 mg/m2 and cyclophosphamide 1,200 mg/m2 were administered to patients with advanced cancer. Patients were randomly assigned to receive blinded study drug, either PEG-rHuMGDF or placebo (3-to-1 ratio), commencing the day after chemotherapy. PEG-rHuMGDF was given at doses of 0.03, 0.1, 0.3, 1.0, 3.0, and 5.0 microg per kilogram body weight by daily subcutaneous injection for between 7 and 20 days. All patients received concurrent filgrastim 5 microg per kilogram body weight per day until neutrophil recovery. Fifteen patients had received PEG-rHuMGDF alone in a previous phase I study. Platelet function and peripheral blood progenitor cells (PBPC) were assessed. PEG-rHuMGDF enhanced platelet recovery in a dose-related manner when compared with placebo. The platelet nadir occurred earlier in patients given PEG-rHuMGDF (P = .002) but there was no difference in the depth of the nadir. Recovery to baseline platelet count was achieved significantly earlier following PEG-rHuMGDF administration compared with placebo (median, 17 days for PEG-rHuMGDF 0.3 to 5.0 microg/kg versus 22 days for placebo, P = .014). In addition, platelet recovery was faster in patients who had previously received PEG-rHuMGDF, suggesting that pretreatment might be beneficial. Platelet function did not change during or after administration of PEG-rHuMGDF. Levels of PBPC on day 15 after chemotherapy were significantly greater in patients administered PEG-rHuMGDF 0.3 to 5.0 microg/kg and filgrastim compared with those given placebo plus filgrastim. PEG-rHuMGDF was well tolerated at all doses. Two patients given PEG-rHuMGDF had a thrombotic episode. PEG-rHuMGDF accelerates platelet recovery after moderately dose-intensive carboplatin and cyclophosphamide, and is likely to be clinically useful in treatment of chemotherapy-induced thrombocytopenia. Because it enhances mobilization of PBPC by filgrastim, PEG-rHuMGDF might also allow more efficient collection of stem cells for autologous or allogeneic transplantation.",1997,The platelet nadir occurred earlier in patients given PEG-rHuMGDF (P = .002) but there was no difference in the depth of the nadir.,"['Fifteen patients had received', '41 patients with advanced cancers', 'patients with advanced cancer']","['PEG-rHuMGDF', 'placebo', 'cyclophosphamide', 'concurrent filgrastim', 'placebo plus filgrastim', 'filgrastim', 'Recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF', 'pegylated recombinant human megakaryocyte growth', 'PEG-rHuMGDF with filgrastim', 'Carboplatin 600 mg/m2 and cyclophosphamide', 'PEG-rHuMGDF or placebo', 'placebo-controlled phase']","['Recovery to baseline platelet count', 'hematologic recovery', 'platelet nadir', 'Levels of PBPC', 'Thrombocytopenia', 'platelet recovery', 'Platelet function and peripheral blood progenitor cells (PBPC', 'thrombotic episode', 'Platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}, {'cui': 'C0025166', 'cui_str': 'Megakaryocytes'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",,0.11377,The platelet nadir occurred earlier in patients given PEG-rHuMGDF (P = .002) but there was no difference in the depth of the nadir.,"[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Basser', 'Affiliation': 'Centre for Developmental Cancer Therapeutics, Parkville, Victoria, Australia.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Rasko', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cebon', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Grigg', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Byrne"", 'Affiliation': ''}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Menchaca', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Begley', 'Affiliation': ''}]",Blood,[]
353,9129016,Recombinant methionyl human stem cell factor and filgrastim for peripheral blood progenitor cell mobilization and transplantation in non-Hodgkin's lymphoma patients--results of a phase I/II trial.,"To examine the safety and efficacy of recombinant-methionyl human stem cell factor (r-metHuSCF), 38 patients with intermediate-grade or immunoblastic high-grade non-Hodgkin's lymphoma who were eligible for autologous transplantation were randomized to receive r-metHuSCF (5, 10, 15, or 20 microg/kg/d) plus Filgrastim (10 microg/kg/d) or Filgrastim (10 microg/kg/d) alone to mobilize peripheral blood progenitor cells. Subcutaneous administration of r-metHuSCF was well tolerated in conjunction with a multi-agent pre-medication regimen; local injection site reactions were the most commonly seen adverse event. The total mononuclear cell count, CD34+ cell content, granulocyte-macrophage colony-forming cells (GM-CFC), and burst-forming units-erythroid (BFU-E) per kilogram in the apheresis product was similar when all patients were analyzed by treatment cohort and mobilization regimen (Filgrastim or r-metHuSCF in combination with Filgrastim); however, when prior chemotherapy was taken into account in a supplementary analysis, clinically important differences were observed. Extensive prior therapy was defined as the amount of exposure to specific stem cell toxic chemotherapeutic agents that patients received. These agents include procarbazine, nitrogen mustard, melphalan, nitrosoureas (> or = 2 cycles of any of these drugs) or greater than 7.5 g of cytosine arabinoside. In these patients, there was an increased number of CD34+ cells (1.76 v 0.28 x 10(6)/kg), GM-CFC (20.5 v 5.0 x 10(4)/kg), and BFU-E (36.9 v 8.9 x 10(4)/kg) in patients receiving r-metHuSCF and Filgrastim (N = 18) compared with Filgrastim alone (N = 5). These patients also had a decreased time to an untransfused platelet count of 20 x 10(9)/L that was 10.5 days shorter in the patients who received r-metHuSCF and Filgrastim (12.5 v 23 days). These differences were not found to be statistically significant, possibly because of small size, but are clinically important.",1997,"In these patients, there was an increased number of CD34+ cells (1.76 v 0.28 x 10(6)/kg), GM-CFC (20.5 v 5.0 x 10(4)/kg), and BFU-E (36.9 v 8.9 x 10(4)/kg) in patients receiving r-metHuSCF and Filgrastim","[""38 patients with intermediate-grade or immunoblastic high-grade non-Hodgkin's lymphoma who were eligible for autologous transplantation"", ""non-Hodgkin's lymphoma patients""]","['Filgrastim (10 microg/kg/d) alone to mobilize peripheral blood progenitor cells', 'procarbazine, nitrogen mustard, melphalan, nitrosoureas (> or = 2 cycles of any of these drugs) or greater than 7.5 g of cytosine arabinoside', 'metHuSCF and Filgrastim', 'mobilization regimen (Filgrastim or r-metHuSCF in combination with Filgrastim', 'recombinant-methionyl human stem cell factor (r-metHuSCF', 'Filgrastim', 'Recombinant methionyl human stem cell factor and filgrastim', 'r-metHuSCF']","['untransfused platelet count', 'number of CD34+ cells', 'total mononuclear cell count, CD34+ cell content, granulocyte-macrophage colony-forming cells (GM-CFC), and burst-forming units-erythroid (BFU-E) per kilogram in the apheresis product']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0025033', 'cui_str': 'chlormethine'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0538777', 'cui_str': 'ancestim'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1257771', 'cui_str': 'Burst-Forming Units, Erythroid'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}]",38.0,0.0523417,"In these patients, there was an increased number of CD34+ cells (1.76 v 0.28 x 10(6)/kg), GM-CFC (20.5 v 5.0 x 10(4)/kg), and BFU-E (36.9 v 8.9 x 10(4)/kg) in patients receiving r-metHuSCF and Filgrastim","[{'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Moskowitz', 'Affiliation': 'Lymphoma Service and the Hematology Service, Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiff', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'McNiece', 'Affiliation': ''}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Broun', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bayer', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wyres', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jelaca-Maxwell', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Nichols', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Nimer', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gabrilove', 'Affiliation': ''}]",Blood,[]
354,9129038,Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study.,"Compared with younger patients, elderly patients with acute myeloid leukemia (AML) respond poorly to conventional chemotherapy. To determine if this poor response is due to differences in the biologic characteristics of AML in the elderly, we studied 211 patients (161 de novo, 50 secondary AML) over 55 years of age (median, 68 years) registered to a single clinical trial for previously untreated AML (SWOG 9031, Phase III randomized trial of standard dose cytosine arabinoside and daunomycin + rhG-CSF). Pretreatment leukemic blasts were karyotyped and were also analyzed for intrinsic drug resistance by quantitating expression of the multidrug resistance glycoprotein MDR1 and functional drug efflux using sensitive flow cytometric techniques. Results were correlated with clinical variables and outcome. These elderly AML patients had a high frequency of unfavorable cytogenetics (32%), MDR1 protein expression (71%), and functional drug efflux (58%); each of these factors occurred at high frequencies in both de novo and secondary AML patients and was associated with a significantly poorer complete remission (CR) rate. In multivariate analysis, secondary AML (P = .0035), unfavorable cytogenetics (P = .0031), and MDR1 (P = .0041) were each significantly and independently associated with lower CR rates. Resistant disease was associated with unfavorable cytogenetics (P = .017) and MDR1 expression (P = .0007). Strikingly, elderly MDR1(-) de novo AML patients with favorable/intermediate cytogenetics had a CR rate of 81%; with increasing MDR1 expression, CR rate decreased in this cytogenetic group. MDR1(+) secondary AML patients with unfavorable cytogenetics had a CR rate of only 12%. Thus, AML in the elderly is associated with an increased frequency of unfavorable cytogenetics and MDR1 expression, both of which independently contribute to poor outcomes. The high frequencies of these features in both de novo and secondary elderly AML patients suggest a common biologic mechanism for these leukemias distinct from that in younger patients. Investigation of biologic parameters at diagnosis in AML in the elderly may help identify patients with a high likelihood of achieving CR with conventional regimens, as well as those who may require alternate regimens designed to overcome therapy resistance.",1997,"In multivariate analysis, secondary AML (P = .0035), unfavorable cytogenetics (P = .0031), and MDR1 (P = .0041) were each significantly and independently associated with lower CR rates.","['Acute myeloid leukemia in the elderly', '211 patients (161 de novo, 50 secondary AML) over 55 years of age (median, 68 years) registered to a single clinical trial for previously untreated AML (SWOG 9031, Phase III randomized trial of', 'elderly patients with acute myeloid leukemia (AML']","['standard chemotherapy', 'standard dose cytosine arabinoside and daunomycin + rhG-CSF']","['unfavorable cytogenetics', 'MDR1 protein expression', 'MDR1', 'functional drug efflux', 'MDR1 expression', 'elderly MDR1', 'CR rate', 'complete remission (CR) rate', 'MDR1 expression, CR rate']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}]","[{'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0242643', 'cui_str': 'ATP Binding Cassette Transporter, Sub-Family B, Member 1'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",211.0,0.0174337,"In multivariate analysis, secondary AML (P = .0035), unfavorable cytogenetics (P = .0031), and MDR1 (P = .0041) were each significantly and independently associated with lower CR rates.","[{'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Leith', 'Affiliation': 'Department of Pathology, University of New Mexico School of Medicine, Albuquerque, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Godwin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'McConnell', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Slovak', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}]",Blood,[]
355,9129047,Dose-dependent enhancements by interferon-gamma on functional responses of neutrophils from chronic granulomatous disease patients.,"Interferon-gamma (IFN-gamma) is recommended as prophylaxis against infections in patients with chronic granulomatous disease (CGD). However, since the optimal dose, the dosing interval, and the mechanisms of action are not well-defined, we studied the effects on CGD neutrophil (PMN) functions ex vivo of interferon-gamma (IFN-gamma). Evaluations were made on oxidative capacity, measured by superoxide anion production and chemiluminescence after stimulation with f-met-leu-phe (f-MLP) or phorbol-myristate-acetate, the killing of Aspergillus fumigatus hyphae (assessed as conversion of the tetrazolium salt MTT to formazan), and on the expression of Fc gammaRI receptor (CD64). After randomization, 9 CGD patients (4 with gp91phox, 3 with p47phox, 1 with p67phox deficiency and 1 with unspecified CGD) were given IFN-gamma, either 50 or 100 microg/m2 subcutaneously on 2 consecutive days after double blinded randomization. Furthermore, one female hyperlyonized X-linked carrier with a CGD phenotype was also studied separately after IFN-gamma treatment. Evaluations were made the day before and on days 1, 3, 8, and 18 after IFN-gamma administration. The killing of A fumigatus hyphae, being close to zero before IFN-gamma, was enhanced on day 3, being 36% higher than pretreatment values in the high-dose CGD group and 17% in the low-dose group. The expression of Fc gammaRI on PMN increased 3.7-fold in the high-dose and 2.3-fold in the low-dose CGD group, being maximal on day 1. Oxidative functions were raised in only selected patients represented by different subtypes of CGD. The hyperlyonized carrier of X-linked CGD responded to IFN-gamma with more enhanced oxidative responses and Aspergillus killing of her PMNs than the other patients. This study suggests that a higher dose of IFN-gamma than currently recommended confers transient enhancements of certain PMN functions in CGD patients.",1997,"The expression of Fc gammaRI on PMN increased 3.7-fold in the high-dose and 2.3-fold in the low-dose CGD group, being maximal on day 1.","['chronic granulomatous disease patients', 'CGD patients', 'patients with chronic granulomatous disease (CGD']","['Interferon-gamma (IFN-gamma', 'interferon-gamma']","['oxidative capacity, measured by superoxide anion production and chemiluminescence', 'expression of Fc gammaRI on PMN', 'oxidative responses and Aspergillus killing of her PMNs', 'Oxidative functions']","[{'cui': 'C0018203', 'cui_str': 'Chronic granulomatous disease (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038836', 'cui_str': 'Superoxide Anion'}, {'cui': 'C0033268'}, {'cui': 'C0162524', 'cui_str': 'Chemiluminescence'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0379193,"The expression of Fc gammaRI on PMN increased 3.7-fold in the high-dose and 2.3-fold in the low-dose CGD group, being maximal on day 1.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ahlin', 'Affiliation': ""Department of Pediatrics, The Karolinska Institute at Sachs' Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Elinder', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Palmblad', 'Affiliation': ''}]",Blood,[]
356,9116271,Subclassification of diffuse large B-cell lymphomas according to the Kiel classification: distinction of centroblastic and immunoblastic lymphomas is a significant prognostic risk factor.,"Among high-grade malignant non-Hodgkin's lymphomas the updated Kiel classification identifies three major B-cell entities: centroblastic (CB), B-immunoblastic (B-IB), and B-large cell anaplastic (Ki-1+) (now termed anaplastic large cell [CD30+], [B-ALC]). The clinical prognostic relevance of this distinction was evaluated in a randomized prospective treatment trial (COP-BLAM/IMVP-16 regimen randomly combined +/- radiotherapy in complete responders) conducted in adult (age 15 to 75) patients with Ann Arbor stage II-IV disease (n = 219) diagnosed by optimal histomorphology (Giemsa staining) and by immunohistochemistry. Overall survival was significantly better in CB lymphoma as compared to B-IB (P = .0002) or B-ALC (P = .046). Relapse-free survival was worse for B-IB (P = .0003) as compared to CB lymphomas. The prognostic differences between CB and B-IB were confirmed by multivariate analyses including the risk factors of the International Index. Overall survival was significantly determined by performance status (P = .0003), serum-LDH (P = .036), and B-IB histology subtype (P = .036). Relapse-free survival was influenced by age (P = .007) and histological subtype (P = .007). Thus, the diagnosis of the CB and B-IB lymphomas by the histological criteria of the Kiel classification was identified as an independent prognostic factor in diffuse large B-cell lymphomas.",1997,Overall survival was significantly better in CB lymphoma as compared to B-IB (P = .0002) or B-ALC (P = .046).,['complete responders) conducted in adult (age 15 to 75) patients with Ann Arbor stage II-IV disease (n = 219) diagnosed by optimal histomorphology (Giemsa staining) and by immunohistochemistry'],['radiotherapy'],"['Overall survival', 'Relapse-free survival', 'histological subtype', 'serum-LDH']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0017542', 'cui_str': 'Giemsa'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}]",219.0,0.0303594,Overall survival was significantly better in CB lymphoma as compared to B-IB (P = .0002) or B-ALC (P = .046).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engelhard', 'Affiliation': 'Department of Medicine, Hematology, Universitätsklinikum Essen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Brittinger', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huhn', 'Affiliation': ''}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Gerhartz', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Meusers', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Siegert', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thiel', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wilmanns', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Aydemir', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bierwolf', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Griesser', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tiemann', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lennert', 'Affiliation': ''}]",Blood,[]
357,9116274,Randomized comparison of DAT versus ADE as induction chemotherapy in children and younger adults with acute myeloid leukemia. Results of the Medical Research Council's 10th AML trial (MRC AML10). Adult and Childhood Leukaemia Working Parties of the Medical Research Council.,"The relative efficacy and toxicity of the chemotherapeutic agents thioguanine (6TG) and etoposide (VP16) were assessed by a randomized comparison of the DAT (daunorubicin, cytarabine, thioguanine) versus ADE (daunorubicin, cytarabine, etoposide) regimens in the Medical Research Council's 10th acute myeloid leukaemia trial (MRC AML 10), which was open to patient entry from May 1988 to April 1995. In this, the largest reported trial of AML therapy to date, 1,857 eligible patients, mostly less than 56 years old, were randomized: 929 (including 143 children under 15 years old) were allocated to DAT and 928 (143 children) to ADE. The two groups were well matched for presentation features. The complete remission (CR) rate was 81% with DAT and 83% with ADE (P = .3). The percentages of remitters achieving remission after 1, 2, or more than 2 courses were 70%, 22%, and 8% for DAT and 74%, 21%, and 5% for ADE. The percentages failing to achieve a CR due to resistant disease were 11% with DAT versus 9% with ADE (P = .07). There was a slightly higher death rate in CR during consolidation chemotherapy with ADE (9%) than with DAT (6%) (P = .06). Patients receiving DAT took slightly but significantly longer to recover from neutropenia and thrombocytopenia but the median number of days in hospital were similar in each group. ADE patients experienced slightly more severe nonhematologic toxicity. There was also no significant difference between the groups in the longer-term measures of efficacy: disease-free survival at 6 years from CR was 42% (+/-4) for DAT and 43% (+/-4) for ADE (P = .8); relapse rate at 6 years was 50% (+/-4) for DAT and 49% (+/-5) for ADE (P = .6); survival at 6 years was 40% (+/-4) for both DAT and ADE (P = .9). Subgroup analysis failed to show any benefit for etoposide in patients with monocytic or myelomonocytic disease, or in any other diagnostic subgroup. In conclusion, DAT and ADE both achieve high remission rates and good long-term survival, and are equally effective chemotherapy regimens for the treatment of AML patients aged up to 55 years.",1997,The complete remission (CR) rate was 81% with DAT and 83% with ADE (P = .3).,"['AML patients aged up to 55 years', 'Adult and Childhood Leukaemia', 'children and younger adults with acute myeloid leukemia', 'patients with monocytic or myelomonocytic disease, or in any other diagnostic subgroup', '1,857 eligible patients, mostly less than 56 years old, were randomized: 929 (including 143 children under 15 years old', ""Medical Research Council's 10th acute myeloid leukaemia trial (MRC AML 10), which was open to patient entry from May 1988 to April 1995""]","['DAT (daunorubicin, cytarabine, thioguanine) versus ADE (daunorubicin, cytarabine, etoposide', 'DAT versus ADE', 'etoposide', 'chemotherapeutic agents thioguanine (6TG) and etoposide (VP16']","['relapse rate', 'death rate', 'remission rates and good long-term survival', 'neutropenia and thrombocytopenia', 'survival', 'severe nonhematologic toxicity', 'relative efficacy and toxicity', 'percentages of remitters achieving remission', 'efficacy: disease-free survival', 'complete remission (CR) rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0729502', 'cui_str': 'Chemotherapeutic agent (product)'}, {'cui': 'C0733688', 'cui_str': 'VP-16'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",143.0,0.0491375,The complete remission (CR) rate was 81% with DAT and 83% with ADE (P = .3).,"[{'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Hann', 'Affiliation': 'Medical Research Council, London, UK.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Goldstone', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Rees', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Gray', 'Affiliation': ''}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Burnett', 'Affiliation': ''}]",Blood,[]
358,9116275,Treatment of polycythemia vera: use of 32P alone or in combination with maintenance therapy using hydroxyurea in 461 patients greater than 65 years of age. The French Polycythemia Study Group.,"Despite myelosuppression, polycythemic (PV) patients greater than 65 years of age have a high risk of vascular complications, and the leukemic risk exceeds 15% after 12 years. Is the addition of low-dose maintenance treatment with hydroxyurea (HU) after radiophosphorus (32P) myelosuppression able to decrease these complications? Since the end of 1979, 461 patients were randomized to receive (or not) low-dose HU (5 to 10 mg/kg/d), after the first 32P-induced remission, and were observed until death or June 1996. Maintenance treatment very significantly prolonged the duration of 32P-induced remissions and reduced the annual mean dose received to one-third. However, despite this maintenance, 25% of the patients had an excessive platelet count and the rate of serious vascular complications was not decreased, except in the most severe cases with short-term relapse of polycythemia. Furthermore, the leukemia rate was significantly increased beyond 8 years and a significant excess of carcinomas was also observed. The continuous use of HU did not decrease the risk of progression to myelofibrosis (incidence of 20% after 15 years). Life expectancy was shorter (a median of 9.3 years v 10.9 years with 32P alone), except in the most severe cases (initial 32P-induced remission lasting <2 years) in which maintenance treatment moderately prolonged the survival by reducing the vascular risk. In most cases of PV, in which the duration of the first 32P-induced remission exceeded 2 years, the introduction of HU maintenance did not reduce the vascular risk. Although it considerably decreased the mean dose of 32P received, HU maintenance therapy significantly increased the leukemia and cancer risks and reduced the mean life expectancy by 15%. However, in cases with more rapid recurrence, the introduction of maintenance treatment reduced the vascular risks and moderately prolonged survival. The use of HU as a maintenance therapy is therefore only justified in this situation.",1997,Maintenance treatment very significantly prolonged the duration of 32P-induced remissions and reduced the annual mean dose received to one-third.,"['polycythemia vera', '461 patients', '461 patients greater than 65 years of age']","['HU maintenance therapy', 'hydroxyurea (HU', '32P alone or in combination with maintenance therapy using hydroxyurea']","['duration of 32P-induced remissions', 'vascular risk', 'excessive platelet count', 'rate of serious vascular complications', 'survival', 'leukemia and cancer risks', 'vascular risks and moderately prolonged survival', 'mean life expectancy', 'risk of progression to myelofibrosis', 'leukemic risk', 'leukemia rate', 'Life expectancy']","[{'cui': 'C0032463', 'cui_str': 'Primary Polycythemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}]",461.0,0.0259438,Maintenance treatment very significantly prolonged the duration of 32P-induced remissions and reduced the annual mean dose received to one-third.,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Najean', 'Affiliation': 'Service de Médecine Nucléaire, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Rain', 'Affiliation': ''}]",Blood,[]
359,9108387,Interleukin-10 inhibits activation of coagulation and fibrinolysis during human endotoxemia.,"Interleukin-10 (IL-10) has been found to inhibit lipopolysaccharide (LPS)-induced tissue factor expression by monocytes in vitro. To determine the effects of IL-10 on LPS-induced activation of the hemostatic mechanisms in vivo, we performed a placebo-controlled, cross-over study of human endotoxemia. Two groups of eight volunteers were challenged with LPS (4 ng/kg) on two occasions: once in conjunction with placebo, and once with recombinant human IL-10 (rhIL-10; 25 microg/kg). In group 1, placebo or rhIL-10 was given 2 minutes before LPS challenge, group 2 received placebo or rhIL-10 1 hour after LPS administration. Pretreatment with rhIL-10 reduced both LPS-induced activation of the fibrinolytic system (plasma concentrations of tissue type plasminogen activator, plasmin-alpha2-antiplasmin complexes, and D-dimer), and inhibition of fibrinolysis (plasma levels of plasminogen activator inhibitor 1), whereas posttreatment only inhibited the latter response. Both IL-10 pre- and posttreatment attenuated activation of the coagulation system (plasma levels of prothrombin fragment F1 + 2 and thrombin-antithrombin complexes). These results indicate that rhIL-10, besides its well-described inhibitory effects on cytokine release, potently modulates the fibrinolytic system and inhibits the coagulant responses during endotoxemia.",1997,Both IL-10 pre- and posttreatment attenuated activation of the coagulation system (plasma levels of prothrombin fragment F1 + 2 and thrombin-antithrombin complexes).,[],"['placebo', 'IL-10', 'placebo, and once with recombinant human IL-10 (rhIL-10', 'LPS', 'placebo or rhIL-10']","['fibrinolytic system (plasma concentrations of tissue type plasminogen activator, plasmin-alpha2-antiplasmin complexes, and D-dimer), and inhibition of fibrinolysis (plasma levels of plasminogen activator inhibitor 1']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C0003410', 'cui_str': 'alpha 2-Plasmin Inhibitor'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}]",8.0,0.16507,Both IL-10 pre- and posttreatment attenuated activation of the coagulation system (plasma levels of prothrombin fragment F1 + 2 and thrombin-antithrombin complexes).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pajkrt', 'Affiliation': 'Laboratory of Experimental Internal Medicine and Center for Hemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Academic Medical Center, University of Amsterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van der Poll', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Cutler', 'Affiliation': ''}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Affrime', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van den Ende', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'ten Cate', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'van Deventer', 'Affiliation': ''}]",Blood,[]
360,9166835,Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma.,"Age is an important prognostic parameter, especially in patients with advanced high-grade non-Hodgkin's lymphoma (HG-NHL) who require more intensive and extensive therapy for any possible chance of cure. We investigated the potential of granulocyte colony-stimulating factor (G-CSF) for reducing myelotoxicity, which is the most important dose-limiting factor for chemotherapy. Between March 1993 and June 1995, 158 previously untreated patients 60 years and older with HG-NHL were included in a cooperative randomized comparative trial and treated with a combination therapy including VNCOP-B (cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin, and prednisone) with or without G-CSF. G-CSF was administered at 5 microg/kg/d throughout the treatment starting on day 3 of every week for 5 consecutive days. Of the 158 patients registered for the trial, 149 patients were evaluable: 77 received VNCOP-B plus G-CSF and 72 received VNCOP-B alone. The overall response rate was 81.5%, with complete response in 59%: 60% in the VNCOP-B plus G-CSF group, and 58% in the VNCOP-B group. At 30 months (median 24 months), 68% of all complete responders were alive without disease in the G-CSF group and 65% in the control group. Neutropenia occurred in 18 out of 77 (23%) of the G-CSF treated patients and in 40 out of 72 (55.5%) of the controls (P = .00005). Clinically relevant infections occurred in 4 out of 77 (5%) of the G-CSF group and in 15 out of 72 (21%) of the controls (P = .004). The delivered dose intensity was higher in patients receiving G-CSF (95% v 85%), but the difference was not statistically significant. Our data show that VNCOP-B is a feasible and effective regimen in elderly HG-NHL patients, and that the use of G-CSF reduces infection and neutropenia rates without producing any significant modifications to the dose intensity, CR rate, and relapse-free survival curve.",1997,"The delivered dose intensity was higher in patients receiving G-CSF (95% v 85%), but the difference was not statistically significant.","['Between March 1993 and June 1995, 158 previously untreated patients 60 years and older with HG-NHL', ""patients with advanced high-grade non-Hodgkin's lymphoma (HG-NHL"", '158 patients registered for the trial, 149 patients were evaluable: 77 received', ""elderly high-grade non-Hodgkin's lymphoma"", 'elderly HG-NHL patients']","['G-CSF', 'granulocyte colony-stimulating factor (G-CSF', 'VNCOP-B plus G-CSF', 'VNCOP-B alone', 'combination therapy including VNCOP-B (cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin, and prednisone) with or without G-CSF', 'without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment']","['CR rate, and relapse-free survival curve', 'Neutropenia', 'Clinically relevant infections', 'alive without disease', 'overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",149.0,0.0280483,"The delivered dose intensity was higher in patients receiving G-CSF (95% v 85%), but the difference was not statistically significant.","[{'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology Seragnoli, University of Bologna, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pavone', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Storti', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moretti', 'Affiliation': ''}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Fattori', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Guardigni', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Falini', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gobbi', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gentilini', 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Lauta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bendandi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gherlinzoni', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Magagnoli', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Venturi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aitini', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tabanelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Leone', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Liso', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tura', 'Affiliation': ''}]",Blood,[]
361,9057634,Cholecystectomy in sickle cell anemia patients: perioperative outcome of 364 cases from the National Preoperative Transfusion Study. Preoperative Transfusion in Sickle Cell Disease Study Group.,"Cholecystectomy is the most common surgical procedure performed in sickle cell anemia (SCA) patients. We investigated the effects of transfusion and surgical method on perioperative outcome. A total of 364 patients underwent cholecystectomy: group 1 (randomized to aggressive transfusion) 110 patients; group 2 (randomized to conservative transfusion) 120 patients; group 3 (nonrandomized nontransfusion) 37 patients; and group 4 (nonrandomized transfusion) 97 patients. Patients were similar except group 3 patients were more likely to be female, over 20 years old, smokers, and more healthy by American Society of Anesthesiologists (ASA) physical status score. Total complication rate was 39%: sickle cell events 19%; intraoperative or recovery room events 11%; transfusion complications 10%; postoperative surgical events 4%; and death 1%. Group 3 patients had the highest incidence of sickle cell events (32%). Open cholecystectomies were performed in 58% and laparoscopic in 42%. Laparoscopic patients were younger and more healthy by ASA score. Laparoscopic patients had longer anesthesia time (3.2 v 2.9 hours), but shorter hospitalization time (6.4 days v 9.8). Complications were similar between these two groups. We conclude that SCA patients undergoing cholecystectomy have a high perioperative morbidity, and the incidence of sickle cell events may be higher in patients not preoperatively transfused. We recommend a conservative preoperative transfusion regimen, and we encourage the use of the laparoscopic technique for SCA patients undergoing elective cholecystectomy.",1997,Total complication rate was 39%:,"['SCA patients undergoing elective cholecystectomy', 'sickle cell anemia (SCA) patients', '364 patients underwent', '364 cases from the National Preoperative Transfusion Study', '120 patients; group 3 (nonrandomized nontransfusion) 37 patients; and group 4 (nonrandomized transfusion) 97 patients', 'Laparoscopic patients were younger and more healthy by ASA score', 'Patients were similar except group 3 patients were more likely to be female, over 20 years old, smokers, and more healthy by American Society of Anesthesiologists (ASA) physical status score', 'sickle cell anemia patients', 'SCA patients undergoing']","['cholecystectomy', 'aggressive transfusion) 110 patients; group 2 (randomized to conservative transfusion', 'Laparoscopic', 'Cholecystectomy']","['sickle cell events', 'longer anesthesia time', 'shorter hospitalization time', 'perioperative morbidity', 'Complications', 'Total complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",364.0,0.0228024,Total complication rate was 39%:,"[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Haberkern', 'Affiliation': 'Department of Anesthesiology, University of Washington, Seattle, USA.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Neumayr', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Orringer', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Earles', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Robertson', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Abboud', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koshy', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Idowu', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Vichinsky', 'Affiliation': ''}]",Blood,[]
362,9028311,High-dose therapy and autologous hematopoietic progenitor cell transplantation for recurrent or refractory Hodgkin's disease: analysis of the Stanford University results and prognostic indices.,"One hundred nineteen patients with relapsed or refractory Hodgkin's disease (HD) received high-dose therapy followed by autologous hematopoietic progenitor cell transplantation. Three preparatory regimens, selected on the basis of prior therapy and pulmonary status, were employed. Twenty-six patients without a history of prior chest or pelvic irradiation were treated with fractionated total body irradiation, etoposide (VP) 60 mg/kg and cyclophosphamide (Cy) 100 mg/kg. Seventy-four patients received BCNU 15 mg/kg with identical doses of VP and Cy. A group of 19 patients with a limited diffusing capacity or history of pneumonitis received a novel high-dose regimen consisting of CCNU 15 mg/kg, VP 60 mg/kg and Cy 100 mg/kg. Twenty-nine patients (24%) had failed induction therapy and 35 (29%) had progressive HD within 1 year of initial chemotherapy. At 4 years actuarial survival was 52%, event-free survival was 48% and freedom from progression (FFP) was 62%. No significant differences were seen in survival data with the three preparatory regimens. Six patients died within 100 days of transplantation and 5 died at a later date of transplant-related complications. Secondary malignancies have developed in 6 patients, including myelodysplasia/leukemia in four patients and solid tumors in two patients. Regression analysis identified systemic symptoms at relapse, disseminated pulmonary or bone marrow disease at relapse and more than minimal disease at the time of transplantation as significant prognostic factors for overall and event-free survival and FFP. Patients with none of these factors enjoyed an 85% FFP at 4 years compared with 41% for patients with one or more unfavorable prognostic factors (P = .0001). Our results confirm the efficacy of high-dose therapy and autografting in recurrent or refractory HD. Although longer follow-up is necessary to address ultimate cure rates and toxicity, our data indicate that a desire to reduce late effects should drive future research efforts in favorable patients whereas new initiatives are needed for those with less favorable prognoses.",1997,"At 4 years actuarial survival was 52%, event-free survival was 48% and freedom from progression (FFP) was 62%.","[""One hundred nineteen patients with relapsed or refractory Hodgkin's disease (HD"", 'Twenty-six patients without a history of prior chest or pelvic irradiation', 'Twenty-nine patients (24%) had failed induction therapy and 35 (29%) had progressive HD within 1 year of initial chemotherapy', '19 patients with a limited diffusing capacity or history of pneumonitis']","['fractionated total body irradiation, etoposide (VP) 60 mg/kg and cyclophosphamide (Cy', 'BCNU', 'CCNU 15 mg/kg, VP 60 mg/kg and Cy', 'autologous hematopoietic progenitor cell transplantation']","['actuarial survival', 'systemic symptoms at relapse, disseminated pulmonary or bone marrow disease at relapse', 'myelodysplasia/leukemia', 'survival data', 'event-free survival']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}]","[{'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0687700', 'cui_str': 'CCNU'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0005956', 'cui_str': 'Bone Marrow Diseases'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",119.0,0.0300022,"At 4 years actuarial survival was 52%, event-free survival was 48% and freedom from progression (FFP) was 62%.","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Horning', 'Affiliation': 'Department of Medicine, Stanford University Medical Center, CA, USA.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Negrin', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Hoppe', 'Affiliation': ''}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Blume', 'Affiliation': ''}]",Blood,[]
363,9028341,Fetal hemoglobin in sickle cell anemia: determinants of response to hydroxyurea. Multicenter Study of Hydroxyurea.,"Hydroxyurea (HU) can increase fetal hemoglobin (HbF) in sickle cell anemia (HbSS). To identify determinants of the HbF response, we studied 150 HU-treated patients grouped by quartiles of change in HbF from baseline to 2 years. Half of the HU-assigned patients had long-term increments in HbF. In the top two quartiles, HbF increased to 18.1% and 8.8%. These patients had the highest baseline neutrophil and reticulocyte counts, and largest treatment-associated decrements in these counts. In the lower two quartiles, 2-year HbF levels (4.2% and 3.9%) and blood counts changed little from baseline. In the highest HbF response quartile, myelosuppression developed in less than 6 months, compliance was best, and final doses of HU were 15 to 22.5 mg/kg. All four quartiles had substantial increases of F cells in the first year. This was maintained for 2 years only in the top three quartiles. Leukocyte and reticulocyte counts decreased initially in all quartiles, but drifted back toward baseline levels in the lowest HbF response quartile. Initial HbF level and phenotype of the F-cell production (FCP) locus were not associated with HbF response, but absence of a Central African Republic (CAR) haplotype was. Bone marrow ability to withstand HU treatment may be important for sustained HbF increases during HU treatment of HbSS.",1997,"Initial HbF level and phenotype of the F-cell production (FCP) locus were not associated with HbF response, but absence of a Central African Republic (CAR) haplotype was.","['150 HU-treated patients grouped by quartiles of change in HbF from baseline to 2 years', 'sickle cell anemia', 'sickle cell anemia (HbSS']","['Hydroxyurea', 'Hydroxyurea (HU', 'hydroxyurea']","['2-year HbF levels', 'myelosuppression', 'highest baseline neutrophil and reticulocyte counts', 'blood counts', 'Leukocyte and reticulocyte counts', 'Initial HbF level and phenotype of the F-cell production (FCP) locus', 'fetal hemoglobin (HbF', 'F cells']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033268'}]",150.0,0.0422843,"Initial HbF level and phenotype of the F-cell production (FCP) locus were not associated with HbF response, but absence of a Central African Republic (CAR) haplotype was.","[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Steinberg', 'Affiliation': 'Veterans Affairs Medical Center, Jackson, MS 39216, USA.'}, {'ForeName': 'Z H', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Barton', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Charache', 'Affiliation': ''}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Dover', 'Affiliation': ''}]",Blood,[]
364,8977237,Retroviral transduction of human progenitor cells: use of granulocyte colony-stimulating factor plus stem cell factor to mobilize progenitor cells in vivo and stimulation by Flt3/Flk-2 ligand in vitro.,"The clinical application of gene transfer is hindered by the availability of the multipotential stem cells and the difficulty in obtaining efficient retroviral transduction. To assess potential means by which gene transfer into human hemopoietic stem cells might be enhanced, the retroviral transduction efficiency of human bone marrow cells (BM) or peripheral blood progenitor cells (PBPC) was compared at multiple time points after in vivo administration of granulocyte colony-stimulating factor (G-CSF). This was further compared with the transduction efficiency of cells mobilized with G-CSF plus stem cell factor (SCF) in a cohort of patients randomized to receive either one or two growth factors and with normal BM function. Using the LNL6 retrovirus, retroviral transduction efficiencies of up to 19% were observed for both PBPC and BM (n = 26 patients). There was at least a 100-fold increase in PBPC with G-CSF alone and a further 30-fold increase in the total number of progenitor cells available for retroviral transduction using the combination of SCF plus G-CSF. However, pretreatment of patients with G-CSF with or without SCF did not enhance the retroviral infectability of growth factor-mobilized progenitor cells. The effect of the growth factor, Flk-2/Flt3 ligand (FL), was also examined with respect to retroviral transduction efficiency of human progenitor cells. FL plus IL-3 in vitro increased the retroviral transduction efficiency up to eightfold compared with results observed using other combinations of cytokines tested (P < .001). These findings have clinical implications both for increasing the number of target cells for in vivo gene-marking/gene-therapy studies and improving the efficiency of gene transfer.",1996,FL plus IL-3 in vitro increased the retroviral transduction efficiency up to eightfold compared with results observed using other combinations of cytokines tested (P < .001).,['human progenitor cells'],"['growth factor, Flk-2/Flt3 ligand (FL', 'granulocyte colony-stimulating factor plus stem cell factor', 'cells mobilized with G-CSF plus stem cell factor (SCF']","['retroviral transduction efficiency', 'retroviral infectability of growth factor-mobilized progenitor cells', 'PBPC']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0249989', 'cui_str': 'fms-like tyrosine kinase 3 ligand'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]",26.0,0.0243136,FL plus IL-3 in vitro increased the retroviral transduction efficiency up to eightfold compared with results observed using other combinations of cytokines tested (P < .001).,"[{'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Elwood', 'Affiliation': 'Rotary Bone Marrow Research Laboratories, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zogos', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Willson', 'Affiliation': ''}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Begley', 'Affiliation': ''}]",Blood,[]
365,9226158,Granulocyte colony-stimulating factor as an adjunct to induction chemotherapy for adult acute lymphoblastic leukemia--a randomized phase-III study.,"Because of the recommendation to avoid the concomitant administration of growth factors and chemotherapy, there is only limited information on colony-stimulating factor (CSF) therapy in acute lymphoblastic leukemia (ALL) induction protocols, in which cytotoxic drugs are administered in divided doses over a prolonged period of time, thus requiring a simultaneous administration of growth factors and chemotherapy. We conducted a prospective, randomized, controlled study to determine the safety and efficacy of granulocyte colony-stimulating factor (G-CSF; filgrastim) as an adjunct to phase I of induction chemotherapy for adult ALL. Patients (n = 53) were randomized to receive no growth factor or G-CSF (5 microg/kg/d subcutaneously) starting on day 2 of chemotherapy consisting of daunorubicin (45 mg/m2) and vincristine (1.5 mg/m2) on days 1, 8, 15, and 22; L-asparaginase (2500 U/m2) on days 1 through 14; and prednisone (60 mg/m2) on days 1 through 28. A total of 25 patients in the G-CSF group and 26 patients in the control arm fulfilled the inclusion criteria of the study. G-CSF markedly ameliorated neutropenia because the median proportion of days with neutropenia less than 1,000/microL was 29% in the G-CSF group as compared with 84% in the control arm (P < .00005). The median time to reach absolute neutrophil counts (ANC) > or = 1,000/microL was 16 days in G-CSF patients and 26 days in controls (P < .001). More importantly, G-CSF significantly reduced the incidence of febrile neutropenia (12% v 42% in controls, P < .05) and documented infections (40% v 77%, P < .05). No significant differences were found with regard to requirements for red blood cell transfusions and platelet concentrates. A total of 24 of 25 (96%) patients in the G-CSF group and 20 of 25 (80%) evaluable control patients had complete remission after phase I of induction therapy. We conclude that G-CSF can be safely administered as an adjunct to induction therapy of ALL and is clinically beneficial by ameliorating neutropenia and reducing infectious complications.",1997,"More importantly, G-CSF significantly reduced the incidence of febrile neutropenia (12% v 42% in controls, P < .05) and documented infections (40% v 77%, P < .05).","['Patients (n = 53', 'adult acute lymphoblastic leukemia', 'adult ALL', '25 patients in the G-CSF group and 26 patients in the control arm fulfilled the inclusion criteria of the study']","['no growth factor or G-CSF', 'granulocyte colony-stimulating factor (G-CSF; filgrastim', 'G-CSF', 'Granulocyte colony-stimulating factor', 'prednisone', 'vincristine', 'daunorubicin']","['incidence of febrile neutropenia', 'red blood cell transfusions and platelet concentrates', 'neutropenia', 'median time to reach absolute neutrophil counts (ANC) > or = 1,000/microL', 'safety and efficacy', 'complete remission', 'infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0445119', 'cui_str': 'No growth (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",53.0,0.027205,"More importantly, G-CSF significantly reduced the incidence of febrile neutropenia (12% v 42% in controls, P < .05) and documented infections (40% v 77%, P < .05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Geissler', 'Affiliation': '1st Medical Department, University of Vienna, Austria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hubmann', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hinterberger', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Geissler', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kyrle', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Knöbl', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Pabinger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Thalhammer', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schwarzinger', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mannhalter', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Heinz', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Linkesch', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': ''}]",Blood,[]
366,9160657,"A multicenter controlled, randomized, open trial of interferon alpha2b treatment of anti-human immunodeficiency virus-negative hemophilic patients with chronic hepatitis C. Hepatitis Study Group of the Association of Italian Hemophilia Centers.","There is limited information about the long-term efficacy of prolonged therapy (more than 6 months) with interferon alpha in hemophilic patients with chronic hepatitis C who are not coinfected with the human immunodeficiency virus (HIV-1). One hundred and seven hemophiliacs were randomly assigned to 3 million U of interferon alpha2b three times weekly for 12 months or no therapy. The patients were followed up for at least 12 months posttreatment. Response was assessed by both serial alanine aminotransferase (ALT) levels and hepatitis C virus (HCV)-RNA measured by reverse transcribed polymerase chain reaction (RT-PCR) method. Before treatment, serum levels of HCV-RNA were measured quantitatively by second-generation branched-DNA assay and the HCV genotype was determined by RT-PCR. Serum HGV-RNA, a marker of infection with the hepatitis G virus, was also measured by RT-PCR. Normalization of ALT was sustained and serum HCV-RNA was cleared in 6 of 45 treated patients, compared with none of the 50 untreated controls (13% v 0% P < .01). Low pretreatment viremia was the only feature that was associated with an increased likelihood of sustained response (P < .01). This study shows that multitransfused hemophiliacs with chronic hepatitis C not coinfected with HIV-1 respond at low rates to prolonged interferon therapy.",1997,"Serum HGV-RNA, a marker of infection with the hepatitis G virus, was also measured by RT-PCR.","['anti-human immunodeficiency virus-negative hemophilic patients with chronic hepatitis C. Hepatitis Study Group of the Association of Italian Hemophilia Centers', 'One hundred and seven hemophiliacs', 'hemophilic patients with chronic hepatitis C who are not coinfected with the human immunodeficiency virus (HIV-1']","['interferon alpha', 'interferon alpha2b three times weekly for 12 months or no therapy', 'interferon alpha2b']","['likelihood of sustained response', 'Serum HGV-RNA', 'serum HCV-RNA', 'serum levels of HCV-RNA', 'serial alanine aminotransferase (ALT) levels and hepatitis C virus (HCV)-RNA']","[{'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019189', 'cui_str': 'Hepatitis, Chronic'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C4307370', 'cui_str': 'IFN-alpha2b'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0376574', 'cui_str': 'Hepatitis G virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}]",107.0,0.0287369,"Serum HGV-RNA, a marker of infection with the hepatitis G virus, was also measured by RT-PCR.","[{'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Rumi', 'Affiliation': 'Institute of Internal Medicine, University of Milan, IRCCS Maggiore Hospital, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morfini', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gringeri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tagariello', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chistolini', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pontisso', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tagger', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colombo', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ''}]",Blood,[]
367,9160697,"Cyclosporine or cyclosporine plus methylprednisolone for prophylaxis of graft-versus-host disease: a prospective, randomized trial.","Patients with a lymphohematopoietic malignancy considered to be at high risk for posttransplant relapse were enrolled in a study to compare the use of cyclosporine (CSP) as a single agent with a combination of methylprednisolone (MP) and CSP for graft-versus-host disease (GVHD) prophylaxis after marrow transplantation from an HLA-identical sibling donor. Sixty patients were randomized to receive CSP only and 62 were randomized to receive CSP plus MP. Daily CSP was started on day -1 (5 mg/kg/d intravenously) and administered at gradually reduced doses until day 180. MP was started on day 7 at 0.5 mg/kg/d, increased to 1.0 mg/kg/d on day 15, started on a taper schedule on day 29, and discontinued on day 72. All 104 evaluable patients (surviving > or =28 days) had sustained engraftment. The incidence rates of grades II-IV acute GVHD were 73% and 60% for patients receiving CSP and CSP plus MP, respectively (P = .01). No difference was seen for grades III-IV GVHD. However, chronic GVHD occurred somewhat more frequently in patients receiving CSP plus MP (44%) than in patients receiving only CSP (21%; P = .02). The incidence of de novo chronic GVHD was marginally higher in patients receiving CSP plus MP (P = .08). No significant differences in the risk of infections were observed. There was a suggestion that the risk of relapse was lower in patients receiving CSP plus MP (P = .10) and, although the overall survival in the two groups was not different (P = .44), there was a slight advantage in favor of CSP plus MP-treated patients for relapse-free survival (P = .07). These results suggest that prophylactic MP, when combined with CSP, has only limited efficacy in acute GVHD prevention and may increase the probability of chronic GVHD.",1997,"There was a suggestion that the risk of relapse was lower in patients receiving CSP plus MP (P = .10) and, although the overall survival in the two groups was not different (P = .44), there was a slight advantage in favor of CSP plus MP-treated patients for relapse-free survival (P = .07).","['Patients with a lymphohematopoietic malignancy considered to be at high risk for posttransplant relapse', 'prophylaxis of graft-versus-host disease', 'Sixty patients']","['CSP', 'methylprednisolone (MP) and CSP for graft-versus-host disease (GVHD) prophylaxis', 'Cyclosporine or cyclosporine plus methylprednisolone', 'CSP plus MP', 'cyclosporine (CSP', 'MP']","['chronic GVHD', 'sustained engraftment', 'incidence rates of grades II-IV acute GVHD', 'incidence of de novo chronic GVHD', 'risk of relapse', 'overall survival', 'relapse-free survival', 'probability of chronic GVHD', 'risk of infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]","[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",60.0,0.0792097,"There was a suggestion that the risk of relapse was lower in patients receiving CSP plus MP (P = .10) and, although the overall survival in the two groups was not different (P = .44), there was a slight advantage in favor of CSP plus MP-treated patients for relapse-free survival (P = .07).","[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Veterans Administration Medical Center, University of Washington, Seattle 98104-2092, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Chauncey', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schoch', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}]",Blood,[]
368,9269786,Association of PML-RAR alpha fusion mRNA type with pretreatment hematologic characteristics but not treatment outcome in acute promyelocytic leukemia: an intergroup molecular study.,"In each case of acute promyelocytic leukemia (APL) one of three PML-RAR alpha mRNA types is produced, depending on the break/fusion site in the PML gene that is linked to a common RAR alpha gene segment: a short (S)-form type, PML exon 3 RAR alpha exon 3; a long (L)-form type, PML exon 6 RAR alpha exon 3; or a variable (V)-form type, variably deleted PML exon 6 RAR alpha exon 3. We evaluated whether PML-RAR alpha mRNA type is associated with distinct pretreatment clinical characteristics and therapeutic outcome in previously untreated adult APL patients registered to protocol INT 0129 by the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the Cancer and Leukemia Group B. Of 279 clinically eligible cases, 230 were molecularly evaluable, and of these, 111 were randomized to receive remission induction therapy with all-trans retinoic acid (ATRA) and 119 with conventional chemotherapy. Nine cases not excluded by central pathology review were PML-RAR alpha negative, and notably, none of five of these cases treated with ATRA achieved complete remission (CR). Among 221 PML-RAR alpha-positive cases, there were 82 S-form cases (37%), 121 L-form cases (55%), and 18 V-form cases (8%). Before any antileukemic therapy, the S-form type, compared with the L-form type, was associated with higher values for the white blood cell (WBC) count (median 2,500/microL v 1,600/microL; P = .009), the percentage of blood blasts plus promyelocytes (median 29% v 8.5%; P = .03), and the absolute blood blasts plus promyelocytes (884/microL v 126/microL; P = .019). Also, an increased percentage of S-form versus L-form cases had the M3 variant phenotype, 24% v 12% (P = .036). There were no differences between S-form and L-form cases in either CR rate (79% v 69%; P = .14) or disease free survival distribution (multivariate analysis adjusting for the association of S-form type and higher WBC count; P = .40). We conclude that the S-form type is associated with previously-identified adverse risk WBC parameters but that the identification of the S-form or L-form type of PML-RAR alpha mRNA, per se, does not predict clinical outcome or add to the value of an increased WBC count as a negative prognostic indicator in APL patients.",1997,There were no differences between S-form and L-form cases in either CR rate (79% v 69%; P = .14) or disease free survival distribution (multivariate analysis adjusting for the association of S-form type and higher WBC count; P = .40).,"['acute promyelocytic leukemia', 'previously untreated adult APL patients registered to protocol INT 0129 by the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the Cancer and Leukemia Group B. Of 279 clinically eligible cases, 230 were molecularly evaluable, and of these, 111 were randomized to receive']","['remission induction therapy with all-trans retinoic acid (ATRA', 'conventional chemotherapy']","['disease free survival distribution', 'absolute blood blasts plus promyelocytes', 'complete remission (CR', 'white blood cell (WBC) count', 'percentage of blood blasts plus promyelocytes']","[{'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0585825', 'cui_str': 'Patient registered (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}]","[{'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033416', 'cui_str': 'Promyelocytes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",279.0,0.029398,There were no differences between S-form and L-form cases in either CR rate (79% v 69%; P = .14) or disease free survival distribution (multivariate analysis adjusting for the association of S-form type and higher WBC count; P = .40).,"[{'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Gallagher', 'Affiliation': 'Department of Oncology, Montefiore Medical Center and Albert Einstein Cancer Center, Bronx, NY 10467, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Willman', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Slack', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Viswanatha', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Bloomfield', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Tallman', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}]",Blood,[]
369,9002942,Avoidance of allogeneic blood transfusions by treatment with epoetin beta (recombinant human erythropoietin) in patients undergoing open-heart surgery.,"In a double-blind, randomized, placebo-controlled trial, we evaluated the ability of epoetin beta (recombinant human erythropoietin) to avoid allogeneic blood transfusions (ABT) and the associated risks in patients undergoing primary elective open-heart surgery and in whom autologous blood donation (ABD) was contraindicated. Seventy-six patients overall were enrolled onto the trial and were randomly assigned to the two treatment groups, 5 x 500 U/kg body weight (BW) epoetin beta or placebo intravenously over 14 days preoperatively. All patients received 300 mg Fe2+ orally per day during the treatment period. Preoperatively, the mean hemoglobin increase was 1.50 g/dL greater in epoetin beta patients than in placebo patients (95% confidence interval, 1.10 to 1.90 g/dL), allowing a rapid return to the baseline value by the seventh postoperative day in most epoetin beta patients. The mean volume of blood collected by intraoperative isovolemic hemodilution was 562 mL (red blood cell mass, 274 mL) in the epoetin beta group and 218 mL (red blood cell mass, 94 mL) in the placebo group, respectively. Only four patients (11%) in the epoetin beta group received an ABT, compared with 19 (53%) in the placebo group (P = .0003). Epoetin beta was most useful in patients with a perioperative blood loss greater than 750 mL, in those with a baseline hematocrit value less than 0.42, and in those aged > or = 60 years. The iron supplementation proved adequate despite the fact that a significant decrease in ferritin (median, 48.1%) and transferrin saturation (median, 40.5%) was observed in epoetin beta patients preoperatively. No influence of epoetin beta therapy on blood pressure, laboratory safety variables, or the frequency of specific adverse events was observed. Intravenous epoetin beta treatment of 5 x 500 U/kg BW in combination with 300 mg Fe2+ orally per day administered over 14 days preoperatively is an adequate therapy for increasing mean hemoglobin levels by approximately 1.50 g/dL and reducing the allogeneic blood requirement in patients undergoing elective open-heart surgery and in whom ABD is contraindicated.",1997,"No influence of epoetin beta therapy on blood pressure, laboratory safety variables, or the frequency of specific adverse events was observed.","['patients undergoing primary elective open-heart surgery and in whom autologous blood donation (ABD) was contraindicated', 'patients undergoing open-heart surgery', 'patients undergoing elective open-heart surgery', 'Seventy-six patients overall were enrolled onto the trial', 'patients with a perioperative blood loss greater than 750 mL, in those with a baseline hematocrit value less than 0.42, and in those aged > or = 60 years']","['allogeneic blood transfusions (ABT', 'placebo', 'epoetin beta therapy', 'allogeneic blood transfusions', 'kg body weight (BW) epoetin beta or placebo', 'Epoetin beta', 'epoetin beta (recombinant human erythropoietin', 'ABT']","['blood pressure, laboratory safety variables, or the frequency of specific adverse events', 'ferritin', 'mean hemoglobin levels', 'mean hemoglobin increase', 'allogeneic blood requirement', 'mean volume of blood', 'transferrin saturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0398307', 'cui_str': 'Blood unit collection for autotransfusion (procedure)'}, {'cui': 'C1444657', 'cui_str': 'Contraindicated'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517458', 'cui_str': '0.42'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0357131', 'cui_str': 'epoetin beta'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0549448', 'cui_str': 'Increased hemoglobin (finding)'}, {'cui': 'C0005768'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}]",,0.374717,"No influence of epoetin beta therapy on blood pressure, laboratory safety variables, or the frequency of specific adverse events was observed.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sowade', 'Affiliation': 'Clinic of Heart Surgery, Medical Faculty (Charité), Humboldt University Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Warnke', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Scigalla', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sowade', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Franke', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Messinger', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gross', 'Affiliation': ''}]",Blood,[]
370,8652810,Timed-sequential induction therapy improves postremission outcome in acute myeloid leukemia: a report from the Children's Cancer Group.,"Timed sequencing of cycles of induction chemotherapy in acute myeloid leukemia (AML) has been proposed as a way to achieve maximal leukemic cell kill through recruitment and synchronization of residual neoplastic cells. Furthermore, whether intensive induction therapy should be continued in the presence of profound myelosuppression is an important question. The Children's Cancer Group (CCG) conducted a prospective randomized trial in which 589 patients with AML were randomized at diagnosis to one of two induction approaches involving a 4-day cycle of five active chemotherapeutic agents, with the second cycle administered either 10 days after the first cycle, despite low or dropping blood counts (intensive timing), or 14 days or later from the beginning of the first cycle, depending on bone marrow status (standard timing). All patients achieving remission received a total of four cycles of induction therapy. They were then allocated to allogeneic bone marrow transplantation (BMT) if a compatible family donor was present or randomized to aggressive nonmyeloablative therapy or to myeloablative therapy with purged autologous BMT rescue. The three postremission arms remain coded. Induction success and median days to complete induction were similar for the 295 patients randomized to the intensive timing arm (75%, 99 days) compared with the 294 patients randomized to the standard timing arm (70%, 105 days; P = .18 for remission). However, a marked improvement in outcome was demonstrated in patients randomized to the intensive timing arm, with an actuarial event-free survival at 3 years of 42% +/- 7% (95% confidence interval [CI]) versus 27% +/- 6% for patients on the standard timing arm (P = .0005). Disease-free survival results at 3 years from the end of induction were superior for patients receiving intensively timed induction therapy (N = 211), 55% +/- 9% versus 37% +/- 9% for standard timing patients (N = 195, P = .0002), with a median follow-up from achieving remission of 28 months. Superior results were documented for patients receiving intensive timing irrespective of the postremission therapy to which they were allocated. Intensively timed induction therapy for patients with AML markedly improves event-free survival, even for patients undergoing myeloablative therapy with BMT rescue. Without controlling for the type of induction therapy received, results of various BMT studies in AML comparing different preparative regimens will be difficult to interpret.",1996,"Disease-free survival results at 3 years from the end of induction were superior for patients receiving intensively timed induction therapy (N = 211), 55% +/-","['acute myeloid leukemia (AML', 'acute myeloid leukemia', '589 patients with AML']","['aggressive nonmyeloablative therapy or to myeloablative therapy with purged autologous BMT rescue', 'induction chemotherapy', 'Timed-sequential induction therapy', 'allogeneic bone marrow transplantation (BMT']","['Induction success and median days to complete induction', 'event-free survival', 'actuarial event-free survival', 'postremission outcome']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0855227', 'cui_str': 'Purging'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",589.0,0.093652,"Disease-free survival results at 3 years from the end of induction were superior for patients receiving intensively timed induction therapy (N = 211), 55% +/-","[{'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Woods', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kobrinsky', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Neudorf', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Barnard', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'DeSwarte', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dusenbery', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kalousek', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Arthur', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Lange', 'Affiliation': ''}]",Blood,[]
371,8695837,Combination of quinine as a potential reversing agent with mitoxantrone and cytarabine for the treatment of acute leukemias: a randomized multicenter study.,"A phase III prospective randomized multicenter study was performed to determine whether quinine could improve the response rate of poor-risk acute leukemias (ALs) to standard chemotherapy including a multidrug resistance (MDR)-related cytotoxic agent. The rationale of the study was based on the negative prognostic value of MDR phenotype in ALs and the ability of quinine to reverse this phenotype both in vitro and ex vivo. Three hundred fifteen patients (median age, 49 years; range, 16 to 65) with relapsed (n = 108) or refractory (n = 32) acute myeloblastic leukemia (AML), relapsed (n = 27) or refractory (n = 9) acute lymphoblastic leukemia (ALL), secondary AL (n = 22) or blastic transformation of myelodysplastic syndrome ([MDS] n = 74) or myeloproliferative syndrome ([MPS] n = 43) were randomly assigned to receive mitoxantrone ([MXN] 12 mg/m2/d, days 2 to 5) and cytarabine ([Ara-C] 1 g/m2/12 h, days 1 to 5) alone or in combination with quinine (30 mg/kg/d, days 1 to 5; continuous intravenous infusion beginning 24 hours before MXN infusion). Side effects of quinine were observed in 56 of 161 quinine-treated patients and disappeared in all but four cases after one or two 20% dose decreases. Sera from quinine-treated patients showed increased MXN uptake in an MDR-positive cell line compared with matched sera obtained before quinine infusion. Quinine induced a significant increase in the incidence of nausea, vomiting, mucositis, and cardiac toxicity. A complete response (CR) was observed in 85 of 161 patients (52.8%) from the quinine-treated group versus 70 of 154 patients (45.5%) in the control group (P = .19). The most important differences between quinine and control group CR rates were observed in patients with refractory AMLs and blastic transformation of MDS and MPS. The CR rate was higher in P-glycoprotein-positive cases, although the difference was not significant. Failure of the regimen due to blastic persistence or blast number increase was higher in the control group (61 of 154 patients) than in the quinine group (45 of 161, P = .04). Early death was observed in eight cases (four in each arm) and death in aplasia in 27 cases (20 in quinine group v seven in control group, P = .01). The significant increase of toxicity in the quinine arm could have masked the clinical benefit of MDR reversion in poor-risk ALs.",1996,Side effects of quinine were observed in 56 of 161 quinine-treated patients and disappeared in all but four cases after one or two 20% dose decreases.,"['Three hundred fifteen patients (median age, 49 years; range, 16 to 65) with relapsed (n = 108) or refractory (n = 32) acute myeloblastic leukemia (AML), relapsed (n = 27) or refractory (n = 9) acute lymphoblastic leukemia (ALL), secondary AL (n = 22) or blastic transformation of myelodysplastic syndrome ([MDS] n = 74) or myeloproliferative syndrome ([MPS] n = 43', 'acute leukemias']","['5) alone or in combination with quinine', 'mitoxantrone ([MXN', 'cytarabine ([Ara-C', 'mitoxantrone and cytarabine']","['Early death', 'toxicity', 'Side effects of quinine', 'response rate of poor-risk acute leukemias (ALs', 'death in aplasia', 'complete response (CR', 'MXN uptake', 'CR rate', 'incidence of nausea, vomiting, mucositis, and cardiac toxicity', 'CR rates', 'blastic persistence or blast number increase']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0876994', 'cui_str': 'Cardiac Toxicity'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",43.0,0.0553084,Side effects of quinine were observed in 56 of 161 quinine-treated patients and disappeared in all but four cases after one or two 20% dose decreases.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Solary', 'Affiliation': 'Clinical Hematology Unit, Centre Hospitalier Universitaire (CHU) Le Bocage, Dijon, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Witz', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Caillot', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Desablens', 'Affiliation': ''}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Cahn', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadoun', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pignon', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Berthou', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maloisel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guyotat', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Casassus', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lamy', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Audhuy', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Colombat', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}]",Blood,[]
372,8695858,AIDA (all-trans retinoic acid + idarubicin) in newly diagnosed acute promyelocytic leukemia: a Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) pilot study.,"From March 1993 to October 1993, 20 consecutive, newly diagnosed acute promyelocytic leukemia (APL) patients from 13 Italian institutions entered in a pilot study named AIDA, combining all-trans retinoic acid (ATRA) with idarubicin (IDA). ATRA was administered orally beginning on the first day of induction at the dosage of 45 mg/m2/d until complete remission (CR), whereas IDA was administered intravenously at the dosage of 12 mg/m2/d on days 2, 4, 6, and 8 of the induction. Patients who achieved CR were consolidated with 3 courses of chemotherapy without ATRA; thereafter, they were followed up for molecular and hematologic CR. The median age was 35.3 years (range, 6.5 to 67.6 years); 8 patients were males and 12 females; 4 had the hypogranular variant of APL (M3v), and 4 (2 with M3v) presented with leukocyte counts > or = 10,000/microL. Molecular analysis for the promyelocytic leukemia-retinoic acid receptor alpha (PML-RAR alpha) hybrid gene at diagnosis was performed in 16 patients by means of reverse transcription-polymerase chain reaction (RT-PCR) analysis, and all were RT-PCR+ for the hybrid gene. In the remaining 4 patients, the cytogenetic study showed the presence of the t(15;17). After a median time of 36 days (range, 28 to 52 days) 18 (90%) patients achieved CR; the remaining 2 patients died 12 and 34 days after diagnosis from myocardial infarction caused by fungal myocarditis and from massive hemoptysis, respectively. ATRA syndrome was observed in only 2 patients, and, after the prompt discontinuation of ATRA and initiation of dexamethasone, both recovered from the syndrome. However, after recovering, 1 patient achieved CR, whereas the other died at day 34 because of massive hemoptysis; other side effects were very limited. At recovery from the third consolidation course, only 3 of 14 (21.4%) tested patients were RT-PCR+ for the PML-RAR alpha hybrid gene. Of these, 2 relapsed shortly afterwards; however, in the last patient, the PML-RAR alpha disappeared at successive testing performed 2 months later. As of September 30, 1995, after a median follow-up period from diagnosis of 27 months (range, 24 to 31 months), the overall survival and event-free survival durations are 85% and 69%, respectively; moreover, 14 of 18 (78%) patients who achieved CR are still alive and in first molecular and hematologic CR. Of the 4 relapsed patients, 3 achieved a second CR with ATRA and, after further treatment, are now in molecular and hematologic CR after 4+, 16+, and 17+ months from the second CR. These results indicate that (1) the AIDA protocol is highly effective in treating APL; (2) after 3 consolidation courses, the majority of patients who achieved CR are RT-PCR- for the hybrid gene PML-RAR alpha; (3) the persistence of an RT-PCR positivity for the PML-RAR alpha hybrid gene after 3 consolidation courses is indicative of early relapse, thus these patients still require additional treatment. These results have prompted the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) to initiate, in cooperation with the Associazione Italiana di Ematologia ed Oncologia Pediatrica and some European Organization for Research and Treatment of Cancer (EORTC) centers, a new multicentric clinical trial named AIDA LAP 0493 for the treatment of adult and pediatric APL patients. All patients are considered eligible if APL diagnosis is confirmed with molecular or cytogenetic studies for PML-RAR alpha hybrid gene or t(15;17) and are enrolled to receive the same induction and consolidation therapy of this pilot study. After consolidation, patients who are RT-PCR- for PML-RAR alpha hybrid gene are randomized to four arms, whereas patients who are RT-PCR+ after consolidation undergo, if eligible, an allogenic transplantation procedure.",1996,"At recovery from the third consolidation course, only 3 of 14 (21.4%) tested patients were RT-PCR+ for the PML-RAR alpha hybrid gene.","['From March 1993 to October 1993, 20 consecutive, newly diagnosed acute promyelocytic leukemia (APL) patients from 13 Italian institutions entered in a pilot study named AIDA, combining all', 'newly diagnosed acute promyelocytic leukemia', 'adult and pediatric APL patients', 'The median age was 35.3 years (range, 6.5 to 67.6 years); 8 patients were males and 12 females; 4 had the hypogranular variant of APL (M3v), and 4 (2 with M3v) presented with leukocyte counts > or = 10,000/microL. Molecular analysis for the promyelocytic leukemia-retinoic acid receptor alpha (PML-RAR alpha']","['AIDA (all-trans retinoic acid + idarubicin', 'dexamethasone', 'ATRA', 'trans retinoic acid (ATRA) with idarubicin (IDA']","['ATRA syndrome', 'CR', 'overall survival and event-free survival durations', 'PML-RAR alpha']","[{'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0140279'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C1739128', 'cui_str': 'ATRA syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",8.0,0.0324882,"At recovery from the third consolidation course, only 3 of 14 (21.4%) tested patients were RT-PCR+ for the PML-RAR alpha hybrid gene.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Avvisati', 'Affiliation': 'Dipartimento di Biopatologia Umana, Università La Sapienza, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lo Coco', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Diverio', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Falda', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lazzarino', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Russo', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Petti', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': ''}]",Blood,[]
373,8943865,CD2 antigen expression on leukemic cells as a predictor of event-free survival after chemotherapy for T-lineage acute lymphoblastic leukemia: a Children's Cancer Group study.,"We examined the prognostic impact of CD2 antigen expression for 651 patients with T-lineage acute lymphoblastic leukemia (ALL), who were enrolled in front-line Childrens Cancer Group treatment studies between 1983 and 1994. There was a statistically significant correlation between the CD2 antigen positive leukemic cell content of bone marrow and probability of remaining in bone marrow remission, as well as overall event-free survival (EFS) (P = .0003 and P = .002, log-rank tests for linear trend). When compared with patients with the highest CD2 expression level (> 75% positivity), the life table relative event rate (RER) was 1.22 for patients with intermediate range CD2 expression level (30% to 75% positivity) and 1.81 for ""CD2-negative"" patients (< 30% positivity). At 6 years postdiagnosis, the EFS estimates for the three CD2 expression groups (low positivity to high positivity) were 52.8%, 65.5%, and 71.9%, respectively. CD2 expression remained a significant predictor of EFS after adjustment for the effects of other covariates by multivariate regression, with a RER of 1.47 for CD2-negative patients (P = .04). Analysis of T-lineage ALL patients shows a significant separation in EFS after adjustment for the National Cancer Institute (NCI) age and white blood cell (WBC) criteria for standard and high-risk ALL (P = .002, RER = 1.67). The determination of CD2 expression on leukemic cells helped identify patients with the better and poorer prognoses in both of these risk group subsets. For standard risk T-lineage ALL, CD2-negative patients had a worse outcome (P = .0007, RER = 2.92) with an estimated 5-year EFS of 55.9% as compared with 78.3% for the CD2-positive patients. Thus, CD2 negativity in standard risk T-lineage ALL identified a group of patients who had a worse outcome than high-risk T-lineage ALL patients who were CD2 positive. The percentage of CD2 antigen positive leukemic cells from T-lineage ALL patients is a powerful predictor of EFS after chemotherapy. This prognostic relationship is the first instance in which a biological marker in T-lineage ALL has been unequivocally linked to treatment outcome.",1996,"For standard risk T-lineage ALL, CD2-negative patients had a worse outcome (P = .0007, RER = 2.92) with an estimated 5-year EFS of 55.9% as compared with 78.3% for the CD2-positive patients.","['651 patients with T-lineage acute lymphoblastic leukemia (ALL), who were enrolled in front-line Childrens Cancer Group treatment studies between 1983 and 1994']",['CD2 antigen expression'],"['life table relative event rate (RER', 'CD2 negativity', 'percentage of CD2 antigen positive leukemic cells', 'CD2 expression', '5-year EFS', 'overall event-free survival (EFS', 'CD2 antigen positive leukemic cell content of bone marrow and probability of remaining in bone marrow remission', 'highest CD2 expression level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0108773', 'cui_str': 'CD2 Antigens'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0023683', 'cui_str': 'Life Tables'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0108773', 'cui_str': 'CD2 Antigens'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0260032,"For standard risk T-lineage ALL, CD2-negative patients had a worse outcome (P = .0007, RER = 2.92) with an estimated 5-year EFS of 55.9% as compared with 78.3% for the CD2-positive patients.","[{'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Uckun', 'Affiliation': ""Children's Cancer Group ALL Biology Reference Laboratory, University of Minnesota, Minneapolis 55113, USA.""}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Steinherz', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sather', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trigg', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Arthur', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tubergen', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gaynon', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Reaman', 'Affiliation': ''}]",Blood,[]
374,8896392,Administration of pegylated recombinant human megakaryocyte growth and development factor to humans stimulates the production of functional platelets that show no evidence of in vivo activation.,"This report describes the effect of pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) on platelet production and platelet function in humans. Subjects with advanced solid tumors received PEG-rHuMGDF daily for up to 10 days. There was no increase in circulating platelet count at doses of 0.03 or 0.1 microgram/kg/d by day 12 of study. At doses of 0.3 and 1.0 microgram/kg/d there was a threefold median increase (maximum 10-fold) in platelet count by day 16. The platelets produced in vivo in response to PEG-rHuMGDF showed unchanged aggregation and adenosine triphosphate (ATP)-release responses in in vitro assays. Tests included aggregation and release of ATP in response to adenosine diphosphate (ADP) (10, 5, 2.5, and 1.25 mumol/L), collagen (2 micrograms/mL), thrombin-receptor agonist peptide (TRAP, 10 mumol/L) and ristocetin (1.5 mg/mL). Administration of aspirin to an individual with platelet count of 1,771 x 10(3)/L resulted in the typical aspirin-induced ablation of the normal aggregation and ATP-release response to stimulation with arachidonic acid (0.5 mg/mL), collagen, and ADP (2.5 and 1.25 mumol/L). There was no change in the expression of the platelet-surface activation marker CD62P (P-selectin) nor induction of the fibrinogen binding site on glycoprotein IIb/IIIa as reported by the monoclonal antibody, D3GP3. An elevation of reticulated platelets was evident after 3 days of treatment with PEG-rHuMGDF and preceded the increase in circulating platelet count by 5 to 8 days; this reflected the production of new platelets in response to PEG-rHuMGDF. At later time points, the mean platelet volume (MPV) decreased in a manner inversely proportional to the platelet count. Levels of plasma glycocalicin, a measure of platelet turnover, rose 3 days after the initial increase in the peripheral platelet count. The level of plasma glycocalicin was proportional to the total platelet mass, suggesting that platelets generated in response to PEG-rHuMGDF were not more actively destroyed. Thus, the administration of PEG-rHuMGDF, to humans, increased the circulating platelet count and resulted in fully functional platelets, which showed no detectable increase in reactivity nor alteration in activation status.",1996,"There was no change in the expression of the platelet-surface activation marker CD62P (P-selectin) nor induction of the fibrinogen binding site on glycoprotein IIb/IIIa as reported by the monoclonal antibody, D3GP3.","['Subjects with advanced solid tumors', 'humans']","['PEG-rHuMGDF', 'arachidonic acid', 'aspirin', 'pegylated recombinant human megakaryocyte growth', 'pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF']","['elevation of reticulated platelets', 'circulating platelet count', 'platelet count', 'aggregation and release of ATP in response to adenosine diphosphate (ADP', 'expression of the platelet-surface activation marker CD62P', 'level of plasma glycocalicin', 'mean platelet volume (MPV', 'aggregation and adenosine triphosphate (ATP)-release responses', 'Levels of plasma glycocalicin, a measure of platelet turnover']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0533199', 'cui_str': 'PEG-MGDF'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025166', 'cui_str': 'Megakaryocytes'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0040052', 'cui_str': 'Thrombocytopoiesis-Stimulating Factor'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0061621', 'cui_str': 'soluble glycoprotein Ib alpha'}, {'cui': 'C0200665', 'cui_str': 'Mean Platelet Volume'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}]",,0.0173716,"There was no change in the expression of the platelet-surface activation marker CD62P (P-selectin) nor induction of the fibrinogen binding site on glycoprotein IIb/IIIa as reported by the monoclonal antibody, D3GP3.","[{'ForeName': 'C J', 'Initials': 'CJ', 'LastName': ""O'Malley"", 'Affiliation': 'Centre for Developmental Cancer Therapeutics, Melbourne, Victoria, Australia.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Rasko', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Basser', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'McGrath', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cebon', 'Affiliation': ''}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Grigg', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hopkins', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Byrne"", 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Berndt', 'Affiliation': ''}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Begley', 'Affiliation': ''}]",Blood,[]
375,8652857,Interferon-alpha and hydroxyurea in early chronic myeloid leukemia: a comparative analysis of the Italian and German chronic myeloid leukemia trials with interferon-alpha.,"In 1994, the Italian and the German Chronic myeloid leukemia (CML) trials comparing interferon-alpha (IFN-alpha) with conventional chemotherapy were published. The survival advantage in favor of IFN-alpha compared with hydroxyurea (HU; 72 v 52 months) was significant in the Italian (P < .002), but not in the German trial (66 v 56 months, P < .44). We set up a collaborative study to identify the reasons for the different outcomes. There are major differences in the trial protocols concerning admission criteria, treatment strategy, and definitions. The German patients were older and more seriously sick. Fifty-two of the 327 patients in the German IFN and HU arms did not fulfil Italian admission criteria, and 41 of the 322 Italian patients did not fulfil German admission criteria. Using mutually uniform admission criteria, the median survival times of the IFN patients are 76 (Italian) and 72 (German) months (P = .56). The Italian group administered IFN combined with HU as needed, whereas the German group strictly used IFN as monotherapy with rerandomization to busulfan (BU) or HU after IFN resistance or intolerability. The differences seen between the Italian and the German trial results can be accounted for by objective differences in study design, especially the admission criteria, treatment strategy, and bias due to intention to treat analysis. The detailed analysis of the data suggests that the combination of IFN with HU as needed is more effective than either agent alone.",1996,"The survival advantage in favor of IFN-alpha compared with hydroxyurea (HU; 72 v 52 months) was significant in the Italian (P < .002), but not in the German trial (66 v 56 months, P < .44).","['In 1994, the Italian and the German Chronic myeloid leukemia (CML) trials comparing', 'early chronic myeloid leukemia', 'Fifty-two of the 327 patients in the German IFN and HU arms did not fulfil Italian admission criteria, and 41 of the 322 Italian patients did not fulfil German admission criteria', 'German patients were older and more seriously sick']","['hydroxyurea (HU', 'interferon-alpha (IFN-alpha) with conventional chemotherapy', 'interferon-alpha', 'IFN as monotherapy with rerandomization to busulfan (BU) or HU', 'IFN combined with HU', 'Interferon-alpha and hydroxyurea']","['median survival times', 'survival advantage']","[{'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.120808,"The survival advantage in favor of IFN-alpha compared with hydroxyurea (HU; 72 v 52 months) was significant in the Italian (P < .002), but not in the German trial (66 v 56 months, P < .44).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Anseri', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tura', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zuffa', 'Affiliation': ''}]",Blood,[]
376,8639796,Clinical analysis of 670 cases in two trials of the European Organization for the Research and Treatment of Cancer Lymphoma Cooperative Group subtyped according to the Revised European-American Classification of Lymphoid Neoplasms: a comparison with the Working Formulation.,"In the Working Formulation (WF), non-Hodgkin's lymphomas (NHL) are grouped according to their clinical behavior. These disorders are listed as entities defined by morphology, phenotype, and cytogenetics in the proposed Revised European-American Classification of Lymphoid Neoplasms (REAL), the clinical relevance of which is still debated. We analyzed 670 NHL cases included in two randomized clinical trials (EORTC 20855 WF-intermediate/high-grade and 20856 WF-low-grade malignancy) with histologic material available for review. Based on hematoxylin-eosin-stained sections, 77% of cases could be subtyped. Immunophenotyping was considered to be mandatory only in diagnosing T-cell lymphoma and anaplastic large-cell lymphoma. Of 522 cases subtyped, 11% were mantle cell lymphoma (MCL), 5% were marginal zone B-cell lymphoma (MZBCL), 46% were follicle center lymphoma, and 32% were diffuse large B-cell lymphoma. Statistical analysis and comparisons between classifications were made only within each trial and treatment group. MCL and MZBCL were characterized by a shorter median survival (3.4 and 4.1 years, respectively) in comparison with low- and intermediate-grade WF groups (> 9.3 and 5.8 years, respectively). In terms of progression-free survival, MCL showed a behavior similar to the low-grade group, with frequent relapses. Follicle center cell lymphomas behaved as low-grade lymphomas as defined by the WF and diffuse large B-cell lymphomas as the WF-intermediate grade group. Because several NHL entities have a clinical behavior of their own, their recognition by the REAL classification offers clinicians additional information that is not obtained when the WF is used.",1996,"MCL and MZBCL were characterized by a shorter median survival (3.4 and 4.1 years, respectively) in comparison with low- and intermediate-grade WF groups (> 9.3 and 5.8 years, respectively).","['670 NHL cases included in two randomized clinical trials (EORTC 20855 WF-intermediate/high-grade and 20856 WF-low-grade malignancy) with histologic material available for review', '670 cases in two trials of the European Organization for the Research and Treatment of Cancer Lymphoma Cooperative Group subtyped according to the Revised European-American Classification of Lymphoid Neoplasms', 'Of 522 cases subtyped, 11% were mantle cell lymphoma (MCL), 5% were marginal zone B-cell lymphoma (MZBCL), 46% were follicle center lymphoma, and 32% were diffuse large B-cell lymphoma']",['Immunophenotyping'],['median survival'],"[{'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0598798', 'cui_str': 'Lymphoid neoplasm'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-Associated Lymphoid Tissue Lymphoma'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}]","[{'cui': 'C0079611', 'cui_str': 'Subtypings, Immunologic'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0178472,"MCL and MZBCL were characterized by a shorter median survival (3.4 and 4.1 years, respectively) in comparison with low- and intermediate-grade WF groups (> 9.3 and 5.8 years, respectively).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pittaluga', 'Affiliation': 'Universitaire Ziekenhuizen, Leuven, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bijnens', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Teodorovic', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hagenbeek', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Meerwaldt', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Somers', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Noordijk', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De Wolf-Peeters', 'Affiliation': ''}]",Blood,[]
377,8639883,Recombinant human erythropoietin in transfusion-dependent anemic patients with multiple myeloma and non-Hodgkin's lymphoma--a randomized multicenter study. The European Study Group of Erythropoietin (Epoetin Beta) Treatment in Multiple Myeloma and Non-Hodgkin's Lymphoma.,"One hundred twenty-one anemic, transfusion-dependent patients with multiple myeloma (MM) or low-grade non-Hodgkin's lymphoma (NHL) were randomly allocated to receive (a) recombinant human erythropoietin (rhEPO) 10,000 U/d subcutaneously 7 days a week (fixed dose group) (n = 38), or (b) rhEPO 2,000 U/d subcutaneously for 8 weeks followed by step-wise escalation of the rhEPO dose (titration group) (n = 44), or (c) no rhEPO therapy (control group) (n = 39). The total treatment period was 24 weeks. There were no differences between the three groups with regard to baseline clinical, demographic, or health status measures. The cumulative response frequency, defined as elimination of the transfusion need in combination with an increase in the hemoglobin concentration by >20 g/L, was 60% in both rhEPO treatment groups and 24% in the control group (P = .01 and .02, respectively, log rank test). For patients in the titration group the response rate on the first dose level (2,000 U/d) was only 14%. Cox's univariate regression analysis revealed that an inadequately low endogenous erythropoietin concentration in relation to the degree of anemia and a baseline platelet concentration > or = 100 x 10(9)/L were significant predictors for response to rhEPO therapy (P < .01). Multivariate regression analysis showed that relative erythropoietin concentration was the most important factor and the platelet count had no additional influence on response. Treatment with rhEPO was well tolerated. We conclude that treatment with rhEPO may be indicated in anemic MM and NHL patients with a relative erythropoietin deficiency. An initial dose of 5,000 U/d subcutaneously may be recommended.",1996,Multivariate regression analysis showed that relative erythropoietin concentration was the most important factor and the platelet count had no additional influence on response.,"[""One hundred twenty-one anemic, transfusion-dependent patients with multiple myeloma (MM) or low-grade non-Hodgkin's lymphoma (NHL"", ""transfusion-dependent anemic patients with multiple myeloma and non-Hodgkin's lymphoma"", ""Multiple Myeloma and Non-Hodgkin's Lymphoma""]","['Erythropoietin (Epoetin Beta', 'recombinant human erythropoietin (rhEPO) 10,000 U', 'rhEPO therapy', 'Recombinant human erythropoietin', 'rhEPO']","['response rate', 'hemoglobin concentration', 'cumulative response frequency', 'tolerated']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0357131', 'cui_str': 'epoetin beta'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0163485,Multivariate regression analysis showed that relative erythropoietin concentration was the most important factor and the platelet count had no additional influence on response.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Osterborg', 'Affiliation': 'Department of Oncology (Radiumhemmet), Karolinska Hospital, Stockholm, Sweden.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boogaerts', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cimino', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Essers', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Holowiecki', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Juliusson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jäger', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Najman', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Peest', 'Affiliation': ''}]",Blood,[]
378,8916958,"Prognostic implications of ploidy and proliferative activity in the diffuse, aggressive non-Hodgkin's lymphomas.","The International Index is a powerful predictor of outcome in the aggressive non-Hodgkin's lymphomas that is based solely on clinical features. Proliferative activity (% S-phase) measured by flow cytometry has been reported to have prognostic significance in many series and may represent a biologic correlate of clinical behavior that further defines prognosis. Flow cytometric analysis of cellular DNA content and proliferative activity (% S-phase) was performed on fixed paraffin-embedded biopsy specimens from 242 previously untreated patients with diffuse, aggressive non-Hodgkin's lymphomas entered on phase III intergroup clinical trials. The International Index was calculated for each patient based on stage, lactate dehydrogenase, performance status, number of extranodal sites, and age, as previously reported. The International Index consistently predicted response to therapy (P = .027) and survival (P = .007) in this series. DNA aneuploidy was shown in 57% of cases, but was not predictive of clinical outcome. The median % S-phase was 9.9 (median coefficient of variation, 3.6%), which was highly correlated with mitotic index (P = .0001). Although a trend associating low proliferative activity with good early survival and very high S-phase with a shortened survival was shown, International Index risk was the only significant predictor of survival in the multivariate analysis. Although proliferative activity quantitated by flow cytometric analysis of nuclei extracted from paraffin-embedded specimens is probably predictive of survival, it is a less powerful prognostic indicator than clinical parameters represented by the International Index and provides no additional prognostic information.",1996,The International Index consistently predicted response to therapy (P = .027) and survival (P = .007) in this series.,"[""242 previously untreated patients with diffuse, aggressive non-Hodgkin's lymphomas entered on phase III intergroup clinical trials""]",[],"['mitotic index', 'survival', 'DNA aneuploidy', 'Proliferative activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]",[],"[{'cui': 'C0812425', 'cui_str': 'Mitotic Index'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",242.0,0.0357411,The International Index consistently predicted response to therapy (P = .027) and survival (P = .007) in this series.,"[{'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Winter', 'Affiliation': 'Robert Lurie Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Variakojis', 'Affiliation': ''}, {'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Oken', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Neiman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Bauer', 'Affiliation': ''}]",Blood,[]
379,8896396,Increased numbers of long-term culture-initiating cells in the apheresis product of patients randomized to receive increasing doses of stem cell factor administered in combination with chemotherapy and a standard dose of granulocyte colony-stimulating factor.,"Long-term culture-initiating cells (LTC-IC) are arguably the most primitive human hematopoietic cells detectable by in vitro functional assays. We have investigated the mobilization of these cells into the blood of patients with ovarian carcinoma randomized to receive granulocyte colony-stimulating factor (G-CSF; 5 micrograms/kg) plus different doses of stem cell factor (SCF; c-kit ligand) after chemotherapy or G-CSF alone after chemotherapy. We have shown a significant SCF dose response for the mobilization of LTC-IC, with a 5.8-fold increase in LTC-IC mobilization in those patients receiving chemotherapy, G-CSF, and 20 micrograms/kg of SCF, the highest dose used, compared with the patients receiving chemotherapy and G-CSF alone. We have shown a threefold increase in CD34+ cells and up to a 64-fold increase in CD34+/33- cells was seen in patients treated with chemotherapy, G-CSF, and 20 micrograms/kg of SCF compared with those patients treated with chemotherapy and G-CSF alone. However, significant numbers of CD34+/38- cells were only found in the patients receiving 20 micrograms/kg of SCF as part of their mobilization regimen. Patients receiving chemotherapy plus G-CSF and SCF have enhanced mobilization of primitive cells and of the more committed progenitor cells compared with those patients receiving chemotherapy followed by G-CSF alone.",1996,"However, significant numbers of CD34+/38- cells were only found in the patients receiving 20 micrograms/kg of SCF as part of their mobilization regimen.",['patients with ovarian carcinoma'],"['Long-term culture-initiating cells (LTC-IC', 'SCF', 'stem cell factor administered in combination with chemotherapy', 'granulocyte colony-stimulating factor (G-CSF; 5 micrograms/kg) plus different doses of stem cell factor (SCF; c-kit ligand) after chemotherapy or G-CSF alone after chemotherapy', 'chemotherapy plus G-CSF and SCF']","['numbers of CD34+/38- cells', 'CD34+ cells', 'LTC-IC mobilization', 'CD34+/33- cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029925'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C0381943', 'cui_str': 'p45(SKP2) Protein'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]",,0.0626335,"However, significant numbers of CD34+/38- cells were only found in the patients receiving 20 micrograms/kg of SCF as part of their mobilization regimen.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weaver', 'Affiliation': 'Cancer Research Campaign Department of Experimental Haematology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ryder', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crowther', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Dexter', 'Affiliation': ''}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Testa', 'Affiliation': ''}]",Blood,[]
380,8839837,Effects of recombinant soluble type I interleukin-1 receptor on human inflammatory responses to endotoxin.,"Effects of soluble recombinant human type I interleukin-1 receptor (sIL-1RI) were evaluated in 18 volunteers given intravenous endotoxin and randomized to placebo (n = 6), low-dose (n = 6), or high-dose (n = 6) sIL-1RI. Soluble IL-1RI decreased IL-1 beta (P = .001), but decreased IL-1ra (P = .0001), and resulted in 10-fold and 43-fold dose-related increases in sIL-1RI-IL-1ra complexes compared with placebo (P < or = .001). High-dose sIL-1RI was associated with increased levels of immunoactive tumor necrosis factor-alpha (P = .02), IL-8 (P = .0001), and cell-associated IL-1 beta (P = .047). C-reactive protein levels were higher after sIL-1RI than placebo (P = .035). Soluble IL-1RI decreased the severity of chills (P = .03), but did not alter other symptoms, changes in temperature, systemic hemodynamic responses, or changes in leukocyte and platelet number. Thus, sIL-1RI had no discernable antiinflammatory effect following endotoxin administration due in part to low levels of circulating IL-1 beta and neutralization of IL-1ra inhibitory function. This latter interaction represents an indirect mechanism of agonist activity elicited by sIL-1RI and may contribute to increases in inflammatory mediators, limiting therapy with sIL-1RI during endotoxemia.",1996,"Soluble IL-1RI decreased IL-1 beta (P = .001), but decreased IL-1ra (P = .0001), and resulted in 10-fold and 43-fold dose-related increases in sIL-1RI-IL-1ra complexes compared with placebo (P < or = .001).",['18 volunteers given intravenous'],"['recombinant soluble type I interleukin-1 receptor', 'endotoxin', 'soluble recombinant human type I interleukin-1 receptor (sIL-1RI', 'placebo']","['IL-1ra', 'severity of chills', 'C-reactive protein levels', 'cell-associated IL-1 beta', 'temperature, systemic hemodynamic responses, or changes in leukocyte and platelet number', 'levels of immunoactive tumor necrosis factor-alpha', 'sIL-1RI-IL-1ra complexes', 'Soluble IL-1RI decreased IL-1 beta', 'IL-8']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0032181', 'cui_str': 'Blood Platelet Number'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",18.0,0.27323,"Soluble IL-1RI decreased IL-1 beta (P = .001), but decreased IL-1ra (P = .0001), and resulted in 10-fold and 43-fold dose-related increases in sIL-1RI-IL-1ra complexes compared with placebo (P < or = .001).","[{'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Preas', 'Affiliation': 'Critical Care Medicine Department, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892-1662, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Reda', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tropea', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Vandivier', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Banks', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Agosti', 'Affiliation': ''}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Suffredini', 'Affiliation': ''}]",Blood,[]
381,8839839,A randomized trial of hydroxyurea versus VP16 in adult chronic myelomonocytic leukemia. Groupe Français des Myélodysplasies and European CMML Group.,"We performed a randomized study of hydroxyurea (HY) versus VP16 in advanced chronic myelomonocytic leukemia (CMML) patients with CMML (according to French-American-British group criteria) and either documented visceral involvement (excluding liver and spleen infiltration) or at least 2 of the following: (1) neutrophils > 16 x 10(9)/I (2) Hemoglobin < 10 g/dL (3) platelets < 100 x 10(9)/L (4) marrow blasts > 5% (5) spleen > 5 cm below costal margin were eligible for this trial. Initial dosage was 1 g/d for HY and 150 mg/week for VP16, orally (doubled in case of visceral involvement). Doses were scheduled to be escalated up to HY 4 g/d and VP16 600 mg/week in the absence of response, and finally adjusted to maintain white blood cells (WBCs) between 5 and 10 x 10(9)/L. Crossing over was scheduled only in case of life threatening visceral involvement or major progression. The major endpoint of the study was survival. The study was closed on first interim analysis that showed a superiority of HY over VP16, after inclusion of 105 pts (HY arm: 53, VP16 arm: 52). Results of the second interim analysis, performed 7 months later, are presented here. Median age was 71 (range 38 to 91), median WBC count 20.10(9)/L (range 10 to 187). Thirteen pts had visceral involvement (3 serous effusions, 8 cutaneous infiltrations, 1 kidney, 1 bone infiltrations). Initial characteristics were similar in the HY and VP16 groups. Median follow up was 11 months in both groups (range 1 to 43+). Response to treatment was seen in 60% of the pts in the HY group, versus 36%, respectively, in the VP16 group (P = .02). Time to response was significantly shorter in the HY group (2.1 v 3.5 months, in the VP16 group, P = .003) and response duration was significantly longer in the HY group (median 24 v 9 months, in the VP16 group, P = .0004). The response rate of patients with visceral involvement was 3 out of 7 in the VP16 arm versus 5 out of 6 in the HY group. Three of the 10 pts crossed over from HY to VP16 responded as compared to 6 pts of the 11 pts crossed over from VP16 to HY. HY yielded better response on leukocytosis (P = .002). The effect on splenomegaly platelets, on hemoglobin level and transfusion requirement was similar in the 2 treatment groups. A significantly higher incidence of alopecia was noted in the VP16 arm (20% v 3%, P = .03). Fourteen (27%) and 20 (38%) patients in the HY and the VP16 group respectively, progressed to acute myeloid leukemia (difference NS). Twenty five (53%) and 44 (83%) patients in the HY and the VP16 group, respectively, had died (P = .002). Median actuarial survival was 20 months in the HY arm, versus 9 months in the VP16 arm (P < 10(-4)). Main factors associated with poor survival were allocation to the VP16 arm, ""unfavorable"" karyotype (ie, monosomy 7 or complex abnormalities) and anemia. In the HY group, unfavorable karyotype (P = .006), and low hemoglobin level (P = .004) were significantly associated with low response rates. Prognostic factors for poor survival in the HY group were also unfavorable karyotype (P = .001), and low hemoglobin level (P < 10(-4). In conclusion, we found that HY gave higher response rates and better survival than VP16 in advanced CMML. However, even with HY responses were only partial and survival was generally poor. This stresses the need for new agents in the treatment of CMML, that will have to be compared with HY in future randomized studies.",1996,"Time to response was significantly shorter in the HY group (2.1 v 3.5 months, in the VP16 group, P = .003) and response duration was significantly longer in the HY group (median 24 v 9 months, in the VP16 group, P = .0004).","['adult chronic myelomonocytic leukemia', 'Median age was 71 (range 38 to 91), median WBC count 20.10(9)/L (range 10 to 187', 'advanced chronic myelomonocytic leukemia (CMML) patients with CMML (according to French-American-British group criteria) and either documented visceral involvement (excluding liver and spleen infiltration) or at least 2 of the following: (1) neutrophils > 16 x 10(9)/I (2) Hemoglobin < 10 g/dL (3) platelets < 100 x 10(9)/L (4) marrow blasts > 5% (5) spleen > 5 cm below costal margin were eligible for this trial', 'Thirteen pts had visceral involvement (3 serous effusions, 8 cutaneous infiltrations, 1 kidney, 1 bone infiltrations']","['hydroxyurea versus VP16', 'hydroxyurea (HY) versus VP16']","['leukocytosis', 'response rates and better survival', 'low hemoglobin level', 'incidence of alopecia', 'Median actuarial survival', 'response rate of patients with visceral involvement', 'Time to response', 'response duration', 'survival', 'acute myeloid leukemia', 'partial and survival', 'splenomegaly platelets, on hemoglobin level and transfusion requirement', 'unfavorable karyotype']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023480', 'cui_str': 'Leukemia, Myelomonocytic, Chronic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0582240', 'cui_str': 'Costal Arch'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0302149', 'cui_str': 'Serous effusion (morphologic abnormality)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0733688', 'cui_str': 'VP-16'}]","[{'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0038002', 'cui_str': 'Enlarged Spleen'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1261273', 'cui_str': 'Karyotype'}]",,0.0407807,"Time to response was significantly shorter in the HY group (2.1 v 3.5 months, in the VP16 group, P = .003) and response duration was significantly longer in the HY group (median 24 v 9 months, in the VP16 group, P = .0004).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wattel', 'Affiliation': 'Groupe Français des Myélodysplasies, Lille, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerci', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hecquet', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Economopoulos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Copplestone', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mahé', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Couteaux', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Resegotti', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Voglova', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Foussard', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pegourié', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Michaux', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deconinck', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Stoppa', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mufti', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Oscier', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ''}]",Blood,[]
382,8822914,Hydroxyurea for treatment of severe sickle cell anemia: a pediatric clinical trial.,"Hydroxyurea (HU) enhances the synthesis of fetal hemoglobin (HbF) and can improve the clinical course of some adult patients with sickle cell anemia (SCA). In a randomized trial, we studied the biologic effects and the clinical benefit of HU in children and young adults with severe SCA. Twenty-five patients (median age, 9 years) were randomized to receive either HU (at the initial dosage of 20 mg/kg/d) or a placebo for 6 months and were then switched to the other arm for the next 6 months. Among the 22 evaluable patients (median age, 8 years), significant increases in HbF and mean corpuscular volume occurred during the HU treatment period. The white blood cell and reticulocytes counts decreased significantly, but these changes were not clinically relevant. Sixteen of 22 patients (73%) experienced a complete disappearance of events requiring hospitalization. The number of days of hospitalization as well as the number of hospitalizations for patients on HU, as compared with those for the patients receiving placebo, were significantly reduced. We conclude that treatment with HU in children and young adults is feasible, well-tolerated, and improves the clinical course of SCA. The long-term effects of HU require further investigation.",1996,"The white blood cell and reticulocytes counts decreased significantly, but these changes were not clinically relevant.","['children and young adults with severe SCA', 'Twenty-five patients (median age, 9 years', 'adult patients with sickle cell anemia (SCA', 'children and young adults', 'severe sickle cell anemia']","['Hydroxyurea', 'Hydroxyurea (HU', 'placebo', 'HU']","['number of days of hospitalization', 'white blood cell and reticulocytes counts', 'HbF and mean corpuscular volume', 'complete disappearance of events requiring hospitalization', 'biologic effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0863148', 'cui_str': 'Erythrocyte mean corpuscular volume determination (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.026609,"The white blood cell and reticulocytes counts decreased significantly, but these changes were not clinically relevant.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': 'Hemato-Oncology Unit, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vermylen', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cornu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buyse', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Corazza', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Devalck', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fondu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toppet', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sariban', 'Affiliation': ''}]",Blood,[]
383,8704237,Evaluation of a CD5-specific immunotoxin for treatment of acute graft-versus-host disease after allogeneic marrow transplantation.,"Acute graft-versus-host disease (GVHD) is most often treated with high dose glucocorticoids, but less than half of patients have durable overall improvement. Previous phase I and phase II studies suggested that treatment with a CD5-specific immunotoxin (XomaZyme-CD5 Plus) could ameliorate symptoms of GVHD. In a randomized, double-blind trial, we compared XomaZyme-CD5 Plus and glucocorticoids versus placebo and glucocorticoids as initial therapy for 243 patients who developed acute GVHD after allogeneic marrow transplantation. The study drug (XomaZyme. CD5-Plus or an identical appearing placebo) was administered at a dose of 0.1 mg/kg body weight on each of 14 consecutive days. All patients were treated concomitantly with a standard regimen of methylprednisolone. At the time of entry on study, 94% of patients had a rash, 56% had hyperbilirubinemia, 61% had diarrhea, and 84% had nausea and vomiting. At 3, 4, and 5 weeks after starting treatment, symptom severity was less in the CD5 group than in the placebo group. At 4 weeks, 40% of patients assigned to the CD5 group had complete response compared with 25% of those assigned to the control group (P = .019). At 6 weeks, 44% of patients assigned to the CD5 group had complete response as compared with 38% in the placebo group (P = .36). Clinical extensive chronic GVHD developed in 65% of patients in the CD5 group compared with 72% in the control group (P = .35). Survival at 1 year after treatment was 49% in the CD5 group and 45% in the control group (P = .68). Side effects required close monitoring and appropriate adjustment of treatment. The combined administration of a CD5-specific immunotoxin and glucocorticoids controls GVHD manifestations more effectively than treatment with glucocorticoids alone during the first 5 weeks after starting treatment. Use of this immunotoxin does not result in any long-term clinical benefit for patients with acute GVHD.",1996,Clinical extensive chronic GVHD developed in 65% of patients in the CD5 group compared with 72% in the control group (P = .35).,"['acute graft-versus-host disease after allogeneic marrow transplantation', '243 patients who developed acute GVHD after allogeneic marrow transplantation', 'patients with acute GVHD']","['CD5-specific immunotoxin (XomaZyme-CD5 Plus', 'placebo', 'XomaZyme-CD5 Plus and glucocorticoids versus placebo and glucocorticoids', 'methylprednisolone', 'CD5', 'glucocorticoids', 'immunotoxin', 'CD5-Plus or an identical appearing placebo', 'CD5-specific immunotoxin']","['complete response', 'nausea and vomiting', 'diarrhea', 'Survival', 'symptom severity', 'hyperbilirubinemia', 'Clinical extensive chronic GVHD']","[{'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021084', 'cui_str': 'Affinotoxins'}, {'cui': 'C0378325', 'cui_str': 'XomaZyme-CD5 Plus'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0287022', 'cui_str': 'CD5 Plus'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]",243.0,0.266295,Clinical extensive chronic GVHD developed in 65% of patients in the CD5 group compared with 72% in the control group (P = .35).,"[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA 98104, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Hansen', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Scannon', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Friedmann', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}]",Blood,[]
384,8874180,A randomized investigation of high-dose versus standard-dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: a Southwest Oncology Group study.,"Interest in high-dose cytarabine (HDAC) for both induction and postremission therapy for acute myeloid leukemia (AML) prompted the Southwest Oncology Group (SWOG) to initiate a randomized trial comparing HDAC with standard-dose cytarabine (SDAC) for remission induction of previously untreated AML and to compare high-dose treatment versus conventional doses for consolidation therapy. Patients less than 65 years of age with de novo or secondary AML were randomized for induction between SDAC 200 mg/ m2/d for 7 days by continuous infusion or HDAC at 2 g/ m2 intravenously every 12 hours for 12 doses; both groups received daunorubicin (DNR) at 45 mg/m2/d intravenously for 3 days. Complete responders to SDAC were randomized to receive either two additional courses of SDAC plus DNR or one course of HDAC plus DNR. Complete responders to HDAC were nonrandomly assigned to receive one additional course of HDAC plus DNR. Of patients randomized between SDAC (n = 493) and HDAC (n = 172) induction, 361 achieved complete remission (CR). The CR rate was slightly poorer with HDAC: 55% versus 58% with SDAC for patients aged less than 50, and 45% (HDAC) versus 53% (SDAC) for patients aged 50 to 64 (age-adjusted one-tailed P = .96). With a median follow-up time of 51 months, survival was not significantly better with HDAC (P = .41); the estimated survival rate at 4 years was 32% (HDAC) versus 22% (SDAC) for those aged less than 50, and 13% (HDAC) versus 11% (SDAC) for those aged 50 to 64. However, relapse-free survival was somewhat better following HDAC Induction (P = .049): 33% (HDAC) versus 21% (SDAC) at 4 years for those aged less than 50, and 21% (HDAC) versus 9% (SDAC) for those aged 50 to 64. Induction with HDAC was associated with a significantly increased risk of fatal (P = .0033) and neurologic (P < .0001) toxicity. Among patients who achieved CR with SDAC, survival and disease-free survival (DFS) following consolidation randomization were not significantly better with HDAC compared with SDAC (P = .77 and .46, respectively). Patients who received both HDAC induction and consolidation had the best postremission outcomes; however, the proportion of CR patients who did not go on to protocol consolidation therapy was more than twice as high after HDAC induction compared with SDAC. Induction therapy with HDAC plus DNR was associated with greater toxicity than SDAC plus DNR, but with no improvement in CR rate or survival. Following CR induction with SDAC, consolidation with HDAC increased toxicity but not survival or DFS. In a nonrandomized comparison, patients who received both HDAC induction and consolidation had superior survival and DFS compared with those who received SDAC induction with either SDAC or HDAC consolidation.",1996,"With a median follow-up time of 51 months, survival was not significantly better with HDAC (P = .41); the estimated survival rate at 4 years was 32% (HDAC) versus 22% (SDAC) for those aged less than 50, and 13% (HDAC) versus 11% (SDAC) for those aged 50 to 64.","['acute myeloid leukemia (AML', 'patients with previously untreated acute myeloid leukemia', 'Patients less than 65 years of age with de novo or secondary AML']","['high-dose versus standard-dose cytosine arabinoside with daunorubicin', 'HDAC with standard-dose cytarabine (SDAC', 'cytarabine (HDAC', 'SDAC', 'HDAC', 'HDAC plus DNR', 'SDAC plus DNR', 'daunorubicin (DNR']","['SDAC, survival and disease-free survival (DFS', 'toxicity', 'superior survival and DFS', 'CR rate or survival', 'risk of fatal', 'estimated survival rate', 'neurologic', 'survival', 'complete remission (CR', 'CR rate', 'relapse-free survival']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",493.0,0.0744619,"With a median follow-up time of 51 months, survival was not significantly better with HDAC (P = .41); the estimated survival rate at 4 years was 32% (HDAC) versus 22% (SDAC) for those aged less than 50, and 13% (HDAC) versus 11% (SDAC) for those aged 50 to 64.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Weick', 'Affiliation': 'Cleveland Clinic Florida, Ft Lauderdale, USA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Kingsbury', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Balcerzak', 'Affiliation': ''}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Bickers', 'Affiliation': ''}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hynes', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Welborn', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grever', 'Affiliation': ''}]",Blood,[]
385,8916975,Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: a randomized double-blind study.,"To determine whether cytomegalovirus (CMV) antigenemiaguided ganciclovir treatment may be as effective, may require less treatment, and thus may cause less marrow toxicity than ganciclovir administered at engraftment, 226 marrow transplant recipients were randomized at engraftment to receive placebo (antigenemia-ganciclovir group) or ganciclovir (ganciclovir group) until day 100 in a double-blind study. In patients with antigenemia of 3 or more positive cells in 2 slides and/or viremia, study drug was discontinued and ganciclovir was started for at least 3 weeks or until negative CMV antigenemia and resumed only if antigenemia recurred. More patients in the antigenemia-ganciclovir group developed CMV disease before day 100 after transplantation compared with the ganciclovir group (14% v 2.7%, P = .002). Of the 16 patients with CMV disease before day 100 in the antigenemia-ganciclovir group, 10 (8.8%) had disease before or during the first episode of antigenemia and 6 (5.3%) developed disease after discontinuation of ganciclovir. Untreated low-grade antigenemia progressed to CMV disease in 19% of patients with grade 3-4 compared with 0% of patients with grade 0-2 acute graft-versus-host disease (P = .04). There was no significant difference in CMV disease by day 180 after transplantation and thereafter. CMV-related death, transplant survival, and neutropenia were not significantly different between the groups. In the ganciclovir group, more invasive fungal infections occurred (P = .03) and more ganciclovir was used (P < .0001). Thus, delaying the start of ganciclovir until highgrade antigenemia and discontinuing ganciclovir based on negative antigenemia results in more CMV disease by day 100 than ganciclovir administered at engraftment. However, ganciclovir at engraftment is associated with more early invasive fungal infections and more late CMV disease resulting in similar survival rates.",1996,"In the ganciclovir group, more invasive fungal infections occurred (P = .03) and more ganciclovir was used (P < .0001).","['16 patients with CMV disease before day 100 in the antigenemia', 'allogeneic marrow transplantation', '226 marrow transplant recipients']","['ganciclovir', 'ganciclovir versus ganciclovir', 'cytomegalovirus (CMV) antigenemiaguided ganciclovir', 'placebo (antigenemia-ganciclovir group) or ganciclovir (ganciclovir']","['CMV-related death, transplant survival, and neutropenia', 'CMV disease', 'invasive fungal infections', 'grade antigenemia progressed to CMV disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}]","[{'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1262313', 'cui_str': 'Invasive Mycoses'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}]",16.0,0.0299442,"In the ganciclovir group, more invasive fungal infections occurred (P = .03) and more ganciclovir was used (P < .0001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boeckh', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Program in Infectious Diseases, Seattle, WA 98104, USA.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Gooley', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Myerson', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cunningham', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schoch', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bowden', 'Affiliation': ''}]",Blood,[]
386,8839865,Activating mutations of N- and K-ras in multiple myeloma show different clinical associations: analysis of the Eastern Cooperative Oncology Group Phase III Trial.,"Mutations of members of the ras family are among the most common oncogene mutations found in multiple myeloma (MM). We have examined the mutational status of the N- and K-ras genes at codons 12, 13, and 61 in 160 newly diagnosed MM patients enrolled on the Eastern Cooperative Oncology Group (ECOG) phase III clinical trial E9486. The total incidence of ras mutations was found to be 39% of the samples analyzed. Five patients showed evidence of more than one mutation. We obtained 22 marrow samples from patients at the time of disease progression or relapse, for whom a ras mutation was identified at diagnosis. In all cases, the ras mutation of the disease progression sample was identical to that found at diagnosis. In contrast, three of 25 patients who did not show any ras mutation at diagnosis acquired a ras mutation at the time of disease progression. No significant association was observed between any ras mutation and stage of disease, beta 2-microglobulin levels, labelling index, or protein type. The mean tumor burden and median survival for patients with mutations of N-ras was indistinguishable from patients with no ras mutations. However, patients with K-ras mutations had a significantly higher mean bone marrow tumor burden at diagnosis than patients with no ras mutations (57% v 36%, P < .02); and the median survival of patients with a K-ras mutation was significantly shorter (2.0 v 3.7 years, P < .02). To determine if the status of ras mutations could affect treatment response, we examined patient survival on the three treatment arms of E9486. Although the presence of a ras mutation in the multidrug treatment, VBMCP alone, showed a marginal significance, neither the VBMCP, nor the addition of interferon-alpha showed statistically significant survival differences between mutant and wildtype ras status. Interestingly, there appeared to be a statistically significant difference in survival of patients treated with VBMCP and alternating high doses of cyclophosphamide + prednisone. Patients with ras mutations had a median survival of 2.1 years; patients with wild-type ras had a median survival of 4.0 years (P < .01).",1996,The mean tumor burden and median survival for patients with mutations of N-ras was indistinguishable from patients with no ras mutations.,"['160 newly diagnosed MM patients enrolled on the Eastern Cooperative Oncology Group (ECOG) phase III clinical trial E9486', '25 patients who did not show any ras mutation at diagnosis acquired a ras mutation at the time of disease progression']","['VBMCP', 'cyclophosphamide + prednisone']","['median survival', 'mean bone marrow tumor burden', 'ras mutation and stage of disease, beta 2-microglobulin levels, labelling index, or protein type', 'total incidence of ras mutations', 'survival', 'mean tumor burden and median survival']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449385', 'cui_str': 'Staging of disease (attribute)'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",160.0,0.0885747,The mean tumor burden and median survival for patients with mutations of N-ras was indistinguishable from patients with no ras mutations.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Leong', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Quam', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Billadeau', 'Affiliation': ''}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Kay', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Greipp', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Oken', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Van Ness', 'Affiliation': ''}]",Blood,[]
387,8547651,Prognostic significance of bcl-2 protein expression in aggressive non-Hodgkin's lymphoma. Groupe d'Etude des Lymphomes de l'Adulte (GELA).,"Little is known about the expression of bcl-2 protein in intermediate and high grade non-Hodgkin's lymphoma (NHL) and its clinical and prognostic significance. We performed immunohistochemical analysis of bcl-2 expression in tumoral tissue sections of 348 patients with high or intermediate grade NHL. These patients were uniformly treated with adriamycin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) in the induction phase of the LNH87 protocol. Fifty eight cases were excluded due to inadequate staining. Of the 290 remaining patients, 131 (45%) disclosed homogeneous positivity (high bcl-2 expression) in virtually all tumor cells, whereas 65 (23%) were negative and 94 (32%) exhibited intermediate staining. High bcl-2 expression was more frequent in B-cell NHL (109 of 214, 51%) than in T-cell NHL (6 of 35, 17%) (P = .0004), and was heterogeneously distributed among the different histological subtypes. Further analysis was performed on the 151 patients with diffuse large B-cell lymphoma (centroblastic and immunoblastic) to assess the clinical significance and potential prognostic value of bcl-2 expression in the most frequent and homogeneous immunohistological subgroup. High bcl-2 expression, found in 44% of these patients (67 of 151), was more frequently associated with III-IV stage disease (P = .002). Reduced disease-free survival (DFS) (P < .01) and overall survival (P < .05) were demonstrated in the patients with high bcl-2 expression. Indeed, the 3-year estimates of DFS and overall survival were 60% and 61%, respectively (high bcl-2 expression) versus 82% and 78%, respectively (negative/intermediate bcl-2 expression). A multivariate regression analysis confirmed the independent effect of bcl-2 protein expression on DFS. Thus bcl-2 protein expression, as demonstrated in routinely paraffin-embedded tissue, appears to be predictive of poor DFS, in agreement with the role of bcl-2 in chemotherapy-induced apoptosis. It might be considered as a new independent biologic prognostic parameter, which, especially in diffuse large B-cell NHL, could aid in the identification of patient risk groups.",1996,Reduced disease-free survival (DFS) (P < .01) and overall survival (P < .05) were demonstrated in the patients with high bcl-2 expression.,"['151 patients with diffuse large B-cell lymphoma (centroblastic and immunoblastic', 'Fifty eight cases were excluded due to inadequate staining', ""aggressive non-Hodgkin's lymphoma"", '348 patients with high or intermediate grade NHL']","['adriamycin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP']","['High bcl-2 expression', 'Reduced disease-free survival (DFS', 'III-IV stage disease', 'overall survival', 'homogeneous positivity', '3-year estimates of DFS and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079744', 'cui_str': 'Diffuse Large-Cell Lymphoma'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",348.0,0.0121204,Reduced disease-free survival (DFS) (P < .01) and overall survival (P < .05) were demonstrated in the patients with high bcl-2 expression.,"[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Département de Pathologie, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lepage', 'Affiliation': ''}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': ""d'Agay"", 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lavignac', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fillet', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Marolleau', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Diebold', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Reyas', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gaulard', 'Affiliation': ''}]",Blood,[]
388,8634416,A randomized study of high-dose cytarabine in induction in acute myeloid leukemia.,"High-dose cytarabine (ara-c) may overcome cytarabine resistance in leukemic blasts. It has been used as a successful salvage and in postremission therapy but not as initial induction treatment. Patients aged 15 to 60 years, presenting with newly diagnosed acute myeloid leukemia (AML) were randomized to receive either high-dose cytarabine, 3 g/m2 12 hourly on days 1, 3, 5, and 7 for 8 doses, daunorubicin 50 mg/m2 days 1 to 3, etoposide 75 mg/m2 days 1 to 7, (HIDAC-3-7) or standard dose cytarabine 100 mg/m2 continuous intravenous infusion for 7 days with daunorubicin and etoposide at the same dose and schedule as above (7-3-7). Patients could receive a second or third induction course if complete remission (CR) was not achieved. All patients received the same postinduction consolidation therapy (5-2-5) for 2 courses. Eligible patients had no prior chemotherapy or myelodysplastic disease. Patients have been followed for a median of 4.5 years. Of 301 patients treated, complete response (CR) was achieved in 71% with HIDAC-3-7 and 74% with 7-3-7. For patients in CR, the estimated median remission duration was 45 months with HIDAC-3-7 and 12 months with 7-3-7 (P = .0005 univariate analysis, P = .0004 multivariate analysis). The estimated percentage of patients relapse free 5 years after achieving a CR was 49% on HIDAC-3-7 and 24% on 7-3-7. Patients in CR tended to survive longer with HIDAC-3-7 but there were no overall survival differences between the two arms. HIDAC-3-7 was associated with significantly more toxicity in induction with more leukopenia, thrombocytopenia, nausea, and vomiting and eye toxicity (all P < .001) but a similar incidence of severe central nervous system and cerebellar toxicity compared to 7-3-7. The consolidation treatment was the same in both arms but caused significantly more leukopenia and thrombocytopenia in patients previously treated with HIDAC-3-7 induction (P < .0001). We conclude that a dose-effect exists for cytarabine in AML and that HIDAC-3-7 prolongs remission duration and disease-free survival and is tolerable when used as initial induction therapy in patients with de novo AML.",1996,Patients in CR tended to survive longer with HIDAC-3-7 but there were no overall survival differences between the two arms.,"['patients with de novo AML', 'Eligible patients had no prior chemotherapy or myelodysplastic disease', 'acute myeloid leukemia', 'Patients aged 15 to 60 years, presenting with newly diagnosed acute myeloid leukemia (AML']","['daunorubicin and etoposide', 'etoposide 75 mg/m2 days 1 to 7, (HIDAC-3-7) or standard dose cytarabine', 'cytarabine', 'daunorubicin', 'High-dose cytarabine (ara-c']","['toxicity', 'leukopenia, thrombocytopenia, nausea, and vomiting and eye toxicity', 'leukopenia and thrombocytopenia', 'remission duration and disease-free survival', 'overall survival differences', 'complete response (CR', 'severe central nervous system and cerebellar toxicity', 'median remission duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",301.0,0.149734,Patients in CR tended to survive longer with HIDAC-3-7 but there were no overall survival differences between the two arms.,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Bishop', 'Affiliation': 'Australian Leukemia Study Group, Peter MacCallum Cancer Institute, Melbourne, Australia.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gillett', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Joshua', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bradstock', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Enno', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cobcroft', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Herrmann', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Der Weyden', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Lowenthal', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Page', 'Affiliation': ''}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Garson', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juneja', 'Affiliation': ''}]",Blood,[]
389,8630380,"Prospective, randomized trial of 5-fluorouracil, leucovorin, doxorubicin, and cyclophosphamide chemotherapy in combination with the interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein (PIXY321) versus GM-CSF in patients with advanced breast cancer.","We conducted a prospective randomized trial to evaluate the ability of the interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein, PIXY321, to ameliorate cumulative thrombocytopenia after multiple cycles of 5-fluorouracil, leucovorin, doxorubicin, cyclophosphamide (FLAC) chemotherapy compared with GM-CSF in patients with advanced breast cancer. Fifty-three patients were randomized to receive either PIXY321. 375 microg/m2 twice a day subcutaneously, or GM-CSF, 250 microg/m2 daily subcutaneously after FLAC chemotherapy. PIXY321 was less well tolerated than GM-CSF, with more patients developing chills and local skin reactions and more patients stopping PIXY321 due to intolerance. While no difference in the neutrophil nadirs was seen with the two cytokines, the duration of the absolute neutrophil count less than 1,000/muL for all cycles was significantly longer with PIXY321 than with GM-CSF. Fifty percent of patients treated with multiple cycles of FLAC chemotherapy on both study arms developed dose-limiting thrombocytopenia. No differences in platelet nadirs, duration of thrombocytopenia, or need for platelet transfusions were observed with PIXY321 versus GM-CSF. The average delivered doses of FLAC chemotherapy were somewhat higher in the GM-CSF study arm. PIXY321 was not superior to GM-CSF in ameliorating the cumulative thrombocytopenia observed with multiple cycles of FLAC chemotherapy and was less well tolerated.",1996,"No differences in platelet nadirs, duration of thrombocytopenia, or need for platelet transfusions were observed with PIXY321 versus GM-CSF.","['patients with advanced breast cancer', 'Fifty-three patients']","['PIXY321', 'interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein (PIXY321) versus GM-CSF', 'FLAC chemotherapy', '5-fluorouracil, leucovorin, doxorubicin, and cyclophosphamide chemotherapy', 'GM-CSF', 'interleukin-3/granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein, PIXY321', '5-fluorouracil, leucovorin, doxorubicin, cyclophosphamide (FLAC) chemotherapy']","['neutrophil nadirs', 'cumulative thrombocytopenia', 'tolerated', 'duration of the absolute neutrophil count', 'dose-limiting thrombocytopenia', 'platelet nadirs, duration of thrombocytopenia, or need for platelet transfusions', 'chills and local skin reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0021757', 'cui_str': 'Interleukin-3'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein product'}, {'cui': 'C4553330', 'cui_str': 'Flac'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}]",53.0,0.0192542,"No differences in platelet nadirs, duration of thrombocytopenia, or need for platelet transfusions were observed with PIXY321 versus GM-CSF.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Medicine Branch, Biostatistics and Data Management Section, National Cancer Institute and Clinical Center, National Institutes of Health, Bethesda, MD USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tolcher', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Riseberg', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Venzon', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zujewski', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Noone', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gossard', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Danforth', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Goldspiel', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Giusti', 'Affiliation': ''}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Cowan', 'Affiliation': ''}]",Blood,[]
390,8562960,Effects of granulocyte colony-stimulating factor on plasma cytokine and cytokine receptor levels and on the in vivo host response to endotoxin in healthy men.,"We investigated the effects of granulocyte colony-stimulating factor (G-CSF) on cytokine and cytokine receptor plasma levels and on the in vivo host response to Salmonella abortus equi endotoxin in healthy males. Twenty volunteers received 0.8 ng/kg endotoxin and saline intravenously 1 week apart in randomized order. Twelve hours before both experiments, 10 of these subjects were pretreated with 300 micrograms G-CSF subcutaneously. G-CSF itself increased granulocyte and monocyte counts and the plasma levels of tumor necrosis factor-alpha (TNF-alpha), soluble TNF receptors (sTNF-R) p55, and p75 and interleukin-1 receptor antagonist (IL-1ra). G-CSF did not influence plasma IL-1 beta and IL-6 levels. In the G-CSF-pretreated subjects endotoxin-induced surges in rectal temperature and in the plasma levels of TNF-alpha plasma levels were about 50% increased, and surges in the plasma levels of both sTNF-Rs and IL-1ra were about twice as high as in the control group. Endotoxin-induced increases in IL-6, cortisol, and heart rate were not modified by G-CSF pretreatment. Endotoxin administration induced a transient 50% reduction in leukocyte counts in the G-CSF-pretreated subjects that was not seen in the control group. We conclude that a single stand dose of G-CSF increases the plasma levels of cytokines and cytokine receptors and considerably modifies the host response of healthy humans to a low dose of endotoxin.",1996,"G-CSF itself increased granulocyte and monocyte counts and the plasma levels of tumor necrosis factor-alpha (TNF-alpha), soluble TNF receptors (sTNF-R) p55, and p75 and interleukin-1 receptor antagonist (IL-1ra).","['healthy men', 'healthy males', 'Twenty volunteers received 0.8 ng/kg']","['G-CSF', 'granulocyte colony-stimulating factor (G-CSF', 'Endotoxin', 'granulocyte colony-stimulating factor', 'endotoxin and saline']","['plasma IL-1 beta and IL-6 levels', 'plasma levels of cytokines and cytokine receptors', 'plasma cytokine and cytokine receptor levels', 'granulocyte and monocyte counts and the plasma levels of tumor necrosis factor-alpha (TNF-alpha), soluble TNF receptors (sTNF-R) p55, and p75 and interleukin-1 receptor antagonist (IL-1ra', 'plasma levels of TNF-alpha plasma levels', 'leukocyte counts', 'IL-6, cortisol, and heart rate']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0206552', 'cui_str': 'Receptors, Cytokine'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0147226', 'cui_str': 'tumor necrosis factor receptor type I, P55 soluble fragment'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",20.0,0.0262013,"G-CSF itself increased granulocyte and monocyte counts and the plasma levels of tumor necrosis factor-alpha (TNF-alpha), soluble TNF receptors (sTNF-R) p55, and p75 and interleukin-1 receptor antagonist (IL-1ra).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pollmächer', 'Affiliation': 'Max Planck Institute of Psychiatry, Department of Psychiatry, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Korth', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mullington', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sauer', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Vedder', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Galanos', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Holsboer', 'Affiliation': ''}]",Blood,[]
391,8555470,Complete remission in severe aplastic anemia after high-dose cyclophosphamide without bone marrow transplantation.,"Severe aplastic anemia (SAA) can be successfully treated with allogeneic bone marrow transplantation (BMT) or immunosuppressive therapy. However, the majority of patients with SAA are not eligible for BMT because they lack an HLA-identical sibling. Conventional immunosuppressive therapy also has major limitations; many of its remissions are incomplete and relapse or secondary clonal disease is common. Cyclophosphamide is a potent immunosuppressive agent that is used in all BMT conditioning regimens for patients with SAA. Preliminary evidence suggested that high-dose cyclophosphamide, even without BMT, may be beneficial to patients with SAA. Therefore, 10 patients with SAA and lacking an HLA-identical sibling were treated with high-dose cyclophosphamide (45 mg/kg/d) for 4 consecutive days with or without cyclosporine. A complete response (hemoglobin level, > 13 g/dL; absolute neutrophil count, > 1.5 x 10(9)/L, and platelet count > 125 x 10(9)/L) was achieved in 7 of the 10 patients. One of the complete responders died from the acquired immunodeficiency syndrome 44 months after treatment with high-dose cyclophosphamide. The 6 remaining patients are alive and in continuous complete remission, with a median follow-up of 10.8 years (range, 7.3 to 17.8 years). The median time to last platelet transfusion and time to 0.5 x 10(9) neutrophils/L were 85 and 95 days, respectively. None of the complete responders has relapsed or developed a clonal disease. These results suggest that high-dose cyclophosphamide, even without BMT, may be more effective than conventional immunosuppressive therapy in restoring normal hematopoiesis and preventing relapse or secondary clonal disorders. Hence, further studies confirming the efficacy of this approach in SAA are indicated.",1996,"A complete response (hemoglobin level, > 13 g/dL; absolute neutrophil count, > 1.5 x 10(9)/L, and platelet count > 125 x 10(9)/L) was achieved in 7 of the 10 patients.","['10 patients with SAA and lacking an HLA-identical sibling', 'without bone marrow transplantation', 'patients with SAA']","['Cyclophosphamide', 'Conventional immunosuppressive therapy', 'cyclophosphamide', 'conventional immunosuppressive therapy', 'allogeneic bone marrow transplantation (BMT) or immunosuppressive therapy', 'cyclosporine']","['median time to last platelet transfusion and time to 0.5 x 10(9) neutrophils/L', 'Severe aplastic anemia (SAA', 'severe aplastic anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]",10.0,0.0307918,"A complete response (hemoglobin level, > 13 g/dL; absolute neutrophil count, > 1.5 x 10(9)/L, and platelet count > 125 x 10(9)/L) was achieved in 7 of the 10 patients.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Brodsky', 'Affiliation': 'Johns Hopkins Oncology Center, Johns Hopkins Medical Institutions, Baltimore, MD 21287-8967, USA.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Sensenbrenner', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': ''}]",Blood,[]
392,8555493,Pharmacokinetics and immunomodulatory properties of intravenously administered recombinant human interleukin-10 in healthy volunteers.,"Normal volunteers received single doses of recombinant human interleukin-10 (rhIL-10; n = 6 per group) or placebo (n = 3 per group) by intravenous injection to characterize pharmacokinetics, tolerability, and immunomodulatory effects. Dosages were 0.1, 0.5, 1.0, 2.5, 5.0, 10.0, 25.0, 50.0, and 100.0 micrograms/kg. Dose-related adverse effects consisted of a mild-to-moderate flu-like syndrome characterized by fever with chills, headache, and myalgias at the highest dose. The mean terminal phase t1/2 ranged from 2.3 +/- 0.5 to 3.7 +/- 0.8 hours. Dose-related effects of rhIL-10 included transient increases of circulating neutrophils and monocytes and decreases of lymphocytes. rhIL-10 markedly suppressed, in a time- and dose-dependent manner, the synthesis of the inflammatory cytokines IL-1 beta and tumor necrosis factor alpha by whole blood stimulated ex vivo with bacterial lipopolysaccharide. Circulating numbers of CD14+/HLA-DR+ cells at 24 hours after the dose were increased in a dose-dependent manner. Effects on expression of HLA-DR by CD14+ cells were variable. There was no apparent effect on HLA-DR expression by CD20+ cells. The immunomodulatory effects of rhIL-10 merit further clinical investigation.",1996,Circulating numbers of CD14+/HLA-DR+ cells at 24 hours after the dose were increased in a dose-dependent manner.,['healthy volunteers'],"['recombinant human interleukin-10', 'recombinant human interleukin-10 (rhIL-10; n = 6 per group) or placebo']","['circulating neutrophils and monocytes and decreases of lymphocytes', 'Circulating numbers of CD14+/HLA-DR+ cells', 'HLA-DR expression', 'expression of HLA-DR by CD14+ cells']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0947286', 'cui_str': 'CD14+ cell'}]",,0.0725677,Circulating numbers of CD14+/HLA-DR+ cells at 24 hours after the dose were increased in a dose-dependent manner.,"[{'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Huhn', 'Affiliation': 'Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Radwanski', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': ""O'Connell"", 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Sturgill', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Cody', 'Affiliation': ''}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Affrime', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Cutler', 'Affiliation': ''}]",Blood,[]
393,8541533,Recombinant human erythropoietin in the anemia associated with multiple myeloma or non-Hodgkin's lymphoma: dose finding and identification of predictors of response.,"Previous phase I-II clinical trials have shown that recombinant human erythropoietin (rHuEpo) can ameliorate anemia in a portion of patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL). Therefore, we performed a randomized controlled multicenter study to define the optimal initial dosage and to identify predictors of response to rHuEpo. A total of 146 patients who had hemoglobin (Hb) levels < or = 11 g/dL and who had no need for transfusion at the time of enrollment entered this trial. Patients were randomized to receive 1,000 U (n = 31), 2,000 U (n = 29), 5,000 U (n = 31), or 10,000 U (n = 26) of rHuEpo daily subcutaneously for 8 weeks or to receive no therapy (n = 29). Of the patients, 84 suffered from MM and 62 from low- to intermediate-grade NHL, including chronic lymphocytic leukemia; 116 of 146 (79%) received chemotherapy during the study. The mean baseline Hb level was 9.4 +/- 1.0 g/dL. The median serum Epo level was 32 mU/mL, and endogenous Epo production was found to be defective in 77% of the patients, as judged by a value for the ratio of observed-to-predicted serum Epo levels (O/P ratio) of < or = 0.9. An intention-to-treat analysis was performed to evaluate treatment efficacy. The median average increase in Hb levels per week was 0.04 g/dL in the control group and -0.04 (P = .57), 0.22 (P = .05), 0.43 (P = .01), and 0.58 (P = .0001) g/dL in the 1,000 U, 2,000 U, 5,000 U, and 10,000 U groups, respectively (P values versus control). The probability of response (delta Hb > or = 2 g/dL) increased steadily and, after 8 weeks, reached 31% (2,000 U), 61% (5,000 U), and 62% (10,000 U), respectively. Regression analysis using Cox's proportional hazard model and classification and regression tree analysis showed that serum Epo levels and the O/P ratio were the most important factors predicting response in patients receiving 5,000 or 10,000 U. Approximately three quarters of patients presenting with Epo levels inappropriately low for the degree of anemia responded to rHuEpo, whereas only one quarter of those with adequate Epo levels did so. Classification and regression tree analysis also showed that doses of 2,000 U daily were effective in patients with an average platelet count greater than 150 x 10(9)/L. About 50% of these patients are expected to respond to rHuEpo. Thus, rHuEpo was safe and effective in ameliorating the anemia of MM and NHL patients who showed defective endogenous Epo production. From a practical point of view, we conclude that the decision to use rHuEpo in an individual anemic patient with MM or NHL should be based on serum Epo levels, whereas the choice of the initial dosage should be based on residual marrow function.",1995,"The median average increase in Hb levels per week was 0.04 g/dL in the control group and -0.04 (P = .57), 0.22 (P = .05), 0.43 (P = .01), and 0.58 (P =","['146 patients who had hemoglobin (Hb) levels < or = 11 g/dL and who had no need for transfusion at the time of enrollment entered this trial', 'patients receiving 5,000 or 10,000 U', ""patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL"", ""anemia associated with multiple myeloma or non-Hodgkin's lymphoma""]","['rHuEpo daily subcutaneously for 8 weeks or to receive no therapy', 'recombinant human erythropoietin (rHuEpo', 'chemotherapy', 'Recombinant human erythropoietin', 'rHuEpo']","['mean baseline Hb level', 'median serum', 'chronic lymphocytic leukemia', 'endogenous Epo production', 'median average increase in Hb levels', 'Epo level', 'serum Epo levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",146.0,0.0194456,"The median average increase in Hb levels per week was 0.04 g/dL in the control group and -0.04 (P = .57), 0.22 (P = .05), 0.43 (P = .01), and 0.58 (P =","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cazzola', 'Affiliation': 'Department of Internal Medicine, University of Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Messinger', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Battistel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bron', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cimino', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Enller-Ziegler', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Essers', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grossi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jäger', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'LeMevel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Najman', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Silingardi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spriano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Hoof', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ehmer', 'Affiliation': ''}]",Blood,[]
394,8541559,A controlled comparison of the efficacy of hetastarch and pentastarch in granulocyte collections by centrifugal leukapheresis.,"Compared with hetastarch (HS), the low molecular weight analog pentastarch (PS) has been reported to be equally effective for granulocyte collection by centrifugal leukapheresis, to result in fewer adverse donor reactions (ADR), and to have a more rapid elimination profile. We prospectively compared the granulocyte collection efficiency (GCE), granulocyte yield, and ADR in 72 randomly paired granulocytapheresis procedures from 36 volunteer donors using the model CS-3000 Plus Blood Cell Separator (CS) and either PS or HS as the sedimenting agent. Paired collections from each donor allowed us to compare the two agents directly while controlling for intrinsic donor differences. In 33 of 36 (92%) donors, HS procedures were significantly more efficient than PS procedures (P < .001). As an average, HS collections yielded 2.3 +/- 0.67 x 10(10) granulocytes at 58% +/- 8.8% GCE, whereas PS procedures resulted in 1.4 +/- 0.76 x 10(10) granulocytes at 33% +/- 15% GCE. No starch-induced ADR were seen with either agent. For granulocyte harvests using the CS, (1) in most donors, using HS as the red blood cell sedimenting agent during centrifugal leukapheresis results in significantly higher (nearly twofold) GCE and larger granulocyte yields in comparison with using PS, (2) ADR were not observed with either agent, and (3) the potential benefit of more rapid PS elimination should be balanced against significantly lower granulocyte yields.",1995,"In 33 of 36 (92%) donors, HS procedures were significantly more efficient than PS procedures (P < .001).",['72 randomly paired granulocytapheresis procedures from 36 volunteer donors using the model CS-3000 Plus Blood Cell Separator (CS) and either PS or HS as the sedimenting agent'],"['hetastarch (HS', 'hetastarch and pentastarch']","['granulocyte collection efficiency (GCE), granulocyte yield, and ADR']","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005773', 'cui_str': 'Blood Corpuscles'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C2350383', 'cui_str': 'Pentastarch'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}]",,0.0144009,"In 33 of 36 (92%) donors, HS procedures were significantly more efficient than PS procedures (P < .001).","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Leitman', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Klein', 'Affiliation': ''}]",Blood,[]
395,8611684,A randomized placebo-controlled trial of recombinant human interleukin-11 in cancer patients with severe thrombocytopenia due to chemotherapy.,"Thrombocytopenia is a complication of cancer treatment that can limit dose intensity. Interleukin-11 (IL-11) is a growth factor that increases platelet production. We conducted a multicenter, randomized, placebo-controlled trial of recombinant human IL-11 (rhIL-11) in 93 patients with cancer who had already been transfused platelets for severe thrombocytopenia resulting from chemotherapy. The patients had received platelet transfusions for nadir platelet counts of < or = 20,000/microL during the chemotherapy cycle immediately preceding study entry. Chemotherapy was continued during the study without dose reduction. Patients were randomized to receive placebo or rhIL-11 at 50 or 25 micrograms/kg subcutaneously once daily for 14 to 21 days beginning 1 day after chemotherapy. Eight of 27 (30%) evaluable patients treated with rhIL-11 at a dose of 50 micrograms/kg did not require platelet transfusions versus 1 of 27 (4%) patients who received placebo (P < .05). Five of 23 (18%) patients treated with rhIL-11 at 25 micrograms/kg avoided platelet transfusions (P = .23). Side effects were fatigue and cardiovascular symptoms, including a low incidence of atrial arrhythmias and syncope. There were no differences among treatment groups in the incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions. This study shows that rhIL-11 treatment of a dose of 50 micrograms/kg significantly increases the likelihood that patients who have already been transfused platelets for severe chemotherapy-induced thrombocytopenia will not require platelet transfusions during a subsequent chemotherapy cycle.",1996,"There were no differences among treatment groups in the incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions.","['93 patients with cancer who had already been transfused platelets for severe thrombocytopenia resulting from chemotherapy', 'cancer patients with severe thrombocytopenia due to chemotherapy']","['placebo', 'Chemotherapy', 'platelet transfusions', 'recombinant human IL-11 (rhIL-11', 'placebo or rhIL-11', 'recombinant human interleukin-11']","['platelet transfusions', 'fatigue and cardiovascular symptoms, including a low incidence of atrial arrhythmias and syncope', 'incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0083031', 'cui_str': 'Interleukin-11'}, {'cui': 'C0537670', 'cui_str': 'Oprelvekin'}]","[{'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0476270', 'cui_str': 'Cardiovascular symptoms (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}]",93.0,0.216288,"There were no differences among treatment groups in the incidence of neutropenic fever, days of hospitalization, or number of red blood cell transfusions.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tepler', 'Affiliation': 'Department of Medicine, Hematology-Oncology Division, Beth Israel Hospital, Boston, MA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Elias', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kuca', 'Affiliation': ''}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Beach', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Loewy', 'Affiliation': ''}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Garnick', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kaye', 'Affiliation': ''}]",Blood,[]
396,8611685,A phase I trial of recombinant human interleukin-11 (neumega rhIL-11 growth factor) in women with breast cancer receiving chemotherapy.,"We performed a phase I trial of recombinant human interleukin-11 (rhIL-11) in women with breast cancer. Cohorts of three to five women were accrued to five dosage levels of rhIL-11 (10, 25, 50, 75, and 100 micrograms/kg/d). rhIL-11 alone was administered by a daily subcutaneous injection for 14 days during a 28-day prechemotherapy ""cycle 0."" Patients (pts) subsequently received up to four 28-day cycles of cyclophosphamide (1,500 mg/m2) and doxorubicin (60 mg/m2) chemotherapy followed by rhIL-11 at their assigned dose (days 3 through 14). Sixteen pts (13 stage IV, 3 stage IIIB) were accrued to this study. Median age was 53 years and median Eastern Cooperative Oncology Group Performance Status was 0. A grade 3 neurologic event was seen in 1 pt at 100 micrograms/kg. Because of the degree of grade 2 constitutional symptoms (myalgias/arthralgias and fatigue) at 75 micrograms/kg, dose escalation was stopped and 75 micrograms/kg was the maximally tolerated dose. No other grade 3 or 4 adverse events related to rhIL-11 were seen. The administration of rhIL-11 was not associated with fever. Reversible grade 2 fatigue and myalgias/arthralgias were seen in all pts at 75 micrograms/kg. Weight gain of 3% to 5% associated with edema was seen at doses > 10 micrograms/kg but a capillary leak syndrome was not seen. rhIL-11 alone was associated with a mean 76%, 93%, 108%, and 185% increase in platelet counts at doses of 10, 25, 50, and 75 micrograms/kg, respectively. No significant changes in leukocytes were seen. A mean 19% decrease in hematocrit was observed. Acute-phase proteins increased with treatment at all doses. Compared with patients at the 10 micrograms/kg dose, patients receiving doses > or = 25 micrograms/kg experienced less thrombocytopenia in the first two cycles of chemotherapy. We conclude that rhIL-11 has thrombopoietic activity at all doses studied, is well tolerated at doses of 10, 25, and 50 micrograms/kg, and at doses > or = 25 micrograms/kg has the potential to reduce chemotherapy-induced thrombocytopenia in this model.",1996,Reversible grade 2 fatigue and myalgias/arthralgias were seen in all pts at 75 micrograms/kg.,"['women with breast cancer receiving chemotherapy', 'Cohorts of three to five women were accrued to five dosage levels of rhIL-11 (10, 25, 50, 75, and 100 micrograms/kg/d', 'Median age was 53 years and median Eastern Cooperative Oncology Group Performance Status was 0', 'women with breast cancer', 'Sixteen pts (13 stage IV, 3 stage IIIB']","['doxorubicin', 'recombinant human interleukin-11 (rhIL-11', 'recombinant human interleukin-11 (neumega rhIL-11 growth factor', 'cyclophosphamide']","['leukocytes', 'hematocrit', 'thrombocytopenia', 'platelet counts', 'Reversible grade 2 fatigue and myalgias/arthralgias', 'edema', 'Weight gain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0537670', 'cui_str': 'Oprelvekin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0083031', 'cui_str': 'Interleukin-11'}, {'cui': 'C0537670', 'cui_str': 'Oprelvekin'}, {'cui': 'C0537668', 'cui_str': 'Neumega'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",5.0,0.0547693,Reversible grade 2 fatigue and myalgias/arthralgias were seen in all pts at 75 micrograms/kg.,"[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Section of Hematology-Oncology, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'McCaskill-Stevens', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Battiato', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Loewy', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Loesch', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Breeden', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': ''}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Beach', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kuca', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': ''}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': ''}]",Blood,[]
397,8605328,A randomized phase-III study of the efficacy of granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia. Berlin-Frankfurt-Münster Study Group.,"Overall chemotherapeutic treatment results in pediatric acute lymphoblastic leukemia (ALL) are good, with event-free survival (EFS) rates over 70%. However, for a subset of patients characterized by high-risk (HR) features the outcome is less favorable, with EFS rates below 50%. Intensification of chemotherapy may improve the outcome for those patients, but increased toxicity, particularly myelosuppression, limits the escalation of dose intensity. Recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF) is known to reduce myelosuppression after cancer chemotherapy in adults. The objective of this study was to examine the effect of r-metHuG-CSF on myelosuppression in HR pediatric ALL patients and on the overall response rate to chemotherapy. Patients with HR pediatric ALL were randomized to receive nine alternating cycles of chemotherapy according to the German ALL-Berlin-Frankfurt-Münster 90 protocol either alone or followed by r-metHuG-CSF administered prophylactically at a dose of 5 microg/kg/d subcutaneously. In both groups, the planned interval between chemotherapy courses was a minimum of 21 days. We report here interim results of 34 patients. The incidence of febrile neutropenia (absolute neutrophil count <0.5 x 10(9)/L and oral temperature > or = 38.5 degrees C) was 17% in children receiving r-metHuG-CSF, as compared with 40% in the control group (P = .007). In addition, the median total duration of febrile neutropenia was reduced from 20.3 to 6.2 days per patient (P = .02). Culture-confirmed infections occurred less frequently in the r-metHuG-CSF group (8% v 15%; P = .04), and the total duration of intravenous antibiotic use was significantly reduced from 32.2 days to 18.2 days per patient (P = .02). A tighter adherence to the planned treatment schedule was also facilitated by r-metHuG-CSF (P = .007). With a median follow-up of 3.3 years, the estimated EFS of 4 years is 41% +/- 12%. In conclusion, r-metHuG-CSF administered prophylactically in the interval between chemotherapy courses significantly reduced febrile neutropenia, culture-confirmed infections, and duration of intravenous antibiotic administration and allowed for tighter adherence to the treatment schedule.",1996,"The incidence of febrile neutropenia (absolute neutrophil count <0.5 x 10(9)/L and oral temperature > or = 38.5 degrees C) was 17% in children receiving r-metHuG-CSF, as compared with 40% in the control group (P = .007).","['children with high-risk acute lymphoblastic leukemia', 'Patients with HR pediatric ALL', '34 patients', 'HR pediatric ALL patients', 'pediatric acute lymphoblastic leukemia (ALL', 'after cancer chemotherapy in adults']","['Recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF', 'granulocyte colony-stimulating factor', 'chemotherapy according to the German ALL-Berlin-Frankfurt-Münster 90 protocol either alone or followed by r-metHuG-CSF administered prophylactically at a dose of 5 microg/kg', 'chemotherapy']","['myelosuppression', 'toxicity, particularly myelosuppression', 'febrile neutropenia', 'median total duration of febrile neutropenia', 'survival (EFS) rates', 'febrile neutropenia, culture-confirmed infections, and duration of intravenous antibiotic administration', 'Culture-confirmed infections', 'total duration of intravenous antibiotic use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0474647,"The incidence of febrile neutropenia (absolute neutrophil count <0.5 x 10(9)/L and oral temperature > or = 38.5 degrees C) was 17% in children receiving r-metHuG-CSF, as compared with 40% in the control group (P = .007).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Welte', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Medical School Hannover, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mempel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pfetsch', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schwab', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riehm', 'Affiliation': ''}]",Blood,[]
398,8541564,Cord blood collection: effects on newborns (medical-legal),,1995,,['newborns (medical-legal'],['Cord blood collection'],[],"[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1301860', 'cui_str': 'Legal'}]","[{'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",[],,0.0195284,,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ende', 'Affiliation': ''}]",Blood,[]
399,2653461,Methotrexate and cyclosporine versus cyclosporine alone for prophylaxis of graft-versus-host disease in patients given HLA-identical marrow grafts for leukemia: long-term follow-up of a controlled trial.,"Patients with acute nonlymphoblastic leukemia (ANL) in first remission (n = 38) or chronic myelocytic leukemia (CML) (n = 55) were given cyclophosphamide and total body irradiation, followed by marrow infusion from HLA-identical siblings. To evaluate postgrafting prophylaxis for acute graft-versus-host disease (GVHD), the patients were randomized to receive either methotrexate and cyclosporine (n = 43) or cyclosporine alone (n = 50). Methotrexate/cyclosporine significantly reduced the incidence and severity of acute GVHD, and improved early survival. This report updates the results with a 3.0 to 4.5 year follow-up. Methotrexate/cyclosporine did not interfere with sustained hematopoietic engraftment, although granulocyte recovery to 1,000/microL was delayed by five days on the average. The incidence of chronic GVHD was identical in the two groups (26% v 24%). Disease-free 3-year survival was slightly better in the methotrexate/cyclosporine group (65% v 54%), but this benefit was restricted to patients with CML (73% v 54%), while no improvement was seen in patients with ANL (41% v 41%). In contrast to patients with CML (relapse rates 8% v 9%), the early survival benefit among patients with ANL given methotrexate/cyclosporine was offset by an increase in leukemic relapses (29% v 16%).",1989,"Disease-free 3-year survival was slightly better in the methotrexate/cyclosporine group (65% v 54%), but this benefit was restricted to patients with CML (73% v 54%), while no improvement was seen in patients with ANL (41% v 41%).","['Patients with acute nonlymphoblastic leukemia (ANL) in first remission (n = 38) or chronic myelocytic leukemia (CML) (n = 55', 'patients given HLA-identical marrow grafts for leukemia', 'acute graft-versus-host disease (GVHD']","['methotrexate/cyclosporine', 'Methotrexate and cyclosporine', 'methotrexate and cyclosporine', 'Methotrexate/cyclosporine', 'cyclophosphamide and total body irradiation, followed by marrow infusion from HLA-identical siblings', 'cyclosporine', 'cyclosporine alone']","['early survival benefit', 'incidence and severity of acute GVHD, and improved early survival', 'sustained hematopoietic engraftment', 'Disease-free 3-year survival', 'leukemic relapses', 'incidence of chronic GVHD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",55.0,0.0277445,"Disease-free 3-year survival was slightly better in the methotrexate/cyclosporine group (65% v 54%), but this benefit was restricted to patients with CML (73% v 54%), while no improvement was seen in patients with ANL (41% v 41%).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98104.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pepe', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beatty', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Berenson', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Clift', 'Affiliation': ''}]",Blood,[]
400,8417806,F reticulocyte response in sickle cell anemia treated with recombinant human erythropoietin: a double-blind study.,"Studies on baboons and preliminary observations in three patients with sickle cell anemia (SS) suggested that high doses of pulse administered recombinant human erythropoietin (rHuEPO) stimulate F-reticulocyte production. We now report on the administration of rHuEPO in a double-blind format to ascertain frequency of response and potential precipitation of side effects. Ten patients were enrolled, but one was discontinued due to the indication of a blood transfusion. Of the other nine, five received rHuEPO in escalating doses (from 400 to 1,500 U per kg twice daily [BID] per week), alternating with a placebo, in blinded fashion. The second group, consisting of four patients, followed an identical protocol (except starting dose was 1,000 U/Kg, BID per week) and were iron supplemented during treatment. The criterion of response was a transient doubling (as a minimum) of the steady-state F-reticulocyte level. We found that none of the five patients in the first group responded to rHuEPO, and two of them became iron deficient, as judged by a significant decrease in ferritin. Of the second group, four patients responded with F-reticulocyte increases. In three patients, open label administration of rHuEPO confirmed the effect. We observed seven painful episodes during this study, two during the EPO administration and five during the placebo arm. Three patients were phlebotomized because the hemoglobin level increased 1.5 g/dL more than steady-state levels. Of the six patients followed-up by percent dense cell determinations, one exhibited increased levels during periods of the treatment, whereas the other five showed no change. No anti-rHuEPO antibodies were detected. We conclude that rHuEPO can stimulate F-reticulocyte response in some patients with sickle cell anemia, without apparent negative clinical side effects. The state of iron stores may be critical. Whether higher doses of rHuEPO and/or a different regimen might induce sustained F cells and fetal hemoglobin increases remains to be determined.",1993,No anti-rHuEPO antibodies were detected.,"['Ten patients were enrolled, but one was discontinued due to the indication of a blood transfusion', 'patients with sickle cell anemia', 'sickle cell anemia treated with', 'three patients with sickle cell anemia (SS']","['recombinant human erythropoietin (rHuEPO', 'rHuEPO', 'placebo', 'recombinant human erythropoietin']","['ferritin', 'No anti-rHuEPO antibodies', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3.0,0.0864583,No anti-rHuEPO antibodies were detected.,"[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Nagel', 'Affiliation': 'Albert Einstein College of Medicine/Montefiore Medical Center, New York, NY 10461.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vichinsky', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Spadacino', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Fabry', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mangahas', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Abel', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stamatoyannopoulos', 'Affiliation': ''}]",Blood,[]
401,8471778,A prospective randomized comparison of total body irradiation-etoposide versus busulfan-cyclophosphamide as preparatory regimens for bone marrow transplantation in patients with leukemia who were not in first remission: a Southwest Oncology Group study.,"Two novel preparatory regimens for conditioning of patients with leukemia for allogeneic bone marrow transplantation (BMT) from histocompatible sibling donors have been tested in a phase III trial under the auspices of the Southwest Oncology Group (SWOG 8612). These two regimens consisted either of fractionated total body irradiation and etoposide (FTBI/VP-16) or high-dose busulfan with cyclophosphamide (BU/CY). Only patients who had failed prior conventional management at least once were study eligible, ie, no patients with acute leukemia in first remission (CR) or in first chronic phase (CP) of chronic myelogenous leukemia (CML) participated. Patients were stratified according to the following risk criteria: ""good-risk"" patients were those who were in second CR of their acute leukemia or in accelerated phase (AP) of CML; ""poor-risk"" patients had further advanced stages of leukemia. During a 52-month period, 131 patients were registered of whom 122 (93%) were study eligible. Sixty-one eligible patients were randomized to the FTBI/VP-16 arm and 61 to the BU/CY regimen. Of these 122 patients, 114 (93%) proceeded to BMT according to protocol. Posttransplant immunosuppression to prevent graft-versus-host disease (GVHD) consisted of cyclosporine and prednisone (CSA/PSE). Neither overall survival nor disease-free survival (DFS) differed significantly between the two treatment groups (P = .89 and .69, respectively). Estimated DFS for ""good-risk"" patients who had been prepared with the FTBI/VP-16 regimen was 55% +/- 11%, as compared with patients treated with BU/CY whose DFS figure was 34% +/- 10% (P = .30). For ""poor-risk"" candidates, the DFS rates at 24 months were 17% +/- 6% (for FTBI/VP-16) and 24% +/- 8% (for BU/CY), respectively (P = .81). These figures do not differ significantly, especially in view of the fact that the ""good-risk"" patients prepared with the FTBI/VP-16 regimen were younger than those treated with BU/CY. Both regimens were well tolerated with no regimen-related deaths encountered during the 6-week period after BMT. This study also confirmed the efficacy of the CSA/PSE combination in the prevention of GVHD with 23 of 113 (20%) of BMT recipients developing moderate to severe acute GVHD. The leading cause for treatment failure was leukemic relapse (45 of the 114 BMT recipients suffered a recurrence of their leukemia), whereas 38 patients died without evidence of relapse. Thirty-one patients are alive and in continued CR after marrow transplantation; four are alive in relapse.(ABSTRACT TRUNCATED AT 400 WORDS)",1993,"Neither overall survival nor disease-free survival (DFS) differed significantly between the two treatment groups (P = .89 and .69, respectively).","['Sixty-one eligible patients', '131 patients were registered of whom 122 (93%) were study eligible', 'patients with leukemia who were not in first remission', '122 patients, 114 (93%) proceeded to BMT according to protocol', 'Patients were stratified according to the following risk criteria: ""good-risk"" patients were those who were in second CR of their acute leukemia or in accelerated phase (AP) of CML; ""poor-risk"" patients had further advanced stages of leukemia', 'Only patients who had failed prior conventional management at least once were study eligible, ie, no patients with acute leukemia in first remission (CR) or in first chronic phase (CP) of chronic myelogenous leukemia (CML) participated', 'patients with leukemia for allogeneic bone marrow transplantation (BMT) from histocompatible sibling donors', 'GVHD with 23 of 113 (20%) of BMT recipients developing moderate to severe acute GVHD']","['FTBI/VP-16', 'CSA/PSE combination', 'total body irradiation-etoposide versus busulfan-cyclophosphamide', 'fractionated total body irradiation and etoposide (FTBI/VP-16) or high-dose busulfan with cyclophosphamide (BU/CY', 'cyclosporine and prednisone (CSA/PSE']","['DFS figure', 'overall survival nor disease-free survival (DFS', 'DFS rates']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0733688', 'cui_str': 'VP-16'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",131.0,0.0177759,"Neither overall survival nor disease-free survival (DFS) differed significantly between the two treatment groups (P = .89 and .69, respectively).","[{'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Blume', 'Affiliation': 'Stanford University Medical Center, CA.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Kopecky', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Henslee-Downey', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Forman', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Stiff', 'Affiliation': ''}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'LeMaistre', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
402,8490166,A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (filgrastim) for treatment of severe chronic neutropenia.,"Patients with idiopathic, cyclic, and congenital neutropenia have recurrent severe bacterial infections. One hundred twenty-three patients with recurrent infections and severe chronic neutropenia (absolute neutrophil count < 0.5 x 10(9)/L) due to these diseases were enrolled in this multicenter phase III trial. They were randomized to either immediately beginning recombinant human granulocyte colony-stimulating factor (filgrastim) (3.45 to 11.50 micrograms/kg/d, subcutaneously) or entering a 4-month observation period followed by filgrastim administration. Blood neutrophil counts, bone marrow (BM) cell histology, and incidence and duration of infection-related events were monitored. Of the 123 patients enrolled, 120 received filgrastim. On therapy, 108 patients had a median absolute neutrophil count of > or = 1.5 x 10(9)/L. Examination of BM aspirates showed increased proportions of maturing neutrophils. Infection-related events were significantly decreased (P < .05) with approximately 50% reduction in the incidence and duration of infection-related events and almost 70% reduction in duration of antibiotic use. Asymptomatic splenic enlargement occurred frequently; adverse events frequently reported were bone pain, headache, and rash, which were generally mild and easily manageable. These data indicate that treatment of patients with severe chronic neutropenia with filgrastim results in a stimulation of BM production and maturation of neutrophils, an increase in circulating neutrophils, and a reduction in infection-related events.",1993,Infection-related events were significantly decreased (P < .05) with approximately 50% reduction in the incidence and duration of infection-related events and almost 70% reduction in duration of antibiotic use.,"['severe chronic neutropenia', 'One hundred twenty-three patients with recurrent infections and severe chronic neutropenia (absolute neutrophil count < 0.5 x 10(9)/L) due to these diseases', 'patients with severe chronic neutropenia with', 'Patients with idiopathic, cyclic, and congenital neutropenia have recurrent severe bacterial infections', '123 patients enrolled, 120 received']","['immediately beginning recombinant human granulocyte colony-stimulating factor (filgrastim', 'recombinant human granulocyte colony-stimulating factor (filgrastim', 'filgrastim']","['bone pain, headache, and rash', 'duration of antibiotic use', 'Infection-related events', 'Blood neutrophil counts, bone marrow (BM) cell histology, and incidence and duration of infection-related events', 'proportions of maturing neutrophils', 'median absolute neutrophil count']","[{'cui': 'C2931027', 'cui_str': 'Neutropenia, severe chronic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0340970', 'cui_str': 'Severe congenital neutropenia'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C0151825', 'cui_str': 'Bone pain (finding)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0005955', 'cui_str': 'Bone Marrow Cells'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",123.0,0.0155957,Infection-related events were significantly decreased (P < .05) with approximately 50% reduction in the incidence and duration of infection-related events and almost 70% reduction in duration of antibiotic use.,"[{'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Dale', 'Affiliation': 'Department of Medicine, University of Washington, Seattle 98195.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bonilla', 'Affiliation': ''}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Nakanishi', 'Affiliation': ''}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Hammond', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kurtzberg', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jakubowski', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Winton', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lalezari', 'Affiliation': ''}]",Blood,[]
403,8427957,Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: a Pediatric Oncology Group study.,"Children with acute lymphoblastic leukemia (ALL) who have completed 2.5 to 3 years of initial chemotherapy have an off-therapy relapse rate of approximately 20%. In an attempt to improve the survival of children with a late bone marrow (BM) relapse (ie, occurring greater than 6 months after cessation of primary therapy), the Pediatric Oncology Group designed a randomized study to compare the efficacy of doxorubicin/prednisone and cytarabine/teniposide in a multidrug retreatment chemotherapy program. Treatment consisted of remission reinduction with vincristine, prednisone, and doxorubicin, central nervous system prophylaxis with triple intrathecal chemotherapy, and continuation therapy (for 132 weeks) with alternating cycles of oral 6-mercaptopurine/methotrexate and intravenous vincristine/cyclophosphamide. Patients received intermittent courses of either prednisone/doxorubicin (regimen 1) or teniposide/cytarabine (regimen 2) during continuation therapy and a late intensification phase with either vincristine, prednisone, and doxorubicin (regimen 1) or teniposide and cytarabine (regimen 2). One hundred two of 105 evaluable patients (97%) achieved a second complete remission. Twenty-eight of 50 patients on regimen 1 have failed compared with 28 or 52 patients on regimen 2 (log-rank analysis, P = .68), indicating that this trial was inconclusive as to which treatment regimen was superior. The overall 4-year event-free survival for children with a late BM relapse was 37% +/- 6%. Age less than 10 years at initial diagnosis (P < or = .001), white blood cell count less than 5,000/microL at relapse (P = .036) and duration of first remission greater than 54 months (P = .039) were independently associated with a more favorable outcome. While the randomized trial was inconclusive, prolonged second complete remissions were secured in more than one-third of children with a late BM relapse of ALL. The prognostic factors identified may help select children with a late BM relapse who can be successfully retreated with chemotherapy alone.",1993,"Twenty-eight of 50 patients on regimen 1 have failed compared with 28 or 52 patients on regimen 2 (log-rank analysis, P = .68), indicating that this trial was inconclusive as to which treatment regimen was superior.","['children with acute lymphoblastic leukemia', 'Children with acute lymphoblastic leukemia (ALL) who have completed 2.5 to 3 years of initial chemotherapy have an off-therapy relapse rate of approximately 20']","['doxorubicin/prednisone and cytarabine/teniposide', 'teniposide/cytarabine', 'vincristine, prednisone, and doxorubicin, central nervous system prophylaxis with triple intrathecal chemotherapy, and continuation therapy', '6-mercaptopurine/methotrexate and intravenous vincristine/cyclophosphamide', 'vincristine, prednisone, and doxorubicin (regimen 1) or teniposide and cytarabine', 'prednisone/doxorubicin']","['second complete remission', 'overall 4-year event-free survival', 'survival of children with a late bone marrow (BM) relapse', 'duration of first remission']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0217388,"Twenty-eight of 50 patients on regimen 1 have failed compared with 28 or 52 patients on regimen 2 (log-rank analysis, P = .68), indicating that this trial was inconclusive as to which treatment regimen was superior.","[{'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Sadowitz', 'Affiliation': 'Department of Pediatrics, SUNY Health Science Center, Syracuse 13210.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Wharam', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Rivera', 'Affiliation': ''}]",Blood,[]
404,8400255,A randomized controlled trial of pentoxifylline for the prevention of regimen-related toxicities in patients undergoing allogeneic marrow transplantation.,"This study evaluated the effect of pentoxifylline (PTX) on the incidence of regimen-related toxicity in patients receiving allogeneic marrow transplants from related donors. All patients received a regimen of methotrexate and cyclosporine as prophylaxis against acute graft-versus-host disease (GVHD). Patients were randomized to receive PTX or a placebo for 70 days and the outcome was examined in a blinded fashion. Forty-four patients were evaluate in each study arm. PTX had no significant effect on engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization. Patients receiving PTX were significantly more likely to develop major elevations of serum creatinine levels. PTX was poorly tolerated and induced significantly more vomiting than the placebo. PTX as administered in this randomized study was associated with significant toxicity and offered no benefit in reducing transplant-related morbidity or mortality.",1993,"PTX had no significant effect on engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization.","['patients undergoing allogeneic marrow transplantation', 'patients receiving allogeneic marrow transplants from related donors']","['pentoxifylline', 'PTX', 'placebo', 'pentoxifylline (PTX', 'methotrexate and cyclosporine']","['toxicity', 'serum creatinine levels', 'engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization', 'vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",44.0,0.145658,"PTX had no significant effect on engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Singer', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bakke', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bowden', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': ''}]",Blood,[]
405,8453092,Natural interferon-alpha in combination with melphalan/prednisone versus melphalan/prednisone in the treatment of multiple myeloma stages II and III: a randomized study from the Myeloma Group of Central Sweden.,"Three hundred thirty-five previously untreated patients with multiple myeloma in clinical stages II and III entered a randomized trial comparing intermittent oral melphalan and prednisone (MP) therapy (n = 171) with MP in combination with natural (leukocyte-derived) alpha-interferon (MP/IFN) (n = 164). The treatment groups were comparable with regard to major prognostic factors. The response frequency was 42% in the MP group and 68% in the MP/IFN group (P < .0001). Eighty-five percent of IgA myelomas and 71% of Bence-Jones myelomas responded to MP/IFN compared with 48% and 27%, respectively, to MP treatment (P = .001). There was no difference in the overall survival between the two treatment groups. However, the survival of 72 patients with IgA or Bence-Jones myeloma randomized to receive MP/IFN was significantly longer (median 32 months) than that of 71 patients treated with MP (median 17 months) (p < .05). No statistically significant difference in response frequency (60% v 46%) or survival was found for patients with IgG myeloma. Hematologic toxicity, WHO grades III and IV, was higher in the MP/IFN group (48%) than in the MP group (33%) (P < .05) during the induction treatment period. Flulike syndrome was observed in 68% of patients receiving MP/IFN. The results show that MP/IFN is a well-tolerated treatment regimen, superior to MP for remission induction, and it improves significantly the overall survival for patients with IgA and Bence-Jones myelomas.",1993,No statistically significant difference in response frequency (60% v 46%) or survival was found for patients with IgG myeloma.,"['Three hundred thirty-five previously untreated patients with multiple myeloma in clinical stages II and III', 'multiple myeloma stages II and III', 'n = 171) with']","['intermittent oral melphalan and prednisone (MP) therapy', 'MP/IFN', 'MP in combination with natural (leukocyte-derived) alpha-interferon (MP/IFN', 'Natural interferon-alpha in combination with melphalan/prednisone versus melphalan/prednisone']","['Flulike syndrome', 'Hematologic toxicity, WHO grades III and IV', 'MP/IFN', 'overall survival', 'response frequency', 'survival']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",335.0,0.0366279,No statistically significant difference in response frequency (60% v 46%) or survival was found for patients with IgG myeloma.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Osterborg', 'Affiliation': 'Department of Oncology (Radiumhemmet), Karolinska Hospital, Stockholm.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Björkholm', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Björeman', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Brenning', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Carlson', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Celsing', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gahrton', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grimfors', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gyllenhammar', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hast', 'Affiliation': ''}]",Blood,[]
406,8461472,Dietary omega-3 fatty acids lower levels of platelet-derived growth factor mRNA in human mononuclear cells.,"Platelet-derived growth factor (PDGF) is a potent mitogen thought to propagate atherosclerosis and other proliferative or inflammatory diseases. Some of these diseases are ameliorated in humans by ingestion of omega-3 fatty acids. We investigated mRNA expression of both PDGF-A and PDGF-B in quiescent peripheral blood mononuclear cells from healthy male volunteers. For this, a highly sensitive, quantitative polymerase chain reaction strategy (3n-PCR) was developed. In contrast to granulocytes, both PDGF-A and PDGF-B mRNAs are expressed in mononuclear cells. This expression occurs at a remarkably constant rate. Moreover, effects of 7 g/d of a 85% omega-3 fatty acid fish oil concentrate were investigated in a 6-week controlled, randomized, observer-blind study in 14 human volunteers, 7 of whom served as controls. omega-3 Fatty acids increased in mononuclear cell phospholipids. We demonstrate for the first time that diet affects human gene regulation. Dietary omega-3 fatty acids downregulate gene expression of both PDGF-A (-66%), and PDGF-B (-70%). This may represent a novel mechanism for the antifibrotic and antiatherosclerotic action of omega-3 fatty acids.",1993,"Dietary omega-3 fatty acids downregulate gene expression of both PDGF-A (-66%), and PDGF-B (-70%).","['14 human volunteers, 7 of whom served as controls', 'human mononuclear cells', 'healthy male volunteers']","['Dietary omega-3 fatty acids', 'PDGF-A and PDGF-B', 'omega-3 fatty acid fish oil concentrate', 'Platelet-derived growth factor (PDGF', 'omega-3 Fatty acids']",['mononuclear cell phospholipids'],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0169533', 'cui_str': 'PDGF-A'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0032200', 'cui_str': 'Platelet-Derived Growth Factor'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}]",14.0,0.0192724,"Dietary omega-3 fatty acids downregulate gene expression of both PDGF-A (-66%), and PDGF-B (-70%).","[{'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Kaminski', 'Affiliation': 'Medizinische Klinik, Klinikum Innenstadt, University of Munich, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jendraschak', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kiefl', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'von Schacky', 'Affiliation': ''}]",Blood,[]
407,8461475,Long-term follow-up of a phase III study of recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid malignancies.,"One hundred and twenty-eight patients with non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), and acute lymphoblastic leukemia (ALL) previously reported from a phase III trial of rhGM-CSF or placebo following autologous bone marrow transplantation (ABMT) were investigated for the development of late toxicities. Median follow-up is 36 months. No apparent long-term deleterious effects on BM function were observed. Moreover, disease-free survival and overall survival were similar for patients on both treatment arms, arguing for the long-term safety of recombinant human granulocyte macrophage-colony-stimulating factor (rhGM-CSF). The only factors predictive for both a high risk of relapse over time and mortality were having the diagnosis of ALL and/or undergoing ABMT in resistant relapse. We attempted to identify clinical variables before BM harvest, at the time of marrow infusion, or events within the first 100 days posttransplant, which might predict speed of neutrophil recovery in the setting of placebo or rhGM-CSF administration after ABMT. Only previous exposure to agents that deplete stem cells led to a significant delay in neutrophil recovery, suggesting their avoidance in patients who may undergo ABMT. Nevertheless, even those patients benefited from rhGM-CSF. For all patients, rhGM-CSF and agents that deplete stem cells were the strongest independent predictors for neutrophil engraftment. With the increasing use of newer hematopoietic growth factors both alone and in combination, long-term follow-up is essential to confirm the same safety that we report with rhGM-CSF.",1993,"For all patients, rhGM-CSF and agents that deplete stem cells were the strongest independent predictors for neutrophil engraftment.","['patients who may undergo ABMT', ""One hundred and twenty-eight patients with non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), and acute lymphoblastic leukemia (ALL) previously reported from a phase III trial of rhGM-CSF or placebo following autologous bone marrow transplantation (ABMT"", 'lymphoid malignancies']",['recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation'],"['neutrophil recovery', 'BM function', 'disease-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",128.0,0.0379909,"For all patients, rhGM-CSF and agents that deplete stem cells were the strongest independent predictors for neutrophil engraftment.","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rabinowe', 'Affiliation': 'Division of Tumor Immunology, Dana-Farber Cancer Institute, Boston, MA 02115.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Neuberg', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Bierman', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Vose', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nemunaitis', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Singer', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Freedman', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mauch', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Demetri', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Onetto', 'Affiliation': ''}]",Blood,[]
408,8193351,Amifostine (WR-2721) shortens the engraftment period of 4-hydroperoxycyclophosphamide-purged bone marrow in breast cancer patients receiving high-dose chemotherapy with autologous bone marrow support.,"4-Hydroperoxycyclophosphamide (4-HC), a commonly used marrow-purging agent, is active against many tumors, but is also toxic to normal marrow progenitors. Amifostine (WR-2721) is a sulfhydryl compound with chemoprotectant activity. Preclinical studies using suspensions of bone marrow and breast cancer cells demonstrated that ex vivo treatment with amifostine followed by 4-HC resulted in protection of marrow progenitors, with no compromise in the antitumor effect of 4-HC. This fact stimulated the development of a clinical trial. Bone marrow was harvested from 15 poor-prognosis breast cancer patients and randomly assigned to ex vivo treatment with amifostine followed by 4-HC (amifostine + 4-HC), or treatment with 4-HC alone. High-dose chemotherapy was then administered followed by infusion of the purged autologous bone marrow support (ABMS). Leukocyte engraftment, defined as a white blood cell count > or = 1 x 10(9)/L, was achieved in an average of 26 days for patients whose marrow was purged with amifostine + 4-HC versus 36 days for patients whose marrow was purged with 4-HC alone (P = .032). The average number of platelet transfusions (12 v 29; P = .017) and days of antibiotic therapy (28 v 40; P = .012) were significantly less for patients whose marrow was exposed to amifostine + 4-HC, compared with 4-HC alone. Unpurged backup marrow fractions were infused into three patients whose marrow was purged with 4-HC alone, because of inadequate marrow recovery. None of the patients who received amifostine + 4-HC-purged marrow required a backup marrow fraction. Complete remissions were achieved in 83% of patients with measurable disease, with no difference between the two cohorts. Forty-three percent of patients remained alive and progression-free at a mean of 13 months posttransplant. There was no significant difference in the rate or pattern of relapse for patients whose marrow was purged with amifostine + 4-HC compared with those whose marrow was purged with 4-HC alone. Ex vivo treatment of marrow with amifostine significantly shortens the time to marrow recovery, thereby reducing the risk of myelosuppressive complications in breast cancer patients receiving high-dose chemotherapy and 4-HC-purged ABMS. Since supportive care requirements are also significantly decreased, amifostine may reduce the cost of such therapy.",1994,"The average number of platelet transfusions (12 v 29; P = .017) and days of antibiotic therapy (28 v 40; P = .012) were significantly less for patients whose marrow was exposed to amifostine + 4-HC, compared with 4-HC alone.","['breast cancer patients receiving high-dose chemotherapy and 4-HC-purged ABMS', '15 poor-prognosis breast cancer patients', 'breast cancer patients receiving high-dose chemotherapy with autologous bone marrow support']","['High-dose chemotherapy', '4-HC alone', 'amifostine followed by 4-HC (amifostine + 4-HC', 'amifostine + 4-HC', '4-Hydroperoxycyclophosphamide (4-HC', 'Amifostine (WR-2721', 'amifostine']","['Complete remissions', 'Leukocyte engraftment', 'average number of platelet transfusions', 'rate or pattern of relapse', 'alive and progression-free', 'risk of myelosuppressive complications', 'protection of marrow progenitors']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0163054', 'cui_str': 'perfosfamide'}, {'cui': 'C0729078', 'cui_str': 'WR-2721'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}]",,0.0129211,"The average number of platelet transfusions (12 v 29; P = .017) and days of antibiotic therapy (28 v 40; P = .012) were significantly less for patients whose marrow was exposed to amifostine + 4-HC, compared with 4-HC alone.","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Shpall', 'Affiliation': 'Bone Marrow Transplant Program, University of Colorado, Denver, CO 80262.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hami', 'Affiliation': ''}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Franklin', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Bonner', 'Affiliation': ''}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Bearman', 'Affiliation': ''}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Bast', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'McCulloch', 'Affiliation': ''}]",Blood,[]
409,8260695,Chemotherapy of intermediate- and high-grade non-Hodgkin's lymphomas with an intensive epirubicin-containing regimen.,"An intensive chemotherapy regimen (EVDAC), including high-dose epirubicin, vincristine, and dexamethasone followed by cyclophosphamide and high-dose cytarabine, was administered to 54 untreated adults with intermediate or high-grade non-Hodgkin's lymphomas (NHL). The median age was 59, 61% were Ann Arbor Stage IV, 57% had ""B"" symptoms, 50% had serum lactate dehydrogenase greater than 250 U/L, and 48% had masses greater than 7 cm (33% > 10 cm) in diameter. Seventy-six percent of patients attained complete or probable complete remissions. The Kaplan-Meier actuarial failure-free survival at 7 years is 50%, and 59% (32 of 54) of all patients started on therapy remain alive and in first remission at a median of 62+ (range, 49+ to 76+) months from completion of therapy. Nearly all patients developed severe neutropenia. Febrile episodes requiring hospitalization during neutropenia occurred after 56% of courses of epirubicin, vincristine, and dexamethasone and after 9% of courses of cyclophosphamide and cytarabine; 80% of patients were hospitalized at least once. Platelet count nadirs of less than 20,000/microL occurred after only 1 of 146 evaluable courses of epirubicin and after none of the cyclophosphamide/cytarabine courses. Although 8 patients had decreases of at least 0.12 in their left ventricular ejection fractions (5 to below normal levels), none have developed clinically evident congestive heart failure. Clinically significant mucositis occurred after only 8% of courses of high-dose epirubicin. Three deaths from infections and one from hyperkalemia with cardiac arrest occurred during therapy. These results confirm that high remission and sustained, failure-free survival rates can be achieved in patients with aggressive NHL, using high-dose anthracycline-containing chemotherapy regimens. Epirubicin appears to have an advantage over doxorubicin at high doses because of decreased toxicity at a therapeutically equivalent dose. These phase II study results need to be validated in a randomized phase III trial, and growth factors should be used to attempt to reduce the neutropenia-associated complications.",1993,"Although 8 patients had decreases of at least 0.12 in their left ventricular ejection fractions (5 to below normal levels), none have developed clinically evident congestive heart failure.","[""Chemotherapy of intermediate- and high-grade non-Hodgkin's lymphomas with an intensive epirubicin-containing regimen"", ""54 untreated adults with intermediate or high-grade non-Hodgkin's lymphomas (NHL""]","['doxorubicin', 'cyclophosphamide/cytarabine', 'epirubicin', 'intensive chemotherapy regimen (EVDAC), including high-dose epirubicin, vincristine, and dexamethasone followed by cyclophosphamide and high-dose cytarabine', 'Epirubicin', 'cyclophosphamide and cytarabine', 'epirubicin, vincristine, and dexamethasone']","['hyperkalemia with cardiac arrest', 'Febrile episodes requiring hospitalization during neutropenia', 'toxicity', 'complete or probable complete remissions', 'Platelet count nadirs', 'mucositis', 'B"" symptoms', 'Kaplan-Meier actuarial failure-free survival', 'serum lactate dehydrogenase', 'severe neutropenia', 'high remission and sustained, failure-free survival rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",54.0,0.0243496,"Although 8 patients had decreases of at least 0.12 in their left ventricular ejection fractions (5 to below normal levels), none have developed clinically evident congestive heart failure.","[{'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Zuckerman', 'Affiliation': 'Department of Medicine, University of South Florida, Tampa.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Case', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gams', 'Affiliation': ''}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Prasthofer', 'Affiliation': ''}]",Blood,[]
410,8142663,Recovery of HLA-restricted cytomegalovirus (CMV)-specific T-cell responses after allogeneic bone marrow transplant: correlation with CMV disease and effect of ganciclovir prophylaxis.,"Protection from cytomegalovirus (CMV) disease in immunocompromised hosts has been shown to correlate with recovery of the host virus-specific CD8+ T-cell response. The administration of ganciclovir to immunosuppressed transplant recipients as antiviral prophylaxis has reduced the early risk of CMV disease, but late disease is observed with increased frequency, suggesting that recovery of the CMV-specific T-cell responses necessary for protective immunity may be delayed in these patients. Therefore, we evaluated reconstitution of CMV-specific T-cell responses in 47 bone marrow transplant (BMT) recipients entered on a randomized placebo-controlled study of ganciclovir. The study drug was initiated at a mean of 24 days after BMT. At day 30 to 40, a minority of patients had recovery of T-cell immunity to CMV and the frequency of reconstitution was equivalent in patients randomized to ganciclovir or placebo. The failure of ganciclovir to effect early reconstitution may reflect the short duration of treatment. Early recovery was associated with the infusion of BM from a CMV seropositive donor (P = .07 for CD8+ cytotoxic T cell (CTL), P = .04 for CD4+ Th). Between day 40 and day 90, recovery of deficient CD8+ and CD4+ CMV-specific T-cell responses occurred in the majority of individuals that received placebo, but in a minority of ganciclovir recipients. Two cases of late-onset CMV disease occurred in ganciclovir recipients. In all patients, the presence of a CTL response to CMV conferred protection from subsequent CMV disease (P = .005), and these protective CTL responses are shown to be specific for structural virion proteins similar to the responses in immunocompetent CMV seropositive individuals. These data confirm the importance of CMV-specific T-cell responses and suggest that a delay in recovery of these responses as a result of ganciclovir prophylaxis may contribute to the occurrence of late CMV disease.",1994,"Early recovery was associated with the infusion of BM from a CMV seropositive donor (P = .07 for CD8+ cytotoxic T cell (CTL), P = .04 for CD4+ Th).","['47 bone marrow transplant (BMT) recipients entered on a randomized', 'immunosuppressed transplant recipients']","['allogeneic bone marrow transplant', 'ganciclovir or placebo', 'placebo', 'ganciclovir prophylaxis', 'ganciclovir']","['Recovery of HLA-restricted cytomegalovirus (CMV)-specific T-cell responses', 'recovery of deficient CD8+ and CD4+ CMV-specific T-cell responses', 'late-onset CMV disease', 'recovery of T-cell immunity to CMV and the frequency of reconstitution']","[{'cui': 'C4545296', 'cui_str': 'Bone marrow transplant recipient'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}]","[{'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0452508,"Early recovery was associated with the infusion of BM from a CMV seropositive donor (P = .07 for CD8+ cytotoxic T cell (CTL), P = .04 for CD4+ Th).","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Li', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Department of Medicine, University of Washington, Seattle 98104.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Gilbert', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Goodrich', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Riddell', 'Affiliation': ''}]",Blood,[]
411,8123837,Prognostic significance of the Ki-67-associated proliferative antigen in aggressive non-Hodgkin's lymphomas: a prospective Southwest Oncology Group trial.,"The growth fraction of tumors from patients with non-Hodgkin's lymphomas (NHL) has been shown to correlate with survival in retrospective studies. The growth fraction can be evaluated using immunohistochemical techniques employing the Ki-67 monoclonal antibody (MoAb) that marks a nuclear protein present in cycling cells. The purpose of this study was to evaluate the clinical utility of the Ki-67 MoAb for predicting survival. Using a prospective trial design in a multi-institutional cooperative trials group, the proliferative index, clinical outcome, and statistical correlations were independently assessed for previously untreated patients with advanced stages of intermediate- and high-grade histologies of NHL treated on Southwest Oncology Group study (SWOG 8516, Intergroup 0067). The proportion of Ki-67-positive cells was determined on snap-frozen thin tissue sections. A proliferative index of 80% or greater, as determined from prior retrospective studies, identified a group of patients (18%) who had a poor outcome. Overall survival was significantly reduced in these patients with a high Ki-67-associated proliferative index compared with those with a low proliferative index (P = .001). One-year survival estimates were 82% (low proliferative index) versus 18% (high proliferative index). A multivariate regression analysis incorporating commonly used clinical prognostic features confirmed the independent effect of proliferation on survival (relative risk estimate 5.9; 95% confidence interval, 2.2, 16.1). The Ki-67 MoAb identifies a group of patients with rapidly fatal NHL for whom currently available chemotherapy is inadequate.",1994,Overall survival was significantly reduced in these patients with a high Ki-67-associated proliferative index compared with those with a low proliferative index (P = .001).,"[""patients with non-Hodgkin's lymphomas (NHL"", ""aggressive non-Hodgkin's lymphomas"", 'previously untreated patients with advanced stages of intermediate- and high-grade histologies of NHL treated on Southwest Oncology Group study (SWOG 8516, Intergroup 0067']",[],"['Overall survival', 'survival', 'proportion of Ki-67-positive cells', 'One-year survival estimates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0330592,Overall survival was significantly reduced in these patients with a high Ki-67-associated proliferative index compared with those with a low proliferative index (P = .001).,"[{'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Miller', 'Affiliation': 'University of Arizona, Tucson.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Grogan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dahlberg', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Spier', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Braziel', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Banks', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Foucar', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Kjeldsberg', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Nathwani', 'Affiliation': ''}]",Blood,[]
412,8338943,"Prevention of regimen-related toxicities after bone marrow transplantation by pentoxifylline: a prospective, randomized trial.","Elevated levels of tumor necrosis factor alpha (TNF-alpha) have been reported to correlate with the development of transplant-related complications after bone marrow transplantation (BMT). In a recent phase I-II trial, oral administration of pentoxifylline (PTX), a xanthine derivative capable of downregulating TNF-alpha production in vitro, was reported to reduce morbidity and mortality in patients undergoing BMT. We conducted a prospective randomized trial of PTX therapy among 140 patients undergoing either allogeneic (n = 51) or autologous BMT (n = 89). Patients were randomized to receive (n = 70) or not receive (n = 70) oral PTX, 1,600 mg/d in four divided doses from day -8 until day + 100 post-BMT. The incidence of mucositis requiring morphine sulfate (MSO4) was similar in both groups (42.9%), with the mean number of days with MSO4 being 7.8 (SD = 3.4) in the PTX group versus 8.2 (SD = 3.4) in the control group (NS). The incidence of renal insufficiency was not affected by PTX administration (15.7% in the PTX group v 21.4% in the control group [NS]) and the highest serum creatinine value during the first 100 days post-BMT was 119 mumol/L (SD = 82.4) in the PTX group versus 103.9 mumol/L (SD = 57) in the control group (NS). The incidence of grade > or = 2 graft-versus-host disease was similar in each group (11/25 [44%] in the PTX group v 12/26 [46%] in the control group). No significant difference was observed in hematologic toxicity, transfusion requirements, duration of fever, and hepatic toxicity between the treatment groups. In conclusion, our study failed to show a prophylactic effect of PTX in transplant-related toxicities after BMT. On the basis of these findings, we cannot recommend that PTX be part of early mortality and morbidity prevention programs after BMT.",1993,"No significant difference was observed in hematologic toxicity, transfusion requirements, duration of fever, and hepatic toxicity between the treatment groups.","['n = 89', 'patients undergoing BMT', '140 patients undergoing either allogeneic (n = 51) or']","['pentoxifylline', 'pentoxifylline (PTX', 'PTX', 'autologous BMT']","['hematologic toxicity, transfusion requirements, duration of fever, and hepatic toxicity', 'incidence of mucositis requiring morphine sulfate (MSO4', 'morbidity and mortality', 'incidence of renal insufficiency', 'incidence of grade > or = 2 graft-versus-host disease', 'highest serum creatinine value']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",140.0,0.0575845,"No significant difference was observed in hematologic toxicity, transfusion requirements, duration of fever, and hepatic toxicity between the treatment groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Department of Hematology, Chu Purpan, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rubie', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Charlet', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schlaifer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huynh', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Laurent', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pris', 'Affiliation': ''}]",Blood,[]
413,8241496,Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group.,"We designed a multicenter randomized trial comparing chemotherapy with daunorubicin-Ara C (chemotherapy group) and all transretinoic acid (ATRA) combined to the same chemotherapy (ATRA group) in newly diagnosed APL patients aged 65 years or less. The major endpoint of the study was event-free survival (EFS) (""events"" being defined as failure to achieve complete remission [CR], occurrence of relapse, or death in CR). Early termination of the trial was decided after the first interim analysis, as EFS was significantly higher in the ATRA group. At the time, 101 patients had been randomized (54 in the ATRA group and 47 in the chemotherapy group). In the ATRA group, 49 (91%) patients achieved CR, 5 (9%) had early death, and 0 had resistant leukemia, compared with 38 (81%), 4 (8%), and 5 (10%) patients, respectively, in the chemotherapy group. The difference in CR rate between the two groups was not significant. The duration of coagulopathy was significantly reduced in the ATRA group, compared with the chemotherapy group. In the ATRA group, six patients relapsed after 7 to 15.5 months. In the chemotherapy group, 12 patients relapsed after 1 to 16 months, and 2 died in CR. Kaplan-Meier EFS was estimated at 79% +/- 7% and 50% +/- 9% at 12 months, respectively, in the ATRA and the chemotherapy group (P = .001). Kaplan-Meier estimate of relapse was 19% +/- 8% and 40% +/- 12% at 12 months (P = .005). In conclusion, ATRA followed by chemotherapy increases EFS in newly diagnosed APL. These results strongly suggest that ATRA should be incorporated in the front line therapy of newly diagnosed APL.",1993,"9% at 12 months, respectively, in the ATRA and the chemotherapy group (P = .001).","['101 patients had been randomized (54 in the ATRA group and 47 in the chemotherapy group', 'newly diagnosed APL patients aged 65 years or less', 'newly diagnosed acute promyelocytic leukemia']","['chemotherapy with daunorubicin-Ara C (chemotherapy group) and all transretinoic acid (ATRA) combined to the same chemotherapy (ATRA group', 'transretinoic acid', 'ATRA']","['duration of coagulopathy', 'resistant leukemia', 'early death', 'Kaplan-Meier estimate of relapse', 'Kaplan-Meier EFS', 'event-free survival (EFS) (""events"" being defined as failure to achieve complete remission [CR], occurrence of relapse, or death in CR', 'CR rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",101.0,0.0888198,"9% at 12 months, respectively, in the ATRA and the chemotherapy group (P = .001).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': 'Service Clinique des Maladies du Sang-Hôpital St Louis, Paris, France.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Castaigne', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Archimbaud', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chomienne', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerci', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Daniel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bowen', 'Affiliation': ''}]",Blood,[]
414,8382969,"Interferon-alpha in mixed cryoglobulinemia patients: a randomized, crossover-controlled trial.","The effects of interferon-alpha (IFN-alpha) on clinical and serologic manifestations of mixed cryoglobulinemia (MC) were investigated by randomized, crossover-controlled trial in 26 patients. The trial alternated 6 months with and 6 months without IFN-alpha therapy (2 x 10(6) IU daily for a month, then every other day for 5 months). In 22 patients, pretreatment steroid dosage remained unchanged during the study. Six patients dropped out (three because of side effects), whereas another 20 patients experienced a significant improvement of purpura (P < .02) and serum transaminases (P < .005) during IFN-alpha treatment. The presence of clinical improvement was supported by the outcome measurements of several immunologic parameters. In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN-alpha therapy. A rebound phenomenon of clinical and serologic parameters was observed after IFN-alpha discontinuation. In addition, no variations were recorded during 6 months without therapy. Hepatitis C virus (HCV) RNA was detected in 91% (20/22) of our MC patients; in 2/13 cases HCV RNA was no longer detectable in serum samples after IFN-alpha therapy. Thus, IFN-alpha could be considered as treatment for MC in patients with HCV seropositivity.",1993,"In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN-alpha therapy.","['mixed cryoglobulinemia patients', 'mixed cryoglobulinemia (MC', '26 patients', 'patients with HCV seropositivity']","['Interferon-alpha', 'interferon-alpha (IFN-alpha', 'IFN-alpha therapy']","['serum cryoglobulins', 'Hepatitis C virus (HCV) RNA', 'serum transaminases']","[{'cui': 'C0543697', 'cui_str': 'Mixed cryoglobulinemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010404', 'cui_str': 'Cryoglobulins'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",26.0,0.0284043,"In particular, serum cryoglobulins were significantly reduced (P < .04) during IFN-alpha therapy.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ferri', 'Affiliation': 'Rheumatology Unit, University of Pisa, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marzo', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Longombardo', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lombardini', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'La Civita', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vanacore', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gerli', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Greco', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gentilini', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bombardieri', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Zignego', 'Affiliation': ''}]",Blood,[]
415,8329700,Randomized comparison of busulfan and hydroxyurea in chronic myelogenous leukemia: prolongation of survival by hydroxyurea. The German CML Study Group.,"In a randomized multicenter study the influence of hydroxyurea versus busulfan on the duration of the chronic phase and on survival of chronic myelogenous leukemia (CML) was determined. In addition cross resistance and adverse reactions of the drugs were analyzed. From July 1983 to January 1991, 441 CML patients were randomized to receive hydroxyurea or busulfan. Of these, 90.7% were Philadelphia positive; 25.7% were low, 38.2% intermediate, and 36.2% high risk patients according to Sokal's score. The median survival of the busulfan treated Philadelphia-positive patients is 45.4 months and of the hydroxyurea group 58.2 months (P = .008). The survival advantage for the hydroxyurea treated patients is recognized in all risk groups. Sixty four patients reached therapy resistance before blast crisis and were crossed over to the alternative drug. The 23 patients with primary hydroxyurea had a median survival of 5.6 years, the 41 patients with primary busulfan therapy a median survival of 2.7 years (P = .02). Adverse reactions were less frequent with hydroxyurea with no severe adverse effects (lung fibrosis, long lasting bone marrow aplasia). The analysis of white blood cell counts in the course of treatment showed lower counts in the hydroxyurea patients. We conclude that hydroxyurea is superior to busulfan in therapy of CML in chronic phase and should be used as first line therapy. Busulfan may have a role as secondary therapy after hydroxyurea resistance or intolerance.",1993,"Adverse reactions were less frequent with hydroxyurea with no severe adverse effects (lung fibrosis, long lasting bone marrow aplasia).","['chronic myelogenous leukemia', 'From July 1983 to January 1991, 441 CML patients', '23 patients with primary']","['busulfan and hydroxyurea', 'hydroxyurea or busulfan', 'hydroxyurea', 'hydroxyurea versus busulfan', 'Busulfan']","['median survival', 'severe adverse effects (lung fibrosis, long lasting bone marrow aplasia', 'survival advantage', 'duration of the chronic phase and on survival of chronic myelogenous leukemia (CML', 'Adverse reactions']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",441.0,0.030105,"Adverse reactions were less frequent with hydroxyurea with no severe adverse effects (lung fibrosis, long lasting bone marrow aplasia).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'Klinikum Mannheim, Universität Heidelberg, Mannheim, Deutschland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Heimpel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pralle', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Queisser', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Löffler', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heinze', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Georgii', 'Affiliation': ''}]",Blood,[]
416,8364194,Treatment of adult chronic autoimmune thrombocytopenic purpura with repeated high-dose intravenous immunoglobulin.,"Intravenous (i.v.) infusions of Ig concentrates are an effective but expensive treatment for patients with autoimmune thrombocytopenic purpura (AITP). The optimal treatment protocol and the long-term results are uncertain, and the precise mechanism by which the platelet count increases is poorly understood. Twenty adult patients with chronic AITP were enrolled in a prospective study to compare the respective efficacy of two high-dose IVIgG induction regimens (1 g v 2 g/kg body weight) and the long-term effect of six 1 g/kg body weight i.v. IgG reinfusions. An initial response was observed in all 18 evaluable patients: the platelet count increased to a mean value of 251 x 10(9)/L (range 72 to 836 x 10(9)/L) and the mean pretreatment platelet count was multiplied by 14.6. No difference in efficiency was observed between the two i.v. IgG dosages. The degree of the platelet count increment correlated in both groups with the increase in the clearance of antibody-coated red blood cells, measured by an isotopic method, but not with the serum IgG elevation. Treatment was considered to have failed in 11 patients, 90 days after the last i.v. IgG reinfusion (D90), because the platelet counts were comparable with pretreatment values. In contrast, a complete response was observed at D90 in five patients (mean platelet count: 184 x 10(9)/L; range: 150 to 250 x 10(9)/L) and a partial response at D90 was obtained in the remaining two patients (platelet counts: 70 and 104 x 10(9)/L). Five of the 7 responders at D90 kept a platelet count above 50 x 10(9)/L during the entire follow-up period (mean 33 months; range: 5 to 66) with no further treatment; unfortunately, no clinical or biologic criteria were found to be predictive of the long-term response. This study shows that an i.v. IgG infusion regimen of 1 g/kg body weight could safely replace the classical 2 g/kg body weight dosage, at least in patients who do not have life-threatening thrombocytopenia. Moreover, repeated i.v. IgG reinfusion could be an alternative for AITP patients in whom splenectomy is contraindicated.",1993,Intravenous (i.v.) infusions of Ig concentrates are an effective but expensive treatment for patients with autoimmune thrombocytopenic purpura (AITP).,"['adult chronic autoimmune thrombocytopenic purpura with', 'Twenty adult patients with chronic AITP', 'patients with autoimmune thrombocytopenic purpura (AITP']","['repeated high-dose intravenous immunoglobulin', 'IVIgG induction regimens', 'IgG reinfusion']","['platelet count increment', 'platelet count', 'platelet counts', 'efficiency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0398650', 'cui_str': 'Autoimmune Thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",20.0,0.0191475,Intravenous (i.v.) infusions of Ig concentrates are an effective but expensive treatment for patients with autoimmune thrombocytopenic purpura (AITP).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Godeau', 'Affiliation': 'Centre Départemental de Transfusion Sanguine, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lesage', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Divine', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Wirquin', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Farcet', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bierling', 'Affiliation': ''}]",Blood,[]
417,8180400,Bedside filtration of blood products in the prevention of HLA alloimmunization--a prospective randomized study. Alloimmunisation Study Group.,"To test the efficacy of poststorage bedside leucodepletion of blood products in the prevention of primary HLA alloimmunization and its clinical sequelae, 172 patients with hematologic malignancy requiring intensive red blood cell and platelet support were randomized to receive either standard or filtered red blood cells and platelets. Quality control of bedside filtration was explored by sequential sampling downstream of the filter, but this did not predict the total number of leucocytes transfused. After exclusions, 123 evaluable patients were assessed every two weeks until the end of therapy. HLA antibodies developed in 21 of 56 (37.5%) nonfilter (NF) and 15 of 67 (22%) filter (F) patients (risk ratio estimate, 0.60 [95% confidence interval, 0.34 to 1.05]; P = .07). Patients with acute myeloid leukemia (AML; n = 53) had higher alloimmunization rates in both arms of the study, with a greater effect of filtration (62.5% NF and 31.0% F; P = .025). Bedside filtration did not affect the overall incidence of febrile transfusion reactions (FTRs; 37% NF and 34% F; P = .71) or of platelet refractoriness assessed in 50 patients (30% NF and 26% F), despite an association between broad HLA reactivity and both FTRs and refractoriness. However, FTRs were also seen in 28 patients without HLA antibodies. Five alloimmunized refractory patients (2 F and 3 NF) required HLA-selected platelets. This report, the first prospective study of bedside filtration, has failed to show clear clinical benefit. Methodological limitations may account in part for this failure, notably the difficulties in accurately assessing the number of leucocytes transfused.",1994,"Bedside filtration did not affect the overall incidence of febrile transfusion reactions (FTRs; 37% NF and 34% F; P = .71) or of platelet refractoriness assessed in 50 patients (30% NF and 26% F), despite an association between broad HLA reactivity and both FTRs and refractoriness.","['Patients with acute myeloid leukemia (AML; n = 53', '28 patients without HLA antibodies', '172 patients with hematologic malignancy requiring intensive red blood cell and platelet support']","['standard or filtered red blood cells and platelets', 'poststorage bedside leucodepletion of blood products']","['HLA antibodies', 'alloimmunization rates', 'overall incidence of febrile transfusion reactions', 'platelet refractoriness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0149993', 'cui_str': 'Febrile transfusion reaction (disorder)'}, {'cui': 'C0920064', 'cui_str': 'Platelet transfusion refractoriness'}]",172.0,0.052177,"Bedside filtration did not affect the overall incidence of febrile transfusion reactions (FTRs; 37% NF and 34% F; P = .71) or of platelet refractoriness assessed in 50 patients (30% NF and 26% F), despite an association between broad HLA reactivity and both FTRs and refractoriness.","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Williamson', 'Affiliation': 'Division of Transfusion Medicine, University of Cambridge, UK.'}, {'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Wimperis', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Copplestone', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Gooi', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Morgenstern', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Norfolk', 'Affiliation': ''}]",Blood,[]
418,8167351,A randomized trial comparing busulfan with total body irradiation as conditioning in allogeneic marrow transplant recipients with leukemia: a report from the Nordic Bone Marrow Transplantation Group.,"Between October 1988 and December 1992, 167 patients with leukemia receiving marrow transplants from HLA-identical donors and conditioned with cyclophosphamide (120 mg/kg) were randomized to additional treatment with either busulfan (16 mg/kg, n = 88) or total body irradiation (TBI; n = 79). The busulfan-treated patients had an increased cumulative incidence of veno-occlusive disease of the liver, ie, 12% compared with 1% in the TBI group (P = .009). Furthermore, hemorrhagic cystitis occurred in 24% of the busulfan patients versus 8% in the TBI patients (P = .003). In patients with advanced disease beyond first remission or first chronic phase, transplantation-related mortality was 62% among the busulfan-treated patients compared with 12% among the TBI recipients (P = .002). These differences between the two groups were statistically significant in multivariate analysis. Seizures were seen in 6% of the busulfan-treated patients and were absent in the TBI group (P = .03). Grade II-IV of acute graft-versus-host disease (GVHD) was similar in the two groups, but grade III-IV and chronic disease was more common in the busulfan-treated group (P = .04). Death associated with GVHD occurred in 17% of the busulfan-treated group and 2% of the TBI group (P = .003). Patients treated with busulfan had a 3-year actuarial survival of 62%, which was worse than the 76% among those treated with TBI (P < .03). In multivariate analysis, poor survival was associated with advanced disease (P < .0001), no posttransplant septicemia (P = .0006), grade II-IV GVHD (P = .006), and busulfan treatment (P < .02). The incidence of relapse did not differ between the two groups. Relapse-free survival was also similar in the two treatment groups on analysis of data from all patients, children, patients with early disease, and those with acute myeloid leukemia, acute lymphoblastic leukemia, and chronic myeloid leukemia. However, in adults (P = .05) and patients with advanced disease (P = .005), leukemia-free survival was significantly better in those treated with TBI. We conclude that patients treated with busulfan have more early toxicity and an increased transplant-related mortality in patients with advanced disease. TBI is therefore the treatment of choice, especially in adults and patients with advanced disease. However, busulfan is an acceptable alternative for patients with early disease and for those in whom TBI is not feasible.",1994,"In multivariate analysis, poor survival was associated with advanced disease (P < .0001), no posttransplant septicemia (P = .0006), grade II-IV GVHD (P = .006), and busulfan treatment (P < .02).","['120 mg/kg', 'patients with early disease', 'patients with advanced disease', 'allogeneic marrow transplant recipients with leukemia', 'adults and patients with advanced disease', 'Between October 1988 and December 1992, 167 patients with leukemia receiving marrow transplants from HLA-identical donors and conditioned with']","['busulfan', 'busulfan with total body irradiation', 'cyclophosphamide']","['early toxicity', 'Grade II-IV of acute graft-versus-host disease (GVHD', 'grade III-IV and chronic disease', 'Seizures', 'posttransplant septicemia', 'transplant-related mortality', 'Death associated with GVHD', '3-year actuarial survival', 'advanced disease beyond first remission or first chronic phase, transplantation-related mortality', 'grade II-IV GVHD', 'advanced disease', 'cumulative incidence of veno-occlusive disease of the liver', 'incidence of relapse', 'hemorrhagic cystitis', 'Relapse-free survival', 'leukemia-free survival']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036690', 'cui_str': 'Poisoning, Blood'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019156', 'cui_str': 'Sinusoidal Obstruction Syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0085692', 'cui_str': 'Hemorrhagic cystitis (disorder)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}]",167.0,0.0427045,"In multivariate analysis, poor survival was associated with advanced disease (P < .0001), no posttransplant septicemia (P = .0006), grade II-IV GVHD (P = .006), and busulfan treatment (P < .02).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ringdén', 'Affiliation': 'Division of Clinical Immunology, Karolinska Institute, Huddinge Hospital, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruutu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Remberger', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nikoskelainen', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Volin', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vindeløv', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parkkali', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lenhoff', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sallerfors', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ljungman', 'Affiliation': ''}]",Blood,[]
419,8167353,Long-term follow-up of a randomized trial of graft-versus-host disease prevention by methotrexate/cyclosporine versus methotrexate alone in patients given marrow grafts for severe aplastic anemia.,,1994,,['patients given marrow grafts for severe aplastic anemia'],['methotrexate/cyclosporine versus methotrexate alone'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]",[],,0.0294685,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': ''}]",Blood,[]
420,7780131,Inhibition of endotoxin-induced activation of the coagulation and fibrinolytic pathways using a recombinant endotoxin-binding protein (rBPI23).,"A recombinant endotoxin-neutralizing protein, rBPI23, was shown to partially prevent endotoxin-induced activation of the fibrinolytic and coagulation systems in experimental endotoxemia in humans. In a placebo-controlled, blinded crossover study, eight volunteers were challenged twice with an intravenous bolus injection of endotoxin (40 EU/kg of body weight) and concurrently received either rBPI23 (1 mg/kg) or placebo (human serum albumin, 0.2 mg/kg). rBPI23 treatment significantly lowered the endotoxin-induced fibrinolytic response, ie, reduced the release of tissue-type plasminogen activator, urokinase-type plasminogen activator, plasminogen activator inhibitor antigen, and complex formation of plasmin alpha 2-antiplasmin (P = .0078 for each). Plasminogen activator inhibitor activity was also reduced, but not significantly according to the Hochberg method (P = .0304). The endotoxin-induced activation of the procoagulant state as reflected by increase in F1 + 2 fragments and TAT complexes was blunted by rBPI23 infusion (P = .0391 [not significant according to the Hochberg method] and .0078, respectively). These results indicate that rBPI23 is capable of reducing both the activation of the fibrinolytic and the coagulation systems after low-dose endotoxin infusion in humans.",1995,"Plasminogen activator inhibitor activity was also reduced, but not significantly according to the Hochberg method (P = .0304).",[],"['endotoxin', 'placebo', 'rBPI23']","['release of tissue-type plasminogen activator, urokinase-type plasminogen activator, plasminogen activator inhibitor antigen, and complex formation of plasmin alpha 2-antiplasmin', 'endotoxin-induced fibrinolytic response', 'F1 + 2 fragments and TAT complexes', 'Plasminogen activator inhibitor activity']",[],"[{'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0369852', 'cui_str': 'Plasminogen activator inhibitor antigen'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C0003410', 'cui_str': 'alpha 2-Plasmin Inhibitor'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen Activator Inhibitors'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",8.0,0.0423442,"Plasminogen activator inhibitor activity was also reduced, but not significantly according to the Hochberg method (P = .0304).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'von der Möhlen', 'Affiliation': 'Center of Thrombosis, Hemostasis, Atherosclerosis and Inflammation Research, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'van Deventer', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'van den Ende', 'Affiliation': ''}, {'ForeName': 'N I', 'Initials': 'NI', 'LastName': 'Wedel', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Friedmann', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'ten Cate', 'Affiliation': ''}]",Blood,[]
421,8049448,Increased risk of infection in marrow transplant patients receiving methylprednisolone for graft-versus-host disease prevention.,"One hundred forty-seven patients with hematologic diseases and treated by allogeneic marrow transplants received graft-versus-host disease (GVHD) prevention with methotrexate and cyclosporine. In addition, 73 of the 147 patients were randomized to receive methylprednisolone during the first 35 days after transplant to improve GVHD prevention, whereas 74 patients were randomized not to receive methylprednisolone. The randomized trial enabled us to examine whether methylprednisolone increased the risk of infection after marrow grafting. Charts of study patients were analyzed retrospectively for infection events including bacteremia, septicemia, and fungemia. The randomization was stratified by diagnosis, patient age, genotypic HLA identity, and assignment to laminar airflow room isolation. All patients were given a short course of methotrexate (no longer than 11 days) and cyclosporine for no longer than 180 days after marrow transplantation. Methylprednisolone was begun on the day of marrow grafting at a dose of 1 mg/kg body weight intravenously in divided AM and PM doses through day 22. Methylprednisolone was administered at a dose of 0.5 mg/kg in divided doses from days 22 through 35, and then discontinued. Infections were analyzed for the time interval ending on day 65 after transplantation, which included the period of methylprednisolone administration and 1 month thereafter. Seventy-one episodes of first infection events were observed in patients receiving methylprednisolone compared with 47 episodes in patients not receiving the drug. Predominant infections were bacteremias, followed in descending order by fungemias and septicemias. The most prevalent organisms cultured were gram-positive bacteria, especially coagulase-negative Staphylococcus and Streptococcus species. Pseudomonas species were the most common gram negative bacteria, and the most prevalent fungus was Candida albicans. Multivariable Cox regression analysis showed that patients receiving methylprednisolone had a 1.5 times higher risk of infection (P = .03), with acute GVHD being another independent risk factor for infections (P = .005). Methylprednisolone, when added to GVHD prevention by methotrexate and cyclosporine, increases the risk of infection during the early posttransplantation period.",1994,"Multivariable Cox regression analysis showed that patients receiving methylprednisolone had a 1.5 times higher risk of infection (P = .03), with acute GVHD being another independent risk factor for infections (P = .005).","['One hundred forty-seven patients with hematologic diseases and treated by allogeneic marrow transplants received graft-versus-host disease (GVHD) prevention with', 'marrow transplant patients receiving', '73 of the 147 patients']","['methotrexate', 'methotrexate and cyclosporine', 'Methylprednisolone', 'cyclosporine', 'methylprednisolone']","['bacteremia, septicemia, and fungemia', 'risk of infection', 'Increased risk of infection', 'episodes of first infection events']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018939', 'cui_str': 'Blood Diseases'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0036690', 'cui_str': 'Poisoning, Blood'}, {'cui': 'C0085082', 'cui_str': 'Fungemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",147.0,0.0349967,"Multivariable Cox regression analysis showed that patients receiving methylprednisolone had a 1.5 times higher risk of infection (P = .03), with acute GVHD being another independent risk factor for infections (P = .005).","[{'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Sayer', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center 98104.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Longton', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bowden', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pepe', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}]",Blood,[]
422,7858269,"High-dose etoposide, cyclophosphamide, and total body irradiation with allogeneic bone marrow transplantation for patients with acute myeloid leukemia in untreated first relapse: a study by the North American Marrow Transplant Group.","Relapse is a major cause of treatment failure following allogeneic bone marrow transplantation (BMT) for acute myeloid leukemia (AML). To reduce the risk of relapse following BMT for patients with hematologic malignancy, our group developed a novel preparative regimen which combines high-dose etoposide with cyclophosphamide and total body irradiation (VPCyTBI). We now report the outcome of therapy with VPCyTBI followed by allogeneic BMT for 40 patients with AML in untreated first relapse. With the exception of increased stomatitis, the toxicity of this regimen was similar to that reported by others for CyTBI. Forty-four months after transplant the actuarial probabilities of disease-free survival (DFS), persistent or recurrent leukemia, and transplant related mortality were .29, .44, and .47 respectively. DFS was improved (P < .01) and risk of persistent or recurrent leukemia reduced (P = .005) among patients with significant (grade > or = 2) acute GVHD. Patients with 30% or more blasts on pre-BMT bone marrow examination were not at increased risk for persistent or recurrent leukemia. We conclude that VPCyTBI with allogeneic BMT is effective therapy for AML in untreated first relapse and that a randomized trial comparing this regimen with CyTBI is warranted.",1995,DFS was improved (P < .01) and risk of persistent or recurrent leukemia reduced (P = .005) among patients with significant (grade > or = 2) acute GVHD.,"['acute myeloid leukemia (AML', 'patients with acute myeloid leukemia in untreated first relapse', 'patients with hematologic malignancy', '40 patients with AML in untreated first relapse']","['VPCyTBI followed by allogeneic BMT', 'allogeneic bone marrow transplantation (BMT', 'etoposide with cyclophosphamide and total body irradiation (VPCyTBI', 'High-dose etoposide, cyclophosphamide, and total body irradiation with allogeneic bone marrow transplantation', 'VPCyTBI with allogeneic BMT']","['toxicity', 'risk of persistent or recurrent leukemia', 'actuarial probabilities of disease-free survival (DFS), persistent or recurrent leukemia, and transplant related mortality', 'risk of relapse', 'DFS']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",40.0,0.0674029,DFS was improved (P < .01) and risk of persistent or recurrent leukemia reduced (P = .005) among patients with significant (grade > or = 2) acute GVHD.,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'Division of Bone Marrow Transplantation and Stem Cell Biology, Washington University, St Louis, MO.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Fay', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pineiro', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Lynch', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Greer', 'Affiliation': ''}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Herzig', 'Affiliation': ''}, {'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Herzig', 'Affiliation': ''}]",Blood,[]
423,7849295,A clinical analysis of two indolent lymphoma entities: mantle cell lymphoma and marginal zone lymphoma (including the mucosa-associated lymphoid tissue and monocytoid B-cell subcategories): a Southwest Oncology Group study.,"The objectives of this study were (1) to determine the clinical presentation and natural history associated with two newly recognized pathologic entities termed mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL), including the mucosa-associated lymphoid tissue (MALT) and monocytoid B-cell subcategories, and (2) to determine whether these entities differ clinically from the other relatively indolent non-Hodgkin's lymphomas with which they have been previously classified. We reviewed the conventional pathology and clinical course of 376 patients who had no prior therapy; had stage III/IV disease; were classified as Working Formulation categories A, B, C, D, or E; and received cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) on Southwest Oncology Group (SWOG) studies no. 7204, 7426, or 7713. All slides were reviewed by the three pathologists who reached a consensus diagnosis. Age, sex, performance status, bone marrow and/or gastrointestinal involvement, failure-free survival, and overall survival were compared among all the categories. We found that (1) MCL and MZL each represent approximately 10% of stage III or IV patients previously classified as Working Formulation categories A through E and treated with CHOP on SWOG clinical trials; (2) the failure-free survival and overall survival of patients with MZL is the same as that of patients with Working Formulation categories A through E, but the failure-free survival and overall survival of the monocytoid B-cell patients were higher than that of the MALT lymphoma patients (P = .009 and .007, respectively); and (3) the failure-free survival and overall survival of patients with MCL is significantly worse than that of patients with Working Formulation categories A through E (P = .0002 and .0001, respectively). In conclusion, patients with advanced stage MALT lymphomas may have a more aggressive course than previously recognized. Patients with MCL do not have an indolent lymphoma and are candidates for innovative therapy.",1995,A through E (P = .0002,"['7204, 7426, or 7713', '376 patients who had no prior therapy; had stage III/IV disease', 'patients with advanced stage MALT lymphomas']","['cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP']","['failure-free survival and overall survival', 'Age, sex, performance status, bone marrow and/or gastrointestinal involvement, failure-free survival, and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0024651', 'cui_str': 'Malt'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}]",,0.0406286,A through E (P = .0002,"[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Fisher', 'Affiliation': 'Loyola University Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dahlberg', 'Affiliation': ''}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Nathwani', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Banks', 'Affiliation': ''}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Grogan', 'Affiliation': ''}]",Blood,[]
424,7949088,A controlled trial of recombinant human erythropoietin after bone marrow transplantation.,"Recombinant human erythropoietin (rHuEPO) stimulates erythropoietic bone marrow cells and increases erythrocyte production. This prospective study was designed to evaluate the effects of rHuEPO on regeneration of erythropoiesis after allogeneic or autologous bone marrow transplantation (BMT). Seventeen centers participated in this randomized, double-blind, placebo-controlled multicenter trial. The randomization was performed centrally for each center and stratified according to allogeneic or autologous BMT and major ABO-blood group incompatibility. One hundred and six patients received rHuEPO after allogeneic BMT and 109 patients received placebo. After autologous BMT, 57 patients were treated with rHuEPO and 57 with placebo. Patients received either 150 IU/kg/day C127 mouse-cell-derived rHuEPO or placebo as continuous intravenous infusion. Therapy started after bone marrow infusion and lasted until independence from erythrocyte transfusions for 7 consecutive days with stable hemoglobin levels > or = 9 g/100 mL or until day 41. After allogeneic BMT, the reticulocyte counts were significantly higher with rHuEPO from day 21 to day 42 after BMT. The median time (95% confidence intervals) to erythrocyte transfusion independence was 19 days (range, 16.3 to 21.6) with rHuEPO and 27 days (range, 22.3 to > 42) with placebo (P < .003). The mean (+/- SD) numbers of erythrocyte transfusions until day 20 after BMT were 6.6 +/- 4.8 with rHuEPO and 6.0 +/- 3.8 with placebo. However, from day 21 to day 41, the rHuEPO-treated patients received 1.4 +/- 2.5 (median, 0) transfusions and the control group received 2.7 +/- 4.0 (median, 2) transfusions (P = .004). In the follow-up period from day 42 up to day 100, 2.4 +/- 5.6 transfusions were required with rHuEPO and 4.5 +/- 9.6 were required with placebo (P = .075). A multivariate analysis (ANOVA) showed that acute graft-versus-host disease (GVHD), major ABO-blood group incompatibility, age greater than 35 years, and hemorrhage significantly increased the number of transfusions. However, after day 20, rHuEPO significantly reduced the number of erythrocyte transfusions in these patient groups, as well as reducing incompatibility in the major ABO-blood group. For the whole study period, rHuEPO reduced the transfusion requirements in GVHD III and IV from 18.4 +/- 8.6 to 8.5 +/- 6.8 U (P = .05). After autologous BMT, there was no difference in the time to independence from erythrocyte transfusions and in the regeneration of reticulocytes. Marrow purging strongly increased the requirement for transfusions as well as the time to transfusion independence.",1994,"After autologous BMT, there was no difference in the time to independence from erythrocyte transfusions and in the regeneration of reticulocytes.","['Seventeen centers participated', 'bone marrow transplantation']","['rHuEPO after allogeneic BMT', 'placebo', 'recombinant human erythropoietin', '150 IU/kg/day C127 mouse-cell-derived rHuEPO or placebo', 'rHuEPO', 'allogeneic or autologous bone marrow transplantation (BMT', 'Recombinant human erythropoietin (rHuEPO']","['erythrocyte production', 'reticulocyte counts', 'median time', 'number of transfusions', 'number of erythrocyte transfusions', 'acute graft-versus-host disease (GVHD), major ABO-blood group incompatibility', 'erythrocyte transfusion independence']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0014819', 'cui_str': 'Erythropoiesis'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0344389', 'cui_str': 'ABO blood group'}]",57.0,0.166699,"After autologous BMT, there was no difference in the time to independence from erythrocyte transfusions and in the regeneration of reticulocytes.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Department of Hematology and Oncology, Medizinische Hochschule Hannover, Germany.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boogaerts', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Fauser', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Slavin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiffers', 'Affiliation': ''}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Gorin', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Carella', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Burdach', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferrant', 'Affiliation': ''}]",Blood,[]
425,7949185,Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86.,"In trial ALL-BFM 86, the largest multicenter trial of the Berlin-Frankfurt-Münster (BFM) study group for childhood acute lymphoblastic leukemia (ALL), treatment response was used as an overriding stratification factor for the first time. In the previous trial ALL-BFM 83, the in vivo response to initial prednisone treatment was evaluated prospectively. A blast cell count of > or = 1,000/microL peripheral blood after a 7-day exposure to prednisone and one intrathecal dose of methotrexate (MTX) identified 10% of the patients as having a significantly worse prognosis. In trial ALL-BFM 86 patients with > or = 1,000/microL blood blasts on day 8 were included in an experimental branch EG. Patients with < 1,000/microL blood blasts on day 8 were stratified by their leukemic cell burden into two branches, Standard Risk Group (SRG) and Risk Group (RG). SRG patients received an eight-drug induction followed by consolidation protocol M (6-mercaptopurine, high-dose [HD] MTX 4 x 5 g/m2) and maintenance. RG patients were treated with an additional eight-drug reinduction element. For EG patients protocol M was replaced by protocol E (prednisone, HD-MTX, HD-cytarabine, ifosfamide, mitoxantrone). All patients received intrathecal MTX therapy; only those of branches RG and EG received cranial irradiation. In branch RG, patients were randomized to receive or not to receive late intensification (prednisone, vindesine, teniposide, ifosfamide, HD-cytarabine) in the 13th month. During the trial reinduction therapy was introduced in branch SRG, because in the follow-up of trial ALL-BFM 83 the randomized low-risk patients receiving reinduction did significantly better. Nine hundred ninety-eight evaluable patients were enrolled, 28.6% in SRG, 61.1% in RG, 10.3% in EG. At a median follow-up of 5.0 (range 3.4 to 6.9) years, the estimated 6-year event-free survival was 72% +/- 2% for the study population, 58% +/- 5% in branch SRG for the first 110 patients without reinduction therapy, 87% +/- 3% for the next 175 patients with reinduction therapy, 75% +/- 2% in branch RG, and 48% +/- 5% in branch EG. Late intensification did not significantly affect treatment outcome of RG patients; however, only 23% of the eligible patients were randomized. Prednisone poor response remained a negative prognostic parameter despite intensified therapy. The results confirmed the benefit of intensive reinduction therapy even for low-risk patients. The strategy of induction, consolidation, and intensive reinduction may offer roughly 75% of unselected childhood ALL patients the chance for an event-free survival.",1994,"Late intensification did not significantly affect treatment outcome of RG patients; however, only 23% of the eligible patients were randomized.","['SRG patients', 'Nine hundred ninety-eight evaluable patients were enrolled, 28.6% in SRG, 61.1% in RG, 10.3% in EG', 'childhood acute lymphoblastic leukemia (ALL', '86 patients with > or = 1,000/microL blood blasts on day 8 were included in an experimental branch EG', 'Patients with < 1,000/microL blood blasts on day 8 were stratified by their leukemic cell burden into two branches, Standard Risk Group (SRG) and Risk Group (RG', '998 unselected childhood acute lymphoblastic leukemia patients']","['late intensification (prednisone, vindesine, teniposide, ifosfamide, HD-cytarabine', 'consolidation protocol M (6-mercaptopurine, high-dose [HD] MTX', 'Chemotherapy', 'intrathecal MTX therapy', 'prednisone', 'protocol E (prednisone, HD-MTX, HD-cytarabine, ifosfamide, mitoxantrone', 'cranial irradiation', 'BFM', 'Prednisone', 'Berlin-Frankfurt-Münster (BFM', 'methotrexate (MTX']",['estimated 6-year event-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0005768'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042682', 'cui_str': 'Vindesine'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",998.0,0.031492,"Late intensification did not significantly affect treatment outcome of RG patients; however, only 23% of the eligible patients were randomized.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Medizinische Hochschule Hannover, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schrappe', 'Affiliation': ''}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sauter', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Henze', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lampert', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Havers', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Niethammer', 'Affiliation': ''}]",Blood,[]
426,8043878,Effect of low-dose interleukin-2 on disease relapse after T-cell-depleted allogeneic bone marrow transplantation.,"T-cell depletion of donor bone marrow has been associated with an increased risk of disease relapse after allogeneic bone marrow transplantation (BMT). Recombinant interleukin-2 (IL-2), which is capable of increasing the antileukemic activity of peripheral blood lymphocytes obtained from patients who have undergone BMT, has been proposed as a potentially useful agent to reduce the risk of relapse post-BMT. We have previously shown that IL-2 administered to patients at very low doses after BMT is both clinically tolerable and immunologically active. We now report on the clinical outcome of 29 patients treated with low-dose IL-2 after CD6-depleted allogenic BMT for hematologic malignancy. IL-2 was administered by continuous infusion for up to 3 months beginning at a median of 67 days post-BMT. Eligibility requirements for IL-2 therapy included demonstration of stable engraftment and absence of acute grade 2-4 graft-versus-host disease (GVHD). Low-dose IL-2 was well tolerated by the majority of patients, with only 4 of 29 subjects withdrawn early. Acute GVHD developed in only one individual. After 12 weeks of treatment, the mean number of circulating natural killer cells in patients increased 10-fold without any significant change in T-cell number. Of the 25 patients who received > or = 1 month of IL-2, only 6 have relapsed. Relapse rate and disease-free survival (DFS) were determined in the 25 patients who completed at least 4 weeks of IL-2 treatment and compared with historical controls transplanted at our institution for the same conditions and treated with an identical ablative regimen and method of T-cell depletion. Only control patients who had survived disease free for 100 days post-BMT were included in this analysis. Cox's proportional hazards regression model suggested that, compared with control patients without a history of GVHD, patients treated with IL-2 had a lower risk of disease relapse (hazard ratio 0.34; range, 0.14 to 0.82) and superior DFS (hazard ratio 0.39; range 0.18 to 0.87). A randomized controlled trial of IL-2 immunotherapy after T-cell-depleted BMT should now be undertaken.",1994,T-cell depletion of donor bone marrow has been associated with an increased risk of disease relapse after allogeneic bone marrow transplantation (BMT).,"['Only control patients who had survived disease free for 100 days post-BMT', '25 patients who received > or = 1 month of IL-2, only 6 have relapsed', '29 patients treated with low-dose IL-2 after CD6-depleted allogenic BMT for hematologic malignancy', 'after T-cell-depleted allogeneic bone marrow transplantation']","['allogeneic bone marrow transplantation (BMT', 'IL-2 immunotherapy', 'Recombinant interleukin-2 (IL-2', 'low-dose interleukin-2', 'IL-2']","['risk of disease relapse', 'Relapse rate and disease-free survival (DFS', 'Acute GVHD', 'superior DFS', 'mean number of circulating natural killer cells', 'disease relapse']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}]",,0.0662142,T-cell depletion of donor bone marrow has been associated with an increased risk of disease relapse after allogeneic bone marrow transplantation (BMT).,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gonin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': ''}]",Blood,[]
427,7994025,Randomized comparison of interferon-alpha with busulfan and hydroxyurea in chronic myelogenous leukemia. The German CML Study Group.,"As curative bone marrow transplantation is available only to a minority of patients with chronic myelogenous leukemia (CML), drug therapy remains of central interest. Several nonrandomized studies have suggested that interferon-alpha (IFN) may prolong survival in CML. In a randomized multicenter study the influence of IFN versus busulfan or hydroxyurea (HU) on survival of Philadelphia-positive (Ph+) CML was examined. A total of 513 Ph+ patients were randomized for treatment as follows: 133 for IFN, 186 for busulfan, and 194 for HU. IFN-treated CML patients have a significant survival advantage over busulfan-treated (P = .008), but not over HU-treated patients (P = .44). The longer survival is due to slower progression to blast crisis. Median survival of IFN-treated patients is 5.5 years [5-year survival, 59%; 95% confidence interval (CI), 48%-70%], of busulfan-treated patients, 3.8 years (5-year survival, 32%; CI, 24%-40%), and of HU-treated patients, 4.7 years (5-year survival, 44%; CI, 36%-53%). Patients who continue on IFN survive longer than those in whom IFN is discontinued before blast crisis (P = .007). Complete hematologic IFN-responders have a survival advantage over partial responders or nonresponders (P = .02). Cytogenetic IFN-responders have no significant survival advantage over nonresponders (P = .2). Patients who attain white blood cell (WBC) counts of 10 x 10(9)/L or less have a survival advantage in the IFN (P = .007) and HU (P = .05) groups. Whereas toxicity in the IFN group was considerably higher than in the busulfan or HU groups, long-lasting cytopenias necessitating discontinuation of therapy as observed with busulfan have not been seen with IFN or HU. The problems of conventional prognostic scores (Sokal's score, Score 1) that we observed in IFN-treated patients support the idea that IFN changes the natural course of CML. We conclude that, with regard to survival of CML in the chronic phase, IFN is superior to busulfan and as effective as HU. Whether and to what extent IFN is superior to HU appears to depend, at least in part, on the degree of WBC suppression by HU-therapy and on the risk profile of the patients.",1994,"IFN-treated CML patients have a significant survival advantage over busulfan-treated (P = .008), but not over HU-treated patients (P = .44).","['chronic myelogenous leukemia', 'patients with chronic myelogenous leukemia (CML', 'A total of 513 Ph+ patients']","['curative bone marrow transplantation', 'IFN versus busulfan or hydroxyurea (HU', 'interferon-alpha (IFN', 'IFN-treated CML', 'interferon-alpha with busulfan and hydroxyurea']","['toxicity', '5-year survival', 'survival advantage', 'Median survival', 'longer survival', 'survival of Philadelphia-positive (Ph+) CML']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0450407', 'cui_str': 'ph+ (qualifier value)'}]","[{'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0457340', 'cui_str': 'Philadelphia positive (qualifier value)'}, {'cui': 'C0450407', 'cui_str': 'ph+ (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]",513.0,0.109725,"IFN-treated CML patients have a significant survival advantage over busulfan-treated (P = .008), but not over HU-treated patients (P = .44).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'Medizinische Klinik III, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Heimpel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pralle', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Queisser', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Löffler', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heinze', 'Affiliation': ''}]",Blood,[]
428,7919326,Passive hyperimmune plasma therapy in the treatment of acquired immunodeficiency syndrome: results of a 12-month multicenter double-blind controlled trial. The Passive Hyperimmune Therapy Study Group.,"High-titer anti-human immunodeficiency virus (HIV) antibodies reduced circulating HIV viral burden and has shown promise in previous small uncontrolled studies, warranting a larger controlled study of passive hyperimmune therapy (PHT) in persons with acquired immunodeficiency syndrome (AIDS). The objective of this study was to determine the efficacy and safety of PHT in 220 AIDS subjects in a 12-month double-blind placebo-controlled dosing study. Subjects were randomized to receive monthly infusions of 500 mL of plasma (full dose), 250 mL of plasma diluted in 250 mL of 5% human serum albumin (half dose), or 500 mL of 5% human serum albumin (placebo). Positive treatment effects occurred only in full-dose-treated subjects with baseline CD4 cell counts between 50 and 200 cells/mm3. Reduced mortality was observed, 1 death in 21 (full dose) versus 3 deaths in 21 (half dose) and 6 deaths in 30 (placebo) (P = .065). CD4 cells improved an average of 32.7 cells/mm3 over baseline (full dose) versus 0.9 cells/mm3 (half dose) and a loss of 3.5 cells/mm3 (placebo) (P = .043). No adverse effects or toxicity was noted in donors or recipients. Based on these findings, PHT appears to be a safe, promising therapy warranting further study.",1994,Positive treatment effects occurred only in full-dose-treated subjects with baseline CD4 cell counts between 50 and 200 cells/mm3.,"['acquired immunodeficiency syndrome', 'persons with acquired immunodeficiency syndrome (AIDS', '220 AIDS subjects in a 12-month double-blind']","['placebo', 'monthly infusions of 500 mL of plasma (full dose), 250 mL of plasma diluted in 250 mL of 5% human serum albumin (half dose), or 500 mL of 5% human serum albumin (placebo', 'PHT', 'Passive hyperimmune plasma therapy', 'passive hyperimmune therapy (PHT', 'High-titer anti-human immunodeficiency virus (HIV) antibodies']","['Positive treatment effects', 'adverse effects or toxicity', 'CD4 cells', 'efficacy and safety', 'Reduced mortality']","[{'cui': 'C0001175', 'cui_str': 'Immunologic Deficiency Syndrome, Acquired'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0019683', 'cui_str': 'AIDS Antibodies'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.291008,Positive treatment effects occurred only in full-dose-treated subjects with baseline CD4 cell counts between 50 and 200 cells/mm3.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'HemaCare Corporation, Sherman Oaks, CA 91403.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Youvan', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': ''}]",Blood,[]
429,7919369,"Therapeutic efficacy of recombinant interleukin-6 (IL-6) alone and combined with recombinant human IL-3 in a nonhuman primate model of high-dose, sublethal radiation-induced marrow aplasia.","Using a nonhuman-primate model of radiation-induced bone marrow aplasia, we examined whether the single, concomitant, or sequential administration of recombinant human interleukin-3 (IL-3) and IL-6 would promote bone marrow regeneration measured by an increase in circulating platelets (PLT) and neutrophils (PMN). Rhesus monkeys were irradiated at 450 cGy and were randomly assigned to one of five treatment protocols, receiving IL-6; IL-3; combined IL-6 and IL-3; sequential IL-3 and IL-6; or human serum albumin (HSA) as a control. Cytokines or HSA were administered at total dosages of 15 micrograms/kg/day. Complete blood counts and white blood cell differentials were monitored for 60 days postirradiation. Both IL-3 and IL-6 significantly enhanced the regeneration of PLTs and decreased the duration of thrombocytopenia (P = .005) without affecting PMN recovery. The radiation-induced anemia that was observed in the HSA-treated controls was less severe and resolved more quickly in the IL-6 treated animals. Sequential IL-3/IL-6 significantly increased the production of PLTs when compared with the HSA-treated controls (P = .003) and monkeys receiving concomitant IL-3/IL-6 (P = .041) but did not alter PMN levels significantly (P = .80). Coadministration of IL-6 and IL-3 did not enhance PLT but improved PMN recovery over IL-6 alone. In this primate model of marrow aplasia, IL-6 significantly enhanced the regeneration of PLTs but had no significant effect on PMN production, and did not exacerbate radiation-induced anemia. Furthermore, the use of sequentially administered IL-3 and IL-6 may improve PLT recovery as compared with concurrent IL-3/IL-6 administration, although this protocol is not significantly different in effect than either cytokine alone.",1994,Coadministration of IL-6 and IL-3 did not enhance PLT but improved PMN recovery over IL-6 alone.,['Rhesus monkeys were irradiated at 450 cGy'],"['Cytokines or HSA', 'recombinant interleukin-6 (IL-6) alone and combined with recombinant human IL-3', 'recombinant human interleukin-3 (IL-3) and IL-6', 'IL-6 and IL-3', 'IL-6; IL-3; combined IL-6 and IL-3; sequential IL-3 and IL-6; or human serum albumin (HSA']","['PLT recovery', 'radiation-induced anemia', 'Complete blood counts and white blood cell differentials', 'duration of thrombocytopenia', 'production of PLTs', 'PMN levels', 'circulating platelets (PLT) and neutrophils (PMN', 'bone marrow regeneration', 'PMN recovery', 'regeneration of PLTs']","[{'cui': 'C0026447', 'cui_str': 'Monkeys'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0556645', 'cui_str': 'cGy'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021757', 'cui_str': 'Interleukin-3'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}]","[{'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test (procedure)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0033268'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}]",,0.0789119,Coadministration of IL-6 and IL-3 did not enhance PLT but improved PMN recovery over IL-6 alone.,"[{'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'MacVittie', 'Affiliation': 'Armed Forces Radiobiology Research Institute, Bethesda, MD 20889-5603.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Farese', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Patchen', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Myers', 'Affiliation': ''}]",Blood,[]
430,7833483,Leukocyte depletion of random single-donor platelet transfusions does not prevent secondary human leukocyte antigen-alloimmunization and refractoriness: a randomized prospective study.,"We studied the value of leukocyte depletion of platelet transfusions for the prevention of secondary human leukocyte antigen (HLA)-alloimmunization in patients with a high-risk of prior immunization induced by pregnancies. Seventy-five female patients with hematologic malignancies (mostly acute leukemia) and a history of pregnancy were randomized to receive either standard random single-donor platelet transfusions (mean leukocytes, 430 x 10(6) per transfusion) or leukocyte-depleted random single-donor platelet transfusions. Leukocyte depletion to less than 5 x 10(6) leukocytes per platelet transfusion (mean leukocytes, 2 x 10(6) per transfusion) was achieved by filtration. Of the 62 evaluable patients, refractoriness to random donor platelets occurred in 41% (14 of 34) of the patients in the standard group and in 29% (8 of 28) of the patients in the filtered group (P = .52); anti-HLA antibodies developed in 43% (9 of 21) of individuals in the standard group and 44% (11 of 25) of cases in the filtered group. The time toward refractoriness and development of anti-HLA antibodies was similar for both groups. We conclude that leukocyte depletion of random single-donor platelet products to less than 5 x 10(6) per transfusion does not reduce the incidence of refractoriness to random donor platelet transfusion because of boostering of anti-HLA antibodies.",1995,"Of the 62 evaluable patients, refractoriness to random donor platelets occurred in 41% (14 of 34) of the patients in the standard group and in 29% (8 of 28) of the patients in the filtered group (P = .52); anti-HLA antibodies developed in 43% (9 of 21) of individuals in the standard group and 44% (11 of 25) of cases in the filtered group.","['Seventy-five female patients with hematologic malignancies (mostly acute leukemia) and a history of pregnancy', 'patients with a high-risk of prior immunization induced by pregnancies']","['standard random single-donor platelet transfusions (mean leukocytes, 430 x 10(6) per transfusion) or leukocyte-depleted random single-donor platelet transfusions', 'random single-donor platelet transfusions']","['anti-HLA antibodies', 'refractoriness to random donor platelets', 'Leukocyte depletion', 'time toward refractoriness and development of anti-HLA antibodies']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1277092', 'cui_str': 'Human platelets, random donor (derived from whole blood donation)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}]","[{'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243107', 'cui_str': 'development'}]",75.0,0.0190812,"Of the 62 evaluable patients, refractoriness to random donor platelets occurred in 41% (14 of 34) of the patients in the standard group and in 29% (8 of 28) of the patients in the filtered group (P = .52); anti-HLA antibodies developed in 43% (9 of 21) of individuals in the standard group and 44% (11 of 25) of cases in the filtered group.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sintnicolaas', 'Affiliation': 'Department of Statistics, Dr Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooij', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'van Prooijen', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'van Dijk', 'Affiliation': ''}, {'ForeName': 'W L', 'Initials': 'WL', 'LastName': 'van Putten', 'Affiliation': ''}, {'ForeName': 'F H', 'Initials': 'FH', 'LastName': 'Claas', 'Affiliation': ''}, {'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Novotny', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': ''}]",Blood,[]
431,8068949,"Immunophenotype of adult acute lymphoblastic leukemia, clinical parameters, and outcome: an analysis of a prospective trial including 562 tested patients (LALA87). French Group on Therapy for Adult Acute Lymphoblastic Leukemia.","The aim of the multicentric trial LALA87 was to test the efficacy of different postremission therapies in adults (15 to 60 year olds) with acute lymphoblastic leukemia (ALL). An immunologic subclassification based on surface marker expression was proposed. Among the 562 tested patients, 511 were assigned either to the B lineage (361 cases, 63%) or to the T lineage (150 cases, 26%). T-ALL were significantly associated with male sex, age less than 35 years, mediastinal mass, central nervous system involvement, high white blood cell count, and low anemia. In a univariate and multivariate analysis, T-cell leukemia had a more favorable outcome than B-cell leukemia with respective median disease-free survivals (DFSs) of 28 and 14 months (P < .005). However, the type of postremission therapy modifies the value of the immunophenotype prognostic factor. In the chemotherapy arm, T-ALL patients (26 patients) had a more favorable outcome than B-ALL patients (57 patients) (P < .003). In the autologous bone marrow transplantation (ABMT) arm, the apparent better outcome of T-ALL patients (35 T/50 B) did not reach statistical significance (P = .2) and there was no difference in the allogeneic bone marrow transplantation (alloBMT) arm (37 T/71 B: P = .9). In the B-cell-lineage leukemias, subclassification by stages and myeloid antigen coexpression (10%) were not associated with different prognosis. CD10+ T-ALL (31 patients) were associated with a better DFS compared with the CD10- T-ALL (73 patients) with respective median DFS, not reached and 18.5 months (P = .04).",1994,"CD10+ T-ALL (31 patients) were associated with a better DFS compared with the CD10- T-ALL (73 patients) with respective median DFS, not reached and 18.5 months (P = .04).","['Adult Acute Lymphoblastic Leukemia', 'adult acute lymphoblastic leukemia', 'adults (15 to 60 year olds) with acute lymphoblastic leukemia (ALL', '562 tested patients (LALA87']","['autologous bone marrow transplantation (ABMT', 'Immunophenotype']",['allogeneic bone marrow transplantation'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0079611', 'cui_str': 'Subtypings, Immunologic'}]","[{'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]",562.0,0.0250929,"CD10+ T-ALL (31 patients) were associated with a better DFS compared with the CD10- T-ALL (73 patients) with respective median DFS, not reached and 18.5 months (P = .04).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boucheix', 'Affiliation': 'Hôpital Paul-Brousse, Institut National de la Santé et de la Recherche Médicale, Unité 268, Villejuif, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'David', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Racadot', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bené', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jouault', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sigaux', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lepage', 'Affiliation': ''}]",Blood,[]
432,8068956,Fractionated total-body irradiation and high-dose etoposide as a preparatory regimen for bone marrow transplantation for 94 patients with chronic myelogenous leukemia in chronic phase.,"Ninety-four consecutive patients with chronic myelogenous leukemia in first clinical chronic phase, median age of 34.0 years (range, 6.8 to 52.4 years), with a histocompatible sibling donor, were treated with fractionated total body irradiation (1,320 cGy) and high-dose etoposide (60 mg/kg) followed by allogeneic bone marrow transplantation (BMT). The median time from diagnosis to BMT was 7.0 months (range, 2.3 to 72.0 months). Sixty patients were treated before BMT with hydroxyurea alone, four patients with busulfan alone, one patient with interferon alone, and the other 29 patients were treated with various combinations of these drugs. Cumulative probabilities of overall survival, event-free survival, and relapse at 5 years were 73%, 64%, and 14%, respectively. The median follow-up time for surviving patients was 38 months, ranging from 12 to 88 months. By stepwise Cox regression analysis, significant prognostic variables were age at transplant, acute graft-versus-host disease > or = grade II, cytomegalovirus-associated interstitial pneumonitis, and years from diagnosis to BMT.",1994,"Cumulative probabilities of overall survival, event-free survival, and relapse at 5 years were 73%, 64%, and 14%, respectively.","['Ninety-four consecutive patients with chronic myelogenous leukemia in first clinical chronic phase, median age of 34.0 years (range, 6.8 to 52.4 years), with a histocompatible sibling donor, were treated with', '94 patients with chronic myelogenous leukemia in chronic phase', 'Sixty patients']","['busulfan alone', 'interferon alone', 'allogeneic bone marrow transplantation (BMT', 'BMT with hydroxyurea', 'fractionated total body irradiation (1,320 cGy) and high-dose etoposide', 'Fractionated total-body irradiation and high-dose etoposide']","['median time from diagnosis to BMT', 'median follow-up time', 'Cumulative probabilities of overall survival, event-free survival, and relapse']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",60.0,0.0172659,"Cumulative probabilities of overall survival, event-free survival, and relapse at 5 years were 73%, 64%, and 14%, respectively.","[{'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Snyder', 'Affiliation': 'Department of Hematology/Bone Marrow Transplantation, City of Hope National Medical Center, Duarte, CA 91010.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Negrin', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Amylon', 'Affiliation': ''}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Nademanee', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Smith', 'Affiliation': ''}]",Blood,[]
433,8080985,Accelerated healing of chronic sickle-cell leg ulcers treated with RGD peptide matrix. RGD Study Group.,"Leg ulcers are a chronic manifestation of sickle-cell disease (SCD) and are often painful, disabling, and difficult to treat. RGD peptide matrix treatment is a novel therapy designed to provide a topical synthetic extracellular matrix that can act as a temporary substitute for the damaged natural matrix at the ulcer site. In this randomized, placebo-controlled, double-blind, prospective, multicenter investigation, SCD patients with full-thickness leg ulcers were treated with standard therapy plus RGD peptide matrix or saline placebo once weekly for up to 10 weeks. Healing in patients with chronic ulcers (2 months or greater in duration) was significantly accelerated (P = .0085) in RGD peptide matrix recipients compared with the placebo group. In these chronic ulcer cases, the average percent ulcer closure (decrease in ulcer surface area) in the RGD peptide matrix group (54.4% +/- 8.9%) exceeded that in the placebo group (19.0% +/- 24.3%) nearly threefold by study endpoint. Furthermore, RGD peptide matrix was equally effective in promoting healing of long persistent ulcers and ulcers of shorter duration. In contrast, standard therapy plus placebo was significantly less effective (P = .001) in promoting healing for ulcers of progressively greater duration. The results of this study provide preliminary evidence that RGD peptide matrix treatment may significantly accelerate healing of chronic sickle-cell leg ulcers.",1994,Healing in patients with chronic ulcers (2 months or greater in duration) was significantly accelerated (P = .0085) in RGD peptide matrix recipients compared with the placebo group.,"['patients with chronic ulcers', 'chronic sickle-cell leg ulcers treated with', 'SCD patients with full-thickness leg ulcers']","['standard therapy plus RGD peptide matrix or saline placebo', 'placebo', 'RGD peptide matrix']","['healing of chronic sickle-cell leg ulcers', 'average percent ulcer closure', 'Leg ulcers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0333297', 'cui_str': 'Chronic ulcer (morphologic abnormality)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0439809', 'cui_str': 'Full thickness (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052350', 'cui_str': 'RGD tripeptide'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",,0.104073,Healing in patients with chronic ulcers (2 months or greater in duration) was significantly accelerated (P = .0085) in RGD peptide matrix recipients compared with the placebo group.,"[{'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Wethers', 'Affiliation': 'St. Lukes/Roosevelt Hospital, Comprehensive Sickle Cell Center, New York, NY 10025.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Ramirez', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koshy', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Steinberg', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Phillips', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Eckman', 'Affiliation': ''}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Prchal', 'Affiliation': ''}]",Blood,[]
434,8081005,Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide.,"A prospective randomized study was conducted comparing two conditioning regimens for the treatment of patients with chronic myeloid leukemia in chronic phase by marrow transplantation from HLA identical siblings. Sixty-nine patients received 60 mg/kg of cyclophosphamide on each of 2 successive days followed by 6 fractions of total body irradiation each of 2.0 Gy (CY-TBI), and 73 patients received 16 mg/kg of busulfan delivered over 4 days followed by 60 mg/kg CY on each of 2 successive days (BU-CY). There was no significant difference between the CY-TBI and the BU-CY groups in the 3-year probabilities of survival (0.80 for both), relapse (0.13 for both), or event-free survival (CY-TBI, 0.68; BU-CY, 0.71) or in speed of engraftment or incidence of venocclusive disease of the liver. The 4-year probabilities of survival and event-free survival for patients transplanted within 1 year of diagnosis were 0.86 and 0.72, respectively, for each group. Significantly more patients in the CY-TBI group experienced major creatinine elevations. There was significantly more acute graft-versus-host disease in the CY-TBI group. Fever days, positive blood cultures, hospitalizations, and inpatient hospital days were significantly more common in the CY-TBI group than in the BU-CY group. In conclusion, the BU-CY regimen was better tolerated than, and associated with survival and relapse probabilities that compare favorably with, the CY-TBI regimen.",1994,"Fever days, positive blood cultures, hospitalizations, and inpatient hospital days were significantly more common in the CY-TBI group than in the BU-CY group.","['chronic myeloid leukemia', 'patients with chronic myeloid leukemia in chronic phase by marrow transplantation from HLA identical siblings']","['Marrow transplantation', 'cyclophosphamide and total body irradiation with busulfan and cyclophosphamide', 'cyclophosphamide']","['major creatinine elevations', 'acute graft-versus-host disease', 'survival and relapse probabilities', 'event-free survival', '3-year probabilities of survival', 'Fever days, positive blood cultures, hospitalizations, and inpatient hospital days', '4-year probabilities of survival and event-free survival', 'speed of engraftment or incidence of venocclusive disease of the liver', 'relapse']","[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023884', 'cui_str': 'Liver'}]",,0.0579406,"Fever days, positive blood cultures, hospitalizations, and inpatient hospital days were significantly more common in the CY-TBI group than in the BU-CY group.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bowden', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Hansen', 'Affiliation': ''}]",Blood,[]
435,8049437,Prognostic value of immunophenotyping in acute myeloid leukemia. Australian Leukaemia Study Group.,"The diagnostic and prognostic value of immunophenotyping with 18 murine monoclonal antibodies (MoAbs) to a variety of leukocyte differentiation antigens was assessed in 168 adults aged 15 to 60 years with acute myeloid leukemia (AML). Patients were entered on the multicentre Australian Leukaemia Study Group M4 protocol, and were randomized to receive either standard or high-dose Ara-C together with daunorubicin and etoposide as induction chemotherapy, followed by standard consolidation and maintenance therapy. Diagnostic bone marrow aspirate (152 cases) or peripheral blood samples (16) were analyzed by indirect immunofluorescence and flow cytometry. MoAbs used were directed at myeloid (CD11b, CD13, CD14, CD15, CD33, CD41), lymphoid (CD2, CD3, CD7, CD9, CD10, CD19), or stem cell (HLA-DR, CD34, c-kit receptor) antigens, as well as the leukocyte integrins CD18 and CD49e, and the transferrin receptor CD71. Of the myeloid markers, CD13 and CD33 were the most useful diagnostically (71% and 79% of cases positive, respectively), with CD11b, CD14, and CD15 less commonly positive. A minority of cases expressed lymphoid antigens, either T cell (CD2 16%, CD3 7%, CD7 28%) or B cell (CD10 2%, CD19 7%). CD34 was detected on 42% and c-kit receptor on 48%. When patients were analyzed for response to treatment, CD2, CD9, and CD14 were significantly associated with complete remission rate: cases expressing these antigens had a poorer response than negative cases. In univariate analysis, CD11b+ cases had shorter periods of remission (relative risk of relapse, 2.33; P = .003) and shorter survival (relative death rate, 1.91; P = .006). In multivariate analysis, adjusting for other prognostic factors, CD9 and CD11b were significantly predictive of shorter survival. No other marker had a significant predictive effect. We conclude that myeloid MoAbs are useful in confirming the diagnosis of AML, but their prognostic value may be limited to CD11b. Lymphoid antigen expression is a consistent phenomenon in a minority of cases of AML, but appears to have little clinical significance.",1994,"In univariate analysis, CD11b+ cases had shorter periods of remission (relative risk of relapse, 2.33; P = .003) and shorter survival (relative death rate, 1.91; P = .006).","['168 adults aged 15 to 60 years with acute myeloid leukemia (AML', 'Patients were entered on the multicentre Australian Leukaemia Study Group M4 protocol', 'acute myeloid leukemia']","['immunophenotyping with 18 murine monoclonal antibodies (MoAbs', 'immunophenotyping', 'standard or high-dose Ara-C together with daunorubicin and etoposide as induction chemotherapy, followed by standard consolidation and maintenance therapy', 'Diagnostic bone marrow aspirate']","['myeloid (CD11b, CD13, CD14, CD15, CD33, CD41), lymphoid (CD2, CD3, CD7, CD9, CD10, CD19), or stem cell (HLA-DR, CD34, c-kit receptor) antigens, as well as the leukocyte integrins CD18 and CD49e, and the transferrin receptor CD71', 'CD2, CD9, and CD14', 'shorter survival', 'CD34']","[{'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0079611', 'cui_str': 'Subtypings, Immunologic'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0857285', 'cui_str': 'Marrow aspirate'}]","[{'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0072470', 'cui_str': 'kit Proto-Oncogene Protein'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0034845', 'cui_str': 'Transferrin Receptor'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",168.0,0.0320471,"In univariate analysis, CD11b+ cases had shorter periods of remission (relative risk of relapse, 2.33; P = .003) and shorter survival (relative death rate, 1.91; P = .006).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bradstock', 'Affiliation': 'Department of Haematology, Westmead Hospital, New South Wales, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Benson', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Page', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': ''}]",Blood,[]
436,7812004,Detection of residual leukemic cells in patients with acute promyelocytic leukemia by the fluorescence in situ hybridization method: potential for predicting relapse.,"The translocation between chromosomes 15 and 17, t(15;17)(q22-24;q11-21), is present in the bone marrow cells of most patients with acute promyelocytic leukemia (APL). Although conventional cytogenetic methods are useful for diagnosing this disease, difficulties are experienced in detecting residual disease among those patients who have achieved remission. In this study, we used the fluorescence in situ hybridization (FISH) method to attempt to detect residual leukemic cells in 10 APL patients in clinical remission. The duration of remission ranged from 2 to 93 months at the time of study. Multiple bone marrow samples were analyzed by FISH in most patients. In 6 patients, no cell with t(15;17) was found. These patients remain in complete remission at present (approximately 25 to 33 months since first studied by FISH). In 4 patients, low frequencies of cells with t(15;17) were observed in at least one bone marrow sample examined. All of these patients relapsed within 1 to 14 months. No cell with t(15;17) was identified by the conventional G-banding method in any sample. The FISH results correlated well with that of a two-round nested reverse transcription polymerase chain reaction assay that was performed on the same samples. Thus, our study suggests that FISH is potentially a useful tool for detecting residual APL cells and for identifying patients at high risk of relapse.",1995,"In 4 patients, low frequencies of cells with t(15;17) were observed in at least one bone marrow sample examined.","['10 APL patients in clinical remission', 'patients with acute promyelocytic leukemia', 'patients with acute promyelocytic leukemia (APL']",['FISH'],"['Multiple bone marrow samples', 'duration of remission', 'low frequencies of cells with t(15;17']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0016163', 'cui_str': 'Fishes'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0438737', 'cui_str': 'Bone marrow specimen'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",,0.0242813,"In 4 patients, low frequencies of cells with t(15;17) were observed in at least one bone marrow sample examined.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Laboratory Medicine, University of Texas M.D. Anderson Cancer Center, Houston 77030.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Estey', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Deisseroth', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Liang', 'Affiliation': ''}]",Blood,[]
437,7727768,Randomized study of didanosine monotherapy and combination therapy with zidovudine in hemophilic and nonhemophilic subjects with asymptomatic human immunodeficiency virus-1 infection. AIDS Clinical Trial Groups.,"To evaluate the safety and efficacy of didanosine (ddl) monotherapy and three different combinations of zidovudine (ZDV) and ddl in asymptomatic human immunodeficiency virus-1 (HIV-1) infection, we conducted an open-label, phase I/II study in 126 asymptomatic HIV-1-infected hemophilic and nonhemophilic subjects with a CD4 count of 200 to 500/mm3 stratified for prior zidovudine treatment and baseline CD4 count. Study arms included arm A, low-dose combination (ZDV 150 mg and ddl 134 mg, daily); arm B, moderate-dose combination (ZDV 300 mg and ddI 334 mg, daily); arm C, high-dose combination (ZDV 600 mg and ddl 500 mg, daily), and arm D, ddl monotherapy (ddl 500 mg, daily). Earlier, more frequent hepatotoxicity was experienced by hemophilic subjects (P = .008), but there were no differences in toxicity between treatment arms (P = .51), nor were there any differences in the rate of development of clinical endpoints by treatment (P = .41). Smaller median CD4 increases occurred over the first 12 weeks for arms A and D, 44/mm3 and 42/mm3, than arms B and C, 105/mm3 and 114/mm3, respectively, (P = .015). Hemophilia status (P = .0004) and prior ZDV experience (P = .044) independently predicted weaker CD4 responses during the first 12 weeks of treatment. Using a regression model and adjusting for hemophilia status, prior ZDV treatment, and baseline CD4, there was a significant reduction in quantitative viral load from baseline by week 12 for all treatment arms combined (P = .0001), with significantly lower median percent reduction for arm A (56.3%) than arms B, C, and D (94.6%, 98.5%, and 91.9%, respectively, P = .015). Although greater hepatoxicity and weaker CD4 responses occur in hemophilic subjects, didanosine monotherapy and combination therapy with zidovudine are safe and effective in asymptomatic HIV-1-infected patients.",1995,"Earlier, more frequent hepatotoxicity was experienced by hemophilic subjects (P = .008), but there were no differences in toxicity between treatment arms (P = .51), nor were there any differences in the rate of development of clinical endpoints by treatment (P = .41).","['126 asymptomatic HIV-1-infected hemophilic and nonhemophilic subjects with a CD4 count of 200 to 500/mm3 stratified for prior zidovudine treatment and baseline CD4 count', 'asymptomatic human immunodeficiency virus-1 (HIV-1) infection', 'hemophilic and nonhemophilic subjects with asymptomatic human immunodeficiency virus-1 infection', 'asymptomatic HIV-1-infected patients']","['didanosine (ddl) monotherapy', 'zidovudine (ZDV) and ddl', 'didanosine monotherapy', 'low-dose combination (ZDV 150 mg and ddl 134 mg, daily); arm B, moderate-dose combination (ZDV 300 mg and ddI 334 mg, daily); arm C, high-dose combination (ZDV 600 mg and ddl 500 mg, daily), and arm D, ddl monotherapy', 'didanosine monotherapy and combination therapy with zidovudine', 'zidovudine']","['CD4 responses', 'toxicity', 'Smaller median CD4 increases', 'rate of development of clinical endpoints', 'safety and efficacy', 'Hemophilia status', 'quantitative viral load', 'frequent hepatotoxicity']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439243', 'cui_str': 'mm3'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0012133', 'cui_str': 'Didanosine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}]",126.0,0.0269975,"Earlier, more frequent hepatotoxicity was experienced by hemophilic subjects (P = .008), but there were no differences in toxicity between treatment arms (P = .51), nor were there any differences in the rate of development of clinical endpoints by treatment (P = .41).","[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Amato', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'LoFaro', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Van Der Horst', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Eyster', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Kessler', 'Affiliation': ''}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Gjerset', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ho', 'Affiliation': ''}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Parenti', 'Affiliation': ''}]",Blood,[]
438,7718899,Allogeneic bone marrow transplantation for chronic myeloid leukemia in first chronic phase: a randomized trial of busulfan-cytoxan versus cytoxan-total body irradiation as preparative regimen: a report from the French Society of Bone Marrow Graft (SFGM).,"From March 1988 to March 1991, 19 French bone marrow transplant (BMT) centers participated in a prospective randomized trial comparing two conditioning regimens for patients with chronic myeloid leukemia transplanted in first chronic phase with an HLA identical sibling donor. A total of 120 consecutive patients were randomized to receive either 120 mg/kg of cyclophosphamide followed by total body irradiation (CY-TBI; n = 55) or 16 mg/kg of busulfan followed by 120 mg/kg of CY (BU-CY; n = 65). Two different TBI regimens were used. Thirteen patients received a 10-Gy single-dose TBI (SDTBI), and 42 received a fractionated TBI (FTBI). Median time between diagnosis and BMT was 315 days. Overall 5-year actuarial survival was 62.9% (65.8% +/- 12.5% for CY-TBI and 60.6 +/- 11.7% for BU-CY; P = .5), and overall disease-free survival was 55% (51% +/- 14% for CY-TBI and 59.1% +/- 11.8% for BU-CY; P = .75). All patients conditioned with CY-TBI experienced sustained engraftment; in contrast, 4 of 65 patients conditioned with BU-CY rejected the graft (P = .18). There was no significant statistical difference between the two groups regarding transplant-related mortality (29% for CY-TBI and 38% for BU-CY; P = .44). So far, with a median follow up of 42 months, 11 patients have relapsed; 9 relapses occurred after CY-TBI, mostly after FTBI (8 of 9) and 2 after BU-CY (P = .02). The actuarial risk of relapse was 4.4% +/- 6.7% after BU-CY, 11.1% +/- 20.8% after SDTBI, and 31.3% +/- 18.1% after FTBI (P = .039). In addition, independently of the conditioning regimen, the increase of posttransplant immunosuppression in 16 patients with an anti-interleukin-2 receptor monoclonal antibody (MoAb) in addition to a short course of methotrexate and cyclosporine was shown to increase the actuarial risk of relapse (57% +/- 30% with MoAb v 9% +/- 7.3% without MoAb; P = .001). We conclude that BU is an acceptable alternative to TBI for patients with chronic myeloid leukemia in first chronic phase receiving BMT from HLA identical sibling donors. Both BU-CY and CY-TBI regimens gave similar transplant-related mortality, and the antileukemic efficiency of BU-CY regimen was either similar or even higher than that of CY-TBI.",1995,"Both BU-CY and CY-TBI regimens gave similar transplant-related mortality, and the antileukemic efficiency of BU-CY regimen was either similar or even higher than that of CY-TBI.","['From March 1988 to March 1991, 19 French bone marrow transplant (BMT) centers participated', '120 consecutive patients', 'patients with chronic myeloid leukemia transplanted in first chronic phase with an HLA identical sibling donor', 'patients with chronic myeloid leukemia in first chronic phase receiving BMT from HLA identical sibling donors', '16 patients with an anti-interleukin-2 receptor monoclonal antibody (MoAb', 'French Society of Bone Marrow Graft (SFGM']","['methotrexate and cyclosporine', 'busulfan-cytoxan versus cytoxan-total body irradiation', 'cyclophosphamide followed by total body irradiation (CY-TBI; n = 55) or 16 mg/kg of busulfan', '10-Gy single-dose TBI (SDTBI), and 42 received a fractionated TBI (FTBI', 'BU', 'Allogeneic bone marrow transplantation']","['actuarial risk of relapse', 'transplant-related mortality', 'antileukemic efficiency', 'sustained engraftment', 'Overall 5-year actuarial survival', 'overall disease-free survival', 'Median time', 'posttransplant immunosuppression']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034819', 'cui_str': 'TCGF Receptors'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0699319', 'cui_str': 'Cytoxan'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]",120.0,0.0363445,"Both BU-CY and CY-TBI regimens gave similar transplant-related mortality, and the antileukemic efficiency of BU-CY regimen was either similar or even higher than that of CY-TBI.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Devergie', 'Affiliation': 'Bone Marrow Transplant Units of Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Tigaud', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Jouet', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Vernant', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bordigoni', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dauriac', 'Affiliation': ''}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Cahn', 'Affiliation': ''}]",Blood,[]
439,7742522,All-trans-retinoic acid as a differentiating agent in the treatment of acute promyelocytic leukemia.,,1995,,['acute promyelocytic leukemia'],[],[],"[{'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]",[],[],,0.0177667,,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Degos', 'Affiliation': 'Service Clinique des Maladies du Sang, Hôpital St Louis, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chomienne', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Daniel', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Micléa', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chastang', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Castaigne', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': ''}]",Blood,[]
440,7742562,Interferon-alpha therapy in chronic myelogenous leukemia: questions related to the German randomized trial.,,1995,,['chronic myelogenous leukemia'],['Interferon-alpha therapy'],[],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0150383,,"[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Talpaz', 'Affiliation': ''}]",Blood,[]
441,7742563,Alpha-interferon in the treatment of chronic myeloid leukemia. The Italian Cooperative Study Group on Chronic Myeloid Leukemia.,,1995,,['chronic myeloid leukemia'],['Alpha-interferon'],[],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]",[],,0.015974,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tura', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': ''}]",Blood,[]
442,7691256,"Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas.","We evaluated recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; Sandoz Pharma [Basel, Switzerland]/Schering-Plough [Kenilworth, NJ]) as an adjunct to a modified (mainly cyclophosphamide and doxorubicin increased 1.5-fold) COP-BLAM regimen in the primary treatment of high-grade malignant non-Hodgkin's lymphomas (NHL). Patients (n = 182; stage II-IV; age, 15 to 73 years) were randomized to rhGM-CSF (400 micrograms) or placebo for 7 days subcutaneously after chemotherapy. Efficacy was analyzed for patients receiving at least 70% of study medication (n = 125). The frequency of clinically relevant infection was reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a cumulative probability of remaining infection free in 70% versus 48% (P = .05 log rank test at 190 days). Periods of neutropenia (P = .01 in 5 of 6 courses), days with fever (2.1 v 4.0, P = .04) and days of hospitalization for infection (3.5 v 8.0 days, P = .01) were significantly reduced. Complete response (CR) rates, assessed by prognostic risk, were 15 of 19 (79%) in treated versus 20 of 21 (95%) in controls in the low-risk group (P = .12). In the high-risk group, 31 of 45 (69%) treated patients achieved CR versus 25 of 52 (48%) of controls (P = .04). No difference in survival has been seen after 1 year. Only injection site reactions (45% treated v 7% controls) and rash (26% v 2%) occurred more frequently in treated patients (n = 176). These data show that rhGM-CSF is well tolerated in most patients with NHL, significantly reduces infection, and improves response.",1993,"The frequency of clinically relevant infection was reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a cumulative probability of remaining infection free in 70% versus 48% (P = .05 log rank test at 190 days).","['patients receiving at least 70% of study medication (n = 125', ""high-grade malignant non-Hodgkin's lymphomas"", ""high-grade malignant non-Hodgkin's lymphomas (NHL"", 'Patients (n = 182; stage II-IV; age, 15 to 73 years']","['rhGM-CSF', 'placebo', 'recombinant human granulocyte-macrophage colony-stimulating factor', 'cyclophosphamide and doxorubicin', 'recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; Sandoz Pharma [Basel, Switzerland]/Schering-Plough [Kenilworth, NJ']","['days of hospitalization for infection', 'frequency of clinically relevant infection', 'Complete response (CR) rates', 'neutropenia', 'Efficacy', 'survival', 'rash', 'cumulative probability of remaining infection free']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.243527,"The frequency of clinically relevant infection was reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a cumulative probability of remaining infection free in 70% versus 48% (P = .05 log rank test at 190 days).","[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Gerhartz', 'Affiliation': 'Medical Department III, Klinikum GroBhadem, Munich University, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Engelhard', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Meusers', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Brittinger', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wilmanns', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schlimok', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huhn', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Musch', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Siegert', 'Affiliation': ''}]",Blood,[]
443,7537110,"Thrombopoietic effects and toxicity of interleukin-6 in patients with ovarian cancer before and after chemotherapy: a multicentric placebo-controlled, randomized phase Ib study.","Recombinant human interleukin-6 (IL-6) has previously been shown to increase platelet counts in normal and sublethally irradiated mice, dogs, and primates. To assess its tolerance and efficacy in clinical use, we performed a randomized phase Ib study in patients with ovarian carcinoma. IL-6 was administered during an initial 7-day cycle before any chemotherapy. Beginning 7 days later, six cycles of chemotherapy containing carboplatin were administered every 3 weeks. During chemotherapy cycles 2 to 6, IL-6 was administered from day 4 through day 17 at escalating dose levels from 0.5 to 10 micrograms/kg/d. At each level, three patients received IL-6 and one patient received a placebo. During the prechemotherapy cycle of IL-6, a dose-dependent increase in platelet count was observed from day 12 to 15 and was maximal on day 15 (r = .77; P < .01). The median ploidy of bone marrow megakaryocytes shifted from 16 N to 32 N after 7 days of the initial prechemotherapy IL-6 administration. Dose-dependent increases in C-reactive protein (CRP) and fibrinogen levels were observed on day 8 (P < .0001 for both). A significant decrease in hemoglobin level occured rapidly after initiation of IL-6 therapy and was maximal on day 8 (P < .001). When given after chemotherapy, IL-6 accelerated platelet recovery after chemotherapy cycles 2 to 6. Postponements of scheduled chemotherapy due to thrombocytopenia were less frequent in patients treated with IL-6. No difference in either neutrophils or peripheral blood progenitor assays was observed during or after IL-6 treatment. Toxicity of IL-6 appeared mild and was not dose-limiting up to 10 micrograms/kg/d. Systemic symptoms such as fever, headache, and myalgia were the main side effects and were easily relieved by acetaminophen administration. No biologic toxicity was observed. The data indicate that IL-6 is a well-tolerated cytokine and capable of accelerating platelet recovery in patients receiving chemotherapy.",1995,Dose-dependent increases in C-reactive protein (CRP) and fibrinogen levels were observed on day 8 (P < .0001 for both).,"['patients receiving chemotherapy', 'patients with ovarian carcinoma', 'patients with ovarian cancer before and after chemotherapy']","['acetaminophen', 'placebo', 'Recombinant human interleukin-6 (IL-6', 'IL-6', 'chemotherapy containing carboplatin']","['platelet count', 'Toxicity of IL-6', 'thrombocytopenia', 'tolerance and efficacy', 'Thrombopoietic effects and toxicity of interleukin-6', 'platelet counts', 'C-reactive protein (CRP) and fibrinogen levels', 'hemoglobin level', 'neutrophils or peripheral blood progenitor assays', 'Systemic symptoms such as fever, headache, and myalgia', 'IL-6 accelerated platelet recovery', 'biologic toxicity', 'median ploidy of bone marrow megakaryocytes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0029925'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2983957', 'cui_str': 'Interleukin-6, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032246', 'cui_str': 'Ploidies'}, {'cui': 'C0555112', 'cui_str': 'Finding of bone marrow megakaryocytes (finding)'}]",,0.163761,Dose-dependent increases in C-reactive protein (CRP) and fibrinogen levels were observed on day 8 (P < .0001 for both).,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Department of Oncology, Catholic University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Humblet', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Guillaume', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baatout', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chatelain', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berlière', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Longueville', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Feyens', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Greve', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Van Oosterom', 'Affiliation': ''}]",Blood,[]
444,7605984,A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490).,"The treatment of adult patients greater than 55 to 70 years of age with acute myelogenous leukemia (AML) is associated with a treatment-related mortality of approximately 25%. This prospective, double-blind randomized study was designed to see if the use of granulocyte-macrophage colony stimulating factor (GM-CSF; yeast-derived) could shorten the period of neutropenia and to determine any effect this would have on therapy-related morbidity and mortality. A total of 124 patients entered this study. Induction consisted of standard daunorubicin and cytarabine. A day-10 bone marrow was examined; if this was aplastic without leukemia, patients received blinded placebo or GM-CSF from day 11 until neutrophil recovery. Patients who entered complete remission received the identical study medication (blinded GM-CSF or placebo) in consolidation that they had received during induction. The overall complete remission rate was 52%; 60% for the GM-CSF arm and 44% for the placebo arm (P = .08). Median times to neutrophil recovery were significantly shortened on the GM-CSF arm. The overall treatment-related toxicity from start of GM-CSF/placebo was reduced on the GM-CSF arm (P = .049). Similarly, the infectious toxicity was significantly reduced on the GM-CSF arm (P = .015). The median survival for all patients was 10.6 months in the GM-CSF group and 4.8 months in the placebo arm (P = .048). It appears that GM-CSF is safe and efficacious for adult patients greater than 55 to 70 years of age with AML; its major impact is in reducing the duration of neutropenia and therapy-related mortality and morbidity. This may result in a better response rate.",1995,The overall complete remission rate was 52%; 60% for the GM-CSF arm and 44% for the placebo arm (P = .08).,"['adult patients (> 55 to 70 years of age) with acute myelogenous leukemia', 'Patients who entered complete remission received the identical study medication (blinded', 'adult patients greater than 55 to 70 years of age with acute myelogenous leukemia (AML', '124 patients entered this study', 'adult patients greater than 55 to 70 years of age with AML']","['GM-CSF or placebo', 'placebo', 'granulocyte-macrophage colony-stimulating factor', 'granulocyte-macrophage colony stimulating factor (GM-CSF', 'GM-CSF', 'placebo or GM-CSF', 'standard daunorubicin and cytarabine']","['median survival', 'infectious toxicity', 'overall complete remission rate', 'Median times to neutrophil recovery', 'overall treatment-related toxicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",124.0,0.35669,The overall complete remission rate was 52%; 60% for the GM-CSF arm and 44% for the placebo arm (P = .08).,"[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rowe', 'Affiliation': 'Hematology Unit, University of Rochester Medical Center, NY 14642, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Andersen', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Mazza', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': ''}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Hayes', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Oette', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Cassileth', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}]",Blood,[]
445,7670096,"Results of a phase I/II trial of recombinant human granulocyte-macrophage colony-stimulating factor in very low birthweight neonates: significant induction of circulatory neutrophils, monocytes, platelets, and bone marrow neutrophils.","Neonates, especially those of very low birthweight (VLBW), have an increased risk of nosocomial infections secondary to deficiencies in development. We previously demonstrated that granulocyte-macrophage colony-stimulating factor (GM-CSF) production and mRNA expression from stimulated neonatal mononuclear cells are significantly less than that from adult cells. Recombinant murine GM-CSF administration to neonatal rats has resulted in neutrophilia, increased neutrophil production, and increased survival of pups during experimental Staphylococcus aureus sepsis. In the present study, we sought to determine the safety and biologic response of recombinant human (rhu) GM-CSF in VLBW neonates. Twenty VLBW neonates (500 to 1,500 g), aged < 72 hours, were randomized to receive either placebo (n = 5) or rhuGM-CSF at 5.0 micrograms/kg once per day (n = 5), 5.0 micrograms/kg twice per day (n = 5), or 10 micrograms/kg once per day (n = 5) given via 2-hour intravenous infusion for 7 days. Complete blood counts, differential, and platelet counts were obtained, and tibial bone marrow aspirate was performed on day 8. Neutrophil C3bi receptor expression was measured at 0 and 24 hours. GM-CSF levels were measured by a sandwich enzyme-linked immunosorbent assay at 2, 4, 6, 12, and 24 hours after the first dose of rhuGM-CSF. At all doses, rhuGM-CSF was well tolerated, and there was no evidence of grade III or IV toxicity. Within 48 hours of administration, there was a significant increase in the circulating absolute neutrophil count (ANC) at 5.0 micrograms/kg twice per day and 10.0 micrograms/kg once per day, which continued for at least 24 hours after discontinuation of rhuGM-CSF. When the ANC was normalized for each patient's first ANC, there was a significant increase in the ANC on days 6 and 7 at each dose level. By day 7, all tested doses of rhuGM-CSF resulted in an increase in the absolute monocyte count (AMC) compared with placebo-treated neonates. In those receiving rhuGM-CSF 5.0 micrograms/kg twice per day, there was additionally a significant increase in the day 7 and 8 platelet count. Tibial bone marrow aspirates demonstrated a significant increase in the bone marrow neutrophil storage pool (BM NSP) at 5.0 micrograms/kg twice per day and 10.0 micrograms/kg once per day. Neutrophil C3bi receptor expression was significantly increased 24 hours after the first dose of rhuGM-CSF at 5.0 micrograms/kg once per day. The elimination half-life (T1/2) of rhuGM-CSF was 1.4 +/- 0.8 to 3.9 +/- 2.8 hours.(ABSTRACT TRUNCATED AT 400 WORDS)",1995,"At all doses, rhuGM-CSF was well tolerated, and there was no evidence of grade III or IV toxicity.","['very low birthweight neonates', 'Twenty VLBW neonates (500 to 1,500 g), aged < 72 hours', 'neonatal rats', 'VLBW neonates']","['rhuGM-CSF', 'placebo', 'recombinant human (rhu) GM-CSF', 'recombinant human granulocyte-macrophage colony-stimulating factor', 'Recombinant murine GM-CSF']","['Neutrophil C3bi receptor expression', 'neutrophilia, increased neutrophil production', 'GM-CSF levels', 'circulating absolute neutrophil count (ANC', 'elimination half-life (T1/2) of rhuGM-CSF', 'safety and biologic response', 'bone marrow neutrophil storage pool (BM NSP', 'absolute monocyte count (AMC', 'Complete blood counts, differential, and platelet counts', 'grade III or IV toxicity']","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0034721', 'cui_str': 'Rats'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0006599', 'cui_str': 'C3bi'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0151683', 'cui_str': 'Neutrophilia (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0312833', 'cui_str': 'Neutrophil production'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C0382121', 'cui_str': '(3H)-AMC'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0450845,"At all doses, rhuGM-CSF was well tolerated, and there was no evidence of grade III or IV toxicity.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cairo', 'Affiliation': ""Children's Hospital of Orange County, CA 92668, USA.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Sender', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van de Ven', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Worcester', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Agosti', 'Affiliation': ''}]",Blood,[]
446,7527674,Marrow transplantation for patients in accelerated phase of chronic myeloid leukemia.,"The records were reviewed of 58 patients receiving transplants in Seattle with unmanipulated marrow from HLA-identical siblings during the accelerated phase (AP) of chronic myeloid leukemia. Variables examined for association with survival and relapse included the interval from diagnosis to transplant, the reasons for categorization as AP, age, regimen, and cytomegalovirus serology. Four patients relapsed. The 4-year probabilities of survival, relapse-free survival, nonrelapse mortality, and relapse were 0.49, 0.43, 0.51, and 0.12, respectively. After completion of the stepwise multivariate analysis, age less than 38 years and categorization as AP solely on the basis of chromosomal abnormalities emerged as being independently significantly associated with improved survival. The 4-year probability of survival for the 16 patients categorized as AP because of chromosomal abnormalities and receiving transplant less than 1 year from diagnosis was 0.74. The low probability of relapse in these patients suggests that more aggressive preparative regimens are not indicated for patients receiving transplants in AP because of the increased risk of transplant-related mortality.",1994,"The 4-year probabilities of survival, relapse-free survival, nonrelapse mortality, and relapse were 0.49, 0.43, 0.51, and 0.12, respectively.","['58 patients receiving transplants in Seattle with unmanipulated marrow from HLA-identical siblings during the accelerated phase (AP) of chronic myeloid leukemia', 'patients in accelerated phase of chronic myeloid leukemia']",['Marrow transplantation'],"['4-year probabilities of survival, relapse-free survival, nonrelapse mortality, and relapse', 'survival', '4-year probability of survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",58.0,0.031462,"The 4-year probabilities of survival, relapse-free survival, nonrelapse mortality, and relapse were 0.49, 0.43, 0.51, and 0.12, respectively.","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bowden', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Fisher', 'Affiliation': ''}]",Blood,[]
447,7670117,Polymerase chain reaction monitoring reduces the incidence of cytomegalovirus disease and the duration and side effects of antiviral therapy after bone marrow transplantation.,"Culture-based preemptive therapy with ganciclovir was shown to reduce the incidence of cytomegalovirus (CMV) disease after bone marrow transplantation (BMT). Culture techniques did not detect CMV in 12% to 13% of patients before the onset of CMV disease. In a prospective study, 71 patients either received preemptive therapy based on polymerase chain reaction (PCR) technique (37 patients) or on culture assays (34 patients). In both groups, therapy was continued until clinical signs disappeared and PCR negativity was documented. Twenty-two patients in the PCR group and 15 patients in the culture group received antiviral therapy. PCR allowed detection of the virus (median day, +32 v day +49; P = .006) and introduction of antiviral therapy (median day, +44 v day +54; P = .02) earlier than did culture assays. The incidences of CMV disease (2 of 37 v 8 of 34 in PCR group v culture group, respectively; P = .02) and CMV-associated mortality (0 of 37 v 5 of 34 in PCR group v culture group, respectively; P = .02) were decreased, and the duration of ganciclovir therapy (P < .001) was shorter in the PCR-monitored group. Incidence and median duration of severe neutropenia (less than 500/microL) were lower in the PCR group (two v eight episodes, P = .02; median duration, 1.5 v 5 days, P = .04), as was the incidence of nonviral infections during/after antiviral therapy (2 of 37 v 9 of 34; P = .012). Thus, preemptive therapy based on more sensitive detection methods such as the PCR assay reduces the incidence of CMV disease and CMV-related mortality. Additionally, stopping and withholding antiviral therapy in a PCR-negative patient is safe and allows reduction of the duration and side effects of antiviral therapy.",1995,"PCR allowed detection of the virus (median day, +32 v day +49; P = .006) and introduction of antiviral therapy (median day, +44 v day +54; P = .02) earlier than did culture assays.","['after bone marrow transplantation (BMT', '71 patients either received', 'after bone marrow transplantation']","['PCR', 'antiviral therapy', 'preemptive therapy based on polymerase chain reaction (PCR) technique (37 patients) or on culture assays', 'Polymerase chain reaction monitoring', 'ganciclovir']","['incidence of nonviral infections', 'CMV-associated mortality', 'incidences of CMV disease', 'incidence of cytomegalovirus disease and the duration and side effects', 'duration of ganciclovir therapy', 'Incidence and median duration of severe neutropenia', 'PCR negativity', 'incidence of cytomegalovirus (CMV) disease']","[{'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",71.0,0.0280507,"PCR allowed detection of the virus (median day, +32 v day +49; P = .006) and introduction of antiviral therapy (median day, +44 v day +54; P = .02) earlier than did culture assays.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Medizinische Klinik und Poliklinik, Abteilung II, Universität Tübingen, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hebart', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Wittkowski', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schuler', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jahn', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mackes', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Herter', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Klingebiel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Löffler', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Müller', 'Affiliation': ''}]",Blood,[]
448,7683221,Hypercoagulability during induction therapy of acute lymphoblastic leukemia is of scarce clinical relevance. Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto.,,1993,,['acute lymphoblastic leukemia'],[],['Hypercoagulability'],"[{'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]",[],"[{'cui': 'C0398623', 'cui_str': 'Hypercoagulability'}]",,0.0177953,,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'de Stefano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gugliotta', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Mazzucconi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Leone', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': ''}]",Blood,[]
449,7756663,Transferrin saturation and recovery from coma in cerebral malaria.,"To determine if the elevated transferrin saturations found in some patients with severe malaria are associated with an adverse outcome in cerebral malaria, we retrospectively measured baseline saturations in stored serum samples from 81 Zambian children with strictly defined cerebral malaria. The children had been treated with quinine, sulfadox-ine-pyrimethamine, and intravenous infusions of either placebo (n = 39) or the iron chelator, desferrioxamine B (n = 42), in a previously reported trial (Gordeuk et al, N Engl J Med 327:1473, 1992). More than one-third of children in both the placebo- and iron chelator-treated groups had transferrin saturations exceeding 43%, which is 3 standard deviations above the expected mean for age. Among children receiving quinine and placebo, those with elevated transferrin saturations had a delayed estimated median time to recover full consciousness (68.2 hours) compared with those with saturations < or = 43% (25.4 hours; P = .006). The addition of iron chelation to quinine therapy in children with high saturations appeared to hasten recovery (P = .046). We conclude that increased transferrin saturations may be associated with delayed recovery from coma during standard therapy for cerebral malaria and that serum iron and total iron binding capacity should be measured in future studies.",1995,"More than one-third of children in both the placebo- and iron chelator-treated groups had transferrin saturations exceeding 43%, which is 3 standard deviations above the expected mean for age.","['children with high saturations', '81 Zambian children with strictly defined cerebral malaria', 'patients with severe malaria']","['quinine, sulfadox-ine-pyrimethamine', 'placebo', 'iron chelator, desferrioxamine B']","['transferrin saturations', 'median time to recover full consciousness', 'Transferrin saturation', 'elevated transferrin saturations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}]","[{'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0034283', 'cui_str': 'Pyrimethamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007974', 'cui_str': 'Complexons'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}]","[{'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",81.0,0.397692,"More than one-third of children in both the placebo- and iron chelator-treated groups had transferrin saturations exceeding 43%, which is 3 standard deviations above the expected mean for age.","[{'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Gordeuk', 'Affiliation': 'Department of Medicine, George Washington University Medical Center, Washington, DC 20037, USA.'}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Thuma', 'Affiliation': ''}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'McLaren', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Biemba', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zulu', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Poltera', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Askin', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Brittenham', 'Affiliation': ''}]",Blood,[]
450,7620184,A randomized trial comparing interferon-alpha with busulfan for newly diagnosed chronic myelogenous leukemia in chronic phase.,"A multicenter randomized study was conducted to compare the effect of interferon-alpha (IFN-alpha) with that of busulfan in newly diagnosed patients with chronic myelogenous leukemia (CML) in chronic phase. From October 1988 to October 1991, 170 patients were randomized to receive either IFN-alpha or busulfan. Of 159 eligible patients, 31 (38.8%) of 80 patients in the IFN-alpha group and 43 (54.4%) of 79 patients in the busulfan group achieved complete hematologic remission, and 38.8% in the IFN-alpha group and 43.0% in the busulfan group achieved partial hematologic remission. A complete cytogenetic response was induced in seven (8.8%) of 80 patients treated with IFN-alpha and two (2.5%) of 79 patients treated with busulfan, and a partial cytogenetic response was 7.5% (6/80) and 2.5% (2/79), respectively. The difference in major (complete and partial) cytogenetic response between the two groups was significant (P = .046). At a median follow-up of 50 months, the predicted 5-year survival rate was 54% in the IFN-alpha group and 32% in the busulfan group (P = .0290), and the predicted 5-year rate of remaining in chronic phase was 41% in the IFN-alpha group and 29% in the busulfan group (P = .1165). As compared with the patients with no cytogenetic response, the patients with any cytogenetic response (complete, partial or minor) after the IFN-alpha or busulfan treatment were significantly superior in the duration of chronic phase (IFN-alpha group; P = .0017, busulfan group; P = .0010) even after correction for the time to response using the landmark analysis. However, there was no significant difference in survival rate in the IFN-alpha group (P = .1065). There was no significant difference in survival rate (P = .3923) and the duration of chronic phase (P = .6258) between the IFN-alpha and the busulfan group in the patients with a cytogenetic response (complete, partial or minor). These results demonstrate that IFN-alpha treatment produces a significantly superior cytogenetic response and survival rate as compared with the busulfan treatment, and unexpectedly, that busulfan can also eliminate Philadelphia chromosome positive clone in a few patients who showed prolonged survival rate and duration of chronic phase.",1995,The difference in major (complete and partial) cytogenetic response between the two groups was significant (P = .046).,"['newly diagnosed patients with chronic myelogenous leukemia (CML) in chronic phase', '159 eligible patients, 31 (38.8%) of 80 patients in the IFN-alpha group and 43 (54.4%) of 79 patients in the', 'From October 1988 to October 1991, 170 patients', 'newly diagnosed chronic myelogenous leukemia in chronic phase']","['interferon-alpha with busulfan', 'interferon-alpha (IFN-alpha', 'IFN-alpha or busulfan', 'busulfan']","['major (complete and partial) cytogenetic response', 'survival rate and duration of chronic phase', 'complete hematologic remission', 'duration of chronic phase', 'partial hematologic remission', 'survival rate', 'partial cytogenetic response', '5-year survival rate', '5-year rate of remaining in chronic phase', 'superior cytogenetic response and survival rate', 'cytogenetic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",170.0,0.0457741,The difference in major (complete and partial) cytogenetic response between the two groups was significant (P = .046).,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Medicine III, Hamamatsu University School of Medicine, Japan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ohno', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tomonaga', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kamada', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Onozawa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kuramoto', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dohy', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mizoguchi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Miyawaki', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tsubaki', 'Affiliation': ''}]",Blood,[]
451,7632972,"Consolidation treatment of adult acute lymphoblastic leukemia: a prospective, randomized trial comparing allogeneic versus autologous bone marrow transplantation and testing the impact of recombinant interleukin-2 after autologous bone marrow transplantation. BGMT Group.","A prospective, randomized trial was initiated in adult acute lymphoblastic leukemia (ALL) to compare (1) disease-free survival (DFS) after allogeneic or autologous bone marrow transplantation (BMT) and (2) the relapse rate of patients treated with or without interleukin-2 (IL-2) after autologous BMT. A total of 135 previously untreated patients, aged under 55 years, received the Berlin-Frankfurt-Muster (BFM) induction regimen: 126 patients (93%), of which 120 were HLA-typed, achieved complete remission (CR). According to this genetic randomization, patients with (n = 43) or without an HLA-identical sibling (n = 77) were to receive allogeneic or autologous BMT, respectively. The 3-year post-CR probability of DFS was significantly higher in the HLA-identical sibling group than in the non-HLA-identical sibling group (68% v 26%; P < .001). Eligible patients were randomized to receive (n = 30) or not to receive (n = 30) IL-2 after autologous BMT: the 3-year post-BMT probability of continuous CR was similar in both groups (29% v 27%, respectively). We conclude that, in ALL, early allogeneic BMT after the BFM induction regimen is an effective consolidation treatment and that IL-2 does not decrease the high relapse rate observed after autologous BMT.",1995,The 3-year post-CR probability of DFS was significantly higher in the HLA-identical sibling group than in the non-HLA-identical sibling group (68% v 26%; P < .001).,"['adult acute lymphoblastic leukemia (ALL) to compare (1) disease-free survival (DFS) after allogeneic or autologous bone marrow transplantation (BMT) and (2', '135 previously untreated patients, aged under 55 years', 'adult acute lymphoblastic leukemia', 'patients with (n = 43) or without an HLA-identical sibling (n = 77', 'Eligible patients']","['allogeneic or autologous BMT', 'recombinant interleukin-2 after autologous bone marrow transplantation', 'allogeneic versus autologous bone marrow transplantation']","['complete remission (CR', 'relapse rate', '3-year post-CR probability of DFS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",135.0,0.0998736,The 3-year post-CR probability of DFS was significantly higher in the HLA-identical sibling group than in the non-HLA-identical sibling group (68% v 26%; P < .001).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Department of Hematology, Hôpital Purpan, Toulouse, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Marit', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Payen', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michallet', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Vernant', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sauvage', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Troussard', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nedellec', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pico', 'Affiliation': ''}]",Blood,[]
452,7520770,"A randomized, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor administration in newborn infants with presumed sepsis: significant induction of peripheral and bone marrow neutrophilia.","Host defenses in the human neonate are limited by immaturity in phagocytic immunity. Such limitations seem to predispose infected newborns to neutropenia from an exhaustion of the neutrophil reserve. Among the critical defects thus far identified in neonatal phagocytic immunity is a specific reduction in the capacity of mononuclear cells to express granulocyte colony-stimulating factor (G-CSF) after stimulation. However, the safety, pharmacokinetics, and biological efficacy of administration of recombinant human (rh)G-CSF to infected human newborns to compensate for this deficiency is unknown. Forty-two newborn infants (26 to 40 weeks of age) with presumed bacterial sepsis within the first 3 days of life were randomized to receive either placebo or varying doses of rhG-CSF (1.0, 5.0 or 10.0 micrograms/kg every 24 hours [36 patients] or 5.0 or 10.0 micrograms/kg every 12 hours [6 patients]) on days 1, 2, and 3. Complete blood counts with differential and platelet counts were obtained at hours 0, 2, 6, 24, 48, 72, and 96. Circulating G-CSF concentrations were determined at hours 0, 2, 6, 12, 14, 16, 18, 24, and 36. Tibial bone marrow aspirates were obtained after 72 hours for quantification of the bone marrow neutrophil storage pool (NSP), neutrophil proliferative pool, granulocyte progenitors, and pluripotent progenitors. Functional activation of neutrophils (C3bi expression) was determined 24 hours after rhG-CSF or placebo administration. Intravenous rhG-CSF was not associated with any recognized acute toxicity. RhG-CSF induced a significant increase in the blood neutrophil concentration 24 hours after the 5 and 10 micrograms/kg doses every 12 and 24 hours and it was sustained as long as 96 hours. A dose-dependent increase in the NSP was seen following rhG-CSF. Neutrophil C3bi expression was significantly increased at 24 hours after 10 micrograms/kg every 24-hour dose of rhG-CSF. The half-life of rhG-CSF was 4.4 +/- 0.4 hours. The rhG-CSF was well tolerated at all gestational ages treated. The rhG-CSF induced a significant increase in the peripheral blood and bone marrow absolute neutrophil concentration and in C3bi expression. Future clinical trials aimed at improving the outcome of overwhelming bacterial sepsis and neutropenia in newborn infants might include the use of rhG-CSF.",1994,Neutrophil C3bi expression was significantly increased at 24 hours after 10 micrograms/kg every 24-hour dose of rhG-CSF.,"['Forty-two newborn infants (26 to 40 weeks of age) with presumed bacterial sepsis within the first 3 days of life', 'newborn infants with presumed sepsis', 'newborn infants']","['recombinant human granulocyte colony-stimulating factor administration', 'placebo', 'placebo or varying doses of rhG-CSF', 'recombinant human (rh)G-CSF']","['peripheral blood and bone marrow absolute neutrophil concentration and in C3bi expression', 'safety, pharmacokinetics, and biological efficacy', 'Neutrophil C3bi expression', 'blood neutrophil concentration', 'Complete blood counts with differential and platelet counts', 'Functional activation of neutrophils (C3bi expression', 'NSP', 'Circulating G-CSF concentrations']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0684256', 'cui_str': 'Bacterial septicemia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006599', 'cui_str': 'C3bi'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}]",42.0,0.0281819,Neutrophil C3bi expression was significantly increased at 24 hours after 10 micrograms/kg every 24-hour dose of rhG-CSF.,"[{'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Gillan', 'Affiliation': ""Children's Hospital of Orange County, CA.""}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Suen', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van de Ven', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cairo', 'Affiliation': ''}]",Blood,[]
453,7541660,Concomitant granulocyte colony-stimulating factor and induction chemoradiotherapy in adult acute lymphoblastic leukemia: a randomized phase III trial.,"This prospective multicenter study examined whether simultaneous administration of granulocyte colony-stimulating factor (G-CSF; Filgrastim) and induction chemotherapy for adult acute lymphoblastic leukemia (ALL) could prevent treatment-related neutropenia, infections, and resulting treatment delays. Seventy-six patients were randomly assigned to receive either G-CSF (n = 37) or no growth factor (n = 39) in conjunction with a uniform chemotherapy consisting of cyclophosphamide, cytarabine, mercaptopurine, intrathecal methotrexate, and cranial irradiation. The median duration of neutropenia (absolute neutrophil count < 1 x 10(9)/L) during chemotherapy was 8 days in patients receiving C-CSF, compared with 12.5 days in the control group (P < .002). A similar reduction from 11.5 to 7 days was observed in patients with T-ALL receiving additional mediastinal irradiation (P = .13). Infections occurred in 43% and 56% of patients in the G-CSF and control arm, respectively (P = .25); the incidence of nonviral infections was reduced by 50%, from 32 episodes in the control arm to 16 episodes in the G-CSF arm. Prolonged interruptions of chemotherapy administration were less frequent, with delays of 2 weeks or more occurring in only 24% of patients receiving G-CSF as opposed to 46% in the control arm (P = .01). Accordingly, chemotherapy was completed significantly earlier with the use of G-CSF (39 v 44 days, P = .008). With a median follow-up of 20 months, the probability of disease-free survival was 0.45 in the G-CSF group and 0.43 in the control group (P = .34). In conclusion, adult ALL patients appear to benefit by the simultaneous administration of G-CSF with induction chemotherapy because of a significant reduction in the duration of neutropenia, a trend to fewer infections, and a more rapid completion of chemotherapy.",1995,"Accordingly, chemotherapy was completed significantly earlier with the use of G-CSF (39 v 44 days, P = .008).","['Seventy-six patients', 'adult acute lymphoblastic leukemia (ALL', 'adult acute lymphoblastic leukemia']","['granulocyte colony-stimulating factor (G-CSF; Filgrastim', 'G-CSF', 'induction chemotherapy', 'no growth factor (n = 39) in conjunction with a uniform chemotherapy consisting of cyclophosphamide, cytarabine, mercaptopurine, intrathecal methotrexate, and cranial irradiation', 'Concomitant granulocyte colony-stimulating factor and induction chemoradiotherapy']","['median duration of neutropenia', 'incidence of nonviral infections', 'Infections', 'probability of disease-free survival', 'duration of neutropenia']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0445119', 'cui_str': 'No growth (qualifier value)'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",76.0,0.0289065,"Accordingly, chemotherapy was completed significantly earlier with the use of G-CSF (39 v 44 days, P = .008).","[{'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Ottmann', 'Affiliation': 'Department of Internal Medicine, University of Frankfurt, Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoelzer', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gracien', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reutzel', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lipp', 'Affiliation': ''}, {'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Busch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schwonzen', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': ''}]",Blood,[]
454,7579372,Oxygen inhalation in nonhypoxic sickle cell patients during vaso-occlusive crisis.,,1995,,['nonhypoxic sickle cell patients during vaso-occlusive crisis'],['Oxygen inhalation'],[],"[{'cui': 'C0221283', 'cui_str': 'Drepanocyte (cell)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750151'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}]",[],,0.0171249,,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Khoury', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Grimsley', 'Affiliation': ''}]",Blood,[]
455,7579435,Activation of the hemostatic mechanism during thrombolysis in patients with unstable angina pectoris.,"In patients with myocardial infarction, thrombolytic therapy induces a paradoxical activation of the hemostatic mechanism. In patients with unstable angina, the effect of thrombolysis on the coagulation cascade is unknown. We prospectively measured the plasma concentrations of prothrombin fragment 1 + 2 and fibrinopeptide A in consecutive patients with unstable angina randomized to receive placebo alone (n = 23), streptokinase 1,500,000 IU over 1 hour followed by a 48-hour placebo infusion (n = 21), or streptokinase 250,000 over 1 hour followed by a continuous infusion of 100,000 IU per hour over 48 hours (n = 20). All the patients received intravenous heparin for 72 hours. The plasma levels of the different markers were measured at baseline, 90 minutes, 24 hours, and 48 hours after the start of therapy. The median baseline plasma concentrations of prothrombin fragment 1 + 2 and fibrinopeptide A were similar in the three treatment groups. In comparison with placebo, an increase in plasma prothrombin fragment 1 + 2 and fibrinopeptide A, was observed after 90 minutes in the two groups receiving thrombolysis. After 24 and 48 hours, the prothrombin fragment 1 + 2 levels remained significantly higher only in the patients receiving the 48-hour streptokinase infusion. In patients with unstable angina, thrombolytic therapy induces an activation of the hemostatic mechanism, despite concomitant heparin administration; in those receiving a prolonged streptokinase infusion, the activation of coagulation persists for as long as the drug is administered.",1995,"In comparison with placebo, an increase in plasma prothrombin fragment 1 + 2 and fibrinopeptide A, was observed after 90 minutes in the two groups receiving thrombolysis.","['patients with unstable angina', 'patients with unstable angina pectoris', 'consecutive patients with unstable angina randomized to receive', 'patients with myocardial infarction']","['placebo', 'streptokinase', 'thrombolytic therapy', 'intravenous heparin', 'placebo alone', 'streptokinase 1,500,000 IU over 1 hour followed by a 48-hour placebo infusion']","['prothrombin fragment 1 + 2 levels', 'plasma concentrations', 'plasma prothrombin fragment', 'median baseline plasma concentrations', 'plasma levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0072435', 'cui_str': 'prothrombin profragment-1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0703995,"In comparison with placebo, an increase in plasma prothrombin fragment 1 + 2 and fibrinopeptide A, was observed after 90 minutes in the two groups receiving thrombolysis.","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Merlini', 'Affiliation': ""2nd Division of Cardiology, Ca'Granda Niguarda Hospital, Milan, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ardissino', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Oltrona', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Spinola', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Diotallevi', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Rosenberg', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ''}]",Blood,[]
456,7579469,A comparison of filtered leukocyte-reduced and cytomegalovirus (CMV) seronegative blood products for the prevention of transfusion-associated CMV infection after marrow transplant.,"We performed a prospective, randomized trial in CMV seronegative marrow recipients to determine if filtered blood products were as effective as CMV-seronegative blood products for the prevention of transfusion-transmitted CMV infection after marrow transplant. Before transplant, 502 patients were randomized to receive either filtered or seronegative blood products. Patients were monitored for the development of CMV infection and tissue-documented CMV disease between days 21 and 100 after transplant. Infections occurring after day 21 from transplant were considered related to the transfusion of study blood products and, thus, were considered evaluable infections for the purpose of this trial. In the primary analysis of evaluable infections, there were no significant differences between the probability of CMV infection (1.3% v 2.4%, P = 1.00) or disease (0% v 2.4%, P = 1.00) between the seronegative and filtered arms, respectively, or probability of survival (P = .6). In a secondary analysis of all infections occurring from day 0 to 100 post-transplant, although the infection rates were similar, the probability of CMV disease in the filtered arm was greater (2.4% v 0% in the seronegative arm, P = .03). However, the disease rate was still within the prestudy clinically defined acceptable rate of < or = 5%. We conclude that filtration is an effective alternative to the use of seronegative blood products for prevention of transfusion-associated CMV infection in marrow transplant patients.",1995,"In a secondary analysis of all infections occurring from day 0 to 100 post-transplant, although the infection rates were similar, the probability of CMV disease in the filtered arm was greater (2.4% v 0% in the seronegative arm, P = .03).","['502 patients', 'marrow transplant patients', 'CMV seronegative marrow recipients', 'transfusion-associated CMV infection after marrow transplant']","['filtered or seronegative blood products', 'filtered leukocyte-reduced and cytomegalovirus (CMV) seronegative blood products']","['infection rates', 'disease rate', 'probability of survival', 'probability of CMV disease', 'probability of CMV infection', 'CMV infection and tissue-documented CMV disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}]","[{'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",502.0,0.0410464,"In a secondary analysis of all infections occurring from day 0 to 100 post-transplant, although the infection rates were similar, the probability of CMV disease in the filtered arm was greater (2.4% v 0% in the seronegative arm, P = .03).","[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bowden', 'Affiliation': 'Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA 98104, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Slichter', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sayers', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weisdorf', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cays', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schoch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Banaji', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Haake', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Welk', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McCullough', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Miller', 'Affiliation': ''}]",Blood,[]
457,7524736,"Natural interferon-alpha versus its combination with 6-methyl-prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized, controlled study.","Type II mixed cryoglobulinemia (MC) is an often progressive vasculitis characterized by circulating cold-precipitable proteins that usually consists of polyclonal IgG and monoclonal IgM kappa with rheumatoid factor (RF) activity. Its etiology is unknown, although recent evidence strongly suggests that hepatitis C virus (HCV) plays a major role. Plasmapheresis, corticosteroids, and cytotoxic drugs have been used in the therapy of MC patients. Recently, favorable results with recombinant interferon-alpha (rIFN alpha) have been reported. To further assess its effectiveness, we studied the effects of natural human interferon-alpha (nIFN alpha), alone and in combination with 6-methyl-prednisolone (PDN), in a prospective, randomized, controlled trial in patients with symptomatic MC. Sixty-five patients were enrolled onto the trial, 52 (80%) of whom presented serum anti-HCV antibodies and specific genomic RNA sequences. Fifteen patients received nIFN alpha (3 MU) intramuscularly (IM) three times weekly, whereas 17 patients also received 16 mg/d of PDN orally on non-IFN days. Moreover, 18 patients received 16 mg/d of PDN only, and 15 were untreated. Treatment was discontinued after 1 year and patients were monitored for 8 to 17 months (mean, 13). A complete response was achieved in eight of 15 patients (53.3%) treated with nIFN alpha and nine of 17 (52.9%) treated with nIFN alpha plus PDN, as compared with three of 18 patients (16.7%) who received PDN only (P < .05) and one of 15 (6.7%) untreated controls (P < .01). Partial response occurred in two of 15 (13.3%) patients treated with nIFN alpha, three of 17 (17.6%) who received nIFN alpha plus PDN, one of 18 (5.5%) who received PDN only, and one of 15 (6.7%) controls. A complete response in six patients (66.7%) was achieved within 3 months in the group that received nIFN alpha plus PDN, as compared with two patients (25%) of those who received nIFN alpha alone (P < .02). In anti-HCV-positive patients, the clinical response occurred in step with reduced or undetectable levels of HCV RNA and transaminase normalization. Quantification of circulating HCV RNA represented a good predictive response marker. The probability of relapse within 3 months after treatment was 100% (three of three patients) and 75% (six of eight patients), respectively, in patients who received PDN alone or nIFN alpha alone as compared with none of those who received nIFN alpha plus PDN (P < .001).(ABSTRACT TRUNCATED AT 250 WORDS)",1994,"A complete response was achieved in eight of 15 patients (53.3%) treated with nIFN alpha and nine of 17 (52.9%) treated with nIFN alpha plus PDN, as compared with three of 18 patients (16.7%) who received PDN only (P < .05) and one of 15 (6.7%) untreated controls (P < .01).","['MC patients', 'patients with symptomatic MC', 'Sixty-five patients were enrolled onto the trial, 52 (80%) of whom presented serum anti-HCV antibodies and specific genomic RNA sequences', 'type II mixed cryoglobulinemia']","['Plasmapheresis, corticosteroids, and cytotoxic drugs', 'Natural interferon-alpha versus its combination with 6-methyl-prednisolone', 'nIFN alpha plus PDN (P < .001).(ABSTRACT', 'recombinant interferon-alpha (rIFN alpha', 'nIFN alpha plus PDN', 'nIFN alpha', 'natural human interferon-alpha (nIFN alpha), alone and in combination with 6-methyl-prednisolone (PDN', 'nIFN alpha alone']","['clinical response', 'HCV RNA and transaminase normalization', 'Partial response', 'probability of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0166049', 'cui_str': 'Hepatitis C Virus Antibodies'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0162327', 'cui_str': 'RNA Sequence'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0543697', 'cui_str': 'Mixed cryoglobulinemia'}]","[{'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic drug'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",65.0,0.0470867,"A complete response was achieved in eight of 15 patients (53.3%) treated with nIFN alpha and nine of 17 (52.9%) treated with nIFN alpha plus PDN, as compared with three of 18 patients (16.7%) who received PDN only (P < .05) and one of 15 (6.7%) untreated controls (P < .01).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dammacco', 'Affiliation': 'Department of Biomedical Sciences, University of Bari Medical School, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sansonno', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Shyamala', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cornacchiulo', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Iacobelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lauletta', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rizzi', 'Affiliation': ''}]",Blood,[]
458,7524759,Effects of in vivo recombinant methionyl human granulocyte colony-stimulating factor on the neutrophil response and peripheral blood colony-forming cells in healthy young and elderly adult volunteers.,"Recombinant granulocyte colony stimulating factor (G-CSF) was administered daily for 14 days to healthy young (Y) (20 to 30 years) and elderly (O) (70 to 80 years) volunteers to evaluate the effects of age on the neutrophil (polymorphonuclear leukocytes, PMN) responses. Thirty-eight volunteers were randomized to receive 0 micrograms, 30 micrograms, or 300 micrograms per day. Baseline neutrophil counts (ANC), peak ANCs, and the rate of attaining the peak ANC were similar in both age groups at both doses. The peak ANC was increased 5-fold at 30 micrograms and 15-fold at 300 micrograms in both the young and elderly. Daily tests of PMN function, as measured by an automated chemiluminescence system, showed nearly identical responses to several agonists for both age groups. Marrow proliferative activity as reflected by the percentage of cells in the marrow neutrophil mitotic pool also increased similarly for both age groups at both doses. In contrast, there was an age-related change in blood colony formation as measured by the blood CFU-GM assay. Compared with controls at the 30 micrograms dose, mean colony formation was increased 2-fold in the young versus no change in the elderly and at the 300 micrograms dose 24-fold in the young versus 12-fold in the elderly. These studies indicate that neutrophil responses to rhG-CSF are equivalent in healthy young and elderly volunteers but the mobilization of progenitor cells, as measured by the CFU-GM assay appears to differ substantially.",1994,"Compared with controls at the 30 micrograms dose, mean colony formation was increased 2-fold in the young versus no change in the elderly and at the 300 micrograms dose 24-fold in the young versus 12-fold in the elderly.","['14 days to healthy young (Y) (20 to 30 years) and elderly (O) (70 to 80 years) volunteers', 'healthy young and elderly adult volunteers', 'Thirty-eight volunteers', 'healthy young and elderly volunteers']","['Recombinant granulocyte colony stimulating factor (G-CSF', 'vivo recombinant methionyl human granulocyte colony-stimulating factor']","['Marrow proliferative activity', 'neutrophil response and peripheral blood colony-forming cells', 'Baseline neutrophil counts (ANC), peak ANCs, and the rate of attaining the peak ANC', 'blood colony formation', 'peak ANC', 'neutrophil (polymorphonuclear leukocytes, PMN) responses', 'marrow neutrophil mitotic pool', 'mean colony formation']","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",38.0,0.0131807,"Compared with controls at the 30 micrograms dose, mean colony formation was increased 2-fold in the young versus no change in the elderly and at the 300 micrograms dose 24-fold in the young versus 12-fold in the elderly.","[{'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Chatta', 'Affiliation': 'Department of Medicine, University of Washington, Puget Sound Blood Center, Seattle.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Dale', 'Affiliation': ''}]",Blood,[]
459,7537116,Effect of granulocyte colony-stimulating factor treatment on ex vivo blood cytokine response in human volunteers.,"We explored the ex vivo alteration in the cytokine release of stimulated blood taken from healthy volunteers treated subcutaneously with 480 micrograms granulocyte colony-stimulating factor (G-CSF). In a double-blind, controlled, randomized study with 21 volunteers who received G-CSF once or twice 24 hours apart, we measured lipopolysaccharide (LPS)-inducible release of various cytokines and soluble receptors at different times after treatment. At day 1 after a single dose of G-CSF, mediator release was also initiated with muramyl dipeptide, Staphylococcus aureus enterotoxin A, lipoteichoic acid, streptolysin O, complement factor C5a, phytohemagglutinin, or phorbol myristate acetate. In blood from G-CSF-treated subjects, our major findings were (1) a maximal 12-fold increase in interleukin-1 receptor antagonist (IL-1ra) release and an increase of both the p55 and p75 soluble tumor necrosis factor (TNF) receptors; (2) a reduction in TNF release when using all the various stimuli described except LPS; (3) an increase in G-CSF and, to lesser extent, in IL-6, IL-8, and IL-10 release; and (4) an attenuation of interferon-gamma (IFN-gamma) and granulocyte-macrophage (GM)-CSF release. Our findings demonstrate that the major effect of G-CSF treatment is a change in the responsiveness of blood towards a variety of stimuli, which we interpret as a shift toward an antiinflammatory cytokine response.",1995,"At day 1 after a single dose of G-CSF, mediator release was also initiated with muramyl dipeptide, Staphylococcus aureus enterotoxin A, lipoteichoic acid, streptolysin O, complement factor C5a, phytohemagglutinin, or phorbol myristate acetate.","['healthy volunteers treated', 'human volunteers', '21 volunteers who received']","['subcutaneously with 480 micrograms granulocyte colony-stimulating factor (G-CSF', 'G-CSF', 'granulocyte colony-stimulating factor treatment']","['ex vivo blood cytokine response', 'TNF release', 'attenuation of interferon-gamma (IFN-gamma) and granulocyte-macrophage (GM)-CSF release', 'interleukin-1 receptor antagonist (IL-1ra) release']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005768'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}]",21.0,0.026159,"At day 1 after a single dose of G-CSF, mediator release was also initiated with muramyl dipeptide, Staphylococcus aureus enterotoxin A, lipoteichoic acid, streptolysin O, complement factor C5a, phytohemagglutinin, or phorbol myristate acetate.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hartung', 'Affiliation': 'Department of Biochemical Pharmacology, University of Konstanz, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Döcke', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gantner', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Krieger', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sauer', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Volk', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendel', 'Affiliation': ''}]",Blood,[]
460,7530507,Immunoreactive interleukin-6 and acute phase proteins as prognostic factors in multiple myeloma. Finnish Leukemia Group.,"High serum level of bioactive interleukin-6 (IL-6) is regarded as a predictor of poor prognosis in multiple myeloma (MM). On the other hand, the reported levels of immunoreactive IL-6 have been highly variable, and the prognostic value of immunoreactive IL-6 in MM is not clear. We have analyzed the prognostic significance of serum immunoreactive IL-6, as measured by a sensitive immunosorbent assay, in 210 patients with newly diagnosed MM subsequently treated with intermittent melphalan and prednisone. The serum levels of acute phase proteins C-reactive protein (CRP), alpha 1-antitrypsin (alpha 1AT), and acid alpha 1-glycoprotein (orosomucoid; OM) were evaluated as surrogates for IL-6. Serum IL-6, CRP, alpha 1AT, and OM levels were raised in 42%, 40%, 41%, and 24% of the patients, respectively. There was a significant correlation between the clinical stage of the patients and serum IL-6 (P = .006), alpha 1AT (P = .001), and OM (P = .004) levels at diagnosis. At 3 years, 52% of the patients were alive. Univariate logistic regression analysis showed that high levels of IL-6 (P = .002), CRP (P = .02), alpha 1AT (P < .001), OM (P = .007), beta 2-microglobulin (beta 2M; P < .001), and thymidine kinase (P < .05) were all associated with 3-year mortality. In multivariate regression analysis, beta 2M (P < .0001) and alpha 1AT (P = .01) had independent prognostic significance. The patients with high levels of both beta 2M and alpha 1AT or IL-6 were at very high risk of dying within 3 years from diagnosis (16% and 21% of the patients in these groups were alive, respectively). When the patients were stratified according to the clinical stage, the prognostic significance of serum IL-6 and alpha 1AT was especially evident in stage II patients. When the patients were divided into two groups according to normal or raised serum IL-6 levels, the patients with high IL-6 levels had more frequent osteolytic bone lesions (P = .03) and a more aggressive disease. We conclude that serum immunoreactive IL-6 is a significant prognostic marker in MM.",1995,"Serum IL-6, CRP, alpha 1AT, and OM levels were raised in 42%, 40%, 41%, and 24% of the patients, respectively.","['Finnish Leukemia Group', '210 patients with newly diagnosed MM subsequently treated with']","['alpha 1AT ', 'intermittent melphalan and prednisone']","['Serum IL-6, CRP, alpha 1AT, and OM levels', 'serum levels of acute phase proteins C-reactive protein (CRP), alpha 1-antitrypsin (alpha 1AT), and acid alpha 1-glycoprotein (orosomucoid; OM', 'alpha 1AT', '3-year mortality', 'CRP', 'serum IL-6', 'High serum level of bioactive interleukin-6 (IL-6', 'beta 2-microglobulin', 'serum IL-6 levels', 'thymidine kinase', 'OM', 'frequent osteolytic bone lesions']","[{'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001347', 'cui_str': 'Reactants, Acute-Phase'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0002191', 'cui_str': 'alfa1 antitrypsin'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}]",210.0,0.0301309,"Serum IL-6, CRP, alpha 1AT, and OM levels were raised in 42%, 40%, 41%, and 24% of the patients, respectively.","[{'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Pelliniemi', 'Affiliation': 'Department of Hematology, Turku University Central Hospital, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Irjala', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mattila', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pulkki', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rajamäki', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tienhaara', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laakso', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lahtinen', 'Affiliation': ''}]",Blood,[]
461,7540062,Hematopoietic growth factors for graft failure after bone marrow transplantation: a randomized trial of granulocyte-macrophage colony-stimulating factor (GM-CSF) versus sequential GM-CSF plus granulocyte-CSF.,"Delay in hematologic recovery after bone marrow transplantation (BMT) can extend and amplify the risks of infection and hemorrhage, compromise patients' survival, and increase the duration and cost of hospitalization. Because current studies suggest that granulocyte-macrophage (GM) colony-stimulating factor (CSF) may potentiate the sensitivity of hematopoietic progenitor cells to G-CSF, we performed a prospective, randomized trial comparing GM-CSF (250 micrograms/m2/d x 14 days) versus sequential GM-CSF x 7 days followed by G-CSF (5 micrograms/kg/d x 7 days) as treatment for primary or secondary graft failure after BMT. Eligibility criteria included failure to achieve a white blood cell (WBC) count > or = 100/microL by day +21 or > or = 300/microL by day +28, no absolute neutrophil count (ANC) > or = 200/microL by day +28, or secondary sustained neutropenia after initial engraftment. Forty-seven patients were enrolled: 23 received GM-CSF (10 unrelated, 8 related allogeneic, and 5 autologous), and 24 received GM-CSF followed by G-CSF (12 unrelated, 7 related allogeneic, and 5 autologous). For patients receiving GM-CSF alone, neutrophil recovery (ANC > or = 500/microL) occurred between 2 and 61 days (median, 8 days) after therapy, while those receiving GM-CSF+G-CSF recovered at a similar rate of 1 to 36 days (median, 6 days; P = .39). Recovery to red blood cell (RBC) transfusion independence was slow, occurring 6 to 250 days (median, 35 days) after enrollment with no significant difference between the two treatment groups (GM-CSF: median, 30 days; GM-CSF+G-CSF; median, 42 days; P = .24). Similarly, platelet transfusion independence was delayed until 4 to 249 days (median, 32 days) after enrollment, with no difference between the two treatment groups (GM-CSF: median, 28 days; GM-CSF+G-CSF: median, 42 days; P = .38). Recovery times were not different between patients with unrelated donors and those with related donors or autologous transplant recipients. Survival at 100 days after enrollment was superior after treatment with GM-CSF alone. Only 1 of 23 patients treated with GM-CSF died versus 7 of 24 treated with GM-CSF+G-CSF who died 16 to 84 days (median, 38 days) after enrollment, yielding Kaplan-Meier 100-day survival estimates of 96% +/- 8% for GM-CSF versus 71% +/- 18% for GM-CSF+G-CSF (P = .026). These data suggest that sequential growth factor therapy with GM-CSF followed by G-CSF offers no advantage over GM-CSF alone in accelerating trilineage hematopoiesis or preventing lethal complications in patients with poor graft function after BMT.(ABSTRACT TRUNCATED AT 400 WORDS)",1995,Recovery times were not different between patients with unrelated donors and those with related donors or autologous transplant recipients.,"[' or = 100/microL by day +21 or > or = 300/microL by day +28, no absolute neutrophil count (ANC) > or = 200/microL by day +28, or secondary sustained neutropenia after initial engraftment', 'graft failure after bone marrow transplantation', 'patients with unrelated donors and those with related donors or autologous transplant recipients', 'Forty-seven patients were enrolled: 23 received GM-CSF (10 unrelated, 8 related allogeneic, and 5 autologous), and 24']","['granulocyte-macrophage (GM) colony-stimulating factor (CSF', 'bone marrow transplantation (BMT', 'GM-CSF followed by G-CSF', 'GM-CSF', 'sequential GM-CSF x 7 days followed by G-CSF', 'granulocyte-macrophage colony-stimulating factor (GM-CSF) versus sequential GM-CSF plus granulocyte-CSF']","['Recovery times', 'Recovery to red blood cell (RBC) transfusion independence', 'Survival', 'lethal complications', 'neutrophil recovery (ANC > or = 500/microL', 'white blood cell (WBC) count', 'duration and cost of hospitalization', 'platelet transfusion independence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}]","[{'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery (finding)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}]",47.0,0.0439469,Recovery times were not different between patients with unrelated donors and those with related donors or autologous transplant recipients.,"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Weisdorf', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, USA.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Verfaillie', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Filipovich', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burroughs', 'Affiliation': ''}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Ramsay', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Kersey', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'McGlave', 'Affiliation': ''}]",Blood,[]
462,7540071,Tacrolimus (FK506) alone or in combination with methotrexate or methylprednisolone for the prevention of acute graft-versus-host disease after marrow transplantation from HLA-matched siblings: a single-center study.,"The pharmacokinetics, safety, and efficacy in marrow transplantation of FK506-based immunosuppression for graft-versus-host disease (GVHD) prophylaxis was evaluated in an open label pilot study of 18 patients. Patients more than 12 years of age (median, 35 years; range, 15 to 50 years) with advanced hematologic malignancies receiving HLA-matched sibling marrow grafts were randomized to receive FK506 alone, FK506 and methotrexate (MTX), or FK506 and methyl-prednisolone. Of 17 evaluable patients, all had evidence of sustained marrow engraftment. The median time to an absolute neutrophil count of greater than 500/microL was 15 days for patients receiving FK506 alone or FK506 plus methylprednisolone and 23 days for FK506 plus short MTX. Pharmacokinetic studies did not show any significant difference in clearance of FK506 when administered alone or in combination with methylprednisolone or MTX. The mean bioavailability after oral administration in these same three groups was 0.49 +/- 0.1, 0.27 +/- 0.12, and 0.16 +/- 0.08, respectively (P = .003). The decrease in bioavailability may have resulted from an exacerbation of radiation-induced gastroenteritis by MTX. The most significant adverse effect associated with the administration of FK506 was nephrotoxicity, which occurred in 14 of 18 patients (78%). The mean glomerular filtration rate, determined by clearance of (99MTc)DTPA, decreased to 56% (+/- 18%) of the pretransplant baseline level by week 8 (P = .002). Eight of 18 patients (44%) developed grades II-IV acute GVHD, predominantly of the skin and gastrointestinal tract. The actuarial probability of transplant-related mortality during the first 100 days was 24%. The actuarial probability of 1-year disease-free survival was 39%. In conclusion, although bioavailability of FK506 may be affected in patients receiving MTX, this study suggests that FK506 may have a role in the management of patients after allogeneic marrow transplantation.",1995,Pharmacokinetic studies did not show any significant difference in clearance of FK506 when administered alone or in combination with methylprednisolone or MTX.,"['Patients more than 12 years of age (median, 35 years; range, 15 to 50 years) with advanced hematologic malignancies receiving HLA-matched sibling marrow grafts', 'acute graft-versus-host disease after marrow transplantation from HLA-matched siblings', 'patients after allogeneic marrow transplantation', '18 patients']","['FK506 plus methylprednisolone', 'FK506 alone, FK506 and methotrexate (MTX), or FK506 and methyl-prednisolone', 'FK506 plus short MTX', 'methylprednisolone or MTX', 'Tacrolimus (FK506) alone or in combination with methotrexate or methylprednisolone', 'FK506', 'MTX', 'FK506-based immunosuppression']","['mean glomerular filtration rate', 'grades II-IV acute GVHD', 'bioavailability', 'actuarial probability of 1-year disease-free survival', 'clearance of FK506', 'actuarial probability of transplant-related mortality', 'pharmacokinetics, safety, and efficacy', 'sustained marrow engraftment', 'mean bioavailability', 'median time to an absolute neutrophil count']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0729218', 'cui_str': 'FK506'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0729218', 'cui_str': 'FK506'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",18.0,0.0325819,Pharmacokinetic studies did not show any significant difference in clearance of FK506 when administered alone or in combination with methylprednisolone or MTX.,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, WA 98104-2092, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Etzioni', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Furlong', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gooley', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Slattery', 'Affiliation': ''}]",Blood,[]
463,7514046,A randomized study of erythropoietin and granulocyte colony-stimulating factor (G-CSF) versus placebo and G-CSF for patients with Hodgkin's and non-Hodgkin's lymphoma undergoing autologous bone marrow transplantation.,"Anemia is a universal finding in patients undergoing autologous bone marrow transplantation (BMT). Effective therapies to increase the number of autologous red blood cells could result in a lower morbidity and mortality associated with red blood cell transfusions. We examined whether the addition of erythropoietin (Epo) to intensive therapy supported by progenitor cell transplantation and granulocyte colony-stimulating factor (G-CSF) would result in a lower requirement for red blood cell transfusions. Thirty-five patients with lymphoma were randomized to receive Epo versus placebo. Epo (600 U/kg three times per week) or placebo was begun 3 weeks before administration of high-dose therapy. Epo was held during the week of the preparatory regimen, and restarted on the day after BMT. All patients also received G-CSF following BMT. No significant differences were noted between the two groups in terms of patient characteristics at pretreatment or post-BMT evaluation. There were no differences in the total number of red blood cell units transfused (median Epo: 8 v placebo: 6, P = .22) nor the number of platelet transfusions given (median Epo: 12 v placebo 5, P = .14). Engraftment of granulocytes (absolute neutrophil count > or = 500/microL) occurred in a median of 12 days (range, 9 to 33) for the patients receiving Epo and G-CSF, compared with a median of 10 days (range, 8 to 22) for those receiving placebo and G-CSF (P = .70). Likewise, there were no differences in the time to platelet count > or = 20,000/microL without further transfusions with a median of 22 days (range, 15 to 150+) for those receiving Epo and G-CSF compared with a median of 20 days (range, 11 to 54) for those patients receiving placebo and G-CSF (P = .28). The combination of G-CSF and Epo as administered in this study appears to be safe but does not result in an improvement in the total number of red blood cell transfusions or total number of single donor platelet units transfused.",1994,"Engraftment of granulocytes (absolute neutrophil count > or = 500/microL) occurred in a median of 12 days (range, 9 to 33) for the patients receiving Epo and G-CSF, compared with a median of 10 days (range, 8 to 22) for those receiving placebo and G-CSF (P = .70).","['patients undergoing autologous bone marrow transplantation (BMT', 'Thirty-five patients with lymphoma', ""patients with Hodgkin's and non-Hodgkin's lymphoma undergoing autologous bone marrow transplantation""]","['placebo', 'Epo', 'erythropoietin and granulocyte colony-stimulating factor (G-CSF', 'Epo versus placebo', 'erythropoietin (Epo', 'placebo and G-CSF', 'progenitor cell transplantation and granulocyte colony-stimulating factor (G-CSF']","['Engraftment of granulocytes (absolute neutrophil count > or = 500/microL', 'number of platelet transfusions', 'total number of red blood cell units transfused']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]",35.0,0.051888,"Engraftment of granulocytes (absolute neutrophil count > or = 500/microL) occurred in a median of 12 days (range, 9 to 33) for the patients receiving Epo and G-CSF, compared with a median of 10 days (range, 8 to 22) for those receiving placebo and G-CSF (P = .70).","[{'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Chao', 'Affiliation': 'Bone Marrow Transplantation Program, Stanford University, CA.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Schriber', 'Affiliation': ''}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Long', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Negrin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Catolico', 'Affiliation': ''}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Blume', 'Affiliation': ''}]",Blood,[]
464,7512838,A double-blind controlled study of granulocyte colony-stimulating factor started two days before induction chemotherapy in refractory acute myeloid leukemia. Kohseisho Leukemia Study Group.,"We conducted a prospective, double-blind controlled study to determine the efficacy of a recombinant granulocyte colony-stimulating factor (G-CSF, 200 microgram/m2) starting daily from 2 days before an induction therapy until neutrophils recovered to above 1,500/microL or until 35 days after the therapy in 58 patients with relapsed or refractory acute myeloid leukemia (AML). Twenty-eight patients in the G-CSF group showed significantly faster recovery of neutrophils (P < .001) than 30 patients in the placebo group. The incidence of febrile episodes and of documented infections was almost the same in both groups. However, among 39 patients who did not show any infectious episodes during the 2-week period after the start of chemotherapy, the incidence of documented infections after the third week tended to be lower in the G-CSF group, but not statistically significantly. There was no evidence that G-CSF stimulated the growth of AML cells in the bone marrow during the 2-day period before the chemotherapy, nor that G-CSF accelerated the regrowth of AML cells during the 5-week period after the therapy. Fifty percent of patients in the G-CSF group and 37% in the placebo group had complete remission (CR). Although the rate was higher in the G-CSF group, the difference was not statistically significant (P = .306). There was no difference between the two groups in event-free survival of all patients and in disease-free survival of patients who had achieved CR.",1994,Twenty-eight patients in the G-CSF group showed significantly faster recovery of neutrophils (P < .001) than 30 patients in the placebo group.,"['refractory acute myeloid leukemia', '58 patients with relapsed or refractory acute myeloid leukemia (AML']","['recombinant granulocyte colony-stimulating factor (G-CSF', 'placebo', 'granulocyte colony-stimulating factor started two days before induction chemotherapy']","['growth of AML cells', 'disease-free survival', 'infectious episodes', 'event-free survival', 'incidence of documented infections', 'incidence of febrile episodes and of documented infections', 'complete remission (CR', 'faster recovery of neutrophils', 'regrowth of AML cells']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",58.0,0.149888,Twenty-eight patients in the G-CSF group showed significantly faster recovery of neutrophils (P < .001) than 30 patients in the placebo group.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ohno', 'Affiliation': 'Department of Medicine, Nagoya University Branch Hospital, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Naoe', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanamaru', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hiraoka', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Minami', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ''}]",Blood,[]
465,7259838,"The treatment of advanced stage favorable histology non-Hodgkin's lymphoma: a preliminary report of a randomized trial comparing single agent chemotherapy, combination chemotherapy, and whole body irradiation.","Between 1975 and 1978, 51 patients with favorable histology non-Hodgkin's lymphomas, pathologic stage III-IV, were treated prospectively on a randomized treatment protocol. Treatment options were single alkylating agent chemotherapy, combination chemotherapy with cyclophosphamide, vincristine, and prednisone (CVP), or fractionated whole body irradiation followed by low dose involved field irradiation. The median follow-up interval in this group of patients is not 41 mo. Actuarial survival is excellent, 84% at 4 yr for the entire group, with similar survival observed for each of the three treatment options. Initial complete remission rates (64%, 88%, and 71%) were not significantly different in the three treatment arms. Frequent relapse after initial remission induction was noted, however, with a freedom from relapse at 4 yr of only 25%. The toxicities of the three therapies were acceptable. Acute complications of therapy were most numerous in the group of patients treated with CVP; however, long-term hematologic depression was most commonly observed in patients treated with whole body irradiation. In general, hematologic complications were more frequent among patients who had marrow involvement and intact spleens at the time of initial therapy. The relationship of this study to other clinical trials in the management of patients with advanced stage favorable histology lymphomas and its implications for future clinical trials are discussed.",1981,"Initial complete remission rates (64%, 88%, and 71%) were not significantly different in the three treatment arms.","['patients with advanced stage favorable histology lymphomas', ""advanced stage favorable histology non-Hodgkin's lymphoma"", ""Between 1975 and 1978, 51 patients with favorable histology non-Hodgkin's lymphomas, pathologic stage III-IV""]","['alkylating agent chemotherapy, combination chemotherapy with cyclophosphamide, vincristine, and prednisone (CVP), or fractionated whole body irradiation followed by low dose involved field irradiation', 'CVP', 'single agent chemotherapy, combination chemotherapy, and whole body irradiation']","['hematologic complications', 'Acute complications', 'toxicities', 'Actuarial survival', 'long-term hematologic depression', 'Initial complete remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0456589', 'cui_str': '1978 (qualifier value)'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0002073', 'cui_str': 'Alkylators'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",51.0,0.0256405,"Initial complete remission rates (64%, 88%, and 71%) were not significantly different in the three treatment arms.","[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Hoppe', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kushlan', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Kaplan', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Rosenberg', 'Affiliation': ''}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Brown', 'Affiliation': ''}]",Blood,[]
466,7517720,Differences in constitutive and post-methotrexate folylpolyglutamate synthetase activity in B-lineage and T-lineage leukemia.,"Folylpolyglutamate synthetase (FPGS) is responsible for the metabolism of natural folates and a broad range of folate antagonists to polyglutamate derivatives. Recent studies indicated increased accumulation of methotrexate (MTX) polyglutamates (MTX-PG) in blast cells as a predictor of favorable treatment outcome in childhood acute lymphoblastic leukemia (ALL). We determined the expression of FPGS activity in blasts from children with ALL at diagnosis and after treatment with MTX as a single agent, before conventional remission induction therapy. The levels of enzyme activity in ALL blasts at diagnosis (median of 689 pmol/h/mg protein) were significantly higher (P = .003) than those found in acute nonlymphoblastic leukemia (ANLL) blasts (median of 181 pmol/h/mg protein). Comparable lineage differences in normal lymphoid versus nonlymphoid cells suggest a lineage-specific control of FPGS expression, FPGS activity increased in ALL blasts after in vivo exposure to MTX. The median increase in FPGS activity was significantly higher (P = .003) in B-lineage ALL (188%) than in T-lineage ALL (37%). Likewise, the percentage of intracellular long chain MTX-PG (Glu3-6) was significantly higher (P = .02) in B-lineage ALL (92%) than in T-lineage ALL (65%), consistent with higher FPGS activity in B-lineage blasts. This finding could explain, at least in part, the superior outcome in children with B-lineage ALL treated with antimetabolite therapy.",1994,The median increase in FPGS activity was significantly higher (P = .003) in B-lineage ALL (188%) than in T-lineage ALL (37%).,"['childhood acute lymphoblastic leukemia (ALL', 'children with B-lineage ALL treated with', 'children with ALL at diagnosis and after treatment with']","['MTX', 'methotrexate (MTX) polyglutamates (MTX-PG', 'antimetabolite therapy', 'Folylpolyglutamate synthetase (FPGS']","['percentage of intracellular long chain MTX-PG', 'levels of enzyme activity', 'FPGS activity']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0066146', 'cui_str': 'Poly(imino(1-carboxy-4-oxo-1,4-butanediyl)), alpha-(4-(((2,4-diamino-6-pteridinyl)methyl)methylamino)benzoyl)-omega-hydroxy-, (S)-'}, {'cui': 'C4542542', 'cui_str': 'Antimetabolite (disposition)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0060626', 'cui_str': 'tetrahydrofolylpolyglutamate synthase'}]","[{'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0246178,The median increase in FPGS activity was significantly higher (P = .003) in B-lineage ALL (188%) than in T-lineage ALL (37%).,"[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Barredo', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston 29425.'}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Synold', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laver', 'Affiliation': ''}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Relling', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ''}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Priest', 'Affiliation': ''}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Evans', 'Affiliation': ''}]",Blood,[]
467,7517725,Hepatitis C virus antibody seroconversion in bone marrow transplant recipients treated with immune globulin: the impact of the problem.,,1994,,['bone marrow transplant recipients treated with'],['immune globulin'],[],"[{'cui': 'C4545296', 'cui_str': 'Bone marrow transplant recipient'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]",[],,0.0333867,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lopez-Jimenez', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Villalon', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Mateos', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Odriozola', 'Affiliation': ''}]",Blood,[]
468,6938259,Filtration versus gravity leukapheresis in febrile granulocytopenic patients: a randomized prospective trial.,"Forty-eight patients with fever greater than 38.3 degrees C for at least 24 hr despite broad spectrum antibiotics and an absolute granulocyte count less than 1000/microliter were randomly allocated to 4 days of granulocyte transfusions obtained by leukapheresis using filtration (n = 27) or gravity (n = 21) techniques, the latter permitting simultaneous nonmechanical collection of granulocytes and platelets utilizing hydroxyethyl starch as a sedimenting agent. Patient characteristics and dose of granulocytes obtained from both techniques were similar. Complete response to granulocyte transfusions was established by a reduction in temperature to less than 37.2 degrees C sustained for at least 48 hr after the fourth transfusion with sterilization of cultures where previously positive and diminution of measurable infection when present. This occurred in 6/21 (29%) for gravity leukapheresis and 9/27 (33%) for filtration leukapheresis. An additional group had diminution in temperature and clinical improvement during transfusions (6/21 gravity leukapheresis versus 10/27 filtration leukapheresis). Eighty-six percent of patients transfused with gravity leukapheresis cells were alive at day 20 compared with 81% for filtration leukapheresis cells. Transfusion reactions were comparable. Thus, gravity leukapheresis appears to be as efficacious as filtration leukapheresis for treating granulocytopenic febrile patients, with the added advantages of availability to any blood bank without new equipment, of having platelets as by-products, and of not requiring donor heparinization.",1981,Transfusion reactions were comparable.,"['febrile granulocytopenic patients', 'granulocytopenic febrile patients', 'Forty-eight patients with fever greater than 38.3 degrees C for at least 24 hr despite broad spectrum antibiotics and an absolute granulocyte count less than 1000/microliter']","['granulocyte transfusions obtained by leukapheresis using filtration (n = 27) or gravity (n = 21) techniques, the latter permitting simultaneous nonmechanical collection of granulocytes and platelets utilizing hydroxyethyl starch as a sedimenting agent', 'Filtration versus gravity leukapheresis']","['Transfusion reactions', 'diminution in temperature and clinical improvement']","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439237', 'cui_str': 'degrees C'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0857490', 'cui_str': 'Granulocyte count (procedure)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439243', 'cui_str': 'mm3'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0023416', 'cui_str': 'Leukocytapheresis'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0274435', 'cui_str': 'Blood Transfusion-Associated Adverse Reactions'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0384626,Transfusion reactions were comparable.,"[{'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Ambinder', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Button', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Goldberg', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Holland', 'Affiliation': ''}]",Blood,[]
469,7028181,Nodular mixed lymphoma: results of a randomized trial failing to confirm prolonged disease-free survival with COPP chemotherapy.,"Fifty-two patients with stage III or IV nodular mixed lymphocytic-histiocytic lymphoma (NM) were entered on a prospective randomized trial comparing cyclophosphamide-prednisone (CP) to either COPP (cyclophosphamide, vincristine, procarbazine, prednisone) or BCVP (BCNU, cyclophosphamide, vincristine, prednisone). The COPP regimen utilized in this Eastern Cooperative Oncology Group (ECOG) trial was similar to the four-drug regimen C-MOPP reported by the National Cancer Institute to achieve prolonged relapse-free survival in this histology. No significant differences in complete response rates, response duration, or overall survival were noted among the three regimens. A pattern of continuous late relapse was observed for all three chemotherapy programs. Although 11 of the 18 (61%) COPP patients achieved a complete response, only 3/11 (27%) remain disease-free with a median follow-up of over 3 yr. However, two of these three long-term complete responders have died with no clinical evidence of recurrent disease. The COPP patients received 84% of the calculated ideal doses of cyclophosphamide and 78% of the ideal dosage of procarbazine. Grade 3-4 hematologic toxicity was noted in 22% of the COPP group, 36% with BCVP, and 0% for the CP patients. We were unable to confirm the ability of COPP to achieve durable complete remissions in NM lymphoma. The cyclophosphamide-prednisone combination was equally effective when compared with COPP and BCVP, but produced minimal toxicity.",1981,"No significant differences in complete response rates, response duration, or overall survival were noted among the three regimens.","['Fifty-two patients with stage III or IV nodular mixed lymphocytic-histiocytic lymphoma (NM', 'Nodular mixed lymphoma']","['cyclophosphamide', 'COPP chemotherapy', 'COPP (cyclophosphamide, vincristine, procarbazine, prednisone) or BCVP (BCNU, cyclophosphamide, vincristine, prednisone', 'COPP', 'cyclophosphamide-prednisone', 'procarbazine', 'cyclophosphamide-prednisone (CP']","['complete response rates, response duration, or overall survival', 'minimal toxicity', 'Grade 3-4 hematologic toxicity']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C0024304', 'cui_str': 'Lymphoma, Mixed-Cell'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",,0.0306545,"No significant differences in complete response rates, response duration, or overall survival were noted among the three regimens.","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Glick', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'E Z', 'Initials': 'EZ', 'LastName': 'Ezdinli', 'Affiliation': ''}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Berard', 'Affiliation': ''}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Orlow', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}]",Blood,[]
470,7006708,Bone marrow transplantation for refractory acute leukemia in 34 patients with identical twins.,"Thirty-four patients aged 4-67 yr (median 17) with acute lymphocytic leukemia (ALL) (18 patients) or acute nonlymphocytic leukemia (ANL) (16 patients) who failed to enter complete remission (CR) or relapsed on conventional chemotherapy were treated with cyclophosphamide (CY), 60 mg/kg/day for 2 days, 1000 rad total body irradiation, and a marrow transplant from a genotypically identical normal twin. Sixteen of the patients received additional chemotherapy within the week before CY. After the transplant, 23 patients received immunotherapy consisting of killed autologous leukemic cells and/or normal twin peripheral blood lymphocytes, 16 as part of a prospectively randomized study. One moribund patient died before engraftment. Nine patients (6 ALL, 3 ANL) continued to have detectable leukemic cells. Twenty-four patients (70%) achieved CR. One of them died of viral hepatitis at 1 mo and another of viral interstitial pneumonitis at 4 mo in CR. Fourteen patients (7 ALL, 7 ANL) relapsed 2-16 mo (median 4) after transplantation. However, 8 patients (24%) (3 ALL, 5 ANL) remain in CR without any maintenance chemotherapy at 29-103 mo (median 80) after the transplant. The end results were not signficantly influenced by the type of leukemia, the immediated pre-CY chemotherapy, or the immunotherapy. The results show that this approach, even when applied to endstage patients with acute leukemia in relapse, causes tolerable morbidity, rare nonleukemic deaths, and frequent remissions, some of which represent cures.",1981,"The end results were not signficantly influenced by the type of leukemia, the immediated pre-CY chemotherapy, or the immunotherapy.","['Fourteen patients (7 ALL, 7 ANL) relapsed 2-16 mo (median 4) after transplantation', 'Thirty-four patients aged 4-67 yr (median 17) with acute lymphocytic leukemia (ALL) (18 patients) or acute nonlymphocytic leukemia (ANL) (16 patients) who failed to enter complete remission (CR) or relapsed on conventional chemotherapy were treated with', '34 patients with identical twins']","['immunotherapy consisting of killed autologous leukemic cells and/or normal twin peripheral blood lymphocytes', 'additional chemotherapy', 'cyclophosphamide (CY', 'Bone marrow transplantation']","['tolerable morbidity, rare nonleukemic deaths', 'CR', 'viral interstitial pneumonitis']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0624017', 'cui_str': 'ANLS'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0041432', 'cui_str': 'Twins, Identical'}]","[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}]",,0.036928,"The end results were not signficantly influenced by the type of leukemia, the immediated pre-CY chemotherapy, or the immunotherapy.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fefer', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Cheever', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Glucksberg', 'Affiliation': ''}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Kaplan', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Weiden', 'Affiliation': ''}]",Blood,[]
471,6982085,Modified LSA2-L2 treatment in 53 children with E-rosette-positive T-cell leukemia: results and prognostic factors (a Pediatric Oncology Group Study).,"In an attempt to improve the poor outlook for children with T-cell leukemia (T-ALL), the Southwest Oncology Group, Pediatric Division, used a modified LSA2-L2 multidrug regimen to treat 53 patients with E-rosette-positive T-ALL. This regimen was chosen because of its demonstrated efficacy in T-cell (mediastinal) non-Hodgkin's lymphoma. Complete remission (CR) rate was 88%. Range of follow-up for those patients remaining in CR is 24-49 mo (median 39 mo). Life table analysis estimates that 40% (SE 8.3%) of all patients who started induction therapy will remain failure-free at 3 yr. For patients achieving CR, 46% (SE 9%) are projected to remain in both marrow and extramedullary CR at 3 yr. Median failure-free duration was 13 mo, but only 1 patient has relapsed beyond 16 mo. Twenty-nine percent of initial relapses were isolated CNS relapses. The following presenting factors did not relate significantly to outcome: hemoglobin, platelet count, uric acid, race, and mediastinal mass. Age greater than 10 yr was a poor prognosis indicator only in the less than 50,000/microliter WBC group. Sex was not a significant factor after adjusting for WBC. WBC was the most important prognostic factor: 19% (SE 8%) of patients with WBC greater than 50,000/microliter are projected to remain failure-free at 3 yr as compared to 67% (SE 11%) of patients with WBC less than 50,000/microliter. Although the overall results are better than those previously reported for pediatric patients with T-ALL, the long-term failure-free rate remains low for patients presenting with greater than 50,000/microliter WBC.",1982,"Age greater than 10 yr was a poor prognosis indicator only in the less than 50,000/microliter WBC group.","['children with T-cell leukemia (T-ALL', '53 children with E-rosette-positive T-cell leukemia']",['Modified LSA2-L2 treatment'],"['outcome: hemoglobin, platelet count, uric acid, race, and mediastinal mass', 'Median failure-free duration', 'WBC', 'Complete remission (CR) rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023492', 'cui_str': 'Lymphocytic Leukemia, T-Cell'}, {'cui': 'C1961099', 'cui_str': 'Leukemia, Lymphocytic, Acute, T-Cell'}, {'cui': 'C0035863', 'cui_str': 'Rosette (morphologic abnormality)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1138375', 'cui_str': 'LSA2-L2'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0240318', 'cui_str': 'Mediastinal mass'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0199877,"Age greater than 10 yr was a poor prognosis indicator only in the less than 50,000/microliter WBC group.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Pullen', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Falletta', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Boyett', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Starling', 'Affiliation': ''}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Land', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Dyment', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vats', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Duncan', 'Affiliation': ''}]",Blood,[]
472,6928104,Combination chemotherapy of adult acute lymphoblastic leukemia with randomized central nervous system prophylaxis.,"Although major progress has been made in the treatment of childhood leukemia, the optimal chemotherapy of acute lymphoblastic leukemia (ALL) in adults has been unclear. In addition, the value of central nervous system prophylaxis (CNS-P) in adults has been assumed, but not established in a systematic fashion. The Southeastern Cancer Study Group has completed a prospective study in which the use of vincristine plus low-dose methotrexate and high-dose prednisone in adult acute lymphoblastic leukemia has produced an 80% (79/99) complete remission rate in patients age 15 yr and over. Younger patients had a significantly higher remission rate but no increase in remission duration. This induction regimen was associated with minimal toxicity. Random assignment to CNS-P or to no prophylaxis, after a multidrug consolidation regimen, has demonstrated a significant prolongation of CNS relapse-free interval (p=0.008) in favor of CNS-P. CNS-P did not improve hematologic remission duration or survival. All complete remitters were maintained on mercaptopurine, methotrexate, and cyclophosphamide with pulses of prednisone and vincristine; the median time from remission to either hematologic or CNS relapse was 19.3 mo after CNS-P, and survival for these patients was 26.1 mo. We conclude that our current induction regimen is highly effective in adult ALL and that CNS-P prophylaxis is indicated in such patients.",1980,Younger patients had a significantly higher remission rate but no increase in remission duration.,['adult acute lymphoblastic leukemia'],"['Combination chemotherapy', 'mercaptopurine, methotrexate, and cyclophosphamide with pulses of prednisone and vincristine', 'vincristine plus low-dose methotrexate and high-dose prednisone']","['hematologic remission duration or survival', 'remission rate', 'CNS relapse-free interval', 'median time from remission to either hematologic or CNS relapse', 'survival', 'remission duration', 'minimal toxicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0272826,Younger patients had a significantly higher remission rate but no increase in remission duration.,"[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Omura', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moffitt', 'Affiliation': ''}, {'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Vogler', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Salter', 'Affiliation': ''}]",Blood,[]
473,5933438,A controlled trial of urethane treatment in multiple myeloma.,,1966,,['multiple myeloma'],['urethane treatment'],[],"[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0041964', 'cui_str': 'ethyl carbamate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.021039,,"[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Holland', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hosley', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Scharlau', 'Affiliation': ''}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Carbone', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Frei', 'Affiliation': ''}, {'ForeName': 'C O', 'Initials': 'CO', 'LastName': 'Brindley', 'Affiliation': ''}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'B I', 'Initials': 'BI', 'LastName': 'Shnider', 'Affiliation': ''}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lasagna', 'Affiliation': ''}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Miller', 'Affiliation': ''}]",Blood,[]
474,6956376,Equivalence of intrathecal chemotherapy and radiotherapy as central nervous system prophylaxis in children with acute lymphatic leukemia: a pediatric oncology group study.,"The efficacy of intrathecal (i.t.) chemoprophylaxis was compared with cranial radiotherapy plus i.t. methotrexate (MTX) in a Southwest Oncology Group (SWOG) study accessing 408 patients from September 10, 1974, to October 29, 1976. Randomization was stratified by prognostic groups (PGs) based on age and white blood cell count at diagnosis. All received induction therapy with vincristine and prednisone (Pred); maintenance therapy consisted of daily 6-mercaptopurine and weekly MTX. Consolidation for arm 1 employed cyclophosphamide and L-asparaginase followed by biweekly 5-day courses of parenteral MTX. The first dose of each course of MTX was given i.t. in triple chemoprophylaxis (MTX, hydrocortisone, and cytosine arabinoside). During maintenance, i.t. chemoprophylaxis was bimonthly and 28-day Pred ""pulses"" were given every 3 mo. Arm 2 i.t. chemoprophylaxis was initiated on achievement of remission, and arm 3 i.t. on treatment day 1; both continued 1 yr. Arm 4 induction included two doses of L-asparaginase. On achievement of remission, CNS prophylaxis (radiotherapy, 2400 rad plus i.t. MTX) was given. For all, therapy was discontinued after 3 yr of continuous complete remission. Survival and the incidence of extramedullary relapse were similar for the treatments employing either i.t. chemoprophylaxis or radiotherapy plus i.t. MTX upon achievement of remission. Among poor prognosis patients, the duration of complete remission was significantly better with the regimen using i.t. chemoprophylaxis as a component of consolidation therapy than with the regimen employing i.t. chemoprophylaxis early in induction or with the treatment using radiotherapy plus i.t. MTX for CNS prophylaxis. In poor prognosis patients, the initiation of i.t. chemoprophylaxis during consolidation was also associated with hematologic remissions that were significantly better than those achieved with the treatment employing early CNS chemoprophylaxis or with the regimen using radiotherapy plus i.t. MTX. Among average prognosis patients, therapy with CNS chemoprophylaxis during consolidation, as well as the regimen employing radiotherapy and i.t. MTX for CNS prophylaxis, produced hematologic remissions that were significantly longer than those obtained with the regimen using early CNS chemoprophylaxis. Hematologic remissions of good prognosis patients who received treatment with the regimen employing i.t. chemoprophylaxis during consolidation were statistically superior when compared to the regimen employing CNS radiotherapy plus i.t. MTX. This study indicates that i.t. chemoprophylaxis may be substituted for cranial radiotherapy when utilizing effective systemic regimens. Additionally, chemoprophylaxis may be reduced from 3 to 1 yr in patients with good prognostic factors.",1982,chemoprophylaxis during consolidation were statistically superior when compared to the regimen employing CNS radiotherapy plus i.t. MTX.,"['children with acute lymphatic leukemia', 'a Southwest Oncology Group (SWOG) study accessing 408 patients from September 10, 1974, to October 29, 1976']","['chemoprophylaxis or radiotherapy plus i.t. MTX', 'cyclophosphamide and L-asparaginase', 'triple chemoprophylaxis (MTX, hydrocortisone, and cytosine arabinoside', 'parenteral MTX', 'CNS prophylaxis (radiotherapy, 2400 rad plus i.t. MTX', 'MTX', 'CNS radiotherapy plus i.t. MTX', 'intrathecal (i.t.) chemoprophylaxis', 'intrathecal chemotherapy and radiotherapy', '6-mercaptopurine and weekly MTX', 'L-asparaginase', 'vincristine and prednisone (Pred); maintenance therapy', 'radiotherapy plus i.t', 'methotrexate (MTX']","['hematologic remissions', 'Survival and the incidence of extramedullary relapse', 'Hematologic remissions', 'duration of complete remission']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia, disease (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456588', 'cui_str': '1974 (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",408.0,0.0191943,chemoprophylaxis during consolidation were statistically superior when compared to the regimen employing CNS radiotherapy plus i.t. MTX.,"[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Dyment', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hvizdala', 'Affiliation': ''}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Steuber', 'Affiliation': ''}]",Blood,[]
475,6421344,"Comparison of two long-term chemotherapy regimens, with or without agents to modify skeletal repair, in multiple myeloma.","A randomized controlled trial was initiated in 1972 to compare two chemotherapeutic regimens [1-3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone], to determine whether the two regimens are cross-resistant, and to evaluate the effectiveness of sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone in the promotion of bone healing. Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same. Patients on either regimen who failed to respond after 6 mo had a very low response rate to the alternative regimen (approximately 10%). Initially responding patients were randomly assigned to either an active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets. There was no significant difference in the low percentage of patients demonstrating bone improvement. Thus, the BCNU, cyclophosphamide, prednisone regimen is as effective as melphalan and prednisone. Fluoride, calcium, vitamin D, and androgenic steroids should not be routinely recommended in myeloma, as they seem to add little to effective chemotherapy and may contribute to morbidity.",1984,Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same.,[],"['chemotherapeutic regimens [1-3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone', 'BCNU, cyclophosphamide, prednisone', 'active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets', 'sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone', 'melphalan and prednisone', 'Fluoride, calcium, vitamin D, and androgenic steroids']","['survival', 'Initial responses']",[],"[{'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C3540781', 'cui_str': 'Nitrosoureas'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3652487', 'cui_str': 'sodium fluoride (18F)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006699', 'cui_str': 'Calcium Gluconate'}, {'cui': 'C0016366', 'cui_str': 'Fluoxymesterone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",,0.0313345,Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same.,"[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Silberman', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tornyos', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Bartolucci', 'Affiliation': ''}]",Blood,[]
476,6871470,Delayed alloimmunization using random single donor platelet transfusions: a prospective study in thrombocytopenic patients with acute leukemia.,"A randomized study was performed in 54 thrombocytopenic patients with acute leukemia. Alloimmunization of recipients of random multiple-donor platelet concentrates (MD group) was compared to that of patients receiving random single-donor platelets (SD group). In the SD patients, formation of alloantibodies (mostly anti-HLA) occurred less frequently (p less than 0.002), after a longer time period (p less than 0.002), and after a higher number of transfusions (p less than 0.005) as compared to MD patients. SD patients also became refractory to random platelets less frequently (p less than 0.005), after a longer time period, and after a higher number of transfusions (p less than 0.02). In SD patients, the increments after the first and the last transfusion were in the same range, whereas in MD patients, the 1-hr (p less than 0.001) and the 24-hr (p less than 0.025) increments decreased from the first to the last transfusion. Thus, the use of random SD platelet transfusions postponed alloimmunization.",1983,"SD patients also became refractory to random platelets less frequently (p less than 0.005), after a longer time period, and after a higher number of transfusions (p less than 0.02).","['thrombocytopenic patients with acute leukemia', '54 thrombocytopenic patients with acute leukemia']",['random single donor platelet transfusions'],"['Delayed alloimmunization', 'Alloimmunization', 'formation of alloantibodies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1277092', 'cui_str': 'Human platelets, random donor (derived from whole blood donation)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0022144', 'cui_str': 'Alloantibodies'}]",54.0,0.0147205,"SD patients also became refractory to random platelets less frequently (p less than 0.005), after a longer time period, and after a higher number of transfusions (p less than 0.02).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gmür', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'von Felten', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Osterwalder', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Honegger', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hörmann', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Deubelbeiss', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Berchtold', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Metaxas', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Scali', 'Affiliation': ''}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Frick', 'Affiliation': ''}]",Blood,[]
477,6338972,The use and safety of Ibuprofen in the hemophiliac.,"After demonstrating initial safety of Ibuprofen administered to hemophiliacs, a 16-wk double-blind individual crossover trial was designed to test the safety and, to a more limited extent, the efficacy of 1600 mg of Ibuprofen or placebo given daily to 20 hemophiliacs with hemophiliac arthropathy. The trial was completed with no evidence of increased frequency or severity of hemophiliac bleeding episodes or clinical or laboratory evidence of bleeding secondary to Ibuprofen. There were five treatment failures, none associated with hemorrhage or lack of compliance. A benefit was obtained in reduction of early morning stiffness and pain. Ibuprofen should be considered as a safe and potentially beneficial antiinflammatory agent in the treatment of carefully monitored hemophiliacs eligible for such therapy.",1983,The trial was completed with no evidence of increased frequency or severity of hemophiliac bleeding episodes or clinical or laboratory evidence of bleeding secondary to Ibuprofen.,['20 hemophiliacs with hemophiliac arthropathy'],"['Ibuprofen', 'Ibuprofen or placebo']",['hemorrhage or lack of compliance'],"[{'cui': 'C0022408', 'cui_str': 'Arthropathy'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.120402,The trial was completed with no evidence of increased frequency or severity of hemophiliac bleeding episodes or clinical or laboratory evidence of bleeding secondary to Ibuprofen.,"[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Inwood', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Killackey', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Startup', 'Affiliation': ''}]",Blood,[]
478,6713092,Prognostic relevance of cellular morphology in multiple myeloma.,"Morphological characteristics of tumor cells have been employed in the prognosis of lymphomas and solid tumors. This report documents an attempt to predict survival from the known cytologic heterogeneity in multiple myeloma. Myeloma cells in bone marrow smears from patients at diagnosis were evaluated by assigning them to morphologically defined categories. Cox's multivariate regression model for censored survival data was used to generate optimal weights, which served as coefficients in two regression equations to estimate death risk from cellular morphology. Step-wise procedures excluded redundant parameters. ""Myeloma morphology score"" (MMS) discriminates significantly (p less than 0.0001) among 3 stages, with median survival times of 42.5, 30.7, and 9.1 mo. For clinical routine application, ""myeloma progression score"" (MPS), the weight sum of the proportion of plasmablasts and the extent of bone marrow plasma cell infiltration, is suggested as a simple prognostic tool. Its discriminative power is very high [p less than 10(-9)]. Median survival times of greater than 71.5, 23.4, and 6.1 mo were found for good, moderate, and poor risk groups, respectively. However, staging is not confined to three subgroups, grouping is flexible, and pairs of data can be matched. This fact may prove to be valuable in designing prognosis-controlled clinical trials or theoretical studies on cellular differentiation. Preliminary results suggest changes in morphology due to disease progression and/or the effect of therapy on tumor kinetics. Most importantly, staging according to MPS or MMS may facilitate the adaption of therapy to the current state of the disease in patients with multiple myeloma.",1984,"Myeloma morphology score"" (MMS) discriminates significantly (p less than 0.0001) among 3 stages, with median survival times of 42.5, 30.7, and 9.1 mo.","['patients with multiple myeloma', 'multiple myeloma']",[],"['median survival times', 'Median survival times', 'Myeloma morphology score"" (MMS) discriminates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205235', 'cui_str': 'Discriminate (qualifier value)'}]",,0.0225137,"Myeloma morphology score"" (MMS) discriminates significantly (p less than 0.0001) among 3 stages, with median survival times of 42.5, 30.7, and 9.1 mo.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fritz', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': ''}]",Blood,[]
479,6580926,Primary therapy of acute promyelocytic leukemia: results of amsacrine- and daunorubicin-based therapy.,"Remission rates for patients with acute promyelocytic leukemia (APL) have improved with the use of anthracyclines and proper management of disseminated intravascular coagulopathy. In a prospective randomized trial of chemotherapy in patients with acute nonlymphoblastic leukemia, there were 16 patients with APL. All 7 of the patients receiving the amsacrine-containing regimen and 5 of 9 receiving the daunorubicin-containing regimen achieved a remission. All patients, except 2 of the 3 who underwent bone marrow transplantation, remain alive and in remission from 1+ to 25+ mo. Amsacrine is an effective replacement for daunorubicin in the treatment of APL, and its use does not compromise the favorable remission duration characteristic of APL.",1984,"Amsacrine is an effective replacement for daunorubicin in the treatment of APL, and its use does not compromise the favorable remission duration characteristic of APL.","['patients with acute nonlymphoblastic leukemia, there were 16 patients with APL', 'acute promyelocytic leukemia', 'patients with acute promyelocytic leukemia (APL']","['Amsacrine', 'chemotherapy', 'amsacrine- and daunorubicin-based therapy', 'daunorubicin', 'amsacrine']",['Remission rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",16.0,0.0156667,"Amsacrine is an effective replacement for daunorubicin in the treatment of APL, and its use does not compromise the favorable remission duration characteristic of APL.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Arlin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kempin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mertelsmann', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Higgins', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jhanwar', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Chaganti', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Clarkson', 'Affiliation': ''}]",Blood,[]
480,6375760,Efficacy of daunorubicin in the therapy of adult acute lymphocytic leukemia: a prospective randomized trial by cancer and leukemia group B.,"The efficacy of the addition of intensive therapy with daunorubicin (45 mg/m2 IV on days 1, 2, 3) to an otherwise identical induction program consisting of vincristine, prednisone, and L-asparaginase was assessed in 177 previously untreated adults (greater than or equal to 20 years of age) with acute lymphocytic leukemia (ALL). In the prospectively randomized phase of the investigation, 46 patients received daunorubicin in induction, whereas 53 did not. The two groups were otherwise comparable for pretreatment variables. A complete response was observed in 38/46 patients (83%) treated with daunorubicin, compared to 25/53 (47%) induced with vincristine, prednisone, and L-asparaginase alone (P = .003). The high response rate attributable to the use of the anthracycline was confirmed by the nonrandomized treatment of 78 subsequent patients, in whom a complete response rate of 76% was attained. A common program for central nervous system therapy and for maintenance therapy was employed in 103 patients achieving complete response. Maintenance consisted of cycles of 6-mercaptopurine (6-MP) and methotrexate with periodic reinforcement with vincristine and prednisone. Maintenance therapy proved to be minimally toxic. The average duration of complete response was 15 months and was not affected by the induction program employed. Approximately 25% of responders are projected to remain in continuing complete response for 36 months. The failure of the daunorubicin-containing programs to produce a higher percentage of long-term survivors, despite the higher complete response rates achieved, was thought to be due to the use of a maintenance program that was weak in intensity and dependent on reinforcement with vincristine and prednisone. These data clearly establish the increased effectiveness of vincristine, prednisone, L-asparaginase, and daunorubicin, as compared to this combination without daunorubicin, in the induction of complete response in adults with ALL. The results support the concept of an intensive, rather than a conservative, chemotherapeutic approach as the most appropriate strategy for the treatment of adult ALL.",1984,"A complete response was observed in 38/46 patients (83%) treated with daunorubicin, compared to 25/53 (47%) induced with vincristine, prednisone, and L-asparaginase alone (P = .003).","['46 patients received', 'adults with ALL', '177 previously untreated adults (greater than or equal to 20 years of age) with acute lymphocytic leukemia (ALL', 'adult acute lymphocytic leukemia', '103 patients achieving complete response']","['vincristine and prednisone', 'intensive therapy with daunorubicin', '6-mercaptopurine (6-MP) and methotrexate with periodic reinforcement with vincristine and prednisone', 'daunorubicin', 'vincristine, prednisone, and L-asparaginase', 'vincristine, prednisone, L-asparaginase, and daunorubicin', 'vincristine, prednisone, and L-asparaginase alone']",['average duration of complete response'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",177.0,0.026843,"A complete response was observed in 38/46 patients (83%) treated with daunorubicin, compared to 25/53 (47%) induced with vincristine, prednisone, and L-asparaginase alone (P = .003).","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Gottlieb', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Weinberg', 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Ellison', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Terebelo', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rafla', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cuttner', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Carey', 'Affiliation': ''}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Levy', 'Affiliation': ''}]",Blood,[]
481,6349715,A randomized trial of leukocyte-depleted platelet transfusion to modify alloimmunization in patients with leukemia.,"In an effort to determine whether the use of leukocyte (WBC) depleted platelets could modify the development of alloimmunization, 98 adult patients with acute nonlymphocytic leukemia receiving initial induction therapy were randomized to receive standard pooled platelet concentrates (PC) or WBC-depleted PC. WBC depletion was produced by an additional centrifugation of pooled PC, with removal of 81% of WBC and an associated platelet loss of 27%. Lymphocytotoxic antibody (LCTAb) levels were monitored as a serologic marker of alloimmunization. Overall, 5 of 25 evaluable patients receiving WBC-depleted PC developed LCTAb, compared to 13/31 receiving standard PC (p = 0.071). There was no significant difference in alloimmunization rate in the subgroup of patients who had no previous exposure to histocompatibility antigens by pregnancy or prior transfusions (4/15 alloimmunized receiving WBC depleted versus 4/12 receiving standard PC). There was no difference in the number of patients in each group who required HLA-matched platelets during induction therapy. In view of the significant loss of platelets with WBC depletion, the expense and difficulty of providing WBC-poor RBC, the absence of impact on the need for HLA-matched platelets during induction, and the small potential benefit from this approach, WBC-depleted platelets should not be utilized to prevent alloimmunization in patients with leukemia.",1983,There was no significant difference in alloimmunization rate in the subgroup of patients who had no previous exposure to histocompatibility antigens by pregnancy or prior transfusions (4/15 alloimmunized receiving WBC depleted versus 4/12 receiving standard PC).,"['98 adult patients with acute nonlymphocytic leukemia receiving initial induction therapy', 'patients with leukemia']","['leukocyte-depleted platelet transfusion', 'standard pooled platelet concentrates (PC) or WBC-depleted PC']","['platelet loss', 'alloimmunization rate', 'WBC depletion', 'Lymphocytotoxic antibody (LCTAb) levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0200601', 'cui_str': 'Platelet concentrate, pooling (procedure)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",98.0,0.0322334,There was no significant difference in alloimmunization rate in the subgroup of patients who had no previous exposure to histocompatibility antigens by pregnancy or prior transfusions (4/15 alloimmunized receiving WBC depleted versus 4/12 receiving standard PC).,"[{'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aisner', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hogge', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Reilly', 'Affiliation': ''}]",Blood,[]
482,6349719,Antithoracic duct lymphocyte globulin therapy of severe aplastic anemia.,"We performed a prospective randomized trial of antithoracic duct lymphocyte globulin (ATDLG), HLA-haploidentical marrow, and androgen (regimen ABA) versus androgen alone (concurrent STANDARD care controls) in 42 newly diagnosed individuals with severe aplastic anemia. ABA patients also were matched with patients from our preceding study (historical STANDARD care controls). Supportive care and pretreatment patient characteristics were the same in all groups. By life table analysis, 76% of patients receiving ABA are alive at 2 yr compared to 31% of the concurrent control group (p less than 0.002 versus ABA) and 19% of the historical controls (p less than 0.0001 versus ABA) given STANDARD care. ABA patients had greater hematologic improvement than either control group (p less than 0.001). However, improvement with ABA was often incomplete. Toxicity of ATDLG was considerable but manageable. Further studies to determine the mechanism of action and active component(s) of ABA are indicated.",1983,ABA patients had greater hematologic improvement than either control group (p less than 0.001).,"['ABA patients also were matched with patients from our preceding study (historical STANDARD care controls', '42 newly diagnosed individuals with severe aplastic anemia', 'severe aplastic anemia']","['antithoracic duct lymphocyte globulin (ATDLG), HLA-haploidentical marrow, and androgen (regimen ABA) versus androgen alone', 'Antithoracic duct lymphocyte globulin therapy']","['Toxicity', 'hematologic improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]","[{'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0017649', 'cui_str': 'Globulins'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}]",,0.0251454,ABA patients had greater hematologic improvement than either control group (p less than 0.001).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Camitta', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': ""O'Reilly"", 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sensenbrenner', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rappeport', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Champlin', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'August', 'Affiliation': ''}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kirkpatrick', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stuart', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Parkman', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nathan', 'Affiliation': ''}]",Blood,[]
483,32493407,"A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol.","BACKGROUND


Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd.
METHODS/DESIGN


REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months.
DISCUSSION


It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.
TRIAL REGISTRATION


Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.",2020,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","['Acute otitis media (AOM', 'Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered', 'children with AOMd', 'acute otitis media with discharge in children', '175 GP practices across the United Kingdom (UK', '399 patients from 175 practices in the UK', 'children, with around 2.8 million cases presenting to primary care in England and Wales annually', '399 children aged (≥\u200912\u2009months and\u2009<\u200916\u2009years) presenting to their GP with AOMd']","['amoxicillin (clarithromycin', 'ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin', 'immediate topically administered or delayed orally administered antibiotics', 'ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin', 'antibiotics']","['time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ', 'cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3853088', 'cui_str': 'Moderately bad'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0004519', 'cui_str': 'Azoxymethane'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",399.0,0.285734,"Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Curtis', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University Of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Christie', 'Initials': 'C', 'LastName': 'Cabral', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vasa', 'Initials': 'V', 'LastName': 'Curcin', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Jeremey', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Morris', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Vibhore', 'Initials': 'V', 'LastName': 'Prasad', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, Addison House 3.07, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schilder', 'Affiliation': 'evidENT, UCL Ear Institute, Royal National Throat, Nose and Ear Hospital, 330 Grays Inn Road, London, WC1X 8DA, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, Faculty of Health Sciences and Wellbeing, University of Sunderland, Sciences Complex, City Campus, Chester Road, Sunderland, SR1 3SD, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trial Collaboration (BRTC), part of the Bristol Trial Centre, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS82PS, UK. j.taylor@bristol.ac.uk.'}]",Trials,['10.1186/s13063-020-04419-7']
484,6704545,A randomized study of the efficacy of consolidation therapy in adult acute nonlymphocytic leukemia.,"The Eastern Cooperative Oncology Group conducted a randomized study to determine the efficacy of consolidation therapy in prolonging the duration of complete remission (CR) in adults with acute nonlymphocytic leukemia (ANLL). Induction chemotherapy with daunorubicin, cytosine arabinoside, and 6-thioguanine (DAT) yielded CR in 65% of 283 patients with ANLL, aged 16-69. For patients aged 60-69, the CR rate was 58%. Of 184 patients in CR, 146 patients were then randomized to receive either maintenance therapy with weekly cytosine arabinoside and 6-thioguanine alone (69 patients) or two courses of reduced doses of DAT 1 mo apart, before commencing the same maintenance program (77 patients). Consolidation therapy resulted in hematologic toxicity, but was not lethal in any of the eligible patients. Patients receiving consolidation plus maintenance therapy experienced a longer CR duration (40 wk) and disease-free survival at 2 yr (28%) than did those patients receiving maintenance therapy alone (34 wk and 14%, respectively). These differences are not statistically significant. These results suggest that approaches to consolidation therapy employing reduced doses of the induction therapy regimen can have, at best, only a small benefit. For consolidation therapy to provide substantial improvement in CR duration, intensive regimens with non-cross-resistant drugs will be required.",1984,"Patients receiving consolidation plus maintenance therapy experienced a longer CR duration (40 wk) and disease-free survival at 2 yr (28%) than did those patients receiving maintenance therapy alone (34 wk and 14%, respectively).","['184 patients in CR, 146 patients', 'adults with acute nonlymphocytic leukemia (ANLL', '65% of 283 patients with ANLL, aged 16-69', 'adult acute nonlymphocytic leukemia']","['maintenance therapy with weekly cytosine arabinoside and 6-thioguanine alone', 'Induction chemotherapy with daunorubicin, cytosine arabinoside, and 6-thioguanine (DAT', 'consolidation therapy', 'Consolidation therapy']","['duration of complete remission (CR', 'longer CR duration (40 wk) and disease-free survival', 'CR rate', 'hematologic toxicity']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",283.0,0.0461497,"Patients receiving consolidation plus maintenance therapy experienced a longer CR duration (40 wk) and disease-free survival at 2 yr (28%) than did those patients receiving maintenance therapy alone (34 wk and 14%, respectively).","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Cassileth', 'Affiliation': ''}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Begg', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bozdech', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kahn', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Weiler', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Glick', 'Affiliation': ''}]",Blood,[]
485,6576814,Comparison of chemotherapy with immunotherapy for maintenance of acute lymphoblastic leukemia in children and adults.,"Two hundred and seventeen patients, 1-50 yr old, with acute lymphoblastic leukemia in complete remission were randomized to receive a 1-yr consolidation chemotherapy of either type P, comprising 7 different drugs, or type M, consisting of methotrexate interspersed with prednisone and vincristine. Thereafter, they were randomized a second time to receive a 4-yr maintenance of either chemotherapy or immunotherapy, comprised of allogeneic blasts and bacillus Calmette-Guérin (BCG). Consolidation P caused more toxicity than consolidation M. However, comparison between the consolidation therapies P and M showed no significant difference, neither for disease-free interval nor for duration of survival. Chemotherapy showed more lethal toxicity in adults than in children. Comparison between chemotherapy (C) and immunotherapy (I) as maintenance treatment showed a significant (p = 0.016) superiority of C for disease-free interval (DFI). The difference was even more pronounced (p = 0.009) in the group with less than 8 g/dl of hemoglobin (Hb) at diagnosis before therapy. On the other hand, for patients with more than 8 g/dl Hb at diagnosis, presumably those with T-ALL, no difference in DFI was seen. No difference has been seen so far between maintenance therapies I and C concerning the duration of survival. The patients who were receiving maintenance I when they relapsed and who were consequently retreated by chemotherapy, survived longer from relapse than those patients retreated for relapse while receiving maintenance C.",1983,Comparison between chemotherapy (C) and immunotherapy (I) as maintenance treatment showed a significant (p = 0.016) superiority of C for disease-free interval (DFI).,"['patients who were receiving maintenance', 'adults than in children', 'acute lymphoblastic leukemia in children and adults', 'Two hundred and seventeen patients, 1-50 yr old, with acute lymphoblastic leukemia in complete remission']","['Chemotherapy', 'chemotherapy or immunotherapy, comprised of allogeneic blasts and bacillus Calmette-Guérin (BCG', 'consolidation M', '1-yr consolidation chemotherapy', 'methotrexate interspersed with prednisone and vincristine', 'chemotherapy (C) and immunotherapy', 'chemotherapy with immunotherapy']","['toxicity', 'DFI', 'lethal toxicity', 'disease-free interval nor for duration of survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0677874', 'cui_str': 'In full remission (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0337091', 'cui_str': 'Blasting (qualifier value)'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0740561,Comparison between chemotherapy (C) and immunotherapy (I) as maintenance treatment showed a significant (p = 0.016) superiority of C for disease-free interval (DFI).,"[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Stryckmans', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Otten', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Delbeke', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fière', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bury', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Solbu', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Benoit', 'Affiliation': ''}]",Blood,[]
486,32493401,Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan.,"BACKGROUND


The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease. An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks.
METHODS/DESIGN


The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end on 30 June 2020. The primary outcome measure of the trial is the urinary albumin excretion level measured at 48 weeks of treatment. This statistical analysis plan presents an update to the published trial protocol and provides a comprehensive description of the statistical methods that will be used for the analysis of the data from this trial. In doing so, we follow the ""Guidelines for the content of statistical analysis plans in clinical trials"" to support transparency and reproducibility of the trial findings.
DISCUSSION


With the use of this prior statistical analysis plan, we aim to minimise bias in the reporting of the findings of this trial, which evaluates the investigational medicinal product GKT137831. The results of the trial are expected to be published in 2022.
TRIAL REGISTRATION


ANZCTR registry: ACTRN12617001187336. Registered on 14 July 2017. Universal Trial Number: U1111-1187-2609; Protocol number: T1DGKT137831; Genkyotex trial number: GSN000241.",2020,"BACKGROUND


The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","['adults with type 1 diabetes and persistently elevated urinary albumin excretion', 'adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48\u2009weeks']","['GKT13783', 'placebo']","['efficacy and safety', 'urinary albumin excretion level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.413203,"BACKGROUND


The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease.","[{'ForeName': 'Alysha M', 'Initials': 'AM', 'LastName': 'De Livera', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia. alyshad@unimelb.edu.au.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Reutens', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Merlin', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Jandeleit-Dahm', 'Affiliation': 'Monash University, Clayton, VIC, 3168, Australia.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Agus', 'Initials': 'A', 'LastName': 'Salim', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, 3004, Australia.'}]",Trials,['10.1186/s13063-020-04404-0']
487,6201211,A randomized comparison of postremission therapy in acute myelogenous leukemia: a Southeastern Cancer Study Group trial.,"The Southeastern Cancer Study Group conducted a post-remission induction randomized trial in adult acute myelogenous leukemia to assess the efficacy of alternate drug therapy during consolidation and of immunotherapy during maintenance. Of 508 evaluable patients entered into the study, 335 (66%) achieved a complete remission treated with a 7-day infusion of cytosine arabinoside at a dose of 100 mg/sq m/day and 3 days of daunorubicin at a dose of 45 mg/sq m/day. Those in remission were randomized to receive 3 courses of 1 of 3 consolidation regimens: (A) a continuous infusion of 5-azacytidine, 150 mg/sq m/day for 5 days; (B) 5-azacytidine plus beta-deoxythioguanosine, 300 mg/sq m/day for 5 days; or (C) cytosine arabinoside, 100 mg/sq m/day intravenously, and thioguanine, 100 mg/sq m orally every 12 hr, plus daunorubicin, 10 mg/sq m every 24 hr daily for 5 days. There was no difference in relapse rate among the 3 arms. Those completing consolidation and remaining in remission were randomized to 1 of 3 maintenance regimens: (D) chemotherapy, 5-day infusion of cytosine arabinoside and 2 days of daunorubicin (same doses as induction) given every 13 wk for 1 yr; (E) BCG given twice weekly for 1 mo and then monthly for 1 yr; or (F) the combination of regimens D and E. The median duration of remission was significantly better on regimen D (17.4 versus 9.4 and 9.5 mo), and median survival was 29 mo compared to 21 mo for the other regimens. Those given different drugs during consolidation than used for induction (regimens A and B) and subsequent chemotherapy for maintenance (regimen D) had the longest remission durations and survival. Immunotherapy was not as good as intensive chemotherapy for maintenance.",1984,There was no difference in relapse rate among the 3 arms.,"['acute myelogenous leukemia', '508 evaluable patients entered into the study, 335 (66%) achieved a complete remission treated with a 7-day infusion of', 'adult acute myelogenous leukemia']","['postremission therapy', 'cytosine arabinoside', '5-azacytidine plus beta-deoxythioguanosine, 300 mg/sq m/day for 5 days; or (C) cytosine arabinoside', 'chemotherapy, 5-day infusion of cytosine arabinoside and 2 days of daunorubicin', '5-azacytidine', 'daunorubicin', 'thioguanine, 100 mg/sq m orally every 12 hr, plus daunorubicin', 'Immunotherapy']","['median survival', 'relapse rate', 'median duration of remission', 'longest remission durations and survival']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",508.0,0.132208,There was no difference in relapse rate among the 3 arms.,"[{'ForeName': 'W R', 'Initials': 'WR', 'LastName': 'Vogler', 'Affiliation': ''}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Winton', 'Affiliation': ''}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Raney', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Go', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': ''}]",Blood,[]
488,32493383,MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial.,"INTRODUCTION


In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC). We aim to assess the non-inferiority of YEARS compared to current guidelines to rule out PE among PERC-positive ED patients with suspicion of PE.
METHODS/DESIGN


The MODIGLIANI study is a multicenter, European, non-inferiority, cluster-randomized, two periods cross-over, controlled trial. Each center will be randomized for the sequence of two 4-month periods: intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1 month of ""wash-out"" between the two periods. In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients). In the MODS period, the threshold of D-dimers to rule out PE will be raised to 1000 ng/ml if no item of the YEARS score is present or will remain unchanged otherwise. Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability.
ETHICS AND DISSEMINATION


The study has received the following approvals: Comité de protection des personnes Ile de France XI (France) and Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona (Spain). Results will be made available to all included participants and other researchers.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04032769. Registered on 24 July 2019.",2020,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","['Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability', 'PERC-positive ED patients with suspicion of PE', 'patients aged 50 years or younger and age ×\u200910 for older patients']","['YEARS', 'intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1\u2009month of ""wash-out"" between the two periods']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]",[],,0.159928,"In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients).","[{'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Philippon', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Dumont', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jimenez', 'Affiliation': 'Emergency Department, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Salhi', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Cachanado', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'Sorbonne Université, Paris, France.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of clinical pharmacology and Clinical Research Platform of East of Paris (URCEST-CRC-CRB), APHP.Sorbonne Universite, hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Yonathan', 'Initials': 'Y', 'LastName': 'Freund', 'Affiliation': 'Emergency department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, APHP, Sorbonne Université, Paris, France. yonathanfreund@gmail.com.'}]",Trials,['10.1186/s13063-020-04379-y']
489,32493398,CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins.,"BACKGROUND


Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins.
METHODS/DESIGN


This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period.
DISCUSSION


This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.",2020,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.",['incompetent saphenous veins'],"['CASS (CyanoAcrylate closure versus Surgical Stripping', 'cyanoacrylate', 'Endovenous thermal ablation', 'cyanoacrylate closure group or the surgical-stripping group', 'cyanoacrylate closure and surgical stripping', 'cyanoacrylate closure', 'cyanoacrylate closure with the VenaSeal™ closure system', 'ligation and stripping of the saphenous vein', 'surgical stripping']","['absence of venous reflux or residual venous tissue after surgical stripping', 'perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates', 'complete closure rate of the target vein']","[{'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0643514', 'cui_str': '6-chloropenicillanic acid S-sulfoxide'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0036186', 'cui_str': 'Saphenous vein structure'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0618221,"Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates.","[{'ForeName': 'Sungsin', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyung Sub', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Taeseung', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Byun', 'Affiliation': 'Department of Surgery, Wonkwang University Hospital, Wonkwang University School of Medicine, Iksan, South Korea.'}, {'ForeName': 'Woo-Sung', 'Initials': 'WS', 'LastName': 'Yun', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Shin-Seok', 'Initials': 'SS', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyangkyoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University Hospital, Chung-Ang School of Medicine, Dongjak-gu, South Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, National Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jin Hyun', 'Initials': 'JH', 'LastName': 'Joh', 'Affiliation': 'Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'In Mok', 'Initials': 'IM', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, 07061 20 Boramae-ro, Dongjak-gu, Seoul, South Korea. sboy5240@gmail.com.'}]",Trials,['10.1186/s13063-020-04393-0']
490,32493411,Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial.,"BACKGROUND


Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP).
METHODS/DESIGN


This study is a randomized, sham-controlled, patient- and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist.
CONCLUSION


This study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR1800017581. Registered on 5 August 2018. URL: http://www.chictr.org.cn.",2020,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"['postmenopausal osteoporosis (PMOP', 'postmenopausal women', 'osteoporotic postmenopausal women', 'women with PMOP', '104 women aged 45-70\u2009years with a diagnosis of PMOP']","['acupuncture', 'acupuncture (OA', 'real herbal medicine treatment', 'OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping', 'Acupuncture', 'OA group and the sham acupuncture (SA', 'OA versus SA', 'OA']","['bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL']","[{'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1333633', 'cui_str': 'FOXO3A protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",104.0,0.305839,Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group.,"[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Ren', 'Affiliation': 'Nanjing University of Chinese Medicine, No.138 Xianlin Road, Nanjing, 210046, China.'}, {'ForeName': 'Y F', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Ao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture, Kunming Municipal Hospital of Traditional Chinese Medicine, 25 Dongfeng Road, Panlong District, Kunming, 650011, Yunnan Province, China.'}, {'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Lai', 'Affiliation': 'School of Acupuncture-Tuina and Rehabilitation, Yunnan University of Chinese Medicine, No.1076 Yuhua Road, Chenggong District, Kunming, 650500, Yunnan Province, China.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Dali University, No. 32 Jiashibo Road, Dali, 671000, Yunnan Province, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital of Yunnan University of Chinese Medicine, No.120 Guanghua Road, Wuhua District, Kunming, 650032, Yunnan Province, China. kmzhaorong@qq.com.'}]",Trials,['10.1186/s13063-020-04435-7']
491,32493442,"Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial.","BACKGROUND


Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch-anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available. Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, there is currently no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis.
METHODS


Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation.
DISCUSSION


On April 30, 2014, the World Health Organization published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03524352. Registered on 14 May 2018.",2020,"Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability.","['chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis', 'patients with ulcerative colitis (UC', 'Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers']","['FMT versus sham transplantation', 'Fecal microbiota transplantation (FMT', 'fecal microbiota transplantation', 'proctocolectomy with ileal pouch-anal anastomosis (IPAA', 'FMT or sham transplantation']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0376620', 'cui_str': 'Pouchitis'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0192755', 'cui_str': 'Ileoanal anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4505465', 'cui_str': 'Ileal Pouch Anal Anastomosis'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0400076', 'cui_str': 'Excision of colon and rectum'}, {'cui': 'C4505465', 'cui_str': 'Ileal Pouch Anal Anastomosis'}]",[],42.0,0.0899589,"Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Trang-Poisson', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Kerdreux', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Planche', 'Affiliation': 'Methodology and Biostatistics Unit, Delegation to Clinical Research and Innovation for CHU Nantes and Vendée departmental Hospital, Nantes, La Roche sur Yon, France.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sokol', 'Affiliation': 'Sorbonne Université, Inserm, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Gastroenterology & Nutrition Department, F-75012, Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Bemer', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Cabanas', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Hivernaud', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Biron', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Flet', 'Affiliation': 'Pharmacy Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Montassier', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Le Garcasson', 'Affiliation': 'MiHAR lab, Nantes University, 44000, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jobert', 'Affiliation': 'Sponsor Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Lepelletier', 'Affiliation': 'Bacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Caillon', 'Affiliation': 'Bacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Le Pape', 'Affiliation': 'Parasitology-Mycology Department, Institute of Biology CHU Nantes, Nantes, France.'}, {'ForeName': 'Berthe-Marie', 'Initials': 'BM', 'LastName': 'Imbert', 'Affiliation': 'Virology Department, CHU Nantes, Nantes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""Gastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.""}]",Trials,['10.1186/s13063-020-04330-1']
492,32506325,Postoperative online follow-up improves the quality of life of patients who undergo extraction of impacted madibular third molars: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of online follow-up on the quality of life of patients who undergo extraction of impacted mandibular third molars.
MATERIALS AND METHODS


This study enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups. The test group received an online follow-up on the first, third, and fifth days after tooth extraction, while the control group was not followed up with. Patients in both groups were reexamined on the postoperative seventh day, completing the postoperative symptom severity (PoSSe) scale to comprehensively and quantitatively evaluate their quality of life after tooth extraction. A visual analogue scale (VAS) was used to evaluate the degree of approval for an online follow-up after tooth extraction by 20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old).
RESULTS


The PoSSe scale scores of the remaining options in the test group were significantly lower than those in the control group. The VAS score of senior doctors for online follow-up was significantly lower than that of young doctors.
CONCLUSIONS


A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars. Compared with senior doctors, young doctors were more likely to approve an online follow-up after tooth extraction.
CLINICAL RELEVANCE


Online medical care can be considered as an auxiliary tool to improve the effect of oral treatment.",2021,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"['patients who undergo extraction of impacted mandibular third molars', 'patients who undergo extraction of impacted madibular third molars', 'enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups', '20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old', 'patients who underwent extraction of impacted mandibular third molars']",[],"['quality of life', 'visual analogue scale (VAS', 'PoSSe scale scores', 'postoperative symptom severity (PoSSe) scale', 'VAS score of senior doctors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0438377,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"[{'ForeName': 'Xianghuai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaoqiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Center of Oral Implantology, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China. 654365980@qq.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03388-0']
493,32493502,Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.,"BACKGROUND


Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations.
METHODS


Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months.
DISCUSSION


The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities.
TRIAL REGISTRATION


This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.",2020,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","['hypertensive patients', 'Responders with persistent hypertension', 'hypertensive patients treated in an urban, safety net Emergency Department (Aim 2', 'Emergency Department patient population']","['primary care provider appointment assistance', 'healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no', 'behavioral intervention', 'facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center']","['blood pressure', 'systolic blood pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0358591,"The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA. wmeurer@med.umich.edu.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Flood', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Whitfield', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Trimble', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cowdery', 'Affiliation': 'School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Borgialli', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Montas', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cunningham', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lorraine R', 'Initials': 'LR', 'LastName': 'Buis', 'Affiliation': 'Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli', 'Initials': 'L', 'LastName': 'Skolarus', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor, MI, USA.'}]",Trials,['10.1186/s13063-020-04340-z']
494,32503869,Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.,"OBJECTIVES


Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC).
DESIGN AND SETTING


This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST).
PARTICIPANTS


Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252).
PRIMARY OUTCOMES


Primary outcomes were psychosocial consequences measured at five time points.
RESULTS


False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives.
CONCLUSIONS


Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes.
TRIAL REGISTRATION NUMBER


NCT00496977.",2020,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","['Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire', 'Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group']",['false-positive lung cancer CT screening'],"['lung cancer mortality', 'psychosocial consequences measured at five time points', 'lung cancer screening', 'Psychosocial consequences of false positives', 'true positives and false positives', 'negative psychosocial consequences', 'false positives or true positives']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0269201,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","[{'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034682']
495,32235883,Safety and immunogenicity of Ad26 and MVA vaccines in acutely treated HIV and effect on viral rebound after antiretroviral therapy interruption.,"We administered Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo in 26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection as an exploratory study to determine the safety and duration of viremic control after treatment interruption. The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).",2020,"The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).",['26 individuals who initiated antiretroviral therapy during acute human immunodeficiency virus infection'],"['Ad26 and MVA vaccines', 'Ad26, modified vaccinia Ankara vectors containing mosaic HIV-1 antigens or placebo', 'placebo']",['delayed time to viral rebound'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}]","[{'cui': 'C3178367', 'cui_str': 'MVA vaccine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439750', 'cui_str': 'Mosaic'}, {'cui': 'C0369498', 'cui_str': 'HIV-1 antigen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}]",26.0,0.159031,"The vaccine was safe and generated robust immune responses, but delayed time to viral rebound compared to that in placebo recipients by only several days and did not lead to viremic control after treatment interruption (clinical trial NCT02919306).","[{'ForeName': 'Donn J', 'Initials': 'DJ', 'LastName': 'Colby', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Sarnecki', 'Affiliation': 'Janssen Vaccines, Bern, Switzerland.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Tipsuk', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Eugène', 'Initials': 'E', 'LastName': 'Kroon', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Intasan', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sacdalan', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Suteeraporn', 'Initials': 'S', 'LastName': 'Pinyakorn', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Pornsuk', 'Initials': 'P', 'LastName': 'Grandin', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Hongshuo', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Sodsai', 'Initials': 'S', 'LastName': 'Tovanabutra', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Zhanna', 'Initials': 'Z', 'LastName': 'Shubin', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Paquin-Proulx', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Rasmi', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'de Souza', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Victoria R', 'Initials': 'VR', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Pagliuzza', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Montréal, Canada.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chomont', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Montréal, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vingerhoets', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, the Netherlands.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Michael', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. mrobb@hivresearch.org.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}]",Nature medicine,['10.1038/s41591-020-0774-y']
496,32493462,"Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial.","BACKGROUND


Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to the stimulated brain area and the type of exercise performed.
METHODS/DESIGN


This is a double-blind crossover study, organised into two parts: the first is to assess the effects of tDCS on explosive performance (jump task) and the second is to assess the effects on endurance performance (cycling time trial task). Participants, who are recreationally active or athletes (parkour practitioners, cyclists), will receive two active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions over 5 days (part B). Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
DISCUSSION


This study investigates the acute and repeated effects of tDCS on the motor and cognitive performance of healthy subjects. It will try to evaluate if tDCS could be considered as a neuroenhancement technology according to the physical task investigated (endurance versus explosive).
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03937115. Registered on 3 May 2019; retrospectively registered.",2020,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
","['Participants, who are recreationally active or athletes (parkour practitioners, cyclists', 'healthy subjects', 'sports performance for two profiles of athletes (power and endurance']","['Transcranial direct current stimulation (tDCS', 'active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions', 'tDCS', 'transcranial direct current stimulation']",['Motor and cognitive performance'],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],,0.0921396,"Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B).
","[{'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Grandperrin', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France. ygrandperrin@chu-besancon.fr.""}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Grosprêtre', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Nicolier', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gimenez', 'Affiliation': 'Laboratoire Culture, Sport, Santé, Société EA 4660, Université de Bourgogne Franche -Comté, UPFR Sports, 25000, Besançon, France.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': ""Centre d'Investigation Clinique, INSERM CIC 1431, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Haffen', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}, {'ForeName': 'Djamila', 'Initials': 'D', 'LastName': 'Bennabi', 'Affiliation': ""Service de Psychiatrie de l'Adulte, Centre Hospitalier Universitaire de Besançon, 25030, Besançon Cedex, France.""}]",Trials,['10.1186/s13063-020-04412-0']
497,32493500,The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial.,"BACKGROUND


Dentin hypersensitivity (DH) is a condition characterized by short and sharp episodes of pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer, Nanoseal, commonly used in Japan.
METHODS/DESIGN


This study protocol is a two-arm, parallel, pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
DISCUSSION


CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin-collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.
TRIAL REGISTRATION


UMIN Clinical Trials Registry (UMIN-CTR), ID: UMIN000038072. Registered on 21 September 2019.
TRIAL STATUS


This study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (Hanke, Am Dent Assoc 27:1379-1393, 1940).",2020,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
","['Japan', 'Forty DH patients']",['novel zinc-containing desensitizer'],"['quality of life', 'dentin hypersensitivity', 'reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0917467,"The primary outcome is the reduction of pain intensity in response to air stimuli measured with a 5-point verbal response scale from baseline to 4 weeks after the intervention, and Fisher's exact test will be used for analyses.
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan. matsuurat@nagasaki-u.ac.jp.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Mae', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohira', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Yamashita', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Nakazono', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Kajiro', 'Initials': 'K', 'LastName': 'Yanagiguchi', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Shizuka', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Periodontology and Endodontology, Nagasaki University Graduate School of Biomedical Sciences, 852-8588, 1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan.'}]",Trials,['10.1186/s13063-020-04426-8']
498,32508218,The Effects of Algebraic Equation Solving Intervention for Students With Mathematics Learning Difficulties.,"The purpose of this study was to examine the effects of algebraic equation solving intervention for sixth graders with mathematics learning difficulties (MD). A total of 48 students with MD were randomly assigned to either the algebraic equation solving intervention,  Mystery Math  ( n  = 24) or control condition ( n  = 24). The multicomponent intervention was based on the principles of explicit instruction and focused on improving conceptual and procedural knowledge of algebraic equation solving using concrete manipulatives. Students in the intervention group received instruction in pairs, 30 min per session, 3 sessions per week for 5 weeks (i.e., 15 sessions). The results indicated that the main effect of intervention was significant for 2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving with large effect sizes. However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations. The findings demonstrate that grade-level standards can be successfully taught to students with MD. Implications for practice are discussed.",2021,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","['sixth graders with mathematics learning difficulties (MD', 'Students With Mathematics Learning Difficulties', '48 students with MD']","['Algebraic Equation Solving Intervention', 'algebraic equation solving intervention,  Mystery Math  ( n  = 24) or control condition', 'algebraic equation solving intervention']","['2 proximal measures of mathematics vocabulary, and conceptual and procedural understanding of algebraic equation solving']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0424939', 'cui_str': 'Learning difficulties'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",48.0,0.0172868,"However, the main effect of intervention was not significant for distal measures of comprehensive pre-algebra skills and whole-number computations.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Namkung', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bricko', 'Affiliation': 'University of Nebraska-Lincoln, USA.'}]",Journal of learning disabilities,['10.1177/0022219420930814']
499,32498098,Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial.,"BACKGROUND


The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE).
METHODS


This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications.
RESULTS


244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %;  P   = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2;  P   < 0.001).
CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.",2020,"CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","['244 patients (122 conventional, 122 MOSE) were enrolled during the study period', 'consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2\u200acm']","['conventional EUS-FNTA', 'MOSE', 'Endoscopic ultrasound-guided tissue acquisition with or without macroscopic', 'conventional arm without ROSE', 'endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA']","['sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications', 'procedure time or rate of procedure-related adverse events', 'diagnostic yield']","[{'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",244.0,0.133709,"CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","[{'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Wah Kheong', 'Initials': 'WK', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Center, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medanta, The Medicity, Gurgaon, India.'}, {'ForeName': 'Majid A', 'Initials': 'MA', 'LastName': 'Almadi', 'Affiliation': 'Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tiing Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kwek', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yasuda', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kida', 'Affiliation': 'Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Hsiu-Po', 'Initials': 'HP', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tsu-Yao', 'Initials': 'TY', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'Chan', 'Affiliation': 'Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Anthony Y B', 'Initials': 'AYB', 'LastName': 'Teoh', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}]",Endoscopy,['10.1055/a-1172-6027']
500,32496886,Influence of virtual keyboard design and usage posture on typing performance and muscle activity during tablet interaction.,"This study aimed to determine the effects of virtual keyboard designs and postures on task performance and muscle activity during tablet use. Eighteen healthy adults were randomly assigned to one of three postures (DESK, LAP, BED) to complete six sessions of 60-minute typing on a tablet with three virtual keyboards (STD, WIDE, SPLIT) twice in an experimental laboratory. Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions were measured by electromyography. The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD,  p  = .015; SPLIT vs WIDE,  p  < .001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD,  p  = .021). Lap posture was associated with faster typing speed ( p  = .018) and higher forearm muscle activity ( p  < .05). Typing performance decreased ( p  < .001) with elevated neck extensor muscle activity ( p  = .042) when the task duration prolonged. The split virtual keyboard showed potential to improve tablet ergonomics under various postures.  Practitioner Summary:  Tablets have become widely used for a variety of tasks and have gradually expanded into the realm of mobile productivity and education. Adequate designs of virtual keyboards for tablets show the potential for increased task performance and decreased muscle activity pertinent to typing activity and posture constraints imposed by non-traditional work positions.  Abbreviations:  WPM: words per minute; IKI: inter-key press interval; EMG: electromyography; EDC: extensor digitorum communis; FDS: flexor digitorum superficialis; CES: cervical erector spinae; UT: upper trapezius; EA: electrical activity; MVC: maximum voluntary contraction; APDF: amplitude probability distribution function.",2020,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).",['Eighteen healthy adults'],"['virtual keyboard design and usage posture', 'virtual keyboard designs and postures']","['Typing performance', 'elevated neck extensor muscle activity', 'muscle activity of extensor digitorum communis', 'task performance and muscle activity', 'Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions', 'forearm muscle activity']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}]",18.0,0.0249073,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).","[{'ForeName': 'Ming-I Brandon', 'Initials': 'MB', 'LastName': 'Lin', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ruei-Hong', 'Initials': 'RH', 'LastName': 'Hong', 'Affiliation': 'Institute of Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Huang', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}]",Ergonomics,['10.1080/00140139.2020.1778097']
501,32513881,"Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial.","INTRODUCTION


Children of incarcerated parents comprise a greatly disadvantaged group in society and positive parenting constitutes an important factor for children's healthy development. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.This study aims to investigate the effects of the parenting programme currently offered in prisons in Sweden, For Our Children's Sake (FOCS), through a controlled trial with a parallel implementation process evaluation.
METHODS AND ANALYSIS


The effectiveness trial is carried out as a non-blinded controlled trial with a parallel investigation of the implementation process using mixed methods. Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents. Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent. The FOCS intervention is carried out in group format over 10 weeks. The primary outcome is closeness in parent-child relationship measured with the Child Parent Relationship Scale. Secondary outcomes comprise parent-child contact, parental criminal attitude and interest in other treatment programmes. Mediators comprise attitude to parenting, and self-efficacy. Outcome data are self-reported and collected over four time points: baseline (September to December 2019), mid and after intervention, and at 3 months follow-up. Implementation data is collected during and after intervention. Intervention fidelity is monitored through audio recordings, dose is registered per participant, reach comprise included versus eligible number of parents and acceptability is investigated through semi-structured interviews. Factors influencing implementation will be investigated using a questionnaire.
ETHICS AND DISSEMINATION


Ethical permission has been obtained by the Swedish Ethical Review Authority 2019-04227. Findings will be published in peer-reviewed journals, presented at scientific conferences and presented to participants in writing.
TRIAL REGISTRATION NUMBER


NCT04101799; Pre-results.",2020,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[""prisons in Sweden, For Our Children's Sake (FOCS"", 'Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents', 'Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent', ""children's healthy development""]","['FOCS intervention', 'parenting programme']","['parent-child contact, parental criminal attitude and interest in other treatment programmes', 'closeness in parent-child relationship measured with the Child Parent Relationship Scale']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.235758,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[{'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden asa.norman@ki.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Enebrink', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034834']
502,32513895,Does delaying discharge from intensive care until after tracheostomy removal affect 30-day mortality? Propensity score matched cohort study.,"OBJECTIVE


To investigate the short-term mortality effect of discharge from an intensive care unit (ICU) with a tracheostomy in place in comparison to delaying discharge until after tracheostomy removal.
DESIGN


A propensity score matched cohort study using data from the TracMan study.
SETTING


Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated).
PARTICIPANTS


622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008. 144 patients left ICU with a tracheostomy. 999 days of observation from 294 patients were included in the control pool.
INTERVENTIONS


We matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place. Propensity models were developed according to discharge destination, accounting for likely confounding factors.
PRIMARY OUTCOME MEASURE


The primary outcome was 30-day mortality from the matching day. For the 'discharged with a tracheostomy' group, this was death within 30 days after the discharge day. For the 'remained in ICU' group, this was death within 30 days after the matched day.
RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
CONCLUSION


Keeping patients on an ICU to provide tracheostomy care was not found to affect mortality. Tracheostomy presence may indicate a higher risk of mortality due to underlying diseases and conditions rather than posing a risk in itself.The TracMan trial was registered on the ISRCTN database (ISRCTN28588190).",2020,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","['Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated', 'matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place', '294 patients were included in the control pool', '622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008', '144 patients left ICU with a tracheostomy']",['intensive care unit (ICU'],['30-day mortality'],"[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",294.0,0.23793,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vollam', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK sarah.vollam@ndcn.ox.ac.uk.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Watkinson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037762']
503,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733']
504,32515065,The effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography during exercise in healthy males.,"KEY POINTS


Diaphragm fatigue may increase the intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea, which may partially explain why diaphragm fatigue negatively affects exercise performance. We hypothesized that diaphragm fatigue would negatively affect exercise performance via increases in both the intensity and unpleasantness of dyspnoea, and that the increase in dyspnoea would be mechanistically linked to an increase in diaphragmatic EMG (EMG di  ), a surrogate measure of neural respiratory drive. Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea. The change in submaximal dyspnoea unpleasantness was significantly correlated with the change in cycling performance. Pre-fatigue of the diaphragm did not increase EMG di  during exercise and is therefore unrelated to the increase in either the sensory or affective dimension of exertional dyspnoea.
ABSTRACT


The purpose of this study was to examine the effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography (EMG di  ) during cycling. Sixteen healthy males (age = 27 ± 5 yr,    V   ̇   O   2   max         = 45.8 ± 9.8 ml kg -1   min -1  ) completed two high-intensity, time-to-exhaustion cycling tests in randomized order: (i) inspiratory pressure threshold loading (PTL) prior to exercise to induce diaphragm fatigue (pre-DF) and (ii) no PTL (control). Diaphragm fatigue after PTL was confirmed via cervical magnetic stimulation of the phrenic nerves. Dyspnoea intensity and unpleasantness were measured throughout exercise with the 0-10 category-ratio Borg scale and following exercise using the Multidimensional Dyspnoea Profile (MDP). EMG di  was continuously recorded via a multipair oesophageal electrode catheter. Time-to-exhaustion decreased with pre-DF vs. control (9.0 ± 5.5 vs. 10.7 ± 7.5 min, P = 0.023). Pre-DF increased dyspnoea intensity ratings by 0.6 ± 1.0 Borg 0-10 units at the highest equivalent submaximal exercise time (HESET) a participant could achieve in both conditions (P = 0.020). Dyspnoea unpleasantness ratings increased with pre-DF by 0.5 ± 1.0, 0.7 ± 1.2 and 0.9 ± 1.4 (all P < 0.05) Borg 0-10 units during the 2nd, 3rd and 4th minutes of exercise, respectively. There was a significant correlation between the change in breathing unpleasantness ratings at HESET and the change in time-to-exhaustion (r = 0.66, P = 0.006). The immediate perception domain, a combination of peak unpleasantness and specific dyspnoea descriptor intensity ratings, was the only component of the MDP that was significantly increased with pre-DF (4.3 ± 1.9 vs. 3.6 ± 1.8, P = 0.04). There were no significant differences in EMG di  . In conclusion, diaphragm fatigue has negative effects on multiple domains of dyspnoea, which may partially explain why exercise performance decreases with it.",2020,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"['healthy males', 'Sixteen healthy males (age\xa0=\xa027\xa0±']",['i) inspiratory pressure threshold loading (PTL) prior to exercise'],"['diaphragmatic EMG (EMG di  ', 'intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea', 'dyspnoea and diaphragm electromyography (EMG di  ', 'submaximal dyspnoea unpleasantness', 'Diaphragm fatigue', 'Dyspnoea intensity and unpleasantness', 'Dyspnoea unpleasantness ratings', 'breathing unpleasantness ratings', 'Time-to-exhaustion', 'time-to-exhaustion', 'diaphragm fatigue (pre-DF) and (ii', 'peak unpleasantness and specific dyspnoea descriptor intensity ratings', 'intensity and unpleasantness of dyspnoea', 'dyspnoea intensity ratings']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282354', 'cui_str': 'Descriptor'}]",16.0,0.0454686,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"[{'ForeName': 'Kyle G', 'Initials': 'KG', 'LastName': 'Boyle', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Schaeffer', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}]",The Journal of physiology,['10.1113/JP279755']
505,32529353,Correction to: A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated inguinal hernia.,,2021,"The title ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia"" should have read ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated inguinal hernia.""","['total extra-peritoneal repair of uncomplicated inguinal hernia', 'total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia']",['triangular versus midline port placement'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.0462465,"The title ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated unilateral inguinal hernia"" should have read ""A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra‑peritoneal repair of uncomplicated inguinal hernia.""","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Awanish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India. awanishkr79@gmail.com.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Pal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Agrawal', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Harvinder S', 'Initials': 'HS', 'LastName': 'Pahwa', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}, {'ForeName': 'Abhinav A', 'Initials': 'AA', 'LastName': 'Sonkar', 'Affiliation': ""Department of General Surgery, King George's Medical University, Lucknow, UP, 226003, India.""}]",Surgical endoscopy,['10.1007/s00464-020-07693-3']
506,32519238,A comparative study of initial changes in pulpal blood flow between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.,"OBJECTIVES


To evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016 × 0.022 NiTi as alignment archwire.
MATERIALS AND METHODS


Twenty-two patients (16 females and 6 males) aged 19.00 ± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. The intervention (self-ligating brackets) was randomly allocated to the right or left side of the patient using the permuted random block size of 2 with 1:1 allocation ratio. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients. Two alignment archwires; 0.016″ NiTi and 0.016 × 0.022″ NiTi were used in this study. PBF was measured for the lower right and left sides using laser Doppler flowmetry at different time intervals (20 min, 24 h, 72 h, 1 week, and 1 month) RESULTS: PBF started to decrease 20 min after insertion of both archwires using both types of brackets. Maximum decrease was reached after 72 h of archwire insertion. After 1 week of force application, PBF started to increase to restore its original values after 1 month. Differences between the 2 groups were not significant (P > 0.05).
CONCLUSIONS


In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month. Changes in PBF at the measured time intervals in the two groups were similar.
CLINICAL RELEVANCE


The use of 0.016 × 0.022″ NiTi immediately after 0.016″ NiTi for alignment does not produce any damaging effect on the teeth.",2021,"In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month.",['Twenty-two patients (16 females and 6 males) aged 19.00 ± 2.53 years who presented with mild lower arch crowding were selected to participate in the study'],['conventional and self-ligating fixed orthodontic brackets'],"['pulpal blood flow', 'pulpal blood flow (PBF', 'PBF']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0085428', 'cui_str': 'Orthodontic bracket'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.026219,"In both treatment groups, PBF reduced within 48 h. PBF started to increase after 1 week until it reached its original values after 1 month.","[{'ForeName': 'Elham S', 'Initials': 'ES', 'LastName': 'Abu Alhaija', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan.'}, {'ForeName': 'Nessrin A', 'Initials': 'NA', 'LastName': 'Taha', 'Affiliation': 'Department of Conservative Dentistry, Faculty of Dentistry, Jordan University of Science and Technology, P.O. Box 3030, Irbid, Jordan. n.taha@just.edu.jo.'}]",Clinical oral investigations,['10.1007/s00784-020-03386-2']
507,32546491,Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.,"INTRODUCTION


Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices.
METHODS AND ANALYSIS


This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling.
ETHICS AND DISSEMINATION


The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences.
TRIAL REGISTRATION NUMBER


NCT04095338.",2020,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","['older people after hip fracture', '195 patients with hip fractures', 'elderly patients with hip fractures']","['innovative rehabilitation treatment', 'technology-assisted gait and balance training', 'traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View']","['risk of falling, gait performance and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",195.0,0.0345737,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy r.bevilacqua@inrca.it.'}]",BMJ open,['10.1136/bmjopen-2019-035508']
508,32532766,Effect of different communication strategies about stopping cancer screening on screening intention and cancer anxiety: a randomised online trial of older adults in Australia.,"OBJECTIVE


To assess different strategies for communicating to older adults about stopping cancer screening.
DESIGN


4 (recommendation statement about stopping screening)×(2; time) online survey-based randomised controlled trial.
SETTING


Australia.
PARTICIPANTS


271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade.
INTERVENTIONS


Time 1: participants read a scenario in which their general practitioner (GP) informed them about the potential benefits and harms of cancer screening, followed by double-blinded randomisation to one of four recommendation statements to stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively ('this test would not help you live longer') and negatively ('you may not live long enough to benefit'). Time 2: in a follow-up scenario, the GP explained why guidelines changed over time (anchoring bias intervention).
MEASURES


Primary outcomes: screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety), measured at both time points.
SECONDARY OUTCOMES


trust (in their GP, the information provided, the Australian healthcare system), decisional conflict and knowledge of the information presented.
RESULTS


271 participants' responses analysed. No main effects were found. However, screening intention was lower for the negatively framed life expectancy versus health status statement (6.0 vs 7.1, mean difference (MD)=1.1, p=0.049, 95% CI 0.0 to 2.2) in post hoc analyses. Cancer anxiety was lower for the negatively versus positively framed life expectancy statement (4.8 vs 5.8, MD=1.0, p=0.025, 95% CI 0.1 to 1.9). The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
CONCLUSION


Older adults may reduce their screening intention without reporting increased cancer anxiety when clinicians use a more confronting strategy communicating they may not live long enough to benefit and add an explicit explanation why the recommendation has changed.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001306202; Results).",2020,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","['Australia', '271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade', ""271 participants' responses analysed"", 'Older adults', 'older adults in Australia']","['communication strategies about stopping cancer screening', ""stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively""]","['Australian healthcare system), decisional conflict and knowledge of the information presented', 'screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety', 'screening intention and cancer anxiety', 'screening intention', 'Cancer anxiety', 'cancer anxiety']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",271.0,0.458737,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael H', 'Initials': 'RH', 'LastName': 'Dodd', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Hersch', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia jesse.jansen@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034061']
509,32532767,Does accreditation of general practice promote patient-reported quality of care? A natural cluster randomised experiment.,"OBJECTIVE


To investigate whether accreditation of general practice in Denmark promotes patient-reported quality of care and patient satisfaction.
DESIGN


A national cluster randomised case control study based on an online version of the Danish Patients Evaluate Practice questionnaire. Mixed effects ordered logit regression models taking account of clustering of patients in different municipalities were used in the analyses.
SETTING


General practice in Denmark.
PARTICIPANTS


A representative sample of the Danish population.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures.
RESULTS


In total, 3609 respondents answered the survey. We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04). However, there was a statistically significant negative relationship between patient satisfaction with the general practice and recent practice accreditation compared with satisfaction with practices not yet accredited (OR=0.81, 95% CI 0.67 to 0.97) but no significant relationship between patient satisfaction with the general practice and previous accreditation (OR=0.91, 95% CI 0.76 to 1.09).
CONCLUSION


Accreditation does not promote patient-reported quality of care or patient satisfaction. On the contrary, patient satisfaction with the general practice decreases when general practice is recently accredited.",2020,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","['A representative sample of the Danish population', 'General practice in Denmark', '3609 respondents answered the survey']",[],"['quality of care and practice accreditation', 'patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",3609.0,0.158256,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Riisgaard', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark hriisgaard@health.sdu.dk.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Kirstine Andersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034465']
510,32532781,Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study.,"INTRODUCTION


Data supports that motor skills are an underlying mechanism that influence physical activity along with perceived motor and physical competence, but the relationship between motor skills and physical activity during the early years is unclear. The goal of this study, Promoting Activity and Trajectories of Health (PATH) for Children, is to examine and compare the immediate (pre-test to post-test) and sustained (3-year follow-up) effect of an intervention on motor performance, physical activity and perceived physical competence to a control condition (ie, standard practice) in preschool-age children.
METHODS AND ANALYSIS


The PATH study is a two-cohort, randomised cluster clinical trial. 300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition. Each assessment involves a measure of motor skill performance; product and process, seven consecutive days of physical activity monitoring and perceived physical competence. These measures will be assessed before and after the intervention (pre-test to post-test) and then each academic year across 3 years, grades kindergarten, first grade and second grade (3-year follow-up). To assess the clustered longitudinal effect of the intervention on outcome measures, random-effects models (eg, mixed model regression, growth curve modelling and structural equation modelling) will be used. The PATH study addresses gaps in paediatric exercise science research. Findings hold the potential to help shape public health and educational policies and interventions that support healthy development and active living during the early years.
ETHICS AND DISSEMINATION


Ethical approval for this study was obtained through the Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan (HUM00133319). The PATH study is funded by the National Institutes of Health. Findings will be disseminated via print, online media, dissemination events and practitioner and/or research journals.
TRIAL REGISTRATION NUMBER


NHLBI ClinicalTrials.gov Identifier, NCT03189862. Registered 17 August 2017, https://clinicaltrials.gov/ct2/show/NCT03189862.",2020,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"['Registered 17 August 2017', 'n=153) or control (n=147) condition', 'preschool-age children', '300 children between the ages of  > 3.5 to 5 years of age']","['motor skills intervention', 'motor skill intervention']","['motor performance, physical activity and perceived physical competence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",300.0,0.0865729,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"[{'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA lerobin@umich.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'Department of Physical Education, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Ulrich', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037497']
511,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763']
512,32535703,"Diagnostic accuracy of periapical radiograph, cone beam computed tomography, and intrasurgical linear measurement techniques for assessing furcation defects: a longitudinal randomised controlled trial.","OBJECTIVES


The aim of this study was to evaluate the accuracy of cone beam computed tomography (CBCT), periapical radiograph, and intrasurgical linear measurements in the assessment of molars with furcation defects.
MATERIALS AND METHODS


This parallel, single-blinded, randomised controlled trial (RCT) consisted of 22 periodontitis patients who had molar with advanced furcation involvement (FI). All patients followed the same inclusion criteria and were treated following the same protocol, except for radiographic evaluation (CBCT vs. periapical). This study proposed and evaluated five parameters that represent the extent and severity of furcation defects in molars teeth, including CEJ-BD (clinical attachment loss), BL-H (depth), BL-V (height), RT (root trunk), and FW (width).
RESULTS


There were no statistically significant differences between CBCT and intrasurgical linear measurements for any clinical parameter (p > 0.05). However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars. Meanwhile, the sensitivity were 62.8% and 56.9% for CBCT and periapical, respectively.
CONCLUSIONS


Overall, when compared to the intrasurgical measurements, CBCT provided better diagnostic, sensitivity, and quantitative information on CAL, height, depth, and width of the furcation defects than periapical radiograph.
CLINICAL RELEVANCE


An accurate presurgical furcation diagnostic can guide the clinicians from the stage of diagnosis to definitive management so that unnecessary periodontal surgical interventions can be prevented.",2021,"However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars.","['22 periodontitis patients who had molar with advanced furcation involvement (FI', 'molars with furcation defects']","['periapical radiograph, cone beam computed tomography, and intrasurgical linear measurement techniques', 'cone beam computed tomography (CBCT), periapical radiograph, and intrasurgical linear measurements']","['CEJ-BD (clinical attachment loss), BL-H (depth), BL-V (height), RT (root trunk), and FW (width', 'BL-V measurements', 'diagnostic, sensitivity, and quantitative information on CAL, height, depth, and width of the furcation defects']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}]","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0227011', 'cui_str': 'Structure of cementoenamel junction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0206306', 'cui_str': 'Furcation Defects'}]",22.0,0.166803,"However, there were statistically significant differences in BL-V measurements (p < 0.05) between periapical and intrasurgical measurements in maxillary molars.","[{'ForeName': 'Nurul Ain Mohamed', 'Initials': 'NAM', 'LastName': 'Yusof', 'Affiliation': 'Center for Periodontology Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia. ainyusof12@yahoo.com.'}, {'ForeName': 'Erni', 'Initials': 'E', 'LastName': 'Noor', 'Affiliation': 'Center for Periodontology Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Nor Hidayah', 'Initials': 'NH', 'LastName': 'Reduwan', 'Affiliation': 'Center for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Mohd Yusmiaidil Putera Mohd', 'Initials': 'MYPM', 'LastName': 'Yusof', 'Affiliation': 'Center for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.'}]",Clinical oral investigations,['10.1007/s00784-020-03380-8']
513,32546490,"Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).","OBJECTIVE


To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study.
DESIGN


A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
SETTING


Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect.
PARTICIPANTS


180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91).
INTERVENTIONS


Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
MAIN OUTCOME MEASURES


Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER).
RESULTS


Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%.
CONCLUSIONS


Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02323412.",2020,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","['patients with chronic low back pain and Modic changes (AIM) study', '180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62', 'Hospital outpatient clinics at six hospitals in Norway', 'patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment', 'patients with chronic low back pain and Modic changes']","['Amoxicillin', 'placebo-control (n=91', 'amoxicillin', 'amoxicillin or placebo', 'antibiotics', 'antibiotic treatment', 'placebo']","['Cost-utility', 'Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss', 'Mean (SD) total cost', 'probability of amoxicillin being cost-effective', 'incremental cost-effectiveness ratio (ICER', 'healthcare consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0029916', 'cui_str': 'Hospital Outpatient Clinics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",180.0,0.51751,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","[{'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Research and Innovation, Oslo University Hospital, Oslo, Norway mgrotle@oslomet.no.'}, {'ForeName': 'Lars Christian', 'Initials': 'LC', 'LastName': 'Bråten', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Zinajda', 'Initials': 'Z', 'LastName': 'Zolic-Karlsson', 'Affiliation': 'Regional Research Support Services, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Munk Killingmo', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tingulstad', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wigemyr', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Clinic for Surgery and Neurology, FORMI, Oslo, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Department of Neurology and FORMI, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035461']
514,32546493,Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol.,"INTRODUCTION


The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.
METHODS AND ANALYSIS


We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks.
ETHICS AND DISSEMINATION


This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900028182; Pre-results.",2020,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","['70 patients with coronary heart disease (CHD', 'patients with coronary heart disease']","['Home-based CR (HBCR', 'IERMS intervention together with usual care for the first 6\u2009weeks and usual care for the last 6\u2009weeks, while patients assigned to group 2 will receive usual care for the first 6\u2009weeks and will use IERMS', 'Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR', 'intelligent exercise rehabilitation management system', 'cardiac rehabilitation (CR']","['exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors', 'adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors', 'adherence of cardiac rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]",70.0,0.0831069,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","[{'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Meidi', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China lifeng2912@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036720']
515,32557475,Educational nurse-led telephone intervention shortly before colonoscopy as a salvage strategy after previous bowel preparation failure: a multicenter randomized trial.,"BACKGROUND


The most important predictor of unsuccessful bowel preparation is previous failure. For those patients with previous failure, we hypothesized that a nurse-led educational intervention by telephone shortly before the colonoscopy appointment could improve cleansing efficacy.
METHODS


We performed a multicenter, endoscopist-blinded, randomized controlled trial. Consecutive outpatients with previous inadequate bowel preparation were enrolled. Both groups received the same standard bowel preparation protocol. The intervention group also received reinforced education by telephone within 48 hours before the colonoscopy. The primary outcome was effective bowel preparation according to the Boston Bowel Preparation Scale. Intention-to-treat (ITT) analysis included all randomized patients. Per-protocol analysis included patients who could be contacted by telephone and the control cases.
RESULTS


657 participants were recruited by 11 Spanish hospitals. In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12). In the intervention group, 267 patients (82.9 %) were contacted by telephone. Per-protocol analysis revealed significantly improved bowel preparation in the intervention group (83.5 % vs. 72.0 %;  P  = 0.001).
CONCLUSION


Among all patients with previous inadequate bowel preparation, nurse-led telephone education did not result in a significant improvement in bowel cleansing. However, in the 83 % of patients who could be contacted, bowel preparation was substantially improved. Phone education may therefore be a useful tool for improving the quality of bowel preparation in those cases.",2020,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","['patients who could be contacted by telephone and the control cases', 'Consecutive outpatients with previous inadequate bowel preparation were enrolled', '657 participants were recruited by 11 Spanish hospitals']","['Educational nurse-led telephone intervention shortly before colonoscopy', 'reinforced education by telephone', 'Intention-to-treat (ITT']","['bowel cleansing', 'rate of successful bowel preparation', 'effective bowel preparation according to the Boston Bowel Preparation Scale', 'bowel preparation', 'cleansing efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1446338', 'cui_str': 'Inadequate bowel preparation'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}]",657.0,0.27856,"In the ITT analysis, there was no significant difference between the intervention and control groups in the rate of successful bowel preparation (77.3 % vs. 72 %;  P  = 0.12).","[{'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Alvarez-Gonzalez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Pantaleón Sánchez', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Bernad Cabredo', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Rodríguez', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Frago Larramona', 'Affiliation': 'Department of Digestive Diseases, Hospital Santa Bárbara, Soria, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nogales', 'Affiliation': 'Department of Digestive Diseases, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Díez Redondo', 'Affiliation': 'Department of Digestive Diseases, Hospital del Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Puig Del Castillo', 'Affiliation': 'Department of Digestive Diseases, Altahia Xarxa Asistencial Universitaria de Manresa, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Romero Mascarell', 'Affiliation': 'Department of Digestive Diseases, Consorci Sanitari de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Caballero', 'Affiliation': 'Department of Digestive Diseases, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Romero Sánchez-Miguel', 'Affiliation': 'Department of Digestive Diseases, Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Pérez Berbegal', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Hernández Negrín', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Bujedo Sadornill', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Pérez Oltra', 'Affiliation': 'Department of Digestive Diseases, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Casals Urquiza', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Amorós Martínez', 'Affiliation': 'Open University of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Seoane Urgorri', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Inés Ana', 'Initials': 'IA', 'LastName': 'Ibáñez Zafón', 'Affiliation': 'Department of Digestive Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno-García', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario de Canarias, La Laguna, Spain.'}]",Endoscopy,['10.1055/a-1178-9844']
516,32533985,Do different culture intervals (2 × 24 hours) after thaw of cleavage stage embryos affect pregnancy rates? A randomized controlled trial.,"The aim of the study was to evaluate whether selecting embryos for transfer after prolonged culture after thaw (18-24 h) has better pregnancy rates than selecting embryos for transfer after short culture after thaw (2-5 h). We performed a double-blinded, randomized, controlled trial, evaluating 388 patients submitted to ART treatment who had embryos frozen on day-2 and subsequently transferred. All patients received the same endometrial priming with estradiol valerate followed by vaginal progesterone. Patients were randomized for Frozen embryo transfer 2-5 h after thaw (Group D2) or 18-24 h after thaw (Group D2/D3). The main Outcome Measure was ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer. A total of 179 patients had embryos transferred 2-5 h after thaw and 209 patients had embryos transferred 18-24 h after thaw. The mean age in group D2 was 36 ± 4.4 and 36 ± 5.4 in group D2/D3. Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively. These results suggest that increasing the culture time of embryos in one day to improve selection before transfer does not increase ongoing pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT03381001.",2020,"Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively.","['179 patients had embryos transferred 2-5\u202fh after thaw and 209 patients had embryos transferred 18-24\u202fh after thaw', '388 patients submitted to ART treatment who had embryos frozen on day-2 and subsequently transferred']",['estradiol valerate followed by vaginal progesterone'],"['pregnancy rates', 'culture time of embryos', 'ongoing pregnancy rate (OPR', 'Ongoing pregnancy rate']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",388.0,0.268769,"Ongoing pregnancy rate was 28% and 33.5% (p = 0.2) for groups D2 and D2/D3, respectively.","[{'ForeName': 'Laudislena', 'Initials': 'L', 'LastName': 'Colodetti', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Pinho de França', 'Affiliation': 'ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sampaio', 'Affiliation': 'ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil.'}, {'ForeName': 'Selmo', 'Initials': 'S', 'LastName': 'Geber', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; ORIGEN - Centre for Reproductive Medicine, Belo Horizonte, Brazil. Electronic address: selmogeber@origen.com.br.'}]",Cryobiology,['10.1016/j.cryobiol.2020.06.002']
517,32530769,International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct.,"PURPOSE


To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naïve advanced anal cancer to establish the optimal regimen.
PATIENTS AND METHODS


Patients who had not received systemic therapy for advanced anal cancer were randomly assigned 1:1 to intravenous cisplatin 60 mg/m 2  (day 1) plus FU 1,000 mg/m 2  (days 1-4) every 21 days or carboplatin (area under the curve, 5; day 1) plus paclitaxel 80 mg/m 2  (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. Primary end point was objective response rate (ORR). Primary and secondary end points were assessed in a hierarchic model to compare the regimens and pick the winner.
RESULTS


We conducted an international multicenter randomized phase II study in 60 centers between December 2013 and November 2017. Median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin plus FU and 45 to carboplatin plus paclitaxel. ORR was 57% (95% CI, 39.4% to 73.7%) for cisplatin plus FU versus 59% (95% CI, 42.1% to 74.4%) for carboplatin plus paclitaxel. More serious adverse events were noted in the cisplatin plus FU arm (62%) compared with the carboplatin plus paclitaxel arm (36%;  P  = .016). Median progression-free survival was 5.7 months (95% CI, 3.3 to 9.0 months) for cisplatin plus FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin plus paclitaxel. Median overall survival was 12.3 months for cisplatin plus FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin plus paclitaxel (hazard ratio, 2.00; 95% CI, 1.15 to 3.47;  P  = .014).
CONCLUSION


This is the first international randomized trial to our knowledge conducted in chemotherapy-naïve advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.",2020,Median overall survival was 12.3 months for cisplatin plus FU,"['60 centers between December 2013 and November 2017', 'Advanced Anal Cancer', 'International Rare Cancers Initiative', 'A total of 91 patients were randomly assigned: 46 to', 'chemotherapy-naïve advanced anal cancer', 'Patients who had not received systemic therapy for advanced anal cancer']","['paclitaxel', 'cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel', 'carboplatin', 'carboplatin plus paclitaxel', 'cisplatin plus FU', 'Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel', 'intravenous cisplatin 60 mg/m 2  (day 1) plus FU 1,000 mg/m 2', 'cisplatin plus FU and 45 to carboplatin plus paclitaxel']","['Median overall survival', 'Median progression-free survival', 'objective response rate (ORR', 'toxicity', 'ORR', 'hierarchic model to compare the regimens and pick the winner', 'serious adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153446', 'cui_str': 'Malignant tumor of anus'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",91.0,0.183791,Median overall survival was 12.3 months for cisplatin plus FU,"[{'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sclafani', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Adams', 'Affiliation': 'Velindre Cancer Centre, Cardiff, Wales.'}, {'ForeName': 'Marianne G', 'Initials': 'MG', 'LastName': 'Guren', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Segelov', 'Affiliation': 'Monash Health and Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Amitesh', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Matt T', 'Initials': 'MT', 'LastName': 'Seymour', 'Affiliation': 'Leeds Cancer Centre, Leeds, United Kingdom.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Welch', 'Affiliation': 'National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Cancer Centre, Manchester, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Dwyer"", 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Shree', 'Initials': 'S', 'LastName': 'Bhide', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Hamburg University Medical Centre, Hamburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03266']
518,32540887,"Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial.","INTRODUCTION


Labour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.
METHODS AND ANALYSIS


This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.
TRIAL REGISTRATION NUMBER


ISRCTN87414969, registered 3 May 2019.",2020,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"['Eligible and consenting patients', 'primigravidae during the first stage of labour in Saudi Arabia', 'labour experiences of primigravidae', 'Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM', 'Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics']","['breathing exercises, foot reflexology and back massage (BRM', 'BRM and standard labour care, and a control group receiving only standard labour care', 'pethidine']","['labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6\u2009cm) and post BRM hourly for 2\u2009hours', 'maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction', 'mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively', 'labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.157332,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"[{'ForeName': 'Kamilya Jamel', 'Initials': 'KJ', 'LastName': 'Baljon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Muhammad Hibatullah', 'Initials': 'MH', 'LastName': 'Romli', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Adibah Hanim', 'Initials': 'AH', 'LastName': 'Ismail', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Khuan', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Boon How', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia chewboonhow@upm.edu.my.'}]",BMJ open,['10.1136/bmjopen-2019-033844']
519,32556659,"Effectiveness of a nutraceutical agent in the non-surgical periodontal therapy: a randomized, controlled clinical trial.","OBJECTIVE


Nutraceutical agents have been demonstrated as adjuncts for the treatment of several inflammatory diseases. The present study analyzed and compared new nutraceutical agent as an adjunct to Scaling and root planing (SRP) versus SRP alone for the treatment of periodontitis.
MATERIALS AND METHODS


Sixty-six patients with moderate periodontitis were enrolled. Through a randomized design, the patients were randomly assigned to SRP + nutraceutical agent (test group) or SRP alone (control group). Patients were regularly examined the clinical, inflammatory mediators and visual analogue scale (VAS) changes over a 6-month period. Clinical attachment level (CAL) was the primary outcome variable chosen. Gingival crevicular fluid (GCF) inflammatory mediator change and the impact of treatment on VAS were evaluated through a linear regression model.
RESULTS


Both treatments demonstrated an improvement in periodontal parameters compared with baseline. After 6 months of treatment, compared with the control group, the test group determined a significant probing depth (PD) (p = 0.003) and bleeding on probing (BOP) reduction (p < 0.001), while CAL gain was significantly obtained at 30 and 60 days after treatment (p < 0.05). In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05). The linear regression analysis demonstrated that the nutraceutical agent exerted, in the test group, a significant influence on VAS at 6, 12, 24, and 48 h after treatment (p < 0.05).
CONCLUSIONS


Nutraceutical agent resulted in a more significant reduction in clinical, inflammatory mediators and short-term pain compared with SRP alone.
CLINICAL RELEVANCE


Nutraceutical agent, when combined with SRP, was demonstrated to be effective in reducing periodontal parameters and controlling the levels of inflammatory mediators and pain in patients with periodontitis.",2021,"In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05).","['Sixty-six patients with moderate periodontitis were enrolled', 'patients with periodontitis']","['nutraceutical agent', 'SRP + nutraceutical agent (test group) or SRP alone (control group', 'Scaling and root planing (SRP) versus SRP alone']","['level of inflammatory mediators', 'CAL gain', 'significant probing depth (PD', 'bleeding on probing (BOP) reduction', 'periodontal parameters', 'clinical, inflammatory mediators and visual analogue scale (VAS) changes', 'VAS', 'Gingival crevicular fluid (GCF) inflammatory mediator change', 'clinical, inflammatory mediators and short-term pain', 'Clinical attachment level (CAL']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.054188,"In the test group, the level of inflammatory mediators was significantly reduced compared with the control group (p < 0.05).","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy. gaetano.isola@unict.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Polizzi', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples ""Federico II"", Via G. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Alibrandi', 'Affiliation': 'Department of Economics, Unit of Statistical and Mathematical Sciences, University of Messina, Piazza Pugliatti 1, Messina, 98123, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples ""Federico II"", Via G. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Leonardi', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, University of Catania, Via S. Sofia 78, 95123, Catania, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03397-z']
520,32553394,ECT non-remitters: prognosis and treatment after 12 unilateral electroconvulsive therapy sessions for major depression.,"BACKGROUND


Depressive disorder causes significant suffering in patients and caregivers worldwide. Electroconvulsive therapy (ECT) is a highly effective antidepressant treatment, but little is known about the prognosis and treatment of patients who do not achieve remission with ECT. We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
METHODS


We conducted a retrospective, naturalistic follow-up study. Patients who had previously participated in a double-blind randomized controlled trial that compared brief pulse with ultra-brief pulse ECT and who had not achieved remission after 12 right unilateral (RUL) ECT sessions were selected for this study. We analysed the type of treatments received during the 6-month follow-up and studied the occurrence of remission and response. The primary outcome was remission, defined as a Montgomery-Åsberg Depression Rating Scale score <10.
RESULTS


Eighty-one patients were randomized, of which 18 patients did not remit. Eight of these non-remitters achieved remission during follow-up (44.4%) while 7 did not achieve remission (38.9%). Remission data could not be retrieved for 3 patients (16.7%). Remission was achieved in 6 patients by a combination of continuing unilateral ECT with antidepressants or switching to bilateral ECT.
LIMITATIONS


This is a retrospective study with only a small number of patients. Treatment after RUL ECT non-remission was not standardized.
CONCLUSION


When patients with major depression do not achieve remission after 12 RUL ECT sessions, they have still a reasonable chance of remission within 6 months. Continuing ECT has the best chance of success.",2020,"We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
","['Patients who had previously participated', 'Eighty-one patients were randomized, of which 18 patients did not remit', 'patients with major depression', 'patients who do not achieve remission with ECT', 'patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions']","['unilateral electroconvulsive therapy sessions', 'ECT', 'RUL ECT', 'Electroconvulsive therapy (ECT', 'brief pulse with ultra-brief pulse ECT and who had not achieved remission after 12 right unilateral (RUL) ECT sessions']","['remission', 'remission, defined as a Montgomery-Åsberg Depression Rating Scale score <10', 'Remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}]","[{'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0444804', 'cui_str': 'Brief pulse'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",81.0,0.162101,"We investigated prognosis and treatment of patients with major depression who did not achieve remission after 12 unilateral electroconvulsive therapy sessions.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Duist', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Spaans', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Verwijk', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands; Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands; Department of Medical Psychology, Amsterdam Unversity Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Kok', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands. Electronic address: r.kok@parnassia.nl.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.134']
521,32569429,A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome.,"OBJECTIVES


Patients with cannabinoid hyperemesis syndrome (CHS) present frequently to the emergency department. Previous case studies suggest dramatic symptomatic improvement with topical capsaicin treatment. This exploratory study examined the potential effectiveness of topical capsaicin in patients with nausea and vomiting due to a suspected CHS exacerbation.
METHODS


This was a double-blind, randomized placebo-controlled pilot trial. Adults who presented with vomiting suspected to be from CHS were eligible for enrollment. We excluded pregnant women and those with resolution of symptoms. Following randomization, topical 0.1% capsaicin or placebo cream was applied to the anterior abdomen in a uniform manner. The primary outcome was the severity of nausea on a visual analog scale (VAS) of 0 to 10 cm assessed at 30 minutes. Secondary outcomes were adverse events, occurrence of posttreatment vomiting, nausea by VAS at 60 minutes, and hospital admission.
RESULTS


This pilot trial enrolled 30 patients, 17 in the capsaicin arm and 13 in the placebo arm. One patient in the capsaicin arm did not tolerate treatment due to skin irritation. Mean ± SD nausea severity at 30 minutes was 4.1 ± 2.3 cm in the capsaicin arm and 6.1 ± 3.3 cm in the placebo arm (difference = -2.0 cm, 95% confidence interval [CI] = 0.2 to -4.2 cm). At 60 minutes, mean ± SD nausea severity was 3.2 ± 3.2 cm versus 6.4 ± 2.8 cm (difference = -3.2 cm, 95% CI = -0.9 to -5.4 cm). The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference = 21.1%, 95% CI = -5.6% to 47.9%). A higher proportion of capsaicin group patients (29.4% vs. 0%) had complete resolution of nausea (relative risk = 3.4, 95% CI = 1.6 to 7.1).
CONCLUSION


In this pilot trial, the application of topical capsaicin cream was associated with a significant reduction in nausea at 60 minutes but not at 30 minutes and provided more complete relief of nausea.",2020,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","['Adults who presented with vomiting suspected to be from CHS were eligible for enrollment', 'patients with nausea and vomiting due to a suspected CHS exacerbation', 'pregnant women and those with resolution of symptoms', '30 patients; 17 in the capsaicin arm and 13 in the placebo arm', 'Patients with cannabinoid hyperemesis syndrome (CHS', 'Cannabinoid Hyperemesis Syndrome']","['Topical Capsaicin Cream', 'topical capsaicin', 'topical 0.1% capsaicin or placebo cream', 'topical capsaicin cream', 'capsaicin', 'placebo']","['skin irritation', 'severity of nausea on a visual analog scale (VAS) of 0-10 cm assessed at 30 minutes', 'Mean nausea severity', 'complete resolution of nausea', 'complete relief of nausea', 'nausea', 'adverse events, occurrence of post-treatment vomiting, nausea by VAS at 60 minutes, and hospital admission', 'mean nausea severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",30.0,0.533538,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Dean', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Sabagha', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'France', 'Affiliation': 'the, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Asmar', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Rammal', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Beyer', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bussa', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaleem', 'Initials': 'K', 'LastName': 'Chaudhry', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smoot', 'Affiliation': 'and the, Frederick Memorial Hospital, Frederick, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14062']
522,32554724,Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.,"INTRODUCTION


Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
METHODS AND ANALYSIS


This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.
ETHICS AND DISSEMINATION


The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03335189.",2020,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","['114 patients will be recruited in oncology clinics prior to initiation of chemotherapy', 'patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre']",['remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can'],"['symptom severity, emotional distress, quality of life and acceptability', 'Feasibility metrics (recruitment, retention and protocol adherence']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",114.0,0.0743316,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Moradian', 'Affiliation': 'School of Nursing, York University Faculty of Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Krzyzanowska', 'Affiliation': 'University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Maguire', 'Affiliation': 'University of Strathclyde Department of Computer and Information Sciences, Glasgow, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kukreti', 'Affiliation': 'Division of Medical Oncology and Hematology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Amir', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Plinio P', 'Initials': 'PP', 'LastName': 'Morita', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University Health Network and Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Howell', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada doris.howell@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035648']
523,32554725,Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study.,"OBJECTIVES


To design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer.
SETTING


Single-centre feasibility study.
PARTICIPANTS


Patients with stage IV lung cancer in antineoplastic treatment.
INTERVENTIONS


This study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses.
PRIMARY OUTCOME MEASURES


The study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance.
RESULTS


In phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable.
CONCLUSIONS


An electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial.
TRIAL REGISTRATION NUMBER


NCT03529851.",2020,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","['patients with metastatic lung cancer', 'Patients with stage IV lung cancer in antineoplastic treatment', '18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed']",['Electronic symptom monitoring'],"['usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance', 'feasibility, usability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0855005', 'cui_str': 'Lung carcinoma cell type unspecified stage IV'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",29.0,0.0401048,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","[{'ForeName': 'Rasmus Blechingberg', 'Initials': 'RB', 'LastName': 'Friis', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark rasfri@rm.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hjollund', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Caroline Trillingsgaard', 'Initials': 'CT', 'LastName': 'Mejdahl', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035673']
524,32560926,Accuracy of diagnostic judgments using ICD-11 vs. ICD-10 diagnostic guidelines for obsessive-compulsive and related disorders.,"BACKGROUND


We report results of an internet-based field study evaluating the diagnostic guidelines for the newly introduced ICD-11 grouping of obsessive-compulsive and related disorders (OCRD). We examined accuracy of clinicians' diagnostic judgments applying draft ICD-11 as compared to the ICD-10 diagnostic guidelines to standardized case vignettes.
METHODS


1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish. Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
RESULTS


Participants using ICD-11 outperformed those using ICD-10 in correctly identifying newly introduced OCRD, although results were mixed for differentiating OCRD from disorders in other groupings largely due to clinicians having difficulty differentiating challenging presentations of OCD. Clinicians had difficulty applying a three-level insight qualifier, although the 'poor to absent' level assisted with differentiating OCRD from psychotic disorders. Brief training on the rationale for an OCRD grouping did not improve diagnostic accuracy suggesting sufficient detail of the proposed guidelines.
LIMITATIONS


Standardized case vignettes were manipulated to include specific characteristics; the degree of accuracy of clinicians' diagnostic judgments about these vignettes may not generalize to application in routine clinical practice.
CONCLUSIONS


Overall, use of the ICD-11 guidelines resulted in more accurate diagnosis of case vignettes compared to the ICD-10 guidelines, particularly in differentiating OCRD presentations from one another. Specific areas in which the ICD-11 guidelines did not perform as intended provided the basis for further revisions to the guidelines.",2020,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
","[""1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish""]","['ICD-11 vs. ICD-10 diagnostic guidelines', 'ICD-11 or ICD-10 guidelines']",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0035967', 'cui_str': 'Russian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C4704940', 'cui_str': 'ICD-11'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]",[],1717.0,0.0236793,"Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes.
","[{'ForeName': 'Cary S', 'Initials': 'CS', 'LastName': 'Kogan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: ckogan@uottawa.ca.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'SAMRC Unit on Risk & Resilience in Mental Disorders, University of Cape Town Dept of Psychiatry & Neuroscience Institute, Groote Schuur Hospital, J-Block, Anzio Road, Observatory 7925, Cape Town, South Africa. Electronic address: dan.stein@uct.ac.za.'}, {'ForeName': 'Tahilia J', 'Initials': 'TJ', 'LastName': 'Rebello', 'Affiliation': 'Global Mental Health Program, Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, Mailman School of Public Health, 722 West 168th, Floor R2, R-233, New York, NY 10032, USA. Electronic address: Tahilia.Rebello@nyspi.columbia.edu.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Keeley', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, 806 West Franklin St, Box 842018, Richmond, VA 23284, USA. Electronic address: jwkeeley@vcu.edu.'}, {'ForeName': 'K Jacky', 'Initials': 'KJ', 'LastName': 'Chan', 'Affiliation': 'School of Psychology, Faculty of Social Sciences, 136 Jean-Jacques Lussier, Vanier Hall, Ottawa, ON K1N 6N5, Canada. Electronic address: jacky.chan@uottawa.ca.'}, {'ForeName': 'Naomi A', 'Initials': 'NA', 'LastName': 'Fineberg', 'Affiliation': 'Highly Specialized Obsessive Compulsive and Related Disorders Service, Hertfordshire Partnership University NHS Foundation Trust, Rosanne House, Welwyn Garden City, UK; Postgraduate Medical School, University of Hertfordshire, Hatfield, UK; University of Cambridge School of Clinical Medicine, Cambridge, UK. Electronic address: naomi.fineberg@btinternet.com.'}, {'ForeName': 'Leonardo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil; ""D\'Or\' Institute for Research and Education, Rio de Janeiro, RJ, Brazil; School of Psychological Sciences, Monash University, Melbourne, Australia. Electronic address: lfontenelle@gmail.com.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Grant', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA. Electronic address: jgrant4@bsd.uchicago.edu.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Matsunaga', 'Affiliation': 'Department of Neuropsychiatry, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya Hyogo, Japan. Electronic address: hisa1311@hyo-med.ac.jp.'}, {'ForeName': 'H Blair', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': 'College of Physicians and Surgeons, Columbia University, New York, NY, USA; Anxiety Disorders Clinic and the Center for OCD and Related Disorders, New York State Psychiatric Institute, New York, NY, USA. Electronic address: hbs1@columbia.edu.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Department for Child and Adolescent Psychiatry, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: per.hove.thomsen@ps.rm.dk.'}, {'ForeName': 'Odile A', 'Initials': 'OA', 'LastName': 'van den Heuvel', 'Affiliation': 'Amsterdam University Medical Centers, Vrije Universiteit, Department of Psychiatry and Department of Anatomy & Neurosciences, Amsterdam Neuroscience, Amsterdam, the Netherlands. Electronic address: oa.vandenheuvel@amsterdamumc.nl.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veale', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Center for Anxiety Disorders and Trauma, South London and Maudsley NHS Foundation Trust, London, UK. Electronic address: david.veale@kcl.ac.uk.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Grenier', 'Affiliation': ""Institut du Savoir Montfort - Hôpital Montfort and Université d'Ottawa, Ottawa, Ontario, Canada. Electronic address: jeangrenier@montfort.on.ca.""}, {'ForeName': 'Mayya', 'Initials': 'M', 'LastName': 'Kulygina', 'Affiliation': 'Alekseev Mental Health Clinic, No. 1, Education Centre, Moscow, Russian Federation. Electronic address: mkulygina@yandex.ru.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'National Study Coordinator for ICD-11 Field Studies, ICD-11 Committee, Japanese Society of Psychiatry and Neurology, Hongo-Yumicho Building, 2-38-4, Hongo, Bunkyo-ku, Tokyo 113-0033. Japan. Electronic address: c.matsumoto@outlook.jp.'}, {'ForeName': 'Tecelli', 'Initials': 'T', 'LastName': 'Domínguez-Martínez', 'Affiliation': 'Center for Research on Global Mental Health, Direction of Epidemiology and Psychosocial Research, National Institute of Psychiatry ""Ramón de la Fuente Muñiz"", Mexico City, Mexico. Electronic address: tecelli.dominguez@gmail.com.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Stona', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, 11 Mandalay Road, Singapore. Electronic address: anne.claire.s@gmail.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 Wan Ping Nan Road, Shanghai 200030, PR China. Electronic address: wangzhen@smhc.org.cn.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Reed', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 1051 Riverside Drive, New York, NY \xa010032, USA; Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland. Electronic address: gmr2142@cumc.columbia.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.103']
525,32560932,Vascular endothelial growth factor and pigment epithelial-derived factor in the peripheral response to ketamine.,"BACKGROUND


Ketamine is a rapid-acting antidepressant but its mechanism remains unclear. Vascular endothelial growth factor growth factor (VEGF) has been reported in the antidepressant action of ketamine in rodents. VEGF and pigment epithelial-derived factor (PEDF) signalling are closely linked and both are dysregulated in depression. We explored the effect of a single infusion of ketamine, with midazolam as comparison, on peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio, in patients with depression.
METHODS


Twenty-five patients with depression were randomised to either ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) infusions over 40 min. Blood plasma samples were taken 1 h before the first infusion and 4 h after the infusion start. mRNA was extracted and qRT-PCR performed to analyse gene expression.
RESULTS


Single infusions of ketamine and midazolam both decreased depression scores (F(1,21) = 102.40, p < 0.000). There was a significant group × time interaction for VEGFA mRNA levels (F(1, 21) = 5.207, p = 0.029), with ketamine increasing VEGFA levels. There was no significant effect of either ketamine or midazolam on PEDF levels. There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
LIMITATIONS


Patients were on psychotropic medication and continued treatment as usual throughout the study.
CONCLUSIONS


These preliminary results support a role for VEGF in the action of ketamine and suggest a novel role for VEGF/PEDF in the molecular response to ketamine.",2020,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
","['patients with depression', 'Twenty-five patients with depression', 'Patients were on psychotropic medication and continued treatment as usual throughout the study']","['ketamine and midazolam', 'ketamine', 'Ketamine', 'midazolam']","['time interaction for VEGFA/PEDF mRNA ratio', 'time interaction for VEGFA mRNA levels', 'depression scores (F(1,21)\xa0', 'PEDF levels', 'peripheral whole blood mRNA levels of vascular endothelial growth factor A (VEGFA) and PEDF, and the VEGFA/PEDF ratio', 'VEGFA levels', 'Blood plasma samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C3874456', 'cui_str': 'On psychotropic medication'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",25.0,0.0481452,"There was a significant group × time interaction for VEGFA/PEDF mRNA ratio, with ketamine alone increasing this ratio (F(1, 11) = 12.085, p = 0.005).
","[{'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'McGrory', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Ryan', 'Affiliation': ""Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin 2, Ireland; Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Gallagher', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Department of Psychiatry, Trinity College Dublin, St Patrick's University Hospital, Dublin 8, Ireland. Electronic address: d.mcloughlin@tcd.ie.""}]",Journal of affective disorders,['10.1016/j.jad.2020.04.013']
526,32560938,Depression prevention in digital cognitive behavioral therapy for insomnia: Is rumination a mediator?,"Background There has been growing support for digital Cognitive Behavioral Therapy (dCBT-I) as a scalable intervention that both reduces insomnia and prevents depression. However, the mechanisms by which dCBT-I reduces and prevents depression is less clear. Methods This was a randomized controlled trial with two parallel arms: dCBT-I (N=358), or online sleep education as the control condition (N=300). Outcome variables were measured at pre-treatment, post-treatment, and one-year follow-up, and included the Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ). The analyses tested change in PTQ scores as a mediator for post-treatment insomnia, post-treatment depression, and incident depression at one-year follow-up. Results Reductions in rumination (PTQ) were significantly larger in the dCBT-I condition compared to control. Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition. Finally, reductions in rumination also significantly mediated the prevention of clinically significant depression via dCBT-I (proportional effect = 42%). Limitations Depression was measured with a validated self-report instrument instead of clinical interviews. Durability of results beyond one-year follow-up should also be tested in future research. Conclusions Results provide evidence that rumination is an important mechanism in how dCBT-I reduces and prevents depression.",2020,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,['insomnia'],"['digital cognitive behavioral therapy', 'dCBT-I (N=358), or online sleep education']","['rumination (PTQ', 'rumination', 'PTQ scores', 'post-treatment insomnia severity', 'Insomnia Severity Index (ISI), the Quick Inventory of Depressive Symptomatology (QIDS-SR 16 ), and the Perseverative Thinking Questionnaire (PTQ', 'Limitations Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0526111,Results also showed that reductions in rumination significantly mediated the improvement in post-treatment insomnia severity (proportional effect = 11%) and post-treatment depression severity (proportional effect = 19%) associated with the dCBT-I condition.,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States. Electronic address: pcheng1@hfhs.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Andrea Cuamatzi', 'Initials': 'AC', 'LastName': 'Castelan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Nimalan', 'Initials': 'N', 'LastName': 'Murugan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, 2779 West Grant Blvd, Detroit, MI, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.184']
527,32560956,Cognitive remediation for the treatment of neuropsychological disturbances in subjects with euthymic bipolar disorder: findings from a controlled study.,"INTRODUCTION


Individuals with euthymic Bipolar Disorder (BD) can experience deteriorated cognitive functioning, with such deterioration being associated with functional impairment. Cognitive remediation (CR) is considered an effective add-on intervention for neuropsychological impairments, but relatively few CR controlled studies have been performed on BD. In the present study the efficacy of a CR intervention designed for the improvement of cognition and functioning in patients with euthymic BD was tested.
METHODS


Patients (n = 54) with euthymic BD were assigned to receive active (n = 27) or control (n = 27) intervention. The active intervention (i.e. the Cognitive Remediation in Integrated Treatment - CRIIT - protocol) was made of 20 individual sessions focused on the treatment of attention, memory and executive functioning through the COGPACK software; each session was integrated with psychoeducation and rehabilitation interventions implemented through a metacognitive approach aimed at ameliorating personal agency.
RESULTS


A significant (p ≤ 0.015) time x group interaction at repeated measures MANOVA was observed on Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale.
LIMITATIONS


A single-blind approach was used.
DISCUSSION


The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions. This study adds to the evidence that CR improves neurocognition in BD, and suggests that CRIIT protocol represents an add-on intervention of potential relevance to increase cognition and functioning in BD euthymic patients.",2020,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","['Individuals with euthymic Bipolar Disorder (BD', 'subjects with euthymic bipolar disorder', 'Patients (n\xa0', 'patients with euthymic BD']","['Cognitive remediation (CR', 'euthymic BD', 'Cognitive remediation', 'CR intervention']","['Rey Auditory Verbal Learning Test, Rey Complex Figure Test, Wisconsin Card Sorting Test, Trail Making Test, Visual Search, Life Skills Profile, and Barratt Impulsiveness Scale', 'executive functions, attention, memory, functioning and impulsivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0589103', 'cui_str': 'Rey complex figure test'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]",54.0,0.0233267,"The results showed that patients undergoing active intervention improved in domains related to executive functions, attention, memory, functioning and impulsivity more significantly than patients undergoing control interventions.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bernabei', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy; Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy. Electronic address: laura.bernabei@uniroma1.it.""}, {'ForeName': 'Francesco Saverio', 'Initials': 'FS', 'LastName': 'Bersani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy. Electronic address: francescosaverio.bersani@uniroma1.it.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Pompili', 'Affiliation': 'Department of Mental Health, ASL Roma 5, Colleferro, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Delle Chiaie', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Valente', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Corrado', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Vergnani', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferracuti', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Biondi', 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}, {'ForeName': 'Maria Antonietta', 'Initials': 'MA', 'LastName': ""Coccanari de'Fornari"", 'Affiliation': ""Department of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome 00185, Italy.""}]",Journal of affective disorders,['10.1016/j.jad.2020.05.073']
528,32565477,Is virtual reality effective to teach prevention of surgical site infections in the operating room? study protocol for a randomised controlled multicentre trial entitled VIP Room study.,"INTRODUCTION


Some surgical site infections (SSI) could be prevented by following adequate infection prevention and control (IPC) measures. Poor compliance with IPC measures often occurs due to knowledge gaps and insufficient education of healthcare professionals. The education and training of SSI preventive measures does not usually take place in the operating room (OR), due to safety, and organisational and logistic issues. The proposed study aims to compare virtual reality (VR) as a tool for medical students to learn the SSI prevention measures and adequate behaviours (eg, limit movements…) in the OR, to conventional teaching.
METHODS AND ANALYSIS


This protocol describes a randomised controlled multicentre trial comparing an educational intervention based on VR simulation to routine education. This multicentre study will be performed in three universities: Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany). Third-year medical students of each university will be randomised in two groups. The students randomised in the intervention group will follow VR teaching. The students randomised in the control group will follow a conventional education programme. Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups. The written exam will be the same in the three countries. Secondary outcomes will be satisfaction and students' progression for the VR group. The data will be analysed with intention-to-treat and per protocol.
ETHICS AND DISSEMINATION


This study has been approved by the Medical Education Ethics Committee of the London Imperial College (MEEC1920-172), by the Ethical Committee for the Research of Grenoble Alpes University (CER Grenoble Alpes-Avis-2019-099-24-2) and by the Ethics Committee of the Medical Faculty of Heidelberg University (S-765/2019). Results will be published in peer-reviewed medical journals, communicated to participants, general public and all relevant stakeholders.",2020,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"['Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany', 'medical students', 'three universities', 'Third-year medical students of each university']","['conventional education programme', 'educational intervention based on VR simulation to routine education', 'virtual reality (VR']","[""satisfaction and students' progression""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0677448,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Birgand', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Vanessa Maria', 'Initials': 'VM', 'LastName': 'Eichel', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Comte', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Terrisse', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Rubens-Duval', 'Affiliation': 'Department of Orthopaedic Surgery and Sport Traumatology, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gillois', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Albaladejo', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Picard', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Nico Tom', 'Initials': 'NT', 'LastName': 'Mutters', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Landelle', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France caroline.landelle@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-037299']
529,32565480,Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Chronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%-30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH.
METHODS AND ANALYSIS


This is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
ETHICS AND DISSEMINATION


The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT04203550.",2020,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
",['after evacuation of chronic subdural haematoma (FINISH'],"['CSDH with intraoperative irrigation and evacuation of CSDH without irrigation', 'intraoperative irrigation versus drain alone', 'intraoperative irrigation and subdural drainage']","['modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH', 'reoperation rates', 'recurrence rates', 'symptomatic CSDH recurrence requiring reoperation']","[{'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C1706059', 'cui_str': 'Finish'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.264025,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
","[{'ForeName': 'Pihla', 'Initials': 'P', 'LastName': 'Tommiska', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland rahul.raj@helsinki.fi.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Kivisaari', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Luostarinen', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Satopää', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Clinical Sciences, Lunds Universitet, Lund, Sweden.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Frantzen', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Posti', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teemu M', 'Initials': 'TM', 'LastName': 'Luoto', 'Affiliation': 'Department of Neurosurgery, Tampere University Hospital and Tampere University, Tampere, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Leinonen', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Tetri', 'Affiliation': 'Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Koivisto', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Lönnrot', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}]",BMJ open,['10.1136/bmjopen-2020-038275']
530,32565482,Health impacts of seated arm ergometry training in patients with a diabetic foot ulcer: protocol for a randomised controlled trial.,"INTRODUCTION


Once diagnosed with a diabetic foot ulcer (DFU), patients are advised to offload, keeping pressure off the foot in order to facilitate ulcer healing. An increase in offloading is often accompanied by reductions in physical activity which can worsen the overall health of patients.While unable to perform traditional forms of upright activity, one mode of exercise that would allow patients to be physically active while adhering to offloading instruction is seated arm ergometry. The merits of tailored aerobic exercise in DFU remain unexplored.
METHODS AND ANALYSIS


This is a prospective open-label randomised controlled trial. Participants will be randomised to one of two groups, an exercise intervention group or control. The intervention group are required to undertake arm ergometry training at a moderate intensity (65%-75% HRpeak), three times per week for 12 weeks as individually prescribed by an exercise physiologist, while the control group will continue to receive standard care alone. Assessment of outcome measures will occur at baseline and after the intervention period, these will include: a seated VO 2  peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires. The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively. Ulcer area will also be measured as an approximate marker of ulcer healing.
ETHICS AND DISSEMINATION


This trial has been approved by 'Yorkshire & The Humber-Leeds West Research Ethics Committee' (19/YH/0269). Trial results will be published in peer-reviewed journals and through conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN16000053. Registered in accordance with WHO Trial Registration Data Set (version 1.3.1).",2020,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.",['patients with a diabetic foot ulcer'],"['seated arm ergometry training', 'exercise intervention group or control', 'undertake arm ergometry training', 'standard care alone', 'tailored aerobic exercise']","['cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life', 'seated VO 2  peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.117669,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK mm636@le.ac.uk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Game', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039062']
531,32569102,Effects of Massage on Post-Operative Pain in Infants with Complex Congenital Heart Disease.,"BACKGROUND


Pain management is an essential component of care for pediatric patients following surgery. Massage reduces self-reported post-operative pain in adults with heart disease but has received little attention in post-operative pediatric patients with congenital heart disease (CCHD).
OBJECTIVES


To evaluate the effectiveness of massage compared to a rest period on post-operative pain scores and physiologic responses in infants with CCHD.
METHODS


We used a two-group randomized clinical trial design with a sample of 60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. Group 1 received a daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, GLMM repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
RESULTS


Adjusted pain scores were lower for the massage group on all days except day 7. Overall there were no group effects on level of pain or differential rate of change in pain. However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR. There was little difference between groups in SpO2. Infants demonstrated immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing.
DISCUSSION


This study provides beginning evidence that post-operative massage may reduce pain and improve physiologic parameters in infants with congenital heart disease. This non-pharmacological adjunct to pain management may provide a particular benefit for this population by reducing demand on the cardiorespiratory system.",2020,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","['infants with CCHD', 'adults with heart disease', 'pediatric patients with congenital heart disease (CCHD', 'infants with congenital heart disease', 'pediatric patients following surgery', '60 infants with CCHD between 1 day and 12 months of age following their first cardiothoracic surgery', 'Infants with Complex Congenital Heart Disease']","['standard post-operative care', 'daily 30-minute restriction of non-essential caregiving (Quiet Time), and Group 2 received a daily 30-minute massage', 'Fentanyl-equivalent narcotic values', 'Massage']","['Daily averages and pre- and post- intervention FLACC scores and physiologic responses', 'Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2', 'Pain', 'Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC', 'immediate effects of massage, with HR and RR decreasing and oxygen saturations increasing', 'daily pain scores', 'Adjusted pain scores', 'level of pain or differential rate of change in pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0852710', 'cui_str': 'Oxygen saturation increased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",60.0,0.174636,"However, the massage group had lower daily pain scores with small to medium effect size differences, largest at days 4, 5 and 6, and lower average daily HR and RR.","[{'ForeName': 'Tondi M', 'Initials': 'TM', 'LastName': 'Harrison', 'Affiliation': ""The Ohio State University College of Nursing, Columbus, Ohio University of Wisconsin-Madison School of Nursing, Madison, Wisconsin Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio COPC Ohio Center for Pediatrics, Dublin, Ohio The Ohio State University College of Nursing, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Duffey', 'Affiliation': ''}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Frey', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bailey', 'Affiliation': ''}, {'ForeName': 'Marliese Dion', 'Initials': 'MD', 'LastName': 'Nist', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Renner', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fitch', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000459']
532,32571859,"The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease.","INTRODUCTION


Frailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.
METHODS AND ANALYSIS


The EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).
ETHICS AND DISSEMINATION


Ethical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.
TRIAL REGISTRATION NUMBER


ISRCTN87708989.",2020,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","['adults with chronic kidney disease (CKD', 'Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment', 'pre-frail and FRAIL, older adults with Chronic Kidney Disease', 'adults with CKD', 'prefrail and frail older adults with CKD']","['multicomponent home-based exercise programme', 'home-based EXercise programme', 'Exercise training', 'exercise or usual care', 'tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression']","['physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2', 'rate of recruitment, intervention adherence, outcome measure completion and participant attrition', 'quality of life (HRQOL), hospitalisation and mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.149749,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","[{'ForeName': 'Andrew Christopher', 'Initials': 'AC', 'LastName': 'Nixon', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK andrew.nixon3@nhs.net.'}, {'ForeName': 'Theodoros M', 'Initials': 'TM', 'LastName': 'Bampouras', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, Lancashire, UK.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gooch', 'Affiliation': 'Centre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Hannah M L', 'Initials': 'HML', 'LastName': 'Young', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kenneth William', 'Initials': 'KW', 'LastName': 'Finlayson', 'Affiliation': 'Research in Childbirth and Health Unit, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Pendleton', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Brady', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Ajay P', 'Initials': 'AP', 'LastName': 'Dhaygude', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035344']
533,32565465,"Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT).","INTRODUCTION


The effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain.
METHODS AND ANALYSIS


The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five ICUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained  Lactobacillus plantarum  299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60.
ETHICS AND DISSEMINATION


ROCIT has been approved by the South Metropolitan Health Service Human Research Ethics Committee (ref: RGS00000004) and the St John of God Health Care Human Research Ethics Committee (ref: 1183). The trial results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Australian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.",2020,The Restoration Of gut microflora in Critical Illness Trial,"['patients admitted to the intensive care unit (ICU', 'Australian and New Zealand', 'days alive and out of hospital in adult ICU patients', 'Adult patients who are within 48\u2009hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained', 'enrol 220 patients in five ICUs']","['Lactobacillus plantarum  299v probiotic therapy', 'probiotic therapy', 'daily probiotic therapy', 'placebo']",['days alive and out of hospital to day 60'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.364712,The Restoration Of gut microflora in Critical Illness Trial,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia ed.litton@health.wa.gov.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Broadhurst', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Currie', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ferrier', 'Affiliation': 'Intensive Care Unit, St John of God Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gummer', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Orr', 'Affiliation': 'Pharmacy, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Palermo', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Paparini', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pellicano', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Raby', 'Affiliation': 'Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Rammohan', 'Affiliation': 'Department of Economics, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Regli', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salman', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Strunk', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Waterson', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035930']
534,32565469,Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial.,"INTRODUCTION


The incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.
METHODS


ACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.
ETHICS AND DISSEMINATION


The trial has approvals from the London-Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.
TRIAL REGISTRATION NUMBER


ISRCTN12146519.",2020,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","['Four large London maternity units', 'women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency', 'women at >24 weeks gestation who are actively bleeding within 24\u2009hours of delivery and for whom transfusion of red blood cells (RBCs) has been started', 'women who develop severe postpartum haemorrhage (ACROBAT) in the UK']",['early cryoprecipitate transfusion versus standard care'],"['Fibrinogen levels', 'feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes', 'severe postpartum haemorrhage (PPH']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0015528', 'cui_str': 'factor XIII'}, {'cui': 'C4316812', 'cui_str': 'Fibrinogen deficiency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",,0.137309,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK Laura.Green27@nhs.net.'}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': 'Department of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez Pérez', 'Affiliation': 'Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Department of Women's and Neonatal Health, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036416']
535,32565474,Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial.,"OBJECTIVE


To assess whether pulse oximetry improves health workers' performance in diagnosing severe childhood pneumonia at health centres in Southern Ethiopia.
DESIGN


Parallel cluster-randomised trial.
SETTING


Government primary health centres.
PARTICIPANTS


Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia. Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019.
INTERVENTION ARM


Use of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter.
CONTROL ARM


Use of the IMCI algorithm only.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was the proportion of children diagnosed with severe pneumonia. Secondary outcomes included referred cases of severe pneumonia and treatment failure on day 14 after enrolment.
RESULT


Twenty-four health centres were randomised into intervention (928 children) and control arms (876 children). The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm. After adjusting for differences in baseline variables children in the intervention arm were more likely to be diagnosed as severe pneumonia cases as compared with those in the control arm (adjusted OR: 5.4, 95% CI 2.0 to 14.3, p=0.001).
CONCLUSION


The combined use of IMCI and pulse oximetry in health centres increased the number of diagnosed severe childhood pneumonia.
TRIAL REGISTRATION NUMBER


PACTR201807164196402.",2020,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"['diagnosing severe childhood pneumonia at health centres in Southern Ethiopia', 'Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019', 'Government primary health centres', 'childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia', 'Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia', 'Twenty-four health centres']","['Pulse oximeter with integrated management', 'pulse oximetry', 'IMCI and pulse oximetry', 'ARM\n\n\nUse of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter']","['referred cases of severe pneumonia and treatment failure on day 14 after enrolment', ""health workers' performance"", 'severe pneumonia cases', 'proportion of children diagnosed with severe pneumonia', 'proportion of children with severe pneumonia']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.256355,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"[{'ForeName': 'Solomon H', 'Initials': 'SH', 'LastName': 'Tesfaye', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia solomon0917242124@gmail.com.'}, {'ForeName': 'Yabibal', 'Initials': 'Y', 'LastName': 'Gebeyehu', 'Affiliation': 'School of Medicine, Dilla University College of Health Sciences, Dilla, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}, {'ForeName': 'Kjell Arne', 'Initials': 'KA', 'LastName': 'Johansson', 'Affiliation': 'Global Public Health and Primary Care, University of Bergen Centre for International Health, Bergen, Norway.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}]",BMJ open,['10.1136/bmjopen-2020-036814']
536,32575977,Effects of Olfactory Training in Patients With Postinfectious Olfactory Dysfunction.,"OBJECTIVES


Postinfectious olfactory dysfunction (PIOD) is the most common etiology of olfactory dysfunction, and olfactory training (OT) is an accepted treatment modality for PIOD. Some studies have investigated OT in Korean patients, but they involved odorants unfamiliar to Koreans or had no control group. The aim of this study was to verify the efficacy of OT in PIOD patients, using odorants familiar to Koreans and including a control group.
METHODS


We enrolled a total of 104 Korean patients with PIOD over the 3-year study period. All participants were assessed using endoscopy and an olfactory function test at the baseline assessment and 3 months after OT. The olfactory function test was performed using the Korean version of Sniffin' stick (KVSS) II. Nasal and psychological function was evaluated using a visual analog scale and the Mini-Mental State Examination. OT was performed over a period of 3 months, using five odorants (rose, lemon, cinnamon, orange, and peach).
RESULTS


OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects. A comparison of changes between the initial and follow-up assessments demonstrated that the OT group had significantly better olfactory results for the total KVSS II, threshold, and identification scores than the non-OT group. The degree of olfactory improvement after OT was affected by the initial score.
CONCLUSION


The effects of OT in patients with PIOD were demonstrated in this study. A meaningful contribution of this study is that Korean patients were tested using odors familiar to them in comparison with a control group.",2021,"Results


OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects.","['104 Korean patients with PIOD over the 3-year study period', 'PIOD patients, using odorants familiar to Koreans and including a control group', 'Patients With Postinfectious Olfactory Dysfunction', 'patients with PIOD', 'Korean patients']","['OT', 'Olfactory Training']","['Nasal and psychological function', 'olfactory function', 'degree of olfactory improvement after OT', 'visual analog scale and the Mini-Mental State Examination']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2985522', 'cui_str': 'Odorants'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",104.0,0.022602,"Results


OT improved olfactory function in approximately 40% of subjects over a period of 12 weeks compared to non-OT subjects.","[{'ForeName': 'Bo Yoon', 'Initials': 'BY', 'LastName': 'Choi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Hamin', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Haemin', 'Initials': 'H', 'LastName': 'Noh', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hoon', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Kook', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Konkuk University School of Medicine, Seoul, Korea.'}]",Clinical and experimental otorhinolaryngology,['10.21053/ceo.2020.00143']
537,32576042,SHORT-TERM VERSUS 6-WEEK PREDNISONE IN THE TREATMENT OF SUBACUTE THYROIDITIS: A RANDOMIZED CONTROLLED TRIAL.,"Objective : Moderate-to-severe subacute thyroiditis is clinically managed with 6-8 weeks of glucocorticoid therapy. However, no studies have evaluated short-term prednisone treatment for subacute thyroiditis.  Methods : This 24-week, prospective, single-blind, randomized controlled study enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014. Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/d prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy. The primary endpoint was intergroup differences in treatment efficacy at the end of treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24.  Results : We screened 96 patients, randomized 52 participants, and 50 completed the study. Efficacy and recurrence rates were not significantly different at withdrawal in both groups ( P=0.65 ). At treatment discontinuation, parathyroid hormone (28.8 vs 38.9 pg/mL,  p=0.011 ) and systolic blood pressure (113.9 vs 122.4 mmHg,  p=0.023 ) were significantly lower in the experimental group than in the control group. There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  Conclusions : Fewer side effects of glucocorticoids and similar efficacy and recurrence rates were observed with short-term prednisone compared with in the 6-week treatment for subacute thyroiditis. Short-term prednisone with a better safety profile may be an alternative strategy for ameliorating moderate-to-severe symptoms of subacute thyroiditis.",2020,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","['Patients with moderate-to-severe symptoms', '96 patients, randomized 52 participants, and 50 completed the study', 'enrolled patients (aged 18-70) with subacute thyroiditis who were hospitalized between August 2013 and December 2014']","['30 mg/d prednisone', 'prednisone', 'nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy', 'glucocorticoid therapy', 'glucocorticoids']","['Efficacy and recurrence rates', 'treatment efficacy', 'post-withdrawal adverse effect parameters and thyroid function', 'systolic blood pressure', 'efficacy and recurrence rates', 'parathyroid hormone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040149', 'cui_str': 'Subacute thyroiditis'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",52.0,0.0775229,"There were no significant intergroup differences in other secondary endpoints at withdrawal and in thyroid function at weeks 6, 12, and 24.  ","[{'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'From: Department of Endocrinology, The Third Affiliated Hospital of Chongqing Medical University (Jie er Hospital), Chongqing, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0096']
538,32576049,MENSTRUAL DISORDERS AND ANDROGEN-RELATED TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS: A CLINICAL STUDY.,"Objective.  To investigate possible causes of menstrual disorders and androgen-related traits in young women with T1DM.  Patients and Methods.  Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited.  Results.  Two women (3.8%) in the T1DM group had not experienced menarche (at 15.5 and 16.6 years); of the rest, 23.5% had oligomenorrhea, 32.1% hirsutism, 45.3% acne. The age at menarche was delayed in the T1DM group compared to controls (12.7±1.3 vs. 12.0±1.0 years, p=0.004), while no difference was observed with the PCOS group (12.4±1.2 years). There were no differences in total testosterone (0.43±0.14 vs. 0.39±0.14 ng/ml, p>0.05), DHEA-S (269±112 vs. 238±106 μg/dl, p>0.05) or Δ4-androstenedione (2.4±1.3 vs. 1.9±0.5 ng/ml, p>0.05) concentrations between T1DM and controls. However, patients with T1DM had lower SHBG concentrations than controls (61±17 vs. 83±18.1 nmol/l, p=0.001), which were even lower in the PCOS group (39.5±12.9 nmol/, p=0.001 compared with T1DM). FAI (free androgen index) was higher in the PCOS group compared with both other groups (T1DM vs. PCOS vs. controls: 2.53±0.54 vs 7.88±1.21 vs. 1.6±0.68, p<0.001). FAI was higher in patients with T1DM compared to controls, too (p=0.038). There was no difference in DHEA-S concentrations between T1DM and PCOS patients (269±112 vs. 297±100 μg/dl, p>0.05).  Conclusions.  Menstrual disorders and androgen-related traits in young women with T1DM may be attributed to an increase in androgen bioavailability due to decreased SHBG concentrations.",2020,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","['TRAITS IN YOUNG WOMEN WITH TYPE 1 DIABETES MELLITUS', 'Fifty-three women with T1DM (duration 8.0±5.6 years), 41 women with PCOS and 51 controls matched for age (19.4±4.3 vs. 21.2±2.7 vs. 20.8±3.1 years, p>0.05) and BMI (22.2±2.7 vs. 21.9±2.0 vs. 21.4±1.9 kg/m2, p>0.05) were prospectively recruited', 'young women with T1DM']",[],"['lower SHBG concentrations', 'FAI (free androgen index', 'total testosterone', 'DHEA-S concentrations', 'FAI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}]",53.0,0.0903609,"FAI was higher in patients with T1DM compared to controls, too (p=0.038).","[{'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Andromachi', 'Initials': 'A', 'LastName': 'Vryonidou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Melissourgou', 'Affiliation': 'Department of Diabetes and Endocrinology, Hellenic Red Cross Hospital, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosteria', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios G', 'Initials': 'DG', 'LastName': 'Goulis', 'Affiliation': 'Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Chrousos', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kanaka-Gantenbein', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics and University Research Institute on Maternal and Child Health and Precision Medicine, ""Aghia Sophia"" Children\'s Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2020-0153']
539,32444190,Investigation of the effect of web-based diabetes education on metabolic parameters in people with type 2 diabetes: A randomized controlled trial.,"OBJECTIVES


The study was done experimentally to test the effect of diabetes on body mass index (BMI), low-density lipoprotein (LDL), high-density lipoprotein (HDL), systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose.
METHODS


In the randomization performed, with 80 percent power, 80 people with Type 2 diabetes were found to be suitable for sampling. Personal data forms were filled in by conducting a face-to-face interview with both the experimental and control groups for randomization purposes. In the study, monitoring of BMI, LDL, HDL, systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose were used as outcome measures. Parameters were monitored pre-trial and at the 3rd, 6th, 9th, and 12th months. Data from the experimental group were collected online while data belonging to the control group were collected by the researcher from patients⿿ medical records in the Endocrinology Outpatient Clinic. Repeated measures analysis of variance (rANOVA) was performed to analyze pre-trial, 3rd, 6th, 9th, and 12th-month data.
RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
CONCLUSIONS


The metabolic data of the experimental group, who had web-based diabetes education, significantly improved between the start of the study (month 0) and the 12th month. In this era of technology, the importance of web-based monitoring of diabetes patients was once again proven.",2020,"RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
","['people with type 2 diabetes', '80 people with Type 2 diabetes']",['web-based diabetes education'],"['metabolic parameters', 'BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average', 'body mass index (BMI), low-density lipoprotein (LDL), high-density lipoprotein (HDL), systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose', 'BMI, LDL, HDL, systolic blood pressure, diastolic blood pressure, fasting blood glucose and postprandial blood glucose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",80.0,0.0197737,"RESULTS


BMI, LDL, HDL, systolic and diastolic blood pressure, fasting and postprandial blood glucose average of the experimental group at 12 months were proven to be ameliorated compared to the average values at the start of the study (month 0).
","[{'ForeName': 'Elif Unsal', 'Initials': 'EU', 'LastName': 'Avdal', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey. Electronic address: elifunsal2003@yahoo.com.'}, {'ForeName': 'Berna Nilgün Özgürsoy', 'Initials': 'BNÖ', 'LastName': 'Uran', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey.'}, {'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Pamuk', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Julide Gulizar', 'Initials': 'JG', 'LastName': 'Yildirim', 'Affiliation': 'Izmir Kâtip Çelebi University, Faculty of Health Sciences, Izmir, Turkey.'}, {'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Konakçi', 'Affiliation': 'Izmir Demokrasi University. Faculty of Health Science, Izmir, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Ateş', 'Affiliation': 'Burdur Mehmet Akif Ersoy University Faculty of Health Science, Burdur, Turkey.'}, {'ForeName': 'Gökşen', 'Initials': 'G', 'LastName': 'Polat', 'Affiliation': 'Izmir Kâtip Çelebi University, Enstitue of Health Sciences, Izmir, Turkey.'}]",Journal of infection and public health,['10.1016/j.jiph.2020.03.008']
540,32562075,"Sealer penetration: effect of separated file's cross-section, taper and motion characteristics.","OBJECTIVES


The separated root canal instruments may affect the quality of root canal filling, hence the success of endodontic treatment. The aim of this study was to evaluate the effects of separated file fragments of nickel-titanium rotary systems with different cross-section, taper and motion characteristics on the apical sealer penetration in oval-shaped root canals via confocal laser scanning microscope (CLSM).
MATERIALS AND METHODS


Distal roots of 60 mandibular molars with oval-shaped root canals were randomly divided into 4 groups as follows: group 1, FlexMaster Nickel Titanium Rotary File System (NTRFS) (separated instrument: 30/.06); group 2, ProTaper Next NTRFS (X3); group 3, ProTaper Universal NTRFS (F3); group 4, Revo-S NTRFS (AS30/.06). Root canals were filled with gutta-percha and AH plus labelled with 0.1% rhodamine B using a warm vertical compaction technique. Each specimen was horizontally sectioned at 1st, 3rd and 5th mm from apical foramen. Amount of maximum and average penetration depths, penetration percentage and sealer penetrated area were measured and analysed with one-way repeated measures of ANOVA and the Bonferroni post hoc tests. p < 0.05 was considered significant.
RESULTS


The penetration depth, percentage and penetrated area of the sealer increased from apical to coronal in all systems. The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05). At the 5th mm, the Revo-S group had a higher penetration percentage, when compared with ProTaper Next and ProTaper Universal groups (p < 0.05).
CONCLUSIONS


In the 1st mm, separated fragments of any system did not allow the penetration of the sealer, while it was observed that the files with constant taper showed more positive results in terms of sealer penetration at apical 3rd and 5th mm.
CLINICAL RELEVANCE


In the presence of a separated file, the taper of the file might significantly affect the amount of penetrated sealer into the dentinal tubules as compared with the cross-section and motion characteristics of the file.",2021,The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05).,['Distal roots of 60 mandibular molars with oval-shaped root canals'],"['gutta-percha and AH plus labelled with 0.1% rhodamine B using a warm vertical compaction technique', 'FlexMaster Nickel Titanium Rotary File System (NTRFS) (separated instrument: 30/.06); group 2, ProTaper Next NTRFS (X3); group 3, ProTaper Universal NTRFS (F3']","['Amount of maximum and average penetration depths, penetration percentage and sealer penetrated area', 'quality of root canal filling', 'penetration depth, percentage and penetrated area of the sealer', 'maximum and average penetration depths and penetration areas']","[{'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}]","[{'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0175671', 'cui_str': 'Universal'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}]",,0.0436713,The maximum and average penetration depths and penetration areas were higher in FlexMaster and Revo-S groups at the 3rd mm (p < 0.05).,"[{'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Eymirli', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Uzunoğlu Özyürek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey. emel_dt@hotmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Serper', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Sihhiye, 06100, Ankara, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03404-3']
541,32562077,Healing of periodontal suprabony defects following treatment with open flap debridement with or without an enamel matrix derivative: A randomized controlled clinical study.,"OBJECTIVES


To compare the healing of suprabony defects following treatment with either open flap debridement (OFD) and application of an enamel matrix derivative (EMD) with OFD alone.
METHODS


Eighty patients with suprabony periodontal defects were randomly assigned to treatment with OFD + EMD (test) or OFD alone (control). The primary outcome variable was the difference in clinical attachment level (CAL) gain. At baseline and after 12 months, full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), gingival recessions (GR), and CAL were recorded.
RESULTS


Sixty-five patients were available for the 12-month follow-up examination. At 12 months, the mean FMPS was 21.9 ± 3.0% in the OFD + EMD and 21.1 ± 2.4% in the OFD group, respectively (p = 0.30), while mean FMBS measured 20.4 ± 3.4% in the OFD + EMD group and 19.9 ± 2.9% in the OFD group (p = 0.48). Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm). A statistically significant difference (p = 0.0001) was found between mean PD change in the OFD + EMD (3.9 ± 0.6 mm) and OFD alone (3.2 ± 0.6 mm) treated groups and also in terms of mean GR change between treatment with OFD + EMD (0.5 ± 0.7 mm) and OFD alone (1.4 ± 1.0 mm) (p = 0.001).
CONCLUSION


Within their limits, the present results indicate that in suprabony periodontal defects, the application of EMD in conjunction with OFD may additionally improve the clinical outcomes compared with OFD alone.
CLINICAL RELEVANCE


In periodontal suprabony defects, the application of EMD in conjunction with OFD may additionally enhance the clinical outcomes in terms of CAL gain and PD reduction.",2021,Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm).,"['Sixty-five patients were available for the 12-month follow-up examination', 'Eighty patients with suprabony periodontal defects']","['open flap debridement (OFD) and application of an enamel matrix derivative (EMD) with OFD alone', 'OFD + EMD', 'open flap debridement with or without an enamel matrix derivative', 'OFD + EMD (test) or OFD alone (control']","['full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), gingival recessions (GR), and CAL', 'Mean CAL gain', 'mean PD change in the OFD + EMD', 'healing of suprabony defects', 'mean GR change', 'mean FMPS', 'clinical attachment level (CAL) gain']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.0935902,Mean CAL gain at sites treated with OFD + EMD was statistically significantly different (p = 0.0001) compared with sites treated with OFD alone (3.4 ± 0.6 mm vs 1.8 ± 0.6 mm).,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Iorio-Siciliano', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy. enzois@libero.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Stefan-Ioan', 'Initials': 'SI', 'LastName': 'Stratul', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramaglia', 'Affiliation': 'Department of Periodontology, University of Naples Federico II, Via S Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Vela', 'Initials': 'V', 'LastName': 'Octavia', 'Affiliation': 'Department of Periodontology, Victor Babes University, Piata Eftimie 2, 300041, Timisoara, Romania.'}, {'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, CH-3010, Bern, Switzerland.'}]",Clinical oral investigations,['10.1007/s00784-020-03392-4']
542,32565450,One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.,"INTRODUCTION


People with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with an active control group.
METHODS AND ANALYSIS


The trial aims to recruit 40 participants with ID. Participants in the intervention arm will receive weekly visits from a volunteer over 6 months. Community befriending schemes will recruit, train, supervise volunteers and match them to individuals with ID. Both groups will receive a booklet about local activities and have access to usual care. Health and social outcomes will be measured at the end of the intervention and 6 months' follow-up. The following outcomes will be assessed: (1) recruitment and retention of individuals with ID and volunteers in the trial, (2) adverse events related to the intervention, (3) the acceptability of the intervention, (4) whether the intervention is delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis in a full trial. Qualitative data from participants, volunteers, staff and carers will identify barriers and facilitators of a future full trial.
ETHICS AND DISSEMINATION


The study has been approved by the London City and East Research Ethics Committee (reference 18/LO/2188). The findings will be presented at conferences and published in a peer-reviewed journal and in the National Institute of Health Research journals library. A public engagement seminar will be held at the end of the study aimed at key stakeholders.
TRIAL REGISTRATION NUMBER


ISRCTN63779614.",2020,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","['volunteers for people with ID, compared with an active control group', 'People with intellectual disability (ID', 'people with intellectual disability and symptoms of depression', 'supervise volunteers and match them to individuals with ID', '40 participants with ID']",[],"['delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis', 'depressive symptoms', 'Health and social outcomes']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.176178,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","[{'ForeName': 'Afia', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Psychiatry, University College London, London, UK afia.ali@ucl.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mckenzie', 'Affiliation': 'Research and Development, North East London NHS Foundation Trust Goodmayes Hospital, Ilford, Essex, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hassiotis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit of Social and Community Psychiatry, Barts and the London School of Medicine and Dentistry, University of London, London, UK.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Panca', 'Affiliation': 'Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fernandez', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Finning', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roe', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033989']
543,32565458,Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).,"INTRODUCTION


Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference.
METHODS AND ANALYSIS


Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019.
ETHICS AND DISSEMINATION


This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant.
TRIAL REGISTRATION NUMBER


NCT03767933, first registered on 07 December 2018.",2020,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"['Parents/caregivers of children presenting to the ED with acute limb injury', 'children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study', '536 children across six Canadian paediatric EDs']","['non-steroidal or opioid analgesia', 'ibuprofen+oral acetaminophen', 'oral ibuprofen+oral hydromorphone', 'hydromorphone', 'ibuprofen', 'acetaminophen', 'placebo']","['efficacy and safety', 'verbal Numerical Rating Scale pain score ≥5']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.346972,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"[{'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Rajagopal', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Klassen', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Richer', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Emergency Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drendel', 'Affiliation': 'Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluation Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Pediatrics, Universite de Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Stang', 'Affiliation': 'Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': 'Pediatrics and Emergency Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Maala', 'Initials': 'M', 'LastName': 'Bhatt', 'Affiliation': 'Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Hickes', 'Affiliation': ""Parent Partner, Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'Paediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035177']
544,32565464,Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.,"INTRODUCTION


Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies.
METHODS AND ANALYSIS


PrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group.
ETHICS AND DISSEMINATION


The protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations.
TRIAL REGISTRATION NUMBER


NCT03875950.",2020,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"['purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya', 'Young Women and Adolescents Program-standardised patient (PrIYA-SP', 'adolescent girls and young women (AGYW) in Kenya', 'Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition']","['standardised patient actor (SP) training intervention', 'counselling for pre-exposure prophylaxis (PrEP', 'Pre-exposure prophylaxis (PrEP', '2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing']","['quality of PrEP counselling', 'quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",24.0,0.17426,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA annalar@uw.edu.'}, {'ForeName': 'Kate S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Pintye', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Abuna', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Harison', 'Initials': 'H', 'LastName': 'Lagat', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': 'Health Sciences Simulation & Clinical Skills Center, Howard University, Seattle, Washington, DC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035689']
545,32554737,Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.,"INTRODUCTION


National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC).
METHODS AND ANALYSIS


This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups.
ETHICS AND DISSEMINATION


The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members.
TRIAL REGISTRATION NUMBER


NCT03964454.",2020,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"['Mothers who were enrolled in WIC and initiated breastfeeding are eligible', 'Participants (n=168', 'mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC', 'low-income mothers in the USA']","['standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding', 'standard breastfeeding services from WIC, home-based individual support and assessments']",['rate of any breastfeeding over 12\u2009months'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0985776,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, North Carolina, USA ywashio@rti.org.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hunt-Johnson', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Value Institute, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Herrine', 'Affiliation': 'Obstetrics and Gynecology Department, Temple University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Obstetrics and Gynecology Department, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kilby', 'Affiliation': 'N.O.R.T.H., Inc-Philadelphia WIC program, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Chapman', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Furman', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}]",BMJ open,['10.1136/bmjopen-2019-034510']
546,32567679,Fitness and strength responses to distinct exercise modes in twins: Studies of Twin Responses to Understand Exercise as a THerapy (STRUETH) study.,"KEY POINTS


Exercise is considered medicine; however, the individual degree of responsiveness to a standardized dose of exercise is idiosyncratic. Individual responsiveness between distinct exercise modalities and the genetic/environmental contributions to exercise response are not well understood. In this novel randomized cross-over design study, monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training, separated by a 3 month washout period, aiming to assess training responses in strength and fitness outcomes to dichotomous training modalities, as well as the genetic/environmental contributions to exercise response. Our findings indicate that (i) individual responsiveness differs between exercise modalities; (ii) low-responders to one mode may be 'rescued' by switching to an alternate mode of exercise; and (iii) genes may not play as large a role, as previously estimated from cross-sectional data, for exercise training adaptation. The present study has implications for those charged with optimizing the benefits of exercise by means of individualizing the exercise prescription.
ABSTRACT


Exercise response is idiosyncratic, although the degree of responsiveness, concordance in response between modalities and genetic contribution to responsiveness are not well understood. We investigated this using a novel randomized cross-over design of dichotomous exercise interventions in mono-(MZ) and di-zygotic (DZ) twin pairs. We studied strength (1RM) and fitness (    V   ̇   O   2   max      ) responses in 84 same-sex untrained twins (30 MZ, 12 DZ pairs; 24.9 ± 5.4 years). Twins, as pairs, underwent 3 months of resistance (RES) and endurance (END) training, separated by a 3 month washout period. Training responses and genetic/environmental contributions to responses were assessed. Leg strength 1RM increased following RES but not END (△47 ± 29 vs. 3 ± 26 kg; P < 0.001), whereas    V   ̇   O   2   max      increased following END but not RES (△0.25 ± 0.26 vs. 0.04 ± 0.25 L min -1  ; P < 0.001). A higher percentage of individuals responded to RES for strength and to END for    V   ̇   O   2   max      (P < 0.0001). Within-individual responses to each mode were not correlated (P > 0.05). Cross-sectional intraclass correlations were higher for MZ than DZ pairs for all variables, largely as a result of shared environment. Following training, MZ, but not DZ pairs, were significantly correlated for strength change to RES (r MZ  = 0.62, P = 0.002) and END (r MZ  = 0.36, P = 0.04), and for    V   ̇   O   2   max      change to END (L min -1  , r MZ  = 0.45, P = 0.02) with a mixture of unshared/shared environmental contributions. Our findings indicate that individual responsiveness differs between modalities and low-responders to one mode may be 'rescued' by switching to an alternate mode. Additionally, genes may not play as large a role as previously estimated from cross-sectional data for training adaptation, and/or cross-sectional data do not reflect longitudinal training effects. The present study has implications for optimizing the individualization of exercise prescription.",2020,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"['84 same-sex untrained twins (30MZ, 12DZ pairs; 24.9\xa0±\xa05.4\xa0yr', 'mono-(MZ) and di-zygotic (DZ) twin pairs', 'monozygotic and dizygotic twins, as pairs, underwent 3 months of resistance and endurance training', 'twins']","['495·In', 'dichotomous exercise interventions']","['Leg strength 1RM', 'resistance (RES) and endurance (END) training', 'strength change to RES', 'strength (1RM) and fitness (VO 2  max) responses']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0041429', 'cui_str': 'Fraternal twin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0319865,A higher percentage of individuals responded to RES for strength and to END for VO 2  max (P < 0.0001).,"[{'ForeName': 'Channa E', 'Initials': 'CE', 'LastName': 'Marsh', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Thomas', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Scurrah', 'Affiliation': 'Twins Research Australia, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences, Exercise and Sport Science, The University of Western Australia, Perth, WA, Australia.'}]",The Journal of physiology,['10.1113/JP280048']
547,32576496,Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.,"BACKGROUND


Trans-arterial chemoembolization (TACE) is one first-line option therapy for patients with hepatocellular carcinoma (HCC) not suitable for surgical resection.
AIMS


We evaluated the effects of sunitinib plus doxorubicin-TACE on bleeding or liver failure.
METHODS


Seventy-eight patients with HCC were included in this randomized, double-blind study. They received one to three TACE plus either sunitinib or placebo four weeks out of six for one year. The occurrence of severe bleeding or liver failure was assessed during the week after the TACE. The safety and survival outcomes were evaluated.
RESULTS


No bleeding complication was reported. One and two liver failures were respectively observed in sunitinib and placebo patients. Compliance to sunitinib treatment was acceptable. Sunitinib dose reduction occurred in 37% of patients due to acute toxicity. Main grade 3-4 toxicities were: thrombocytopenia, neutropenia, increased bilirubin, increased ALT and asthenia. In the sunitinib group, the median PFS and OS were 9.05 [5.81;11.63] and 25.0 [13.5;36.8] months, respectively. In the placebo group, the median PFS and OS were 5.51 [4.14;7.79] and 20.5 [15.1;30.6] months, respectively.
CONCLUSIONS


TACE plus sunitinib in the first-line therapy for patients with HCC not suitable for surgical resection was feasible. CLINICALTRIALS.
GOV NUMBER


NCT01164202.",2020,No bleeding complication was reported.,"['unresectable hepatocellular carcinoma', 'Seventy-eight patients with HCC', 'patients with hepatocellular carcinoma (HCC) not suitable for surgical resection']","['TACE plus sunitinib', 'Liver transarterial chemoembolization and sunitinib', 'TACE plus either sunitinib or placebo', 'sunitinib plus doxorubicin-TACE', 'Trans-arterial chemoembolization (TACE', 'placebo']","['acute toxicity', 'thrombocytopenia, neutropenia, increased bilirubin, increased ALT and asthenia', 'bleeding or liver failure', 'median PFS and OS', 'safety and survival outcomes', 'severe bleeding or liver failure', 'bleeding complication']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",78.0,0.0655466,No bleeding complication was reported.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turpin', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France. Electronic address: anthony.turpin@chru-lille.fr.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'de Baere', 'Affiliation': 'Department of Surgical Radiology, Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Heurgué', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Robert Debré, Reims, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Statistics Department, Fédération Francophone de cancérologie Digestive, Dijon, France; EPICAD inserm LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ollivier-Hourmand', 'Affiliation': 'Department of Hepato-Gastroenterology and Nutrition, University Hospital Côte de Nacre, Caen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital, Tours, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Perrier', 'Affiliation': 'Department of Hepato-Gastroenterology and Oncology, Saint-Joseph Hospital, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Vergniol', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital, Pessac, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sefrioui', 'Affiliation': 'Inserm 1245, IRON group, Hepato-Gastroenterology unit, University Hospital, Rouen, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rinaldi', 'Affiliation': 'Oncology Unit, European Hospital, Marseille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Department of Medical Oncology, Eugène Marquis center, Rennes, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Jouve', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital François Mitterrand, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Silvain', 'Affiliation': 'Hepato-Gastroenterology Unit, University Hospital, Poitiers, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Becouarn', 'Affiliation': 'Digestive Tumours Unit, Bergonié Institute, Bordeaux, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dauvois', 'Affiliation': 'Department of Hepato-gastroenterology, La Source Hospital, Orléans, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Baconnier', 'Affiliation': 'Gastroenterology Department, CH Annecy Genevois, Pringy, France.'}, {'ForeName': 'Maryline', 'Initials': 'M', 'LastName': 'Debette-Gratien', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Medical Oncology, Saint Joseph Hospital, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Dharancy', 'Affiliation': 'Department of Hepato-Gastroenterology, inserm U995, University Hospital, Lille, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-Gastroenterology, University Hospital François Mitterrand, Dijon, France; EPICAD inserm LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hebbar', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.05.012']
548,32568593,"Letter to the Editor RE:  Giusti et al., Editorial Comment on: Influence of Lower Pole Infundibulopelvic Angle on Success of Retrograde Flexible Ureteroscopy and Laser Lithotripsy for the Treatment of Renal Stones by Dresner et al. (J Endourol 2020;34(6):660-661; DOI: 10.1089/end.2020.0209).",,2020,,[],['Retrograde Flexible Ureteroscopy and Laser Lithotripsy'],[],[],"[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]",[],,0.0156807,,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Dresner', 'Affiliation': 'Department of Urology, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Nakada', 'Affiliation': 'Department of Urology, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}]",Journal of endourology,['10.1089/end.2020.29087.sld']
549,32450733,Surgical Field Visualization during Functional Endoscopic Sinus Surgery: Comparison of Propofol- vs Desflurane-Based Anesthesia.,"OBJECTIVE


To assess if the type of general anesthetic affects bleeding and field visualization during endoscopic sinus surgery.
STUDY DESIGN


Prospective, randomized, controlled trial.
SETTING


Academic teaching hospital and Veterans Affairs hospital in the United States.
SUBJECTS AND METHODS


Seventy patients were randomized to 1 of 3 anesthetic regimens: (1) the volatile anesthetic desflurane (n = 22), (2) intravenous anesthesia with propofol (n = 25), or (3) a combination of propofol and desflurane (n = 23). Intravenous remifentanil was titrated to decrease the mean arterial pressure to 60 to 70 mm Hg but not ≥30% from baseline. Surgical bleeding scores were recorded along with bleeding rates and hemodynamic parameters, including cardiac output and systemic vascular resistance through pulse contour analysis from a radial arterial line. Statistics: multiple comparison tests and regression analyses; α = .05.
RESULTS


There were no differences in bleeding rate (median, 0.58, 0.85, 0.57 mL min -1 ), bleeding score (2.1, 2.0, 2.0), surgery duration (79, 81, 86 minutes), extubation time (9, 7, 8 minutes), recovery room time (65, 61, 61 minutes), or any hemodynamic parameters among groups 1 through 3, respectively. Group 1 required lower remifentanil infusions than group 2 (0.11 vs 0.26 µg kg -1  min -1 ;  P  = .01). The bleeding score correlated positively with height ( P  = .014) and the Lund-MacKay score ( P  = .013). Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
CONCLUSION


When remifentanil is used for controlled hypotension, propofol has no advantage over desflurane to improve surgical field visualization during functional endoscopic sinus surgery.",2020,"Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
","['Academic teaching hospital and Veterans Affairs hospital in the United States', 'Functional Endoscopic Sinus Surgery', 'Seventy patients']","['Intravenous remifentanil', 'propofol and desflurane', 'intravenous anesthesia with propofol', 'Propofol- vs Desflurane-Based Anesthesia', 'volatile anesthetic desflurane', 'remifentanil', 'desflurane']","['longer surgery duration', 'bleeding rate', 'bleeding score', 'recovery room time', 'mean arterial pressure', 'Surgical bleeding scores', 'extubation time', 'Lund-MacKay score', 'cardiac output and systemic vascular resistance through pulse contour analysis from a radial arterial line', 'surgery duration']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}]",70.0,0.0604682,"Bilateral vs unilateral surgery led to longer surgery duration ( P  = .001) and recovery room time ( P  = .004).
","[{'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Gollapudy', 'Affiliation': 'Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Drake A', 'Initials': 'DA', 'LastName': 'Gashkoff', 'Affiliation': 'Medical School, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Poetker', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Loehrl', 'Affiliation': 'Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Matthias L', 'Initials': 'ML', 'LastName': 'Riess', 'Affiliation': 'Anesthesiology, TVHS VA Medical Center, Nashville, Tennessee, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820921863']
550,32451528,Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial.,"OBJECTIVE


Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain.
DESIGN


Randomized comparison trial.
SETTING


Outpatient clinics at the West Los Angeles VA Medical Center.
SUBJECTS


Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain.
METHODS


Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up.
RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had >30% pain reduction, one-third had >50%, and 12.5% had >70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance.
CONCLUSIONS


This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.",2020,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","['Fifty-three veterans (mean age\u2009=\u200973.5\u2009years, 92.4% male) with chronic musculoskeletal pain', 'patients with chronic musculoskeletal pain', 'Patients', 'older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain', 'chronic pain', 'Older Adults with Chronic Musculoskeletal Pain', 'Outpatient clinics at the West Los Angeles VA Medical Center']","['Emotional awareness and expression therapy (EAET', 'EAET with CBT', 'Cognitive Behavioral Therapy', 'Psychotherapy', 'cognitive behavioral therapy (CBT']","['pain reduction', 'Pain Reduction', 'Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes', 'small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance', 'pain', 'pain severity', 'Emotional Awareness and Expression Therapy']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",,0.074013,"RESULTS


EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively).","[{'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Yarns', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Justina T', 'Initials': 'JT', 'LastName': 'Cassidy', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Steers', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Osato', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Providence Hospital, Southfield, Michigan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Sultzer', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California, Irvine School of Medicine, Irvine, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa145']
551,32458301,The Disaggregated Repeated Measures Design: A Novel Approach to Assess Sexual Risk Behaviors.,"Although numerous studies have examined sexual and substance use behaviors that put people at risk for sexually transmitted infections including HIV, most focus on an overall measure of aggregate risk or a few simple and particular subtypes of sexual acts assessed in separate analyses. In this article, we introduce a more sensitive approach to assess how the relative characteristics of sex acts may determine the level of risk in which an individual chooses to engage. Project AWARE, a randomized clinical trial conducted among 5012 patients in nine STD clinics across the U.S., is used to illustrate the approach. Our study was guided by two aims: (1) describe a new approach to examine the count of sexual acts using a disaggregated repeated measures design and (2) show how this new approach can be used to evaluate interactions among different categories of sexual risk behaviors and other predictors of interest (such as gender/sexual orientation). Profiles of different subtypes of sexual acts in the past 6 months were assessed. Potential interactions of the characteristics associated with each subtype which resulted in up to 48 distinct subtypes of sexual risk behaviors-sex with a primary/non-primary partner; partner's HIV status; vaginal/anal sex; condom use; and substance use before or during sex act-can be examined. Specifically, we chose condom use and primary and non-primary status of partner as an application in this paper to illustrate our method. There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001). In addition, there were significant differences for the count of sexual risk behaviors among women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM) for sex acts with and without condom use, primary and non-primary partner, and their interaction (ps = .03, < .0001, and .001, respectively). This approach extends our understanding of how people make choices among sexual behaviors and may be useful in future research on disaggregated characteristics of sex acts.",2021,"There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001).","[""48 distinct subtypes of sexual risk behaviors-sex with a primary/non-primary partner; partner's HIV status; vaginal/anal sex"", '5012 patients in nine STD clinics across the U.S', 'women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM']",[],"['Sexual Risk Behaviors', 'condomless sex acts', 'sexual risk behaviors']","[{'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],"[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",5012.0,0.0334994,"There were significantly more condomless sex acts (M = 23, SE = 0.9) and sex acts with primary partners (M = 27.1, SE = 0.9) compared to sex acts with condoms (M = 10.9, SE = 0.4, IRR = 2.10, 95% CI 1.91-2.32, p < .001) and sex acts with non-primary partner (M = 10.9, SE = 0.5, IRR = 2.5, 95% CI 2.33-2.78, p < .001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA. panyue@med.miami.edu.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Gooden', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Alejandro Max Antonio', 'Initials': 'AMA', 'LastName': 'Mantero', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Clinical Research Building, Room 1034, 1120 N.W. 14th St., Miami, FL, 33136, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01582-0']
552,32459597,Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer.,"PURPOSE


Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC.
METHODS


Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13.
RESULTS


Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5%  v  8.2%; ABCP, 48.6%  v  21.2%; BCP, 44.7%  v  11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly.
CONCLUSION


ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.",2020,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","['Non-Small-Cell Lung Cancer', 'chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC', 'Patients']","['Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy', 'Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP', 'atezolizumab to chemotherapy with and without bevacizumab', 'ABCP', 'bevacizumab, carboplatin, and paclitaxel (BCP', 'atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP']","['incidence of serious AEs (SAEs', 'Completion rates of the PRO questionnaires', 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13', 'global health status or physical functioning scores', 'incidence, nature, and severity of adverse events (AEs', 'overall survival and investigator-assessed progression-free survival', 'Treatment tolerability']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.253518,"During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wehler', 'Affiliation': 'Evangelisches Krankenhaus Hamm gGmbH, Hamm, Germany.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Orlandi', 'Affiliation': 'Instituto Nacional del Tórax, Santiago, Chile.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer & Research Center, Chandler, AZ.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'González Larriba', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rothenstein', 'Affiliation': 'Durham Regional Cancer Center, Lakeridge Health, Oshawa, Ontario, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Früh', 'Affiliation': 'Cantonal Hospital of St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Shankar', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kelsch', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'AdventHealth Cancer Institute, Orlando, FL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03158']
553,32463117,K ATP  channels modulate cerebral blood flow and oxygen delivery during isocapnic hypoxia in humans.,"KEY POINTS


ATP-sensitive K +  (K ATP  ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP  channels blockade affects the increase in human cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia. Hypoxia-induced increases in the anterior circulation and total cerebral perfusion were attenuated under K ATP  channels blockade affecting the relative changes of brain oxygen delivery. Therefore, in humans, K ATP  channels activation modulates the vascular tone in the anterior circulation of the brain, contributing to CBF and CDO 2  responses to hypoxia.
ABSTRACT


ATP-sensitive K +  (K ATP  ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP  channels blockade affects the increase in cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2  ) during hypoxia in humans. Nine healthy men were exposed to 5-min trials of normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3 h after glibenclamide ingestion (AGB). Mean arterial pressure (MAP), arterial saturation (  S   a   O   2        ), partial pressure of oxygen (  P   a   O   2        ) and carbon dioxide (  P   aC   O   2        ), internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler ultrasound) and CDO 2  were quantified during the trials. IHX provoked similar reductions in  S   a   O   2        and  P   a   O   2        , while MAP was not affected by oxygen desaturation or K ATP  blockade. A smaller increase in ICABF (ΔBGB: 36 ± 23 vs. ΔAGB 11 ± 18%, p = 0.019) but not in VABF (∆BGB 26 ± 21 vs. ∆AGB 27 ± 27%, p = 0.893) was observed during the hypoxic trial under K ATP  channels blockade. Thus, IHX-induced increases in tCBF (∆BGB 32 ± 19 vs. ∆AGB 14 ± 13%, p = 0.012) and CDO 2  relative changes (∆BGB 7 ± 13 vs. ∆AGB -6 ± 14%, p = 0.048) were attenuated during the AGB hypoxic trial. In a separate protocol, 6 healthy men (5 from protocol 1) underwent a 5-min exposure to normoxia and IHX before and 3 h after placebo (5 mg of cornstarch) ingestion. IHX reduced  S   a   O   2        and  P   a   O   2        , but placebo did not affect the ICABF, VABF, tCBF, or CDO 2  responses. Therefore, in humans, K ATP  channels activation modulates vascular tone in the anterior rather than the posterior circulation of the brain, contributing to tCBF and CDO 2  responses to hypoxia.",2020,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","['6\xa0healthy men (5 from protocol 1) underwent', 'Nine healthy men', 'humans']","['normoxia and isocapnic hypoxia (IHX, 10% O 2  ) before (BGB) and 3\xa0h after glibenclamide ingestion (AGB', 'IHX', 'KATP channels blockade', '5-min exposure to normoxia and IHX before and 3\xa0h after placebo (5\xa0mg of cornstarch) ingestion', 'KATP channels', 'placebo']","['anterior circulation and total cerebral perfusion', 'ICABF', 'human cerebral blood flow (CBF', 'tCBF', 'Mean arterial pressure (MAP), arterial saturation (SaO 2  ), oxygen (PaO 2  ) and carbon dioxide (PaCO 2  ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2', 'cerebral blood flow (CBF', 'cerebral blood flow and oxygen delivery', 'ICABF, VABF, tCBF, or CDO 2  responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}]",9.0,0.0504265,"IHX reduced SaO 2  and PaO 2  , but placebo did not affect ICABF, VABF, tCBF, or CDO 2  responses.","[{'ForeName': 'Marcos P', 'Initials': 'MP', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'Mattos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Mansur', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Helena N M', 'Initials': 'HNM', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, The Copenhagen Muscle Research Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Antonio C L', 'Initials': 'ACL', 'LastName': 'Nóbrega', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brazil.'}]",The Journal of physiology,['10.1113/JP279751']
554,32460511,"Ultra-low-dose CT-guided lung biopsy in clinic: radiation dose, accuracy, image quality, and complication rate.","BACKGROUND


Computed tomography (CT)-guided percutaneous lung biopsy is usually performed by helical scanning. However, there are no studies on radiation dose, diagnostic accuracy, image quality, and complications based on axial scan mode.
PURPOSE


To determine radiation dose, accuracy, image quality, and complication rate following an ultra-low-dose (ULD) protocol for CT-guided lung biopsy in clinic.
MATERIAL AND METHODS


A total of 105 patients were enrolled to receive CT-guided lung biopsy. The use of an ULD protocol (axial scan) for CT-guided biopsy was initiated. Patients were randomly assigned to axial mode (Group A) and conventional helical mode (Group B) CT groups. 64-slice CT was performed for CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle. The radiation dose, accuracy, image quality, and complication rate were measured.
RESULTS


Ninety-seven patients were selected for the final phase of the study. There was no significant difference between the two groups for pulmonary nodule characteristics ( P  > 0.05). The mean effective dose in group A (0.077 ± 0.010 mSv) was significantly reduced relative to group B (0.653 ± 0.177 mSv,  P  < 0.001). There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
CONCLUSION


An ULD protocol for CT-guided lung nodule biopsy yields a reduction in the radiation dose without significant change in the accuracy, image quality, and complication rate relative to the conventional helical mode scan.",2021,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","['Ninety-seven patients were selected for the final phase of the study', '105 patients were enrolled to receive']","['Computed tomography (CT)-guided percutaneous lung biopsy', 'ultra-low-dose (ULD) protocol for CT-guided lung biopsy', 'CT-guided pulmonary biopsy with an 18-G coaxial cutting biopsy needle', 'CT-guided lung biopsy', 'ULD protocol (axial scan', 'Ultra-low-dose CT-guided lung biopsy', 'conventional helical mode (Group B']","['accuracy, image quality, and complication rate relative', 'pulmonary nodule characteristics', 'accuracy, image quality, and complication rate', 'radiation dose, accuracy, image quality, and complication rate']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456637', 'cui_str': '18G'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0181960', 'cui_str': 'Biopsy needle'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",105.0,0.0266202,"There was no significant difference in accuracy, image quality, and complication rate ( P  > 0.050) between the two modes.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, PR China.""}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185120917622']
555,32472255,The effect of radiotherapy delivery time and obturation materials on the fracture resistance of mandibular premolars.,"OBJECTIVES


This ex vivo study was performed to investigate the effect of radiotherapy (RT) delivery time on fracture resistance of mandibular premolars filled with Biodentine or gutta-percha/sealer (GPS).
MATERIALS AND METHODS


Seventy-two mandibular premolars were used in this study. Randomly selected 24 teeth were kept intact for the control groups (with and without irradiation). Then, the remaining 48 teeth were randomly assigned into 4 groups (n = 12) according to RT delivery time (irradiated before or after root canal treatment) and obturation materials as follows: Group RT + GPS, Group: GPS + RT, Group RT + Biodentine and Group Biodentine + RT. The samples were either initially endodontically treated and then irradiated or initially irradiated and then endodontically treated with one of the abovementioned materials. The samples were irradiated at 2 Gy per fraction, 5 times a week for a total dose of 60 Gy in 30 fractions over 6 weeks. The roots were embedded in self-polymerizing acrylic resin. The fracture resistance was evaluated in a universal testing machine. Data was analyzed by one-way ANOVA and Games-Howell post hoc test at p < 0.05.
RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05). The highest fracture resistance was observed in intact/non-irradiated teeth and the lowest fracture resistance in Biodentine + RT group (p < 0.05). The effect of RT delivery time was insignificant when GPS was preferred as the root canal filling material (p > 0.05); it was significant when preferring Biodentine (p < 0.05). When RT was applied to the teeth after Biodentine obturation, the fracture resistance decreased significantly compared to the teeth that were obturated with GPS after or before RT application (p < 0.05).
CONCLUSION


Both RT time and obturation materials (Biodentine or gutta-percha/sealer) affect the fracture resistance of the endodontically treated teeth.
CLINICAL RELEVANCE


Endodontic treatment could be completed with both materials after RT; however, when the endodontic treatment was initially completed and the teeth were subsequently exposed to RT, it was shown that the reinforcement effect of Biodentine decreased.",2021,"RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05).","['Seventy-two mandibular premolars', 'remaining 48 teeth', 'fracture resistance of mandibular premolars filled with Biodentine or gutta-percha/sealer (GPS', 'mandibular premolars']","['RT delivery time (irradiated before or after root canal treatment) and obturation materials as follows: Group RT + GPS, Group: GPS + RT, Group RT + Biodentine and Group Biodentine + RT', 'Biodentine + RT', 'radiotherapy', 'radiotherapy (RT']","['fracture resistance of intact teeth', 'RT delivery time', 'fracture resistance', 'root canal filling material', 'highest fracture resistance']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450439', 'cui_str': 'Obturation material'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0205250', 'cui_str': 'High'}]",24.0,0.0135154,"RESULTS


Radiation therapy significantly reduced fracture resistance of intact teeth (p < 0.05).","[{'ForeName': 'Sevinç', 'Initials': 'S', 'LastName': 'Aktemur Türker', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Zonguldak Bülent Ecevit University, Zonguldak, Turkey. sevincaktemur@hotmail.com.'}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Kaşıkçı', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Zonguldak Bülent Ecevit University, Zonguldak, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Uzunoğlu Özyürek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Keziban', 'Initials': 'K', 'LastName': 'Olcay', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Elmas', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Zonguldak Bülent Ecevit University , Zonguldak, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03378-2']
556,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND


Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities.
METHODS


Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response.
RESULTS


We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus.
LIMITATIONS


Only young Chinese males without any trauma experience were recruited in this study.
CONCLUSIONS


The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123']
557,32469819,Short and Long-Term Effects of Cannabis on Symptoms of Post-Traumatic Stress Disorder.,"BACKGROUND


Many individuals use cannabis to manage symptoms of post-traumatic stress disorder (PTSD), and evidence indicates that the endocannabinoid system represents a viable target for treating these symptoms.
METHOD


Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time. This sample collectively used the app 11,797 times over 31 months to track PTSD-related symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety) immediately before and after inhaling cannabis. Latent change score models were used to examine changes in symptom severity and predictors of these changes (gender, dose, cannabis constituents, time). Multilevel models were used to explore long-term consequences of repeatedly using cannabis to manage these symptoms.
RESULTS


All symptoms were reduced by more than 50% immediately after cannabis use. Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions. Higher doses of cannabis predicted larger reductions in intrusions and anxiety, and dose used to treat anxiety increased over time. Baseline severity of all symptoms remained constant across time.
LIMITATIONS


The sample was self-selected, self-identified as having PTSD, and there was no placebo control group.
CONCLUSIONS


Cannabis provides temporary relief from PTSD-related symptoms. However, it may not be an effective long-term remedy as baseline symptoms were maintained over time and dose used for anxiety increased over time, which is indicative of development of tolerance.",2020,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","['Data from 404 medical cannabis users who self-identified as having PTSD were obtained from Strainprint®, a medical cannabis app that patients use to track changes in symptoms as a function of different strains and doses of cannabis across time']",['Cannabis'],"['intrusions and irritability', 'symptom relief', 'intrusions and anxiety, and dose used to treat anxiety', 'symptoms (intrusive thoughts, flashbacks, irritability, and/or anxiety']","[{'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0558066', 'cui_str': 'Intrusive thoughts'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}]",,0.0308863,"Time predicted larger decreases in intrusions and irritability, with later cannabis use sessions predicting greater symptom relief than earlier sessions.","[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Glodosky', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Bonn-Miller', 'Affiliation': 'The University of Pennsylvania Perelman School of Medicine, Department of Psychiatry, 3535 Market Street, Suite 500, Philadelphia, PA 19104.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, P.O. Box 644820, Pullman, WA, USA, 99164-4820. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.132']
558,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES


Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults.
METHODS


Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual.
RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)].
DISCUSSION


The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS


Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054']
559,32609847,Exploratory Analyses of the Popularity and Efficacy of Four Behavioral Methods of Gradual Smoking Cessation.,"INTRODUCTION


Around half of smokers attempt to stop by cutting-down first. Evidence suggests that this results in similar quit rates to abrupt quitting. Evidence for the effectiveness and popularity of different gradual cessation methods is sparse.
METHODS


Secondary, exploratory, analyses of a randomized trial of gradual versus abrupt smoking cessation. Gradual participants (N = 342) chose between four methods of cutting-down over 2 weeks: cutting-out the easiest cigarettes first (HR-E); cutting-out the most difficult cigarettes first (HR-D); smoking on an increasing time schedule (SR); and not smoking during particular periods (SFP). Nicotine replacement therapy and behavioral support were provided before and after quit day. We used logistic and linear regression modeling to test whether the method chosen was associated with smoking reduction, quit attempts, and abstinence, while adjusting for potential confounders.
RESULTS


Participants were on average 49 years old, smoked 20 cigarettes per day, and had a Fagerstrom Test for Cigarette Dependence score of 6. 14.9% (51/342) chose HR-E, 2.1% (7/342) HR-D, 46.2% (158/342) SFP, and 36.8% (126/342) SR. We found no evidence of adjusted or unadjusted associations between method and successful 75% reduction in cigarette consumption, reduction in percentage cigarettes per day or exhaled carbon monoxide, quit attempts, or abstinence at 4-week or 6-month follow-up.
CONCLUSIONS


Future research and practice could focus more heavily on the SR and SFP methods as these appeared notably more popular than HR. There was substantial imprecision in the efficacy data, which should be treated with caution; however, none of the gradual cessation methods showed clear evidence of being more efficacious than others.
IMPLICATIONS


There is evidence that people who would like to quit smoking gradually should be supported to do so. However, as this is relatively new thinking and there is large potential for variation in methods, guidance on the best way to offer support is sparse. This article is an exploratory analysis of the popularity and efficacy of various methods in an attempt to move the topic forward and inform the implementation of gradual smoking cessation methods in practice. The identified popularity of some methods over others signposts directions for future research.",2020,"We used logistic and linear regression modelling to test whether method chosen was associated with smoking reduction, quit attempts, and abstinence, whilst adjusting for potential confounders.
","['Participants were on average 49 years old, smoked 20 cigarettes per day, and had an FTCD of 6']","['Nicotine replacement therapy', 'cutting-out the easiest cigarettes first (HR-E); cutting-out the most difficult cigarettes first (HR-D); smoking on an increasing time schedule (SR); and not smoking during particular periods (SFP']","['cigarette consumption, reduction in percentage cigarettes per day or exhaled carbon monoxide, quit attempts, or abstinence']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0075029', 'cui_str': 'spleen fibrinolytic proteinase (human)'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0340359,"We used logistic and linear regression modelling to test whether method chosen was associated with smoking reduction, quit attempts, and abstinence, whilst adjusting for potential confounders.
","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lindson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa123']
560,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND


Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD.
METHODS


Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention.
RESULTS


The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected.
LIMITATIONS


The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study.
CONCLUSIONS


Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007']
561,32613634,Evidence for improved systemic and local vascular function after long-term passive static stretching training of the musculoskeletal system.,"KEY POINTS


Vascular function and arterial stiffness are important markers of cardiovascular health and cardiovascular co-morbidity. Transitional phases of hypoemia and hypermia, with consequent fluctuations in shear rate, occuring during repetitive passive stretching adminstration (passive stretching training) may constitute an effective stimulus to induce an amelioration in vascular function, arterial stiffness and vascular remodelling by improving central and local blood flow control mechanisms. Vascular function, arterial stiffness and vascular remodelling were evaluated before and after 12 weeks of passive stretching training and after 6 weeks from training cessation, in the femoral, popliteal (treated with stretching), and brachial arteries (untreated) of both sides. After passive stretching training, vascular function and arterial remodelling improved, and arterial stiffness decreased in all the arteries, suggesting modifications of both central and local blood flow control mechanisms. Passive stretching-induced improvements related to central mechanisms seemed to have a short duration, as they returned to pre-training baseline within 6 weeks from training cessation, whereas those more related to a local mechanism persisted in the follow-up.
ABSTRACT


Acute passive stretching (PS) effects on blood flow (  Q   ̇    ), shear rate (  Y   ̇    ), and vascular function in the feeding arteries of the stretched muscle have been extensively investigated; however, few data are available on vascular adjustments induced by long-term PS training. We investigated the effects of PS training on vascular function and stiffness of the involved (femoral and popliteal) and uninvolved (brachial) arteries. Our hypothesis was that PS-induced changes in  Q   ̇    and  Y   ̇    would improve central and local mechanisms of  Q   ̇    control. Thirty-nine participants were randomly assigned to bilateral PS (n = 14), monolateral PS (n = 13) or no PS training (n = 12). Vascular function was measured before and after 12 weeks of knee extensor and plantar flexor muscles' PS training by single passive limb movement and flow-mediated dilatation (FMD). Central (carotid-femoral artery PWV, PWV CF  ) and peripheral (carotid-radial artery PWV, PWV CR  ) arterial stiffness was measured by pulse-wave velocity (PWV), together with systolic (SBP) and diastolic (DBP) blood pressure. After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ  Q   ̇    , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups. A decrease in PWV CF  , PWV CR  , SBP and DBP (-25%, -17%, -4% and -8%, respectively; P < 0.05) was noted. No changes occurred in controls. Vascular function improved and arterial stiffness reduced in the arteries involved and uninvolved with PS training, suggesting modifications in both central and local  Q   ̇    control mechanisms. PS-induced improvements had a short duration in some of vascular function parameters, as they returned to baseline within 6 weeks of PS training cessation.",2020,"After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ  Q   ̇    , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups.",['Thirty-nine participants'],"['bilateral PS', 'repetitive passive stretching adminstration (passive stretching training', 'passive stretching training', 'monolateral PS (n\xa0=\xa013) or no PS training', 'PS training']","['pulse-wave velocity (PWV), together with systolic (SBP) and diastolic (DBP) blood pressure', 'blood flow (  Q   ̇    ), shear rate (  Y   ̇    ), and vascular function', 'vascular function and arterial remodelling improved, and arterial stiffness', 'Vascular function improved and arterial stiffness', 'systemic and local vascular function', 'vascular function and stiffness of the involved (femoral and popliteal) and uninvolved (brachial) arteries', 'Vascular function', 'Central (carotid-femoral artery PWV, PWV CF  ) and peripheral (carotid-radial artery PWV, PWV CR  ) arterial stiffness', 'cardiovascular health and cardiovascular co-morbidity', 'Vascular function, arterial stiffness and vascular remodelling', 'PWV CF  , PWV CR  , SBP and DBP ', 'vascular function parameters']","[{'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",39.0,0.0690637,"After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ  Q   ̇    , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bisconti', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cè', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Internal Medicine, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Limonta', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Doria', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rampichini', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}]",The Journal of physiology,['10.1113/JP279866']
562,32398324,"Combination of PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab, in Recurrent Ovarian Cancer: a Proof-of-Concept Phase II Study.","PURPOSE


Preclinical studies suggest PARP inhibition (PARPi) induces immunostimulatory micromilieu in ovarian cancer thus complementing activity of immune checkpoint blockade. We conducted a phase II trial of PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies and blood samples to test this hypothesis.
PATIENTS AND METHODS


In a single-center, proof-of-concept phase II study, we enrolled women aged ≥18 with recurrent ovarian cancer. All patients were immune checkpoint inhibitor-naïve and had measurable disease per RECISTv1.1, ECOG performance status 0-2, and adequate organ and marrow function. Patients received olaparib 300 mg twice daily and durvalumab 1,500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Primary endpoint was overall response rate (ORR). Secondary objectives were safety and progression-free survival (PFS). Translational objectives included biomarker evaluation for relationships with clinical response and immunomodulatory effects by treatment.
RESULTS


Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77%)] received at least one full cycle of treatment. ORR was 14% [5/35; 95% confidence interval (CI), 4.8%-30.3%]. Disease control rate (PR+SD) was 71% (25/35; 95% CI, 53.7%-85.4%). Treatment enhanced  IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes, indicating an immunostimulatory environment. Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
CONCLUSIONS


The PARPi and anti-PD-L1 combination showed modest clinical activity in recurrent ovarian cancer. Our correlative study results suggest immunomodulatory effects by olaparib/durvalumab in patients and indicate that VEGF/VEGFR pathway blockade would be necessary for improved efficacy of the combination.",2020,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","['recurrent ovarian cancer', 'enrolled women aged ≥18 with recurrent ovarian cancer', 'Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77', 'Recurrent Ovarian Cancer']","['olaparib 300 mg twice daily and durvalumab', 'PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies', 'PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab', 'PARP inhibition (PARPi']","['IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes', 'Disease control rate (PR+SD', 'overall response rate (ORR', 'safety and progression-free survival (PFS', 'ORR', 'elevated VEGFR3 levels', 'Increased IFNγ production']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3657407', 'cui_str': 'vegfr3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",35.0,0.174604,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","[{'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Lampert', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zimmer', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Padget', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cimino-Mathews', 'Affiliation': 'Department of Pathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Jayakumar R', 'Initials': 'JR', 'LastName': 'Nair', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hodge', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Nichols', 'Affiliation': 'Clinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bagheri', 'Affiliation': 'Department of Radiology and Imaging Sciences, Clinical Center, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, NIH Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Radke', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Lipkowitz', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Annunziata', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Taube', 'Affiliation': 'Department of Dermatopathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. leej6@mail.nih.gov.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0056']
563,32590411,An Isolated Transosseous Flexible Suture Frame in the Treatment of Patellar Tendon Rupture Provides Adequate Mechanical Resistance.,"INTRODUCTION


Acute patellar tendon ruptures are frequently observed in patients with metabolic comorbidities, and the benchmark treatment is surgical repair. It is desirable not to harm an already fragile biologic environment with sutures and hardware. We aimed to compare the mechanical requirements of an isolated, flexible, high-strength nonabsorbable transosseous suture frame with that of the Krackow suture technique.
METHODS


A total of 12 cadaveric pieces were randomized into two groups: the isolated flexible frame group (n = 6) and the standard Krackow fixation group (n = 6). A traumatic rupture of the patellar tendon was performed, and a transosseous displacement sensor was installed on a validated biomechanical system. Gap formation was measured during 50 cycles of flexion and extension with traction on the quadriceps (250 N). Subsequently, specimens underwent progressive loading in a fixed flexion position until failure occurred. The data were analyzed using nonparametric statistical tools with a significance level of 5%.
RESULTS


The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01). No significant difference existed in the median failure end points of the two groups (676 and 530 N, respectively; P = 0.11).
DISCUSSION


Patellar tendon repair using an isolated, transosseous, flexible, suture frame outperformed using the traditional Krakow repair technique in gap formation. Further studies are needed to determine if this will result in better functional outcomes or fewer clinical failures.
LEVEL OF EVIDENCE


Level IV, experimental case series.",2021,The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01).,"['patients with metabolic comorbidities', '12 cadaveric pieces']","['Krackow suture technique', 'standard Krackow fixation']","['Gap formation', 'median failure end points', 'smaller gap formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.0456217,The isolated frame group had a smaller gap formation (1.7 mm) than the Krackow group (3.4 mm; P = 0.01).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Besa', 'Affiliation': 'From the Department of Orthopedic Surgery, Pontificia Universidad Católica de Chile (Dr. Besa, Dr. Irarrázaval, and Dr. M. Orrego), the School of Medicine, Universidad de Los Andes Santiago, Chile (Dr. F. Orrego and Dr. Cariola), the Department of Orthopedic Surgery, School of Medicine, Universidad de los Andes Santiago, Chile (Dr. Telias and Dr. Amenábar), and the Integrative Biomechanics and Physiology of Strain Laboratory (LIBFE), School of Kinesiology, Universidad de los Andes (Dr. Guzmán-Venegas and Mr. Palma), Santiago, Chile.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Telias', 'Affiliation': ''}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Orrego', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Guzmán-Venegas', 'Affiliation': ''}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Cariola', 'Affiliation': ''}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Amenábar', 'Affiliation': ''}, {'ForeName': 'Felipe H', 'Initials': 'FH', 'LastName': 'Palma', 'Affiliation': ''}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Irarrázaval', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Orrego', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00509']
564,32613433,Evaluation of local hemostatic efficacy after dental extractions in patients taking antiplatelet drugs: a randomized clinical trial.,"OBJECTIVES


The purpose of this study was to evaluate clinical efficacy of four different local hemostatics in patients taking oral antiplatelet therapy, after multiple dental extractions without discontinuing drugs.
MATERIALS AND METHODS


Study sample included 102 patients (mean age 64.1 ± 17.4 years) in treatment with oral antiplatelet agents needing multiple dental extractions. After surgery, the sockets were randomly sealing with suture alone (control group), hemostatic plug (HEM), advanced platelet-rich fibrin (A-PRF+), and leukocyte-platelet-rich fibrin (L-PRF). Primary outcomes were post-operative bleeding, wound healing index, and possible complications. Secondary outcomes were correlation between primary outcomes and patient's comorbidities and voluptuous habits. Descriptive statistics, bivariate comparisons, and logistic regression analysis were performed (p < 0.05).
RESULTS


Both A-PRF+ and L-PRF showed a reduced bleeding risk when compared with suture alone (OR = 0.09, p = 0.001 for A-PRF+; OR = 0.09, p = 0.005 for L-PRF). Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019). Patients affected by hypertension (OR 3.91, p = 0.015) and diabetes (OR 3.24, p = 0.026) had the highest bleeding risk. Smoking (OR 4.30, p = 0.016) and diabetes (OR 3.79, p = 0.007) interfered with healing process.
CONCLUSION


L-PRF and A-PRF represent a valid alternative to the traditional hemostatics, reducing post-surgical bleeding and promoting wound healing.
CLINICAL RELEVANCE


In patients taking antiplatelet drugs, different local hemostatics are useful to control potential post-operative bleeding and to favor wound healing. However, comorbidities and voluptuous habits may increase bleeding risk, interfering with healing process.",2021,"Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019).","['Study sample included 102 patients (mean age 64.1 ± 17.4 years) in treatment with oral antiplatelet agents needing multiple dental extractions', 'patients taking oral antiplatelet therapy, after multiple dental extractions without discontinuing drugs', 'patients taking antiplatelet drugs']","['suture alone (control group), hemostatic plug (HEM), advanced platelet-rich fibrin (A-PRF+), and leukocyte-platelet-rich fibrin']","['highest bleeding risk', ""patient's comorbidities and voluptuous habits"", 'bleeding risk', 'reduced risk for incomplete wound healing', 'Smoking (OR', 'post-operative bleeding, wound healing index, and possible complications', 'local hemostatic efficacy', 'hypertension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3653417', 'cui_str': 'Local hemostatics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",102.0,0.0402847,"Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019).","[{'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Brancaccio', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Barone', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bennardo', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Leonzio', 'Initials': 'L', 'LastName': 'Fortunato', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Amerigo', 'Initials': 'A', 'LastName': 'Giudice', 'Affiliation': 'Department of Health Sciences, Magna Graecia University of Catanzaro, Viale Europa, 88100, Catanzaro, Italy. a.giudice@unicz.it.'}]",Clinical oral investigations,['10.1007/s00784-020-03420-3']
565,32490650,The effect of sacrospinous ligament fixation during vaginal hysterectomy on postoperative de novo stress incontinence occurrence: a prospective study with 2-year follow-up,"Background/aim


To investigate the risk of de novo stress urinary incontinence (SUI) occurrence in women who were treated for pelvic organ prolapse (POP) with sacrospinous ligament fixation (SSLF) in addition to vaginal hysterectomy (VAH) and antero-posterior colporrhaphy (CAP) over a 24-month follow-up period.
Materials and methods


A prospective randomized study was designed. Women without occult or obvious SUI were randomized into either one of the study groups: Group 1: VAH + CAP, and Group 2: VAH + CAP + SSLF. Postoperatively, the patients were reevaluated for de novo SUI occurrence.
Results


A total of 150 women were analyzed [G1 = VAH + CAP (n: 77) and G2 = VAH + CAP + SSLF (n: 73)]. Mean age, parity, body mass index, menopausal status, and preoperative POP degree, grade 1 and grade 2-3 cystocele and rectocele frequencies were similar between the 2 groups. During follow-up period, de novo SUI developed in 7 patients (9.1%) of Group 1, and in 6 patients (8.2%) of Group 2 (P > 0.05). In Groups 1 and 2, POP recurrence occurred in 5 (6.4%) vs. 1 (1.3%) cases,respectively (P < 0.05).
Conclusion


In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI. Careful patient selection, and informing the patients about the risks and benefits of the planned surgical procedure are essential steps in each case of POP.",2020,"In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI.","['Women without occult or obvious SUI', 'A total of 150 women were analyzed [G1=VAH+CAP (n:77) and G2= VAH+CAP+SSLF (n:73', 'women who were treated for pelvic organ prolapse (POP) with', 'patients undergoing surgery for POP']","['Group1: VAH+CAP, and Group2: VAH+CAP+SSLF', 'sacrospinous ligament fixation (SSLF', 'vaginal hysterectomy (VAH) and antero-posterior colporrhaphy (CAP', 'sacrospinous ligament fixation', 'vaginal hysterectomy']","['POP recurrence', 'Mean age, parity, body mass index, menopausal status, and preoperative POP degree, grade 1 and grade 2-3 cystocele and rectocele frequencies', 'postoperative de-novo stress incontinence occurrence', 'rate of de novo SUI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0195230', 'cui_str': 'Posterior repair of vagina'}, {'cui': 'C0009416', 'cui_str': 'Suture of vagina'}]","[{'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0010695', 'cui_str': 'Cystocele'}, {'cui': 'C0149771', 'cui_str': 'Herniation of rectum into vagina'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",150.0,0.0426981,"In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI.","[{'ForeName': 'Eralp', 'Initials': 'E', 'LastName': 'Başer', 'Affiliation': 'Department of Obstetrics and Gynecology, Liv Hospital Ulus, İstanbul, Turkey'}, {'ForeName': 'Kerem Doğa', 'Initials': 'KD', 'LastName': 'Seçkin', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, İstanbul Health Sciences University, Kanuni Sultan Süleyman Training and Research Hospital, İstanbul, Turkey'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Kadiroğullari', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Acıbadem University, İstanbul, Turkey'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Kiyak', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, İstanbul Health Sciences University, Kanuni Sultan Süleyman Training and Research Hospital, İstanbul, Turkey'}]",Turkish journal of medical sciences,['10.3906/sag-2005-117']
566,32591310,Machine-Learning-Based In-Hospital Mortality Prediction for Transcatheter Mitral Valve Repair in the United States.,"BACKGROUND


Transcatheter mitral valve repair (TMVR) utilization has increased significantly in the United States over the last years. Yet, a risk-prediction tool for adverse events has not been developed. We aimed to generate a machine-learning-based algorithm to predict in-hospital mortality after TMVR.
METHODS


Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database. The study population was randomly divided into a training set (n = 636) and a testing set (n = 213). Prediction models for in-hospital mortality were obtained using five supervised machine-learning classifiers.
RESULTS


A total of 849 TMVRs were analyzed in our study. The overall in-hospital mortality was 3.1%. A naïve Bayes (NB) model had the best discrimination for fifteen variables, with an area under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80-0.87), compared to 0.77 for logistic regression (95% CI, 0.58-0.95), 0.73 for an artificial neural network (95% CI, 0.55-0.91), and 0.67 for both a random forest and a support-vector machine (95% CI, 0.47-0.87). History of coronary artery disease, of chronic kidney disease, and smoking were the three most significant predictors of in-hospital mortality.
CONCLUSIONS


We developed a robust machine-learning-derived model to predict in-hospital mortality in patients undergoing TMVR. This model is promising for decision-making and deserves further clinical validation.",2021,The overall in-hospital mortality was 3.1%.,"['A total of 849 TMVRs', 'Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database', 'patients undergoing TMVR']","['machine-learning-based algorithm', 'Transcatheter mitral valve', 'repair']",['hospital mortality'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",849.0,0.053033,The overall in-hospital mortality was 3.1%.,"[{'ForeName': 'Dagmar F', 'Initials': 'DF', 'LastName': 'Hernandez-Suarez', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, PR, USA. Electronic address: dagmar.hernandez@upr.edu.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Ranka', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Yeunjung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Wiley', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lopez-Candales', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Duane S', 'Initials': 'DS', 'LastName': 'Pinto', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maday C', 'Initials': 'MC', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ramakrishna', 'Affiliation': 'Division of Cardiovascular and Thoracic Anesthesiology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sanina', 'Affiliation': 'Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.'}, {'ForeName': 'Brenda G', 'Initials': 'BG', 'LastName': 'Nieves-Rodriguez', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Jovaniel', 'Initials': 'J', 'LastName': 'Rodriguez-Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Feliu Maldonado', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Israel J', 'Initials': 'IJ', 'LastName': 'Rodriguez-Ruiz', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Istoni', 'Initials': 'I', 'LastName': ""da Luz Sant'Ana"", 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}, {'ForeName': 'Karlo A', 'Initials': 'KA', 'LastName': 'Wiley', 'Affiliation': 'College of Agriculture and Life Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cox-Alomar', 'Affiliation': 'Division of Cardiology, Department of Medicine, Louisiana State University, New Orleans, LA, USA.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Villablanca', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Abiel', 'Initials': 'A', 'LastName': 'Roche-Lima', 'Affiliation': 'Center for Collaborative Research in Health Disparities, University of Puerto Rico School of Medicine, San Juan, PR, USA.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.06.017']
567,32595160,Protocol for creating new warnings on cigarette packs and evaluating their efficacy in a randomised experimental setting.,"INTRODUCTION


Tobacco smoking is one of the leading causes of preventable death. This is not inevitable as tobacco control tools have become more powerful and more effective. Among these, warnings on cigarette packs have proven to be somewhat effective. Our objective is to increase the efficacy of antismoking warnings by using innovative psychological approaches and to create an experimental setting for the evaluation of these new warnings based on behavioural indicators.
METHODS AND ANALYSIS


First, we created new warnings based on three categories of motivational leverage and on harm reduction. New warnings with innovative texts and pictures were designed for each category and inserted on plain packs. We will then use standard indicators to compare their effect to that of control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning. Second, the novelty of our approach will consist in designing an experimental protocol that uses monetary incentives to evaluate the effect of warnings. Subjects will be able to 'sacrifice' part of their participation defrayal to purchase a good whose subjective value is related to one's attitude towards smoking. These monetarily incentivised measures are designed to assess smokers' immediate/mid-term intention to quit and non-smokers' aversion to smoking. In both cases, the monetary amounts individuals accept to sacrifice may be a more reliable measure than declarative responses, which may be distorted by several hypothetical biases. In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
ETHICS AND DISSEMINATION


The ethics committee of the  Groupement des Hôpitaux de l'Institut Catholique de Lille  approved the research protocol on 5 July 2019 (CIER 2019-22). Results will be presented at scientific meetings and published.",2020,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
",[],"['control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning']",[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.014774,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ben Lakhdar', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France christian.ben-lakhdar@univ-lille.fr.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Deplancke', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Le Lec', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Massin', 'Affiliation': 'LEM UMR 9221 CNRS, Artois University, Arras, Hauts-de-France, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Piermatteo', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vaillant', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France.'}]",BMJ open,['10.1136/bmjopen-2019-036166']
568,32595159,Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol.,"INTRODUCTION


Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and  Clostridioides difficile -associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic  Lactobacillus rhamnosus  GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU.
METHODS AND ANALYSIS


The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  L. rhamnosus  GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer's perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital 'hoteling' costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach.
ETHICS AND DISSEMINATION


Study approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT01782755; Pre-results.",2020,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  ,"['critically ill patients admitted to the ICU', 'critically ill patients']","['probiotic  Lactobacillus rhamnosus  GG with usual care versus usual care without probiotics', 'L. rhamnosus  GG plus usual care versus usual care without probiotics', 'PROSPECT (Probiotics']",['incremental cost per VAP'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.217057,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  ,"[{'ForeName': 'Vincent Issac', 'Initials': 'VI', 'LastName': 'Lau', 'Affiliation': 'Department of Critical Care, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada vinceissaclau@gmail.com.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Institute, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Johnstone', 'Affiliation': 'Public Health Ontario, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Centre de Recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Basmaji', 'Affiliation': 'Department of Medicine, Division of Critical Care, Western University, London, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036047']
569,32580984,Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol.,"INTRODUCTION


Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care.
METHODS


Convergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms.
ANALYSIS


Investigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study.
ETHICS AND DISSEMINATION


The study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. Trial registration number NCT03867474; Pre-results.",2020,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","['Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment', ""Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418"", 'older adults living with subjective cognitive decline or mild cognitive impairment in primary care', '40 participants from an interprofessional primary care team in Toronto, Ontario']","['Mindfulness-based stress reduction (MBSR', 'MBSR group or wait-list control', 'occupational therapist-led MBSR programme', 'Occupational therapist-led mindfulness-based stress reduction']","['cognitive efficiency', 'psychological symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",40.0,0.109064,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Family Practice, Women's College Hospital, Toronto, Ontario, Canada Todd.tran@wchospital.ca.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Donnelly', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Emily Joan', 'Initials': 'EJ', 'LastName': 'Nalder', 'Affiliation': 'Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Trothen', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035299']
570,32488238,"Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial.","OBJECTIVES


To investigate the effects of applying dry needling into a trigger point (TrP) or non-TrP area in people who have suffered a stroke and to investigate if the effects of dry needling are maintained at six-week follow-up.
METHODS


A controlled, repeated-measures, crossover, double-blinded randomized trial was conducted. Nineteen patients with hemiparetic shoulder pain after a stroke event were randomly assigned to receive a single multimodal treatment session combined with TrP dry needling or non-TrP dry needling. The neuro-rehabilitation session included modulatory interventions targeting the central nervous system. Spasticity (Modified Ashworth Scale), shoulder pain intensity (numerical pain rate scale, 0-10), and upper extremity function (Motor Evaluation Scale for Upper Extremity in Stroke [MESUPES], Reaching Performance Scale [RPS]) were assessed before (baseline) and one, two, three, four, five, and six weeks after the treatment session by a blinded assessor. All participants received both sessions in a randomized order where they were followed up for six weeks before receiving the opposite treatment and then followed up for another six weeks.
RESULTS


Changes in muscle tone (all P > 0.266) and upper extremity function (MESUPES: F = 0.544, P  = 0.465; RPS close task: F = 0.820, P = 0.371; RPS far task: 0.830, P  = 0.368) were similar after both interventions at all follow-up periods. The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P  = 0.01).
CONCLUSIONS


The effect of dry needling on muscle tone (spasticity) and upper extremity function is not related to its application in or outside of a TrP area. The effect of dry needling on shoulder pain was slightly superior when applied over a TrP in poststroke people. These effects were maintained six weeks after treatment.",2020,"The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P  = 0.01).
","['people who have suffered a stroke', 'Nineteen patients with hemiparetic shoulder pain after a stroke event', 'Stroke Patients']","['dry needling', 'dry needling into a trigger point (TrP', 'single multimodal treatment session combined with TrP dry needling or non-TrP dry needling']","['muscle tone (spasticity) and upper extremity function', 'Spasticity (Modified Ashworth Scale), shoulder pain intensity (numerical pain rate scale, 0-10), and upper extremity function (Motor Evaluation Scale for Upper Extremity in Stroke [MESUPES], Reaching Performance Scale [RPS', 'muscle tone', 'upper extremity function', 'shoulder pain', 'Muscle Tone, Function, and Pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",19.0,0.133599,"The decrease in shoulder pain was higher within the TrP dry needling group as compared with the non-TrP dry needling group, particularly at two and four weeks (P  = 0.01).
","[{'ForeName': 'Alma R', 'Initials': 'AR', 'LastName': 'Hernández-Ortíz', 'Affiliation': 'Escuela Internacional de Doctorado, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Ponce-Luceño', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sáez-Sánchez', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'García-Sánchez', 'Affiliation': 'Centro de Atención Integral Para Personas con Daño Cerebral, Polibea Sur, Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'de-la-Llave-Rincón', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa132']
571,32589501,Implementing Automated Triggers to Identify Hospitalized Patients with Possible Unmet Palliative Needs: Assessing the Impact of This Systems Approach on Clinicians.,"Background:  Understanding patients' goals and values is important to ensure goal-concordant care; however, such discussions can be challenging. Little is known about the impact of having these discussions on hospitalists.  Objective:  To assess the impact on hospitalists of a system that reminds them to have serious illness conversations with their patients identified with potential unmet palliative needs.  Design:  Two group cohort trial.  Setting/Subjects:  Single academic center. Internal medicine hospitalist physicians, nurse practitioners, and physician's assistants.  Measurements:  Before the trial, all participants received serious illness conversation training. During the trial, hospitalists on intervention units received verbal notification when their recently admitted patients were identified using a computer algorithm as having possible unmet palliative needs. Hospitalists on the control unit received no notifications. At baseline and three months, hospitalists completed questionnaires regarding communication skill acquisition, perception of the importance of these conversations, and sense of the meaning gained from having them.  Results:  Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were. Neither group perceived having the discussions as being affectively harmful to patients. The intervention hospitalists, over time, reported a slight reduction in the sense of meaning they achieved from the conversations.  Conclusion:  Routinely informing hospitalists when their patients were identified as being at increased risk for unmet palliative needs did not increase the sense of meaning these providers achieved. It is likely the pretrial training accounted for many of the positive outcomes in communication skills observed in both arms of the trial.",2020,Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were.,"['Hospitalized Patients with Possible Unmet', ""Internal medicine hospitalist physicians, nurse practitioners, and physician's assistants""]",['serious illness conversation training'],"['communication skill acquisition, perception of the importance of these conversations, and sense of the meaning gained from having them']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0600620', 'cui_str': 'Hospitalist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.0407718,Both groups had similar improvements in their self-reported communication skills and experienced a small decline in how important they felt the conversations were.,"[{'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Greenwald', 'Affiliation': 'Core Educator Faculty, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Gace', 'Affiliation': 'Hospital Medicine Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Sommer', 'Affiliation': 'Center for Psychiatric Oncology and Behavioral Sciences, Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Bethany-Rose', 'Initials': 'BR', 'LastName': 'Daubman', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Leah B', 'Initials': 'LB', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'LaSala', 'Affiliation': 'Department of Nursing, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Palliative Care and Geriatric Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0161']
572,32609653,Baseline pain characteristics predict pain reduction after physical therapy in women with chronic pelvic pain. Secondary analysis of data from a randomized controlled trial.,"Background and aims Women with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome. Methods In this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0-10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group. Results Fifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was -1.2 points (95% CI -1.8 to -0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3-2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis. Conclusions We identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers. Implications Based on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women's needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.",2020,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"['Results Fifty women (mean age 38.1, SD\u2009=\u200912.2) were included in the analysis', 'participants were women with chronic pelvic pain randomized to two different', 'women with chronic pelvic pain']","['physical therapy treatments', 'physical therapy']","['pain reduction', 'change in pain intensity', 'pain intensity', 'pelvic pain duration', 'numeric rating scale', 'Baseline pain intensity', 'pelvic surgeries', 'mean pelvic pain intensity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",50.0,0.245129,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"[{'ForeName': 'Ane S', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro K', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': ""Norwegian Advisory Unit on Complex Symptom Disorders, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0026']
573,32479320,Antidepressive effect of left dorsolateral prefrontal cortex neurofeedback in patients with major depressive disorder: A preliminary report.,"Background Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) have recently attracted attention as a novel, individualized treatment method for major depressive disorder (MDD). In this study, the antidepressant effect of neurofeedback training for left dorsolateral prefrontal cortex (DLPFC) activity was examined. Methods Six patients with MDD completed 5 days of neurofeedback training sessions. In each session, the patients observed a BOLD signal within their left DLPFC as a line graph, and attempted to up-regulate the signal using the graphical cue. Primary outcome measures were clinical scales of severity of depression and rumination. Results After neurofeedback training, the clinical measures were improved significantly. In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom. Limitations Study limitations include the lack of a control group or condition, the lack of transfer run, and the small number of participants. Conclusions This small sample study suggests the possible efficacy of DLPFC activity regulation training for the treatment of MDD. As a next step, a sham-controlled randomized clinical trial is needed to confirm the antidepressive effect of left DLPFC neurofeedback.",2020,"In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom.","['Methods Six patients with MDD completed 5\xa0days of neurofeedback training sessions', 'patients with major depressive disorder']","['DLPFC activity regulation training', 'neurofeedback training', ' Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf']","['rumination symptom', 'BOLD signal', 'clinical scales of severity of depression and rumination', 'left dorsolateral prefrontal cortex (DLPFC) activity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.0291146,"In addition, patient proficiency for neurofeedback training was related significantly to the improvement of the rumination symptom.","[{'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takamura', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Chiyo', 'Initials': 'C', 'LastName': 'Shibasaki', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Yoshino', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Okada', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Yamawaki', 'Affiliation': 'Brain, Mind and KANSEI Sciences Research Center, Hiroshima University, Hiroshima, Japan; Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. Electronic address: yamawaki@hiroshima-u.ac.jp.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.080']
574,32479321,"Appraising esketamine nasal spray for the management of treatment-resistant depression in adults: Number needed to treat, number needed to harm, and likelihood to be helped or harmed.","INTRODUCTION


This post hoc study assessed the evidence-base for esketamine nasal spray for management of treatment-resistant depression (TRD) using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).
METHODS


Data sources were four phase III randomized, double-blind studies including two positive studies (acute flexible-dose; maintenance) in patients with TRD. Key efficacy study outcomes: acute response (≥50% decrease from baseline on Montgomery-Asberg Depression Rating Scale [MADRS] total score), acute remission (MADRS scores ≤12). NNT, NNH were calculated for esketamine nasal spray+newly initiated oral antidepressant (esketamine+AD) vs. placebo+AD.
RESULTS


In the pivotal acute flexible-dose study, MADRS response (63.4% vs. 49.5%) and remission (48.2% vs. 30.3%) at 4 weeks resulted in NNT of 8 and 6 for esketamine+AD vs. placebo+AD. NNH values <10 included dissociation (26.1% vs. 3.7%), vertigo (26.1% vs. 2.8%), nausea (26.1% vs. 6.4%), dizziness (20.9% vs. 4.6%), and dysgeusia (24.3% vs. 11.9%). Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17. LHH comparing MADRS remission vs. discontinuation due to AE was 17 vs. 6. Maintenance use of esketamine+AD demonstrated NNT values<10 for relapse and/or maintenance of remission. In maintenance study, discontinuation due to AE (2.6% vs. 2.1%) yielded NNH=178 (non-significant).
LIMITATIONS


Only dichotomous outcomes were included.
CONCLUSION


NNT<10 for efficacy outcomes suggests potential benefit of esketamine+AD for both acute and maintenance use. LHH was favorable: esketamine+AD was 3 times likely to result in acute remission vs. discontinuations due to AE.",2020,Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17.,"['adults', 'Data sources were four phase III randomized, double-blind studies including two positive studies (acute flexible-dose; maintenance) in patients with TRD']",['AE'],"['dizziness', 'Montgomery-Asberg Depression Rating Scale [MADRS] total score), acute remission (MADRS scores ≤12', 'vertigo', 'dysgeusia', 'MADRS response', 'acute response', 'nausea', 'remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.323776,Discontinuation rates due to adverse events (AE) (7.0% vs. 0.9%) yielded NNH=17.,"[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Citrome', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY 10595, United States. Electronic address: citrome@cnsconsultant.com.'}, {'ForeName': 'Allitia', 'Initials': 'A', 'LastName': 'DiBernardo', 'Affiliation': 'Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, United States.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, LLC, 3210 Merryfield Row, San Diego, CA 92121, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.106']
575,32479328,Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population.,"BACKGROUND


Perinatal depression is a public health burden impacting mothers and their offspring. This study extended brief-Interpersonal Psychotherapy delivered during pregnancy by incorporating a postpartum attachment based dyadic-component to maintain mother's treatment gains and enhance the mother-infant relationship (called IPT-Dyad). The current report presents data from a pilot randomized controlled trial comparing IPT-Dyad to Enhanced Treatment as Usual (ETAU).
METHODS


Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible. Participants were randomized to either IPT-Dyad (n = 21) or ETAU (n = 21). Maternal and infant outcomes were assessed through one-year postpartum.
RESULTS


Participants were primarily African American (77%), single (80%), with low-incomes. Attrition was high in both groups (IPT-Dyad 30%; ETAU 40%). Depression scores improved from baseline in both groups and remained improved over the 12 month follow-up. There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
LIMITATIONS


The small sample size of this study was further reduced by attrition, despite efforts to maintain engagement. Reliance on self-report outcome measures is also a limitation.
CONCLUSIONS


IPT-Dyad may be a promising intervention for perinatal depression with potential benefit for mothers and babies. Treatment engagement and management of psychosocial needs were persistent challenges throughout the postpartum period. Further refinement of intervention content and schedule to better meet the needs and values of under-resourced mothers is needed. Earlier screening; better integration of care within OB settings; and delivering care in conjunction with social service resources may also improve outcomes.",2020,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","['perinatal depression in a low-income population', 'Participants were primarily African American (77%), single (80%), with low-incomes', 'Women, ages 18 and older, between 12-30 weeks gestation meeting criteria for a depressive disorder were eligible']","['IPT-Dyad (n\xa0=\xa021) or ETAU', 'Interpersonal Psychotherapy', 'dyadic interpersonal psychotherapy']","['Depression scores', 'parenting stress, mother-infant interactions, and infant socioemotional functioning', 'Attrition']","[{'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3658199', 'cui_str': 'Mother-Infant Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",,0.157194,"There were no between group differences on measures of parenting stress, mother-infant interactions, and infant socioemotional functioning.
","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA. Electronic address: slenze@wustl.edu.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Potts', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Campus Box 8504, 660 S Euclid, St. Louis, MO 63110, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.03.084']
576,31843232,Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).,"Little data are available regarding the determinants and prognostic significance of serum albumin in Heart Failure with Preserved Ejection Fraction (HFpEF). We sought to examine the phenotypic correlates of albumin and its independent prognostic implications in HFpEF. We analyzed data from 3,254 subjects enrolled the TOPCAT trial. We stratified subjects according to tertiles of albumin and examined differences in various phenotypic traits between these strata, including 8 protein biomarkers selected ad hoc and measured from frozen samples available in a subset of participants (n = 372). We also assessed the relationship between albumin and the trial primary endpoint. Lower albumin was associated with older age, black race, and greater prevalence of NYHA class III-IV, peripheral arterial disease, atrial fibrillation and diabetes mellitus. Lower albumin was also associated with increased levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension. Albumin was a strong predictor of the primary trial endpoint, even after adjustment for the MAGGIC risk score (hazard ratio [HR] 0.72, confidence interval [CI] 0.67 to 0.78; p <0.0001) and prespecified traditional risk factors (HR 0.78, CI 0.71 to 0.85; p <0.0001). Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease. Albumin is a powerful risk predictor independent of traditional risk prediction models, even within normal ranges.",2020,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","['3,254 subjects enrolled the TOPCAT trial', 'Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial']",[],"['levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension', 'Serum Albumin Levels']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",3254.0,0.0639009,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Prenner', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cvijic', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spires', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Yarde', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Bhattacharya', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Zamani', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Mazurek', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gordon', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.006']
577,32591869,Alveolar ridge dimensional changes after two socket sealing techniques. A pilot randomized clinical trial.,"OBJECTIVES


This pilot study aimed to assess dimensional changes following two different alveolar socket sealing techniques.
MATERIAL AND METHODS


Twenty-one patients requiring tooth extraction and implant placement were randomly allocated to two different alveolar ridge preservation techniques. In the control group, demineralized bovine bone mineral (DBBM) and a gingival soft tissue punch were used to fill and seal the socket, whereas in the test group, the extraction socket was filled with DBBM and sealed with a hemostatic gelatin sponge. Digitalized impressions were taken before and 6 months after tooth extraction. The comparison was made on horizontal and vertical dimensional changes.
RESULTS


The mean vertical loss was 0.8 ± 0.6 mm for the control group and 0.7 ± 0.5 mm for the test one. No statistical difference was found between groups for the vertical shrinkage. The horizontal dimensional narrowing of the alveolar socket was respectively 7.1/4.0/2.5 mm at levels 1, 3, and 5 mm from a coronal reference level for the control group. The test group showed dimensional changes of 4.8/2.3/1.3 mm at the three different levels, respectively. A significant difference was found at levels 3 and 5 mm. Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10). The difference was statistically highly significant (P ≤ 0.001).
CONCLUSIONS


A significant difference was found between control and test groups regarding the horizontal dimensional changes and the post-operative pain.
CLINICAL RELEVANCE


Regarding this primary result, the socket sealing technique with a hemostatic sponge provides an effective and inexpensive protocol with less post-operative pain.",2021,"Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10).",['Twenty-one patients requiring tooth extraction and implant placement'],"['alveolar ridge preservation techniques', 'DBBM and sealed with a hemostatic gelatin sponge', 'alveolar socket sealing techniques', 'demineralized bovine bone mineral (DBBM']","['horizontal dimensional changes and the post-operative pain', 'visual analog pain scale', 'horizontal dimensional narrowing of the alveolar socket', 'Alveolar ridge dimensional changes', 'severe pain', 'mean vertical loss']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0333164', 'cui_str': 'Narrow'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",21.0,0.0591021,"Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Debel', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium. maxim.debel@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Toma', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vandenberghe', 'Affiliation': 'Advimago, Center for Advanced Oral Imaging, Rue Emile Claus 42, 1050, Brussels, Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Brecx', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Lasserre', 'Affiliation': 'Department of Periodontology, Université Catholique de Louvain (UCL)-Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, 1200, Brussels, Belgium.'}]",Clinical oral investigations,['10.1007/s00784-020-03428-9']
578,32615179,Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos).,"BACKGROUND AND AIMS


Precut sphincterotomy, usually performed after prolonged and failed cannulation, is considered a risk factor for post-ERCP pancreatitis (PEP). There are limited studies on primary needle-knife precut for the prevention of PEP. The aim of this study was to assess the safety and efficacy of primary precut.
METHODS


A randomized controlled trial was conducted in a tertiary care setting on patients who underwent ERCP. Patients were randomized to very early precut (group A, precut after 2 failed attempts of wire-guided sphincterotome cannulation) and primary precut (group B, direct needle-knife precut). All procedures were done by an experienced endoscopist. The primary outcome of the study was to compare the incidence of PEP between the 2 groups.
RESULTS


Three hundred three patients were randomized to group A (n = 152, age 48.2 ± 15.4 years, 61 men) and group B (n = 151, age 46.7 ± 13.8 years, 65 men). There was no significant difference in baseline characteristics and indications for ERCP between the 2 groups. Development of PEP (5.2% vs .67%; P = .04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; P = .01) were lower in group B compared with group A. The bile duct cannulation time (13.8 ± 2.2 vs 7.2 ± 1.7 minutes; P = .001) was lower in group B, whereas the overall cannulation success rate (98% vs 98.6%; P = 1.0) was similar in both the groups.
CONCLUSIONS


Primary precut by an experienced endoscopist results in low risk of PEP. (Clinical trial registration number: CTRI/2017/08/009510.).",2021,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"['patients who underwent ERCP', 'Three hundred three patients were randomized to group A (n= 152, age 48.2±15.4 years, 61 men) and group B (n= 151, age 46.7±13.8 years, 65 men']","['wire guided sphincterotome cannulation) and primary precut (group B: direct needle-knife precut', 'Early precut versus primary precut sphincterotomy']","['asymptomatic hyperamylasemia', 'safety and efficacy', 'bile duct cannulation time', 'incidence of PEP', 'low risk of PEP', 'overall cannulation success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0183424', 'cui_str': 'Sphincterotome'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441189', 'cui_str': 'Direct needle'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0221773', 'cui_str': 'Hyperamylasaemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",303.0,0.106841,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Maharshi', 'Affiliation': 'Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India.'}, {'ForeName': 'Shyam Sunder', 'Initials': 'SS', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.064']
579,32618627,Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial.,"BACKGROUND


Perioperative pediatric anxiety is common and can have a negative psychological impact on children undergoing surgery and anesthesia. Studies have shown an incidence of anxiety at induction of up to 50%. Audiovisual distraction, including virtual reality (VR), is a noninvasive, nonpharmacological modality that may reduce perioperative anxiety. The goal of this study was to determine whether immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA) in pediatric patients reduced preoperative anxiety.
METHODS


In this randomized-controlled, parallel-group study, 71 children 5-12 years of age scheduled for elective surgery with GA were randomly allocated to a VR group or a non-VR (No VR) control group. VR group patients underwent audiovisual distraction with a VR headset during induction in the operating room, whereas the control group received no audiovisual distraction. The primary outcome was the Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety: in the preoperative holding area before randomization, on entering the operating room, and during induction of GA. The primary outcome was analyzed using univariate analysis and a linear mixed-effects model. Secondary outcomes included postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction.
RESULTS


Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female. Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients). No patients received preoperative anxiolytic medication. Baseline mYPAS scores were not different between the groups, with scores of 28.3 (23.3-28.3) (median [interquartile range {IQR}]) in both. The change in mYPAS scores from baseline to time of induction was significantly lower in the VR group versus control group (0.0 [0.0-5.0] vs 13.3 [5.0-26.7]; P < .0001). In the mixed-effects model, the VR group had an estimated 6.0-point lower mYPAS score (95% confidence interval [CI], 0.7-11.3; P = .03) at room entry than the No VR group, and 14.5-point lower score (95% CI, 9.3-19.8; P < .0001) at induction versus control. Randomization to VR did not alter parental anxiety (0 [-2 to 2]), pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 [-8 to 2]) (difference in medians [95% CI]).
CONCLUSIONS


This study demonstrates a reduction in pediatric preoperative anxiety with the use of VR. Preoperative VR may be an effective noninvasive modality for anxiolysis during induction of anesthesia in children.",2021,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"['children', 'Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female', 'children undergoing surgery and anesthesia', '71 children 5-12 years of age scheduled for elective surgery with GA', 'pediatric patients reduced preoperative anxiety']","['Anesthesia With Virtual Reality and Perioperative Anxiolysis', 'immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA', 'Audiovisual distraction, including virtual reality (VR', 'audiovisual distraction with a VR headset', 'preoperative anxiolytic medication', 'Pediatric Distraction', 'control group received no audiovisual distraction', 'VR group or a non-VR (No VR) control group']","['Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety', 'pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 ', 'postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction', 'mYPAS score', 'pediatric preoperative anxiety', 'parental anxiety', 'perioperative anxiety', 'Baseline mYPAS scores', 'mYPAS scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",71.0,0.0798988,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Libaw', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Feiner', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Jina L', 'Initials': 'JL', 'LastName': 'Sinskey', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005004']
580,32580990,"OASIS-a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol.","INTRODUCTION


Sciatica is a lower spine condition characterised by radiating leg pain below the knee. It may be accompanied by motor and sensory loss in the distribution of a spinal nerve. There are few effective treatments for sciatica. Orally administered glucocorticoids have shown some promise, however, any beneficial effects need to be confirmed and weighed against drug safety and cost-effectiveness, in a high-quality, definitive trial.
METHODS AND ANALYSIS


The Oral Steroids In Sciatica (OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica. Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments and randomised to receive orally administered prednisolone 50 mg per day, up to 3 days then tapering to cessation over 10 days, or placebo, for a maximum of 13 days, in addition to guideline advice. Participants will be followed for 1 year. The primary endpoint will be leg pain intensity at 2 weeks. Secondary outcomes will include back pain intensity, disability, time to recovery, quality of life and treatment success rate. Adverse events will be assessed and a cost-effectiveness analysis will be conducted.
ETHICS AND DISSEMINATION


Ethical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media.
TRIAL REGISTRATION NUMBER


ACTRN12619001716156.",2020,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","['200 participants with acute sciatica', 'Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments', 'patients with acute sciatica']","['oral prednisolone', 'oral glucocorticoids', 'glucocorticoids', 'prednisolone', 'placebo']","['leg pain', 'back pain intensity, disability, time to recovery, quality of life and treatment success rate', 'leg pain intensity']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",200.0,0.722215,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","[{'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia chang.liu1@sydney.edu.au.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Abdel Shaheed', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': 'Department of Clinical Pharmacology & Toxicology, St Vincent Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Richards', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040559']
581,32371537,"NSABP B-41, a Randomized Neoadjuvant Trial: Genes and Signatures Associated with Pathologic Complete Response.","PURPOSE


In NSABP B-41, pathologic complete response (pCR) was associated with prolonged survival among women with HER2-positive operable breast cancer treated with neoadjuvant chemotherapy and lapatinib, trastuzumab, or the combination. We used a large human breast cancer gene expression panel to select candidate prognostic biomarkers for pCR among women treated with trastuzumab in NSABP B-41.
PATIENTS AND METHODS


Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent. We analyzed extracted RNA using the human nCounter Breast Cancer 360 gene expression panel. Gene counts were normalized to housekeeping genes and transformed into logarithmic scale with base 2. To screen for candidate genes and metagene signatures prognostic of pCR, we used univariate logistic regression. Variable selection was done by multivariable logistic regression with lasso regularization.
RESULTS


Analyses of data from 130 patients revealed that a composite of gene expression from 19 genes and one gene signature appeared to predict pCR in women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens. The identified genes are involved in important pathways such as epithelial-mesenchymal transition, adhesion and migration, estrogen receptor signaling, DNA damage and repair, apoptosis, and proliferation. The AUC from a 10-fold cross-validation on predicting pCR, with these 20 genomic markers in a logistic regression model, was 0.73.
CONCLUSIONS


The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens. These findings need to be validated and calibrated in future studies.",2020,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","['130 patients', 'women with HER2-positive operable breast cancer treated with', 'Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent', 'human nCounter Breast Cancer 360 gene expression panel', 'women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens']","['trastuzumab', 'neoadjuvant chemotherapy and lapatinib, trastuzumab']",[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]",[],,0.0832425,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC. sms248@georgetown.edu.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Heather Ann', 'Initials': 'HA', 'LastName': 'Brauer', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goerlitz', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brent T', 'Initials': 'BT', 'LastName': 'Harris', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bandos', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0152']
582,32623524,Efficacy of ozonated water mouthwash on early plaque formation and gingival inflammation: a randomized controlled crossover clinical trial.,"OBJECTIVES


To evaluate the effect of ozonated water in early plaque formation and gingival inflammation.
MATERIALS AND METHODS


This was a randomized, controlled, double-blind, crossover clinical trial with two experimental periods of 96 h each, with 10 washout days between them. The sample consisted of 42 dental students divided into Test Group, mouthwash of ozonated water, and Control Group, bidistilled water mouthwash. The participants were instructed not to perform oral hygiene and used the assigned mouthwash under supervision once a day. For the investigation of the initial subgingival biofilm formation, the Plaque Free Zone Index was used at 24, 48, 72, and 96 h. The volume of gingival crevicular fluid, a questionnaire for taste perception assessment, and analysis of the adverse effects were also carried out.
RESULTS


The percentage of conversion scores 0 and 1 to 2 of PFZ Index, the main outcome, for all dental surfaces showed no statistical difference between Test and Control groups, with 19.07 and 19.79, respectively. Also, there was not a significant difference in the score frequencies at each time point. Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups. Test group had worse evaluation of taste perception and more adverse effects.
CONCLUSIONS


Ozonated water seems not to affect the formation of supra and subgingival biofilms, as well as gingival inflammation.
CLINICAL SIGNIFICANCE


Mouthwash with ozonated water once a day do not affect supra and subgingival biofilm formation.",2021,Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups.,['42 dental students divided into'],"['Test Group, mouthwash of ozonated water, and Control Group, bidistilled water mouthwash', 'GCF', 'ozonated water mouthwash']","['formation of supra and subgingival biofilms', 'score frequencies', 'taste perception and more adverse effects', 'early plaque formation and gingival inflammation', 'percentage of conversion scores', 'supra and subgingival biofilm formation']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3693482', 'cui_str': 'Giant cell fibroblastoma'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",42.0,0.168695,Evaluation of GCF demonstrated that both groups had an increase in volume during experimental periods and that there was no statistically significant difference among groups.,"[{'ForeName': 'Alessandra Cardoso', 'Initials': 'AC', 'LastName': 'Nicolini', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. alessandrac_nicolini@hotmail.com.'}, {'ForeName': 'Isadora Dos Santos', 'Initials': 'IDS', 'LastName': 'Rotta', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Gerson Pedro José', 'Initials': 'GPJ', 'LastName': 'Langa', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Stephanie Anagnostopoulos', 'Initials': 'SA', 'LastName': 'Friedrich', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'David Alejandro', 'Initials': 'DA', 'LastName': 'Arroyo-Bonilla', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcius Comparsi', 'Initials': 'MC', 'LastName': 'Wagner', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Weidlich', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cassiano Kuchenbecker', 'Initials': 'CK', 'LastName': 'Rösing', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Cavagni', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03441-y']
583,32633196,Swallowing Patterns in the HNC Population: Timing of Penetration-Aspiration Events and Residue.,"OBJECTIVE


This study described swallowing patterns in a large head/neck cancer (HNC) cohort.
STUDY DESIGN


In a retrospective review of data from a randomized controlled trial, we studied timing of penetration events as they related to aspiration and oral/pharyngeal residue.
SETTING


Retrospective review of a multicenter randomized controlled trial.
SUBJECTS AND METHODS


In total, 168 patients who were >3 months postradiation received baseline modified barium swallow evaluations. Retrospective analyses of data from these exams were studied, including Penetration-Aspiration Scale (PAS) scores and timing of these events (before, during, or after the swallow), as well as percentage of oral and pharyngeal residue.
RESULTS


Aspiration occurred more frequently  after  than before or during the swallow ( P  < .05). There were significantly more events of  penetration  that led to aspiration after the swallow (n = 260) when compared to events before (n = 6) or after (n = 81) the swallow. There was more pharyngeal (16%-25%) than oral residue (5%-20%). Weak correlations were found between thin liquid, nectar-thick liquid, pudding residue, and PAS scores, with varying significance (pharyngeal residue/PAS  r s : .26*, .35*, .07*; oral residue/PAS  r s : .21*, .16, .3; * P  < .05).
CONCLUSION


The predominant pattern for this sample of postradiation patients with HNC with dysphagia was aspiration that occurred after the swallow, rather than before or during the swallow. The aspiration was directly caused by penetration events that occurred during the swallow, resulting in aspiration as the airway reopened. Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events. These results guide clinicians in targeting appropriate swallowing interventions.",2020,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","['swallowing patterns in a large head/neck cancer (HNC) cohort', 'Swallowing Patterns in the HNC Population', '168 patients who were >3 months postradiation received baseline modified barium swallow evaluations']",['oral residue/PAS'],"['pharyngeal residue', 'percentage of oral and pharyngeal residue', 'Penetration-Aspiration Scale (PAS) scores and timing of these events']","[{'cui': 'C0426602', 'cui_str': 'Swallowing pattern'}, {'cui': 'C2243051', 'cui_str': 'Large head'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0203065', 'cui_str': 'Barium swallow'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",168.0,0.0169387,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Pisegna', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Langmore', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Meyer', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pauloski', 'Affiliation': 'University of Wisconsin-Milwaukee, College of Health Sciences, Comm-unication Sciences and Disorders, Milwaukee, Wisconsin, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820933883']
584,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
585,32645771,Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.,"OBJECTIVE


Nitric oxide (NO) plays several protective roles in ischemia/reperfusion (I/R) injury. Neonates undergoing the Norwood procedure are subject to develop I/R injury due to the immaturity of their organs and the potential need to interrupt or decrease systemic flow during surgery. We hypothesized that NO administration during cardiopulmonary bypass (CPB) ameliorates the I/R and could help the postoperative recovery after the Norwood procedure.
METHODS


Twenty-four neonates who underwent a Norwood procedure were enrolled in a prospective randomized blinded controlled trial to receive NO (12 patients) or placebo (12 patients) into the oxygenator of the CPB circuit during the Norwood procedure. Markers of I/R injury were collected at baseline (T0), after weaning from CPB before modified ultrafiltration (T1), after modified ultrafiltration (T2), and at 12 hours (T3) and 24 hours (T4) after surgery, and they were compared between both groups, as well as other postoperative clinical variables.
RESULTS


There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups. Troponin levels were lower in the study group at T1 (0.62 ± 58 ng/mL vs 0.87 ± 0.58 ng/mL,  P  = .31) and became significantly lower at T2 (0.36 ± 0.32 ng/mL vs 0.97 ± 0.48 ng/mL,  P  = .009).There were no significant differences between both groups for all other markers. Despite a lower troponin level, there was no difference in inotropic scores or ventricular function between both groups. Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay were not different between both groups.
CONCLUSION


Systemic administration of NO during the Norwood procedure has myocardial protective effects (lower Troponin levels) but we observed no effect on postoperative recovery. Larger sample size may be needed to show clinical differences.",2020,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.",['Twenty-four neonates who underwent a Norwood procedure'],"['Nitric Oxide Administration', 'oxygenator of the CPB circuit', 'placebo']","['Troponin levels', 'Ischemia/Reperfusion Injury', 'inotropic scores or ventricular function', 'myocardial protective effects (lower Troponin levels', 'age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time', 'Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C2242650', 'cui_str': 'Norwood procedure'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0018830', 'cui_str': 'Cardiopulmonary bypass circuit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",24.0,0.147463,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.","[{'ForeName': 'Chawki', 'Initials': 'C', 'LastName': 'Elzein', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Urbas', 'Affiliation': ""Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Hughes', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Patient-Centered Outcomes Research, Advocate Center for Pediatric Research, Research Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lefaiver', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ilbawi', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vricella', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120911034']
586,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
587,32645767,Randomized Pilot Trial of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients.,"BACKGROUND


Due to the substantial improvement in survival among pediatric patients undergoing congenital heart surgery, reducing early and long-term morbidity is becoming the major focus of care. Blood transfusion is associated with worse postoperative outcomes after cardiac surgery. Acute normovolemic hemodilution (ANH) is a blood conservation strategy that aims to reduce allogenic blood transfusion during cardiac surgery. However, there are scant data regarding its efficacy for pediatric cardiac surgery patients.
METHODS


We designed a single-center, controlled, randomized, pilot trial in patients between 6 and 36 months old undergoing pediatric heart surgery. Patients were equally assigned to undergo ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care. The primary end point was the amount of blood product transfused perioperatively. Secondary end points were markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay. The analysis was by intention-to-treat. Estimates of differences between groups are presented with 95% CIs.
RESULTS


Twelve pediatric heart surgery patients were randomized to each group, ANH and usual care. Baseline characteristics were similar between groups. Acute normovolemic hemodilution implementation did not result in a reduction in the administration of blood product transfused (difference between ANH and usual care among patients transfused = -1.4 mL [-29.4 to 26.6],  P  = .92). Secondary end points were not different between groups.
CONCLUSIONS


In this small trial of pediatric cardiac surgery patients, ANH as a strategy to reduce blood component therapy was safe; however, the study failed to show a reduction in perioperative transfusion or other postoperative outcomes.",2020,"Secondary end points were not different between groups.
","['Pediatric Cardiac Surgery Patients', 'Twelve pediatric heart surgery patients', 'pediatric cardiac surgery patients', 'pediatric patients undergoing congenital heart surgery', 'patients between 6 and 36 months old undergoing pediatric heart surgery']","['ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care', 'Acute Normovolemic Hemodilution', 'Acute normovolemic hemodilution (ANH']","['markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay', 'blood product transfused', 'amount of blood product transfused perioperatively', 'allogenic blood transfusion']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3163775', 'cui_str': 'Acute normovolemic hemodilution'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C3160876', 'cui_str': 'Allogenic blood transfusion'}]",12.0,0.15526,"Secondary end points were not different between groups.
","[{'ForeName': 'Weronika M', 'Initials': 'WM', 'LastName': 'Harris', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Miriam M', 'Initials': 'MM', 'LastName': 'Treggiari', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Giacomuzzi', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jayme J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Muralidaran', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120923627']
588,32651140,Dose preservation of ligament flavum really help prevent postoperative epidural fibrosis and improve outcome in microdiscectomy?,"OBJECTIVE


A prospective, randomized, controlled clinical study was conducted with surgery performed by the same surgeon. The aim was to present a new technique for preserving the ligament flavum during lumbar microdiscectomy, and to evaluate whether this helps prevent postoperative fibrosis and improve outcome.
METHODS


From January to December 2017, 251 patients with indication for microdiscectomy were randomly divided into test group using ligament flavum preservation technique and control group using conventional procedures. Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) were assessed before the surgery, and 3 days, 1 month, 6 months, 1 year and 2 years after the operation respectively. The grade of epidural fibrosis on MRI after 6 months was evaluated by two radiologists independently and double-blindly.
RESULTS


Both groups' VAS and ODI were significantly improved after surgery, but there was no significant difference between two groups at 3d and 1 month after operation. The grade of epidural fibrosis in test group was significantly lower than that in control group at 6 months postoperative. The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
CONCLUSION


Preservation of more ligament flavum is practicable during the procedure of microdiscectomy. It can prevent postoperative epidural fibrosis, and is helpful to achieve a better clinical outcome.",2020,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","['From January to December 2017, 251 patients with indication for microdiscectomy']",['ligament flavum preservation technique and control group using conventional procedures'],"['grade of epidural fibrosis', 'Visual analogue scale (VAS) scores and Oswestry Disability Index (ODI', 'VAS and ODI', 'postoperative epidural fibrosis']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C1041712', 'cui_str': 'Brevibacterium flavum'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3203500', 'cui_str': 'Epidural fibrosis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",251.0,0.0163517,"The VAS and ODI were significantly lower in test group than that in control group at 6 months,1 year and 2 years after operation.
","[{'ForeName': 'Jigang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Department of Clinical Laboratory, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zibo Central Hospital, Zibo City, Shandong Province 255000, China. Electronic address: litaozhongguo@vip.163.com.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Shandong University Qilu Hospital. Jinan City, Shandong Province, 250000, China.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.013']
589,32651028,Colonoscopic techniques in polyp detection: An Egyptian study.,"INTRODUCTION AND AIMS


The polyp detection rate (PDR) is defined as the percentage of colonoscopies in which one or more polyps are detected, and has been shown to be highly correlated with the adenoma detection rate. The aim of the present study was to evaluate the PDR at the Endoscopy Unit of the Kasr Al-Ainy Hospital, Cairo University, Egypt, through the i-SCAN, Endocuff, and underwater colonoscopy techniques.
MATERIALS AND METHODS


The study was conducted on 100 Egyptian subjects over 50 years of age. Their polyp detection rate was measured through 4 different colonoscopic techniques. An equal number of patients were divided into 4 groups: i-SCAN, Endocuff, underwater colonoscopy, and controls. The control group was examined using standard white light colonoscopy. The colonoscopy evaluation included the type of agent utilized for bowel preparation, preparation grade, and colonoscopy withdrawal time.
RESULTS


The general PDR was 48%. The i-SCAN technique had the highest rate (56%), followed by the underwater (52%) and the Endocuff (48%) techniques.
CONCLUSION


The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.",2021,"The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.",['100 Egyptian subjects over 50 years of age'],"['standard white light colonoscopy', 'Colonoscopic techniques']","['polyp detection rate', 'polyp detection rate (PDR']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",100.0,0.0190728,"The i-SCAN and underwater colonoscopy techniques produced higher PDR than the Endocuff-assisted and standard techniques, but with no statistical significance.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abdelbary', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shehab', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'ElGarhy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Menesy', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marzaban', 'Affiliation': 'Medicina Tropical, Facultad de Medicina, Universidad de El Cairo, El Cairo, Egipto. Electronic address: egymarz@yahoo.com.'}]",Revista de gastroenterologia de Mexico,['10.1016/j.rgmx.2020.02.004']
590,32651587,Epidural Anesthesia in Liver Surgery-A Propensity Score-Matched Analysis.,"OBJECTIVE


To assess the effects of epidural anesthesia (EA) on patients who underwent liver resection.
DESIGN


Secondary analysis of a prospective randomized controlled trial.
SETTING


This single-center study was conducted at an academic medical center.
METHODS


A subset of 110 1:1 propensity score-matched patients who underwent liver resection with and without EA were analyzed. Outcome measures were pain intensity ≥5 on a numeric rating scale (NRS) at rest and during movement on postoperative days 1-5, analyzed with logistic mixed-effects models, and postoperative complications according to the Clavien-Dindo classification, length of hospital stay (LOS), and one-year survival. One-year survival in the matched cohorts was compared using a frailty model.
RESULTS


EA patients were less likely to experience NRS ≥5 at rest (odds ratio = 0.06, 95% confidence interval [CI] = 0.01 to 0.28, P < 0.001). These findings were independent of age, sex, Charlson comorbidity index, baseline NRS, and surgical approach (open vs laparoscopic). The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively). Reduced mortality rates were seen in the EA group one year after surgery (9.1% vs 30.9%, hazard ratio = 0.32, 95% CI = 0.11 to 0.90, P = 0.031). No EA-related adverse events occurred. Earlier recovery of bowel function was seen in EA patients.
CONCLUSIONS


Patients with EA had better postoperative pain control and required fewer systemic opioids. Postoperative complications and LOS did not differ, although one-year survival was significantly improved in patients with EA. EA applied in liver surgery was effective and safe.",2020,"The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively).","['patients who underwent liver resection', 'This single-center study was conducted at an academic medical center']","['Epidural Anesthesia', 'epidural anesthesia (EA', 'liver resection with and without EA']","['year survival', 'mortality rates', 'Postoperative complications and LOS', 'bowel function', 'postoperative pain control', 'systemic opioids', 'number and severity of postoperative complications and LOS', 'pain intensity ≥5 on a numeric rating scale (NRS) at rest and during movement on postoperative days 1-5, analyzed with logistic mixed-effects models, and postoperative complications according to the Clavien-Dindo classification, length of hospital stay (LOS), and one-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",,0.132358,"The number and severity of postoperative complications and LOS were comparable between groups (P = 0.258, P > 0.999, and P = 0.467, respectively).","[{'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Knaak', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Jara', 'Affiliation': 'Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Vorderwülbecke', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Anna Dorothea', 'Initials': 'AD', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'von Haefen', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Lachmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Schulte', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa130']
591,32651644,Comparison between isolated and associated with codeine acetaminophen in pain control of acute apical abscess: a randomized clinical trial.,"OBJECTIVES


The study aimed to compare the acetaminophen administration efficacy or its combination with codeine for pain control in acute apical abscesses cases.
MATERIALS AND METHODS


Thirty-nine patients who sought emergency treatment in the Faculty of Dentistry of the Federal University of Rio Grande do Sul were included, all of them with acute apical abscess diagnosis. These patients were divided into two groups: acetaminophen group-prescription of acetaminophen (1000 mg) and acetaminophen-codeine group-prescription of acetaminophen (1000 mg) + codeine (30 mg), both with oral intake every 6 h for 3 days. The pain scores were recorded by the patients on their own at 6, 12, 24, 48, and 72 h after finishing clinical assistance, by filling a pain evolution journal, containing a visual analogue scale (VAS). Student t test was conducted to investigate different mean ages between groups 1 and 2. A comparison of weight and means of initial pain scores between groups was carried out using the Mann-Whitney U test. Chi-square test was performed to compare gender, affected tooth, education, initial swelling, and frequency of adverse effect between test and control groups. Mann-Whitney U test was applied to compare groups in the same period. Friedman's test was used to compare results from the same group over time.
RESULTS


Both groups showed score reduction over time (P < 0.05). Paracetamol-codeine group showed significant pain score reduction at 48 h registers when compared to baseline and at 6 h scores (P < 0.05). Further, pain scores at 72 h were significantly lower, when compared to the baseline, at 6 h, and at 12 h scores (P < 0.05). Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05). There were no significant differences in pain score reduction over time between groups (P > 0.05). There was no difference between the groups regarding the frequency of adverse reactions (P > 0.05).
CONCLUSION


Both medications were effective for pain control in acute apical abscess cases. The findings might have inferred in pain control of acute apical abscess associated pain in patients who used an antibiotic drug. External validity of the findings for acute apical abscess cases with no need for an antibiotic prescription is uncertain.
CLINICAL RELEVANCE


This paper suggests acetaminophen 1000 mg can be used for pain control in the treatment of acute apical abscess associated with systemic manifestation.",2021,"Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05).","['patients who used an antibiotic drug', 'pain control of acute apical abscess', 'Thirty-nine patients who sought emergency treatment in the Faculty of Dentistry of the Federal University of Rio Grande do Sul were included, all of them with acute apical abscess diagnosis', 'acute apical abscesses cases']","['Acetaminophen', 'codeine', 'Paracetamol-codeine', 'acetaminophen-codeine group-prescription of acetaminophen (1000\xa0mg)\u2009+\u2009codeine', 'codeine acetaminophen', 'acetaminophen group-prescription of acetaminophen', 'acetaminophen']","['pain scores', 'initial pain scores', 'pain score reduction', 'frequency of adverse reactions', 'visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1290646', 'cui_str': 'Acute apical abscess'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0013969', 'cui_str': 'Emergency treatment'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C2351132', 'cui_str': 'codeine and paracetamol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",39.0,0.0436955,"Acetaminophen group showed significant pain score reduction observed at 72 h, when compared to the baseline and at 6 h scores (P < 0.05).","[{'ForeName': 'Paula Barcellos', 'Initials': 'PB', 'LastName': 'da Silva', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Aline Teixeira', 'Initials': 'AT', 'LastName': 'Mendes', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maria Beatriz Ferreira', 'Initials': 'MBF', 'LastName': 'Cardoso', 'Affiliation': 'Pharmacology Department, Basic Health Sciences Institute, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo Abreu', 'Initials': 'RA', 'LastName': 'da Rosa', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Angela Longo', 'Initials': 'AL', 'LastName': 'do Nascimento', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jefferson Ricardo', 'Initials': 'JR', 'LastName': 'Pereira', 'Affiliation': 'Department of Prosthodontics, School of Dentistry, University of Southern Santa Catarina, Tubarão, SC, Brazil.'}, {'ForeName': 'Marcus Vinícius Reis', 'Initials': 'MVR', 'LastName': 'Só', 'Affiliation': 'Conservative Dentistry Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil. endo-so@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03374-6']
592,32650345,Adding efficiency to proficiency: a study of trainee polypectomy efficiency metrics.,"BACKGROUND


Although validated colonoscopy assessment tools exist, they do not measure efficiency. This study aimed to assess content validity of polypectomy efficiency (PE) and neoplastic polypectomy efficiency (NPE) as colonoscopy efficiency indices.
METHODS


Data from a randomized controlled trial evaluating polypectomy among gastroenterology trainees were utilized. PE and NPE were defined as number of polyps (or neoplastic polyps) removed/withdrawal time × 100. Content validity was assessed by determining the association between efficiency indices and polypectomy times.
RESULTS


20 trainees performed 601 colonoscopies. There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48 ( P  = 0.001) and NPE decreased by 0.24 ( P  = 0.03).
CONCLUSIONS


The study proposed and provided content validity for PE and NPE as colonoscopy efficiency indices.",2020,"There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48",['20 trainees performed 601 colonoscopies'],"['polypectomy', 'polypectomy efficiency (PE) and neoplastic polypectomy efficiency (NPE']","['number of polyps (or neoplastic polyps) removed/withdrawal time', 'Content validity', 'NPE', 'polypectomy time', 'PE']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0538042,"There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Muething', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Wani', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""Biostatistics, Children's Hospital Association, Kansas City, Kansas, United States.""}, {'ForeName': 'Violette', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Ezenwanyi', 'Initials': 'E', 'LastName': 'Ezekwe', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Nguyen-Vu', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Malvar', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Duloy', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Kaltenbach', 'Affiliation': 'Gastroenterology, University of California, San Francisco, California, United States.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Keswani', 'Affiliation': 'Gastroenterology, Northwestern University, Chicago, Illinois, United States.'}, {'ForeName': 'Swati G', 'Initials': 'SG', 'LastName': 'Patel', 'Affiliation': 'Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States.'}]",Endoscopy,['10.1055/a-1192-4250']
593,32650346,Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration in solid pancreatic lesions: a single-center prospective randomized trial.,"BACKGROUND


Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) can visualize necrotic areas and vessels inside lesions. CH-EUS findings combined with EUS-guided fine-needle aspiration (EUS-FNA) improves diagnosis in pancreatic solid masses. CH-EUS can also guide EUS-FNA (CH-EUS-FNA), potentially improving the diagnostic rate of EUS-FNA, but such superiority has not been proved in prospective studies. We aimed to assess whether CH-EUS-FNA is superior to standard EUS-FNA for specific diagnosis of solid pancreatic masses and what factors affect the diagnostic rate.
METHODS


This randomized controlled study in one tertiary medical academic center included patients with suspected pancreatic solid masses on transabdominal ultrasound or computed tomography (CT) scan. Two passes with a 22-G standard FNA needle were done using EUS-FNA and CH-EUS-FNA in random order, and the visible core obtained was sent for histological analysis. Final diagnosis was based on EUS-FNA or surgical specimen results and on 12-month follow-up by imaging.
RESULTS


148 patients were evaluated. EUS-FNA and CH-EUS-FNA showed diagnostic sensitivities of 85.5 % and 87.6 %, respectively (not significantly different) and the combined sensitivity of the two passes was 93.8 %. The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results. No differences were seen for the results related to location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent.
CONCLUSIONS


The diagnostic rates for samples obtained using 22-G needles with standard EUS-FNA and CH-EUS-FNA were not statistically significantly different.",2020,The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results.,"['148 patients were evaluated', 'one tertiary medical academic center included patients with suspected pancreatic solid masses on', 'solid pancreatic lesions']","['EUS-FNA and CH-EUS', 'EUS-guided fine-needle aspiration (EUS-FNA', 'Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS', 'CH-EUS', 'CH-EUS-FNA', 'transabdominal ultrasound or computed tomography (CT) scan', 'Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration']","['diagnostic sensitivities', 'location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent', 'diagnostic rates', 'false-negative rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",148.0,0.0229746,The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results.,"[{'ForeName': 'Andrada', 'Initials': 'A', 'LastName': 'Seicean', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Andrada', 'Initials': 'A', 'LastName': 'Samarghitan', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Sorana D', 'Initials': 'SD', 'LastName': 'Bolboacă', 'Affiliation': 'Department of Medical Informatics and Biostatistics, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pojoga', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Rusu', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rusu', 'Affiliation': 'Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gheorghiu', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Al Hajjar', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Seicean', 'Affiliation': 'Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",Endoscopy,['10.1055/a-1193-4954']
594,32666349,Probiotic strains of Lactobacillus brevis and Lactobacillus plantarum as adjunct to non-surgical periodontal therapy: 3-month results of a randomized controlled clinical trial.,"OBJECTIVES


To determine if periodontitis patients benefit from treatment with Lactobacillus brevis and Lactobacillus plantarum strains, applied into periodontal pockets as gel and thereafter taken as lozenges, as an adjunct to scaling and root planing (SRP).
MATERIALS AND METHODS


In a double-blind, randomized, placebo-controlled trial, 40 patients received scaling and root planing (SRP) in two sessions within 7 days. Patients then received either probiotic gel and lozenges (n = 20) or placebo (n = 20). The primary outcome variable was the number of diseased sites (DS: PD > 4 mm + BOP) at the 3-month re-evaluation. The effects of gender, age, probiotic therapy, presence of Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans, smoking, tooth being a molar and interdental location were evaluated using a multivariate multilevel logistic regression model.
RESULTS


The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups. Both groups showed substantial but equivalent improvements in periodontal parameters. The logistic regression showed higher odds for the healing of gingival bleeding (OR = 2.12, p = 0.048) and lower odds for the healing of DS (OR = 0.51; p < 0.001) in the probiotic group.
CONCLUSIONS


Patients with periodontitis benefit from adjunctive use of probiotics containing L. brevis and L. plantarum in terms of reduction of gingival bleeding. However, adjunctive probiotics increase the number of persisting diseased sites with PD > 4 mm and BOP.
CLINICAL RELEVANCE


The adjunctive use of probiotics containing L. brevis and L. plantarum strains in treating chronic periodontitis results in a higher number of residual diseased sites when compared with SRP + placebo; its use is therefore unfounded.",2021,"The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups.","['40 patients received', 'periodontitis patients']","['Lactobacillus brevis and Lactobacillus plantarum', 'SRP + placebo', 'Lactobacillus brevis and Lactobacillus plantarum strains', 'probiotics containing L. brevis and L. plantarum strains', 'probiotic gel and lozenges', 'scaling and root planing (SRP', 'placebo']","['healing of gingival bleeding', 'number of DS', 'periodontal parameters', 'healing of DS', 'Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans, smoking, tooth being a molar and interdental location', 'number of diseased sites (DS: PD\u2009>\u20094\xa0mm\u2009+\u2009BOP', 'gingival bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0317604', 'cui_str': 'Lactobacillus brevis'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085488', 'cui_str': 'Aggregatibacter actinomycetemcomitans'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}]",40.0,0.0876832,"The number of DS after 3 months was similar in the test (Me = 8, IQR = 5-11) and control (Me = 5, IQR = 1-10) groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pudgar', 'Affiliation': 'Public Health Centre, 2360, Radlje ob Dravi, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Povšič', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Čuk', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seme', 'Affiliation': 'Faculty of Medicine, Institute of Microbiology and Immunology, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Petelin', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gašperšič', 'Affiliation': 'Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Hrvatski trg 6, 1000, Ljubljana, Slovenia. rok.gaspersic@mf.uni-lj.si.'}]",Clinical oral investigations,['10.1007/s00784-020-03449-4']
595,32653445,Insufficient Calorie Intake Worsens Post-Discharge Quality of Life and Increases Readmission Burden in Heart Failure.,"OBJECTIVES


The purpose of this study was to evaluate the relationship between calorie intake and post-discharge outcomes in hospitalized patients with heart failure (HF).
BACKGROUND


Malnutrition increases adverse outcomes in HF, and dietary sodium restriction may inadvertently worsen nutritional intake.
METHODS


In a dietary intervention trial, baseline nutritional intake in HF inpatients was estimated using the Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI) was calculated. Insufficient calorie intake was defined as <90% of metabolic needs, and a 15-point micronutrient deficiency score was created. Adjusted linear, logistic, and negative binomial regression were used to evaluate associations between insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized over 12 weeks.
RESULTS


Among 57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8 kg/m 2 ); median sodium and calorie intake amounts were 2,987 mg/day (interquartile range [IQR]: 2,160 to 3,540 mg/day) and 1,602 kcal/day (IQR: 1,201 to 2,142 kcal/day), respectively; 11% of these patients were screened as malnourished by the NRI. All patients consuming <2,000 mg/day sodium had insufficient calorie intake; this group also more frequently had dietary micronutrient and protein deficiencies. At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio: 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio: 31.3; 95% CI: 4.3 to 229.3).
CONCLUSIONS


Despite a high prevalence for obesity and rare overt malnutrition, insufficient calorie intake was associated with poorer post-discharge quality of life and increased burden of readmission in patients with HF. Inpatient dietary assessment could improve readmission risk stratification and identify patients for nutritional intervention. (Geriatric Out of Hospital Randomized Meal Trial in Heart Failure [GOURMET-HF] NCT02148679).",2020,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","['Heart\xa0Failure', 'patients with HF', '57 participants (70 ± 8 years of age; 31% female; mean body mass index 32 ± 8\xa0kg/m 2 ); median sodium and calorie intake amounts were 2,987 (interquartile range [IQR]: 2,160 to 3,540) mg/day and 1,602', 'hospitalized patients with heart failure (HF']",[],"['burden of readmission', 'insufficient calorie intake and quality of life (using the Kansas City Cardiomyopathy Questionnaire Clinical Summary [KCCQ-CS]), readmission risk, and days rehospitalized', 'KCCQ-CS score', 'Insufficient calorie intake', 'Block Food Frequency Questionnaire (FFQ), and the Nutritional Risk Index (NRI', 'readmission risk stratification']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0695731,"At 12 weeks, patients with insufficient calorie intake had less improvement in the KCCQ-CS score (β = -14.6; 95% confidence interval [CI]: -27.3 to -1.9), higher odds of readmission (odds ratio [OR] 14.5; 95% CI: 2.2 to 94.4), and more days rehospitalized (incident rate ratio [IRR]: 31.3; 95% CI: 4.3 to 229.3).
","[{'ForeName': 'Feriha', 'Initials': 'F', 'LastName': 'Bilgen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Armella', 'Initials': 'A', 'LastName': 'Poggi', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Trumble', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Helmke', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Teruya', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Tonimarie', 'Initials': 'T', 'LastName': 'Catalan', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Rosenblum', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Cornellier', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Wahida', 'Initials': 'W', 'LastName': 'Karmally', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Ann Arbor Veterans Affairs Health System, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan; Columbia University, New York, New York. Electronic address: scothumm@med.umich.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.004']
596,32653446,Sex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure.,"OBJECTIVES


This study sought to use INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) results to evaluate sex differences in the use and clinical outcomes of left ventricular assist devices (LVAD).
BACKGROUND


Despite a similar incidence of heart failure in men and women, prior studies have highlighted potential underuse of LVADs in women, and studies of clinical outcomes have yielded conflicting results.
METHODS


Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted.
RESULTS


Among the 18,868 patients, 3,984 (21.1%) were women. At 1 year, women were less likely to undergo heart transplantation than men (17.9% vs. 20.0%, respectively; p = 0.003). After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction. Although women younger than 50 years of age had an increased risk of death compared to men of the same age (HR: 1.34; 95% CI: 1.12 to 1.6), men and women 65 years of age and older had a similar risk of death (HR: 1.09; 95% CI: 0.95 to 1.24).
CONCLUSIONS


This study found that women had a higher risk of mortality and adverse events after LVAD. Only 1 in 5 LVADs were implanted in women, and women were less likely to receive a heart transplant than men. Further investigation is needed to understand the causes of adverse events and potential underuse of advanced treatment options in women.",2020,"After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction.","['Patients Receiving Left Ventricular Assist Devices for End-Stage Heart\xa0Failure', 'women', 'Patients were enrolled from the INTERMACS study who underwent implantation of their first continuous-flow LVAD between 2008 and 2017, and survival analyses stratified by sex were conducted', '18,868 patients, 3,984 (21.1%) were women', 'men and women']",[],"['likely to undergo heart transplantation', 'rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction', 'risk of death', 'risk of mortality and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C1868938', 'cui_str': 'End stage cardiac failure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1504465', 'cui_str': 'Device malfunction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18868.0,0.331156,"After multivariable adjustments, women had a higher risk of death (hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 1.07 to 1.23; p < 0.001) and were more likely to incur post-implantation adverse events, including rehospitalization, bleeding, stroke, and pump thrombosis or device malfunction.","[{'ForeName': 'Jadry', 'Initials': 'J', 'LastName': 'Gruen', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Caraballo', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'P Elliott', 'Initials': 'PE', 'LastName': 'Miller', 'Affiliation': 'Yale National Clinician Scholars Program, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McCullough', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mezzacappa', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Ravindra', 'Affiliation': 'Department of Biophysics and Biochemistry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Clancy W', 'Initials': 'CW', 'LastName': 'Mullan', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Reinhardt', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Arnar', 'Initials': 'A', 'LastName': 'Geirsson', 'Affiliation': 'Section of Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nihar R', 'Initials': 'NR', 'LastName': 'Desai', 'Affiliation': 'Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, Connecticut; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: nihar.desai@yale.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.015']
597,32653447,Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial.,"OBJECTIVES


This study assessed the efficacy and safety of dapagliflozin in patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial.
BACKGROUND


Both the angiotensin receptor neprilysin-inhibitor sacubitril/valsartan and the sodium glucose co-transporter 2 inhibitor dapagliflozin reduced cardiovascular death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Whether either of these classes of drugs influences the effectiveness or safety of the other remains unknown.
METHODS


DAPA-HF was a 4,744 patient trial that compared dapagliflozin with placebo in patients with HFrEF. Patients were analyzed according to whether they were taking sacubitril/valsartan at randomization. The efficacy of dapagliflozin on the primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death was examined according to sacubitril/valsartan and the interaction tested. Predefined safety outcomes were examined by sacubitril/valsartan group.
RESULTS


A total of 508 patients (10.7%) enrolled in DAPA-HF were treated with sacubitril/valsartan at baseline. Patients prescribed sacubitril/valsartan were more likely to be from North America or Europe, to have lower ejection fractions and systolic and diastolic blood pressures, but were similar with respect to age, New York Heart Association functional class, history of diabetes, and use of other evidence-based HF therapies. The benefit of dapagliflozin compared with placebo was similar in patients taking sacubitril/valsartan (hazard ratio: 0.75; 95% confidence interval 0.50 to 1.13) compared with those not taking sacubitril/valsartan (hazard ratio: 0.74; 95% confidence interval 0.65 to 0.86) for the primary endpoint of cardiovascular death or worsening HF; similar findings were observed for secondary endpoints. All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
CONCLUSIONS


Dapagliflozin was similarly efficacious and safe in patients who were and who were not taking sacubitril/valsartan in the DAPA-HF trial, which suggested that the use of both agents together could further lower morbidity and mortality in patients with HFrEF. (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure [DAPA-HF]; NCT03036124).",2020,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","['patients with HF with reduced ejection fraction (HFrEF', '508 patients (10.7%) enrolled in DAPA-HF were treated with', 'Patients With HFrEF', 'DAPA-HF was a 4,744 patient trial that compared', 'patients who were and who were not taking sacubitril', 'patients with HFrEF', 'patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of', 'Patients With Chronic Heart Failure) trial']","['dapagliflozin or placebo', 'valsartan', 'dapagliflozin with placebo', 'dapagliflozin', 'background sacubitril/valsartan', 'Dapagliflozin', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'placebo']","['cardiovascular death', 'primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death', 'efficacy and safety', 'cardiovascular death and heart failure (HF) hospitalization', 'ejection fractions and systolic and diastolic blood pressures', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",508.0,0.140024,"All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Riggshospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Kansas.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Section of Endocrinology, Yale University Medical School, New Haven, Connecticut.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjostrand', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.04.008']
598,32658830,The feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial.,"BACKGROUND


Antenatal depression is common and associated with adverse consequences for mothers, babies, and future generations. Limitations with conventional approaches has resulted in additional therapies being considered. This study examined the feasibility and effectiveness of acupuncture for improving mental health.
METHODS


Fifty-seven pregnant women with depressive symptomologies were randomised to acupuncture (n=19) plus treatment as usual (TAU), progressive muscle relaxation (PMR, n=19) plus TAU or TAU (n=19). Treatments were conducted from 24 to 31 weeks gestation. Clinical assessments were performed throughout the intervention, as well as at a six-week postnatal follow-up. The primary outcome measure was depression. Secondary outcome measurements were stress, anxiety, psychological distress, quality of life and adjustment to mothering. Intention to treat (ITT), Linear Mixed Model (LMM) repeated measures and per protocol (PP) analyses were conducted.
RESULTS


At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD) -5.84 (95% CI -9.10 to -2.58); MD -3.42 (95% CI -6.64 to -0.20)]. LMM repeated measures analysis (including postnatal follow-up) also demonstrated significantly lowered acupuncture group scores for stress (p=0.006) and psychological distress (p<0.001) when compared to PMR and TAU. Between group differences were not significant at six-weeks postnatal. No adverse events were reported.
LIMITATIONS


Main limitations are small sample size and the use of self-reported outcome measures.
CONCLUSION


Prenatal acupuncture reduced depression, stress and distress, whilst also being well-tolerated and free from adverse events. Further research is warranted.",2020,"At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD)","['Fifty-seven pregnant women with depressive symptomologies', 'antenatal depression']","['acupuncture', 'acupuncture (n=19) plus treatment as usual (TAU), progressive muscle relaxation (PMR, n=19) plus TAU or TAU']","['mean difference (MD', 'depression scores', 'depression', 'adverse events', 'depression, stress and distress, whilst also being well-tolerated and free from adverse events', 'psychological distress', 'stress, anxiety, psychological distress, quality of life and adjustment to mothering']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0032533', 'cui_str': 'Polymyalgia rheumatica'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",57.0,0.185105,"At end-of-intervention there were significantly lower depression scores in the acupuncture group versus TAU and PMR respectively [ITT p<0.001, mean difference (MD)","[{'ForeName': 'Simone M', 'Initials': 'SM', 'LastName': 'Ormsby', 'Affiliation': 'Adjunct Fellow, NICM Health Research Institute, Level 1, Building J, Western Sydney University, Westmead Campus, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: simone.ormsby@westernsydney.edu.au.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'Professor of Clinical Research, NICM Health Research Institute, Level 1, Building J, Western Sydney University, Westmead Campus, Locked Bag 1797, Penrith, NSW, 2751, Australia. Electronic address: caroline.smith@westernsydney.edu.au.edu.au.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Dahlen', 'Affiliation': 'Professor of Midwifery, Associate Dean Research and HDR, Midwifery Discipline, Building EB, UWS Parramatta Campus, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: H.Dahlen@westernsydney.edu.au.'}, {'ForeName': 'Phillipa J', 'Initials': 'PJ', 'LastName': 'Hay', 'Affiliation': 'Professor of Mental Health, Translational Health Research Institute, School of Medicine Western Sydney University and Camden and Campbelltown Hospitals SWSLHD, Locked Bag 1797, Penrith, NSW 2751, Australia. Electronic address: P.Hay@westernsydney.edu.au.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.089']
599,32663945,Placebo prevents rumination: An experimental study.,"BACKGROUND


Rumination is a risk factor for the development and maintenance of depressive symptoms and represents an important target for the treatment of depression. In the present study, we aimed to examine whether rumination can be reduced when participants are led to believe that they would receive medication that would prevent them from ruminating.
METHODS


In healthy participants (N= 91), an initial dysphoric state was induced via mood-suggestive music and autobiographic recall. Subsequently, participants were randomly assigned to one of two groups: an experimental group that received a deceptive active placebo via intranasal application accompanied by expectancy-enhancing instructions vs. a no-treatment control group. Then, rumination was induced via a rumination-activating task. The primary outcome was current rumination; experienced sadness was considered a secondary outcome.
RESULTS


Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
LIMITATIONS


The external validity of this study might be limited due to the highly educated student sample.
CONCLUSIONS


The results suggest that rumination processes as well as experienced sadness can be positively influenced by placebo treatment. To evaluate its clinical potential, placebo-induced expectancy effects in rumination research should be further examined, particularly with clinically depressed patients. Also, the results imply that clinicians might consider the effects of expectations on patients' rumination tendencies, for example by explicitly addressing patients' expectations about rumination, mood, and the treatment in general.",2020,"Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
","['healthy participants (N=\xa091), an initial dysphoric state was induced via mood-suggestive music and autobiographic recall']","['Placebo', 'deceptive active placebo via intranasal application accompanied by expectancy-enhancing instructions vs. a no-treatment control group', 'placebo']","['current rumination; experienced sadness', 'current rumination', 'rumination', 'sadness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}]",,0.185686,"Consistent with the hypothesis, participants receiving the placebo reported a significantly lower increase in current rumination (d= 0.57) and a higher decrease in sadness (d= 0.69) after the experimental induction than the control group.
","[{'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Rebstock', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany. Electronic address: lea.rebstock@uni-marburg.de.'}, {'ForeName': 'Leonora N', 'Initials': 'LN', 'LastName': 'Schäfer', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kube', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany; Department for Clinical Psychology and Psychotherapy, University of Koblenz-Landau, Ostbahnstraße 10, 76829 Landau, Germany.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Ehmke', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department for Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstraße 18, 35032 Marburg, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.010']
600,32663974,A randomized controlled trial of a standard 4-week protocol of repetitive transcranial magnetic stimulation in severe treatment resistant depression.,"BACKGROUND


Treatment options for major depressive disorder (MDD) in individuals who are depressed for at least 2 years and failed two or more different types of therapeutic intervention, remain scarce. Being less invasive than electroconvulsive therapy, repetitive transcranial magnetic stimulation (rTMS) might be an alternative treatment option.
RESEARCH QUESTION


Does high frequency rTMS applied over the left prefrontal cortex ameliorate depressive symptoms in patients with treatment resistant major depressive disorder and is the efficacy dependent on treatment resistance?
METHOD


We performed a randomized controlled trial investigating the effect of twenty sessions of real or sham-rTMS, during 4 consecutive weeks. Efficacy was blindly rated with the Hamilton depression rating scale (HDRS-17) at baseline and 1 week after end of treatment, and the Dutch method for quantification of treatment resistance in Depression (DM-TRD) was assessed at baseline.
RESULTS


An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients. The mean difference of the HDRS score between baseline and post-treatment was 3.7 (± 4.0; change 16%), indicating a small but significant improvement across time (F(1,30)=25.4;p < 0.01). There were no differences however between the treatment arms (F(1.30) = 1.5;p = 0.23). We did find a negative correlation between the change in HDRS score and DM-TRD in the active rTMS group, but this correlation was not significantly different from the sham group.
CONCLUSION


""Standard"" 4-week rTMS treatment is not effective in chronic, severe treatment-resistant depressed patients. While a replication of our data in this patient group may be ethically difficult, further research with less treatment resistant patients might help in positioning rTMS within the current stepped care approach to depression.",2020,An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients.,"['severe treatment resistant depression', 'major depressive disorder (MDD) in individuals who are depressed for at least 2 years and failed two or more different types of therapeutic intervention, remain scarce', 'patients with treatment resistant major depressive disorder']","['electroconvulsive therapy, repetitive transcranial magnetic stimulation (rTMS', 'repetitive transcranial magnetic stimulation', 'real or sham-rTMS']","['HDRS score and DM-TRD', 'Hamilton depression rating scale (HDRS-17', 'Depression (DM-TRD', 'antidepressant response', 'HDRS score']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]",,0.0985111,An interim analysis showed no differences in antidepressant response between real and sham rTMS and we therefore discontinued the RCT after 31 patients.,"[{'ForeName': 'P F P', 'Initials': 'PFP', 'LastName': 'van Eijndhoven', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Philip.vanEijndhoven@radboudumc.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bartholomeus', 'Affiliation': 'Rijnstate Hospital Arnhem, Department of Psychiatry, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioral Science Institute, Department of Clinical Psychology, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Bruijn', 'Affiliation': 'Depression Expertise Centre, Pro Persona Mental Health Care, Reinier Postlaan 6, 6525 GC Nijmegen,The Netherlands.'}, {'ForeName': 'G R A', 'Initials': 'GRA', 'LastName': 'Ferrari', 'Affiliation': 'Behavioral Science Institute, Department of Clinical Psychology, Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mulders', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Schene', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'D J L G', 'Initials': 'DJLG', 'LastName': 'Schutter', 'Affiliation': 'Department of Experimental Psychology, Helmholtz Institute, Utrecht University, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spijker', 'Affiliation': 'Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands; Depression Expertise Centre, Pro Persona Mental Health Care, Reinier Postlaan 6, 6525 GC Nijmegen,The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tendolkar', 'Affiliation': 'Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen, The Netherlands; Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.055']
601,32663977,Combined treatment with escitalopram and memantine increases gray matter volume and cortical thickness compared to escitalopram and placebo in a pilot study of geriatric depression.,"BACKGROUND


Geriatric depression with subjective cognitive complaints increases the risk of Alzheimer's Disease (AD). Memantine is a cognitive enhancer used to treat AD. In a 6-month double-blind randomized placebo-controlled trial of escitalopram and memantine (ESC/MEM), ESC/MEM improved cognition at 12 month in geriatric depression (NCT01902004). We now investigated structural neuroplastic changes at 3 months.
METHODS


Forty-one older depressed adults (mean age=70.43, SD=7.33, 26 female) were randomized to receive ESC/MEM or ESC/PBO. Mood scores (Hamilton Depression Rating Scale, HAMD) and high-resolution structural T1-weighted images were acquired at baseline and 3 months. Freesurfer 6.0 for image processing and General Linear Models was used to examine group differences in symmetrized percent change gray matter volume (GMV) and cortical thickness, controlling for age and intracranial volume. Nonparametric tests were used to investigate group differences in mood and subcortical volume change.
RESULTS


Among 27 completers (ESC/MEM n = 13; ESC/PBO n = 14), 62% achieved remission (HAMD≤6) with ESC/MEM and 43% with ESC/PBO (Fisher's exact p=.45). Change in HAMD did not differ between groups (F(1,23)=0.14, p=.7). GMV and thickness increased more with ESC/MEM than with ESC/PBO in the left middle and inferior temporal lobe, right medial, and lateral orbito-frontal cortex (OFC).
LIMITATIONS


included small sample size, dropout, and the lack of cognitive data at 3 months.
CONCLUSIONS


Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo. Larger longitudinal clinical trials can further examine the neuroprotective effect of memantine in geriatric depression.",2020,"Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo.","['geriatric depression', 'Forty-one older depressed adults (mean age=70.43, SD=7.33, 26 female']","['escitalopram and memantine (ESC/MEM), ESC/MEM', 'ESC/MEM or ESC/PBO', 'memantine', 'Memantine', 'escitalopram and placebo', 'escitalopram and memantine', 'placebo']","['GMV and thickness', 'left middle and inferior temporal lobe, right medial, and lateral orbito-frontal cortex (OFC', 'Change in HAMD', 'Mood scores (Hamilton Depression Rating Scale, HAMD) and high-resolution structural T1-weighted images', 'mood improvement', 'gray matter volume (GMV) and cortical thickness, controlling for age and intracranial volume', 'mood and subcortical volume change', 'GMV and cortical thickness', 'gray matter volume and cortical thickness']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",41.0,0.0984536,"Although significant group differences in mood improvement were not observed, ESC/MEM resulted in increased GMV and cortical thickness in several brain regions compared to placebo.","[{'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Krause-Sorio', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: bkrause@ucla.edu.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Siddarth', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: PSiddarth@mednet.ucla.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kilpatrick', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: lakilpatrick@mednet.ucla.edu.'}, {'ForeName': 'Kelsey T', 'Initials': 'KT', 'LastName': 'Laird', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Michaela M', 'Initials': 'MM', 'LastName': 'Milillo', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ercoli', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: LErcoli@mednet.ucla.edu.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Narr', 'Affiliation': 'Department of Neurology, 635 Charles E. Young Drive South, Los Angeles, CA 90095, USA. Electronic address: knarr@ucla.edu.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095, USA. Electronic address: hlavretsky@mednet.ucla.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.092']
602,32663980,Plasma Circular RNA DYM Related to Major Depressive Disorder and Rapid Antidepressant Effect Treated by Visual Cortical Repetitive Transcranial Magnetic Stimulation.,"BACKGROUND


Reduced plasma circular RNA DYM (circDYM) has been detected in patients with major depressive disorder (MDD). Mechanism research has demonstrated that circDYM, acting as a microRNA-9 sponge, suppressed microglial activation by increasing Heat Shock Protein 90 ubiquitination, indicating that circDYM could be a potential biomarker of MDD.
METHODS


Thirty-two normal controls (NCs) and 60 MDD patients were recruited. Enrolled patients were randomly allocated to the real or sham repetitive transcranial magnetic stimulation (rTMS) group, followed by continuous five-day visual cortical rTMS or sham treatment. All participants underwent multidimensional neuropsychological assessments and detection of circDYM levels.
RESULTS


Initial scores on all emotional and psychosocial assessments in MDD were significantly different from those of NCs. As compared with the NC group, baseline plasma circDYM levels in MDD patients decreased remarkably (p=0.030) and showed significant positive correlations with the scores of the 24-item Hamilton Depression Rating Scale (r=0.318, p=0.031) and retardation subscale (r=0.323, p=0.029). The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
LIMITATIONS


It was not estimated on the correlation between plasma circDYM levels and long-term efficacy of rTMS. The mechanism of upregulated circDYM expression in response to visual cortical rTMS remained unrevealed, and the sample size was relatively small.
CONCLUSIONS


This study verified the reduced circDYM levels in MDD patients, and further determined the upregulated circDYM expression after rTMS treatment, revealing the potential of circDYM as a biomarker for MDD diagnosis and antidepressant effect of visual cortical rTMS.",2020,"The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
","['Thirty-two normal controls (NCs) and 60 MDD patients were recruited', 'patients with major depressive disorder (MDD', 'MDD patients']","['Visual Cortical Repetitive Transcranial Magnetic Stimulation', 'real or sham repetitive transcranial magnetic stimulation (rTMS) group, followed by continuous five-day visual cortical rTMS or sham treatment']","['emotional and psychosocial assessments in MDD', '24-item Hamilton Depression Rating Scale', 'retardation subscale', 'baseline plasma circDYM levels', 'plasma circDYM levels', 'increase in circDYM']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",32.0,0.0328053,"The increase in circDYM was noteworthy after rTMS (p=0.006), while downregulation with no statistical significance was observed after sham treatment (p=0.170).
","[{'ForeName': 'Ruize', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Pharmacology, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Xianrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Jianli', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China; Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Yachen', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Bi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Haisan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Second Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, Henan, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Affiliated ZhongDa Hospital, School of Medicine, Southeast University, Nanjing 210009, Jiangsu, China; Department of Psychology, Xinxiang Medical University, Xinxiang 453003, Henan, China. Electronic address: janemengzhang@vip.163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.109']
603,32668474,Endoscopic submucosal dissection with additional radiotherapy in the treatment of T1a esophageal squamous cell cancer: randomized controlled Trial.,"BACKGROUND


Endoscopic submucosal dissection (ESD) is effective for treating T1a early esophageal squamous cell carcinoma (ESCC). However, occasional recurrences are inevitable. This trial was designed to clarify the efficacy of combining ESD with additional radiotherapy in the treatment of T1a ESCC.
METHODS


Between January 2015 and September 2018, patients with early ESCC (T1aN0M0) following ESD were randomly assigned (1:1) to the radiotherapy group or non-radiotherapy group. Patients in the radiotherapy group received a median radiation dose of 59.4 Gy within 2 months after ESD. In the non-radiotherapy group, patients underwent regular follow-up only. Recurrence-free survival, cancer-specific survival, overall survival, and complications were evaluated.
RESULTS


70 patients completed the per-protocol treatment. Three patients in the non-radiotherapy group experienced intraluminal mucosal recurrence compared with none in the radiotherapy group. No local lymph node or distant metastases occurred in either group. The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86). However, there was no significant difference in RFS between the treatments within the T1a invasion subgroups ( P  > 0.05). No patient died in either group. Mucosal defects of more than three-quarters of the esophageal circumference were positively correlated with stenosis ( P  < 0.01; odds ratio 23.26, 95 %CI 4.04 - 133.86). No severe radiation toxicities were recorded.
CONCLUSIONS


Radiotherapy after ESD might be a safe and effective optional therapeutic strategy to prevent recurrence of T1a ESCC.",2020,"The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86).","['T1a esophageal squamous cell cancer', 'Between January 2015 and September 2018, patients with early ESCC (T1aN0M0) following ESD', 'T1a ESCC', 'T1a early esophageal squamous cell carcinoma (ESCC']","['Endoscopic submucosal dissection with additional radiotherapy', 'ESD with additional radiotherapy', 'radiotherapy', 'Endoscopic submucosal dissection (ESD', 'radiotherapy group or non-radiotherapy group']","['esophageal circumference', '3-year cumulative recurrence-free survival', 'Recurrence-free survival, cancer-specific survival, overall survival, and complications', 'Mucosal defects', 'intraluminal mucosal recurrence', 'severe radiation toxicities', 'local lymph node or distant metastases', 'RFS']","[{'cui': 'C0475383', 'cui_str': 'Tumor stage T1a'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",,0.164958,"The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( P  = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86).","[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Liansong', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongze', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xianglei', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yuyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Zhou', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}]",Endoscopy,['10.1055/a-1198-5232']
604,32657946,"A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103).","BACKGROUND AND OBJECTIVE


Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI.
METHODS


Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding.
RESULTS


Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ± 15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ± 2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
CONCLUSION


Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.",2020,"Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
","['17 patients with major protocol violations before unblinding', 'Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148', 'mean age 55\u200a±\u200a15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5\u200a±\u200a2.4', 'Patients With Necrotizing Soft Tissue Infections (NSTI']","['reltecimod', 'placebo']","['mITT necrotizing infection clinical composite endpoint success', 'modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution', 'resolution of organ dysfunction', 'Resolution of organ dysfunction', 'resolution of organ dysfunction and hospital discharge status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517679', 'cui_str': '28.6'}, {'cui': 'C1868725', 'cui_str': 'Perineal infection'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0149778', 'cui_str': 'Soft tissue infection'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0275521', 'cui_str': 'Clinical infection'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",290.0,0.653613,"Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.
","[{'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': 'University of Washington, Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'Addison K', 'Initials': 'AK', 'LastName': 'May', 'Affiliation': 'Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'University of Washington, Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Evans', 'Affiliation': 'Ohio Health, Grant & Mansfield Hospitals, Columbus, Ohio.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Henry', 'Affiliation': 'University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Green', 'Affiliation': 'Carolinas Medical Center, Charlotte, North Carolina.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Toschlog', 'Affiliation': 'East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fagenholz', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Niels D', 'Initials': 'ND', 'LastName': 'Martin', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Dankner', 'Affiliation': 'Atox Bio Ltd, Durham, North Carolina.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Maislin', 'Affiliation': 'Biomedical Statistical Consulting, Wynnewood, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilfret', 'Affiliation': 'Atox Bio Ltd, Durham, North Carolina.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bernard', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004102']
605,32658817,Effects of family-focused therapy on suicidal ideation and behavior in youth at high risk for bipolar disorder.,"BACKGROUND


Youth who are at clinical and familial risk for bipolar disorder (BD) often have significant suicidal ideation (SI). In a randomized trial, we examined whether family-focused therapy (FFT) is associated with reductions in SI and suicidal behaviors in high-risk youth.
METHODS


Participants (ages 9-17 years) met diagnostic criteria for unspecified BD or major depressive disorder with active mood symptoms and had at least one relative with BD type I or II. Participants were randomly allocated to 12 sessions in 4 months of FFT or 6 sessions in 4 months of psychoeducation (enhanced care, EC), with pharmacotherapy as needed. Clinician- and child-rated assessments of mood, suicidal thoughts and behaviors, and family conflict were obtained at baseline and 4-6 month intervals over 1-4 years.
RESULTS


Participants (N=127; mean 13.2±2.6 yrs., 82 female) were followed over an average of 105.9±64.0 weeks. Youth with high baseline levels of SI who received FFT had lower levels of (and fewer weeks with) SI at follow-up compared to youth with high baseline SI who received EC. Participants in FFT had longer intervals without suicidal behaviors than participants in EC. Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
LIMITATIONS


Family conflict was based on questionnaires rather than observer ratings of family interactions.
CONCLUSIONS


Family psychoeducation with skill training can be an effective deterrent to suicidal thoughts and behaviors in youth at high risk for BD. Reducing parent/offspring conflict should be a central objective of psychosocial interventions for high-risk youth with SI.",2020,"Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
","['Youth who are at clinical and familial risk for bipolar disorder (BD', 'youth at high risk for bipolar disorder', 'Participants (N=127; mean 13.2±2.6 yrs., 82 female', 'high-risk youth with SI', 'Participants (ages 9-17 years) met diagnostic criteria for unspecified BD or major depressive disorder with active mood symptoms and had at least one relative with BD type I or II', 'Youth with high baseline levels of SI who received']","['FFT or 6 sessions in 4 months of psychoeducation (enhanced care, EC', 'family-focused therapy', 'FFT', 'skill training', 'family-focused therapy (FFT']","['longer intervals without suicidal behaviors', 'SI and suicidal behaviors', 'mood, suicidal thoughts and behaviors, and family conflict', 'suicidal ideation and behavior']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}]",127.0,0.111281,"Youths' ratings of family conflict significantly mediated the effects of treatment on SI at follow-up.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA. Electronic address: dmiklowitz@mednet.ucla.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Merranko', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Los Angeles (UCLA) School of Medicine, University of California, 760 Westwood Plaza Rm A8-256, Los Angeles, 90024-1759 CA, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.015']
606,32658822,Improvements in irritability with sertraline versus placebo: Findings from the EMBARC study.,"BACKGROUND


This report seeks to evaluate improvements in symptoms of irritability with sertraline (a selective serotonin reuptake inhibitor antidepressant) versus placebo.
METHODS


Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who were randomized to 8 weeks of treatment with either sertraline or placebo and completed 5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR) at baseline were included (n = 292). Repeated measures mixed model analysis with CAST-IRR as the outcome variable and treatment arm-by-time interaction as the independent variable of interest evaluated whether changes in irritability with treatment differed between sertraline and placebo arms. A separate analysis controlled for levels of overall depression severity (17-item Hamilton Depression Rating Scale). Covariates included age, sex, race, ethnicity, and site.
RESULTS


There was a significant treatment arm-by-time interaction (F = 6.96, df = 6, 1418, p <0.0001) suggesting that changes in irritability with sertraline differed from placebo. The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56). After controlling for levels of overall depression severity at each visit, reduction in irritability with time continued to be significant with sertraline but not with placebo.
LIMITATIONS


Secondary analysis, limited generalizability, lack of non-serotonergic antidepressants.
DISCUSSION


There is greater improvement in irritability with sertraline than with placebo. Improvement in irritability with sertraline was independent of its effects on overall depression severity. CLINICALTRIALS.
GOV IDENTIFIER


NCT01407094.",2020,The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56).,['Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who'],"['sertraline or placebo', 'sertraline', 'placebo']","['5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR', 'reduction in irritability', 'overall depression severity', 'irritability', 'overall depression severity (17-item Hamilton Depression Rating Scale']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",,0.370511,The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56).,"[{'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin Fatt', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9119, United States. Electronic address: madhukar.trivedi@utsouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.021']
607,32663998,Immediate and long-term effectiveness of adding an Internet intervention for depression to routine outpatient psychotherapy: Subgroup analysis of the EVIDENT trial.,"OBJECTIVE


To examine immediate and long-term effectiveness of an adjunctive Internet intervention for depression in a large sample of patients undergoing routine psychotherapy.
METHOD


The current study evaluated a subgroup of patients from the Evident trial, a randomized investigation of a 12-week minimally guided Internet intervention (Deprexis) for the treatment of mild to moderate depression. 340 adults (mean age = 43.3 years; 71.7 % female) of the original sample received routine outpatient psychotherapy during the trial period, resulting in a standard psychotherapy group (n = 174) and an augmented therapy group (n = 166). Outcomes were assessed at baseline, post-treatment and 6-month follow-up.
RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (d = 0.36; p = .003), and higher mental health-related quality of life (d = 0.34; p = .004). There was no intervention effect on physical health-related quality of life. The same pattern was found at 6-month follow-up, and adjunctive treatment also resulted in increased rates of clinical improvement. Treatment success was independent from therapeutic orientation of combined face-to-face therapy.
CONCLUSION


Results indicate that the adjunctive use of the investigated intervention can produce additional and lasting effects in routine outpatient psychotherapy for mild to moderate levels of depression. The study adds to the ongoing evidence on augmented effects of blended treatment. Future studies should investigate different types of blends in diverse populations by means of change-sensitive assessment strategies.",2020,"RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (","['340 adults (mean age\xa0=\xa043.3 years; 71.7 % female) of the original sample received routine outpatient psychotherapy during the trial period, resulting in a standard psychotherapy group (n\xa0=\xa0174) and an augmented therapy group (n\xa0=\xa0166', 'patients undergoing routine psychotherapy', 'mild to moderate depression']","['Internet intervention', 'adjunctive Internet intervention', 'minimally guided Internet intervention (Deprexis']","['higher mental health-related quality of life', 'symptoms of depression', 'therapeutic progress ', 'physical health-related quality of life', 'rates of clinical improvement']","[{'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",340.0,0.0623093,"RESULTS


Intention-to-treat analyses indicated that combined treatment led to a greater reduction in symptoms of depression (effect size d = 0.32; p = .002), improved therapeutic progress (","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Schuster', 'Affiliation': 'Department of Psychology, University of Salzburg, Austria; Outpatient Center for Clinical Psychology, Psychotherapy and Health Psychology, Department of Psychology, University of Salzburg, Salzburg, Austria. Electronic address: raphael.schuster@sbg.ac.at.'}, {'ForeName': 'Anton-Rupert', 'Initials': 'AR', 'LastName': 'Laireiter', 'Affiliation': 'Department of Psychology, University of Salzburg, Austria; Faculty of Psychology, University of Vienna, Austria; Outpatient Center for Clinical Psychology, Psychotherapy and Health Psychology, Department of Psychology, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Berne, Switzerland.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia AG, Hamburg, and Department of Psychology, City, University of London, London, United Kingdom.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Hohagen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.122']
608,32664000,Depressive symptom severity mediates the association between avoidant problem-solving style and suicidal ideation.,"BACKGROUND


The contemporaneous association between avoidant style, a maladaptive social problem-solving strategy, and adolescent suicidal ideation has been well established. However, the mechanisms underlying this association are not well understood. Using cross-lagged panel modeling, the present study examined whether depressive symptom severity mediates the relation between avoidant style and severity of suicidal ideation. The specificity of depressive symptom severity as a mediator was also evaluated by simultaneously testing whether avoidant style mediates the association between depressive symptom and suicidal ideation severity.
METHODS


The sample included 110 adolescents enrolled in a randomized controlled clinical effectiveness trial. Avoidant style as well as depressive symptom and suicidal ideation severity were assessed via self-report with the Social Problem-Solving Inventory-Revised, Children's Depression Scale-2, and Suicidal Ideation Questionnaire-Junior, respectively, at baseline, 3-and 6-months.
RESULTS


After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
LIMITATIONS


Results may not be generalizable to non-clinical samples. Causality cannot be inferred from study results. Data were exclusively collected via self-report.
CONCLUSIONS


Findings suggest that avoidant style is indirectly related to suicidal ideation through depressive symptom severity. Thus, treatment targeted at improving social problem-solving skills, particularly avoidant style, may help reduce depressive symptoms and lower suicide risk.",2020,"After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
",['110 adolescents enrolled'],[],"[""Social Problem-Solving Inventory-Revised, Children's Depression Scale-2, and Suicidal Ideation Questionnaire-Junior"", 'depressive symptom and suicidal ideation severity', 'avoidant style and 6-month suicidal ideation severity']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0451069', 'cui_str': 'Child depression scale'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",110.0,0.0278102,"After accounting for participant age, sex, and treatment condition, path analyses supported the specificity of 3-month depressive symptom severity as a mediator of the association between baseline levels of avoidant style and 6-month suicidal ideation severity.
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'George Mason University, Department of Psychology. Electronic address: rlopez_jr@post.harvard.edu.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Brick', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Annamarie B', 'Initials': 'AB', 'LastName': 'Defayette', 'Affiliation': 'George Mason University, Department of Psychology.'}, {'ForeName': 'Emma D', 'Initials': 'ED', 'LastName': 'Whitmyre', 'Affiliation': 'George Mason University, Department of Psychology.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wolff', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Frazier', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Esposito-Smythers', 'Affiliation': 'George Mason University, Department of Psychology.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.120']
609,32664003,"Can personalized treatment prediction improve the outcomes, compared with the group average approach, in a randomized trial? Developing and validating a multivariable prediction model in a pragmatic megatrial of acute treatment for major depression.","BACKGROUND


Clinical trials have traditionally been analysed at the aggregate level, assuming that the group average would be applicable to all eligible and similar patients. We re-analyzed a mega-trial of antidepressant therapy for major depression to explore whether a multivariable prediction model may lead to different treatment recommendations for individual participants.
METHODS


The trial compared the second-line treatment strategies of continuing sertraline, combining it with mirtazapine or switching to mirtazapine after initial failure to remit on sertraline among 1,544 patients with major depression. The outcome was the Personal Health Questionnaire-9 (PHQ-9) at week 9: the original analyses showed that both combining and switching resulted in greater reduction in PHQ-9 by 1.0 point than continuing. We considered several models of penalized regression or machine learning.
RESULTS


Models using support vector machines (SVMs) provided the best performance. Using SVMs, continuing sertraline was predicted to be the best treatment for 123 patients, combining for 696 patients, and switching for 725 patients. In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
LIMITATIONS


Stronger predictors are needed to make more precise predictions.
CONCLUSIONS


The multivariable prediction models led to improved recommendations for a minority of participants than the group average approach in a megatrial.",2020,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","['123 patients, combining for 696 patients, and switching for 725 patients', 'individual participants', '1,544 patients with major depression']","['support vector machines (SVMs', 'antidepressant therapy', 'mirtazapine or switching to mirtazapine']","['Personal Health Questionnaire-9 (PHQ-9', 'PHQ-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1544.0,0.0523889,"In the last two subgroups, both combining and switching were equally superior to continuing by 1.2 to 1.4 points, resulting in the same treatment recommendations as with the original aggregate data level analyses; in the first subgroup, however, switching was substantively inferior to combining (-3.1, 95%CI: -5.4 to -0.5).
","[{'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan. Electronic address: furukawa@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Thomas P A', 'Initials': 'TPA', 'LastName': 'Debray', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: T.Debray@umcutrecht.nl.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Neuropsychopharmacology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan. Electronic address: mitsuhiko_yamada@ncnp.go.jp.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic, Nagoya, Japan. Electronic address: aratama8177@yahoo.co.jp.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seo', 'Affiliation': 'Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. Electronic address: swj8874@gmail.com.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Efthimiou', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland. Electronic address: oremiou@gmail.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.141']
610,32664033,Expectation-induced placebo effect on acute sadness in women with major depression: An experimental investigation.,"BACKGROUND


Meta-analyses demonstrate that placebo effects play an important role in antidepressant treatment. Expectations seem to constitute a highly relevant placebo mechanism in this context. This study investigated whether an expectation manipulation combined with the intake of an active placebo could reduce acute sadness in depressed participants following a sadness-inducing mood manipulation.
METHODS


Women who suffered from a major depressive episode (N = 94) were randomly allocated to the drug expectation group (expectation to receive a fast-operating antidepressant), the placebo expectation group (expectation to receive a placebo) or the no treatment group (no expectation, no placebo). The drug expectation and the placebo expectation group received a placebo. All participants watched a sadness-inducing film. Sadness was assessed at baseline, after randomization and after placebo intake and mood induction. Data were analyzed by a 3 × 3 analysis of variance.
RESULTS


There were significant between-group differences in sadness change from the baseline after mood induction. While sadness increased in the no treatment group, it did not change in the placebo expectation group. In the drug expectation group, sadness even decreased.
LIMITATIONS


Only a single medication intake was simulated. Effects on acute sadness do not allow inferences about depression symptoms.
CONCLUSION


This experimental study found a placebo effect on sadness in clinically depressed participants. The effects were even larger than expected. Future research must investigate placebo effects on depression symptoms as well as long-term placebo intake.",2020,"While sadness increased in the no treatment group, it did not change in the placebo expectation group.","['clinically depressed participants', 'Women who suffered from a major depressive episode (N\xa0=\xa094', 'depressed participants following a sadness-inducing mood manipulation', 'women with major depression']","['placebo expectation group (expectation to receive a placebo) or the no treatment group (no expectation, no placebo', 'drug expectation group (expectation to receive a fast-operating antidepressant', 'Expectation-induced placebo', 'placebo']","['depression symptoms', 'acute sadness', 'sadness change']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",94.0,0.443496,"While sadness increased in the no treatment group, it did not change in the placebo expectation group.","[{'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Haas', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr. 18, 35032 Marburg, Germany. Electronic address: julia.wittkowski@uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University of Marburg, Gutenbergstr. 18, 35032 Marburg, Germany.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Glombiewski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Winkler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Department of Clinical and Biological Psychology, Catholic University of Eichstätt-Ingolstadt, Eichstätt, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.056']
611,32672643,Lifetime Risk of Visual Impairment Resulting from Glaucoma in Patients Initially Followed up for Elevated Intraocular Pressure.,"PURPOSE


To report the lifetime risk of visual impairment resulting from glaucoma in patients originally followed up in a 10-year prospective randomized study initiated in 1981 to assess patients with elevated intraocular pressure (IOP).
DESIGN


Retrospective patient chart review.
PARTICIPANTS


Data on deceased patients who initially were followed up prospectively in the randomized controlled study and thereafter were followed up in ordinary clinical practice were collected until the end of 2017. Inclusion in the original study required an untreated IOP of 22 mmHg or more and 1 or more risk factors for glaucoma.
METHODS


Visual impairment, low vision, and blindness were defined according to the World Health Organization criteria. All eyes that became visually impaired were registered, including the date and cause of the impairment; the cumulative incidence of visual impairment corrected for competing risks was calculated; and the Kaplan-Meier method was used to analyze the importance of risk factors present at baseline for 1 eye per patient.
MAIN OUTCOME MEASURES


The proportion of patients who became bilaterally visually impaired because of glaucoma, the cumulative incidence of glaucoma-related visual impairment in at least 1 eye, and potential baseline risk factors for visual impairment caused by glaucoma.
RESULTS


Seventy-seven of 90 patients (86%) included in the initial randomized study were deceased at the end of 2017. Four patients were lost to follow-up during the clinical follow-up. Of the 77 patients, 7 (9%) became bilaterally visually impaired and 2 of those 7 became bilaterally blind because of glaucoma. The cumulative incidence of glaucoma-induced visual impairment in at least 1 eye increased from 0.00 after 5 years to 0.22 (95% confidence interval [CI], -0.01 to 0.67) after 30 years. The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years. No specific risk factor significantly increased the risk of visual impairment caused by glaucoma.
CONCLUSIONS


Although the investigated patients showed elevated IOP and at least 1 additional glaucoma risk factor (i.e., they were high-risk patients), only a relatively small proportion of the patients with glaucoma demonstrated visual impairment.",2020,"The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years.","['Visual impairment, low vision, and blindness were defined according to the World Health Organization criteria', 'Data on deceased patients who initially were followed up prospectively in the randomized controlled study and thereafter were followed up in ordinary clinical practice were collected until the end of 2017', 'visual impairment resulting from glaucoma in patients originally followed up in a 10-year prospective randomized study initiated in 1981 to assess patients with elevated intraocular pressure (IOP', 'Seventy-seven of 90 patients (86%) included in the initial randomized study were deceased at the end of 2017']",[],"['cumulative incidence of glaucoma blindness', 'visual impairment', 'Lifetime Risk of Visual Impairment', 'elevated IOP', 'cumulative incidence of glaucoma-induced visual impairment', 'risk of visual impairment']","[{'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",4.0,0.240291,"The cumulative incidence of glaucoma blindness in at least 1 eye increased from 0.00 after 5 years to 0.17 (95% CI, 0.10-0.54) after 30 years.","[{'ForeName': 'Sigridur E', 'Initials': 'SE', 'LastName': 'Oskarsdottir', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden. Electronic address: sigridur.oskarsdottir@med.lu.se.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Heijl', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Midlöv', 'Affiliation': 'Department of Clinical Sciences Malmö, Center for Primary Health Care Research, Lund University, Malmö, Sweden.'}, {'ForeName': 'Boel', 'Initials': 'B', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Clinical Sciences Malmö, Department of Ophthalmology, Lund University, Malmö, Sweden.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.09.002']
612,32672594,Outflow Facility Effects of 3 Schlemm's Canal Microinvasive Glaucoma Surgery Devices.,"PURPOSE


To study the effect of 3 Schlemm's canal (SC) microinvasive glaucoma surgery (MIGS) devices on outflow facility.
DESIGN


Paired comparisons, randomized design, baseline-controlled study.
PARTICIPANTS


Thirty-six pairs of dissected anterior segments from donated human eye bank eyes without glaucoma were studied. A baseline measurement was collected from each eye to serve as its control.
METHODS


Using a constant pressure perfusion method, outflow facility was measured in paired eyes from human donors. Measurements were made at perfusion pressures of 10 mmHg, 20 mmHg, 30 mmHg, and 40 mmHg. Outflow facility was measured before (baseline control) and after the implantation of an SC glaucoma drainage device or sham procedure. Three sets of experiments were carried out comparing 1 and 2 iStent Trabecular Micro-Bypass Stents and 2 iStent Inject implants with the Hydrus Microstent.
MAIN OUTCOME MEASURES


Change in outflow facility from baseline or contralateral eye.
RESULTS


After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001). The percent increase in outflow facility was 79±21% for the Hydrus and 11±16% for the 2 iStent Inject devices, a difference that was significant (P = 0.018). Outflow facility with 1 iStent (0.38±0.07 μl/minute per millimeter of mercury) was greater than baseline (0.28±0.03 μl/minute per millimeter of mercury; P = 0.031). The 1 iStent showed a greater increase in outflow facility from baseline (0.10±0.04 μl/minute per millimeter of mercury) compared with the sham procedure (-0.08±0.05 μl/minute per millimeter of mercury; P = 0.042). No other significant differences were found.
CONCLUSIONS


The longer the MIGS device, and thus the more SC that it dilates, the greater the outflow facility.",2020,"After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001).","[""3 Schlemm's Canal Microinvasive Glaucoma Surgery Devices"", 'paired eyes from human donors', 'Thirty-six pairs of dissected anterior segments from donated human eye bank eyes without glaucoma were studied']","[""3 Schlemm's canal (SC) microinvasive glaucoma surgery (MIGS"", 'iStent Trabecular Micro-Bypass Stents and 2 iStent Inject implants with the Hydrus Microstent']","['Change in outflow facility from baseline or contralateral eye', 'Outflow facility', 'outflow facility', 'minute per millimeter of mercury']","[{'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0015394', 'cui_str': 'Eye Banks'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205622', 'cui_str': 'Microinvasive tumor'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}]",,0.139625,"After Hydrus placement, the outflow facility increased from 0.23±0.03 μl/minute per millimeter of mercury at baseline to 0.38±0.03 μl/minute per millimeter of mercury (P < 0.001).","[{'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Toris', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio; Department of Ophthalmology and Visual Sciences, University of Nebraska Medical Center, Omaha, Nebraska. Electronic address: ctoris@unmc.edu.'}, {'ForeName': 'Padmanabhan P', 'Initials': 'PP', 'LastName': 'Pattabiraman', 'Affiliation': 'Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tye', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Samuelson', 'Affiliation': 'Minnesota Eye Consultants, Minneapolis, Minnesota; Department of Ophthalmology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rhee', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.11.013']
613,32672612,"Safety and Efficacy of 0.1% Nepafenac versus 1% Prednisolone Acetate Eye Drops after Laser Peripheral Iridotomy: A Prospective, Randomized Trial.","PURPOSE


To compare 0.1% nepafenac, a topical nonsteroidal anti-inflammatory drop, with 1% prednisolone acetate in controlling inflammation after neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI) in primary angle-closure suspects (PACS).
DESIGN


Randomized controlled trial.
PARTICIPANTS


One hundred fifty-two PACS undergoing bilateral LPI.
METHODS


Patients were randomized to 0.1% nepafenac or 1% prednisolone acetate eye drops in both eyes. Medications were given 4 times daily for 7 days, then twice daily for additional 7 days. Investigators were masked to the type of medication. Right eyes in patients with bilateral PACS and the PACS eye in asymmetrical disease (primary angle closure in fellow eye) were analyzed.
MAIN OUTCOME MEASURES


Noninferior control of inflammation, defined as absence of cell in the anterior chamber at 2 weeks and absence of rebound iritis with medication discontinuation, was the primary outcome, whereas difference in the rise in intraocular pressure (IOP) was a secondary outcome.
RESULTS


Both groups were comparable in baseline characteristics, including IOP and total laser energy. Nepafenac was noninferior to prednisolone with regard to inflammation control, with 1 nepafenac-treated eye (1.3%) not meeting the primary end point because of 1+ anterior chamber cell at 2 weeks and 4 prednisolone-treated eyes (5.4%) failing to meet the primary end point because of rebound iritis (P < 0.001). A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both). Two weeks after LPI, 3 nepafenac-treated eyes and 10 prednisolone-treated eyes demonstrated a 6- to 15-mmHg IOP elevation from baseline (P = 0.10), whereas 2 prednisolone-treated eyes and no nepafenac-treated eyes showed IOP elevation of more than 15 mmHg (P = 0.20). Four weeks after LPI, more prednisolone-treated eyes showed IOP elevation of 6 to 15 mmHg as compared with nepafenac-treated eyes (6 eyes vs. 1 eye; P = 0.04); no eyes showed IOP elevation of more than 15 mmHg.
CONCLUSIONS


Nepafenac was noninferior to prednisolone in controlling inflammation after LPI in PACS.",2020,"A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both).","['One hundred fifty-two PACS undergoing bilateral LPI', 'primary angle-closure suspects (PACS', 'after Laser Peripheral Iridotomy', 'Patients', 'patients with bilateral PACS and the PACS eye in asymmetrical disease (primary angle closure in fellow eye']","['Prednisolone Acetate Eye Drops', 'prednisolone acetate', 'nepafenac', 'prednisolone', 'prednisolone-treated eyes and no nepafenac', 'nepafenac or 1% prednisolone acetate eye drops', 'Nepafenac', 'neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI']","['rebound iritis', 'Safety and Efficacy', 'absence of cell in the anterior chamber at 2 weeks and absence of rebound iritis with medication discontinuation', 'IOP elevation', 'IOP and total laser energy', 'IOP', 'intraocular pressure (IOP']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0197497', 'cui_str': 'Anterior segment of eye incision'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}]","[{'cui': 'C0022081', 'cui_str': 'Iritis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]",152.0,0.244206,"A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both).","[{'ForeName': 'Keerthi', 'Initials': 'K', 'LastName': 'Gayam', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins University, Baltimore, Maryland; Glaucoma Department, Wilmer Eye Institute, John Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Rengaraj', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Kavitha', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': 'Glaucoma Department, Aravind Eye Hospital, Pondicherry, India. Electronic address: skavitha.shree@gmail.com.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.02.006']
614,33067121,Mobile health technology-supported atrial fibrillation screening and integrated care: A report from the mAFA-II trial Long-term Extension Cohort.,"BACKGROUND


In the mobile Atrial Fibrillation App (mAFA)-II trial, the use of mobile health (mHealth) technology, incorporating AF screening and integrated management strategy, was associated with improved short-term clinical outcomes. The aim of this study was to report adherence/persistence and long term (≥1 year) clinical outcomes of the mAFA-II trial, with mHealth-supported optimised stroke prevention, symptom control and comorbidity management.
METHODS


We studied an adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention. In this cluster randomised trial, comparing mHeath intervention to usual care, the primary composite outcome was 'stroke/thromboembolism, all-cause death and rehospitalization'.
RESULTS


The 1261 subjects (mean age 67.0 years, 38.0% female) who were followed up over one year (mean follow-up 687 (standard deviation, SD 191) days) in the intervention arm, had a lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization' (hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female). Of 842 patients using their smart devices for 'Better symptom management', 70.8% had good management adherence (monitoring time/follow-up since initial monitoring ≥ 70%), with the persistence of use of 91.7%.
CONCLUSION


Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.",2020,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[""842 patients using their smart devices for 'Better symptom management', 70.8% had"", '1261 subjects (mean age 67.0 years, 38.0% female', 'hazard ratio, HR 0.18, 95% confidence interval, CI: 0.13-0.25, P < 0.001), compared to usual care (1212 subjects, mean age 70.1 years, 42.1% female', 'adult population screened for AF, where identified patients could enter a structured program of holistic and integrated care based on the ABC (Atrial fibrillation Better Care) pathway using mHealth with a mAFA intervention']",['Mobile health technology-supported atrial fibrillation screening and integrated care'],"['stroke/thromboembolism, all-cause death and rehospitalization', 'good management adherence', ""lower risk of the composite outcome of 'ischaemic stroke/systemic thromboembolism, death, and rehospitalization""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4517433', 'cui_str': '0.18'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4517428', 'cui_str': '0.13'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C4517385', 'cui_str': '0.001'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.11083,"Amongst AF patients with long term use (≥1 year) of mHealth technology for optimising stroke prevention, symptom control and comorbidity management, adherence/persistence was good and associated with a reduction in adverse clinical outcomes.","[{'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: dor_guoyt@hotmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiangmin', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Institute for Hospital Management Research, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of internal medicine,['10.1016/j.ejim.2020.09.024']
615,33066973,Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis.,"OBJECTIVE


To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with moderate to severe endometriosis-associated pain.
DESIGN


Analysis of data from two phase III randomized clinical trials (EM-I [NCT01620528] and EM-II [NCT01931670]).
SETTING


Not applicable.
PATIENT(S)


Premenopausal women ages 18-49 years with moderate to severe endometriosis-associated pain.
INTERVENTION(S)


Participants in both trials were randomized 3:2:2 to receive placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months.
MAIN OUTCOME MEASURE(S)


NRS-DYS and NRS-NMPP.
RESULT(S)


EM-I enrolled 871 women and EM-II enrolled 815 women. For patients with a global impression of improvement at month 3, the least-squares mean change between baseline and month 3 was -3.6 (EM-I and EM-II) for NRS-DYS and -1.9 (EM-I) and -2.0 (EM-II) for NRS-NMPP. Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP. Baseline half standard deviations were 0.78 (EM-I) and 0.85 (EM-II) for NRS-DYS and 0.92 (EM-I) and 0.96 (EM-II) for NRS-NMPP. Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP.
CONCLUSION(S)


This study demonstrated the utility and responsiveness of separate numerical rating scales to assess worst pain for dysmenorrhea and NMPP in women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change.",2021,Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP.,"['871 women and EM-II enrolled 815 women', 'women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change', 'women with moderate to severe endometriosis-associated pain', '\n\n\nPremenopausal women ages 18-49 years with moderate to severe endometriosis-associated pain', 'women with moderate to severe endometriosis']","['nonmenstrual pelvic pain (NRS-NMPP', 'placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],871.0,0.0907509,Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP.,"[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Evidera, Bethesda, Maryland. Electronic address: robin.pokrzywinski@evidera.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, North Chicago, Illinois.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Evidera, Bethesda, Maryland.'}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Evidera, Bethesda, Maryland.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.07.013']
616,33068037,Safety and Efficacy of Omaveloxolone in Friedreich Ataxia (MOXIe Study).,"OBJECTIVE


Friedreich ataxia (FA) is a progressive genetic neurodegenerative disorder with no approved treatment. Omaveloxolone, an Nrf2 activator, improves mitochondrial function, restores redox balance, and reduces inflammation in models of FA. We investigated the safety and efficacy of omaveloxolone in patients with FA.
METHODS


We conducted an international, double-blind, randomized, placebo-controlled, parallel-group, registrational phase 2 trial at 11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23). Eligible patients, 16 to 40 years of age with genetically confirmed FA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80, were randomized 1:1 to placebo or 150mg per day of omaveloxolone. The primary outcome was change from baseline in the mFARS score in those treated with omaveloxolone compared with those on placebo at 48 weeks.
RESULTS


One hundred fifty-five patients were screened, and 103 were randomly assigned to receive omaveloxolone (n = 51) or placebo (n = 52), with 40 omaveloxolone patients and 42 placebo patients analyzed in the full analysis set. Changes from baseline in mFARS scores in omaveloxolone (-1.55 ± 0.69) and placebo (0.85 ± 0.64) patients showed a difference between treatment groups of -2.40 ± 0.96 (p = 0.014). Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury. Headache, nausea, and fatigue were also more common among patients receiving omaveloxolone.
INTERPRETATION


In the MOXIe trial, omaveloxolone significantly improved neurological function compared to placebo and was generally safe and well tolerated. It represents a potential therapeutic agent in FA. ANN NEUROL 2021;89:212-225.",2021,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"['patients with FRDA', '155 patients were screened and 103', ""Eligible patients, 16 to 40\u2009years of age with genetically confirmed FRDA and baseline modified Friedreich's Ataxia Rating Scale (mFARS) scores between 20 and 80"", '11 institutions in the United States, Europe, and Australia (NCT02255435, EudraCT2015-002762-23']","['omaveloxolone patients and 42 placebo', 'placebo', 'Omaveloxolone', 'omaveloxolone']","['mFARS scores', 'total bilirubin', 'Safety and Efficacy', 'safety and efficacy', 'Headache, nausea, and fatigue', 'safe and well tolerated', 'mitochondrial function, restores redox balance', 'aminotransferase levels', 'mFARS score', 'neurological function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",155.0,0.684078,Transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lynch', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Chin', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Delatycki', 'Affiliation': ""Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Subramony', 'Affiliation': 'Department of Neurology, McKnight Brain Institute, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Corti', 'Affiliation': 'Department of Pediatrics, University of Florida Health System, Gainesville, FL, USA.'}, {'ForeName': 'J Chad', 'Initials': 'JC', 'LastName': 'Hoyle', 'Affiliation': 'Department of Neurology, Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Boesch', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Nachbauer', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Mariotti', 'Affiliation': 'Istituto di Ricovero e Cura a Carattere Scientifico-Carlo Besta Neurological Institute, Milan, Italy.'}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Mathews', 'Affiliation': 'Department of Neurology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Giunti', 'Affiliation': 'University College London Hospital, London, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wilmot', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Zesiewicz', 'Affiliation': 'Department of Neurology, University of South Florida Ataxia Research Center, Tampa, FL, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Goldsberry', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': ""O'Grady"", 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Meyer', 'Affiliation': 'Reata Pharmaceuticals, Dallas, TX, USA.'}]",Annals of neurology,['10.1002/ana.25934']
617,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5)  = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5)  = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
618,33070235,"Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device.","BACKGROUND


Standard microscopic lumbar discectomy (MLD) is a short operation with minimal blood loss, and a low rate of peri- and intraoperative complications. The objective of this study was to evaluate intraoperative findings, complications, and early postoperative neurological outcome (< 105 days) in patients undergoing MLD with or without implantation of an annular closure device (ACD).
METHODS


This study is based on data analysis of a post-marketing, prospective, multicenter RCT in Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group.
RESULTS


Mean operation time was 70 min in the ACD group and 52 min in the control group (p < 0.0001). Intraoperative fluoroscopy time was 24 s in the ACD group and 7 s in the control group (p < 0.0001). Average blood loss was 94.2 ml in the ACD group and 64.7 ml in the control group (p = 0.0001). Serious device- or procedure-related adverse events occurred in 3.7% (10/272) of the ACD group and 7.9% (22/278) of the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Surgical complications included 3 hematomas in the ACD group and 4 in the control group; 3 infections occurred in both groups. Device migrations were documented in 3 patients in the ACD group. Patients in the ACD group (n = 7, 2.6%) underwent fewer reoperations compared with that in the control group (n = 16, 5.8%, OR = 2.3 (0.9-5.7)). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
CONCLUSION


Short-term outcome after MLD with or without implantation of ACD was similar in both groups. Patients included in the ACD group underwent fewer reoperations in the first 3 months after surgery. Nevertheless, longer operation time, higher amount of blood loss, and risk of nerve root lesion during device implantation should be considered additional risks in patients undergoing ACD implantation after MLD.",2021,"Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
","['patients undergoing ACD implantation after MLD', '554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group', 'Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA', 'patients undergoing MLD with or without implantation of an annular closure device (ACD']","['ACD', 'microscopic lumbar discectomy (MLD']","['Dural injuries', 'Mean operation time', 'Mean VAS leg pain', 'Average blood loss', 'Device migrations', 'Serious device- or procedure-related adverse events', 'longer operation time, higher amount of blood loss, and risk of nerve root lesion', 'intraoperative findings, complications, and early postoperative neurological outcome', 'Intraoperative fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0105231', 'cui_str': 'Periodontal pack - light-curing system'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0002873', 'cui_str': 'Anemia of chronic disease'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549474', 'cui_str': 'Device migration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0235919', 'cui_str': 'Nerve root lesion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",276.0,0.0522238,"Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.
","[{'ForeName': 'Jenny C', 'Initials': 'JC', 'LastName': 'Kienzler', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Heidecke', 'Affiliation': 'Department of Neurosurgery, Klinikum Augsburg, Augsburg, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Assaker', 'Affiliation': 'Department of Neurosurgery, Centre Hospitalier Régional Universitaire of Lille, Lille, France.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fandino', 'Affiliation': 'Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland. fandino@neurochirurgie-ag.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Barth', 'Affiliation': 'Department of Neurosurgery, Klinikum Frankfurt, Frankfurt, Germany.'}]",Acta neurochirurgica,['10.1007/s00701-020-04612-2']
619,33083913,Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study.,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial. Subsequently, the combination of TAS-102 and bevacizumab was shown to extend the median PFS (C-TASK FORCE study). However, the study included patients who received second- and third-line treatment. Our study exclusively examined patients receiving this combination as a third-line treatment to investigate the clinical impact beyond cytotoxic doublets.
METHODS


This investigator-initiated, open-label, single-arm, multi-centered phase II study was conducted in Japan. Eligible CRC patients were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy. TAS-102 (35 mg/m 2 ) was given orally twice daily on days 1-5 and 8-12 in a 4-week cycle, and bevacizumab (5 mg/kg) was administered by intravenous infusion every 2 weeks. The primary endpoint was PFS and the secondary endpoints were time-to-treatment failure, response rate, overall survival (OS), and safety.
RESULTS


Between June 2016 and August 2017, 32 patients were enrolled. All patients previously received bevacizumab. The median PFS was 4.5 months; the median overall survival was 9.3 months. Partial response was observed in two patients. The most common adverse events above grade 3 were neutropenia followed by thrombocytopenia. There were no non-hematological adverse events above grade 3 and no treatment-related deaths occurred.
CONCLUSIONS


This study met its primary endpoint of PFS, which is comparable to the results of the C-TASK FORCE study. The TAS-102 and bevacizumab combination has the potential to be a therapeutic option for third-line treatment of metastatic CRC.",2021,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial.","['metastatic colorectal cancer', 'Eligible CRC patients were refractory or intolerant to', 'metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS', 'Between June 2016 and August 2017, 32 patients were enrolled']","['fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy', 'TAS-102 and bevacizumab', 'TAS-102', 'bevacizumab']","['hematological adverse events', 'time-to-treatment failure, response rate, overall survival (OS), and safety', 'Partial response', 'median overall survival', 'overall survival', 'median PFS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C1451803', 'cui_str': 'TAS-102'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",32.0,0.0465772,"BACKGROUND


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial.","[{'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. yyoshida@fukuoka-u.ac.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kosugi', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgical Oncology, Dokkyo Medical University, Tochigi, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan.""}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Fukazawa', 'Affiliation': 'Department of Gastroenterological Surgery, Iwata City Hospital, Shizuoka, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Sonoda', 'Affiliation': 'Department of Surgery, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yoshimatsu', 'Affiliation': 'Department of Surgery, Saiseikai Kurihashi Hospital, Saitama, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Matsuda', 'Affiliation': 'Department of Surgery, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Dept of Hygiene and Public Health, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Koda', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01794-8']
620,33078216,Passive Versus Active Intra-Abdominal Drainage Following Pancreaticoduodenectomy: A Retrospective Study Using The American College of Surgeons NSQIP Database.,"BACKGROUND


Prophylactic drainage following pancreaticoduodenectomy (PD) reduces morbidity and mortality. Little evidence exists to advise on whether passive gravity (PG) or active suction (AS) drainage systems result in superior outcomes. This study examines the relationship between drainage system and morbidity following PD.
METHODS


All patients undergoing elective PD with an operatively placed drain in the 2016 ACS-NSQIP database were included. Pre- and intra-operative factors were examined. Multivariable logistic regression and coarsened exact matching (CEM) were used to assess for an association between drainage system (PG vs. AS) and morbidity. The primary outcome was postoperative pancreatic fistula (POPF).
RESULTS


In total, 3430 patients were included: 563 (16.4%) with PG and 2867 (83.6%) with AS drainage system. On multivariable regression, 1787 patients were included. Drainage type was not associated with POPF, surgical site infection, delayed gastric emptying, or re-operation. AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033). In the CEM cohort (n = 268), superficial SSI was higher in the AS group (0.8% vs. 6.0%, p = 0.036). There was a trend toward higher rates of composite total SSI (PG 15.7%, AS 23.9%, p = 0.092) and organ space SSI (PG 14.2%, AS 20.2%, p = 0.195) in the AS group; this did not demonstrate statistical significance.
CONCLUSIONS


The findings of this study suggest that AS drainage is protective against percutaneous drain insertion, but may be associated with increased risk of SSI. There was no relation between drainage type and POPF. A prospective, randomized controlled trial is warranted to further explore these findings.",2021,"AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033).","['1787 patients were included', 'All patients undergoing elective PD with an operatively placed drain in the 2016 ACS-NSQIP database were included', '3430 patients were included: 563 (16.4%) with PG and 2867 (83.6%) with AS drainage system', 'American College of Surgeons NSQIP Database']","['Pancreaticoduodenectomy', 'pancreaticoduodenectomy (PD', 'passive gravity (PG) or active suction (AS) drainage systems', 'Passive Versus Active Intra-Abdominal Drainage']","['risk of SSI', 'superficial SSI', 'postoperative pancreatic fistula (POPF', 'POPF, surgical site infection, delayed gastric emptying, or re-operation', 'morbidity and mortality', 'rates of composite total SSI', 'organ space SSI', 'drainage type and POPF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",3430.0,0.286681,"AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033).","[{'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Lemke', 'Affiliation': ""School of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Fady K', 'Initials': 'FK', 'LastName': 'Balaa', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Martel', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Jad Abou', 'Initials': 'JA', 'LastName': 'Khalil', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Bertens', 'Affiliation': 'School of Medicine, University of Ottawa, Ottawa, ON, Canada. kbertens@toh.ca.'}]",World journal of surgery,['10.1007/s00268-020-05823-5']
621,33075711,The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points.,"Abnormal muscle stiffness is a potential complication after injury and identifying interventions that modify muscle stiffness may be useful to promote recovery. The purpose of this study was to identify the short-term effects of dry needling (DN) on resting and contracted gastrocnemius muscle stiffness and strength of the triceps surae in individuals with latent myofascial trigger points (MTrPs). In this randomized controlled trial, 52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two sham needling sessions. Resting and contracted muscle stiffness were assessed both at the treatment site and a standardized central site in the medial gastrocnemius head immediately post-treatment and one week after the last session. There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29). Post-needling between group comparison indicated that the DN group had significantly lower resting muscle stiffness at the site of the MTrP than the sham group after adjusting for baseline differences. There were no significant between group differences in contracted muscle stiffness or muscle strength. Identifying strategies that can reduce aberrant muscle stiffness may help to guide management of individuals with neuromuscular pain-related conditions. Level of evidence: Therapy, level 2.",2020,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","['participants with latent trigger points', '52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two', 'individuals with latent myofascial trigger points (MTrPs', 'individuals with neuromuscular pain-related conditions']","['sham needling sessions', 'dry needling', 'dry needling (DN']","['resting muscle stiffness', 'contracted muscle stiffness or muscle strength', 'gastrocnemius muscle stiffness and strength', 'Level of evidence', 'Resting and contracted muscle stiffness', 'time interactions for resting muscle stiffness']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1405031', 'cui_str': 'Neuromuscular pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.067405,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University Doctoral Program in Physical Therapy, Waco, TX, United States.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'MacDonald', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capoccia', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ngo', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phippen', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendlandt', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hoffman', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102479']
622,33108624,Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy is Safe and Effective in Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study.,"INTRODUCTION


We investigate the safety and efficacy of telmisartan plus S-amlodipine single-pill combination in a real-world population.
METHODS


A total of 44,715 patients who had hypertension and received a telmisartan/S-amlodipine single-pill combination at least once were included for safety and efficacy evaluation from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019. They were followed up for 3-6 months in terms of safety and efficacy of blood pressure (BP) lowering.
RESULTS


A total of 44,715 patients were included for safety analysis and 41,579 for efficacy analysis. Mean duration of taking the drug was 175.86 ± 48.45 days. A total of 28,096 (62.8%) patients were on telmisartan 40 mg plus S-amlodipine 2.5 mg combination followed by 80/2.5 mg (8664, 19.4%) and 40/5 mg of the drug (7136, 16.0%). Adverse events, total adverse drug reactions, and serious adverse drug reactions were found in 808 patients (1.81%), 352 (0.79%), and 1 (0.002%), respectively. Dizziness and headache were most common (134 [0.30%] and 81 [0.18%]) among all adverse events. Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively. Systolic BP (SBP) and diastolic BP (DBP) was lowered from 143.1 ± 16.1/88.1 ± 11.8 mmHg to 129.6 ± 11.4/80.1 ± 9.0 mmHg (difference - 13.5/- 7.9 mmHg, P < 0.0001 for both). Target BP goal attainment rate defined as SBP < 140 mmHg and DBP < 90 mmHg was 74.6% (95% confidence interval [CI] 74.2-75.0) and BP response rate (defined as SBP < 140 mmHg or ≥ 20 mmHg reduction; DBP < 90 mmHg or ≥ 10 mmHg reduction) was 94.5% (95% CI 94.3-94.7).
CONCLUSION


Telmisartan plus S-amlodipine single-pill combination was safe and effective in patients with hypertension in a large real-world population.",2021,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","['Patients with Hypertension from Large-Scale Nationwide Surveillance Data in Korea (NOVEL) Study', 'patients with hypertension in a large real-world population', '44,715 patients who had hypertension and received a', 'A total of 28,096 (62.8%) patients were on', '44,715 patients', 'from 2852 primary to tertiary hospitals in Korea from August 2013 to December 2019']","['telmisartan plus S-amlodipine single-pill combination', 'telmisartan/S-amlodipine single-pill combination', 'Telmisartan plus S-amlodipine single-pill combination', 'telmisartan 40\xa0mg plus S-amlodipine', 'Telmisartan Plus S-Amlodipine Single-Pill Combination Therapy']","['Total edema and leg edema', 'Adverse events, total adverse drug reactions, and serious adverse drug reactions', 'safety and efficacy of blood pressure (BP) lowering', 'safety and efficacy', 'Target BP goal attainment rate', 'BP response rate', 'safety and efficacy evaluation', 'Systolic BP (SBP) and diastolic BP (DBP', 'Dizziness and headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0990502', 'cui_str': 'telmisartan 40 MG'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0235886', 'cui_str': 'Leg edema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",44715.0,0.107475,"Total edema and leg edema were rarely reported, 38 (0.08%) and 25 (0.06%), respectively.","[{'ForeName': 'Sang-Ho', 'Initials': 'SH', 'LastName': 'Jo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sung-Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Medicine, Cardiovascular Imaging Center, Samsung Medical Center, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Cardiovascular-Arrhythmia Center, Chung-Ang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea. parkcg@kumc.or.kr.'}]",Advances in therapy,['10.1007/s12325-020-01533-5']
623,33104835,Subcuticular Sutures Versus Staples for Wound Closure in Open Liver Resection: A Randomised Clinical Trial.,"BACKGROUND


Subcuticular sutures reduce wound complication rates only in clean surgeries. Repeat resection is frequently required in liver surgery, due to the high recurrence rate (30-50%) of liver cancers. The aim of this study is to assess that subcuticular sutures is superior to staples in liver surgery.
METHODS


This single-centre, single-blinded, randomised controlled trial was conducted at a university hospital between January 2015 and October 2018. Patients were randomly assigned (1:1) to receive either subcuticular sutures or staples for skin closure. Three risk factors (repeat resection, diabetes mellitus and liver function) were matched preoperatively for equal allocation. The primary endpoint was the wound complication rate, while secondary endpoints were surgical site infection (SSI), duration of postoperative hospitalisation and total medical cost. Subset analyses were performed only for the 3 factors allocated as secondary endpoints.
RESULTS


Of the 581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed. As the primary outcome, the wound complication rate with subcuticular sutures (12.5%) did not differ from that with staples [15.9%; odds ratio (OR), 1.33; 95% confidence interval (CI), 0.83-2.15; p = 0.241]. As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
CONCLUSION


Subcuticular sutures were not shown to reduce wound complications compared to staples in open liver resection, but appear beneficial for repeat incisions.",2021,"As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
","['clean surgeries', 'university hospital between January 2015 and October 2018', '581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed', 'Open Liver Resection']","['subcuticular sutures', 'Subcuticular Sutures Versus Staples for Wound Closure', 'subcuticular sutures or staples for skin closure', 'Subcuticular sutures']","['wound complications', 'wound complication rate with subcuticular sutures', 'overall wound complications', 'wound complication rate', 'wound complication rates', 'risk factors (repeat resection, diabetes mellitus and liver function', 'surgical site infection (SSI), duration of postoperative hospitalisation and total medical cost']","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}]","[{'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",581.0,0.233861,"As secondary outcomes, no significant differences were identified between the two procedures in the overall cohort while overall wound complications [7 patients (8.5%) vs. 17 patients (20.0%); OR, 2.68; 95% CI, 1.08-7.29; p = 0.035] with repeat incision were significantly less frequent with subcuticular sutures.
","[{'ForeName': 'Yoritaka', 'Initials': 'Y', 'LastName': 'Matsuno', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan. yamazaki-nmed@umin.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mitsuka', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Abe', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Tokio', 'Initials': 'T', 'LastName': 'Higaki', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Tadatoshi', 'Initials': 'T', 'LastName': 'Takayama', 'Affiliation': 'Department of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan.'}]",World journal of surgery,['10.1007/s00268-020-05833-3']
624,33105394,Reduction in Stigma Drivers Partially Mediates the Effect of a Stigma Reduction Intervention Among Nursing Students in India: The DriSti Cluster Randomized Controlled Trial.,"BACKGROUND


HIV stigma in health care settings acts as a significant barrier to health care. Stigma drivers among health professionals include transmission fears and misconceptions and pre-existing negative attitudes toward marginalized groups vulnerable to HIV. The DriSti intervention, consisted of 2 sessions with videos and interactive exercises on a computer tablet and one interactive face-to-face group session, mostly tablet administered, was designed to target key stigma drivers that included instrumental stigma, symbolic stigma, transmission misconceptions and blame to reduce HIV stigma, and discrimination among nursing students (NS) and ward staff and tested in a cluster randomized trial.
SETTING


This report focuses on second and third year NS recruited from a range of nursing schools that included private, nonprofit, and government-run nursing schools in south India.
RESULTS


Six hundred seventy-nine NS received intervention and 813 NS were in the wait-list control group. Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (P < 0.001) and in the number of situations in which NS intended to discriminate against PLWH (P < 0.001). Mediation analysis revealed that the effects of intervention on endorsement of coercive policies and intent to discriminate against PLWH were partially mediated by reductions in key stigma drivers.
CONCLUSIONS


This brief scalable stigma reduction intervention targeting key stigma drivers fills a critical gap in identifying the mechanistic pathways that aid in stigma reduction among health professionals.",2021,Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (p<.001) and in the number of situations in which NS intended to discriminate against PLWH (p<.001).,"['second and third year nursing students (NS) recruited from a range of nursing schools that included private, non-profit, and government- run nursing schools from south India', 'Six hundred seventy nine NS', 'nursing students in India']","['videos and interactive exercises on a computer tablet and one interactive skills-based face-to-face group session, mostly tablet administered, was designed to target key stigma drivers that included instrumental stigma, symbolic stigma, transmission misconceptions and blame to reduce HIV stigma and discrimination among nursing students and ward staff', 'stigma reduction intervention']",[],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0036380', 'cui_str': 'Nursing Schools'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0029247', 'cui_str': 'Non-profit organization'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0505196,Twelve months outcome analyses showed significant reduction among intervention participants in endorsement of coercive policies (p<.001) and in the number of situations in which NS intended to discriminate against PLWH (p<.001).,"[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St John's Research Institute and St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Raj', 'Affiliation': ""Division of Medical Informatics, St John's Research Institute, and St. John's Medical College, Bangalore, India; and.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Nyblade', 'Affiliation': 'Global Health Division, International Development Group, RTI International, Washington, DC.'}, {'ForeName': 'Dhinagaran', 'Initials': 'D', 'LastName': 'Devadass', 'Affiliation': ""Division of Medical Informatics, St John's Research Institute, and St. John's Medical College, Bangalore, India; and.""}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Division of Prevention Sciences, Department of Medicine, University of California, San Francisco, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002543']
625,33089386,Comparative Analysis of Efficacy of Lactic Acid with Ferulic Peel (Combination Peel) Vs Ferulic Peel Alone as a Monotherapy for Photoaging.,"OBJECTIVES


Chemical peels are used to treat fine lines, photoaging, skin discoloration and scars. The objective of this study is to do a comparative analysis of lactic acid 30 % with ferulic peel 12 % (combination peel) versus ferulic peel 12% alone as a monotherapy for photoaging.
MATERIALS AND METHODS


This is a prospective study from Feb 2016 to 2020 in which a total of 60 female patients with ages between 25 and 36 years were treated. Randomization of patients was done for both groups with 30 patients enrolled in each group. The first group of 30 patients was treated with ferulic peel 12 % (hydroalcohol base) with L-ascorbic acid 15% as a sealer alone (i.e., Group A). In the second group, 30 patients were treated with lactic acid 30 % with ferulic peel 12% (hydroalcohol base) with L-ascorbic acid 15% as a sealer (combination peel) (i.e., Group B). Inclusion and exclusion criteria have been defined for the study. Two scales have been used for assessing the results, Allergan Skin Roughness Scale (ASRS) and Allergan Fine Line Scale (AFLS). ASRS and AFLS scores were assessed at pre-treatment (pre) and post-treatment (post 1 month after last peel session) and compared using Student's paired t test and independent t test.
RESULTS


The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone. No complications were observed in our study.
CONCLUSION


The study found the combination of lactic acid and ferulic peel significantly more effective than ferulic peel alone in the management of fine lines, photoaging and skin discoloration. The findings of this study may need to be further validated on a larger sample size and multicentric analysis. Initial results of our 4-year study have yielded promising results.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,"The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone.","['Feb 2016 to 2020 in which a total of 60 female patients with ages between 25 and 36 years were treated', '30 patients enrolled in each group']","['ferulic peel 12\xa0% (hydroalcohol base) with L-ascorbic acid', 'lactic acid 30 % with ferulic peel 12% (hydroalcohol base) with L-ascorbic acid', 'ferulic peel 12\xa0% (combination peel) versus ferulic peel', 'ferulic peel alone', 'Lactic Acid with Ferulic Peel (Combination Peel', 'Vs Ferulic Peel Alone', 'lactic acid and ferulic peel']","['ASRS and AFLS scores', 'AFLS', 'fine lines, photoaging and skin discoloration', 'Allergan Skin Roughness Scale (ASRS) and Allergan Fine Line Scale (AFLS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}]","[{'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}]",60.0,0.0455024,"The results showed significant and higher improvement of 27% and 42%, respectively, in ASRS (1.37 ± 0.49 vs. 1.87 ± 0.51, diff = 0.50, 95% CI = 0.24 to 0.76, p < 0.001) and AFLS (1.20 ± 0.41 vs. 2.07 ± 0.58, diff = 0.87, 95% CI = 0.61-1.13, p < 0.001) scores in patients treated with lactic acid and ferulic peel as compared to patients treated with ferulic peel alone.","[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Renaissance clinic, Jaipuria mall, Indirapuram, Ghaziabad, 201010, India.'}, {'ForeName': 'Sukhbir', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Resplendent the cosmetic studio, R-9, Greater Kailash part 1, NewDelhi, 110048, India. sukhi_1@yahoo.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-02004-6']
626,33099665,Impact of Mesh and Fixation on Chronic Inguinal Pain in Lichtenstein Hernia Repair: 5-Year Outcomes from the Finn Mesh Study.,"OBJECTIVE


To find out the mesh fixation technique that minimises chronic pain in Lichtenstein hernioplasty. Mesh fixation may affect chronic pain and recurrence after inguinal hernia surgery, but long-term results of comparative trials are lacking.
METHODS


Lichtenstein hernioplasty was performed under local anaesthesia on 625 patients in day care units. The patients were randomised to receive either a cyanoacrylate glue (n = 216), self-gripping mesh (n = 202) or non-absorbable 3-0 polypropylene sutures (n = 216) for the fixation of mesh. A standardised telephone interview or postal questionnaire was conducted 5 years after the index operation. The patients with complaints suggesting recurrence or chronic pain (visual analogue scale ≥ 3, 0-10) were examined clinically. The rate of occasional pain, chronic severe pain, recurrence, re-operations, daily use of analgesics, overall patient satisfaction and sensation of a foreign object were recorded.
RESULTS


A total of 82% of patients (n = 514) completed the 5-year audit including 177, 167 and 170 patients in the glue, self-fixation and suture groups, respectively. There were no significant differences in the incidence of pain (7-8%), operated recurrences (2-4%), overall re-operations (4-5%), need for analgesics (1-2%), patient's satisfaction (93-97%) or in the feeling of a foreign object (11-18%) between the study groups.
CONCLUSION


The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia. Less penetrating fixation (glue or self-gripping mesh) is a safe option for the fixation of mesh in Lichtenstein hernia repair.",2021,"The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia.","['625 patients in day care units', 'patients with complaints suggesting recurrence or chronic pain (visual analogue scale\u2009≥\u20093, 0-10', 'Lichtenstein hernioplasty', 'Lichtenstein Hernia Repair', 'A total of 82% of patients (n\u2009=\u2009514) completed the 5-year audit including 177, 167 and 170 patients in the glue, self-fixation and suture groups, respectively']","['Lichtenstein hernioplasty', 'self-gripping mesh (n\u2009=\u2009202) or non-absorbable 3-0 polypropylene sutures', 'mesh fixation technique', 'Mesh fixation', 'penetrating fixation (glue or self-gripping mesh', 'Mesh and Fixation', 'cyanoacrylate glue']","['operated recurrences', 'incidence of pain', 'Chronic Inguinal Pain', 'rate of occasional pain, chronic severe pain, recurrence, re-operations, daily use of analgesics, overall patient satisfaction and sensation of a foreign object', ""patient's satisfaction"", 'overall re-operations', 'chronic pain and recurrence', 'overall long-term outcome, pain or recurrence of hernia']","[{'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0491217', 'cui_str': 'Polypropylene suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016542', 'cui_str': 'Foreign body'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]",625.0,0.140513,"The choice of the mesh or fixation method had no effect on the overall long-term outcome, pain or recurrence of hernia.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matikainen', 'Affiliation': 'North-Karelia Central Hospital, Joensuu, Finland. markku.matikainen@siunsote.fi.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vironen', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kössi', 'Affiliation': 'Päijät-Häme Central Hospital, Lahti, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hulmi', 'Affiliation': 'North-Karelia Central Hospital, Joensuu, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hertsi', 'Affiliation': 'Savonlinna Central Hospital, Savonlinna, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}]",World journal of surgery,['10.1007/s00268-020-05835-1']
627,33119135,The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes.,"AIMS


Postprandial glycaemic variability carries on being a clinical challenge in optimizing glucose control in type 1 diabetes. The aim of this study was to compare the postprandial glycaemic effects of carbohydrate counting and food insulin index algorithms following the consumption of protein-rich, high-fat meals with different glycaemic index (GI) in adolescents with type 1 diabetes.
METHODS


A randomized, single-blind and crossover trial included 15 adolescents aged 14-18 years with type 1 diabetes. Participants consumed two different test meals with similar energy, macronutrients and food insulin index but the approximately twofold difference in GI, in random order on four consecutive mornings at their home. Insulin dose for high- and low-GI test meals was determined by using the carbohydrate counting and food insulin index algorithms. Four-hour postprandial glycaemia was assessed by the continuous glucose monitoring system.
RESULTS


Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between the two algorithms in the low-GI meal. The occurrence of hypoglycaemia did not significantly differ between insulin dosing algorithms for the high-GI (p = 0.58) and low-GI (p = 0.20) meals.
CONCLUSIONS


The food insulin index algorithm may be beneficial for postprandial glycaemic control after the consumption of high-GI meals in adolescents with type 1 diabetes.",2021,"Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between two algorithms in the low-GI meal.","['15 adolescents aged 14-18 years with type 1 diabetes', 'adolescents with type 1 diabetes', 'type 1 diabetes']","['food insulin index algorithm', 'carbohydrate counting and food insulin index algorithms']","['coefficient variation of blood glucose', 'postprandial glycaemia', 'incremental area under the curve', 'occurrence of hypoglycaemia', 'peak glucose excursion']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",15.0,0.0471502,"Compared with carbohydrate counting, the food insulin index algorithm significantly decreased peak glucose excursion (-57%, p = 0.02), incremental area under the curve (-65%, p = 0.02) and coefficient variation of blood glucose (-37%, p = 0.03) in the high-GI meal, though there was no difference between two algorithms in the low-GI meal.","[{'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Erdal', 'Affiliation': 'Institute of Health Sciences, Department of Nutrition and Dietetics, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Caferoglu', 'Affiliation': 'Faculty of Health Sciences, Department of Nutrition and Dietetics, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Hatipoglu', 'Affiliation': 'Faculty of Medicine, Department of Paediatric Endocrinology, Erciyes University, Kayseri, Turkey.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14444']
628,33070307,Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma: Final results of the MARC-2 trial.,"MARC-2, a prospective, multicenter phase IV trial, aimed to investigate clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy and to identify subgroups benefiting most, based on clinical characteristics and biomarkers. Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity. Primary endpoint was 6-month progression-free survival rate (6moPFS). Secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Between 2011 and 2015, 63 patients were enrolled. Median age was 65.4 years (range 43.3-81.1). 6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index (BMI) >25 vs ≤25 kg/m 2  . A Cox proportional hazards model confirmed a longer PFS for patients aged ≥65 years (hazard ratio [HR] 0.46; 95% CI, 0.26-0.80) and a longer OS for patients with BMI >25 kg/m 2  (HR 0.36; 95% CI, 0.18-0.71). Median PFS and median OS were 3.8 months (95% CI, 3.2-6.2) and 16.8 months (95% CI, 14.3-24.3). ORR was 7.9% and disease control rate was 60.3%. No new safety signals emerged. Most common adverse events were stomatitis (31.7%), fatigue (31.7%), and anemia (30.2%). One patient died from treatment-related upper gastrointestinal hemorrhage. Everolimus remains a safe and effective treatment option for mRCC patients after one prior VEGFR-TKI therapy. Patients aged ≥65 years and patients with BMI >25 kg/m 2  benefited most.",2021,"6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index","['metastatic renal cell carcinoma', 'patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor', 'Median age was 65.4\u2009years (range 43.3-81.1', '25', 'mRCC patients after one prior VEGFR-TKI therapy', 'Between 2011 and 2015, 63 patients were enrolled', 'Patients aged ≥65\u2009years and patients with BMI ', 'Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity']","['VEGF-targeted therapy', 'receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy', 'Everolimus']","['disease control rate', 'overall response rate (ORR), PFS, overall survival (OS), and safety', 'ORR', 'anemia', 'fatigue', 'Median PFS and median OS', '6-month progression-free survival rate (6moPFS', '6moPFS']","[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",63.0,0.323122,"6moPFS was 39.3% (95% confidence interval [CI], 27.0-51.3) overall, 54.4% (95% CI, 35.2-70.1) vs 23.7% (95% CI, 10.5-39.9) for patients aged ≥65 vs <65 years and 51.4% (95% CI, 34.7-65.7) vs 18.2% (95% CI, 5.7-36.3) for patients with body mass index","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'Department of Urology, Interdisciplinary Center of Renal Tumors, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stöckle', 'Affiliation': 'Department of Urology and Paediatric Urology, Saarland University Medical Center, Homburg (Saar), Germany.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Christoph', 'Affiliation': 'Department of Medical Oncology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Hospital Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Potthoff', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Klein', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Harde', 'Affiliation': 'Biostatistics, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Brüning', 'Affiliation': 'Department of Urology and Pediatric Urology, Philipps-University Marburg, University Hospital Giessen and Marburg GmbH, Marburg, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goebell', 'Affiliation': 'Department of Urology and Clinic for Haematology and Internistic Oncology, University Hospital Erlangen, Ambulatory Uro-Oncological Therapy Unit Erlangen (AURONTE), Erlangen, Germany.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Nuremberg, Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Roos', 'Affiliation': 'Department of Urology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Benz-Rüd', 'Affiliation': 'Medical Department, iOMEDICO, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Marschner', 'Affiliation': 'Outpatient-Centre for Interdisciplinary Oncology and Haematology, Freiburg, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, University Hospital Hannover Medical School, Hannover, Germany.'}]",International journal of cancer,['10.1002/ijc.33349']
629,33105455,Can Upstream Patient Education Improve Fracture Care in a Digital World? Use of a Decision Aid for the Treatment of Displaced Diaphyseal Clavicle Fractures.,"BACKGROUND


The increasing proportion of telemedicine and virtual care in orthopaedic surgery presents an opportunity for upstream delivery of patient facing tools, such as decision aids. Displaced diaphyseal clavicle fractures (DDCFs) are ideal for a targeted intervention because there is no superior treatment, and decisions are often dependent on patient's preference. A decision aid provided before consultation may educate a patient and minimize decisional conflict similarly to inperson consultation with an orthopaedic traumatologist.
METHODS


Patients with DDCF were enrolled into 2 groups. The usual care group participated in a discussion with a trauma fellowship-trained orthopaedic surgeon. Patients in the intervention group were administered a DDCF decision aid designed with the International Patient Decision Aid Standards. Primary comparisons were made based on a decisional conflict score. Secondary outcomes included treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance.
RESULTS


A total of 41 patients were enrolled. Decisional conflict scores were similar and low between the 2 groups: 11.8 (usual care) and 11.4 (decision aid). There were no differences in secondary outcomes between usual care and the decision aid.
DISCUSSION


Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon. This decision aid could be a useful resource for surgeons who infrequently treat this injury or whose practices are shifting toward telemedicine visits. Providing a decision aid before consultation may help incorporate patient's values and preferences into the decision-making process between surgery and nonoperative management.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2021,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"['Patients with DDCF were enrolled into two groups', 'displaced diaphyseal clavicle fractures', '41 patients enrolled', 'Displaced diaphyseal clavicle fractures (DDCF']","['usual care group participated in a discussion with a trauma fellowship trained orthopaedic surgeon', 'DDCF decision aid designed with International Patient Decision Aid Standards']","['decisional conflict score', 'Decisional conflict scores', 'treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",41.0,0.0517422,Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon.,"[{'ForeName': 'Cara H', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA; and.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Van Rysselberghe', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Geoffrey D', 'Initials': 'GD', 'LastName': 'Abrams', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gardner', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001916']
630,33119884,Is survival really better after repeated lung metastasectomy?,"Several groups have observed that average survival time after a second lung metastasectomy is longer than after a first metastasectomy. The randomised controlled trial Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) found no survival benefit from lung metastasectomy. In fact, median survival was longer, and four-year overall survival was higher, in the control group than in those randomly assigned to metastasectomy, although not significantly so. The illusion of benefit is because survival without metastasectomy has been assumed to be near zero, as stated in Society of Thoracic Surgeons' Expert Consensus Document on Pulmonary Metastasectomy 2019. It has been repeatedly found that survival is influenced by the selection of patients who have characteristics associated with better prognosis. The passage of time while monitoring and assessing patients, and observing their rate of progression, provides for immortal time bias. Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.",2021,Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.,['Colorectal Cancer'],[],"['survival benefit', 'average survival time', 'overall survival', 'median survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.103264,Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, UK. tom.treasure@gmail.com.'}]",Clinical & experimental metastasis,['10.1007/s10585-020-10061-z']
631,33121939,"Re: Nizar M. Tannir, Sabina Signoretti, Toni K. Choueiri, et al. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clin Cancer Res. In press. https://doi.org/10.1158/1078-0432.ccr-20-2063.",,2020,,['Patients with Advanced Sarcomatoid Renal Cell Carcinoma'],['Nivolumab Plus Ipilimumab'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1266043', 'cui_str': 'Renal cell carcinoma, sarcomatoid'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0202491,,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2020.10.005']
632,33120862,"One-Year Effects of Omega-3 Treatment on Fatty Acids, Oxylipins, and Related Bioactive Lipids and Their Associations with Clinical Lipid and Inflammatory Biomarkers: Findings from a Substudy of the Vitamin D and Omega-3 Trial (VITAL).","Omega-3 (n-3) treatment may lower cardiovascular risk, yet its effects on the circulating lipidome and relation to cardiovascular risk biomarkers are unclear. We hypothesized that n-3 treatment is associated with favorable changes in downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers. We examined these VITAL200, a nested substudy of 200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL). VITAL is a randomized double-blind trial of 840 mg/d eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo among 25,871 individuals. Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells were measured using three independent assaying techniques at baseline and one year. The Women's Health Study (WHS) was used for replication with dietary n-3 intake. Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids. N-3 related changes in the bioactive lipidome were heterogeneously associated with changes in clinical lipid and inflammatory biomarkers. N-3 treatment significantly modulates the bioactive lipidome, which may contribute to its clinical benefits.",2020,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","['25,871 individuals', '200 subjects balanced on demographics and treatment and randomly selected from the Vitamin D and Omega-3 Trial (VITAL']","['n-3 treatment', 'Omega-3 Treatment', 'Omega-3 (n-3', 'N-3 treatment', 'eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) vs. placebo']","['downstream fatty acids (FAs), oxylipins, bioactive lipids, clinical lipid and inflammatory biomarkers', 'Fatty Acids, Oxylipins, and Related Bioactive Lipids', '143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR', 'EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids', 'Small polar bioactive lipid features, oxylipins and FAs from plasma and red blood cells']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",,0.199205,"Randomized n-3 treatment led to changes in 143 FAs, oxylipins and bioactive lipids (False Discovery Rate (FDR) < 0.05 in VITAL200, validated ( p -values < 0.05)) in WHS with increases in 95 including EPA, DHA, n-3 docosapentaenoic acid (DPA-n3), and decreases in 48 including DPA-n6, dihomo gamma linolenic (DGLA), adrenic and arachidonic acids.","[{'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Jeramie D', 'Initials': 'JD', 'LastName': 'Watrous', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Lagerborg', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Dashti', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Giulianini', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Heath', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'OmegaQuant Analytics, Sioux Falls, SD 57106, USA.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Allen M', 'Initials': 'AM', 'LastName': 'Andres', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Tivari', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Long', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Mahan', 'Initials': 'M', 'LastName': 'Najhawan', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Khoi', 'Initials': 'K', 'LastName': 'Dao', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, San Juan Capistrano, CA 92673, USA.'}, {'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Ctr, Los Angeles, CA 90048, USA.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Pharmacology, University of California San Diego, La Jolla, CA 92037, USA.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}]",Metabolites,['10.3390/metabo10110431']
633,33123718,A randomized controlled trial comparing controlled reoxygenation and standard cardiopulmonary bypass in paediatric cardiac surgery.,"OBJECTIVES


Controlled reoxygenation on starting cardiopulmonary bypass (CPB) rather than hyperoxic CPB may confer clinical advantages during surgery for congenital cyanotic heart disease.
METHODS


A single-centre, randomized controlled trial was carried out to compare the effectiveness of controlled reoxygenation (normoxia) versus hyperoxic CPB in children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2). The co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay. Analysis of the primary outcomes included data from a previous trial (Oxic-1) conducted to the same protocol.
RESULTS


Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial. There were no significant differences between the groups for any of the co-primary outcomes: inotrope duration geometric mean ratio (normoxia/hyperoxic) 0.97, 95% confidence interval (CI) (0.69-1.37), P-value = 0.87; intubation time hazard ratio (HR) 1.03, 95% CI (0.74-1.42), P-value = 0.87; postoperative ICU stay HR 1.14 95% CI (0.77-1.67), P-value = 0.52, hospital stay HR 0.90, 95% CI (0.65-1.25), P-value = 0.53. Lower oxygen levels were successfully achieved during the operative period in the normoxic group. Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5. Childhood developmental outcomes were similar. In the year following surgery, 85 serious adverse events were reported (51 normoxic group and 34 hyperoxic group).
CONCLUSIONS


Controlled reoxygenation (normoxic) CPB is safe but with no evidence of a clinical advantage over hyperoxic CPB.
CLINICAL TRIAL REGISTRATION NUMBER


Current Controlled Trials-ISRCTN81773762.",2021,"Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5.","['children with congenital cyanotic heart disease undergoing open-heart surgery (Oxic-2', 'Ninety participants were recruited to Oxic-2 and 79 were recruited to the previous Oxic-1 trial', 'paediatric cardiac surgery']","['Controlled reoxygenation (normoxic) CPB', 'hyperoxic CPB', 'controlled reoxygenation and standard cardiopulmonary bypass', 'controlled reoxygenation (normoxia) versus hyperoxic CPB']","['duration of inotropic support, intubation time and postoperative intensive care unit (ICU) and hospital stay', 'Serum creatinine levels', 'inotrope duration geometric mean ratio (normoxia/hyperoxic', 'Lower oxygen levels', 'postoperative ICU stay HR']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C1394290', 'cui_str': 'Cyanotic heart disease'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.265704,"Serum creatinine levels were lower in the normoxic group at day 2, but not on days 1, 3-5.","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Caputo', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Toity', 'Initials': 'T', 'LastName': 'Deave', 'Affiliation': 'Department of Cardiac Surgery, Centre for Health and Clinical Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Dabner', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Parry', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Gianni D', 'Initials': 'GD', 'LastName': 'Angelini', 'Affiliation': 'Department of Cardiac Surgery, Bristol Heart Institute, University of Bristol, Bristol, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Stoica', 'Affiliation': 'Department of Cardiac Surgery, Bristol Royal Hospital for Children, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Department of Cardiac Surgery, Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, Bristol, UK.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa318']
634,33125944,Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).,"BACKGROUND


Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).
METHODS


This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m 2  Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.
RESULTS


Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV: NCT02999087.",2020,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","['locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN', 'Between September 2017 and August 2018, 82 patients with LA-SCCHN', 'locally advanced squamous-cell carcinoma of the head and neck']","['avelumab with cetuximab and radiotherapy', 'cisplatin', 'avelumab-cetuximab-RT combination', 'Avelumab-cetuximab-radiotherapy', 'SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin', 'unfit to cisplatin', 'IMRT with cetuximab and avelumab', 'entire radiotherapy']","['Grade ≥IV AEs', 'mucositis, radio-dermatitis, and dysphagia', 'grade ≥IV AEs', 'grade V haemorrhage']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0711299,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Le Havre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU, Amiens, France.'}, {'ForeName': 'Cedrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Liem', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': 'ICO Rene-Gauducheau, Nantes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Colin-Batailhou', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.008']
635,33123968,"Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study.","INTRODUCTION


Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation).
METHODS


In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m 2  or placebo before topotecan 1.5 mg/m 2  on days 1-5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy.
RESULTS


Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms.
CONCLUSIONS


Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02514447.",2021,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","['Patients Receiving Topotecan for Small Cell Lung Cancer', 'patients with previously treated extensive-stage small cell lung cancer (ES-SCLC']","['trilaciclib', 'placebo', 'intravenous trilaciclib 240\xa0mg/m 2  or placebo before topotecan 1.5\xa0mg/m 2', 'Myelopreservation with Trilaciclib', 'Placebo']","['occurrence of SN', 'duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN', 'myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy', 'antitumor efficacy', 'anemia', 'safety profile, improved quality of life', 'neutropenia', '3 hematologic adverse events', 'Antitumor efficacy', 'additional neutrophil, red blood cell, and platelet measures', 'grade\u2009≥', 'DSN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}]",,0.542584,"3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%).","[{'ForeName': 'Lowell L', 'Initials': 'LL', 'LastName': 'Hart', 'Affiliation': 'Medical Oncology, Florida Cancer Specialists, Fort Myers, FL, USA. lhart@flcancer.com.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'Department of Thoracic and Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zoran G', 'Initials': 'ZG', 'LastName': 'Andric', 'Affiliation': 'Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Department of Medical Oncology and Hematology, Highlands Oncology Group, Rogers, MI, USA.'}, {'ForeName': 'Janakiraman', 'Initials': 'J', 'LastName': 'Subramanian', 'Affiliation': ""Department of Medicine, Saint Luke's Hospital, Kansas City, MO, USA.""}, {'ForeName': 'Davorin Z', 'Initials': 'DZ', 'LastName': 'Radosavljevic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Bojan', 'Initials': 'B', 'LastName': 'Zaric', 'Affiliation': 'Faculty of Medicine, Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Sremska Kamenica, Serbia.'}, {'ForeName': 'Wahid T', 'Initials': 'WT', 'LastName': 'Hanna', 'Affiliation': 'Hematology/Oncology, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Raid', 'Initials': 'R', 'LastName': 'Aljumaily', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.'}, {'ForeName': 'Taofeek K', 'Initials': 'TK', 'LastName': 'Owonikoko', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Medical Oncology, AZ Klina Brasschaat, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Shannon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Joyce M', 'Initials': 'JM', 'LastName': 'Antal', 'Affiliation': 'G1 Therapeutics, Inc., Research Triangle Park, NC, USA.'}, {'ForeName': 'Maen A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Department of Oncology, Florida Cancer Specialists, Leesburg, FL, USA.'}]",Advances in therapy,['10.1007/s12325-020-01538-0']
636,33129705,A Randomized Controlled Trial of Music for Pain Relief after Arthroplasty Surgery.,"PURPOSE


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


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


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


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


Study findings provide further evidence for the effectiveness of music listening, combined with analgesics, for reducing postsurgical pain, and extend the literature by examining music listening postdischarge. Music listening is an effective adjuvant pain management strategy. It is easy to administer, accessible, and affordable. Patient education is needed to encourage patients to continue to use music to reduce pain at home during the postoperative recovery period.",2021,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"['50 participants scheduled for arthroplasty surgery at a large university-affiliated hospital', 'patients undergoing orthopedic surgery', 'patients undergoing arthroplasty surgery', 'Participants', 'after Arthroplasty Surgery', 'Forty-seven participants completed the study']","['Music', 'Music listening', 'treatment (music and analgesic medication; n\xa0=\xa025) or control (analgesic medication only; n\xa0=\xa025) groups', 'music listening (treatment group) or meals (control group']","['pain intensity and distress', 'analgesic medication', 'Pain Relief', 'pain intensity and distress in hospital and postdischarge at home']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",50.0,0.294345,Participants who listened to music after surgery reported significantly lower pain intensity and distress in hospital and postdischarge at home.,"[{'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Laframboise-Otto', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida. Electronic address: lafrajm@ufl.edu.'}, {'ForeName': 'MaryBeth', 'Initials': 'M', 'LastName': 'Horodyski', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Hari K', 'Initials': 'HK', 'LastName': 'Parvataneni', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Horgas', 'Affiliation': 'College of Nursing, University of Florida, Gainesville, Florida.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2020.09.003']
637,33151350,Perceptual amplification following sustained attention: implications for hypervigilance.,"It is known that attending to a cutaneous stimulus briefly increases its subjective intensity. The purpose of the present study was to determine whether an extended period of attention would produce a longer-lasting perceptual amplification. Eighty subjects were assigned alternately to experimental and control groups. Members of the two groups received identical series of tactile stimuli (near-threshold von Frey filaments applied to the forearm), but those in the experimental group carried out a two-interval forced-choice detection task that required attention to the filaments, while subjects in the control group attended instead to a video game. After this initial phase, all subjects gave magnitude estimates of the intensity of a wide range of von Frey filaments. The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin. The aftereffect of sustained attention lasted for at least 15 min. This phenomenon, demonstrated in normal subjects, may have implications for the hypervigilance of some chronic pain patients, which is characterized by both heightened attention to pain and long-lasting perceptual amplification of noxious stimuli.",2021,"The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin.","['Eighty subjects', 'normal subjects']","['tactile stimuli (near-threshold von Frey filaments applied to the forearm), but those in the experimental group carried out a two-interval forced-choice detection task that required attention to the filaments, while subjects in the control group attended instead to a video game']",[],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0010851', 'cui_str': 'Cytoskeletal Filaments'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]",[],80.0,0.0141772,"The experimental group gave estimates 42% greater than those of the control group, both for filaments used in the initial phase, and others not presented previously; the perceptual amplification did not, however, transfer to a different type of pressure stimulus, a 5 mm-diameter rod applied to the skin.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hollins', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. mhollins@email.unc.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Athans', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}]",Experimental brain research,['10.1007/s00221-020-05910-y']
638,33133739,High-Flow Nasal Cannula versus Continuous Positive Airway Pressure in Critical Bronchiolitis: A Randomized Controlled Pilot.,"We conducted a randomized controlled pilot study in infants with critical bronchiolitis (  n   = 63) comparing high-flow nasal cannula (HFNC,  n   = 35) to continuous positive airway pressure (CPAP,  n   = 28). The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation. Treatment failure occurred in 10 patients (35.7%) in the CPAP group and 13 patients (37.1%) in the HFNC group (  p   = 0.88). Pediatric intensive care unit length of stay was similar between the CPAP and HFNC groups (5 [4-7] days and 5 [4-8] days,  p   = 0.46, respectively). In this pilot study, treatment with HFNC resulted in a rate of treatment failure similar to CPAP.",2020,"The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation.","['infants with critical bronchiolitis (  n  \u2009=\u200963) comparing', 'Critical Bronchiolitis']","['HFNC', 'CPAP', 'high-flow nasal cannula (HFNC,  n  \u2009=\u200935) to continuous positive airway pressure (CPAP,  n  \u2009=\u200928', 'High-Flow Nasal Cannula versus Continuous Positive Airway Pressure']","['treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation', 'Pediatric intensive care unit length of stay', 'Treatment failure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.175343,"The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation.","[{'ForeName': 'Regina Grigolli', 'Initials': 'RG', 'LastName': 'Cesar', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Bibiane Ramos Pinheiro', 'Initials': 'BRP', 'LastName': 'Bispo', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Priscilla Helena Costa Alves', 'Initials': 'PHCA', 'LastName': 'Felix', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Maria Carolina Caparica', 'Initials': 'MCC', 'LastName': 'Modolo', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Andreia Aparecida Freitas', 'Initials': 'AAF', 'LastName': 'Souza', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Nelson K', 'Initials': 'NK', 'LastName': 'Horigoshi', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital Infantil Sabará e Instituto PENSI, São Paulo, Brazil.'}, {'ForeName': 'Alexandre T', 'Initials': 'AT', 'LastName': 'Rotta', 'Affiliation': 'Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina, United States.'}]",Journal of pediatric intensive care,['10.1055/s-0040-1709656']
639,33150799,Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated  RET  positive non-small-cell lung cancer.,"Selpercatinib, a novel, highly selective and potent, inhibitor of  RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive  RET  fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic  RET  fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival.  Clinical trial registration:  NCT04194944 (ClinicalTrials.gov).",2021,"Selpercatinib, a novel, highly selective and potent, inhibitor of  RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive  RET  fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial.",['treatment-naive patients with locally advanced/metastatic  RET  fusion-positive nonsquamous non-small-cell lung cancer'],"['selpercatinib vs chemotherapy ', 'pembrolizumab', 'selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab']","['progression-free survival', 'overall survival, response rate, duration of response\xa0and progression-free survival']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.166224,"Selpercatinib, a novel, highly selective and potent, inhibitor of  RET , demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive  RET  fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial.","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Solomon', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Cai Cun', 'Initials': 'CC', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Drilon', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Manhattan, NY 10065, USA.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': 'Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Elamin', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX\xa077030, USA.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Davis', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Soldatenkova', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Sashegyi', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Aimee Bence', 'Initials': 'AB', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Boris K', 'Initials': 'BK', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and\xa0Company, Indianapolis, IN\xa046225, USA.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'F Loong', 'Affiliation': 'The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, AOU San Luigi-Orbassano, University of Turin, Italy.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Arriola', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Léon Bérard Cancer Center of Lyon, Lyon, France.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Santini', 'Affiliation': 'Oncology Center, Hospital Sírio Libanês, Sao Paulo, Brazil.'}]","Future oncology (London, England)",['10.2217/fon-2020-0935']
640,33152791,[The Maastricht Education System in Aachen - a Few Miles Away or Worlds Apart?],"INTRODUCTION


Education for residents in surgery varies not only throughout the world, but also throughout Europe. Our clinic is well connected to Maastricht University Medical in Centre in the Netherlands (European Surgical Centre Aachen Maastricht). On the other hand, there are clear differences in resident programs. In the Netherlands, a structured feedback according to the OSATS concept (Objective Structured Assessment of Technical Skills) is mandatory after every operation performed by residents. The aim of the present study was to transfer the OSATS concept from Maastricht to Aachen and to evaluate the feasibility and benefits of this concept for surgical education.
MATERIAL AND METHODS


The OSATS concept was implemented for 3 months in our clinic within a prospective clinical trial. Seven out of 10 residents that were working in our clinic at that time participated in the study (70%). Half of these were assigned to structured written feedback after every autonomously performed operation. Additionally, all participants performed structured written proper feedback according to the OSATS concept. The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
RESULTS


The OSATS-concept was easily implemented in our clinic and met wide acceptance. Evaluation was performed after a mean of 70% of operations. External evaluation was regarded as more beneficial for residents than self-evaluation. Structured written evaluation according to the OSATS concept was not time-consuming (< 3 minutes) and most residents (86%) supported permanent implementation of the OSATS concept in our clinic.
CONCLUSION


The OSATS concept is a suitable approach to provide structured feedback to residents in continuous education. It can easily be implemented in resident education in Germany. Structured, written feedback by senior physicians is perceived as beneficial by residents.",2021,"The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
",['Seven out of 10 residents that were working in our clinic at that time participated in the study (70'],[],['feasibility of the OSATS concept'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",[],[],,0.0144992,"The primary endpoint was the feasibility of the OSATS concept in our clinic; secondary endpoints were the benefits for the residents and the differences between external and self-evaluation.
","[{'ForeName': 'Sophia M', 'Initials': 'SM', 'LastName': 'Schmitz', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Ulmer', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Steven W M', 'Initials': 'SWM', 'LastName': 'Olde Damink', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Ulf P', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}, {'ForeName': 'Anjali A', 'Initials': 'AA', 'LastName': 'Roeth', 'Affiliation': 'Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Aachen, Deutschland.'}]",Zentralblatt fur Chirurgie,['10.1055/a-1265-7384']
641,33150424,Public attitudes toward an authorization for contact program for clinical research.,"We conducted an online experimental survey to evaluate attitudes toward an authorization for contact (AFC) program allowing researchers to contact patients about studies based on electronic record review. A total of 1070 participants were randomly assigned to 1 of 3 flyers varying in design and framing. Participants were asked to select concerns about and reasons for signing up for AFC. Logistic regression and latent class analysis were conducted. The most commonly selected concerns included needing more information (43%), privacy (40%), and needing more time to think (28%). A minority were not interested in participating in research (16%) and did not want to be bothered (15%). Latent class analysis identified clusters with specific concerns about privacy, lack of interest in research, and not wanting to be bothered. A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01). Many concerns about AFC programs appear nonspecific. Addressing privacy, lack of interest in research, and not wanting to be bothered warrant further study as ways to enhance recruitment.",2021,A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01).,['A total of 1070 participants'],['authorization for contact (AFC) program'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],1070.0,0.0339943,A novel flyer with simple and positive framing was associated with lower odds of both not wanting to be bothered (P = .01) and not being interested in research (P = .01).,"[{'ForeName': 'Nyiramugisha K', 'Initials': 'NK', 'LastName': 'Niyibizi', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'Speight', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Gregor', 'Affiliation': 'Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Kraft', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Mitchell', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Phillips', 'Affiliation': 'Department of Clinical and Administrative Pharmacy, University of Georgia College of Pharmacy, Athens, Georgia, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Porter', 'Affiliation': ""Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Seema K', 'Initials': 'SK', 'LastName': 'Shah', 'Affiliation': ""Research Ethics, Stanley Manne Research Institute, Ann and Robert Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Sugarman', 'Affiliation': 'Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, USA.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Wilfond', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Neal W', 'Initials': 'NW', 'LastName': 'Dickert', 'Affiliation': 'Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa214']
642,33180039,Training using a simulation-based workshop reduces inaccuracies in estimations of testicular volume.,"OBJECTIVES


Measuring testicular volume (TV) by orchidometer is routine in the clinic when staging male puberty. We have developed a simulation model for TV estimation and investigated whether training medical students, using a workshop with simulation models, could improve the accuracy and reliability of TV estimation.
METHODS


All participating medical students watched a video representing standard undergraduate training in male pubertal assessment. Volunteers were then randomised directly to assessment or to attend a workshop consisting of a further video and four stations contextualising and practising the skills required for TV estimation, prior to assessment. Three child mannequins displaying testes of 3 mL, 4 mL (twice), 5, 10 and 20 mL were used for assessment. Participants were asked to return a fortnight later for repeat assessment to assess intra-observer reliability, the effect of repeated examinations on accuracy and time on skill retention.
RESULTS


Ninety students participated (55F), 46 attended the workshop and were considered ""trained"". There was no difference between the groups in numbers of correct estimations (29% trained, 27% untrained, p=0.593). However, the trained group's estimations were closer to the true volume, with more from the trained group one bead away (p=0.002) and fewer more than three beads away from the true volume (p<0.001), compared to the untrained group. Trained participants were more accurate at the second assessment (n=80) (p<0.001) and had greater intra-observer reliability (p=0.004).
CONCLUSIONS


Overall TV estimation accuracy was poor. Workshop-style training improved accuracy, reliability and retention of skill acquisition and could be considered as a useful learning tool.",2021,Trained participants were more accurate at the second assessment (n=80) (p<0.001) and had greater intra-observer reliability (p=0.004).,"['participating medical students watched a video representing standard undergraduate training in male pubertal assessment', 'Results Ninety students participated (55F), 46 attended the workshop and were considered ""trained', 'staging male puberty']",['Workshop-style training'],"['greater intra-observer reliability', 'numbers of correct estimations', 'accuracy, reliability and retention of skill acquisition']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",90.0,0.0461881,Trained participants were more accurate at the second assessment (n=80) (p<0.001) and had greater intra-observer reliability (p=0.004).,"[{'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Craig', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Sharman', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ciara G', 'Initials': 'CG', 'LastName': 'Fitzgerald', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Wigg', 'Affiliation': 'Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Williams', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Wilkinson', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Wright', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Elder', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2020-0312']
643,33157357,Effects of modified version of the Hospital Elder Life Program on post-discharge cognitive function and activities of daily living among older adults undergoing total knee arthroplasty.,"OBJECTIVES


This study aimed to investigate the effects of a modified Hospital Elder Life Program (mHELP) on post-discharge cognition and physical function among older adults undergoing total knee arthroplasty (TKA), and to evaluate the incidence of postoperative delirium.
DESIGN


Non-randomized intervention trial.
SETTING AND PARTICIPANTS


A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included.
METHODS


Ward-level stratification was used with one surgical ward receiving mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group). All participants were assigned to two surgical wards. Outcome measures were collected using MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments at 1, 6, and 12 months after discharge. Multiple linear regression analysis was used to measure effects of mHELP intervention on mean differences in tMMSE, ADL and IADL scores from baseline to 1-, 6- and 12-months.
RESULTS


Effects of mHELP intervention significantly preserved cognitive function at 1 and 12 months, but not at 6 months, compared with controls, regardless of adjustments for confounders. However, no intervention effects were noted in ADL and IADL scores. Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
CONCLUSIONS


mHELP intervention preserves post-discharge cognitive function, but has no notable effect on ADL and IADL function in older adults undergoing elective TKA surgery.",2021,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","['older adults undergoing total knee arthroplasty', 'older adults undergoing elective TKA surgery', 'A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included', 'older adults undergoing total knee arthroplasty (TKA']","['modified version of the Hospital Elder Life Program', 'mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group', 'mHELP intervention', 'modified Hospital Elder Life Program (mHELP']","['MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments', 'tMMSE, ADL and IADL scores', 'ADL and IADL scores', 'cognitive function', 'Postoperative delirium']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",140.0,0.0811517,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Che-Sheng', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ying-Hsin', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Yu-Te', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jenn-Huei', 'Initials': 'JH', 'LastName': 'Renn', 'Affiliation': 'Department of Orthopaedics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Medical Affair Administration, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yun', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Division of Clinical Toxicology & Occupational Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: ccyang@vghtpe.gov.tw.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104284']
644,33169409,Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH.,"BACKGROUND AND AIMS


Advanced fibrosis attributable to NASH is a leading cause of end-stage liver disease.
APPROACH AND RESULTS


In this phase 2b trial, 392 patients with bridging fibrosis or compensated cirrhosis (F3-F4) were randomized to receive placebo, selonsertib 18 mg, cilofexor 30 mg, or firsocostat 20 mg, alone or in two-drug combinations, once-daily for 48 weeks. The primary endpoint was a ≥1-stage improvement in fibrosis without worsening of NASH between baseline and 48 weeks based on central pathologist review. Exploratory endpoints included changes in NAFLD Activity Score (NAS), liver histology assessed using a machine learning (ML) approach, liver biochemistry, and noninvasive markers. The majority had cirrhosis (56%) and NAS ≥5 (83%). The primary endpoint was achieved in 11% of placebo-treated patients versus cilofexor/firsocostat (21%; P = 0.17), cilofexor/selonsertib (19%; P = 0.26), firsocostat/selonsertib (15%; P = 0.62), firsocostat (12%; P = 0.94), and cilofexor (12%; P = 0.96). Changes in hepatic collagen by morphometry were not significant, but cilofexor/firsocostat led to a significant decrease in ML NASH CRN fibrosis score (P = 0.040) and a shift in biopsy area from F3-F4 to ≤F2 fibrosis patterns. Compared to placebo, significantly higher proportions of cilofexor/firsocostat patients had a ≥2-point NAS reduction; reductions in steatosis, lobular inflammation, and ballooning; and significant improvements in alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, bile acids, cytokeratin-18, insulin, estimated glomerular filtration rate, ELF score, and liver stiffness by transient elastography (all P ≤ 0.05). Pruritus occurred in 20%-29% of cilofexor versus 15% of placebo-treated patients.
CONCLUSIONS


In patients with bridging fibrosis and cirrhosis, 48 weeks of cilofexor/firsocostat was well tolerated, led to improvements in NASH activity, and may have an antifibrotic effect. This combination offers potential for fibrosis regression with longer-term therapy in patients with advanced fibrosis attributable to NASH.",2021,"Changes in hepatic collagen by morphometry were not significant, but CILO/FIR led to a significant decrease in ML NASH CRN fibrosis score (p=0.040) and a shift in biopsy area from F3-F4 to ≤F2 fibrosis patterns.","['patients with advanced fibrosis due to NASH', '392 patients with bridging fibrosis or compensated cirrhosis (F3-F4', 'Advanced fibrosis due to nonalcoholic steatohepatitis (NASH']","['placebo', 'placebo, selonsertib 18 mg (SEL), cilofexor 30 mg (CILO), or firsocostat 20 mg (FIR), alone or in two-drug combinations']","['≥1-stage improvement in fibrosis without worsening of NASH', 'NASH activity', 'FIR', 'CILO', 'CILO/FIR', 'FIR/SEL', 'Pruritus', 'NAFLD Activity Score (NAS), liver histology assessed using a machine learning (ML) approach, liver biochemistry, and noninvasive markers', 'CILO/SEL', 'ML NASH CRN fibrosis score', 'ALT, AST, bilirubin, bile acids, CK18, insulin, eGFR, ELF score, and liver stiffness', 'hepatic collagen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0334160', 'cui_str': 'Bridging fibrosis'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4743336', 'cui_str': 'firsocostat'}, {'cui': 'C0013162', 'cui_str': 'Drug Combinations'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4743336', 'cui_str': 'firsocostat'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C2363999', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]",392.0,0.360092,"Changes in hepatic collagen by morphometry were not significant, but CILO/FIR led to a significant decrease in ML NASH CRN fibrosis score (p=0.040) and a shift in biopsy area from F3-F4 to ≤F2 fibrosis patterns.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California at San Diego, La Jolla, CA.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Fatty Liver Program, Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, WA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Arizona Liver Health, Chandler, AZ.'}, {'ForeName': 'Aasim', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'GI Specialists of Georgia, Marietta, GA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, LLC, Sarasota, FL.'}, {'ForeName': 'Bal Raj', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, LLC, Bastrop, LA.'}, {'ForeName': 'Nadege', 'Initials': 'N', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, Austin, TX.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Wapinski', 'Affiliation': 'PathAI, Boston, MA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Resnick', 'Affiliation': 'PathAI, Boston, MA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Beck', 'Affiliation': 'PathAI, Boston, MA.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Jen-Chieh', 'Initials': 'JC', 'LastName': 'Chuang', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Huss', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences Inc., Foster City, CA.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Borg', 'Affiliation': 'Southern Therapy and Advanced Research, Jackson, MS.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Ghalib', 'Affiliation': 'Texas Clinical Research Institute, Arlington, TX.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Kabler', 'Affiliation': 'Jubilee Clinical Research, Las Vegas, NV.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Poulos', 'Affiliation': 'Cumberland Research Associates, Fayetteville, NC.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One, Germantown, TN.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Hassanein', 'Affiliation': 'Southern California Research Center, Coronado, CA.'}, {'ForeName': 'Rajalakshmi', 'Initials': 'R', 'LastName': 'Iyer', 'Affiliation': 'Iowa Digestive Disease Center, Clive, IA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ruane', 'Affiliation': 'Ruane Medical and Liver Health Institute, Los Angeles, CA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Mercy Health, Richmond, VA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Strasser', 'Affiliation': 'Royal Prince Alfred Hospital and The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, UT Health San Antonio, San Antonio, TX.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hepatology (Baltimore, Md.)",['10.1002/hep.31622']
645,33164692,Safety and Effectiveness of Del Nido Cardioplegia in Comparison to Blood-Based St. Thomas Cardioplegia in Congenital Heart Surgeries: A Prospective Randomized Controlled Study.,"BACKGROUND


To compare the safety and effectiveness of del Nido cardioplegia with blood-based St Thomas Hospital (BSTH) cardioplegia in myocardial protection in congenital heart surgery.
METHODS


It is a prospective, open-labeled, randomized controlled study conducted at National Heart Institute, Kuala Lumpur from July 2018 to July 2019. All patients with simple and complex congenital heart diseases (CHD) with good left ventricular function (left ventricular ejection fraction [LVEF] >50%) were included while those with LVEF <50% were excluded. A total of 100 patients were randomized into two groups of 50 each receiving either del Nido or BSTH cardioplegia. Primary end points were the spontaneous return of activity following aortic cross-clamp release and ventricular function between two groups. Secondary end point was myocardial injury as assessed by troponin T levels.
RESULTS


Cardiopulmonary bypass and aortic cross-clamp time, return of spontaneous cardiac activity following the aortic cross-clamp release, the duration of mechanical ventilation, and intensive care unit stay were comparable between two groups. Statistically significant difference was seen in the amount and number of cardioplegia doses delivered ( P  < .001). The hemodilution was significantly less in the del Nido complex CHD group compared to BSTH cardioplegia ( P  = .001) but no difference in blood usage ( P  = .36). The myocardial injury was lesser (lower troponin T release) with del Nido compared to BSTH cardioplegia ( P  = .6).
CONCLUSION


Our study showed that both del Nido and BSTH cardioplegia are comparable in terms of myocardial protection. However, single, less frequent, and lesser volume of del Nido cardioplegia makes it more suitable for complex repair.",2020,"The myocardial injury was lesser (lower troponin T release) with del Nido compared to BSTH cardioplegia ( P  = .6).
","['All patients with simple and complex congenital heart diseases (CHD) with good left ventricular function (left ventricular ejection fraction [LVEF] >50%) were included while those with LVEF <50% were excluded', 'Congenital Heart Surgeries', 'at National Heart Institute, Kuala Lumpur from July 2018 to July 2019', '100 patients']","['del Nido cardioplegia with blood-based St Thomas Hospital (BSTH) cardioplegia', 'BSTH cardioplegia', 'Del Nido Cardioplegia', 'del Nido or BSTH cardioplegia']","['myocardial injury as assessed by troponin T levels', 'amount and number of cardioplegia doses delivered ', 'spontaneous return of activity following aortic cross-clamp release and ventricular function', 'aortic cross-clamp time, return of spontaneous cardiac activity', 'hemodilution', 'blood usage', 'duration of mechanical ventilation, and intensive care unit stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity'}, {'cui': 'C0019009', 'cui_str': 'Hemodilution'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",100.0,0.0308353,"The myocardial injury was lesser (lower troponin T release) with del Nido compared to BSTH cardioplegia ( P  = .6).
","[{'ForeName': 'Maruti', 'Initials': 'M', 'LastName': 'Haranal', 'Affiliation': 'Department of Pediatric Cardiac Surgery, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hew Chee', 'Initials': 'HC', 'LastName': 'Chin', 'Affiliation': 'Department of Pediatric Cardiac Surgery, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sivakumar', 'Initials': 'S', 'LastName': 'Sivalingam', 'Affiliation': 'Department of Pediatric Cardiac Surgery, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Natesan', 'Initials': 'N', 'LastName': 'Raja', 'Affiliation': 'Department of Cardiac Anesthesia, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohammad Sharif', 'Initials': 'MS', 'LastName': 'Mohammad Shaffie', 'Affiliation': 'Department of Cardiac Anesthesia, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Thiru Kumar', 'Initials': 'TK', 'LastName': 'Namasiwayam', 'Affiliation': 'Department of Cardiac Anesthesia, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fadleen', 'Affiliation': 'Department of Perfusion Sciences, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Fakhri', 'Affiliation': 'Department of Clinical Research, 65282National Heart Institute, Kuala Lumpur, Malaysia.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120936119']
646,33157152,Intranasal oxytocin attenuates insula activity in response to dynamic angry faces.,"The effects of intranasal oxytocin on amygdala activity during emotional perception are often mixed. Given that the brain is organized into networks of interconnected areas, functional connectivity might provide an effective way to further understand the oxytocin effect. The aim of the present study was to investigate whether oxytocin administration affects amygdala activity and its functional connectivity during dynamic facial expression perception. Using a between-group, double-blind, placebo-controlled design, 55 participants were randomly assigned to groups receiving a single dose of 24 IU oxytocin or a placebo via intranasal administration. An implicit emotional task was employed to investigate the effect of oxytocin on neural responses to dynamic angry, neutral, and happy facial expressions with fMRI. Participants were instructed to respond only when the inverted dynamic faces were presented. The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces. However, functional connectivity between the regions involved in the perception of dynamic angry faces was not changed following oxytocin administration. The present findings may contribute to our understanding of the anxiolytic effects of oxytocin and eventually facilitate human clinical applications.",2020,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.",['55 participants'],"['placebo', 'intranasal oxytocin', 'oxytocin', 'Intranasal oxytocin']","['neural responses to dynamic angry, neutral, and happy facial expressions with fMRI', 'activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG', 'amygdala activity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",55.0,0.160768,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.","[{'ForeName': 'Yuanxiao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China; School of Psychology, Nanjing Normal University, Nanjing, 210024, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Ran', 'Affiliation': 'Institute of Education, China West Normal University, Nanchong, 637002, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, 200062, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Wenshuang', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China. Electronic address: chenxu@swu.edu.cn.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107976']
647,33161523,Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial.,"BACKGROUND


The aim of this study was to assess the usefulness of protective negative-pressure wound therapy (NPWT) in the reduction of wound healing complications (WHC) and surgical site infections (SSI) after diverting ileostomy closure in patients who underwent surgery for colorectal cancer.
METHODS


In this prospective randomized clinical trial in a tertiary academic surgical center, patients who had colorectal cancer surgery with protective loop ileostomy and were scheduled to undergo ileostomy closure with primary wound closure from January 2016 to December 2018 were randomized to be treated with or without NPWT. The primary endpoint was the incidence of WHC. Secondary endpoints were incidence of SSI, length of postoperative hospital stay (LOS), and length of complete wound healing (CWH) time.
RESULTS


We enrolled 35 patients NPWT (24 males [68.6%]; mean age 61.6 ± 11.3 years), with NPWT and 36 patients (20 males [55.6%]; mean age 62.4 ± 11.3 years) with only primary wound closure (control group). WHC was observed in 11 patients (30.6%) in the control group and 3 (8.57%) in the NPWT group (p = 0.020). Patients in the NPWT group had a significantly lower incidence of SSI (2 [5.71%] vs. 8 [22.2%] in the control group; p = 0.046) as well as significantly shorter median CWH (7 [7-7] days vs. 7 [7-15.5] days, p = 0.030). There was no difference in median LOS between groups (3 [2.5-5] days in the control group vs. 4 [2-4] days in the NPWT group; p = 0.072).
CONCLUSIONS


Prophylactic postoperative NPWT after diverting ileostomy closure in colorectal cancer patients reduces the incidence of WRC and SSI.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov (NCT04088162).",2021,"There was no difference in median LOS between groups (3 [2.5-5] days in the control group vs. 4 [2-4] days in the NPWT group; p = 0.072).
","['patients who underwent surgery for colorectal cancer', 'We enrolled 35 patients NPWT (24 males [68.6%]; mean age 61.6\u2009±\u200911.3\xa0years), with NPWT and 36 patients (20 males [55.6%]; mean age 62.4\u2009±\u200911.3\xa0years) with only primary wound closure (control group', 'colorectal cancer patients', 'tertiary academic surgical center, patients who had colorectal cancer surgery with protective loop ileostomy and were scheduled to undergo ileostomy closure with primary wound closure from January 2016 to December 2018']","['without NPWT', 'NPWT', 'Prophylactic negative-pressure wound therapy', 'protective negative-pressure wound therapy (NPWT']","['incidence of WHC', 'incidence of WRC and SSI', 'shorter median CWH', 'WHC', 'wound healing complications (WHC) and surgical site infections (SSI', 'incidence of SSI, length of postoperative hospital stay (LOS), and length of complete wound healing (CWH) time', 'median LOS', 'incidence of SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0192775', 'cui_str': 'Closure of ileostomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",35.0,0.140058,"There was no difference in median LOS between groups (3 [2.5-5] days in the control group vs. 4 [2-4] days in the NPWT group; p = 0.072).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wierdak', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pisarska-Adamczyk', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wysocki', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland. m.wysocki@doctoral.uj.edu.pl.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Major', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kołodziejska', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nowakowski', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vongsurbchart', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pędziwiatr', 'Affiliation': '2nd Department of General Surgery, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Krakow, Poland.'}]",Techniques in coloproctology,['10.1007/s10151-020-02372-w']
648,33175291,Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO ®  Trials.,"INTRODUCTION


Since chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, a composite endpoint of clinically important deterioration (CID) may provide a more holistic assessment of treatment efficacy. We compared long-acting muscarinic antagonist/long-acting β 2 -agonist combination therapy with tiotropium/olodaterol versus tiotropium alone using a composite endpoint for CID. CID was evaluated overall and in patients with low exacerbation history (at most one moderate exacerbation in the past year [not leading to hospitalisation]), Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2 patients and maintenance-naïve patients with COPD. We assessed whether early treatment optimisation is more effective with tiotropium/olodaterol versus tiotropium in delaying and reducing the risk of CID.
METHODS


Data were analysed from 2055 patients treated with either tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (delivered via Respimat ® ) in two replicate, 52-week, parallel-group, double-blind studies (TONADO ®  1/2). CID was defined as a decline of at least 0.1 L from baseline in trough forced expiratory volume in 1 s, increase from baseline of at least 4 units in St. George's Respiratory Questionnaire score, or moderate/severe exacerbation. Time to first occurrence of one of these events was recorded as time to first CID.
RESULTS


Overall, treatment with tiotropium/olodaterol significantly increased the time to, and reduced the risk of, CID versus tiotropium (median time to CID 226 versus 169 days; hazard ratio [HR] 0.76 [95% confidence interval 0.68, 0.85]; P < 0.0001). Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
CONCLUSION


In patients with COPD, including patients with low exacerbation history, GOLD 2 patients and maintenance-naïve patients, tiotropium/olodaterol reduced the risk of CID versus tiotropium. These results demonstrate the advantages of treatment optimisation with tiotropium/olodaterol over tiotropium monotherapy.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: TONADO ®  1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011).",2021,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
","['Data were analysed from 2055 patients treated with either', 'Patients with Early COPD']","['Tiotropium Monotherapy', 'tiotropium/olodaterol', 'tiotropium/olodaterol 5/5\xa0μg or tiotropium 5\xa0μg (delivered via Respimat ® ', 'tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium/Olodaterol']","['risk of, CID', 'CID', 'Respiratory Questionnaire score, or moderate/severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2.0,0.379732,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Tayside Respiratory Research Group, University of Dundee, Dundee, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.""}, {'ForeName': 'Janwillem W H', 'Initials': 'JWH', 'LastName': 'Kocks', 'Affiliation': 'General Practitioners Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Tsiligianni', 'Affiliation': 'Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Crete, Greece.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK.'}]",Advances in therapy,['10.1007/s12325-020-01528-2']
649,33180985,Prevention of Epilepsy in Infants with Tuberous Sclerosis Complex in the EPISTOP Trial.,"OBJECTIVE


Epilepsy develops in 70 to 90% of children with tuberous sclerosis complex (TSC) and is often resistant to medication. Recently, the concept of preventive antiepileptic treatment to modify the natural history of epilepsy has been proposed. EPISTOP was a clinical trial designed to compare preventive versus conventional antiepileptic treatment in TSC infants.
METHODS


In this multicenter study, 94 infants with TSC without seizure history were followed with monthly video electroencephalography (EEG), and received vigabatrin either as conventional antiepileptic treatment, started after the first electrographic or clinical seizure, or preventively when epileptiform EEG activity before seizures was detected. At 6 sites, subjects were randomly allocated to treatment in a 1:1 ratio in a randomized controlled trial (RCT). At 4 sites, treatment allocation was fixed; this was denoted an open-label trial (OLT). Subjects were followed until 2 years of age. The primary endpoint was the time to first clinical seizure.
RESULTS


In 54 subjects, epileptiform EEG abnormalities were identified before seizures. Twenty-seven were included in the RCT and 27 in the OLT. The time to the first clinical seizure was significantly longer with preventive than conventional treatment [RCT: 364 days (95% confidence interval [CI] = 223-535) vs 124 days (95% CI = 33-149); OLT: 426 days (95% CI = 258-628) vs 106 days (95% CI = 11-149)]. At 24 months, our pooled analysis showed preventive treatment reduced the risk of clinical seizures (odds ratio [OR] = 0.21, p = 0.032), drug-resistant epilepsy (OR = 0.23, p = 0.022), and infantile spasms (OR = 0, p < 0.001). No adverse events related to preventive treatment were noted.
INTERPRETATION


Preventive treatment with vigabatrin was safe and modified the natural history of seizures in TSC, reducing the risk and severity of epilepsy. ANN NEUROL 2021;89:304-314.",2021,"The time to the first clinical seizure was significantly longer with preventive than conventional treatment (RCT: 364 95% CI: 223, 535) vs. 124 days (95% CI: 33, 149); OLT: 426 (95% CI: 258, 628) vs. 106 days (95% CI: 11, 149).","['children with Tuberous Sclerosis Complex (TSC', 'TSC infants', '94 infants with TSC without seizure history', 'Twenty-seven were included in the RCT and 27 in the OLT', 'infants with Tuberous Sclerosis']","['vigabatrin', 'monthly video electroencephalography (EEG), and received vigabatrin']","['drug-resistant epilepsy', 'time to first clinical seizure', 'infantile spasms', 'risk of clinical seizures', 'time to the first clinical seizure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0048044', 'cui_str': 'Vigabatrin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",94.0,0.114008,"The time to the first clinical seizure was significantly longer with preventive than conventional treatment (RCT: 364 95% CI: 223, 535) vs. 124 days (95% CI: 33, 149); OLT: 426 (95% CI: 258, 628) vs. 106 days (95% CI: 11, 149).","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kotulska', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kwiatkowski', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Curatolo', 'Affiliation': 'Child Neurology and Psychiatry Unit, Systems Medicine Department, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weschke', 'Affiliation': 'Department of Child Neurology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Riney', 'Affiliation': ""Neurosciences Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.""}, {'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Child Neurology, Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Feucht', 'Affiliation': 'Department of Pediatrics, University Hospital Vienna, Vienna, Austria.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Krsek', 'Affiliation': 'Motol University Hospital, Charles University, Prague 5, Czech Republic.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nabbout', 'Affiliation': 'Department of Pediatric Neurology, Reference Centre for Rare Epilepsies, Necker- Enfants Malades Hospital, University Paris Descartes, Imagine Institute, Paris, France.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Jansen', 'Affiliation': 'Pediatric Neurology Unit-UZ Brussel, Brussels, Belgium.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Wojdan', 'Affiliation': 'Transition Technologies, Warsaw, Poland.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Sijko', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Jagoda', 'Initials': 'J', 'LastName': 'Głowacka-Walas', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Julita', 'Initials': 'J', 'LastName': 'Borkowska', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Sadowski', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Domańska-Pakieła', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Moavero', 'Affiliation': ""Child Neurology Unit, Neuroscience and Neurorehabilitation Department, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hertzberg', 'Affiliation': 'Department of Child Neurology, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Hulshof', 'Affiliation': 'Department of Child Neurology, Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Scholl', 'Affiliation': 'Department of Pediatrics, University Hospital Vienna, Vienna, Austria.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Benova', 'Affiliation': 'Motol University Hospital, Charles University, Prague 5, Czech Republic.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Aronica', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of (Neuro)Pathology, Amsterdam Neuroscience, Amsterdam, The Netherlands.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'de Ridder', 'Affiliation': 'Department of Development and Regeneration-Section Pediatric Neurology, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Lagae', 'Affiliation': 'Department of Development and Regeneration-Section Pediatric Neurology, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Sergiusz', 'Initials': 'S', 'LastName': 'Jóźwiak', 'Affiliation': ""Department of Neurology and Epileptology, The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25956']
650,33159496,Comparative biomarkers for HBsAg loss with antiviral therapy shows dominant influence of quantitative HBsAg (qHBsAg).,"BACKGROUND


Biomarkers such as quantitative HBsAg (qHBsAg), quantitative hepatitis B virus (HBV) core-related antigen (qHBcrAg) and HBV RNA may be useful in predicting HBsAg loss in patients with chronic hepatitis B (CHB) undergoing antiviral therapy.
AIM(S)


Our study evaluated qHBsAg, HBV RNA and qHBcrAg as a posthoc analysis of a randomized clinical trial of peginterferon±NA to determine their utility in predicting HBsAg loss.
METHODS


CHB patients who completed therapy with 48weeks peginterferon alpha2b ± nucleoside analogue therapy (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBsAg loss. The predictive ability of qHBsAg, qHBcrAg, HBV RNA and other variables were investigated by univariate and multivariate logistic models for HBeAg-negative patients by odds ratios, area under the curve (AUC), sensitivity, specificity, and positive and negative likelihood ratios (LR).
RESULTS


HBsAg loss occurred in 15/114(13%) HBeAg-negative CHB patients who completed 48 weeks of peginterferon. At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively. Using multivariate analysis, the model comprising treatmentarm, age, gender, baseline qHBsAg, HBcrAg and HBV RNA, weeks 4 & 8 qHBsAg had the highest AUC(0.98), but the univariate model with week 8 qHBsAg <70 IU/mL had AUC 0.96. Hence, the contributions of variables other than qHBsAg were marginal. HBV RNA and qHBcrAg were weak predictors of HBsAg loss. Kinetics of the novel markers showed only qHBsAg had a good relationship with HBsAg loss while HBV RNA had a marginal relationship and HBcrAg did not change at all, and none had a good relationship with viral rebound.
CONCLUSIONS


On-treatment biomarker predictors were better than baseline ones, and the best predictor of HBsAg loss at 72 weeks was week 8 qHBsAg <70 IU/mL.",2021,"At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively.","['CHB patients who completed therapy with 48weeks peginterferon alpha2b\xa0±\xa0nucleoside analogue therapy (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBsAg loss', 'patients with chronic hepatitis B (CHB) undergoing antiviral therapy']",['peginterferon'],"['predictive ability of qHBsAg, qHBcrAg, HBV RNA', 'area under the curve (AUC), sensitivity, specificity, and positive and negative likelihood ratios (LR', 'quantitative HBsAg (qHBsAg', 'HBsAg loss']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]",[],"[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.052194,"At baseline, qHBsAg was superior to HBcrAg and HBV RNA with AUC 0.916, 0.649 and 0.542, respectively.","[{'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Wah Wah', 'Initials': 'WW', 'LastName': 'Phyo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Joanna Zhi Jie', 'Initials': 'JZJ', 'LastName': 'Ling', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cloherty', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Butler', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Kuhns', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'McNamara', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Holzmayer', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gersch', 'Affiliation': 'Abbott Laboratories, Abbott Park, IL, USA.'}, {'ForeName': 'Wei Lyn', 'Initials': 'WL', 'LastName': 'Yang', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Jing Hieng', 'Initials': 'JH', 'LastName': 'Ngu', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Taufique', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Khoo Teck Puat Hospital, Singapore.'}, {'ForeName': 'Yock Young', 'Initials': 'YY', 'LastName': 'Dan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Yin Mei', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Guan Huei', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Poh Seng', 'Initials': 'PS', 'LastName': 'Tan', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Daniel Q', 'Initials': 'DQ', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Htet Toe Wai', 'Initials': 'HTW', 'LastName': 'Khine', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16149']
651,33164569,The patient's perspective on treatment with dacomitinib: patient-reported outcomes from the Phase III trial ARCHER 1050.,"Aim:  Patient-reported symptoms, functioning and overall quality of life (QoL) were compared between dacomitinib and gefitinib in ARCHER 1050.  Patients & methods:  Patients (n = 448) with advanced  EGFR  mutation-positive non-small-cell lung cancer completed the EORTC-QLQ-C30 questionnaire and its lung-specific module, LC-13. Mean scores over time were analyzed using a mixed model for repeated measures.  Results:  Both treatments showed early improvement in disease-related symptoms that was maintained during treatment. Treatment-related diarrhea and sore mouth decreased following dose reduction with dacomitinib. There were no clinically meaningful changes in functioning and overall QoL in either treatment group.  Conclusion:  Longer treatment duration, enabled by dose reduction, allowed patients on dacomitinib to improve treatment-related symptoms and maintain functioning and overall QoL for longer than gefitinib.",2021,There were no clinically meaningful changes in functioning and overall QoL in either treatment group.  ,"['Patients & methods:  Patients (n = 448) with advanced  EGFR  mutation-positive non-small-cell lung cancer completed the EORTC-QLQ-C30 questionnaire and its lung-specific module, LC-13']",[],"['diarrhea and sore mouth', 'functioning and overall QoL', 'disease-related symptoms', 'treatment-related symptoms and maintain functioning and overall QoL', 'symptoms, functioning and overall quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",[],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0013570', 'cui_str': 'Orf virus disease'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",448.0,0.146,There were no clinically meaningful changes in functioning and overall QoL in either treatment group.  ,"[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paty', 'Affiliation': 'IQVIA, Durham, NC\xa027703, USA.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Sandin', 'Affiliation': 'Pfizer AB, Sollentuna, Sweden.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Reisman', 'Affiliation': 'Pfizer Inc, New York, NY\xa010017, USA.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Maria Rita', 'Initials': 'MR', 'LastName': 'Migliorino', 'Affiliation': 'Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'First Affiliated Hospital of Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University Hospital, Osaka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Płużański', 'Affiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Linke', 'Affiliation': 'SFJ Pharmaceuticals, Pleasanton, CA 94588, USA.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Meyers', 'Affiliation': 'IQVIA, New York, NY 10282, USA.'}, {'ForeName': 'Tony S', 'Initials': 'TS', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.'}]","Future oncology (London, England)",['10.2217/fon-2020-0888']
652,32601460,Exposure to peers' pro-diversity attitudes increases inclusion and reduces the achievement gap.,"There is a dearth of empirically validated pro-diversity methods that effectively create a more inclusive social climate. We developed two scalable interventions that target people's perceptions of social norms by communicating to them that their peers hold pro-diversity attitudes and engage in inclusive behaviours. We tested the interventions in six randomized controlled trials at a large public university in the United States (total n = 2,490). Non-marginalized students exposed to our interventions reported more positive attitudes toward outgroups and greater appreciation of diversity, whereas marginalized students had an increased sense of belonging, reported being treated more inclusively by their peers and earned better grades. While many current pro-diversity initiatives focus on raising awareness about the fact that implicit bias and subtle discrimination are widespread, our findings spotlight the importance of drawing people's attention to their peers' pro-diversity values and attitudes to create positive and lasting effects on the social climate.",2020,"Non-marginalized students exposed to our interventions reported more positive attitudes toward outgroups and greater appreciation of diversity, whereas marginalized students had an increased sense of belonging, reported being treated more inclusively by their peers and earned better grades.","['six randomized controlled trials at a large public university in the United States (total n\u2009=\u20092,490']",[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],[],,0.0268444,"Non-marginalized students exposed to our interventions reported more positive attitudes toward outgroups and greater appreciation of diversity, whereas marginalized students had an increased sense of belonging, reported being treated more inclusively by their peers and earned better grades.","[{'ForeName': 'Sohad', 'Initials': 'S', 'LastName': 'Murrar', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Mitchell R', 'Initials': 'MR', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Brauer', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, Madison, WI, USA. markus.brauer@wisc.edu.'}]",Nature human behaviour,['10.1038/s41562-020-0899-5']
653,33184633,"Commentary on: Spare Roof Technique Versus Component Dorsal Hump Reduction: A Randomized Prospective Study in 250 Primary Rhinoplasties, Aesthetic and Functional Outcomes.",,2021,,"['250 Primary Rhinoplasties, Aesthetic and Functional Outcomes']","['Dorsal Hump Reduction', 'Spare Roof Technique Versus Component']",[],"[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",[],,0.0114618,,"[{'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Gruber', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rochlin', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'McClure', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of California, San Francisco, San Francisco, CA.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa253']
654,33159658,"Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial.","INTRODUCTION


Once-weekly (OW) subcutaneous (s.c.) semaglutide is an injectable glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes. This trial was designed to assess the pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects.
METHODS


In this single-centre, randomised, double-blind, placebo-controlled trial, 36 healthy subjects were randomised to OW s.c. semaglutide 0.5 mg (n = 12), 1.0 mg (n = 12), or placebo (n = 12). Treatment (semaglutide or placebo) was blinded for the subjects, investigators and sponsor. The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168 h,SS ).
RESULTS


In total, 34 subjects completed the trial. The steady-state exposure of semaglutide was higher for subjects treated with 1.0 mg semaglutide (AUC 0-168 h,ss : 7961 nmol h/l and C max,ss : 55.9 nmol/l) compared to 0.5 mg semaglutide (AUC 0-168 h,ss : 4000 nmol h/l and C max,ss : 28.8 nmol/l). The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg) [95% confidence interval] for AUC 0-168 h,SS  was 1.99 [1.78; 2.23]. Treatment with OW s.c. semaglutide was well tolerated in healthy Chinese subjects. As expected for the GLP-1 receptor agonist class, the most common adverse events were gastrointestinal, and no new safety signals were identified.
CONCLUSION


The pharmacokinetics, safety and tolerability of OW s.c. semaglutide in healthy Chinese subjects were consistent with previous clinical pharmacology trials of OW s.c. semaglutide in other populations. The results suggest that no dose adjustment is necessary for semaglutide in Chinese patients with T2D.
TRIAL REGISTRATION


ClinicalTrials.gov, identifier NCT03288740.",2021,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"['Healthy Chinese Subjects', '34 subjects completed the trial', 'healthy Chinese subjects', '36 healthy subjects']","['Treatment (semaglutide or placebo', 'placebo', 'Once-Weekly Subcutaneous Semaglutide', 'semaglutide 0.5']","['steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0-168\xa0h,SS ', 'Pharmacokinetics, Safety and Tolerability', 'total exposure of semaglutide', 'steady-state exposure of semaglutide', 'pharmacokinetics, safety and tolerability of OW', 'pharmacokinetics, safety and tolerability']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]",36.0,0.221703,The total exposure of semaglutide increased in a dose-proportional manner in healthy Chinese subjects; the treatment ratio (1.0 mg/0.5 mg),"[{'ForeName': 'Aixin', 'Initials': 'A', 'LastName': 'Shi', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. aixins0302@126.com.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Lasse Lykke', 'Initials': 'LL', 'LastName': 'Nielsen', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Trine Vang', 'Initials': 'TV', 'LastName': 'Skjøth', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Clinical Trial Center, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.""}, {'ForeName': 'Sine Pfeiffer', 'Initials': 'SP', 'LastName': 'Haugaard', 'Affiliation': 'Novo Nordisk A/S, Bagsværd, Denmark.'}]",Advances in therapy,['10.1007/s12325-020-01548-y']
655,33185269,Effect of Antenatal Couple Counselling on Postpartum Uptake of Contraception among Antenatal Clients and their Spouses attending Antenatal Clinic of a Northern Nigeria Tertiary Hospital: A Randomized Controlled Trial.,"BACKGROUND


Contraceptive non-use has great influence on maternal health and mortality in Northern Nigeria. Contraception counselling improves utilization, compliance to and efficiency of contraceptive methods. This study aimed at determining the effect of antenatal couple counselling on postpartum uptake of contraception among antenatal clients and their spouses.
MATERIALS AND METHODS


This was a randomized controlled trial of 150 antenatal clients with their spouses at a tertiary hospital in Northern Nigeria. Participants were randomly assigned to intervention and control groups. A well-designed questionnaire was used to assess participants' contraception awareness, contraceptive uptake pre- and post-intervention and husband participation. A validated counselling tool GATHER was used for the counselling.
RESULTS


Baseline knowledge of contraception was high (92%) among participants however, contraceptive uptake was low (28.3%); there was no significant difference between intervention and control groups (P= 0.94) at baseline. Post-intervention, there was significant difference in postpartum contraceptive uptake between intervention and control groups (48.5% versus 31.0%, respectively; McNemar's chi-square P=0.0001). The determinants of postpartum contraceptive uptake were participants' educational status [Odds ratio (OR)= 10.26, 95% CI =1.31-80.48,P= 0.03], occupation (OR= 10.25, 95% CI=1.06-87.38,P=0.03) and husbands' participation (OR = 0.03, 95% CI = 0.005-0.21,P=0.0001).
CONCLUSION


Antenatal couple counselling impacted positively on postpartum contraceptive uptake. Inclusion of antenatal couple contraception counselling services should be promoted.",2020,"RESULTS


Baseline knowledge of contraception was high (92%) among participants however, contraceptive uptake was low (28.3%); there was no significant difference between intervention and control groups (P= 0.94) at baseline.","['Northern Nigeria', 'antenatal clients and their spouses', 'Antenatal Clients and their Spouses attending Antenatal Clinic of a Northern Nigeria Tertiary Hospital', '150 antenatal clients with their spouses at a tertiary hospital in Northern Nigeria']","['Antenatal Couple Counselling', 'Contraception counselling', 'antenatal couple counselling']","['postpartum uptake of contraception', 'contraceptive uptake', 'Postpartum Uptake of Contraception', 'utilization, compliance to and efficiency of contraceptive methods', 'postpartum contraceptive uptake']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",150.0,0.215626,"RESULTS


Baseline knowledge of contraception was high (92%) among participants however, contraceptive uptake was low (28.3%); there was no significant difference between intervention and control groups (P= 0.94) at baseline.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Abdulkadir', 'Affiliation': 'Department of Family Medicine, Aminu Kano Teaching Hospital,P.M.B. 3452, Kano, Nigeria.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Grema', 'Affiliation': 'Department of Family Medicine, Aminu Kano Teaching Hospital,P.M.B. 3452, Kano, Nigeria.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Michael', 'Affiliation': 'Department of Family Medicine, Aminu Kano Teaching Hospital,P.M.B. 3452, Kano, Nigeria.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Omeiza', 'Affiliation': 'Department of Family Medicine, Aminu Kano Teaching Hospital,P.M.B. 3452, Kano, Nigeria.'}]",West African journal of medicine,[]
656,33187948,Do perioperative antibiotics reduce complications of mandibular third molar removal? A double-blind randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to compare the effects of different antibiotic prophylaxis regimens versus placebo in relation to possible postoperative complications derived from the surgical extraction of impacted lower third molars.
STUDY DESIGN


The final study sample of this double-blind randomized controlled trial comprised 92 Caucasian volunteers. Patients were assigned to 3 groups by using a randomization table. Group 1 (n = 30) received 750 mg oral amoxicillin both before and after the surgery; group 2 (n = 32) received the same oral dose after surgery alone; and group 3 (n = 30) received placebo both before and after surgery. Infectious complications, postoperative pain, and inflammation intensity were measured. The requirement for and the timing of rescue medication were also measured.
RESULTS


Postoperative pain and inflammation intensity were significantly higher (P < .05) in group 3 than in groups 1 or 2 at 48 hours, 72 hours, and 1 week. A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics) (P = .013) compared with groups 1 or 2.
CONCLUSIONS


Greater pain and inflammation were experienced by patients receiving placebo before lower third molar extraction than by those receiving antibiotics either before surgery or both before and after surgery. Other options, such as use of local antibiotics, should be considered to reduce the problems, including bacterial resistance, caused by overuse of systemic antibiotics.",2021,A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics),['92 Caucasian volunteers'],"['750 mg oral amoxicillin', 'placebo']","['pain and inflammation', 'Infectious complications, postoperative pain, and inflammation intensity', 'Postoperative pain and inflammation intensity', 'rescue medication (analgesics and rescue antibiotics']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",92.0,0.61802,A significantly higher proportion of group 3 required rescue medication (analgesics and rescue antibiotics),"[{'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Mariscal-Cazalla', 'Affiliation': 'Student, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Manzano-Moreno', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Granada, Spain. Electronic address: Fjmanza@ugr.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Vázquez', 'Affiliation': 'Student, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}, {'ForeName': 'Manuel F', 'Initials': 'MF', 'LastName': 'Vallecillo-Capilla', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery; Director, Oral Surgery and Implantology Masters Clinic, University of Granada, Spain.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Olmedo-Gaya', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, University of Granada, Spain.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.08.034']
657,33189801,Rechargeable adhesive with calcium phosphate nanoparticles inhibited long-term dentin demineralization in a biofilm-challenged environment.,"OBJECTIVES


This study aims to investigate the long-term demineralization-inhibition capability of a rechargeable adhesive with nanoparticles of amorphous calcium phosphate (NACP) on dentin in a biofilm-challenged environment.
METHODS


The NACP adhesive was immersed in a pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions. Dentin samples were demineralized underStreptococcus mutans biofilms for 24 h and randomly divided into two groups: (1) dentin control, (2) dentin with recharged NACP adhesives. Each day, all the samples were immersed in brain heart infusion broth with 1% sucrose (BHIS) for 4 h, and then in artificial saliva (AS) for 20 h. This cycle was repeated for 10 days. The pH of BHIS, the Ca and P ions content of the BHIS and AS were measured daily. After 10 days, the lactic acid production and colony-forming units of the biofilms were tested. The changes of remineralization/demineralization were also analyzed.
RESULTS


Dentin in the control group showed further demineralization. The recharged NACP adhesive neutralized acids, increasing the pH to above 5, and released large amounts of Ca and P ions each day. The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
CONCLUSIONS


The NACP adhesive could continuously inhibit dentin demineralization in a biofilm-challenged environment by recharging with Ca and P ions.
SIGNIFICANCE


The rechargeable NACP adhesive could provide long-term dentin bond protection.",2021,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
",[],"['amorphous calcium phosphate (NACP', 'dentin control, (2) dentin with recharged NACP adhesives', 'pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions']","['lactic acid production and colony-forming units of the biofilms', 'changes of remineralization/demineralization', 'pH of BHIS, the Ca and P ions content of the BHIS and AS', 'demineralization', 'dentin hardness', 'production of lactic acid']",[],"[{'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0022023', 'cui_str': 'Ions'}]","[{'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0188217,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
","[{'ForeName': 'Zhaohan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Tao', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hockin H K', 'Initials': 'HHK', 'LastName': 'Xu', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weir', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Menglin', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Kunneng', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China; Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA. Electronic address: kunnengliang@163.com.'}, {'ForeName': 'Jiyao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China. Electronic address: jiyaoliscu@163.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103529']
658,33189635,Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2.,"OBJECTIVES


This study sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial.
BACKGROUND


Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available.
METHODS


Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed.
RESULTS


By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and noncardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF.
CONCLUSIONS


Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778).",2020,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"['patients with AHF across the spectrum of ejection fraction (EF), was analyzed', 'Patients With Acute Heart', 'Adjudicated cause of death of patients in RELAX-AHF-2', 'Patients with AHF', 'Older patients (≥75 years']","['serelaxin', 'placebo', 'Serelaxin']","['heart failure (HF', 'acute heart failure (AHF', 'Efficacy, Safety and Tolerability', 'non-cardiovascular (CV) death', 'CV mortality', 'Cause of Death', 'rates of HF-related mortality', 'rates of mortality', 'overall mortality', 'deaths from HF or sudden death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",,0.323088,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"[{'ForeName': 'Rahul S', 'Initials': 'RS', 'LastName': 'Loungani', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, ASST Civil Hospitals, and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Department of Cardiology, Washington VA Medical Center, Washington, DC, USA.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Durham, North Carolina, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Durham, North Carolina, USA.'}, {'ForeName': 'Zubin J', 'Initials': 'ZJ', 'LastName': 'Eapen', 'Affiliation': 'Anthem Incorporated, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, University of Cyprus, Nicosia, Cyprus, Greece; Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gimpelewicz', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'University of California San Diego Health, Cardiovascular Institute, La Jolla, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holbro', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Harvard Medical School, and Cardiometabolic Trials, Baim Institute for Clinical Research, Boston, Massachusetts, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Division of Cardiology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Cardiology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiology, University of Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA. Electronic address: Michael.felker@duke.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.09.010']
659,33191408,A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer.,"BACKGROUND


This study compared the efficacy/safety of the camptothecin analogues belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC).
METHODS


One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m 2 ) or belotecan (0.5 mg/m 2 ), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint.
RESULTS


In the belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
CONCLUSIONS


The efficacy/safety of belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance.",2021,"More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
","['sensitive-relapsed small-cell lung cancer', 'patients aged <65 years, with more advanced disease, or poor performance', 'One-hundred-and-sixty-four patients']","['topotecan', 'belotecan vs. topotecan', 'camptothecin analogues belotecan and topotecan', 'belotecan']","['efficacy/safety', 'DCR', 'efficacy and safety', 'ORR', 'objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity', 'PFS', 'Median OS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0762737', 'cui_str': 'belotecan'}, {'cui': 'C0006812', 'cui_str': 'Camptothecin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",164.0,0.129079,"More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
","[{'ForeName': 'Jin-Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Ki-Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joo-Hang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'CHA University Bundang Medical Center, Seongnam, South Korea.'}, {'ForeName': 'Jin-Hyuk', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Ho Jung', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': ""The Catholic University of Korea St. Vincent's Hospital, Seoul, South Korea.""}, {'ForeName': 'Jin-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Joung-Soon', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bong-Seog', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Heung Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'National Cancer Center, Goyang, South Korea. htkim@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-020-01055-5']
660,33189909,Does prophylactic use of topical gelatin-thrombin matrix sealant affect postoperative drainage volume and hematoma formation following microendoscopic spine surgery? A randomized controlled trial.,"BACKGROUND CONTEXT


Microendoscopic spinal surgery has demonstrated efficacy and is increasingly utilized as a minimally invasive approach to neural decompression, but there is a theoretical concern that bleeding and postoperative epidural hematoma (PEH) may occur with increased frequency in a contained small surgical field. Hemostatic agents, such as topical gelatin-thrombin matrix sealant (TGTMS), are routinely used in spine surgery procedures, yet there has been no data on whether PEH is suppressed by these agents when administered in microendoscopic spine surgery.
PURPOSE


The purpose of this study was to investigate the effect of TGTMS on bleeding and PEH formation in lumbar micoroendoscopic surgery.
STUDY DESIGN


This is a randomized controlled trial (RCT) with additional prospective observational cohort.
PATIENT SAMPLE


Patients were registered from July 2017 to September 2018 and a hundred and three patients undergoing microendoscopic laminectomy for lumbar spinal stenosis at a single institution were enrolled in this study.
OUTCOME MEASURES


The primary outcome was the drainage volume within 48 hours after surgery. Secondary outcomes were the numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI).
METHODS


In the RCT, 41 cases that received TGTMS (F group) were compared with 41 control group cases (C group) that did not receive TGTMS at the end of the procedure. Drainage volume, NRS2, NRS7, and HAR on MRI were evaluated. Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis. I group was compared with C group in the drainage volume and NRS of leg pain as a prospective observational study.
RESULTS


The RCT demonstrated no statistically significant difference in drainage volume between those receiving TGTMS (117.0±71.7; mean±standard deviation) and controls (125.0±127.0; p=.345). The NRS2 and NRS7 was 3.5±2.6 and 2.8±2.5 in the F group, respectively, and 3.1±2.6 and 2.1±2.3 in the C group, respectively. The HAR on MRI was 0.19±0.19 in the F group and 0.17±0.13 in the C group. There was no significant difference in postoperative leg pain and HAR (p=.644 for NRS2, p=.129 for NRS7, and p=.705 for HAR). In the secondary observational cohort, the drainage volume in the I group was 118.3±151.4, and NRS2 and NRS7 was 3.5±2.0 and 2.6±2.6, respectively. There were no statistically significant differences in drainage volume (p=.386) or postoperative NRS of leg pain between these two groups (p=.981 and .477 for NRS2 and NRS7, respectively).
CONCLUSIONS


The prophylactic use of TGTMS in patients undergoing microendoscopic laminotomy for lumbar spinal stenosis did not demonstrate any difference in postoperative bleeding or PEH. Nonetheless, for patients that had active bleeding that required the use of TGTMS, there was no evidence of difference in postoperative clinical outcomes relative to controls.",2021,"There were no statistically significant differences in drainage volume (p=0.386) or postoperative NRS of leg pain between these two groups (p=0.981 and 0.477 for NRS2 and NRS7, respectively).
","['patients undergoing microendoscopic laminotomy for lumbar spinal stenosis', 'Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis', 'SAMPLE\n\n\nPatients were registered from July 2017 to September 2018 and a hundred and three patients undergoing', 'for lumbar spinal stenosis at a single institution were enrolled in this study', 'lumbar micoroendoscopic surgery']","['topical gelatin-thrombin matrix sealant', 'microendoscopic laminectomy', 'TGTMS', 'topical gelatin-thrombin matrix sealant (TGTMS']","['postoperative NRS of leg pain', 'numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI', 'NRS2 and NRS7', 'Drainage volume, NRS2, NRS7, and HAR on MRI', 'drainage volume', 'postoperative bleeding or PEH', 'HAR on MRI', 'bleeding and PEH formation', 'postoperative drainage volume and hematoma formation', 'postoperative leg pain and HAR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",19.0,0.104434,"There were no statistically significant differences in drainage volume (p=0.386) or postoperative NRS of leg pain between these two groups (p=0.981 and 0.477 for NRS2 and NRS7, respectively).
","[{'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Takami', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan. Electronic address: takami@wakayama-med.ac.jp.'}, {'ForeName': 'Munehito', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Minamide', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hashizume', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Yasutsugu', 'Initials': 'Y', 'LastName': 'Yukawa', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Spine Care Center, Wakayama Medical University Kihoku Hospital, 219 Myoji, Katsuragi-cho, Wakayama 649-7113, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Taiji', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Nishi', 'Affiliation': 'Department of Orthopaedic Surgery, Hidaka Hospital, 116-2 Sono, Gobo-city, Wakayama 644-0002, Japan.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Schoenfeld', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Simpson', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8510, Japan.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.11.004']
661,33199490,Randomized Phase II and Biomarker Study of Pembrolizumab plus Bevacizumab versus Pembrolizumab Alone for Patients with Recurrent Glioblastoma.,"PURPOSE


VEGF is upregulated in glioblastoma and may contribute to immunosuppression. We performed a phase II study of pembrolizumab alone or with bevacizumab in recurrent glioblastoma.
PATIENTS AND METHODS


Eighty bevacizumab-naïve patients with recurrent glioblastoma were randomized to pembrolizumab with bevacizumab (cohort A,  n  = 50) or pembrolizumab monotherapy (cohort B,  n  = 30). The primary endpoint was 6-month progression-free survival (PFS-6). Assessed biomarkers included evaluation of tumor programmed death-ligand 1 expression, tumor-infiltrating lymphocyte density, immune activation gene expression signature, and plasma cytokines. The neurologic assessment in neuro-oncology (NANO) scale was used to prospectively assess neurologic function.
RESULTS


Pembrolizumab alone or with bevacizumab was well tolerated but of limited benefit. For cohort A, PFS-6 was 26.0% [95% confidence interval (CI), 16.3-41.5], median overall survival (OS) was 8.8 months (95% CI, 7.7-14.2), objective response rate (ORR) was 20%, and median duration of response was 48 weeks. For cohort B, PFS-6 was 6.7% (95% CI, 1.7-25.4), median OS was 10.3 months (95% CI, 8.5-12.5), and ORR was 0%. Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased posttherapy plasma VEGF (cohort A) and mutant  IDH1 , unmethylated  MGMT , and increased baseline PlGF and sVEGFR1 levels (cohort B). The NANO scale contributed to overall outcome assessment.
CONCLUSIONS


Pembrolizumab was ineffective as monotherapy and with bevacizumab for recurrent glioblastoma. The infrequent radiographic responses to combinatorial therapy were durable. Tumor immune biomarkers did not predict outcome. Baseline dexamethasone use and tumor MGMT warrant further study as potential biomarkers in glioblastoma immunotherapy trials.",2021,"Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels (cohort B).","['Eighty bevacizumab-naive, recurrent glioblastoma patients randomized to', 'recurrent glioblastoma patients']","['pembrolizumab', 'pembrolizumab alone or with bevacizumab', 'pembrolizumab plus bevacizumab', 'pembrolizumab with bevacizumab', 'bevacizumab', 'pembrolizumab monotherapy', 'Pembrolizumab']","['Tumor immune markers', 'ORR', 'six-month progression-free survival (PFS-6', 'evaluation of tumor PD-L1 expression, TIL density, immune activation gene expression signature and plasma cytokines', 'median OS', 'post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels', 'Neurologic Assessment in Neuro-Oncology (NANO) scale']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0069197', 'cui_str': 'Methylated-DNA-protein-cysteine methyltransferase'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.100615,"Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels (cohort B).","[{'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Nayak', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Molinaro', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Clarke', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Jordan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'de Groot', 'Affiliation': 'M.D. Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Leia', 'Initials': 'L', 'LastName': 'Nghiemphu', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kaley', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCluskey', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gaffey', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Smith', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cote', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Severgnini', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Yearley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Blumenschein', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Dan G', 'Initials': 'DG', 'LastName': 'Duda', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Rakesh K', 'Initials': 'RK', 'LastName': 'Jain', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts. david_reardon@dfci.harvard.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2500']
662,33201025,"Effects of high protein, low-glycemic index diet on lean body mass, strength, and physical performance in late postmenopausal women: a randomized controlled trial.","OBJECTIVE


To investigate whether increasing protein consumption to twice the recommended daily allowance (RDA) by The Institute of Medicine affects lean body mass (LBM), muscle strength, and physical performance in late postmenopausal women.
METHODS


Parallel-group randomized trial with 26 apparently healthy women aged ≥ 65 years. Participants were randomly assigned to low-glycemic index diets with protein consumption at current RDA (0.8 g/kg body weight) or twice the RDA (2RDA, 1.6 g/kg body weight). Protein intake was assessed by 24-hours urinary nitrogen excretion. Change in LBM was measured by dual-energy X-ray absorptiometry at 3 and 6 months. Secondary outcomes were appendicular lean mass, handgrip strength by dynamometry, and physical performance by gait speed.
RESULTS


Mean age was 70.8 ± 3.6 years, and mean BMI was 26.1 ± 3.5 kg/m2 in the overall sample. The RDA and 2RDA groups did not differ regarding baseline dietary intake. Changes from baseline in LBM (0.07 kg; 95% CI, -0.39; 0.52 kg; P = 0.100) and appendicular lean mass (0.07 kg; 95% CI, -0.34; 0.47 kg; P = 0.100) did not differ between the groups. Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55; -0.24 kg; P = 0.005) decreased similarly in both groups at the end of intervention. Adjusting for baseline BMI did not alter these findings. Handgrip strength and 4-m gait speed increased after the intervention, with no significant difference between the groups.
CONCLUSIONS


Protein intake exceeding the RDA did not increase LBM, strength, and physical performance in a sample of late postmenopausal woman consuming a low-glycemic index diet for 6 months.",2020,"Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55;","['26 apparently healthy women aged\u200a≥\u200a65 years', 'late postmenopausal women', 'Mean age was 70.8\u200a±\u200a3.6 years, and mean BMI was 26.1\u200a±\u200a3.5\u200akg/m in the overall sample']","['low-glycemic index diets with protein consumption at current RDA', 'high protein, low-glycemic index diet']","['lean body mass (LBM), muscle strength, and physical performance', 'lean body mass, strength, and physical performance', 'Handgrip strength and 4-m gait speed', 'appendicular lean mass', 'trunk fat mass', 'Total body fat', '24-hours urinary nitrogen excretion', 'Change in LBM', 'Protein intake', 'appendicular lean mass, handgrip strength by dynamometry, and physical performance by gait speed', 'LBM, strength, and physical performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowance'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",26.0,0.13807,"Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55;","[{'ForeName': 'Thaís R', 'Initials': 'TR', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Suzana C', 'Initials': 'SC', 'LastName': 'Lago', 'Affiliation': 'Gynecological Endocrinology Unit, Division of Endocrinology, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Yavorivski', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Laís L', 'Initials': 'LL', 'LastName': 'Ferreira', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Tayane M', 'Initials': 'TM', 'LastName': 'Fighera', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Poli Mara', 'Initials': 'PM', 'LastName': 'Spritzer', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001692']
663,33201029,Comparative validity and reliability of the WeChat-based electronic and paper-and-pencil versions of the PISQ-12 for collecting participant-reported data in Chinese.,"OBJECTIVE


The objective of this study is to assess the consistency between the WeChat-based Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) in Chinese and the paper version and to determine the test-retest reliability of the WeChat questionnaire.
METHODS


A total of 120 women aged between 24 and 69 years were recruited from the outpatient clinic at Peking Union Medical College Hospital and randomly assigned to two groups. All participants completed the WeChat and paper questionnaires twice. Group A completed the paper questionnaire before the WeChat version; Group B completed the WeChat questionnaire before the paper version. Two weeks later, all participants completed the questionnaires in the opposite order. Then, the reliability and validity of the two versions were assessed using Pearson correlation coefficients, intraclass correlation coefficients, and Bland-Altman graphs.
RESULTS


No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67). Half of the participants (60/120) preferred the WeChat questionnaire, 15% (18/120) preferred the paper form (P < 0.01), and 35% had no preference (42/120). The response time was positively correlated with age (P < 0.01) and negatively correlated with the degree of education (P < 0.01). A Pearson correlation coefficient of 0.92 and an intraclass correlation coefficient of 0.94 indicated strong consistency between the two versions. The WeChat form exhibited strong test-retest reliability (Pearson correlation coefficient, 0.86; intraclass correlation coefficient, 0.86). The Bland-Altman plots supported these results.
CONCLUSIONS


The WeChat questionnaire was preferred over the paper version in a Chinese sample and had excellent consistency with the paper version and high test-retest reliability for collecting data on private topics.",2020,No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67).,"['Chinese', '120 women aged between 24 and 69 years were recruited from the outpatient clinic at Peking Union Medical College Hospital and randomly assigned to two groups']","['WeChat-based electronic and paper-and-pencil versions of the PISQ-12', 'WeChat-based Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12']","['completion time', 'response time', 'WeChat questionnaire']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.0212777,No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67).,"[{'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jinghe', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001691']
664,33197609,Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework.,"BACKGROUND


Behavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss.
STUDY DESIGN


Five experimental intervention components will be tested as adjuncts to an established 12-month online BLI: virtual reality for BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition. Following the Multiphase Optimization Strategy (MOST) framework, the components will first be refined and finalized during Preparation Phase pilot testing and then evaluated in a factorial experiment with 384 adults with overweight or obesity. A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components. Mediation analysis will be conducted to test hypothesized mechanisms of action and a moderator analysis will be conducted to understand for whom and under what circumstances the interventions are effective.
CONCLUSION


This study will provide important information about intervention strategies that are useful for improving outcomes of online BLI. The finalized treatment package will be suitable for testing in a future randomized trial in the MOST Evaluation Phase.",2021,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,['384 adults with overweight or obesity'],"['BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition', 'behavioral obesity treatment delivered online', 'Behavioral lifestyle intervention (BLI']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]",[],384.0,0.0288169,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,"[{'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA. Electronic address: john_g_thomas@brown.edu.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Hekler', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego (UCSD), Center for Wireless and Population Health Systems, Qualcomm Institute at UCSD, 9500 Gilman Ave., San Diego, CA 92093, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Hallie M', 'Initials': 'HM', 'LastName': 'Espel-Huynh', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 S Main St., Providence, RI 02903, USA.'}, {'ForeName': 'E Whitney', 'Initials': 'EW', 'LastName': 'Evans', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Computer Science, Brown University, 115 Waterman St., Providence, RI 02906, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106217']
665,33197610,Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings.,"The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",2021,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",[],['MBRP-SA'],['risk of morbidity and mortality'],[],[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.019142,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Hemenway', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'University of New Mexico, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Unrod', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'University of Utah, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA. Electronic address: christine.vinci@moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106218']
666,32066784,Correlation of age-of-onset of Atopic Dermatitis with Filaggrin loss-of-function variant status.,"The genetic background of Atopic Dermatitis (AD) with chronic pruritus is complex. Filaggrin (FLG) is an essential gene in the epidermal barrier formation s. Loss-of-function (LOF) variants in FLG associated with skin barrier dysfunction constitute the most well-known genetic risk factor for AD. In this study, we focused on the frequency and effect of FLG loss-of-function variants in association with self-reported age-of-onset of AD. The dataset consisted of 386 whole-genome sequencing (WGS) samples. We observe a significant association between FLG LOF status and age-of-onset, with earlier age of onset of AD observed in the FLG LOF carrier group (p-value 0.0003, Wilcoxon two-sample test). We first tested this on the two most prevalent FLG variants. Interestingly, the effect is even stronger when considering all detected FLG LOF variants. Having two or more FLG LOF variants associates with the onset of AD at 2 years of age. In this study, we have shown enrichment of rare variants in the EDC region in cases compared with controls. Age-of-onset analysis shows not only the effect of the FLG and likely EDC variants in terms of the heightened risk of AD, but foremost enables to predict early-onset, lending further credence to the penetrance and causative effect of the identified variants. Understanding the genetic background and risk of early-onset is suggestive of skin barrier dysfunction etiology of AD with chronic pruritus.",2020,Filaggrin (FLG) is an essential gene in the epidermal barrier formation s.,['Atopic Dermatitis with Filaggrin loss-of-function variant status'],"['FLG', 'Filaggrin (FLG']",['FLG LOF status and age-of-onset'],"[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0117738', 'cui_str': 'filaggrin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0117738', 'cui_str': 'filaggrin'}]","[{'cui': 'C0117738', 'cui_str': 'filaggrin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",386.0,0.0296545,Filaggrin (FLG) is an essential gene in the epidermal barrier formation s.,"[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Smieszek', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA. Sandra.Smieszek@vandapharma.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welsh', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Birznieks', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}]",Scientific reports,['10.1038/s41598-020-59627-7']
667,33201535,"A Pilot Randomized, Controlled, Double-Blind Trial of Bumetanide to Treat Neonatal Seizures.","OBJECTIVE


In the absence of controlled trials, treatment of neonatal seizures has changed minimally despite poor drug efficacy. We tested bumetanide added to phenobarbital to treat neonatal seizures in the first trial to include a standard-therapy control group.
METHODS


A randomized, double-blind, dose-escalation design was employed. Neonates with postmenstrual age 33 to 44 weeks at risk of or with seizures were eligible. Subjects with electroencephalography (EEG)-confirmed seizures after ≥20 and <40mg/kg phenobarbital were randomized to receive additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide (treatment). Continuous EEG monitoring data from ≥2 hours before to ≥48 hours after study drug administration (SDA) were analyzed for seizures.
RESULTS


Subjects were randomized to treatment (n = 27) and control (n = 16) groups. Pharmacokinetics were highly variable among subjects and altered by hypothermia. The only statistically significant adverse event was diuresis in treated subjects (48% vs 13%, p = 0.02). One treated (4%) and 3 control subjects died (19%, p = 0.14). Among survivors, 2 of 26 treated subjects (8%) and 0 of 13 control subjects had hearing impairment, as did 1 nonrandomized subject. Total seizure burden varied widely, with much higher seizure burden in treatment versus control groups (median = 3.1 vs 1.2 min/h, p = 0.006). There was significantly greater reduction in seizure burden 0 to 4 hours and 2 to 4 hours post-SDA (both p < 0.01) compared with 2-hour baseline in treatment versus control groups with adjustment for seizure burden.
INTERPRETATION


Although definitive proof of efficacy awaits an appropriately powered phase 3 trial, this randomized, controlled, multicenter trial demonstrated an additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. Future trials of bumetanide and other drugs should include a control group and balance seizure severity. ANN NEUROL 2021;89:327-340.",2021,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","['Subjects with EEG-confirmed seizures after ≥20 and <40mg/kg phenobarbital', 'neonatal seizures', 'Subjects were randomized to treatment (n=27) and control (n=16) groups', 'Neonates with postmenstrual age 33-44weeks at risk of or with seizures were eligible']","['phenobarbital', 'additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide', 'bumetanide']","['Total seizure burden', 'adverse event was diuresis', 'seizure burden', 'hearing impairment']","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0006376', 'cui_str': 'Bumetanide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.392446,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","[{'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Soul', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Bergin', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stopp', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Hayes', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Carmen R', 'Initials': 'CR', 'LastName': 'Fortuno', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kalpathy', 'Initials': 'K', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Jensen', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rofeberg', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Staley', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25959']
668,33202263,"Attention bias modification in depression: A randomized trial using a novel, reward-based, eye-tracking approach.","BACKGROUND AND OBJECTIVES


Biased attention to negative information is a mechanism for risk and relapse in depression. Attentional bias modification (ABM) paradigms manipulate attention away from negative information to reduce this bias. ABM results have been mixed due to inconsistent methodologies and stimuli design. This randomized controlled trial used a novel approach to modifying attentional bias.
METHODS


An eye tracker manipulated stimuli in response to participants' fixations to preferentially reward attention to positive stimuli by obscuring or enhancing image quality of negative and positive stimuli, respectively. Participants with major depressive disorder completed three 35-min sessions of active (n = 20) or sham (n = 20) ABM training. Attentional bias, memory for emotional words, and mood were assessed pre- and post-training.
RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096). Active training participants remembered more happy than sad words in an emotional word learning task, indicating a distal transfer of training to emotional memory (p = .036, η p 2  = 0.11). Training did not significantly affect mood in the one-week trial.
LIMITATIONS


Future studies should build on this proof-of-principle study with larger sample sizes and more intensive treatment to explore which mechanisms of training may lead to improvements in mood.
CONCLUSIONS


Attention biases in depression are modifiable through reward-based, eye-tracking training. These data suggest generalizability of training to other cognitive faculties - recall for affective information.",2020,"RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096).",['Participants with major depressive disorder'],"['active (n\xa0=\xa020) or sham (n\xa0=\xa020) ABM training', 'Attentional bias modification (ABM']","['Attentional bias, memory for emotional words, and mood', 'negative attentional bias']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.153622,"RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Woolridge', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Geoffrey W', 'Initials': 'GW', 'LastName': 'Harrison', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Best', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada; Department of Psychological Clinical Science, University of Toronto Scarborough Science Wing, Room SW427D 1265 Military Trail Toronto, Ontaro, M1C 1A4, Canada.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada. Electronic address: bowiec@queensu.ca.""}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101621']
669,33197213,Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial.,"BACKGROUND


Despite the recent worldwide dissemination of laparoscopic liver surgery, no high-level evidence supports the oncologic safety of this approach.
OBJECTIVE


To evaluate long-term oncologic outcomes after laparoscopic versus open liver resection in patients with colorectal metastases.
DESIGN


A single-center, assessor-blinded, randomized controlled trial (OSLO-COMET [Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Trial]). (ClinicalTrials.gov: NCT01516710).
SETTING


Oslo University Hospital, the only provider of liver surgery for the 3 million inhabitants of southeastern Norway.
PARTICIPANTS


Patients with resectable colorectal liver metastases were randomly assigned to have open or laparoscopic liver resection.
INTERVENTION


From February 2012 to January 2016, a total of 280 patients were included in the trial (laparoscopic surgery:  n  = 133; open surgery:  n  = 147).
MEASUREMENTS


The primary outcome was postoperative morbidity within 30 days. Five-year rates of overall and recurrence-free survival were predefined secondary end points.
RESULTS


At a median follow-up of 70 months, rates of 5-year overall survival were 54% in the laparoscopic group and 55% in the open group (between-group difference, 0.5 percentage point [95% CI, -11.3 to 12.3 percentage points]; hazard ratio, 0.93 [CI, 0.67 to 1.30];  P  = 0.67). Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
LIMITATION


The trial was not powered to detect differences in secondary end points and was not designed to address a noninferiority hypothesis for survival outcomes.
CONCLUSION


In this randomized trial of laparoscopic and open liver surgery, no difference in survival outcomes was found between the treatment groups. However, differences in 5-year overall survival up to about 10 percentage points in either direction cannot be excluded. This trial should be followed by pragmatic multicenter trials and international registries.
PRIMARY FUNDING SOURCE


The South-Eastern Norway Regional Health Authority.",2021,"Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
","['patients with colorectal metastases', 'Colorectal Liver Metastases ', 'Patients with resectable colorectal liver metastases', '280 patients were included in the trial ', 'Oslo University Hospital, the only provider of liver surgery for the 3 million inhabitants of southeastern Norway']","['laparoscopic surgery:  n \xa0= 133; open surgery:  n \xa0= 147', 'laparoscopic liver resection', 'laparoscopic and open liver surgery', 'Laparoscopic Versus Open Resection', 'OSLO-COMET [Oslo Randomized Laparoscopic Versus Open Liver Resection', 'laparoscopic versus open liver resection']","['5-year overall survival', 'Rates of 5-year recurrence-free survival', 'survival outcomes', 'rates of 5-year overall survival', 'postoperative morbidity', 'overall and recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",280.0,0.503681,"Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
","[{'ForeName': 'Davit L', 'Initials': 'DL', 'LastName': 'Aghayan', 'Affiliation': 'The Intervention Centre at Oslo University Hospital and Institute of Clinical Medicine at University of Oslo, Oslo, Norway, and Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia (D.L.A.).'}, {'ForeName': 'Airazat M', 'Initials': 'AM', 'LastName': 'Kazaryan', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, and Østfold Hospital Trust, Grålum, Norway, Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia, and I.M. Sechenov First Moscow State Medical University, Moscow, Russia (A.M.K.).'}, {'ForeName': 'Vegar Johansen', 'Initials': 'VJ', 'LastName': 'Dagenborg', 'Affiliation': 'Institute of Clinical Medicine at University of Oslo and Oslo University Hospital, Oslo, Norway (V.J.D., K.F.).'}, {'ForeName': 'Bård I', 'Initials': 'BI', 'LastName': 'Røsok', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Oslo, Norway (B.I.R.).'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway (M.W.F.).'}, {'ForeName': 'Gudrun Maria', 'Initials': 'GM', 'LastName': 'Waaler Bjørnelv', 'Affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway (G.M.W.).'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Kristiansen', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, Norway (R.K., Å.A.F.).'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Flatmark', 'Affiliation': 'Institute of Clinical Medicine at University of Oslo and Oslo University Hospital, Oslo, Norway (V.J.D., K.F.).'}, {'ForeName': 'Åsmund Avdem', 'Initials': 'ÅA', 'LastName': 'Fretland', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, Norway (R.K., Å.A.F.).'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': 'The Intervention Centre at Oslo University Hospital and Institute of Clinical Medicine at University of Oslo, Oslo, Norway (B.E.).'}]",Annals of internal medicine,['10.7326/M20-4011']
670,33210192,Impact of Metformin on Statin Persistence: a Post Hoc Analysis of a Large Randomized Controlled Trial.,,2020,,[],['Metformin'],['Statin Persistence'],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]",,0.194436,,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Cheon', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsalatsanis', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cowart', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Magness', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Srinivas M', 'Initials': 'SM', 'LastName': 'Tipparaju', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Carris', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA. carris@usf.edu.'}]",Journal of general internal medicine,['10.1007/s11606-020-06344-6']
671,33210299,Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease.,"BACKGROUND


Fatigue is a burdensome symptom for patients with inflammatory bowel disease (IBD). Few pharmacological interventions have documented effect on fatigue in patients with IBD. A pilot study indicated a 20-day effect  with high-dose thiamine.
AIMS


To investigate the effect and safety of high-dose oral thiamine (600-1800 mg/d) based on gender and weight on chronic fatigue in patients with quiescent IBD.
METHODS


This was a randomised, double-blinded, placebo-controlled crossover trial. Patients had quiescent IBD, severe chronic fatigue and no other explanation for fatigue. Patients were allocated 1:1 to either 1) high-dose oral thiamine for 4 weeks, 4 weeks of washout, 4 weeks of oral placebo or 2) oral placebo for 4 weeks, 4 weeks of washout, 4 weeks of high-dose oral thiamine. Fatigue was measured using the Inflammatory Bowel Disease-Fatigue Questionnaire. The primary outcome was improvement (≥3 points) of fatigue after 4 weeks on thiamine.
RESULTS


Forty patients were enrolled between November 2018 and October 2019. Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo. Furthermore, 55% of group 1 and 75% of group 2 showed an improvement ≥ 3 points while on thiamine compared with 25% of group 1 and 35% of group 2 while on placebo. Only mild side effects were detected.
CONCLUSION


We showed a significant beneficial effect of high-dose oral thiamine on chronic fatigue in IBD. The treatment was well tolerated.
TRIAL REGISTRATION


NCT03634735.",2021,Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo.,"['patients with quiescent inflammatory bowel disease', 'patients with quiescent IBD', 'patients with inflammatory bowel disease (IBD', 'Forty patients were enrolled between November 2018 and October 2019', 'patients with IBD']","['placebo or 2) oral placebo', 'high-dose thiamine', 'thiamine', '1) high-dose oral thiamine', 'high-dose oral thiamine', 'placebo', 'thiamine versus placebo']","['quiescent IBD, severe chronic fatigue', 'fatigue', 'Inflammatory Bowel Disease-Fatigue Questionnaire', 'mild side effects', 'tolerated', 'Fatigue', 'improvement (≥3 points) of fatigue', 'chronic fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}]","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.652538,Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo.,"[{'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Bager', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Christian Lodberg', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Charlotte Lock', 'Initials': 'CL', 'LastName': 'Rud', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16166']
672,33208340,Randomized Phase II Trial of Anthracycline-free and Anthracycline-containing Neoadjuvant Carboplatin Chemotherapy Regimens in Stage I-III Triple-negative Breast Cancer (NeoSTOP).,"PURPOSE


Addition of carboplatin (Cb) to anthracycline chemotherapy improves pathologic complete response (pCR), and carboplatin plus taxane regimens also yield encouraging pCR rates in triple-negative breast cancer (TNBC). Aim of the NeoSTOP multisite randomized phase II trial was to assess efficacy of anthracycline-free and anthracycline-containing neoadjuvant carboplatin regimens.
PATIENTS AND METHODS


Patients aged ≥18 years with stage I-III TNBC were randomized (1:1) to receive either paclitaxel (P) weekly × 12 plus carboplatin AUC6 every 21 days × 4 followed by doxorubicin/cyclophosphamide (AC) every 14 days × 4 (CbP → AC, arm A), or carboplatin AUC6 + docetaxel (D) every 21 days × 6 (CbD, arm B). Stromal tumor-infiltrating lymphocytes (sTIL) were assessed. Primary endpoint was pCR in breast and axilla. Other endpoints included residual cancer burden (RCB), toxicity, cost, and event-free (EFS) and overall survival (OS).
RESULTS


One hundred patients were randomized; arm A ( n  = 48) or arm B ( n  = 52). pCR was 54% [95% confidence interval (CI), 40%-69%] in arm A and 54% (95% CI, 40%-68%) in arm B. RCB 0+I rate was 67% in both arms. Median sTIL density was numerically higher in those with pCR compared with those with residual disease (20% vs. 5%;  P  = 0.25). At median follow-up of 38 months, EFS and OS were similar in the two arms. Grade 3/4 adverse events were more common in arm A compared with arm B, with the most notable differences in neutropenia (60% vs. 8%;  P  < 0.001) and febrile neutropenia (19% vs. 0%;  P  < 0.001). There was one treatment-related death (arm A) due to acute leukemia. Mean treatment cost was lower for arm B compared with arm A ( P  = 0.02).
CONCLUSIONS


The two-drug CbD regimen yielded pCR, RCB 0+I, and survival rates similar to the four-drug regimen of CbP → AC, but with a more favorable toxicity profile and lower treatment-associated cost.",2021,"Mean treatment cost was lower for Arm-B compared to Arm-A ( P =0.02).
","['Patients aged ≥18 years with stage', 'stage I-III triple-negative breast cancer (NeoSTOP', '100 patients']","['Q14 days X4 (CbP->AC, Arm-A), or to Cb AUC6 + docetaxel(D) Q21 days X6 (CbD, Arm-B', 'carboplatin (Cb) to anthracycline chemotherapy', 'paclitaxel(P) weekly X12 plus Cb AUC6 Q21 days X4 followed by doxorubicin/cyclophosphamide(AC', 'anthracycline-free and anthracycline-containing neoadjuvant carboplatin', 'anthracycline-free and anthracycline-containing neoadjuvant carboplatin chemotherapy regimens', 'carboplatin plus taxane']","['febrile neutropenia', 'pCR, RCB 0+I, and survival rates', 'pCR', 'pCR in breast and axilla', 'Grade 3/4 adverse events', 'event-free and overall survival', 'favorable toxicity profile', 'RCB, toxicity, cost, and event-free and overall survival', 'neutropenia', 'Stromal tumor-infiltrating lymphocytes (sTILs', 'Median sTILs density', 'Mean treatment cost']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301039', 'cui_str': '1-chloro-3-bromopropene-1'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0879615', 'cui_str': 'Stromal tumor'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",100.0,0.162061,"Mean treatment cost was lower for Arm-B compared to Arm-A ( P =0.02).
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas. psharma2@kumc.edu.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Dea"", 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Nye', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Yen Y', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yoder', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Staley', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Prochaska', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Amin', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Larson', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Balanoff', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Manana', 'Initials': 'M', 'LastName': 'Elia', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Crane', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Sheshadri', 'Initials': 'S', 'LastName': 'Madhusudhana', 'Affiliation': 'Department of Internal Medicine, University of Missouri-Kansas City, Kansas City, Missouri.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sheehan', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology, Hays Medical Center, Hays, Kansas.'}, {'ForeName': 'Karissa', 'Initials': 'K', 'LastName': 'Finke', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Rajvi', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Satelli', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Richard & Annette Bloch Cancer Center, Truman Medical Center, Kansas City, Missouri.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Beck', 'Affiliation': 'Tammy Walker Cancer Center, Salina Regional Health Center, Salina, Kansas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McKittrick', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pluenneke', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Raja', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Venkatadri', 'Initials': 'V', 'LastName': 'Beeki', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Corum', 'Affiliation': 'Olathe Cancer Care, Olathe Medical Center, Olathe, Kansas.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Heldstab', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'LaFaver', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Micki', 'Initials': 'M', 'LastName': 'Prager', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Phadnis', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Dinesh Pal', 'Initials': 'DP', 'LastName': 'Mudaranthakam', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Roy A', 'Initials': 'RA', 'LastName': 'Jensen', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salgado', 'Affiliation': 'Division of Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathan', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3646']
673,33211386,Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial.,"OBJECTIVES


To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.
BACKGROUND


CTO crossing remains a challenge during peripheral artery interventions.
METHODS


In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%.
RESULTS


A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%.
CONCLUSIONS


Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.",2021,Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%).,"['Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14', 'patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a', '85 patients', 'peripheral artery chronic total occlusions']","['peripheral artery chronic total occlusion (CTO) crossing catheter', 'Wingman catheter', 'crossing catheter (Wingman, Reflow Medical']","['safety and effectiveness', 'CTO crossing success', 'met¾CTO crossing success', 'ankle-brachial index', 'safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]",85.0,0.0788505,Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%).,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Laird', 'Affiliation': 'Adventist Heart and Vascular Institute, Adventist St. Helena Hospital, St. Helena, California.'}, {'ForeName': 'S Jay', 'Initials': 'SJ', 'LastName': 'Mathews', 'Affiliation': 'Bradenton Cardiology Center, Bradenton, Florida.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Soukas', 'Affiliation': 'Lifespan Cardiovascular Institute, The Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29366']
674,33212487,Impact of surgical treatment of pectus carinatum on cardiopulmonary function: a prospective study.,"OBJECTIVES


The frequency of sternochondroplasty in cases of pectus carinatum (PC) has increased due to greater surgeon experience and modified surgical techniques. PC deformity does not usually cause cardiopulmonary malfunction or impairment. However, whether cardiopulmonary function changes after surgical repair remains a matter of controversy. The aim of our prospective study was to determine if surgery changes preoperative cardiopulmonary function.
METHODS


Nineteen patients (16 males, 3 females) were enrolled in a prospective, open-label, single-arm, single-centre clinical trial (Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Function) (NCT02163265) between July 2013 and January 2017. All patients underwent PC repair via a modified Ravitch procedure and wore a lightweight, patient-controlled chest brace for 8 weeks postoperatively (the Innsbruck protocol). The average follow-up surgical examination was 8.3 months after surgery. In all enrolled patients, before surgery and not before 6 months postoperatively chest X-ray, 3-dimensional volume-rendered computed tomography thorax imaging, cardiopulmonary function tests with stepwise cycle spiroergometry (sitting and supine position) and Doppler echocardiography were performed; questionnaires about daily physical activity were also completed.
RESULTS


Fourteen patients (aged 16.3 ± 2.6 years at study entry) completed the study. Changes in submaximal and peak power output were not detected during sitting, or when in the supine position. Also, no clinically relevant postoperative changes in spirometry or echocardiography were noted.
CONCLUSIONS


Our findings confirm that surgical correction of PC does not impair cardiopulmonary function at rest or during physical exercise.
CLINICAL REGISTRATION NUMBER


clinicaltrials.gov NCT02163265.",2021,"Changes in submaximal and peak power output were not detected during sitting, or when in the supine position.","['Nineteen patients (16 males, 3 females', 'Fourteen patients (aged 16.3\u2009±\u20092.6\u2009years at study entry) completed the study']","['PC repair via a modified Ravitch procedure and wore a lightweight, patient-controlled chest brace', 'pectus carinatum']","['cardiopulmonary function', 'Changes in submaximal and peak power output']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.026703,"Changes in submaximal and peak power output were not detected during sitting, or when in the supine position.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Del Frari', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Sigl', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'Schwabegger', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morawetz', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gassner', 'Affiliation': 'Department of Radiology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schobersberger', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa335']
675,33212231,How effective is periarticular multimodal drug injection in open elbow arthrolysis? A prospective double-blind randomized controlled trial.,"BACKGROUND


Evidence on the efficacy and safety of periarticular multimodal drug injection (PMDI) in open elbow arthrolysis (OEA) is limited. This study aimed to investigate differences in postoperative pain, blood loss, and range of motion (ROM) between PMDI vs. no injection among patients undergoing OEA, and the presence of PMDI-related complications.
METHODS


This prospective, double-blind randomized controlled trial included 59 patients who underwent OEA. Patients randomly received PMDI (ropivacaine, epinephrine, ketoprofen) before wound closure or no injection. The primary outcomes were elbow pain over the first postoperative week at rest and during motion, measured using the visual analog scale (VAS). VAS scores were compared to attain the 20-mm threshold values for a minimum clinically important difference. Parecoxib consumption on OEA night and postoperative days (PODs) 1-3 and total consumption during the first postoperative week were recorded. Blood loss was recorded every 24 hours until POD 3. ROM during rehabilitation was measured daily from day 1 to day 7 after surgery, as well as at 3-month follow-up. Medication-related side effects were recorded prospectively.
RESULTS


The mean VAS score showed clinically important differences between PMDI and control groups at rest on OEA night (mean difference [MD], 25 mm; P < .001) and first 3 PODs with motion (POD 1: MD, 28 mm, P < .001; POD 2: MD, 21 mm, P < .001; POD 3: MD, 21 mm, P < .001) but not in other postoperative assessments. Parecoxib consumption was lower in the PMDI group on OEA night and PODs 1-3. Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. the control group (MD, 148 mg; P < .001). Blood drainage was less in the PMDI group vs. the control group on POD 1 (MD, 38 mL; P = .016) but not on POD 2 (P = .950), POD 3 (P = .259), or total (P = .184). The PMDI group exhibited significantly better ROM during the first 4 PODs than the control group, whereas there was no difference at 3-month follow-up. No medication-related side effects were noted in the PMDI group.
CONCLUSION


PMDI effectively relieves pain and reduces analgesic consumption for OEA patients, without an apparent increase in risks.",2020,"Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. control group (MD, 148 mg; p<0.001).","['patients undergoing OEA, and the presence of PMDI-related complications', '59 patients who underwent OEA']","['Parecoxib', 'PMDI (ropivacaine, epinephrine, ketoprofen) prior to wound closure or no injection', 'periarticular multimodal drug injection (PMDI']","['Blood loss', 'Parecoxib consumption', 'Blood drainage', 'elbow pain over the first postoperative week at rest and during motion, measured using the visual analog scale (VAS', 'ROM', 'postoperative pain, blood loss and range of motion (ROM', 'side effects', 'Total parecoxib consumption', 'pain and reduces analgesic consumption', 'VAS scores', 'mean VAS score', 'OEA night and postoperative day (POD)1-3 and total consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0239266', 'cui_str': 'Pain in elbow'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",59.0,0.311479,"Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. control group (MD, 148 mg; p<0.001).","[{'ForeName': 'Ziyang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Juehong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Weixuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Cunyi', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. Electronic address: cyfan@sjtu.edu.cn.""}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.10.012']
676,33208010,Re: Cryoanalgesic versus EMLA® cream to reduce pain during analgesic injection in upper eyelid surgery: a randomized trial.,,2021,,['upper eyelid surgery'],['EMLA® cream'],['pain'],"[{'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0943688,,"[{'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Sweety Girijashankar', 'Initials': 'SG', 'LastName': 'Tiple', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1846762']
677,33223285,Celiprolol Treatment in Patients with Vascular Ehlers-Danlos Syndrome.,"OBJECTIVE


Vascular Ehlers-Danlos syndrome (vEDS) is a rare monogenetic disease caused by pathogenic variants in procollagen 3A1. Arterial rupture is the most serious clinical manifestation. A randomised controlled trial, the Beta-Blockers in Ehlers-Danlos Syndrome Treatment (BBEST) trial, reported a significant protective effect of the beta blocker celiprolol. The aim was to study the outcome of celiprolol treatment in a cohort of Swedish patients with vEDS.
METHODS


Uppsala is a national referral centre for patients with vEDS. They are assessed by vascular surgeons, angiologists, and clinical geneticists. Family history, previous and future clinical events, medication, and side effects are registered. Celiprolol was administered twice daily and titrated up to a maximum dose of 400 mg daily. Logistic regression was used to analyse predictors of vascular events.
RESULTS


Forty patients with pathogenic sequence variants in COL3A1 were offered treatment with celiprolol in the period 2011-2019. The median follow up was 22 months (range 1-98 months); total follow up was 106 patient years. In two patients, uptitration of the dose is ongoing. Of the remaining 38, 26 (65%) patients reached the target dose of 400 mg daily. Dose uptitration was unsuccessful in six patients because of side effects; one died before reaching the maximum dose, and five terminated the treatment. Five major vascular events occurred; four were fatal (ruptured ascending aorta; aortic rupture after type B dissection; ruptured cerebral aneurysm; and ruptured pulmonary artery). One bled from a branch of the internal iliac artery, which was successfully coiled endovascularly. The annual risk of a major vascular event was 4.7% (n = 5/106), similar to the treatment arm of the BBEST trial (5%) and lower than in the control arm of the same trial (12%). No significant predictor of vascular events was identified.
CONCLUSION


Treatment with celiprolol is tolerated in most patients with vEDS. Despite fatal vascular events, these observations suggest that celiprolol may have a protective effect in vEDS.",2021,"The annual risk of a major vascular event was 4.7% (n = 5/106), similar to the treatment arm of the BBEST trial (5%) and lower than in the control arm of the same trial (12%).","['Uppsala is a national referral centre for patients with vEDS', 'patients with vEDS', 'cohort of Swedish patients with vEDS', 'Patients with Vascular Ehlers-Danlos Syndrome', 'Forty patients with pathogenic sequence variants in COL3A1']","['celiprolol', 'Celiprolol Treatment', 'Beta-Blockers', 'Celiprolol']","['vascular events', 'aortic rupture', 'annual risk of a major vascular event']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0055021', 'cui_str': 'Celiprolol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0003496', 'cui_str': 'Aortic rupture'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",40.0,0.113829,"The annual risk of a major vascular event was 4.7% (n = 5/106), similar to the treatment arm of the BBEST trial (5%) and lower than in the control arm of the same trial (12%).","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Baderkhan', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala, Sweden. Electronic address: baderkhan.hassan@surgsci.uu.se.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wanhainen', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stenborg', 'Affiliation': 'Department of Medical Sciences, Uppsala, Sweden.'}, {'ForeName': 'Eva-Lena', 'Initials': 'EL', 'LastName': 'Stattin', 'Affiliation': 'Department of Clinical Genetics, all Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Björck', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala, Sweden.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.10.020']
678,33217124,"Our reaction on the comment of Yosiko Myoken et al. on 'The effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene: A Randomized Controlled Trial by Scheerman et al.'",,2021,"commented on our article about the effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene  2  .",[],"['mobile application (""WhiteTeeth']",['oral hygiene'],[],"[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",,0.0207079,"commented on our article about the effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene  2  .","[{'ForeName': 'Janneke F M', 'Initials': 'JFM', 'LastName': 'Scheerman', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Berno', 'Initials': 'B', 'LastName': 'van Meijel', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van Empelen', 'Affiliation': 'TNO Research Group, Leiden, The Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cor', 'Initials': 'C', 'LastName': 'van Loveren', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'VU Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Matheus C T', 'Initials': 'MCT', 'LastName': 'van den Braak', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gem J C', 'Initials': 'GJC', 'LastName': 'Kramer', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}]",International journal of dental hygiene,['10.1111/idh.12482']
679,33220095,Acute metabolic effects of melatonin-A randomized crossover study in healthy young men.,"Melatonin regulates circadian rhythm, but may also have effects on glucose homeostasis. A common G-allele in the MTNR1B locus has been associated with an increased risk of type 2 diabetes (T2DM). We aimed to examine acute effects of high doses of melatonin on glucose metabolism with attention to MTNR1B genotype. Twenty men were examined in a double-blinded, randomized crossover study on two nonconsecutive days with four doses of 10 mg oral melatonin or placebo. Insulin sensitivity and insulin secretion were assessed by an intravenous glucose tolerance test (IVGTT) and a hyperinsulinaemic-euglycaemic clamp (HEC). Blood samples were drawn to determine the metabolic profile and MTNR1B rs10830963 genotype. Indirect calorimetry and blood pressure measurements were also performed. Insulin sensitivity index was significantly reduced on the melatonin day (P = .028) in the whole group and in homozygous carriers of the rs10830963 C-allele (P = .041). Glucose during the IVGTT was unaffected, but there was a tendency towards lower insulin and C-peptide levels in the first minutes after glucose administration in G-allele carriers. Systolic blood pressure decreased and lipid oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers. Overall, our study reports that acute administration of melatonin in supra-physiological doses may have a negative impact on insulin sensitivity. Clinical trial registration number (clinicaltrial.gov): NCT03204877.",2021,Systolic blood pressure decreased and lipid-oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers.,"['Twenty men', 'healthy young men']","['melatonin', 'hyperinsulinemic euglycemic clamp (HEC', 'Melatonin', 'melatonin or placebo']","['Systolic blood pressure decreased and lipid-oxidation', 'Indirect calorimetry and blood pressure measurements', 'Insulin sensitivity and insulin secretion', 'lower insulin and C-peptide levels', 'Insulin sensitivity index', 'Glucose', 'Acute metabolic effects']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",20.0,0.345836,Systolic blood pressure decreased and lipid-oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben S', 'Initials': 'ES', 'LastName': 'Lauritzen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Grarup', 'Affiliation': 'Faculty of Health and Medical Sciences, Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Faculty of Health and Medical Sciences, Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of pineal research,['10.1111/jpi.12706']
680,33225464,Randomised clinical study of plaque removal efficacy of an electric toothbrush in primary and mixed dentition.,"BACKGROUND


Clinical investigations of electric toothbrushes in young children are limited.
AIM


To assess plaque reduction efficacy of an oscillating-rotating electric versus manual toothbrush in a paediatric population in primary and mixed dentitions.
DESIGN


In this randomised, single-brushing, 2-treatment, 4-period, replicate-use crossover study, subjects were divided into 2 age groups (3-6 years; 7-9 years) and assigned to a treatment sequence involving an Oral-B Kids electric brush and a manual brush control. Plaque was assessed pre- and post-brushing (Turesky Modified Quigley-Hein Plaque Index). Parents brushed the teeth of their children aged 3-6 years, whereas children aged 7-9 years brushed their own teeth under supervision. Plaque removal scores were analysed for brush differences in each age group separately using an analysis of covariance for crossover design.
RESULTS


Forty-one children (n = 20, 3-6 years; n = 21, 7-9 years) completed the study. For the primary dentition in children 3-6 years, the electric brush reduced 32.3% more plaque than the manual brush (P = .005). For the mixed dentition in children 7-9 years, the electric brush reduced 51.9% more plaque than the manual brush (P < .001).
CONCLUSIONS


An electric toothbrush reduced significantly more plaque than a manual toothbrush in 2 paediatric age groups.",2020,"For the primary dentition in children 3-6 years, the electric brush reduced 32.3% more plaque than the manual brush (P = 0.005).","['paediatric population in primary and mixed dentitions', 'Forty-one children (n = 20, 3-6 years; n = 21, 7-9 years) completed the study', 'young children', 'primary and mixed dentition', 'Parents brushed the teeth of their children aged 3-6 years, while children aged 7-9 years brushed their own teeth under supervision']","['oscillating-rotating electric versus manual toothbrush', 'electric toothbrush', 'Oral-B Kids electric brush and a manual brush control', 'electric toothbrushes']","['plaque reduction efficacy', 'Plaque removal scores']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011444', 'cui_str': 'Mixed dentition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0307255,"For the primary dentition in children 3-6 years, the electric brush reduced 32.3% more plaque than the manual brush (P = 0.005).","[{'ForeName': 'Esti', 'Initials': 'E', 'LastName': 'Davidovich', 'Affiliation': 'Faculty of Dental Medicine, Hebrew University & Hadassah, Jerusalem, Israel.'}, {'ForeName': 'Renzo A', 'Initials': 'RA', 'LastName': 'Ccahuana-Vasquez', 'Affiliation': 'Procter & Gamble Service GmbH, Kronberg, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Timm', 'Affiliation': 'Procter & Gamble Service GmbH, Kronberg, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grender', 'Affiliation': 'Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Zini', 'Affiliation': 'Faculty of Dental Medicine, Hebrew University & Hadassah, Jerusalem, Israel.'}]",International journal of paediatric dentistry,['10.1111/ipd.12753']
681,33220568,Comparison of health service use trajectories of residential aged care residents reviewed by a hospital avoidance program versus usual care.,"OBJECTIVE


To compare health service use trajectories of residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care.
METHODS


A retrospective group-based trajectory analysis of RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted. Health service use trajectories were followed for two years to 30 June 2018 and compared to RACF residents aged ≥65 years who lived in the same Local Health District and received usual care.
RESULTS


There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16. Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups. Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents. Additionally, gender predicted group membership in ARRT-reviewed RACF residents and fall-related injuries predicted group membership in usual care RACF residents.
CONCLUSION


The identification of health service use trajectories assists in understanding hospital use by older RACF residents and may offer guidance in the design of prevention measures, including hospital avoidance programs.",2021,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","['residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care', 'Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents', 'residential aged care residents', 'RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted', 'residents aged ≥65 years who lived in the same Local Health District and received usual care', 'Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups', 'There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16', 'older RACF residents']","['RACF', 'hospital avoidance program versus usual care']",[],"[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C2718033', 'cui_str': 'Hospital Medical Emergency Team'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0135492,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia. Electronic address: luke.testa@mq.edu.au.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Hardy', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia; The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Jepson', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Braithwaite', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Mitchell', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104293']
682,33217618,End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To report the end-of-study results from the Ladder clinical trial of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
DESIGN


Multicenter, randomized, active treatment-controlled phase 2 clinical trial.
PARTICIPANTS


Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220).
METHODS


Patients were randomized 3:3:3:2 to treatment with the PDS filled with ranibizumab 10-mg/ml, 40-mg/ml, and 100-mg/ml formulations or monthly intravitreal ranibizumab 0.5-mg injections.
MAIN OUTCOME MEASURES


End-of-study results for the time to first meeting refill criteria (first refill), mean change from baseline for best-corrected visual acuity (BCVA) and central foveal thickness (CFT), and safety.
RESULTS


At study end, the mean time on study was 22.1 months (range, 10.8-37.6 months) for all PDS patients. Median time to first refill was 8.7 months, 13.0 months, and 15.8 months, and 28.9%, 56.0%, and 59.4% of patients went 12 months or longer without meeting refill criteria in the PDS 10-mg/ml, 40-mg/ml, and 100-mg/ml treatment arms, respectively. At month 22, the observed mean BCVA change from baseline was ‒4.6 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, ‒2.3 ETDRS letters, +2.9 ETDRS letters, and +2.7 ETDRS letters in the PDS 10-mg/ml, 40-mg/ml, 100-mg/ml, and monthly intravitreal ranibizumab 0.5-mg treatment arms, respectively. At month 22, the observed mean CFT change from baseline was similar in the PDS 100-mg/ml and monthly intravitreal ranibizumab 0.5-mg treatment arms. No new safety signals were detected during the additional follow-up.
CONCLUSIONS


Over a mean of 22 months on study, vision and anatomic outcomes were comparable between the PDS 100-mg/ml and monthly intravitreal ranibizumab 0.5-mg arms, with a lower total number of ranibizumab treatments with the PDS. The Ladder end-of-study findings were consistent with the primary analysis, and the PDS generally was well tolerated throughout the entire study period. The PDS has the potential to reduce treatment burden in patients with nAMD while maintaining vision.",2020,"No new safety signals were detected during the additional follow-up.
","['neovascular age-related macular degeneration (nAMD', 'Patients', 'patients with nAMD while maintaining vision', 'Neovascular Age-Related Macular Degeneration', 'Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220']","['Ranibizumab', 'ranibizumab (PDS', 'PDS filled with ranibizumab 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations or monthly intravitreal ranibizumab 0.5 mg injections', 'ranibizumab']","['time to first meeting refill criteria (first refill), mean change from baseline for best-corrected visual acuity (BCVA) and central foveal thickness (CFT), and safety', 'new safety signals', 'vision and anatomic outcomes', 'mean CFT change', 'Median time to first refill', 'observed mean BCVA change']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C1724107', 'cui_str': 'ranibizumab 10 MG/ML'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",220.0,0.131031,"No new safety signals were detected during the additional follow-up.
","[{'ForeName': 'Arshad M', 'Initials': 'AM', 'LastName': 'Khanani', 'Affiliation': 'Sierra Eye Associates and the Reno School of Medicine, University of Nevada, Reno, Nevada. Electronic address: arshad.khanani@gmail.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Texas Retina Associates, Arlington, Texas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dreyer', 'Affiliation': 'Retina Northwest, Portland, Oregon, and Baylor University, Waco, Texas.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Orange County Retina, Santa Ana, California.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Howard', 'Affiliation': 'Retina Associates of Utah and the Department of Ophthalmology and Visual Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'J Jill', 'Initials': 'JJ', 'LastName': 'Hopkins', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Chin-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Lorenz-Candlin', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Makadia', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shienal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Tam', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.11.004']
683,33222767,"Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


There is an unmet need to develop therapeutic interventions directed at the neurodegeneration that underlies progression in multiple sclerosis. High-dose, pharmaceutical-grade biotin (MD1003) might enhance neuronal and oligodendrocyte energetics, resulting in improved cell function, repair, or survival. The MS-SPI randomised, double-blind, placebo-controlled study found that MD1003 improved disability outcomes over 12 months in patients with progressive multiple sclerosis. The SPI2 study was designed to assess the safety and efficacy of MD1003 in progressive forms of multiple sclerosis in a larger, more representative patient cohort.
METHODS


SPI2 was a randomised, double-blind, parallel-group, placebo-controlled trial done at 90 academic and community multiple sclerosis clinics across 13 countries. Patients were aged 18-65 years, had a diagnosis of primary or secondary progressive multiple sclerosis fulfilling the revised International Panel criteria and Lublin criteria, a Kurtzke pyramidal functional subscore of at least 2 (defined as minimal disability), an expanded disability status scale (EDSS) score of 3·5-6·5, a timed 25-foot walk (TW25) of less than 40 s, evidence of clinical disability progression, and no relapses in the 2 years before enrolment. Concomitant disease-modifying therapies were allowed. Patients were randomly assigned (1:1) by an independent statistician using an interactive web response system, with stratification by study site and disease history, to receive MD1003 (oral biotin 100 mg three times daily) or placebo. Participants, investigators, and assessors were masked to treatment assignment. The primary endpoint was a composite of the proportion of participants with confirmed improvement in EDSS or TW25 at month 12, confirmed at month 15, versus baseline. The primary endpoint was assessed in the intention-to-treat analysis set, after all participants completed the month 15 visit. Safety analyses included all participants who received at least one dose of MD1003. This trial is registered with ClinicalTrials.gov (NCT02936037) and the EudraCT database (2016-000700-29).
FINDINGS


From Feb 22, 2017, to June 8, 2018, 642 participants were randomly assigned MD1003 (n=326) or placebo (n=316). The double-blind, placebo-controlled phase of the study ended when the primary endpoint for the last-entered participant was assessed on Nov 15, 2019. The mean time in the placebo-controlled phase was 20·1 months (SD 5·3; range 15-27). For the primary outcome, 39 (12%) of 326 patients in the MD1003 group compared with 29 (9%) of 316 in the placebo group improved at month 12, with confirmation at month 15 (odds ratio 1·35 [95% CI 0·81-2·26]). Treatment-emergent adverse events occurred in 277 (84%) of 331 participants in the MD1003 group and in 264 (85%) of 311 in the placebo group. 87 (26%) of 331 participants in the MD1003 group and 82 (26%) of 311 participants in the placebo group had at least one serious treatment-emergent adverse event. One (<1%) person died in the MD1003 group and there were no deaths in the placebo group. Despite use of mitigation strategies, MD1003 led to inaccurate laboratory results for tests using biotinylated antibodies.
INTERPRETATION


This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
FUNDING


MedDay Pharmaceuticals.",2020,"This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
","['patients with progressive multiple sclerosis (SPI2', '90 academic and community multiple sclerosis clinics across 13 countries', 'participants who received at least one dose of MD1003', '2016-000700-29).\nFINDINGS\n\n\nFrom Feb 22, 2017, to June 8, 2018, 642 participants were randomly assigned MD1003 (n=326) or', 'Patients were aged 18-65 years, had a diagnosis of primary or secondary progressive multiple sclerosis fulfilling the revised International Panel criteria and Lublin criteria, a Kurtzke pyramidal functional subscore of at least 2 (defined as minimal disability), an expanded disability status scale (EDSS) score of 3·5-6·5, a timed 25-foot walk (TW25) of less than 40 s, evidence of clinical disability progression, and no relapses in the 2 years before enrolment', 'patients with progressive multiple sclerosis', '87 (26%) of 331 participants in the MD1003 group and']","['placebo', 'MD1003', 'MD1003 (high-dose biotin', 'MD1003 (oral biotin 100 mg three times daily) or placebo', 'EudraCT database']","['disability or walking speed', 'intention-to-treat analysis set', 'serious treatment-emergent adverse event', 'Treatment-emergent adverse events', 'safety and efficacy', 'composite of the proportion of participants with confirmed improvement in EDSS or TW25', 'cell function, repair, or survival', 'mean time', 'Safety and efficacy', 'disability outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",642.0,0.697256,"This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
","[{'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'University of Alabama, School of Public Health, Birmingham, AL, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Institute of Experimental Neurology, IRCCS San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, London, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Block', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Frederick E', 'Initials': 'FE', 'LastName': 'Munschauer', 'Affiliation': 'MedDay Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Sedel', 'Affiliation': 'MedDay Pharmaceuticals, Paris, France.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30347-1']
684,33217362,"Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.","BACKGROUND


With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity.
METHODS


In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China. Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded. The experimental vaccine for the phase 1 trial was manufactured using a cell factory process (CellSTACK Cell Culture Chamber 10, Corning, Wujiang, China), whereas those for the phase 2 trial were produced through a bioreactor process (ReadyToProcess WAVE 25, GE, Umea, Sweden). The phase 1 trial was done in a dose-escalating manner. At screening, participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants were assigned to block 1 (low dose CoronaVac [3 μg per 0·5 mL of aluminium hydroxide diluent per dose) then another 36 were assigned to block 2 (high-dose Coronavc [6 μg per 0·5 mL of aluminium hydroxide diluent per dse]). Within each block, participants were randomly assigned (2:1), using block randomisation with a block size of six, to either two doses of CoronaVac or two doses of placebo. In the phase 2 trial, at screening, participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants were randomly assigned (2:2:1), using block randomisation with a block size of five, to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. Participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after injection in all participants who were given at least one dose of study drug (safety population). The primary immunogenic outcome was seroconversion rates of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 cohort, and at day 28 after the last dose in the days 0 and 28 cohort in participants who completed their allocated two-dose vaccination schedule (per-protocol population). This trial is registered with ClinicalTrials.gov, NCT04352608, and is closed to accrual.
FINDINGS


Between April 16 and April 25, 2020, 144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial. 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population). In the phase 1 trial, the incidence of adverse reactions for the days 0 and 14 cohort was seven (29%) of 24 participants in the 3 ug group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group, and for the days 0 and 28 cohort was three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group. The seroconversion of neutralising antibodies on day 14 after the days 0 and 14 vaccination schedule was seen in 11 (46%) of 24 participants in the 3 μg group, 12 (50%) of 24 in the 6 μg group, and none (0%) of 24 in the placebo group; whereas at day 28 after the days 0 and 28 vaccination schedule, seroconversion was seen in 20 (83%) of 24 in the 3 μg group, 19 (79%) of 24 in the 6 μg group, and one (4%) of 24 in the placebo group. In the phase 2 trial, the incidence of adverse reactions for the days 0 and 14 cohort was 40 (33%) of 120 participants in the 3 μg group, 42 (35%) of 120 in the 6 μg group, and 13 (22%) of 60 in the placebo group, and for the days 0 and 28 cohort was 23 (19%) of 120 in the 3 μg group, 23 (19%) of 120 in the 6 μg group, and 11 (18%) of 60 for the placebo group. Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
INTERPRETATION


Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.
FUNDING


Chinese National Key Research and Development Program and Beijing Science and Technology Program.",2021,"Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
","['Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded', 'healthy adults aged 18-59 years', '144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial', '743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population', 'healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China', 'Between April 16 and April 25, 2020', 'participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants', 'participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants']","['low-dose CoronaVac, high-dose CoronaVac, or placebo', 'placebo', 'inactivated SARS-CoV-2 vaccine', 'aluminium hydroxide diluent per dose', 'aluminium hydroxide', 'block 1 (low dose CoronaVac [3 μg per 0·5']","['Safety, tolerability, and immunogenicity', 'seroconversion rates of neutralising antibodies to live SARS-CoV-2', 'seroconversion of neutralising antibodies', 'Seroconversion of neutralising antibodies', 'incidence of adverse reactions', 'adverse reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",144.0,0.639885,"Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
","[{'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Weixiao', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Congbing', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Minnan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Infection and Immunity, National Laboratory of Macromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Xiangxi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'CAS Key Laboratory of Infection and Immunity, National Laboratory of Macromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Sinovac Life Sciences, Beijing, China. Electronic address: gaoq@sinovac.com.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30843-4']
685,32690730,Identifying significant contributors for smoking cessation among male prisoners in Australia: results from a randomised clinical trial.,"INTRODUCTION


In Australia, an estimated 90% of those entering prison are current tobacco smokers and three-quarters of current prisoners are tobacco smokers.
AIMS


To identify factors and their relative contributions to smoking cessation among male prisoners.
METHODS


A total of 425 male tobacco smokers with a median age of 32 years in Australian prisons. The primary outcome was continuous abstinence at 3, 6 and 12 months. We measured various sociodemographic characteristics, drug use, psychological distress and the mental and physical health status of the participants. Multivariate logistic regression models and population attributable risks (PAR%) were used to identify the significant factors and their contributions to smoking cessation rates.
RESULTS


The median age of participants was 32 years (IQR 25-41 years). High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
CONCLUSION


Our study suggests that not using drugs and being in good mental/physical health are the important contributors to continuous abstinence among prisoners. Thus, effective smoking cessation programmes require a multicomponent approach that includes addressing drug problems and mental health functioning.
TRIAL REGISTRATION NUMBER


12606000229572.",2020,"High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
","['425 male tobacco smokers with a median age of 32 years in Australian prisons', 'male prisoners', 'male prisoners in Australia']",[],"['psychological distress, good mental health scores and better physical health', 'continuous abstinence', 'High smoking cessation rates', 'various sociodemographic characteristics, drug use, psychological distress and the mental and physical health status']","[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",425.0,0.0559297,"High smoking cessation rates were collectively associated with not using drugs, lower psychological distress, good mental health scores and better physical health (PAR%: 93%, 98% and 88% at 3, 6 and 12 months).
","[{'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Wand', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richmond', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Armita', 'Initials': 'A', 'LastName': 'Adily', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Le', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Wilhelm', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney, Australila.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Butler', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia tbutler@kirby.unsw.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034046']
686,33220488,Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model.,"BACKGROUND


The treatment of suicidal patients often suffers owing to a lack of integrated care and standardized approaches for identifying and reducing risk. The National Strategy for Suicide Prevention endorsed the Zero Suicide (ZS) model, a multi-component, system-wide approach to identify, engage, and treat suicidal patients. The ZS model is a framework for suicide prevention in healthcare systems with the aspirational goal of eliminating suicide in healthcare. While the approach is widely endorsed, it has yet to be evaluated in a systematic manner. This trial evaluates two ZS implementation strategies statewide in specialty mental health clinics.
METHODS/STUDY DESIGN


This trial is the first large-scale implementation of the ZS model in mental health clinics using the Assess, Intervene, and Monitor for Suicide Prevention (A-I-M) clinical model. Using a hybrid effectiveness-implementation type 1 design, we are testing the effectiveness of ZS implementation in 186 mental health clinics in 95 agencies in New York State. Agencies are randomly assigned to either: ""Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives; enhanced consultation for site champions). Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
DISCUSSION


This project has the potential to have a significant public health impact by determining the effectiveness of the ZS model in mental health clinics, a setting where suicide attempts and suicides occur at a higher rate than any other healthcare setting. It will also provide guidance on the implementation level required to achieve uptake and sustainability of ZS.
TRIAL REGISTRATION


N/A.",2021,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","['186 mental health clinics in 95 agencies in New York State', 'suicidal patients', 'specialty mental health clinics']","['Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives', 'ZS implementation']","['suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation']","[{'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",186.0,0.0632626,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Christa D', 'Initials': 'CD', 'LastName': 'Labouliere', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Hanga C', 'Initials': 'HC', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Molly T', 'Initials': 'MT', 'LastName': 'Finnerty', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Prabu', 'Initials': 'P', 'LastName': 'Vasan', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Anni Kramer', 'Initials': 'AK', 'LastName': 'Cummings', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Wainberg', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Carruthers', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Dixon', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106224']
687,33227408,Adjuvant chemotherapy is superior to chemoradiation after D2 surgery for gastric cancer in the per-protocol analysis of the randomized CRITICS trial.,"BACKGROUND


The Intergroup 0116 and the MAGIC trials changed clinical practice for resectable gastric cancer in the Western world. In these trials, overall survival improved with post-operative chemoradiotherapy (CRT) and perioperative chemotherapy (CT). Intention-to-treat analysis in the CRITICS trial of post-operative CT or post-operative CRT did not show a survival difference. The current study reports on the per-protocol (PP) analysis of the CRITICS trial.
PATIENTS AND METHODS


The CRITICS trial was a randomized, controlled trial in which 788 patients with stage Ib-Iva resectable gastric or esophagogastric adenocarcinoma were included. Before start of preoperative CT, patients from the Netherlands, Sweden and Denmark were randomly assigned to receive post-operative CT or CRT. For the current analysis, only patients who started their allocated post-operative treatment were included. Since it is uncertain that the two treatment arms are balanced in such PP analysis, adjusted proportional hazards regression analysis and inverse probability weighted analysis were used to minimize the risk of selection bias and to estimate and compare overall and event-free survival.
RESULTS


Of the 788 patients, 478 started post-operative treatment according to protocol, 233 (59%) patients in the CT group and 245 (62%) patients in the CRT group. Patient and tumor characteristics between the groups before start of the post-operative treatment were not different. After a median follow-up of 6.7 years since the start of post-operative treatment, the 5-year overall survival was 57.9% (95% confidence interval: 51.4% to 64.3%) in the CT group versus 45.5% (95% confidence interval: 39.2% to 51.8%) in the CRT group (adjusted hazard ratio CRT versus CT: 1.62 (1.24-2.12), P = 0.0004). Inverse probability weighted analysis resulted in similar hazard ratios.
CONCLUSION


After adjustment for all known confounding factors, the PP analysis of patients who started the allocated post-operative treatment in the CRITICS trial showed that the CT group had a significantly better 5-year overall survival than the CRT group (NCT00407186).",2021,Patient and tumor characteristics between the groups before start of the postoperative treatment were not different.,"['patients from the Netherlands, Sweden, and Denmark', '788 patients', 'resectable gastric cancer in the Western world', '788 patients with stage Ib-IVa resectable gastric or esophagogastric adenocarcinoma were included']","['Adjuvant chemotherapy', 'postoperative chemoradiotherapy and perioperative chemotherapy', 'postoperative CT or CRT', 'postoperative chemotherapy (CT) or postoperative chemoradiotherapy']","['5-year overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0376556', 'cui_str': 'Western World'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",788.0,0.316095,Patient and tumor characteristics between the groups before start of the postoperative treatment were not different.,"[{'ForeName': 'W O', 'Initials': 'WO', 'LastName': 'de Steur', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'van Amelsfoort', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Hartgrink', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Meershoek-Klein Kranenbarg', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'N C T', 'Initials': 'NCT', 'LastName': 'van Grieken', 'Affiliation': 'Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'van Sandick', 'Affiliation': 'Department of Surgical Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Y H M', 'Initials': 'YHM', 'LastName': 'Claassen', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J P B M', 'Initials': 'JPBM', 'LastName': 'Braak', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'E P M', 'Initials': 'EPM', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biometrics, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biometrics, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands; Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nordsmark', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Centers (UMC), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'H W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centers (UMC), University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cats', 'Affiliation': 'Department of Gastrointestinal Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Verheij', 'Affiliation': 'Department of Radiation Oncology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'C J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgical Oncology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: C.J.H.van_de_Velde@lumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.11.004']
688,33229200,The importance of glycemic index on post-prandial glycaemia in the context of mixed meals: A randomized controlled trial on pasta and rice.,"BACKGROUND AND AIMS


Post-prandial glycemic response (PPGR) depends on the intrinsic characteristic of the carbohydrate-rich foods as well as on the amount and type of other nutrients. This study aimed to explore whether the addition of condiments can affect the difference in PPGR between a low and a medium-high Glycemic Index (GI) food.
METHODS AND RESULTS


Spaghetti (S) and rice ® were consumed plain and after adding tomato sauce and extra virgin olive oil (TEVOO), or pesto sauce (P). The GI of R (63 ± 3) was statistically higher than that of S (44 ± 7) (p = 0.003). The Incremental Area Under the Curve (IAUC) for R was significantly greater than S (124.2 ± 12.1 and 82.1 ± 12.9 mmol∗min/L respectively) (p = 0.016) for blood glucose but not for insulin (1192.6 ± 183.6 and 905.2 ± 208.9 mU∗min/L, respectively) (p = 0.076). There were no significant differences after the addition of either TEVOO or P. The postprandial peaks of blood glucose and insulin for R (6.7 ± 0.3 mmol/L and 36.4 ± 4.9 mU/L, respectively) were significantly higher compared to S (6.0 ± 0.2 mmol/L and 26.7 ± 3.6 mU/L, respectively) (p = 0.033 and p = 0.025). The postprandial peak for insulin remained significantly higher with P (36.8 ± 3.7 and 28.6 ± 2.9 mU/L for R + P and S + P, p = 0.045) but not with EVOO (p = 0.963). Postprandial peaks for blood glucose were not significantly different with condiment.
CONCLUSIONS


The differences in PPGR were significant between spaghetti and rice consumed plain, they reduced or disappeared with fat adding, depending on the type of condiment used. REGISTRATION NUMBER: (www.clinicaltrial.gov):NCT03104712.",2021,The GI of R (63 ± 3) was statistically higher than that of S (44 ± 7) (p = 0.003).,[],"['Spaghetti (S) and rice ® were consumed plain and after adding tomato sauce and extra virgin olive oil (TEVOO), or pesto sauce (P']","['PPGR', 'Postprandial peaks for blood glucose', 'Incremental Area Under the Curve (IAUC) for R', 'blood glucose', 'postprandial peak for insulin', 'postprandial peaks of blood glucose and insulin for R']",[],"[{'cui': 'C0452698', 'cui_str': 'Spaghetti'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0453373', 'cui_str': 'Tomato sauce'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.0893824,The GI of R (63 ± 3) was statistically higher than that of S (44 ± 7) (p = 0.003).,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Chiavaroli', 'Affiliation': ""Department of Food and Drugs, University of Parma, Parma, 43125, Italy; Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Toronto, ON, M5C 2T2, Canada; Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5C 2T2, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Pede', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': ""Dall'Asta"", 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy; Department of Animal Science, Food and Nutrition, Università Cattolica del Sacro Cuore, 29122, Piacenza, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cossu', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Francinelli', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Goldoni', 'Affiliation': 'Medical Statistics, Department of Medicine and Surgery, University of Parma, Parma, 43126, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy. Electronic address: francesca.scazzina@unipr.it.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Department of Food and Drugs, University of Parma, Parma, 43125, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.09.025']
689,32690738,Risk assessment and antibiotic prescribing decisions in children presenting to UK primary care with cough: a vignette study.,"OBJECTIVES


The validated 'STARWAVe' (Short illness duration, Temperature, Age, Recession, Wheeze, Asthma, Vomiting) clinical prediction rule (CPR) uses seven variables to guide risk assessment and antimicrobial stewardship in children presenting with cough. We aimed to compare general practitioners' (GPs) risk assessments and prescribing decisions to those of STARWAVe and assess the influence of the CPR's clinical variables.
SETTING


Primary care.
PARTICIPANTS


252 GPs, currently practising in the UK.
DESIGN


GPs were randomly assigned to view four (of a possible eight) clinical vignettes online. Each vignette depicted a child presenting with cough, who was described in terms of the seven STARWAVe variables. Systematically, we manipulated patient age (20 months vs 5 years), illness duration (3 vs 6 days), vomiting (present vs absent) and wheeze (present vs absent), holding the remaining STARWAVe variables constant.
OUTCOME MEASURES


Per vignette, GPs assessed risk of hospitalisation and indicated whether they would prescribe antibiotics or not.
RESULTS


GPs overestimated risk of hospitalisation in 9% of vignette presentations (88/1008) and underestimated it in 46% (459/1008). Despite underestimating risk, they overprescribed: 78% of prescriptions were unnecessary relative to GPs' own risk assessments (121/156), while 83% were unnecessary relative to STARWAVe risk assessments (130/156). All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
CONCLUSIONS


Relative to STARWAVe, GPs underestimated risk of hospitalisation, overprescribed and appeared to misinterpret illness duration (prescribing for longer rather than shorter illnesses). It is important to ascertain discrepancies between CPRs and current clinical practice. This has implications for the integration of CPRs into the electronic health record and the provision of intelligible explanations to decision-makers.",2020,"All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
","['children presenting with cough', '252 GPs, currently practising in the UK', 'children presenting to UK primary care with cough']",[],"['illness duration', 'vomiting', 'risk of hospitalisation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",252.0,0.0689741,"All four of the manipulated variables influenced risk assessments, but only three influenced prescribing decisions: a shorter illness duration reduced prescribing odds (OR 0.14, 95% CI 0.08 to 0.27, p<0.001), while vomiting and wheeze increased them (OR vomit  2.17, 95% CI 1.32 to 3.57, p=0.002; OR wheeze  8.98, 95% CI 4.99 to 16.15, p<0.001).
","[{'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Nurek', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK m.nurek@imperial.ac.uk.'}, {'ForeName': 'Brendan C', 'Initials': 'BC', 'LastName': 'Delaney', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kostopoulou', 'Affiliation': 'Surgery and Cancer, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035761']
690,33227793,Preceding T-Cell-Mediated Rejection Is Associated with the Development of Chronic Active Antibody-Mediated Rejection by de Novo Donor-Specific Antibody.,"AIM


Chronic active antibody-mediated rejection (CAABMR) is an important cause of late-stage renal allograft loss. Early inflammatory events such as acute rejection and infection after transplantation are considered to be the risk factors of de novo donor-specific antibody (dnDSA) production. In this study, we investigated the relationship between pre-disposing T-cell-mediated rejection and dnDSA-positive CAABMR.
METHODS


We recruited 365 patients who underwent ABO-compatible renal transplantation at our hospital. Among them, 16 patients diagnosed as having dnDSA-positive CAABMR were designated as a CAABMR group, and 38 randomly selected patients were designated as a control group. All biopsies from 1 month after transplantation were included in the study. The presence or absence of borderline changes (BLCs), acute T-cell-mediated rejection (ATMR), microvascular inflammation (MVI), and C4d positive on peritubular capillaries (C4d-P) was examined.
RESULTS


In the CAABMR group, BLC/ATMR was found in 12 cases (75%), and the mean duration until appearance of BLC/ATMR was 282.7 ± 328.7 days. C4d-P was found in 11 cases (68.8%), and the mean duration until its appearance was 1,432 ± 1,307 days. MVI was found in all cases, and the mean duration until its appearance was 1,333 ± 1,126 days. The mean duration until diagnosis of CAABMR was 2,268 ± 1,191 days. In the control group, BLC/ATMR was found in 13 cases (34.2%), and the mean duration until the appearance of BLC/ATMR was 173.1 ± 170.4 days. C4d-P was found in 2 cases (5.3%), and the durations until its appearance were 748 and 1,881 days. No cases of MVI were found in the control group. The frequency of BLC/ATMR was significantly higher in the CAABMR group (p < 0.01).
CONCLUSION


Preceding BLC/ATMR is associated with the development of CAABMR with dnDSA.",2020,"The frequency of BLC/ATMR was significantly higher in the CAABMR group (p < 0.01).
","['365 patients who underwent ABO-compatible renal transplantation at our hospital', '16 patients diagnosed as having dnDSA-positive CAABMR']",['Chronic active antibody-mediated rejection (CAABMR'],"['frequency of BLC/ATMR', 'mean duration until appearance of BLC/ATMR', 'mean duration until diagnosis of CAABMR', 'presence or absence of borderline changes (BLCs), acute T-cell-mediated rejection (ATMR), microvascular inflammation (MVI), and C4d positive on peritubular capillaries (C4d-P', 'MVI', 'BLC/ATMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332212', 'cui_str': 'Chronic active'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]","[{'cui': 'C0332212', 'cui_str': 'Chronic active'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332212', 'cui_str': 'Chronic active'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0056195', 'cui_str': 'Complement component C4d'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456918', 'cui_str': 'Peritubular'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}]",365.0,0.013485,"The frequency of BLC/ATMR was significantly higher in the CAABMR group (p < 0.01).
","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan, tsuji.takahiro@gmail.com.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Makita', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Imamoto', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Naomichi', 'Initials': 'N', 'LastName': 'Ishidate', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Mitsuke', 'Affiliation': 'Department of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Fukuzawa', 'Affiliation': 'Department of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Harada', 'Affiliation': 'Department of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Fukazawa', 'Affiliation': 'Department of Pathology, Sapporo City General Hospital, Sapporo, Japan.'}]",Nephron,['10.1159/000512659']
691,32696210,Adhesive restoration of molars affected by molar incisor hypomineralization: a randomized clinical trial.,"OBJECTIVE


This randomized clinical trial evaluated the survival of direct restorations on first permanent molars (FPMs) with molar incisor hypomineralization (MIH) and its impact on self-reported dental pain and dental anxiety.
MATERIAL AND METHOD


FPMs with MIH of 35 patients aged 7 to 16 years were included. The FPMs were randomized into the following two groups: total-etch (TE-37% phosphoric acid etching) and self-etch (SE-no prior etching). The FPMs were restored with universal adhesive and bulk-fill resin composites. The restoration survival was evaluated according to USPHS criteria modified by a blinded examiner. Dental anxiety (Venham picture test) and dental pain (Faces pain scale-revised) were evaluated before treatment and at 1, 6, and 12 months post-treatment. Survival rates were analyzed by the Kaplan-Meier method and the log-rank test. Nonparametric tests compared pain and anxiety in the follow-up periods.
RESULTS


A total of 64 FPMs were restored (TE = 33; SE = 31). Survival rates were 96.9% (TE) and 96.7% (SE) after 1 month, 90.5% (TE) and 80.6% (SE) after 6 months, and 80.8% (TE) and 62.3% (SE) after 12 months (p > 0.05). Self-reported dental pain and anxiety level decreased after treatment in both groups (p < 0.05). Self-reported pain decreased after 1 month in SE, but it occurred at 6 months in TE.
CONCLUSION


Both restorative protocols presented similar longevity, decreasing self-reported pain and anxiety levels.
CLINICAL RELEVANCE


A universal adhesive could be appropriate for restoration of MIH-affected teeth, and the survival of restorations could be higher in the total-etch technique, reducing dental pain and anxiety.",2021,Self-reported dental pain and anxiety level decreased after treatment in both groups (p < 0.05).,"['molars affected by molar incisor hypomineralization', 'FPMs with MIH of 35 patients aged 7 to 16\xa0years were included']","['molar incisor hypomineralization (MIH', 'total-etch (TE-37% phosphoric acid etching) and self-etch']","['Dental anxiety (Venham picture test) and dental pain (Faces pain scale-revised', 'Self-reported pain', 'restoration survival', 'Survival rates', 'pain and anxiety', 'Self-reported dental pain and anxiety level', 'similar longevity, decreasing self-reported pain and anxiety levels']","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2350038', 'cui_str': 'Molar incisor hypomineralization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",64.0,0.0636983,Self-reported dental pain and anxiety level decreased after treatment in both groups (p < 0.05).,"[{'ForeName': 'Tatiane Zahn Cardoso', 'Initials': 'TZC', 'LastName': 'Rolim', 'Affiliation': 'Department of Stomatology, Universidade Federal do Parana Setor de Ciencias da Saude, Av. Prefeito Lothário Meissner 632, Curitiba, State of Paraná, 80210-170, Brazil.'}, {'ForeName': 'Thays Regina Ferreira', 'Initials': 'TRF', 'LastName': 'da Costa', 'Affiliation': 'Department of Stomatology, Universidade Federal do Parana Setor de Ciencias da Saude, Av. Prefeito Lothário Meissner 632, Curitiba, State of Paraná, 80210-170, Brazil.'}, {'ForeName': 'Leticia Maira', 'Initials': 'LM', 'LastName': 'Wambier', 'Affiliation': 'School of Health and Biological Sciences, Universidade Positivo, Curitiba, Brazil.'}, {'ForeName': 'Ana Claudia', 'Initials': 'AC', 'LastName': 'Chibinski', 'Affiliation': 'Department of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Denise Stadler', 'Initials': 'DS', 'LastName': 'Wambier', 'Affiliation': 'Department of Dentistry, State University of Ponta Grossa, Ponta Grossa, Brazil.'}, {'ForeName': 'Luciana Reichert', 'Initials': 'LR', 'LastName': 'da Silva Assunção', 'Affiliation': 'Department of Stomatology, Universidade Federal do Parana Setor de Ciencias da Saude, Av. Prefeito Lothário Meissner 632, Curitiba, State of Paraná, 80210-170, Brazil.'}, {'ForeName': 'José Vitor Borges Nogara', 'Initials': 'JVBN', 'LastName': 'de Menezes', 'Affiliation': 'Department of Stomatology, Universidade Federal do Parana Setor de Ciencias da Saude, Av. Prefeito Lothário Meissner 632, Curitiba, State of Paraná, 80210-170, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Feltrin-Souza', 'Affiliation': 'Department of Stomatology, Universidade Federal do Parana Setor de Ciencias da Saude, Av. Prefeito Lothário Meissner 632, Curitiba, State of Paraná, 80210-170, Brazil. julianafeltrin1@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03459-2']
692,32697707,Antidepressant effects of ketamine and ECT: A pilot comparison.,"BACKGROUND


To compare the antidepressant effects and cognitive adverse effects of intravenous ketamine infusion and Electro-convulsive therapy (ECT) in persons with severe depressive episodes.
METHODS


This assessor-blinded randomized control trial included 25 patients (either sex; 18-65 years) meeting ICD-10 criteria for severe depression (bipolar or unipolar). Patients received either ECT (n = 13) or intravenous infusions of ketamine hydrochloride (0.5 mg/kg over 45 min; n = 12) for six alternate day sessions over a period of two weeks. Severity of depression was assessed at baseline and on every alternate day of intervention using the Hamilton Depression Rating Scale (HDRS) and self-reported Beck Depression Inventory (BDI).
RESULTS


Baseline socio-demographic and clinical variables including HDRS (ECT: 25.15±6.58; Ketamine: 23.33±4.05, p = 0.418) and BDI (ECT: 37.07±6.58; Ketamine: 33.33±9.29; p = 0.254) were comparable. Repeated-measures analysis of variance revealed that ECT patients showed significantly greater reduction in HDRS (group*time interaction effect; F = 4.79; p<0.001) and BDI scores (group*time interaction effect; F = 3.83; p<0.01). ECT patients had higher response rate than ketamine patients [HDRS: ECT- 13/13(100%) vs ketamine- 8/12 (66.70%); p = 0.04]. This was true for remission as well [ECT- 12/13(92.30%) vs ketamine- 6/12(50%), p = 0.030; both HDRS and BDI]. Performance on Digit Symbol Substitution Test (as part of the Battery for ECT-Related Cognitive Deficits scale) significantly improved in ketamine patients (p = 0.02) while that in ECT patients worsened non significantly (p = 0.30).
LIMITATIONS


Relatively small sample size; higher proportion of dropouts in the Ketamine arm.
CONCLUSION


This study favoured ECT over ketamine for a better efficacy over six treatment sessions in severe depression. The results need to be replicated in larger studies.
TRIAL REGISTRATION


CTRI/2019/09/021184.",2020,"Performance on Digit Symbol Substitution Test (as part of the Battery for ECT-Related Cognitive Deficits scale) significantly improved in ketamine patients (p = 0.02) while that in ECT patients worsened non significantly (p = 0.30).
","['25 patients (either sex; 18-65 years) meeting ICD-10 criteria for severe depression (bipolar or unipolar', 'persons with severe depressive episodes', 'severe depression']","['ECT', 'ketamine', 'Ketamine', 'ketamine infusion and Electro-convulsive therapy (ECT', 'ketamine and ECT', 'ketamine hydrochloride']","['Severity of depression', 'Hamilton Depression Rating Scale (HDRS) and self-reported Beck Depression Inventory (BDI', 'HDRS', 'Cognitive Deficits scale', 'Performance on Digit Symbol Substitution Test', 'response rate', 'BDI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0009953', 'cui_str': 'Convulsive therapy'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0700541', 'cui_str': 'Ketamine hydrochloride'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}]",25.0,0.172461,"Performance on Digit Symbol Substitution Test (as part of the Battery for ECT-Related Cognitive Deficits scale) significantly improved in ketamine patients (p = 0.02) while that in ECT patients worsened non significantly (p = 0.30).
","[{'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Sharma', 'Affiliation': 'Department of Psychiatry, Trivanta Medical and Neuro-psychiatry Hospital and Research Center, Udaipur, Rajasthan 313001, India. Electronic address: drravisharma1984@gmail.com.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Psychiatry, Magna Centers for Obesity, Diabetes and Endocrinology, Bangalore, Karnataka 560076, India. Electronic address: gajanan.kulkarni.97@gmail.com.'}, {'ForeName': 'Channaveerachari Naveen', 'Initials': 'CN', 'LastName': 'Kumar', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka 60029, India. Electronic address: cnkumar1974@gmail.com.'}, {'ForeName': 'Shyam Sundar', 'Initials': 'SS', 'LastName': 'Arumugham', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka 60029, India. Electronic address: a.shyamsundar@gmail.com.'}, {'ForeName': 'Venkataramaiah', 'Initials': 'V', 'LastName': 'Sudhir', 'Affiliation': 'Department of Neuro-anaesthesia, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka 560029, India. Electronic address: vsudhir77@gmail.com.'}, {'ForeName': 'Urvakhsh M', 'Initials': 'UM', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka 60029, India. Electronic address: urvakhsh@gmail.com.'}, {'ForeName': 'Sayantanava', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Queensland Health and Faculty of Medicine, University of Queensland Rural Medical\xa0School, Rockhampton, Queensland 4700, Australia. Electronic address: sayantanava@gmail.com.'}, {'ForeName': 'Milind Vijay', 'Initials': 'MV', 'LastName': 'Thanki', 'Affiliation': 'Hertfordshire Partnership University, NHS Foundation Trust, Hatfeild, Hertfordshire, AL108YE England United Kingdom. Electronic address: milind_thanki@yahoo.com.'}, {'ForeName': 'Jagadisha', 'Initials': 'J', 'LastName': 'Thirthalli', 'Affiliation': 'Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka 60029, India. Electronic address: jagatth@yahoo.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.066']
693,32693852,Targeted adaptation in infants following live exposure to an accented talker.,"Infants struggle to understand familiar words spoken in unfamiliar accents. Here, we examine whether accent exposure facilitates accent-specific adaptation. Two types of pre-exposure were examined: video-based (i.e., listening to pre-recorded stories; Experiment 1) and live interaction (reading books with an experimenter; Experiments 2 and 3). After video-based exposure, Canadian English-learning 15- to 18-month-olds failed to recognize familiar words spoken in an unfamiliar accent. However, after face-to-face interaction with a Mandarin-accented talker, infants showed enhanced recognition for words produced in Mandarin English compared to Australian English. Infants with live exposure to an Australian talker were not similarly facilitated, perhaps due to the lower vocabulary scores of the infants assigned to the Australian exposure condition. Thus, live exposure can facilitate accent adaptation, but this ability is fragile in young infants and is likely influenced by vocabulary size and the specific mapping between the speaker and the listener's phonological system.",2021,"Infants with live exposure to an Australian talker were not similarly facilitated, perhaps due to the lower vocabulary scores of the infants assigned to the Australian exposure condition.",['Infants with live exposure to an Australian talker'],[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],[],,0.0208127,"Infants with live exposure to an Australian talker were not similarly facilitated, perhaps due to the lower vocabulary scores of the infants assigned to the Australian exposure condition.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Paquette-Smith', 'Affiliation': 'Department of Psychology, University of California Los Angeles, 502 Portola Plaza, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology, University of Toronto, 3359 Mississauga Rd., Mississauga, ON, L5L 1C6, CANADA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, University of Toronto, 3359 Mississauga Rd., Mississauga, ON, L5L 1C6, CANADA.'}]",Journal of child language,['10.1017/S030500092000029X']
694,32251400,Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers.,"PD-1 plus CTLA-4 blockade is highly effective in advanced-stage, mismatch repair (MMR)-deficient (dMMR) colorectal cancers, yet not in MMR-proficient (pMMR) tumors. We postulated a higher efficacy of neoadjuvant immunotherapy in early-stage colon cancers. In the exploratory NICHE study (ClinicalTrials.gov: NCT03026140), patients with dMMR or pMMR tumors received a single dose of ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib. The primary objective was safety and feasibility; 40 patients with 21 dMMR and 20 pMMR tumors were treated, and 3 patients received nivolumab monotherapy in the safety run-in. Treatment was well tolerated and all patients underwent radical resections without delays, meeting the primary endpoint. Of the patients who received ipilimumab + nivolumab (20 dMMR and 15 pMMR tumors), 35 were evaluable for efficacy and translational endpoints. Pathological response was observed in 20/20 (100%; 95% exact confidence interval (CI): 86-100%) dMMR tumors, with 19 major pathological responses (MPRs, ≤10% residual viable tumor) and 12 pathological complete responses. In pMMR tumors, 4/15 (27%; 95% exact CI: 8-55%) showed pathological responses, with 3 MPRs and 1 partial response. CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors. These data indicate that neoadjuvant immunotherapy may have the potential to become the standard of care for a defined group of colon cancer patients when validated in larger studies with at least 3 years of disease-free survival data.",2020,CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors.,"['early-stage colon cancers', '40 patients with 21 dMMR and 20 pMMR tumors', 'patients with dMMR or pMMR tumors']","['ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib', 'Neoadjuvant immunotherapy', 'CD8 + PD-1 +  T cell infiltration', 'ipilimumab\u2009+\u2009nivolumab', 'nivolumab monotherapy', 'neoadjuvant immunotherapy', 'PD-1 plus CTLA-4 blockade']","['safety and feasibility', 'Pathological response', 'pathological responses']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",40.0,0.120671,CD8 + PD-1 +  T cell infiltration was predictive of response in pMMR tumors.,"[{'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Chalabi', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. m.chalabi@nki.nl.'}, {'ForeName': 'Lorenzo F', 'Initials': 'LF', 'LastName': 'Fanchi', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Krijn K', 'Initials': 'KK', 'LastName': 'Dijkstra', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'José G', 'Initials': 'JG', 'LastName': 'Van den Berg', 'Affiliation': 'Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Arend G', 'Initials': 'AG', 'LastName': 'Aalbers', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lopez-Yurda', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Geerard L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Snaebjornsson', 'Affiliation': 'Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Radiology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Mertz', 'Affiliation': 'Bioimaging Facility, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Veninga', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Gergana', 'Initials': 'G', 'LastName': 'Bounova', 'Affiliation': 'Oncode Institute, Utrecht, the Netherlands.'}, {'ForeName': 'Annegien', 'Initials': 'A', 'LastName': 'Broeks', 'Affiliation': 'Core Facility Molecular Pathology & Biobanking, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Regina G', 'Initials': 'RG', 'LastName': 'Beets-Tan', 'Affiliation': 'GROW School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'de Wijkerslooth', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Anja U', 'Initials': 'AU', 'LastName': 'van Lent', 'Affiliation': 'Gastroenterology & Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Hendrik A', 'Initials': 'HA', 'LastName': 'Marsman', 'Affiliation': 'Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Nuijten', 'Affiliation': 'Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels F', 'Initials': 'NF', 'LastName': 'Kok', 'Affiliation': 'Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kuiper', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Wieke H', 'Initials': 'WH', 'LastName': 'Verbeek', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kok', 'Affiliation': 'Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Van Leerdam', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton N', 'Initials': 'TN', 'LastName': 'Schumacher', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Emile E', 'Initials': 'EE', 'LastName': 'Voest', 'Affiliation': 'Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. e.voest@nki.nl.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Haanen', 'Affiliation': 'Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Nature medicine,['10.1038/s41591-020-0805-8']
695,32702252,Safety Assessment of HEA-Enriched  Cordyceps cicadae  Mycelium: A Randomized Clinical Trial.,"Objective:   Cordyceps cicadae , a medicinal fungus, is assessed as having many functions: anti-cancer, anti-fatigue, anti-aging, immune-boosting, renal and liver protection. Since the industrial production of  C. cicadae  mycelium consistently manufactures bioactive compounds superior to wild fruiting bodies, there is a need to confirm the toxicity of liquid fermented  C. cicadae  mycelium. Studies showed the toxicity evaluation of  C. cicadae  mycelium in animal models, but safety reports in clinical studies are scarce. As such, a safety assessment of oral N6-(2-hydroxyethyl) adenosine (HEA-enriched)  C. cicadae  mycelium in humans is provided here. Method:  After 49 participants ingested granules of 1.05 g of freeze-dried  C. cicadae  mycelium once a day for 3 months, their blood samples were collected at the beginning and end of the experiment for analysis. Results:  There were no significant differences between the initial and final measurements in renal and liver function. Also, there was no influence on blood electrolytes as well as blood lipid levels. In clinical observation, there were also no side effects or adverse feelings mentioned by participants. Conclusion:  These results suggested that HEA-enriched  C. cicadae  mycelium produced by liquid fermentation is safe and can be developed as a functional health food.",2021,There were no significant differences between the initial and final measurements in renal and liver function.,[],"['HEA-Enriched  Cordyceps cicadae  Mycelium', 'oral N6-(2-hydroxyethyl) adenosine (HEA-enriched']","['toxicity evaluation', 'blood electrolytes', 'renal and liver function', 'blood lipid levels']",[],"[{'cui': 'C0449204', 'cui_str': 'HEA'}, {'cui': 'C1011843', 'cui_str': 'Cordyceps'}, {'cui': 'C0949695', 'cui_str': 'Mycelium'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",49.0,0.0359934,There were no significant differences between the initial and final measurements in renal and liver function.,"[{'ForeName': 'You-Shan', 'Initials': 'YS', 'LastName': 'Tsai', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.'}, {'ForeName': 'Jui-Hsia', 'Initials': 'JH', 'LastName': 'Hsu', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.'}, {'ForeName': 'David Pei-Cheng', 'Initials': 'DP', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Laboratory Science and Biotechnology, Chung Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Han-Hsin', 'Initials': 'HH', 'LastName': 'Chang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Wen-Jui', 'Initials': 'WJ', 'LastName': 'Chang', 'Affiliation': 'Department of Ophthalmology, Landseed International Hospital, Taoyuan City, Taiwan.'}, {'ForeName': 'Yen-Lien', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Biotech Research Institute, Grape King Bio Ltd, Taoyuan City, Taiwan.'}, {'ForeName': 'Chin-Chu', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Institute of Food Science and Technology, National Taiwan University, Taipei City, Taiwan.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1743211']
696,32715482,"Effect of novel short-arm human centrifugation-induced gravitational gradients upon cardiovascular responses, cerebral perfusion and g-tolerance.","KEY POINTS


The aim of this study was to determine the effect of rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC) upon cardiovascular responses, cerebral perfusion and g-tolerance. In 10 male and 10 female participants, 10 min passive SAHC runs were performed with the RAP above the head (P1), at the apex of the head (P2), or at heart level (P3), with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. We hypothesized that movement of the RAP from above the head (the conventional position) towards the heart might reduce central hypovolaemia, limit cardiovascular responses, aid cerebral perfusion, and thus promote g-tolerance. Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance. Our results also suggest that RAP, and thus g-gradient, warrants further investigation as it may support use as a holistic spaceflight countermeasure.
ABSTRACT


Artificial gravity (AG) through short-arm human centrifugation (SAHC) has been proposed as a holistic spaceflight countermeasure. Movement of the rotational axis position (RAP) from above the head towards the heart may reduce central hypovolaemia, aid cerebral perfusion, and thus promote g-tolerance. This study determined the effect of RAP upon cardiovascular responses, peripheral blood displacement (i.e. central hypovolaemia), cerebral perfusion and g-tolerance, and their inter-relationships. Twenty (10 male) healthy participants (26.2 ± 4.0 years) underwent nine (following a familiarization run) randomized 10 min passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart level (P3) with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolaemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP) were continuously recorded, in addition to incidence of pre-syncopal symptoms (PSS). ΔCC and ΔHR increases were attenuated from P1 to P3 (ΔCC: 5.46 ± 0.54 mm to 2.23 ± 0.42 mm; ΔHR: 50 ± 4 bpm to 8 ± 2 bpm, P < 0.05). In addition, ΔcTSI decrements were also attenuated (ΔcTSI: -2.85 ± 0.48% to -0.95 ± 0.34%, P < 0.05) and PSS incidence lower in P3 than P1 (P < 0.05). A positive linear relationship was observed between ΔCC and ΔHR with increasing +Gz, and a negative relationship between ΔCC and ΔcTSI, both independent of RAP. Our data suggest that movement of RAP towards the heart (reduced g-gradient), independent of foot-level Gz, leads to improved g-tolerance. Further investigations are required to assess the effect of differential baroreceptor feedback (i.e. aortic-carotid g-gradient).",2020,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","['10 male and 10 female participants, 10-min passive SAHC runs were performed with the RAP above (P1), or at the apex of the head (P2), or at heart-level (P3), with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'Twenty (10 male) healthy participants (26.2\xa0±\xa04.0\xa0yr) underwent nine (following a familiarisation run) randomised']","['novel short-arm human centrifugation induced gravitational gradients', 'rotational axis position (RAP', 'short-arm human centrifugation (SAHC', 'RAP', '10-minute passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart-level (P3) with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC']","['incidence of pre-syncopal symptoms (PSS', 'ΔcTSI decrements', 'cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance', 'ΔCC and ΔHR increases', 'cardiovascular responses, peripheral blood displacement (i.e. central hypovolemia), cerebral perfusion and g-tolerance, and their inter-relationships', 'cardiovascular responses, cerebral perfusion and g-tolerance', 'PSS incidence', 'Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",10.0,0.0415868,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Laing', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': ""King's College London, Centre for Human and Applied Physiological Sciences (CHAPS), London, UK.""}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Mulder', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hinghofer-Szalkay', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Blaber', 'Affiliation': 'Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rittweger', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Nandu', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}]",The Journal of physiology,['10.1113/JP273615']
697,32706638,First Randomized Trial Supporting the Use of Proton Over Photon Chemoradiotherapy in Esophageal Cancer.,,2020,,['Esophageal Cancer'],['Proton Over Photon Chemoradiotherapy'],[],"[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]",[],,0.0869142,,"[{'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Simone', 'Affiliation': 'Department of Radiation Oncology, New York Proton Center and Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01405']
698,32712793,Zygomaticomaxillary fracture fixation: a prospective comparative evaluation of two-point versus three-point fixation.,"PURPOSE


Zygomatic bone has a higher risk of sustaining injuries in the maxillofacial skeleton. On fracturing, zygomatic bone separates from the four neighbouring bones at its articulations. Treatment for zygomaticomaxillary fractures has evolved a long way since 3000 BC. With the advent of miniplates for midface fracture, controversies still exist regarding the stability of zygoma following 1, 2, and 3 points for fixation. The study aims to compare and determine the most effective technique for the reduction of zygomaticomaxillary fractures and the ability to retain the fractured zygoma in a stable position. Hence, a study was conducted in our institute to compare 2 and 3-point fixation of zygomaticomaxillary fractures taking into account the clinical and radiographic parameters.
METHODS


Twenty-four patients were divided into 2 equal groups A and B, receiving 2- and 3-point fixation respectively. Fracture displacement and stability were assessed using coronal and axial CT scan tracings at preoperatively, immediate, and 5-week postoperatively.
RESULTS


Group B showed a significant reduction in postoperative mean displacement at sphenozygomatic and infraorbital region when compared with group A. Patients in group A had an increase incidence in vertical dystopia and enophthalmos. There was no postoperative displacement at any site in both the groups.
CONCLUSION


The fractured segment was held in place by both the fixation methods but 3-point fixation gave better stability in maintaining the fractured segment in desired reduced position.",2021,"RESULTS


Group B showed a significant reduction in postoperative mean displacement at sphenozygomatic and infraorbital region when compared with group A. Patients in group A had an increase incidence in vertical dystopia and enophthalmos.",['Twenty-four patients'],['Zygomaticomaxillary fracture fixation'],"['postoperative mean displacement at sphenozygomatic and infraorbital region', 'postoperative displacement', 'vertical dystopia and enophthalmos', 'Fracture displacement and stability']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",24.0,0.013502,"RESULTS


Group B showed a significant reduction in postoperative mean displacement at sphenozygomatic and infraorbital region when compared with group A. Patients in group A had an increase incidence in vertical dystopia and enophthalmos.","[{'ForeName': 'Saikrishna', 'Initials': 'S', 'LastName': 'Degala', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysore, Karnataka, 570015, India.'}, {'ForeName': 'Sathish', 'Initials': 'S', 'LastName': 'Radhakrishna', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysore, Karnataka, 570015, India. drsathish75@gmail.com.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Dharmarajan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Mysore, Karnataka, 570015, India.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00881-4']
699,32711801,"Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Abrocitinib, an oral selective Janus kinase 1 inhibitor, was effective and well tolerated in adults with moderate-to-severe atopic dermatitis in a phase 2b trial. We aimed to assess the efficacy and safety of abrocitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis.
METHODS


In this multicentre, double-blind, randomised phase 3 trial (JADE MONO-1), patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA. Patients were randomly assigned (2:2:1) to oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo once daily for 12 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity and age. Patients, investigators, and the funder of the study were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved an Investigator Global Assessment response (score of 0 [clear] or 1 [almost clear] with a ≥2-grade improvement from baseline), and the proportion of patients who achieved at least a 75% improvement in EASI score from baseline (EASI-75) score, both assessed at week 12. Efficacy was assessed in the full analysis set, which included all randomised patients who received at least one dose of study medication. Safety was assessed in all randomised patients. This study is registered with ClinicalTrials.gov, NCT03349060.
FINDINGS


Between Dec 7, 2017, and March 26, 2019, 387 patients were enrolled: 156 were assigned to abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo. All enrolled patients received at least one dose of study treatment and thus were evaluable for 12-week efficacy. Of the patients with available data for the coprimary endpoints at week 12, the proportion of patients who had achieved an Investigator Global Assessment response was significantly higher in the abrocitinib 100 mg group than in the placebo group (37 [24%] of 156 patients vs six [8%] of 76 patients; p=0·0037) and in the abrocitinib 200 mg group compared with the placebo group (67 [44%] of 153 patients vs six [8%] of 76 patients; p<0·0001). Of the patients with available data for the coprimary endpoints at week 12, compared with the placebo group, the proportion of patients who had achieved an EASI-75 response was significantly higher in the abrocitinib 100 mg group (62 [40%] of 156 patients vs nine [12%] of 76 patients; p<0·0001) and abrocitinib 200 mg group (96 [63%] of 153 patients vs nine [12%] of 76 patients; p<0·0001). Adverse events were reported in 108 (69%) of 156 patients in the abrocitinib 100 mg group, 120 (78%) of 154 patients in the abrocitinib 200 mg group, and 44 (57%) of 77 patients in the placebo group. Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group. No treatment-related deaths were reported.
INTERPRETATION


Monotherapy with oral abrocitinib once daily was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis.
FUNDING


Pfizer.",2020,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","['adolescents and adults with moderate-to-severe atopic dermatitis', 'patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA', '387 patients were enrolled: 156', 'adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1', 'adults with moderate-to-severe atopic dermatitis', 'Between Dec 7, 2017, and March 26, 2019']","['abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo', 'abrocitinib monotherapy', 'oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo', 'abrocitinib', 'placebo']","['Safety', 'proportion of patients who had achieved an Investigator Global Assessment response', 'Investigator Global Assessment response', 'Adverse events', 'Efficacy and safety', 'efficacy and safety', 'Efficacy', 'EASI-75 response', 'EASI score', 'Serious adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",387.0,0.611278,"Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group.","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Sinclair', 'Affiliation': 'Sinclair Dermatology, Melbourne, VIC, Australia.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'ForCare Clinical Research, Tampa, FL, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Aschoff', 'Affiliation': 'University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cork', 'Affiliation': ""Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield Children's Hospital, Sheffield Teaching Hospitals, Sheffield, UK.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University Hospital, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Magnolo', 'Affiliation': 'University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montréal, QC, Canada; University of Montreal Hospital Center, Montréal, QC, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer UK, Surrey, UK.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Tatulych', 'Affiliation': 'Pfizer, Groton, CT, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer, Groton, CT, USA. Electronic address: ricardo.rojo@pfizer.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30732-7']
700,32712847,Spectrophotometric insights: calcium hydroxide influences tooth discolorations induced by short-term application of antibiotic/corticosteroid pastes.,"OBJECTIVES


This in vitro study aimed to assess the influence of a calcium hydroxide dressing regarding the relative color change (ΔE) of enamel-dentin specimens previously exposed to antibiotic/corticosteroid pastes.
MATERIALS AND METHODS


Eighty bovine enamel-dentin specimens with a cylindrical central cavity were randomly allocated to four groups: NEG (empty), POS (blood), LED (Ledermix), and ODO (Odontopaste) (n = 20 each). The materials were applied and sealed with self-adhesive resin luting material. After 3 weeks, the materials were removed and a calcium hydroxide (Ca(OH) 2 ) dressing was placed in all cavities. After a further 3-week storage period, the cavities were restored with resin-based composite. Spectrophotometric color measurements were taken over 6 months, and ΔE values were calculated. A Tukey's multiple comparison test was performed to assess significant differences within the treatment groups (p < 0.05).
RESULTS


Tooth discolorations were present after 3 weeks in LED (ΔE 29.14 ± 6.55) and POS (ΔE 18.05 ± 7.03); NEG and ODO remained color stable (ΔE 3.2 ± 1.36 and ΔE 2.3 ± 1.16). The 3-week Ca(OH) 2  dressing decreased discolorations of POS (ΔE 15.93 ± 6.63; p = 0.37), whereas LED showed a further significant increase (ΔE 39.55; p < 0.0001). Between the end of the Ca(OH) 2  dressing and the final restoration no significant color changes were observed in any group (p > 0.9).
CONCLUSIONS


Discolorations induced by LED progressed during the Ca(OH) 2  dressing despite careful removal of all residues.
CLINICAL RELEVANCE


Calcium hydroxide might negatively affect the discoloring potential of Ledermix. This highlights the need for direct intracanal application methods of Ledermix ensuring a material-free access cavity or alternative antibiotic/corticosteroid pastes such as Odontopaste should be used.",2021,"Between the end of the Ca(OH) 2  dressing and the final restoration no significant color changes were observed in any group (p > 0.9).
",['Eighty bovine enamel-dentin specimens with a cylindrical central cavity'],"['NEG (empty), POS (blood), LED (Ledermix), and ODO (Odontopaste', 'calcium hydroxide dressing']","['discolorations of POS', 'Spectrophotometric color measurements']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",80.0,0.0193277,"Between the end of the Ca(OH) 2  dressing and the final restoration no significant color changes were observed in any group (p > 0.9).
","[{'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Eggmann', 'Affiliation': 'Department of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rihs', 'Affiliation': 'Department of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Lenherr', 'Affiliation': 'Department of Reconstructive Dentistry, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Weiger', 'Affiliation': 'Department of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Krastl', 'Affiliation': 'Department of Operative Dentistry and Periodontology and Center of Dental Traumatology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Lucia K', 'Initials': 'LK', 'LastName': 'Zaugg', 'Affiliation': 'Department of Reconstructive Dentistry, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland. lucia.zaugg@unibas.ch.'}]",Clinical oral investigations,['10.1007/s00784-020-03414-1']
701,32729273,Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial.,"OBJECTIVE


We aimed to assess the effects of remote ischemic pre-conditioning (RIPC) on the incidence of contrast-induced nephropathy (CIN) after an intravenous (IV) or intra-arterial injection of contrast medium (CM) in patient and control groups.
MATERIALS AND METHODS


This prospective, randomized, single-blinded, controlled trial included 26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six. All the patients underwent four cycles of five minute-blood pressure cuff inflation followed by five minutes of total deflation. In the RIPC group (n = 13), the cuff was inflated to 50 mm Hg above the patient's systolic blood pressure (SBP); in the control group (n = 13), it was inflated to 10 mm Hg below the patient's SBP. The primary endpoint was the occurrence of CIN. Additionally, variation in the serum levels of cystatin C was assessed.
RESULTS


One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients). Mean creatinine values at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 88 ± 32 μmol/L, 91 ± 28 μmol/L and 82 ± 29 μmol/L, respectively ( p  = 0.73) in the RIPC group, whereas in the control group, they were 100 ± 36 μmol/L, 110 ± 36 μmol/L, and 105 ± 34 μmol/L, respectively ( p  = 0.78). Cystatin C values (median [Q1, Q3]) at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 1.10 [1.08, 1.18] mg/L, 1.17 [0.97, 1.35] mg/L, and 1.12 [0.99, 1.24] mg/L, respectively ( p  = 0.88) in the RIPC group, whereas they were 1.11 [0.97, 1.28] mg/L, 1.13 [1.08, 1.25] mg/L, and 1.16 [1.03, 1.31] mg/L, respectively ( p  = 0.93), in the control group.
CONCLUSION


The risk of CIN after an IV injection of CM is very low in patients with Mehran risk score greater than or equal to six and even in the patients who are unable to receive preventive hyperhydration. Hence, the Mehran risk score may not be an appropriate method for the estimation of the risk of CIN after IV CM injection.",2020,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","['patient and control groups', '26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six']","['Intravenous Contrast Medium Injection', 'remote ischemic pre-conditioning (RIPC', 'intravenous (IV) or intra-arterial injection of contrast medium (CM', 'Remote Ischemic Pre-Conditioning']","['incidence of contrast-induced nephropathy (CIN', 'Mean creatinine values', 'Cystatin C values (median [Q1, Q3', 'serum levels of cystatin C', 'CIN', 'occurrence of CIN', 'systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0021487', 'cui_str': 'Intra-arterial injection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",26.0,0.0690735,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","[{'ForeName': 'Dihia', 'Initials': 'D', 'LastName': 'Belabbas', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Radiodology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Chaudru', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Lederlin', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Le Pabic', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boulmier', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Heautot', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mahe', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France. maheguillaume@yahoo.fr.'}]",Korean journal of radiology,['10.3348/kjr.2019.0916']
702,32722776,"Spare Roof Technique Versus Component Dorsal Hump Reduction: A Randomized Prospective Study in 250 Primary Rhinoplasties, Aesthetic and Functional Outcomes.","BACKGROUND


Most Caucasian aesthetic rhinoplasty patients complain about having a noticeable hump in profile view. Taking the integrity of the middle vault into consideration, there are 2 ways to dehump a nose: the structured technique and the preservation technique.
OBJECTIVES


The aim of this study was to compare the aesthetic and functional outcomes of 2 reduction rhinoplasty techniques.
METHODS


We performed a prospective, randomized, interventional, and longitudinal study on 250 patients randomly divided into 2 groups: the component dorsal hump reduction group (CDRg) (n = 125) and the spare roof technique group (SRTg) (n = 125). We utilized the Utrecht Questionnaire for Outcome Assessment in Aesthetic Rhinoplasty. Patients answered the questionnaire before the surgery, and at 3 and 12 months after surgery. In addition, we utilized a visual analog scale (VAS) to score nasal patency for each side.
RESULTS


Analyses of the preoperative and postoperative aesthetic VAS scores showed a significant improvement in both groups, from 3.66 to 7.00 (at 3 months) to 7.35 (at 12 months) in the CDRg, and from 3.81 to 8.14 (at 3 months) to 8.45 (at 12 months) in the SRTg. Analyses of postoperative means of aesthetic VAS scores showed a significant improvement in both groups over time. However, aesthetic improvement was higher in the SRTg than in the CDRg at both 3 (P < 0.001) and 12 months (P < 0.001) postsurgery. Analyses of the mean functional VAS scores showed a significant improvement with both techniques, with a better result for the SRTg.
CONCLUSIONS


The SRT is a reliable technique that can help deliver consistently better aesthetic and functional results than CDR for reduction rhinoplasty in Caucasian patients with a dorsal hump.
LEVEL OF EVIDENCE: 2


",2021,"However, aesthetical improvement was higher in SRTg than CDRg, concerning 3 (P < .001) and 12 months (P < 0.001) postsurgery.","['Caucasian patients with dorsal hump', '250 patients randomly divided into two groups: the', '250 Primary Rhinoplasties, Aesthetic and Functional Outcomes']","['Spare Roof Technique', 'Component Dorsal Hump Reduction', 'component dorsal hump reduction group (CDRg) (n = 125) and the spare roof technique group (SRTg']","['aesthetical improvement', 'mean functional VAS scores', 'preoperative and postoperative aesthetical VAS scores', 'Visual Analog Scale (VAS) to score nasal patency', 'aesthetic VAS scores']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]",250.0,0.0142415,"However, aesthetical improvement was higher in SRTg than CDRg, concerning 3 (P < .001) and 12 months (P < 0.001) postsurgery.","[{'ForeName': 'Miguel Gonçalves', 'Initials': 'MG', 'LastName': 'Ferreira', 'Affiliation': 'Centro Hospitalar Universitário do Porto, Instituto de Ciências Biomédicas Abel Salazar-Universidade do Porto, Portugal.'}, {'ForeName': 'Mariline', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Centro Hospitalar Universitário do Porto, Instituto de Ciências Biomédicas Abel Salazar-Universidade do Porto, Portugal.'}, {'ForeName': 'Diogo Oliveira', 'Initials': 'DO', 'LastName': 'E Carmo', 'Affiliation': 'Hospital CUF Infante Santo, Lisboa, Portugal.'}, {'ForeName': 'Aureliano', 'Initials': 'A', 'LastName': 'Fertuzinhos', 'Affiliation': 'Universidade do Minho, Departamento de Engenharia Mecânica, Guimarães, Portugal.'}, {'ForeName': 'Cecília Almeida', 'Initials': 'CA', 'LastName': 'E Sousa', 'Affiliation': 'Centro Hospitalar Universitário do Porto, Instituto de Ciências Biomédicas Abel Salazar-Universidade do Porto, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': 'Centro Hospitalar Universitário do Porto, Instituto de Ciências Biomédicas Abel Salazar-Universidade do Porto, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Dourado', 'Affiliation': 'Universidade do Minho, Departamento de Engenharia Mecânica, Guimarães, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Amarante', 'Affiliation': 'Faculdade de Medicina da Universidade do Porto, Portugal.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa221']
703,32725573,Analgesia and side effects of codeine phosphate associated with paracetamol vs. paracetamol after the extraction of mandibular third molars: a randomized double-blind clinical trial using the split-mouth model.,"PURPOSE


To assess the analgesia and side effects of codeine phosphate associated with paracetamol (test medication) as compared to paracetamol (control medication) after the extraction of impacted mandibular third molars.
MATERIALS AND METHODS


Forty-seven patients removed the right and left impacted mandibular third molars. After one surgery, patients took the test medication and after the other surgery, they took the control medication. Patients with exacerbated pain were prescribed to use the rescue medication instead of the medication initially administered and were included in the rescue group. They were evaluated for 7 days postoperatively, and the mean score of the visual analogue scale (VAS) of pain between test and control medications was assessed by the Poisson distribution. The side effects of these medications were assessed by the patient's complaints. A P value of < .05 was considered to be statistically significant.
RESULTS


The mean score of the VAS of pain was not statistically different between test and control medications in the non-rescue group, but it was significantly greater in patients previously using paracetamol in the rescue group. The most common side effects reported in both groups, predominantly in patients using the test medication, were drowsiness, dizziness, and nausea.
CONCLUSION


The use of codeine phosphate associated with paracetamol after the extraction of impacted mandibular third molars is a better choice to control the postoperative pain rather than paracetamol, but with more side effects, which are clinically acceptable.",2021,"The mean score of the VAS of pain was not statistically different between test and control medications in the non-rescue group, but it was significantly greater in patients previously using paracetamol in the rescue group.","['Forty-seven patients removed the right and left impacted mandibular third molars', 'Patients with exacerbated pain', 'mandibular third molars', 'impacted mandibular third molars']","['paracetamol (control medication', 'paracetamol', 'paracetamol vs. paracetamol', 'codeine phosphate', 'paracetamol (test medication']","['mean score of the VAS of pain', 'mean score of the visual analogue scale (VAS) of pain between test and control medications', 'drowsiness, dizziness, and nausea']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009217', 'cui_str': 'Codeine phosphate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",47.0,0.114144,"The mean score of the VAS of pain was not statistically different between test and control medications in the non-rescue group, but it was significantly greater in patients previously using paracetamol in the rescue group.","[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Furtado de Carvalho', 'Affiliation': 'Department of Maxillofacial Surgery, Federal University of Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Slusarenko da Silva', 'Affiliation': 'School of Dentistry, UniFG University Center (Faculty of Guanambi), Avenida Pedro Felipe Duarte 4911 São Sebastião, Guanambi, Bahia, 46430-000, Brazil. yu.slu@hotmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reher', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Griffith, Australia.'}, {'ForeName': 'Maria da Graça', 'Initials': 'MDG', 'LastName': 'Naclério-Homem', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Traumatology and Prosthesis, Faculty of Dentistry, University of São Paulo, Sao Paulo, Brazil.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00888-x']
704,32726666,Intermittent theta burst stimulation over the dorsomedial prefrontal cortex modulates resting-state connectivity in depressive patients: A sham-controlled study.,"The mechanisms underlying repetitive transcranial magnetic stimulation (rTMS) treatment are largely unknown. Although there is a general lack of sham controlled studies, findings show altered functional connectivity to the stimulated region following treatment. When targeting the dorsolateral prefrontal cortex (dlPFC), connectivity with the subgenual anterior cingulate cortex (sgACC) is predictive of response, but less is known about the effects on functional connectivity of targeting the dorsomedial PFC (dmPFC). Here, 30 patients with an ongoing depressive episode were recruited and randomized to 20 sessions at target intensity of either active or sham intermittent theta burst stimulation (iTBS) over dmPFC. Those receiving sham were offered active treatment in a subsequent open phase. A seven minute resting-state scan and depressive symptom assessment was performed before and after treatment. After exclusions due to attrition and excessive head movements 23 patients remained for analysis. Seed-based resting-state connectivity was calculated using two seeds for the dmPFC target as well as the sgACC. A symptom related increase in dmPFC connectivity after active treatment, compared to sham treatment, was found. The effect was observed in a region overlapping the precuneus and the posterior cingulate cortex (PCC), suggesting an increase in the connectivity between the targeted salience network and the default mode network mediating improvement in depressive symptoms. Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment. The findings have implications for understanding the mechanisms behind iTBS and may inform future efforts to individualize the treatment.",2020,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"['30 patients with an ongoing depressive episode', 'depressive patients']","['repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation', 'active or sham intermittent theta burst stimulation (iTBS) over dmPFC']",['dmPFC connectivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",30.0,0.0349908,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden. Electronic address: jonas.persson@neuro.uu.se.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden; Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fällmar', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112834']
705,32729275,Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial.,"OBJECTIVE


To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs).
MATERIALS AND METHODS


In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator.
RESULTS


Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585). No procedural or post-procedural complications were identified.
CONCLUSION


Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.",2020,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"['39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis', 'Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas', 'n = 19, PBA group) between June 2016 and June 2018', 'dysfunctional radiocephalic arteriovenous fistulas (RCAVFs']","['Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty', 'drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA', 'DBA and PBA', 'Paclitaxel-coated balloon', 'PBA alone']","['Technical and clinical success rates', 'mean duration of TLPP', 'No procedural or post-procedural complications', 'TLPP or TLSP', 'technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1141930', 'cui_str': 'Post procedural complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0701242,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"[{'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. ho7ok7@gilhospital.com.'}, {'ForeName': 'Sung Su', 'Initials': 'SS', 'LastName': 'Byun', 'Affiliation': 'Health Promotion Center, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Korean journal of radiology,['10.3348/kjr.2020.0067']
706,32734919,Goal management training as a cognitive remediation intervention in depression: A randomized controlled trial.,"BACKGROUND


Major depressive disorder (MDD) is associated with deficits in executive functioning (EF) that may have a detrimental effect on everyday functioning. Despite this, there are no established cognitive remediation interventions available targeting EF in MDD. Hence, the primary aim of the present pre-registered randomized controlled trial was to evaluate the effectiveness of Goal Management Training (GMT), a metacognitive and strategy-based cognitive remediation intervention to improve EF in MDD.
METHODS


Sixty-three participants with current or previous mild or moderate MDD and self-reported executive deficits were included and randomized to nine sessions of either GMT (two hours, once weekly; n = 35) or computerized cognitive training (one hour, twice weekly; n = 28). Assessments were conducted at baseline (T1), immediately following training (T2), and at six-month follow-up (T3). The primary outcome measure was The Behavior Rating Inventory of Executive Function - Adult version, pertained to daily life EF. Secondary outcome measures included additional EF assessments (performance-based measures and questionnaires), and depressive symptom severity.
RESULTS


Forty-three participants completed treatment. Both groups improved following training, and linear mixed model analyses revealed no statistically significant differences between the groups for any outcome measure. Additional exploratory within-group analyses revealed a statistically significant reduction of everyday executive dysfunction and reduced depressive symptoms at the six-month follow-up in GMT only.
LIMITATIONS


The study was single-blind, and the sample size was modest.
CONCLUSIONS


Our findings indicate comparable improvements in everyday and performance-based measures of EF, in addition to reductions in depressive symptoms following both GMT and CCT.",2020,"Both groups improved following training, and linear mixed model analyses revealed no statistically significant differences between the groups for any outcome measure.","['Forty-three participants completed treatment', 'Major depressive disorder (MDD', 'depression', 'Sixty-three participants with current or previous mild or moderate MDD and self-reported executive deficits']","['cognitive remediation intervention', 'computerized cognitive training', 'Goal management training', 'GMT', 'Goal Management Training (GMT), a metacognitive and strategy-based cognitive remediation intervention']","['everyday executive dysfunction and reduced depressive symptoms', 'everyday and performance-based measures of EF', 'additional EF assessments (performance-based measures and questionnaires), and depressive symptom severity', 'Behavior Rating Inventory of Executive Function - Adult version, pertained to daily life EF', 'depressive symptoms']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",63.0,0.270869,"Both groups improved following training, and linear mixed model analyses revealed no statistically significant differences between the groups for any outcome measure.","[{'ForeName': 'Bjørn Ingulfsvann', 'Initials': 'BI', 'LastName': 'Hagen', 'Affiliation': 'Department of Research, Lovisenberg Diaconal Hospital, Norway. Electronic address: boha@lds.no.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Department of Psychology, University of Oslo, Norway.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Joormann', 'Affiliation': 'Department of Psychology, Yale University, United States.'}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': 'Department of Research, Lovisenberg Diaconal Hospital, Norway; Faculty of Health Science, Oslo Metropolitan University, Norway.'}, {'ForeName': 'Nils Inge', 'Initials': 'NI', 'LastName': 'Landrø', 'Affiliation': 'Department of Psychology, University of Oslo, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stubberud', 'Affiliation': 'Department of Research, Lovisenberg Diaconal Hospital, Norway; Department of Psychology, University of Oslo, Norway.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.015']
707,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
708,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
709,33230268,Intrinsic reward circuit connectivity profiles underlying symptom and quality of life outcomes following antidepressant medication: a report from the iSPOT-D trial.,"There is a critical need to better understand the neural basis of antidepressant medication (ADM) response with respect to both symptom alleviation and quality of life (QoL) in major depressive disorder (MDD). Reward neurocircuitry has been implicated in QoL, the neural basis of MDD, and the mechanisms of ADM response. Yet, we do not know whether change in reward neurocircuitry as a function of ADM is associated with change in symptoms and QoL. To address this gap in knowledge, we analyzed data from 128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to sertraline, venlafaxine-XR, or escitalopram). 58 matched healthy controls were scanned at the same time points. We quantified functional connectivity (FC) of reward neurocircuitry using nucleus accumbens (NAc) seed regions of interest, and then characterized how changes in FC relate to symptom response (primary outcome) and QoL response (secondary outcome). Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC) FC relative to non-responders (p < 0.001) which was associated with improvement in physical QoL (p < 0.0003), and a decrease in NAc-inferior parietal lobule FC relative to controls (p < 0.001). QoL response was characterized by increases in FC between NAc-ventral ACC for environmental, NAc-thalamus for physical, and NAc-paracingulate gyrus for social domains (p < 0.001). Symptom responders to sertraline were distinguished by a decrease in NAc-insula FC (p < 0.001) and to venlafaxine-XR by an increase in NAc-inferior temporal gyrus FC (p < 0.005). Findings suggest that change in reward neurocircuitry may underlie differential ADM response profiles with respect to symptoms and QoL in depression.",2021,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"['128 patients with MDD who participated in the iSPOT-D trial and were assessed with functional neuroimaging pre- and post-ADM treatment (randomized to', '58 matched healthy controls']","['antidepressant medication', 'sertraline, venlafaxine-XR, or escitalopram']","['QoL response', 'NAc-inferior parietal lobule FC relative', 'NAc-insula FC', 'physical QoL', 'NAc-dorsal anterior cingulate cortex (ACC', 'NAc-inferior temporal gyrus FC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}]",128.0,0.0573567,Symptom responders showed an increase in NAc-dorsal anterior cingulate cortex (ACC),"[{'ForeName': 'Adina S', 'Initials': 'AS', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. adinaf@stanford.edu.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Holt-Gosselin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Fleming', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Hack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Tali M', 'Initials': 'TM', 'LastName': 'Ball', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. leawilliams@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00905-3']
710,31813658,The efficacy of pentosan polysulfate monotherapy for preventing recurrent urinary tract infections in women: A multicenter open-label randomized controlled trial.,"BACKGROUND/PURPOSE


Pentosan polysulfate sodium (PPS), a semi-synthetic polysaccharide that adheres to bladder mucosa, is effective in treating interstitial cystitis. We evaluated the clinical benefit of PPS for the prevention of recurrent urinary tract infection (UTI) in women.
METHODS


We conducted a multicenter, open-label, prospective, phase II, randomized controlled trial enrolling women with recurrent UTI ≥ 2 times in the past 6 months or ≥ 3 times in the past 12 months. Patients received oral PPS monotherapy for 16 weeks in treatment group. All patients were followed every 28 days until UTI recurrence or up to 112 days. The primary endpoint was the UTI recurrence-free survival. Adverse events were recorded as secondary endpoint.
RESULTS


A total of 26 women were eligible for analysis. In the PPS group, none (0%) of the 12 patients had UTI recurrence during the study period. However, 9 (64%) of 14 patients had UTI recurrence in the control group. The UTI recurrence-free survival was significantly higher in the PPS group than in the control group (log-rank test p = 0.0004). One adverse event which led to discontinuation of the trial regimen was regarded as irrelevance of PPS treatment. The limitation was the small number of cases.
CONCLUSION


Among women with recurrent UTI, 16-week PPS monotherapy significantly reduced UTI recurrence when compared with the control group.",2020,The UTI recurrence-free survival was significantly higher in the PPS group than in the control group (log-rank test p = 0.0004).,"['26 women were eligible for analysis', 'enrolling women with recurrent UTI\xa0≥\xa02 times in the past 6 months or\xa0≥\xa03 times in the past 12 months', 'women with recurrent UTI', 'women']","['oral PPS monotherapy', 'pentosan polysulfate monotherapy', 'PPS', 'Pentosan polysulfate sodium (PPS']","['UTI recurrence-free survival', 'recurrent urinary tract infections', 'Adverse events', 'UTI recurrence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524684', 'cui_str': 'pentosan polysulfate sodium'}, {'cui': 'C0600296', 'cui_str': 'Pentosan Polysulfate'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",26.0,0.0950051,The UTI recurrence-free survival was significantly higher in the PPS group than in the control group (log-rank test p = 0.0004).,"[{'ForeName': 'Chi-Shin', 'Initials': 'CS', 'LastName': 'Tseng', 'Affiliation': 'Department of Urology, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Shang-Jen', 'Initials': 'SJ', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Taipei Tzu Chi Hospital, New Taipei, Taiwan.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Meng', 'Affiliation': 'Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hong-Chiang', 'Initials': 'HC', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yuan-Ju', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan. Electronic address: leeyuanju@hotmail.com.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.11.007']
711,32738662,"Reaching reliable change using short, daily, cognitive training exercises delivered on a mobile application: The case of Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions in a subclinical cohort.","BACKGROUND


Relationship Obsessive Compulsive Disorder (ROCD) is a presentation of OCD centering on interpersonal relationships. The aim of this Randomized Control Trial (RCT) was to assess the efficacy of short, game like, daily cognitive interventions delivered via mobile application in reducing subclinical ROCD symptoms and associated phenomena.
METHODS


Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version) were randomized into: immediate-use group (iApp group; n = 25) and delayed-use group (dApp group; n = 25). The iApp group started using the evaluated cognitive-behavioral training application at baseline for 15 days (T0 to T1). The dApp group commenced using the application at T1 for 15 days (T1 to T2). All participants completed questionnaires at baseline (T0), 15 days from baseline (T1), and 30 days from baseline (T2).
RESULTS


Repeated measure MANOVAs showed significant Group (iApp vs. dApp) × Time (T0 vs. T1) interactions. These interactions indicated greater decrease in ROCD symptoms, OCD beliefs and social anxiety symptoms, as well as a greater increase in self-esteem in the iApp group compared to dApp group at T1. Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
LIMITATIONS


Sample size and the use of self-report measures limits the generalizability of the results.
CONCLUSIONS


Short, daily cognitive training interventions delivered via mobile applications may be useful in reducing subclinical ROCD symptoms and associated features. Further testing is needed for clinical populations.",2020,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
",['Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version'],"['immediate-use group (iApp group; n\xa0=\xa025) and delayed-use group (dApp group; n\xa0=\xa025', 'cognitive training exercises delivered on a mobile application']","['subclinical ROCD symptoms', 'Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions', 'ROCD symptoms, OCD beliefs and social anxiety symptoms', 'subclinical ROCD symptoms and associated phenomena', 'self-esteem', 'ROCD symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0088932', 'cui_str': '1-(diethylaminopropyl)-4-phenylpiperazine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0611703,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cerea', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy. Electronic address: silvia.cerea@unipd.it.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ghisi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Bottesi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Carraro', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Broggio', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, PO Box 167, Herzliya 46150, Israel. Electronic address: gdoron@idc.ac.il.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.043']
712,32739704,Aerobic exercise or stretching as add-on to inpatient treatment of depression: Similar antidepressant effects on depressive symptoms and larger effects on working memory for aerobic exercise alone.,"BACKGROUND


Aerobic exercise (AE) has positive effects on symptom severity and cognitive symptoms of depression. Since data on AE as add-on to inpatient treatment in depression is still scarce, we conducted this double-blind randomized controlled study.
METHODS


Patients aged between 18 and 60 years were recruited into the study if Hamilton Depression Rating Scale 17 (HDRS-17) score was >16. Participants were randomly assigned to either AE or basic stretching activities (control), which took place 3x/week for 6 weeks. Primary outcome was depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI). Further physiological and psychological variables and cognitive performance were assessed as secondary outcomes.
RESULTS


Forty-two patients were included in the analysis (exercise: n = 22; control: n = 20). Regardless of group allocation, we found a significant short-term time effect for symptom-severity (HDRS17: p<0.001, η²=0.70; BDI: p<0.001, η²=0.51), mental toughness (p<0.001, η²=0.32), physical self-description endurance score (p = 0.013, η²=0.16), cognitive flexibility (p = 0.013, η²=0.14), and body mass index (BMI) (p = 0.006, η²=0.19). Working memory showed a significant time by group interaction in favor of AE (p = 0.043, η²=0.10). Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period. Finally, self-reported physical activity increased significantly from baseline to follow-up (p = 0.014, η²=0.15).
LIMITATIONS


The sample-size is rather small. The control intervention might have been too active as to find a time by group interaction for symptom severity.
CONCLUSIONS


AE was associated with comparably large depression alleviation vs. stretching and with add-on benefits on working memory.",2020,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","['Forty-two patients were included in the analysis (exercise: n\xa0=\xa022; control: n\xa0=\xa020', 'Patients aged between 18 and 60 years']","['Aerobic exercise or stretching', 'Aerobic exercise (AE', 'AE or basic stretching activities (control', 'aerobic exercise alone']","['mental toughness', 'depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI', 'physical activity', 'symptom severity, mental toughness and BMI', 'physical self-description endurance score', 'Hamilton Depression Rating Scale 17 (HDRS-17) score', 'cognitive flexibility', 'body mass index (BMI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",42.0,0.225194,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland; Private Clinic Wyss, Muenchenbuchsee, Switzerland. Electronic address: christian.imboden@pkwyss.ch.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland; Private Clinic Sonnenhalde, Riehen, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.052']
713,32739569,Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach.,"BACKGROUND & AIMS


Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs.
METHODS


We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group.
RESULTS


Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call.
CONCLUSIONS


In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125.",2020,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","['individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening', 'patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT', 'reminding health center patients who had not previously completed a FIT to complete a mailed FIT']",['live phone call primer (n = 1203) or a text message primer'],"['FIT completion rate', 'FIT completion rates', 'voice message']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332127', 'cui_str': 'No record of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]",2825.0,0.236928,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon. Electronic address: gloria.d.coronado@kpchr.org.'}, {'ForeName': 'Denis B', 'Initials': 'DB', 'LastName': 'Nyongesa', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Escaron', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Younger', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Harbison', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.053']
714,32740235,Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma.,"OBJECTIVE


The optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear.
METHODS


S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity.
RESULTS


Between 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA.
CONCLUSIONS


We have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging.",2020,"Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy.","['103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7', 'resectable pancreatic ductal adenocarcinoma (PDA', 'Resectable Pancreatic Ductal Adenocarcinoma', 'resectable PDA', '73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy', 'Between 2015 and 2018, 147 patients were randomized', '44 (30%) were deemed ineligible (43 by central review']","['SWOG S1505', 'perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel', 'Gemcitabine/Nab-paclitaxel']","['vascular reconstruction', 'complete or major pathologic response', 'grade 3-5 postoperative complication rate', 'resection rate, margin positivity, pathologic response, and toxicity']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",147.0,0.0486099,"Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy.","[{'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Ahmad', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'SWOG Statistical and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Davendra P S', 'Initials': 'DPS', 'LastName': 'Sohal', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Namita S', 'Initials': 'NS', 'LastName': 'Gandhi', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Muhammad Shaalan', 'Initials': 'MS', 'LastName': 'Beg', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Washington University Siteman Cancer Center, St. Louis, Missouri.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Wade', 'Affiliation': 'Heartland NCORP/Cancer Care Specialists of Illinois, Decatur, Illinois.'}, {'ForeName': 'Elena Gabriela', 'Initials': 'EG', 'LastName': 'Chiorean', 'Affiliation': 'University of Washington, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistical and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Lowy', 'Affiliation': 'University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Philip', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, Michigan.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}]",Annals of surgery,['10.1097/SLA.0000000000004155']
715,32776101,"Changes in Biomarkers of Exposure on Switching From a Conventional Cigarette to the glo Tobacco Heating Product: A Randomized, Controlled Ambulatory Study.","INTRODUCTION


Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes.
AIMS AND METHODS


This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90.
RESULTS


In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers.
CONCLUSION


glo is a reduced-exposure tobacco product.
IMPLICATIONS


This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely.
CLINICAL TRIAL REGISTRATION


ISRCTN81075760.",2021,"For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls.","['subjects asked to refrain from combustible cigarette smoking', 'Control groups include smokers who are abstaining from cigarette smoking and never-smokers']","['valine (CEVal', 'Tobacco heating products (THPs', 'N-(2-cyanoethyl']","['tobacco smoke toxicants', 'exhaled carbon monoxide', 'number of BoE']","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}]","[{'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0018851', 'cui_str': 'Heating'}]","[{'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0117907,"For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Gale', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McEwan', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Oscar M', 'Initials': 'OM', 'LastName': 'Camacho', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hardie', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Proctor', 'Affiliation': 'British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa135']
716,32768361,"One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study.","PURPOSE


A phase 3 trial (MERCURY-1) investigated efficacy and safety of a once-daily, fixed-dose combination (FDC) of netarsudil and latanoprost, compared with each active component, in reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A planned 3-month analysis demonstrated the superiority of netarsudil/latanoprost FDC over its individual active components at every assessment. Herein, the 12-month efficacy and safety of netarsudil/latanoprost FDC are reported.
DESIGN


Double-masked, randomized, active-controlled, parallel-group trial.
PARTICIPANTS


Patients had unmedicated IOP >20 to <36 mmHg in both eyes at 8:00 am and met other standard criteria for OAG or OHT.
METHODS


Randomization to once-daily netarsudil 0.02%/latanoprost 0.005% FDC (n = 238), netarsudil 0.02% only (n = 243), or latanoprost 0.005% only (n = 237). Patients instilled study drug into each eye between 8:00 pm and 10:00 pm.
MAIN OUTCOME MEASURES


IOP was obtained at 8:00 am, 10:00 am, and 4:00 pm on day 1 (baseline); at weeks 2 and 6; and at months 3, 6, 9, and 12. Ocular and systemic safety were evaluated up to month 12.
RESULTS


Netarsudil/latanoprost FDC maintained statistically superior IOP lowering compared to its components at every assessment for 12 months. Least squares mean diurnal IOP (± standard error) at month 12 was 16.2 ± 0.23 mmHg for netarsudil/latanoprost FDC, 17.9 ± 0.20 mmHg for netarsudil, and 17.6 ± 0.18 mmHg for latanoprost (P < 0.05 for netarsudil/latanoprost FDC versus each comparator). The safety profile of netarsudil/latanoprost FDC was consistent with its individual components. The proportion of patients who experienced at least 1 adverse event (AE) was 82.8% (197/238) in the netarsudil/latanoprost FDC group, 78.2% (190/243) in the netarsudil group, and 54.0% (128/237) in the latanoprost group. The most common AE was conjunctival hyperemia, mostly of mild severity, with an incidence of 63.0% in the netarsudil/latanoprost FDC treatment group compared with 51.4% in the netarsudil group and 21.9% in the latanoprost group.
CONCLUSIONS


Results at 12 months revealed superior efficacy for netarsudil/latanoprost FDC compared with the individual components, netarsudil and latanoprost, at every time point assessed and an ocular tolerability profile similar to that of netarsudil alone.",2020,"The most common AE was conjunctival hyperemia, mostly of mild severity, with an incidence of 63.0% in the netarsudil/ latanoprost FDC treatment group compared with 51.4% in the netarsudil group and 21.9% in the latanoprost group.
","['Patients had unmedicated IOP >20 to <36 mmHg in both eyes at 8:00 am and met other standard criteria for OAG or OHT', 'patients with open-angle glaucoma (OAG) or ocular hypertension (OHT']","['Netarsudil and Latanoprost Fixed-Dose Combination', 'netarsudil/latanoprost FDC', 'latanoprost', 'latanoprost FDC', 'fixed-dose combination (FDC) of netarsudil and latanoprost']","['elevated intraocular pressure (IOP', 'ocular tolerability profile', 'Ocular and systemic safety', 'efficacy and safety', 'conjunctival hyperemia']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}]",,0.143493,"The most common AE was conjunctival hyperemia, mostly of mild severity, with an incidence of 63.0% in the netarsudil/ latanoprost FDC treatment group compared with 51.4% in the netarsudil group and 21.9% in the latanoprost group.
","[{'ForeName': 'Jacob W', 'Initials': 'JW', 'LastName': 'Brubaker', 'Affiliation': 'Sacramento Eye Consultants, Sacramento, California. Electronic address: jbrubaker@SacEye.com.'}, {'ForeName': 'Savak', 'Initials': 'S', 'LastName': 'Teymoorian', 'Affiliation': 'Harvard Eye Associates, Laguna Hills, California.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Sacramento Eye Consultants, Sacramento, California; Aerie Pharmaceuticals, Inc., Durham, North Carolina.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Usner', 'Affiliation': 'Statistics & Data Corporation, Tempe, Arizona.'}, {'ForeName': 'Hayley J', 'Initials': 'HJ', 'LastName': 'McKee', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, North Carolina.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Ramirez', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, North Carolina.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, North Carolina.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, North Carolina.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.05.008']
717,32779029,Virtual reality for intravenous placement in the emergency department-a randomized controlled trial.,"This study sought to determine whether adding virtual reality (VR) was superior to standard of care alone in facilitating reduction in pain and anxiety among children who underwent intravenous catheterization in the emergency department (ED). Sixty-six children aged 6-16 years who needed intravenous placement received VR, or standard of care in the ED (videos, television, iPad, child life specialist). Outcome measures included change in pain score, level of anxiety, patient and parent satisfaction (pain and anxiety), number of trials, and procedure time. Compared with controls, the intervention group had similar age, sex, number of trials, and anesthetic use. Time of procedure was shorter in the VR group (median 5 min) but this was not statistically significant compared with 7 min for the control group. Pain in the intervention group was lower, even before the procedure. Difference in pain (before and after) and anxiety (after the procedure) were similar in both groups. Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.Trial registration: clinicaltrials.gov ID NCT03681730, https://clinicaltrials.gov/ct2/show/NCT03681730 What is Known: • Virtual reality is an evolving computer technology that shows some promise in the areas of acute and chronic pain management due to its ability to create effective distraction. What is New: • We report that among children in the emergency setting with intravenous catheterization, satisfaction from the use of VR for anxiety management should support implementation of VR systems for this procedure.",2021,"Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.","['Sixty-six children aged 6-16 years who needed intravenous placement received VR, or standard of care in the ED (videos, television, iPad, child life specialist', 'children who underwent intravenous catheterization in the emergency department (ED']","['virtual reality (VR', 'https://clinicaltrials.gov/ct2/show/NCT03681730']","['pain and anxiety', 'Time of procedure', 'anxiety', 'Satisfaction from anxiety management', 'Pain', 'change in pain score, level of anxiety, patient and parent satisfaction (pain and anxiety), number of trials, and procedure time', 'pain']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",66.0,0.112043,"Satisfaction from anxiety management was higher for the VR group (p < 0.007) and children rated VR significantly more ""fun"" (p < 0.024).Conclusion: VR was an effective distraction tool and increased satisfaction from anxiety management for this common pediatric procedure, and should be incorporated in management of anxiety in children in the ED setting.","[{'ForeName': 'Ran D', 'Initials': 'RD', 'LastName': 'Goldman', 'Affiliation': 'The Pediatric Research in Emergency Therapeutics (PRETx) Program, Division of Pediatric Emergency Medicine, Department of Pediatrics, University of British Columbia, Vancouver, Canada. rgoldman@cw.bc.ca.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Behboudi', 'Affiliation': 'Emergency Medicine, Peace Arch Hospital, White Rock, BC, Canada.'}]",European journal of pediatrics,['10.1007/s00431-020-03771-9']
718,32770246,QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.,"INTRODUCTION


The QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service.
METHODS


QuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking.
RESULTS


Retention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups.
CONCLUSIONS


Clients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm.
TRIAL REGISTRATION NUMBER


ACTRN12617000849392.
IMPLICATIONS


This pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.",2021,Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked.,"['smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service', 'smoking cessation following residential detoxification']","['NVP', 'combination nicotine replacement therapy (NRT', 'nicotine vaping product (NVP', 'telephone Quitline behavioural support and either 12-weeks supply of NRT, or an NVP', 'nicotine replacement and Quitline-delivered cognitive behavioural counselling', 'QuitNic', 'NRT', 'nicotine replacement therapy', 'nicotine']","['cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms', 'Mean CPD', 'Treatment adherence and acceptability, self-reported abstinence', 'quit smoking cigarettes', 'Acceptability ratings', 'Cravings and withdrawal symptoms']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",,0.148324,Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked.,"[{'ForeName': 'Billie', 'Initials': 'B', 'LastName': 'Bonevski', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre and Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wynne', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Gartner', 'Affiliation': 'Faculty of Medicine, School of Public Health, The University of Queensland, Herston, Queensland, Australia.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Borland', 'Affiliation': 'The Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Segan', 'Affiliation': 'The Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Skelton', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Lyndell', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Ramez', 'Initials': 'R', 'LastName': 'Bathish', 'Affiliation': 'Monash Addiction Research Centre and Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Hunter Medical Research Institute (HMRI), Lambton, NSW, Australia.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Guillaumier', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre and Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa143']
719,32771456,Phaco-endocycloplasty versus Phacotrabeculectomy in Primary Angle-Closure Glaucoma: A Prospective Randomized Study.,"PURPOSE


To investigate the efficacy and safety of endocycloplasty (ECPL) versus trabeculectomy when it is combined with phacotrabeculectomy in medically controlled or uncontrolled primary angle-closure (PAC) or primary angle-closure glaucoma (PACG) after laser peripheral iridotomy (LPI).
DESIGN


Prospective, interventional, randomized control trial.
PARTICIPANTS


Subjects with PAC/PACG aged 30 years or more after LPI with visually significant cataract.
METHODS


Subjects underwent computer-generated randomized sequence of either procedure, phaco-ECPL or phacotrabeculectomy, for standard indications of combined glaucoma and cataract surgery.
MAIN OUTCOME MEASURES


Primary outcome measure was intraocular pressure (IOP). Secondary outcome measures were best-corrected visual acuity (BCVA), number of antiglaucoma medications (AGMs), complications, and failure.
RESULTS


A total of 45 eyes of 39 subjects were included. A total of 25 eyes underwent phaco-ECPL, and 20 eyes underwent phacotrabeculectomy. Five eyes in the phaco-ECPL group were excluded; 2 were excluded because laser was not delivered per protocol, and the rest had less than 3 months of follow-up. Mean follow-up was 16.25±8.1 months in the phaco-ECPL group and 18.9±9.5 months in the phacotrabeculectomy group. Mean preoperative and postoperative IOP, AGM, and BCVA did not differ between the groups. However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
CONCLUSIONS


Both procedures are efficacious in lowering IOP in PACG, but the rate of complication and interventions for these were more in the phacotrabeculectomy group. Longer follow-up is indicated to probe the feasibility of phaco-ECPL, a minimally invasive procedure, as first-step management in PAC disease, for which combined cataract and glaucoma surgery is indicated.",2020,"However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
","['A total of 45 eyes of 39 subjects were included', 'Subjects with PAC/PACG aged 30 years or more after LPI with visually significant cataract', 'Primary Angle-Closure Glaucoma', 'Subjects underwent computer-generated randomized sequence of either', 'medically controlled or uncontrolled primary angle-closure (PAC) or primary angle-closure glaucoma (PACG) after laser peripheral iridotomy (LPI']","['procedure, phaco-ECPL or phacotrabeculectomy, for standard indications of combined glaucoma and cataract surgery', 'Phaco-endocycloplasty versus Phacotrabeculectomy', 'phacotrabeculectomy', 'phaco-ECPL', 'endocycloplasty (ECPL) versus trabeculectomy']","['intraocular pressure (IOP', 'best-corrected visual acuity (BCVA), number of antiglaucoma medications (AGMs), complications, and failure', 'rate of complications', 'Mean preoperative and postoperative IOP, AGM, and BCVA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0429528', 'cui_str': 'Angle closure'}, {'cui': 'C0017605', 'cui_str': 'Angle-closure glaucoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0395459', 'cui_str': 'Laser iridotomy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1167708', 'cui_str': 'Phacotrabeculectomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",39.0,0.155981,"However, the rate of complications (P = 0.011) and interventions (P = 0.047) was greater in the phacotrabeculectomy group.
","[{'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Pathak-Ray', 'Affiliation': 'Centre for Sight, Hyderabad, India. Electronic address: vpathakray@gmail.com.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Choudhari', 'Affiliation': 'VST Centre for Glaucoma, L V Prasad Eye Institute, L V Prasad Marg, Hyderabad, India.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.06.006']
720,32745830,A randomised trial comparing a brief online delivery of mindfulness-plus-values versus values only for symptoms of depression: Does baseline severity matter?,"BACKGROUND


Acceptance/mindfulness-based interventions often focus on (a) developing dispositional mindfulness and (b) pursuing personally meaningful and valued activities. Acceptance/mindfulness-based interventions can reduce depression, but little is known about the combined effects of components or the influence of baseline variables on outcomes. This study tested whether practicing a brief (10-min) mindfulness meditation over a 2-week period followed by a single values session (mindfulness+values) was more effective than values alone (values only) in reducing symptoms of depression. The study was delivered online and modules were fully self-help (i.e., no therapist contact).
METHODS


206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10) were randomised to: mindfulness+values condition or a 2-week wait period followed by the values session (i.e., values only condition). Symptoms of depression were assessed at baseline, after the 2-week mindfulness practice/wait period, and 1-week following the values session.
RESULTS


Reductions in depression and recovery rates were significantly greater following mindfulness+values than values only. Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression. Outcomes did not differ for those with low levels of depression. Rates of deterioration were higher than expected for values only participants.
LIMITATIONS


Conclusions are preliminary and tentative due to no follow-up period and a small sample. Drop-out was high (50%) and findings cannot be assumed to generalise to treatment seeking or more diverse samples.
CONCLUSIONS


Tentatively, results suggest mindfulness+values can significantly reduce depression, especially for individuals with higher baseline depression.",2020,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"['206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10']","['mindfulness-plus-values', 'practicing a brief (10-min) mindfulness meditation']","['Symptoms of depression', 'Rates of deterioration', 'depression and recovery rates']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",206.0,0.0678318,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom. Electronic address: Jessica.kingston@rhul.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woeginger', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.087']
721,32788067,Risk of Leukemia in Children With Peripheral Facial Palsy.,"Most children with peripheral facial palsy will not have a cause identified. Although leukemia can cause facial nerve palsy, the magnitude of the risk is unknown and recommendations for investigations are variable. We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network. In the course of the assessment for eligibility of the trial, from 644 acute-onset facial palsy presentations we identified 5 children with previously undiagnosed leukemia. We estimate the rate of leukemia in children with acute-onset facial palsy who present to emergency departments to be 0.6% (95% confidence interval 0.2% to 1.6%). In accordance with these cases, we suggest consideration of a screening CBC count for acute-onset peripheral facial palsy presentations in children before initiation of corticosteroid treatment.",2021,"We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network.","['children with peripheral facial palsy', '644 acute-onset facial palsy presentations we identified 5 children with previously undiagnosed leukemia', ""Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network"", 'Children With Peripheral Facial Palsy', 'children with acute-onset facial palsy']","['prednisolone', 'placebo']",['rate of leukemia'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266178', 'cui_str': 'Peripheral facial palsy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023418', 'cui_str': 'Leukemia'}]",5.0,0.28117,"We are currently conducting a randomized, placebo-controlled trial of prednisolone for the treatment of Bell's palsy in children within the Paediatric Research in Emergency Departments International Collaborative emergency research network.","[{'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': ""Emergency Department, Royal Children's Hospital, and Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia; Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia. Electronic address: franz.babl@rch.org.au.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Women's and Children's Hospital, Adelaide, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Osborn', 'Affiliation': ""Department of Haematology and Oncology, Women's and Children's Hospital, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Borland', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Perth Children's Hospital, and the Divisions of Emergency Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'West', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Monash Emergency Research Collaborative, School of Clinical Sciences at Monash Health, Monash University, and the Paediatric Emergency Department, Monash Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': ""Emergency Department, Royal Children's Hospital, and Murdoch Children's Research Institute, Parkville, Victoria, Australia; Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': ""Paediatric Research in Emergency Departments International Collaborative (PREDICT), Melbourne, Australia; Emergency Department, Starship Children's Hospital, and the Departments of Surgery and Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.06.029']
722,32830855,Clinician-Patient Racial/Ethnic Concordance Influences Racial/Ethnic Minority Pain: Evidence from Simulated Clinical Interactions.,"OBJECTIVE


Racial and ethnic minorities in the United States report higher levels of both clinical and experimental pain, yet frequently receive inadequate pain treatment. Although these disparities are well documented, their underlying causes remain largely unknown. Evidence from social psychological and health disparities research suggests that clinician-patient racial/ethnic concordance may improve minority patient health outcomes. Yet whether clinician-patient racial/ethnic concordance influences pain remains poorly understood.
METHODS


Medical trainees and community members/undergraduates played the role of ""clinicians"" and ""patients,"" respectively, in simulated clinical interactions. All participants identified as non-Hispanic Black/African American, Hispanic white, or non-Hispanic white. Interactions were randomized to be either racially/ethnically concordant or discordant in a 3 (clinician race/ethnicity) × 2 (clinician-patient racial/ethnic concordance) factorial design. Clinicians took the medical history and vital signs of the patient and administered an analogue of a painful medical procedure.
RESULTS


As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients. Contrary to our prediction, concordance was associated with increased pain report in Hispanic white patients. Finally, the influence of concordance on pain-induced physiological arousal was largest for patients who reported prior experience with or current worry about racial/ethnic discrimination.
CONCLUSIONS


Our findings inform our understanding of the sociocultural factors that influence pain within medical contexts and suggest that increasing minority, particularly non-Hispanic Black/African American, physician numbers may help reduce persistent racial/ethnic pain disparities.",2020,"As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients.","['Hispanic white patients', 'All participants identified as non-Hispanic Black/African American, Hispanic white, or non-Hispanic white', 'racially/ethnically concordant or discordant in a 3 (clinician race/ethnicity', 'Medical trainees and community members/undergraduates played the role of ""clinicians"" and ""patients,"" respectively, in simulated clinical interactions']",[],"['pain-induced physiological arousal', 'pain report']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0329859,"As predicted, clinician-patient racial/ethnic concordance reduced self-reported and physiological indicators of pain for non-Hispanic Black/African American patients and did not influence pain for non-Hispanic white patients.","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gianola', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Elizabeth A Reynolds', 'Initials': 'EAR', 'LastName': 'Losin', 'Affiliation': 'Department of Psychology, University of Miami, Miami, Florida, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa258']
723,32790051,The effect of symptom-tracking apps on symptom reporting.,"OBJECTIVE


The use of health apps is increasing worldwide, with a common feature being daily symptom tracking. However, symptom tracking has been shown to increase symptom reporting. This study investigated whether using a menstrual-monitoring app with a symptom-tracking feature increases symptom reporting compared to an app without this feature or no app at all.
DESIGN


Experimental study.
METHODS


Ninety-one participants were randomly allocated to use either a menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group. The number of period-related symptoms as well as general symptom reporting was assessed at baseline prior to group allocation and then 1 and 4 months later. The change in the proportion of people classified as high symptom reporters was also examined.
RESULTS


We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010). At the 4-month time point, significantly more participants in the symptom-tracking group were now classified as high period symptom reporters (baseline 50%, 4 months 70%, p = .031), while the other two groups did not change from baseline. There were no differences in general symptom reporting across the three groups.
CONCLUSION


A period-monitoring app with a symptom tracker may increase the reporting of period symptoms. This effect does not appear to generalize to broader symptom reporting. Further research is needed to support these findings and to examine the impact of symptom-tracking apps on daily functioning and health anxiety. Statement of contribution What is already known on this subject? The experience of transient symptoms is common in day-to-day life. These symptoms often do not have an underlying cause or are a sign of illness. Actively tracking symptoms has been shown to result in greater symptom reporting, symptom severity, and slower recovery from injury. The use of health apps is increasing, with a common feature being symptom tracking. Menstrual-monitoring apps, in particular, frequently require users to track symptoms. What does this study add? Using a menstrual-monitoring app with a symptom tracker for 4 months increases the number of period-specific symptoms reported compared a basic calendar app. A greater proportion of people were now classified as high period symptom reporters after using the symptom-tracking app. These effects do not seem to generalize to broader non-specific symptom reporting.",2020,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).",['Ninety-one participants'],"['menstrual-monitoring app with a symptom tracker or a simple calendar app, or to a no app control group']","['number of period-related symptoms', 'number of period-specific symptoms', 'period-related symptoms', 'general symptom reporting']","[{'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449955', 'cui_str': 'Number of periods'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}]",91.0,0.0449667,"We found that the symptom-tracking app group reported significantly more period-related symptoms at 4 months than the calendar app group (mean difference = 1.16 symptoms, p = .010).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'MacKrill', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Groom', 'Affiliation': 'Liggins Institute, University of Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}]",British journal of health psychology,['10.1111/bjhp.12459']
724,32787506,A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings.,"BACKGROUND AND OBJECTIVES


Many family members struggle to negotiate their aging relative's care with nursing home staff, potentially leading to depression and other negative outcomes for residents' families. This pilot study tested an intervention designed to empower residents' family members to attend and participate in nursing home care plan meetings.
RESEARCH DESIGN AND METHODS


We conducted a small, randomized, controlled trial of the Families Involved in Nursing home Decision-making (FIND) intervention, which used web conferencing to facilitate family participation in care plan meetings.
RESULTS


Overall, FIND was feasible and acceptable. Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
DISCUSSION AND IMPLICATIONS


FIND is a promising approach to reduce depression among family members of nursing home residents. Findings support the need for a follow-up clinical trial.",2020,"Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
","['family members of nursing home residents', ""empower residents' family members to attend and participate in nursing home care plan meetings""]",[],['depressive symptoms'],"[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0402854,"Family members who received the FIND intervention were more likely to experience decreased depressive symptoms than those who did not.
","[{'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Washington', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Kruse', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Popejoy', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'Jamie B', 'Initials': 'JB', 'LastName': 'Smith', 'Affiliation': 'University of Missouri, Columbia, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'The University of Pennsylvania School of Nursing, Philadelphia, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464820946927']
725,32803412,Effect of 2 years of calorie restriction on liver biomarkers: results from the CALERIE phase 2 randomized controlled trial.,"PURPOSE


Calorie restriction (CR) is an effective treatment for obesity-related liver and metabolic disease. However, CR studies in individuals without obesity are needed to see if CR could delay disease onset. Liver biomarkers indicate hepatic health and are linked to cardiometabolic disease. Our aim was to examine the effects of a 2-year CR intervention on liver biomarkers in healthy individuals without obesity.
METHODS


The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) study was a 2-year randomized controlled trial. Overall, 218 participants (body mass index: 25.1 ± 1.7 kg/m 2 ) were enrolled into a control group (n = 75) that ate ad libitum (AL), or a CR group (n = 143) that aimed to decrease energy intake by 25%. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin were measured during the trial.
RESULTS


At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed. However, sex-by-treatment-by-time interactions (P < 0.01) were observed, with CR (vs. control) inducing reduced ALT and GGT and increased AST in men only (P ≤ 0.02).
CONCLUSIONS


In metabolically healthy individuals without obesity, 2 years of CR improves several liver biomarkers, with potentially greater improvements in men. These data suggest that sustained CR may improve long-term liver and metabolic disease risk in healthy adults.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT00427193). Registered January 2007.",2020,"At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed.","['218 participants (body mass index: 25.1\u2009±\u20091.7\xa0kg/m 2 ', 'healthy adults', 'healthy individuals without obesity', 'individuals without obesity']","['Calorie restriction (CR', 'CR intervention', 'calorie restriction']","['Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin', 'bilirubin', 'reduced ALT and GGT and increased AST', 'liver biomarkers']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.110205,"At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA. jdorling326@gmail.com.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Sai K', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'JM, USDA, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-020-02361-7']
726,32800508,NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study.,"OBJECTIVES


This study examined the effects of sacubitril/valsartan on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and determined patient characteristics associated with favorable NT-proBNP reduction response.
BACKGROUND


NT-proBNP levels reflect cardiac wall stress and predict event risk in patients with acute decompensated heart failure (ADHF).
METHODS


Post-hoc analysis of the TRANSITION (Comparison of Pre- and Post-discharge Initiation of Sacubitril/Valsartan Therapy in HFrEF Patients After an Acute Decompensation Event) study, including stabilized ADHF patients with reduced ejection fraction, randomized to open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge. NT-proBNP was measured at randomization (baseline), discharge, and 4 and 10 weeks post-randomization. A favorable NT-proBNP response was defined as reduction to ≤1,000 pg/ml or >30% from baseline.
RESULTS


In patients receiving sacubitril/valsartan in-hospital, NT-proBNP was reduced by 28% at discharge, with 46% of patients obtaining favorable NT-proBNP reduction response compared with a 4% reduction and 18% favorable response rate in patients initiated post-discharge (p < 0.001). NT-proBNP was reduced similarly in patients initiating sacubitril/valsartan pre- and post-discharge (reduction at 4 weeks: 25%/22%; 10 weeks: 38%/34%) with comparable favorable response rates (46%/42% and 51%/48% at 4 and 10 weeks, respectively). NT-proBNP favorable response at 4 weeks was associated with lower risk of first heart failure (HF) rehospitalization or cardiovascular death through 26 weeks (hazard ratio: 0.57; 95% confidence interval [CI]: 0.38 to 0.86; p = 0.007). Predictors of a favorable response at 4 weeks were starting dose ≥49/51 mg twice daily, higher baseline NT-proBNP, lower baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor-naive or angiotensin receptor blocker-naive, and no prior myocardial infarction.
CONCLUSIONS


In-hospital initiation of sacubitril/valsartan produced rapid reductions in NT-proBNP, statistically significant at discharge. A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile. (Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event [TRANSITION]; NCT02661217).",2020,A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile.,"['patients with acute decompensated heart failure (ADHF', 'HFrEF Patients', 'Failure Patients With Reduced Ejection Fraction', 'Hospitalized Heart', 'stabilized ADHF patients with reduced ejection fraction']","['LCZ696 Therapy', 'proBNP', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'Sacubitril/Valsartan Therapy', 'open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge']","['lower risk of first heart failure (HF) rehospitalization or cardiovascular death', 'favorable NT-proBNP reduction response', 'NT-proBNP', 'N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels', 'response rates', 'baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor-naive or angiotensin receptor blocker-naive, and no prior myocardial infarction', 'response rate', 'favorable NT-proBNP response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}]","[{'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",,0.162888,A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile.,"[{'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: dpascual@um.es.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany; Clinic for Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany; German Cardiovascular Research Center, partner site Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Noè', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schwende', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Butylin', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.012']
727,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND


In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS


PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS


At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS


In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
728,32807403,Effect of crystalline phase assemblage on reliability of 3Y-TZP.,"STATEMENT OF PROBLEM


Strengthening mechanisms of zirconia ceramics stabilized with 3 mol% yttria (3Y-TZP) are complex and dictated by the crystalline phase assemblage. Although their clinical performance for dental restorations has been excellent, there is evidence that framework fractures do occur and have been underreported. Meanwhile, the relationship between phase assemblage and reliability of 3Y-TZP is not properly understood.
PURPOSE


The purpose of this in vitro study was to elucidate the relationship between crystalline phase assemblage and the reliability of 3Y-TZP and to calculate the associated probabilities of survival.
MATERIAL AND METHODS


Disks of 3Y-TZP were prepared from cylindrical blanks and randomly assigned to 12 experimental groups (n=20 per group). Different crystalline phase assemblages were produced by either varying the sintering temperature from 1350 °C to 1600 °C and/or treating the surface by airborne-particle abrasion with 50-mm alumina particles at a pressure of 0.2 MPa for 1 minute with or without subsequent heat treatment. Crystalline phases were analyzed by standard and grazing incidence X-ray diffraction (GIXRD). The relationship between phase assemblage and reliability was determined by measuring the biaxial flexural strength (BFS) according to ISO standard 6872 and by using Weibull statistics to calculate the Weibull modulus (m), probability of survival, and maximum allowable stresses. XRD results were analyzed by ANOVA to detect statistically significant differences between groups. Adjustment for all pairwise group comparisons was made using the Tukey method (α=.05).
RESULTS


Standard incidence XRD confirmed the presence of a small amount of cubic phase after sintering at 1350 °C. A cubic-derived nontransformable tetragonal t'-phase was observed at sintering temperatures of 1450 °C and above, the amount of which increased linearly. GIXRD revealed that airborne-particle abraded groups sintered at 1350 °C and 1600 °C had the highest variability in monoclinic phase fraction as a function of depth. These groups were also associated with the lowest reliability. Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550 °C were associated with the highest modulus (from 15.0 [1.4] to 20.9 [1.4]) and Ps (≥0.9999). The lower strength and reliability of groups sintered at 1600 °C was consistent with the presence of a significant amount of nontransformable t'-phase. The pattern of BFS results indicated that ferro-elastic domain switching was a dominant strengthening mechanism in 3Y-TZP.
CONCLUSIONS


The present study first reported on the detrimental effect of the cubic-derived nontransformable t'-phase on the mechanical properties of 3Y-TZP. It was demonstrated that phase assemblage determined reliability and was directly linked to the probability of survival.",2020,"Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550",['Disks of 3Y-TZP were prepared from cylindrical blanks and randomly assigned to 12 experimental groups (n=20 per group'],[],"['probability of survival', 'probability of survival (Ps', 'biaxial flexural strength (BFS', 'GIXRD', 'lower strength and reliability']","[{'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C1302752', 'cui_str': 'Abrasion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043301', 'cui_str': 'Xray Diffraction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0269623,"Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Denry', 'Affiliation': 'Professor, Iowa Institute for Oral Health Research, University of Iowa College of Dentistry and Department of Prosthodontics, Iowa City, Iowa. Electronic address: Isabelle-Denry@uiowa.edu.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Abdelaal', 'Affiliation': 'Clinical Assistant Professor, Division of Prosthodontics, Department of General Dentistry, East Carolina University School of Dental Medicine, Greenville, N.C.'}, {'ForeName': 'Deborah V', 'Initials': 'DV', 'LastName': 'Dawson', 'Affiliation': 'Professor, Department of Biostatistics, University of Iowa College of Public Health, Iowa City, Iowa.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Holloway', 'Affiliation': 'Professor and Head, Department of Prosthodontics, University of Iowa College of Dentistry, Iowa City, Iowa.'}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Kelly', 'Affiliation': 'Professor, Department of Reconstructive Sciences, University of Connecticut Health Center, Farmington, Conn.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.05.023']
729,32813124,Chest shielding in preterm neonates under phototherapy-a randomised control trial.,"Shielding the precordium can effect manifestation of haemodynamically significant patent ductus arteriosus (hsPDA). Preterm neonates born at ≤ 32 weeks of gestation if needed phototherapy within 72 h of birth and had no echocardiographically proven hsPDA were eligible to be enrolled in this open-label randomised controlled trial. In chest shielding group, in addition to the standard care, left side of the chest was covered using food grade aluminium foil during phototherapy while control group received standard care. Mean gestational age (weeks; 30.1 ± 1.5 vs 30.1 ± 1.6) was comparable in the two groups. However, neonates in the chest shield group had lower birth weight (g; 1281 ± 259 vs 1422 ± 307) and were more likely to be small-for-gestational age (21.6% vs 8.0%). It was seen that 4 (7.8%) babies in the chest shield group and 5 (10%) babies in the standard group developed hsPDA after starting phototherapy with relative risk (RR) of 0.78 (95% CI 0.22-2.75). The left atrium to aortic ratio was significantly different in the two groups with 1.5 ± 0.1 in the chest shield group and 1.8 ± 0.2 in standard group (p value 0.03).Conclusion: Chest shielding of preterm babies during phototherapy has no effect on the incidence of haemodynamically significant patent ductus arteriosus.Trial registration: Trial was registered with Clinical trial registry of India (CTRI/2018/01/011069). What is Known: • Chest shielding in preterm neonates under phototherapy has inconclusive effect on the manifestation of patent ductus arteriosus. What is New: • Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.",2021,• Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.,"['preterm neonates under', 'Preterm neonates born at ≤\u200932\xa0weeks of gestation if needed phototherapy within 72\xa0h of birth and had no echocardiographically proven hsPDA', 'Mean gestational age (weeks; 30.1\u2009±\u20091.5 vs 30.1\u2009±\u20091.6', 'haemodynamically significant patent ductus arteriosus (hsPDA']",['phototherapy'],"['manifestation of haemodynamically significant patent ductus arteriosus', 'left atrium to aortic ratio', 'hsPDA', 'lower birth weight', 'incidence of haemodynamically significant patent ductus arteriosus']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.133377,• Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.,"[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Chawla', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Suksham', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India. dr.sukshamj@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03763-9']
730,32838417,Correlation of Implant Stability between two Non-Invasive Methods Using Submerged and non submerged healing protocols; A randomized clinical trail.,"Various invasive and non-invasive methods have been used for measuring primary implant stability. Periotest damping device, and resonance frequency analysis (RFA) with the Osstell device have been classified as non-invasive methods.In this clinical randomized trial, a general correlation of primary implant stability was recorded using both the Osstell and Periotest device at the day of implant installation and 3 month after healing for the submerged and non submerged   loading protocols. The gender of included patients were investigated in the correlation of the two devices.Eighty completely edentulous patients were recruited, all patients were of age ranging from 50 to 69 years old. A single implant was installed in the midline of the completely edentulous mandible to improve retention of their lower denture. After implant installation, Implant Stability was recorded using the osstel and periotest device. Patients were then randomized into two groups using sealed envelopes; Submerged (S), and Non Submerged (NS). All ISQ and PTV were recorded at the day of implant installation, and 3 month after healing for both groups.When the ISQ was correlated to the (PTV), there was a moderate negative statistically significant correlation between the two readings, correlation coefficient= -0.466, p=0.000 . There tends to be a weak negative correlation between the two devices in the male group ,while there tends to be no correlation between the two devices in the female group After 3 month healing, there was no statistically significant correlation of the readings with in both groups ;NS and S ; Correlation coefficient =-0.014, -0.430, p=0.942, 0.052 respectively.   A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group. While there was no statistically significant correlation with in the male group for both groups.The present study concluded that there is a significant negative correlation between the two devices when recording primary implant stability, while this significance is lost after 3 month of loading when recording secondary implant stability. Gender would affect the implant stability recording, this would mainly due to the difference in bone density between the male and female group.",2020,"A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group.","['Eighty completely edentulous patients were recruited, all patients were of age ranging from 50 to 69 years old']","['sealed envelopes; Submerged (S), and Non Submerged (NS']","['Implant Stability', 'bone density', 'All ISQ and PTV']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]",,0.0639128,"A strong negative statistically significant correlation between the two devices for the female group for both, NS and the S group.","[{'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdel Aal', 'Affiliation': 'Lecturer- Removable Prosthodontic department -Faculty of dentistry-Cairo university.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El Far', 'Affiliation': 'Professor - Removable Prosthodontic department -faculty of dentistry-Cairo University.'}, {'ForeName': 'Nora Mohamed', 'Initials': 'NM', 'LastName': 'Sheta', 'Affiliation': 'Associate professor - Removable Prosthodontic Department - faculty of dentistry-Cairo University.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fayyad', 'Affiliation': 'Associate Professor - Removable Prosthodontic department Faculty of dentistry-Cairo University.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'El Desouky', 'Affiliation': 'Associate professor-Department of Bio-statistics and Epidemiology , National Cancer Institute , Cairo University Cairo.'}, {'ForeName': 'Nouran Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel Nabi', 'Affiliation': 'Faculty of dentistry -cairo university Associate professor Prosthodontics 25 street 263 new maadi EGYPT Cairo Cairo 19348 01001539310 Associate professor -Removable prosthodontic department- faculty of dentistry-Cairo University.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00130']
731,32789656,OCT evaluation of orthodontic surface sealants: a 12-month follow-up randomized clinical trial.,"OBJECTIVES


The aim of this single-center randomized controlled trial (NCT03753256) was to assess orthodontic surface sealant layer thickness and integrity in vivo during a 12-month follow-up by optical coherence tomography (OCT).
MATERIALS AND METHODS


Using a split-mouth design, quadrants of 20 patients treated with fixed orthodontic appliances were included. Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS). OCT scans were performed immediately after the application of the sealants and after 3, 6, 9, and 12 months. Sealant layer thicknesses and their integrity were determined at 5 regions of interest (ROIs) known for high risks of demineralization. Sealant integrity loss was determined using a self-developed scale.
RESULTS


A total of 16 patients successfully completed the study. The studied sealants showed significant differences in initial layer thickness. Mean layer thickness was significantly lower for PS (67.8 μm, (95% CI, 56.1-79.5)) than for OS (110.7 μm, (95% CI, 97.3-124.1)). Layer thickness loss was significant after 3 months for PS and after 6 months for OS. Sealant integrity was compromised in more than 50% of the ROIs already after 3 months for both sealants.
CONCLUSIONS


Patients treated with fixed orthodontic surface sealants lost the integrity of the protective layer in more than 50% of cases after 3 months, and the layer thickness of the sealants was significantly reduced after 3-6 months.
CLINICAL RELEVANCE


The protective effect against demineralization lesions of orthodontic sealants in patients treated with fixed appliances appears to be limited in time. Further preventive measures should be investigated.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03753256).",2021,Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS).,"['patients treated with fixed appliances', '16 patients successfully completed the study', '20 patients treated with fixed orthodontic appliances were included']","['orthodontic surface sealants', 'sealants Pro Seal® (PS) or Opal® Seal™ (OS']","['Layer thickness loss', 'initial layer thickness', 'OCT scans', 'Mean layer thickness', 'layer thickness of the sealants', 'Sealant integrity loss', 'integrity of the protective layer', 'Sealant integrity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0205266', 'cui_str': 'Intact'}]",16.0,0.185348,Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS).,"[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Orhan', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03462-7']
732,32809161,Neck dissection with harmonic instruments and electrocautery: a prospective comparative study.,"BACKGROUND


Harmonic instruments are becoming popular in head and neck surgeries. In this prospective, randomized study, the efficacy of the harmonic instruments and electrosurgical technique is compared.
MATERIALS AND METHODS


A total of 48 patients undergoing unilateral neck dissection were divided into two groups. In one group, surgery was performed using conventional hemostatic instruments while in the other, only harmonic instruments were used. The two techniques were then compared with regard to intra- and post-operative blood loss, complications in operating time, drain, tracheotomy and nasogastric tube duration, and post-operative hospital stay.
RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant. The average blood loss during surgery was significantly greater in the CH group (P = 0.003) as the number of hemoclips and resorbable ligature used (P = 0.002).
CONCLUSIONS


In contrast to what has been reported up to now, our study did not reveal a net advantage in the use of harmonic instruments with respect to classical instruments in terms of surgical outcome. On the contrary, harmonic tools had a higher complication rate (i.e., salivary fistula and lymphatic leak) probably due to the decreased ability of this instruments to permanently close glandular structures and lymphatic ducts. In these cases, a closure technique such as electrocautery or classic knot-tying should be used.",2021,"RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant.",['48 patients undergoing unilateral neck dissection'],"['Neck dissection with harmonic instruments and electrocautery', 'harmonic instruments and electrosurgical technique']","['average blood loss', 'operative blood loss, complications in operating time, drain, tracheotomy and nasogastric tube duration, and post-operative hospital stay', 'operative time', 'total suction drainage', 'complication rate', 'nasogastric tube']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]",48.0,0.0212225,"RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant.","[{'ForeName': 'Luigi Angelo', 'Initials': 'LA', 'LastName': 'Vaira', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy. luigi.vaira@gmail.com.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'De Riu', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Ligas', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Deiana', 'Affiliation': 'Direction, Hygiene and Hospital Infection Control Operative Unit, University Hospital of Sassari, Via Padre Manzella 4, 07100, Sassari, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Vacca', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Olindo', 'Initials': 'O', 'LastName': 'Massarelli', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Piombino', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University of Naples ""Federico II"" Hospital, Via Pansini 5, 80131, Napoli, Italy.'}, {'ForeName': 'Bruno Carlo', 'Initials': 'BC', 'LastName': 'Brevi', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Pisa, Via Roma 67, 56126, Pisa, Italy.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00897-w']
733,32842783,Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms: rationale and design.,"Thoracic aortic aneurysms are correlated with significant mortality and morbidity. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture. Angiotensin-converting enzyme inhibitors can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. A total of 636 patients will be randomized into one of three parallel arms, receiving captopril, atenolol or placebo. The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months. The trial will investigate the efficacy of angiotensin-converting enzyme inhibitors versus beta-blocker therapy in reducing the growth rate of thoracic aortic aneurysms and rupture.  Trial registration number:  NCT04224675.",2021,The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months.,['636 patients'],"['Captopril', 'Angiotensin-converting enzyme inhibitors', 'atenolol', 'angiotensin-converting enzyme inhibitors versus beta-blocker therapy', 'captopril, atenolol or placebo']","['rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",636.0,0.0442182,The primary end point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Spartalis', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Tzatzaki', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Dimitrios C', 'Initials': 'DC', 'LastName': 'Iliopoulos', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Spartalis', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Patelis', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Athanasiou', 'Affiliation': 'Laboratory of Experimental Surgery & Surgical Research, University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Stavroula A', 'Initials': 'SA', 'LastName': 'Paschou', 'Affiliation': '1st Department of Cardiology, Hippokration Hospital, National & Kapodistrian University of Athens, Medical School, Athens, Greece.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Voudris', 'Affiliation': 'Division of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Siasos', 'Affiliation': '1st Department of Cardiology, Hippokration Hospital, National & Kapodistrian University of Athens, Medical School, Athens, Greece.'}]",Future cardiology,['10.2217/fca-2020-0062']
734,32843299,Effect of repetitive transcranial magnetic stimulation on the cognitive impairment induced by sleep deprivation: a randomized trial.,"OBJECTIVE


Currently, an efficient method for improving cognitive impairment due to sleep deprivation (SD) is lacking. The aim of this study is to evaluate the effect of high-frequency repetitive transcranial magnetic stimulation (rTMS) during SD on reversing the adverse effects of SD.
METHODS


A total of 66 healthy people were randomized into the rTMS group and sham group. Both groups were deprived of sleep for 24 h. During SD, participants were asked to complete several cognitive tasks and underwent mood assessments. Saliva cortisol levels, plasma concentrations of brain-derived neurotrophic factor (BDNF), precursor BDNF (proBDNF), and tissue-type plasminogen activator (tPA), and frontal blood activation were detected before and after SD. The rTMS group received real rTMS stimulation for 2 sessions of 10 Hz rTMS (40 trains of 50 pulses with a 20-second intertrain interval) to the left dorsolateral prefrontal cortex and the sham group received sham stimulation during SD.
RESULTS


Twenty-four hours of SD induced a reduced accuracy in the n-back task, increases in both anxiety and depression, increased cortisol levels, decreased frontal blood activation and decreased BDNF levels in healthy people. Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
CONCLUSIONS


Twenty-four hours of SD induced a cognitive impairment. The administration of high-frequency rTMS during sleep deprivation exerted positive effects on HPA axis and frontal activation and might help alleviate cognitive impairment in the long term.",2021,"Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
","['cognitive impairment induced by sleep deprivation', '66 healthy people']","['real rTMS stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation']","['hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation', 'HPA axis and frontal activation', 'consumption of plasma proBDNF', 'cognitive impairment', 'Saliva cortisol levels, plasma concentrations of brain-derived neurotrophic factor (BDNF), precursor BDNF (proBDNF), and tissue-type plasminogen activator (tPA), and frontal blood activation', 'anxiety and depression, increased cortisol levels, decreased frontal blood activation and decreased BDNF levels']","[{'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032144', 'cui_str': 'Plasminogen activator'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1295655', 'cui_str': 'Increased cortisol level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.06412,"Notably, rTMS improved the hyperactivity of the hypothalamic-pituitary-adrenal axis and decreased frontal blood activation induced by SD, and reduced the consumption of plasma proBDNF.
","[{'ForeName': 'Shangda', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Hetong', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yueran', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Lyu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Mou', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Gongde', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; The Key Laboratory of Mental Disorder Management in Zhejiang Province, Hangzhou, China; Brain Research Institute of Zhejiang University, Hangzhou, China; Zhejiang Engineering Center for Mathematical Mental Health, Hangzhou, China. Electronic address: xuyizju@zju.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.06.019']
735,32841169,Exploring the impact of pain management programme attendance on complex regional pain syndrome (CRPS) patients' decision making regarding immunosuppressant treatment to manage their chronic pain condition.,"Objectives Complex regional pain syndrome (CRPS) is a rare chronic pain condition for which no curative treatment exists. Patients in tertiary centres are often required to make decisions about treatment options. This study was conducted to explore how prior attendance of a pain management program might alter patients' decision making processes. Methods This qualitative study uses focus groups to gather patient views on an immunosuppressant drug treatment (mycophenolate) for the management of CRPS. Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP. Outcomes were considered within the framework of Leventhal's Common Sense Model (CSM) in relation to the decision making process. Results Thematic analysis identified differing themes for each group. Group 1: (1) Medication as a positive form of treatment, (2) The trial/drug and (3) Pacing. Group 2: (1) Medication as form of treatment, (2) Other forms of support/treatment and (3) Side effects of mycophenolate. Group 3: (1) Varied view of medication, (2) Consideration of other forms of support and (3) Side effects. Conclusions Attendance on a PMP might provide patients with skills to better manage uncertainty when faced with various treatment options. Leventhal's model goes some way to explaining this. The specific importance of, and benefit from understanding pacing when commencing an effective drug treatment for chronic pain became apparent.",2020,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,['complex regional pain syndrome (CRPS) patients'],"['immunosuppressant drug treatment (mycophenolate', 'pain management programme attendance', 'mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP', 'pain management program', 'mycophenolate']",[],"[{'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],6.0,0.0247237,Participants were allocated to one of three focus groups based on their treatment journey; Group 1 (n=3) were involved in a recent mycophenolate drug trial; Group 2 (n=5) were neither involved in the trial nor attended a Pain Management Programme (PMP); Group 3 (n=6) were not involved in the trial but had attended a PMP.,"[{'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Harrison', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Twiddy', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, UK.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0142']
736,32844309,Age is negatively associated with upper limb recovery after conventional but not robotic rehabilitation in patients with stroke: a secondary analysis of a randomized-controlled trial.,"BACKGROUND


There is consistent evidence that robotic rehabilitation is at least as effective as conventional physiotherapy for upper extremity (UE) recovery after stroke, suggesting to focus research on which subgroups of patients may better respond to either intervention. In this study, we evaluated which baseline variables are associated with the response after the two approaches.
METHODS


This is a secondary analysis of a randomized-controlled trial comparing robotic and conventional treatment for the UE. After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment. Variables associated with the response were identified in a univariate analysis. Then, variables independently associated with recovery were investigated, in the whole group, and the two groups separately.
RESULTS


A sample of 190 patients was evaluated after the treatment; 121 were responders. Age, baseline impairment, and neglect were significantly associated with worse response to the treatment. Age was the only independently associated variable (OR 0.967, p = 0.023). Considering separately the two interventions, age remained negatively associated with recovery (OR 0.948, p = 0.013) in the conventional group, while none of the variables previously identified were significantly associated with the response to treatment in the robotic group.
CONCLUSIONS


We found that, in our sample, age is significantly associated with the outcome after conventional but not robotic UE rehabilitation. Possible explanations may include an enhanced positive attitude of the older patients towards technological training and reduced age-associated fatigue provided by robotic-assisted exercise. The possibly higher challenge proposed by robotic training, unbiased by the negative stereotypes concerning very old patients' expectations and chances to recover, may also explain our findings.
TRIAL REGISTRATION NUMBER


NCT02879279.",2021,"After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment.","['A sample of 190 patients was evaluated after the treatment; 121 were responders', 'patients with stroke']",['robotic rehabilitation'],['Fugl-Meyer Assessment UE score'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",190.0,0.0894912,"After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy. mgermanotta@dongnocchi.it.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Macchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Galeri', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Diverio', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Catiuscia', 'Initials': 'C', 'LastName': 'Falsini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Martini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mosca', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Langone', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Carrozza', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aprile', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci 269, 50143, Florence, Italy.'}]",Journal of neurology,['10.1007/s00415-020-10143-8']
737,32869064,Intradiscal Platelet-Rich Plasma Injection for Discogenic Low Back Pain and Correlation with Platelet Concentration: A Prospective Clinical Trial.,"OBJECTIVE


Discogenic pain is common cause of low back ache and may result in significant morbidity. Platelet-rich plasma (PRP) is an upcoming regenerative therapy that has treatment potential for this condition. The objective of this study was to correlate platelet concentration in intradiscal PRP injection with improvement in low back pain and functional status at three and six months.
DESIGN


Prospective single-arm interventional study.
SETTING


Outpatient pain clinic and operation theater.
SUBJECTS


Twenty-five patients with discogenic pain diagnosed by clinical means and imaging with confirmation by provocative discography were recruited.
METHODS


The patients received PRP injection at a single or multiple disc levels. Preprocedure numerical rating scale (NRS) pain scores and Oswestry Disability Index (ODI) scores were calculated. Platelet counts of patients and PRP samples were measured. At three and six months postprocedure, NRS and ODI scores were measured, and improvement in these scores was correlated with platelet concentrations in the PRP sample.
RESULTS


Twenty patients completed the study. The improvement in NRS and ODI scores positively correlated with platelet concentrations in the PRP sample. We determined the correlation coefficient (r) of platelet concentrations with a reduction in NRS at three months (r = 0.65) and six months (r = 0.73) and in ODI score at three months (r = 0.72) and six months (r = 0.7).
CONCLUSIONS


This study supports the use of intradiscal PRP for treatment of discogenic pain with preferably higher platelet counts to elicit a favorable response.",2020,The improvement in NRS and ODI scores positively correlated with platelet concentrations in the PRP sample.,"['Twenty-five patients with discogenic pain diagnosed by clinical means and imaging with confirmation by provocative discography were recruited', 'Twenty patients completed the study', 'Outpatient pain clinic and operation theater']","['Intradiscal Platelet-Rich Plasma Injection', 'PRP injection', 'intradiscal PRP', 'Platelet-rich plasma (PRP']","['low back pain and functional status', 'Platelet counts', 'NRS and ODI scores', 'Preprocedure numerical rating scale (NRS) pain scores and Oswestry Disability Index (ODI) scores', 'ODI score']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3662528', 'cui_str': 'Discogenic pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0203206', 'cui_str': 'Discogram'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.0613979,The improvement in NRS and ODI scores positively correlated with platelet concentrations in the PRP sample.,"[{'ForeName': 'Dhruv', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Titiksha', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Nimisha', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Paswan', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Rajeev Kumar', 'Initials': 'RK', 'LastName': 'Dubey', 'Affiliation': 'Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa254']
738,32858228,DO-HEALTH: Vitamin D3 - Omega-3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors.,"DO-HEALTH is a multi-center clinical trial among 2157 community-dwelling European men and women age 70 and older. The 2x2x2 randomized-control factorial design trial tested the individual and additive benefit, as well as the cost-effectiveness, of 3 interventions: vitamin D 2000 IU/day, omega-3 fatty acids 1000 mg/day (EPA + DHA, ratio 1:2), and a 30-minute 3 times/week home exercise (strength versus flexibility). Each treatment tested has shown considerable prior promise from mechanistic studies, small clinical trials, or large cohort studies, in the prevention of common age-related chronic diseases, but definitive data are missing. DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty). As the 3 interventions have distinct mechanisms of action for each of the 6 primary endpoints, a maximum benefit is expected for their additive benefit as a ""multi-modal"" intervention. The trial duration is 3 years with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls. Baseline and follow-up blood samples were collected in all participants to measure changes in 25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations. Our objective was to test interventions that are expected to promote healthy aging and longer life expectancy and that can be easily and safely implemented by older community-dwelling adults.",2021,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","['healthy aging among European seniors', 'older community-dwelling adults', '3\u202fyears with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls', '2157 community-dwelling European men and women age 70 and older']","['3 interventions: vitamin D 2000\u202fIU/day, omega-3 fatty acids 1000']","['falls and injurious falls, joint pain, oral health, quality of life, and incident frailty', 'systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections', '25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations']","[{'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",2157.0,0.100229,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","[{'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland; University Clinic for Acute Geriatric Care, City Hospital Waid&Triemli, Zurich, Switzerland. Electronic address: Heike.Bischoff@usz.ch.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Rival', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': 'Division of Bone Diseases, Geneva University Hospitals, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Reto W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': 'University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield Medical School, United Kingdom; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José A P', 'Initials': 'JAP', 'LastName': 'da Silva', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blauth', 'Affiliation': 'Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ferrari', 'Affiliation': 'Ferrari Data Solutions, Feldmeilen, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106124']
739,32864734,Zolpidem increases sleep efficiency and the respiratory arousal threshold without changing sleep apnoea severity and pharyngeal muscle activity.,"KEY POINTS


A decreased respiratory arousal threshold is one of the main contributors to obstructive sleep apnoea (OSA) pathogenesis. Several recent studies have sought to find a drug capable of increasing the respiratory arousal threshold without impairing pharyngeal muscle activity to reduce OSA severity, with variable success. Here we show that zolpidem increases the respiratory arousal threshold by ∼15%, an effect size which was insufficient to systematically decrease OSA severity as measured by the apnoea-hypopnoea index. Unlike recent physiological findings that showed paradoxical increases in pharyngeal muscle responsiveness during transient manipulations of airway pressure, zolpidem did not alter pharyngeal muscle responsiveness during natural sleep. It did, however, increase sleep efficiency without changing apnoea length, oxygen desaturation, next-day perceived sleepiness and alertness. These novel findings indicate that zolpidem was well tolerated and effective in promoting sleep in people with OSA, which may be therapeutically useful for people with OSA and comorbid insomnia.
ABSTRACT


A recent physiology study performed using continuous positive airway pressure (CPAP) manipulations indicated that the hypnotic zolpidem increases the arousal threshold and genioglossus responsiveness in people with and without obstructive sleep apnoea (OSA). Thus, zolpidem may stabilise breathing and reduce OSA severity without CPAP. Accordingly, we sought to determine the effects of zolpidem on OSA severity, upper airway physiology and next-day sleepiness and alertness. Nineteen people with OSA with low-to-moderate arousal threshold received 10 mg zolpidem or placebo according to a double-blind, randomised, cross-over design. Participants completed two overnight in-laboratory polysomnographies (1-week washout), with an epiglottic catheter, intramuscular genioglossus electromyography, nasal mask and pneumotachograph to measure OSA severity, arousal threshold and upper airway muscle responsiveness. Next-morning sleepiness and alertness were also assessed. Zolpidem did not change the apnoea-hypopnoea index versus placebo (40.6 ± 12.3 vs. 40.3 ± 16.4 events/h (means ± SD), p = 0.938) or nadir oxyhaemoglobin saturation (79.6 ± 6.6 vs. 79.7 ± 7.4%, p = 0.932), but was well tolerated. Zolpidem increased sleep efficiency by 9 ± 14% (83 ± 11 vs. 73 ± 17%, p = 0.010). Arousal threshold increased by 15 ± 5% with zolpidem throughout all sleep stages (p = 0.010), whereas genioglossus muscle responsiveness did not change. Next-morning sleepiness and alertness were not different between nights. In summary, a single night of 10 mg zolpidem is well tolerated and does not cause next-day impairment in alertness or sleepiness, or overnight hypoxaemia in OSA. However, despite increases in arousal threshold without any change in pharyngeal muscle responsiveness, zolpidem does not alter OSA severity. It does, however, increase sleep efficiency by ∼10%, which may be beneficial in people with OSA and insomnia.",2020,"Arousal threshold increased by 15 ± 5% with zolpidem throughout all sleep stages (p = 0.010), whereas genioglossus muscle responsiveness did not change.","['people with and without obstructive sleep apnoea (OSA', 'Nineteen people with OSA with low-to-moderate arousal threshold received']","['continuous positive airway pressure (CPAP) manipulations', 'zolpidem', 'Zolpidem', 'hypnotic zolpidem', 'epiglottic catheter, intramuscular genioglossus electromyography, nasal mask and pneumotachograph', 'placebo', '10\xa0mg\xa0zolpidem or placebo']","['genioglossus muscle responsiveness', 'sleep efficiency', 'OSA severity, arousal threshold and upper airway muscle responsiveness', 'nadir oxyhaemoglobin saturation', 'OSA severity', 'respiratory arousal', 'arousal threshold and genioglossus responsiveness', 'OSA severity, upper airway physiology and next-day sleepiness and alertness', 'tolerated', 'sleep efficiency without changing apnoea length, oxygen desaturation, next-day perceived sleepiness and alertness', 'pharyngeal muscle responsiveness', 'Arousal threshold', 'apnoea-hypopnoea index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0182334', 'cui_str': 'Pneumotachograph'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224194', 'cui_str': 'Structure of genioglossus muscle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031346', 'cui_str': 'Muscle structure of pharynx'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",19.0,0.0609529,"Arousal threshold increased by 15 ± 5% with zolpidem throughout all sleep stages (p = 0.010), whereas genioglossus muscle responsiveness did not change.","[{'ForeName': 'Ludovico', 'Initials': 'L', 'LastName': 'Messineo', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Randwick, Sydney, New South Wales, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Randwick, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Randwick, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Randwick, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Azarbarzin', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sophie G', 'Initials': 'SG', 'LastName': 'Carter', 'Affiliation': 'Neuroscience Research Australia (NeuRA) and the University of New South Wales, Randwick, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), Flinders Health and Medical Research Institute (FHMRI), Flinders University, Bedford Park, Adelaide, South Australia, Australia.'}]",The Journal of physiology,['10.1113/JP280173']
740,32852294,"Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study.","BACKGROUND


For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia.
METHODS


In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF. Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of ""epidural labor analgesia to surgical anesthesia."" The primary outcome was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation.
RESULTS


In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF, a difference in means of 97 seconds (90% confidence interval [CI], SD = -10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
CONCLUSION


Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.",2021,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","['70 women were enrolled in the study', 'adult healthy women undergoing CD', 'Epidural Extension Anesthesia in Elective Cesarean Delivery']","['epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF', 'epidural anesthesia with either CP or LEBF', 'LEBF', 'Epinephrine, Sodium Bicarbonate, and Fentanyl', 'Chloroprocaine', 'chloroprocaine (CP', 'Lidocaine', 'lidocaine']","['mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level', 'time to loss of touch sensation at the T7 level', 'intraoperative analgesia', 'need for intraoperative analgesia supplementation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0448760', 'cui_str': 'Dermatome of seventh thoracic nerve'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0702221', 'cui_str': 'Touch sensation, function'}, {'cui': 'C0446425', 'cui_str': 'Level of the seventh thoracic vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",70.0,0.19062,"There was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.
","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Sharawi', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Prannal', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Spencer', 'Affiliation': 'Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Mhyre', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005141']
741,32869399,A randomized trial of oral immunotherapy for pediatric cow's milk-induced anaphylaxis: Heated vs unheated milk.,"BACKGROUND


Severe reactions may develop during cow's milk (CM) oral immunotherapy (OIT). We investigated the safety and efficacy of low-dose OIT with heated milk (HM) or unheated milk (UM) in children with anaphylaxis.
METHODS


Children with symptom onset after ingestion of 3-mL HM on a double-blind, placebo-controlled food challenge were randomly assigned to the HM (n = 17) or UM (n = 16) group. HM group ingested milk powder heated at 125°C for 30 seconds, whereas the UM group used UM. Patients were hospitalized for 5 days; the HM or UM was gradually increased to 3 mL/day; 3-mL/day ingestion was continued at home. One year later, the patients underwent 2-day consecutive 3- and 25-mL HM-oral food challenges (OFCs) after 2-week avoidance.
RESULTS


At baseline, milk- and casein-specific immunoglobulin E (IgE) levels were 56.0 and 51.4 kUA/L in the HM group, and 55.2 and 65.6 kUA/L in the UM group, respectively. One year later, 35% and 18% in the HM group and 50% and 31% in UM group passed the 3 and 25 mL OFCs, respectively. Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, P < .001). β-lactoglobulin-specific IgG 4  levels significantly increased from baseline only in the UM group, whereas casein-specific IgG 4  levels significantly increased from baseline in both groups.
CONCLUSIONS


HM-OIT induced immunological changes more safely than the UM-OIT. The possibility of lower treatment efficacy with HM-OIT needs to be evaluated in larger studies.",2021,"Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, p <0.001).","[""pediatric cow's milk-induced anaphylaxis"", 'children with anaphylaxis', 'Children with symptom onset after ingestion of 3-mL HM on a double-blind, placebo-controlled food challenge']","['low-dose OIT with heated-milk (HM) or unheated-milk (UM', 'HM', 'oral immunotherapy', 'UM']","['casein-specific IgG4 levels', 'safety and efficacy', 'milk- and casein-specific immunoglobulin E (IgE) levels', 'β-lactoglobulin-specific IgG4 levels', 'HM or UM', 'Rates of moderate or severe symptoms and respiratory symptoms per home dose']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1270793', 'cui_str': 'Casein specific immunoglobulin E'}, {'cui': 'C0022945', 'cui_str': 'Lactoglobulins'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0690652,"Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, p <0.001).","[{'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Nagakura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Asaumi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kiyotake', 'Initials': 'K', 'LastName': 'Ogura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Yanagida', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13352']
742,32869230,Impact of mechanical simulator practice on clinical ERCP performance by novice surgical trainees: a randomized controlled trial.,"BACKGROUND


Lack of forward-viewing endoscopy experience impairs training in endoscopic retrograde cholangiopancreatography (ERCP). We evaluated the effect of ERCP mechanical simulator (EMS) practice on ERCP performance by surgical trainees.
PATIENTS AND METHODS


12 surgical trainees without endoscopy experience were randomly allocated to non-EMS (n = 6) programs or to EMS (n = 6) programs with coaching and 20 hours of supervised EMS practice. All trainees then received supervised hands-on clinical ERCP training. Trainers provided verbal instructions and hands-on assistance, and took over if cannulation was not achieved by 20 minutes. Blinded trainers rated clinical performance.
RESULTS


Each group performed 150 clinical ERCPs. Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001). EMS trainees showed a significantly better mean performance score ( P  = 0.006). In multivariate analysis, after adjusting for case sequence, CBD stone, complexity, and EMS training, the effect of EMS practice on odds for successful cannulation remained highly significant (odds ratio [OR] 2.10 [95 %CI 1.46 - 3.01]). At 6 months EMS trainees still had better cannulation success vs. non-EMS controls ( P  = 0.045); no difference was observed after 1 year.
CONCLUSIONS


EMS practice shortens the ERCP early learning curve of inexperienced surgical trainees, improves clinical success in selective biliary cannulation, and may reduce complications.",2020,"Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001).","['novice surgical trainees', '12 surgical trainees without endoscopy experience']","['supervised hands-on clinical ERCP training', 'mechanical simulator practice', 'non-EMS (n\u200a=\u200a6) programs or to EMS (n\u200a=\u200a6', 'ERCP mechanical simulator (EMS) practice']","['Biliary cannulation success', 'mean performance score', 'clinical ERCP performance', 'cannulation success', 'ERCP performance']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]",,0.1062,"Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group ( P  = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all  P  < 0.001).","[{'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': 'Department of Special Minimally Invasive Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yue', 'Affiliation': 'Department of Special Minimally Invasive Surgery, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Leung', 'Affiliation': 'Department of Gastroenterology, Sacramento VA Medical Center, Mather, California, United States.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Fangzhao', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Kexiang', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhengfeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Wence', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province, Clinical Medical College Cancer Center of Lanzhou University, Lanzhou, China.'}]",Endoscopy,['10.1055/a-1217-6727']
743,32876831,Patient preferences for development in MRI scanner design: a survey of claustrophobic patients in a randomized study.,"OBJECTIVE


To investigate which magnetic resonance imaging (MRI) scanner designs claustrophobic patients prefer.
MATERIAL/METHODS


We analyzed questionnaires completed by 160 patients at high risk for claustrophobia directly after a scan in either a short-bore or open panoramic scanner as part of a prospective randomized trial Enders et al (BMC Med Imaging 11:4, 2011). Scanner preferences were judged based on schematic drawings of four scanners. Information on the diagnostic performance of the depicted scanners was provided, too.
RESULTS


A majority of patients suggested upright open (59/160, 36.9%) and open panoramic (53/160, 33.1%) before short-bore designs (26/160, 16.3%, for all p < 0.001) for future development. When asked about patients' preferred scanner choice for an upcoming examination, information about a better diagnostic performance of a short-bore scanner significantly improved its preference rates (from 6/160 to 49/160 or 3.8 to 30.5%, p < 0.001). Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047). Patients scanned in a short-bore scanner in our trial preferred this design significantly more often (p = 0.003). Noise reduction (51/160, 31.9%), more space over the head (44/160, 27.5%), and overall more space (33/160, 20.6%) were the commonest suggested areas of improvement.
CONCLUSION


Patients at high risk for claustrophobia visually prefer open- over short-bore MRI designs for further development. Education about a better diagnostic performance of a visually less-attractive scanner can increase its acceptance. Noise and space were of most concern for claustrophobic patients. This information can guide individual referral of claustrophobic patients to scanners and future scanner development.
KEY POINTS


• Patients at high risk for claustrophobia visually favor the further development of open scanners as opposed to short- and closed-bore scanner designs. • Educating claustrophobic patients about a higher diagnostic performance of a short-bore scanner can significantly increase their acceptance of this otherwise visually less-attractive design. • A medical history of earlier claustrophobic events in a given MRI scanner type and focusing on the features ""more space"" and ""noise reduction"" can help to guide referral of patients who are at high risk for claustrophobia.",2021,Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047).,"['160 patients at high risk for claustrophobia directly after a scan in either a', 'patients who are at high risk for claustrophobia']","['short-bore or open panoramic scanner', 'magnetic resonance imaging (MRI) scanner']","['diagnostic performance', 'preference rates', 'open panoramic', 'Noise reduction']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008909', 'cui_str': 'Claustrophobia'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2945608', 'cui_str': 'Bore'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0373504,Patients with a claustrophobic event preferred open designs significantly more often than patients without a claustrophobic event (p = 0.047).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Iwan', 'Affiliation': 'Departement of Anaesthesiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Enders', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Adriane Elisabeth', 'Initials': 'AE', 'LastName': 'Napp', 'Affiliation': 'Department of Radiology, Campus Virchow-Klinikum Klinik für Pädiatrie m.S. Onkologie und Hämatologie, Charité Berlin, Mittelallee 8, 4. OG Augustenburger Platz 1, 13353, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rief', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}]",European radiology,['10.1007/s00330-020-07060-9']
744,32876871,[Effectiveness of nurse-led care: a prospective randomized controlled multicenter study (ERFASS)].,,2020,,[],['nurse-led care'],[],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],,0.0505769,,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hoeper', 'Affiliation': 'Klinik für Rheumatologie und Immunologie, Medizinische Hochschule Hannover, Carl-Neuberg-Str.\xa01, 30625, Hannover, Deutschland. hoeper.kirsten@mh-hannover.de.'}]",Zeitschrift fur Rheumatologie,['10.1007/s00393-020-00863-7']
745,32871662,Cognitive remediation therapy for partially remitted unipolar depression: A single-blind randomized controlled trial.,"BACKGROUND


There is an urgent need for the development and evaluation of targeted interventions for cognitive impairment (CI) in patients with (partially) remitted major depressive disorder (MDD). The aim of our study was therefore to evaluate the effect of cognitive remediation therapy (CRT) on cognitive and psychosocial functioning in a sample of patients with MDD, taking into account comorbidity, psychopathology, remission status and CI profile. Furthermore, we compared a generalized training (GT) with an individualized training (IT) approach regarding their effects on cognition.
METHODS


Sixty-two MDD patients in partial remission with CI were randomly assigned to a control group (CG), IT or GT. Participants of GT trained six cognitive subdomains (divided attention, selective attention, alertness, working memory, planning and response inhibition), whereas participants of IT trained their three most deficient cognitive subdomains as identified at baseline. Participants of both intervention groups trained three times per week over a five-week period. Both training groups received additional 30-minute compensatory-transfer sessions once per week.
RESULTS


Attention appeared to be the most frequently impaired cognitive domain as well as the domain which was significantly improved by CRT, with medium to large effect sizes. No difference in improvement was found between IT and GT. The analyses also revealed greater improvement in self-assessed psychosocial functioning in training participants (GT and IT combined) compared to the CG.
LIMITATIONS


Due to the small sample size, the present results are preliminary in nature.
CONCLUSION


CRT was well accepted, and patients transferred the attentional improvement to real life, as measured by self-assessed psychosocial functioning. IT yielded no additional advantages over GT. We propose CRT as an integral part of the treatment plan for patients with depression suffering from CI.",2020,"The analyses also revealed greater improvement in self-assessed psychosocial functioning in training participants (GT and IT combined) compared to the CG.
","['Participants of GT trained six cognitive subdomains (divided', 'patients with (partially) remitted major depressive disorder (MDD', 'Sixty-two MDD patients in partial remission with CI', 'partially remitted unipolar depression', 'patients with depression suffering from CI', 'patients with MDD, taking into account comorbidity, psychopathology, remission status and CI profile']","['CRT', 'generalized training (GT) with an individualized training (IT) approach', 'cognitive remediation therapy (CRT', 'Cognitive remediation therapy', 'control group (CG), IT or GT']","['self-assessed psychosocial functioning', 'attention, selective attention, alertness, working memory, planning and response inhibition', 'cognitive and psychosocial functioning']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",62.0,0.0342158,"The analyses also revealed greater improvement in self-assessed psychosocial functioning in training participants (GT and IT combined) compared to the CG.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Listunova', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany. Electronic address: lena.listunova@med.uni-heidelberg.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kienzle', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Bartolovic', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jaehn', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Thea Marianne', 'Initials': 'TM', 'LastName': 'Grützner', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Robert Christian', 'Initials': 'RC', 'LastName': 'Wolf', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Cognitive Neuropsychiatry Section, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Aschenbrenner', 'Affiliation': 'Department of Adult Psychiatry, SRH-Klinik, Karlsbad-Langensteinbach, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weisbrod', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany; Department of Adult Psychiatry, SRH-Klinik, Karlsbad-Langensteinbach, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Roesch-Ely', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Psychiatry, Division Neurocognition, Heidelberg University Hospital, Voßstraße 4, 69115 Heidelberg, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.008']
746,32871674,The role of distress and fear transdiagnostic dimensions in emotion regulation choice.,"BACKGROUND


Most research in the area of psychopathology and emotion regulation has focused on specific disorder categories and maladaptive strategy implementation. This study aimed to extend previous research by examining emotion regulation choice in higher-order dimensions (i.e., the distress and fear transdiagnostic dimensions) predisposing individuals toward commonly co-occurring internalizing syndromes.
METHODS


The sample consisted of 127 college students with varying levels of distress and fear proneness. They were randomly assigned to a short- or long-term goal condition and were asked to select between two strategies, distraction and reappraisal, in response to pictures of differing emotional intensity. The moderating effects of distress and fear dimensions were explored to assess whether they interact with emotional intensity and goal proximity to influence strategy selection.
RESULTS


Fear proneness was positively, and distress proneness was negatively, associated with the odds of choosing distraction. Fear proneness was a significant moderator in our analysis, suggesting that increased fear magnifies the effect of emotional intensity on choosing distraction as a regulatory strategy.
LIMITATIONS


Although an effort was made to select individuals from the full range of the internalizing spectrum, this was a college student sample and thus results should be replicated in clinical samples. Additionally, the response rate in this study was low.
CONCLUSION


These findings expand our understanding of emotion regulation choice in internalizing psychopathology by identifying common tendencies of individuals who share dispositions toward fear and distress.",2020,"RESULTS


Fear proneness was positively, and distress proneness was negatively, associated with the odds of choosing distraction.",['127 college students with varying levels of distress and fear proneness'],[],"['distress proneness', 'response rate', 'fear']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",127.0,0.0503649,"RESULTS


Fear proneness was positively, and distress proneness was negatively, associated with the odds of choosing distraction.","[{'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Argyriou', 'Affiliation': 'Department of Psychology, Indiana University - Purdue University Indianapolis, 402 North Blackford St. LD 124, Indianapolis, IN 46202, United States; Department of Psychological Science, Ball State University, 2000W University Ave, Muncie, IN 47306, United States. Electronic address: evargyri@iu.edu.'}, {'ForeName': 'Tayla T C', 'Initials': 'TTC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychological Science, Ball State University, 2000W University Ave, Muncie, IN 47306, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.060']
747,32871687,Effectiveness of an alternative intervention in the treatment of depressive symptoms.,"BACKGROUND


There is a scarcity of studies in the international literature regarding alternative treatment to the pharmacological and psychotherapeutic intervention in the face of depression symptoms. This study aimed to test a protocol based on natural therapy, alternatives to pharmacological and psychotherapeutic, through Mindfulness Meditation, Reiki, Acupuncture and Auriculotherapy, to treat the symptoms of depression for those who were with no pharmacological or psychotherapeutic treatment for these symptoms.
METHODS


this is a randomized single-blind controlled pilot study. The final sample was 21 participants divided in two groups: experimental and control. Participants were evaluated by validated instruments during the screening process and after the intervention. The instruments were: Depression, Anxiety and Stress Scale and Beck Depression Inventory. Intervention was performed in eight sessions, during two months. All the techniques were used in the experimental group. Analysis of variance with repeated measures was used to compare pre-intervention to post-intervention moments.
RESULTS


the result of analysis indicates a significant reduction in the symptoms of depression after the intervention among the experimental group.
LIMITATIONS


there is no way to determine which of the techniques used produced the most significant result.
CONCLUSIONS


The protocol proposed in this study was effective in reducing the symptoms of depression to whom are not eligible for traditional treatment.",2020,"the result of analysis indicates a significant reduction in the symptoms of depression after the intervention among the experimental group.
",['symptoms of depression for those who were with no pharmacological or psychotherapeutic treatment for these symptoms'],"['pharmacological and psychotherapeutic, through Mindfulness Meditation, Reiki, Acupuncture and Auriculotherapy', 'alternative intervention', 'psychotherapeutic intervention']","['Depression, Anxiety and Stress Scale and Beck Depression Inventory', 'symptoms of depression', 'depressive symptoms']","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0751715', 'cui_str': 'Reiki'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",21.0,0.0298692,"the result of analysis indicates a significant reduction in the symptoms of depression after the intervention among the experimental group.
","[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Cardozo-Batista', 'Affiliation': 'Interdisciplinary Health Sciences Program, Federal University of São Paulo, Brazil.'}, {'ForeName': 'Adriana Marcassa', 'Initials': 'AM', 'LastName': 'Tucci', 'Affiliation': 'Interdisciplinary Health Sciences Program, Federal University of São Paulo, Brazil; Department of Health, Education and Society, Federal University of São Paulo, 136, Silva Jardim street - Federal University of São Paulo, Santos, SP, Brazil. Electronic address: atucci@unifesp.br.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.060']
748,32871696,A randomised wait-list controlled pilot trial of one-session virtual reality exposure therapy for blood-injection-injury phobias.,"Virtual reality exposure therapy (VRET) has been recognized as an effective treatment for specific phobias and has the potential to overcome the limitations of traditional in vivo exposure therapy (e.g., acceptability). No past research has evaluated the efficacy of VRET for the treatment of blood-injection-injury (BII) phobia. Therefore, we conducted a randomized controlled trial to examine the acceptability and efficacy of a single-session VRET intervention for BII phobias. Participants who met DSM-5 criteria for BII phobia (N = 43) were randomized to VRET or a waiting list control group, and completed self-report measures of BII severity (Medical Fear Survey [MFS] and Multidimensional Blood Phobia Inventory [MBPI]) and dental anxiety (Modified Dental Anxiety Scale), as well as clinician ratings of BII phobia severity and catastrophic cognitions at baseline, one-week post-treatment, and 3-month follow-up. We found medium to large differences in catastrophic cognitions (probability [g = 0.88] and cost [g = 0.66] ratings), favouring VRET. We found moderate to large differences favouring VRET on the MBPI Injection and Injury fears subscales (g's=0.64-1.14) at one-week post-treatment and 3-month follow-up, and on the MBPI Fainting subscale (g = 0.84) and Injections subscale of the Medical Fear Survey (g = 0.63) at follow-up. There were no other significant group differences. These findings provided some initial evidence to suggest that a single-session VRET may provide some improvements in fears of injections, injury, and fainting. While it may be a useful adjunct or interim step before in vivo exposure therapy, it is not sufficient as a standalone treatment for BII phobia.",2020,No past research has evaluated the efficacy of VRET for the treatment of blood-injection-injury (BII) phobia.,"['Participants who met DSM-5 criteria for BII phobia (N\xa0=\xa043', 'BII phobias', 'blood-injection-injury phobias']","['VRET', 'single-session VRET intervention', 'Virtual reality exposure therapy (VRET']","['catastrophic cognitions', 'fears of injections, injury, and fainting', 'BII severity (Medical Fear Survey [MFS] and Multidimensional Blood Phobia Inventory [MBPI]) and dental anxiety (Modified Dental Anxiety Scale), as well as clinician ratings of BII phobia severity and catastrophic cognitions', 'MBPI Fainting subscale', 'MBPI Injection and Injury fears subscales', 'acceptability and efficacy', 'Injections subscale of the Medical Fear Survey ']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}]","[{'cui': 'C3494470', 'cui_str': 'Virtual Reality Therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424187', 'cui_str': 'Fear of needles'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",43.0,0.0131514,No past research has evaluated the efficacy of VRET for the treatment of blood-injection-injury (BII) phobia.,"[{'ForeName': 'Michelle Y W', 'Initials': 'MYW', 'LastName': 'Jiang', 'Affiliation': 'School of Psychology, UNSW Sydney, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Upton', 'Affiliation': 'School of Psychology, UNSW Sydney, Australia.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': 'School of Psychology, UNSW Sydney, Australia. Electronic address: j.newby@unsw.edu.au.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.076']
749,32871701,Development and efficacy of a family-focused treatment for depression in childhood.,"BACKGROUND


Depression in childhood frequently involves significant impairment, comorbidity, stress, and mental health problems within the family. Family-Focused Treatment for Childhood Depression (FFT-CD) is a 15-session developmentally-informed, evidence-based intervention targeting family interactions to enhance resiliency within the family system to improve and manage childhood depression.
METHODS


We present the conceptual framework underlying FFT-CD, the treatment development process, the intervention strategies, a case illustration, and efficacy data from a recent 2-site randomized clinical trial (N = 134) of 7-14 year old children randomly assigned to FFT-CD or individual supportive psychotherapy (IP) conditions.
RESULTS


Compared to children randomized to IP, those randomized to FFT-CD showed higher rates of depression response (≥50% Children's Depression Rating Scale-Revised reduction) across the course of acute treatment (77.7% vs. 59.9%, t = 1.97, p = .0498). The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences. By final follow-up (9 months post-treatment), one FFT-CD child and six IP children had suffered depressive recurrences, and four IP children attempted suicide.
LIMITATIONS


Without a no treatment control group it is not possible to disentangle the impact of the interventions from time alone.
CONCLUSIONS


While seldom evaluated, family interventions may be particularly appropriate for childhood depression. FFT-CD has demonstrated efficacy compared to individual supportive therapy. However, findings underscore the need for an extended/chronic disease model to enhance outcomes and reduce risk over time.",2020,"The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences.","['depression in childhood', 'N\xa0=\xa0134) of 7-14 year old children randomly assigned to']","['FFT-CD or individual supportive psychotherapy (IP) conditions', 'FFT-CD']","['suffered depressive recurrences', 'index depressive episodes', 'rates of depression response']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0417671,"The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences.","[{'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological & Brain Sciences, Boston University, 900 Commonwealth Ave, 2nd Floor, Boston, MA 02215, United States. Electronic address: mtompson@bu.edu.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, Suffolk University, Boston, MA, United States.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Asarnow', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.057']
750,32871702,Melancholic depression and response to quetiapine: A pooled analysis of four randomized placebo-controlled trials.,"BACKGROUND


Melancholic depression may preferentially respond to certain treatments. This study examined the efficacy of extended-release quetiapine monotherapy in patients with melancholic and nonmelancholic major depressive disorder.
METHODS


Data from four randomized placebo-controlled trials was pooled. Melancholic features were assessed with baseline depression scale items according to DSM criteria. The outcome measure was response on the Montgomery-Åsberg Depression Rating Scale. Cox regression models predicting response over time with interactions between treatment condition and melancholic status were used to test for treatment effect heterogeneity.
RESULTS


The 6-week response rate difference between quetiapine and placebo was roughly 10% greater in the melancholic subgroup, primarily due to a lower placebo response, although the subgroup-treatment interactions did not reach statistical significance. The main effect of quetiapine was significant in every model.
LIMITATIONS


The main limitations were the retrospective analysis and the post-hoc designation of melancholic depression based on scale items not designed for that purpose. Results should be considered preliminary and exploratory until replicated.
CONCLUSIONS


The lower placebo response rate in the melancholic subgroup is consistent with past research and reinforces the benefit of pharmacotherapy for these patients.",2020,"The 6-week response rate difference between quetiapine and placebo was roughly 10% greater in the melancholic subgroup, primarily due to a lower placebo response, although the subgroup-treatment interactions did not reach statistical significance.",['patients with melancholic and nonmelancholic major depressive disorder'],"['quetiapine and placebo', 'placebo', 'quetiapine', 'extended-release quetiapine monotherapy']","['placebo response rate', '6-week response rate difference', 'response on the Montgomery-Åsberg Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",,0.111874,"The 6-week response rate difference between quetiapine and placebo was roughly 10% greater in the melancholic subgroup, primarily due to a lower placebo response, although the subgroup-treatment interactions did not reach statistical significance.","[{'ForeName': 'Evyn M', 'Initials': 'EM', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry, University of Saskatchewan, Room 119 Ellis Hall, Royal University Hospital, 103 Hospital Drive, Saskatoon S7N0W8, SK, Canada. Electronic address: evyn.peters@usask.ca.'}, {'ForeName': 'Rudy', 'Initials': 'R', 'LastName': 'Bowen', 'Affiliation': 'Department of Psychiatry, University of Saskatchewan, Room 119 Ellis Hall, Royal University Hospital, 103 Hospital Drive, Saskatoon S7N0W8, SK, Canada.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Balbuena', 'Affiliation': 'Department of Psychiatry, University of Saskatchewan, Room 119 Ellis Hall, Royal University Hospital, 103 Hospital Drive, Saskatoon S7N0W8, SK, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.071']
751,32871704,Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial.,"BACKGROUND


The response to placebo is robust in studies of various antidepressant treatments. The strong placebo response, combined with the absence of side-effects, has prompted suggestions to use the ethically sound open-label placebo (OLP) as a treatment for depression. The aim of the present study was to assess the efficacy of OLP as an adjunct to treatment as usual (TAU) in the setting of a randomized controlled trial for the treatment of unipolar depression.
METHODS


Thirty-eight patients (age: 50 ± 17.1; 73.7% females) were randomized to either eight-week OLP treatment (n = 18) or four weeks of TAU followed by four weeks of OLP (n = 20). Clinical and socio-demographic measures were assessed at baseline, after four weeks, and at the end of the trial. Response to treatment was determined using the QIDS SR-16.
RESULTS


There was an overall decrease in depression levels over time, F(2,35) = 3.98, p = .028. A significant group x time interaction was found only among non-geriatric patients (<65years) with an early onset of depression (<50years), F(2,22) = 3.89, p = .036. Post-hoc tests indicated a significant decrease during the first four weeks, but only in the OLP group, t(11) = 2.29, p = .043.
LIMITATIONS


Small sample size and the use of a self-report questionnaire to assess depressive symptoms.
CONCLUSIONS


Our findings support the possibility that OLP is an effective treatment for the relatively young population of depressed patients. Additional studies are warranted to explore the use of OLP in clinical practice.",2020,"Post-hoc tests indicated a significant decrease during the first four weeks, but only in the OLP group, t(11) = 2.29, p = .043.
","['unipolar depression', 'Thirty-eight patients (age: 50 ± 17.1; 73.7% females']","['TAU followed by four weeks of OLP', 'OLP treatment', 'placebo', 'Open-Label placebo', 'OLP', 'placebo (OLP']","['depression levels', 'Clinical and socio-demographic measures']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.19846,"Post-hoc tests indicated a significant decrease during the first four weeks, but only in the OLP group, t(11) = 2.29, p = .043.
","[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Nitzan', 'Affiliation': 'Shalvata Mental Health Center, P.O.B 94, Hod-Hasharon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: urini@clalit.org.il.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Carmeli', 'Affiliation': 'Shalvata Mental Health Center, P.O.B 94, Hod-Hasharon, Israel.'}, {'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Chalamish', 'Affiliation': 'Kibbuzim College, Tel-Aviv, Israel.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Braw', 'Affiliation': 'Department of Psychology, Ariel University, Israel.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MS, USA.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Shefet', 'Affiliation': 'Shalvata Mental Health Center, P.O.B 94, Hod-Hasharon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Krieger', 'Affiliation': 'Shalvata Mental Health Center, P.O.B 94, Hod-Hasharon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Mendlovic', 'Affiliation': 'Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Shalvata Mental Health Center, P.O.B 94, Hod-Hasharon, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Pesach', 'Initials': 'P', 'LastName': 'Lichtenberg', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Hebrew University of Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.077']
752,32881403,Waist Circumference Change During Intensive Lifestyle Intervention and Cardiovascular Morbidity and Mortality in the Look AHEAD Trial.,"OBJECTIVE


The Action for Health in Diabetes (Look AHEAD) trial was a randomized trial comparing effects of intensive lifestyle intervention (ILI) and diabetes support and education (DSE) on cardiovascular disease (CVD) among individuals with overweight/obesity and type 2 diabetes. A secondary analysis was conducted to evaluate the association between change in weight and waist circumference (WC) and CVD outcomes.
METHODS


Participants (N = 5,490) were classified into four categories based on change in weight and WC between baseline and year 1 (both increased, both decreased, etc.). Separate Cox proportional hazards regression models were fit for ILI and DSE (using group that reduced weight/WC as reference), and time to first occurrence of primary and secondary CVD outcomes from year 1 through a median of almost 10 years were compared. Second, time to first event among all four ILI groups relative to DSE was evaluated.
RESULTS


Within DSE, CVD outcomes did not differ. ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
CONCLUSIONS


In this secondary analysis, increased WC during the first year of ILI, independent of weight change, was associated with higher risk for subsequent cardiovascular outcomes.",2020,"ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
","['Participants (N\u2009=\u20095,490', 'Diabetes', 'individuals with overweight/obesity and type 2 diabetes']",['intensive lifestyle intervention (ILI) and diabetes support and education (DSE'],"['weight loss', 'weight gain', 'weight and waist circumference (WC) and CVD outcomes', 'Waist Circumference Change', 'cardiovascular disease (CVD']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",5490.0,0.140174,"ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
","[{'ForeName': 'KayLoni L', 'Initials': 'KL', 'LastName': 'Olson', 'Affiliation': 'Warren Alpert Medical School, Brown University, The Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Obesity Research Center, New York, New York, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Warren Alpert Medical School, Brown University, The Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22942']
753,32888085,Intravenous paracetamol in comparison with ibuprofen for the treatment of patent ductus arteriosus in preterm infants: a randomized controlled trial.,"Our aim was to assess the efficacy and safety of intravenous (i.v.) paracetamol vs. i.v. ibuprofen for the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25 +0 -31 +6  weeks were randomized to receive i.v. paracetamol (15 mg/kg/6 h for 3 days) or i.v. ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with paracetamol or ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received paracetamol or ibuprofen, respectively. Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar.Conclusions: Intravenous paracetamol was less effective in closing hsPDA than ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.Trial registration: Clinicaltrials.gov : NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: • The successful closure of patent ductus arteriosus with oral paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous paracetamol. What is New: • Intravenous paracetamol is less effective in closing hsPDA than ibuprofen, but have a similar constriction effect. • These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.",2021,"Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis.","['Infants with a gestational age of 25 +0 -31 +6 \xa0weeks', 'several preterm infants', 'no: 2013-003883-30', 'patent ductus arteriosus in preterm infants', 'hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants', 'hsPDA.Trial registration']","['intravenous (i.v.) paracetamol', 'paracetamol or ibuprofen', 'Paracetamol', 'Intravenous paracetamol', 'ibuprofen', 'paracetamol', 'EudraCT']","['efficacy and safety', 'constriction rate of the ductus', 'closure rate of hsPDA', 'constriction rate of hsPDA, the re-opening rate, and the need for surgical closure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0185003', 'cui_str': 'Closure'}]",,0.164891,"Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Department of Neuroscience, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. cdani@unifi.it.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': 'Division of Neonatology, ""V. Buzzi"" Children Hospital of Milan, Via Castelvetro 22, 20154, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bianchi', 'Affiliation': 'Division of Neonatology, ""V. Buzzi"" Children Hospital of Milan, Via Castelvetro 22, 20154, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan - NICU, Via Della Commenda 12, 20122, Milan, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan - NICU, Via Della Commenda 12, 20122, Milan, Italy.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ramenghi', 'Affiliation': ""Department of Neonatology Obstetrics and Neuroscience, G. Gaslini Children's University Hospital of Genova, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Zecca', 'Affiliation': 'Division of Neonatology, Catholic University of Rome, Largo Agostino Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Division of Neonatology, Catholic University of Rome, Largo Agostino Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Poggi', 'Affiliation': 'Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Leonardi', 'Affiliation': 'Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Minghetti', 'Affiliation': ""Department of Neonatology Obstetrics and Neuroscience, G. Gaslini Children's University Hospital of Genova, Via Gerolamo Gaslini 5, 16147, Genoa, Italy.""}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': 'Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Cattaneo', 'Affiliation': 'Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lipone', 'Affiliation': 'Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.'}]",European journal of pediatrics,['10.1007/s00431-020-03780-8']
754,33235314,Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP.,"BACKGROUND


Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP.
METHODS


This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS).
RESULTS


One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9-4.8 and 6.8-9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups. Response rate tended to be better for chemotherapy plus cetuximab compared to chemotherapy alone (22% vs 15%). Adverse events grade ≥3 were comparable between the two groups, except for significantly increased skin toxicity in the cetuximab arm.
CONCLUSIONS


Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone. Addition of cetuximab resulted in additional skin toxicity.
CLINICAL TRIAL REGISTRATION


The study was registered at clinicaltrials.gov as NCT00894569.",2021,"CONCLUSIONS


Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone.","['patients with unfavourable, untreated adeno- or undifferentiated CUP', 'One-hundred-and-fifty patients', 'Patients with carcinoma of unknown primary (CUP', 'carcinoma of unknown primary (CUP']","['cetuximab to paclitaxel and carboplatin', 'cetuximab', 'paclitaxel and carboplatin', 'Cetuximab plus paclitaxel/carboplatin', 'paclitaxel/carboplatin plus cetuximab', 'paclitaxel/carboplatin']","['PFS', 'median PFS and OS', 'Response rate', 'PFS, OS and RR', 'RR, toxicity and overall survival (OS', 'additional skin toxicity', 'skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205698', 'cui_str': 'Carcinoma, undifferentiated'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",150.0,0.137112,"CONCLUSIONS


Cetuximab plus paclitaxel/carboplatin did not improve PFS, OS and RR in metastatic CUP compared to paclitaxel/carboplatin alone.","[{'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'Technische Universität Dresden/University Hospital Carl Gustav Carus, Medical Department I, Dresden, Germany. gunnar.folprecht@uniklinikum-dresden.de.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Trautmann', 'Affiliation': 'Technische Universität Dresden/University Hospital Carl Gustav Carus, Medical Department I, Dresden, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gerdt', 'Initials': 'G', 'LastName': 'Huebner', 'Affiliation': 'oho! ostholstein-onkologie, Oldenburg i.H., Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Evangl. Kliniken Essen-Mitte, Department of Medical Oncology, Essen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'West German Cancer Centre, University Hospital Essen, Department of Medical Oncology, Essen, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Kretzschmar', 'Affiliation': 'MVZ Mitte, Leipzig, Germany.'}, {'ForeName': 'Claus-Henning', 'Initials': 'CH', 'LastName': 'Köhne', 'Affiliation': 'University Clinic for Internal Medicine, Oncology und Hematology, Oldenburg, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology & Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hofheinz', 'Affiliation': 'University Medical Center Mannheim, Tagestherapiezentrum am ITM, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schütte', 'Affiliation': 'Technische Universität Dresden/University Hospital Carl Gustav Carus, Medical Department I, Dresden, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Löffler', 'Affiliation': 'Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Clinical Cooperation Unit Molecular Hematology/Oncology, German Cancer Research Center (DKFZ) and Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-020-01141-8']
755,32881796,Effects of an intervention on internalized HIV-related stigma for individuals newly entering HIV care.,"OBJECTIVE


Considering the association between internalized HIV-related stigma and treatment adherence, an intervention addressing HIV treatment adherence may have the added benefit of reducing internalized stigma. The 'integrating ENGagement and Adherence Goals upon Entry' (iENGAGE) intervention was developed to facilitate adjustment to living with HIV among individuals newly engaged in HIV care. We evaluated the effects of this intervention on internalized stigma and examined whether the effect is moderated by depressive symptoms and coping styles.
DESIGN


The iENGAGE intervention was tailored individually to improve information, motivation, and behavioral skills to promote treatment adherence and viral suppression. Three hundred and seventy-one participants initiating HIV care at four sites in the United States were randomly assigned to either the intervention receiving four face-to-face sessions or standard of care control arm.
METHODS


Baseline and 48-week follow-up assessments were conducted, which included validated measures of internalized HIV-related stigma, depressive symptoms, and coping mechanisms (behavioral disengagement and self-blame) as secondary outcomes. A repeated measures ANOVA evaluated the effect of the intervention on change in internalized HIV stigma. Furthermore, the moderating effects of depressive symptoms and coping mechanisms on the decrease in internalized stigma were examined.
RESULTS


The decrease in internalized stigma from baseline to 48 weeks was significantly larger in the intervention arm compared with the control arm. This effect was significantly moderated by baseline levels of depressive symptoms and self-blame.
CONCLUSION


The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.",2020,"The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.","['individuals newly entering HIV care', 'Three hundred and seventy-one participants initiating HIV care at four sites in the United States']",['intervention receiving four face-to-face sessions or standard of care control arm'],"['internalized HIV-related stigma', 'internalized stigma', 'internalized HIV stigma', 'depressive symptoms and self-blame', 'internalized HIV-related stigma, depressive symptoms, and coping mechanisms (behavioral disengagement and self-blame']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",371.0,0.0461738,"The multifaceted iENGAGE intervention is effective in reducing internalized stigma for new-to-HIV care individuals, especially with higher depressive symptoms or when using higher levels of self-blame coping.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Yigit', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'Division of HIV, ID and Global Medicine, Department of Medicine.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Division of Infectious Diseases, School of Medicine.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Turan', 'Affiliation': 'Department of Psychology.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002566']
756,32881797,A multilevel intervention to reduce stigma among alcohol consuming men living with HIV receiving antiretroviral therapy: findings from a randomized control trial in India.,"OBJECTIVE


To examine the effectiveness of a multilevel intervention to reduce HIV stigma among alcohol consuming men living with HIV in India.
DESIGN


A crossover randomized controlled trial in four sites.
SETTING


Government ART centres (ARTCs) offering core services in the greater Mumbai area.
PARTICIPANTS


Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited.
INTERVENTION


Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA) in three distinct sequences over three cycles of 9 months each.
MAIN OUTCOME MEASURE


HIV stigma, measured using the 16-item Berger Stigma scale.
METHODS


The article examines the effectiveness of the interventions to reduce stigma using Linear Mixed Model regression.
RESULTS


At baseline, 57% of participants had moderate-high levels of stigma (scores >40). All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy: βcoeff = -9.71; p < 0.001; group intervention: βcoeff = -5.22; p < 0.001; individual counselling: βcoeff = -4.43; p < 0.001). At then end of the second cycle, effects from the first cycle were sustained with no significant change in stigma scores. At the end of the third cycle, the site, which received CA+IC+GI sequence had maximum reduction in stigma scores (βcoeff = -10.29; p < 0.001), followed by GI+CA+IC (βcoeff = -8.23, p < 0.001).
CONCLUSION


Baseline findings suggest that stigma remains a problem even with experienced patients, despite advances in treatment and adherence. Results of multilevel stigma reduction interventions argue for inclusion in HIV prevention and treatment program.",2020,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","['Government ART centres (ARTCs) offering core services in the greater Mumbai area', 'consuming men living with HIV in India', 'Seven hundred and fifty two (188 per site) alcohol-consuming male PLHIV on ART were recruited', 'consuming men living with HIV receiving antiretroviral therapy']","['alcohol', 'multilevel intervention', 'Multilevel intervention to reduce alcohol consumption and promote adherence by addressing stigma, implemented at the individual (individual counselling, IC), group (group intervention, GI) and community levels (collective advocacy, CA']","['stigma scores', 'HIV stigma, measured using the 16-item Berger Stigma scale', 'moderate-high levels of stigma', 'HIV stigma']","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",752.0,0.0978675,"All three counseling interventions were effective in reducing stigma when delivered individually, in the first cycle (collective advocacy:","[{'ForeName': 'Roopal J', 'Initials': 'RJ', 'LastName': 'Singh', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Sarna', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Jean J', 'Initials': 'JJ', 'LastName': 'Schensul', 'Affiliation': 'Institute for Community Research, Hartford.'}, {'ForeName': 'Bidhubhushan', 'Initials': 'B', 'LastName': 'Mahapatra', 'Affiliation': 'Population Council, New Delhi, India.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Schensul', 'Affiliation': 'University of Connecticut, School of Medicine, Farmington, Connecticut, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002604']
757,32883514,Highly elevated level of antimüllerian hormone associated with preterm delivery in polycystic ovary syndrome patients who underwent ovulation induction.,"OBJECTIVE


To determine the relationship between high antimüllerian hormone (AMH) levels and increased preterm delivery risk in populations of women with polycystic ovary syndrome (PCOS) or unexplained infertility undergoing ovulation induction.
DESIGN


Secondary analysis of data from two multicenter randomized clinical trials: Pregnancy in Polycystic Ovary Syndrome II (PPCOS II); and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS).
SETTING


Not applicable.
PATIENTS


Live births at ≥24 weeks' gestation from both the PPCOS II (n = 172) and AMIGOS (n = 222) cohorts were evaluated, and those at risk for iatrogenic preterm delivery including placental conditions, fetal growth restriction, multiple gestations, hypertensive diseases of pregnancy, and pre-gestational diabetes were excluded. The final analysis included 118 women with PCOS from the PPCOS II cohort and 146 women with unexplained infertility from the AMIGOS cohort.
INTERVENTION(S)


None.
MAIN OUTCOME MEASURE(S)


Spontaneous preterm delivery.
RESULTS


In the PCOS population, median AMH overall was 5.5 ng/dL (interquartile range 2.9-9.3 ng/dL). In all, 62% of participants who delivered preterm had AMH levels above the 75th percentile. When comparing clinical covariates between the preterm and term deliveries, women with PCOS who delivered preterm had notably higher AMH than their term counterparts (11.1 vs. 5.4 ng/mL). In the univariate logistic regression analysis, each unit increase in AMH raised the odds of preterm delivery by 14% (odds ratio 1.14, 95% confidence interval 1.02-1.26). The effect was magnified only after adjusting for age, race, body mass index, smoking status, testosterone, homeostatic model assessment for insulin resistance, and treatment randomization group (adjusted odds ratio 1.25, 95% confidence interval 1.06-1.49). Unlike in the PCOS population, the unexplained infertility cohort had no significant difference in AMH levels between those with or without preterm delivery (2.3 vs. 2.6 ng/mL).
CONCLUSIONS


Our findings suggest that women with PCOS and high AMH who conceived after ovulation induction represent a high-risk group for preterm delivery. These data indicate that closer monitoring in the third trimester of pregnancies in PCOS patients with early first trimester AMH levels above 9.3 ng/mL may be warranted.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01044862.",2021,"Unlike in the PCOS population, the unexplained infertility cohort had no significant difference in AMH levels between those with or without preterm delivery (2.3 vs. 2.6 ng/mL).
","['polycystic ovary syndrome patients who underwent ovulation induction', '118 women with PCOS from the PPCOS II cohort and 146 women with unexplained infertility from the AMIGOS cohort', ""Live births at ≥24 weeks' gestation from both the PPCOS II (n = 172) and AMIGOS (n = 222"", 'Polycystic Ovary Syndrome II (PPCOS II); and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS', 'populations of women with polycystic ovary syndrome (PCOS) or unexplained infertility undergoing ovulation induction']",[],"['placental conditions, fetal growth restriction, multiple gestations, hypertensive diseases of pregnancy, and pre-gestational diabetes', 'AMH levels', 'median AMH overall']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",118.0,0.501431,"Unlike in the PCOS population, the unexplained infertility cohort had no significant difference in AMH levels between those with or without preterm delivery (2.3 vs. 2.6 ng/mL).
","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kaing', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California. Electronic address: Amy.Kaing@ucsf.edu.'}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Jaswa', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Huddleston', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.015']
758,32891506,"[Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial].","OBJECTIVE


A single immediate instillation of mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate-risk patients with NMIBC. Actually, post-TURB instillation is seldom used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of mitomycin C.
METHODS


We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
RESULTS


Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-up was comparable: 12,3±1,6 months in the SI group and 10,2±4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn't have any instillation. We did not identify significant differences in disease-free interval. Tolerance at 1 month after TURB was similar in both groups.
CONCLUSION


Tolerance and efficacy were not significantly different. As expected, logisitics were easier for the health providers in the pre-TURB group where all patients had their instillation conversely to the post-TURB group. These results suggest that the advantages of a single immediate pre-TURB instillation warrant further evaluation of this strategy in a phase III randomized trial.",2021,"Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
","['February 17, 2014 and November 24, 2016 (registration number 2012-004341-32', 'Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned', 'patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of', 'low- and intermediate-risk patients with NMIBC', 'non-muscle invasive bladder cancer (NMIBC', '35 eligible participants']","['immediate postoperative intra-vesical instillation (SI', 'TURB instillation group and 15 in the post-TURB instillation', 'mitomycin C']","['recurrence rate', 'disease-free interval', 'Tolerance']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",60.0,0.0804939,"Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breton', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France. Electronic address: jbreto200e@gmail.com.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bernardeau', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vallée', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pillot', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebacle', 'Affiliation': ""Service d'urologie, hôpital Bicêtre AP-HP, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.""}, {'ForeName': 'P-O', 'Initials': 'PO', 'LastName': 'Delpech', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Charles', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Biscans', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vallat', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pfister', 'Affiliation': ""Service d'urologie, CHU de Rouen, 37, boulevard Gambetta, 76000 Rouen, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Irani', 'Affiliation': ""Service d'urologie, hôpital Bicêtre AP-HP, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.""}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.07.245']
759,32881712,Stretch-induced hypoalgesia: a pilot study.,"Objectives Stretching is an intervention often used in various kinds of rehabilitation protocols and the effects on pain sensitivity has sparsely been investigated, especially when addressing potential effects on pain. The objective is to investigate the immediate effects of an axial and peripheral prolonged stretch on pressure pain sensitivity (PPT) and temporal summation (TS) on local and distal sites in healthy subjects. Methods Twenty-two healthy volunteers were recruited to participate in this pilot study. Two prolonged stretching protocols were performed: low back and wrist extensors stretches. PPT and pinprick TS were measured pre- and post-intervention at local and remote sites. Repeated measures analysis of variance (ANOVA) was used to examine the effects and significance of the interventions. Results The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site. TS did not change. Conclusions Low back stretching induced an increase in PPT at both local and remote sites whereas the wrist stretch only increased PPT locally, suggesting hypoalgesia at these sites. Further studies are needed to confirm the effect and mechanisms using randomised, controlled and parallel study design. Considering that pain sensitivity is different than clinical pain, results are difficult to extrapolate to clinical practice. Future studies testing clinical pain are needed to better understand the clinical implication of these results.",2020,"The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site.","['Methods Twenty-two healthy volunteers', 'healthy subjects']","['axial and peripheral prolonged stretch', 'Stretch-induced hypoalgesia']","['PPT and pinprick TS', 'pressure pain sensitivity (PPT) and temporal summation (TS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}]",22.0,0.0337781,"The low back stretch induced an increase in PPT for both local and remote sites, and the wrist stretch produced a PPT increase only at the local site.","[{'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Larouche', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Camiré Bernier', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Racine', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Collin', 'Affiliation': 'McGill University, School of Occupational and Physical Therapy, Montreal, Canada.'}, {'ForeName': 'Mikaël', 'Initials': 'M', 'LastName': 'Desmons', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mailloux', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Massé-Alarie', 'Affiliation': 'Cirris research centre, Université Laval, Quebec City, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0018']
760,32888187,The 90% effective dose of intranasal dexmedetomidine for procedural sedation in children with congenital heart disease before and after surgery: A biased-coin design up-and-down sequential allocation trial.,"BACKGROUND


Intranasal dexmedetomidine can provide adequate sedation during short procedures. However, there are few reports investigating the effective dose of intranasal dexmedetomidine for sedation in children with congenital heart disease (CHD) before and after surgery.
METHODS


Children aged 13-36 months with acyanotic CHD requiring trans-thoracic echocardiography before cardiac surgery were recruited for this study. One month after the cardiac surgery, the same children were studied again. The 90% effective dose was established using a biased-coin design up-and-down sequential method. Onset time, examination time, wake-up time and adverse effects were measured. Safety was evaluated in terms of changes in vital signs.
RESULTS


A total of fifty-eight subjects were recruited for this study. The 90% effective dose of intranasal dexmedetomidine for sedation was 2.13 μg/kg (95% CI, 1.73-2.34 μg/kg) in children with CHD before cardiac surgery and 3.51 μg/kg (95% CI, 2.99-3.63 μg/kg) after cardiac surgery (P < .01). There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
CONCLUSIONS


The 90% effective dose of intranasal dexmedetomidine for sedation in children with CHD was 2.13 μg/kg before cardiac surgery and 3.51 μg/kg after cardiac surgery.",2021,"There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
","['children with congenital heart disease before and after surgery', 'A total of fifty-eight subjects', 'Children aged 13-36 months with acyanotic congenital heart disease requiring trans-thoracic echocardiography before cardiac surgery were recruited for this study', 'children with congenital heart disease was 2.13 μg/kg before cardiac surgery and 3.51 μg/kg after cardiac surgery']","['intranasal dexmedetomidine', 'dexmedetomidine']","['Onset time, examination time, wake-up time and adverse effects', 'Safety', 'demographic variables, onset time, examination time, wake-up time or adverse effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0265807', 'cui_str': 'Acyanotic congenital heart disease'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",58.0,0.377805,"There were no differences between the groups in terms of demographic variables, onset time, examination time, wake-up time or adverse effects.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'YuJiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'ShangYingYing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'ShengFen', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13693']
761,32890299,Effect of Multimodal Drugs Infiltration on Postoperative Pain in Split Laminectomy of Lumbar Spine: A Randomized Controlled Trial.,"STUDY DESIGN


A randomized, double-blinded controlled trial.
OBJECTIVE


This study tested the effect of single-dose wound infiltration with multiple drugs for pain management after lumbar spine surgery.
SUMMARY OF BACKGROUND DATA


Patients undergoing spine surgery often experience severe pain especially in early postoperative period. We hypothesized that intraoperative wound infiltration with multiple drugs would improve outcomes in lumbar spine surgery.
METHODS


Fifty-two patients who underwent one to two levels of spinous process splitting laminectomy of lumbar spine, were randomized into two groups. Infiltration group received intraoperative wound infiltration of local anesthetics, morphine sulfate, epinephrine, and nonsteroidal anti-inflammatory drugs at the end of surgery, and received patient-controlled analgesia (PCA) postoperatively. The control group received only PCA postoperatively. The primary outcome measures were amount of morphine consumption and visual analogue scale (VAS) for pain. The secondary outcome measures were Oswestry Disability Index (ODI), Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), patient satisfaction, length of hospital stay, and side effects.
RESULTS


A total of 49 patients (23 patients for local infiltration group, and 26 patients for control group) were analyzed. There were statistically significant [P < 0.001, the effect size -5.0, 95% CI (-6.1, -3.9)] less morphine consumptions in the local infiltration group than the control group during the first 12 hours, 12 to 24 hours, and 24 to 48 hours after surgery. The VAS of postoperative pain reported by patients at rest and during motion was significantly lower in the local infiltration group than the control group at all assessment times (P < 0.001). The effect size of VAS of postoperative pain at rest and during motion were -2.0, 95% CI (-2.5, -1.4) and -2.0, 95% CI (-2.6, -1.4) respectively. ODI and RMDQ at 2 week and 3 month follow-ups in both groups had significant improvement from baseline (P < 0.001). No significant differences were found between groups (P = 0.262 for ODI and P = 0.296 for RMDQ). There were no significant differences of patient satisfaction, length of stay, and side effects between both groups (P = 0.256, P = 0.262, P = 0.145 respectively).
CONCLUSION


Intraoperative wound infiltration with multimodal drugs reduced postoperative morphine consumption, decreased pain score with no increased side effects.
LEVEL OF EVIDENCE


1.",2020,"ODI and RMDQ at 2 week and 3 month follow ups, in both groups had significant improvement from baseline (P < 0.001).","['Patients undergoing spine surgery often experience severe pain especially in early postoperative period', 'pain management after lumbar spine surgery', '49 patients (23 patients for local infiltration group, and 26 patients for control group', 'Fifty-two patients who underwent 1-2 levels of spinous process splitting laminectomy of lumbar spine', 'Split Laminectomy of Lumbar Spine']","['intraoperative wound infiltration of local anesthetics, morphine sulfate, epinephrine, and nonsteroidal anti-inflammatory drugs', 'Multimodal Drugs Infiltration']","['ODI and RMDQ', 'postoperative morphine consumption', 'Oswestry Disability Index(ODI', 'patient satisfaction, length of stay and side effects', 'Roland-Morris Low Back Pain and Disability Questionnaire(RMDQ), patient satisfaction, length of hospital stay, and side effects', 'side effects', 'amount of morphine consumption and visual analogue scale (VAS) for pain', 'Postoperative Pain', 'pain score', 'morphine consumptions', 'VAS of postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0582277', 'cui_str': 'Wound infiltration of local anesthetic'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",49.0,0.293146,"ODI and RMDQ at 2 week and 3 month follow ups, in both groups had significant improvement from baseline (P < 0.001).","[{'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Kraiwattanapong', 'Affiliation': 'Department of Orthopaedics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Vanlapa', 'Initials': 'V', 'LastName': 'Arnuntasupakul', 'Affiliation': 'Department of Anesthesiology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungthiwa', 'Initials': 'R', 'LastName': 'Kantawan', 'Affiliation': 'Department of Nursing, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Patarawan', 'Initials': 'P', 'LastName': 'Woratanarat', 'Affiliation': 'Department of Orthopaedics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Keorochana', 'Affiliation': 'Department of Orthopaedics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nantida', 'Initials': 'N', 'LastName': 'Langsanam', 'Affiliation': 'Department of Nursing, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Spine,['10.1097/BRS.0000000000003679']
762,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
763,32889846,"Head Rotation Reduces Oropharyngeal Leak Pressure of the i-gel and LMA® Supreme™ in Paralyzed, Anesthetized Patients: A Randomized Trial.","BACKGROUND


Second-generation supraglottic airway (SGA) devices are useful for airway management during positive pressure ventilation in general anesthesia and emergency medicine. In some clinical settings, such as the anesthetic management of awake craniotomy, SGAs are used in the head-rotated position, which is required for exposure of the surgical field, although this position sometimes worsens the efficiency of mechanical ventilation with SGAs. In this study, we investigated and compared the influence of head rotation on oropharyngeal leak pressures (OPLP) of the i-gel and LMA® Supreme™, which are second-generation SGA devices.
METHODS


Patients who underwent elective surgery under general anesthesia were enrolled in this study and randomly divided into i-gel or LMA Supreme groups. After induction of anesthesia with muscle relaxation, the i-gel or LMA Supreme was inserted according to computerized randomization. The primary outcome was the OPLP at 0°, 30°, and 60° head rotation. The secondary outcomes were the maximum airway pressure and expiratory tidal volume when patients were mechanically ventilated using a volume-controlled ventilation mode with a tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords.
RESULTS


Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively. The OPLPs of the i-gel and LMA Supreme significantly decreased as the head rotation angle increased (mean difference [95% confidence interval], P value: i-gel; 0° vs 30°: 3.5 [2.2-4.8], P < .001; 30° vs 60°: 2.0 [0.6-3.5], P = .002; 0° vs 60°: 5.5 [3.3-7.8], P < .001, LMA Supreme; 0° vs 30°: 4.1 [2.6-5.5], P < .001; 30° vs 60°: 2.4 [1.1-3.7], P < .001; 0° vs 60°: 6.5 [5.1-8.0], P < .001). There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group. There was no statistically significant difference between the 2 devices in all outcome measures. The incidences of adverse events, such as hoarseness or sore throat, were not significantly different between i-gel and LMA Supreme.
CONCLUSIONS


Head rotation to 30° and 60° reduces OPLP with both i-gel and LMA Supreme. There is no difference in OPLP between i-gel and LMA Supreme in the 3 head rotation positions.",2021,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"['Paralyzed, Anesthetized Patients', 'Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively', 'Patients who underwent elective surgery under general anesthesia']","[' i-gel', 'Second-generation supraglottic airway ', 'Head Rotation', 'head rotation']","['ventilation score', 'maximum airway pressure and expiratory tidal volume', 'expiratory tidal volume and ventilation score', 'adverse events, such as hoarseness or sore throat', 'head rotation angle', 'tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords', 'OPLP at 0°, 30°, and 60° head rotation', 'OPLP', 'Oropharyngeal Leak Pressure', 'oropharyngeal leak pressures (OPLP']","[{'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0015979', 'cui_str': 'Fiber Optic Technology'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.121973,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tachibana', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kumita', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Honami', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hamada', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005150']
764,32897319,"Feasibility and Acceptability of an Abbreviated, Four-Week Mindfulness Program for Chronic Pain Management.","OBJECTIVE


The Mindfulness-Based Stress Reduction program is effective at improving chronic pain outcomes, but the time demand hinders participation. This preliminary study evaluated the feasibility, acceptability, and potential effects of providing an abbreviated mindfulness program for patients with chronic pain.
DESIGN


A single-arm, mixed-methods, pre-post intervention study.
SETTING


An outpatient rehabilitation clinic at an academic medical center.
SUBJECTS


Participants were N = 23 adults with chronic pain who were new to mindfulness practice.
METHODS


Mindfulness-based Stress Reduction was adapted to shorten the program to four weekly 90-minute sessions and to focus content on pain management. Three cohorts of six to nine participants completed baseline and post-treatment measures of 1) patient-reported outcomes, including pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences.
RESULTS


Acceptable rates of retention and attendance and high ratings of satisfaction indicated that the intervention was feasible and acceptable. In interviews, participants found the program acceptable and beneficial and provided suggestions to improve it. From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
CONCLUSIONS


In adults with chronic pain, a four-week mindfulness program is feasible and acceptable, addresses the barrier of a lengthy program, and may improve quality of life and psychological functioning. An appropriately powered randomized controlled trial with a comparison group is needed to assess the intervention's effectiveness.",2020,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","['Participants were N = 23 adults with chronic pain who were new to mindfulness practice', 'Chronic Pain Management', 'adults with chronic pain', 'An outpatient rehabilitation clinic at an academic medical center', 'patients with chronic pain']","['abbreviated mindfulness program', 'Abbreviated, Four-Week Mindfulness Program', 'Mindfulness-Based Stress Reduction program']","['Feasibility and Acceptability', 'physical functioning and anxiety', 'quality of life and psychological functioning', 'pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences', 'retention and attendance and high ratings of satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0312875,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","[{'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Brintz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Keturah', 'Initials': 'K', 'LastName': 'Faurot', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gaylord', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa208']
765,32892184,A single bout of coordination training does not lead to EIH in young healthy men - a RCT.,"OBJECTIVES


Physical activity can lead to hypoalgesic effects and is often recommended as part of multidisciplinary pain management. Based on the idea, that in future specific and more differentiated sports therapeutic interventions could be used for a multidisciplinary pain management, various type of sports and their effects on pain sensitivity should be analysed. Whereas endurance as well as strengthening exercises are associated with a decrease in pain sensitivity in healthy people as well as people with chronic pain states, the effects of a specific coordination training (CT) on pain sensitivity have not yet been sufficiently investigated. Therefore, aim of the present study was to examine if a single bout of CT leads to exercised-induced hypoalgesia in young healthy men.
METHODS


Thirty five healthy men (mean age 27 ± 3 years) were examined in a randomised crossover design before and after a single bout of 45-min CT and a 45-min resting session as control condition by means of Quantitative Sensory Testing (QST). The QST is a validated instrument to assess the function of the somatosensory system, by applying thermal and mechanical stimuli. By doing so, various detection and pain thresholds were determined at the dorsum of one foot. Exercises of CT were chosen to generate high proprioceptive input for the ankle joints.
RESULTS


Analysis of the QST data in respect of the factors group (CT/control condition), time (pre/post) and stimuli (parameter of QST) revealed no statistically significant main effects of a single bout of CT on somatosensory system, neither for the factors group*time (p=0.51), nor the factors group*time*stimuli (p=0.32). All stimuli remained constant in the course of both conditions (e.g. mean ± sd of heat pain threshold pre/post in °C: coordination: 44.7 ± 3.1/44.8 ± 2.9; rest: 45.5 ± 3.0/44.9 ± 3.0).
CONCLUSIONS


In this setting, a single bout of CT had no effect on the somatosensory system in young healthy men. Therefore, this specific CT did not lead to an exercised-induced hypoalgesia in healthy people. Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men. Further research is needed to clarify if a CT can induce exercised-induced hypoalgesia in people with pathological alterations of the somatosensory system. In addition, it has to examined if analgesic effects can be induced by changing the intensity of CT in healthy people. Detailed knowledge regarding the effects of different training interventions on pain modulation is needed to completely understand the mechanism of exercised-induced hypoalgesia.",2021,Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men.,"['healthy people', 'young healthy men\xa0- a RCT', 'Methods Thirty five healthy men (mean age 27\xa0±\xa03 years', 'young healthy men']","['specific coordination training (CT', 'QST', '45-min CT and a 45-min resting session as control condition by means of Quantitative Sensory Testing (QST', 'coordination training', 'CT']",['pain sensitivity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",35.0,0.0257008,Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Herzig', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Krüger', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hilberg', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0036']
766,32901302,Is fasting still necessary prior to contrast-enhanced computed tomography? A randomized clinical study.,"OBJECTIVES


There is very limited evidence to support the common practice of preparative fasting prior to contrast-enhanced computerized tomography (CT). This study examined the effect of withholding fasting orders, prior to contrast-enhanced CT, on the incidence of aspiration pneumonitis and adverse gastrointestinal symptoms.
METHODS


This randomized controlled trial enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4 h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT. The primary outcome was incidence of aspiration pneumonitis and the secondary outcomes were rates of adverse gastrointestinal symptoms (nausea and/or vomiting).
RESULTS


After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group. Aspiration pneumonitis was not identified in either group. The mean time of fasting in the fasting group was 8.4 ± 1.6 h. Rates of nausea and vomiting were not statistically different between the fasting group compared with the non-fasting group, 6.6% vs. 7.6% (p = 0.37) and 2.6% vs. 3.0% (p = 0.58), respectively. A subgroup analysis of patients who were required to drink oral contrast agent (n = 1257) showed that rates of nausea and vomiting were not statistically different between the fasting and non-fasting groups, 6.8% vs. 8.0% (p = 0.42) and 2.6% vs. 3.6% (p = 0.3), respectively.
CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT03533348 KEY POINTS: • Is fasting necessary prior to contrast-enhanced computed tomography (CT)? • In this randomized clinical study including 2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting was not associated with a greater risk of aspiration pneumonitis or clinically significant increase in rates of adverse gastrointestinal symptoms. • Eating and drinking prior to contrast-enhanced CT can be allowed and are not associated with an increased risk of aspiration pneumonitis.",2021,"CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
","['After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group', 'enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4\xa0h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT', '2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting']",[],"['Aspiration pneumonitis', 'rates of nausea and vomiting', 'incidence of aspiration pneumonitis', 'mean time of fasting', 'nausea and vomiting', 'risk of aspiration pneumonitis', 'rates of adverse gastrointestinal symptoms', 'rates of adverse gastrointestinal symptoms (nausea and/or vomiting']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",2091.0,0.0465246,"CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
","[{'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Neeman', 'Affiliation': 'Department of Radiology, Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Mayasa', 'Initials': 'M', 'LastName': 'Abu Ata', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Touma', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Saliba', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Barnett-Griness', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Gralnek', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Rock', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Naiel', 'Initials': 'N', 'LastName': 'Bisharat', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel. bisharat_na@clalit.org.il.'}]",European radiology,['10.1007/s00330-020-07255-0']
767,32901316,Intrathecal treatment trial of rituximab in progressive MS: results after a 2-year extension.,"OBJECTIVES


To evaluate the effect of intrathecally (IT) delivered rituximab as a therapeutic intervention for progressive multiple sclerosis (PMS) during a 3-year follow-up period.
METHODS


Participants of a 1-year open-label phase 1b study of IT delivered rituximab to patients with PMS were offered extended treatment with follow-up for an additional 2 years. During the extension phase, treatment with 25 mg rituximab was administered every 6 months via a subcutaneous Ommaya reservoir connected to the right frontal horn with a ventricular catheter.
RESULTS


Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion. During the entire 3-year period, two cases of low-virulent bacterial meningitis occurred, which were successfully treated. Walking speed deteriorated significantly during the study.
CONCLUSIONS


IT administration of rituximab via a ventricular catheter was well tolerated. Considering the meningitis cases, the risk of infection was not negligible. The continued loss of walking speed indicates that IT rituximab was not able to stop disease progression.
CLASSIFICATION OF EVIDENCE


This study provides class IV evidence that intraventricularly administered rituximab in progressive MS is associated with a risk for bacterial meningitis and does not halt disease progression.
EU CLINICAL TRIAL REGISTER


EudraCT; 2008-002626-11 and 2012-000721-53.",2021,Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion.,"['progressive multiple sclerosis (PMS', 'Participants of a 1-year open-label phase 1b study of IT delivered rituximab to patients with PMS', 'progressive MS', 'EudraCT; 2008-002626-11 and 2012-000721-53']","['intrathecally (IT) delivered rituximab', 'rituximab']","['Walking speed deteriorated', 'tolerated', 'moderate vertigo and nausea']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",14.0,0.0298035,Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion.,"[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Bergman', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Burman', 'Affiliation': 'Department of Neurosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Bergenheim', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden. anders.svenningsson@ki.se.'}]",Journal of neurology,['10.1007/s00415-020-10210-0']
768,32910352,A Multidimensional Model of Sexual Empowerment Among Young Black Men Who have Sex with Men: A Latent Profile Analysis.,"Sexual empowerment is a key strategy in HIV prevention intervention design, yet its measurement has been conceptualized as homogeneous. To date, no studies have examined whether young Black men who have sex with men (YBMSM) exhibit heterogeneity across sexual empowerment. Using baseline data from a randomized controlled trial (N = 275, HIV-negative YBMSM), we classified YBMSM into sexual empowerment profiles based on five indicators using a latent profile analysis and assessed the associations between the sexual empowerment profiles and stigma-related experiences using multinomial logistic regression. Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3). YBMSM reporting fewer stigma-related experiences were more likely to be profile 1 than profile 2 and profile 3. To empower YBMSM, interventions based on sexual empowerment profile targeting the psychological/behavioral aspects of empowerment and addressing stigma are needed.",2021,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"['Who have Sex with Men', 'young Black men who have sex with men (YBMSM', 'Young Black Men']",['YBMSM'],[],"[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],3.0,0.028098,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"[{'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA. skchoi@nursing.upenn.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Muessig', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ennett', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marcella H', 'Initials': 'MH', 'LastName': 'Boynton', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03031-9']
769,32914161,"Analgesic Effect of Intrathecal Fentanyl vs Dexmedetomidine as Adjuvants to Bupivacaine Following Abdominal Surgery for Cancer in Children, a Randomized Trial.","BACKGROUND


Intrathecal fentanyl in spinal anesthesia improves intra- and postoperative analgesia. Dexmedetomidine is a fascinating adjuvant with regards to neuraxial anesthesia in children experiencing surgery for abdominal malignancy.
PATIENTS AND METHODS


After endorsement by the institutional reviewing board (IRB) and guardians' written informed consent, this research was carried out on 60 pediatric malignancy patients scheduled for major abdominal surgery. Children were randomly distributed into three groups (20 patients each): Group C: given 2 mL of bupivacaine 0.5% (0.4 mg/kg) intrathecally, injected gradually over 20 seconds. Group F: the same as group C, plus fentanyl 0.2 μg/kg. Group D: the same as group C, plus dexmedetomidine 0.2 μg/kg. Pain at zero, two, four, six, 12, 18, and 24 hours postoperatively was evaluated by Face, Legs, Activity, Crying, and Consolability (FLACC) score. First analgesic request and postoperative unfavorable effects were recorded for 24 hours postoperatively.
RESULTS


A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05). First analgesic request was significantly prolonged in group D (7.67 ± 0.57 hours), in contrast to groups F and C (5.40 ± 1.09 hours and 4.23 ± 3.27 hours, respectively, P < 0.04). Paracetamol utilization was significantly decreased in group D (316.67 ± 28.86 mg), in contrast to group C (391.00 ± 52.00 mg, P < 0.03), without a significant difference between group F (354.44 ± 46.67 mg) and groups D and C (P > 0.05).
CONCLUSIONS


Adding dexmedetomidine and fentanyl to intrathecal bupivacaine improved postoperative analgesia following abdominal surgery for cancer in children, with better overall analgesia of dexmedetomidine compared with fentanyl.",2020,"A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05).","['60 pediatric malignancy patients scheduled for major abdominal surgery', 'children experiencing surgery for abdominal malignancy', 'abdominal surgery for cancer in children', 'Abdominal Surgery for Cancer in Children']","['bupivacaine', 'Bupivacaine', 'fentanyl', 'Intrathecal Fentanyl vs Dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine']","['First analgesic request', 'postoperative analgesia', 'mean FLACC score', 'Face, Legs, Activity, Crying, and Consolability (FLACC) score', 'Paracetamol utilization', 'intra- and postoperative analgesia', 'Pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0381543,"A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05).","[{'ForeName': 'Khaled Mohamed', 'Initials': 'KM', 'LastName': 'Fares', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sahar Abdel-Baky', 'Initials': 'SA', 'LastName': 'Mohamed', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmad Mohammad', 'Initials': 'AM', 'LastName': 'Abd El-Rahman', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Rania Mohammed', 'Initials': 'RM', 'LastName': 'AbdeLemam', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Amira Mahmoud Mohamed', 'Initials': 'AMM', 'LastName': 'Osman', 'Affiliation': 'Pediatric Oncology, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa259']
770,32909218,"Patient Perspectives of Quality of the Same-Day Antiretroviral Therapy Initiation Process in Gauteng Province, South Africa: Qualitative Dominant Mixed-Methods Analysis of the SLATE II Trial.","BACKGROUND


HIV patients in South Africa continue to report operational barriers to starting antiretroviral therapy (ART). In the Simplified Algorithm for Treatment Eligibility (SLATE) II trial, same-day initiation (SDI) of ART increased the number of patients commencing ART and achieving HIV viral suppression by using a screening tool to distinguish between patients eligible for SDI and those requiring additional care before starting treatment. We conducted a mixed-methods evaluation to explore trial patients' perceptions and experiences of SDI.
METHODS


SLATE II was implemented at three urban, public primary health care clinics in Gauteng Province, South Africa. We conducted a short quantitative survey and in-depth interviews among a purposive sample of 89 of the 593 trial participants in the intervention and standard arms, using a mixed inductive-deductive framework approach.
RESULTS


Nearly all respondents (95%) were satisfied with their care, despite reporting clinic wait times of ≥ 3 h (72%). Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic. No intervention arm patients felt that SDI was ""too fast"" or indicated a preference for a more gradual process. Both groups highlighted the need for good counselling and non-judgmental, respectful staff. Standard patients suggested improving patient-provider relations, strengthening counselling, reducing wait times, and minimising referrals.
CONCLUSIONS


While it is difficult to untangle the role of providers from that of the SLATE algorithm in influencing patient experiences, adoption of SLATE II implementation procedures could improve patient experience of treatment initiation.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03315013, registered October 19, 2017.",2021,Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic.,"[""trial patients' perceptions and experiences of SDI"", 'short quantitative survey and in-depth interviews among a purposive sample of 89 of the 593 trial participants in the intervention and standard arms, using a mixed inductive-deductive framework approach', 'Gauteng Province, South Africa', 'SLATE II was implemented at three urban, public primary health care clinics in Gauteng Province, South Africa', 'patient experiences', 'HIV patients in South Africa']",[],"['patient-provider relations, strengthening counselling, reducing wait times, and minimising referrals']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",,0.198945,Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic.,"[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA. nscott@bu.edu.'}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Olson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}]",The patient,['10.1007/s40271-020-00437-4']
771,32909675,Modulation of Cardiometabolic Disease Markers by Type I Interferon Inhibition in Systemic Lupus Erythematosus.,"OBJECTIVE


Neutrophil dysregulation and the type I interferon (IFN) axis have been proposed to contribute to premature cardiovascular disease, a leading cause of mortality in patients with systemic lupus erythematosus (SLE). In the present study, we evaluated the ability of anifrolumab, a type I IFN receptor-blocking antibody, to reduce neutrophil extracellular trap (NET) formation and modulate cardiometabolic disease markers in comparison to placebo.
METHODS


Study subjects comprised patients with moderate-to-severe SLE who were enrolled in phase IIb of the MUSE trial (A Phase II, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus), with healthy individuals as controls. Blood samples were collected from SLE patients (n = 305) and healthy controls (n = 10-20) before the initiation of treatment (baseline) and from SLE patients after they had been treated with 300 mg of anifrolumab (n = 99) or placebo (n = 102). Baseline IFN gene signature test status was determined, and the IFN gene signature (21-gene panel) was monitored over time. Serum proteins were measured by multiplex immunoassay or ultrasensitive Simoa assay. NET complexes, cholesterol efflux capacity (CEC), and glycoprotein acetylation (GlycA) and other lipid parameters were assessed in plasma.
RESULTS


Formation of NET complexes and levels of tumor necrosis factor (TNF) and interleukin-10 (IL-10) were correlated with extent of type I IFN pathway activity. NET complexes and IL-10 levels were up-regulated in SLE patients compared to healthy controls (P < 0.008). The cardiometabolic disease markers CEC and GlycA were also found to be dysregulated in patients with SLE (P < 0.001 versus healthy controls). Type I IFN receptor inhibition with anifrolumab significantly reduced NET complexes and GlycA and improved CEC compared to baseline (P < 0.05) whereas no improvements were seen with placebo. Levels of TNF and IL-10 were reduced with anifrolumab compared to placebo (P < 0.05).
CONCLUSION


These data support a key role for type I IFNs in modulating factors contributing to SLE vasculopathy and suggest that inhibition of this pathway could decrease cardiovascular risk in individuals with SLE.",2020,"TNF-α and IL-10 were reduced versus placebo (p<0.05).
","['systemic lupus erythematosus', 'patients with moderate to severe SLE enrolled in the phase 2b MUSE trial (NCT01438489', 'patients with systemic lupus erythematosus (SLE']",['placebo'],"['NET complexes, tumor necrosis factor alpha (TNF-α), and interleukin (IL)-10 correlated with type I IFN pathway activity; NET complexes and IL-10', 'cardiovascular risk', 'TNF-α and IL-10', 'Cardiometabolic disease markers CEC and GlycA', 'NET complexes, cholesterol efflux capacity (CEC), and full NMR LipoProfile ®', 'NET complexes and GlycA and improved CEC', 'Serum proteins']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3850088', 'cui_str': 'NETs (Neutrophil Extracellular Traps)'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}]",305.0,0.18026,"TNF-α and IL-10 were reduced versus placebo (p<0.05).
","[{'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Casey', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Sinibaldi', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Nickie L', 'Initials': 'NL', 'LastName': 'Seto', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Xinghao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Carlucci', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Liangwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Illei', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Binbing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, Maryland.'}, {'ForeName': 'Mariana J', 'Initials': 'MJ', 'LastName': 'Kaplan', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Wendy I', 'Initials': 'WI', 'LastName': 'White', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41518']
772,32912633,"Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study.","OBJECTIVE


To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain.
DESIGN


Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
SETTING


Hospitals and clinics.
PATIENT(S)


Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
INTERVENTION(S)


During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
MAIN OUTCOME MEASURE(S)


Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
RESULT(S)


The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
CONCLUSION(S)


Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01458301.",2021,Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated.,"['women with endometriosis-associated pain', 'Hospitals and clinics', 'Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain']","['Relugolix, an oral gonadotropin-releasing hormone receptor antagonist', 'Relugolix', 'placebo and leuprorelin', 'placebo', 'leuprorelin', 'relugolix 10 mg', 'relugolix, a gonadotropin-releasing hormone receptor antagonist']","['mean visual analog scale score for pelvic pain', 'efficacy and safety', 'hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease', 'tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}]","[{'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0025874', 'cui_str': 'Intermenstrual bleeding - irregular'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0156404', 'cui_str': 'Irregular periods'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",103.0,0.454383,Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated.,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: yutakaos-tky@umin.ac.jp.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Seki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tanimoto', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Terakawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Yonago, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.07.055']
773,32910353,Willingness to Participate in At-Home HIV Testing Among Young Adults Who Use Opioids in Rural Appalachia.,"New HIV infections associated with injection drug use are of major concern in rural US communities. This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia. Eligible participants were 18-35 years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30 days. A majority reported being likely (63.6%, 96/151) to take a free at-home HIV tests and 66.9% (101/151) consented to receive one. Among those who were randomly selected to receive a Home Access HIV-1 test kit (n = 37), 37.8% mailed in blood spots and 21.6% called to receive results. This study provides evidence that PWUD may be willing to take an at-home test, but other barriers may inhibit actual completion.",2021,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","['Young Adults', 'Rural Appalachia', 'Eligible participants were 18-35\xa0years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30\xa0days', ""people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia""]",['Home Access HIV-1 test kit'],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}]",[],,0.0668314,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","[{'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Ballard', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA. april.ballard@emory.edu.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardöerfer', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Prood', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Chukwudi', 'Initials': 'C', 'LastName': 'Mbagwu', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Hannah L F', 'Initials': 'HLF', 'LastName': 'Cooper', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03034-6']
774,30325270,Effects of upper and lower body wearable resistance on spatio-temporal and kinetic parameters during running.,"Wearable resistance training involves added load attached directly to the body during sporting movements. The effects of load position during running are not yet fully established. Therefore, the purpose of this research was to determine spatio-temporal and kinetic characteristics during submaximal running using upper, lower and whole-body wearable resistance (1-10% body mass (BM)). Twelve trained male runners completed eight 2-min treadmill running bouts at 3.9 m/s with and without wearable resistance. The first and last bouts were unloaded, while the middle 6 were randomised wearable resistance conditions: upper body (UB) 5% BM, lower body (LB) 1%, 3%, 5% BM and whole body (WB) 5%, 10% BM. Wearable resistance of 1-10% BM resulted in a significant increase in heart rate (5.40-8.84%), but minimal impact on spatio-temporal variables. Loads of 5% BM and greater caused changes in vertical stiffness, vertical and horizontal force, and impulse. Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%. Wearable resistance may be used to increase muscular kinetics during running without negatively impacting spatio-temporal variables. The application of these findings will vary depending on athlete goals. Future longitudinal studies are required to validate training contentions.",2020,"Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%.",['Twelve trained male runners completed eight'],['2-min treadmill running bouts at 3.9\xa0m/s with and without wearable resistance'],"['Functional and effective propulsive force', 'vertical stiffness, vertical and horizontal force, and impulse', 'Wearable resistance', 'heart rate', 'muscular kinetics']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",12.0,0.0197937,"Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%.","[{'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Couture', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Simperingham', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Cronin', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Lorimer', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Kilding', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Macadam', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}]",Sports biomechanics,['10.1080/14763141.2018.1508490']
775,32919915,Angiotensin-Neprilysin Inhibition in Black Americans: Data From the PIONEER-HF Trial.,"OBJECTIVES


This study compared the efficacy and safety of sacubitril/valsartan to enalapril in Black and non-Black Americans with acute decompensated heart failure (ADHF).
BACKGROUND


Black patients have a different response to treatment with angiotensin-converting enzyme inhibitors compared with other racial and ethnic groups. How Black patients with ADHF respond to sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is unclear. PIONEER-HF was a double-blind randomized clinical trial of sacubitril/valsartan versus enalapril in hospitalized patients with ADHF following hemodynamic stabilization.
METHODS


In a pre-specified subgroup analysis, we examined changes in N-terminal pro-B-type natriuretic peptide, clinical outcomes, and safety according to race.
RESULTS


The study population, all enrolled in the United States, included 316 (36%) Black participants, 515 (58%) White participants, and 50 (5.7%) participants of other racial groups. The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00). Compared with enalapril, sacubitril/valsartan also reduced the pre-specified exploratory composite of cardiovascular death or HF rehospitalization in both Black (hazard ratio: 0.47; 95% CI: 0.24 to 0.93) and non-Black patients (hazard ratio: 0.65; 95% CI: 0.40 to 1.06; interaction p = 0.44).
CONCLUSIONS


Among Black patients admitted with ADHF in the United States, the in-hospital initiation of sacubitril/valsartan was more effective than enalapril in reducing natriuretic peptide levels and the composite of cardiovascular death or HF rehospitalization. The effect of sacubitril/valsartan did not differ by race. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00).,"['The study population, all enrolled in the United States, included 316 (36', 'Patients', 'White participants, and 50 (5.7%) participants of other racial groups', 'Black participants, 515 (58', 'Black Americans', 'Black patients', 'Black patients admitted with ADHF in the United States', 'Black and non-Black Americans with acute decompensated heart failure (ADHF', 'hospitalized patients with ADHF following hemodynamic stabilization', 'How Black patients with ADHF respond to']","['sacubitril/valsartan', 'Angiotensin-Neprilysin Inhibition', 'angiotensin-converting enzyme inhibitors', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril, sacubitril/valsartan', 'enalapril']","['reduction in N-terminal pro-B-type natriuretic peptide concentration', 'efficacy and safety', 'NT-proBNP', 'natriuretic peptide levels and the composite of cardiovascular death or HF rehospitalization', 'pre-specified exploratory composite of cardiovascular death or HF rehospitalization']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.173707,The reduction in N-terminal pro-B-type natriuretic peptide concentration at weeks 4 and 8 was significantly greater with sacubitril/valsartan than enalapril in both Black (ratio of change with sacubitril/valsartan vs. enalapril: 0.71; 95% confidence interval [CI]: 0.58 to 0.88) and non-Black patients (ratio of change: 0.71; 95% CI: 0.61 to 0.83; interaction p = 1.00).,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Berardi', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hillary S', 'Initials': 'HS', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Terrence X', 'Initials': 'TX', 'LastName': ""O'Brien"", 'Affiliation': 'Ralph H. Johnson Veterans Affairs Medical Center, South Carolina, Charleston; Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address: adam.devore@duke.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.019']
776,32919912,Associations Between Depressive Symptoms and HFpEF-Related Outcomes.,"OBJECTIVES


This study analyzed changes in depressive symptoms in patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial.
BACKGROUND


There are limited longitudinal data for depressive symptoms in patients with HFpEF.
METHODS


In patients enrolled in the United States and Canada (n = 1,431), depressive symptoms were measured using Patient Health Questionnaire-9 (PHQ-9). Clinically meaningful changes in PHQ-9 scores were defined as worse (≥3-point increase) or better (≥3-point decrease). Multivariate models were used to identify predictors of change in depressive symptoms. Cox proportional hazard models were used to determine the impact of symptom changes from baseline on subsequent incident cardiovascular events.
RESULTS


At 12 months, 19% of patients experienced clinically worsening depressive symptoms, 31% better, and 49% unchanged. Independent predictors of clinically meaningful improvement in depressive symptoms included higher baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease, and randomization to spironolactone. After data were adjusted for cardiovascular comorbidities, higher baseline PHQ-9 was associated with all-cause mortality (hazard ratio [HR]: 1.09; 95% confidence interval [CI]: 1.02 to 1.16; p = 0.011), whereas worsening depressive symptoms at 12 months were associated with cardiovascular death (HR: 2.47; 95% CI: 1.32 to 4.63; p = 0.005) and all-cause mortality (HR: 1.82; 95% CI: 1.13 to 2.93; p = 0.014). Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
CONCLUSIONS


Higher baseline depressive symptoms and worsening depressive symptoms were associated with all-cause mortality. Randomization to spironolactone was associated with modest reduction in depressive symptoms. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302).",2020,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","['patients with HFpEF', 'patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the', 'for Adults With Heart\xa0Failure and Preserved Systolic Function) trial']","['Aldosterone Antagonist Therapy', 'TOPCAT (Aldosterone Antagonist Therapy', 'spironolactone']","['baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease', 'baseline depressive symptoms and worsening depressive symptoms', 'clinically worsening depressive symptoms', 'depressive symptoms', 'PHQ-9 scores', 'cardiovascular death', 'worsening depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.485354,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': 'Cardiology Division, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Michael A D', 'Initials': 'MAD', 'LastName': 'Alcala', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Presbyterian-Brooklyn Methodist Hospital, New York, New York, USA.'}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California, USA. Electronic address: eflewis@stanford.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.010']
777,32919914,Similar Yet Different: Examining the Effects of Sacubitril/Valsartan by Race in the PIONEER-HF Trial.,,2020,,[],['Sacubitril/Valsartan'],[],[],"[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}]",[],,0.0216378,,"[{'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute and Edward Hospital Center for Advanced Heart Failure, Naperville, Illinois. Electronic address: mariarosa.costanzo@aah.com.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.002']
778,32920647,A Delta-Opioid Receptor Gene Polymorphism Moderates the Therapeutic Response to Extended-Release Buprenorphine in Opioid Use Disorder.,"BACKGROUND


Buprenorphine treatment is not equally effective in all patients with opioid use disorder (OUD). Two retrospective studies showed that, among African Americans (AAs), rs678849, a polymorphism in the delta-opioid receptor gene, moderated the therapeutic effect of sublingual buprenorphine.
METHODS


We examined rs678849 as a moderator of the response to an extended-release subcutaneous buprenorphine formulation (BUP-XR) in a 24-week OUD treatment study of 127 AAs and 327 European Americans (EAs). Participants were randomly assigned to receive: (1) BUP-XR as 2 monthly injections of 300 mg followed by either 300 mg monthly or 100 mg monthly for 4 months, or (2) monthly volume-matched placebo injections. Generalized estimating equations logistic regression analyses tested, per population group, the main and interaction effects of treatment (BUP-XR vs placebo) and genotype group (rs678849*CC vs CT/TT) on weekly urine drug screens (UDS).
RESULTS


Among AAs, the placebo group had higher rates of opioid-positive UDS than the BUP-XR group (log odds ratio = 1.67, 95% CI = 0.36, 2.98), but no genotype by treatment effect (P = .80). Among EAs, the placebo group also showed higher rates of opioid-positive UDS than the BUP-XR group (log odds ratio = 1.97, 95% CI = 1.14, 2.79) but a significant genotype by treatment interaction (χ 2(1) = 4.33, P = .04).
CONCLUSION


We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs. These findings require replication in well-powered, prospective studies of both AA and EA OUD patients treated with BUP-XR and stratified on rs678849 genotype.",2021,"We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs.","['patients with opioid use disorder (OUD', '127 AAs and 327 European Americans (EAs']","['Buprenorphine', 'BUP-XR as 2 monthly injections of 300\xa0mg followed by either 300\xa0mg monthly or 100\xa0mg monthly for four months or 2) monthly volume-matched placebo injections', 'buprenorphine', 'placebo', 'buprenorphine formulation (BUP-XR']",['rates of opioid-positive UDS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0239307', 'cui_str': 'European'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0798136,"We found a moderating effect of rs678849 on the response to buprenorphine treatment of OUD in EAs, but not AAs.","[{'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Mental Illness Research, Education and Clinical Center of the Veterans Integrated Service Network 4, Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Crist', 'Affiliation': 'Center for Neurobiology and Behavior, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hartwell', 'Affiliation': 'Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Moigne', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}, {'ForeName': 'Celine M', 'Initials': 'CM', 'LastName': 'Laffont', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Andorn', 'Affiliation': 'Indivior Inc., North Chesterfield, Virginia, USA.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa069']
779,32928937,Effect of combined facial exercise with botulinum toxin A on health-related quality of life in Thai adults with hemifacial spasm: a randomised controlled pilot cross-over trial.,,2021,,['Thai adults with hemifacial spasm'],['combined facial exercise with botulinum toxin A'],['health-related quality of life'],"[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0278152', 'cui_str': 'Hemifacial spasm'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454333', 'cui_str': 'Facial exercises'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.118923,,"[{'ForeName': 'Yuvadee', 'Initials': 'Y', 'LastName': 'Pitakpatapee', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pannathat', 'Initials': 'P', 'LastName': 'Soontrapa', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Arpakorn', 'Initials': 'A', 'LastName': 'Suengtaworn', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jindapa', 'Initials': 'J', 'LastName': 'Srikajon', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanita', 'Initials': 'T', 'LastName': 'Sangpeamsook', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chulalak', 'Initials': 'C', 'LastName': 'Komoltri', 'Affiliation': 'Research Group and Research Network Division, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Prachaya', 'Initials': 'P', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand cloundbuffy@gmail.com.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323604']
780,32925060,"Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study.","BACKGROUND


Apathy, a profound loss of motivation, initiation, and goal directed cognition, is a common comorbidity of Alzheimer's disease (AD). The presence of apathy is associated with rapid progression of AD, long-term impairment, disability, and higher mortality. Pharmacological treatments of apathy are limited.
OBJECTIVE


The primary objective was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy in AD.
METHODS


A randomized, double-blind, parallel-arm, sham-controlled pilot study was conducted in subjects with AD and apathy (N = 20). Subjects were randomized to rTMS or sham treatment (5 days/week) for four weeks. Primary outcome, apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI), were assessed at baseline and four weeks. Follow-up visits were conducted at 8 and 12 weeks to test the durability of effects of intervention.
RESULTS


Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks. There was also significantly greater improvement in 3MS (6.9 (1.7 to 12.0); t (15)  = 2.85; p = 0.012), IADL (3.4 (1.0 to 5.9); χ21 = 7.72; p = 0.006), CGI-S (1.4 (0.5 to 2.3), t (16)  = 3.29; p = 0.005), and CGI-I (-2.56 (-3.5 to -1.6), t (17)  = -5.72; p < 0.001) for rTMS compared to the sham at 4 weeks. The effects of rTMS were durable at 12 weeks.
CONCLUSION


rTMS may be safely used in subjects with AD and may improve apathy, function, and some aspects of cognition.",2020,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[""Alzheimer's Disease"", 'subjects with AD and apathy (N\u200a=\u200a20', 'Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females', 'subjects with AD']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS', 'IADL', 'apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI', 'CGI-S']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.540663,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16)  = -3.69; p = 0.002) at 4 weeks.","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Eugenia M', 'Initials': 'EM', 'LastName': 'Boozer', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200640']
781,32928185,Women's views about physical activity as a treatment for vasomotor menopausal symptoms: a qualitative study.,"BACKGROUND


Women commonly seek medical advice about menopausal symptoms. Although menopausal hormone therapy is the most effective treatment, many women prefer non-pharmacological treatments, such as physical activity. The effectiveness of physical activity has been inconclusive when assessed by randomised controlled trials, and it remains unclear how women feel about it as a possible treatment approach. The aim of the study was to explore symptomatic menopausal women's views and experiences of physical activity as a treatment for vasomotor and other menopausal symptoms.
METHODS


An in-depth qualitative study was embedded within a randomised controlled trial that assessed the effectiveness of physical activity as a treatment for vasomotor menopausal symptoms in previously inactive vasomotor symptomatic women. Participants were randomised to one of two physical activity interventions or a usual care group. Both physical activity interventions involved two one-to-one consultations, plus either supporting materials or access to physical activity support groups, over 6 months. Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up. Interviews were audio recorded, transcribed verbatim, and analysed by constant comparison.
RESULTS


All participants talked positively about physical activity as a treatment for their menopausal symptoms, with most reporting participation had improved their hot flushes and night sweats. They reported that they had experienced improved sleep, physical health and psychological well-being. Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved. Many participants commented that they would prefer doctors to discuss physical activity as a possible treatment for their hot flushes and night sweats, before offering medication.
CONCLUSIONS


Based on the views and experiences of the women who participated in this study, healthcare professionals should continue discussing physical activity as a potential first treatment option with menopausal women. Furthermore, healthcare professionals should ensure they prepare, support, and encourage these women both physically and emotionally.
TRIAL REGISTRATION


ISRCTN ISRCTN06495625 Registered 10/11/2010.",2020,Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved.,"['previously inactive vasomotor symptomatic women', 'Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up']","['physical activity interventions or a usual care group', 'physical activity plus social-support intervention', 'menopausal hormone therapy', 'physical activity']","['hot flushes and night sweats', 'vasomotor menopausal symptoms', 'sleep, physical health and psychological well-being']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}]","[{'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}]",17.0,0.085535,Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved.,"[{'ForeName': 'Adèle', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Office of HDR Training and Partnerships, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK. a.daley@lboro.ac.uk.'}]",BMC women's health,['10.1186/s12905-020-01063-w']
782,32964308,Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity.,"PURPOSE


Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS.
METHODS


We examined the intensity, duration, correlation with the treatment, up to 1 year after the end of rTMS treatment.
RESULTS


Descriptive analysis included a total of 63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3 ± 10.4 years; BMI 36.3 ± 4.4 kg/m 2 ): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham). Thirty-two subjects (50.8%) reported a total of 52 AEs, including mainly moderate (51.9%) events. The most frequently reported side effects were headaches of moderate intensity (40.4%) and local pain/discomfort (19.2%) and resulted significantly more frequent in HF group compared to other groups (p < 0.05). No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis. No AEs potentially related to the rTMS arised up to 1 year from the end of the treatment.
CONCLUSIONS


This is the first comprehensive safety analysis in obese patients treated with rTMS. The analysis did not reveal any unexpected safety concerns. Only headaches and local pain/discomfort have been significantly more frequent in the HF group, confirming the good tolerability of rTMS even in the obese population potentially more susceptible to side effects of brain stimulation.",2021,"No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis.","['obese patients treated with rTMS', 'obese individuals treated with rTMS', 'individuals with obesity', 'obesity', '63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3\u2009±\u200910.4\u2009years; BMI 36.3\u2009±\u20094.4\u2009kg/m 2 ): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham']","['rTMS', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'deep transcranial magnetic stimulation']","['AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis', 'Safety and tolerability', 'local pain/discomfort', 'headaches of moderate intensity', 'headaches and local pain/discomfort']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",63.0,0.056414,"No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrulli', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Massarini', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Macrì', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy. livio.luzi@multimedica.it.'}]",Endocrine,['10.1007/s12020-020-02496-x']
783,32926803,Continuous Positive Airway Pressure Does Not Improve Nonalcoholic Fatty Liver Disease in Patients with Obstructive Sleep Apnea. A Randomized Clinical Trial.,"Rationale:  Obstructive sleep apnea (OSA) is associated with development of nonalcoholic fatty liver disease (NAFLD). The effects of continuous positive airway pressure (CPAP) on NAFLD in patients with concomitant OSA are unknown. Objectives:  To investigate the effects of autoadjusting CPAP versus subtherapeutic CPAP treatment over 6 months on NAFLD activities. Methods:  Patients with NAFLD and OSA, as defined by respiratory event index ≥5/h diagnosed by a validated level 3 Embletta device, were randomized into group A) autoadjusting CPAP (4-20 cm H 2 O) or group B) subtherapeutic CPAP (pressure fixed at 4 cm H 2 O). The primary endpoint was the difference in changes in intrahepatic triglyceride as measured by proton magnetic resonance spectroscopy after 6 months of therapy. Key secondary endpoints included changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment. Measurements and Main Results:  A total of 120 patients were randomized equally into two groups. There were significant correlations between CAP and respiratory event index ( r  = 0.203,  P  = 0.026), percentage of total recording time with Sa O 2  < 90% ( r  = 0.265,  P  = 0.003), and oxygen desaturation index ( r  = 0.214,  P  = 0.019). After 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the two treatment groups. Regression analysis showed that weight change over 6 months correlated with changes in both intrahepatic triglyceride and CAP ( P  < 0.001). Conclusions:  Despite significant correlations between hepatic steatosis and markers of severity of OSA, CPAP alone did not improve hepatic steatosis and fibrosis. However, the additional role of weight reduction through lifestyle modification deserves further investigation.",2021,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","['Patients with NAFLD and OSA, as defined by respiratory event index (REI) ≥ 5/hr diagnosed by a validated level 3 Embletta device', 'Patients with Obstructive Sleep Apnea', 'Obstructive sleep apnea (OSA', 'A total of 120 patients', 'patients with concomitant OSA are unknown']","['autoCPAP', 'autoCPAP (4-20cmH2O) or group B) subtherapeutic CPAP (pressure fixed at 4cmH2O', 'continuous positive airway pressure (CPAP', 'CPAP', 'subtherapeutic CPAP']","['percentage of total recording time', 'changes in controlled attenuation parameter (CAP) and liver stiffness measurement measured with transient elastography, and serum cytokeratin-18 fragment', 'hepatic steatosis and fibrosis', 'oxygen desaturation index', 'Nonalcoholic Fatty Liver Disease', 'intrahepatic triglyceride (IHTG', 'hepatic steatosis and markers of severity of OSA', 'weight change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",120.0,0.124748,"Following 6 months of treatment, there were no significant differences of changes in primary and secondary endpoints between the 2 treatment groups.","[{'ForeName': 'Susanna S S', 'Initials': 'SSS', 'LastName': 'Ng', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Vincent W S', 'Initials': 'VWS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, and.'}, {'ForeName': 'Grace L H', 'Initials': 'GLH', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, and.'}, {'ForeName': 'Winnie C W', 'Initials': 'WCW', 'LastName': 'Chu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tat-On', 'Initials': 'TO', 'LastName': 'Chan', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Kin-Wang', 'Initials': 'KW', 'LastName': 'To', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Fanny W S', 'Initials': 'FWS', 'LastName': 'Ko', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'Ka-Pang', 'Initials': 'KP', 'LastName': 'Chan', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': 'SH Ho Sleep Apnea Management Center, Department of Medicine and Therapeutics.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1868OC']
784,32932009,"The preliminary effects of henna on chemotherapy-induced peripheral neuropathy in women receiving oxaliplatin-based treatment: A parallel-group, randomized, controlled pilot trial.","PURPOSE


Chemotherapy-induced peripheral neuropathy (CIPN) may frequently occur in patients receiving oxaliplatin-based treatment. The aim of the present parallel-group, randomized, controlled pilot trial was to investigate the effect of henna on CIPN in women receiving oxaliplatin-based treatment.
METHOD


Sixty female patients receiving oxaliplatin-based treatment were randomly divided into two groups, i.e., one intervention group (n = 30) where henna was applied topically and one control group (n = 30) that received routine treatment and care. Women in the intervention group were provided a pack of henna prepared by the investigators following each treatment course (2nd, 3rd, and 4th courses) and were instructed to apply the henna on their palms, fingers, and soles. The chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) was completed by women subsequent to the 2nd (baseline), 3rd, and 4th courses of treatment.
RESULTS


The intragroup assessment performed for the intervention group revealed that the total CIPNAT score significantly declined in the intervention group (p < 0.05). The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group × time interaction was η 2  = 0.169. Similarly, regarding the symptoms intervention section of the tool, a positive change by time in the intervention group was observed, and the effect size concerning this change was large, i.e., η 2  = 0.284.
CONCLUSIONS


The present study results showed that henna application on hands and feet has a beneficial effect on peripheral neuropathy. Applying henna is a promising approach in CIPN management.",2020,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","['women receiving oxaliplatin-based treatment', 'patients receiving oxaliplatin-based treatment', 'Sixty female patients receiving oxaliplatin-based treatment']","['henna was applied topically and one control group (n\xa0=\xa030) that received routine treatment and care', 'chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT']",['total CIPNAT score'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064698', 'cui_str': 'lawsone'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0266703,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Necmettin Erbakan University, Faculty of Nursing, Konya, Turkey. Electronic address: seldaarslan@erbakan.edu.tr.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Zorba Bahceli', 'Affiliation': 'Izmir Bakircay University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: pinarzorba85@gmail.com.'}, {'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'İlik', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: yeteriner@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Artaç', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: mehmetartac@yahoo.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101827']
785,32934890,The consensus Immunoscore in phase 3 clinical trial (N0147) and impact on patient management decisions.,"The consensus Immunoscore is a routine assay quantifying the adaptive immune response within the tumor microenvironment. It has a prognostic value that has been confirmed in a phase 3 clinical trial (NCCTG N0147) in stage III colon cancers. Moreover, results from another phase 3 randomized trial revealed the predictive value of Immunoscore for response to adjuvant chemotherapy duration. These results highlight the clinical utility of Immunoscore. In its latest edition, the World Health Organization classification of Digestive System Tumors introduced for the first time the immune response as an essential and desirable diagnostic criterion for colorectal cancer. Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer. The international validation of the prognostic value of the consensus Immunoscore together with its prognostic value in the N0147 trial and its predictive utility for response to chemotherapy in stage III patients provide valuable information for patient management.",2020,"Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer.",[],[],[],[],[],[],,0.0335885,"Within the tumor microenvironment, the immune response provides an important estimate of the risk of recurrence and death in colon cancer.","[{'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Lanzi', 'Affiliation': 'INSERM, Laboratory of Integrative Cancer Immunology, Cordeliers Research Center, Paris, France.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Galon', 'Affiliation': 'INSERM, Laboratory of Integrative Cancer Immunology, Cordeliers Research Center, Paris, France.'}]",Oncoimmunology,['10.1080/2162402X.2020.1796003']
786,32944843,"Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study.","PURPOSE


Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.
METHODS


CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18-65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.
RESULTS


A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: -33.58 ± 2.11 (GMB 120 mg) and -32.67 ± 2.04 (GMB 240 mg).
CONCLUSION


Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.",2021,Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period.,"['Patients aged 18-65\xa0years with diagnosis of migraine (≥\u20094 migraine headache days per month) as defined by International Classification of Headache Disorders', 'patients with migraine', 'patients with episodic or chronic migraine', '135 patients']","['galcanezumab (GMB', 'galcanezumab', 'Galcanezumab', 'subcutaneous GMB', 'GMB']","['Role function-restrictive (RF-R) domain (overall least squares (LS', 'Functional impairment and disability', 'Mean (SD) baseline MSQ total scores', 'Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS', 'For MIDAS, mean (SD) total scores', 'health-related quality of life and decreased disability', 'MSQ and MIDAS total scores and all individual item/domain scores', 'PRO measures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517566', 'cui_str': '135'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",135.0,0.0199321,Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period.,"[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA. ford_janet@lilly.com.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Stauffer', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, USA.'}, {'ForeName': 'Sreelatha', 'Initials': 'S', 'LastName': 'Akkala', 'Affiliation': 'Eli Lilly Services India Pvt Ltd, Bengaluru, India.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sexson', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02632-0']
787,32939556,"Glycine, a Dispensable Amino Acid, Is Conditionally Indispensable in Late Stages of Human Pregnancy.","BACKGROUND


Recently, we showed that there are higher protein, lysine, and phenylalanine requirements in late stages of pregnancy compared with early stages. Animal studies have suggested an increased dietary need for specific dispensable amino acids in pregnancy; whether such a need exists in human pregnancies is unknown.
OBJECTIVE


The objective of the current study was to examine whether healthy pregnant women at midgestation (20-29 wk) and late gestation (30-40 wk) have a dietary demand for glycine, a dispensable amino acid, using the indicator amino acid oxidation method and measurement of plasma 5-oxoproline concentrations.
METHODS


Seventeen healthy women (aged 26-36 y) randomly received different test glycine intakes (range: 5-100 mg·kg-1·d-1) during each study day in midgestation (∼26 wk, n = 17 observations in 9 women) and late gestation (∼35 wk, n = 19 observations in 8 women). Diets were isocaloric with energy at 1.7 × resting energy expenditure. Protein was given as a crystalline amino acid mixture based on egg protein composition at current estimated average requirement (EAR; 0.88 g·kg-1·d-1). Breath samples were collected at baseline and isotopic steady state to measure oxidation of L-[1-13C]phenylalanine to 13CO2 (F13CO2). Plasma was collected at the sixth hour of the study day. Linear regression crossover analysis and simple linear regression were used to assess responses in F13CO2 and plasma 5-oxoproline concentrations to different glycine intakes.
RESULTS


No statistically significant responses were observed in midgestation. However, in late gestation, lower glycine intakes resulted in higher rates of F13CO2 (suggesting low protein synthesis) with a breakpoint for phenylalanine oxidation at >37 mg glycine·kg-1·d-1 and higher plasma 5-oxoproline (suggesting low glycine availability) with a breakpoint >27 mg glycine·kg-1·d-1.
CONCLUSIONS


The findings suggest that glycine should be considered a ""conditionally"" indispensable amino acid during late gestation, especially when protein intakes are at 0.88 g·kg-1·d-1, the current EAR. This trial was registered at clinicaltrials.gov as NCT02149953.",2021,No statistically significant responses were observed in midgestation.,"['healthy pregnant women at midgestation (20-29 wk) and late gestation (30-40 wk', 'Seventeen healthy women (aged 26-36 y) randomly received']","['Glycine', 'different test glycine intakes', 'glycine']","['plasma 5-oxoproline', 'F13CO2 and plasma 5-oxoproline concentrations', 'Plasma']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0034330', 'cui_str': 'Pyrrolidonecarboxylic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.482536,No statistically significant responses were observed in midgestation.,"[{'ForeName': 'Betina F', 'Initials': 'BF', 'LastName': 'Rasmussen', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Madeleine A', 'Initials': 'MA', 'LastName': 'Ennis', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Dyer', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Lim', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': ""BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}]",The Journal of nutrition,['10.1093/jn/nxaa263']
788,32934137,"Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR).","OBJECTIVE


To examine the efficacy and safety of pegloticase in combination with methotrexate (MTX) in patients with uncontrolled gout in an exploratory, open-label clinical trial (ClinicalTrials.gov: NCT03635957) prior to a randomized, controlled trial.
METHODS


A multicenter, open-label efficacy and safety study of pegloticase with MTX co-treatment was conducted in patients with uncontrolled gout. Patients were administered oral MTX (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as serum uric acid (sUA) < 6 mg/dL for ≥ 80% of the time during Month 6 (Weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥ 1 pegloticase infusion.
RESULTS


Seventeen patients were screened and 14 patients (all men, average age 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL, and 12 of the 14 patients had visible tophi. At the 6-month timepoint, 11/14 (78.6%, 95% CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (preinfusion sUA values > 6 mg/ dL at 2 consecutive scheduled visits). All patients tolerated MTX. No new safety concerns were identified.
CONCLUSION


In this study, an increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with MTX and pegloticase as compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of MTX or placebo with pegloticase to validate these open-label findings.",2020,"At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits).","['patients with uncontrolled gout', 'Seventeen patients were screened and 14 patients (all men, average age: 49.3 ± 8.7 years) were enrolled', 'patients with uncontrolled gout in an exploratory, open-label clinical trial (NCT03635957) prior']","['folic acid', 'methotrexate', 'oral methotrexate', 'methotrexate cotreatment', 'methotrexate or placebo', 'Pegloticase in combination with methotrexate']","['efficacy and safety', 'proportion of responders', 'proportion of patients maintained therapeutic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2350656', 'cui_str': 'Pegloticase'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}]",17.0,0.033204,"At the 6 month timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits).","[{'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Botson', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'John R P', 'Initials': 'JRP', 'LastName': 'Tesser', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Bennett', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Kenney', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Peloso', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Obermeyer', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'LaMoreaux', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': ""This work was supported by Horizon Therapeutics. J.K. Botson, MD, RPh, Orthopedic Physicians Alaska, Anchorage, Alaska; J.R. Tesser, MD, R. Bennett, MD, Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona; H.M. Kenney, MD, Arthritis Northwest, PLLC, Spokane, Washington; P.M. Peloso, MD, MSc, K. Obermeyer, MS, B. LaMoreaux, MD, MS, Horizon Therapeutics, Lake Forest, Illinois; M.E. Weinblatt, MD, Brigham and Women's Hospital, Boston, Massachusetts; 6J. Peterson, MD, Western Washington Arthritis Clinic, Bothell, Washington, USA. JKB has received research support from Horizon Therapeutics and Radius Health as a study site and principal investigator. He has received consulting/ speaker fees > $10k from Horizon Therapeutics, Celgene, Novartis, and AbbVie. JRT has received research grants/support from Horizon. HMK has received research support from Horizon Therapeutics as a study site and principal investigator, and has served as a speaker. PMP, KO, and BL are employees of and own stock in Horizon Therapeutics. MEW has received grants from Amgen, Bristol Myers Squibb, Crescendo Bioscience, Lilly, and Sanofi; has received consulting fees > $10k from Bristol Myers Squibb, Corona, and Lilly and < 10k from AbbVie, Amgen, Arena, GlaxoSmithKline, Gilead Sciences, Horizon Therapeutics, Lycera, Novartis, Pfizer, Roche, Samsung, Scipher Medicine, and Set Point; and has stock options in Lycera, Can-Fite BioPharma, Scipher Medicine, Inmedix, and Vorso. JP has received research support from Horizon Therapeutics (study site/investigator), and has also served as an advisor and speaker for Horizon Therapeutics. RB has no financial relationships that pose a potential conflict of interest. Address correspondence to Dr. J.K. Botson, Orthopedic Physicians Alaska, 3801 Lake Otis Parkway, Anchorage, AK 99508, USA. Email: jbotson@opaak.com. Full Release Article. For details see Reprints and Permissions at jrheum.org. Accepted September 11, 2020.""}]",The Journal of rheumatology,['10.3899/jrheum.200460']
789,32949942,The effect of individualized education with support on breast cancer patients' anxiety and depression during radiation therapy: A pilot study.,"PURPOSE


This study was undertaken to determine the effects of individualized education with support intervention on breast cancer patients' anxiety and depression while undergoing radiation therapy (RT). Moreover, the intervention was assessed for its feasibility in the context of Pakistan.
METHODS


A quasi-experimental design was used to conduct this study in RT department of a public hospital in Karachi. A total of 61 breast cancer patients receiving radiation as adjuvant therapy participated in the study. The experimental group (n = 31) received individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT. In addition, the nurse remained available for the consultation during the RT sessions and on telephone throughout the RT period. However, the control group received only information booklet. Patients' anxiety and depression were measured in both of the groups before the commencement of RT, and at the completion of RT by using the Aga Khan University Anxiety and Depression Scale (AKUADS).
RESULTS


A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test. The overall mean anxiety and depression scores of the control group showed no significant difference (p = 0.187). The effect size of the intervention was large (Cohen's d = 2.5).
CONCLUSION


The intervention was effective in reducing anxiety and depression among breast cancer patients receiving RT. Replication of the study on a larger scale in multiple settings on other cancer patients is recommended.",2020,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"['61 breast cancer patients receiving radiation as adjuvant therapy participated in the study', ""breast cancer patients' anxiety and depression during radiation therapy"", ""breast cancer patients' anxiety and depression while undergoing radiation therapy (RT"", 'RT department of a public hospital in Karachi', 'breast cancer patients receiving RT']","['individualized education', 'individualized education with support intervention', 'individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT']","['overall mean anxiety and depression scores', 'anxiety and depression']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0131595,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Zaheer', 'Affiliation': 'Institute of Nursing, Combined Military Hospital (CMH) Lahore Medical College, Pakistan. Electronic address: shaziazaheer911@gmail.com.'}, {'ForeName': 'Raisa B', 'Initials': 'RB', 'LastName': 'Gul', 'Affiliation': 'Shifa Tameer-e-Millat University, Shifa College of Nursing, Islamabad, Pakistan.'}, {'ForeName': 'Shireen S', 'Initials': 'SS', 'LastName': 'Bhamani', 'Affiliation': 'Aga Khan University School of Nursing and Midwifery, Karachi, Pakistan.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Memon', 'Affiliation': 'Atomic Energy Medical Center, Jinnah Post Graduate Medical Center, Karachi, Pakistan.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101826']
790,32951121,Herbal medicines as anxiolytics prior to third molar surgical extraction. A randomized controlled clinical trial.,"OBJECTIVES


This study aimed to compare the effects of Passiflora incarnata, Erythrina mulungu, and midazolam in controlling anxiety in patients undergoing mandibular third molar extraction.
METHODS


The volunteers underwent extraction of their third mandibular molars in a randomized, placebo-controlled, triple-blind, and parallel clinical trial. Passiflora incarnata (500 mg), Erythrina mulungu (500 mg), or midazolam (15 mg) was orally administered 60 min before the surgery. The anxiety level of participants was evaluated using questionnaires and measurements of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO 2 ).
RESULTS


A total of 200 volunteers were included in this clinical trial. Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
CONCLUSIONS


Passiflora incarnata showed a similar effect to midazolam but differed from placebo and mulungu, which were unable to control anxiety in this situation. Therefore, the results suggest that Passiflora configures an herbal medicine with an anxiolytic effect, adequate to use in third molar extractions.
CLINICAL RELEVANCE


The use of Passiflora incarnata may be an alternative to benzodiazepines for controlling anxiety in patients scheduled for oral surgery under local anesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov : ANSI-388.427.",2021,"Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
","['200 volunteers', 'patients scheduled for oral surgery under local anesthesia', 'patients undergoing mandibular third molar extraction']","['Passiflora incarnata, Erythrina mulungu, and midazolam', 'benzodiazepines', 'Passiflora incarnata (500 mg), Erythrina mulungu', 'Herbal medicines', 'placebo', 'midazolam']","['heart rate (HR), blood pressure (BP), and oxygen saturation (SpO 2 ', 'BP, HR, and SpO 2', 'anxiety level']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C2919980', 'cui_str': 'passiflora incarnata flowering top extract'}, {'cui': 'C4042780', 'cui_str': 'Erythrina mulungu'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",200.0,0.364556,"Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
","[{'ForeName': 'Rafael Soares', 'Initials': 'RS', 'LastName': 'da Cunha', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Klinger Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil. klinger.amorim@outlook.com.'}, {'ForeName': 'Anne Caroline', 'Initials': 'AC', 'LastName': 'Gercina', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Allan Carlos Araújo', 'Initials': 'ACA', 'LastName': 'de Oliveira', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Liciane', 'Initials': 'L', 'LastName': 'Dos Santos Menezes', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Liane Maciel Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03468-1']
791,32965691,"Effects of different mean arterial pressure targets on plasma volume, ANP and glycocalyx-A randomized trial.","BACKGROUND


Arterial haematocrit (Hct) has been shown to decrease after anaesthesia induction, most probably because of an increased plasma volume (PV). The primary objective was to quantify change in PV if mean arterial pressure (MAP) was kept at baseline level or allowed to decrease to 60 mm Hg. Our secondary objective was to evaluate underlying mechanisms of this response.
METHODS


Twenty-four coronary artery bypass patients were randomized to a higher (90 mm Hg, intervention group) or lower (60 mm Hg, control group) MAP by titration of norepinephrine. During the experimental procedure, no fluids were administered. Baseline PV was measured by  125  I-albumin and the change in PV was calculated from the change in Hct. Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components were measured from baseline to 50 minutes after anaesthesia induction.
RESULTS


The MAP during the trial was 93 ± 9 mm Hg in the intervention group and 62 ± 5 mm Hg in the control group. PV increased with up to 420 ± 180 mL in the control group and 45 ± 130 mL in the intervention group (P < .001). Albumin and colloid osmotic pressure decreased significantly more in the control group. MR-proANP increased in the control group but no shedding of the glycocalyx layer was detected in either of the groups.
CONCLUSION


Allowing mean arterial pressure to fall to 60 mm Hg during anaesthesia induction, increases the plasma volume due to reabsorption of interstitial water, with no ANP-induced degradation of the endothelial glycocalyx.",2021,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,['Twenty-four coronary artery bypass patients'],['norepinephrine'],"['Albumin and colloid osmotic pressure', 'Baseline PV', 'glycocalyx layer', 'PV', 'plasma volume (PV', 'PV if mean arterial pressure (MAP', 'MR-proANP', 'Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0029393', 'cui_str': 'Osmotic pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",24.0,0.08616,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,"[{'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Damén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Forssell-Aronsson', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hesse', 'Affiliation': 'Department of Laboratory Medicine, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentzer', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg and Lund University, Helsingborg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nygren', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13710']
792,32966587,The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation-A randomized controlled trial.,"BACKGROUND


Mannitol, an osmotic diuretic, is proposed to be an oxygen radical scavenger. Mannitol is often used in renal transplantation to attenuate oxidative stress and thus to protect renal graft function. We tested the hypothesis that mannitol reduces overall oxidative stress during deceased donor renal transplantation.
METHODS


We randomly assigned 34 patients undergoing deceased donor renal transplantation to receive a solution of mannitol or placebo shortly before graft reperfusion until the end of surgery. We evaluated oxidative stress by measuring the static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP). sORP and cORP were measured pre-operatively, before and within 10 minutes after graft reperfusion, and post-operatively.
RESULTS


Seventeen patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group. Mannitol had no significant effect on sORP (148.5 mV [136.2; 160.2]) as compared to placebo (143.6 mV [135.8; 163.2], P = .99). There was also no significant difference in cORP between the mannitol (0.22 µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = .76).
CONCLUSION


Mannitol showed no systemic redox scavenging effects during deceased donor renal transplantation. To evaluate the direct effect of mannitol on the renal graft further studies are needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02705573.",2021,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","['34 patients undergoing deceased donor renal transplantation to receive a', '17 patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group', 'patients undergoing deceased donor renal transplantation ', 'deceased donor renal transplantation']","['mannitol', 'placebo', 'solution of mannitol or placebo', 'Mannitol']","['systemic redox scavenging effects', 'sORP and cORP', 'overall oxidative stress', 'cORP', 'sORP', 'static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",34.0,0.381711,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Clinical Department of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Sljivic', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falkner von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13713']
793,32974881,"Evaluation of the ECOHIS and the CARIES-QC among an Australian ""Aboriginal"" population.","PURPOSE


An evaluation of the reliability and validity of two child oral health-related quality of life (COHRQoL) measures among Australian Aboriginal children who participated in a randomised trial was undertaken.
METHODS


Study participants completed the Early Childhood Oral Health Impact Scale (ECOHIS) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC). The questionnaires were completed a second time to test the scales' test-retest reliability. Internal consistency, convergent and discriminant validity were evaluated through Cronbach's alpha, correlation of the scale scores with the global oral health evaluation, and comparison of scale scores among children with varying levels of caries experience, respectively.
RESULTS


Worse COHRQoL was reported by parents who rated their child's oral health as poor and by children who rated their teeth as being a lot of problem. Cronbach's alpha for the child impact section (CIS), family impact section (FIS), total ECOHIS score and the total CARIES-QC scale were 0.88, 0.81, 0.91 and 0.84, respectively. Spearman's correlations between scale scores and global oral health ratings of the CIS, FIS, total ECOHIS and the CARIES-QC were 0.42, 0.34, 0.45 and 0.70, respectively, p < 0.001. The Kruskal-Wallis test of scale scores with grouped caries experience was statistically significant, p < 0.005. Test-retest reliabilities for the ECOHIS were CIS ICC = 0.91, FIS ICC = 0.89, total ECOHIS ICC = 0.93 and for the CARIES-QC, ICC = 0.61.
CONCLUSIONS


Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
TRIAL REGISTRATION


ACTRN12616001537448, date of registration-08 November 2016.",2021,"Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
",['Australian Aboriginal children who participated in a randomised trial was undertaken'],[],"['child impact section (CIS), family impact section (FIS), total ECOHIS score and the total CARIES-QC scale', 'quality of life (COHRQoL) measures', 'Early Childhood Oral Health Impact Scale (ECOHIS) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC', 'scale scores and global oral health ratings of the CIS, FIS, total ECOHIS and the CARIES-QC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0543899,"Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, Perth, Australia. parrow@ozemail.com.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Mackean', 'Affiliation': 'Southgate Institute for Health, Society and Equity, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'McPhee', 'Affiliation': 'Kimberley Aboriginal Medical Services, Broome, Australia.'}, {'ForeName': 'Sanjeewa', 'Initials': 'S', 'LastName': 'Kularatna', 'Affiliation': 'Australian Centre for Health Services Innovation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, Australia.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02646-8']
794,32970955,Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial.,"BACKGROUND


Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults.
PURPOSE


To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months.
RESULTS


At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, -7.22 to 7.45];  P  = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  P  = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89];  P  = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%).
CONCLUSION


Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group.
REGISTRATION


NCT01623843 (ClinicalTrials.gov identifier).",2021,"For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  ","['Young Adults With Femoroacetabular Impingement', 'young adults', 'A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis']","['FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair', 'Osteochondroplasty and Labral Repair', 'osteochondroplasty']","['reoperation rate', 'hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events', 'HOS activities of daily living domain', 'pain (VAS', 'patient-reported pain (using the 100-point visual analog scale [VAS', 'pain or function', 'reoperation included hip pain']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0265264', 'cui_str': 'Holt-Oram syndrome'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}]",220.0,0.252438,"For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Musahl', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Naudie', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Slobogean', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Shanmugaraj', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Crouch', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckingham', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Petteri', 'Initials': 'P', 'LastName': 'Kousa', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Carsen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Choudur', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sim', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Johnston', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Wong', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ryland', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sparavalo', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Whelan', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gavin C A', 'Initials': 'GCA', 'LastName': 'Wood', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Howells', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Grant', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Naudie', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Zomar', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Willits', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wanlin', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alliya', 'Initials': 'A', 'LastName': 'Remtulla', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kaniki', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Etienne L', 'Initials': 'EL', 'LastName': 'Belzile', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Turmel', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Jørgensen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Gam-Pedersen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tays', 'Initials': 'T', 'LastName': 'Hatanpää', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Raivio', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mari Pirjetta', 'Initials': 'MP', 'LastName': 'Routapohja', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546520952804']
795,32974732,"Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study.","BACKGROUND


We investigated the efficacy and safety of apararenone (MT-3995), a non-steroidal compound with mineralocorticoid receptor agonist activity, in patients with stage 2 diabetic nephropathy (DN).
METHODS


The study had two parts: a dose-response, parallel-group, randomized, double-blind, placebo-controlled, multicenter, phase 2, 24-week study and an open-label, uncontrolled, 28-week extension study. Primary and secondary endpoints were the 24-week percent change from baseline in urine albumin to creatine ratio (UACR) and 24- and 52-week UACR remission rates. Safety parameters were changes from baseline in estimated glomerular filtration rate (eGFR) and serum potassium at 24 and 52 weeks, and incidences of adverse events (AEs) and adverse drug reactions (ADRs).
RESULTS


In the dose-response period, 73 patients received placebo and 73, 74, and 73 received apararenone 2.5 mg, 5 mg, and 10 mg, respectively. As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo). UACR remission rates at week 24 were 0.0%, 7.8%, 29.0%, and 28.1% in the placebo and apararenone 2.5 mg, 5 mg, and 10 mg groups, respectively. eGFR tended to decrease and serum potassium tended to increase, but these events were not clinically significant. AE incidence increased with dose while ADR incidence did not.
CONCLUSION


The UACR-lowering effect of apararenone administered once daily for 24 weeks in patients with stage 2 DN was confirmed, and the 52-week administration was safe and tolerable.
CLINICAL TRIAL REGISTRATION


NCT02517320 (dose-response study) and NCT02676401 (extension study).",2021,"As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo).","['patients with stage 2 diabetic nephropathy (DN', 'patients with diabetic nephropathy']","['apararenone (MT-3995', 'placebo and apararenone', 'Apararenone', 'placebo', 'apararenone']","['UACR remission rates', 'AE incidence', 'glomerular filtration rate (eGFR) and serum potassium', 'mean UACR', 'safe and tolerable', 'serum potassium', 'urine albumin to creatine ratio (UACR) and 24- and 52-week UACR remission rates', 'incidences of adverse events (AEs) and adverse drug reactions (ADRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",,0.469329,"As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Data Science Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yoshinari', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Terata', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Totsuka', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Gotou', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Hashimoto', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan. hashimoto.gaia@ma.mt-pharma.co.jp.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01963-z']
796,33236464,Metformin dose increase versus added linagliptin in non-alcoholic fatty liver disease and type 2 diabetes: An analysis of the J-LINK study.,"We validated the effect of linagliptin, an oral dipeptidyl peptidase-4 inhibitor, on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM). A total of 50 patients with NAFLD and T2DM treated with metformin were randomized (1:1) to metformin plus add-on linagliptin (linagliptin group) or to an increased dose of metformin (metformin group) for 52 weeks. The primary endpoint was change in hepatic steatosis from baseline to week 52 as quantified by unenhanced computed tomography imaging. Secondary endpoints included changes in the levels of anthropometric, biochemical and adipokinetic markers. The linagliptin group showed no statistically significant reduction in hepatic steatosis as compared to the metformin group (P = 0.97), although changes in hepatic steatosis were significantly correlated with decreased liver enzymes in both groups. Body weight was significantly reduced in the metformin group but not in the linagliptin group (P = 0.002). Serum leptin levels were significantly increased in the linagliptin group compared to the metformin group (P = 0.003), and were correlated with the changes body weight in whole samples. Adverse events were not different between the two groups (P = 0.78). Add-on linagliptin demonstrated a safe profile but was not superior to increased metformin in reducing hepatic steatosis.",2021,"Serum leptin levels were significantly increased in L-group compared to M-group (P = 0.003), being correlated to the changes body weight in whole samples.","['nonalcoholic liver disease and type 2 diabetes', 'A totalof 50 patients with NAFLD and T2DM treated with', 'patients with type 2 diabetes mellitus (T2DM']","['metformin', 'metformin add-on linagliptin (L-group) or increased metformin', 'linagliptin', 'Metformin']","['nonalcoholic fatty liver disease (NAFLD', 'changes of HS', 'Serum leptin levels', 'levels of anthropometric, biochemical, adipokinetic markers', 'liver enzymes', 'change in hepatic steatosis (HS', 'Adverse events', 'HS', 'Body weight']","[{'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",50.0,0.0345337,"Serum leptin levels were significantly increased in L-group compared to M-group (P = 0.003), being correlated to the changes body weight in whole samples.","[{'ForeName': 'Yasuji', 'Initials': 'Y', 'LastName': 'Komorizono', 'Affiliation': 'Department of Hepatology, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Hosoyamada', 'Affiliation': 'Department of Internal Medicine, Kagoshima Kouseiren Hospital, Kagoshima, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Imamura', 'Affiliation': 'Jiaikai Clinic, Kagoshima, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Kajiya', 'Affiliation': 'Uenomachi-Kajiya Clinic, Kagoshima, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashiguchi', 'Affiliation': 'Tempozan Naika Medical Clinic, Kagoshima, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ueyama', 'Affiliation': 'Ueyama Clinic, Kagoshima, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Shinmaki', 'Affiliation': 'Shinmaki Clinic, Kagoshima, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Koriyama', 'Affiliation': 'Department of Diabetes and Endocrinology, National Hospital Organization, Kagoshima Medical Center, Kagoshima, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Tsukasa', 'Affiliation': 'Department of Diabetes and Endocrinology, Nanpuh Hospital, Kagoshima, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Kamada', 'Affiliation': 'Center of Diabetes, Idzuro-Imamura Hospital, Kagoshima, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14263']
797,33236509,Results from the Effects of MEtformin on cardiovasculaR function in AdoLescents with type 1 Diabetes (EMERALD) study: A brief report of kidney and inflammatory outcomes.,"Youth with type 1 diabetes (T1D) demonstrate insulin resistance, independently of glycaemia, when compared to normoglycaemic peers. Insulin resistance increases the risk of cardiovascular disease and diabetic kidney disease, factors also associated with systemic inflammation. We evaluated the effect of metformin on markers of inflammation and diabetic kidney disease in adolescents with T1D. EMERALD, a double-blind, randomized, placebo-controlled trial of 3 months of metformin in 48 participants aged 12-21 years with T1D, included baseline and follow-up assessments of serum creatinine and cystatin C to estimate glomerular filtration rate (eGFR), aspartate aminotransferase, alanine aminotransferase, high-sensitivity C-reactive protein, white blood count, platelets, adiponectin, leptin, and urine albumin: creatinine ratio (UACR). Metformin was associated with a 13.9 mL/min/1.73 m 2  (95% confidence interval 4.7-23.1 mL/min/1.73 m 2  ) increase in estimated GFR by serum creatinine versus placebo (P ≤ 0.01), with a significant difference remaining after multivariable adjustments (P = 0.03). Whereas eGFR measured by serum creatinine increased significantly after metformin treatment, no differences were observed in cystatin C, UACR, or systemic inflammatory markers. Additional studies with directly measured GFR in response to metformin in T1D are needed.",2021,"Whereas eGFR measured by serum creatinine increased significantly following metformin, no differences were observed with cystatin C, UACR, or systemic inflammatory markers.","['Youth with type 1 diabetes (T1D', 'AdoLescents with Type 1 Diabetes', '48 youth aged 12-21\u2009years with T1D, included baseline and follow-up assessments of']","['metformin', 'MEtformin', 'Metformin', 'placebo']","['eGFR measured by serum creatinine', 'eGFR by serum creatinine', 'CardiovasculaR Function', 'cystatin C, UACR, or systemic inflammatory markers', 'serum creatinine and cystatin C to estimate glomerular filtration rate (eGFR), AST, ALT, highly sensitive c-reactive protein, white blood count, platelets, adiponectin, leptin, and urine albumin:creatinine ratio (UACR', 'risk for cardiovascular disease (CVD) and diabetic kidney disease (DKD']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]",,0.154029,"Whereas eGFR measured by serum creatinine increased significantly following metformin, no differences were observed with cystatin C, UACR, or systemic inflammatory markers.","[{'ForeName': 'Kalie L', 'Initials': 'KL', 'LastName': 'Tommerdahl', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': 'Department of Medicine, Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cree-Green', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Baumgartner', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pyle', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Jane E B', 'Initials': 'JEB', 'LastName': 'Reusch', 'Affiliation': ""Center for Women's Health Research, Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.""}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Endocrinology, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14266']
798,33236518,A single-dose euglycaemic clamp study in two cohorts to compare the exposure of SAR341402 (insulin aspart) Mix 70/30 with US- and European-approved versions of insulin aspart Mix 70/30 and SAR341402 rapid-acting solution in subjects with type 1 diabetes.,"AIM


To compare the pharmacokinetic exposure of SAR341402 Mix 70/30 (SAR Asp  -Mix) with US- and European (EU)-approved versions of insulin aspart Mix 70/30 (NovoLog Mix 70/30 [NN-Mix-US]/NovoMix 30 [NN-Mix-EU]) and SAR341402 insulin aspart solution (SAR-Asp) in subjects with type 1 diabetes.
MATERIALS AND METHODS


This was a randomized, double-blind, crossover trial in two cohorts. Fifty-two subjects received a single subcutaneous 0.3 U/kg dose of each treatment and underwent a euglycaemic clamp procedure lasting for a maximum of 24 hours after dosing. In cohort 1, subjects (N = 36) were exposed once each to SAR Asp  -Mix, NN-Mix-US and NN-Mix-EU. In cohort 2, subjects (N = 16) were exposed once each to SAR Asp  -Mix and SAR-Asp.
RESULTS


Of the 52 subjects randomized, 48 completed all treatment periods. In cohort 1, the extent of exposure (total and maximum concentration) was similar among the three treatments, with the 90% confidence intervals for pairwise treatment ratios meeting the predefined acceptance range (0.80 to 1.25). In cohort 2, statistically significant differences (P < .001) in early (0-4 hours) and intermediate (4-12 hours) exposure to SAR Asp  -Mix compared with SAR-Asp were observed, all exceeding a 20% difference. Pharmacodynamic results were in support of the pharmacokinetic findings for both cohorts. All treatments were well tolerated and there were no relevant differences in safety variables among treatments.
CONCLUSIONS


SAR Asp  -Mix showed similar pharmacokinetic exposure to commercially available insulin aspart Mix 70/30 formulations, and a distinct exposure profile compared with SAR-Asp.",2021,"In Cohort 2, statistically significant differences (p<0.001) in early (0-4 h) and intermediate (4-12 h) exposure to SAR Asp  -Mix compared with SAR-Asp were observed, all exceeding a 20% difference.","['52 subjects randomized', 'subjects with type 1 diabetes']","['SAR341402 (insulin aspart', 'SAR341402 insulin aspart solution (SAR-Asp', 'insulin aspart Mix 70/30 and SAR341402 rapid-acting solution', 'euglycemic clamp procedure lasting', 'SAR Asp']",['extent of exposure (total and maximum concentration'],"[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",36.0,0.135111,"In Cohort 2, statistically significant differences (p<0.001) in early (0-4 h) and intermediate (4-12 h) exposure to SAR Asp  -Mix compared with SAR-Asp were observed, all exceeding a 20% difference.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Nosek', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schmider', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Teichert', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nowotny', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14260']
799,32949941,Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial.,"PURPOSE


To investigate whether Immersive Virtual Reality (VR) has a greater positive influence on oncology patients' physical and emotional mood states when compared to an iPad attentional control condition. Our secondary objective was to understand what factors influenced VR effectiveness.
METHOD


Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver. Using a randomized controlled study design patients were allocated to VR (three content groups) or an iPad control condition. Pre-post-intervention self-report state measures were collected using visual analogue scales and an objective measure of physiological arousal (pulse rate). Post-intervention, patients reported on level of immersion, enjoyment and simulator sickness.
RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes. However, patients accessing Immersive VR consistently reported greater positive shifts in mood state and reductions in negative symptoms when compared with iPad. No change was observed in physiological arousal levels (pulse rate) in either condition before, during or immediately after intervention. Moderation analysis showed that the degree of child illness (PedsQL), sex, age, and level of immersion were important in influencing the magnitude of differences between the VR and iPad conditions on mood, anxiety and pain.
CONCLUSIONS


These preliminary findings support the use of Immersive VR in clinical oncology settings to improve patient well-being. Further studies examining the application of Immersive VR in supporting children adjusting to hospitalization and cancer treatment are therefore warranted. Factors found to moderate VR effectiveness provide important clinical implications.",2020,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","['Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver', 'Pediatric Oncology']","['Immersive VR', 'Immersive Virtual Reality', 'Immersive Virtual Reality (VR', 'iPad control condition']","['physiological arousal levels (pulse rate', 'physiological arousal (pulse rate', 'mood, anxiety and pain', 'level of immersion, enjoyment and simulator sickness', 'VR effectiveness', 'degree of child illness (PedsQL), sex, age, and level of immersion', 'negative symptoms']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0255989,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia. Electronic address: michelle.tennant@mcri.edu.au.""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Deakin Child Study Centre, School of Psychology, Deakin University, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McMillan', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia; Department of Paediatrics, University of Melbourne, Parkville, Victoria, 3052, Australia.""}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101804']
800,32959232,Prognostic value of preoperative glucose to lymphocyte ratio in patients with resected pancreatic cancer.,"BACKGROUND


Inflammatory factors and fasting blood glucose were verified to be associated with the prognosis of pancreatic ductal adenocarcinoma. The goal of this study is to confirm the prognostic role of preoperative blood glucose to lymphocyte ratio for patients with resected pancreatic ductal adenocarcinoma.
METHODS


A total of 259 pancreatic ductal adenocarcinoma patients were enrolled and randomly divided into training cohort and validation cohort. The training cohort was used to generate an optimal cutoff value and the validation cohort was used to further validate the model.
RESULTS


A total of 259 patients were incorporated in this study and randomly divided into the training cohort (n = 130, 1/2 of 259) and the validation cohort (129, 1/2 of 259). The optimal cutoff value of glucose to lymphocyte ratio was calculated to be 3.47 for overall survival. Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival. Prognostic values of glucose to lymphocyte ratio on overall survival were observed in younger male patients with pancreatic body and tail cancer, American Joint Committee on Cancer 8th N1 stage, without microvascular and peripancreatic fat invasion, and Carbohydrate antigen 19-9 higher than 200 U/ml. A prognostic prediction model of overall survival was designed and presented in nomogram.
CONCLUSION


Preoperative blood glucose to lymphocyte ratio is an independent biomarker to predict the overall survival for pancreatic ductal adenocarcinoma patients who underwent curative resection.",2021,Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival.,"['A total of 259 patients', '259 pancreatic ductal adenocarcinoma patients', 'patients with resected pancreatic cancer', 'patients with resected pancreatic ductal adenocarcinoma', 'pancreatic ductal adenocarcinoma patients who underwent curative resection', 'younger male patients with pancreatic body and tail cancer']",[],"['optimal cutoff value of glucose to lymphocyte ratio', 'preoperative blood glucose to lymphocyte ratio', 'overall survival']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0227582', 'cui_str': 'Structure of body of pancreas'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",259.0,0.0207054,Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival.,"[{'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Yaolin', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Dansong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Tiantao', 'Initials': 'T', 'LastName': 'Kuang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Wenchuan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China. lou.wenhui@zs-hospital.sh.cn.'}]",International journal of clinical oncology,['10.1007/s10147-020-01782-y']
801,32975823,Thermal suit connected to a forced-air warming unit for preventing intraoperative hypothermia: A randomised controlled trial.,"BACKGROUND


Inadvertent intraoperative hypothermia is a common occurrence in surgical patients. A thermal suit is an option for passive insulation. However, active warming is known to be more effective. Therefore, we hypothesised that a forced-air warming (FAW) unit connected to the thermal suit is superior to a commercial FAW blanket and a warming mattress in breast cancer surgery.
METHODS


Forty patients were randomised to this prospective, clinical trial to wear either the thermal suit or conventional hospital clothes under general anaesthesia. The Thermal suit group had a FAW unit set to 38°C and connected to the legs of the suit. The Hospital clothes group had a lower body blanket set to 38°C and a warming mattress set to 37°C. Core temperature was measured with zero-heat-flux sensor. The primary outcome was core temperature on admission to the recovery room.
RESULTS


There was no difference in mean core temperatures at anaesthetic induction (P = .4) or on admission to the recovery room (P = .07). One patient in the Thermal suit group (5%) vs six patients in the Hospital clothes group (32%) suffered from intraoperative hypothermia (P = .04, 95% CI 1.9%-49%). Mean skin temperatures (MSTs) were higher in the Thermal suit group during anaesthesia. No burns or skin irritations were reported. Two patients in the Thermal suit group sweated.
CONCLUSIONS


A thermal suit connected to a FAW unit was not superior to a commercial FAW blanket, although the incidence of intraoperative hypothermia was lower in patients treated with a thermal suit.",2021,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"['Forty patients', 'surgical patients']","['Thermal suit connected to a forced-air warming unit', 'thermal suit or conventional hospital clothes under general anaesthesia']","['mean core temperatures at anaesthetic induction', 'Mean skin temperatures', 'core temperature on admission to the recovery room', 'intraoperative hypothermia', 'No burns or skin irritations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}]",40.0,0.0619649,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"[{'ForeName': 'Sirkka-Liisa', 'Initials': 'SL', 'LastName': 'Lauronen', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marja-Tellervo', 'Initials': 'MT', 'LastName': 'Mäkinen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Annila', 'Affiliation': 'Department of Anaesthesia, Tays Hatanpää, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Maija-Liisa', 'Initials': 'ML', 'LastName': 'Kalliomäki', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13714']
802,32979646,Randomised controlled trial confirms benefit of enhanced recovery after surgery on length of stay in ovarian cancer: How low can we go?,,2020,,['ovarian cancer'],[],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]",[],[],,0.150722,,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bisch', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada. Electronic address: gsnelson@ucalgary.ca.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.015']
803,32926423,Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial.,"BACKGROUND


Postoperative throat complications after intubation are undesirable but frequent outcomes. A randomized, double-blinded study was performed to determine whether thermal softening of endotracheal tubes reduced throat complications after intubation.
METHODS


Patients (n = 196) undergoing nasal surgery were randomly allocated into the control group and thermal softening groups. Sore throat and hoarseness were evaluated 1 and 24 hours after extubation. The severity of sore throat was evaluated using the numeric rating scale (NRS). The primary outcome was the incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat. The secondary outcomes were the incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries.
RESULTS


The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs 52.7%, P = .02). Moreover, thermal softening decreased the mean NRS score for sore throat in the thermal softening group by 10% an hour after extubation (thermal softening group, 1.29 [95% CI, 0.88-1.70] vs control group, 2.33 [95% CI, 1.77-2.89]; P < .01). At 24 hours after extubation, the incidence of sore throat (38.3% vs 40.7%, P = .77) and hoarseness (34.0% vs 35.2%, 0.95 [0.52-1.74], P = .74) were comparable between the two groups.
CONCLUSIONS


Intubation using endotracheal tubes with thermal softening significantly decreased the incidence of sore throat 1 hour after extubation when compared with endotracheal tubes without thermal softening.",2021,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).",['Patients (n= 196) undergoing nasal surgery'],"['thermal softening of endotracheal tubes', 'control group and thermal softening groups']","['incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat', 'hoarseness', 'incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries', 'throat complications', 'postoperative sore throat', 'incidence of sore throat 1 hour after extubation', 'incidence of sore throat', 'numeric rating scale', 'mean numeric rating scale score for sore throat', 'Sore throat and hoarseness', 'severity of sore throat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3887441', 'cui_str': 'Scratchy sensation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",196.0,0.32656,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).","[{'ForeName': 'Je Hyuk', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Paik', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Ho Geol', 'Initials': 'HG', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13705']
804,32931959,Higher Adenoma Detection Rates at Screening Associated With Lower Long-Term Colorectal Cancer Incidence and Mortality.,"BACKGROUND & AIMS


Detection and removal of adenomas reduces colorectal cancer (CRC) risk. The impact of adenoma detection rates (ADRs) on long-term CRC incidence and mortality is unknown. We investigated this using data from the UK Flexible Sigmoidoscopy Screening Trial.
METHODS


Of 167,882 UK Flexible Sigmoidoscopy Screening Trial participants, 40,085 were in the intervention arm and underwent flexible sigmoidoscopy screening at 13 trial centers. The median follow-up period was 17 years. At each center, 1 endoscopist performed most flexible sigmoidoscopies. Multivariable logistic regression was used to classify centers into high-, intermediate-, and low-detector groups based on their main endoscopist's ADR. We calculated the incidence and mortality of distal and all-site CRC, and estimated hazard ratios (HRs) with 95% CIs using Cox regression.
RESULTS


Five, 4, and 4 centers, respectively, were classified into the high-detector, intermediate-detector, and low-detector groups. The average ADRs in each respective group were 15%, 12%, and 9%. Distal CRC incidence and mortality were reduced among those screened compared with controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector group (incidence: HR, 0.34; 95% CI, 0.27-0.42; mortality: HR, 0.22, 95% CI, 0.13-0.37) than in the low-detector group (incidence: HR, 0.55; 95% CI, 0.44-0.68; mortality: HR, 0.54; 95% CI, 0.34-0.86). Similar results were observed for all-site CRC, with larger effects seen in the high-detector (incidence: HR, 0.58; 95% CI, 0.50-0.67; mortality: HR, 0.52; 95% CI, 0.39-0.69) than in the low-detector group (incidence: HR, 0.72; 95% CI, 0.61-0.85; mortality: HR, 0.68; 95% CI, 0.51-0.92), although the heterogeneity was not statistically significant.
CONCLUSIONS


Higher ADRs at screening provide greater long-term protection against CRC incidence and mortality. Isrctn.org, number: ISRCTN28352761.",2020,"Distal CRC incidence and mortality were reduced among those screened compared to controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector (incidence: HR=0·34, 0·27-0·42; mortality: HR=0·22, 0·13-0·37) than low-detector group (incidence: HR=0·55, 0·44-0·68; mortality: HR=0·54, 0·34-0·86).","['Of 167,882 UKFSST participants, 40,085 were in the intervention arm and underwent']",['flexible sigmoidoscopy screening'],"['incidence and mortality of distal and all-site CRC, and estimated hazard ratios (HRs', 'Distal CRC incidence and mortality', 'Higher adenoma detection rates', 'Average ADRs']","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",167882.0,0.0406585,"Distal CRC incidence and mortality were reduced among those screened compared to controls in all groups, and effects of screening varied significantly by detector ranking, with larger reductions in incidence and mortality seen in the high-detector (incidence: HR=0·34, 0·27-0·42; mortality: HR=0·22, 0·13-0·37) than low-detector group (incidence: HR=0·55, 0·44-0·68; mortality: HR=0·54, 0·34-0·86).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, United Kingdom. Electronic address: amanda.cross1@imperial.ac.uk.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Robbins', 'Affiliation': 'Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Saunders', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital, London, United Kingdom.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Wooldrage', 'Affiliation': 'Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.09.020']
805,32936897,Striatal Dopamine D2 Receptor Occupancy Induced by Daily Application of Blonanserin Transdermal Patches: Phase II Study in Japanese Patients With Schizophrenia.,"BACKGROUND


Transdermal antipsychotic patch formulations offer potential benefits, including improved adherence. This study investigated the striatal dopamine D2 receptor occupancy with daily blonanserin transdermal patch application.
METHODS


This open-label, phase II study enrolled 18 Japanese outpatients (20 to <65 years) with schizophrenia (DSM-IV-TR criteria; total Positive and Negative Syndrome Scale score <120 at screening) treated with blonanserin 8-mg or 16-mg tablets. Patients continued tablets for 2-4 weeks at their current dose and were then assigned to once-daily blonanserin patches (10/20/40/60/80 mg daily) for 2-4 weeks based on the oral dose. [11C]raclopride positron emission tomography scanning determined blonanserin striatal dopamine D2 receptor occupancy (primary endpoint). Secondary endpoints included assessment of receptor occupancy by dose, changes in Positive and Negative Syndrome Scale and Clinical Global Impressions-Severity of Illness-Severity scores, patient attitudes towards adherence, and patch adhesiveness.
RESULTS


Of 18 patients who started the blonanserin tablet treatment period, 14 patients completed treatment. Mean D2 receptor occupancy for blonanserin tablets 8 mg/d (59.2%, n = 5) and 16 mg/d (66.3%, n = 9) was within the values for blonanserin patches: 10 mg/d (33.3%, n = 3), 20 mg/d (29.9%, n = 2), 40 mg/d (61.2%, n = 3), 60 mg/d (59.0%, n = 3), and 80 mg/d (69.9%, n = 3). Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/d and 31.9 mg/d, respectively. Diurnal variability in occupancy was lower during transdermal patch treatment than during tablet treatment. Blonanserin transdermal patches were well tolerated with no major safety concerns.
CONCLUSIONS


Blonanserin patches (40/80 mg/d) have lower diurnal variability in occupancy than blonanserin tablets (8/16 mg/d), and patches at doses of 40 mg/d and 80 mg/d appear to be a suitable alternative for blonanserin tablets at doses of 8 mg/d and 16 mg/d, respectively. Blonanserin patches represent a potential new treatment option for patients with schizophrenia.
TRIAL REGISTRY


JAPIC Clinical Trials Information registry (www.clinicaltrials.jp; JapicCTI-No: JapicCTI-121914).",2021,"Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/day and 31.9 mg/day, respectively.","['18 Japanese outpatients (20 to <65 years) with schizophrenia (DSM-IV-TR criteria; total Positive and Negative Syndrome Scale [PANSS] score <120 at screening) treated with', 'Japanese patients with schizophrenia', '18 patients who started the blonanserin tablet treatment period, 14 patients completed treatment', 'patients with schizophrenia']","['Blonanserin transdermal patches', 'blonanserin transdermal patches', 'blonanserin 8\xa0mg or 16\xa0mg tablets', 'Blonanserin patches', 'blonanserin tablets', 'blonanserin', 'blonanserin patches']","['assessment of receptor occupancy by dose, changes in PANSS and CGI-S scores, patient attitudes towards adherence, and patch adhesiveness', 'Occupancy', 'Diurnal variability in occupancy', 'Mean D2 receptor occupancy']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0001515', 'cui_str': 'Adhesiveness'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0058698', 'cui_str': 'Dopamine-D2 Receptor'}]",18.0,0.0297833,"Occupancy generally increased with increasing blonanserin dose for both formulations with the half maximal receptor occupancy for tablets and patches associated with doses of 6.9 mg/day and 31.9 mg/day, respectively.","[{'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nishibe', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Tateno', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakayori', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'WooChan', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa071']
806,32947496,Translational Studies on Biologic Fusion of a Vertebral Segment as a Novel Treatment Modality for Low Back Pain.,"STUDY DESIGN


Preclinical studies: Efficacy and toxicological studies on lactic acid (LA)-induced sclerozation in pig lumbar discs. Clinical study: Prospective, randomized, double-blinded, placebo-controlled, single ascending dose study investigating the safety and local tolerability of LA.
OBJECTIVE


To determine if LA produces sclerozation of the porcine nucleus pulposus (NP) followed by a phase Ib study to evaluate preliminary safety, tolerability, and efficacy of LA in patients with chronic discogenic low back pain.
SUMMARY OF BACKGROUND DATA


Surgical stabilization of a motion segment harboring a painful degenerated disc often affords symptomatic relief. In the present study, the hypothesis was tested that LA can produce sclerozation and stabilization of the NP.
METHODS


LA (0.2 mL; 60, 120, or 240 mg/mL) or vehicle was injected into the NP or close to the extra spinal region of spinal nerves of young female pigs. The size of the NP, MRI changes, flexural stiffness, and histology of the disc was studied after up to 84 days of survival. Fifteen patients injected intra discally with placebo (iohexol, 1.5 mL, n = 6) or iohexol plus LA (30, 60, or 120 mg/mL; three patients in each group) were followed for up to 12 months.
RESULTS


Injection of LA in the pig reproducibly induced sclerozation of the NP and increased flexural rigidity. Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised. Adverse events in patients were limited to transiently increased low back pain with no obvious difference between treatment groups. There was indication of lower water content of NP injected with the two highest doses of LA.
CONCLUSION


LA has a sclerozing effect on the NP in pigs and patients and is therefore a candidate for further clinical studies powered to determine its potential as a treatment of chronic discogenic low back pain.
LEVEL OF EVIDENCE


2.",2020,Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised.,"['Low Back Pain', 'patients with chronic discogenic low back pain', 'Fifteen patients injected intra discally with', 'pig lumbar discs', 'young female pigs', 'LA (0.2\u200amL']","['LA', 'placebo', 'placebo (iohexol, 1.5\u200amL, n\u200a=\u200a6) or iohexol plus LA']","['low back pain', 'generation of connective tissue and increased expression of collagen I. No safety concerns', 'Adverse events', 'safety and local tolerability', 'sclerozation of the NP and increased flexural rigidity', 'size of the NP, MRI changes, flexural stiffness and histology of the disc']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1185714', 'cui_str': 'Nucleus Pulposus'}, {'cui': 'C0439748', 'cui_str': 'Flexural'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",15.0,0.118782,Histological changes included generation of connective tissue and increased expression of collagen I. No safety concerns were raised.,"[{'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Olmarker', 'Affiliation': 'Musculoskeletal Research, Department of Medical Chemistry and Cell Biology, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gerward', 'Affiliation': 'Stayble Therapeutics AB, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Isberg', 'Affiliation': 'Department of Radiology, Läkarhuset Odenplan, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lehmann', 'Affiliation': 'Stayble Therapeutics AB, Gothenburg, Sweden.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Stockholm Spine Center, Löwenströmska Hospital, Upplands Väsby, Sweden.'}]",Spine,['10.1097/BRS.0000000000003699']
807,32947541,"Balloon compression vs radiofrequency for primary trigeminal neuralgia: a randomized, controlled trial.","ABSTRACT


Surgical procedures are necessary in up to 50% of trigeminal neuralgia patients. Although radiofrequency (RF) is more widely used, it is associated with high intraprocedural costs and long technical learning time. Other simpler procedures such as balloon compression (BC) require a lower training period and have significant lower costs. We evaluated the effects of BC and RF in pain control in primary trigeminal neuralgia in a randomized, double-blinded, head-to-head trial. Individuals were randomly allocated in 1 of 2 groups: BC and RF. Throughout pain, psychological and quality of life measurements were performed at baseline and after surgery. The main outcome was the worst pain in the last 24 hours (0-10) at 6 months postoperatively. After the inclusion of half of the estimated sample, a preplanned interim analysis was performed when 33 patients (62.1 ± 9.4 y.) completed the study. Pain intensity (confidence interval [CI] 95% 0.6 to 3.8, and -0.6 to 2.2, for BC and RF) did not significantly differ. Complications, interference of pain in daily life (CI 95% -0.1 to 2.3 and -0.4 to 2.3, for BC and RF), neuropathic pain symptoms (CI 95% 1.7 to 3.6 and 3.0 to 5.7, for BC and RF), mood (CI 95% 4.8 to 11.5 and 5.5 to 15.1, BC and RF, respectively), medication use, and quality of life (CI 95% 80.4 to 93.1 and 83.9 to 94.2, for BC and RF) were also not different. Radiofrequency presented more paresthetic symptoms than BC at 30 days after intervention. Based on these results, the study was halted due to futility because BC was not superior to RF.",2021,"Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ.",['primary trigeminal neuralgia'],"['radiofrequency (RF', 'BC and RF', 'Balloon compression versus radiofrequency']","['medication use and quality of life', 'neuropathic pain symptoms', 'Complications, interference of pain in daily life', 'worst pain', 'pain, psychological and quality of life measurements', 'paresthetic symptoms', 'Pain intensity']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040997', 'cui_str': 'Trigeminal neuralgia'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.164675,"Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ.","[{'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Sterman-Neto', 'Affiliation': 'LIM-62, Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiane Yoko', 'Initials': 'CY', 'LastName': 'Fukuda', 'Affiliation': 'Department of Anesthesiologie and Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Kleber Paiva', 'Initials': 'KP', 'LastName': 'Duarte', 'Affiliation': 'Department and Institute of Psychiatry, School of Medicine, University of São Paulo, Service of Interdisciplinary Neuromodulation, São Paulo, SP, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Aparecida da Silva', 'Affiliation': 'LIM-62, Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Antonia Lilian de Lima', 'Initials': 'ALL', 'LastName': 'Rodrigues', 'Affiliation': 'LIM-62, Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Silvia R D T', 'Initials': 'SRDT', 'LastName': 'de Siqueira', 'Affiliation': 'LIM-62, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'José Tadeu Tesseroli', 'Initials': 'JTT', 'LastName': 'de Siqueira', 'Affiliation': 'LIM-62, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel Jacobsen', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ciampi de Andrade', 'Affiliation': 'LIM-62, Pain Center Department of Neurology, University of São Paulo, SP, Brazil.'}]",Pain,['10.1097/j.pain.0000000000002070']
808,32947547,Optimized acupuncture treatment (acupuncture and intradermal needling) for cervical spondylosis-related neck pain: a multicenter randomized controlled trial.,"ABSTRACT


Cervical spondylosis (CS)-related neck pain is difficult to treat because of its degenerative nature. The aim of this 9-center, single-blinded, randomized controlled trial was to evaluate the efficacy of optimized acupuncture for CS-related neck pain. Participants who met the inclusion criteria were randomized to optimized, shallow, and sham acupuncture groups (1:1:1). The primary outcome was the change from baseline in the Northwick Park Neck Pain Questionnaire score at week 4. Participants were followed up until week 16. Of the 896 randomized participants, 857 received ≥1 intervention session; 280, 286, and 291 received optimized, shallow, and sham acupuncture, respectively. A total of 835 (93.2%) participants completed the study. At week 4, significant differences (P < 0.001) were observed in the changes in Northwick Park Neck Pain Questionnaire scores between the optimized acupuncture group and both the shallow {7.72 (95% confidence interval [CI], 5.57-9.86)} and sham acupuncture (10.38 [95% CI, 8.25-12.52]) groups. The difference in the scores at week 16 between the optimized acupuncture group and the shallow (8.84 [95% CI, 6.34-11.34]) and sham acupuncture (10.81 [95% CI, 8.32-13.30]) groups were significant. The center effect indicated wide variability in the treatment effects (Cohen's d = 0.01-2.19). Most SF-36 scores were higher in the optimized acupuncture group than those in the other groups. These results suggest that 4-week optimized acupuncture treatment alleviates CS-related neck pain and improves the quality of life, with the effects persisting for minimum 3 months. Therefore, acupuncture can have positive effects on CS-related neck pain, although the effect size may vary widely.",2021,"At week 4, significant differences (P<0.001) were observed in the changes in NPQ scores between the optimized acupuncture group and both the shallow (7.72 [95% confidence interval {CI}, 5.57-9.86]) and sham acupuncture groups (10.38 [95%CI, 8.25-12.52]).","['cervical spondylosis-related neck pain', '896 randomized participants, 857 received ≥1 intervention session; 280, 286, and 291 received', 'Cervical spondylosis (CS)-related neck pain', 'Participants who met the inclusion criteria', 'A total of 835 (93.2%) participants completed the study']","['acupuncture treatment (acupuncture and intradermal needling', 'acupuncture', 'optimized, shallow, and sham acupuncture']","['NPQ scores', 'quality of life', 'CS-related neck pain', 'Most SF-36 scores', 'Northwick Park Neck Pain Questionnaire (NPQ) score']","[{'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1384641', 'cui_str': 'Cervical spondylosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}]",896.0,0.575719,"At week 4, significant differences (P<0.001) were observed in the changes in NPQ scores between the optimized acupuncture group and both the shallow (7.72 [95% confidence interval {CI}, 5.57-9.86]) and sham acupuncture groups (10.38 [95%CI, 8.25-12.52]).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Minying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Traditional Therapy Center, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'York University, Toronto, ON, Canada.'}, {'ForeName': 'Zhiyan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Urumqi, China.'}, {'ForeName': 'Lingmei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Acupuncture and Massage, Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hainan General Hospital, Haikou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Chinese Medicine Centre for Training and Research, Yan Chai Hospital cum Hong Kong Baptist University (Yan Chai), Hongkong, China.'}, {'ForeName': 'Xiaokai', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Huizhou Third People's Hospital, Guangzhou Medical University, Huizhou, China.""}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Ou', 'Affiliation': 'Department of Big Data Research of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiangshan', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Baile', 'Initials': 'B', 'LastName': 'Ning', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Pain,['10.1097/j.pain.0000000000002071']
809,32950650,The p Factor Consistently Predicts Long-Term Psychiatric and Functional Outcomes in Anxiety-Disordered Youth.,"OBJECTIVE


Pediatric anxiety disorders can have a chronic course and are considered gateway disorders to adult psychopathology, but no consistent predictors of long-term outcome have been identified. A single latent symptom dimension that reflects features shared by all mental health disorders, the p factor, is thought to reflect mechanisms that cut across mental disorders. Whether p predicts outcome in youth with psychiatric disorders has not been examined. We tested whether the p factor predicted long-term psychiatric and functional outcomes in a large, naturalistically followed-up cohort of anxiety-disordered youth.
METHOD


Children and adolescents enrolled in a randomized controlled treatment trial of pediatric anxiety were followed-up on average 6 years posttreatment and then annually for 4 years. Structural equation modeling was used to estimate p at baseline. Both p and previously established predictors were modeled as predictors of long-term outcome.
RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points. p Predicted outcome above and beyond previously identified predictors, including diagnostic comorbidity at baseline. Post hoc analyses showed that p predicted long-term anxiety outcome, but not acute treatment outcome, suggesting that p may be uniquely associated with long-term outcome.
CONCLUSION


Children and adolescents with anxiety disorders who present with a liability toward broad mental health problems may be at a higher risk for poor long-term outcome across mental health and functional domains. Efforts to assess and to address this broad liability may enhance long-term outcome.",2020,"RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","['Youth with anxiety disorders', 'youth with psychiatric disorders', 'Youth enrolled']",[],"['mental health disorders, poorer functioning', 'diagnostic comorbidity']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0743218,"RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Cervin', 'Affiliation': 'Lund University, Sweden. Electronic address: matti.cervin@med.lu.se.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut School of Medicine, West Hartford, Connecticut.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gosch', 'Affiliation': 'Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.08.440']
810,32965030,Efficacy of topical Calendula officinalis on prevalence of radiation-induced dermatitis: A randomised controlled trial.,"OBJECTIVES


A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy.
METHODS


A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation.
RESULTS


The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
CONCLUSION


This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison.",2021,"There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
","['prevalence of radiation-induced dermatitis', 'A total of 271 women were screened and 82 were randomised', 'women undergoing breast cancer radiotherapy', 'A total of n\xa0=\xa081 participants were analysed (n\xa0=\xa040 Calendula; n\xa0=\xa041 Sorbolene']","['topical Calendula officinalis (Calendula) versus standard of care', 'Calendula and standard of care (Sorbolene', 'topical Calendula officinalis']","['prevalence of radiation-induced dermatitis', 'prevalence of radiation-induced dermatitis grade 2', 'prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites']","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0752223', 'cui_str': 'Marigold'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0752222', 'cui_str': 'Calendula officinalis'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0752223', 'cui_str': 'Marigold'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",271.0,0.344656,"There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
","[{'ForeName': 'Shihab', 'Initials': 'S', 'LastName': 'Siddiquee', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'McGee', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, Australia.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vincent', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, Australia.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Giles', 'Affiliation': 'Department of Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Clothier', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Carruthers', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Penniment', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13434']
811,32975783,Effect of ultrafiltration profiling on outcomes among maintenance hemodialysis patients: a pilot randomized crossover trial.,"BACKGROUND


More rapid fluid removal during hemodialysis is associated with adverse cardiovascular outcomes and longer dialysis recovery times. The effect of ultrafiltration (UF) profiling, independent of concomitant sodium profiling, on markers of intradialytic hemodynamics and other outcomes has been inadequately studied.
METHODS


Four-phase, blinded crossover trial. Participants (UF rates > 10 mL/h/kg) were assigned in random order to receive hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control). Each 3-week 9-treatment period was followed by a 1-week 3-treatment washout period. Participants crossed into each study arm twice (2 phases/arm); 18 treatments per treatment type. The primary outcomes were intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain. Other outcomes included intradialytic symptoms and blood volume measured-plasma refill (post-dialysis volume status measure), among others. Each participant served as their own control.
RESULTS


On average, the 34 randomized patients (mean age 56 years, 24% female, mean dialysis vintage 6.3 years) had UF rates > 10 mL/h/kg in 56% of treatments during the screening period. All but 2 patients completed the 15-week study (prolonged hospitalization, kidney transplant). There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF. With UF profiling, participants had significantly lower odds of light-headedness and plasma refill compared to hemodialysis with conventional UF.
CONCLUSIONS


Ultrafiltration (UF) profiling did not reduce the odds of treatment-related cardiac stress but did reduce the odds of light-headedness and post-dialysis hypervolemia.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03301740 (registered October 4, 2017).",2021,"There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF.","['34 randomized patients (mean age 56\xa0years, 24% female, mean dialysis vintage 6.3\xa0years) had UF rates\u2009>\u200910\xa0mL/h/kg in 56% of treatments during the screening period', 'Participants (UF rates\u2009>\u200910\xa0mL/h/kg', 'maintenance hemodialysis patients']","['Ultrafiltration (UF', 'hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control', 'ultrafiltration profiling', 'ultrafiltration (UF']","['intradialytic hypotension, troponin T change, or left ventricular strain', 'intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain', 'light-headedness and plasma refill', '15-week study (prolonged hospitalization, kidney transplant', 'intradialytic symptoms and blood volume measured-plasma refill']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1264635', 'cui_str': 'Post-dialysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0220870', 'cui_str': 'Lightheadedness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.294154,"There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Flythe', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA. jflythe@med.unc.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Tugman', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Narendra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Magdalene M', 'Initials': 'MM', 'LastName': 'Assimon', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Yueting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Brunelli', 'Affiliation': 'DaVita Clinical Research, Needham, MA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Division of Cardiology, Department of Medicine, UNC School of Medicine, Chapel Hill, NC, USA.'}]",Journal of nephrology,['10.1007/s40620-020-00862-6']
812,32980041,The Effect of Patient Education and Telemedicine Reminders on Adherence to Eye Drops for Glaucoma.,"PURPOSE


To determine the improvement in patient adherence to topical ocular hypotensive therapy by introducing a personalized illustrated medication reference chart and telereminder.
DESIGN


Prospective randomized controlled clinical trial.
PARTICIPANTS


Fifty-nine patients with glaucoma who were using at least 3 or more eye drops were recruited from the ophthalmology clinic at the National University Hospital of Singapore.
METHODS


Participants were randomized into 3 groups: control, reference chart only, and reference chart with telereminder. They completed a survey on demographics, barriers to glaucoma medication adherence, and self-adherence (measured by the Morisky adherence scale) before and 6 weeks after intervention. Logistic regression analysis was performed on the barriers that contribute to nonadherence and paired t tests were conducted for the preimplementation and postimplementation effects of intervention on adherence score.
MAIN OUTCOME MEASURES


Changes in mean adherence score based on the Morisky adherence scale before and after intervention in participants from all 3 groups.
RESULTS


In our study, 71% of participants who were nonadherent to medications had multiple barriers to adherence, with lack of self-efficacy and forgetfulness being the most common factors. Only the reference chart with telereminder group showed a statistically significant increase in mean adherence score, from 7.18 to 7.69 (P = 0.047).
CONCLUSIONS


Adherence to medication in chronic diseases like glaucoma is an important healthcare issue to address. Most of these patients have poor adherence because of multiple factors, and hence interventions aimed at improving adherence should be multifaceted to target these barriers.",2020,"Only the reference chart with telereminder group showed a statistically significant increase in mean adherence score, from 7.18 to 7.69 (P = 0.047).
","['Fifty-nine patients with glaucoma who were using at least 3 or more eye drops were recruited from the ophthalmology clinic at the National University Hospital of Singapore', 'Participants', 'Glaucoma']",['Patient Education and Telemedicine Reminders'],"['Morisky adherence scale', 'adherence score', 'glaucoma medication adherence, and self-adherence', 'mean adherence score']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",59.0,0.042262,"Only the reference chart with telereminder group showed a statistically significant increase in mean adherence score, from 7.18 to 7.69 (P = 0.047).
","[{'ForeName': 'Yien', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology, National University Hospital, Singapore, Republic of Singapore. Electronic address: yienlai1988@gmail.com.'}, {'ForeName': 'Yanlong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Ophthalmology, National University Hospital, Singapore, Republic of Singapore.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Department of Ophthalmology, National University Hospital, Singapore, Republic of Singapore.'}, {'ForeName': 'Ching-Chiuan', 'Initials': 'CC', 'LastName': 'Yen', 'Affiliation': 'Keio-NUS CUTE Centre, National University of Singapore, Singapore, Republic of Singapore.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Ho', 'Affiliation': 'Keio-NUS CUTE Centre, National University of Singapore, Singapore, Republic of Singapore.'}, {'ForeName': 'Teng Chuan', 'Initials': 'TC', 'LastName': 'Eng', 'Affiliation': 'Keio-NUS CUTE Centre, National University of Singapore, Singapore, Republic of Singapore.'}, {'ForeName': 'Pravar', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Keio-NUS CUTE Centre, National University of Singapore, Singapore, Republic of Singapore.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Koh', 'Affiliation': 'Department of Ophthalmology, National University Hospital, Singapore, Republic of Singapore.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.05.005']
813,33237533,Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE.,"INTRODUCTION


Baricitinib is an oral, selective inhibitor of Janus kinase which demonstrates clinical efficacy in patients with rheumatoid arthritis (RA). This report aims to analyze the onset time of baricitinib in Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate.
METHODS


This post hoc analysis evaluated clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA-BALANCE. Efficacy measures including American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP ≤ 3.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24 (except for FACIT-F evaluated every 4 weeks). A logistic regression model and an analysis of covariance model were used to analyze treatment comparisons of categorical and continuous measures, respectively.
RESULTS


Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures. For other outcomes including 66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤ 3.2 response rate, differences were evident (p ≤ 0.05) by week 4 in the baricitinib group compared with placebo. Significant improvements in all efficacy measures were sustained through 24 weeks.
CONCLUSIONS


Baricitinib demonstrated a rapid onset of efficacy on ACR20 response, ACR core set values, disease activity, and patient-reported outcome improvements in Chinese patients from RA-BALANCE.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02265705.",2021,Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures.,"['Chinese Patients with Moderate to Severe Rheumatoid Arthritis', 'patients with rheumatoid arthritis (RA', 'Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate']","['placebo', 'Baricitinib']","['American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP\u2009≤\u20093.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue', '66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP ≤\u20093.2 response rate', 'efficacy measures', 'ACR20 response, ACR core set values, disease activity']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.145173,Statistically significant (p ≤ 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures.,"[{'ForeName': 'Zhan-Guo', 'Initials': 'ZG', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com.""}, {'ForeName': 'Jian-Kang', 'Initials': 'JK', 'LastName': 'Hu', 'Affiliation': ""Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Xiang-Pei', 'Initials': 'XP', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xing-Fu', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Bao', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Dong-Yi', 'Initials': 'DY', 'LastName': 'He', 'Affiliation': 'GuangHua Hospital, Shanghai, China.'}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Zuo', 'Affiliation': 'Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zheng-Yu', 'Initials': 'ZY', 'LastName': 'Xiao', 'Affiliation': 'First Affiliated Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Chen', 'Affiliation': 'The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xia-Fei', 'Initials': 'XF', 'LastName': 'Xin', 'Affiliation': 'Ningbo First Hospital, Ningbo, China.'}, {'ForeName': 'Jing-Yang', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Zhuzhou Central Hospital, Zhuzhou, China.'}, {'ForeName': 'Lin-Di', 'Initials': 'LD', 'LastName': 'Jiang', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Meng-Ru', 'Initials': 'MR', 'LastName': 'Liu', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Chen-Ge', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}]",Advances in therapy,['10.1007/s12325-020-01572-y']
814,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
815,32981068,"Evaluation of the efficacy of cysteamine cream compared to hydroquinone in the treatment of melasma: A randomised, double-blinded trial.","BACKGROUND/OBJECTIVE


Melasma is a commonly acquired disorder of hyperpigmentation that often poses a therapeutic challenge for dermatologists. Recently, cysteamine cream has shown promising results compared to placebo. This study aims to determine the efficacy of cysteamine cream compared to hydroquinone cream in the treatment of melasma.
METHODS


A randomised, double-blinded, single-centre trial was conducted in Victoria, Australia. 20 recruited participants were given either cysteamine cream or hydroquinone cream for 16 weeks. The primary outcome measure was a change in the modified Melasma Area and Severity Index (mMASI). Quality of life at baseline and week 16 as well as standard digital photography at each follow-up visit was assessed as secondary outcome measures.
RESULTS


At week 16, 14 participants completed the study with 5 participants in the cysteamine group and 9 patients in the hydroquinone group. In the intention to treat analysis, there was a 1.52 ± 0.69 (21.3%) reduction in mMASI for the cysteamine group and a 2.96 ± 1.15 (32%) reduction in the hydroquinone group. The difference between groups was not statistically significant (P = 0.3). Hydroquinone cream was generally better tolerated that cysteamine cream.
CONCLUSION


Our study suggests that topical cysteamine may have comparable efficacy to topical hydroquinone. Cysteamine thus provides a possible alternative to patients and clinicians who wish to avoid or rotate off topical hydroquinone. While side effects were more common for participants using cysteamine compared with hydroquinone, these were mild and reversible. Larger studies comparing cysteamine and hydroquinone are required to support these findings.",2021,The difference between groups was not statistically significant (P = 0.3).,"['14 participants completed the study with 5 participants in the cysteamine group and 9 patients in the hydroquinone group', '20 recruited participants were given either', 'melasma', 'patients and clinicians who wish to avoid or rotate off topical hydroquinone']","['hydroquinone', 'Hydroquinone cream', 'hydroquinone cream', 'topical hydroquinone', 'placebo', 'cysteamine cream or hydroquinone cream', 'cysteamine and hydroquinone', 'cysteamine cream']","['modified Melasma Area and Severity Index (mMASI', 'Quality of life', 'mMASI']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C1252137', 'cui_str': 'hydroquinone Topical Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.28277,The difference between groups was not statistically significant (P = 0.3).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Victorian Melanoma Service, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Remyn', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, Melbourne University, Parkville, Victoria, Australia.'}, {'ForeName': 'In Young', 'Initials': 'IY', 'LastName': 'Chung', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Honigman', 'Affiliation': ""St Vincent's Hospital, Fitzroy, Victoria, Australia.""}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Gourani-Tehrani', 'Affiliation': 'Chroma Dermatology, Pigment and Skin of Colour Centre, Wheelers Hill, Victoria, Australia.'}, {'ForeName': 'Ilycia', 'Initials': 'I', 'LastName': 'Wutami', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, Melbourne University, Parkville, Victoria, Australia.'}, {'ForeName': 'Celestine', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Chroma Dermatology, Pigment and Skin of Colour Centre, Wheelers Hill, Victoria, Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Chroma Dermatology, Pigment and Skin of Colour Centre, Wheelers Hill, Victoria, Australia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13432']
816,32990779,Efficacy and safety of low-dose everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex.,"BACKGROUND


The aim of this study was to evaluate the safety and efficacy of low-dose everolimus treatment in patients with tuberous sclerosis complex (TSC)-associated angiomyolipoma (AML) with renal dysfunction or low body weight.
METHODS


We investigated a total of 50 adult patients underwent everolimus treatment for AML associated with TSC. For patients with renal dysfunction (serum creatinine level ≥ 1.5 mg/dl) or low body weight (body weight < 35 kg), 5 mg of everolimus was administered daily (low-dose group). For patients without renal dysfunction or low body weight, 10 mg of everolimus was administered daily (conventional-dose group). The treatment effects and adverse events were compared between the two groups.
RESULTS


There were 20 patients in the low-dose group, and 30 in the conventional-dose group. The average reduction rate of the AML volume in the low-dose group was 52%, whereas it was 60% in the conventional-dose group. No significant differences were found in the average reduction rate between the groups (P = 0.24). The average blood everolimus trough levels were 7.7 ± 3.1 ng/mL in the low-dose group and 12.2 ± 5.7 ng/mL in the conventional-dose group. The level was significantly higher in the conventional-dose group than in the low-dose group (P = 0.004). The incidences of stomatitis and irregular menstruation were significantly lower in the low-dose group than in the conventional-dose group (P = 0.009, P = 0.045, respectively).
CONCLUSIONS


The present study demonstrates that low-dose everolimus treatment is safe and effective for TSC-associated AML. This treatment was well tolerated and adverse events were mild in all cases.",2021,"The incidences of stomatitis and irregular menstruation were significantly lower in the low-dose group than in the conventional-dose group (P = 0.009, P = 0.045, respectively).
","['50 adult patients underwent everolimus treatment for AML associated with TSC', 'patients with renal dysfunction (serum creatinine level\u2009≥\u20091.5\xa0mg/dl) or low body weight (body weight\u2009<\u200935\xa0kg), 5\xa0mg of', 'patients with tuberous sclerosis complex (TSC)-associated angiomyolipoma (AML) with renal dysfunction or low body weight', 'renal angiomyolipoma associated with tuberous sclerosis complex']","['low-dose everolimus', 'everolimus']","['average reduction rate of the AML volume', 'incidences of stomatitis and irregular menstruation', 'tolerated and adverse events', 'average blood everolimus trough levels', 'average reduction rate', 'safety and efficacy', 'Efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041341', 'cui_str': 'Tuberous sclerosis syndrome'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0241961', 'cui_str': 'Angiomyolipoma of kidney'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0206633', 'cui_str': 'Angiomyolipoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0156404', 'cui_str': 'Irregular periods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.0201418,"The incidences of stomatitis and irregular menstruation were significantly lower in the low-dose group than in the conventional-dose group (P = 0.009, P = 0.045, respectively).
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatano', 'Affiliation': 'Department of Urology, Seirei Yokohama Hospital, Kanagawa, Japan. hatano-t@jreast.co.jp.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Endo', 'Affiliation': 'Department of Urology, JR Tokyo General Hospital, 2-1-3 Yoyogi Shibuya-ku, Tokyo, 151-8528, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Tamari', 'Affiliation': 'Research Center for Medical Science, Division of Molecular Genetics, The Jikei University School of Medicine, Tokyo, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01792-w']
817,33237534,Pharmacokinetics and Safety of INL-001 (Bupivacaine HCl) Implants Compared with Bupivacaine HCl Infiltration After Open Unilateral Inguinal Hernioplasty.,"INTRODUCTION


Surgical site infiltration with bupivacaine HCl results in short-lived analgesia for postsurgical pain and carries the risk of systemic bupivacaine toxicity due to accidental intravascular injection. INL-001 is a bupivacaine HCl collagen-matrix implant that provides extended delivery of bupivacaine directly at the site and avoids the risk of accidental injection. Here, we examine the pharmacokinetic (PK) and safety profile of INL-001 placement during unilateral open inguinal hernioplasty.
METHODS


This multicenter, single-blind study (NCT03234374) enrolled patients undergoing open inguinal hernioplasty to receive three INL-001 implants, each containing 100 mg bupivacaine HCl (n = 34) or local infiltration of 0.25% bupivacaine HCl 175 mg (n = 16). Acetaminophen was provided in the postsurgical period and supplemented by opioids for breakthrough pain, as needed. PK blood samples were taken before surgery and up to 96 h after drug administration.
RESULTS


INL-001 demonstrated a prolonged rate of absorption and clearance of bupivacaine compared with 0.25% bupivacaine HCl 175 mg, as demonstrated by a longer time to peak plasma concentration and terminal elimination half-life. Peak plasma concentration with INL-001 300 mg was comparable to bupivacaine HCl 175 mg and well below levels associated with systemic bupivacaine toxicity. The most common adverse events (AEs) in both groups were associated with general anesthesia and the postsurgical setting. No AE was related to the implant, including those associated with wound healing.
CONCLUSIONS


These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing.
TRIAL REGISTRATION


Clinicaltrials.gov identifier, NCT03234374.",2021,"These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing.
","['patients undergoing open inguinal hernioplasty', 'enrolled patients undergoing']","['INL-001 (Bupivacaine HCl) Implants', 'open inguinal hernioplasty to receive three INL-001 implants, each containing 100\xa0mg bupivacaine HCl (n\u2009=\u200934) or local infiltration of 0.25% bupivacaine HCl', 'bupivacaine', 'bupivacaine HCl', 'Bupivacaine HCl Infiltration', 'Acetaminophen', 'INL-001', 'INL-001 placement']","['systemic bupivacaine toxicity', 'wound healing', 'prolonged rate of absorption and clearance', 'pharmacokinetic (PK) and safety profile', 'Peak plasma concentration', 'PK blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.186851,"These findings demonstrate that INL-001 provides immediate and extended delivery of bupivacaine and is well tolerated in patients undergoing open inguinal hernioplasty with no adverse effect on wound healing.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'HD Research LLC, Houston, TX, USA. leimanmd@gmail.com.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Niebler', 'Affiliation': 'Innocoll Inc, Newtown Square, PA, USA.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research LLC, Houston, TX, USA.'}]",Advances in therapy,['10.1007/s12325-020-01565-x']
818,32990882,A randomised online experimental study to compare responses to brief and extended surveys of health-related quality of life and psychosocial outcomes among women with breast cancer.,"PURPOSE


Collecting patient-reported outcomes is important in informing the well-being of women with breast cancer. Consumer perceptions are important for successful implementation of monitoring systems, but are rarely formally assessed. We compared reactions to two different surveys (assessing psychosocial outcomes and/or Health-related Quality of Life (HrQoL) outcomes) among Australian women with breast cancer.
METHODS


Women (18 + years) within 5 years diagnosis of breast cancer were randomly allocated to complete one of two online surveys: (i) minimum HrQoL measures or (ii) minimum HrQoL measures plus psychosocial outcomes (body image, depression, anxiety stress, fear of cancer recurrence, decisional difficulties and unmet need). Participants completed questions regarding their perceptions of the survey, including qualitative feedback.
RESULTS


Data were available for 171 participants (n (i)  = 89; n (ii)  = 82), with 92% (n = 158) providing 95-100% complete data. Perceptions were comparable between survey groups, and high (80-100%) regarding time burden, ease of completion, comprehensible, appropriateness and willingness to participate again and moderately high (67-74%) regarding willingness to answer more questions and relevance. Qualitative feedback indicated gaps across both surveys, including financial/work-related issues, satisfaction with information and care, need for nuanced questions, and impact of side effects/treatment, and from the minimum set only, emotional well-being and support. Impairment in some HrQoL and psychosocial outcomes were observed among participants.
CONCLUSIONS


Assessment of HrQoL and psychosocial outcomes was well received by consumers. Results alleviate concern regarding possible patient burden imposed by longer more in-depth surveys. The importance placed on assessment brevity should not outweigh the need to assess outcomes that consumers consider important.",2021,"Perceptions were comparable between survey groups, and high (80-100%) regarding time burden, ease of completion, comprehensible, appropriateness and willingness to participate again and moderately high (67-74%) regarding willingness to answer more questions and relevance.","['Women (18\u2009+\u2009years) within 5\xa0years diagnosis of breast cancer', 'Australian women with breast cancer', 'women with breast cancer', '171 participants (n (i) \u2009=\u200989; n (ii) \u2009=\u200982), with 92% (n\u2009=\u2009158) providing 95-100% complete data']",['online surveys: (i) minimum HrQoL measures or (ii) minimum HrQoL measures plus psychosocial outcomes'],"['psychosocial outcomes and/or Health-related Quality of Life (HrQoL) outcomes', 'time burden, ease of completion, comprehensible, appropriateness and willingness to participate again and moderately high']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}]",171.0,0.0474717,"Perceptions were comparable between survey groups, and high (80-100%) regarding time burden, ease of completion, comprehensible, appropriateness and willingness to participate again and moderately high (67-74%) regarding willingness to answer more questions and relevance.","[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Ettridge', 'Affiliation': 'South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA, Australia. Kerry.ettridge@sahmri.com.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Caruso', 'Affiliation': 'South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roder', 'Affiliation': 'University of South Australia, Adelaide, SA, Australia.'}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Prichard', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Scharling-Gamba', 'Affiliation': 'South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wright', 'Affiliation': 'South Australian Health and Medical Research Institute, North Terrace, Adelaide, SA, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'University of Adelaide, Adelaide, SA, Australia.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02651-x']
819,32990919,Efficacy of peg-interferon-nucleoside analog sequential optimization therapy in HBeAg-positive patients with CHB.,"OBJECTIVE


This study aimed to evaluate the efficacy of Peg-interferon (Peg-IFN)-nucleoside analog (NA) sequential optimization therapy (SOT) in HBeAg-positive patients with chronic hepatitis B (CHB).
METHODS


In this prospective two-center study, 132 CHB patients were assigned to receive Peg-IFN standard therapy for 48 weeks (65 patients) or Peg-IFN monotherapy for 12-24 weeks and NA add-on for those without early virological response (EVR) (67 patients). Both patient groups were monitored and followed for 24 weeks after treatments stop.
RESULTS


At week 24 after treatments stop, the Peg-IFN-NA SOT group achieved more HBsAg levels drop (- 1.35 vs - 0.67 log 10  IU/mL, p = 0.016), higher HBsAg ≤ 100 IU/mL (32.8% vs 9.2%, p = 0.001), HBV DNA undetectable (79.1% vs 49.2%, p < 0.001), and ALT normalization (80.6% vs 38.5%, p < 0.001) rates compared with Peg-IFN monotherapy. At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group.
CONCLUSION


Starting with Peg-IFN followed by addition of NA achieved more HBsAg levels drop, and higher HBsAg ≤ 100 IU/mL, HBV DNA undetectable, and ALT normalization rates compared with Peg-IFN monotherapy.",2021,"At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group.
","['132 CHB patients', 'HBeAg-positive patients with CHB', 'HBeAg-positive patients with chronic hepatitis B (CHB']","['Peg-interferon (Peg-IFN)-nucleoside analog (NA) sequential optimization therapy (SOT', 'Peg-IFN monotherapy', 'peg-interferon-nucleoside analog sequential optimization therapy', 'Peg-IFN standard therapy']","['HBsAg loss', 'HBsAg seroconversion rates', 'HBeAg seroconversion', 'HBV DNA', 'ALT normalization', 'ALT normalization rates', 'HBsAg levels']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",132.0,0.049443,"At week 24 after treatments stop, no significant difference was found in HBeAg seroconversion (35.8% vs 27.7%, p = 0.316), HBsAg loss (8.9% vs 4.6%, p = 0.323) and HBsAg seroconversion rates (4.5% vs 1.5%, p = 0.325) between Peg-IFN monotherapy group and Peg-IFN-NA SOT group.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China. liqiang66601@163.com.'}, {'ForeName': 'Chenlu', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.'}, {'ForeName': 'Qiankun', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China.'}, {'ForeName': 'Jiming', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, 2901 Cao Lang Road, Shanghai, 201508, China. chenliang@shphc.org.cn.'}]",Hepatology international,['10.1007/s12072-020-10095-1']
820,33001324,"The role of tibial nerve stimulation for enhanced postoperative recovery after colorectal surgery: a double-blind, parallel-group, randomized controlled trial.","BACKGROUND


Postoperative ileus (POI) is the most common cause of prolonged hospital stay following abdominal surgery, despite an optimized enhanced recovery after surgery (ERAS) program. The aim of the study was to evaluate the role of postoperative transcutaneous electrical tibial nerve stimulation (TTNS) in the recovery of bowel function and in shortening hospital stay after colonic resection.
METHODS


Patients having elective laparoscopic colonic surgery within an ERAS program at our institution between June 2016 and June 2019 were enrolled and randomly assigned to a treatment protocol with TTNS or sham electrical stimulation. The primary endpoint was the time of recovery of gastrointestinal motility, measured as the first passage of stool. Secondary endpoints included: first passage of flatus, length of hospital stay, and complication rate related to the use of TTNS.
RESULTS


One hundred and seventy patients who had right hemicolectomy (median age 71 years (range 43-89 years); 47.5% women) and 170 patients who had left colectomy (median age 67 years range (37-92 years); 41.5% women) were enrolled. The only factor significantly affected by TTNS was time to first passage of flatus after right hemicolectomy (reduced from 46 to 33 h, p = 0.04). However, if only patients with low compliance to early oral nutrition (63 of 340; 18.5%) were considered, a statistically significant difference in time until first flatus (p < 0.01) and first bowel movement (p < 0.0001) and a shorter time until discharge (median 5 vs 7 days) were found in both left and right colectomies groups, respectively.
CONCLUSIONS


TTNS may have a positive effect on gastrointestinal tract motility and recovery from POI after colorectal surgery in a selected group, who has low compliance with an ERAS program, without increasing the risk of complications.",2021,"The only factor significantly affected by TTNS was time to first passage of flatus after right hemicolectomy (reduced from 46 to 33 h, p = 0.04).","['One hundred and seventy patients who had right hemicolectomy (median age 71\xa0years (range 43-89\xa0years); 47.5% women) and 170 patients who had left colectomy (median age 67\xa0years range (37-92\xa0years); 41.5% women) were enrolled', 'Patients having elective laparoscopic colonic surgery within an ERAS program at our institution between June 2016 and June 2019', 'colorectal surgery']","['TTNS or sham electrical stimulation', 'postoperative transcutaneous electrical tibial nerve stimulation (TTNS', 'tibial nerve stimulation', 'TTNS']","['first bowel movement', 'shorter time until discharge', 'gastrointestinal tract motility', 'time until first flatus', ' first passage of flatus, length of hospital stay, and complication rate related to the use of TTNS', 'time of recovery of gastrointestinal motility, measured as the first passage of stool']","[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",170.0,0.128982,"The only factor significantly affected by TTNS was time to first passage of flatus after right hemicolectomy (reduced from 46 to 33 h, p = 0.04).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martellucci', 'Affiliation': 'General, Emergency and Minimally Invasive Surgery, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy. jamjac64@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sturiale', 'Affiliation': 'General, Emergency and Minimally Invasive Surgery, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alemanno', 'Affiliation': 'General, Emergency and Minimally Invasive Surgery, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bartolini', 'Affiliation': 'Oncologic and Robotic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pesi', 'Affiliation': 'Oncologic and Robotic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Perna', 'Affiliation': 'Oncologic and Robotic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Coratti', 'Affiliation': 'Oncologic and Robotic Surgery, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Prosperi', 'Affiliation': 'General, Emergency and Minimally Invasive Surgery, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Valeri', 'Affiliation': 'General, Emergency and Minimally Invasive Surgery, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.'}]",Techniques in coloproctology,['10.1007/s10151-020-02347-x']
821,33047687,Enhanced recovery after surgery in laparoscopic distal gastrectomy: Protocol for a prospective single-arm clinical trial.,"Background


The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections. However, a recent prospective, randomised, open, parallel-controlled trial (Chinese Laparoscopic Gastrointestinal Surgery Study-01 trial), initiated by our team, indicated that under conventional peri-operative management, the reduction of the post-operative hospital stay of laparoscopic distal gastrectomy (LDG) is quite limited compared with open gastrectomy. Thus, if we could provide valuable clinical evidence for demonstrating the efficacy of the ERAS programme for gastric cancer patients undergoing LDG, it would significantly enhance the peri-operative management of gastrectomy and benefit the patients.
Methods


In this prospective single-arm trial, patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study. All participants underwent LDG with peri-operative management under the ERAS programme. The primary outcome measures included the post-operative hospital stays and rehabilitative rate of the post-operative day 4. The secondary outcome measures are morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge.
Conclusion


With reasonable and scientific designing, the trial may be a great help to further discuss the benefit of ERAS programme and thus improving the peri-operative management of patients with gastrectomy.",2020,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","['All participants underwent LDG with peri-operative management under the ERAS programme', 'gastric cancer patients undergoing LDG', 'patients with gastrectomy', 'patients who are 18-75 years of age with gastric adenocarcinoma diagnosed with cT1-4aN0-3M0 and expected to undergo curative resection through LDG, are considered eligible for this study']","['laparoscopic distal gastrectomy (LDG', 'ERAS programme', 'laparoscopic distal gastrectomy', 'surgery (ERAS) programme']","['morbidity and mortality (time frame: 30 days), post-operative recovery index (time frame: 30 days), post-operative pain intensity (time frame: 3 days) and the medical costs from surgery to discharge', 'post-operative hospital stays and rehabilitative rate of the post-operative day 4', 'length of hospital stay, overall complication rates and medical costs']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0800456,"The enhanced recovery after surgery (ERAS) programme is feasible and effective in reducing the length of hospital stay, overall complication rates and medical costs when applied to cases involving colonic and rectal resections.","[{'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yuehong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_35_19']
822,33021563,"Ambulatory continuous peripheral nerve blocks to treat postamputation phantom limb pain: a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial.","Phantom limb pain is thought to be sustained by reentrant neural pathways, which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0 to 12 weeks. Pretreatment pain scores were similar in both groups, with a median (interquartile range) of 5.0 (4.0, 7.0) for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic vs 4.5 (2.6) in those given placebo (difference [95% confidence interval] 1.3 [0.4, 2.2], P = 0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 (0, 5.0) vs 1.5 (0, 5.0) for the placebo group; there seemed to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.",2021,"Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores.",['enrolled patients who had an upper- or lower-limb amputation and established phantom pain'],"['local anesthetic', '6-day continuous peripheral nerve block', 'placebo', 'ropivacaine or normal saline', 'Ambulatory continuous peripheral nerve blocks']","['global impression of change and less pain-induced physical and emotional dysfunction', 'phantom limb pain', 'average phantom pain severity as measured with a Numeric Rating Scale', 'average phantom limb pain intensity', 'depression scores', 'Pretreatment pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.757738,"Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Ilfeld', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Khatibi', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Madison', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Mariano', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Palo Alto Veterans Affairs, Palo Alto, CA, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kent', 'Affiliation': 'Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, MD, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hanling', 'Affiliation': 'Department of Anesthesiology, Naval Medical Center San Diego, San Diego, CA, United States.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Eisenach', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Cohen', 'Affiliation': 'Department of Anesthesiology, Johns Hopkins, Baltimore, MD, United States.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, the Cleveland Clinic, Cleveland, OH, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Padwal', 'Affiliation': 'Department of Radiology, University of California San Diego, San Diego, CA, United States.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Outcomes Research Consortium, Cleveland, OH, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002087']
823,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES


We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS


Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS


We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2  = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2  = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS


Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
824,33040273,Comparison between bilateral implantation of a trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens).,"PURPOSE


To compare the visual performance outcomes following bilateral cataract surgery using trifocal intraocular lens (Alcon Acrysof IQ® PanOptix) and extended depth of focus lens (Tecnis® Symfony® ZXR00 lens).
METHODS


In this prospective, non-randomized, comparative trial, a total of 40 subjects (80 eyes) were divided into two different groups and submitted to bilateral cataract surgery and implantation of the two different IOLs, Alcon Acrysof IQ® PanOptix® TNFT00 in group A and Tecnis® Symfony® ZXR00 lens (Johnson & Johnson Vision) in group B, was assessed. The uncorrected and corrected near (33 cm), intermediate (60 cm), and far (4 m) binocular visual acuity was measured, and visual binocular defocus curves were also measured in the photopic condition with a long-distance visual acuity and the qualitative visual function was assessed by NEI VFQ-25.
RESULTS


Group A comprised 20 patients; 11 women (55%) and 9 men (45%) with a mean age of 62.1 ± 5.4. In group B 20 patients were recruited; 12 women (60%) and 8 men (40%) with a mean age of 63.2 ± 6.1. The postoperatively calculated mean sphere was + 0.35 ± 0.12 D and - 0.14 ± 0.13 D in groups A and B, respectively. The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
CONCLUSION


Both strategies were able to provide good vision for far, intermediate and near distances.",2021,"The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
","['40 subjects (80 eyes', 'In group B 20 patients were recruited; 12 women (60%) and 8 men (40%) with a mean age of 63.2\u2009±\u20096.1', 'Group A comprised 20 patients; 11 women (55%) and 9 men (45%) with a mean age of 62.1\u2009±\u20095.4']","['bilateral implantation of a trifocal intraocular lens (Alcon Acrysof IQ® PanOptix', 'bilateral cataract surgery using trifocal intraocular lens (Alcon Acrysof IQ® PanOptix', 'bilateral cataract surgery and implantation of the two different IOLs, Alcon Acrysof IQ® PanOptix® TNFT00 in group A and Tecnis® Symfony® ZXR00 lens (Johnson & Johnson Vision']","['VFQ-25 questionnaire, then ear vision score', 'photopic condition with a long-distance visual acuity and the qualitative visual function', 'visual binocular defocus curves', 'uncorrected intermediate visual acuity (UIVA', 'postoperative uncorrected near visual acuity (UNVA', 'postoperative uncorrected distance visual acuity (UDVA', 'binocular visual acuity', 'visual performance outcomes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C4517792', 'cui_str': '5.4'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",40.0,0.0481988,"The postoperative uncorrected distance visual acuity (UDVA) as well as uncorrected intermediate visual acuity (UIVA) were statistically equal in both groups (P = 0.12, P = 0.17); meanwhile, the postoperative uncorrected near visual acuity (UNVA) was significantly better in patients with PanOptix IOL implantation (P = 0.01) compared to the binocular defocus curve; the results of the PanOptix group were better than the Symfony group in intermediate and near distance (P = 0.089, P = 0.001) and according to the VFQ-25 questionnaire, then ear vision score as well as sum score turned out to be significantly higher in groups A than B (P = 0.001 and P = 0.015, respectively).
","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Mohammadkarim', 'Initials': 'M', 'LastName': 'Johari', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran. mkjoharii@gmail.com.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Attarzade', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Feisal', 'Initials': 'F', 'LastName': 'Rahat', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Farvardin', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars, Iran.'}]",International ophthalmology,['10.1007/s10792-020-01608-w']
825,33003108,When pain becomes uncontrollable: an experimental analysis of the impact of instructions on pain-control attempts.,"ABSTRACT


Under some conditions, people persist in their attempts to control their pain even when no such control is possible. Theory suggests that such pain-control attempts arise from actual pain experiences. Across 3 experiments we examined how (1) losing control over pain and (2) instructions concerning pain, moderated pain-control attempts. In each experiment, participants completed a learning task. Before the task, one group of participants received instructions outlining a strategy through which they could control pain, whereas another group had to develop such a strategy through trial-and-error learning. During the first half of the task, the pain-control instructions allowed participants to successfully control pain, whereas during the second half of the task, this was no longer the case. Instead, participants lost control over pain because of an unannounced change in the learning task. Results indicated that when participants lost control over pain, they generally stuck to the previously effective pain-control strategy, and that this tendency was larger if they received instructions from others than when they developed a strategy by themselves. These findings suggest that when pain is no longer controllable, very persistent pain-control attempts might be the result of adherence to previously effective pain-control instructions.",2021,"Across three experiments we examined how (a) losing control over pain and (b) instructions concerning pain, moderate pain-control attempts.",[],"['instructions outlining a strategy via which they could control pain, whereas another group had to develop such a strategy via trial-and-error learning']",[],[],"[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0443034,"Across three experiments we examined how (a) losing control over pain and (b) instructions concerning pain, moderate pain-control attempts.","[{'ForeName': 'Ama', 'Initials': 'A', 'LastName': 'Kissi', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Van Ryckeghem', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Houwer', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Crombez', 'Affiliation': 'Department of Experimental-Clinical and Health Psychology, Ghent University, Ghent, Belgium.'}]",Pain,['10.1097/j.pain.0000000000002088']
826,33048342,The effect of remote ischaemic preconditioning on endothelial function after hip fracture surgery.,"BACKGROUND


Endothelial dysfunction seems to play a role in the pathophysiology of myocardial injury after surgery. The aim of this randomised clinical trial was to examine whether remote ischaemic preconditioning in relation to hip fracture surgery ameliorates post-operative systemic endothelial dysfunction.
METHODS


This was a planned single-centre pilot sub-study of a multicentre, randomised clinical trial. Patients ≥45 years with a cardiovascular risk factor were randomised to remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation with their hip fracture operation. RIPC consisted of four cycles of 5 minutes forearm ischaemia and reperfusion. The procedure was performed non-invasively with a tourniquet. The endothelial function was assessed with non-invasive digital pulse amplitude tonometry on post-operative day 1 and expressed as the reactive hyperaemia index (RHI). Endothelial dysfunction was defined as RHI < 1.22.
RESULTS


Between February 2015 and December 2016, 18 patients were allocated to the RIPC group and 20 patients to the control group. The endothelial function was impaired in both groups on post-operative day 1. RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, P = .76. Endothelial dysfunction was present in 3/18 patients (16.7%) in the RIPC group and 8/20 patients (40%) in the control group, P = .11.
CONCLUSION


No beneficial effect of remote ischaemic preconditioning on the systemic endothelial dysfunction, assessed at a single time point on post-operative day one, was detected after hip fracture surgery.",2021,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","['Patients ≥ 45 years with a cardiovascular risk factor', 'Between February 2015 and December 2016', 'after hip fracture surgery', '18 patients were allocated to the RIPC group and 20 patients to the control group']","['remote ischaemic preconditioning', 'remote ischaemic preconditioning (RIPC) or control (standard treatment) performed in relation to their hip fracture operation']","['Endothelial dysfunction', 'systemic endothelial dysfunction', 'reactive hyperaemia index (RHI', 'RHI', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",18.0,0.0816998,"RHI did not differ between the groups, 1.47 (95% CI 1.20-1.75) in the RIPC group vs. 1.54 (95% CI 1.17-1.91) in the control group, p=0.76.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ekeloef', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ossian', 'Initials': 'O', 'LastName': 'Gundel', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Falkenberg', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Gögenur', 'Affiliation': 'Center for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13724']
827,33002924,"A Comparison of the Required Bronchial Cuff Volume Obtained by 2 Cuff Inflation Methods, Capnogram Waveform-Guided Versus Pressure-Guided: A Prospective Randomized Controlled Study.","BACKGROUND


Double-lumen endobronchial tubes (DLTs) are used for one-lung ventilation (OLV) during thoracic surgery. Overinflation into the bronchial cuff causes damage to the tracheobronchial mucosa, whereas underinflation leads to an incomplete collapse of the nonventilated lung or incomplete ventilation of the ventilated lung. However, how to determine the appropriate bronchial cuff volume and pressure during OLV is unclear. The objective of this study is to compare the required bronchial cuff volume for lung separation obtained by 2 different cuff inflation methods under closed- and open-chest conditions.
METHODS


A total of 64 patients scheduled to undergo elective thoracic surgery requiring OLV were recruited. Left DLTs were used for both right- and left-sided surgery. The patients were randomly assigned to 1 of 2 inflation-type groups to estimate the bronchial cuff volume. In the capnogram waveform-guided bronchial cuff inflation group (capno group, n = 27), the bronchial cuff was inflated until a capnometer sampling gas containing CO2 from the nonventilated lung displayed a flat line. The corresponding bronchial cuff volume and pressure were then recorded. In the pressure-guided bronchial cuff inflation group (pressure group, n = 29), the bronchial cuff was inflated by a cuff inflator to a pressure of 20 cm H2O. Lung separation was confirmed when a flat line of a capnometer was observed after gas sampling from the nonventilated lung.
RESULTS


Under closed-chest conditions, the bronchial cuff sealing volume for the capno group was significantly lower than that for the pressure group (mean [standard deviation {SD}], 1.00 [0.65] mL vs 1.44 [0.59] mL, mean difference, -0.44; 97.5% confidence interval [CI], -0.78 to -0.11; P = .010). Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66] mL vs 1.22 [0.45] mL, mean difference, -0.58; 97.5% CI, -0.88 to -0.27; P < .001).
CONCLUSIONS


The lowest cuff volume providing an air-tight bronchial seal was obtained by the capnogram waveform-guided bronchial cuff inflation method. Since the cuff volume required to achieve an air-tight seal decreases after opening the chest, readjustment of the bronchial cuff volume to prevent bronchial cuff damage to the tracheobronchial mucosa after opening the chest may be advisable.",2021,"Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66]",['64 patients scheduled to undergo elective thoracic surgery requiring OLV were recruited'],"['Guided Versus Pressure-Guided', 'Bronchial Cuff Volume Obtained by 2 Cuff Inflation Methods, Capnogram Waveform', 'Double-lumen endobronchial tubes (DLTs']","['lowest cuff volume providing an air-tight bronchial seal', 'bronchial cuff sealing volume', 'corresponding bronchial cuff volume and pressure']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4761260', 'cui_str': 'Capnogram'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",64.0,0.0167947,"Under open-chest conditions, the bronchial cuff sealing volume for the capno group was also significantly lower than that for the pressure group (mean [SD], 0.65 [0.66]","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Nagase', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Gifu University Hospital Innovative and Clinical Research Promotion Center, Gifu University, Gifu, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Iida', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005179']
828,33008559,Postural Changes and the Trans-Lamina Cribrosa Pressure Difference: A Pilot Study in Neurosurgical Patients without Glaucoma.,"PURPOSE


To evaluate the effect of changes in position in the trans-lamina cribrosa pressure difference (TLCPD) by simultaneously measuring and comparing intracranial pressure (ICP) with intraocular pressure (IOP) in seated and supine positions.
DESIGN


Prospective cohort study.
PARTICIPANTS


Patients admitted to the neurosurgery unit at Toronto Western Hospital with an external ventricular drain placed for ICP monitoring. Exclusion criteria were any ophthalmic surgical procedures within the preceding 6 months, history of glaucoma, and corneal abnormalities affecting IOP measurement.
METHODS


Intraocular pressure and ICP were recorded simultaneously in both the supine and seated positions with the order of positions randomized. Measurements were made 10 minutes after assuming each position. The TLCPD (IOP minus ICP) was calculated for the sitting and supine positions. The paired t test was used to assess significance of differences.
MAIN OUTCOME MEASURE


The TLCPD.
RESULTS


Twenty patients were included in the study. The average age was 54±17 years. Results were similar for left and right eyes. Data are shown for right eyes only. Mean sitting and supine IOPs were 15.3±3.5 mmHg and 15.9±3.7 mmHg, respectively (P = 0.32). Mean sitting and supine ICPs were 12.5±6.8 mmHg and 12.8±5.1 mmHg, respectively (P = 0.66). Mean TLCPD was 3.1±6.0 mmHg in the sitting position and 3.1±7.0 mmHg in the supine position (P = 1.00). Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
CONCLUSIONS


In this pilot study of 20 neurosurgical patients without glaucoma, posture-induced TLCPD changes were variable.",2020,"Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
","['20 neurosurgical patients without glaucoma, posture-induced TLCPD changes were variable', 'Patients admitted to the neurosurgery unit at Toronto Western Hospital with an external ventricular drain placed for ICP monitoring', 'Neurosurgical Patients without Glaucoma', 'Twenty patients were included in the study']",['simultaneously measuring and comparing intracranial pressure (ICP) with intraocular pressure (IOP'],"['Mean sitting and supine IOPs', 'TLCPD (IOP minus ICP', 'Mean sitting and supine ICPs', 'Mean TLCPD', 'Postural Changes and the Trans-Lamina Cribrosa Pressure Difference', 'Supine TLCPD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0150260', 'cui_str': 'Intracranial pressure monitoring regime'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0010316', 'cui_str': 'Structure of cribriform plate'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.033462,"Supine TLCPD increased in 10 patients (50%), decreased in 8 patients (40%), and was unchanged in 2 patients (10%).
","[{'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Belkin', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada. Electronic address: avner.belkin@gmail.com.'}, {'ForeName': 'Rana A', 'Initials': 'RA', 'LastName': 'Greene', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Graham E', 'Initials': 'GE', 'LastName': 'Trope', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Jin', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Gentili', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Buys', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.02.007']
829,33025372,"Randomized controlled trial of a group intervention combining self-hypnosis and self-care: secondary results on self-esteem, emotional distress and regulation, and mindfulness in post-treatment cancer patients.","PURPOSE


Cancer patients often report low self-esteem and high emotional distress. Two factors seem particularly linked to these symptoms: emotion regulation strategies and mindfulness. The interest of hypnosis and self-care to relieve these symptoms is not well documented. Our randomized controlled trial aimed at assessing the effect of a group intervention combining self-hypnosis and self-care on self-esteem, emotional distress, emotion regulation, and mindfulness abilities of post-treatment cancer patients, as well as investigating the links between these variables.
METHODS


One hundred and four patients who had suffered from cancer were randomized into the intervention group (N = 52) and the wait-list control group (N = 52). They had to answer questionnaires before (T1) and after the intervention (T2). Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer. Group-by-time changes were assessed with MANOVA, and associations with self-esteem and emotional distress were investigated with hierarchical linear regression models.
RESULTS


Participants in the intervention group (mean age = 51.65; SD = 12.54) reported better self-esteem, lower emotional distress, a decreased use of maladaptive emotion regulation strategies, and more mindfulness abilities after the intervention, compared to the WLCG. This increase in mindfulness explained 33% of the improvement of self-esteem and 41.6% of the decrease of emotional distress in the intervention group. Self-esteem and emotional distress also predicted each other.
CONCLUSION


Our study showed the efficacy of our hypnosis-based intervention to improve all the investigated variables. Mindfulness predicted the improvement of self-esteem and emotional distress. The primary impact of our intervention on mindfulness abilities seems to explain, at least in part, its efficacy. Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.",2021,Mindfulness predicted the improvement of self-esteem and emotional distress.,"['post-treatment cancer patients', 'Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer', 'Cancer patients often report low self-esteem and high emotional distress', 'One hundred and four patients who had suffered from cancer']",['group intervention combining self-hypnosis and self-care'],"['better self-esteem, lower emotional distress', 'self-esteem', 'emotional distress', 'self-esteem, emotional distress and regulation, and mindfulness', 'mindfulness abilities', 'maladaptive emotion regulation strategies', 'self-esteem, emotional distress, emotion regulation, and mindfulness abilities', 'Self-esteem and emotional distress', 'self-esteem and emotional distress']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C2712312', 'cui_str': 'High self-esteem'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",95.0,0.0485733,Mindfulness predicted the improvement of self-esteem and emotional distress.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grégoire', 'Affiliation': 'Faculty of Psychology, Speech Therapy and Educational Sciences, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium. ch.gregoire@chuliege.be.'}, {'ForeName': 'M-E', 'Initials': 'ME', 'LastName': 'Faymonville', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vanhaudenhuyse', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'Medical Oncology Department, CHU Liège and University of Liège, Liège, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Faculty of Psychology, Speech Therapy and Educational Sciences, University of Liège, Liège, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bragard', 'Affiliation': 'Haute Ecole Libre Mosane (HELMo), Liège, Belgium.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02655-7']
830,33033996,Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial.,"We evaluated the effect of an option B-plus Enhanced Adherence Package (BEAP), on early ART uptake in a randomized controlled trial. HIV-positive, ART naïve pregnant women in Lusaka, Zambia, were randomized to receive BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC). The primary outcome was initiating and remaining on ART at 30 days. Analysis was by intention to treat (ITT) using logistic regression. Additional per protocol analysis was done. We enrolled 454 women; 229 randomized to BEAP and 225 to SOC. Within 30 days of eligibility, 445 (98.2%) initiated ART. In ITT analysis, 82.5% BEAP versus 80.4% SOC participants reached primary outcome (crude relative risk [RR] 1.03; 95% confidence interval [CI] 0.91-1.16; Wald test statistic = 0.44; p-value = 0.66). In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03). Early ART initiation in pregnancy was nearly universal but there was early drop out suggesting need for additional adherence support.This trial was registered at ClinicalTrials.gov (trials number NCT02459678) on May 14, 2015.",2021,"In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03).","['We enrolled 454 women; 229 randomized to BEAP and 225 to SOC', 'HIV-Positive Pregnant Women in Zambia', 'HIV-positive, ART naïve pregnant women in Lusaka, Zambia']","['BEAP (phone calls/home visits, additional counseling, male partner engagement and missed-visit follow-up) versus standard of care (SOC', 'option B-plus Enhanced Adherence Package (BEAP', 'Enhanced Adherence Package']",[],"[{'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],454.0,0.626768,"In per protocol analysis, (92 participants (40.2%) excluded), 91.9% BEAP versus 80.4% SOC participants reached primary outcome (crude RR 1.14; 95% CI 1.02-1.29; Wald test statistic = 2.23; p-value = 0.03).","[{'ForeName': 'Mwangelwa', 'Initials': 'M', 'LastName': 'Mubiana-Mbewe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia. Mwangelwa.Mbewe@cidrz.org.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bosomprah', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Kadota', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Aybüke', 'Initials': 'A', 'LastName': 'Koyuncu', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}, {'ForeName': 'Thankian', 'Initials': 'T', 'LastName': 'Kusanathan', 'Affiliation': 'Department of Gender Studies, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Mweebo', 'Affiliation': 'Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.'}, {'ForeName': 'Kebby', 'Initials': 'K', 'LastName': 'Musokotwane', 'Affiliation': 'Prevention, Care and Treatment Branch, U.S. Centers for Disease Control and Prevention, Lusaka, Zambia.'}, {'ForeName': 'Priscilla L', 'Initials': 'PL', 'LastName': 'Mulenga', 'Affiliation': 'Directorate of Public Health, Zambian Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vinikoor', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Plot 34620 Off Alick Nkhata Road, P.O. Box 34681, Lusaka, Zambia.'}]",AIDS and behavior,['10.1007/s10461-020-03060-4']
831,33035194,A proof-of-concept study on the impact of a chronic pain and physical activity training workshop for exercise professionals.,"OBJECTIVES


Physical activity is essential for long-term chronic pain management, yet individuals struggle to participate. Exercise professionals, including fitness instructors, and personal trainers, are preferred delivery agents for education and instruction on chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills. However, exercise professionals receive no relevant training during certification or continuing education opportunities to effectively support their participants living with chronic pain. Based on the ORBIT model for early pre-efficacy phases of development and testing of new behavioral treatments, the present Phase IIa proof-of-concept study was conducted. The purpose was to examine the impacts of a newly developed chronic pain and physical activity training workshop on psychosocial outcomes among exercise professionals. Outcomes included knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain.
METHODS


Forty-eight exercise professionals ( M   age =44.4±11.0 years) participated in a three-hour, in-person workshop that was offered at one of four different locations. Participants completed pre- and post-workshop outcome assessment surveys.
RESULTS


Mixed MANOVA results comparing time (pre- versus post-workshop) by workshop location (sites 1 to 4) illustrated a significant within-subjects time effect ( p <0.001). All outcomes significantly improved from pre- to post-workshop ( p 's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).
CONCLUSIONS


Findings offer early phase preliminary support for the effectiveness of the chronic pain and physical activity training workshop for exercise professionals. Based on ORBIT model recommendations, findings warrant future phased testing via a pilot randomized clinical trial as well as testing for impacts that trained professionals have on activity adherence among their clients living with chronic pain. Eventual workshop adoption by exercise professional certification organizations would ensure widespread and sustainable access to qualified exercise professionals to help individuals engage in physical activity. By increasing the capacity of available exercise professionals to deliver effective support, active individuals could better manage their chronic pain and live well.",2021,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","['participants living with chronic pain', 'clients living with chronic pain']","['physical activity training workshop', 'exercise professionals receive no relevant training during certification or continuing education opportunities']","['knowledge and attitudes regarding chronic pain, attitudes and beliefs about the relationship between pain and impairment, and self-efficacy to educate and instruct participants with chronic pain', 'chronic pain, physical activity, and strategies to use adherence-promoting behavioral skills']","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",48.0,0.0595817,"All outcomes significantly improved from pre- to post-workshop (p's<0.001), demonstrating large effect sizes (partial eta-squared values ranging from 0.45 to 0.59).","[{'ForeName': 'Nancy C', 'Initials': 'NC', 'LastName': 'Gyurcsik', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Tupper', 'Affiliation': 'Pain Quality Improvement and Research for the Saskatchewan Health Authority, Saskatoon, SK, Canada.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Brittain', 'Affiliation': 'University of Northern Colorado, College of Natural and Health Sciences, Greeley, CO, USA.'}, {'ForeName': 'Lawrence R', 'Initials': 'LR', 'LastName': 'Brawley', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Miranda A', 'Initials': 'MA', 'LastName': 'Cary', 'Affiliation': 'University of British Columbia, School of Health and Exercise Science, Kelowna, BC, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Ratcliffe-Smith', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Jocelyn E', 'Initials': 'JE', 'LastName': 'Blouin', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Mackenzie G', 'Initials': 'MG', 'LastName': 'Marchant', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Sessford', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Laurie-Ann M', 'Initials': 'LM', 'LastName': 'Hellsten', 'Affiliation': 'University of Winnipeg, Faculty of Education, Winnipeg, MB, Canada.'}, {'ForeName': 'Bart E', 'Initials': 'BE', 'LastName': 'Arnold', 'Affiliation': 'University of Saskatchewan, College of Kinesiology, 87 Campus Drive, Saskatoon, SK, Canada.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Downe', 'Affiliation': 'University of Saskatchewan, Department of Archaeology and Anthropology, Saskatoon, SK, Canada.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0089']
832,33051719,"Efficacy of Topical Tranexamic Acid (Cyclokapron) in ""Wet"" Field Infiltration with Dilute Local Anaesthetic Solutions in Plastic Surgery.","BACKGROUND


Surgical bleeding may lead to the need for blood transfusion and minimizing blood loss has been a basic principle followed by surgeons for generations. Antifibrinolytic agents are widely used to reduce perioperative haemorrhage. The present study sought to assess the efficacy of directly infiltrated tranexamic acid in ameliorating bruising in participants undergoing cosmetic plastic surgery (liposuction).
MATERIALS AND METHODS


The study employed a blinded, prospective, randomized, case control design. Thirty-three patients were studied. Tranexamic acid free infiltration tumescent solution (saline, bupivacaine lignocaine and adrenalin) was infiltrated to one flank of patients undergoing liposuction of flanks. The other flank was infiltrated with the same tumescent solution (saline, bupivacaine lignocaine and adrenalin) mixed with tranexamic acid (0.1%). Bruises were photographed one and seven days after surgery and measured for size. The surface area of the bruises was calculated using ImageJ software. We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient. The model employed involved measuring the bruises on each flank of the same patient, with surgery by a single surgeon using the same infiltration and surgical techniques for both sides. The only variable was the difference in tranexamic acid concentration between study and control flanks.
RESULTS


We found that use of tranexamic acid consistently resulted in a smaller bruise area on days one and seven after liposuction of flanks. Results were statistically significant.
CONCLUSIONS


This is the first study examining addition of tranexamic acid to a tumescent infiltration solution-to produce a predictable local concentration of tranexamic acid-in order to maximize surgical site effect and minimize systemic effect. The authors recommend incorporation of tranexamic acid as a routine component along with adrenaline and local anaesthetics in tumescent field infiltration solution 10-15 min before commencement of the cosmetic surgery.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient.,"['patients undergoing liposuction of flanks', 'Plastic Surgery', 'Thirty-three patients were studied', 'participants undergoing cosmetic plastic surgery (liposuction']","['Tranexamic acid free infiltration tumescent solution (saline, bupivacaine lignocaine and adrenalin', 'Topical Tranexamic Acid (Cyclokapron', 'tranexamic acid', 'tumescent solution (saline, bupivacaine lignocaine and adrenalin) mixed with tranexamic acid']","['tranexamic acid concentration', 'perioperative haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038640', 'cui_str': 'Liposuction of subcutaneous tissue'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4546042', 'cui_str': 'Perioperative hemorrhage'}]",33.0,0.140906,We compared the bruised surface are between the tranexamic acid infiltrated flank and non-tranexamic acid infiltrated flank in the same patient.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fayman', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa. info@doctorfayman.co.za.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beeton', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Potgieter', 'Affiliation': 'Netcare Rosebank Hospital, 14 Sturdee Ave, Rosebank, Johannesburg, 2196, South Africa.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ndou', 'Affiliation': 'Anatomy Department, Sefako Mokgatho Health Sciences University, Molotlegi Street, Pretoria, 0204, South Africa.'}, {'ForeName': 'Pedzisai', 'Initials': 'P', 'LastName': 'Mazengenya', 'Affiliation': 'College of Medicine, Ajman University, Ajman, United Arab Emirates.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-02001-9']
833,33053283,Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis.,"BACKGROUND


Upadacitinib is an oral selective Janus kinase inhibitor to treat rheumatoid arthritis. The efficacy and safety of upadacitinib as compared with abatacept, a T-cell costimulation modulator, in patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs) are unclear.
METHODS


In this 24-week, phase 3, double-blind, controlled trial, we randomly assigned patients in a 1:1 ratio to receive oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs. The primary end point was the change from baseline in the composite Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP; range, 0 to 9.4, with higher scores indicating more disease activity) at week 12, assessed for noninferiority. Key secondary end points at week 12 were the superiority of upadacitinib over abatacept in the change from baseline in the DAS28-CRP and the percentage of patients having clinical remission according to a DAS28-CRP of less than 2.6.
RESULTS


A total of 303 patients received upadacitinib, and 309 patients received abatacept. From baseline DAS28-CRP values of 5.70 in the upadacitinib group and 5.88 in the abatacept group, the mean change at week 12 was -2.52 and -2.00, respectively (difference, -0.52 points; 95% confidence interval [CI], -0.69 to -0.35; P<0.001 for noninferiority; P<0.001 for superiority). The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority). During the treatment period, one death, one nonfatal stroke, and two venous thromboembolic events occurred in the upadacitinib group, and more patients in the upadacitinib group than in the abatacept group had elevated hepatic aminotransferase levels.
CONCLUSIONS


In patients with rheumatoid arthritis refractory to biologic DMARDs, upadacitinib was superior to abatacept in the change from baseline in the DAS28-CRP and the achievement of remission at week 12 but was associated with more serious adverse events. Longer and larger trials are required in order to determine the effect and safety of upadacitinib in patients with rheumatoid arthritis. (Funded by AbbVie; SELECT-CHOICE Clinicaltrials.gov number, NCT03086343.).",2020,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","['303 patients received upadacitinib, and 309 patients received', 'Rheumatoid Arthritis', 'patients with rheumatoid arthritis', 'patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs (DMARDs']","['abatacept', 'oral upadacitinib (15 mg once daily) or intravenous abatacept, each in combination with stable synthetic DMARDs', 'Upadacitinib or Abatacept']","['disease activity', 'superiority of upadacitinib over abatacept', 'death, one nonfatal stroke, and two venous thromboembolic events', 'elevated hepatic aminotransferase levels', 'percentage of patients having remission', 'composite Disease Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",303.0,0.246607,"The percentage of patients having remission was 30.0% with upadacitinib and 13.3% with abatacept (difference, 16.8 percentage points; 95% CI, 10.4 to 23.2; P<0.001 for superiority).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rubbert-Roth', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Khan', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': ""From the Division of Rheumatology, Cantonal Clinic St. Gallen, St. Gallen, Switzerland (A.R.-R.); AbbVie, North Chicago, IL (J.E., A.L.P., N.K., Y.Z., N.M.); Centre Hospitalier de l'Université de Montréal, Montreal (B.H.); Queen Elizabeth Hospital and University of Adelaide, Adelaide, SA, Australia (M.R.); and Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (R.M.X.).""}]",The New England journal of medicine,['10.1056/NEJMoa2008250']
834,33059886,Lifestyle modifications alone or combined with hormonal contraceptives improve sexual dysfunction in women with polycystic ovary syndrome.,"OBJECTIVE


To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function.
DESIGN


Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS.
SETTING


Two academic medical centers.
PATIENTS


Women with PCOS (N = 114) defined by the Rotterdam criteria.
INTERVENTIONS


Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks.
MAIN OUTCOME MEASURES


Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores after 16 weeks.
RESULTS


There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores.
CONCLUSION(S)


Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00704912.",2021,"There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period.","['women with polycystic ovary syndrome', 'Women with PCOS (N = 114) defined by the Rotterdam criteria', 'Two academic medical centers', '33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55', 'women with PCOS']","['oral contraceptive pills', 'OCPs', 'Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks', 'Lifestyle modifications alone or combined with hormonal contraceptives']","['prevalence of sexual dysfunction', 'FSFI scores', 'Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) scores', 'total FSFI or FSDS-R score', 'Female sexual dysfunction', 'FSFI score', 'FSFI desire domain subscore', 'sexual function', 'sexual desire', 'sexual dysfunction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}]",114.0,0.171257,"There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period.","[{'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Steinberg Weiss', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrea Hsu', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Department of Psychology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dodson', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, Penn State College of Health and Human Development, University Park, Pennsylvania.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Kunselman', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Christy M', 'Initials': 'CM', 'LastName': 'Stetter', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Penn State College of Health and Human Development, University Park, Pennsylvania.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Gnatuk', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Stepanie J', 'Initials': 'SJ', 'LastName': 'Estes', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Center for Obesity Research and Education, Temple University College of Public Health, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: adokras@pennmedicine.upenn.edu.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1396']
835,33027531,Extended Perineural Analgesia After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine: Preliminary Report from a Randomized Clinical Trial.,"OBJECTIVE


We tested the hypothesis that buprenorphine-clonidine-dexamethasone (BCD) extends perineural analgesia compared with plain bupivacaine (BPV) nerve blocks used for hip and knee replacement surgery.
DESIGN


Prospective, parallel-arms, randomized, double-blind trial.
SETTING


A single veterans' hospital.
SUBJECTS


Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic.
METHODS


Participants underwent nerve/plexus blocks at L2-L4 and L4-S3 in advance of hip or knee joint replacement surgery. Patients were randomized to receive BPV-BCD or plain BPV in a 4:1 allocation ratio. Patients answered four block duration questions (listed below). Time differences between treatments were analyzed using the t test.
RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV (N = 16). The time until start of postoperative pain was 26 vs 11 hours (mean difference = 15 hours, 95% CI = 8 to 21). The time until no pain relief from the blocks was 32 vs 15 hours (mean difference = 17 hours, 95% CI = 10 to 24). The time until the numbness wore off was 37 vs 21 hours (mean difference = 16 hours, 95% CI = 8 to 23). The time until the worst postoperative pain was 39 vs 20 hours (mean difference = 19 hours, 95% CI = 11 to 27).
CONCLUSIONS


BPV-BCD provided 26-39 hours of perineural analgesia in the L2-L4 and L4-S3 nerve distributions after hip/knee replacement surgery, compared with 11-21 hours for plain BPV.",2020,"RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV","['Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic', 'Participants underwent', ""A single veterans' hospital""]","['Bupivacaine', 'Buprenorphine-Clonidine-Dexamethasone', 'Hip and Knee Replacement', 'plain BPV', 'BPV-BCD or plain BPV', 'Perineural Analgesia', 'nerve/plexus blocks at L2-L4 and L4-S3 in advance of hip or knee joint replacement surgery', 'buprenorphine-clonidine-dexamethasone (BCD', 'plain bupivacaine (BPV) nerve blocks']","['time until the numbness', 'time until no pain relief', 'time until start of postoperative pain', 'time until the worst postoperative pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020030', 'cui_str': 'Veterans Hospitals'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0584885', 'cui_str': 'Local anesthetic block of nerve plexus'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.215519,"RESULTS


Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Williams', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Ibinson', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Ritter', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Ezaru', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hulimangala R', 'Initials': 'HR', 'LastName': 'Rakesh', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Paiste', 'Affiliation': 'Foundation for Anesthesia Education and Research (FAER), Schaumburg, Illinois.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Gilbert', 'Affiliation': 'Veterans Research Foundation of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Mikolic', 'Affiliation': 'StatCore, Veterans Research Foundation of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Visala S', 'Initials': 'VS', 'LastName': 'Muluk', 'Affiliation': 'Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sara R', 'Initials': 'SR', 'LastName': 'Piva', 'Affiliation': 'Physical Therapy-Clinical Translational Research Center, Pittsburgh, Pennsylvania.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa229']
836,33052555,Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.,"PURPOSE


In the phase III CLARINET study (NCT00353496), lanreotide autogel/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.
METHODS


Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).
RESULTS


Overall, 89 patients took part in the OLE (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN-LAN group) was 59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.
CONCLUSIONS


This study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel/depot in indolent and progressive metastatic intestinal or pancreatic NETs.",2021,"In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.","['Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only', 'advanced enteropancreatic neuroendocrine tumours', 'patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs', '89 patients took part in the', 'indolent and progressive metastatic intestinal or pancreatic NETs']","['Computed tomography or magnetic resonance imaging scans', 'lanreotide autogel/depot (lanreotide', 'OLE (lanreotide', 'Lanreotide autogel/depot', 'placebo', 'lanreotide autogel/depot', 'lanreotide']","['overall incidences of adverse events (AEs) and treatment-related AEs', 'progression-free survival (PFS', 'time to death or subsequent PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.113599,"In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study.","[{'ForeName': 'Martyn E', 'Initials': 'ME', 'LastName': 'Caplin', 'Affiliation': 'Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK. m.caplin@ucl.ac.uk.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Diabetology, Universitätsklinikum Erlangen, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Alexandria T', 'Initials': 'AT', 'LastName': 'Phan', 'Affiliation': 'Department of Hematology-Oncology, University of Texas Health Science Center at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Jarosław B', 'Initials': 'JB', 'LastName': 'Ćwikła', 'Affiliation': 'Department of Cardiology and Cardiac Surgery, School of Medicine, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Sedláčková', 'Affiliation': 'Department of Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.'}, {'ForeName': 'Xuan-Mai Truong', 'Initials': 'XT', 'LastName': 'Thanh', 'Affiliation': 'Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Wolin', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ruszniewski', 'Affiliation': 'Division of Gastroenterology and Pancreatology, Beaujon Hospital, Clichy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endocrine,['10.1007/s12020-020-02475-2']
837,33002598,"Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial.","Childhood obesity is a major health concern in the United States (US) and those living in rural communities are at higher risk than their urban counterparts. Few prevention trials have engaged whole families of school-age children in community settings, and none to date have promoted family meals, family activity and healthful home environments in rural settings through a rigorous, randomized controlled trial (RCT). The New Ulm at HOME (NU-HOME) study recruited 114 parent/child dyads in a two-arm (intervention versus wait-list control) RCT to test the efficacy of a family meals-focused program aimed to prevent excess weight gain among 7-10 year-old children in rural Minnesota. The NU-HOME program was adapted from a previously tested program for urban families through a unique community collaboration. The program included 7 monthly in-person sessions for all family members. Parents also participated in 4 motivational goal-setting phone calls. The primary outcome measures were age- and sex-adjusted child body mass index (BMI) z-score, percent body fat, and incidence of overweight and obesity post-intervention. Secondary outcomes included quality of food and beverage availability in the home; family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior. The NU-HOME RCT was a collaborative effort of academic and health system researchers, interventionists and community leaders that aimed to prevent childhood obesity in rural communities through engagement of the whole family in an interactive intervention.",2021,"Secondary outcomes included quality of food and beverage availability in the home, family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior.","['Parents also participated in 4 motivational goal-setting phone calls', '114 parent/child dyads in a two']","['arm (intervention versus wait-list control) RCT', 'family meals-focused program aimed to prevent excess weight gain among 7-10\u202fyear-old children in rural Minnesota']","['age- and sex-adjusted child body mass index (BMI) z-score, percent body fat, and incidence of overweight and obesity post-intervention', ""quality of food and beverage availability in the home, family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.0747319,"Secondary outcomes included quality of food and beverage availability in the home, family meals and snacks; children's dietary intake quality (e.g., Healthy Eating Index (HEI)-2015, fruits and vegetables, sugar-sweetened beverages, snacks); and children's screen time and weekly minutes of moderate-to-vigorous physical activity, total physical activity, and sedentary behavior.","[{'ForeName': 'Jayne A', 'Initials': 'JA', 'LastName': 'Fulkerson', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA. Electronic address: fulke001@umn.edu.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Horning', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA. Electronic address: horn0199@umn.edu.'}, {'ForeName': 'Daheia J', 'Initials': 'DJ', 'LastName': 'Barr-Anderson', 'Affiliation': 'School of Kinesiology, University of Minnesota, 1900 University Ave SE, Cooke Hall 209, Minneapolis, MN 55455, USA. Electronic address: barra027@umn.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Linde', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, 1300 S. 2(nd) St., Suite 300, Minneapolis, MN 55454, USA. Electronic address: linde074@umn.edu.'}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Sidebottom', 'Affiliation': 'Care Delivery Research, Allina Health, 710 East 24(th) Street, MR 43402, Minneapolis, MN 55404, USA. Electronic address: abbey.sidebottom@allina.com.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lindberg', 'Affiliation': 'Minneapolis Heart Institute Foundation, 920 East 28(th) Street, Suite 100, Minneapolis, MN 55407, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friend', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 Weaver-Densford Hall, 308 Harvard Street SE, Minneapolis, MN 55455, USA. Electronic address: adki0032@umn.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Flattum', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, 1300 S. 2(nd) St., Suite 300, Minneapolis, MN 55454, USA. Electronic address: flatt018@umn.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Freese', 'Affiliation': 'Biostatistical Design and Analysis Center, Clinical and Translational Science Institute, University of Minnesota, 717 Delaware Street, SE, Minneapolis, MN 55414, USA. Electronic address: frees048@umn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106160']
838,33009245,"Effect of a brief scenario-tailored educational program on parents' risk knowledge, perceptions, and decisions to administer prescribed opioids: a randomized controlled trial.","ABSTRACT


This randomized, controlled trial evaluated whether a brief educational program (ie, Scenario-Tailored Opioid Messaging Program [STOMP]) would improve parental opioid risk knowledge, perceptions, and analgesic efficacy; ensure safe opioid use decisions; and impact prescription opioid use after surgery. Parent-child dyads (n = 604) who were prescribed an opioid for short-term use were randomized to routine instruction (Control) or routine plus STOMP administered preoperatively. Baseline and follow-up surveys assessed parents' awareness and perceived seriousness of adverse opioid effects, and their analgesic efficacy. Parents' decisions to give an opioid in hypothetical scenarios and total opioid doses they gave to children at home were assessed at follow-up. Scenario-Tailored Opioid Messaging Program parents gained enhanced perceptions of opioid-related risks over time, whereas Controls did not; however, risk perceptions did not differ between groups except for addiction risk. Scenario-Tailored Opioid Messaging Program parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs controls = 0.58 [95% confidence interval 0.08-1.09], P = 0.023). Scenario-Tailored Opioid Messaging Program parents had a 53% lower odds of giving an opioid in an excessive sedation scenario (odds ratio 0.47 [95% confidence interval 0.28-0.78], P = 0.003), but otherwise made similar scenario-based opioid decisions. Scenario-Tailored Opioid Messaging Program was not associated with total opioid doses administered at home. Instead, parents' analgesic efficacy and pain-relief preferences explained 7%, whereas child and surgical factors explained 22% of the variance in opioid doses. Scenario-tailored education enhanced parents' opioid risk knowledge, perceptions, and scenario-based decision-making. Although this may inform later situation-specific decision-making, our research did not demonstrate an impact on total opioid dosing, which was primarily driven by surgical and child-related factors.",2021,"STOMP parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs. controls=0.58 [95% CI 0.08, 1.09], p=.023).","['Parent-child dyads', 'n=604) who were prescribed an opioid for short-term use']","['routine instruction (Control) or routine plus STOMP', 'brief educational program (i.e., Scenario-Tailored Opioid Messaging Program [STOMP', 'brief scenario-tailored educational program']","[""parents' awareness and perceived seriousness of adverse opioid effects, and their analgesic efficacy"", 'excessive sedation scenario', 'risk perceptions', 'analgesic efficacy and pain-relief preferences', ""parents' risk knowledge, perceptions and decisions to administer prescribed opioids"", 'self-efficacy']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205404', 'cui_str': 'Serious'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",604.0,0.0613903,"STOMP parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs. controls=0.58 [95% CI 0.08, 1.09], p=.023).","[{'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Voepel-Lewis', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Malviya', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Grant', 'Affiliation': 'Department of Orthopedic Surgery at the University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwyer', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Becher', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jacob H', 'Initials': 'JH', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Tait', 'Affiliation': 'Department of Anesthesiology, University of Michigan, Ann Arbor, MI, United States.'}]",Pain,['10.1097/j.pain.0000000000002095']
839,33022654,The Efficacy of Simultaneously Training 2 Motion Targets During a Squat Using Auditory Feedback.,"Auditory feedback is a simple, low-cost training solution that can be used in rehabilitation, motor learning, and performance development. The use has been limited to the instruction of a single kinematic or kinetic target. The goal of this study was to determine if auditory feedback could be used to simultaneously train 2 lower-extremity parameters to perform a bodyweight back squat. A total of 42 healthy, young, recreationally active males participated in a 4-week training program to improve squat biomechanics. The Trained group (n = 22) received 4 weeks of auditory feedback. Feedback focused on knee flexion angle and center of pressure under the foot at maximum squat depth. The Control group (n = 20) performed squats without feedback. Subjects were tested pre, post, and 1 week after training. The Trained group achieved average target knee flexion angle within 1.73 (1.31) deg (P < .001) after training and 5.36 (3.29) deg (P < .01) at retention. While achieving target knee flexion angle, the Trained group maintained target center of pressure (P < .001). The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90). Results from this study demonstrate that auditory feedback is an effective way to train 2 independent biomechanical targets simultaneously.",2020,"The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90).","['42 healthy, young, recreationally active males participated in a']","['4-week training program to improve squat biomechanics', 'auditory feedback']","['average target knee flexion angle', 'knee range of motion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}]",42.0,0.0250706,"The Control group improved knee range of motion, but were not able to achieve both parameter targets at maximum squat depth (P < .90).","[{'ForeName': 'Rena F', 'Initials': 'RF', 'LastName': 'Hale', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Dorgo', 'Affiliation': 'The University of Texas at El Paso.'}, {'ForeName': 'Roger V', 'Initials': 'RV', 'LastName': 'Gonzalez', 'Affiliation': 'The University of Texas at El Paso.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Hausselle', 'Affiliation': 'Oklahoma State University.'}]",Journal of applied biomechanics,['10.1123/jab.2019-0276']
840,33045402,The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design.,"OBJECTIVES


To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts.
METHODS


We report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 1:1 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored.
CONCLUSIONS


The proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.",2021,The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.,"['COVID-19 infection', 'N\u202f=\u202f2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts']","['vitamin D supplementation', 'vitamin D3 supplementation', 'placebo', 'vitamin D3']","['occurrence of hospitalization and/or mortality', 'risk of hospitalization/death', 'vitamin D 25(OH)D levels', 'symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.515984,The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA. Electronic address: rwang@hsph.harvard.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Takeda Pharmaceutical Company, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep Medicine and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Davaasambuu', 'Initials': 'D', 'LastName': 'Ganmaa', 'Affiliation': ""Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106176']
841,33053431,"Medical assistant health coaching (""MAC"") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.","In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. ""Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching."" While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.",2021,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","['eligible patients at both health systems', 'individuals with diabetes. ', 'diabetes clinical control among N\u202f=\u202f600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California']","['Medical Assistant Health Coaching', 'MA health coaching versus usual care', 'Medical assistant health coaching (""MAC']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]",[],,0.0371121,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Fortmann.Adelaide@scrippshealth.org.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Euyoque.Johanna@scrippshealth.org.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, USA. Electronic address: tlclark@sdsu.edu.'}, {'ForeName': 'Daniela G', 'Initials': 'DG', 'LastName': 'Vital', 'Affiliation': 'San Diego State University Research Foundation, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: dvital@sdsu.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Sandoval.Haley@scrippshealth.org.'}, {'ForeName': 'Julia I', 'Initials': 'JI', 'LastName': 'Bravin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, USA. Electronic address: jbravin-w@sdsu.edu.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Savin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, USA. Electronic address: ksavin@sdsu.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jones', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Jones.Jennifer2@scrippshealth.org.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: sroesch@sdsu.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, USA. Electronic address: tgilmer@ucsd.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodenheimer', 'Affiliation': 'Department of Family and Community Medicine, University of California at San Francisco School of Medicine, 533 Parnassus Ave, San Francisco, CA 94143, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Neighborhood Healthcare, 460 N Elm St, Escondido, CA 92025, USA. Electronic address: jims@nhcare.org.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: lgallo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106164']
842,33063273,"The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments.","PURPOSE


Replicating the physiological cortisol secretion is key in the treatment of glucocorticoid insufficient individuals and optimization may enhance quality of life. The study investigates fatigue measured by ecological momentary assessments in patients treated with conventional hydrocortisone compared with once-daily dual-release hydrocortisone (Plenadren).
METHODS


A 21-week open-label switch pilot trial included 30 patients with adrenal insufficiency due to hypopituitarism. Fatigue was assessed four times daily for 20 days using a momentary item version of the Multidimensional Fatigue Inventory on patients' usual hydrocortisone regimen. Participants switched treatment to an identical daily dose of Plenadren for 16 weeks where fatigue assessments were repeated. Change in fatigue and diurnal variation of fatigue was analyzed using mixed models for repeated measurements.
RESULTS


In four out of five fatigue subscales fatigue was significantly reduced 0.7-1.1 points (scales ranging from 4 to 20), when treated with Plenadren compared with conventional hydrocortisone, corresponding to small effect sizes below the scale-specific minimal important changes. However, 33% of the participants completing the study (9/27) experienced reductions in fatigue above the minimal important change. On Plenadren, we found larger between-person variances and smaller within-person variances. Finally, we identified diurnal fatigue curves for both treatments.
CONCLUSIONS


The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level. However, there was a large interindividual variation in treatment effect, why patients with a large benefit in quality of life should be identified. Future RCTs should be powered to detect the effect magnitudes identified here.",2021,The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level.,"['patients treated with', '30 patients with adrenal insufficiency due to hypopituitarism']","['conventional hydrocortisone', 'conventional hydrocortisone compared with once-daily dual-release hydrocortisone (Plenadren']","['fatigue subscales fatigue', 'Change in fatigue and diurnal variation of fatigue', 'diurnal fatigue curves', 'fatigue', 'Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020635', 'cui_str': 'Hypopituitarism'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",30.0,0.0417176,The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level.,"[{'ForeName': 'Victor Brun', 'Initials': 'VB', 'LastName': 'Boesen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Stina Willemoes', 'Initials': 'SW', 'LastName': 'Borresen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Christoffersen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Klose', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Feldt-Rasmussen', 'Affiliation': 'Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. ufeldt@rh.dk.'}]",Endocrine,['10.1007/s12020-020-02507-x']
843,33039447,N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes: Vericiguat Heart Failure With Reduced Ejection Fraction Study.,"OBJECTIVES


The purpose of this study was to examine the treatment effect of vericiguat in relation to N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at randomization.
BACKGROUND


Vericiguat compared with placebo reduced the primary outcome of cardiovascular death (CVD) or heart failure hospitalization (HFH) in patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction) trial. Because an interaction existed between treatment and the primary outcome according to pre-specified quartiles of NT-proBNP at randomization, we examined this further.
METHODS


This study evaluated the NT-proBNP relationship with the primary outcome in 4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented.
RESULTS


Median NT-proBNP was 2,816 pg/ml (25th to 75th percentile: 1,556 to 5,314 pg/ml). The study treatment effect varied across the spectrum of NT-proBNP at randomization (with log 2  transformation, p for interaction = 0.002). A significant association between treatment effects existed in patients with levels <4,000 pg/ml and remained evident up to 8,000 pg/ml. A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88). For NT-proBNP values ≤4,000 pg/ml (n = 3,100), the HR was 0.78 (95% CI: 0.67 to 0.90) for HFH and 0.75 (95% CI: 0.60 to 0.94) for CVD. For NT-proBNP ≤8,000 pg/ml (n = 4,133), the HR was 0.85 (95% CI: 0.76 to 0.95) for the primary outcome, 0.84 (95% CI: 0.75 to 0.95) for HFH, and 0.84 (95% CI: 0.71 to 0.99) for CVD. For NT-proBNP >8,000 pg/ml (n = 672), the HR was 1.16 (95% CI: 0.94 to 1.41) for the primary outcome.
CONCLUSIONS


A reduction in the primary composite endpoint and its CVD and HFH components was observed in patients on vericiguat compared with subjects on placebo with NT-proBNP levels up to 8,000 pg/ml. This provided new insight into the benefit observed in high-risk patients with worsening HFrEF. (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction [HFrEF] [MK-1242-001] [VICTORIA]; NCT02861534).",2020,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","['4,805 of 5,050 patients as a risk-adjusted, log-transformed continuous variable', 'high-risk patients with worsening HFrEF', 'patients with HF with reduced ejection fraction (HFrEF) in the VICTORIA (A Study of Vericiguat in Participants With Heart\xa0Failure With Reduced Ejection Fraction) trial', 'Participants With Heart']","['HFrEF', 'placebo', 'MK-1242-001] [VICTORIA']","['cardiovascular death (CVD) or heart failure hospitalization (HFH', 'Hazard ratios (HRs) and 95% confidence intervals (CIs', 'Vericiguat Heart', 'CVD and HFH components', 'Failure With Reduced Ejection Fraction', 'risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.381183,"A 23% relative risk reduction occurred in the primary endpoint with NT-proBNP ≤4,000 pg/ml (HR: 0.77; 95% CI: 0.68 to 0.88).","[{'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Troughton', 'Affiliation': 'Department of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Wendimagegn G', 'Initials': 'WG', 'LastName': 'Alemayehu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'Department of Cardiology and Thorax Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Department of Cardiology, National Heart Centre Singapore and Duke-National University of Singapore.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Department of Heart Disease, Wroclaw, Poland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Cardiothoracic Department, Fondazione Toscana Gabriele Monasterio, Pisa, Italy; and Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck & Co. Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine-Cardiology, Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Division of Cardiology, Department of Medicine, Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada. Electronic address: parmstro@ualberta.ca.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.008']
844,33039448,Estimating the Lifetime Benefits of Treatments for Heart Failure.,"OBJECTIVES


This study compared ways of describing treatment effects. The objective was to better explain to clinicians and patients what they might expect from a given treatment, not only in terms of relative and absolute risk reduction, but also in projections of long-term survival.
BACKGROUND


The restricted mean survival time (RMST) can be used to estimate of long-term survival, providing a complementary approach to more conventional metrics (e.g., absolute and relative risk), which may suggest greater benefits of therapy in high-risk patients compared with low-risk patients.
METHODS


Relative and absolute risk, as well as the RMST, were calculated in heart failure with reduced ejection fraction (HFrEF) trials.
RESULTS


As examples, in the RALES trial (more severe HFrEF), the treatment effect metrics for spironolactone versus placebo on heart failure hospitalization and/or cardiovascular death were a hazard ratio (HR) of 0.67 (95% confidence interval [CI]: 0.5 to 0.77), number needed to treat = 9 (7 to 14), and age extension of event-free survival +1.1 years (-0.1 to + 2.3 years). The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5). In patients in PARADIGM-HF aged younger than 65 years, the metrics for sacubitril/valsartan versus enalapril were 0.77 (95% CI: 0.68 to 0.88), 23 (15 to 44), and +1.7 (0.6 to 2.8) years; for those aged 65 years or older, the metrics were 0.83 (95% CI: 0.73 to 0.94), 29 (17 to 83), and +0.9 (0.2 to 1.6) years, which provided evidence of a greater potential life extension in younger patients. Similar observations were found for lower risk patients.
CONCLUSIONS


RMST event-free (and overall) survival estimates provided a complementary means of evaluating the effect of therapy in relation to age and risk. They also provided a clinically useful metric that should be routinely reported and used to explain the potential long-term benefits of a given treatment, especially to younger and less symptomatic patients.",2020,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).",[],"['placebo', 'sacubitril/valsartan versus enalapril', 'HF (eplerenone vs. placebo', 'spironolactone']","['age extension of event-free survival', 'number needed to treat\xa0', 'heart failure hospitalization and/or cardiovascular death', 'RMST event-free (and overall) survival estimates', 'mean survival time (RMST']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.184145,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stienen', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences. Amsterdam University Medical Center, University of Amsterdam, Amsterdam the Netherlands.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.004']
845,33260076,"Transcranial direct current stimulation of dorsolateral prefrontal cortex improves dual-task gait performance in patients with Parkinson's disease: A double blind, sham-controlled study.","BACKGROUND


Despite advances in pharmacological treatments and surgical processes, the problem of impaired dual-tasking persists in people with Parkinson's disease (PD). Recently, transcranial direct current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) has shown the potential to improve dual-task walking.
RESEARCH QUESTION


Can combining left DLPFC stimulation using tDCS with dual-task performance reduce the cost of dual-tasking in individuals with PD?
METHODS


We conducted a sham-controlled, cross-over, and double-blind study to investigate the effect of combining tDCS with the dual-task walk and its sustained effects among people with PD. Twenty participants with PD completed two sessions (anodal or sham tDCS) with at least a 1-week gap. Stimulation involved transferring 2 mA current through the left DLPFC for 30 min. Single- and dual-task gait was assessed before, during, immediately after, 15, and 30 min after stimulation ceased. Phoneme verbal fluency task was given as the cognitive distractor during dual task.
RESULTS AND CONCLUSION


The results of this study show that in the dual-task condition, participants walked faster at fifteen minutes (p = 0.017) and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham. Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham. Furthermore, the dual-task cost (DTC) associated with gait speed was significantly lower (p = 0.022) at fifteen minutes after anodal tDCS compared to sham tDCS. However, no significant effect of tDCS was observed on gait and cognitive performance under the single-task condition. In conclusion, left DLPFC stimulation can improve dual-tasking in participants with PD and the peaking of the tDCS effect was observed at fifteen minutes after stimulation ceased.",2020,"Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham.","['individuals with PD', ""patients with Parkinson's disease"", ""people with Parkinson's disease (PD"", 'people with PD', 'Twenty participants with PD completed two']","['transcranial direct current stimulation (tDCS', 'tDCS', 'Transcranial direct current stimulation of dorsolateral prefrontal cortex', 'anodal tDCS', 'sessions (anodal or sham tDCS']","['tDCS effect', 'dual-task gait performance', 'gait and cognitive performance', 'cost of dual-tasking', 'Phoneme verbal fluency task', 'Single- and dual-task gait', 'dual-task cost (DTC) associated with gait speed', 'higher number of words per minute']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0702093', 'cui_str': '/minute'}]",20.0,0.051601,"Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham.","[{'ForeName': 'Ram Kinker', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, TX, USA. Electronic address: rmishra2@uh.edu.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Thrasher', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, TX, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.11.012']
846,33057829,"Aesthetic Comparison of Abdominal Donor Site Scar Between Absorbable Dermal Staple and Subcutaneous Suture after Autologous Breast Reconstruction: A Prospective Randomized Controlled, Double-Blinded Study.","BACKGROUND


Abdominal tissue transfer has become the most commonly used tool for breast reconstruction. However, a secondary operator is often responsible for donor closure, which leaves dissatisfaction to patients due to inconsistent donor scars. Now, an absorbable dermal stapler is popularized worldwide and currently used for wound closure in many surgical fields. In this study, we aim to evaluate the abdominal donor site scar in using an absorbable dermal staple compared to a conventional suture.
METHODS


This is a prospective, randomized controlled and double-blinded study. Between January 2018 and April 2019, a total of 30 patients who underwent breast reconstruction using abdominal flap were included. Donor sites were divided into equal halves, and the each dermal layer was sutured with either dermal staples or traditional suturing, respectively. At 1, 3 and 6 months after operation, the scar was evaluated by two blinded plastic surgeons by using the modified Manchester scar scale (MSS).
RESULTS


An averaged sum of modified MSS was lower for the side sutured with a dermal stapler at the first month (11.76 ± 2.12 vs. 12.28 ± 2.03, p = 0.097), third month (12.17 ± 1.86 vs. 12.62 ± 2.31, p = 0.301) and sixth month (11.28 ± 2.63 vs. 12.14 ± 2.76, p = 0.051). Also, the dermal stapler side scored significantly higher for patient satisfaction than did the suture side (4.03 ± 0.98 vs 3.66 ± 0.97, p < 0.05).
CONCLUSION


The objective outcome of the scar closed by an absorbable dermal stapler was not statistically superior to conventional suturing. (p > 0.05) In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,"In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
","['Between January 2018 and April 2019, a total of 30 patients who underwent breast reconstruction using abdominal flap were included', 'after Autologous Breast Reconstruction']","['absorbable dermal staple', 'absorbable dermal stapler', 'Abdominal Donor Site Scar', 'Absorbable Dermal Staple and Subcutaneous Suture', 'conventional suture']","['modified MSS', ""patients' satisfaction"", 'modified Manchester scar scale (MSS', 'patient satisfaction']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0440910', 'cui_str': 'Abdominal flap'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0441062', 'cui_str': 'Stapler'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",30.0,0.0593795,"In the subjective outcome, however, it showed a significantly higher patients' satisfaction (p < 0.05).
","[{'ForeName': 'Jae-Ho', 'Initials': 'JH', 'LastName': 'Chung', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Kyu', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Yun-Hwan', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hi-Jin', 'Initials': 'HJ', 'LastName': 'You', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea.'}, {'ForeName': 'Deok-Woo', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15355, Republic of Korea. deokwookim@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01969-8']
847,33260699,Effects of an Educational Program for Professional Caregivers on Behavioral Alterations in Nursing Home Residents: Pilot Study.,"This pilot study aims to analyze the effectiveness of a type of non-pharmacological intervention such as the educating and training of professional caregivers on behavioral alterations and prescription of psychotropic drugs of older adults in nursing homes. One hundred and forty-five people from two nursing homes were randomized to either treatment (educational training program for healthcare professionals) or a no-treatment group. Twenty-two professional caregivers in the experimental group received 20 h of a training program. Five data collection points were collected (pre and post, and three follow-ups, all six months apart). Intervention consisted of the behavioral alterations and psychopharmacological treatment. The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record. The results show that an improvement in the educating and training of professional caregivers can reduce behavioral alterations (F3,407 = 9.29,  p  < 0.001, η 2 = 0.063) and prescription of psychotropic drugs (F2,10 = 18.90,  p  < 0.001, η 2  = 0.117). In addition, these effects are maintained over time. Educating health professionals on ways to care for residents who present behavioral alterations may be one alternative for improving the quality of care that residents receive. Non-pharmacological interventions, besides being individualized and adapted to the needs and experiences of individuals, achieve effects that last longer at low cost. An educational program shows new alternatives to pharmacological intervention, achieving a reduction in behavioral alterations without the costs and effects that psychopharmaceuticals entail.",2020,The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record.,"['older adults in nursing homes', 'Nursing Home Residents', 'One hundred and forty-five people from two nursing homes']","['Educational Program', 'treatment (educational training program for healthcare professionals) or a no-treatment group', 'psychopharmacological treatment']","['behavioral alterations', 'prescription of psychotropic drugs', 'Behavioral Alterations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}]",145.0,0.023454,The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Pinazo-Clapés', 'Affiliation': 'Faculty of Psychology, European University, 46010 Valencia, Spain.'}, {'ForeName': 'Sacramento', 'Initials': 'S', 'LastName': 'Pinazo-Hernandis', 'Affiliation': 'Department of Social Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Sales', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17238845']
848,33260697,"An mHealth Workplace-Based ""Sit Less, Move More"" Program: Impact on Employees' Sedentary and Physical Activity Patterns at Work and Away from Work.","BACKGROUND


Most workplace interventions that aim to reduce sedentary behaviour have 38 focused on employees' sedentary patterns at-work but less have focused on understanding the 39 impact beyond working time. The aim of this study was to evaluate the impact of a 13-week m-40 health workplace-based 'sit less, move more' intervention (Walk@WorkApp; W@W-App) on 41 physical activity (PA) and sitting in desk-based employees at-work and away from work.
METHODS


Participants ( n  = 141) were assigned by hospital to an intervention group (IG; used the W@W-App;  n  = 90) or an active comparison group (A-CG; monitored occupational activity;  n  = 51). The W@W-App, installed on the participants´ own smartphones, provided real-time feedback for occupational sitting, standing, and stepping, and gave access to automated strategies to sit less and move more at work. Changes between groups were assessed for total sitting time, sedentary bouts and breaks, and light and moderate-to-vigorous PA (activPAL3TM; min/day) between the baseline and after program completion.
RESULTS


Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min,  p  = 0.047) during weekends. Changes in shortest sedentary bouts (5-10 min) during weekends were also statistically significant ( p  < 0.05). No changes in workday PA or sitting were observed.
CONCLUSION


Desk-based employees seemed to transfer the W@W-App program knowledge outside of work. Evaluating the impact of workplace (mHealth-based or not) interventions at work but also away from work would provide a better understating of the impact of such interventions.",2020,"Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min,  p  = 0.047) during weekends.","['Participants ( n  = 141', '41 physical activity (PA) and sitting in desk-based employees at-work and away from work']","[""13-week m-40 health workplace-based 'sit less, move more' intervention (Walk@WorkApp; W@W-App"", 'workplace (mHealth-based or not) interventions']","['number of daily breaks and the time spent on short sedentary bouts', 'total sitting time, sedentary bouts and breaks, and light and moderate-to-vigorous PA (activPAL3TM', 'shortest sedentary bouts', 'workday PA or sitting']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0213052', 'cui_str': 'M40'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",141.0,0.0254173,"Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min,  p  = 0.047) during weekends.","[{'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Bort-Roig', 'Affiliation': 'Sport and Physical Activity Research Group, Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Chirveches-Pérez', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, 08022 Barcelona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Navarro-Blasco', 'Affiliation': 'Occupational Health Service, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Bausà-Peris', 'Affiliation': 'Occupational Health Service, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Iturrioz-Rosell', 'Affiliation': 'Unidad Docente Pluridisciplinar de Atención Familiar y Comunitaria, Hospital Universitario de Donostia, 20014 Donostia-San Sebastián, Spain.'}, {'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'González-Suárez', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country, 01007 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Martínez-Lemos', 'Affiliation': 'Well-Move Research Group (HI-23), Faculty of Educational Sciences and Sports, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Puigoriol-Juvanteny', 'Affiliation': 'Tissue Repair and Regeneration Laboratory (TR2Lab), Faculty of Sciences and Technology, University of Vic-Central University of Catalonia, 08500 Vic, Barcelona, Spain.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dowd', 'Affiliation': 'Department of Sport and Health Sciences, Athlone Institute of Technology, N37 HD68 Athlone, Co. Westmeath, Ireland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Puig-Ribera', 'Affiliation': 'Sport and Physical Activity Research Group, Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17238844']
849,33259244,Metronomic treatment of vinorelbine with oral capecitabine is tolerable in the randomized Phase 2 study XeNa including patients with HER2 non-amplified metastatic breast cancer.,"BACKGROUND


Metronomic treatment is hypothesized to be less toxic and more effective as compared to standard maximal tolerable dosing treatment in metastatic cancer disease.
MATERIAL AND METHODS


We tested the metronomic treatment principle with vinorelbine in a randomized phase 2 setting combined with standard capecitabine treatment in the XeNa trial with Clinical Trials.gov identifier number: NCT0141771. 120 patients with disseminated HER2 non-amplified breast cancer were included. Randomization was between Arm A: vinorelbine 60 mg/m 2  day 1 + day 8 in the first cycle followed by 80 mg/m 2  day 1 + day 8 in the following cycles or Arm B: vinorelbine 50 mg three times a week. Capecitabine 1000 mg/m 2  twice a day for days 1-14 was administered in both arms.
RESULTS


The treatment was generally well-tolerated. The response rate (RR) was 24% (arm A)  versus  29% (arm B) ( p  = .67). The clinical benefit rate (CBR) 46.8% (arm A)  versus  51.7% (arm B) ( p  = .72). We found a median progression-free survival (PFS) of 7.1 months (95% confidence interval [CI] 3.9-10.3) in arm A and 6.3 months (95% CI 4.1-8.5) in arm B ( p  = .25) whereas median overall survival (OS) was 23.3 months (95% CI 20.2-26.4) in arm A and 22.3 months (95% CI 14.3-30.3) in arm B ( p  = .76).
CONCLUSIONS


We confirmed that the combination of vinorelbine and capecitabine was well tolerated. Metronomic treatment can be used with acceptable adverse events (AEs), but we did not find significant difference in the effect compared to the standard treatment.",2021,The clinical benefit rate (CBR) 46.8% (arm A)  versus  51.7% (arm B) ( p  = .72).,"['metastatic cancer disease', '120 patients with disseminated HER2 non-amplified breast cancer', 'patients with HER2 non-amplified metastatic breast cancer']","['vinorelbine and capecitabine', 'vinorelbine with oral capecitabine', 'vinorelbine', 'standard capecitabine', 'Capecitabine 1000']","['tolerated', 'response rate (RR', 'median overall survival (OS', 'median progression-free survival (PFS']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",120.0,0.121848,The clinical benefit rate (CBR) 46.8% (arm A)  versus  51.7% (arm B) ( p  = .72).,"[{'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Brems-Eskildsen', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Linnet', 'Affiliation': 'Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.'}, {'ForeName': 'Hella', 'Initials': 'H', 'LastName': 'Danø', 'Affiliation': 'Department of Oncology, Region Hospital in Hilleroed, Hillerod, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Luczak', 'Affiliation': 'Department of Oncology, University Hospital of Aalborg, Aalborg, Denmark.'}, {'ForeName': 'Peter Michael', 'Initials': 'PM', 'LastName': 'Vestlev', 'Affiliation': 'Department of Oncology, Roskilde Hospital, Roskilde, Denmark.'}, {'ForeName': 'Erik Hugger', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Region Hospital in Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Jeppe', 'Initials': 'J', 'LastName': 'Neimann', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Charlotte Buch', 'Initials': 'CB', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Dongsgaard', 'Affiliation': 'Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.'}, {'ForeName': 'Sven Tyge', 'Initials': 'ST', 'LastName': 'Langkjer', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1851045']
850,33269530,"The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity.","AIM


To investigate the effects of once-weekly subcutaneous (s.c.) semaglutide 2.4 mg on gastric emptying, appetite, and energy intake in adults with obesity.
MATERIALS AND METHODS


A double-blind, parallel-group trial was conducted in 72 adults with obesity, randomized to once-weekly s.c. semaglutide (dose-escalated to 2.4 mg) or placebo for 20 weeks. Gastric emptying was assessed using paracetamol absorption following a standardized breakfast. Participant-reported appetite ratings and Control of Eating Questionnaire (CoEQ) responses were assessed, and energy intake was measured during ad libitum lunch.
RESULTS


The area under the concentration-time curve (AUC) for paracetamol 0 to 5 hours after a standardized meal (AUC 0-5h,para  ; primary endpoint) was increased by 8% (P = 0.005) with semaglutide 2.4 mg versus placebo at week 20 (non-significant when corrected for week 20 body weight; P = 0.12). No effect was seen on AUC 0-1h,para  , maximum observed paracetamol concentration, or time to maximum observed paracetamol concentration. Ad libitum energy intake was 35% lower with semaglutide versus placebo (1736 versus 2676 kJ; estimated treatment difference -940 kJ; P <0.0001). Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02). The CoEQ indicated better control of eating and fewer/weaker food cravings with semaglutide versus placebo (P <0.05). Body weight was reduced by 9.9% with semaglutide and 0.4% with placebo. Safety was consistent with the known profile of semaglutide.
CONCLUSIONS


In adults with obesity, once-weekly s.c. semaglutide 2.4 mg suppressed appetite, improved control of eating, and reduced food cravings, ad libitum energy intake and body weight versus placebo. There was no evidence of delayed gastric emptying at week 20, assessed indirectly via paracetamol absorption.",2021,"Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02).","['subjects with obesity', '72 adults with obesity']","['subcutaneous semaglutide', 'placebo']","['gastric emptying, appetite, and energy intake', 'AUC 0-1h,para  , C max,para  , or t max,para  ', 'control of eating and fewer/weaker food cravings', 'Ad libitum energy intake', 'appetite, improved control of eating, and reduced food cravings', 'appetite ratings and Control of Eating Questionnaire (CoEQ) responses', 'delayed gastric emptying', 'Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety', 'Gastric emptying', 'Bodyweight', 'energy intake, appetite, control of eating and gastric emptying']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",72.0,0.463599,"Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedrichsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Breitschaft', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Wizert', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Skovgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14280']
851,33275326,"Extended-release naltrexone/bupropion and liver health: Pooled, post hoc analysis from four randomized controlled trials.","Sustained weight loss improves liver histology in non-alcoholic fatty liver disease. This post hoc analysis of four phase III, 56-week, randomized controlled trials investigated if extended-release naltrexone and bupropion (NB) affects alanine aminotransferase (ALT) and Fibrosis-4 (FIB-4) index in adults with overweight or obesity. Two thousand and seventy-three subjects (NB = 1310; placebo = 763; 79.0% female; 81.6% Caucasian) had baseline mean weight 101 kg, body mass index 36.2 kg/m 2  , ALT 26.9 IU/L and FIB-4 0.79. At 56 weeks, NB-treated subjects experienced more weight loss than placebo (8.7 vs. 3.2 kg, respectively, P < .0001). Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (P < .0001). There was a significant independent effect of NB on change from baseline for FIB-4 (P < .0001), but not for ALT (P = .54). Categorical ALT response (from above to within normal ranges: 10-40 IU/L for men; 7-35 IU/L for women) and achievement of 25% and 50% reduction in ALT were greater for NB versus placebo, and independently affected by weight loss (P < .0001), but not treatment. NB-associated weight loss may improve liver health by normalizing ALT values for those with high baseline levels.",2021,"Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (p<0.0001).","['adults with overweight or obesity', '2073 subjects (NB\xa0=\xa01310; placebo\xa0=\xa0763; 79.0% female; 81.6% Caucasian) had baseline mean: weight 101 kg, BMI 36.2 kg/m 2  , ALT 26.9 IU/L, and FIB-4 0.79']","['naltrexone/bupropion', 'naltrexone and bupropion (NB', 'placebo']","['Categorical ALT response', 'weight loss', 'alanine aminotransferase (ALT) and Fibrosis Index (FIB-4', 'ALT', 'Weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",2073.0,0.291568,"Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (p<0.0001).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, Ontario, Canada.'}, {'ForeName': 'Melonie', 'Initials': 'M', 'LastName': 'Burrows', 'Affiliation': 'Bausch Health, Laval, Quebec, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Blavignac', 'Affiliation': 'Bausch Health, Laval, Quebec, Canada.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Paron', 'Affiliation': 'Bausch Health, Laval, Quebec, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Camacho', 'Affiliation': 'Department of Statistics and Actuarial Sciences, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Errol', 'Initials': 'E', 'LastName': 'Gould', 'Affiliation': 'Currax Pharmaceuticals LLC, Morristown, New Jersey, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Barakat', 'Affiliation': 'Bausch Health, Laval, Quebec, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14284']
852,33275318,"Efficacy and safety of imeglimin in Japanese patients with type 2 diabetes: A 24-week, randomized, double-blind, placebo-controlled, dose-ranging phase 2b trial.","AIM


To assess the efficacy and safety of imeglimin monotherapy compared with placebo for 24 weeks in Japanese patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 2b clinical trial, Japanese adults (age ≥ 20 years) with T2D either treatment-naïve or previously treated with one oral antidiabetes agent were eligible for participation. Patients were randomly assigned (1:1:1:1) to receive orally imeglimin 500, 1000 or 1500 mg, or placebo twice-daily over a 24-week period. The primary endpoint was the placebo-adjusted change at week 24 in HbA1c. Safety outcomes were assessed in all patients who received at least one dose of study drug.
RESULTS


A total of 299 patients were randomized to receive double-blind treatment with orally twice-daily placebo (n = 75), imeglimin 500 mg (n = 75), 1000 mg (n = 74) or 1500 mg (n = 75). At week 24, imeglimin significantly decreased HbA1c (difference vs. placebo: imeglimin 500 mg -0.52% [95% CI: -0.77%, -0.27%], imeglimin 1000 mg -0.94% [95% CI: -1.19%, -0.68%], imeglimin 1500 mg -1.00% [95% CI: -1.26%, -0.75%]; P < .0001 for all). Treatment-emergent adverse events were reported for 68.0%, 62.2%, 73.3% and 68.0% of patients receiving imeglimin 500, 1000 or 1500 mg and placebo, respectively. A small increase in gastrointestinal adverse effects (e.g. diarrhoea) occurred with the 1500 mg dose level. Hypoglycaemia was balanced among groups.
CONCLUSIONS


Imeglimin as monotherapy in Japanese patients with T2D was well tolerated and significantly improved glycaemic control with no significant increase in hypoglycaemic events versus placebo. Given the marginal increase in efficacy with the 1500 versus 1000 mg dose (along with the potential for gastrointestinal tolerability issues), a dose of 1000 mg twice-daily was selected for subsequent phase 3 studies.",2021,"At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all).","['Japanese patients with type 2 diabetes mellitus (T2DM', 'A total of 299 patients', 'Japanese adults (age ≥\u200920\u2009years) with T2DM either treatment-naïve or previously treated with one oral anti-diabetes agent were eligible for participation', 'Japanese patients with T2DM', 'Japanese Patients With Type 2 Diabetes Mellitus']","['placebo', 'Imeglimin', 'orally imeglimin 500 mg or imeglimin 1000 mg or imeglimin 1500 mg, or placebo', 'Placebo', 'imeglimin monotherapy', 'imeglimin 500 mg']","['Safety outcomes', 'placebo-adjusted change at week 24 in HbA1c', 'Hypoglycemia', 'hypoglycemic events', 'gastrointestinal adverse effects (e.g. diarrhea', 'efficacy and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3501765', 'cui_str': 'imeglimin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",299.0,0.552657,"At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'Poxel, Lyon, France.'}, {'ForeName': 'Kohjiro', 'Initials': 'K', 'LastName': 'Ueki', 'Affiliation': 'Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Grouin', 'Affiliation': 'University of Rouen, Rouen, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'Poxel, Lyon, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14285']
853,33277992,"Changes in hypertension control in a community-based population of older adults, 2011-2013 to 2016-2017.","BACKGROUND


The 2014 hypertension guideline raised treatment goals in older adults. The study objective was to examine changes in blood pressure (BP) control (<140/90 mmHg) from 2011-2013 to 2016-2017 among Black and white older adults with treated hypertension.
METHODS


Participants were 1600 white and 650 Black adults aged 71-90 years in the Atherosclerosis Risk in Communities (ARIC) Study with treated hypertension in 2011-2013 (baseline) who had BP measured in 2016-2017 (follow up). Factors associated with changes in BP control were examined by race.
RESULTS


BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up. Among those with controlled BP at baseline, risk factors for incident uncontrolled BP included age (RR 1.15 per 5 years, 95% CI 1.07-1.25), female sex (RR 1.36, 95% CI 1.16-1.60), and chronic kidney disease (CKD) (RR 1.19, 95% CI 1.01-1.40) among white participants, and hypertension duration (RR 1.14 per 5 years, 95% CI 1.03-1.27) and diabetes (RR 1.48, 95% CI 1.15-1.91) among Black participants. Among those with uncontrolled BP at baseline, white females vs males (RR 0.60, 95% CI 0.46-0.78) and Black participants with CKD vs without (RR 0.58, 95% CI 0.36-0.93) were less likely to have incident controlled BP.
CONCLUSIONS


BP control decreased among white and Black older adults. Black individuals with diabetes or CKD were less likely to have controlled BP at follow up. Higher treatment goals may have contributed to these findings and unintended differences by race.",2020,"RESULTS


BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up.","['2011-2013 to 2016-2017 among Black and white older adults with treated hypertension', 'Black individuals with diabetes or CKD', 'hypertension control in a community-based population of older adults, 2011-2013 to 2016-2017', 'older adults', 'Participants were 1600 white and 650 Black adults aged 71-90 years in the Atherosclerosis Risk in Communities (ARIC) Study with treated hypertension in 2011-2013 (baseline) who had BP measured in 2016-2017 (follow up', 'white and Black older adults']",[],"['BP', 'hypertension duration', 'chronic kidney disease (CKD', 'BP control', 'blood pressure (BP) control']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",1600.0,0.0670298,"RESULTS


BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Foti', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Koton', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Keenan A', 'Initials': 'KA', 'LastName': 'Walker', 'Affiliation': 'Laboratory of Behavioral Neuroscience, Intramural Research Program, National Institute on Aging, Baltimore, Maryland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",American journal of hypertension,['10.1093/ajh/hpaa206']
854,33275913,Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities.,"BACKGROUND AND AIMS


Optical polyp diagnosis using image-enhanced endoscopy (IEE) allows for real-time histology prediction of colorectal polyps. The aim of this study was to evaluate a recently introduced IEE modality (Optivista [OV]; Pentax Medical, Tokyo, Japan) in a randomized controlled trial.
METHODS


In a prospective cohort of subjects (ages 45-80 years) undergoing elective screening, surveillance, or diagnostic colonoscopy, all colorectal polyps between 1 and 5 mm underwent IEE assessment. Study subjects were randomized before their colonoscopy procedure to undergo optical polyp diagnosis using either OV IEE or iScan (IS) IEE. A validated IEE scale (NBI International Colorectal Endoscopic classification) was used for optical polyp diagnosis. The primary outcome was the agreement of surveillance intervals determined when using OV IEE compared with IS IEE in reference with pathology-based surveillance intervals. Secondary outcomes were the percentage of surveillance intervals that could be given on the same day as the procedure, percentage of pathology tests avoided, diagnostic performance, and negative predictive value (NPV) of optical diagnosis for rectosigmoid adenomas.
RESULTS


Four hundred ten patients were enrolled in the trial. The polyp detection rate was 58.6%, and the adenoma detection rate was 38.8%. The proportion of correct surveillance interval assignment when using OV or IS IEE was 96.5% versus 96.0% (P = .75). A total of 65.1% of patients could be given same-day surveillance intervals when using OV IEE versus 73.1% for IS IEE (P = .07). The NPV for rectosigmoid adenomas (including sessile serrated adenomas) was 97.5% when using OV IEE and 88.2% when using IS IEE. Using high-confidence optical diagnosis instead of pathology would have resulted in a 44.3% elimination of required pathology examinations for OV IEE versus 52.8% for IS IEE (P = .34).
CONCLUSIONS


Optical diagnosis using OV and IS IEE both surpassed the 90% benchmark of surveillance interval assignment, and no significant difference with regard to correct surveillance interval assignment was found. OV IEE surpassed the ≥90% NPV for rectosigmoid adenomas, whereas IS IEE did not. (Clinical trial registration number: NCT03515343.).",2021,The NPV for rectosigmoid adenomas (including SSAs) was 97.5% when using OV IEE and 88.2% when using IS IEE.,"['subjects (age 45-80 years) undergoing elective screening, surveillance, or diagnostic colonoscopy', 'colorectal polyps', '410 patients were enrolled in the trial']","['colonoscopy procedure to undergo optical polyp diagnosis either using Optivista (OV) IEE or iScan (IS) IEE', 'image enhancing endoscopy (IEE']","['adenoma detection rate', 'agreement of surveillance intervals', 'polyp detection rate', 'percentage of surveillance intervals that could be given on the same day as the procedure, percentage of pathology tests avoided, diagnostic performance, and negative predictive value (NPV) of optical diagnosis for rectosigmoid adenomas']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2242630', 'cui_str': 'Pathology test'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521377', 'cui_str': 'Rectosigmoid structure'}]",410.0,0.12731,The NPV for rectosigmoid adenomas (including SSAs) was 97.5% when using OV IEE and 88.2% when using IS IEE.,"[{'ForeName': 'Roupen', 'Initials': 'R', 'LastName': 'Djinbachian', 'Affiliation': 'Division of Internal Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Marchand', 'Affiliation': 'Faculty of Medicine, University of Montreal and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pohl', 'Affiliation': 'Division of Gastroenterology, Department of Veterans Affairs Medical Center, White River Junction, Vermont, USA; Division of Gastroenterology, Dartmouth Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Aguilera-Fish', 'Affiliation': 'Division of Gastroenterology, Department of Veterans Affairs Medical Center, White River Junction, Vermont, USA; Division of Gastroenterology, Dartmouth Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bouin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Érik', 'Initials': 'É', 'LastName': 'Deslandres', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Panzini', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Renteln', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Quebec, Canada.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.11.023']
855,33276145,Targeting self-control as a behavior change mechanism to increase physical activity: Study protocol of a randomized controlled trial.,"Despite the highly publicized beneficial effects of physical activity, 51.1% of middle-aged US adults do not achieve the recommended minimum of aerobic physical activity needed to maintain health. A sedentary lifestyle can be attributed in part to a lack of self-control and there is some evidence that self-control strategies can be improved with targeted interventions. The overall aim of this study is to test self-control as a behavior change mechanism for physical activity and to investigate whether a smartphone-based self-control intervention can increase physical activity among sedentary middle-aged adults. This protocol describes the design of a randomized controlled trial with two experimental conditions: The self-control treatment group and the control group. Both groups track their daily physical activity using a Fitbit step counter for eight weeks. Additionally, the self-control intervention group receives a 7-week smartphone-based self-control intervention to learn strategies how to potentiate desirable impulses or weaken undesirable ones. It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group. All participants will be assessed at pretest (baseline), at the end of each week (weeks 1-7), at posttest (week 8), and at follow-up (week 12). If this self-control intervention proves effective, this digital approach would represent a low-threshold and cost-effective approach to increasing physical activity. Such an intervention could be delivered to a large number of people to improve their health outcomes in the long run. Trial Registration:ClinicalTrials.gov: NCT04522141.",2021,It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group.,['sedentary middle-aged adults'],['smartphone-based self-control intervention'],['physical activity'],"[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0395786,It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group.,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'Department of Psychology, Brandeis University, USA. Electronic address: stieger@brandeis.edu.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Allemand', 'Affiliation': 'Department of Psychology & URPP Dynamics of Healthy Aging, University of Zurich, Switzerland. Electronic address: m.allemand@psychologie.uzh.ch.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, USA. Electronic address: lachman@brandeis.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106236']
856,33269509,Flash glucose monitoring data analysed by detrended fluctuation function on beta-cell function and diabetes classification.,"AIM


We aimed to use data-driven glucose pattern analysis to unveil the correlation between the metrics reflecting glucose fluctuation and beta-cell function, and to identify the possible role of this metric in diabetes classification.
MATERIALS AND METHODS


In total, 78 participants with type 1 diabetes and 59 with type 2 diabetes were enrolled in this study. All participants wore a flash glucose monitoring system, and glucose data were collected. A detrended fluctuation function (DFF) was utilized to extract glucose fluctuation information from flash glucose monitoring data and a DFF-based glucose fluctuation metric was proposed.
RESULTS


For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P <.001), which was larger than the correlation coefficient between the fasting C-peptide and mean amplitude of plasma glucose excursions (r = -0.639; P < .001), standard deviation (r = -0.649; P <.001), mean blood glucose (r = -0.519; P < .001) and time in range (r = 0.593; P < .001). As glucose data analysed by DFF revealed a clear bimodal distribution among the total participants, we randomly assigned the 137 participants into discovery cohorts (n = 100) and validation cohorts (n = 37) for 10 times to evaluate the consistency and effectiveness of the proposed metric for diabetes classification. The confidence interval for area under the curve according to the receiver operating characteristic analysis in the 10 discovery cohorts achieved (0.846, 0.868) and that for the 10 validation cohorts was (0.799, 0.862). In addition, the confidence intervals for sensitivity and specificity in the discovery cohorts were (75.5%, 83.0%), (81.3%, 88.5%) and (71.8%, 88.3%), (76.5%, 90.3%) in the validation cohorts, indicating the potential capacity of DFF in distinguishing type 1 and type 2 diabetes.
CONCLUSIONS


Our study first proposed the possible role of data-driven analysis acquired glucose metric in predicting beta-cell function and diabetes classification, and a large-scale, multicentre study will be needed in the future.",2021,"For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P < 0.001), which was larger than the correlation coefficient between the fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE) (r = -0.639; P < 0.001), Standard Deviation (SD) (r = -0.649; P < 0.001), Mean Blood Glucose (BG) (r = -0.519; P < 0.001), and Time in Range (TIR) (r = 0.593; P < 0.001).","['78 type 1 diabetes and 59 type 2 diabetes participants', 'newly diagnosed diabetes participants', '137 participants into discovery cohorts (n=100) and validation cohorts (n=37']",[],"['Time in Range (TIR', 'sensitivity and specificity', 'Flash Glucose Monitoring (FGM) and glucose data', 'fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE', 'Mean Blood Glucose (BG', 'potential capacity of DFF', 'confidence interval (CI) for area under the curve (AUC', 'DFF-based glucose fluctuation metric and fasting C-peptide']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",137.0,0.0413881,"For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P < 0.001), which was larger than the correlation coefficient between the fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE) (r = -0.639; P < 0.001), Standard Deviation (SD) (r = -0.649; P < 0.001), Mean Blood Glucose (BG) (r = -0.519; P < 0.001), and Time in Range (TIR) (r = 0.593; P < 0.001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, China.'}, {'ForeName': 'Luxi', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Siqian', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, China.'}, {'ForeName': 'Junzheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, China.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, China.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14282']
857,33276255,"Effect of high protein and fat diet on postprandial blood glucose levels in children and adolescents with type 1 diabetes in Cairo, Egypt.","BACKGROUND AND AIMS


To determine the effect of high protein and high fat meals on post prandial glycemia in patients with type 1 diabetes.
METHODS


This study included 51 children and adolescents with type 1 diabetes who were following up at Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Abo Elrish Children's hospital, Cairo University. Post prandial blood glucose levels were recorded and compared following three breakfast meals with varying protein and fat content (standard carbohydrate meal, high fat meal, and high protein meal) over a period of 5 hours on 3 consecutive days.
RESULTS


High protein meal resulted in hyperglycemia with the peak level at 3.5 hours and continued for 5 hours post prandial while high fat meal caused early hyperglycemia reached the peak at 2 hours then declined towards 5 hours. Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
CONCLUSION


Meals high in protein caused sustained increase in postprandial glucose levels over a period of 5 h. However, high fat meals caused early postprandial hyperglycemia. Protein and fat content of meals affect the timing and values of the peak blood glucose as well as the duration of postprandial hyperglycemia. Therefore, fat/protein unit should be taken in consideration while calculating the bolus insulin dose and anticipating the postprandial glucose response.",2020,"Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
","['patients with type 1 diabetes', ""51 children and adolescents with type 1 diabetes who were following up at Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Abo Elrish Children's hospital, Cairo University"", 'children and adolescents with type 1 diabetes in Cairo, Egypt']","['high protein and fat diet', 'high protein and high fat meals']","['Post prandial blood glucose levels', 'hyperglycemia with the peak level', 'postprandial hyperglycemia', 'postprandial glycemia', 'Protein and fat content of meals affect the timing and values of the peak blood glucose', 'duration of postprandial hyperglycemia', 'postprandial glucose levels', 'postprandial blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301585', 'cui_str': 'Fat diet'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",51.0,0.0158324,"Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
","[{'ForeName': 'Marise', 'Initials': 'M', 'LastName': 'Abdou', 'Affiliation': 'Department of Pediatrics, Member of the Diabetes Endocrine and Metabolism Pediatric Unit (DEMPU), Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: Mariseabdou@gmail.com.'}, {'ForeName': 'Mona Hassan', 'Initials': 'MH', 'LastName': 'Hafez', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Children Hospital, Cairo University, Cairo, Egypt. Electronic address: mshereen57@yahoo.com.'}, {'ForeName': 'Ghada Mohammad', 'Initials': 'GM', 'LastName': 'Anwar', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Children Hospital, Cairo University, Cairo, Egypt. Electronic address: ghadaanwar@yahoo.co.uk.'}, {'ForeName': 'Wafaa Ahmed', 'Initials': 'WA', 'LastName': 'Fahmy', 'Affiliation': 'Head of Growth and Nutrient Requirements Department, National Nutrition Institute, Cairo, Egypt. Electronic address: drwafaa.fahmi@gmail.comNaglaa.'}, {'ForeName': 'Naglaa Mohammed', 'Initials': 'NM', 'LastName': 'Abd Alfattah', 'Affiliation': 'National Nutrition Institute, Cairo, Egypt. Electronic address: Naglaa.mhamed@yahoo.com.'}, {'ForeName': 'Rania Ibrahim', 'Initials': 'RI', 'LastName': 'Salem', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: dr_rania2@yahoo.com.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Arafa', 'Affiliation': 'Department of Pediatrics, Member of the Diabetes Endocrine and Metabolism Pediatric Unit (DEMPU), Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: Noha.hussein@kasralainy.edu.eg.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.11.020']
858,33276251,"A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study.","BACKGROUND


Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control.
OBJECTIVE


This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 μg/50 μg, twice daily).
METHODS


Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting β 2 -agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits.
RESULTS


Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events.
CONCLUSIONS


Fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 μg/50 μg, twice daily) DPI.",2021,"Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity.",['Adults with asthma (n = 231'],"['corticosteroid', 'Fluticasone propionate/salmeterol', 'fluticasone propionate/salmeterol ', 'fluticasone propionate/salmeterol DPI', 'MDI HFA', 'fluticasone propionate/salmeterol', 'fluticasone propionate/salmeterol MDI HFA', 'hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol']","['peak expiratory flow ([MDI HFA', 'efficacy and safety', 'forced expiratory volume in one second, and forced vital capacity', 'Asthma symptoms, exacerbations, short-acting β 2 -agonist (SABA) use, physical activity, lung function, and general health status', 'incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity', 'incidence of hoarseness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C2723051', 'cui_str': 'salmeterol Dry Powder Inhaler'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}]",231.0,0.160735,"Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity.","[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kupczyk', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland. Electronic address: maciej.kupczyk@umed.lodz.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Majak', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Asankowicz-Bargiel', 'Affiliation': 'Asankowicz-Bargiel & Partners, Outpatient Specialist Clinic, ul. Pilsudskiego 33, 63-400, Ostrow Wielkopolski, Poland.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Barańska', 'Affiliation': 'Specialist Outpatient Clinic, ul. Wojska Polskiego 44, 64-800, Chodziez, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Dobek', 'Affiliation': 'Manamedica Medical Center, ul. Inwalidow Wojennych 13, 56-100, Wolow, Poland; Institute of Tuberculosis and Lung Diseases, ul. Plocka 26, 01-138, Warszawa, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Garbicz', 'Affiliation': 'Pulmonology & Allergology Outpatient Clinic, ul. Hubalczykow 5, 76-200, Slupsk, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jerzyńska', 'Affiliation': 'Amicare Research Center, ul. Zeligowskiego 46 lok. 10, 90-644, Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Latos', 'Affiliation': 'Artimed Medical Center, ul. Paderewskiego 4B, 25-017, Kielce, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Machowiak', 'Affiliation': 'Intermedius Medical Service, ul. Rynek 19, 64-000, Koscian, Poland.'}, {'ForeName': 'Bernadetta', 'Initials': 'B', 'LastName': 'Majorek-Olechowska', 'Affiliation': 'Alergomed Medical Center, ul. PCK 26, 33-100, Tarnow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Olech-Cudzik', 'Affiliation': 'Ostrowiec Medical Center, ul. Ilzecka 31a, 27-400, Ostrowiec Sw., Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Poziomkowska-Gęsicka', 'Affiliation': 'Dept of Clinical Allergology, Pomeranian Medical University of Szczecin, ul. Powstancow Wlkp. 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Mirosława', 'Initials': 'M', 'LastName': 'Rulewicz-Warniełło', 'Affiliation': 'Specialist Outpatient Clinic for Pulmonary Diseases, ul. Krotka 4, 11-400, Ketrzyn, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Świderska', 'Affiliation': 'Allergology Outpatient Clinic, ul. Joanny Zubr 18, 98-300, Wielun, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Tarnowski', 'Affiliation': 'Pharmaceutical Company LEK-AM, Al. Jana Pawła II 80, 00-175, Warszawa, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Kopyto', 'Affiliation': 'QAH CRO, ul. Stefana Skrzywana 6, 93-588, Lodz, Poland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106274']
859,33272980,A Randomized Phase IIb Study of Low-dose Tamoxifen in Chest-irradiated Cancer Survivors at Risk for Breast Cancer.,"PURPOSE


Low-dose tamoxifen reduces breast cancer risk, but remains untested in chest-irradiated cancer survivors-a population with breast cancer risk comparable with  BRCA  mutation carriers. We hypothesized that low-dose tamoxifen would be safe and efficacious in reducing radiation-related breast cancer risk.
PATIENTS AND METHODS


We conducted an investigator-initiated, randomized, phase IIb, double-blinded, placebo-controlled trial (FDA IND107367) between 2010 and 2016 at 15 U.S. sites. Eligibility included ≥12 Gy of chest radiation by age 40 years and age at enrollment ≥25 years. Patients were randomized 1:1 to low-dose tamoxifen (5 mg/day) or identical placebo tablets for 2 years. The primary endpoint was mammographic dense area at baseline, 1 and 2 years. IGF-1 plays a role in breast carcinogenesis; circulating IGF-1 and IGF-BP3 levels at baseline, 1 and 2 years served as secondary endpoints.
RESULTS


Seventy-two participants (low-dose tamoxifen:  n  = 34, placebo:  n  = 38) enrolled at a median age of 43.8 years (35-49) were evaluable. They had received chest radiation at a median dose of 30.3 Gy. Compared with the placebo arm, the low-dose tamoxifen arm participants had significantly lower mammographic dense area ( P  = 0.02) and IGF1 levels ( P  < 0.0001), and higher IGFBP-3 levels ( P  = 0.02). There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and antithrombin III; urine N-telopeptide cross-links) between the treatment arms. We did not identify any grade 3-4 adverse events related to low-dose tamoxifen.
CONCLUSIONS


In this randomized trial in chest-irradiated cancer survivors, we find that low-dose tamoxifen is effective in reducing established biomarkers of breast cancer risk and could serve as a risk-reduction strategy.",2021,"There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks) between the treatment arms.","['Chest-irradiated Cancer Survivors at risk for Breast Cancer', '2010 and 2016 at 15 US sites', 'chest-irradiated cancer survivors', 'Eligibility included ≥12Gy of chest radiation by age 40y and age at enrollment ≥25y', 'n=38) enrolled at a median age of 43.8y (35-49) were evaluable']","['placebo', 'Low-dose Tamoxifen', 'tamoxifen', 'placebo tablets']","['toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks', 'higher IGFBP-3 levels', 'IGF1 levels', 'mammographic dense area']","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1096172', 'cui_str': 'N-telopeptide urine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.341647,"There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks) between the treatment arms.","[{'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama. sbhatia@peds.uab.edu.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Palomares', 'Affiliation': 'Cancer Prevention Movement, Arcadia, California.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hageman', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Landier', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kandice', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Umphrey', 'Affiliation': 'MidSouth Imaging, Germantown, Tennessee.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Reich', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Kathryn W', 'Initials': 'KW', 'LastName': 'Zamora', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Saro H', 'Initials': 'SH', 'LastName': 'Armenian', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Blaes', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Henderson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hodgson', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, Washington, DC.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Melin', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Sofia D', 'Initials': 'SD', 'LastName': 'Merajver', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Overholser', 'Affiliation': 'University of Colorado, Denver, Colorado.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Pruthi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'F Lennie', 'Initials': 'FL', 'LastName': 'Wong', 'Affiliation': 'City of Hope, Duarte, California.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3609']
860,33278599,"A randomized phase III trial comparing adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin in patients with node-positive gastric cancer after D2 resection: the ARTIST 2 trial ☆ .","BACKGROUND


Adjuvant chemotherapy and chemoradiotherapy are some of the standards of care for gastric cancer (GC). The Adjuvant chemoRadioTherapy In Stomach Tumors (ARTIST) 2 trial compares two adjuvant chemotherapy regimens and chemoradiotherapy in patients with D2-resected, stage II or III, node-positive GC.
PATIENTS AND METHODS


The ARTIST 2 compared, in a 1:1:1 ratio, three adjuvant regimens: oral S-1 (40-60 mg twice daily 4 weeks on/2 weeks off) for 1 year, S-1 (2 weeks on/1 week off) plus oxaliplatin 130 mg/m 2  every 3 weeks (SOX) for 6 months, and SOX plus chemoradiotherapy 45 Gy (SOXRT). Randomization was stratified according to surgery type (total or subtotal gastrectomy), pathologic stage (II or III), and Lauren histologic classification (diffuse or intestinal/mixed). The primary endpoint was disease-free survival (DFS) at 3 years; a reduction of 33% in the hazard ratio (HR) for DFS with SOX or SOXRT, when compared with S-1, was considered clinically meaningful. The trial is registered at clinicaltrials.gov (NCT0176146).
RESULTS


A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively. Median follow-up period was 47 months, with 178 DFS events observed. Estimated 3-year DFS rates were 64.8%, 74.3%, and 72.8% in the S-1, SOX, and SOXRT arms, respectively. HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 versus SOX, 0.692 (P = 0.042) and S-1 versus SOXRT, 0.724 (P = 0.074). No difference in DFS was found between SOX and SOXRT (HR 0.971; P = 0.879). Adverse events were as anticipated in each arm, and were generally well-tolerated and manageable.
CONCLUSIONS


In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX or SOXRT was effective in prolonging DFS, when compared with S-1 monotherapy. The addition of radiotherapy to SOX did not significantly reduce the rate of recurrence after D2 gastrectomy.",2021,"HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 vs. SOX, 0.692","['patients with node-positive gastric cancer after D2 resection', 'patients with D2-resected, stage II or III, node-positive gastric cancer', 'Stomach Tumors', 'A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively']","['SOX plus chemoradiotherapy 45 Gy (SOXRT', 'oral S-1', 'oxaliplatin', 'Adjuvant chemoRadioTherapy', 'Adjuvant chemotherapy', 'adjuvant chemotherapy regimens and chemoradiotherapy', 'adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin']","['rate of recurrence', 'DFS', 'Estimated 3-year DFS rates', 'Adverse events', 'disease-free survival (DFS', 'tolerated and manageable', 'HR for DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",546.0,0.200634,"HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 vs. SOX, 0.692","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'D Y', 'Initials': 'DY', 'LastName': 'Zang', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Department of Hematology-Oncology, Dong-A University, Busan, Korea.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'K-M', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: jmoon.bae@samsung.com.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: wkkang@skku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.11.017']
861,33284677,"The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial.","BACKGROUND


Vitamin D supplementation may prevent falls in older persons, but evidence is inconsistent, possibly because of dosage differences.
OBJECTIVE


To compare the effects of 4 doses of vitamin D 3  supplements on falls.
DESIGN


2-stage Bayesian, response-adaptive, randomized trial. (ClinicalTrials.gov: NCT02166333).
SETTING


2 community-based research units.
PARTICIPANTS


688 participants, aged 70 years and older, with elevated fall risk and a serum 25-hydroxyvitamin D [25-(OH)D] level of 25 to 72.5 nmol/L.
INTERVENTION


200 (control), 1000, 2000, or 4000 IU of vitamin D 3  per day. During the dose-finding stage, participants were randomly assigned to 1 of the 4 vitamin D 3  doses, and the best noncontrol dose for preventing falls was determined. After dose finding, participants previously assigned to receive noncontrol doses received the best dose, and new enrollees were randomly assigned to receive 200 IU/d or the best dose.
MEASUREMENTS


Time to first fall or death over 2 years (primary outcome).
RESULTS


During the dose-finding stage, the primary outcome rates were higher for the 2000- and 4000-IU/d doses than for the 1000-IU/d dose, which was selected as the best dose (posterior probability of being best, 0.90). In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d;  n  = 308) and those randomly assigned to receive 200 IU/d ( n  = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15];  P  = 0.54). Analysis of falls with adverse outcomes suggested greater risk in the experience-with-best-dose group versus the 200-IU/d group (serious fall: HR, 1.87 [CI, 1.03 to 3.41]; fall with hospitalization: HR, 2.48 [CI, 1.13 to 5.46]).
LIMITATIONS


The control group received 200 IU of vitamin D 3  per day, not a placebo. Dose finding ended before the prespecified thresholds for dose suspension and dose selection were reached.
CONCLUSION


In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D 3  supplementation at doses of 1000 IU/d or higher did not prevent falls compared with 200 IU/d. Several analyses raised safety concerns about vitamin D 3  doses of 1000 IU/d or higher.
PRIMARY FUNDING SOURCE


National Institute on Aging.",2021,"In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d;  n  = 308) and those randomly assigned to receive 200 IU/d ( n  = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15];  P  = 0.54).","['older persons with elevated fall risk and low serum 25-(OH)D levels', 'Older Adults ', '2 community-based research units', '688 participants, aged 70 years and older, with elevated fall risk and a serum 25-hydroxyvitamin D [25-(OH)D] level of 25 to 72.5 nmol/L', 'older persons']","['Vitamin D supplementation', 'placebo', 'vitamin D 3  supplements', 'Vitamin D Supplements', '200 IU of vitamin D']","['falls', 'Time to first fall or death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.600178,"In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d;  n  = 308) and those randomly assigned to receive 200 IU/d ( n  = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15];  P  = 0.54).","[{'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Mitchell', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts (S.P.J.).'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Schrack', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland (S.L.S.).'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Minotti', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Sheriza N', 'Initials': 'SN', 'LastName': 'Baksh', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., J.M.G.).'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Lea T', 'Initials': 'LT', 'LastName': 'Drye', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Guralnik', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., J.M.G.).'}, {'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Kalyani', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Larner College of Medicine at the University of Vermont, Burlington, Vermont (T.B.P.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).'}]",Annals of internal medicine,['10.7326/M20-3812']
862,33288437,Perimenopausal transdermal estradiol replacement reduces serum HDL cholesterol efflux capacity but improves cardiovascular risk factors.,"BACKGROUND


The cardiovascular (CV) safety of estrogen replacement therapy (ERT) in perimenopausal women remains uncertain. Although exogenous estrogens increase HDL cholesterol (HDL-C), estrogen-mediated effects on alternative metrics of HDL that may better predict CV risk are unknown.
OBJECTIVE


To determine the effects of transdermal ERT on HDL composition and cholesterol efflux capacity (CEC), as well as the relationships between these metrics and CV risk factors.
METHODS


Fasting plasma samples were analyzed from 101 healthy, perimenopausal women randomized to receive either transdermal placebo or transdermal estradiol (100 μg/24 h) with intermittent micronized progesterone. At baseline and after 6 months of treatment, serum HDL CEC, HDL particle concentration, HDL protein composition, insulin resistance and brachial artery flow-mediated dilatation (FMD) were measured.
RESULTS


No difference between groups was found for change in plasma HDL-C (p = 0.69). Between-group differences were found for changes in serum HDL total CEC [median change from baseline -5.4 (-17.3,+8.4)% ERT group versus +5.8 (-6.3,+16.9)% placebo group, p = 0.01] and ABCA1-specific CEC [median change from baseline -5.3 (-10.7,+6.7)% ERT group versus +7.4 (-1.5,+18.1)% placebo group, p = 0.0002]. Relative to placebo, transdermal ERT led to reductions in LDL-C (p < 0.0001) and insulin resistance (p = 0.0002). An inverse correlation was found between changes in serum HDL total CEC and FMD (β = -0.26, p = 0.004).
CONCLUSIONS


Natural menopause leads to an increase in serum HDL CEC, an effect that is abrogated by transdermal ERT. However, transdermal ERT leads to favorable changes in major CV risk factors.",2021,"Relative to placebo, transdermal ERT led to reductions in LDL-C (p < 0.0001) and insulin resistance (p = 0.0002).","['Fasting plasma samples were analyzed from 101 healthy, perimenopausal women', 'perimenopausal women']","['transdermal ERT', 'placebo, transdermal ERT', 'transdermal placebo or transdermal estradiol', 'intermittent micronized progesterone', 'Perimenopausal transdermal estradiol replacement', 'estrogen replacement therapy (ERT']","['LDL-C', 'ABCA1-specific CEC', 'insulin resistance', 'serum HDL CEC', 'plasma HDL-C', 'HDL composition and cholesterol efflux capacity (CEC', 'serum HDL total CEC', 'serum HDL CEC, HDL particle concentration, HDL protein composition, insulin resistance and brachial artery flow-mediated dilatation (FMD', 'serum HDL total CEC and FMD', 'serum HDL cholesterol efflux capacity', 'HDL cholesterol (HDL-C']","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014935', 'cui_str': 'Oestrogen replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428472', 'cui_str': 'Serum HDL cholesterol measurement'}, {'cui': 'C1278148', 'cui_str': 'Plasma HDL cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",101.0,0.0824071,"Relative to placebo, transdermal ERT led to reductions in LDL-C (p < 0.0001) and insulin resistance (p = 0.0002).","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vaisar', 'Affiliation': 'Diabetes Institute, Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, 750 Republican St, Seattle WA 98109, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, 101 Manning Drive, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Wimberger', 'Affiliation': 'Diabetes Institute, Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, 750 Republican St, Seattle WA 98109, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Heinecke', 'Affiliation': 'Diabetes Institute, Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, 750 Republican St, Seattle WA 98109, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, 101 Manning Drive, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, 101 Manning Drive, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Girdler', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill School of Medicine, 101 Manning Drive, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Katya B', 'Initials': 'KB', 'LastName': 'Rubinow', 'Affiliation': 'Diabetes Institute, Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, 750 Republican St, Seattle WA 98109, USA. Electronic address: rubinow@uw.edu.'}]",Journal of clinical lipidology,['10.1016/j.jacl.2020.11.009']
863,33289297,"Efficacy and safety of adding sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m 2 .","Sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1/SGLT2 inhibitor, is currently approved in Europe as an adjunct to optimal insulin therapy in adults with type 1 diabetes (T1D) and a body mass index (BMI) ≥ 27 kg/m 2  . In this post hoc analysis, efficacy at 24 weeks and safety at 52 weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI ≥ 27 kg/m 2  . Sotagliflozin 200 mg and 400 mg added to insulin reduced glycated haemoglobin level and increased time in range assessed by continuous glucose monitoring versus placebo and also reduced body weight and systolic blood pressure. Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI ≥ 27 kg/m 2  compared to those with baseline BMI < 27 kg/m 2  . Consistent with published results for the entire population, fewer severe hypoglycaemia and documented hypoglycaemia ≤3.1 mmol/L events and a higher incidence of diabetic ketoacidosis occurred with sotagliflozin versus placebo in patients with BMI ≥ 27 kg/m 2  . Sotagliflozin as an adjunct to optimized insulin therapy in overweight/obese patients with T1D addressed some unmet needs and may help achieve optimal glycaemic control, mitigating weight gain without increasing hypoglycaemia risk in this high-risk population.",2021,Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI ≥27 kg/m 2  compared to those with baseline BMI <27 kg/m 2 .,"['adults with type 1 diabetes (T1D) and a body mass index (BMI) ≥27 kg/m 2 ', 'overweight/obese patients with T1D', 'adults with type 1 diabetes and baseline BMI ≥27 kg/m 2 ']","['sotagliflozin and placebo', 'placebo', 'sotagliflozin, a dual SGLT1 and SGLT2 inhibitor', 'sotagliflozin versus placebo', 'Sotagliflozin']","['Efficacy and safety', 'diabetic ketoacidosis', 'efficacy endpoints', 'body weight and systolic blood pressure', 'severe hypoglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1564997', 'cui_str': 'SLC5A1 protein, human'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",,0.0980215,Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI ≥27 kg/m 2  compared to those with baseline BMI <27 kg/m 2 .,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes-Zentrum für Kinder und Judendliche, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'Department of Medicine, University of California San Diego, Veterans Affairs Medical Center, San Diego, California.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Ampudia-Blasco', 'Affiliation': 'Diabetes Reference Unit, Endocrinology and Nutrition Department, Clinic University Hospital and INCLIVA Biomedical Research Institute, Valencia, Spain.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Banks', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Sawhney', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14271']
864,33289350,Inhibition of fatty acid synthase with FT-4101 safely reduces hepatic de novo lipogenesis and steatosis in obese subjects with non-alcoholic fatty liver disease: Results from two early-phase randomized trials.,"AIMS


To assess the therapeutic potential of fatty acid synthase (FASN) inhibition with FT-4101, a potent, selective, orally bioavailable, small-molecule by (a) evaluating the dose-response of single FT-4101 doses (3, 6 and 9 mg) on hepatic de novo lipogenesis (DNL) in healthy participants (Study 1) and (b) demonstrating the safety, tolerability and efficacy on hepatic steatosis after 12 weeks of FT-4101 dosing in patients with non-alcoholic fatty liver disease (NAFLD; Study 2).
MATERIALS AND METHODS


In Study 1, three sequential cohorts of healthy men (n = 10/cohort) were randomized to receive a single dose of FT-4101 (n = 5/cohort) or placebo (n = 5/cohort) followed by crossover dosing after 7 days. Hepatic DNL was assessed during fructose stimulation from  13  C-acetate incorporation. In Study 2, men and women with NAFLD (n = 14) randomly received 12 weeks of intermittent once-daily dosing (four cycles of 2 weeks on-treatment, followed by 1 week off-treatment) of 3 mg FT-4101 (n = 9) or placebo (n = 5). Steady-state DNL based on deuterated water labelling, hepatic steatosis using magnetic resonance imaging-proton density fat fraction and sebum lipids and circulating biomarkers were assessed.
RESULTS


Single and repeat dosing of FT-4101 were safe and well tolerated. Single FT-4101 doses inhibited hepatic DNL dose-dependently. Twelve weeks of 3 mg FT-4101 treatment improved hepatic steatosis and inhibited hepatic DNL. Decreases in sebum sapienate content with FT-4101 at week 11 were not significant compared to placebo and rebounded at week 12. Biomarkers of liver function, glucose and lipid metabolism were unchanged.
CONCLUSIONS


Inhibition of FASN with 3 mg FT-4101 safely reduces hepatic DNL and steatosis in NAFLD patients.",2021,Decreases in sebum sapienate content with FT-4101 at week 11 were not significant compared to placebo and rebounded at week 12.,"['obese subjects with NAFLD non-alcoholic fatty liver disease', 'male and female NAFLD subjects (n=14', 'three sequential cohorts of healthy males (n=10/cohort', 'NALFD patients (study 2', 'NAFLD patients']","['placebo', 'FT-4101 (n=9) or placebo', 'FT-4101', 'FT-4101 (n=5/cohort) or placebo (n=5/cohort', 'fatty acid synthase with FT-4101 safely']","['Hepatic DNL', 'safety, tolerability and efficacy on hepatic steatosis', 'hepatic steatosis and inhibited hepatic DNL', 'safe and well tolerated', 'Biomarkers of liver function, glucose, and lipid metabolism', 'hepatic DNL and steatosis', 'sebum sapienate content']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",14.0,0.122152,Decreases in sebum sapienate content with FT-4101 at week 11 were not significant compared to placebo and rebounded at week 12.,"[{'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Beysen', 'Affiliation': 'FluxBio, San Mateo, California.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Schroeder', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brevard', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ribadeneira', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Dole', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Tempe, Arizona.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento Inc, Chula Vista, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Hompesch', 'Affiliation': 'ProSciento Inc, Chula Vista, California.'}, {'ForeName': 'Marc K', 'Initials': 'MK', 'LastName': 'Hellerstein', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Antaros Medical, Mölndal, Sweden.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Kelly', 'Affiliation': 'Forma Therapeutics, Watertown, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14272']
865,33293201,"The effect of Emotional Freedom Techniques on nurses' stress, anxiety, and burnout levels during the COVID-19 pandemic: A randomized controlled trial.","BACKGROUND AND OBJECTIVE


Infectious disease outbreaks pose psychological challenges to the general population, and especially to healthcare workers. Nurses who work with COVID-19 patients are particularly vulnerable to emotions such as fear and anxiety, due to fatigue, discomfort, and helplessness related to their high intensity work. This study aims to investigate the efficacy of a brief online form of Emotional Freedom Techniques (EFT) in the prevention of stress, anxiety, and burnout in nurses involved in the treatment of COVID patients.
METHODS


The study is a randomized controlled trial. It complies with the guidelines prescribed by the Consolidated Standards of Reporting Trials (CONSORT) checklist. It was conducted in a COVID-19 department at a university hospital in Turkey. We recruited nurses who care for patients infected with COVID-19 and randomly allocated them into an intervention group (n = 35) and a no-treatment control group (n = 37). The intervention group received one guided online group EFT session.
RESULTS


Reductions in stress (p < .001), anxiety (p < .001), and burnout (p < .001) reached high levels of statistical significance for the intervention group. The control group showed no statistically significant changes on these measures (p > .05).
CONCLUSIONS


A single online group EFT session reduced stress, anxiety, and burnout levels in nurses treating COVID-19.",2020,"RESULTS


Reductions in stress (p < .001), anxiety (p < .001), and burnout (p < .001) reached high levels of statistical significance for the intervention group.","['COVID patients', 'COVID-19 department at a university hospital in Turkey']","['guided online group EFT session', 'Emotional Freedom Techniques (EFT']","['anxiety', 'stress, anxiety, and burnout levels']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0753102,"RESULTS


Reductions in stress (p < .001), anxiety (p < .001), and burnout (p < .001) reached high levels of statistical significance for the intervention group.","[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Dincer', 'Affiliation': 'Deparment of Internal Medicine Nursing, Faculty of Health Science, Istanbul Medeniyet University, Istanbul, Turkey. Electronic address: berna.dincer@medeniyet.edu.tr.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Inangil', 'Affiliation': 'Fundamental of Nursing Department, Hamidiye Faculty of Nursing, University of Health Sciences, 38, Tıbbiye Street, Istanbul, Uskudar 34668, Istanbul, Turkey. Electronic address: demet.inangil@sbu.edu.tr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.012']
866,33164570,Association of Baseline and Longitudinal Changes in Body Composition Measures With Risk of Heart Failure and Myocardial Infarction in Type 2 Diabetes: Findings From the Look AHEAD Trial.,"BACKGROUND


Intentional weight loss is associated with lower risk of heart failure (HF) and atherosclerotic cardiovascular disease among patients with type 2 diabetes. However, the contribution of baseline measures and longitudinal changes in fat mass (FM), lean mass (LM), and waist circumference (WC) to the risk of HF and myocardial infarction (MI) in type 2 diabetes is not well established.
METHODS


Adults from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included. FM and LM were predicted using validated equations and compared with dual-energy x-ray absorptiometry measurements in a subgroup. Adjusted Cox models were used to evaluate the associations of baseline and longitudinal changes in FM, LM, and WC over 1- and 4-year follow-up with risk of overall HF, HF with preserved ejection fraction (EF; EF ≥50%), HF with reduced EF (EF <50%), and MI.
RESULTS


Among 5103 participants, there were 257 incident HF events over 12.4 years of follow-up. Predicted and measured FM/LM were highly correlated ( R 2 =0.87-0.90; n=1369). FM and LM decreased over 4-year follow-up with greater declines in the intensive lifestyle intervention arm. In adjusted analysis, baseline body composition measures were not significantly associated with HF risk. Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]). Decline in FM was significantly associated with lower risk of both HF subtypes. In contrast, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Similar patterns of association were observed for 4-year changes in body composition and HF risk. Longitudinal changes in body composition were not significantly associated with risk of MI.
CONCLUSIONS


In adults with type 2 diabetes, a lifestyle intervention is associated with significant loss of FM and LM. Declines in FM and WC, but not LM, were each significantly associated with lower risk of HF but not MI. Furthermore, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00017953.",2020,"Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]).","['Adults from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included', 'adults with type 2 diabetes', '5103 participants, there were 257 incident HF events over 12.4 years of follow-up', 'Type 2 Diabetes', 'patients with type 2 diabetes']",[],"['body composition', 'Body Composition Measures', 'FM and LM', 'FM, LM, and WC', 'fat mass (FM), lean mass (LM), and waist circumference (WC) to the risk of HF and myocardial infarction (MI', 'loss of FM and LM', 'Decline in FM and WC', 'FM/LM', 'Decline in FM', 'lower risk of overall HF']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1285593', 'cui_str': 'Body composition measure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",5103.0,0.124659,"Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68-0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62-0.95]).","[{'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (J.L.B., S.A.G.).'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (J.L.B., S.A.G.).'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Columbia University Medical Center (X.P.).'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge (U.W.).'}, {'ForeName': 'KayLoni L', 'Initials': 'KL', 'LastName': 'Olson', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown Medical School, Providence, RI (K.L.O.).'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC (A.G.B.).'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Sections on Cardiovascular Medicine and Geriatrics, Wake Forest School of Medicine, Winston-Salem, NC (D.W.K.).'}, {'ForeName': 'Jarett D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (K.V.P., J.D.B., A.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.050941']
867,33296467,Evaluating an Intervention to Increase Cereal Fiber Intake in Children: A Randomized Controlled Feasibility Trial.,"BACKGROUND


Observational studies have shown that higher cereal fiber intake is associated with reduced type 2 diabetes risk. However, it remains uncertain whether this association is causal.
OBJECTIVE


This study evaluated the feasibility of an intervention to increase cereal fiber intake in children using breakfast cereals.
METHODS


The study was a 2-arm parallel group randomized controlled trial in 9-10-y-old children, who received free supplies of high-fiber breakfast cereals (>3.5 g/portion) or low-fiber breakfast cereals (<1.0 g/portion) to eat daily for 1 mo with behavioral support to promote adherence. Children provided baseline and 1-mo fasting blood samples, physical measurements, and 24-h dietary recalls. The primary outcome was the group difference in change in plasma total alkylresorcinol (AR) concentration; secondary outcomes were group differences in nutrient intakes and adiposity indices. Analyses (complete case and multiple imputation) were conducted by regressing the final AR concentration on baseline AR in models adjusted for sex, ethnicity, age, and school (random effect).
RESULTS


Two-hundred seventy-two children were randomly assigned (137 receiving a low-fiber and 135 a high-fiber diet) and 193 (71%) provided fasting blood samples at baseline and follow-up. Among randomized participants, median (IQR) of baseline AR was 43.1 (24.6-85.5) nmol/L and of cereal fiber intake was 4.5 (2.7-6.4) g; 87% of participants reported consuming the cereal on most or all days. Compared with changes in the low-fiber group, the high-fiber group had greater increases in AR (40.7 nmol/L; 95% CI: 21.7, 59.8 nmol/L, P < 0.0001) and in reported cereal fiber intake (2.9g/d; 95% CI: 2.0, 3.7 g; P < 0.0001). There were no appreciable differences in other secondary outcomes.
CONCLUSIONS


We have developed a simple and acceptable nutritional intervention that increases markers of daily cereal fiber intake in children. This intervention could be used to test whether increases in cereal fiber intake in children might reduce insulin resistance. This trial was registered at www.isrctn.com as ISRCTN33260236.",2021,"< 0.0001) and in reported cereal fiber intake (2.9g/d; 95% CI: 2.0, 3.7 g; P < 0.0001).","['Two-hundred seventy-two children', 'children', 'children using breakfast cereals', 'Children', '9-10-y-old children, who received free supplies of high-fiber breakfast cereals (>3.5 g/portion) or']",['low-fiber breakfast cereals (<1.0 g/portion) to eat daily for 1\xa0mo with behavioral support to promote adherence'],"['baseline and 1-mo fasting blood samples, physical measurements, and 24-h dietary recalls', 'fasting blood samples', 'AR', 'nutrient intakes and adiposity indices', 'change in plasma total alkylresorcinol (AR) concentration', 'cereal fiber intake', 'median (IQR) of baseline AR']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",272.0,0.296631,"< 0.0001) and in reported cereal fiber intake (2.9g/d; 95% CI: 2.0, 3.7 g; P < 0.0001).","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Donin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Nightingale', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Perkin', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Division of Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Owen', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Alicja R', 'Initials': 'AR', 'LastName': 'Rudnicka', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Cook', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Whincup', 'Affiliation': ""Population Health Research Institute, St George's, University of London, London, United Kingdom.""}]",The Journal of nutrition,['10.1093/jn/nxaa347']
868,33307444,Association between social isolation and outpatient follow-up in older adults following emergency department discharge.,"OBJECTIVES


Follow-up with outpatient clinicians after discharge from the emergency department (ED) reduces adverse outcomes among older adults, but rates are suboptimal. Social isolation, a common factor associated with poor health outcomes, may help explain these low rates. This study evaluates social isolation as a predictor of outpatient follow-up after discharge from the ED.
MATERIALS AND METHODS


This cohort study uses the control group from a randomized-controlled trial investigating a community paramedic-delivered Care Transitions Intervention with older patients (age≥60 years) at three EDs in mid-sized cities. Social Isolation scores were measured at baseline using the PROMIS 4-item social isolation questionnaire, grouped into tertiles for analysis. Chart abstraction was conducted to identify follow-up with outpatient primary or specialty healthcare providers and method of contact within 7 and 30 days of discharge.
RESULTS


Of 642 patients, highly socially-isolated adults reported significantly worse overall health, as well as increased anxiety, depressive symptoms, functional limitations, and co-morbid conditions compared to those less socially-isolated (p<0.01). We found no effect of social isolation on 30-day follow-up. Patients with high social isolation, however, were 37% less likely to follow-up with a provider in-person within 7 days of ED discharge compared to low social isolation (OR:0.63, 95% CI:0.42-0.96).
CONCLUSION


This study adds to our understanding of how and when socially-isolated older adults seek outpatient care following ED discharge. Increased social isolation was not significantly associated with all-contact follow-up rates after ED discharge. However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.",2021,"However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.","['with older patients (age≥60 years) at three EDs in mid-sized cities', 'older adults', '642 patients, highly socially-isolated adults', 'socially-isolated older adults seek outpatient care following ED discharge', 'older adults following emergency department discharge']",['community paramedic-delivered Care Transitions Intervention'],"['low social isolation', 'overall health', 'Increased social isolation', 'Social Isolation scores', 'anxiety, depressive symptoms, functional limitations, and co-morbid conditions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}]",642.0,0.0490657,"However, patients reporting higher social isolation had lower rates of in-person follow-up in the week following ED discharge.","[{'ForeName': 'Nia A', 'Initials': 'NA', 'LastName': 'Cayenne', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Gwen Costa', 'Initials': 'GC', 'LastName': 'Jacobsohn', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States. Electronic address: gjacobsohn@wisc.edu.'}, {'ForeName': 'Courtney M C', 'Initials': 'CMC', 'LastName': 'Jones', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, United States; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Eva H', 'Initials': 'EH', 'LastName': 'DuGoff', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of Maryland, College Park, MD, United States; Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States; Berkeley Research Group, Washington, DC, United States.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Cochran', 'Affiliation': 'Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Caprio', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Cushman', 'Affiliation': 'Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, United States; Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, United States.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Green', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Amy J H', 'Initials': 'AJH', 'LastName': 'Kind', 'Affiliation': 'Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States; William S. Middleton Veterans Affairs Geriatrics Research, Education, and Clinical Center, Madison, WI, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lohmeier', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Ranran', 'Initials': 'R', 'LastName': 'Mi', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States; Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States; Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, United States.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104298']
869,33340845,Internal and external focus show similar effect on the gait kinematics in patients with patellofemoral pain: A randomised controlled trial.,"PURPOSE


The purpose of this study was to examine how attentional focus during training influences the effects of a 6-week hip-knee strength training program on pain, function, strength, and kinematics in males and females with Patellofemoral pain (PFP).
METHODS


Seventy-five males and females with PFP were randomly allocated to a group that trained with an internal focus (n = 25), a group that trained with an external focus (n = 25), or a control group (n = 25). All patients completed testing before (baseline) and after (posttest) the 6-week period. The primary outcome was pain, assessed by Visual Analog Scale (VAS). The secondary outcomes were function, hip muscles strength and lower extremity kinematics, assessed by Kujala Questionnaire, handheld dynamometer and a 2-D motion capture, respectively. All outcomes were measured at the baseline and after the 6-week intervention. Analysis of covariance was used to compare posttest outcomes among the groups while accounting for group differences in baseline performance.
RESULTS


The hip-knee strengthening exercises resulted in improved knee valgus (ES(95 % CI) = 0.43(0.26 to 0.75), p = 0.03), and external rotator strength (ES(95 % CI) = 0.51(0.12 to 0.78), p = 0.03) for males and females who trained with an external compared to internal focus.
CONCLUSIONS


Our findings indicate that males and females with PFP may benefit from completing a hip-knee strengthening training program with an external focus vs. an internal focus. Physical therapists and clinicians should consider using instructions that promote an external focus when implementing hip-knee strengthening training programs with PFP patients. This result could be strengthened or re-enforced by larger studies with longer follow up.",2020,"The hip-knee strengthening exercises resulted in improved knee valgus (ES(95 % CI) = 0.43(0.26 to 0.75), p = 0.03), and external rotator strength (ES(95 % CI) = 0.51(0.12 to 0.78), p = 0.03) for males and females who trained with an external compared to internal focus.
","['males and females with PFP', 'males and females with Patellofemoral pain (PFP', 'Seventy-five males and females with PFP', 'patients with patellofemoral pain']",['hip-knee strength training program'],"['gait kinematics', 'pain, assessed by Visual Analog Scale (VAS', 'pain, function, strength, and kinematics', 'external rotator strength', 'knee valgus', 'function, hip muscles strength and lower extremity kinematics, assessed by Kujala Questionnaire, handheld dynamometer and a 2-D motion capture, respectively']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",75.0,0.0484772,"The hip-knee strengthening exercises resulted in improved knee valgus (ES(95 % CI) = 0.43(0.26 to 0.75), p = 0.03), and external rotator strength (ES(95 % CI) = 0.51(0.12 to 0.78), p = 0.03) for males and females who trained with an external compared to internal focus.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Aghakeshizadeh', 'Affiliation': 'Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran. Electronic address: fatemeaghakeshii@gmail.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Sports Injury and Corrective Exercises, Kharazmi University, Tehran, Iran. Electronic address: letafatkaramir@yahoo.com.'}, {'ForeName': 'Abbey C', 'Initials': 'AC', 'LastName': 'Thomas', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Charlotte, Charlotte, NC, United States. Electronic address: afenwick@uncc.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.11.030']
870,33321287,Hypofractionated chemoradiation for head and cancer: Data from the PET NECK trial.,"There has been increased interest in hypofractionated accelerated chemoradiation for head and neck cancer during the recent first peak of the COVID-19 pandemic. Prospective data regarding this approach from randomised trials is lacking. In the PET NECK study, 564 patients with squamous cell carcinoma of the head and neck receiving definitive chemoradiation were randomised to either planned neck dissection or PET CT scan guided surveillance. In this surgical trial, three radiotherapy fractionation schedules delivered over 7, 6 or 4 weeks were permitted with synchronous chemotherapy. The purpose of this study was to determine efficacy and quality of life outcomes associated with the use of these schedules. Primary local control and overall survival in addition to quality of life measures at immediately post treatment and 6, 12 and 24 months post-treatment were compared between the three fractionation cohorts. In the 525 patients where fractionation data was available, 181 (34%), 288 (55%) and 56 (11%) patients received 68-70 Gy in 34-35 fractions (#), 60-66 Gy in 30# and 55 Gy in 20# respectively. At a minimum follow up of two years following treatment there was no significant difference between the three fractionation schemes in local control, overall survival or any quality of life measure. Despite the obvious limitations of this study, some data is provided to support the use of hypofractionated accelerated chemoradiation to avoid delays in cancer treatment and reduce hospital visits during the peak of a pandemic. Data from on-going randomised trials examining hypofractionated chemoradiation may be useful for selecting fractionation schedules during future pandemics.",2021,"At a minimum follow up of two years following treatment there was no significant difference between the three fractionation schemes in local control, overall survival or any quality of life measure.","['564 patients with squamous cell carcinoma of the head and neck receiving definitive chemoradiation', 'head and cancer']","['planned neck dissection or PET CT scan guided surveillance', 'Hypofractionated chemoradiation', 'hypofractionated chemoradiation']","['overall survival', 'hospital visits', 'quality of life measures', 'efficacy and quality of life outcomes', 'local control, overall survival or any quality of life measure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",564.0,0.0768462,"At a minimum follow up of two years following treatment there was no significant difference between the three fractionation schemes in local control, overall survival or any quality of life measure.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vreugdenhil', 'Affiliation': 'Institute of Head & Neck Studies and Education, University of Birmingham, UK; Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fong', 'Affiliation': 'Institute of Head & Neck Studies and Education, University of Birmingham, UK; Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'Institute of Head & Neck Studies and Education, University of Birmingham, UK; Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hartley', 'Affiliation': 'Institute of Head & Neck Studies and Education, University of Birmingham, UK; Hall-Edwards Radiotherapy Research Group, Queen Elizabeth Hospital, Birmingham, UK. Electronic address: andrew.hartley@uhb.nhs.uk.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Mehanna', 'Affiliation': 'Institute of Head & Neck Studies and Education, University of Birmingham, UK.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105112']
871,33321247,"""Was I asking for it?"": An experimental investigation of perceived responsibility, mental contamination and workplace sexual harassment.","BACKGROUND AND OBJECTIVES


Mental contamination (i.e., contamination concerns that arise in the absence of direct contact with a contaminant) is a common symptom in obsessive-compulsive disorder (OCD). Cognitive theories suggest that it results from individuals' misinterpretations of perceived violations. Cognitive theories of OCD also highlight the importance of appraisals of inflated responsibility in the maintenance of other OCD symptoms. However, the role of responsibility in mental contamination has not yet been examined experimentally. The present study examined the role of perceived responsibility and violation in the relationship between workplace sexual harassment imagery and subsequent mental contamination.
METHODS


One hundred and forty-nine participants listened to a workplace sexual harassment imagery task, wherein responsibility was manipulated. Participants were randomly assigned to one of three conditions (high responsibility (HR), low responsibility (LR), no responsibility (NR)). Participants completed questionnaires assessing mental contamination and completed a hand washing task.
RESULTS


Those in the NR condition reported significantly lower levels of responsibility than those in the LR or HR conditions. Accordingly, those in the NR condition also reported significantly lower levels of anxiety and dirtiness than in the LR condition. There were no significant differences between the LR and HR condition on variables of interest.
LIMITATIONS


The nature of the victim blaming used for the responsibility induction may have elicited compensatory responses from participants.
CONCLUSIONS


Findings may highlight the central role of perceptions of violation in the understanding and treatment of mental contamination.",2020,"Accordingly, those in the NR condition also reported significantly lower levels of anxiety and dirtiness than in the LR condition.",['One hundred and forty-nine participants listened to a'],"['three conditions (high responsibility (HR), low responsibility (LR), no responsibility (NR', 'workplace sexual harassment imagery task']",['levels of responsibility'],"[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0162790', 'cui_str': 'Sexual harassment'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",149.0,0.0301005,"Accordingly, those in the NR condition also reported significantly lower levels of anxiety and dirtiness than in the LR condition.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Concordia University, Department of Psychology, 7141 Rue Sherbrooke Ouest, Montreal, Quebec, H4B 1R6, Canada.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Radomsky', 'Affiliation': 'Concordia University, Department of Psychology, 7141 Rue Sherbrooke Ouest, Montreal, Quebec, H4B 1R6, Canada. Electronic address: adam.radomsky@concordia.ca.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101633']
872,33317326,Gender-Based Differences in Outcomes Among Resuscitated Patients With Out-of-Hospital Cardiac Arrest.,"BACKGROUND


Studies examining gender-based differences in outcomes of patients experiencing out-of-hospital cardiac arrest have demonstrated that, despite a higher likelihood of return of spontaneous circulation, women do not have higher survival.
METHODS


Patients successfully resuscitated from out-of-hospital cardiac arrest enrolled in the CCC trial (Trial of Continuous or Interrupted Chest Compressions during CPR) were included. Hierarchical multivariable logistic regression models were constructed to evaluate the association between gender and survival after adjustment for age, gender, cardiac arrest rhythm, witnessed status, bystander cardiopulmonary resuscitation, episode location, epinephrine dose, emergency medical services response time, and duration of resuscitation. Do not resuscitate (DNR) and withdrawal of life-sustaining therapy (WLST) order status were used to assess whether differences in postresuscitation outcomes were modified by baseline prognosis. The analysis was replicated among ALPS trial (Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest) participants.
RESULTS


Among 4875 successfully resuscitated patients, 1825 (37.4%) were women and 3050 (62.6%) were men. Women were older (67.5 versus 65.3 years), received less bystander cardiopulmonary resuscitation (49.1% versus 54.9%), and had a lower proportion of cardiac arrests that were witnessed (55.1% versus 64.5%) or had shockable rhythm (24.3% versus 44.6%,  P <0.001 for all). A significantly higher proportion of women received DNR orders (35.7% versus 32.1%,  P =0.009) and had WLST (32.8% versus 29.8%,  P =0.03). Discharge survival was significantly lower in women (22.5% versus 36.3%,  P <0.001; adjusted odds ratio, 0.78 [95% CI, 0.66-0.93];  P =0.005). The association between gender and survival to discharge was modified by DNR and WLST order status such that women had significantly reduced survival to discharge among patients who were not designated DNR (31.3% versus 49.9%,  P =0.005; adjusted odds ratio, 0.74 [95% CI, 0.60-0.91]) or did not have WLST (32.3% versus 50.7%,  P =0.002; adjusted odds ratio, 0.73 [95% CI, 0.60-0.89]). In contrast, no gender difference in survival was noted among patients receiving a DNR order (6.7% versus 7.4%,  P =0.90) or had WLST (2.8% versus 2.4%,  P =0.93). Consistent patterns of association between gender and postresuscitation outcomes were observed in the secondary cohort.
CONCLUSIONS


Among patients resuscitated after experiencing out-of-hospital cardiac arrest, discharge survival was significantly lower in women than in men, especially among patients considered to have a favorable prognosis.",2021,"Among resuscitated out-of-hospital cardiac arrest patients, discharge to survival was significantly lower in women compared with men especially among patients considered to have a favorable prognosis.","['Resuscitated Patients with Out-of-Hospital Cardiac Arrest', '4,875 successfully resuscitated patients, 1,825 (37.4%) were women and 3,050 (62.6%) were men', 'Patients successfully resuscitated from out-of-hospital cardiac arrest enrolled in the Continuous Chest Compression trial were included']","['Amiodarone, Lidocaine']","['survival', 'gender and discharge survival', 'discharge to survival', 'Discharge survival', 'bystander cardiopulmonary resuscitation', 'discharge survival', 'WLST', 'shockable rhythm']","[{'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",4875.0,0.153359,"Among resuscitated out-of-hospital cardiac arrest patients, discharge to survival was significantly lower in women compared with men especially among patients considered to have a favorable prognosis.","[{'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Mody', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Departments of Medicine, Surgery, and Biomedical Engineering, Interdepartmental Division of Critical Care (A.S.S.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Segar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M., A.P., M.W.S.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Evaluative Clinical Sciences, Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Institute for Health Policy and Management (A.K.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, Division of Cardiology, Department of Medicine, Faculty of Medicine, Institute of Medical Sciences (P.D.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': ""Applied Health Research Centre at the Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Physical Therapy and the Rehabilitation Sciences Institute (J.P.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Damon C', 'Initials': 'DC', 'LastName': 'Scales', 'Affiliation': 'Sunnybrook Health Sciences Center, Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, Institute for Health Policy and Management (D.C.S.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Ted Rogers Centre for Heart Research and Peter Munk Cardiac Centre and Toronto General Hospital Research Institute, Toronto Health Economics and Technology Assessment (THETA) Collaborative, Institute of Health Policy, Management and Evaluation (V.E.R.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cheskes', 'Affiliation': 'Sunnybrook Centre for Prehospital Medicine, Division of Emergency Medicine, Department of Family and Community Medicine (S.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Arlene S', 'Initials': 'AS', 'LastName': 'Bierman', 'Affiliation': 'Centre for Practice Improvement, Agency for Healthcare Research and Quality, Rockville, MD (A.S.B.).'}, {'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Abramson', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, Division of Cardiology, Department of Medicine, Faculty of Medicine (B.L.A.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': ""Emergency Medicine and Critical Care, St Michael's Hospital, Division of Emergency Medicine, Department of Medicine, Interdepartmental Division of Critical Care, Faculty of Medicine (S.G.), University of Toronto, Ontario, Canada.""}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Center, Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, Institute for Health Policy and Management (R.A.F.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Katie N', 'Initials': 'KN', 'LastName': 'Dainty', 'Affiliation': 'North York General Hospital, Institute for Health Policy and Management (K.N.D.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine (A.H.I.), University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': ""Rescu at the Li Ka Shing Knowledge Institute, Emergency Medicine, St. Michael's Hospital, Division of Emergency Medicine, Department of Medicine, Faculty of Medicine, Institute for Health Policy and Management (L.M.), University of Toronto, Ontario, Canada.""}]",Circulation,['10.1161/CIRCULATIONAHA.120.050427']
873,33338232,"Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial.","INTRODUCTION


Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection.
METHODS


This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1.
RESULTS


Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001.
CONCLUSIONS


In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.",2021,Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month.,"['COVID-19 outpatients', 'Between 8 April 2020 and 19 May 2020, 55 patients', 'outpatients with mild COVID-19 infection', 'outpatients with mild COVID-19']","['Sofosbuvir and daclatasvir', 'sofosbuvir/daclatasvir treatment', 'sofosbuvir/daclatasvir plus hydroxychloroquine', 'sofosbuvir and daclatasvir versus standard care', 'hydroxychloroquine alone']","['hospital admission', 'fatigue', 'Fatigue, dyspnoea and loss of appetite', 'number of patients with fatigue and dyspnoea', 'alleviate symptoms', 'symptom alleviation']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",55.0,0.133239,Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month.,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Roozbeh', 'Affiliation': 'Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh-Navaei', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh-Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Emergency Medicine, Homerton University Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shamshirian', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa501']
874,33349674,Distinct trajectories of response to prefrontal tDCS in major depression: results from a 3-arm randomized controlled trial.,"Transcranial direct current stimulation (tDCS) is a safe, effective treatment for major depressive disorder (MDD). While antidepressant effects are heterogeneous, no studies have investigated trajectories of tDCS response. We characterized distinct improvement trajectories and associated baseline characteristics for patients treated with prefrontal tDCS, an active pharmacotherapy (escitalopram), and placebo. This is a secondary analysis of a randomized, non-inferiority, double-blinded trial (ELECT-TDCS, N = 245). Participants were diagnosed with an acute unipolar, nonpsychotic, depressive episode, and presented Hamilton Depression Rating Scale (17-items, HAM-D) scores ≥17. Latent trajectory modeling was used to identify HAM-D response trajectories over a 10-week treatment. Top-down (hypothesis-driven) and bottom-up (data-driven) methods were employed to explore potential predictive features using, respectively, conservatively corrected regression models and a cross-validated stability ranking procedure combined with elastic net regularization. Three trajectory classes that were distinct in response speed and intensity (rapid, slow, and no/minimal improvement) were identified for escitalopram, tDCS, and placebo. Differences in response and remission rates were significant early for all groups. Depression severity, use of benzodiazepines, and age were associated with no/minimal improvement. No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively). Additional features are suggested in bottom-up analyses. Summarily, groups treated with tDCS, escitalopram, and placebo differed in trajectory class distributions and baseline predictors of response. Our results might be relevant for designing further studies.",2021,"No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively).","['patients treated with prefrontal tDCS, an active pharmacotherapy (escitalopram), and', 'Participants were diagnosed with an acute unipolar, nonpsychotic, depressive episode, and presented Hamilton Depression Rating Scale (17-items, HAM-D) scores ≥17', 'major depressive disorder (MDD', 'major depression']","['prefrontal tDCS', 'Transcranial direct current stimulation (tDCS', 'placebo', 'tDCS, escitalopram, and placebo']","['trajectory assignment', 'response and remission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.251709,"No significant differences in trajectory assignment were found in tDCS vs. placebo comparisons (38.3, 34, and 27.6%; vs. 23.3, 43.3, and 33.3% for rapid, slow, and no/minimal trajectories, respectively).","[{'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nußbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nußbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sarubin', 'Affiliation': 'Hochschule Fresenius, University of Applied Sciences, Infanteriestraße 11A, 80797, Munich, Germany.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Kaster', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Borrione', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil.'}, {'ForeName': 'Lais B', 'Initials': 'LB', 'LastName': 'Razza', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, R Dr Ovidio Pires de Campos 785, 2o andar, 05403-000, São Paulo, Brazil. brunoni@usp.br.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00935-x']
875,33306999,The Tube Versus Trabeculectomy IRIS® Registry Study: Cohort Selection and Follow-up and Comparisons to the Randomized Controlled Trial.,"PURPOSE


To assess the feasibility of replicating a randomized controlled trial (RCT) with a cohort of eyes, from IRIS® Registry data, analogous to the Tube Versus Trabeculectomy (TVT) RCT cohort and compare characteristics and follow-up.
DESIGN


Comparison of RCT and IRIS Registry cohorts and follow-up.
METHODS


We identified a cohort of IRIS Registry eyes (2013-2017) that received either a glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction; extracted clinical and demographic characteristics for baseline surgery and follow-up visits through 1 year; and compared treatment groups in the IRIS Registry cohort and this cohort to the TVT RCT cohort.
RESULTS


The IRIS Registry cohort included 419 eyes: 183 (43.7%) trabeculectomy; 236 (56.3%) tube. There were significant differences between treatment groups, including race (White: trabeculectomy 61.8%, tube 44.9%; Black: trabeculectomy 20.8%, tube 35.6%; P = .003) and the percentage of follow-up visits completed (trabeculectomy 88.4%, tube 83.8%, P = .004). There were also significant differences between the TVT IRIS Registry cohort and the TVT RCT cohort in the percentage of follow-up visits completed (IRIS Registry 85.6%, RCT 96.1%, P < .001) and in the probability of having a 1-year follow-up visit (IRIS Registry 81.4%, RCT 89.2%, P = .011).
CONCLUSION


The TVT IRIS Registry cohort had several significant treatment group differences at baseline, whereas there had been none in the TVT RCT cohort. Follow-up in the TVT IRIS Registry cohort was inferior to that of the TVT RCT. Some data needed to refine the selection of eyes for the cohort were not available in the IRIS Registry.",2020,"There were significant differences between treatment groups including race (White: trabeculectomy 61.8%, tube 44.9%; Black: trabeculectomy 20.8%, tube 35.6%; P=0.003) and the percentage of follow-up visits completed (trabeculectomy 88.4%, tube 83.8%, P=0.004).",['419 eyes: 183 (43.7%) trabeculectomy; 236 (56.3%) tube'],"['glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction', 'Tube Versus Trabeculectomy (TVT) RCT']",['percentage of follow-up visits'],"[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C0181041', 'cui_str': 'Glaucoma drainage device'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]",,0.0798074,"There were significant differences between treatment groups including race (White: trabeculectomy 61.8%, tube 44.9%; Black: trabeculectomy 20.8%, tube 35.6%; P=0.003) and the percentage of follow-up visits completed (trabeculectomy 88.4%, tube 83.8%, P=0.004).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Vanner', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA. Electronic address: EAV45@med.miami.edu.'}, {'ForeName': 'Catherine Q', 'Initials': 'CQ', 'LastName': 'Sun', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA; University of California, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McSoley', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA; University of Miami Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Patrice J', 'Initials': 'PJ', 'LastName': 'Persad', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Lum', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, California, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Kelly', 'Affiliation': 'American Academy of Ophthalmology, San Francisco, California, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Parrish', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Ta C', 'Initials': 'TC', 'LastName': 'Chang', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, Miami, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.11.014']
876,33309774,Cobimetinib plus atezolizumab in BRAF V600  wild-type melanoma: primary results from the randomized phase III IMspire170 study.,"BACKGROUND


Emerging data suggest that the combination of MEK inhibitors and immunotherapeutic agents may result in improved efficacy in melanoma. We evaluated whether combining MEK inhibition and immune checkpoint inhibition was more efficacious than immune checkpoint inhibition alone in patients with previously untreated BRAF V600  wild-type advanced melanoma.
PATIENTS AND METHODS


IMspire170 was an international, randomized, open-label, phase III study. Patients were randomized 1 : 1 to receive cobimetinib (60 mg, days 1-21) plus anti-programmed death-ligand 1 atezolizumab (840 mg every 2 weeks) in 28-day cycles or anti-programmed death-1 pembrolizumab (200 mg every 3 weeks) alone until loss of clinical benefit, unacceptable toxicity, or consent withdrawal. The primary outcome was progression-free survival (PFS), assessed by an independent review committee in the intention-to-treat population.
RESULTS


Between 11 December 2017, and 29 January 2019, 446 patients were randomized to receive cobimetinib plus atezolizumab (n = 222) or pembrolizumab (n = 224). Median follow-up was 7.1 months [interquartile range (IQR) 4.8-9.9] for cobimetinib plus atezolizumab and 7.2 months (IQR 4.9-10.1) for pembrolizumab. Median PFS was 5.5 months [95% confidence interval (CI) 3.8-7.2] with cobimetinib plus atezolizumab versus 5.7 months (95% CI 3.7-9.6) with pembrolizumab [stratified hazard ratio 1.15 (95% CI 0.88-1.50); P = 0.30]. Hazard ratios for PFS were consistent across prespecified subgroups. In exploratory biomarker analyses, higher tumor mutational burden was associated with improved clinical outcomes in both treatment arms. The most common grade 3-5 adverse events (AEs) were increased blood creatine phosphokinase (10.0% with cobimetinib plus atezolizumab versus 0.9% with pembrolizumab), diarrhea (7.7% versus 1.9%), rash (6.8% versus 0.9%), hypertension (6.4% versus 3.7%), and dermatitis acneiform (5.0% versus 0). Serious AEs occurred in 44.1% of patients with cobimetinib plus atezolizumab and 20.8% with pembrolizumab.
CONCLUSION


Cobimetinib plus atezolizumab did not improve PFS compared with pembrolizumab monotherapy in patients with BRAF V600  wild-type advanced melanoma.",2021,"The most common grade 3-5 adverse events were increased blood creatine phosphokinase (10.0% with cobimetinib plus atezolizumab vs 0.9% with pembrolizumab), diarrhea (7.7% vs 1.9%), rash (6.8% vs 0.9%), hypertension (6.4% vs 3.7%), and dermatitis acneiform (5.0% vs 0).Serious adverse events occurred in 44.1% of patients with cobimetinib plus atezolizumab and 20.8% with pembrolizumab.
","['patients with BRAF V600  wild-type advanced melanoma', 'patients with previously untreated BRAF V600  wild-type advanced melanoma', 'Between December 11, 2017, and January 29, 2019', 'BRAF V600  wild-type melanoma', '446 patients']","['pembrolizumab monotherapy', 'atezolizumab', 'pembrolizumab', 'cobimetinib plus atezolizumab', 'cobimetinib (60 mg, days 1-21) plus anti-programmed death-ligand 1 atezolizumab (840 mg every 2 weeks) in 28-day cycles or anti-programmed death-1 pembrolizumab', 'Cobimetinib plus atezolizumab']","['PFS', 'dermatitis acneiform', 'clinical outcomes', 'progression-free survival (PFS), assessed by an independent review committee in the intention-to-treat population', 'rash', 'hypertension', 'blood creatine phosphokinase', 'adverse events', 'Median PFS', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0853165', 'cui_str': 'Blood creatine phosphokinase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",446.0,0.475574,"The most common grade 3-5 adverse events were increased blood creatine phosphokinase (10.0% with cobimetinib plus atezolizumab vs 0.9% with pembrolizumab), diarrhea (7.7% vs 1.9%), rash (6.8% vs 0.9%), hypertension (6.4% vs 3.7%), and dermatitis acneiform (5.0% vs 0).Serious adverse events occurred in 44.1% of patients with cobimetinib plus atezolizumab and 20.8% with pembrolizumab.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'First Department of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. Electronic address: helgogas@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Dermatology Department, CHU Nantes, CIC 1413, CRCINA, University Nantes, Nantes, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Ministry of Health, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital #62 of Moscow Healthcare Department, Moscow Oblast, Russia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Eroglu', 'Affiliation': 'Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Francesco Ferrucci', 'Affiliation': 'European Institute of Oncology - IRCCS, Milan, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pigozzo', 'Affiliation': 'Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Medical and Experimental Oncology, Poznan University of Medical Sciences, and Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan, Poland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rooney', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Voulgari', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Troutman', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pitcher', 'Affiliation': 'Hoffmann-La Roche Ltd., Mississauga, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mulla', 'Affiliation': 'Hoffmann-La Roche Ltd., Mississauga, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Department of Medical Oncology and IDIBAPS, Hospital Clínic Barcelona, Barcelona, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.12.004']
877,33309538,Alcohol substitution during one month of cannabis abstinence among non-treatment seeking youth.,"OBJECTIVE


Cannabis and alcohol use are correlated behaviors among youth. It is not known whether discontinuation of cannabis use is associated with changes in alcohol use. This study assessed alcohol use in youth before, during, and after 4 weeks of paid cannabis abstinence.
METHODS


Healthy, non-treatment seeking, cannabis users (n = 160), aged 14-25 years, 84% of whom used alcohol in the last month, were enrolled for a 4-week study with a 2-4 week follow-up. Participants were randomly assigned to 4 weeks of either biochemically-verified cannabis abstinence achieved through a contingency management framework (CB-Abst) or monitoring with no abstinence requirement (CB-Mon). Participants were assessed at baseline and approximately 4, 6, 10, 17, 24, and 31 days after enrollment. A follow-up visit with no cannabis abstinence requirement for CB-Abst was conducted after 2-4 weeks.
RESULTS


Sixty percent of individuals assigned to the CB-Abst condition increased in frequency and quantity of alcohol consumption during the 4-week period of incentivized cannabis abstinence. As a whole, CB-Abst increased by a mean of 0.6 drinking days and 0.2 drinks per day in the initial week of abstinence (p's < 0.006). There was no evidence for further increases in drinking frequency or quantity during the 30-day abstinence period (p's > 0.53). There was no change in drinking frequency or quantity during the 4-week monitoring or follow-up periods among CB-Mon.
CONCLUSIONS


On average, 4 weeks of incentivized (i.e., paid) cannabis abstinence among non-treatment seeking youth was associated with increased frequency and amount of alcohol use in week 1 that was sustained over 4 weeks and resolved with resumption of cannabis use. However, there was notable variability in individual-level response, with 60% increasing in alcohol use and 23% actually decreasing in alcohol use during cannabis abstinence. Findings suggest that increased alcohol use during cannabis abstinence among youth merits further study to determine whether this behavior occurs among treatment seeking youth and its clinical significance.",2021,"There was no change in drinking frequency or quantity during the 4-week monitoring or follow-up periods among CB-Mon.
","['non-treatment seeking youth', 'Healthy, non-treatment seeking, cannabis users (n\u202f=\u202f160), aged 14-25\u202fyears, 84% of whom used alcohol in the last month, were enrolled for a 4-week study with a 2-4\u202fweek follow-up']","['biochemically-verified cannabis abstinence achieved through a contingency management framework (CB-Abst) or monitoring with no abstinence requirement (CB-Mon', 'Alcohol substitution']","['drinking frequency or quantity', 'frequency and quantity of alcohol consumption']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026409', 'cui_str': 'Mongolian language'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0292264,"There was no change in drinking frequency or quantity during the 4-week monitoring or follow-up periods among CB-Mon.
","[{'ForeName': 'Randi Melissa', 'Initials': 'RM', 'LastName': 'Schuster', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: Rschuster@mgh.harvard.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Lamberth', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'Natali', 'Initials': 'N', 'LastName': 'Rychik', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Hareli', 'Affiliation': 'Department of Psychology, Loyola University Chicago, United States of America.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Broos', 'Affiliation': 'Department of Psychology, University of Miami, United States of America.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Mustoe', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'Jodi M', 'Initials': 'JM', 'LastName': 'Gilman', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America; Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Pachas', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry, MA General Hospital, United States of America; Harvard Medical School, Boston, MA, United States of America.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110205']
878,33346857,[Advanced prostate cancer: sequence of androgen receptor-targeted substances and chemotherapy determines long-term survival].,"The treatment of advanced prostate cancer is changing. New study data and the resulting new therapeutic options have led to increasingly differentiated treatment decisions. Despite the changing therapy landscape, taxane-based chemotherapy-being a life-prolonging treatment-remains an indispensable therapeutic component for chemotherapy-fit patients in the metastatic setting. The current results of the randomized study CARD show that cabazitaxel has a higher oncological effectiveness, including a significant survival benefit and no negative impact on quality of life parameters, compared to a second androgen receptor targeted agent (ARTA) in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after treatment with docetaxel and an androgen receptor-targeted agent (ARTA). In mCNPC the combination therapies of ADT (androgen deprivation therapy) plus docetaxel or of ADT plus ARTA have been established. In addition, three ARTAs tested in recent phase III studies in a clinical setting for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) showed that their use significantly prolongs metastasis-free survival and overall survival. The potential early use of ARTAs also has implications for the treatment of mCNPC. The aim of this publication is to provide guidance for clinical routine and to develop criteria for individual therapy decisions with a special focus on the use of chemotherapy.",2021,"The current results of the randomized study CARD show that cabazitaxel has a higher oncological effectiveness, including a significant survival benefit and no negative impact on quality of life parameters, compared to a second androgen receptor targeted agent (ARTA) in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after treatment with docetaxel and an androgen receptor-targeted agent (ARTA).","['patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after treatment with docetaxel and an androgen receptor-targeted agent (ARTA', 'patients with nonmetastatic castration-resistant prostate cancer (nmCRPC', 'Advanced prostate cancer']","['androgen receptor-targeted substances and chemotherapy', 'taxane-based chemotherapy', 'ADT (androgen deprivation therapy) plus docetaxel']","['quality of life parameters', 'metastasis-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.021678,"The current results of the randomized study CARD show that cabazitaxel has a higher oncological effectiveness, including a significant survival benefit and no negative impact on quality of life parameters, compared to a second androgen receptor targeted agent (ARTA) in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after treatment with docetaxel and an androgen receptor-targeted agent (ARTA).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wülfing', 'Affiliation': 'Asklepios Tumorzentrum, Abteilung für Urologie, Asklepios Klinik Altona, Paul-Ehrlich-Straße\xa01, 22763, Hamburg, Deutschland. c.wuelfing@asklepios.com.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goebell', 'Affiliation': 'Urologische und Kinderurologische Universitätsklinik, Erlangen, Deutschland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Eichenauer', 'Affiliation': 'Urologikum Hamburg MVZ, Standort Alstertal, Hamburg, Deutschland.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lange', 'Affiliation': 'Urologische Praxis Bernburg, Bernburg, Deutschland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Machtens', 'Affiliation': 'Klinik für Urologie und Kinderurologie, GFO Kliniken Rhein Berg, Betriebsstätte, Marien-Krankenhaus, Bergisch Gladbach, Deutschland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schwentner', 'Affiliation': 'Urologische Klinik am Diakonie-Klinikum Stuttgart, Stuttgart, Deutschland.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Todenhöfer', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Deutschland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tauber', 'Affiliation': 'Urologische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, München, Deutschland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': 'Klinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie, Universitätsklinikum Magdeburg, Magdeburg, Deutschland.'}]",Der Urologe. Ausg. A,['10.1007/s00120-020-01411-6']
879,33219014,A Phase I Trial of Talimogene Laherparepvec in Combination with Neoadjuvant Chemotherapy for the Treatment of Nonmetastatic Triple-Negative Breast Cancer.,"PURPOSE


Talimogene laherparepvec (TVEC) is an oncolytic herpes simplex 1 virus approved for treatment of melanoma. We hypothesized intratumoral TVEC may enhance response to neoadjuvant chemotherapy (NAC). This article reports the results of a trial combining NAC with TVEC for triple-negative breast cancer (TNBC).
PATIENTS AND METHODS


Patients with stage II-III TNBC enrolled in a 3+3 phase I trial (NCT02779855) of two TVEC dose levels [DL; DL 1 = 10 6  plaque-forming units (PFU) × 5 doses; DL 2 = 10 6  PFUs first dose, then 10 8  PFUs × 4 doses] on weeks 1, 4, 6, 8, and 10 plus weekly paclitaxel (80 mg/m 2 ) for 12 weeks, followed by doxorubicin/cyclophosphamide (60/600 mg/m 2 ) every 2 weeks for 8 weeks. Postoperative response assessment using residual cancer burden (RCB) was performed. Primary endpoints were safety and MTD. Secondary endpoints were RCB0 rate and immune correlates. Dose-limiting toxicity (DLT) rule was grade 3-5 adverse events due to TVEC during first 5 weeks.
RESULTS


Nine patients [DL 1 ( n  = 3); DL 2 ( n  = 6)] were enrolled. Six had stage II disease, and 3 had stage III (6 clinically N + ). No DLTs occurred, and MTD was DL 2. Most common toxicities with TVEC were fever ( n  = 8), chills ( n  = 3), hematomas ( n  = 3), and injection site pain ( n  = 3). Thromboembolic events ( n  = 2) and bradycardia ( n  = 1) occurred during or after NAC. Five patients (55%) achieved RCB0, 2 had RCB1 (22%), and 2 had RCB2 (22%).
CONCLUSIONS


The addition of TVEC to NAC was feasible at the approved dose, with manageable toxicity. The complete response rate was 55%.",2021,Thromboembolic events ( n  = 2) and bradycardia ( n  = 1) occurred during or after NAC.,"['Nine patients [DL 1 ( n  = 3); DL 2 ( n  = 6)] were enrolled', 'Patients with stage', 'Nonmetastatic Triple-Negative Breast Cancer']","['paclitaxel', 'doxorubicin/cyclophosphamide', 'TVEC', 'NAC with TVEC', 'Talimogene laherparepvec (TVEC', 'Talimogene Laherparepvec in Combination with Neoadjuvant Chemotherapy']","['safety and MTD', 'complete response rate', 'Thromboembolic events', 'bradycardia', 'RCB0 rate and immune correlates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C1831828', 'cui_str': 'talimogene laherparepvec'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.157847,Thromboembolic events ( n  = 2) and bradycardia ( n  = 1) occurred during or after NAC.,"[{'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida. hatem.soliman@moffitt.org.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Hogue', 'Affiliation': 'Clinical Trials Office, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Hyo', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Mooney', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Niell', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Falcon', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Khakpour', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Weinfurtner', 'Affiliation': 'Radiology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hoover', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kiluk', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Marilin', 'Initials': 'M', 'LastName': 'Rosa', 'Affiliation': 'Anatomic Pathology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Hung', 'Initials': 'H', 'LastName': 'Khong', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Czerniecki', 'Affiliation': 'Breast Oncology Department, Moffitt Cancer Center, Tampa, Florida.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3105']
880,33357505,"Effects of empagliflozin on estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate in patients with heart failure (Empire HF Renal): a prespecified substudy of a double-blind, randomised, placebo-controlled trial.","BACKGROUND


SGLT2 inhibitors are a promising treatment option in patients with heart failure and reduced ejection fraction. We aimed to investigate the effects of empagliflozin on estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate (GFR) in patients with heart failure and reduced ejection fraction.
METHODS


Empire HF Renal was a prespecified substudy of the investigator-initiated, double-blind, randomised, placebo-controlled Empire HF trial. The study was done at Herlev and Gentofte University Hospital (Herlev, Denmark), with patients recruited from four Danish heart failure outpatient clinics. Patients with New York Heart Association class I-III symptoms, with a left ventricular ejection fraction of 40% or lower, and on guideline-directed heart failure therapy were randomly assigned (1:1) to receive either oral empagliflozin 10 mg or matched placebo once daily for 12 weeks. The allocation sequence was computer-generated. Patients and study investigators were masked to treatment allocation. The coprimary prespecified renal outcomes were the between-group difference in the changes in estimated extracellular volume, estimated plasma volume, and measured GFR from baseline to 12 weeks. All analyses were done in the intention-to-treat population (apart from safety analyses, which were done in patients who received at least one dose of study drug), with no interim analyses done during the trial. The Empire HF trial is registered with ClinicalTrials.gov, NCT03198585, and EudraCT, 2017-001341-27.
FINDINGS


Between June 29, 2017, and July 15, 2019, we assessed 391 patients for eligibility, of whom 120 (31%) were randomly assigned to empagliflozin or placebo, including 105 (88%) without diabetes. In intention-to-treat analyses, 60 (100%) patients in the empagliflozin group and 59 (98%) patients in the placebo group were included for estimated extracellular volume and estimated plasma volume, and 59 (98%) patients in the empagliflozin group and 58 (97%) patients in the placebo group were included for measured GFR. Empagliflozin treatment resulted in reductions in estimated extracellular volume (adjusted mean difference -0·12 L, 95% CI -0·18 to -0·05; p=0·00056), estimated plasma volume (-7·3%, -10·3 to -4·3; p<0·0001), and measured GFR (-7·5 mL/min, -11·2 to -3·8; p=0·00010) compared with placebo. Five (8%) of 60 patients in the empagliflozin group and three (5%) of 60 patients in the placebo group had one or more serious adverse events.
INTERPRETATION


In patients with heart failure and reduced ejection fraction, empagliflozin reduced estimated extracellular volume, estimated plasma volume, and measured GFR after 12 weeks. Fluid volume changes might be an important mechanism underlying the beneficial clinical effects of SGLT2 inhibitors.
FUNDING


Research Council at Herlev and Gentofte University Hospital, Research and Innovation Foundation of the Department of Cardiology at Herlev and Gentofte University Hospital, Capital Region of Denmark, Danish Heart Foundation, and AP Møller Foundation for the Advancement of Medical Science.",2021,"In patients with heart failure and reduced ejection fraction, empagliflozin reduced estimated extracellular volume, estimated plasma volume, and measured GFR after 12 weeks.","['patients with heart failure and reduced ejection fraction', 'Patients with New York Heart Association class', '40% or lower, and on guideline-directed heart failure therapy', 'patients with heart failure (Empire HF Renal', 'Empire HF Renal', 'Between June 29, 2017, and July 15, 2019, we assessed 391 patients for eligibility, of whom 120 (31', 'Herlev and Gentofte University Hospital (Herlev, Denmark), with patients recruited from four Danish heart failure outpatient clinics']","['empagliflozin', 'placebo', 'Empagliflozin', 'empagliflozin or placebo', 'oral empagliflozin 10 mg or matched placebo']","['estimated plasma volume', 'estimated extracellular volume', 'estimated extracellular volume, estimated plasma volume, and measured GFR', 'serious adverse events', 'estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate (GFR', 'estimated extracellular volume, estimated plasma volume, and measured glomerular filtration rate', 'estimated extracellular volume and estimated plasma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",391.0,0.654776,"In patients with heart failure and reduced ejection fraction, empagliflozin reduced estimated extracellular volume, estimated plasma volume, and measured GFR after 12 weeks.","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Steno Diabetes Center Odense, Odense, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mariam Elmegaard', 'Initials': 'ME', 'LastName': 'Malik', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Emil Loldrup', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Thorbjørn', 'Initials': 'LT', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. Electronic address: morten.schou.04@regionh.dk.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30382-X']
881,33355914,Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial).,"OBJECTIVES


Evidence comparing the economic and patient values of the World Health Organization's preferred (dolutegravir 50 mg [DTG]-based) and alternative (low-dose [400 mg] efavirenz [EFV400]-based) first-line antiretroviral regimens is limited. We compared patient-reported outcomes (PROs), costs, and the cost-utility of DTG- versus EFV400-based regimens in treatment-naive HIV-1 adults in the randomised NAMSAL ANRS 12313 trial in Yaoundé, Cameroon.
METHODS


We used clinical data, PROs, and health resource use data collected in the trial's first 96 weeks (2016-2019). Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale. Other PROs included perceived symptoms, depression, anxiety, and stress. In the 96-week base-case analysis, we estimated the unadjusted and multivariate-adjusted (1) mean costs (in US$, 2016 values) and QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB). Outcomes were extrapolated over 5 and 10 years. Uncertainty was assessed using the cost-effectiveness acceptability curve and scenario and cost-effective price threshold analyses.
RESULTS


In the base-case analysis, the NHB (95% confidence interval) for the DTG-based regimen relative to the EFV400-based regimen was 0.056 (- 0.037 to 0.153), corresponding to an 88% probability of DTG being cost-effective. A 10% decrease in this regimen's price (from $5.2 to $4.7/month) would increase its cost-effectiveness probability to 95%. When extrapolating outcomes over 5 and 10 years, the DTG-based regimen had a 100% probability of being cost-effective for a large range of cost-effectiveness thresholds.
CONCLUSIONS


At 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02777229.",2021,Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale.,['HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313'],"['Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen', 'dolutegravir 50\xa0mg\xa0[DTG]-based) and alternative (low-dose\xa0[400 mg] efavirenz [EFV400]-based']","['QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB', '12-item Short Form (SF-12) generic health scale', 'cost-effectiveness acceptability curve and\xa0scenario and cost-effective price threshold analyses', 'cost-effectiveness probability', 'Quality-adjusted life-years (QALYs', 'outcomes (PROs), costs, and the cost-utility of DTG', 'symptoms, depression, anxiety, and stress']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.092667,Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale.,"[{'ForeName': 'Marwân-Al-Qays', 'Initials': 'MA', 'LastName': 'Bousmah', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France.""}, {'ForeName': 'Marie Libérée', 'Initials': 'ML', 'LastName': 'Nishimwe', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France.""}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Tovar-Sanchez', 'Affiliation': 'Recherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le développement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Lantche Wandji', 'Affiliation': 'ANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Mpoudi-Etame', 'Affiliation': 'Military Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Gwenaëlle', 'Initials': 'G', 'LastName': 'Maradan', 'Affiliation': ""ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.""}, {'ForeName': 'Pierrette', 'Initials': 'P', 'LastName': 'Omgba Bassega', 'Affiliation': 'Cité Verte Hospital, Yaoundé, Cameroon.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Varloteaux', 'Affiliation': 'ANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Montoyo', 'Affiliation': 'ANRS, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'ANRS Cameroon Site, Central Hospital of Yaoundé, Yaoundé, Cameroon.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'Recherches Translationnelles sur le VIH et les Maladies Infectieuses (TransVIHMI), University of Montpellier, Institut de recherche pour le développement (IRD)-INSERM, and University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boyer', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de La Santé & Traitement de l'Information Médicale, Aix-Marseille University, Marseille, France. sylvie.boyer@inserm.fr.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics,['10.1007/s40273-020-00987-3']
882,33310265,Glycemic and cardiometabolic effects of exercise in South Asian Sri Lankans with type 2 diabetes mellitus: A randomized controlled trial Sri Lanka diabetes aerobic and resistance training study (SL-DARTS).,"BACKGROUND AND AIMS


To examine the effects of aerobic training (AT) and resistance training (RT) compared to standard care on glycemic control in South Asian Sri Lankan adults with Type 2 Diabetes Mellitus (T2DM).
METHODS


Randomized controlled trial (RCT) with parallel-group design recruited 86 sedentary Sri Lankans (aged 35-65 years) with T2DM into aerobic training (AT, n = 28), resistance training (RT, n = 28) and control (CN, n = 30) groups. Supervised progressive exercise training consisting of 75 min per session, 2 days per week for 12 weeks was conducted. The primary outcome was pre- and post-intervention absolute change in hemoglobin A1c (HBA1c). Secondary outcomes were serum lipids, liver enzymes, chronic inflammatory status, anthropometry, body composition and blood pressure.
RESULTS


The absolute change in HbA1c of RT vs. CN was -0.08% (95% CI, 0.8% to -0.7%, p = 0.8) and AT vs. CN was -0.22% (95% CI, 0.95% to -0.5%). Subgroup analysis (n = 49) with a high baseline HbA1c (>7.5%), absolute reduction in HbA1c in exercise groups were statistically significant (RT vs. CN was -0.37%; 95% CI 1.3% to -0.6%, p = 0.04 and AT vs. CN was -0.57%; 95% CI 1.7% to -0.6%, p = 0.03). The effect sizes (total and subgroup HbA1c >7.5%) ranged from 0.7 to 1.0 in AT, 0.4 to 1.1 in RT compared to 0.35 to 0.6 for the CN. Secondary outcomes did not significantly differ among groups.
CONCLUSIONS


Exercise training 2 days/week improved glycemic control in Sri Lankan adults with T2DM and the effects were significant in high baseline HbA1c (>7.5%) groups (RT > AT).",2020,"The absolute change in HbA1c of RT vs. CN was -0.08% (95% CI, 0.8% to -0.7%, p = 0.8) and AT vs. CN was -0.22% (95% CI, 0.95% to -0.5%).","['South Asian Sri Lankans with type 2 diabetes mellitus', '86 sedentary Sri Lankans (aged 35-65 years) with T2DM into aerobic training (AT, n\xa0=\xa028', 'South Asian Sri Lankan adults with Type 2 Diabetes Mellitus (T2DM']","['exercise', 'aerobic training (AT) and resistance training (RT', 'resistance training (RT, n\xa0=\xa028) and control (CN', 'Supervised progressive exercise training', 'Exercise training']","['Glycemic and cardiometabolic effects', 'absolute change in HbA1c of RT vs. CN', 'pre- and post-intervention absolute change in hemoglobin A1c (HBA1c', 'glycemic control', 'serum lipids, liver enzymes, chronic inflammatory status, anthropometry, body composition and blood pressure']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",86.0,0.141933,"The absolute change in HbA1c of RT vs. CN was -0.08% (95% CI, 0.8% to -0.7%, p = 0.8) and AT vs. CN was -0.22% (95% CI, 0.95% to -0.5%).","[{'ForeName': 'Chathuranga', 'Initials': 'C', 'LastName': 'Ranasinghe', 'Affiliation': 'Sports and Exercise Medicine Unit & Department of Allied Health Sciences, Faculty of Medicine, University of Colombo, Sri Lanka; School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Australia. Electronic address: chath_r@med.cmb.ac.lk.'}, {'ForeName': 'Sabeena', 'Initials': 'S', 'LastName': 'Devage', 'Affiliation': 'Sports and Exercise Medicine Unit & Department of Allied Health Sciences, Faculty of Medicine, University of Colombo, Sri Lanka.'}, {'ForeName': 'Godwin R', 'Initials': 'GR', 'LastName': 'Constantine', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Sri Lanka.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Katulanda', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Sri Lanka.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Hills', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Australia; School of Health Sciences, University of Tasmania, Launceston, Australia; Mater Research Institute, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'King', 'Affiliation': 'School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Australia.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.12.011']
883,33341644,Continuous positive airway pressure treatment and anxiety in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial.,"BACKGROUND


Anxiety and obstructive sleep apnea (OSA) coexist among adults with coronary artery disease (CAD) following revascularization. Continuous positive airway pressure (CPAP) is the first line treatment of OSA patients with daytime sleepiness. The current study evaluated the effect of CPAP on anxiety in CAD patients with nonsleepy OSA.
METHODS


Two hundred forty-four revascularized CAD patients with nonsleepy OSA (apnea-hypopnea index ≥15/h, Epworth Sleepiness Scale score <10) were randomly assigned to CPAP or no-CPAP between 2005 and 2010. Zung Self-rating Anxiety Scale (SAS) was administered at baseline and after 3 and 12 months with higher scores suggesting more anxiety.
RESULTS


A total of 208 patients with complete SAS scores at baseline and 12-month follow-up were included (CPAP, n = 103; no-CPAP, n = 105). In the intention-to-treat analysis, CPAP had no significant effect on the SAS scores. On-treatment analysis revealed a significant increase in the median of delta SAS score (+3.75) after three months among the participants using the device 2.8 h/day or more while there was a decline in the median of delta SAS score (-1.25) in the non-adherent or no-CPAP group (p = 0.031). The increase in the SAS score (+1.25) in the adherent group, and the decline (-1.25 points) in the non-adherent/no-CPAP group remained significant after one year (p = 0.011). Baseline SAS score predicted non-adherence [adjusted odds ratio 1.11; 95% confidence interval (CI) 1.04-1.18; p = 0.003], and there was an association between the increase in the SAS scores and accumulated CPAP hours/day [standardized β = 0.144 (95% CI 0.005-0.695), p = 0.047].
CONCLUSION


Our results suggest that anxiety should be considered in the management of CAD patients with nonsleepy OSA following revascularization.
CLINICAL TRIAL REGISTRATION


NCT00519597.",2021,"Baseline SAS score predicted non-adherence [adjusted odds ratio 1.11; 95% confidence interval (CI) 1.04-1.18; p = 0.003], and there was an association between the increase in the SAS scores and accumulated CPAP hours/day [standardized β = 0.144","['CAD patients with nonsleepy OSA.\nMETHODS\n\n\nTwo hundred forty-four revascularized CAD patients with nonsleepy OSA (apnea-hypopnea index ≥15/h, Epworth Sleepiness Scale score <10', 'CAD patients with nonsleepy OSA following revascularization', 'adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial', 'Anxiety and obstructive sleep apnea', 'adults with coronary artery disease (CAD) following revascularization', 'OSA patients with daytime sleepiness', '208 patients with complete SAS scores at baseline and 12-month follow-up were included (CPAP, n\xa0=\xa0103; no-CPAP, n\xa0=\xa0105']","['Continuous positive airway pressure treatment and anxiety', 'CPAP or no-CPAP', 'CPAP']","['SAS score', 'median of delta SAS score', 'Zung Self-rating Anxiety Scale (SAS', 'SAS scores', 'Continuous positive airway pressure (CPAP']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0451595', 'cui_str': ""Zung's self-rating anxiety scale""}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]",208.0,0.0703621,"Baseline SAS score predicted non-adherence [adjusted odds ratio 1.11; 95% confidence interval (CI) 1.04-1.18; p = 0.003], and there was an association between the increase in the SAS scores and accumulated CPAP hours/day [standardized β = 0.144","[{'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Celik', 'Affiliation': 'Koc University Research Center for Translational Medicine (KUTTAM), Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Dept. of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'Dept of Clinical Sciences, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Koc University Research Center for Translational Medicine (KUTTAM), Istanbul, Turkey; Dept. of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Sweden; Dept of Clinical Sciences, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: yuksel.peker@lungall.gu.se.'}]",Sleep medicine,['10.1016/j.sleep.2020.11.034']
884,33341518,Does ankle tape improve proprioception acuity immediately after application and following a netball session? A randomised controlled trial.,"OBJECTIVES


To assess whether ankle tape applied by a Sport and Exercise Physiotherapist (SEP) or self-applied by the athlete results in a change in proprioception and whether it is maintained during a netball session.
DESIGN


Randomised controlled trial.
SETTING


Australian Institute of Sport.
PARTICIPANTS


53 pre-elite netball athletes.
MAIN OUTCOME MEASURES


Athlete proprioception was assessed using the Active Movement Extent Discrimination Apparatus (AMEDA) on four occasions for each taping condition: 1) pre-tape, 2) post-tape, 3) post-netball & 4) post-netball no-tape.
RESULTS


Mixed effect linear models were used for analysis. A significant increase in proprioception was observed when self-tape: 0.022 (95% CI: [-0.000 - 0.044], p = 0.05), and SEP tape: 0.034 (95% CI: [0.012-0.055], p < 0.01), were initially applied. These improvements were maintained during a netball session for both, self-taping: 0.01 (95% CI: [-0.01 - 0.02], p = 0.45) and SEP-taping: <0.01 (95% CI: [-0.02 - 0.01], p = 0.56). Results also indicate there was no significant difference between taping conditions (β = -0.001, 95% CI: [-0.02 - 0.02], p = 0.90).
CONCLUSIONS


Proprioception improves and is maintained during a netball session with either SEP or self-applied taping.",2021,"A significant increase in proprioception was observed when self-tape: 0.022 (95% CI: [-0.000 - 0.044], p = 0.05), and SEP tape: 0.034 (95% CI: [0.012-0.055], p < 0.01), were initially applied.","['53 pre-elite netball athletes', 'Australian Institute of Sport']",['ankle tape applied by a Sport and Exercise Physiotherapist (SEP'],"['Athlete proprioception', 'proprioception', 'proprioception acuity']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",,0.174054,"A significant increase in proprioception was observed when self-tape: 0.022 (95% CI: [-0.000 - 0.044], p = 0.05), and SEP tape: 0.034 (95% CI: [0.012-0.055], p < 0.01), were initially applied.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smyth', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, Building 29, University of Canberra, Bruce, ACT, 2617, Australia; Australian Institute of Sport, Leverrier St, Bruce, ACT, 2617, Australia. Electronic address: erin.smyth@ausport.gov.au.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Waddington', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, Building 29, University of Canberra, Bruce, ACT, 2617, Australia; Australian Institute of Sport, Leverrier St, Bruce, ACT, 2617, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Witchalls', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, Building 29, University of Canberra, Bruce, ACT, 2617, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Newman', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise, Building 29, University of Canberra, Bruce, ACT, 2617, Australia.'}, {'ForeName': 'Juanita', 'Initials': 'J', 'LastName': 'Weissensteiner', 'Affiliation': 'Sport Development Group, New South Wales Office of Sport, Level 3, 6B Figtree Drive, Sydney Olympic Park, Sydney, NSW, 2127, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'New South Wales Institute of Sport, Bdg B, Level 1, 6 Figtree Drive, Sydney Olympic Park, NSW, 2127, Australia.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Niyonsenga', 'Affiliation': 'Health Research Institute, Locked Bag 1, University of Canberra, Bruce, ACT, 2601, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Drew', 'Affiliation': 'Australian Institute of Sport, Leverrier St, Bruce, ACT, 2617, Australia.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.12.010']
885,33354815,"A randomized, noninferiority, controlled trial of two doses of intravenous subdissociative ketamine for analgesia in the emergency department.","OBJECTIVE


This study aimed to determine if 0.15 mg/kg intravenous (IV) subdissociative ketamine is noninferior to 0.3 mg/kg in emergency department (ED) patients with acute pain.
METHODS


This randomized, prospective, double-blinded, noninferiority trial included patients' age 18 to 59 years presenting to the ED with acute moderate to severe pain. Subjects were randomized to IV subdissociative ketamine, 0.15 mg/kg (""low"" dose) or 0.30 mg/kg (""high"" dose), over 15 minutes. The primary endpoint was the 11-point numeric rating scale (NRS) pain score between groups at 30 minutes. Secondary endpoints included NRS pain scores at 15 and 60 minutes; change in NRS at 15, 30, and 60 minutes; rescue analgesia; and adverse effects. The noninferiority limit, δ 0  , was set to 1.3.
RESULTS


Forty-nine patients were included in each group. After the differences in the baseline NRS score were adjusted for, the mean NRS score at 30 minutes was 4.7 (95% confidence interval [CI] = 3.8 to 5.5) in the low-dose group and 5.0 (95% CI = 4.2 to 5.8) in the high-dose group (mean difference = 0.4, 95% CI = -0.8 to 1.5), indicating that the low-dose subdissociative ketamine was noninferior to the high dose (lower limit of 95% CI = -0.8 to ≥1.3 = -δ 0  ). Adverse effects were similar at 30 minutes. At 15 minutes, the high-dose group experienced greater change in NRS; however, more adverse effects occurred.
CONCLUSION


Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.",2020,Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.,"['Forty-nine patients were included in each group', 'emergency department (ED) patients with acute pain', 'patients age 18-59 years presenting to the ED with acute moderate to severe pain']","['ketamine', 'IV sub-dissociative ketamine', 'intravenous (IV) sub-dissociative ketamine', 'Intravenous Sub-Dissociative Ketamine']","['Adverse effects', '11-point numerical rating scale (NRS) pain score', 'analgesia or adverse effect profile', 'change in NRS', 'mean NRS score', 'NRS pain scores at 15 and 60 minutes, change in NRS at 15, 30 and 60 minutes, rescue analgesia, and adverse effects', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]",49.0,0.629963,Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.,"[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Lovett', 'Affiliation': 'Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Trent', 'Initials': 'T', 'LastName': 'Reed', 'Affiliation': 'Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riggs', 'Affiliation': 'Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Lew', 'Affiliation': 'Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Koch', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Ramon A', 'Initials': 'RA', 'LastName': 'Durazo-Arvizu', 'Affiliation': 'School of Health Sciences and Public Health, Loyola University Chicago, Maywood, Illinois, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Rech', 'Affiliation': 'Department of Emergency Medicine, Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14200']
886,33372127,Unburdening the Weight of Stigma: Findings From a Compassion-Focused Group Program for Women With Overweight and Obesity.,"OBJECTIVE


The aim of this study was to develop a 2-day intensive-format, Compassion-Focused Therapy (CFT) based group program targeting weight stigma in women with overweight and obesity, and to conduct a pilot study to determine the feasibility and acceptability of the intervention.
METHOD


Participants were 15 females aged 18-62 years (mean [M] = 43.60, standard deviation [SD] = 12.38), who participated in the program and completed measures of self-compassion, internalized weight stigma, psychological distress, life-satisfaction, loneliness, eating self-efficacy, body dissatisfaction, and body shame, at pre-treatment, post-treatment, and 3-month follow-up.
RESULTS


Significant improvements were found from pre-treatment to post-treatment for self-compassion and internalized weight stigma, with gains maintained at 3-month follow-up. Significant improvements were also found on measures of psychological distress, life satisfaction, loneliness, eating self-efficacy, and body dissatisfaction at the post-treatment assessment. Credibility ratings of the program were high.
CONCLUSIONS


This study has contributed to existing stigma research, being the first proof-of-concept study to demonstrate support for an intensive, CFT based group approach targeting the effects of weight stigma for women with overweight and obesity. The findings are discussed in terms of the potential of CFT to assist women develop resilience to the harmful effects of weight stigma, and possible future research directions to further develop and evaluate this approach.",2020,"RESULTS


Significant improvements were found from pre-treatment to post-treatment for self-compassion and internalized weight stigma, with gains maintained at 3-month follow-up.","['women with overweight and obesity', 'Participants were 15 females aged 18-62 years (mean [M] = 43.60, standard deviation [SD] = 12.38), who participated in the program and completed measures of self-compassion, internalized weight stigma, psychological distress, life-satisfaction, loneliness, eating self-efficacy, body dissatisfaction, and body shame, at pre-treatment, post-treatment, and 3-month follow-up', 'Women With Overweight and Obesity']","['2-day intensive-format, Compassion-Focused Therapy (CFT) based group program targeting weight stigma']","['self-compassion and internalized weight stigma', 'Credibility ratings', 'psychological distress, life satisfaction, loneliness, eating self-efficacy, and body dissatisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",15.0,0.0176831,"RESULTS


Significant improvements were found from pre-treatment to post-treatment for self-compassion and internalized weight stigma, with gains maintained at 3-month follow-up.","[{'ForeName': 'Yvette N', 'Initials': 'YN', 'LastName': 'Forbes', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, QLD, Australia yvette.forbes@griffithuni.edu.au.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Moffitt', 'Affiliation': 'Psychology, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Van Bokkel', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, QLD, Australia.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Donovan', 'Affiliation': 'School of Applied Psychology, Griffith University, Mt Gravatt, QLD, Australia.'}]",Journal of cognitive psychotherapy,['10.1891/JCPSY-D-20-00015']
887,33372125,Efficacy of Mindfulness Based Cognitive Therapy on Children With Anxiety.,"This study examined the efficacy of mindfulness based cognitive therapy on children (MBCT-C) with anxiety. Two hundred and forty children were screened, of which 52 (25 boys and 27 girls) with anxiety were randomly allocated to either MBCT-C or group therapy (GT including cognitive behavioral principles). Both groups were rated on the Spence Children's Anxiety Scale and Emotion Regulation Questionnaire-Child and Adolescent, pre- and 12 weeks post-interventions. MBCT-C was found to be more effective than GT in improving anxiety among children (between-group effect size Cohen's  d  1.05) and as effective as GT in reducing emotion suppression for effective emotion regulation. This study provides support for MBCT-C as an effective group intervention for children with anxiety.",2020,MBCT-C was found to be more effective than GT in improving anxiety among children (between-group effect size Cohen's  d  1.05) and as effective as GT in reducing emotion suppression for effective emotion regulation.,"['Two hundred and forty children were screened, of which 52 (25 boys and 27 girls) with anxiety', 'children (MBCT-C) with anxiety', 'children with anxiety', 'Children With Anxiety']","['MBCT-C', 'Mindfulness Based Cognitive Therapy', 'MBCT-C or group therapy (GT including cognitive behavioral principles', 'mindfulness based cognitive therapy']","['anxiety', 'emotion suppression for effective emotion regulation', ""Spence Children's Anxiety Scale and Emotion Regulation Questionnaire-Child and Adolescent""]","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",240.0,0.0117746,MBCT-C was found to be more effective than GT in improving anxiety among children (between-group effect size Cohen's  d  1.05) and as effective as GT in reducing emotion suppression for effective emotion regulation.,"[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Shetty', 'Affiliation': 'Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Sreejayan', 'Initials': 'S', 'LastName': 'Kongasseri', 'Affiliation': 'Department of Psychiatry, NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India shwetaraisrcp@gmail.com.'}]",Journal of cognitive psychotherapy,['10.1891/JCPSY-D-20-00014']
888,33300183,"Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials.","In AMBER and EMERALD, darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg demonstrated high virological response and low virological failure (VF) through week 96. Week 96 resistance analyses are presented. Post-baseline samples for genotyping/phenotyping were analyzed from protocol-defined-VFs with viral load (VL) ≥ 400 copies/ml at failure/later time points. Post-hoc analyses were deep sequencing (AMBER) and HIV-1 proviral DNA sequencing from baseline samples (VL < 50 copies/ml) (EMERALD). Through week 96 across studies, no darunavir, primary protease inhibitor (PI), or tenofovir resistance-associated-mutations (RAMs) occurred in patients continuing (N = 1125) or switching to D/C/F/TAF (N = 715). M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER. In EMERALD D/C/F/TAF patients with prior VF and baseline genoarchive data (N = 98), 4% had darunavir RAMs, 36% emtricitabine RAMs, mainly at position 184 (32%), 4% tenofovir RAMs, and 19% ≥3 thymidine-analogue-associated-mutations at screening. The predicted phenotype showed 0% had reduced susceptibility to darunavir, 37% to emtricitabine, and 22% to tenofovir. All achieved VL < 50 copies/ml at week 96/prior discontinuation, with no VF. D/C/F/TAF has a high barrier to resistance; no darunavir, primary PI, or tenofovir RAMs occurred through 96 weeks in AMBER and EMERALD. In EMERALD, baseline archived darunavir, emtricitabine, and tenofovir RAMs in patients with prior VF did not preclude virologic response.",2020,M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER.,['adults living with HIV-1 from the phase 3 randomized AMBER'],"['Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF', 'Single-tablet Regimen (STR', 'emtricitabine/tenofovir alafenamide (D/C/F/TAF', 'tenofovir', 'M184I/V (emtricitabine RAM']","['virologic response', 'virological response and low virological failure (VF', 'protease inhibitor (PI) or tenofovir resistance-associated-mutations (RAMs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0242864', 'cui_str': 'Amber'}]","[{'cui': 'C3871454', 'cui_str': 'darunavir and cobicistat'}, {'cui': 'C4059167', 'cui_str': 'emtricitabine and tenofovir alafenamide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0587468,M184I/V (emtricitabine RAM) was detected in one patient in each arm of AMBER.,"[{'ForeName': 'Erkki', 'Initials': 'E', 'LastName': 'Lathouwers', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Weinsteiger', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Baugh', 'Affiliation': 'Janssen Research & Development LLC, Raritan, New Jersey, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ghys', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jezorwski', 'Affiliation': 'Janssen Research & Development, Pennington, New Jersey, USA.'}, {'ForeName': 'El Ghazi', 'Initials': 'EG', 'LastName': 'Mohsine', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Van Landuyt', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'De Meyer', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}]",Journal of medical virology,['10.1002/jmv.26721']
889,33310488,Effects of a mindfulness-induction on subjective and physiological stress response in adolescents at-risk for adult obesity.,"BACKGROUND


Mindfulness-training may benefit stress response and stress-eating, yet few studies have experimentally tested these effects in adolescents. In this short communication, we report whether a brief mindfulness-induction affected acute stress response and stress-eating in adolescents at-risk for adult obesity. We explored disordered eating as a moderator.
METHOD


Twenty-nine adolescents (age 14 ± 2 y) at-risk for adult obesity participated in a within-subjects, randomized crossover experiment. Following a 10-minute mindfulness or neutral-induction on different days in random order, the Trier Social Stress Test adapted for adolescents was administered, followed by an ad libitum lunch meal. Physiological stress response (heart rate, blood pressure) and subjective stress response (anxiety, mindlessness) were determined with area under the curve with respect to increase. Stress-eating was measured as test meal energy consumed. Global disordered-eating and binge-eating were assessed with the Eating Disorders Examination-Questionnaire.
RESULTS


Relative to a neutral-induction, a mindfulness-induction reduced state anxiety response (p = .04). There were significant interactions of induction-type by global disordered-eating (p = .02) and binge-eating (p = .03), such that the mindfulness-induction most reduced anxiety response in adolescents with relatively lower global disordered-eating and those with no binge-eating. Induction-type also interacted with binge-eating in predicting diastolic blood pressure (p = .03). A mindfulness-induction, versus neutral-induction, most reduced diastolic blood pressure response in adolescents with binge-eating.
CONCLUSIONS


Brief mindfulness-training may alter some aspects of acute stress response, with variations by disordered-eating. Future research should test alternative mindfulness induction-types (e.g., acceptance/self-compassion) to improve our understanding of how mindfulness-training may benefit adolescents at-risk for adult obesity.",2020,"RESULTS


Relative to a neutral-induction, a mindfulness-induction reduced state anxiety response (p = .04).","['adolescents with binge-eating', 'Twenty-nine adolescents (age 14\xa0±\xa02\xa0y) at-risk for adult obesity participated in a within-subjects', 'adolescents at-risk for adult obesity']",['mindfulness-induction'],"['Physiological stress response (heart rate, blood pressure) and subjective stress response (anxiety, mindlessness', 'diastolic blood pressure response', 'state anxiety response', 'binge-eating', 'acute stress response and stress-eating', 'anxiety response', 'Stress-eating', 'Global disordered-eating and binge-eating', 'induction-type by global disordered-eating', 'subjective and physiological stress response', 'diastolic blood pressure']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C2350025', 'cui_str': 'Physiological Stress Reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",29.0,0.0138487,"RESULTS


Relative to a neutral-induction, a mindfulness-induction reduced state anxiety response (p = .04).","[{'ForeName': 'Reagan L', 'Initials': 'RL', 'LastName': 'Miller', 'Affiliation': 'Department of Human Development & Family Studies, College of Health & Human Sciences, Colorado State University, Fort Collins, CO, United States of America.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Department of Human Development & Family Studies, College of Health & Human Sciences, Colorado State University, Fort Collins, CO, United States of America; Colorado School of Public Health, Fort Collins, CO, United States of America.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Sanchez', 'Affiliation': 'Colorado School of Public Health, Fort Collins, CO, United States of America.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Smith', 'Affiliation': 'Department of Human Development & Family Studies, College of Health & Human Sciences, Colorado State University, Fort Collins, CO, United States of America.'}, {'ForeName': 'Shelly K', 'Initials': 'SK', 'LastName': 'Annameier', 'Affiliation': 'Department of Human Development & Family Studies, College of Health & Human Sciences, Colorado State University, Fort Collins, CO, United States of America.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Casamassima', 'Affiliation': 'Colorado School of Public Health, Fort Collins, CO, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Verros', 'Affiliation': 'Colorado School of Public Health, Fort Collins, CO, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Melby', 'Affiliation': 'Colorado School of Public Health, Fort Collins, CO, United States of America; Department of Food Science & Human Nutrition, College of Health & Human Sciences, Colorado State University, United States of America.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science & Human Nutrition, College of Health & Human Sciences, Colorado State University, United States of America.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Shomaker', 'Affiliation': 'Department of Human Development & Family Studies, College of Health & Human Sciences, Colorado State University, Fort Collins, CO, United States of America; Colorado School of Public Health, Fort Collins, CO, United States of America. Electronic address: lauren.shomaker@colostate.edu.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101467']
890,33318635,A randomized cross-over trial to define neurophysiological correlates of AV-101 N-methyl-D-aspartate receptor blockade in healthy veterans.,"The kynurenine pathway (KP) is a strategic metabolic system that combines regulation of neuronal excitability via glutamate receptor function and neuroinflammation via other KP metabolites. This pathway has great promise in treatment of depression and suicidality. The KP modulator AV-101 (4-chlorokynurenine, 4-Cl-KYN), an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), an N-methyl-D-aspartate receptor (NMDAR) glycine site antagonist, and of 4-chloro-3-hydroxyanthranilic acid (4-Cl-3-HAA), a suppressor of NMDAR agonist quinolinic acid (QUIN), is a promising potential antidepressant that targets glutamate functioning via the KP. However, a recent placebo-controlled clinical trial of AV-101 in depression found negative results. This raises the question of whether AV-101 can penetrate the brain and engage the NMDAR and KP effectively. To address this problem, ten healthy US military veterans (mean age = 32.6 years ± 6.11; 1 female) completed a phase-1 randomized, double-blind, placebo-controlled, crossover study to examine dose-related effects of AV-101 (720 and 1440 mg) on NMDAR engagement measured by γ-frequency band auditory steady-state response (40 Hz ASSR) and resting EEG. Linear mixed models revealed that 1440 mg AV-101, but not 720 mg, increased 40 Hz ASSR and 40 Hz ASSR γ-inter-trial phase coherence relative to placebo. AV-101 also increased 4-Cl-KYN, 7-Cl-KYNA, 4-Cl-3-HAA, 3-HAA, and KYNA in a dose-dependent manner, without affecting KYN and QUIN. AV-101 was safe and well tolerated. These results corroborate brain target engagement of 1440 mg AV-101 in humans, consistent with blockade of interneuronal NMDAR blockade. Future studies should test higher doses of AV-101 in depression. Suicidal behavior, which has been associated with high QUIN and low KYNA, is also a potential target for AV-101.",2021,"Linear mixed models revealed that 1440 mg AV-101, but not 720 mg, increased 40 Hz ASSR and 40 Hz ASSR γ-inter-trial phase coherence relative to placebo. AV-101 also increased 4-Cl-KYN, 7-Cl-KYNA, 4-Cl-3-HAA, 3-HAA, and KYNA in a dose-dependent manner, without affecting KYN and QUIN. AV-101 was safe and well tolerated.","['healthy veterans', 'ten healthy US military veterans (mean age\u2009=\u200932.6 years\u2009±\u20096.11; 1 female']","['7-chlorokynurenic acid (7-Cl-KYNA), an N-methyl-D-aspartate receptor (NMDAR) glycine site antagonist, and of 4-chloro-3-hydroxyanthranilic acid (4-Cl-3-HAA', 'AV-101 N-methyl-D-aspartate receptor blockade', 'placebo']","['safe and well tolerated', 'NMDAR engagement measured by γ-frequency band auditory steady-state response (40\u2009Hz ASSR) and resting EEG']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0049860', 'cui_str': '7-chlorokynurenic acid'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0048166', 'cui_str': '4-chloro-3-hydroxyanthranilic acid'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",,0.145351,"Linear mixed models revealed that 1440 mg AV-101, but not 720 mg, increased 40 Hz ASSR and 40 Hz ASSR γ-inter-trial phase coherence relative to placebo. AV-101 also increased 4-Cl-KYN, 7-Cl-KYNA, 4-Cl-3-HAA, 3-HAA, and KYNA in a dose-dependent manner, without affecting KYN and QUIN. AV-101 was safe and well tolerated.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Murphy', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA. Nicholas.Murphy@bcm.edu.'}, {'ForeName': 'Nithya', 'Initials': 'N', 'LastName': 'Ramakrishnan', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Bylinda', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'VistaGen Therapeutics, Inc., 343 Allerton Avenue, South San Francisco, CA, 94080, USA.'}, {'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Swann', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Lijffijt', 'Affiliation': 'Michael E. DeBakey VA Medical Center, 2002 Holcomb Boulevard, Houston, TX, 77030, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00917-z']
891,33335322,Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses.,"More than 190 vaccines are currently in development to prevent infection by the novel severe acute respiratory syndrome coronavirus 2. Animal studies suggest that while neutralizing antibodies against the viral spike protein may correlate with protection, additional antibody functions may also be important in preventing infection. Previously, we reported early immunogenicity and safety outcomes of a viral vector coronavirus vaccine, ChAdOx1 nCoV-19 (AZD1222), in a single-blinded phase 1/2 randomized controlled trial of healthy adults aged 18-55 years ( NCT04324606 ). Now we describe safety and exploratory humoral and cellular immunogenicity of the vaccine, from subgroups of volunteers in that trial, who were subsequently allocated to receive a homologous full-dose (SD/SD D56; n = 20) or half-dose (SD/LD D56; n = 32) ChAdOx1 booster vaccine 56 d following prime vaccination. Previously reported immunogenicity data from the open-label 28-d interval prime-boost group (SD/SD D28; n = 10) are also presented to facilitate comparison. Additionally, we describe volunteers boosted with the comparator vaccine (MenACWY; n = 10). In this interim report, we demonstrate that a booster dose of ChAdOx1 nCoV-19 is safe and better tolerated than priming doses. Using a systems serology approach we also demonstrate that anti-spike neutralizing antibody titers, as well as Fc-mediated functional antibody responses, including antibody-dependent neutrophil/monocyte phagocytosis, complement activation and natural killer cell activation, are substantially enhanced by a booster dose of vaccine. A booster dose of vaccine induced stronger antibody responses than a dose-sparing half-dose boost, although the magnitude of T cell responses did not increase with either boost dose. These data support the two-dose vaccine regime that is now being evaluated in phase 3 clinical trials.",2021,"A booster dose of vaccine induced stronger antibody responses than a dose-sparing half-dose boost, although the magnitude of T cell responses did not increase with either boost dose.","['healthy adults aged 18-55 years ( NCT04324606 ', '32']","['viral vector coronavirus vaccine, ChAdOx1 nCoV-19 (AZD1222', 'ChAdOx1 nCoV-19', 'SARS-CoV-2 vaccine', 'vaccine', 'homologous full-dose (SD/SD D56; n\u2009=\u200920) or half-dose (SD/LD D56; n\u2009', 'ChAdOx1 booster vaccine 56']","['multifunctional antibody responses', 'magnitude of T cell responses', 'stronger antibody responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",,0.125576,"A booster dose of vaccine induced stronger antibody responses than a dose-sparing half-dose boost, although the magnitude of T cell responses did not increase with either boost dose.","[{'ForeName': 'Jordan R', 'Initials': 'JR', 'LastName': 'Barrett', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Belij-Rammerstorfer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Gilbride', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Halkerston', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Daniel.Jenkin@ndm.ox.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Stockdale', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marije K', 'Initials': 'MK', 'LastName': 'Verheul', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Miles W', 'Initials': 'MW', 'LastName': 'Carroll', 'Affiliation': 'Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Breeze', 'Initials': 'B', 'LastName': 'Cavell', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Edwards', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Fuskova', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gorringe', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Linder', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Madhavan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Mellors', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Minassian', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yama', 'Initials': 'Y', 'LastName': 'Mujadidi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maheshi N', 'Initials': 'MN', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Rollier', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rinn', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Thomas', 'Affiliation': 'Public Health England, Salisbury, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marion E E', 'Initials': 'MEE', 'LastName': 'Watson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Green', 'Affiliation': 'Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Andrew.Pollard@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-020-01179-4']
892,33354755,Pharmacist Identification of Medication Therapy Problems Involving Cognition Among Older Adults Followed by a Home-Based Care Team.,"BACKGROUND


Dementia, depression, and delirium alone or in combination (3Ds) can threaten independence among older adults, and polypharmacy may further accelerate decline. Clinical pharmacists can play an important role on multidisciplinary home-based care teams by identifying medication therapy problems (MTPs) involving cognition. Within a larger ongoing clinical trial, this paper describes cognition-related MTPs and pharmacist recommendations among older adults with 3Ds followed by a home-based care team.
METHODS


We conducted a retrospective analysis of medication data among Medicare Advantage members aged ≥ 65 years living at home in Connecticut with International Statistical Classification of Diseases and Related Health Problems, 10th Revision codes related to 3Ds; analyses include the first 105 subjects randomized to the home-based care team from March 2017 to January 2019. Advanced practice registered nurses conducted in-home medication reconciliations along with medical and cognitive assessments. Clinical pharmacists then conducted medication reviews centered on agents treating or exacerbating 3Ds. After review by the study advanced practice registered nurse, geriatrician, and psychiatrist, salient recommendations were forwarded to primary care providers for consideration. Medication therapy problems related to cognition were retrospectively abstracted and classified as: (1) indication: underuse or overuse; (2) effectiveness: ineffective agent or low dose (mainly for antidepressants); and (3) safety: undesirable effect (e.g., impaired cognition, dementia treatment side effects), unsafe medication (e.g., potentially inappropriate medications that can harm cognition), drug interaction, or high dose.
RESULTS


Pharmacists identified 166 cognitive MTPs, with a mean (standard deviation) of 1.58 (1.35) [range 0-6] MTPs per subject. Indication MTPs represented 34% of total MTPs, of which 79% involved underuse and 21% overuse; effectiveness represented 13% of total MTPs; and safety represented over half (52%) of all MTPs, with benzodiazepines and anticholinergics frequently implicated. Recommendations commonly included medication reduction (discontinuation 23% and dose reduction 19%). We found MTPs involving cognition among most (79%) patients.
CONCLUSIONS


Our study findings support the role of pharmacists on multidisciplinary teams to identify cognitively harmful medications, dementia treatment side effects, and untreated cognitive conditions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02945085.",2021,Clinical pharmacists can play an important role on multidisciplinary home-based care teams by identifying medication therapy problems (MTPs) involving cognition.,"['older adults with 3Ds followed by a home-based care team', 'Older Adults', 'Medicare Advantage members aged ≥\xa065 years living at home in Connecticut with International Statistical Classification of Diseases and Related Health Problems, 10th Revision codes related to 3Ds; analyses include the first 105 subjects randomized to the\xa0home-based care team from March 2017 to January 2019']","['unsafe medication (e.g., potentially inappropriate medications that can harm cognition), drug interaction, or high dose']",['medication reduction'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009778', 'cui_str': 'Connecticut'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",105.0,0.0213299,Clinical pharmacists can play an important role on multidisciplinary home-based care teams by identifying medication therapy problems (MTPs) involving cognition.,"[{'ForeName': 'Allison M P', 'Initials': 'AMP', 'LastName': 'Levine', 'Affiliation': 'Center on Aging, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA. allevine@uchc.edu.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Emonds', 'Affiliation': 'PGY1 Pharmacy Practice Residency Program, UConn Health, Farmington, CT, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Center on Aging, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Rickles', 'Affiliation': 'Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kuchel', 'Affiliation': 'Center on Aging, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Steffens', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Alis', 'Initials': 'A', 'LastName': 'Ohlheiser', 'Affiliation': 'Center on Aging, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Fortinsky', 'Affiliation': 'Center on Aging, UConn Health, 263 Farmington Avenue, Farmington, CT, 06030, USA.'}]",Drugs & aging,['10.1007/s40266-020-00821-7']
893,33358713,Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status?,"BACKGROUND AND AIMS


This study examined if the weight loss and metabolic benefits of alternate day fasting (ADF) varies according to sex and menopausal status in adults with obesity.
METHODS AND RESULTS


This secondary analysis pooled the data of men and women (n = 75) who participated in three 12-week ADF studies (500 kcal fast day; alternated with an ad libitum intake feast day). Body weight decreased in premenopausal women (-4.6 ± 3.2%), postmenopausal women (-6.5 ± 3.2%) and men (-6.2 ± 4.4%) (main effect of time, P < 0.001), with no difference between groups (no group × time interaction). Energy intake on fast days was higher than prescribed in all groups (∼400-500 excess kcal consumed), with no differences between groups. Fat mass, lean mass, fasting insulin, and insulin resistance, and blood pressure decreased similarly in all groups (main effect of time, P < 0.05 for all comparisons). LDL cholesterol decreased more in postmenopausal versus premenopausal women (group × time interaction, P = 0.01). Fasting glucose, HDL cholesterol, and triglycerides remained unchanged in all groups.
CONCLUSION


These findings suggest that the weight loss and metabolic benefits of ADF do not generally vary according to sex or menopausal status in adults with obesity.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT00960505; NCT03528317.",2021,"LDL cholesterol decreased more in postmenopausal versus premenopausal women (group × time interaction, P = 0.01).","['men and women (n\xa0=\xa075) who participated in three 12-week ADF studies (500\xa0kcal fast day; alternated with an ad libitum intake feast day', 'adults with obesity']",['alternate day fasting (ADF'],"['weight loss and metabolic benefits of ADF', 'Fasting glucose, HDL cholesterol, and triglycerides', 'Fat mass, lean mass, fasting insulin, and insulin resistance, and blood pressure', 'LDL cholesterol', 'Body weight']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0558287', 'cui_str': 'Alternate days'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0558351,"LDL cholesterol decreased more in postmenopausal versus premenopausal women (group × time interaction, P = 0.01).","[{'ForeName': 'Shuhao', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Manoela', 'Initials': 'M', 'LastName': 'Lima Oliveira', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gabel', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Kalam', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ezpeleta', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Bhutani', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: varady@uic.edu.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.10.018']
894,33373678,Coffee effectively attenuates impaired attention in ADORA2A C/C-allele carriers during chronic sleep restriction.,"Many people consume coffee to attenuate increased sleepiness and impaired vigilance and attention due to insufficient sleep. We investigated in genetically caffeine sensitive men and women whether 'real world' coffee consumption during a simulated busy work week counteracts disabling consequences of chronically restricted sleep. We subjected homozygous C-allele carriers of ADORA2A (gene encoding adenosine A 2A  receptors) to five nights of only 5 h time-in-bed. We administered regular coffee (n = 12; 200 mg caffeine at breakfast and 100 mg caffeine after lunch) and decaffeinated coffee (n = 14) in double-blind fashion on all days following sleep restriction. At regular intervals four times each day, participants rated their sleepiness and performed the psychomotor vigilance test, the visual search task, and the visuo-spatial and letter n-back tasks. At bedtime, we quantified caffeine and the major caffeine metabolites paraxanthine, theobromine and theophylline in saliva. The two groups did not differ in age, body-mass-index, sex-ratio, chronotype and mood states. Subjective sleepiness increased in both groups across consecutive sleep restriction days and did not differ. By contrast, regular coffee counteracted the impact of repeated sleep loss on sustained and selective attention, as well as executive control when compared to decaffeinated coffee. The coffee also induced initial or transient benefits on different aspects of baseline performance during insufficient sleep. All differences between the groups disappeared after the recovery night and the cessation of coffee administration. The data suggest that 'real world' coffee consumption can efficiently attenuate sleep restriction-induced impairments in vigilance and attention in genetically caffeine sensitive individuals. German Clinical Trial Registry: # DRSK00014379.",2020,"The 2 groups did not differ in age, body-mass-index, sex-ratio, chronotype and mood states.","[""genetically caffeine sensitive individuals whether 'real world' coffee consumption during a simulated busy work week counteracts disabling consequences of chronically restricted sleep""]","['ADORA2A', 'regular coffee (n\u202f=\u202f12; 200\u202fmg caffeine at breakfast and 100\u202fmg caffeine after lunch) and decaffeinated coffee', 'caffeine metabolites paraxanthine, theobromine and theophylline']","['psychomotor vigilance test, the visual search task, and the visuo-spatial and letter n-back tasks', 'Subjective sleepiness']","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C1527412', 'cui_str': 'ADORA2A protein, human'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1879668', 'cui_str': 'After lunch'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0044060', 'cui_str': '1,7-dimethylxanthine'}, {'cui': 'C0039763', 'cui_str': 'Theobromine'}, {'cui': 'C0039771', 'cui_str': 'Theophylline'}]","[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",,0.0488599,"The 2 groups did not differ in age, body-mass-index, sex-ratio, chronotype and mood states.","[{'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland; Sleep & Health Zurich, University Center of Competence, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': 'Department of Sleep and Human Factors, Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Elmenhorst', 'Affiliation': 'Department of Sleep and Human Factors, Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany; Institute for Occupational and Social Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elmenhorst', 'Affiliation': 'Institute of Neuroscience and Medicine, Forschungszentrum Jülich, Jülich, Germany; Faculty of Medicine, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bauer', 'Affiliation': 'Institute of Neuroscience and Medicine, Forschungszentrum Jülich, Jülich, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aeschbach', 'Affiliation': 'Department of Sleep and Human Factors, Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany; Faculty of Medicine, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, Zurich, Switzerland; Sleep & Health Zurich, University Center of Competence, University of Zurich, Zurich, Switzerland. Electronic address: landolt@pharma.uzh.ch.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110232']
895,33375222,Effects of Infection Control Education for Nursing Students Using Standardized Patients vs. Peer Role-Play.,"This study was conducted to identify and compare the effects of two education programs for infection control-a simulation using standardized patients and a peer role-play-on standard precaution knowledge, standard precaution awareness, infection-related anxiety, and infection control performance. This study used a nonequivalent control group pretest-posttest design. A total of 62 undergraduate nursing students in their 3rd year participated in the study, and were assigned to the experimental and control groups, accordingly. The infection control education program was developed based on the analysis, design, development, implementation, and evaluation model. The program for the experimental group included lectures, skills training, simulation using standardized patients, and debriefing, while the control group participated in the usual infection control education, consisting of lectures, skills training, and peer tutoring practices. Both groups exhibited statistically significant increases in knowledge, awareness of standard precaution, and infection control performance after the intervention. Infection-related anxiety and infection control performance were significantly higher in the simulation using a standardized patient group. Both education programs influenced compliance with the standard precaution for infection control. The results of this study contribute to the evidence regarding effective educational methods to improve infection control.",2020,"Both groups exhibited statistically significant increases in knowledge, awareness of standard precaution, and infection control performance after the intervention.","['Nursing Students Using Standardized Patients vs. Peer Role-Play', '62 undergraduate nursing students in their 3rd year participated in the study']","['Infection Control Education', 'lectures, skills training, simulation using standardized patients, and debriefing, while the control group participated in the usual infection control education, consisting of lectures, skills training, and peer tutoring practices']","['knowledge, awareness of standard precaution, and infection control performance', 'Infection-related anxiety and infection control performance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1161237', 'cui_str': 'Infection control education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",62.0,0.0187261,"Both groups exhibited statistically significant increases in knowledge, awareness of standard precaution, and infection control performance after the intervention.","[{'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Sang Suk', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}, {'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18010107']
896,33319493,"Co-ablation versus cryoablation for the treatment of stage III-IV non-small cell lung cancer: A prospective, noninferiority, randomized, controlled trial (RCT).","BACKGROUND


This study compared a co-ablation (CA) system, which is a novel ablation device, with an argon-helium cryoablation (AHC) system. We aimed to compare the efficacy and safety of CA and AHC for the treatment of stage III-IV non-small cell lung cancer (NSCLC).
METHODS


We conducted a multicenter randomized controlled trial (RCT) to determine whether CA was noninferior to AHC. The primary efficacy endpoints were the iceball coverage rate (ICR) and the disease control rate (DCR) one month after treatment. Noninferiority was declared if the lower limit of two-sided 95% confidence interval (CI) was less than 10%. The ICR and DCR were identified by logistic regression. Treatment safety was assessed.
RESULTS


A total of 81 patients underwent randomization (41 assigned to the CA and 40 assigned to the AHC groups)and transthoracic ablation. The ICRs in the CA and AHC groups were 99.24% ± 2.18% and 98.66% ± 3.79%, respectively. Central lesions were associated with an increased risk of an incomplete ICR. The DCRs in the CA and AHC groups were 97.6% and 95%, respectively. A smaller lesion area in the CA group was significantly correlated with a better DCR. The rate of complications was 29.26% in the CA group and 30% in the AHC group. (P = 0.943). There was less probe usage per patient in the CA group.
CONCLUSIONS


We determined that CA is noninferior to AHC in terms of efficacy and safety for the treatment of stage III-IV NSCLC. A smaller lesion area in the CA group was significantly correlated with a better DCR.
KEY POINTS


CA was noninferior to AHC for stage III-IV NSCLC.",2021,The primary efficacy endpoints were the iceball coverage rate (ICR) and the disease control rate (DCR) one month after treatment.,"['81 patients underwent randomization (41 assigned to the CA and 40 assigned to the', 'stage III-IV non-small cell lung cancer (NSCLC', 'stage III-IV non-small cell lung cancer']","['AHC groups)and transthoracic ablation', 'co-ablation (CA) system', 'CA and AHC', 'CA', 'Co-ablation versus cryoablation']","['rate of complications', 'efficacy and safety', 'ICR and DCR', 'iceball coverage rate (ICR) and the disease control rate (DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0003781', 'cui_str': 'Argon'}, {'cui': 'C0018880', 'cui_str': 'Helium'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",81.0,0.0665149,The primary efficacy endpoints were the iceball coverage rate (ICR) and the disease control rate (DCR) one month after treatment.,"[{'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Tumor Minimally Invasive Treatment, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'An', 'Affiliation': 'Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Quanwang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Oncology Department, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chuanbo', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Oncology Department, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Baorang', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Department of Tumor Minimally Invasive Treatment, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qianfu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Hygea Medical Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Hygea Medical Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Hygea Medical Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Huasong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory Medicine, The Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kaiwen', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Oncology Department, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}]",Thoracic cancer,['10.1111/1759-7714.13779']
897,33342710,"Tolerability of lacosamide rapid dose titration: A randomized, multicenter, prospective, open-label study.","OBJECTIVE


Currently recommended dosing of lacosamide often necessitates long titration periods. However, the use of a regimen consisting of initial loading dose of 200 mg followed by a maintenance dose of 200 mg/day in practice suggests tolerability of more rapid titration schedules. We aimed to clarify whether the shortened titration schedule affects tolerability of lacosamide.
METHODS


We evaluated the safety of two rapid titration protocols designed to reach the target dose of 400 mg/day within 1 week, and the conventional weekly titration protocol (reaching the target dose of 400 mg/day in three weeks). The ≥50% responder rate and steady-state plasma concentration of lacosamide were also analyzed. Adverse events were assessed at 1 week and 5 weeks after reaching the target dose.
RESULTS


Seventy-five patients with epilepsy were enrolled and evenly distributed to three titration protocols, from which 5 patients were lost to follow-up and excluded from the safety analysis. Discontinuation of lacosamide or dose reductions due to adverse events occurred in 32 patients (46%), of whom a large majority (74%) had experienced adverse events after reaching 400 mg/day, demonstrating apparent dose-dependency. There was no difference in safety outcomes among the three titration groups. Concomitant use of sodium channel blockers significantly increased the risk of adverse events.
CONCLUSION


Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol. Uptitration of lacosamide at shorter intervals to an effective target dosage may be feasible in appropriate clinical situations.",2021,"CONCLUSION


Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol.",['Seventy-five patients with epilepsy'],"['lacosamide', 'sodium channel blockers', 'lacosamide rapid dose titration']","['responder rate and steady-state plasma concentration of lacosamide', 'Tolerability', 'Adverse events', 'safety outcomes', 'adverse events', 'risk of adverse events']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",5.0,0.0525716,"CONCLUSION


Rapid titration protocols for lacosamide were not associated with an increased risk of adverse events compared to the conventional weekly titration protocol.","[{'ForeName': 'Yong-Won', 'Initials': 'YW', 'LastName': 'Shin', 'Affiliation': 'Center for Hospital Medicine, Department of Neurosurgery, Seoul National University Hospital, Seoul, Republic of Korea; Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jangsup', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Rare Disease Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Bin', 'Initials': 'SB', 'LastName': 'Hong', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do-Yong', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeyeon', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Seo Hyun', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Soon-Tae', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Hwa', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Il', 'Initials': 'KI', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Manho', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea; Protein Metabolism and Dementia Neuroscience Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kon', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: leejh413@snu.ac.kr.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: sangkun2923@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107663']
898,33342658,"Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation.","OBJECTIVE


The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019.
METHODS


Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery.
RESULTS


Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
CONCLUSION


For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).",2021,"Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
","['Patients at high risk of type II EL', 'selected patients at risk of EL', 'patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019', 'Ninety-four patients were enrolled, 47 in each group']","['ASCE', 'EVAR with coil ASCE', 'Endovascular Repair of Abdominal Aortic Aneurysm', 'CTA and Duplex ultrasound scans', 'standard EVAR', 'endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA', 'aneurysm sac coil embolisation (ASCE']","['intra-operative complications', 'freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation', 'rate of all types of EL', 'Aneurysm sac volume', 'aneurysm volume shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C1504464', 'cui_str': 'Endoleak'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0918249', 'cui_str': 'Endovascular repair of abdominal aortic aneurysm'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}]",94.0,0.0633954,"Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001).
","[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fabre', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France. Electronic address: fabre.dominique@gmail.com.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Mougin', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Mitilian', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Cochennec', 'Affiliation': 'Henri Mondor Hospital, University Paris XII, Creteil, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia Alonso', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Becquemin', 'Affiliation': 'Henri Mondor Hospital, University Paris XII, Creteil, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Desgranges', 'Affiliation': 'Henri Mondor Hospital, University Paris XII, Creteil, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Allaire', 'Affiliation': 'Henri Mondor Hospital, University Paris XII, Creteil, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hamdi', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brenot', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Riyad', 'Initials': 'R', 'LastName': 'Bourkaib', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Haulon', 'Affiliation': 'Vascular Centre, Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Université Paris Saclay, France.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.11.028']
899,33357995,"Reply to Satoshi Funada, Takashi Yoshioka, and Yan Luo's Letter to the Editor re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol 2020;78:701-10.",,2021,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.0672767,,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Athene Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.12.004']
900,33357992,"Re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol 2020;78:701-10.",,2021,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.120006,,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Funada', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan; Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan. Electronic address: sfunada@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshioka', 'Affiliation': 'Center for Innovative Research for Communities and Clinical Excellence, Fukushima Medical University, Fukushima, Japan; Department of Healthcare Epidemiology, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan.'}]",European urology,['10.1016/j.eururo.2020.12.014']
901,33375123,Effect of a Tailored Activity Pacing Intervention on Fatigue and Physical Activity Behaviours in Adults with Multiple Sclerosis.,"Tailored activity pacing could help manage fatigue and improve physical activity. However, little is known about how to tailor activity pacing for people with multiple sclerosis. This study aims to evaluate the effect of a tailored activity pacing intervention on fatigue and physical activity behaviours in adults with multiple sclerosis. Twenty-one adults with multiple sclerosis, stratified by age and gender, are randomly allocated to either a tailored pacing or control group. Participants wear an accelerometer for seven days that measures physical activity behaviours, and self-report fatigue at the baseline and four-week follow-up. Physical activity behaviours are assessed by examining activity level (seven-day average activity counts per minute) and activity variability (seven-day average highest activity counts each day divided by activity counts on that day). The intervention improves activity levels (Mean difference = 40.91; 95% Confidence Interval [CI] (3.84-77.96);  p  = 0.03) and lessens activity variability (Mean difference = -0.63; 95% CI (-1.25-0.02);  p  = 0.04). No significant effect is found for fatigue (Mean difference = -0.36; 95% CI (-1.02-0.30);  p  = 0.27). This investigation shows that tailoring activity pacing based on physical activity behaviours and fatigue is effective in improving physical activity levels, without exacerbating fatigue symptoms.",2020,The intervention improves activity levels (Mean difference = 40.91; 95% Confidence Interval [CI] (3.84-77.96);  p  = 0.03) and lessens activity variability (Mean difference = -0.63; 95% CI (-1.25-0.02);  p  = 0.04).,"['Twenty-one adults with multiple sclerosis, stratified by age and gender', 'people with multiple sclerosis', 'Adults with Multiple Sclerosis', 'adults with multiple sclerosis']","['Tailored Activity Pacing Intervention', 'tailored pacing or control group', 'tailored activity pacing intervention', 'Tailored activity pacing']","['Physical activity behaviours', 'activity level', 'Fatigue and Physical Activity Behaviours', 'physical activity behaviours, and self-report fatigue', 'activity levels', 'fatigue', 'physical activity levels', 'fatigue and physical activity behaviours', 'activity variability', 'lessens activity variability']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",21.0,0.0416204,The intervention improves activity levels (Mean difference = 40.91; 95% Confidence Interval [CI] (3.84-77.96);  p  = 0.03) and lessens activity variability (Mean difference = -0.63; 95% CI (-1.25-0.02);  p  = 0.04).,"[{'ForeName': 'Ulric S', 'Initials': 'US', 'LastName': 'Abonie', 'Affiliation': 'Department of Physiotherapy and Rehabilitation Sciences, University of Health and Allied Sciences, Ho, Volta Region PMB 31, Ghana.'}, {'ForeName': 'Florentina J', 'Initials': 'FJ', 'LastName': 'Hettinga', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Science, University of Essex, Wivenhoe Park, Colchester CO4 3SQ, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph18010017']
902,33354337,Web-based virtual reality to enhance behavioural skills training and weight loss in a commercial online weight management programme: The Experience Success randomized trial.,"Objective


Commercial online weight management programmes are popular and easily accessible but often lack training in empirically validated behaviour change strategies and produce suboptimal outcomes. This study evaluated the effects of a Web-based virtual reality (VR) programme for enhancing behavioural skills training and weight loss when offered as an adjunct to a commercial online weight management programme.
Methods


N  = 146 adults with overweight/obesity (body mass index [BMI] 27-40 kg/m 2 ) were randomized to 6 months of no-cost access to the Weight Watchers (WW) online platform alone or enhanced with the Experience Success (WW + ES) programme, consisting of four Web-based VR sessions for training in behavioural weight-loss skills related to the home environment, the workplace, physical activity and social situations (i.e., a party at a friend's house). Weight was measured at the research centre at baseline, 3 and 6 months.
Results


Both groups achieved statistically significant weight loss across the trial, with no difference in mean ± standard error (SE) weight loss between WW and WW + ES at 3 months (2.7 ± 1.1 kg vs. 4.2 ± 1.1 kg, respectively;  P  = .086) but greater weight loss in WW + ES at 6 months (2.6 ± 1.3 kg vs. 4.9 ± 1.3 kg, respectively;  P  = .042).
Conclusions


This study demonstrates the potential of Web-based VR skills training to enhance outcomes of commercial online weight management programmes that are widely accessible. Compared with traditional didactic methods for online skills training, VR simulation provides opportunities to learn behavioural skills via modelling and experiment with skills in real-world situations. More research is needed to identify specific behavioural mechanisms by which ES may improve outcomes.",2020,"Both groups achieved statistically significant weight loss across the trial, with no difference in mean ± standard error (SE) weight loss between WW and WW + ES at 3 months (2.7 ± 1.1 kg vs. 4.2 ± 1.1 kg, respectively;  P  = .086) but greater weight loss in WW + ES at 6 months (2.6 ± 1.3 kg vs. 4.9 ± 1.3 kg, respectively;  P  = .042).
",['Methods\n\n\nN  = 146 adults with overweight/obesity (body mass index [BMI] 27-40 kg/m 2 '],"['Web-based virtual reality (VR) programme', ""no-cost access to the Weight Watchers (WW) online platform alone or enhanced with the Experience Success (WW + ES) programme, consisting of four Web-based VR sessions for training in behavioural weight-loss skills related to the home environment, the workplace, physical activity and social situations (i.e., a party at a friend's house"", 'Web-based VR skills training']","['weight loss', 'Weight', 'mean ± standard error (SE) weight loss']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",146.0,0.0527714,"Both groups achieved statistically significant weight loss across the trial, with no difference in mean ± standard error (SE) weight loss between WW and WW + ES at 3 months (2.7 ± 1.1 kg vs. 4.2 ± 1.1 kg, respectively;  P  = .086) but greater weight loss in WW + ES at 6 months (2.6 ± 1.3 kg vs. 4.9 ± 1.3 kg, respectively;  P  = .042).
","[{'ForeName': 'John Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center Providence Rhode Island USA.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry and Human Behavior Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center Providence Rhode Island USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center Providence Rhode Island USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hadley', 'Affiliation': 'College of Education University of Oregon Eugene Oregon USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Virtually Better, Inc. Decatur Georgia USA.'}]",Obesity science & practice,['10.1002/osp4.451']
903,33374465,Acute Effects of Different Postactivation Potentiation Protocols on Traditional Rowing Performance.,"Postactivation potentiation (PAP) describes an initial muscular activation with a submaximal or maximal load intensity that produces acute improvements in muscle power and performance in subsequent explosive activities. The objective of this study was to compare the effect of different PAP protocols in rowing performance. A crossover design involving seven rowers was used, in which two different PAP protocols were applied: PAP of maximal conditioning contractions (PAP MCC) on a rowing ergometer to provide greater transferability and, thus, enhance the magnitude of PAP stimuli on subsequent rowing performance; and PAP of maximal strength contractions (PAP MSC) in half squat and bench pull exercises, similar to the main exercises in rowing strength training, to perform a 20 s ""all-out"" test simulating a competition start. Student's  t -test was used to compare means of the variables ( p  < 0.05). Effect size statistics were calculated using Cohen's  d . The PAP MCC protocol resulted in significant differences, with an extremely large effect size in average power output ( p  = 0.034,  d  = 0.98) in the first 3 ( p  = 0.019,  d  = 1.15) and first 5 ( p  = 0.036,  d  = 0.91) strokes. This group also reached a greater number of strokes ( p  = 0.049,  d  = 2.29) and strokes per minute ( p  = 0.046,  d  = 1.15). PAP with maximal conditioning contractions in rowing warm-up enhanced subsequent rowing sprint and is an advisable strategy to potentiate performance at the start of rowing competitions and sprint regattas.",2020,"This group also reached a greater number of strokes ( p  = 0.049,  d  = 2.29) and strokes per minute ( p  = 0.046,  d  = 1.15).",['seven rowers'],"['Postactivation potentiation (PAP', 'PAP of maximal conditioning contractions (PAP MCC', 'Different Postactivation Potentiation Protocols', 'maximal strength contractions (PAP MSC) in half squat and bench pull exercises, similar to the main exercises in rowing strength training']","['Traditional Rowing Performance', 'number of strokes']","[{'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0007129', 'cui_str': 'Merkel cell carcinoma'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",7.0,0.0232821,"This group also reached a greater number of strokes ( p  = 0.049,  d  = 2.29) and strokes per minute ( p  = 0.046,  d  = 1.15).","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Penichet-Tomas', 'Affiliation': 'Department of General and Specific Didactics, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Jimenez-Olmedo', 'Affiliation': 'Department of General and Specific Didactics, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Serra Torregrosa', 'Affiliation': 'Department of General and Specific Didactics, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Basilio', 'Initials': 'B', 'LastName': 'Pueo', 'Affiliation': 'Department of General and Specific Didactics, University of Alicante, 03690 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph18010080']
904,33374791,Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial.,"Oral lichen planus (OLP) is a chronic, inflammatory, immune-mediated disease, which can alter the quality of life of patients. The aim of this randomized clinical trial was to compare the therapeutic efficacy of clobetasol oral gel 0.05% versus an anti-inflammatory in oral solution (mouthwash) in the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects. Forty patients were assigned (20 patients for group), through a randomized design, to receive clobetasol gel 0.05% or an anti-inflammatory mouthwash, which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric pro-anthocyanidins) for three months. At baseline (T0) and after 3 months (T1), patients underwent dental and dermatological examinations to assess their symptoms (Numerical Pain Scale (NRS) score) and signs (Thongprasom score). Data were calculated using  T -test for the dependent variable, Wilcoxon test and Mann-Whitney u test. Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, ( p  < 0.001 and  p  = 0.02, respectively) and symptoms ( p  < 0.001 for clobetasol and  p  = 0.02 for anti-inflammatory). In conclusion, the results evidenced that, compared to clobetasol, the anti-inflammatory was less effective in determining the reduction of signs and symptom in OLP patients.",2020,"Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, ( p  < 0.001 and  p  = 0.02, respectively) and symptoms ( p  < 0.001 for clobetasol and  p  = 0.02 for anti-inflammatory).","['Patients with Symptomatic Oral Lichen Planus', 'Forty patients were assigned (20 patients for group', 'patients suffering from symptomatic OLP']","['clobetasol gel 0.05% or an anti-inflammatory mouthwash, which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric pro-anthocyanidins', 'Oral lichen planus (OLP', 'clobetasol oral gel', 'anti-inflammatory in oral solution (mouthwash']","['therapeutic efficacy', 'greater risk of developing side effects', 'symptoms (Numerical Pain Scale (NRS) score) and signs (Thongprasom score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0041631', 'cui_str': '7-Hydroxycoumarins'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0175820', 'cui_str': 'Anthocyanidin'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C1154190', 'cui_str': 'Oral gel'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",40.0,0.153104,"Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, ( p  < 0.001 and  p  = 0.02, respectively) and symptoms ( p  < 0.001 for clobetasol and  p  = 0.02 for anti-inflammatory).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Santonocito', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Oral Pathology, School of Dentistry, University of Catania, 95124 Catania, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Polizzi', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Oral Pathology, School of Dentistry, University of Catania, 95124 Catania, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'De Pasquale', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Dermatology, University of Catania, 95124 Catania, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Ronsivalle', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Oral Pathology, School of Dentistry, University of Catania, 95124 Catania, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Lo Giudice', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Oral Pathology, School of Dentistry, University of Catania, 95124 Catania, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Isola', 'Affiliation': 'Department of General Surgery and Surgical-Medical Specialties, Unit of Oral Pathology, School of Dentistry, University of Catania, 95124 Catania, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph18010056']
905,33381989,Core Strength Training Can Alter Neuromuscular and Biomechanical Risk Factors for Anterior Cruciate Ligament Injury.,"BACKGROUND


Core stability is influential in the incidence of lower extremity injuries, including anterior cruciate ligament (ACL) injuries, but the effects of core strength training on the risk for ACL injury remain unclear.
HYPOTHESIS


Core muscle strength training increases the knee flexion angle, hamstring to quadriceps (H:Q) coactivation ratio, and vastus medialis to vastus lateralis (VM:VL) muscle activation ratio, as well as decreases the hip adduction, knee valgus, and tibial internal rotation angles.
STUDY DESIGN


Controlled laboratory study.
METHODS


A total of 48 male participants were recruited and randomly assigned to either the intervention group (n = 32) or the control group (n = 16). Three-dimensional trunk, hip, knee, and ankle kinematic data and muscle activations of selected trunk and lower extremity muscles were obtained while the participants performed side-step cutting. The core endurance scores were measured before and after training. Two-way analyses of variance were conducted for each dependent variable to determine the effects of 10 weeks of core strength training.
RESULTS


The trunk endurance scores in the intervention group significantly increased after training ( P  < .05 for all comparisons). The intervention group showed decreased knee valgus ( P  = .038) and hip adduction angles ( P  = .032) but increased trunk flexion angle ( P  = .018), rectus abdominis to erector spinae coactivation ratio ( P  = .047), H:Q coactivation ratio ( P  = .021), and VM:VL activation ratio ( P  = .016). In addition, the knee valgus angle at initial contact was negatively correlated with the VM:VL activation ratio in the precontact phase ( R 2  = 0.188;  P  < .001) but was positively correlated with the hip adduction angle ( R 2  = 0.120;  P  < .005). No statistically significant differences were observed in the trunk endurance scores, kinematics, and muscle activations for the control group.
CONCLUSION


Core strength training altered the motor control strategies and joint kinematics for the trunk and the lower extremity by increasing the trunk flexion angle, VM:VL activation ratio, and H:Q activation ratio and reducing the knee valgus and hip adduction angles.
CLINICAL RELEVANCE


Training core muscles can modify the biomechanics associated with ACL injuries in a side-step cutting task; thus, core strength training might be considered in ACL injury prevention programs to alter the lower extremity alignment in the frontal plane and muscle activations during sports-related tasks.",2021,"The intervention group showed decreased knee valgus ( P  = .038) and hip adduction angles ( P  = .032) but increased trunk flexion angle ( P  = .018), rectus abdominis to erector spinae coactivation ratio ( P  =","['anterior cruciate ligament (ACL) injuries', '48 male participants', 'Anterior Cruciate Ligament Injury']",['Core strength training'],"['H:Q coactivation ratio', 'core endurance scores', 'trunk endurance scores, kinematics, and muscle activations', 'hip adduction angle', 'VM:VL activation ratio', 'trunk flexion angle', 'knee valgus', 'knee flexion angle, hamstring to quadriceps (H:Q) coactivation ratio, and vastus medialis to vastus lateralis (VM:VL) muscle activation ratio', 'hip adduction angles', 'rectus abdominis to erector spinae coactivation ratio', 'trunk endurance scores']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}]",48.0,0.0134268,"The intervention group showed decreased knee valgus ( P  = .038) and hip adduction angles ( P  = .032) but increased trunk flexion angle ( P  = .018), rectus abdominis to erector spinae coactivation ratio ( P  =","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Department of Mechanical Engineering, Sogang University, Mapo-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Dai-Hyuk', 'Initials': 'DH', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Education, Graduate School of Education, Sogang University, Mapo-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Choongsoo S', 'Initials': 'CS', 'LastName': 'Shin', 'Affiliation': 'Department of Mechanical Engineering, Sogang University, Mapo-gu, Seoul, Republic of Korea.'}]",The American journal of sports medicine,['10.1177/0363546520972990']
906,33385299,Low-dose rifaximin prevents complications and improves survival in patients with decompensated liver cirrhosis.,"BACKGROUND AND AIMS


Rifaximin has been recommended as a prophylactic drug for hepatic encephalopathy (HE) and spontaneous bacterial peritonitis (SBP). This study aims to explore whether low-dose rifaximin can prevent overall complications and prolong survival in cirrhotic patients.
METHODS


In this multi-centre randomized open-labelled prospective study, 200 patients with decompensated cirrhosis were randomly assigned at a ratio of 1:1. Patients in rifaximin group were administered 400 mg rifaximin twice daily for 6 months, and all other therapeutic strategies were kept unchanged in both groups as long as possible. The primary efficacy endpoints were the incidence of overall complications and liver transplantation-free survival. The secondary endspoints were the incidence of each major cirrhosis-related complication, as well as the Child-Pugh score and class.
RESULTS


The major baseline characteristics were similar in the two groups except for HE. The cumulative incidence and frequency of overall complications were significantly lower in rifaximin group than in the control group (p < 0.001). Though liver transplantation-free survival was not significantly different between the two groups, subgroup analysis showed rifaximin markedly prolonged liver transplantation-free survival in patients with Child-Pugh score ≥ 9 (p = 0.007). Moreover, rifaximin markedly reduced the episodes of ascites exacerbation (p < 0.001), HE (p < 0.001) and gastric variceal bleeding (EGVB, p = 0.031). The incidence of adverse events was similar in the two groups.
CONCLUSION


Low-dose rifaximin significantly decreases the occurrence of overall complications, leading to prolonged survival in patients with advanced stages of cirrhosis in this trail. Further study should be carried out to compare the effect of this low-dose rifaximin with normal dose (1200 mg/day) rifaximin in preventing cirrhosis-related complications.
CLINICAL TRIAL NUMBER


NCT02190357.",2021,"Though liver transplantation-free survival was not significantly different between the two groups, subgroup analysis showed rifaximin markedly prolonged liver transplantation-free survival in patients with Child-","['200 patients with decompensated cirrhosis', 'patients with Child', 'patients with decompensated liver cirrhosis', 'patients with advanced stages of cirrhosis', 'cirrhotic patients']","['rifaximin', 'Low-dose rifaximin']","['cumulative incidence and frequency of overall complications', 'survival', 'incidence of each major cirrhosis-related complication, as well as the Child-Pugh score and class', 'gastric variceal bleeding', 'incidence of overall complications and liver transplantation-free survival', 'occurrence of overall complications', 'overall complications and prolong survival', 'adverse events', 'liver transplantation-free survival', 'episodes of ascites exacerbation']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]",200.0,0.246619,"Though liver transplantation-free survival was not significantly different between the two groups, subgroup analysis showed rifaximin markedly prolonged liver transplantation-free survival in patients with Child-","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Pei-Qin', 'Initials': 'PQ', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Hai-Guang', 'Initials': 'HG', 'LastName': 'Xin', 'Affiliation': 'Department of Infectious Disease, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, China.'}, {'ForeName': 'Yi-Bin', 'Initials': 'YB', 'LastName': 'Guo', 'Affiliation': 'Department of Health Statistics, Second Military Medical University, Shanghai, 200433, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Cheng-Zhi', 'Initials': 'CZ', 'LastName': 'He', 'Affiliation': 'Division of Gastroenterology and Hepatology, Institute of Digestive Disease, Tongji Hospital, Tongji University School of Medicine, Shanghai, 200065, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Tao-Tao', 'Initials': 'TT', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Wei-Juan', 'Initials': 'WJ', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and HepatologyState Key Laboratory for Oncogenes and Related GenesSchool of Medicine, Ministry of HealthRenji HospitalShanghai Jiao Tong University; Shanghai Institute of Digestive Disease, Shanghai, 200001, China.'}, {'ForeName': 'Pei-Mei', 'Initials': 'PM', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Zong-Li', 'Initials': 'ZL', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and HepatologyState Key Laboratory for Oncogenes and Related GenesSchool of Medicine, Ministry of HealthRenji HospitalShanghai Jiao Tong University; Shanghai Institute of Digestive Disease, Shanghai, 200001, China.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China.'}, {'ForeName': 'Xi-Zhong', 'Initials': 'XZ', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Institute of Digestive Disease, Tongji Hospital, Tongji University School of Medicine, Shanghai, 200065, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Nong-Hua', 'Initials': 'NH', 'LastName': 'Lv', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Wei-Fen', 'Initials': 'WF', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. weifenxie@medmail.com.cn.'}]",Hepatology international,['10.1007/s12072-020-10117-y']
907,33383396,The effectiveness of diaphragmatic breathing relaxation training for improving sleep quality among nursing staff during the COVID-19 outbreak: a before and after study.,"OBJECTIVES


Recent studies have demonstrated that first-line nurses involved in the coronavirus disease-2019 (COVID-19) crisis may experience sleep disturbances. As breathing relaxation techniques can improve sleep quality, anxiety, and depression, the current study aimed to evaluate the effectiveness of diaphragmatic breathing relaxation training (DBRT) for improving sleep quality among nurses in Wuhan, China during the COVID-19 outbreak.
METHODS


This study used a quasi-experimental (before and after) intervention strategy, with 151 first-line nurses from four wards in Leishenshan hospital. The Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) to evaluate the effectiveness of DBRT before and after the intervention. Data were examined using the Shapiro-Wilk test, Levene's test, and paired t-test.
RESULTS


A total of 140 nurses completed the DBRT sessions. First-line nurses achieved significant reductions in global sleep quality (p < 0.01), subjective sleep quality (p < 0.001), sleep latency (p < 0.01), sleep duration (p < 0.001), sleep disturbances (p < 0.001), habitual sleep efficiency (p = 0.015), daytime dysfunction (p = 0.001), and anxiety (p = 0.001). There were no significant reductions in the use of sleeping medication (p = 0.134) and depression (p = 0.359).
CONCLUSION


DBRT is a useful non-pharmacological treatment for improving sleep quality and reducing anxiety among first-line nurses involved in the COVID-19 outbreak. The study protocol was clinically registered by the Chinese Clinical Trial Registry.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000032743.",2021,"First-line nurses achieved significant reductions in global sleep quality (p < 0.01), subjective sleep quality (p < 0.001), sleep latency (p < 0.01), sleep duration (p < 0.001), sleep disturbances (p < 0.001), habitual sleep efficiency (","['nursing staff during the COVID-19 outbreak', '151 first-line nurses from four wards in Leishenshan hospital', '140 nurses completed the DBRT sessions', 'nurses in Wuhan, China during the COVID-19 outbreak']","['diaphragmatic breathing relaxation training (DBRT', 'DBRT', 'diaphragmatic breathing relaxation training']","['subjective sleep quality', 'global sleep quality', 'anxiety', 'sleep duration', 'habitual sleep efficiency', 'daytime dysfunction', 'sleep quality, anxiety, and depression', 'sleeping medication', 'sleep latency', 'Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS', 'sleep quality and reducing anxiety', 'sleep disturbances']","[{'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",140.0,0.0164119,"First-line nurses achieved significant reductions in global sleep quality (p < 0.01), subjective sleep quality (p < 0.001), sleep latency (p < 0.01), sleep duration (p < 0.001), sleep disturbances (p < 0.001), habitual sleep efficiency (","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: 1227608241@qq.com.'}, {'ForeName': 'Tong-Tong', 'Initials': 'TT', 'LastName': 'Jiang', 'Affiliation': 'The Graduate School of Nursing, Chiba University, Chiba, 263-0043, Japan. Electronic address: 2415326237@qq.com.'}, {'ForeName': 'Tie-Ying', 'Initials': 'TY', 'LastName': 'Shi', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: sty11177@163.com.'}, {'ForeName': 'Yong-Ning', 'Initials': 'YN', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: lyn_88818@163.com.'}, {'ForeName': 'Xiu-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: liuxiumei0411@163.com.'}, {'ForeName': 'Guo-Jun', 'Initials': 'GJ', 'LastName': 'Xu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: xgj1973@163.com.'}, {'ForeName': 'Fang-Lin', 'Initials': 'FL', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: 746069668@qq.com.'}, {'ForeName': 'Yue-Liang', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: wyl_moon@163.com.'}, {'ForeName': 'Xiao-Yu', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning Province, 116011 PR China. Electronic address: 18098872716@163.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.12.003']
908,33372122,Three-Year Outcomes After Brief Treatment of Substance Use and Mood Symptoms.,"BACKGROUND


Screening, brief intervention, and referral to treatment (SBIRT) for adolescents exhibiting co-occurring substance use and mental health problems may improve outcomes and have long-lasting effects. This study examined the relationship between access to SBIRT and substance use, depression and medical diagnoses, and health services use at 1 and 3 years postscreening for such adolescents.
METHODS


The study draws from a cluster-randomized trial comparing SBIRT to usual care (UC) for adolescents endorsing past-year substance use and recent mood symptoms during visits to a general pediatrics clinic between November 1, 2011, and October 31, 2013, in a large, integrated health system ( N  = 1851); this sample examined the subset of adolescents endorsing both problems ( n  = 289). Outcomes included depression, substance use and medical diagnoses, and emergency department and outpatient visits 1 and 3 years later.
RESULTS


The SBIRT group had lower odds of depression diagnoses at 1 (odds ratio [OR] = 0.31; confidence interval [CI] = 0.11-0.87) and 3 years (OR = 0.51; CI = 0.28-0.94) compared with the UC group. At 3 years, the SBIRT group had lower odds of a substance use diagnosis (OR = 0.46; CI = 0.23-0.92), and fewer emergency department visits (rate ratio = 0.65; CI = 0.44-0.97) than UC group.
CONCLUSIONS


The findings suggest that SBIRT may prevent health complications and avert costly services use among adolescents with both mental health and substance use problems. As SBIRT is implemented widely in pediatric primary care, training pediatricians to discuss substance use and mental health problems can translate to positive outcomes for these vulnerable adolescents.",2021,The SBIRT group had lower odds of depression diagnoses at 1 (odds ratio [OR] = 0.31; confidence interval [CI] = 0.11-0.87) and 3 years (OR = 0.51; CI = 0.28-0.94) compared with the UC group.,"['adolescents exhibiting co-occurring substance use and mental health problems', 'adolescents endorsing past-year substance use and recent mood symptoms during visits to a general pediatrics clinic between November 1, 2011, and October 31, 2013, in a large, integrated health system ( N  = 1851); this sample examined the subset of adolescents endorsing both problems ( n  = 289', 'adolescents with both mental health and substance use problems']","['SBIRT to usual care (UC', 'SBIRT']","['emergency department visits', 'depression diagnoses', 'depression, substance use and medical diagnoses, and emergency department and outpatient visits 1 and 3 years later', 'health complications']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0771096,The SBIRT group had lower odds of depression diagnoses at 1 (odds ratio [OR] = 0.31; confidence interval [CI] = 0.11-0.87) and 3 years (OR = 0.51; CI = 0.28-0.94) compared with the UC group.,"[{'ForeName': 'Sujaya', 'Initials': 'S', 'LastName': 'Parthasarathy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California; and sujaya.parthasarathy@kp.org.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Kline-Simon', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hartman', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Saba', 'Affiliation': 'The Permanente Medical Group, Oakland, California.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Weisner', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California; and.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sterling', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California; and.'}]",Pediatrics,['10.1542/peds.2020-009191']
909,33385766,Effect of 8 weeks' supplementation grape seed extract on insulin resistance in iranian adolescents with metabolic syndrome: A randomized controlled trial.,"BACKGROUND AND AIMS


Insulin resistance in adolescents is a major health concern. The aim of this study was to evaluate the effect of grape seed extract on insulin resistance in adolescents with metabolic syndrome (MetS).
METHODS


Participants were divided into grape seed extract (GSE) and placebo groups (n = 24 each) and received 100 mg/day of GSE or placebo and were placed on a weight loss diet for 8 weeks. Anthropometric and biochemical indices, blood pressure, dietary intake, and physical activity were measured before and after the intervention.
RESULTS


Forty-two participants completed the trial. After the intervention, the age, sex, baseline values, energy intake and physical activity as a covariate adjusted using ANCOVA for determine differences between groups. The MD (mean difference ±SEM) of HOMA-IR between the GSE group (-1.46 ± 0.45) and the placebo group (-0.48 ± 0.47), (p = 0.020), and the MD of insulin between the GSE group (-7.05 ± 2.11) and the placebo group (-1.71 ± 2.12), (p = 0.024), were significant. Although changes were observed in other variables, they were not statistically significant.
CONCLUSIONS


GSE improves insulin concentration and insulin resistance in adolescents with MetS and provides a basis for possible application of the GSE in the clinical management of MetS in adolescents. This study registered under Randomized Clinical Trials.gov Identifier no. IRCT2013112611288N7.",2020,"The MD (mean difference ±SEM) of HOMA-IR between the GSE group (-1.46 ± 0.45) and the placebo group (-0.48 ± 0.47), (p = 0.020), and the MD of insulin between the GSE group (-7.05 ± 2.11) and the placebo group (-1.71 ± 2.12), (p = 0.024), were significant.","['adolescents with MetS', 'adolescents with metabolic syndrome (MetS', 'iranian adolescents with metabolic syndrome', 'Forty-two participants completed the trial', 'Participants were divided into']","['GSE or placebo', 'placebo', 'supplementation grape seed extract', 'grape seed extract (GSE) and placebo', 'GSE', 'grape seed extract']","['Anthropometric and biochemical indices, blood pressure, dietary intake, and physical activity', 'HOMA-IR', 'insulin resistance', 'MD of insulin', 'insulin concentration and insulin resistance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",42.0,0.530667,"The MD (mean difference ±SEM) of HOMA-IR between the GSE group (-1.46 ± 0.45) and the placebo group (-0.48 ± 0.47), (p = 0.020), and the MD of insulin between the GSE group (-7.05 ± 2.11) and the placebo group (-1.71 ± 2.12), (p = 0.024), were significant.","[{'ForeName': 'Alizadeh', 'Initials': 'A', 'LastName': 'Mohammad', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, Iran, Postal code: 5166614711, POBOX: 14711. Electronic address: mdalizadeh@tbzmed.ac.ir.'}, {'ForeName': 'Taghizadeh', 'Initials': 'T', 'LastName': 'Shahnaz', 'Affiliation': 'Student Research Committee, Department of Biochemistry and Diet Therapy, Faculty of Nutrition Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, Iran, Postal code: 5166614711, POBOX: 14711. Electronic address: sh.taghizadeh54@gmail.com.'}, {'ForeName': 'Kheirouri', 'Initials': 'K', 'LastName': 'Sorayya', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, Iran, Postal code: 5166614711, POBOX: 14711. Electronic address: kheirouris@tbzmed.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.12.028']
910,33360642,A block randomised controlled trial investigating changes in postural control following a personalised 12-week exercise programme for individuals with lower limb amputation.,"BACKGROUND


Individuals with a lower limb amputation (LLA) have an increased risk of falls and often report lower balance confidence. They must compensate for altered mechanics and prosthetic limitations in order to execute appropriate motor responses to postural perturbations. Personalised exercise could be an effective strategy to enhance balance and reduce falls.
RESEARCH QUESTION


In this study, we investigated whether a personalised exercise programme could improve postural control and self-reported balance confidence in individuals with an LLA.
METHODS


Participants were block randomised into two groups (exercise, n = 7; control, n = 7) based on age and level of amputation. The exercise group completed a 12-week personalised exercise programme, including home-based exercise sessions, consisting of balance, endurance, strength, and flexibility training. The control group continued with their normal daily activities. All participants performed the Sensory Organization Test (SOT) and Motor Control Test (MCT) on the NeuroCom SMART Equitest, and completed the Activities-specific Balance Confidence-UK (ABC) self-report questionnaire, at baseline and post-intervention.
RESULTS AND SIGNIFICANCE


Exercise group equilibrium scores improved significantly when standing on an unstable support surface with no visual input and inaccurate somatosensory feedback (SOT condition 5, P < 0.012, d = 1.45). There were significant group*time interactions for medium (P = 0.029) and large (P = 0.048) support surface forward translations, which were associated with a trend towards increased weight-bearing on the intact limb in the control group (medium: P = 0.055; large: P = 0.087). No significant changes in ABC score were observed. These results indicate reduced reliance on visual input, and/or enhanced interpretation of somatosensory input, following an exercise programme. However, objective improvements in aspects of postural control were not associated with subjective improvements in self-reported balance confidence. More weight-bearing asymmetry in the control group suggests that a lack of targeted exercise training may have detrimental effects, with potential adverse long-term musculoskeletal consequences, that were quantifiable within a short timeframe.",2020,"RESULTS AND SIGNIFICANCE


Exercise group equilibrium scores improved significantly when standing on an unstable support surface with no visual input and inaccurate somatosensory feedback (SOT condition 5, P < 0.012, d = 1.45).","['Individuals with a lower limb amputation (LLA', 'individuals with an LLA', 'individuals with lower limb amputation', 'Participants']","['Personalised exercise', 'personalised 12-week exercise programme', 'personalised exercise programme, including home-based exercise sessions, consisting of balance, endurance, strength, and flexibility training', 'targeted exercise training', 'personalised exercise programme']","['postural control and self-reported balance confidence', 'Sensory Organization Test (SOT) and Motor Control Test (MCT) on the NeuroCom SMART Equitest, and completed the Activities-specific Balance Confidence-UK (ABC) self-report questionnaire', 'weight-bearing on the intact limb', 'ABC score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C4720933', 'cui_str': 'Motor control test'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0369056,"RESULTS AND SIGNIFICANCE


Exercise group equilibrium scores improved significantly when standing on an unstable support surface with no visual input and inaccurate somatosensory feedback (SOT condition 5, P < 0.012, d = 1.45).","[{'ForeName': 'Zoe A', 'Initials': 'ZA', 'LastName': 'Schafer', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, HU6 7RX, United Kingdom.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Vanicek', 'Affiliation': 'Department of Sport, Health and Exercise Science, University of Hull, Hull, HU6 7RX, United Kingdom. Electronic address: n.vanicek@hull.ac.uk.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.001']
911,33360382,Interference of balance tasks revisited: Consolidation of a novel balance task is impaired by subsequent learning of a similar postural task.,"BACKGROUND


Interference effects have repeatedly been demonstrated for simple motor tasks but not for the complex whole-body task of balancing. It was therefore assumed that different balance tasks are so specific that they do not elicit interacting adaptations; neither in a positive (contextual interference) nor in a negative way (disruption of motor consolidation).
RESEARCH QUESTION


Is a novel balancing task susceptible to interference if a similar balance task is learned shortly afterwards?
METHODS


The common A 1 -B-A 2  interference intervention design was applied. Participants were assigned to one of four intervention groups that differed with respect to task B. All four groups performed postural task A on a rocker board device (6 series of 8 trials of 8 s). Shortly after completion of task A, participants performed their respective task B (postural wobble board (P-WB), ballistic force, accuracy) or rested (control group). 24 h later, all groups performed a retention test of task A consisting of one series of 8 trials. To test for interference, we calculated repeated mixed design analysis of covariance (ANCOVA).
RESULTS


For the retention test, the ANCOVA revealed a significant TIME*GROUP interaction (p = .010), which was followed up by separate Bonferroni-corrected post-hoc tests for each group. These tests showed a significant performance decrease for the P-WB group (p = .016) but no change in performance for the other three groups.
SIGNIFICANCE


In contrast to previous findings, our results indicate that the complex whole-body task of balancing is susceptible to interference, but only, when task B consists of a similar balance task. This is of great functional relevance as for example fall prevention programs incorporate many different balance tasks to prepare participants for all sorts of situations. In such interventions, it seems therefore advisable to apply a random instead of a blocked practice design.",2020,"These tests showed a significant performance decrease for the P-WB group (p = .016) but no change in performance for the other three groups.
",[],[],[],[],[],[],,0.0289971,"These tests showed a significant performance decrease for the P-WB group (p = .016) but no change in performance for the other three groups.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Egger', 'Affiliation': 'Department of Neurosciences and Movement Science, University of Fribourg, Fribourg, Switzerland. Electronic address: sven.egger@unifr.ch.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wälchli', 'Affiliation': 'Department of Neurosciences and Movement Science, University of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rüeger', 'Affiliation': 'Department of Neurosciences and Movement Science, University of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Taube', 'Affiliation': 'Department of Neurosciences and Movement Science, University of Fribourg, Fribourg, Switzerland.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.015']
912,33388335,Effects of fact-checking social media vaccine misinformation on attitudes toward vaccines.,"Social media vaccine misinformation can negatively influence vaccine attitudes. It is urgent to develop communication approaches to reduce the misinformation's impact. This study aimed to test the effects of fact-checking labels for misinformation on attitudes toward vaccines. An online survey experiment with 1198 participants recruited from a U.S. national sample was conducted in 2018. Participants were randomly assigned to six conditions: misinformation control, or fact-checking label conditions attributed to algorithms, news media, health institutions, research universities, or fact-checking organizations. We analyzed differences in vaccine attitudes between the fact-checking label and control conditions. Further, we compared perceived expertise and trustworthiness of the five categories of fact-checking sources. Fact-checking labels attached to misinformation posts made vaccine attitudes more positive compared to the misinformation control condition (P = .003, Cohen's d= 0.21). Conspiracy ideation moderated the effect of the labels on vaccine attitudes (P = .02). Universities and health institutions were rated significantly higher on source expertise than other sources. Mediation analyses showed labels attributed to universities and health institutions indirectly resulted in more positive attitudes than other sources through perceived expertise. Exposure to fact-checking labels on misinformation can generate more positive attitudes toward vaccines in comparison to exposure to misinformation. Incorporating labels from trusted universities and health institutions on social media platforms is a promising direction for addressing the vaccine misinformation problem. This points to the necessity for closer collaboration between public health and research institutions and social media companies to join efforts in addressing the current misinformation threat.",2021,Exposure to fact-checking labels on misinformation can generate more positive attitudes toward vaccines in comparison to exposure to misinformation.,['1198 participants recruited from a U.S. national sample was conducted in 2018'],"['misinformation control, or fact-checking label conditions attributed to algorithms, news media, health institutions, research universities, or fact-checking organizations', 'fact-checking social media vaccine misinformation', 'fact-checking labels']","['vaccine attitudes', 'attitudes toward vaccines', 'positive attitudes']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0079843', 'cui_str': 'Misinformation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",1198.0,0.0258633,Exposure to fact-checking labels on misinformation can generate more positive attitudes toward vaccines in comparison to exposure to misinformation.,"[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave, Davis, CA 95616, United States of America; Department of Public Health Sciences, University of California Davis, One Shields Ave, Davis, CA 95616, United States of America. Electronic address: jwzzhang@ucdavis.edu.'}, {'ForeName': 'Jieyu Ding', 'Initials': 'JD', 'LastName': 'Featherstone', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave, Davis, CA 95616, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Calabrese', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave, Davis, CA 95616, United States of America.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Wojcieszak', 'Affiliation': 'Department of Communication, University of California Davis, One Shields Ave, Davis, CA 95616, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106408']
913,33385534,Effects of cervical restorations on the periodontal tissues: 5-year follow-up results of a randomized clinical trial.,"OBJECTIVE


This study evaluated the effect of resin composite restorations of non-carious cervical lesions (NCCLs) on the occurrence/progression of gingival recession (GR), considering different tooth isolation techniques.
METHODS


A randomized controlled split-mouth and blinded trial was carried out. Patients (n = 38) with at least two NCCLs were included. Before the cervical restoration placement, the NCCLs (181 teeth) were randomly allocated into two treatment groups according to the tooth isolation techniques: cotton roll or rubber dam. Experienced, trained, blinded, and calibrated examiners performed periodontal evaluations at baseline and 5-year follow-up, using a periodontal probe. Restorations were assessed with the FDI criteria. Thirty-two patients (154 teeth) were evaluated at 5 years. The occurrence/progression of GR between baseline and follow-up was considered the primary outcome. The relative risk (RR) and 95 % confidence interval (95 %CI) were calculated by Poisson regression (α < 0.05).
RESULTS


After 5 year, 31 teeth (13.6 %) presented occurrence/progression of GR. In the multivariate analyses, the occurrence/progression of GR was associated with the use of rubber dam isolation (RR; 95 %CI: 2.65; 1.01-7.00) and a lack of marginal adaptation of the restoration (RR; 95 %CI: 10.98; 2.31-52.30). Toothbrush stiffness, use of abrasive dentifrice, tooth type, and the presence of biofilm or gingivitis did not present a statistically significant higher risk for occurrence/progression of GR.
CONCLUSION


The use of rubber dam isolation associated with retraction clamp and the lack of a proper marginal adaptation of the composite restorations are risk indicators for the occurrence/progression of GR in individuals who received a restoration for an NCCL.
CLINICAL SIGNIFICANCE


Isolation with a rubber dam and dental clamps may promote GR in sites with restored NCCLs. Moreover, clinical examinations for lack of marginal adaptations of the restorations may be included in a clinical setting.",2020,"In the multivariate analyses, occurrence/progression of GR was associated with the use of rubber dam isolation (RR; 95%CI: 2.65; 1.01 - 7.00) and lack of marginal adaptation of the restoration (RR; 95%CI: 10.98; 2.31 - 52.30).","['Patients (n\u2009=\u200938) with at least two NCCL were included', '181 teeth']","['resin composite restorations', 'NCCL', 'tooth isolation techniques: cotton roll or rubber dam', 'cervical restorations']","['relative risk (RR) and 95% confidence interval (95%CI', 'occurrence/progression of GR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0204727', 'cui_str': 'Isolation technique'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0085275', 'cui_str': 'Dental rubber dam'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]",,0.120644,"In the multivariate analyses, occurrence/progression of GR was associated with the use of rubber dam isolation (RR; 95%CI: 2.65; 1.01 - 7.00) and lack of marginal adaptation of the restoration (RR; 95%CI: 10.98; 2.31 - 52.30).","[{'ForeName': 'Morgana', 'Initials': 'M', 'LastName': 'Favetti', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Anelise Fernandes', 'Initials': 'AF', 'LastName': 'Montagner', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Silvia Terra', 'Initials': 'ST', 'LastName': 'Fontes', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Thiago Marchi', 'Initials': 'TM', 'LastName': 'Martins', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Alexandre Severo', 'Initials': 'AS', 'LastName': 'Masotti', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Patricia Dos Santos', 'Initials': 'PDS', 'LastName': 'Jardim', 'Affiliation': 'Private Dental Practioner, Pelotas, RS, Brazil.'}, {'ForeName': 'Fernanda Oliveira Bello', 'Initials': 'FOB', 'LastName': 'Corrêa', 'Affiliation': 'Department of Dentistry. Federal University of Juiz de Fora, Governador Valadares, MG, Brazil.'}, {'ForeName': 'Maximiliano Sergio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil.'}, {'ForeName': 'Francisco Wilker Mustafa Gomes', 'Initials': 'FWMG', 'LastName': 'Muniz', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, RS, Brazil. Electronic address: muniz.fwmg@ufpel.edu.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103571']
914,33390029,Effect on health-related quality of life of the X-Bolt dynamic plating system versus the sliding hip screw for the fixation of trochanteric fractures of the hip in adults: the WHiTE Four randomized clinical trial.,"AIMS


Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures.
METHODS


We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.
RESULTS


Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar.
CONCLUSION


Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article:  Bone Joint J  2021;103-B(2):256-263.",2021,Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important.,"['Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals', 'trochanteric fractures of the hip in adults', 'fragility hip fractures', '1,128 participants were randomized with 564 participants allocated to each group']","['X-Bolt dynamic plating system', 'sliding hip screw', 'XHS or SHS', 'novel X-Bolt Hip System (XHS', 'sliding hip screw (SHS']","['EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures', 'lower risks of revision surgery', 'EuroQol five-dimension five-level health status (EQ-5D-5L) utility', 'safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0302113', 'cui_str': 'Fragility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336726', 'cui_str': 'Archery bolt'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0445192', 'cui_str': 'Plating system'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1128.0,0.279794,Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important.,"[{'ForeName': 'Xavier L', 'Initials': 'XL', 'LastName': 'Griffin', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heather Marie', 'Initials': 'HM', 'LastName': ""O'Connor"", 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford.'}, {'ForeName': 'Matt L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The bone & joint journal,['10.1302/0301-620X.103B.BJJ-2020-1404.R1']
915,33390020,Randomized comparative study between extensile lateral and sinus tarsi approaches for the treatment of Sanders type 2 calcaneal fracture.,"AIMS


No randomized comparative study has compared the extensile lateral approach (ELA) and sinus tarsi approach (STA) for Sanders type 2 calcaneal fractures. This randomized comparative study was conducted to confirm whether the STA was prone to fewer wound complications than the ELA.
METHODS


Between August 2013 and August 2018, 64 patients with Sanders type 2 calcaneus fractures were randomly assigned to receive surgical treatment by the ELA (32 patients) and STA (32 patients). The primary outcome was development of wound complications. The secondary outcomes were postoperative complications, pain scored of a visual analogue scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) score, 36-item Short Form health survey, operative duration, subtalar joint range of motion (ROM), Böhler's angle and calcaneal width, and posterior facet reduction.
RESULTS


Although four patients (12.5%) in the ELA groups and none in the STA group experienced complications, the difference was not statistically significant (p = 0.113). VAS and AOFAS score were significantly better in the STA group than in the ELA group at six months (p = 0.017 and p = 0.021), but not at 12 months (p = 0.096 and p = 0.200) after surgery. The operation time was significantly shorter in the STA group than in the ELA group (p < 0.001). The subtalar joint ROM was significantly better in the STA group (p = 0.015). Assessment of the amount of postoperative reduction compared with the uninjured limb showed significant restoration of calcaneal width in the ELA group compared with that in the STA group (p < 0.001).
CONCLUSION


The ELA group showed higher frequency of wound complications than the STA group for Sanders type 2 calcaneal fractures even though this was not statistically significant. Cite this article:  Bone Joint J  2021;103-B(2):286-293.",2021,The ELA group showed higher frequency of wound complications than the STA group for Sanders type 2 calcaneal fractures even though this was not statistically significant.,"['Sanders type 2 calcaneal fracture', 'Between August 2013 and August 2018, 64 patients with Sanders type 2 calcaneus fractures', 'Sanders type 2 calcaneal fractures']","['ELA', 'STA', 'surgical treatment by the ELA', 'extensile lateral and sinus tarsi approaches', 'extensile lateral approach (ELA) and sinus tarsi approach (STA']","['subtalar joint ROM', ""postoperative complications, pain scored of a visual analogue scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) score, 36-item Short Form health survey, operative duration, subtalar joint range of movement (ROM), Böhler's angle and calcaneal width, and posterior facet reduction"", 'VAS and AOFAS score', 'calcaneal width', 'frequency of wound complications', 'operation time', 'wound complications', 'development of wound complications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281926', 'cui_str': 'Fracture of calcaneus'}]","[{'cui': 'C0205514', 'cui_str': 'Lateral approach'}, {'cui': 'C4082813', 'cui_str': 'Sinus Tarsi'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0576287', 'cui_str': 'Subtalar joint - range of movement'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",64.0,0.0430762,The ELA group showed higher frequency of wound complications than the STA group for Sanders type 2 calcaneal fractures even though this was not statistically significant.,"[{'ForeName': 'Chul Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'College of Medicine, Yeungnam University, Daegu, Republic of Korea, Daegu, Korea.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedic Surgery, Yeungnam University Medical Center, Daegu, Korea.'}, {'ForeName': 'Jeongjin', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Yeungnam University Medical Center, Daegu, Korea.'}]",The bone & joint journal,['10.1302/0301-620X.103B.BJJ-2020-1313.R1']
916,33390285,"Reply to Amit Bansal, Ruchir Maheshwari, and Anant Kumar's Letter to the Editor re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol 2020;78:757-63.",,2021,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0189044,,"[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden. Electronic address: fredrik.liedberg@med.lu.se.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Kollberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Allerbo', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Baseckas', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brändstedt', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Gudjonsson', 'Affiliation': 'Department of Urology, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hagberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Regional Cancer Centre South, Skåne Region, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Håkansson', 'Affiliation': 'Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jerlström', 'Affiliation': 'Department of Urology, School of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Löfgren', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Patschan', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sörenby', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bläckberg', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}]",European urology,['10.1016/j.eururo.2020.12.027']
917,33401232,"The effectiveness of mobilization with movement on pain, balance and function following acute and sub acute inversion ankle sprain - A randomized, placebo controlled trial.","OBJECTIVES


To determine the effect of mobilization with movement (MWM) on pain, ankle mobility and function in patients with acute and sub-acute grade I and II inversion ankle sprain.
STUDY DESIGN


Randomized placebo controlled trial.
SETTING


A general hospital.
SUBJECTS


32 adults with inversion ankle sprain.
MAIN OUTCOME MEASURES


The primary outcome was pain intensity on an 11 point Numeric Rating Scale (NRS) with higher score indicating greater pain intensity. Ankle disability identified by the Foot and Ankle Disability index (FADI) with higher score indicating lower disability, functional ankle dorsiflexion range, pressure pain threshold, and dynamic balance measured with the Y balance test were secondary outcomes.
RESULTS


Thirty participants completed the study. At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables. Pain intensity showed a mean difference of 1.7 points (95% confidence interval, 1.4 to 2.1) and 0.9 points (95% confidence interval, 0.5 to 1.3) at one and six-months follow-up respectively. Benefits were also shown for FADI, ankle mobility, pressure pain threshold and balance.
CONCLUSION


This study provides preliminary data for the benefits of MWM for acute and sub-acute ankle sprain in terms of pain, ankle mobility, disability and balance.",2021,"At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables.","['Thirty participants completed the study', '32 adults with inversion ankle sprain', 'patients with acute and sub-acute grade I and II inversion ankle sprain', 'A general hospital']","['MWM', 'placebo', 'mobilization with movement (MWM']","['Ankle disability identified by the Foot and Ankle Disability index (FADI', 'disability, functional ankle dorsiflexion range, pressure pain threshold, and dynamic balance', 'pain intensity', 'FADI, ankle mobility, pressure pain threshold and balance', 'pain, balance and function', 'pain, ankle mobility and function', 'pain intensity on an 11 point Numeric Rating Scale (NRS', 'Pain intensity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",32.0,0.355875,"At each follow-up point, significant differences were found between groups favouring those receiving MWM for all variables.","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Gogate', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Pune, Maharashtra, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Satpute', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Pune, Maharashtra, India. Electronic address: kiran_ptist@yahoo.co.in.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, P.O. Box U1987, Perth, WA, 6845, Australia.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.12.016']
918,33398562,Double-clip traction could be superior to the pocket-creation method with cylindrical cap for colonic ESD: a randomized study in an ex vivo model.,"INTRODUCTION


In Western countries, debates between ESD vs piece-meal EMR as the best treatment for large colorectal adenomas persist regarding the difficulty of ESD the colon, and the safety and relatively good results of piece-meal endoscopic mucosal resection (EMR). Pocket-creation method (PCM) and double-clip countertraction (DCT) are two strategies recently published to facilitate ESD in this challenging situation.
METHOD


This is a randomized animal study to compare PCM and DCT strategies for colonic ESD on ex vivo models (bovine colon) performed by 3 operators novice in ESD. Hybridknife type T was used to inject normal saline tinted with a small amount of blue dye in all procedures. Randomization was stratified according to the use of gravity assist. Primary endpoint was the difference in resection speed between PCM and DCT strategies.
RESULTS


Resection speed was significantly higher in the DCT group than in the PCM group (56.3 vs. 31.6 mm 2 /min, p = 0.01). Technical success rate, defined as en bloc resection in under 60 min, was significantly better in the DCT group than in the PCM group (100% vs. 84.4%, p = 0.024), perforation rate was lower (0% vs. 18.8%, p = 0.012), and difficulty score was better (2.4 vs. 6.2, p < 0.0001) as was procedure duration (24.2 vs. 40.2 min, p < 0.0001).
CONCLUSION


DCT was superior to PCM for ESD in our validated bovine colon model. This strategy is inexpensive, easy to use and adaptive. It might facilitate the widespread use of colonic ESD in Western countries and change Western ideas regarding the use of colonic ESD compared with piece-meal EMR for large benign lesions.",2021,"Technical success rate, defined as en bloc resection in under 60 min, was significantly better in the DCT group than in the PCM group (100% vs. 84.4%, p = 0.024), perforation rate was lower (0% vs. 18.8%, p = 0.012), and difficulty score was better (2.4 vs. 6.2, p < 0.0001) as was procedure duration (24.2 vs. 40.2 min, p < 0.0001).
",[],"['Pocket-creation method (PCM) and double-clip countertraction (DCT', 'PCM', 'Hybridknife type T', 'DCT', 'Double-clip traction', 'ESD vs piece-meal EMR']","['resection speed between PCM and DCT strategies', 'Technical success rate', 'Resection speed', 'difficulty score', 'perforation rate']",[],"[{'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}]",,0.0241622,"Technical success rate, defined as en bloc resection in under 60 min, was significantly better in the DCT group than in the PCM group (100% vs. 84.4%, p = 0.024), perforation rate was lower (0% vs. 18.8%, p = 0.012), and difficulty score was better (2.4 vs. 6.2, p < 0.0001) as was procedure duration (24.2 vs. 40.2 min, p < 0.0001).
","[{'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Albouys', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France. jeremie.albouys@gmail.com.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dahan', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Lepetit', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Charissoux', 'Affiliation': ""Service d'anatomopathologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Guyot', 'Affiliation': ""Service d'anatomopathologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pioche', 'Affiliation': ""Service d'hépato-gastro-entérologie, Hôpital Edouard Herriot, Hospices civils de lyon, 69003, Lyon, France.""}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Legros', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Carrier', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Loustaud-Ratti', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Geyl', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Jacques', 'Affiliation': ""Service d'hépato-gastro-entérologie, CHU Dupuytren, 2 avenue Martin Luther-King, 87042, Limoges, France.""}]",Surgical endoscopy,['10.1007/s00464-020-08171-6']
919,33402551,A randomized noninferiority trial comparing the diagnostic yield of the 25G ProCore needle to the standard 25G needle in suspicious pancreatic lesions.,"Background and Objectives


The aim of the study was to perform the first randomized trial comparing the diagnostic yield, bloodiness, and cellularity of the 25G standard needle (25S) and the 25G ProCore™ needle (25P).
Materials and Methods


All patients referred to the tertiary care referral center for EUS guided fine-needle aspiration (EUS-FNA) of suspicious solid pancreatic lesions were eligible. EUS-FNA was performed in each lesion with both 25S and 25P needles (the choice of the first needle was randomized), using a multipass sampling pattern, without stylet or suction. Rapid on-site evaluation was used when possible. Pap-stained slides were read by a single experienced cytopathologist, blinded to the needle type.
Results


One hundred and forty-three patients were recruited. Samples were positive for cancer in 122/143 (85.3%) with the 25S needle versus 126/143 (88.1%) with the 25P needle, negative in 17/143 (11.9%) with the 25S needle versus 13/143 (9.1%) with the 25P needle, and suspicious in 4/143 (2.8%) with each needle. There was no difference in any outcome based on the type of the first needle. No carryover effect was detected (P = 0.214; NS). Cumulative logistic regression analyses showed no associations between the type of needle and diagnostic yield for cancer, cellularity, or bloodiness. The difference in the yield for cancer was 2.9% (-4.2; 10.1%); with the confidence interval upper within the predetermined noninferiority margin of 15%.
Conclusion


The 25S needle is noninferior to the 25P needle for diagnosing cancer in suspicious pancreatic lesions.",2021,"Cumulative logistic regression analyses showed no associations between the type of needle and diagnostic yield for cancer, cellularity, or bloodiness.","['patients referred to the tertiary care referral center for EUS guided fine-needle aspiration (EUS-FNA) of suspicious solid pancreatic lesions were eligible', 'One hundred and forty-three patients were recruited', 'suspicious pancreatic lesions']","['25G standard needle (25S) and the 25G ProCore™ needle (25P', '25G ProCore needle to the standard 25G needle']","['yield for cancer', 'carryover effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",143.0,0.0229344,"Cumulative logistic regression analyses showed no associations between the type of needle and diagnostic yield for cancer, cellularity, or bloodiness.","[{'ForeName': 'Galab M', 'Initials': 'GM', 'LastName': 'Hassan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Réseau Hospitalier Neuchâtelois, Switzerland; Department of social and preventive Medicine, School of Public Health, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Wyse', 'Affiliation': 'Division of Gastroenterology, Jewish General Hospital, McGill University, Montreal, Canada.'}, {'ForeName': 'Sarto C', 'Initials': 'SC', 'LastName': 'Paquin', 'Affiliation': 'Division of Gastroenterology, Centre Hospitalier Universitaire de Montréal, Québec, Canada.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Gariepy', 'Affiliation': 'Department of pathology, Centre Hospitalier Universitaire de Montréal, Québec, Canada.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Albadine', 'Affiliation': 'Department of pathology, Centre Hospitalier Universitaire de Montréal, Québec, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Mâsse', 'Affiliation': 'Department of social and preventive Medicine, School of Public Health, Université de Montréal, Québec, Canada; Research Center, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Trottier', 'Affiliation': 'Department of social and preventive Medicine, School of Public Health, Université de Montréal, Québec, Canada; Research Center, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Anand V', 'Initials': 'AV', 'LastName': 'Sahai', 'Affiliation': 'Division of Gastroenterology, Centre Hospitalier Universitaire de Montréal, Québec, Canada.'}]",Endoscopic ultrasound,['10.4103/eus.eus_69_20']
920,33400943,"Effects of CYP2D6, CYP3A5, and ABCB1 gene polymorphisms on the pharmacokinetics of two risperidone long-acting injection microsphere formulations.","BACKGROUND


LY03004, a novel investigational risperidone long-acting injection (LAI) microsphere formulation, can release risperidone more quickly after injection than Risperdal Consta®. This study aimed to investigate the effects of genetic polymorphisms on the pharmacokinetics of LY03004 compared with those on Risperdal Consta®.
METHODS


A total of 100 Chinese patients with stable schizophrenia were randomly assigned to the LY03004 or Risperdal Consta® treatment group. Each patient received five biweekly intramuscular injections of 25 mg risperidone long-acting injection microspheres. A total of 34 blood samples before and after injections from Day 1 to Day 113 were collected from each patient, and polymorphic alleles of cytochrome P450 enzymes CYP2D6 (*4, *10, *14), CYP3A5 (*3), and ABCB1 (C1236 > T, G2677T/A, and C3435T) were analyzed using Sanger sequencing and polymerase chain reaction-restriction fragment length polymorphism.
RESULTS


The risperidone C max,ss , C min,ss , AUC 0-tau,ss , and the ratio of risperidone to 9-hydroxyrisperidone (9-OH-R) in CYP2D6 intermediate metabolizers (IMs) were significantly different compared with those in normal metabolizers (NMs) in both the LY03004 and Risperdal Consta® groups (P < 0.05). However, 9-OH-R was not significantly different between IMs and NMs (P > 0.05). The AUC 0-tau,ss  of the active moiety (risperidone plus 9-OH-R) was 6.51 ± 3.34 in NMs and 7.00 ± 1.81 in IMs (P = 0.071) in the LY03004 group and 6.07 ± 2.31 and 7.95 ± 3.42 (P = 0.053) in NMs and IMs, respectively, in the Risperdal Consta® group. In the LY03004 group, the C max,ss  of risperidone in carriers of the ABCB1-C3435T TT variant was significantly lower than that in CC and CT carriers (TT 7.76 ± 4.23 ng/mL, CT 11.6 ± 8.27 ng/mL, CC 14.3 ± 7.66 ng/ml; P = 0.045), but no significant differences were found in the active moiety. In the Risperdal Consta® group, C3435T TT carriers had significantly lower C min,ss  of the active moiety (TT 5.09 ± 4.38 ng/mL, CT 11.4 ± 8.42 ng/mL, CC 14.3 ± 6.43 ng/mL; P = 0.007). Furthermore, C min,ss  of the active moiety was significantly different among all ABCB1-G2677T/A genotypes (P < 0.05).
CONCLUSION


The pharmacokinetics of risperidone and the ratio of risperidone to 9-OH-R were highly dependent on CYP2D6 activity. However, there was no significant effect in 9-OH-R. A future study involving a larger sample is required to verify whether CYP2D6 IMs have lower risperidone active moiety clearance than CYP2D6 NMs for LAI formulations. In addition, the risperidone active moiety was eliminated faster in ABCB1-G2677T/A and C3435T TT carriers receiving Risperdal Consta®.",2021,"However, 9-OH-R was not significantly different between IMs and NMs (P > 0.05).",['100 Chinese patients with stable schizophrenia'],"['risperidone long-acting injection microspheres', 'LY03004 or Risperdal Consta® treatment group', 'risperidone']","['active moiety', 'CYP3A5 (*3), and ABCB1', 'ABCB1-C3435T TT variant', 'risperidone C max,ss , C min,ss , AUC 0-tau,ss , and the ratio of risperidone to 9-hydroxyrisperidone (9-OH-R) in CYP2D6 intermediate metabolizers (IMs', 'Furthermore, C min,ss  of the active moiety', '9-OH-R']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C1320098', 'cui_str': 'Risperdal Consta'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3714750', 'cui_str': 'Cytochrome p450 CYP3A5 enzyme'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0753678', 'cui_str': 'paliperidone'}, {'cui': 'C4545383', 'cui_str': 'CYP2D6 intermediate metabolizer'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]",100.0,0.0295377,"However, 9-OH-R was not significantly different between IMs and NMs (P > 0.05).","[{'ForeName': 'Lingyue', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Psychiatry Research Center, Beijing Huilongguan Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Psychiatry Research Center, Beijing Huilongguan Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Zining', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pinglan', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Shandong Luye Pharmaceutical Co., Ltd, Yantai, China.'}, {'ForeName': 'Kaoxiang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Shandong Luye Pharmaceutical Co., Ltd, Yantai, China; School of Pharmacy in Yantai university, Yantai, China.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shandong Luye Pharmaceutical Co., Ltd, Yantai, China.'}, {'ForeName': 'Fuxi', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Tianjin Anding Hospital, Tianjin, China.'}, {'ForeName': 'Maosheng', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Wuhan Mental Health Center, Wuhan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing, China. Electronic address: gangwangdoc@gmail.com.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China. Electronic address: cui.pharm@pkufh.com.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110241']
921,33395602,Reappraisal of disgust: Self-report and behavioural assessment of individuals with moderate to high contamination fears.,"Previous research has linked certain psychological disorders, including obsessive-compulsive disorder (OCD), to the experience of disgust and how it is interpreted/appraised. Therefore, the present study examined whether targeting primary and secondary disgust appraisals (i.e., cognitive reappraisal) in individuals with moderate to high OCD-relevant contamination fears can effectively reduce disgust. Fifty-two participants were randomly assigned to one of three conditions; two of which involved reading a brief script modifying either a primary disgust appraisal (i.e., likelihood of a feared outcome) or a secondary disgust appraisal (i.e., the individual's ability to cope), and a third control condition with no reappraisal script. Following this experimental manipulation of disgust appraisal, participants completed two contamination-relevant behavioural approach tasks which involved 1) increasing proximity to, and eventually touching, a dead cockroach, and 2) drinking apple juice from an unused urine sample collection container. Results indicated that the interventions successfully modified their intended appraisal targets. Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition. Our results incrementally add to the existing literature that emphasises the potential advantages of modifying disgust appraisals and specifically secondary disgust appraisals when treating disgust-based psychological disorders.",2020,"Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition.","['individuals with moderate to high contamination fears', 'individuals with moderate to high OCD-relevant contamination fears', 'Fifty-two participants']","[""brief script modifying either a primary disgust appraisal (i.e., likelihood of a feared outcome) or a secondary disgust appraisal (i.e., the individual's ability to cope), and a third control condition with no reappraisal script""]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],52.0,0.0138854,"Furthermore, on the second behavioural approach task, the secondary reappraisal condition demonstrated significantly less disgust-related avoidance relative to the control condition and reported significantly less disgust relative to the primary reappraisal condition.","[{'ForeName': 'Shiu F', 'Initials': 'SF', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, Concordia University, Canada. Electronic address: shiu.wong@concordia.ca.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Department of Psychology, Concordia University, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marishel', 'Affiliation': 'School of Psychology, University of New South Wales, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, University of New South Wales, Australia. Electronic address: jessicag@unsw.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102346']
922,33400078,Psychological distress and postponed fertility care during the COVID-19 pandemic.,"PURPOSE


To evaluate perceptions of delayed fertility care secondary to the COVID-19 pandemic.
METHODS


This was a cross-sectional anonymous survey of N = 787/2,287 patients (response rate = 42.6%) from a single academic fertility center. Participants were randomized 1:1 to receive supplemental educational explaining the rationale behind recommendations to delay fertility treatments due to the COVID-19 pandemic. Assessment of well-being was conducted via the Personal Health Questionnaire Depression Scale, the Generalized Anxiety Disorder-7, the Ways of Coping-Revised, the Appraisal of Life Events Scale, and influence of supplemental education on agreement with ASRM COVID-19 Taskforce recommendations and associated distress.
RESULTS


Participants in the education v. no education groups were 35.51 (SD = 4.06) and 37.24 (SD = 5.34) years old, married (90.8% v. 89.8%), had a graduate degree (53.9% v. 55.4%), > 1 year of infertility (73.4% v. 74.4%), and were nulliparous (69.0% v. 72.6%), with moderate to high distress (64.9% v. 64.2%) (ns). Distress was related to age, duration of infertility, and engagement in social support seeking and avoidant coping strategies (P < 0.001). Agreement with recommendations was related to receipt of supplemental education, history of pregnancy loss, and use of cognitive coping (P = 0.001).
CONCLUSION


Most participants were distressed by the delay of treatments. Supplemental education increased acceptance of recommendations but did not decrease distress. Future treatment delays should include education related to and assessment of understanding of recommendations, and inclusion of mental health professionals in patient care.",2021,"Distress was related to age, duration of infertility, and engagement in social support seeking and avoidant coping strategies (P < 0.001).","['years old, married (90.8% v. 89.8%), had a graduate degree (53.9% v. 55.4', 'Participants in the education v. no education groups were 35.51 (SD = 4.06) and 37.24 (SD = 5.34', 'N = 787/2,287 patients (response rate = 42.6%) from a single academic fertility center']",['supplemental educational explaining the rationale behind recommendations to delay fertility treatments due to the COVID-19 pandemic'],"['Psychological distress and postponed fertility care', 'receipt of supplemental education, history of pregnancy loss, and use of cognitive coping', 'Personal Health Questionnaire Depression Scale', 'Distress', 'duration of infertility, and engagement in social support seeking and avoidant coping strategies']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C1171194', 'cui_str': 'Fertility care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032967', 'cui_str': 'H/O: pregnancy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.0354824,"Distress was related to age, duration of infertility, and engagement in social support seeking and avoidant coping strategies (P < 0.001).","[{'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Lawson', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.'}, {'ForeName': 'Dana B', 'Initials': 'DB', 'LastName': 'McQueen', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.'}, {'ForeName': 'Amelia C', 'Initials': 'AC', 'LastName': 'Swanson', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Confino', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.'}, {'ForeName': 'Eve C', 'Initials': 'EC', 'LastName': 'Feinberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Pavone', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, 60611, USA. MaryEllen.Pavone@nm.org.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-020-02023-x']
923,33394894,Effects of Four Different Velocity-Based Training Programming Models on Strength Gains and Physical Performance.,"ABSTRACT


Riscart-López, J, Rendeiro-Pinho, G, Mil-Homens, P, Costa, RS-d, Loturco, I, Pareja-Blanco, F, and León-Prados, JA. Effects of Four different velocity-based training programming models on strength gains and physical performance. J Strength Cond Res 35(3): 596-603, 2021-The aim of this study was to compare the effects of 4 velocity-based training (VBT) programming models (linear programming [LP], undulating programming [UP], reverse programming [RP], and constant programming [CP]) on the physical performance of moderately strength-trained men. Forty-three young (age: 22.9 ± 4.8 years; body mass [BM]: 71.7 ± 7.6; full squat [SQ] relative strength 1.32 ± 0.29) subjects were randomly assigned to LP (gradually increase training intensity and decrease volume), UP (volume and intensity increase or decrease repeatedly), RP (gradually increases volume and decrease intensity), and CP (maintains constant volume and intensity) groups and followed an 8-week VBT intervention using the SQ exercise and monitoring movement velocity for every repetition. All groups trained with similar relative average intensity (67.5% 1 repetition maximum [1RM]), magnitude of velocity loss within the set (20%), number of sets (3), and interset recoveries (4 minutes) throughout the training program. Pre-training and post-training measurements included predicted SQ (1RM), average velocity attained for all loads common to pre-tests and post-tests (AV), average velocity for those loads that were moved faster (AV > 1) and slower (AV < 1) than 1 m·s-1 at pre-tests, countermovement jump height (CMJ), and 20-m sprint time (T20). No significant group × time interactions were observed for any of the variables analyzed. All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35; UP: 0.53; RP: 0.49; CP: 0.34), and sprint performance (LP: 0.34; UP: 0.35; RP: 0.32; CP: 0.30). These results suggest that different VBT programming models induced similar physical performance gains in moderately strength-trained subjects.",2021,"All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35;","['moderately strength-trained men', 'Forty-three young (age: 22.9 ± 4.8 years; body mass [BM', 'moderately strength-trained subjects']","['Four different velocity-based training programming models', 'VBT intervention using the SQ exercise and monitoring movement velocity for every repetition', 'J Strength Cond Res XX(X', 'Four Different Velocity-Based Training Programming Models', '4 velocity-based training (VBT) programming models (linear programming [LP], undulating programming [UP], reverse programming [RP], and constant programming [CP']","['training intensity and decrease volume), UP (volume and intensity increase or decrease repeatedly), RP (gradually increases volume and decrease intensity), and CP (maintains constant volume and intensity', 'number of sets (3), and interset recoveries', 'magnitude of velocity loss', 'Strength Gains and Physical Performance', 'strength gains and physical performance', 'time interactions', '1RM strength', 'SQ (1RM), average velocity attained for all loads common to pre-tests and post-tests (AV), average velocity for those loads', 'physical performance gains', 'countermovement jump height (CMJ), and 20-m sprint time (T20', 'CMJ height']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0033349', 'cui_str': 'Programming, Linear'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",,0.0183238,"All groups obtained similar increases (shown in effect size values) in 1RM strength (LP: 0.88; UP: 0.54; RP: 0.62; CP: 0.51), velocity-load-related variables (LP: 0.74-4.15; UP: 0.46-5.04; RP: 0.36-3.71; CP: 0.74-3.23), CMJ height (LP: 0.35;","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Riscart-López', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}, {'ForeName': 'Gonçalo', 'Initials': 'G', 'LastName': 'Rendeiro-Pinho', 'Affiliation': 'Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mil-Homens', 'Affiliation': 'Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Soares-daCosta', 'Affiliation': 'Jamor High Performance Sports Center, Lisboa, Portugal.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Nucleus of High Performance in Sport, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pareja-Blanco', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'León-Prados', 'Affiliation': 'Faculty of Sport Sciences, Pablo de Olavid University, Seville, Spain.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003934']
924,33406277,A Multipurpose First-in-Human Study With the Novel CXCR7 Antagonist ACT-1004-1239 Using CXCL12 Plasma Concentrations as Target Engagement Biomarker.,"The C-X-C chemokine receptor 7 (CXCR7) has evolved as a promising, druggable target mainly in the immunology and oncology fields modulating plasma concentrations of its ligands CXCL11 and CXCL12 through receptor-mediated internalization. This ""scavenging"" activity creates concentration gradients of these ligands between blood vessels and tissues that drive directional cell migration. This randomized, double-blind, placebo-controlled first-in-human study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-1004-1239, a first-in-class drug candidate small-molecule CXCR7 antagonist. Food effect and absolute bioavailability assessments were also integrated in this multipurpose study. Healthy male subjects received single ascending oral doses of ACT-1004-1239 (n = 36) or placebo (n = 12). At each of six dose levels (1-200 mg), repeated blood sampling was done over 144 hours for pharmacokinetic/pharmacodynamic assessments using CXCL11 and CXCL12 as biomarkers of target engagement. ACT-1004-1239 was safe and well tolerated up to the highest tested dose of 200 mg. CXCL12 plasma concentrations dose-dependently increased and more than doubled compared with baseline, indicating target engagement, whereas CXCL11 concentrations remained unchanged. An indirect-response pharmacokinetic/pharmacodynamic model well described the relationship between ACT-1004-1239 and CXCL12 concentrations across the full dose range, supporting once-daily dosing for future clinical studies. At doses ≥ 10 mg, time to reach maximum plasma concentration ranged from 1.3 to 3.0 hours and terminal elimination half-life from 17.8 to 23.6 hours. The exposure increase across the dose range was essentially dose-proportional and no relevant food effect on pharmacokinetics was determined. The absolute bioavailability was 53.0% based on radioactivity data after oral vs. intravenous  14  C-radiolabeled microtracer administration of ACT-1004-1239. Overall, these comprehensive data support further clinical development of ACT-1004-1239.",2021,"CXCL12 plasma concentrations dose-dependently increased and more than doubled compared to baseline indicating target engagement, whereas CXCL11",['Healthy male subjects received'],"['single, ascending oral doses of ACT-1004-1239 (n=36) or placebo', 'CXCL11', 'placebo', 'CXCR7']","['CXCL12 plasma concentrations dose', 'safe and well tolerated', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'absolute bioavailability', 'Food effect and absolute bioavailability assessments']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1335987', 'cui_str': 'chemokine (C-X-C motif) ligand 11, human'}, {'cui': 'C1259316', 'cui_str': 'CXCR7 protein, human'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.180752,"CXCL12 plasma concentrations dose-dependently increased and more than doubled compared to baseline indicating target engagement, whereas CXCL11","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Huynh', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Henrich', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Strasser', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Boof', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Ibrahim', 'Affiliation': 'Pharmaron CPC Inc, Baltimore, Maryland, USA.'}, {'ForeName': 'Henriette E', 'Initials': 'HE', 'LastName': 'Meyer Zu Schwabedissen', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2154']
925,33395182,The Effect of Low-Volume Preseason Plyometric Training on Force-Velocity Profiles in Semiprofessional Rugby Union Players.,"ABSTRACT


Watkins, CM, Gill, ND, Maunder, E, Downes, P, Young, JD, McGuigan, MR, and Storey, AG. The effect of low-volume preseason plyometric training on force-velocity profiles in semiprofessional rugby union players. J Strength Cond Res 35(3): 604-615, 2021-Rugby union is a physically demanding and complex team sport requiring athletes across all positions to express speed and acceleration. Plyometrics can effectively improve speed profiles by enhancing both force- and velocity-(FV) characteristics; however, the optimal dose and exercise direction for trained athletes is still relatively unknown. Therefore, the aim of this investigation was to determine the efficacy of a low-dose, directionally specific plyometric training program for improving speed profiles in semiprofessional rugby players. Players were randomly allocated to one of 2 plyometric training groups that performed low-volume (40-60 ground contacts per session) plyometrics twice weekly, or a control group that did not participate in any plyometric training. The 2 training groups underwent reverse back-to-back three-week vertically and horizontally focused plyometric training programs, with a 12-day washout. Body composition, aerobic capacity, and sprint performance (10-, 20-, 30-m split time, horizontal FV profile) were measured. During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; ∆30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; ∆30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; ∆30 m = +0.071; p = 0.019). In addition, vertical plyometrics may preferentially benefit secondary acceleration (∆10-20 m split time: -0.01 seconds; p = 0.03) and many force-oriented FV profile characteristics. Correlational analyses (r2 = -0.568 to 0.515) showed sprint improvements were hindered in athletes with lower initial aerobic fitness, suggesting accumulated fatigue may have limited the magnitude of adaptation. Therefore, including low-volume plyometric training may be beneficial for improving sprint profiles or attenuating decrements realized during periods of high-volume sport-specific training.",2021,"During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; [INCREMENT]30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; [INCREMENT]30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; [INCREMENT]30 m = +0.071; p = 0.019).","['semiprofessional rugby union players', ' 000-000, 2020-Rugby union is a physically demanding and complex team sport requiring athletes across all positions to express speed and acceleration', 'Semiprofessional Rugby Union Players', 'semiprofessional rugby players']","['J Strength Cond Res XX(X', 'reverse back-to-back three-week vertically and horizontally focused plyometric training programs', 'Low-Volume Preseason Plyometric Training', 'directionally specific plyometric training program', 'low-volume preseason plyometric training', 'plyometric training groups that performed low-volume (40-60 ground contacts per session) plyometrics twice weekly, or a control group that did not participate in any plyometric training']","['Body composition, aerobic capacity, and sprint performance ', 'sprint performance', 'force-velocity profiles']","[{'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0230405,"During the intervention, HV-1 (horizontal/vertical training group 1) improved sprint performance (n = 12; [INCREMENT]30 m = -0.020 seconds; p = 0.038), VH-2 (vertical/horizontal training group 2) maintained sprint performance (n = 8; [INCREMENT]30 m = +0.049 seconds; p = 0.377), and the control group progressively declined in sprint performance (n = 12; [INCREMENT]30 m = +0.071; p = 0.019).","[{'ForeName': 'Casey M', 'Initials': 'CM', 'LastName': 'Watkins', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Gill', 'Affiliation': 'Health, Sport and Human Performance, University of Waikato, Tauranga, New Zealand; and.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Maunder', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Downes', 'Affiliation': 'Auckland Rugby Union, Auckland, New Zealand.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Auckland Rugby Union, Auckland, New Zealand.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McGuigan', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Storey', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003917']
926,33411207,The influence of student engagement on the effects of an inferential reading comprehension intervention for struggling middle school readers.,"Although many students benefit from evidence-based reading comprehension interventions, not all students will exhibit adequate response. Moderation analysis provides a statistical approach to examine for whom and under what conditions interventions are most effective. Conducted within a parent project, which investigated the effects of an inferential reading comprehension intervention, the current study examined factors related to the deployment of students' attention as well as language status that might be associated with differential response to intervention. Sixty-six struggling middle school readers were randomly assigned to a computerized version of the intervention, a teacher-led version, or business-as-usual (BaU) control instruction. The influence of language status (i.e., English Learner status) and pre-intervention levels of mind-wandering, anxiety, and mindset on the effects of the inferential reading comprehension intervention were examined. There were no moderator effects for the teacher-led group compared to the BaU control. Conversely, anxiety, mind-wandering, and language status moderated the effects of the computer-led intervention for some reading and inference-making outcomes. The computer-led intervention was associated with improved inference-making for students with higher levels of self-reported anxiety and mind-wandering. In contrast, the computer-led intervention was less beneficial than BaU instruction for English learners. Findings are discussed with respect to how these factors might be relevant for interpreting the effects of interventions for struggling middle school readers in general, and for English learners in particular. The findings also point to the importance of considering the characteristics of both student and instructional features in the creation and testing of reading comprehension interventions.",2021,The computer-led intervention was associated with improved inference-making for students with higher levels of self-reported anxiety and mind-wandering.,"['struggling middle school readers', 'Sixty-six struggling middle school readers']","['inferential reading comprehension intervention', 'computerized version of the intervention, a teacher-led version, or business-as-usual (BaU) control instruction']",[],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C4517841', 'cui_str': '66'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],66.0,0.0145713,The computer-led intervention was associated with improved inference-making for students with higher levels of self-reported anxiety and mind-wandering.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Martinez-Lincoln', 'Affiliation': 'Department of Special Education, Peabody College at Vanderbilt University, Nashville, TN, 37203, USA. Amanda.Martinez-Lincoln@Vanderbilt.Edu.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Barnes', 'Affiliation': 'Department of Special Education, Peabody College at Vanderbilt University, Nashville, TN, 37203, USA.'}, {'ForeName': 'Nathan H', 'Initials': 'NH', 'LastName': 'Clemens', 'Affiliation': 'Department of Special Education, The University of Texas at Austin, Austin, TX, USA.'}]",Annals of dyslexia,['10.1007/s11881-020-00209-7']
927,33415793,Impact of distance from implant center on mechanical circulatory device patient outcomes.,"OBJECTIVES


Patients on left ventricular assist device (LVAD) support receive extensive care and education before discharge home. We investigated the impact of patient's residential distance from LVAD implantation center on outcomes and survival.
METHODS


A total of 214 patients received a LVAD between 2006 and 2018 at our institution. Patient's residential distance from the LVAD implantation center, LVAD complications, hospitalization, and death were recorded. Patients were divided into two groups: patients living less than or equal to 100 miles (Group 1), patients living more than 100 (Group 2).
RESULTS


A total of 106 patients were assigned to Group 1 and 108 patients were assigned to Group 2. Destination therapy was intended in 20% of patients in Group 1 and 34% in Group 2 (p = .023). Mean length of stay was 13 ± 9 days for Group 1 and 21 ± 12 for Group 2 (p < .001). Major postoperative complications were unplanned readmissions due to infections (9% and 12%), gastrointenstinal bleeding (15% and 14%), cerebrovascular accidents (6% and 7.4%), and acute kidney injury (5% and 2%), respectively for Group 1 and Group 2. There was no difference in major complications (all p > .05) and survival between patients in both groups (p > .05).
CONCLUSIONS


Distance from implanting center had no impact on adverse outcomes after LVAD implantation. There was a significant increase in hospital stay for patients who live far from the implanting center, suggesting that distance should not be a contraindication when considering patients for LVAD therapy, but plans should be made for prolonged hospital stay or extended local stay near the hospital for close follow-up.",2021,"There was no difference in major complications (all p > .05) and survival between patients in both groups (p > .05).
","['214 patients received a LVAD between 2006 and 2018 at our institution', 'Patients on left ventricular assist device (LVAD) support receive extensive care and education before discharge home', 'Patients were divided into two groups: patients living less than or equal to 100\u2009miles (Group 1), patients living more than 100 (Group 2', '106 patients were assigned to Group 1 and 108 patients']",[],"['major complications', 'Mean length of stay', 'acute kidney injury', 'survival', 'LVAD complications, hospitalization, and death', 'hospital stay', 'cerebrovascular accidents', 'gastrointenstinal bleeding', 'adverse outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517530', 'cui_str': '108'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",106.0,0.0785633,"There was no difference in major complications (all p > .05) and survival between patients in both groups (p > .05).
","[{'ForeName': 'Entela B', 'Initials': 'EB', 'LastName': 'Lushaj', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fiedler', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'DeCamp', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Chan J', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Division of Cardiology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",Journal of cardiac surgery,['10.1111/jocs.15201']
928,33412281,Stimulation artifact source separation (SASS) for assessing electric brain oscillations during transcranial alternating current stimulation (tACS).,"Brain oscillations, e.g. measured by electro- or magnetoencephalography (EEG/MEG), are causally linked to brain functions that are fundamental for perception, cognition and learning. Recent advances in neurotechnology provide means to non-invasively target these oscillations using frequency-tuned amplitude-modulated transcranial alternating current stimulation (AM-tACS). However, online adaptation of stimulation parameters to ongoing brain oscillations remains an unsolved problem due to stimulation artifacts that impede such adaptation, particularly at the target frequency. Here, we introduce a real-time compatible artifact rejection algorithm (Stimulation Artifact Source Separation, SASS) that overcomes this limitation. SASS is a spatial filter (linear projection) removing EEG signal components that are maximally different in the presence versus absence of stimulation. This enables the reliable removal of stimulation-specific signal components, while leaving physiological signal components unaffected. For validation of SASS, we evoked brain activity with known phase and amplitude using 10 Hz visual flickers across 7 healthy human volunteers. 64-channel EEG was recorded during and in absence of 10 Hz AM-tACS targeting the visual cortex. Phase differences between AM-tACS and the visual stimuli were randomized, so that steady-state visually evoked potentials (SSVEPs) were phase-locked to the visual stimuli but not to the AM-tACS signal. For validation, distributions of single-trial amplitude and phase of EEG signals recorded during and in absence of AM-tACS were compared for each participant. When no artifact rejection method was applied, AM-tACS stimulation artifacts impeded assessment of single-trial SSVEP amplitude and phase. Using SASS, amplitude and phase of single trials recorded during and in absence of AM-tACS were comparable. These results indicate that SASS can be used to establish adaptive (closed-loop) AM-tACS, a potentially powerful tool to target various brain functions, and to investigate how AM-tACS interacts with electric brain oscillations.",2021,"When no artifact rejection method was applied, AM-tACS stimulation artifacts impeded assessment of single-trial SSVEP amplitude and phase.",['7 healthy human volunteers'],"['electro- or magnetoencephalography (EEG/MEG', 'SASS', 'Stimulation Artifact Source Separation (SASS', 'transcranial alternating current stimulation (tACS']",['64-channel EEG'],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",,0.0198407,"When no artifact rejection method was applied, AM-tACS stimulation artifacts impeded assessment of single-trial SSVEP amplitude and phase.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haslacher', 'Affiliation': 'Clinical Neurotechnology Lab, Neuroscience Research Center (NWFZ), Department of Psychiatry and Psychotherapy, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Nasr', 'Affiliation': 'Clinical Neurotechnology Lab, Neuroscience Research Center (NWFZ), Department of Psychiatry and Psychotherapy, Charité - University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Robinson', 'Affiliation': 'National Institute of Mental Health (NIMH), MEG Core Facility, Bethesda, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Braun', 'Affiliation': 'MEG Center, University of Tübingen, Germany; CIMeC, Center of Mind/Brain Sciences, University of Trento, Italy.'}, {'ForeName': 'Surjo R', 'Initials': 'SR', 'LastName': 'Soekadar', 'Affiliation': 'Clinical Neurotechnology Lab, Neuroscience Research Center (NWFZ), Department of Psychiatry and Psychotherapy, Charité - University Medicine Berlin, Berlin, Germany; Applied Neurotechnology Lab, Department of Psychiatry and Psychotherapy, University Hospital of Tübingen, Germany. Electronic address: surjo.soekadar@charite.de.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117571']
929,33416200,A 52-week randomized controlled trial of ipragliflozin or sitagliptin in type 2 diabetes combined with metformin: The N-ISM study.,"AIM


To compare the long-term efficacy of sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors as second-line drugs after metformin for patients not at high risk of atherosclerotic cardiovascular disease (ASCVD).
MATERIALS AND METHODS


In a 52-week randomized open-label trial, we compared ipragliflozin and sitagliptin in Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with metformin. The primary endpoint was a glycated haemoglobin (HbA1c) reduction of ≥0.5% (5.5 mmol/mol) without weight gain at 52 weeks.
RESULTS


Of a total of 111 patients (mean age 59.2 years, mean body mass index [BMI] 26.6 kg/m 2  , 61.3% men), 54 patients received ipragliflozin and 57 received sitagliptin. After 52 weeks, achievement of the primary endpoint was not significantly different (37.0% and 40.3%; P = 0.72). HbA1c reduction rate at 24 weeks was greater for sitagliptin (56.1%) than for ipragliflozin (31.5%; P = 0.01). From 24 to 52 weeks, the HbA1c reduction with sitagliptin was attenuated, with no significant difference in HbA1c reduction after 52 weeks between sitagliptin (54.4%) and ipragliflozin (38.9%; P = 0.10). Improvements in BMI, C-peptide and high-density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin. Adverse events occurred in 17 patients with ipragliflozin and in 10 patients with sitagliptin (P = 0.11).
CONCLUSION


The HbA1c-lowering effect at 24 weeks was greater with sitagliptin than with ipragliflozin, but with no difference in efficacy related to HbA1c and body weight at 52 weeks. However, some ASCVD risk factors improved with ipragliflozin.",2021,"Improvements in BMI, C-peptide and high-density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin.","['17 patients with', 'mean age 59.2\u2009years, mean body mass index', 'patients not at high risk of atherosclerotic cardiovascular disease (ASCVD', '111 patients', 'Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with']","['ipragliflozin and sitagliptin', 'ipragliflozin or sitagliptin', 'metformin', 'sitagliptin', 'ipragliflozin', 'sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors']","['efficacy related to HbA1c and body weight', 'HbA1c reduction with sitagliptin', 'ASCVD risk factors', 'HbA1c reduction', 'Adverse events', 'weight gain', 'HbA1c reduction rate', 'HbA1c-lowering effect', 'BMI, C-peptide and high-density lipoprotein cholesterol', 'glycated haemoglobin (HbA1c) reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",111.0,0.0904795,"Improvements in BMI, C-peptide and high-density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin.","[{'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kitazawa', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Katagiri', 'Affiliation': 'Kashiwazaki General Hospital and Medical Center, Kashiwazaki, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Niigata Prefectural Shibata Hospital, Shibata, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Matsunaga', 'Affiliation': 'Niigata Prefectural Chuo Hospital, Joetsu, Japan.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'H Yamada', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Ikarashi', 'Affiliation': 'Niigata Medical Center, Niigata, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Furukawa', 'Affiliation': 'Nagaoka Red Cross Hospital, Nagaoka, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Iwanaga', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Hatta', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Takaho', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics/Clinical Biostatistics Course, Graduate School of Medicine Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14288']
930,33415448,Randomized Clinical Trial of 14-French (14F) Pigtail Catheters versus 28-32F Chest Tubes in the Management of Patients with Traumatic Hemothorax and Hemopneumothorax.,"INTRODUCTION


Traditional management of traumatic hemothorax/hemopneumothorax (HTX/HPTX) has been insertion of large-bore 32-40 French (Fr) chest tubes (CTs). Retrospective studies have shown 14Fr percutaneous pigtail catheters (PCs) are equally effective as CTs. Our aim was to compare effectiveness between PCs and CTs by performing the first randomized controlled trial (RCT). We hypothesize PCs work equally as well as CTs in management of traumatic HTX/HPTX.
METHODS


Prospective RCT comparing 14Fr PCs to 28-32Fr CTs for management of traumatic HTX/HPTX from 07/2015 to 01/2018. We excluded patients requiring emergency tube placement or who refused. Primary outcome was failure rate defined as retained HTX or recurrent PTX requiring additional intervention. Secondary outcomes included initial output (IO), tube days and insertion perception experience (IPE) score on a scale of 1-5 (1 = tolerable experience, 5 = worst experience). Unpaired Student's t-test, chi-square and Wilcoxon rank-sum test were utilized with significance set at P < 0.05.
RESULTS


Forty-three patients were enrolled. Baseline characteristics between PC patients (N = 20) and CT patients (N = 23) were similar. Failure rates (10% PCs vs. 17% CTs, P = 0.49) between cohorts were similar. IO (median, 650 milliliters[ml]; interquartile range[IR], 375-1087; for PCs vs. 400 ml; IR, 240-700; for CTs, P = 0.06), and tube duration was similar, but PC patients reported lower IPE scores (median, 1, ""I can tolerate it""; IR, 1-2) than CT patients (median, 3, ""It was a bad experience""; IR, 3-4, P = 0.001).
CONCLUSION


In patients with traumatic HTX/HPTX, 14Fr PCs were equally as effective as 28-32Fr CTs with no significant difference in failure rates. PC patients, however, reported a better insertion experience. www.ClinicalTrials.gov Registration ID: NCT02553434.",2021,"Failure rates (10% PCs vs. 17% CTs, P = 0.49) between cohorts were similar.","['patients requiring emergency tube placement or who refused', 'Patients with Traumatic Hemothorax and Hemopneumothorax', 'Prospective RCT comparing 14Fr PCs to 28-32Fr CTs for management of traumatic HTX/HPTX from 07/2015 to 01/2018', 'Forty-three patients were enrolled']","['Pigtail Catheters versus 28-32F Chest Tubes', '14Fr percutaneous pigtail catheters (PCs', '14-French (14F', 'hemopneumothorax (HTX/HPTX']","['initial output (IO), tube days and insertion perception experience (IPE) score on a scale of 1-5 (1\u2009=\u2009tolerable experience, 5\u2009=\u2009worst experience', 'failure rates', 'tube duration', 'IPE scores', 'Failure rates', 'failure rate defined as retained HTX or recurrent PTX requiring additional intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0340006', 'cui_str': 'Traumatic hemothorax'}, {'cui': 'C0019077', 'cui_str': 'Hemopneumothorax'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C2585679', 'cui_str': '32 French gauge'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019077', 'cui_str': 'Hemopneumothorax'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",43.0,0.0971546,"Failure rates (10% PCs vs. 17% CTs, P = 0.49) between cohorts were similar.","[{'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Bauman', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Nebraska, Omaha, NE, USA.'}, {'ForeName': 'Narong', 'Initials': 'N', 'LastName': 'Kulvatunyou', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, 1501 N. Campbell Ave., Room 5411, PO Box 245063, Tucson, AZ, 85724-5063, USA. nkulvatunyou@surgery.arizona.edu.'}, {'ForeName': 'Bellal', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, 1501 N. Campbell Ave., Room 5411, PO Box 245063, Tucson, AZ, 85724-5063, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Gries', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, 1501 N. Campbell Ave., Room 5411, PO Box 245063, Tucson, AZ, 85724-5063, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': ""O'Keeffe"", 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, 1501 N. Campbell Ave., Room 5411, PO Box 245063, Tucson, AZ, 85724-5063, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Tang', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, University of Arizona, 1501 N. Campbell Ave., Room 5411, PO Box 245063, Tucson, AZ, 85724-5063, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rhee', 'Affiliation': 'Department of Surgery, New York Medical College, Valhalla, NY, USA.'}]",World journal of surgery,['10.1007/s00268-020-05852-0']
931,33412260,Estimates of Alpha/Beta (α/β) Ratios for Individual Late Rectal Toxicity Endpoints: An Analysis of the CHHiP Trial.,"PURPOSE


Changes in fraction size of external beam radiation therapy exert nonlinear effects on subsequent toxicity. Commonly described by the linear-quadratic model, fraction size sensitivity of normal tissues is expressed by the α/β ratio. We sought to study individual α/β ratios for different late rectal effects after prostate external beam radiation therapy.
METHODS AND MATERIALS


The CHHiP trial (ISRCTN97182923) randomized men with nonmetastatic prostate cancer 1:1:1 to 74 Gy/37 fractions (Fr), 60 Gy/20 Fr, or 57 Gy/19 Fr. Patients in the study had full dosimetric data and zero baseline toxicity. Toxicity scales were amalgamated to 6 bowel endpoints: bleeding, diarrhea, pain, proctitis, sphincter control, and stricture. Lyman-Kutcher-Burman models with or without equivalent dose in 2 Gy/Fr correction were log-likelihood fitted by endpoint, estimating α/β ratios. The α/β ratio estimate sensitivity was assessed using sequential inclusion of dose modifying factors (DMFs): age, diabetes, hypertension, inflammatory bowel or diverticular disease (IBD/diverticular), and hemorrhoids. 95% confidence intervals (CIs) were bootstrapped. Likelihood ratio testing of 632 estimator log-likelihoods compared the models.
RESULTS


Late rectal α/β ratio estimates (without DMF) ranged from bleeding (G1 + α/β = 1.6 Gy; 95% CI, 0.9-2.5 Gy) to sphincter control (G1 + α/β = 3.1 Gy; 95% CI, 1.4-9.1 Gy). Bowel pain modelled poorly (α/β, 3.6 Gy; 95% CI, 0.0-840 Gy). Inclusion of IBD/diverticular disease as a DMF significantly improved fits for stool frequency G2+ (P = .00041) and proctitis G1+ (P = .00046). However, the α/β ratios were similar in these no-DMF versus DMF models for both stool frequency G2+ (α/β 2.7 Gy vs 2.5 Gy) and proctitis G1+ (α/β 2.7 Gy vs 2.6 Gy). Frequency-weighted averaging of endpoint α/β ratios produced: G1 + α/β ratio = 2.4 Gy; G2 + α/β ratio = 2.3 Gy.
CONCLUSIONS


We estimated α/β ratios for several common late adverse effects of rectal radiation therapy. When comparing dose-fractionation schedules, we suggest using late a rectal α/β ratio ≤ 3 Gy.",2021,"Bowel pain modelled poorly (α/β 3.6 Gy, 95% CI 0.0 - 840 Gy).","['men with non-metastatic prostate cancer 1:1:1 to 74Gy/37 fractions (Fr), 60Gy/20Fr or 57Gy/19Fr']","['XXXXXXX', 'Lyman-Kutcher-Burman models ', 'external beam radiotherapy (EBRT']","['Alpha/Beta (α/β) Ratios', 'Toxicity scales', 'Bowel pain', 'full dosimetric data and zero baseline toxicity', 'Late rectal α/β ratio estimates', 'bleeding, diarrhoea, pain, proctitis, sphincter control and stricture']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033246', 'cui_str': 'Proctitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",,0.191073,"Bowel pain modelled poorly (α/β 3.6 Gy, 95% CI 0.0 - 840 Gy).","[{'ForeName': 'Douglas H', 'Initials': 'DH', 'LastName': 'Brand', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom. Electronic address: douglas.brand@icr.ac.uk.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Brüningk', 'Affiliation': 'Department of Biosystems Science and Engineering, ETH Zurich, Basel, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilkins', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom; Tumour Cell Biology Laboratory, The Francis Crick Institute, London, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Fernandez', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'Radiotherapy Trials QA Group, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Radiotherapy Department, Clatterbridge Cancer Centre, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Tree', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'van As', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Urology Unit, Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gulliford', 'Affiliation': 'Department of Medical Physics and Biomedical Engineering, University College London, London, United Kingdom; Department of Radiotherapy Physics, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.12.041']
932,33418103,Persistent occiput posterior position outcomes following manual rotation: a randomized controlled trial.,"BACKGROUND


Persistent occiput posterior position in labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation from the occiput posterior position to the occiput anterior position in the second stage of labor is considered a safe and easy to perform procedure that in observational studies has shown promise as a method for preventing operative deliveries.
OBJECTIVE


This study aimed to determine the efficacy of prophylactic manual rotation in the management of occiput posterior position for preventing operative delivery. The hypothesis was that among women who are at least 37 weeks pregnant and whose baby is in the occiput posterior position early in the second stage of labor, manual rotation will reduce the rate of operative delivery compared with the ""sham"" rotation.
STUDY DESIGN


A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 4 tertiary hospitals was conducted in Australia. A total of 254 nulliparous and parous women with a term pregnancy and a baby in the occiput posterior position in the second stage of labor were randomly assigned to receive either a prophylactic manual rotation (n=127) or a sham rotation (n=127). The primary outcome was operative delivery (cesarean, forceps, or vacuum delivery). Secondary outcomes were cesarean delivery, combined maternal mortality and serious morbidity, and combined perinatal mortality and serious morbidity. Analysis was by intention to treat. Proportions were compared using chi-square tests adjusted for stratification variables using the Mantel-Haenszel method or the Fisher exact test. Planned subgroup analyses by operator experience and by manual rotation technique (digital or whole-hand rotation) were performed.
RESULTS


Operative delivery occurred in 79 of 127 women (62%) assigned to prophylactic manual rotation and 90 of 127 women (71%) assigned to sham rotation (common risk difference, 12; 95% confidence interval, -1.7 to 26; P=.09). Among more experienced operators or investigators, operative delivery occurred in 46 of 74 women (62%) assigned to manual rotation and 52 of 71 women (73%) assigned to a sham rotation (common risk difference, 18; 95% confidence interval, -0.5 to 36; P=.07). Cesarean delivery occurred in 22 of 127 women (17%) in both groups. Instrumental delivery (forceps or vacuum) occurred in 57 of 127 women (45%) assigned to prophylactic manual rotation and 68 of 127 women (54%) assigned to sham rotation (common risk difference, 10; 95% confidence interval, -3.1 to 22; P=.14). There was no significant difference in the combined maternal and perinatal outcomes.
CONCLUSION


Prophylactic manual rotation did not result in a reduction in the rate of operative delivery. Given manual rotation was associated with a nonsignificant reduction in operative delivery, more randomized trials are needed, as our trial might have been underpowered. In addition, further research is required to further explore the potential impact of operator or investigator experience.",2021,"women assigned to a sham rotation (common risk difference 18 percentage points, 95% confidence interval -0.5 to 36, p = 0.07).","['four tertiary hospitals was conducted in Australia', 'Two hundred and fifty-four nulliparous and parous women, with a term pregnancy and a baby in the occiput posterior position in the second stage of labor']","['manual rotation', 'technique of manual rotation (digital or whole hand rotation', 'prophylactic manual rotation', 'prophylactic manual rotation (n=127) or a sham procedure']","['cesarean section; combined maternal mortality and serious morbidity; and combined perinatal mortality and serious morbidity', 'Instrumental delivery (forceps or vacuum', 'Cesarean section', 'Operative delivery', 'combined maternal and perinatal outcomes', 'operative (cesarean section, forceps or vacuum) delivery', 'rate of operative delivery', 'operative delivery']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0856256', 'cui_str': 'Occiput posterior'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",254.0,0.372299,"women assigned to a sham rotation (common risk difference 18 percentage points, 95% confidence interval -0.5 to 36, p = 0.07).","[{'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Phipps', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Discipline of Obstetrics, Gynaecology and Neonatology, The University of Sydney, Sydney, New South Wales, Australia. Electronic address: hala.phipps@health.nsw.gov.au.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Hyett', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kuah', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pardey', 'Affiliation': 'Nepean Hospital, Penrith, New South Wales, Australia.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Matthews', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ludlow', 'Affiliation': 'Discipline of Obstetrics, Gynaecology and Neonatology, The University of Sydney, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia; Ultrasound Care, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rajit', 'Initials': 'R', 'LastName': 'Narayan', 'Affiliation': 'Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Santiagu', 'Affiliation': 'Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Earl', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wilkinson', 'Affiliation': ""Women's and Children's Hospital, Adelaide, South Australia, Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bisits', 'Affiliation': ""Royal Hospital for Women, Sydney, New South Wales, Australia; Discipline of Obstetrics, Gynaecology and Neonatology, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Carseldine', 'Affiliation': 'Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Tooher', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Royal Prince Alfred Hospital Women and Babies Ambulatory Care, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'de Vries', 'Affiliation': 'Sydney Institute for Women, Children and their Families, Sydney Local Health District, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100306']
933,33418100,Changes in marrow adipose tissue in relation to changes in bone parameters following estradiol replacement in adolescent and young adult females with functional hypothalamic amenorrhea.,"CONTEXT


Low energy availability causes disruption of hypothalamic gonadotropin-releasing hormone secretion leading to functional hypothalamic amenorrhea (FHA) and hypoestrogenism, which in turn contributes to decreased bone mineral density (BMD) and increased bone marrow adipose tissue (MAT). Transdermal estradiol administration in physiologic doses increases BMD in adolescents and adults with FHA. However, the impact of estrogen replacement on MAT in relation to changes in BMD has not been studied in adolescents and young adults. We hypothesized that physiologic estrogen replacement would lead to decreases in MAT, associated with increases in BMD.
METHODS AND MATERIALS


We studied 15 adolescent and young adult females with FHA (14-25 years). All participants received a17β- estradiol transdermal patch at a dose of 0.1 mg/day (applied twice weekly) for 12 months. Participants also received cyclic progestin for 10-12 days each month. We quantified MAT (lipid/water ratio) of the fourth lumbar (L4) vertebral body and femoral diaphysis by single proton (1H)-magnetic resonance spectroscopy, and compartmental volumetric BMD of the distal radius and tibia using high-resolution peripheral quantitative computed tomography.
RESULTS


Transdermal estradiol therapy over 12 months resulted in a decrease in MAT at the lumbar (L4) vertebra from 0.92 ± 0.55 at baseline to 0.63 ± 0.29 at 12-months (p = 0.008), and an increase in radial and tibial cortical vBMD (p = 0.006, p = 0.0003). Changes in L4 MAT trended to be inversely associated with changes in radial cortical vBMD (rho = -0.47, p = 0.08).
CONCLUSION


We show that in adolescent and young adult girls with FHA, MAT decreases following transdermal estrogen therapy and these changes are associated with increased cortical vBMD.",2021,"RESULTS


Transdermal estradiol therapy over 12 months resulted in a decrease in MAT at the lumbar (L4) vertebra from 0.92 ± 0.55 at baseline to 0.63 ± 0.29 at 12-months (p=0.008), and an increase in radial and tibial cortical vBMD (p=0.006, p=0.0003).","['adolescents and young adults', '15 adolescent and young adult females with FHA (14-25 years', 'adolescents and adults with FHA', 'Adolescent and Young Adult Females with Functional Hypothalamic Amenorrhea']","['a17β- estradiol transdermal patch', 'cyclic progestin', 'Estradiol Replacement', 'physiologic estrogen replacement', 'Transdermal estradiol therapy', 'Transdermal estradiol', 'hypothalamic gonadotropin-releasing hormone secretion']","['BMD', 'MAT', 'radial and tibial cortical vBMD', 'radial cortical vBMD', 'cortical vBMD', 'bone mineral density (BMD) and increased bone marrow adipose tissue (MAT']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0014935', 'cui_str': 'Oestrogen replacement therapy'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0419954,"RESULTS


Transdermal estradiol therapy over 12 months resulted in a decrease in MAT at the lumbar (L4) vertebra from 0.92 ± 0.55 at baseline to 0.63 ± 0.29 at 12-months (p=0.008), and an increase in radial and tibial cortical vBMD (p=0.006, p=0.0003).","[{'ForeName': 'Vibha', 'Initials': 'V', 'LastName': 'Singhal', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States; Division of Pediatric Endocrinology, Mass General Hospital for Children and Harvard Medical School, Boston, MA, United States; MGH Weight Center, Massachusetts General Hospital, Boston, MA, United States. Electronic address: Vsinghal1@partners.org.'}, {'ForeName': 'Nazanin Hazhir', 'Initials': 'NH', 'LastName': 'Karzar', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: nhazhirkarzar@mgh.harvard.edu.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Bose', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: Abose1@mgh.harvard.edu.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: Cbuckless@mgh.harvard.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Ackerman', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: Kathryn.ackerman@childrens.harvard.edu.'}, {'ForeName': 'Miriam A', 'Initials': 'MA', 'LastName': 'Bredella', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: mbredella@mgh.harvard.edu.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Klibanski', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States. Electronic address: aklibanski@partners.org.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States; Division of Pediatric Endocrinology, Mass General Hospital for Children and Harvard Medical School, Boston, MA, United States. Electronic address: mmisra@mgh.harvard.edu.'}]",Bone,['10.1016/j.bone.2021.115841']
934,33418095,Cognitive effects of theta frequency bilateral subthalamic nucleus stimulation in Parkinson's disease: A pilot study.,"BACKGROUND


There is significant evidence for cognitive decline following deep brain stimulation (DBS). Current stimulation paradigms utilize gamma frequency stimulation for optimal motor benefits; however, little has been done to optimize stimulation parameters for cognition. Recent evidence implicates subthalamic nucleus (STN) theta oscillations in executive function, and theta oscillations are well-known to relate to episodic memory, suggesting that theta frequency stimulation could potentially improve cognition in Parkinson's disease (PD).
OBJECTIVE


To evaluate the acute effects of theta frequency bilateral STN stimulation on executive function in PD versus gamma frequency and off, as well as investigate the differential effects on episodic versus nonepisodic verbal fluency.
METHODS


Twelve patients (all males, mean age 60.8) with bilateral STN DBS for PD underwent a double-blinded, randomized cognitive testing during stimulation at (1) 130-135 Hz (gamma), (2) 10 Hz (theta) and (3) off. Executive functions and processing speed were evaluated using verbal fluency tasks (letter, episodic category, nonepisodic category, and category switching), color-word interference task, and random number generation task. Performance at each stimulation frequency was compared within subjects.
RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off. There were no significant differences between stimulation frequencies in other tests.
CONCLUSION


In this pilot trial, our results corroborate the role of theta oscillations in episodic retrieval, although it is unclear whether this reflects direct modulation of the medial temporal lobe and whether similar effects can be found with more canonical memory paradigms. Further work is necessary to corroborate our findings and investigate the possibility of interleaving theta and gamma frequency stimulation for concomitant motor and cognitive effects.",2021,"RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off.","[""Parkinson's Disease"", 'Twelve patients (all males, mean age 60.8) with bilateral STN DBS for PD underwent a double-blinded, randomized cognitive testing during stimulation at (1) 130-135Hz (gamma), (2) 10Hz (theta) and (3) off']","['theta frequency bilateral STN stimulation', 'Theta Frequency Bilateral Subthalamic Nucleus Stimulation']","['Executive functions and processing speed', 'stimulation frequencies', 'episodic category fluency', 'executive function', 'verbal fluency tasks (letter, episodic category, nonepisodic category, and category switching), color-word interference task, and random number generation task']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1174074', 'cui_str': 'AT 130'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]",,0.173535,"RESULTS


Theta frequency significantly improved episodic category fluency compared to gamma, but not compared to off.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lam', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': ""King's College London Medical School, London, United Kingdom.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cohn', 'Affiliation': 'Department of Psychology, University of Toronto, Toronto, Canada; Krembil Brain Institute, University Health Network, Toronto, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mark', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Esnaashari', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Petkus', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Feigenbaum', 'Affiliation': 'Department of Neurology, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Liker', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Charles Y', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States.'}, {'ForeName': 'Darrin J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurological Surgery, Keck School of Medicine of USC, Los Angeles, United States; USC Neurorestoration Center, Keck School of Medicine of USC, Los Angeles, United States. Electronic address: Darrin.lee@med.usc.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.12.014']
935,33420951,"Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child-Pugh B cirrhosis.","BACKGROUND AND AIMS


There is limited data regarding the role for systemic treatment in patients with Hepatocellular Carcinoma with Child-Pugh B cirrhosis.
METHODS


PRODIGE 21 was a multicentric prospective non-comparative randomized trial. Patients were randomized to receive sorafenib (Arm A), pravastatin (Arm B), sorafenib-pravastatin (Arm C) combination, or best supportive care (Arm D). Primary endpoint was time to progression (TTP), secondary endpoints included safety and overall survival (OS).
RESULTS


160 patients were randomized and 157 patients were included in the final analysis. 86% of patients were BCLC C and 55% had macrovascular invasion. The safety profiles of the drugs were as expected. Median TTP was 3.5, 2.8, 2.0 and 2.2 months in arms A, B, C and D, respectively, but analysis was limited by the number of patients deceased without radiological progression (59%). Median OS was similar between the four arms: 3.8 [95% CI: 2.4-6.5], 3.1 [95% CI: 1.9-4.3], 4.0 [95% CI: 3.2-5.5] and 3.5 months [95% CI: 2.2-5.4] in arms A, B, C and D, respectively. Median OS was 4.0 months [95% CI: 3.3-5.5] for patients treated with sorafenib, vs 2.9 months [95% CI: 2.2-3.9] for patients not treated with sorafenib. In patients with ALBI grade 1/2, median OS was 6.1 months [95% CI: 3.8-8.3] in patients treated with sorafenib vs 3.1 months [95% CI: 1.9-4.8] for patients not treated with sorafenib.
CONCLUSION


In the overall Child-Pugh B population, neither sorafenib nor pravastatin seemed to provide benefit. In the ALBI grade 1/2 sub-population, our trial suggests potential benefit of sorafenib.
CLINICAL TRIAL REGISTRATION


The study was referenced in clinicaltrials.gov (NCT01357486).",2021,"Median OS was similar between the four arms: 3.8 [95% CI: 2.4-6.5], 3.1 [95% CI: 1.9-4.3], 4.0 [95% CI: 3.2-5.5] and 3.5 months [95% CI: 2.2-5.4] in arms A, B, C and D, respectively.","['160 patients were randomized and 157 patients were included in the final analysis', 'patients with Hepatocellular Carcinoma with Child-Pugh B cirrhosis', 'HCC with Child-Pugh B cirrhosis']","['sorafenib, pravastatin, their combination or supportive care', 'pravastatin (Arm B), sorafenib-pravastatin (Arm C) combination, or best supportive care (Arm D', 'sorafenib nor pravastatin', 'sorafenib']","['Median TTP', 'time to progression (TTP', 'safety and overall survival (OS', 'Median OS', 'macrovascular invasion', 'median OS']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",160.0,0.34484,"Median OS was similar between the four arms: 3.8 [95% CI: 2.4-6.5], 3.1 [95% CI: 1.9-4.3], 4.0 [95% CI: 3.2-5.5] and 3.5 months [95% CI: 2.2-5.4] in arms A, B, C and D, respectively.","[{'ForeName': 'Jean-Frédéric', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Hepatology, CHU Bordeaux, (HOPITAL SAINT-ANDRE-CHU), 1 Rue Jean Burguet, 33000, Bordeaux, France. jean-frederic.blanc@chu-bordeaux.fr.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Khemissa', 'Affiliation': 'CH Saint Jean, Perpignan, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bronowicki', 'Affiliation': 'CHU Nancy-Brabois, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Monterymard', 'Affiliation': 'FFCD, Dijon, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Perarnau', 'Affiliation': 'CHU Tours Hôpital Trousseau, Tours, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bourgeois', 'Affiliation': 'Hôpital Duchenne, Boulogne-Sur-Mer, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Obled', 'Affiliation': 'CHU Carémeau, Nîmes, France.'}, {'ForeName': 'Meher Ben', 'Initials': 'MB', 'LastName': 'Abdelghani', 'Affiliation': 'Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Mabile-Archambeaud', 'Affiliation': 'CHU Hôtel Dieu, Nantes, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'CHD Vendée, La Roche-Sur-Yon, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Seitz', 'Affiliation': 'CHU la TIMONE, Marseille, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Centre Hospitalier de Meaux, Meaux, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Senellart', 'Affiliation': 'ICO Centre René Gauducheau, Saint-Herblain, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Villing', 'Affiliation': 'Centre Hospitalier Auxerre, Auxerre, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Audemar', 'Affiliation': 'CH de la Côte Basque, Bayonne, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Costentin', 'Affiliation': 'AP-HP Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Gaël', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Groupe Hospitalier Saint Joseph, Paris, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'Faculté de Médecine, INSERM U1231, Université de Bourgogne, Franche-Comté, Dijon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hepatology international,['10.1007/s12072-020-10120-3']
936,33419678,"Re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol 2020;78:757-63.",,2021,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0223123,,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Specialty Hospital Saket, New Delhi, India. Electronic address: dramitbansalurology@gmail.com.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Specialty Hospital Saket, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Specialty Hospital Saket, New Delhi, India.'}]",European urology,['10.1016/j.eururo.2020.12.028']
937,33418483,tDCS-Augmented in vivo exposure therapy for specific fears: A randomized clinical trial.,"Exposure therapy is highly effective for anxiety-related disorders, but there is a need for enhancement. Recent trials of adjunctive neuromodulation have shown promise, warranting evaluation of transcranial direct current stimulation (tDCS) as an augmentation. In a double-blind, placebo-controlled trial, contamination- and animal-phobic participants (N = 49) were randomized to active tDCS (1.7 mA, 20 min; n = 27), or sham tDCS (1.7 mA, 30 s; n = 22), followed by 30 min of in-vivo exposure. Active tDCS targeted excitation of the left mPFC and inhibition of the right dlPFC; polarity was counterbalanced for controls. We predicted tDCS would result in accelerated and better maintained gains, contingent on the subsequent in-session response, and baseline negative prognostic indicators. Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize. tDCS was most beneficial given high phobic severity, anxiety sensitivity, and a suboptimal early response. tDCS may promote engagement and response among individuals who are resistant or refractory to standard treatment. tDCS should be applied to more severe anxiety-related disorders, with parameters yoked to individual differences to improve outcomes in exposure-based interventions.",2020,"Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize.","['individuals who are resistant or refractory to standard treatment', 'and animal-phobic participants (N = 49']","['tDCS-Augmented in vivo exposure therapy', 'contamination', 'placebo', 'active tDCS', 'tDCS', 'sham tDCS', 'Exposure therapy', 'transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],49.0,0.175303,"Consistent with predictions, tDCS promoted engagement and reductions in threat appraisals during exposure, and greater reductions in distress and threat appraisals through 1-month, although effects did not uniformly generalize.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Cobb', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States; Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, National Crime Victims Research and Treatment Center, Brain Stimulation Laboratory, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, PTSD Clinical Team, Charleston, SC, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': ""O'Connor"", 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zaizar', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Caulfield', 'Affiliation': 'Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, National Crime Victims Research and Treatment Center, Brain Stimulation Laboratory, Charleston, SC, United States.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gonzalez-Lima', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'The University of Texas at Austin, Department of Psychology, Laboratory for the Study of Anxiety Disorders, Institute for Mental Health Research, Texas Consortium in Behavioral Neuroscience, Austin, TX, United States. Electronic address: telch@austin.utexas.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102344']
938,33421647,"Propranolol for Induction of Labor in Nulliparas trial a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Propranolol hydrochloride is a nonselective beta-adrenergic antagonist that has a known activity in the myometrium. Small trials have shown that propranolol decreases the duration of induced labor, although those studies are limited by methodological variability.
OBJECTIVE


Our objective was to determine whether the addition of a single dose of propranolol to induce labor in nulliparous women would decrease total time to vaginal delivery.
STUDY DESIGN


This study was a double-blind, randomized, placebo-controlled trial of nulliparous patients undergoing term induction of labor with a singleton, nonanomalous gestation. Subjects were randomized to 2 mg of intravenous propranolol hydrochloride or an identical-appearing saline placebo, administered 30 minutes after starting the induction of labor. Investigators, labor floor staff, and patients were blinded to the study drug allocation. The primary outcome was time to vaginal delivery. Secondary outcomes included mode of delivery, duration of the phases of labor, time to full dilation, composite maternal morbidity, and composite neonatal morbidity. Data were analyzed by intention-to-treat analysis with a P value of ≤.05 considered significant.
RESULTS


In this study, 240 patients were enrolled from December 2017 to December 2018, with 121 patients randomized to the propranolol group and 119 to the placebo group. The 2 groups had similar baseline characteristics. Of the patients randomized, 154 (64.2%) delivered vaginally. There was no significant difference in time from the start of the induction of labor to vaginal delivery (13.8±5.4 hours for propranolol vs 14.3±5.3 hours for placebo; P=.58). There was also no difference in the rate of cesarean delivery (38% vs 33.6%; P=.48), time to active labor (11.0±5.0 vs 11.2±4.5 hours; P=.77), or time to full dilation (12.4±5.1 vs 12.8±5.2 hours; P=.60) in patients receiving propranolol compared with those receiving placebo. Subjects randomized to the propranolol group had a significantly lower rate of composite maternal morbidity (28.9% vs 41.2%; risk ratio, 0.70; 95% confidence interval, 0.49-1.00; P=.047). Rates of postpartum hemorrhage (12.4% vs 21.8%; P=.05) and transfusion (0% vs 4.2%; P=.03) were also lower in the treated group. There was no significant difference in neonatal outcomes or composite morbidity (risk ratio, 0.74; 95% confidence interval, 0.44-1.22).
CONCLUSION


In this study, there is no evidence that the addition of a 1-time dose of propranolol to induce labor in nulliparous women decreases time to delivery or the rate of cesarean delivery. However, propranolol significantly reduced composite maternal morbidity without adverse neonatal effects.",2021,"There were no significant differences in neonatal outcomes or composite morbidity (RR 0.74, 95% CI 0.44, 1.22).
","['nulliparous patients undergoing term induction with a singleton, non-anomalous gestation', '240 patients enrolled from December 2017 to December 2018, with 121 patients randomized to', 'Labor in Nulliparas (The PIN Trial']","['propranolol', 'placebo', 'intravenous propranolol hydrochloride or an identical-appearing saline placebo', 'Propranolol hydrochloride', 'Propranolol']","['transfusion', 'time to active labor', 'Rates of postpartum hemorrhage', 'time to full dilation', 'rate of composite maternal morbidity', 'composite maternal morbidity', 'total time to vaginal delivery', 'neonatal outcomes or composite morbidity', 'rate of cesarean section', 'time to vaginal delivery', 'mode of delivery, duration of the phases of labor, time to full dilation, composite maternal morbidity, and composite neonatal morbidity']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0282321', 'cui_str': 'Propranolol hydrochloride'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",240.0,0.784519,"There were no significant differences in neonatal outcomes or composite morbidity (RR 0.74, 95% CI 0.44, 1.22).
","[{'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Bigelow', 'Affiliation': 'Minnesota Perinatal Physicians, Allina Health, Minneapolis, MN; Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY. Electronic address: Catherine.Bigelow@allina.com.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overbey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, New York, NY.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2020.100301']
939,33483897,The Impact of a Mobile Gaming Intervention to Increase Adherence to Pre-exposure Prophylaxis.,"Pre-exposure prophylaxis is effective in preventing HIV, but data show that its effectiveness is compromised by suboptimal adherence. This randomized controlled trial (n = 69) tested the impact of an iPhone game, Viral Combat, on PrEP adherence over 24 weeks. Tenofovir-diphosphate in red blood cells was collected as a biological outcome of adherence. At 24-weeks, intervention participants were 3.75 (95% CI: 1.20-11.77; p = 0.02) times as likely to engage in optimal PrEP dosing compared to controls. Viral Combat showed preliminary efficacy in improving PrEP adherence for diverse young men who have sex with men.",2021,"At 24-weeks, intervention participants were 3.75 (95% CI: 1.20-11.77; p = 0.02) times as likely to engage in optimal PrEP dosing compared to controls.",['diverse young men who have sex with men'],"['Tenofovir-diphosphate', 'Mobile Gaming Intervention']","['red blood cells', 'PrEP adherence']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0959273,"At 24-weeks, intervention participants were 3.75 (95% CI: 1.20-11.77; p = 0.02) times as likely to engage in optimal PrEP dosing compared to controls.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Whiteley', 'Affiliation': 'Residence Training Program, Warren Alpert Medical School, Brown University, 345 Blackstone Boulevard, Providence, RI, 02906, USA. laura_whiteley@brown.edu.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Craker', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Kayla K', 'Initials': 'KK', 'LastName': 'Haubrick', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital, Providence, RI, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Arnold', 'Affiliation': 'Residence Training Program, Warren Alpert Medical School, Brown University, 345 Blackstone Boulevard, Providence, RI, 02906, USA.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'Department of Population Health Science, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Olsen', 'Affiliation': 'Residence Training Program, Warren Alpert Medical School, Brown University, 345 Blackstone Boulevard, Providence, RI, 02906, USA.'}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Brown', 'Affiliation': 'Residence Training Program, Warren Alpert Medical School, Brown University, 345 Blackstone Boulevard, Providence, RI, 02906, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03118-3']
940,33484821,Graph Theoretic Analysis Reveals Intranasal Oxytocin Induced Network Changes Over Frontal Regions.,"In this study, we aim to elucidate how intranasal oxytocin modulates brain network characteristics, especially over the frontal network. As an essential brain hub of social cognition and emotion regulation, we will also explore the association between graphic properties of the frontal network and individual personality traits under oxytocin (OT) administration. 59 male participants administered intranasal OT or placebo were followed by resting-state fMRI scanning. The Correlation-based network model was applied to study OT modulation effects. We performed community detection algorithms and conducted further network analyses, including clustering coefficient, average shortest path and eigenvector centrality. In addition, we conducted a correlation analysis between clustering coefficients and the self-assessed psychological scales. Modular organizations in the OT group reveal integrations of the frontoparietal network (FPN) and the default mode network (DMN) over frontal regions. Results show that frontal nodes within the FPN are characterized by lower clustering coefficients and higher average shortest path values compared to the placebo group. Notably, these modulation effects on frontal network property are associated with Interpersonal Reactivity Index (IRI) fantasy value. Our results suggest that OT elevates integrations between FPN, DMN and limbic system as well as reduces small-worldness within the FPN. Our results support graph theoretic analysis as a potential tool to assess OT induced effects on the information integration in the frontal network.",2021,Results show that frontal nodes within the FPN are characterized by lower clustering coefficients and higher average shortest path values compared to the placebo group.,['59 male participants administered'],"['intranasal OT or placebo', 'intranasal oxytocin', 'placebo']",['Interpersonal Reactivity Index (IRI) fantasy value'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015630', 'cui_str': 'Fantasy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",59.0,0.0856232,Results show that frontal nodes within the FPN are characterized by lower clustering coefficients and higher average shortest path values compared to the placebo group.,"[{'ForeName': 'Shuhan', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Southern University of Science and Technology, Shenzhen 518005, China.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Punia', 'Affiliation': 'University of California, Irvine, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Centre for Cognitive and Brain Sciences and Department of Psychology, University of Macau, Taipa, Macau. Electronic address: liuqy@sustech.edu.cn.'}, {'ForeName': 'Quanying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Southern University of Science and Technology, Shenzhen 518005, China. Electronic address: haiyanwu@um.edu.mo.'}]",Neuroscience,['10.1016/j.neuroscience.2021.01.018']
941,33485162,"Can anxiety in undergraduate students in a high-fidelity clinical simulation be predicted? A randomized, sham-controlled, blinded trial.","INTRODUCTION


High-fidelity clinical simulation has implied a revolution in health science training. Despite its benefits, some drawbacks could hinder the learning process, especially the anxiety produced during such scenarios.
OBJECTIVES


The aim of the present work is to develop a predictive model capable of determining which students will present high levels of anxiety.
DESIGN


We performed a randomized, sham-controlled, blinded trial in which students were randomly assigned to four scenarios and played one of two possible roles.
METHODS


Before and after the simulation we assessed the anxiety level along with physiological and analytical parameters. The main analyzed outcome was an increase of ≥25% in anxiety compared with baseline.
RESULTS


The type of scenario or the role played had no effect on anxiety. The predictive model presented an Area Under the Receiver Operating Characteristics of 0.798 (95% CI: 0.69-0.90; p < 0.001), with age and systolic blood pressure being protective factors against anxiety.
CONCLUSIONS


Our results showed that the anxiety level developed during simulation could be predicted. The application of this predictive model when associated to appropriate techniques to deal with increased anxiety levels could improve the learning process of medical students during simulations.",2021,The type of scenario or the role played had no effect on anxiety.,['undergraduate students'],[],"['anxiety level', 'anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.186049,The type of scenario or the role played had no effect on anxiety.,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Martín-Rodríguez', 'Affiliation': 'Faculty of Medicine, Valladolid University, Valladolid, Spain; Advanced Life Support, Emergency Medical Services, Valladolid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Castro Villamor', 'Affiliation': 'Faculty of Medicine, Valladolid University, Valladolid, Spain; Community Health Center, La Cistérniga, Valladolid, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'López-Izquierdo', 'Affiliation': 'Faculty of Medicine, Valladolid University, Valladolid, Spain; Emergency Department, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Portillo Rubiales', 'Affiliation': 'Faculty of Medicine, Valladolid University, Valladolid, Spain; Community Health Center, La Cistérniga, Valladolid, Spain.'}, {'ForeName': 'Guillermo J', 'Initials': 'GJ', 'LastName': 'Ortega', 'Affiliation': 'Data Analysis Unit, Health Research Institute, Hospital de la Princesa, Madrid (IIS-IP), Spain; National Scientific and Technical Research Council, Buenos Aires, Argentina.'}, {'ForeName': 'Ancor', 'Initials': 'A', 'LastName': 'Sanz-García', 'Affiliation': 'Data Analysis Unit, Health Research Institute, Hospital de la Princesa, Madrid (IIS-IP), Spain. Electronic address: ancor.sanz@salud.madrid.org.'}]",Nurse education today,['10.1016/j.nedt.2021.104774']
942,33482315,"First-in-human safety, tolerability, and pharmacokinetics of ammoxetine in healthy subjects: a randomized, double-blind, placebo-controlled phase I study.","BACKGROUND


Ammoxetine is a novel selective serotonin and norepinephrine reuptake inhibitor. Preclinical studies have indicated the potential utility of ammoxetine for therapy in major depressive disorder.
PURPOSE


To investigate the first-in-human safety, tolerability, and pharmacokinetics (PK) of ammoxetine in healthy subjects and evaluate the effect of CYP2C19 polymorphisms on metabolism of ammoxetine.
METHODS


In this randomized, double-blind, placebo-controlled phase I study, healthy Chinese subjects were allocated to receive 2.5, 7.5, 15, 30, 45, 65, 100 mg ammoxetine or placebo in single-dose part and 15, 30, 45 mg ammoxetine or placebo twice daily for 8 days in multiple-dose part. Pharmacokinetic, safety and tolerability assessments were performed.
RESULTS


A total of 134 subjects were screened and 94 were enrolled. All the ammoxetine-related adverse events (AEs) were mild and resolved spontaneously. No hepatic AEs were reported during the study. Ammoxetine was well absorbed after oral administration with T max  reached in 5.0-6.0 h. After single-dosing, C max  and AUC increased proportionally with dose, except at 65 mg. After multiple-dosing, the exposures of ammoxetine at steady state increased slightly in a more-than-dose-proportional manner over the dose range studied, probably due to the saturated elimination. Steady state was achieved 6 days after multiple-dosing was initiated. The low extent of urinary excretion of ammoxetine (< 2%) indicated it is undergoing extensive metabolism. CYP2C19 polymorphisms had minimal effect on metabolism of ammoxetine.
CONCLUSIONS


Ammoxetine has a favorable pharmacokinetic profile after oral administration and good safety properties. The PK and safety profiles of ammoxetine could enable further clinical development in patients with major depressive disorder.",2021,No hepatic AEs were reported during the study.,"['healthy Chinese subjects', 'healthy subjects', 'patients with major depressive disorder', 'A total of 134 subjects were screened and 94 were enrolled']","['ammoxetine or placebo', 'Ammoxetine', 'ammoxetine', 'placebo']","['tolerability, and pharmacokinetics (PK', 'C max  and AUC', 'Pharmacokinetic, safety and tolerability assessments', 'urinary excretion of ammoxetine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C4505867', 'cui_str': 'ammoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C4505867', 'cui_str': 'ammoxetine'}]",134.0,0.165855,No hepatic AEs were reported during the study.,"[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'GCP Center/ Institute of Drug Clinical Trials, West China Hospital of Sichuan University, Sichuan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'GCP Center/ Institute of Drug Clinical Trials, West China Hospital of Sichuan University, Sichuan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'GCP Center/ Institute of Drug Clinical Trials, West China Hospital of Sichuan University, Sichuan, China.'}, {'ForeName': 'Junxia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Medicine, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Department of Project Management, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Medicine, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Shaonan', 'Initials': 'S', 'LastName': 'Ni', 'Affiliation': 'Department of Biostatistics, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Hebei, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center/ Institute of Drug Clinical Trials, West China Hospital of Sichuan University, Sichuan, China. Electronic address: wangy756@163.com.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'GCP Center/ Institute of Drug Clinical Trials, West China Hospital of Sichuan University, Sichuan, China. Electronic address: luozhu720@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2021.105724']
943,33482298,Implementation of daily chlorhexidine bathing in intensive care units for reduction of central line-associated bloodstream infections.,"BACKGROUND


Daily chlorhexidine bathing has been associated with a reduction in central line-associated bloodstream infections (CLABSI). In the setting of an already established CLABSI surveillance system and an implemented CLABSI prevention bundle, we analysed the effect of daily chlorhexidine bathing in ICU patients on CLABSI incidence and its causative pathogens.
METHODS


This was a before-and-after study in intensive care units (ICUs) at a tertiary-care centre in Switzerland. Prospective surveillance of CLABSIs and their aetiologies was established. The intervention consisted of daily chlorhexidine bathing of ICU patients with a central venous catheter. A baseline period of 19 months was followed by an intervention period of 9 months.
FINDINGS


A total of 5008 patients were included. In the baseline period a mean CLABSI rate of 2.45/1000 catheter days (95% confidence interval (CI) 1.93-3.07) was observed, followed by 1.00/1000 catheter days (95% CI 0.55-1.67; P<0.001) in the intervention period. Introduction of chlorhexidine bathing was independently associated with a reduced risk of CLABSI (adjusted odds ratio 0.47, 95% CI 0.26-0.84, P=0.011). We did not observe a significant change in aetiology except for an increase of Serratia marcescens in the intervention period.
CONCLUSIONS


Introduction of daily chlorhexidine bathing resulted in a decline in CLABSI incidence on ICUs. Starting from a baseline CLABSI rate that can be considered standard in a high-income setting and several measures for CLABSI prevention implemented, chlorhexidine bathing proved helpful for a further reduction.",2021,"We did not observe a significant change in etiology except for an increase of Serratia marcescens in the intervention period.
","['A total of 5008 patients were included', 'Before-and-after study in intensive care units (ICU) at a tertiary care centre in Switzerland']","['chlorhexidine', 'chlorhexidine bathing of ICU patients with a central venous catheter']","['CLABSI incidence on ICUs', 'reduced risk of CLABSI', 'Serratia marcescens', 'mean CLABSI rate', 'central line-associated bloodstream infections']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}]","[{'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036766', 'cui_str': 'Serratia marcescens'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",5008.0,0.0999113,"We did not observe a significant change in etiology except for an increase of Serratia marcescens in the intervention period.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Scheier', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saleschus', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dunic', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Clinical Nursing Science & Department of Perioperative Medicine, Kantonsspital Aarau, Aaurau, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schüpbach', 'Affiliation': 'Institute for Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falk', 'Affiliation': 'Information and Communication Technology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sax', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Kuster', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology and University of Zurich, Zurich, Switzerland. Electronic address: peterwerner.schreiber@usz.ch.'}]",The Journal of hospital infection,['10.1016/j.jhin.2021.01.007']
944,33485159,How does group cooperation help improve self-directed learning ability in nursing students? A trial of one semester intervention.,"BACKGROUND


Self-directed learning (SDL) ability prepares nursing students to adapt to learning after graduation. Jiang An-li's four-dimension model of SDL ability includes the ""ability of self-management, ability to apply learning strategy, ability to obtain information and ability to cooperate"". Students learning in small heterogeneous groups get the opportunity to work with peers from different backgrounds.
OBJECTIVE


To explore the effect of group cooperative learning on improving SDL ability and its possible path.
DESIGN


A quasi-experimental design was adopted.
PARTICIPANTS


Ninety nine sophomore nursing students (Mean age 21.29 ± 0.57) were enrolled in the study. Using the cluster sampling method, thirty students in one administrative class were arranged as a Group Cooperative Class (GCC) and another class (with 69 students) were arranged as a Conventional Class (CC).
METHODS


The teaching materials in both the GCC and the CC were from the same course - Fundamental Nursing Theories. The teaching activities in the GCC focused on group learning while those in the CC focused on the educator. Scale of SDL Ability (SSDLA) was employed to measure the SDL ability. SSDLA data and class evaluations were collected.
RESULTS


There were statistically significant differences in the total scores of SSDLA and sub dimensions of ""ability of self-management"", ""ability to cooperate"" between the GCC and the CC. The GCC scores of a paper test at the end of the semester were higher than those in the CC, with no statistical significance (p > 0.05). GCC students' evaluation of the course was higher than the CC's evaluation, but there was no statistical significance except on the questions of ""diversity of teaching methods"" and ""flexibility of teacher-student interaction"" (P < 0.05).
CONCLUSIONS


The result of the current study is consistent with Jiang's four-dimension model and suggests that heterogeneous group learning in a small capacity class improves nursing students' SDL ability, possibly through improving their self-management and cooperation abilities.",2021,"There were statistically significant differences in the total scores of SSDLA and sub dimensions of ""ability of self-management"", ""ability to cooperate"" between the GCC and the CC.","['thirty students in one administrative class were arranged as a Group Cooperative Class (GCC) and another class (with 69 students', 'Ninety nine sophomore nursing students (Mean age 21.29\xa0±\xa00.57) were enrolled in the study']","['Conventional Class (CC', 'group cooperative learning']","['questions of ""diversity of teaching methods"" and ""flexibility of teacher-student interaction', 'total scores of SSDLA and sub dimensions of ""ability of self-management"", ""ability to cooperate', 'GCC scores', 'Scale of SDL Ability (SSDLA', 'SDL ability and its possible path']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0039403', 'cui_str': 'Teaching Methods'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}]",1.0,0.0118647,"There were statistically significant differences in the total scores of SSDLA and sub dimensions of ""ability of self-management"", ""ability to cooperate"" between the GCC and the CC.","[{'ForeName': 'YongHong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}, {'ForeName': 'JingHua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China. Electronic address: guyanmei@hebcm.edu.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Faculty of Nursing, HeBei University of Chinese Medicine, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, Hebei 050200, China.'}]",Nurse education today,['10.1016/j.nedt.2021.104750']
945,33485128,Changing Polish university students' attitudes toward cluttering.,"PURPOSE


This quasi-experimental design study in Poland explored the extent to which attitudes toward cluttering of university students could be changed or improved after a series of activities dedicated to attaining deeper recognition of problems associated with fluency disorders.
METHOD


University students were assigned to either an Experimental or a Control group, with 39 in each (total = 78). They all completed the Polish version of the Public Opinion Survey of Human Attributes-Cluttering (POSHA-Cl) on two occasions up to eight weeks apart. Participants in the Experimental group attended the following intervention activities: watching and discussing an educational video on cluttering, participating in a workshop on the nature of cluttering, and watching and discussing a documentary on the life experiences of people struggling with fluency disorders. The Experimental group also filled out an open-ended questionnaire at the end of the study.
RESULTS


Pre-intervention comparisons indicated that participants assigned to either of the Experimental or Control groups differed significantly on 2 of the 15 summary ratings (13 %) of their pre-POSHA-Cl attitudes toward cluttering. For the Experimental group, the intervention resulted in significant positive changes in cluttering attitudes on 8 of the 15 summary ratings (53 %). In contrast, pre- and post- POSHA-Cl scores for the Control group were essentially unchanged (0 of 15 ratings).
CONCLUSIONS


This quasi-experimental study demonstrated that it is possible to positively modify the cluttering attitudes of university students. This has implications for the length, content, and experiential components of interventions designed to improve public attitudes toward fluency disorders.",2021,"For the Experimental group, the intervention resulted in significant positive changes in cluttering attitudes on 8 of the 15 summary ratings (53 %).","['university students', 'University students']","['intervention activities: watching and discussing an educational video on cluttering, participating in a workshop on the nature of cluttering, and watching and discussing a documentary on the life experiences of people struggling with fluency disorders']","['cluttering attitudes', 'POSHA-Cl scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0454533', 'cui_str': 'Disorder of fluency'}]","[{'cui': 'C0009090', 'cui_str': 'Cluttering'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0127381,"For the Experimental group, the intervention resulted in significant positive changes in cluttering attitudes on 8 of the 15 summary ratings (53 %).","[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Węsierska', 'Affiliation': 'University of Silesia, Poland. Electronic address: katarzyna.wesierska@us.edu.pl.'}, {'ForeName': 'Kenneth O', 'Initials': 'KO', 'LastName': 'St Louis', 'Affiliation': 'West Virginia University, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Wesierska', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Porwoł', 'Affiliation': 'Christian Theological Academy in Warsaw, Poland.'}]",Journal of fluency disorders,['10.1016/j.jfludis.2021.105828']
946,33485090,Introduction of a smartphone based behavioral intervention for migraine in the emergency department.,"OBJECTIVE


To determine whether a smartphone application (app) with an electronic headache diary and a progressive muscle relaxation (PMR) intervention is feasible and acceptable to people presenting to the Emergency Department (ED) with migraine.
METHODS


This single arm prospective study assessed feasibility by actual use of the app and acceptability by satisfaction with the app. We report preliminary data on change in migraine disability and headache days.
RESULTS


The 51 participants completed PMR sessions on a mean of 13 ± 19 (0,82) days for the 90-day study period, lasting a median of 11 min (IQR 6.5, 17) each. Median number of days of diary use was 34 (IQR 10, 77). Diaries were completed at least twice a week in half of study weeks (337/663). Participants were likely (≥4/5 on a 5-point Likert scale) to recommend both the app (85%) and PMR (91%). MIDAS scores significantly decreased by a mean of 38 points/participant (p < 0.0001). More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
CONCLUSION


Smartphone-based PMR introduced to patients who present to the ED for migraine is feasible and acceptable. More frequent users have more headache free days. Future work should focus on intervention engagement.",2021,"More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
",['people presenting to the Emergency Department (ED) with migraine'],"['smartphone based behavioral intervention', 'smartphone application (app) with an electronic headache diary and a progressive muscle relaxation (PMR) intervention', 'Smartphone-based PMR']","['Median number of days of diary use', 'migraine disability and headache days', 'MIDAS scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0432556,"More frequent PMR use was associated with a higher odds of headache free days (p = 0.0148).
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America; Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America. Electronic address: Minenmd@gmail.com.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, 1300 Morris Park Ave, The Bronx, NY 10461, United States of America.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Corner', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Powers', 'Affiliation': ""Division of Behavioral Medicine & Clinical Psychology, Cincinnati Children's Hospital; Headache Center, Cincinnati Children's Hospital, 3333 Burnet Ave, Cincinnati, OH 45229, United States of America.""}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Seng', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University; Saul R. Korey Department of Neurology, Albert Einstein College of Medicine, 1165 Morris Park Ave, The Bronx, NY 10461, United States of America.'}, {'ForeName': 'Corita', 'Initials': 'C', 'LastName': 'Grudzen', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave, New York, NY 10016, United States of America; Department of Emergency Medicine, NYU Langone Health, 550 1st Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center; Departments of Neurology, Population Health, and Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, 250 Waters Pl #8, The Bronx, NY 10461, United States of America.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.12.009']
947,33485023,Continuous local bupivacaine wound infusion reduces oral opioid use for acute postoperative pain control following myelomeningocele repair.,"BACKGROUND


For pregnancies complicated by fetal myelomeningocele who meet the established criteria, prenatal closure is a viable management option. Prenatal closure is an open procedure, with some techniques requiring greater dissection of maternal tissue than cesarean delivery; pain control is an important postoperative goal. Given the rising rates of opioid dependence and concerns regarding the fetal and neonatal effects of opioid use, our practice has turned to nonopioid pain management techniques.
OBJECTIVE


This study aimed to compare postoperative opioid use and pain scores in women undergoing open fetal myelomeningocele repair with and without continuous local bupivacaine wound infusion.
STUDY DESIGN


This was a retrospective, single-center chart review of all consecutive patients who underwent open myelomeningocele repair from March 2013 to December 2019. Women were enrolled at the time of referral and locally followed for 2 weeks postoperatively. The control group received patient-controlled epidural analgesia for 48 hours with acetaminophen and oral and intravenous opioids as needed. The treatment group received patient-controlled epidural analgesia for 24 hours with acetaminophen, oral and intravenous opioids, and continuous local bupivacaine infusion. Pain scores, medication use, and postoperative milestones and complications through discharge were abstracted from the chart and compared.
RESULTS


Of 72 subjects, 51 were in the control group and 21 in the treatment group. Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group. In addition, 24% of women in the treatment group used no opioid postoperatively, compared with 4% in the control group. There was no difference in postoperative day 1 to 4 pain scores, antiemetic use, or bowel function; the treatment group was discharged significantly earlier.
CONCLUSION


Postoperative opioid use was reduced in women who received continuous local wound infusion of bupivacaine for incisional pain control after prenatal myelomeningocele repair. Pain control is paramount following open myelomeningocele repair; local bupivacaine wound infusion is an important adjunct to reduce opioid use postoperatively.",2020,"Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group.","['acute postoperative pain control following myelomeningocele repair', 'consecutive patients who underwent open myelomeningocele repair from March 2013 to December 2019', 'women undergoing open fetal myelomeningocele repair with and without continuous local bupivacaine wound infusion']","['acetaminophen and oral and intravenous opioids', 'bupivacaine', 'acetaminophen, oral and intravenous opioids, and continuous local bupivacaine infusion', 'bupivacaine wound infusion', 'patient-controlled epidural analgesia']","['postoperative day 1 to 4 pain scores, antiemetic use, or bowel function', 'daily average oral opioid use', 'postoperative opioid use and pain scores', 'Pain scores, medication use, and postoperative milestones and complications through discharge']","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025312', 'cui_str': 'Meningomyelocele'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0566913,"Total opioid use, including intravenous doses (165 vs 52.5 mg; P=.001) and daily average oral opioid use (30 vs 10.5 mg; P=.002) were lower in the treatment group.","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Porter', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO. Electronic address: anne.porter@aah.org.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Behrendt', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Zaretsky', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Liechty', 'Affiliation': ""Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO; Division of Pediatric Surgery; Department of Surgery, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Wood', 'Affiliation': ""Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Chow', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Galan', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO; Colorado Fetal Care Center, Children's Hospital Colorado, Aurora, CO; Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO.""}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2020.100296']
948,33485731,"Effect of atorvastatin on lipogenic, inflammatory and thrombogenic markers in women with the metabolic syndrome.","BACKGROUND AND AIM


Specific drug therapy to target the underlying proinflammatory and prothrombotic state in patients with metabolic syndrome (MS) is lacking. We sought to study the effect of high-intensity atorvastatin on markers of lipogenesis, inflammation and thrombogenesis, in women with MS in the absence of cardiovascular disease or diabetes.
METHODS AND RESULTS


This randomized double-blinded controlled trial included 88 women with MS (according to National Cholesterol Education Panel Adult Treatment Panel III criteria) and low atherosclerotic cardiovascular risk. Participants were randomized to receive atorvastatin 80 mg or matching placebo. Thrombogenic, lipogenic and inflammatory markers were collected at the time of enrollment, after a 6-week dietary run-in phase (time of randomization), and at 6- and 12-weeks after randomization. At 6 weeks post-randomization, there was significant reduction in total cholesterol, low density lipoprotein cholesterol, triglycerides, apolipoprotein-B (Apo-B) and Apo-B/Apo-A1 ratio in the atorvastatin arm compared to placebo. This difference persisted at 12-weeks post randomization. There was no significant difference in fasting blood glucose, high-density lipoprotein cholesterol, high sensitivity C-reactive protein, serum leptin, Apo-A1, intercellular adhesion molecule 1 and platelet activity. A significant increase in vascular adhesion molecule 1 at 6 and 12 weeks was seen within the atorvastatin arm. No difference was observed in blood pressure and waist circumference.
CONCLUSIONS


In conclusion, high-intensity atorvastatin has an early and significant impact on lipoproteins and apolipoproteins but did not lower inflammatory, thrombogenic or biomarkers of platelet activity and aggregation in women with MS. The use of statins for primary prevention in these patients should be further explored.",2021,"There was no significant difference in fasting blood glucose, high-density lipoprotein cholesterol, high sensitivity C-reactive protein, serum leptin, Apo-A1, intercellular adhesion molecule 1 and platelet activity.","['patients with metabolic syndrome (MS', 'women with the metabolic syndrome', 'women with MS in the absence of cardiovascular disease or diabetes', 'women with MS', '88 women with MS (according to National Cholesterol Education Panel Adult Treatment Panel III criteria) and low atherosclerotic cardiovascular risk']","['high-intensity atorvastatin', 'atorvastatin', 'placebo', 'atorvastatin 80 mg or matching placebo']","['blood pressure and waist circumference', 'Thrombogenic, lipogenic and inflammatory markers', 'total cholesterol, low density lipoprotein cholesterol, triglycerides, apolipoprotein-B (Apo-B) and Apo-B/Apo-A1 ratio', 'vascular adhesion molecule', 'lipogenic, inflammatory and thrombogenic markers', 'fasting blood glucose, high-density lipoprotein cholesterol, high sensitivity C-reactive protein, serum leptin, Apo-A1, intercellular adhesion molecule 1 and platelet activity', 'markers of lipogenesis, inflammation and thrombogenesis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1124482', 'cui_str': 'atorvastatin 80 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",88.0,0.171658,"There was no significant difference in fasting blood glucose, high-density lipoprotein cholesterol, high sensitivity C-reactive protein, serum leptin, Apo-A1, intercellular adhesion molecule 1 and platelet activity.","[{'ForeName': 'Gladys P', 'Initials': 'GP', 'LastName': 'Velarde', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville FL, USA. Electronic address: gladys.velarde@jax.ufl.edu.'}, {'ForeName': 'Naila', 'Initials': 'N', 'LastName': 'Choudhary', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville FL, USA.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Bravo-Jaimes', 'Affiliation': 'Division of Cardiovascular Medicine, University of Texas Health Science Center at Houston, Houston TX, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Smotherman', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville FL, USA; Center for Health Equity and Quality Research, University of Florida College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Saadia', 'Initials': 'S', 'LastName': 'Sherazi', 'Affiliation': 'Department of Internal Medicine, University of Rochester Medical Center, Rochester NY, USA.'}, {'ForeName': 'Dale F', 'Initials': 'DF', 'LastName': 'Kraemer', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville FL, USA; Center for Health Equity and Quality Research, University of Florida College of Medicine, Jacksonville, FL, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.10.002']
949,33453563,Association between COMT methylation and response to treatment in children with ADHD.,"BACKGROUND


COMT had been considered a promising candidate gene in pharmacogenetic studies in ADHD; yet the findings from these studies have been inconsistent. Part of these inconsistencies could be related to epigenetic mechanisms (including DNA methylation). Here we investigated the role of genetic variants of the COMT gene on the methylation levels of CpG sites in the same gene and explored the effect of methylation on methylphenidate (MPH) and placebo (PBO) response in children with ADHD.
METHODS


Two hundred and thirty children with ADHD (6-12 years) participated in a randomized, double-blind, placebo-controlled crossover trial with MPH. Univariate analysis was performed to examine the associations between genotypes in the COMT gene and DNA methylation in the same genetic loci. Association between the DNA methylation of 11 CpG sites and PBO/MPH responses were then assessed using spearman's correlation analysis in 212 children. Multiple linear regression analyses were performed to test the interaction between these factors while accounting for sex.
RESULTS


Associations were observed between specific genetic variants and methylation level of cg20709110. Homozygous genotypes of GG (rs6269), CC (rs4633), GG (rs4818), Val/Val (rs4680) and the haplotype (ACCVal/GCGVal) were significantly associated with higher level of methylation. This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051). Regression analysis showed that in the model including rs4818, sex and DNA methylation of cg20709110 contributed significantly to treatment response.
CONCLUSIONS


These preliminary results could provide evidence for the effect of genetic variations on methylation level and the involvement of the epigenetic variation of COMT loci in modulating the response to treatment in ADHD.
TRIAL REGISTRATION


clinicaltrials.gov, number NCT00483106.",2021,"This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051).","['children with ADHD', '212 children', 'Two hundred and thirty children with ADHD (6-12 years']","['MPH', 'placebo']","['Homozygous genotypes of GG (rs6269), CC (rs4633), GG (rs4818), Val/Val (rs4680) and the haplotype (ACCVal/GCGVal', 'methylphenidate (MPH) and placebo (PBO) response', 'PBO/MPH responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",230.0,0.141356,"This CpG showed a significant correlation with placebo response (r = -0.15, P = 0.045) according to the teachers' evaluation, and a close-to significance correlation with response to MPH according to parents' evaluation (r = -0.134, p = 0.051).","[{'ForeName': 'Weam', 'Initials': 'W', 'LastName': 'Fageera', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Chaumette', 'Affiliation': 'Institute of Psychiatry and Neurosciences of Paris, Paris, France; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Ève', 'Initials': 'MÈ', 'LastName': 'Fortier', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Labbe', 'Affiliation': 'Department of Decision Sciences, HEC Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Quebec, Canada; Department of Human Genetics, McGill University, Montreal, Quebec, Canada; Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada. Electronic address: ridha.joober@mcgill.ca.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.008']
950,33485646,Immunogenicity and safety of different dose schedules and antigen doses of an MF59-adjuvanted H7N9 vaccine in healthy adults aged 65 years and older.,"BACKGROUND


The number of human influenza A (H7N9) infections has escalated since 2013 with high resultant mortality. We conducted a phase II, randomized, partially-blinded trial to evaluate the safety and immunogenicity of an MF59-adjuvanted inactivated, split virion, H7N9 influenza vaccine (H7N9 IIV) administered at various dose levels and schedules in older adults.
METHODS


479 adults ≥ 65 years of age in stable health were randomized to one of six groups to receive either 3.75, 7.5 or 15 µg of influenza A/Shanghai/02/2013 (H7N9) IIV adjuvanted with MF59 given as a 3-dose series either on days 1, 28 and 168 or on days 1, 57 and 168. Immunogenicity was assessed using both hemagglutination inhibition (HAI) and microneutralization (MN) assays prior to and 28 days following each dose. Safety was assessed through 1 year following the last dose.
RESULTS


Subjects in all groups had only modest immune responses, with the HAI GMT < 20 after the second vaccine dose and <29 after the third vaccine dose. HAI titers ≥ 40 were seen in <37% of subjects after the second dose and <49% after the third dose. There were no significant differences seen between the two dose schedules. MN titers followed similar patterns, although the titers were approximately two-fold higher than the HAI titers. Logistic regression modeling demonstrated no statistically significant associations between the immune responses and age, sex or body mass index whereas recent prior receipt of seasonal influenza vaccine significantly reduced the HAI response [OR 0.13 (95% CI 0.05, 0.33); p < 0.001]. Overall, the vaccine was well tolerated. Two mild potentially immune mediated adverse events occurred, lichen planus and guttate psoriasis.
CONCLUSIONS


MF59-adjuvanted H7N9 IIV was only modestly immunogenic in the older adult population following three doses. There were no significant differences in antibody responses noted among the various antigen doses or the two dose schedules.",2021,"CONCLUSIONS


MF59-adjuvanted H7N9 IIV was only modestly immunogenic in the older adult population following three doses.","['65\xa0years of age in stable health', 'older adults', '479 adults', 'healthy adults aged 65\xa0years and older']","['influenza A/Shanghai/02/2013 (H7N9', 'MF59-adjuvanted H7N9 vaccine', 'MF59', 'MF59-adjuvanted inactivated, split virion, H7N9 influenza vaccine (H7N9 IIV']","['Immunogenicity', 'immune responses and age, sex or body mass index', 'antibody responses', 'HAI response', 'Immunogenicity and safety', 'hemagglutination inhibition (HAI) and microneutralization (MN) assays', 'Safety', 'safety and immunogenicity', 'HAI titers\xa0≥\xa040', 'tolerated']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0016627', 'cui_str': 'Avian influenza'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C3665951', 'cui_str': 'Influenza due to Influenza A virus subtype H7N9'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.103287,"CONCLUSIONS


MF59-adjuvanted H7N9 IIV was only modestly immunogenic in the older adult population following three doses.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Winokur', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, University of Iowa, Iowa City, Iowa, United States. Electronic address: patricia-winokur@uiowa.edu.'}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'El Sahly', 'Affiliation': 'Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'The Hope Clinic of the Emory Vaccine Center, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Frey', 'Affiliation': 'Department of Medicine, Saint Louis University School of Medicine, Saint Louis, MO, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rupp', 'Affiliation': 'Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, TX, United States.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Anderson', 'Affiliation': ""Emory Children's Center, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schmader', 'Affiliation': 'Duke University, United States.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jackson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.'}, {'ForeName': 'Wilbur H', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Bellamy', 'Affiliation': 'The Emmes Corporation, Rockville, MD, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.11.051']
951,33486403,Living with severe multiple sclerosis: Cost-effectiveness of a palliative care intervention and cost of illness study.,"BACKGROUND


Little is known about the economic consequences of living with severe multiple sclerosis (SMS).
AIMS


To assess the cost-effectiveness of a home-based palliative approach (HPA) for people with SMS (pwSMS). To assess direct healthcare costs in this population.
METHODS


PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months. Direct healthcare costs were collected on a monthly basis. Incremental cost-effectiveness was gauged from a national healthcare system (NHS) and a personal perspective, considering the Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs), both completed at baseline, after three and six months.
RESULTS


Of 78 randomized pwSMS, 76 (50 HPA, 26 usual care) were analyzed. Mean QALYs were close to zero, and the mean group difference was -0.006 (95% CI -0.057 to 0.044). The mean baseline-adjusted cost difference was € -394 (95% confidence interval, CI -3,532 to 2,743). POS-S-MS cost-effectiveness showed a slight mean reduction of symptom burden (-1.9; 95% CI -1.1 to 5.0) with unchanged costs. Mean direct costs due to MS were € 23,195/year, almost equally distributed between NHS (€ 13,108) and pwSMS (€ 10,087). Personal care, medications and home rehabilitation accounted for 80% of total expenditures. Most personal care costs were covered by pwSMS, and these costs were 3/4 of pwSMS out-of-pocket.
CONCLUSIONS


The slight reduction of symptom burden produced by the HPA was not associated with an increase in costs. NHS and pwSMS almost equally sustained these costs.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN73082124.",2021,"Mean QALYs were close to zero, and the mean group difference was -0.006","['people with SMS (pwSMS', 'PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months', 'Living with severe multiple sclerosis']","['home-based palliative approach (HPA', 'palliative care intervention']","['Mean direct costs', 'costs', 'Direct healthcare costs', 'cost-effectiveness', 'symptom burden', 'POS-S-MS cost-effectiveness', 'Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs', 'Incremental cost-effectiveness', 'Mean QALYs', 'direct healthcare costs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0881442,"Mean QALYs were close to zero, and the mean group difference was -0.006","[{'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Rosato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy; Unit of Clinical Epidemiology, ""Città della Salute e della Scienza"" Hospital, Turin, Italy and CPO Piemonte, Turin, Italy. Electronic address: rosalba.rosato@unito.it.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pagano', 'Affiliation': 'Unit of Clinical Epidemiology, ""Città della Salute e della Scienza"" Hospital, Turin, Italy and CPO Piemonte, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy; Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: andrea.giordano@istituto-besta.it.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Farinotti', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: mariangela.farinotti@istituto-besta.it.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ponzio', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Via Operai 40, 16149 Genoa, Italy. Electronic address: michela.ponzio@aism.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Veronese', 'Affiliation': 'Fondazione FARO, Via Morgari 12, 10125 Turin, Italy. Electronic address: simone.veronese@fondazionefaro.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Confalonieri', 'Affiliation': 'Multiple Sclerosis Center, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: paolo.confalonieri@istituto-besta.it.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Grasso', 'Affiliation': 'Multiple Sclerosis Unit, IRCCS S. Lucia Foundation, Via Ardeatina 306, 00179 Rome, Italy. Electronic address: mg.grasso@hsantalucia.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Multiple Sclerosis Center, Neurology Clinic, University Hospital Policlinico Vittorio Emanuele, Via S. Sofia 78, 95123 Catania, Italy. Electronic address: patti@unict.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Solari', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address: alessandra.solari@istituto-besta.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102756']
952,33485895,"Subgroup analysis of nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone to prevent recurrences in patients with high-risk, HER2 low-expressing breast cancer.","HER2-targeted therapy has not benefited patients with low levels of HER2 expression; however, combination therapy may be effective. Primary analysis of a phase IIb trial investigating the HER2-derived vaccine nelipepimut-S (NPS) did not benefit the intention-to-treat population, but subset analysis showed a benefit in triple-negative breast cancer (TNBC) patients. The subset analysis of this multicenter, randomized, single-blind, phase IIb trial identified significant improvement in 36-month disease-free survival (DFS) between NPS (n = 55) and placebo (n = 44) in TNBC (HR 0.25, p = 0.01) and those who express HLA-A24 (HR 0.41, p = 0.05). The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01). NPS vaccination with trastuzumab was associated with improved 36-month DFS among patients with TNBC. The observed benefit to this high-risk subgroup warrants confirmation in a phase III trial.",2021,"The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01).","['patients with TNBC', 'patients with high-risk, HER2 low-expressing breast cancer']","['HER2-targeted therapy', 'placebo', 'HER2-derived vaccine nelipepimut-S (NPS', 'trastuzumab', 'nelipepimut-S plus GM-CSF combined with trastuzumab versus trastuzumab alone']","['36-month disease-free survival (DFS', '36-month DFS', 'HLA-A24 positivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0062802', 'cui_str': 'HLA-A24 antigen'}]",,0.0646247,"The TNBC cohort demonstrated improved 36-month DFS in those with HER2 1+ expression (HR 0.17, p = 0.01), HLA-A24 positivity (HR 0.08, p < 0.01), or in those who received neoadjuvant chemotherapy (HR 0.21, p < 0.01).","[{'ForeName': 'R Connor', 'Initials': 'RC', 'LastName': 'Chick', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'G Travis', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Diane F', 'Initials': 'DF', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Annelies T', 'Initials': 'AT', 'LastName': 'Hickerson', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Kemp Bohan', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX 78234, USA. Electronic address: p.m.mccarthy.0@gmail.com.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, P.O. Box 30149, Houston, TX, 77230, USA.'}, {'ForeName': 'Gheath', 'Initials': 'G', 'LastName': 'Alatrash', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 900, Houston, TX 77030, USA.'}, {'ForeName': 'Rashmi K', 'Initials': 'RK', 'LastName': 'Murthy', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, P.O. Box 30149, Houston, TX, 77230, USA.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Qiao', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Unit 1434, P.O. Box 301439, Houston, TX 77230, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Philips', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Unit 1434, P.O. Box 301439, Houston, TX 77230, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lukas', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington, 825 Eastlake Ave E., Seattle, WA 98109, USA.'}, {'ForeName': 'Jarrod P', 'Initials': 'JP', 'LastName': 'Holmes', 'Affiliation': 'Department of Medical Oncology, St. Joseph Health Cancer Center, 3555 Round Barn Circle, Suite A, Santa Rosa, CA 95403, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA; Breast Oncology Program, Dana-Farber/Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA.""}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Cancer Vaccine Development Program, 1422 E. Grayson, 3rd Floor, San Antonio, TX 78208, USA.'}]","Clinical immunology (Orlando, Fla.)",['10.1016/j.clim.2021.108679']
953,33486121,"A commentary on ""prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. A double-blinded randomized controlled trial"" (Int. J. Surg. 2020; 84: 41-49).",,2021,,['2020; 84: 41-49'],['norepinephrine infusion versus a fixed-rate phenylephrine infusion'],[],[],"[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]",[],,0.60783,,"[{'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lou', 'Affiliation': ""Department of Emergency Internal Medicine, Taizhou First People's Hospital, Zhejiang, 318020, China.""}, {'ForeName': 'Jichen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Thoracic Surgery, Taizhou First People's Hospital, Zhejiang, 318020, China. Electronic address: feileh@163.com.""}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2021.01.002']
954,33487468,Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial.,"INTRODUCTION


In a first-in-human study immune responses to rabies virus glycoprotein (RABV-G)-mRNA vaccine were dependent on the route of administration, necessitating specialized devices. Following successful preclinical studies with mRNA encapsulated in lipid nanoparticles (LNP), we tested an mRNA-LNP formulation (CV7202).
METHODS


In this phase 1, multi-center, controlled study in Belgium and Germany we enrolled 55 healthy 18-40-year-olds to receive intramuscular injections of 5 μg (n = 10), 1 μg (n = 16), or 2 μg (n = 16) CV7202 on Day 1; subsets (n = 8) of 1 μg and 2 μg groups received second doses on Day 29. Controls (n = 10) received rabies vaccine, Rabipur, on Days 1, 8 and 29. Safety and reactogenicity were assessed up to 28 days post-vaccination using diary cards; immunogenicity was measured as RABV-G-specific neutralizing titers (VNT) by RFFIT and IgG by ELISA.
RESULTS


As initially tested doses of 5 μg CV7202 elicited unacceptably high reactogenicity we subsequently tested 1 and 2 μg doses which were better tolerated. No vaccine-related serious adverse events or withdrawals occurred. Low, dose-dependent VNT responses were detectable from Day 15 and by Day 29%, 31% and 22% of 1, 2 and 5 μg groups, respectively, had VNTs ≥ 0·5 IU/mL, considered an adequate response by the WHO. After two 1 or 2 μg doses all recipients had titers ≥ 0.5 IU/mL by Day 43. Day 57 GMTs were not significantly lower than those with Rabipur, which elicited adequate responses in all vaccinees after two doses. CV7202-elicited VNT were significantly correlated with RABV-G-specific IgG antibodies (r 2  = 0.8319, p < 0.0001).
CONCLUSIONS


Two 1 μg or 2 μg doses of CV7202 were well tolerated and elicited rabies neutralizing antibody responses that met WHO criteria in all recipients, but 5 μg had unacceptable reactogenicity for a prophylactic vaccine. ClinicalTrials.gov Identifier: NCT03713086.",2021,"Two 1 μg or 2 μg doses of CV7202 were well tolerated and elicited rabies neutralizing antibody responses that met WHO criteria in all recipients, but 5 μg had unacceptable reactogenicity for a prophylactic vaccine.","['Belgium and Germany we enrolled 55 healthy 18-40-year-olds to receive', 'human volunteers']","['low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles', 'intramuscular injections of 5\xa0μg', 'rabies vaccine, Rabipur', 'CV7202', 'rabies virus glycoprotein (RABV-G)-mRNA vaccine']","['Safety and reactogenicity', 'VNT responses', 'tolerated and elicited rabies neutralizing antibody responses', 'titers\xa0≥', 'RABV-G-specific neutralizing titers (VNT) by RFFIT and IgG by ELISA', 'RABV-G-specific IgG antibodies', 'tolerated']","[{'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034497', 'cui_str': 'Rabies virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0034494', 'cui_str': 'Rabies'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",55.0,0.266379,"Two 1 μg or 2 μg doses of CV7202 were well tolerated and elicited rabies neutralizing antibody responses that met WHO criteria in all recipients, but 5 μg had unacceptable reactogenicity for a prophylactic vaccine.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Aldrich', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Katell Bidet', 'Initials': 'KB', 'LastName': 'Huang', 'Affiliation': 'CureVac AG, Tübingen, Germany.'}, {'ForeName': 'Mihai Alexandru', 'Initials': 'MA', 'LastName': 'Bica', 'Affiliation': 'CureVac AG, Tübingen, Germany.'}, {'ForeName': 'Edde', 'Initials': 'E', 'LastName': 'Loeliger', 'Affiliation': 'CureVac AG, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schoenborn-Kellenberger', 'Affiliation': 'CureVac AG, Tübingen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Walz', 'Affiliation': 'CureVac AG, Tübingen, Germany.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'von Sonnenburg', 'Affiliation': 'Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'CureVac AG, Tübingen, Germany. Electronic address: lidia.oostvogels@curevac.com.'}]",Vaccine,['10.1016/j.vaccine.2020.12.070']
955,33492782,"Effectiveness of Evidence-Based Practice (EBP) Education on Emergency Nurses' EBP Attitudes, Knowledge, Self-Efficacy, Skills, and Behavior: A Randomized Controlled Trial.","BACKGROUND


Emergency care clinicians are expected to use the latest research evidence in practice. However, emergency nurses do not always consistently implement evidence-based practice (EBP). An educational intervention on EBP was implemented to promote emergency nurses' use of EBP, and the effectiveness of it was evaluated.
AIMS


This study aimed to evaluate the effectiveness of an EBP educational intervention on emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior. The study also examined learners' satisfaction with the EBP educational intervention.
METHODS


A randomized controlled trial with parallel groups with evaluations before the education, immediately after it, and 6 and 12 months after the education was conducted at four emergency departments in two university hospitals. The experimental group (N = 40) received EBP education while the control group (N = 40) completed self-directed EBP education. The primary outcomes were emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior, while the secondary outcome was satisfaction with the EBP education.
RESULTS


Thirty-five participants of an experimental and 29 participants of a control group completed the study. There were no statistically significant (p < .05) improvements and differences between groups in EBP attitude, self-efficacy, or behavior immediately after the EBP education. At the 6-month measurement point, the experimental group showed significantly better EBP attitudes, behavior, knowledge, and self-efficacy than the control group. At the 12-month measurement point, the improvements began to decrease. The groups also differed significantly in terms of participant satisfaction with how the teacher encouraged learners to ask clinical questions.
LINKING EVIDENCE TO ACTION


The EBP educational intervention implemented in this study had a positive effect on emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior. The effects of the education appeared the best 6 months after the education. After this point, the results began to decrease and approached baseline levels. EBP educational interventions designed for emergency nurses should apply various teaching strategies to improve their EBP attitude, knowledge, self-efficacy, skills, behavior, and satisfaction with the education.",2021,"The EBP educational intervention implemented in this study had a positive effect on emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior.","['parallel groups with evaluations before the education, immediately after it, and 6 and 12\xa0months after the education was conducted at four emergency departments in two university hospitals', 'Thirty-five participants of an experimental and 29 participants of a control group completed the study']","['EBP education while the control group (N\xa0=\xa040) completed self-directed EBP education', 'EBP educational intervention', 'Evidence-Based Practice (EBP) Education']","['EBP attitudes, behavior, knowledge, and self-efficacy', 'participant satisfaction with how the teacher encouraged learners to ask clinical questions', 'EBP attitude, knowledge, self-efficacy, skills, behavior, and satisfaction', ""emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior"", ""emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior, while the secondary outcome was satisfaction with the EBP education"", 'EBP attitude, self-efficacy, or behavior']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",40.0,0.0359763,"The EBP educational intervention implemented in this study had a positive effect on emergency nurses' EBP attitudes, knowledge, self-efficacy, skills, and behavior.","[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Koota', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Helvi', 'Initials': 'H', 'LastName': 'Kyngäs', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Lääperi', 'Affiliation': 'Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hanna-Leena', 'Initials': 'HL', 'LastName': 'Melender', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu, Finland.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12485']
956,33492523,Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study.,No specific antiviral drugs have been approved for the treatment of COVID-19. This study aimed to evaluate the efficacy of favipiravir in treatment of COVID-19. This was a multicenter randomized controlled study including 96 patients with COVID- 19 who were randomly assigned into a chloroquine (CQ) group and a favipiravir group. None of the patients in the favipiravir group needed mechanical ventilation (p = 0.129). One patient (2.3%) in the favipiravir group and two patients (4.2%) in the CQ group died (p = 1.00). Favipiravir is a promising drug for COVID-19 that decreases the hospital stay and the need for mechanical ventilation.ClinicalTrials.gov Identifier NCT04351295.,2021,None of the patients in the favipiravir group needed mechanical ventilation (p = 0.129).,['96 patients with COVID- 19 who were randomly assigned into a'],"['chloroquine (CQ', 'favipiravir group', 'favipiravir']","['hospital stay', 'mechanical ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",96.0,0.0712719,None of the patients in the favipiravir group needed mechanical ventilation (p = 0.129).,"[{'ForeName': 'Hany M', 'Initials': 'HM', 'LastName': 'Dabbous', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt. sherif.abdelbaky@med.tanta.edu.ed.'}, {'ForeName': 'Manal H', 'Initials': 'MH', 'LastName': 'El-Sayed', 'Affiliation': 'Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center (MASRI-CRC), Cairo, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Sherief', 'Affiliation': 'Tropical Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Fatma F S', 'Initials': 'FFS', 'LastName': 'Ebeid', 'Affiliation': 'Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center (MASRI-CRC), Cairo, Egypt.'}, {'ForeName': 'Mohamed Samir Abd', 'Initials': 'MSA', 'LastName': 'El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elbahnasawy', 'Affiliation': 'Emergency Medicine and Traumatology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Badawi', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt.'}, {'ForeName': 'Mohamed Awad', 'Initials': 'MA', 'LastName': 'Tageldin', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Archives of virology,['10.1007/s00705-021-04956-9']
957,33422887,The effect of a neuromuscular warm-up on the injury rates in New Zealand amateur futsal players.,"OBJECTIVES


To investigate the effectiveness of a futsal-specific warm-up to reduce injuries in amateur teams.
DESIGN


Quasi-experimental.
SETTING


Two futsal centres followed over one season using a specific report card.
PARTICIPANTS


878 teams (Intervention group, n = 458; Control group, n = 420) of both genders and three age groups (U13, U17, adults).
INTERVENTION


A futsal-specific warm-up consisting of cardiovascular exercises, dynamic stretches, and game-related skills.
MAIN OUTCOME MEASURES


The incidence rate and severity of all injuries, lower extremity (LE) injuries and contact injuries. A multivariate Poisson regression analysis was used to compare between-group rates.
RESULTS


The rate of all injuries was lower in the intervention group (rate ratio (RR) = 0.72, 95% CI = 0.59 to 1.06), yet not significant. There was a significantly lower rate of contact injuries in the intervention group (RR = 0.68, 95% CI = 0.51 to 0.98). Subgroup analysis, based on the warm-up adherence of intervention teams (low, intermediate, high), showed a lower rate of all injuries (RR = 0.52, 95% CI = 0.29 to 0.97), and LE injuries (RR = 0.32, 95% CI = 0.14 to 0.81) in the high compared to low adherence group.
CONCLUSION


A futsal-specific warm-up can reduce the rate of contact injuries in amateur players. With high adherence the rate of all injuries and LE injuries may also reduce.",2021,"There was a significantly lower rate of contact injuries in the intervention group (RR = 0.68, 95% CI = 0.51 to 0.98).","['amateur players', 'New Zealand amateur futsal players', '878 teams (Intervention group, n\xa0=\xa0458; Control group, n\xa0=\xa0420) of both genders and three age groups (U13, U17, adults', 'Two futsal centres followed over one season using a specific report card']","['neuromuscular warm-up', 'futsal-specific warm-up']","['rate of all injuries', 'LE injuries', 'rate of contact injuries', 'incidence rate and severity of all injuries, lower extremity (LE) injuries and contact injuries']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0478233,"There was a significantly lower rate of contact injuries in the intervention group (RR = 0.68, 95% CI = 0.51 to 0.98).","[{'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Tomsovsky', 'Affiliation': 'Sports Performance Research Institute New Zealand; Auckland University of Technology (AUT), School of Sport and Recreation, Auckland, New Zealand. Electronic address: lubostomsovsky@gmail.com.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Reid', 'Affiliation': 'Auckland University of Technology (AUT), School of Clinical Sciences, Auckland, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whatman', 'Affiliation': 'Sports Performance Research Institute New Zealand; Auckland University of Technology (AUT), School of Sport and Recreation, Auckland, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borotkanics', 'Affiliation': 'Sports Performance Research Institute New Zealand; Auckland University of Technology (AUT), School of Sport and Recreation, Auckland, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fulcher', 'Affiliation': 'Axis Sports Medicine Specialists; New Zealand Football, Auckland, New Zealand.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.12.015']
958,33486392,"Improved social functioning following social recovery therapy in first episode psychosis: Do social cognition and neurocognition change following therapy, and do they predict treatment response?","There is a need to develop and refine psychosocial interventions to improve functioning in First Episode Psychosis (FEP). Social cognition and neurocognition are closely linked to functioning in psychosis; examinations of cognition pre- and post- psychosocial intervention may provide insights into the mechanisms of these interventions, and identify which individuals are most likely to benefit.
METHOD


Cognition was assessed within a multi-site trial of Social Recovery Therapy (SRT) for individuals with FEP experiencing poor functioning (<30 h weekly structured activity). Fifty-nine participants were randomly allocated to the therapy group (SRT + Early intervention), and 64 were allocated to treatment as usual group (TAU - early intervention care). Social cognition and neurocognition were assessed at baseline and 9 months; assessors were blind to group allocation. It was hypothesized that social cognition would improve following therapy, and those with better social cognition prior to therapy would benefit the most from SRT.
RESULTS


There was no significant impact of SRT on individual neurocognitive or social cognitive variables, however, joint models addressing patterns of missingness demonstrate improvement across a number of cognitive outcomes following SRT. Further, regression analyses showed those who had better social cognition at baseline were most likely to benefit from the therapy (ß = 0.350; 95% CI = 0.830 to 8.891; p = .019).
CONCLUSION


It is not clear if SRT impacts on social cognitive or neurocognitive function, however, SRT may be beneficial in those with better social cognition at baseline.",2021,"There was no significant impact of SRT on individual neurocognitive or social cognitive variables, however, joint models addressing patterns of missingness demonstrate improvement across a number of cognitive outcomes following SRT.","['first episode psychosis', 'individuals with FEP experiencing poor functioning ', 'Fifty-nine participants']","['usual group (TAU - early intervention care', 'therapy group (SRT\xa0+\xa0Early intervention', 'SRT', 'social recovery therapy', 'Social Recovery Therapy (SRT']","['social functioning', 'Social cognition and neurocognition', 'social cognition', 'individual neurocognitive or social cognitive variables']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3830128', 'cui_str': '59'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",59.0,0.0188365,"There was no significant impact of SRT on individual neurocognitive or social cognitive variables, however, joint models addressing patterns of missingness demonstrate improvement across a number of cognitive outcomes following SRT.","[{'ForeName': 'Siân Lowri', 'Initials': 'SL', 'LastName': 'Griffiths', 'Affiliation': 'Institute for Mental Health, University of Birmingham, Birmingham, UK. Electronic address: s.l.griffiths@bham.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Wood', 'Affiliation': 'Institute for Mental Health, University of Birmingham, Birmingham, UK; Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia; Centre for Youth Mental Health, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Psychology Department, University of Sussex, Brighton, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute for Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hodgekins', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Jones', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'University of Chester, Chester, UK; Cheshire and Wirral Partnership NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Birchwood', 'Affiliation': 'University of Chester, Chester, UK.'}]",Schizophrenia research,['10.1016/j.schres.2020.12.023']
959,33422683,Neuro-cardiac coupling predicts transcutaneous auricular vagus nerve stimulation effects.,"BACKGROUND


Transcutaneous auricular Vagus Nerve Stimulation (taVNS) is a non-invasive neuromodulation technique that may constitute an effective treatment for a wide range of neurological, psychiatric, and medical conditions. One key challenge in taVNS research is the high interindividual response variability. To gain an understanding of this variability, reliable biomarkers for taVNS responsiveness would be highly desirable. In this study, we investigated physiological candidate biomarkers while systematically varying stimulation conditions and observing physiological state characteristics.
METHODS


Forty-four healthy young adults received taVNS and sham-stimulation. Subjects were pseudo-randomly assigned to stimulation of the left or right ear. Each subject underwent six blocks of stimulation. Across blocks, respiration-locking (inhalation-locked taVNS vs. exhalation-locked taVNS vs. sham) and the electrode location (tragus vs. cymba conchae) were varied. We analyzed heart rate (HR), various heart rate variability (HRV) scores, and neuro-cardiac coupling (NCC), indexed by the relationship between electroencephalographic delta power and heartbeat length.
RESULTS


We observed an effect of taVNS on HR and HRV scores during, but not after stimulation. The direction of the effects was consistent with parasympathetic activation. We did not observe any systematic influence of the stimulation conditions that we varied. However, we found baseline NCC scores to be significant predictors for the individual effect of taVNS on HRV scores.
CONCLUSION


Cardiac effects of taVNS indicate parasympathetic activation. These effects were short lived, which might explain that some previous studies were unable to detect them. We propose NCC as a novel candidate biomarker for responsiveness to taVNS.",2021,We did not observe any systematic influence of the stimulation conditions that we varied.,['Forty-four healthy young adults'],"['respiration-locking (inhalation-locked taVNS vs. exhalation-locked taVNS vs. sham', 'Transcutaneous auricular Vagus Nerve Stimulation (taVNS', 'taVNS', 'NCC', 'taVNS and sham-stimulation']","['heart rate (HR), various heart rate variability (HRV) scores, and neuro-cardiac coupling (NCC), indexed by the relationship between electroencephalographic delta power and heartbeat length', 'HR and HRV scores', 'HRV scores']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",44.0,0.102139,We did not observe any systematic influence of the stimulation conditions that we varied.,"[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Keute', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany. Electronic address: marius.keute@uni-tuebingen.de.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Machetanz', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Levan', 'Initials': 'L', 'LastName': 'Berelidze', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Guggenberger', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Institute for Neuromodulation and Neurotechnology, Department of Neurosurgery and Neurotechnology, And Tuebingen NeuroCampus, University of Tuebingen, Tuebingen, Germany. Electronic address: alireza.gharabaghi@uni-tuebingen.de.'}]",Brain stimulation,['10.1016/j.brs.2021.01.001']
960,33422659,Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial.,"BACKGROUND


Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.
OBJECTIVE


This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation.
STUDY DESIGN


This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.
RESULTS


A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).
CONCLUSION


In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.",2021,"Preterm birth at less than 37 weeks of gestation occurred in 14 women (43.8%) in the pessary group, and 6 women (20.7%) in the control group (relative risk 2.98, 95% confidence interval 0.96 to 9.30).
","['singleton gestations with arrested preterm labor', 'Eligible women were those with a diagnosis of arrested preterm labor between 24 0/7 - 33 6/7 weeks of gestations', '32 women', 'women with singleton pregnancies and arrested preterm labor', 'women with singleton pregnancy, and with arrested preterm labor', 'asymptomatic women with singleton gestations', '61 women with singleton pregnancies and arrested preterm labor at 24 0/7 - 33 6/7 weeks were enrolled in the trial', '120 participants was planned, but the trial was stopped before complete enrollment']","['Cervical pessary', 'cervical pessary or no pessary']","['Preterm birth', 'rate of preterm birth', 'preterm birth at less than 37 weeks of gestation']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",32.0,0.490109,"Preterm birth at less than 37 weeks of gestation occurred in 14 women (43.8%) in the pessary group, and 6 women (20.7%) in the control group (relative risk 2.98, 95% confidence interval 0.96 to 9.30).
","[{'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Mastantuoni', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. Electronic address: gabriele.saccone.1990@gmail.com.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Gragnano', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Di Spiezio Sardo', 'Affiliation': 'Department of Public Health, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mariavittoria', 'Initials': 'M', 'LastName': 'Locci', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100307']
961,33486385,Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder.,"INTRODUCTION


Individuals with social anxiety disorder (SAD) are at elevated risk of loneliness, yet little research has examined loneliness in this population. Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR) have demonstrated efficacy in treating SAD, yet research has not examined whether they lead to reductions in loneliness.
METHODS


This sample comprised 108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to CBGT or MBSR following WL. Assessments were completed pre- and post-treatment, and 3-, 6-, 9-, and 12-month follow-up assessments.
RESULTS


Compared to WL, individuals in CBGT and MBSR were less lonely at post-treatment; there was no difference between treatments after treatment or during follow-up. Greater reductions in social anxiety from pre- to post-treatment predicted lower levels of loneliness during follow-up. Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
DISCUSSION


Individuals who experience reductions in their social anxiety during treatment may also feel less lonely following treatment. Reductions in loneliness also lead to improvements in social anxiety. Future research should continue to examine the relationship between social anxiety and loneliness and how interventions for SAD may help reduce loneliness.",2021,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","['Individuals with social anxiety disorder (SAD', '108 individuals with SAD who were randomized to CBGT, MBSR, or a waitlist control (WL); WL participants were re-randomized to', 'individuals with social anxiety disorder']","['CBGT or MBSR', 'Cognitive-behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR']",['social anxiety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}]",108.0,0.0170514,"Greater reductions in loneliness from pre- to post-treatment also predicted lower levels of social anxiety during follow-up.
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': ""O'Day"", 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Butler', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychology, California State University, East Bay, Hayward, CA 94542, USA.'}, {'ForeName': 'Philippe R', 'Initials': 'PR', 'LastName': 'Goldin', 'Affiliation': 'UC Davis Medical Center, University of California, Davis, Davis, CA, 95616, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, PA, 19122, USA. Electronic address: heimberg@temple.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2021.102362']
962,33450486,Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study.,"BACKGROUND


Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding.
METHODS


This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%.
RESULTS


526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005).
CONCLUSION


The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.",2021,"One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005).
","['9 hospitals in China', 'Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment', '526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414']","['intermittent low-dose or continuous high-dose PPIs treatment', 'esomeprazole', 'esomeprazole treatment group without dropouts within7 days', 'proton pump inhibitors (PPIs']","['post-ESD bleeding', 'hospital costs', 'total post-ESD bleeding', 'scar stage', 'absolute risk reduction (ARR']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0854441', 'cui_str': 'Gastric mucosal lesion'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517771', 'cui_str': '414'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",526.0,0.0738462,"One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Qi', 'Affiliation': 'Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Hubei, China.'}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Chongqing University Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Qinghong', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, the First Hospital of Lanzhou University, Gansu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Zunyi Medical University, Guizhou, China.'}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, the Fourth Affiliated Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Shanyu', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Gastroenterology, the First Affiliated Hospital of Guangxi Medical University, Guangxi, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Fuling Central Hospital, Chongqing, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Den', 'Affiliation': 'Department of Gastroenterology, the Affiliated Hospital of Southwest Medical University, Sichuan, China.'}, {'ForeName': 'Chaoqiang', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Jianyin', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China. Electronic address: hguoxqyy@163.com.'}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital of Army Medical University, Chongqing, China. Electronic address: Yangshiming@tmmu.edu.cn.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2021.111251']
963,33450639,Effects of an external focus of attention and target occlusion on performance in virtual reality.,"The use of virtual reality as a training mechanism continues to gain popularity as equipment becomes more readily available. It is important to not only understand the relationship between virtual reality training and motor learning, but to understand the extent to which practice manipulations enhance performance in virtual reality. One common practice manipulation is adopting an external focus of attention, which has been shown to facilitate motor learning in a variety tasks. The purposes of the present study were to investigate the effectiveness of an external focus of attention and the effects of target occlusion times in virtual reality. Fifty-six participants performed a single-leg long jump during baseline, training, and retention and were randomly assigned to either an external or control group. During baseline and retention, all participants performed the task in both a virtual reality (VR) and real world (RW) environments. Training was all done in VR where participants were provided an external focus cue or no cue. Results revealed that individuals jumped significantly further in RW than VR in both baseline and retention (p < .001). During training, the external group jumped significantly further than control (p < .05). These results suggest that the adoption of an external focus improves performance during training. However, we did not see a benefit of an external focus in retention. These findings should be taken into consideration when using virtual reality as a training tool when performance must be transferred to a real world environment.",2021,Results revealed that individuals jumped significantly further in RW than VR in both baseline and retention (p < .001).,[],"['external focus cue or no cue', 'external or control group', 'external focus of attention and target occlusion']",[],[],"[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",[],56.0,0.0206385,Results revealed that individuals jumped significantly further in RW than VR in both baseline and retention (p < .001).,"[{'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Cochran', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, USA; Department of Kinesiology and Dance, New Mexico State University, NM, USA. Electronic address: smcochra@nmsu.edu.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Aiken', 'Affiliation': 'Department of Kinesiology and Dance, New Mexico State University, NM, USA. Electronic address: aiken@nmsu.edu.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rhea', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, USA. Electronic address: ckrhea@uncg.edu.'}, {'ForeName': 'Louisa D', 'Initials': 'LD', 'LastName': 'Raisbeck', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, Greensboro, USA. Electronic address: ldraisbe@uncg.edu.'}]",Human movement science,['10.1016/j.humov.2021.102753']
964,33450595,Ankle dorsiflexors and plantarflexors neuromuscular electrical stimulation training impacts gait kinematics in older adults: A pilot study.,"BACKGROUND


While ankle muscles, highly affected by aging, are highly implicated in the changes in gait kinematics and involved in the limitation of seniors' mobility, whether neuromuscular electrical stimulation (NMES) training of these muscles could impact gait kinematics in older adults has not been investigated yet.
RESEARCH QUESTION


What are the effects of 12 weeks of ankle plantar and dorsiflexors NMES training on strength and gait kinematics in healthy older adults?
METHODS


Fourteen older adults (73.6 ± 4.9 years) performed a three-time per week, three months long NMES training of both ankle plantar and dorsiflexors. Before and after training, neuromuscular parameters, gait kinematic parameters, and daily physical activity were measured.
RESULTS


The participants significantly increased their lower limb muscle mass and their plantar and dorsiflexors isometric strength after training. They reduced the hip abduction/adduction and the pelvic anterior tilt range of motion and variability during gait. However, the participants became less active after the training.
SIGNIFICANCE


NMES training of ankle muscles, by increasing ankle muscle mass and strength,modified gait kinematics. NMES training of ankle muscles is feasible and effective to lower the hip implication and increment foot progression angle during gait. Further study should determine if this could lower the risk of falling.",2020,The participants significantly increased their lower limb muscle mass and their plantar and dorsiflexors isometric strength after training.,"['Fourteen older adults (73.6 ± 4.9 years', 'older adults', 'healthy older adults']","['Ankle dorsiflexors and plantarflexors neuromuscular electrical stimulation training', 'NMES training of both ankle plantar and dorsiflexors', 'NMES training', 'ankle plantar and dorsiflexors NMES training']","['strength and gait kinematics', 'lower limb muscle mass and their plantar and dorsiflexors isometric strength', 'neuromuscular parameters, gait kinematic parameters, and daily physical activity', 'hip abduction/adduction and the pelvic anterior tilt range of motion and variability during gait', 'ankle muscle mass and strength,modified gait kinematics']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0230456', 'cui_str': 'Both ankles'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",14.0,0.0233959,The participants significantly increased their lower limb muscle mass and their plantar and dorsiflexors isometric strength after training.,"[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Langeard', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, COMETE, 14000, Caen, France. Electronic address: antoine.langeard@unicaen.fr.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, COMETE, 14000, Caen, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Loggia', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, CHU Caen, Department of Geriatrics, COMETE, 14000, Caen, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bherer', 'Affiliation': 'University of Montréal, Department of Medicine and Research Center Montreal Heart Institute, Montreal, Canada; Department of Medicine, Université de Montréal, Montreal, QC, Canada; Research Centre, Montreal Heart Institute, Montreal, QC, Canada; Research Centre, Institut Universitaire de Gériatrie de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chastan', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, CHU Rouen, Department of Neurophysiology, COMETE, 14000, Caen, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': 'Normandie Univ, UNICAEN, INSERM, COMETE, 14000, Caen, France.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.016']
965,33428924,Oxytocin intensifies the mortality salience effect: Novel evidence for the social salience model of oxytocin.,"Oxytocin plays an important role in human responses to threat processing. Few studies have directly examined the effects of oxytocin on our response to death-related stimuli. In the current study, 63 participants intranasally received either 32 IU of oxytocin or a placebo and thereafter completed a visual dot-probe task consisting of death-related and non-death related images. The results indicated that oxytocin enhanced participants' vigilance toward death-related images as well as increased their anxiety about and fear of death. Overall, oxytocin amplifies the defensive responses to a mortality threat, supporting the social salience model of oxytocin.",2021,The results indicated that oxytocin enhanced participants' vigilance toward death-related images as well as increased their anxiety about and fear of death.,['63 participants intranasally received either 32\xa0IU of'],"['oxytocin', 'oxytocin or a placebo', 'Oxytocin']",['anxiety about and fear of death'],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}]",63.0,0.0730017,The results indicated that oxytocin enhanced participants' vigilance toward death-related images as well as increased their anxiety about and fear of death.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China.'}, {'ForeName': 'Yu L L', 'Initials': 'YLL', 'LastName': 'Luo', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China. Electronic address: yangzy@psych.ac.cn.'}, {'ForeName': 'Huajian', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'CAS Key Laboratory of Behavioral Science, Institute of Psychology, Beijing 100101, China; Department of Psychology, University of Chinese Academy of Sciences, Beijing 100049, China. Electronic address: caihj@psych.ac.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104920']
966,33422612,"Phase 3 Multi-Center, Prospective, Randomized Trial Comparing Single-Dose 24 Gy Radiation Therapy to a 3-Fraction SBRT Regimen in the Treatment of Oligometastatic Cancer.","PURPOSE


This prospective phase 3 randomized trial was designed to test whether ultra high single-dose radiation therapy (24 Gy SDRT) improves local control of oligometastatic lesions compared to a standard hypofractionated stereotactic body radiation therapy regimen (3 × 9 Gy SBRT). The secondary endpoint was to assess the associated toxicity and the impact of ablation on clinical patterns of metastatic progression.
METHODS AND MATERIALS


Between November 2010 and September 2015, 117 patients with 154 oligometastatic lesions (≤5/patient) were randomized in a 1:1 ratio to receive 24 Gy SDRT or 3 × 9 Gy SBRT. Local control within the irradiated field and the state of metastatic spread were assessed by periodic whole-body positron emission tomography/computed tomography and/or magnetic resonance imaging. Median follow-up was 52 months.
RESULTS


A total of 59 patients with 77 lesions were randomized to 24 Gy SDRT and 58 patients with 77 lesions to 3 × 9 Gy SBRT. The cumulative incidence of local recurrence for SDRT-treated lesions was 2.7% (95% confidence interval [CI], 0%-6.5%) and 5.8% (95% CI, 0.2%-11.5%) at years 2 and 3, respectively, compared with 9.1% (95% CI, 2.6%-15.6%) and 22% (95% CI, 11.9%-32.1%) for SBRT-treated lesions (P = .0048). The 2- and 3-year cumulative incidences of distant metastatic progression in the SDRT patients were 5.3% (95% CI, 0%-11.1%), compared with 10.7% (95% CI, 2.5%-18.8%) and 22.5% (95% CI, 11.1%-33.9%), respectively, for the SBRT patients (P = .010). No differences in toxicity were observed.
CONCLUSIONS


The study confirms SDRT as a superior ablative treatment, indicating that effective ablation of oligometastatic lesions is associated with significant mitigation of distant metastatic progression.",2021,"The cumulative incidence of local recurrence for SDRT lesions was 2.7% (95% CI 0-6.5%) and 5.8% (95% CI 0.2-11.5%) at years two and three, respectively, compared to 9.1% (95% CI 2.6-15.6%) and 22% (95% CI 11.9-32.1%) for SBRT lesions (P=.0048).","['Oligometastatic Cancer', '59 patients with 77 lesions', 'Between November 2010 and September 2015, 117 patients with 154 oligometastatic lesions (≤ 5/patient']","['24 Gy SDRT or 3 x 9 Gy SBRT', 'ultra-high single-dose radiotherapy (24 Gy SDRT', 'standard hypofractionated stereotactic body radiotherapy regimen', '3-Fraction SBRT Regimen']","['local control of oligometastatic lesions', 'associated toxicity and the impact of ablation on clinical patterns of metastatic progression', 'cumulative incidence of local recurrence for SDRT lesions', 'distant metastatic progression', 'toxicity']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}]",117.0,0.116135,"The cumulative incidence of local recurrence for SDRT lesions was 2.7% (95% CI 0-6.5%) and 5.8% (95% CI 0.2-11.5%) at years two and three, respectively, compared to 9.1% (95% CI 2.6-15.6%) and 22% (95% CI 11.9-32.1%) for SBRT lesions (P=.0048).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zelefsky', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: zelefskm@mskcc.org.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Greco', 'Affiliation': 'Department of Radiation Oncology, Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lis', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Schöder', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lobaugh', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Bilsky', 'Affiliation': 'Department of Neurosurgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Powell', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kolesnick', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Zvi', 'Initials': 'Z', 'LastName': 'Fuks', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2021.01.004']
967,33449509,Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial.,"ABSTRACT


Photobiomodulation therapy (PBMT) has been used in several musculoskeletal disorders to reduce pain, inflammation, and promoting tissue regeneration. The current evidence about the effects of PBMT on low back pain (LBP) is still conflicting. We aimed to evaluate the effects of PBMT against placebo on pain intensity and disability in patients with chronic nonspecific LBP. This was a prospectively registered, randomised placebo-controlled trial, with blinded patients, therapists, and assessors. The study was conducted on an outpatient physical therapy clinic in Brazil, between April 2017 and May 2019. A total of 148 patients with chronic nonspecific LBP were randomised to either active PBMT (n = 74) or placebo (n = 74). Patients from both groups received 12 treatment sessions, 3 times a week, for 4 weeks. Patients from both groups also received an educational booklet based on ""The Back Book."" Clinical outcomes were measured at baseline and at follow-up appointments at 4 weeks, 3, 6, and 12 months after randomisation. The primary outcomes were pain intensity and disability measured at 4 weeks. We estimated the treatment effects using linear mixed models following the principles of intention-to-treat. There was no clinical important between-group differences in terms of pain intensity (mean difference = 0.01 point; 95% confidence interval = -0.94 to 0.96) and disability (mean difference = -0.63 points; 95% confidence interval = -2.23 to 0.97) at 4 weeks. Patients did not report any adverse events. Photobiomodulation therapy was not better than placebo to reduce pain and disability in patients with chronic nonspecific LBP.",2021,Photobiomodulation therapy was not better than placebo to reduce pain and disability in patients with chronic non-specific low back pain.,"['148 patients with chronic non-specific low back pain', 'patients with chronic non-specific low back pain', 'outpatient physical therapy clinic in Brazil, between April 2017 and May 2019']","['Photobiomodulation therapy', 'photobiomodulation therapy against placebo', 'placebo', 'active photobiomodulation therapy', 'PBMT', 'educational booklet', 'Photobiomodulation therapy (PBMT']","['disability', 'pain intensity', 'pain intensity and disability', 'adverse events', 'pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",148.0,0.413019,Photobiomodulation therapy was not better than placebo to reduce pain and disability in patients with chronic non-specific low back pain.,"[{'ForeName': 'Layana de Souza', 'Initials': 'LS', 'LastName': 'Guimarães', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Universidade Nove de Julho (UNINOVE), São Paulo, Brazil Post-graduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Lucíola da Cunha Menezes', 'Initials': 'LDCM', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Amanda Costa', 'Initials': 'AC', 'LastName': 'Araujo', 'Affiliation': ''}, {'ForeName': 'Dafne Port', 'Initials': 'DP', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Flávia Cordeiro', 'Initials': 'FC', 'LastName': 'Medeiros', 'Affiliation': ''}, {'ForeName': 'Marina Athayde', 'Initials': 'MA', 'LastName': 'Avanzi', 'Affiliation': ''}, {'ForeName': 'Ernesto Cesar Pinto', 'Initials': 'ECP', 'LastName': 'Leal-Junior', 'Affiliation': ''}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002189']
968,33452861,Reply to 'The importance of establishing a suitable study population in Osteoarthritis studies'.,"We appreciate the comments from Tecer et al. 1  Our intent in reporting the results of a randomized trial of marine omega-3s and/or vitamin D supplementation and knee pain in a large community-based population of older adults (VITAL) 2  , was that our findings would be generalizable to the broader knee osteoarthritis (OA) population and relevant to the practicing clinician. We recruited participants nationwide, reducing biases from focusing only on a local population, but precluding the ability to perform physical exams. We did not include fibromyalgia or mood disorders in the analysis. However, a strength of this trial is the large cohort and randomization such that these potential confounders would be equally distributed among the treatment groups and thus the results still valid.",2021,We did not include fibromyalgia or mood disorders in the analysis.,[],['marine omega-3s and/or vitamin D supplementation'],['fibromyalgia or mood disorders'],[],"[{'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}]",,0.0188431,We did not include fibromyalgia or mood disorders in the analysis.,"[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41642']
969,33442456,"Effect of non-alcoholic beer, diet and exercise on endothelial function, nutrition and quality of life in patients with cirrhosis.","BACKGROUND


The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds that exert antioxidant, anti-inflammatory and nutritional properties.
AIM


To evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.
METHODS


In this randomized open clinical trial, patients with cirrhosis were randomized into two groups: The intervention (non-alcoholic beer + diet + exercise) and control (water + diet + exercise) group. Treatment consisted of 330 mL non-alcoholic beer/day or the same amount of water, plus an individualized dietary plan and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/d and > 2500 above the baseline during 8 wk. Endothelial function (flow-mediated dilation, plethysmography), biochemical and nutritional variables and quality of life (CLDQ) were evaluated.
RESULTS


Forty-three patients were included in the study, 21 in the control group and 22 in the intervention group. The mean age was 53.5 ± 7.8 years, 60% were women, the median MELD score was 8 (7-10) and most patients were Child-Pugh A (88%). Adherence to the interventions was > 90% in both groups, there were no adverse events and all biochemical parameters remained stable in both groups. Endothelial function improved in both groups. All measured nutritional parameters improved in the intervention group, compared to only 2 in the control group and quality of life improved in both groups; however, more domains improved in the intervention group.
CONCLUSION


The intervention consisting of non-alcoholic beer, diet and exercise seems to be safe and well tolerated in patients with cirrhosis, and shows improvement in nutritional status, endothelial function, and quality of life. These results need to be further confirmed.",2020,"Adherence to the interventions was > 90% in both groups, there were no adverse events and all biochemical parameters remained stable in both groups.","['patients with cirrhosis', 'Forty-three patients were included in the study, 21 in the control group and 22 in the intervention group']","['non-alcoholic beer, diet and exercise', 'diet + exercise and non-alcoholic', 'intervention (non-alcoholic beer + diet + exercise) and control (water + diet + exercise', '330 mL non-alcoholic beer/day or the same amount of water, plus an individualized dietary plan and an exercise program']","['Endothelial function (flow-mediated dilation, plethysmography), biochemical and nutritional variables and quality of life (CLDQ', 'nutritional status, endothelial function, and quality of life', 'Endothelial function', 'nutritional status, endothelial function and quality of life', 'median MELD score', 'quality of life', 'nutritional parameters', 'endothelial function, nutrition and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",43.0,0.0355292,"Adherence to the interventions was > 90% in both groups, there were no adverse events and all biochemical parameters remained stable in both groups.","[{'ForeName': 'Ricardo U', 'Initials': 'RU', 'LastName': 'Macías-Rodríguez', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ruiz-Margáin', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Berenice M', 'Initials': 'BM', 'LastName': 'Román-Calleja', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'May E', 'Initials': 'ME', 'LastName': 'Espin-Nasser', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Nayelli C', 'Initials': 'NC', 'LastName': 'Flores-García', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Torre', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Gretel', 'Initials': 'G', 'LastName': 'Galicia-Hernández', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Silvia L', 'Initials': 'SL', 'LastName': 'Rios-Torres', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Fernández-Del-Rivero', 'Affiliation': 'Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Orea-Tejeda', 'Affiliation': 'Department of Cardiology, Instituto Nacional de Enfermedades Respiratorias, Mexico City 14080, Mexico.'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Lozano-Cruz', 'Affiliation': 'Department of Internal Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico.'}]",World journal of hepatology,['10.4254/wjh.v12.i12.1299']
970,33450335,Acute kidney injury after in-hospital cardiac arrest.,"AIM


Determine 1) frequency and risk factors for acute kidney injury (AKI) after in-hospital cardiac arrest (IHCA) in the Therapeutic Hypothermia after Pediatric Cardiac Arrest In-Hospital (THAPCA-IH) trial and associated outcomes; 2) impact of temperature management on post-IHCA AKI.
METHODS


Secondary analysis of THAPCA-IH; a randomized controlled multi-national trial at 37 children's hospitals.
ELIGIBILITY


Serum creatinine (Cr) within 24 h of randomization.
OUTCOMES


Prevalence of severe AKI defined by Stage 2 or 3 Kidney Disease Improving Global Outcomes Cr criteria. 12-month survival with favorable neurobehavioral outcome. Analyses stratified by entire cohort and cardiac subgroup. Risk factors and outcomes compared among cohorts with and without severe AKI.
RESULTS


Subject randomization: 159 to hypothermia, 154 to normothermia. Overall, 80% (249) developed AKI (any stage), and 66% (207) developed severe AKI. Cardiac patients (204, 65%) were more likely to develop severe AKI (72% vs 56%,p = 0.006). Preexisting cardiac or renal conditions, baseline lactate, vasoactive support, and systolic blood pressure were associated with severe AKI. Comparing hypothermia versus normothermia, there were no differences in severe AKI rate (63% vs 70%,p = 0.23), peak Cr, time to peak Cr, or freedom from mortality or severe AKI (p = 0.14). Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
CONCLUSION


Severe post-IHCA AKI occurred frequently especially in those with preexisting cardiac or renal conditions and peri-arrest hemodynamic instability. Severe AKI was associated with decreased survival with favorable neurobehavioral outcome. Hypothermia did not decrease incidence of severe AKI post-IHCA.",2021,"Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
","[""37 children's hospitals"", 'Acute kidney injury after in-hospital cardiac arrest']",['THAPCA-IH'],"['develop severe AKI', 'peak Cr, time to peak Cr, or freedom from mortality or severe AKI', 'severe AKI rate', '12-month survival with favorable neurobehavioral outcome', '12-month survival', 'hospital survival', 'severe AKI', 'Preexisting cardiac or renal conditions, baseline lactate, vasoactive support, and systolic blood pressure', 'survival with favorable neurobehavioral outcome']","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",37.0,0.267372,"Severe AKI was associated with decreased hospital survival (48% vs 65%,p = 0.006) and decreased 12-month survival with favorable neurobehavioral outcome (30% vs 53%,p < 0.001).
","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Mah', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States; The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States. Electronic address: Kenneth.Mah@cchmc.org.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Alten', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States; The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States.""}, {'ForeName': 'Timothy T', 'Initials': 'TT', 'LastName': 'Cornell', 'Affiliation': ""Department of Pediatrics, Lucile Packard Children's Hospital Stanford, Stanford University, Palo Alto, CA, United States.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Selewski', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Askenazi', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fitzgerald', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Topjian', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States.""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Slomine', 'Affiliation': 'Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Christensen', 'Affiliation': 'Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Moler', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.12.023']
971,33443117,The STARS Phase 2 Study: A Randomized Controlled Trial of Gaboxadol in Angelman Syndrome.,"OBJECTIVE


To evaluate safety and tolerability and exploratory efficacy end points for gaboxadol (OV101) compared with placebo in individuals with Angelman syndrome (AS).
METHODS


Gaboxadol is a highly selective orthosteric agonist that activates δ-subunit-containing extrasynaptic γ-aminobutyric acid type A (GABA A ) receptors. In a multicenter, double-blind, placebo-controlled, parallel-group trial, adolescent and adult individuals with a molecular diagnosis of AS were randomized (1:1:1) to 1 of 3 dosing regimens for a duration of 12 weeks: placebo morning dose and gaboxadol 15 mg evening dose (qd), gaboxadol 10 mg morning dose and 15 mg evening dose (bid), or placebo morning and evening dose. Safety and tolerability were monitored throughout the study. Prespecified exploratory efficacy end points included adapted Clinical Global Impression-Severity and Clinical Global Impression-Improvement (CGI-I) scales, which documented the clinical severity at baseline and change after treatment, respectively.
RESULTS


Eighty-eight individuals were randomized. Of 87 individuals (aged 13-45 years) who received at least 1 dose of study drug, 78 (90%) completed the study. Most adverse events (AEs) were mild to moderate, and no life-threatening AEs were reported. Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
CONCLUSION


After 12 weeks of treatment, gaboxadol was found to be generally well-tolerated with a favorable safety profile. The efficacy as measured by the AS-adapted CGI-I scale warrants further studies.
CLINICALTRIALSGOV IDENTIFIER


NCT02996305.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for individuals with AS, gaboxadol is generally safe and well-tolerated.",2021,"Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
","['Eighty-eight individuals', 'Angelman Syndrome', 'adolescent and adult individuals with a molecular diagnosis of AS', '87 individuals (aged 13-45 years) who received at least 1 dose of study drug, 78 (90%) completed the study', 'individuals with Angelman syndrome (AS']","['gaboxadol', 'placebo', 'gaboxadol qd vs placebo', 'placebo morning dose and gaboxadol 15 mg evening dose (qd); gaboxadol 10 mg morning dose and 15 mg evening dose (bid); or placebo', 'Gaboxadol', 'gaboxadol (OV101']","['safety and tolerability and exploratory efficacy endpoints', 'Safety and tolerability', 'Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI']","[{'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162635', 'cui_str': 'Angelman syndrome'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0047845', 'cui_str': 'gaboxadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",88.0,0.392542,"Efficacy of gaboxadol, as measured by CGI-I improvement in an exploratory analysis, was observed in gaboxadol qd vs placebo ( p  = 0.0006).
","[{'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Ochoa-Lubinoff', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Wen-Hann', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Gali', 'Initials': 'G', 'LastName': 'Heimer', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Raun D', 'Initials': 'RD', 'LastName': 'Melmed', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Rakhit', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Visootsak', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'During', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Holcroft', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Rebecca D', 'Initials': 'RD', 'LastName': 'Burdine', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston. alexander.kolevzon@mssm.edu.""}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Thibert', 'Affiliation': ""From the University of California, San Diego (L.M.B.); Rady Children's Hospital (L.M.B.), San Diego, CA; Division of Developmental-Behavioral Pediatrics (C.O.-L.), Rush University Medical Center, Chicago, IL; Division of Genetics and Genomics (W.-H.T.), Boston Children's Hospital, Harvard Medical School, MA; Pediatric Neurology Unit (G.H.), Safra Children's Hospital, the Sheba Medical Center, Ramat Gan; The Sackler School of Medicine (G.H.), Tel Aviv University, Israel; Southwest Autism Research and Resource Center (R.D.M.), Phoenix, AZ; Ovid Therapeutics Inc. (A.R., M.J.D.); Neurogene (J.V.), New York, NY; Prometrika, LLC (C.H.), Cambridge, MA; Department of Molecular Biology (R.D.B.), Princeton University, NJ; Seaver Autism Center for Research and Treatment, Department of Psychiatry (A.K.), Icahn School of Medicine at Mount Sinai, New York, NY; and Angelman Syndrome Clinic, Department of Neurology (R.L.T.), Massachusetts General Hospital, Boston.""}]",Neurology,['10.1212/WNL.0000000000011409']
972,33449843,A Comparison of Efficacy and Safety of Fractional Carbon Dioxide Laser and Fractional Er:YAG Laser for the Treatment of Xanthelasma Palpebrarum: A Two-Center Randomized Split-Face Controlled Trial.,"Background:  Xanthelasma palpebrarum (XP) is a form of cutaneous xanthoma that presents as collections of yellowish papules or plaques around the eyelids or canthus, affecting patients cosmetically.  Objective:  This study aimed to compare the efficacy and safety of fractional carbon dioxide (CO 2 ) laser to that of fractional Er:YAG laser for the treatment of XP.  Methods:  Two centers recruited patients diagnosed with XP of bilaterally symmetrical lesions. The lesion on one side was randomly assigned to be treated with fractional CO 2  laser while the lesion on the other side was treated with fractional Er:YAG laser. All subjects received up to five treatments, with a 4-week interval between each treatment.  Results:  Thirty-nine patients completed the study and a total of 82 lesions were available for final assessment. The percentage of ""Excellent Improvement"" on third and fourth visit was 60.98% versus 39.02% and 90.24% versus 63.41%, respectively,  p  < 0.05. In a follow-up for 12 to 25 months, the number of lesions recurred on the side treated with fractional CO 2  laser and fractional Er:YAG laser are 9 (22%) and 10 (24%), respectively.  Conclusions:  In this study, fractional CO 2  laser therapy appears superior since a fewer treatments are required for patients to show significant clinical improvement.",2021,"In a follow-up for 12 to 25 months, the number of lesions recurred on the side treated with fractional CO 2  laser and fractional Er:YAG laser are 9 (22%) and 10 (24%), respectively.  ","['Xanthelasma Palpebrarum', 'Two centers recruited patients diagnosed with XP of bilaterally symmetrical lesions', 'Thirty-nine patients completed the study and a total of 82 lesions were available for final assessment']","['Fractional Carbon Dioxide Laser and Fractional Er:YAG Laser', 'fractional carbon dioxide (CO 2 ) laser', 'Xanthelasma palpebrarum (XP', 'fractional CO 2  laser while the lesion on the other side was treated with fractional Er:YAG laser']","['percentage of ""Excellent Improvement', 'number of lesions']","[{'cui': 'C0155210', 'cui_str': 'Xanthoma of eyelid'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0155210', 'cui_str': 'Xanthoma of eyelid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}]",82.0,0.0423073,"In a follow-up for 12 to 25 months, the number of lesions recurred on the side treated with fractional CO 2  laser and fractional Er:YAG laser are 9 (22%) and 10 (24%), respectively.  ","[{'ForeName': 'Hsiaohan', 'Initials': 'H', 'LastName': 'Tuan', 'Affiliation': 'Department of Dermatology, School of Clinical Medicine, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cosmetology, Guangdong Provincial Dermatology Hospital, Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Cosmetology, Guangdong Provincial Dermatology Hospital, Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, School of Clinical Medicine, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, School of Clinical Medicine, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, School of Clinical Medicine, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4874']
973,33452565,Retraction Note to: Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities.,,2021,,[],['sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass'],[],[],"[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]",[],,0.00976555,,"[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ruiz-Tovar', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain. jruiztovar@gmail.com.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Carbajo', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'Jimenez', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Castro', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Gonzalez', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ortiz-de-Solorzano', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}, {'ForeName': 'Lorea', 'Initials': 'L', 'LastName': 'Zubiaga', 'Affiliation': 'Bariatric Surgery Unit, Centro de Excelencia para el Estudio y Tratamiento de la Obesidad, Valladolid, Spain.'}]",Surgical endoscopy,['10.1007/s00464-021-08298-0']
974,33444565,The effect of vitamin D supplementation on acute respiratory tract infection in older Australian adults: an analysis of data from the D-Health Trial.,"BACKGROUND


Observational studies have linked vitamin D deficiency with acute respiratory tract infection, but results from randomised controlled trials are heterogeneous. We analysed data from the D-Health Trial to determine whether supplementing older Australian adults, recruited from the general population, with monthly doses of vitamin D reduced the risk, duration, and severity of acute respiratory tract infections.
METHODS


We used data from the D-Health Trial, a randomised, double-blind, placebo-controlled trial of monthly vitamin D supplementation, for which acute respiratory infection was a pre-specified trial outcome. Participants were supplemented and followed for up to 5 years. The trial was set within the Australian general population, using the Commonwealth Electoral Roll as the sampling frame, but also allowing some volunteers to participate. Participants were men and women aged 60 to 79 years (with volunteers up to age 84 years). Participants were randomly assigned to receive either vitamin D or placebo (1:1) using computer-generated permuted block randomisation, which was stratified by age, sex, and state. This was an automated process and the assignment list was not visible to study staff or investigators. Active and placebo gel capsules, identical in appearance to ensure masking, were labelled A and B and the code was not available to study staff or investigators. Participants were asked to report occurrence of acute respiratory symptoms over the previous month via annual surveys, and a subset of participants completed 8-week respiratory symptom diaries in winter. As part of our process to maintain blinding, a random sample of participants was selected for analysis of survey data and a separate sample selected for analysis of diary data. Blood samples were obtained from a random sample of participants (about 450 per group per year) and serum 25-hydroxy vitamin D (25[OH]D) concentrations were measured to monitor adherence. We used regression models to estimate odds ratios (OR), rate ratios, and rate differences. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000743763.
FINDINGS


Between Jan 13, 2014, and May 26, 2015, 421 207 invitations were sent, 40 824 people were interested in participating, and 21 315 participants were recruited and randomised. Of the 16 000 participants selected for potential analysis of survey data, 15 373 were included in the analysis; 295 in the vitamin D group and 332 in the placebo group who were missing data for all five annual surveys were excluded from the analysis. Of the 3800 selected for potential analysis of diary data, 3070 were invited to complete the diaries because 730 had already withdrawn. 2598 people were included in the analysis; 218 people in the vitamin D group and 254 in the placebo group were missing data and were therefore excluded from the analysis. In blood samples collected from randomly sampled participants throughout the trial, the mean serum 25(OH)D concentration was 114·8 (SD 30·3) nmol/L in the vitamin D group and 77·5 (25·2) nmol/L in the placebo group. Vitamin D supplementation did not reduce the risk of acute respiratory tract infection (survey OR 0·98, 95% CI 0·93 to 1·02; diary OR 0·98, 0·83 to 1·15). Analyses of diary data showed reductions in the overall duration of symptoms and of severe symptoms, but these were small and unlikely to be clinically significant.
INTERPRETATION


Monthly bolus doses of 60 000 IU of vitamin D did not reduce the overall risk of acute respiratory tract infection, but could slightly reduce the duration of symptoms in the general population. These findings suggest that routine vitamin D supplementation of a population that is largely vitamin D replete is unlikely to have a clinically relevant effect on acute respiratory tract infection.
FUNDING


National Health and Medical Research Council.",2021,"Vitamin D supplementation did not reduce the risk of acute respiratory tract infection (survey OR 0·98, 95% CI 0·93 to 1·02; diary OR 0·98, 0·83 to 1·15).","['3800 selected for potential analysis of diary data, 3070 were invited to complete the diaries because 730 had already withdrawn', 'older Australian adults', 'supplementing older Australian adults, recruited from the general population, with monthly doses of', 'Between Jan 13, 2014, and May 26, 2015, 421\u2008207 invitations were sent, 40\u2008824 people were interested in participating, and 21\u2008315 participants were recruited and randomised', '2598 people were included in the analysis; 218 people in the vitamin D group and 254 in the', 'group and 77·5', 'Of the 16\u2008000 participants selected for potential analysis of survey data, 15\u2008373 were included in the analysis; 295 in the vitamin D group and 332 in the placebo group who were missing data for all five annual surveys were excluded from the analysis', 'Participants were men and women aged 60 to 79 years (with volunteers up to age 84 years']","['Vitamin D supplementation', 'vitamin D or placebo', 'placebo', 'vitamin D supplementation', 'monthly vitamin D supplementation', 'vitamin D', 'placebo gel capsules']","['risk of acute respiratory tract infection', 'duration of symptoms', 'acute respiratory tract infection', 'overall risk of acute respiratory tract infection', 'odds ratios (OR), rate ratios, and rate differences', 'overall duration of symptoms and of severe symptoms', 'acute respiratory symptoms', 'serum 25-hydroxy vitamin D (25[OH]D) concentrations', 'mean serum 25(OH)D concentration']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",421207.0,0.702965,"Vitamin D supplementation did not reduce the risk of acute respiratory tract infection (survey OR 0·98, 95% CI 0·93 to 1·02; diary OR 0·98, 0·83 to 1·15).","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Pham', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Waterhouse', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Baxter', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Duarte Romero', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Donald S A', 'Initials': 'DSA', 'LastName': 'McLeod', 'Affiliation': ""Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Bruce K', 'Initials': 'BK', 'LastName': 'Armstrong', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Dallas R', 'Initials': 'DR', 'LastName': 'English', 'Affiliation': 'Melbourne School of Population Health, University of Melbourne, Melbourne, VIC, Australia; Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Hartel', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kimlin', 'Affiliation': 'School of Biomedical Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Martineau', 'Affiliation': 'Institute for Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connell"", 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jolieke C', 'Initials': 'JC', 'LastName': 'van der Pols', 'Affiliation': 'Faculty of Health, School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Venn', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whiteman', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Neale', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia. Electronic address: rachel.neale@qimrberghofer.edu.au.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30380-6']
975,33449503,Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial.,"ABSTRACT


Placebo effects have traditionally involved concealment or deception. However, recent evidence suggests that placebo effects can also be elicited when prescribed transparently as ""open-label placebos"" (OLPs), and that the pairing of an unconditioned stimulus (eg, opioid analgesic) with a conditioned stimulus (eg, placebo pill) can lead to the conditioned stimulus alone reducing pain. In this randomized control trial, we investigated whether combining conditioning with an OLP (COLP) in the immediate postoperative period could reduce daily opioid use and postsurgical pain among patients recovering from spine surgery. Patients were randomized to COLP or treatment as usual, with both groups receiving unrestricted access to a typical opioid-based postoperative analgesic regimen. The generalized estimating equations method was used to assess the treatment effect of COLP on daily opioid consumption and pain during postoperative period from postoperative day (POD) 1 to POD 17. Patients in the COLP group consumed approximately 30% less daily morphine milligram equivalents compared with patients in the treatment as usual group during POD 1 to 17 (-14.5 daily morphine milligram equivalents; 95% CI: [-26.8, -2.2]). Daily worst pain scores were also lower in the COLP group (-1.0 point on the 10-point scale; 95% CI: [-2.0, -0.1]), although a significant difference was not detected in average daily pain between the groups (-0.8 point; 95% CI: [-1.7, 0.2]). These findings suggest that COLP may serve as a potential adjuvant analgesic therapy to decrease opioid consumption in the early postoperative period, without increasing pain.",2021,"Patients in the COLP group consumed approximately 30% less daily morphine mg equivalents (MMEs) compared to patients in the TAU group during POD 1-17 (-14.5 daily MME; 95% CI: [-26.8, -2.2]).","['spine surgery', 'patients recovering from spine surgery']","['COLP', 'placebo', 'COLP or treatment as usual (TAU), with both groups receiving unrestricted access to a typical opioid-based postoperative analgesic regimen', 'Conditioned open-label placebo', 'combining conditioning with an open-label placebo (COLP']","['daily opioid consumption and pain', 'opioid consumption', 'daily opioid use and postsurgical pain', 'Daily worst pain scores', 'average daily pain']","[{'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.395493,"Patients in the COLP group consumed approximately 30% less daily morphine mg equivalents (MMEs) compared to patients in the TAU group during POD 1-17 (-14.5 daily MME; 95% CI: [-26.8, -2.2]).","[{'ForeName': 'Kelsey M', 'Initials': 'KM', 'LastName': 'Flowers', 'Affiliation': ""Departments of Anesthesiology, Perioperative, and Pain Medicine and Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States Program in Placebo Studies and Therapeutic Encounter, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Hruschak', 'Affiliation': ''}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Zeballos', 'Affiliation': ''}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Rob R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ''}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': ''}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000002185']
976,33453782,Machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE): a modelling study of pooled datasets.,"BACKGROUND


The accuracy of current prediction tools for ischaemic and bleeding events after an acute coronary syndrome (ACS) remains insufficient for individualised patient management strategies. We developed a machine learning-based risk stratification model to predict all-cause death, recurrent acute myocardial infarction, and major bleeding after ACS.
METHODS


Different machine learning models for the prediction of 1-year post-discharge all-cause death, myocardial infarction, and major bleeding (defined as Bleeding Academic Research Consortium type 3 or 5) were trained on a cohort of 19 826 adult patients with ACS (split into a training cohort [80%] and internal validation cohort [20%]) from the BleeMACS and RENAMI registries, which included patients across several continents. 25 clinical features routinely assessed at discharge were used to inform the models. The best-performing model for each study outcome (the PRAISE score) was tested in an external validation cohort of 3444 patients with ACS pooled from a randomised controlled trial and three prospective registries. Model performance was assessed according to a range of learning metrics including area under the receiver operating characteristic curve (AUC).
FINDINGS


The PRAISE score showed an AUC of 0·82 (95% CI 0·78-0·85) in the internal validation cohort and 0·92 (0·90-0·93) in the external validation cohort for 1-year all-cause death; an AUC of 0·74 (0·70-0·78) in the internal validation cohort and 0·81 (0·76-0·85) in the external validation cohort for 1-year myocardial infarction; and an AUC of 0·70 (0·66-0·75) in the internal validation cohort and 0·86 (0·82-0·89) in the external validation cohort for 1-year major bleeding.
INTERPRETATION


A machine learning-based approach for the identification of predictors of events after an ACS is feasible and effective. The PRAISE score showed accurate discriminative capabilities for the prediction of all-cause death, myocardial infarction, and major bleeding, and might be useful to guide clinical decision making.
FUNDING


None.",2021,"The PRAISE score showed accurate discriminative capabilities for the prediction of all-cause death, myocardial infarction, and major bleeding, and might be useful to guide clinical decision making.
","['acute coronary syndrome (ACS', 'acute coronary syndrome (PRAISE', 'Different machine learning models for the prediction of 1-year post-discharge all-cause death, myocardial infarction, and major bleeding (defined as Bleeding Academic Research Consortium type 3 or 5) were trained on a cohort of 19\u2008826 adult patients with ACS (split into a training cohort [80%] and internal validation cohort [20%]) from the BleeMACS and RENAMI registries, which included patients across several continents', '3444 patients with ACS']",[],[],"[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0557963', 'cui_str': 'Praising'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}]",[],[],19826.0,0.0561764,"The PRAISE score showed accurate discriminative capabilities for the prediction of all-cause death, myocardial infarction, and major bleeding, and might be useful to guide clinical decision making.
","[{'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Ascenzo"", 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy; Cardiology, Department of Medical Sciences, University of Turin, Turin, Italy. Electronic address: fabrizio.dascenzo@gmail.com.'}, {'ForeName': 'Ovidio', 'Initials': 'O', 'LastName': 'De Filippo', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy; Cardiology, Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Gallone', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy; Cardiology, Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Mittone', 'Affiliation': 'Department of Computer Science, University of Turin, Turin, Italy.'}, {'ForeName': 'Marco Agostino', 'Initials': 'MA', 'LastName': 'Deriu', 'Affiliation': 'Polito BIO Med Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Iannaccone', 'Affiliation': 'Department of Cardiology, S G Bosco Hospital, Turin, Italy.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Ariza-Solé', 'Affiliation': 'Department of Cardiology, University Hospital de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'Kerckhoff Heart and Thorax Center, Frankfurt, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Manzano-Fernández', 'Affiliation': 'Department of Cardiology, University Hospital Virgen Arrtixaca, Murcia, Spain.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Quadri', 'Affiliation': 'Interventional Cardiology Unit, Degli Infermi Hospital, Turin, Italy.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kinnaird', 'Affiliation': 'Cardiology Department, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Jose Paulo', 'Initials': 'JP', 'LastName': 'Simao Henriques', 'Affiliation': 'University of Amsterdam, Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Hughes', 'Affiliation': 'Candiolo Cancer Institute, FPO - IRCCS, Turin, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Dominguez-Rodriguez', 'Affiliation': 'Servicio de Cardiologìa, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Aldinucci', 'Affiliation': 'Department of Computer Science, University of Turin, Turin, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Morbiducci', 'Affiliation': 'Polito BIO Med Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Patti', 'Affiliation': 'Catheterization Laboratory, Maggiore della Carità Hospital, Novara, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Raposeiras-Roubin', 'Affiliation': 'Department of Cardiology, University Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Abu-Assi', 'Affiliation': 'Department of Cardiology, University Hospital Álvaro Cunqueiro, Vigo, Spain.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy; Cardiology, Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32519-8']
977,33453783,"A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.","BACKGROUND


Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes.
METHODS


In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA 1c ) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA 1c  and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete.
FINDINGS


Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group.
INTERPRETATION


Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.",2021,"One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group.
","['individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA 1c ) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia', 'adolescents and young adults with type 1 diabetes (FLAIR', 'Between June 3 and Aug 22, 2019', '113 individuals were enrolled into the trial', 'Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female', 'adolescents and young adults with type 1 diabetes']","['G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic', 'commercially available hybrid closed-loop system', 'hybrid closed-loop systems', 'Fuzzy Logic Automated Insulin Regulation [FLAIR']","['Hyperglycaemia', 'superiority, and proportion of time that glucose levels', 'proportion of time that glucose levels', 'Mean 24-h proportion of time with glucose levels', 'hypoglycaemia', 'Safety', 'Mean proportion of time with daytime glucose levels', 'severe hypoglycaemic event']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0386744', 'cui_str': 'AM 19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0162586', 'cui_str': 'Logic, Fuzzy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",113.0,0.117743,"One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group.
","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA. Electronic address: richard.bergenstal@parknicollet.com.'}, {'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""Schneider Children's Medical Center, Petah Tikva, Israel.""}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research Foundation, Tampa, FL, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Criego', 'Affiliation': 'International Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""University Medical Center Ljubljana, University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Auf der Bult Centre for Children and Adolescents, Diabetology, Endocrinology and General Paediatrics, Hannover, Germany.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Center for Health Research Foundation, Tampa, FL, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'International Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Bailey', 'Affiliation': 'Jaeb Center for Health Research Foundation, Tampa, FL, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research Foundation, Tampa, FL, USA.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Carlson', 'Affiliation': 'International Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bello', 'Affiliation': ""Schneider Children's Medical Center, Petah Tikva, Israel.""}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': ""Albanese-O'Neill"", 'Affiliation': 'Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""University Medical Center Ljubljana, University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Auf der Bult Centre for Children and Adolescents, Diabetology, Endocrinology and General Paediatrics, Hannover, Germany.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Weyman', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University School of Medicine, Stanford Diabetes Research Center, Palo Alto, CA, USA.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Schneider Children's Medical Center, Petah Tikva, Israel.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32514-9']
978,33464721,Increasing skeletal muscle carnitine content in older individuals increases whole-body fat oxidation during moderate-intensity exercise.,"Intramyocellular lipid (IMCL) utilization is impaired in older individuals, and IMCL accumulation is associated with insulin resistance. We hypothesized that increasing muscle total carnitine content in older men would increase fat oxidation and IMCL utilization during exercise, and improve insulin sensitivity. Fourteen healthy older men (69 ± 1 year, BMI 26.5 ± 0.8 kg/m 2  ) performed 1 h of cycling at 50% VO 2  max and, on a separate occasion, underwent a 60 mU/m 2  /min euglycaemic hyperinsulinaemic clamp before and after 25 weeks of daily ingestion of a 220 ml insulinogenic beverage (44.4 g carbohydrate, 13.8 g protein) containing 4.5 g placebo (n = 7) or L-carnitine L-tartrate (n = 7). During supplementation, participants performed twice-weekly cycling for 1 h at 50% VO 2  max. Placebo ingestion had no effect on muscle carnitine content or total fat oxidation during exercise at 50% VO 2  max. L-carnitine supplementation resulted in a 20% increase in muscle total carnitine content (20.1 ± 1.2 to 23.9 ± 1.7 mmol/kg/dm; p < 0.01) and a 20% increase in total fat oxidation (181.1 ± 15.0 to 220.4 ± 19.6 J/kg lbm/min; p < 0.01), predominantly due to increased IMCL utilization. These changes were associated with increased expression of genes involved in fat metabolism (ACAT1, DGKD & PLIN2; p < 0.05). There was no change in resting insulin-stimulated whole-body or skeletal muscle glucose disposal after supplementation. This is the first study to demonstrate that a carnitine-mediated increase in fat oxidation is achievable in older individuals. This warrants further investigation given reduced lipid turnover is associated with poor metabolic health in older adults.",2021,Placebo ingestion had no effect on muscle carnitine content or total fat oxidation during exercise at 50% VO 2  max.,"['older men', 'older adults', 'older individuals', 'Fourteen healthy older men (69\xa0±\xa01\xa0year, BMI 26.5\xa0±\xa00.8']","['L-carnitine supplementation', 'placebo', 'L-carnitine L-tartrate', 'mU/m 2  /min euglycaemic hyperinsulinaemic clamp', 'Placebo ingestion']","['total fat oxidation', 'fat oxidation', 'fat oxidation and IMCL utilization', 'muscle carnitine content or total fat oxidation', 'resting insulin-stimulated whole-body or skeletal muscle glucose disposal', 'muscle total carnitine content', 'insulin sensitivity', 'expression of genes involved in fat metabolism', 'Intramyocellular lipid (IMCL) utilization', 'IMCL utilization']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1337234', 'cui_str': 'LEVOCARNITINE TARTRATE'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",14.0,0.0632987,Placebo ingestion had no effect on muscle carnitine content or total fat oxidation during exercise at 50% VO 2  max.,"[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chee', 'Affiliation': 'MRC/Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Shannon', 'Affiliation': 'Diabetes Division, University of Texas Health Science Centre, San Antonio, TX, USA.'}, {'ForeName': 'Aisling', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Sam and Ann Barshop Institute for Longevity and Aging Studies, University of Texas Health Science Centre, San Antonio, TX, USA.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Selby', 'Affiliation': 'MRC/Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wilkinson', 'Affiliation': 'MRC/Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC/Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Greenhaff', 'Affiliation': 'MRC/Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': ""Department of Sport and Health Sciences, St Luke's Campus, University of Exeter, Exeter, UK.""}]",Aging cell,['10.1111/acel.13303']
979,33434852,Impact of bifrontal transcranial Direct Current Stimulation on decision-making and stress reactivity. A pilot study.,"Stress is an adaptive response with repercussions on the human health. The dorsolateral prefrontal cortex (DLPFC) is thought to be involved in stress regulation by contributing to limit its biological and behavioral pejorative consequences. Here, to investigate the contribution of the DLPFC in stress response, we applied transcranial Direct Current Stimulation (tDCS) over the DLPFC during acute stress exposure in healthy participants. We hypothesized that active tDCS compared to sham would impact top-down control of the DLPFC on goal-directed behavior and hypothalamo-pituitary-adrenal (HPA) axis activity. In a double-blind sham-controlled study, 30 healthy subjects were randomly allocated to receive either active (2 mA, n = 15) or sham tDCS (n = 15) with the anode over the left DLPFC and the cathode over the right DLFPC. During the 30-min stimulation period, participants faced an experimental acute stress paradigm. Changes in goal-directed behavior were measured with a decision-making task. HPA axis reactivity was assessed by repeated measures of salivary cortisol. Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group. During stress exposure, we observed a significant larger elevation of salivary cortisol (p = 0.045; Cohen's d = 0.431) in the sham tDCS group (+179.8%; Standard error of the mean (SEM) = 20.6) than in the active group (+138.5%; SEM = 14.2). Stimulating the DLPFC using bifrontal tDCS may prevent stress-induced acute effects on both biological and behavioral outcomes.",2020,Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group.,"['30 healthy subjects', 'healthy participants']","['transcranial Direct Current Stimulation (tDCS', 'active tDCS', 'bifrontal transcranial Direct Current Stimulation', 'active (2\xa0mA, n\xa0=\xa015) or sham tDCS']","['decision-making and stress reactivity', 'elevation of salivary cortisol', 'HPA axis reactivity', 'stress']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C5200800', 'cui_str': 'Hypothalamo-Pituitary-Adrenal Axis'}]",30.0,0.0655343,Acute stress decreased appetite for immediate reward in the sham group (mean - 4.40%; p = 0.017) whereas no significant effect of stress was observed in the active group.,"[{'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre Intégré Universitaire en Santé et Services Sociaux de La Capitale-Nationale, Quebec City, QC, Canada; Centre Hospitalier Le Vinatier, F69500, Bron, France; INSERM, U1028, CNRS, UMR5292, Lyon Neuroscience Research Center, Psychiatric Disorders: from Resistance to Response-PSYR2 Team, Lyon, France. Electronic address: jerome.brunelin@ch-le-vinatier.fr.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Fecteau', 'Affiliation': 'Department of Psychiatry and Neurosciences, Medical School, Université Laval, CERVO Brain Research Center, Centre Intégré Universitaire en Santé et Services Sociaux de La Capitale-Nationale, Quebec City, QC, Canada.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.12.068']
980,33443770,The Effects of Anger on Alcohol Demand and Subjective Alcohol Craving.,"BACKGROUND


Anger and anger-related traits have been related to alcohol use in both cross-sectional and prospective studies. However, only a small number of studies have experimentally manipulated anger to examine whether the manipulation of anger influences alcohol craving or the relative reinforcing value of alcohol.
METHODS


Participants (N = 231) recruited through Amazon's MTurk were randomly assigned to a provocation condition or a neutral condition prior to completing both the Alcohol Purchase Task and a self-report measure of alcohol craving. Linear regression analyses were conducted to examine the effects of the anger induction, trait hostility, frequency of alcohol use in the past month, and relevant demographic characteristics (gender, age, income) on alcohol craving and indices of alcohol demand.
RESULTS


Participants assigned to the provocation condition had greater P Max  (B = 0.17, p = 0.012) and breakpoint (B = 0.18, p = 0.006) values, less elastic demand (B = -0.15, p = 0.020), and lower drinking intensity (B = -0.14, p = 0.025) than participants assigned to the neutral condition. Trait hostility was positively related to O Max  (B = 0.22, p = 0.001), intensity of demand (B = 0.27, p < 0.001), and subjective alcohol craving posttask (B = 0.32, p < 0.001), but did not moderate the relationship between condition and outcomes.
CONCLUSIONS


Although most persistence indices of alcohol demand were sensitive to the anger induction, we did not observe higher scores on amplitude indices or subjective craving in the provocation condition relative to the neutral condition. Further investigation into the role which anger plays in alcohol use is warranted.",2021,"RESULTS


Participants assigned to the provocation condition had greater P Max  (B = 0.17, p = 0.012) and breakpoint","[""Participants (N\xa0=\xa0231) recruited through Amazon's MTurk""]",['provocation condition or a neutral condition prior to completing both the Alcohol Purchase Task and a self-report measure of alcohol craving'],"['Alcohol Demand and Subjective Alcohol Craving', 'subjective alcohol craving posttask', 'intensity of demand', 'Trait hostility', 'anger induction, trait hostility, frequency of alcohol use in the past month, and relevant demographic characteristics (gender, age, income) on alcohol craving and indices of alcohol demand', 'lower drinking intensity']","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}]","[{'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",231.0,0.0133177,"RESULTS


Participants assigned to the provocation condition had greater P Max  (B = 0.17, p = 0.012) and breakpoint","[{'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Grekin', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14531']
981,33449867,Combination of Fractional CO 2  Laser and Rhodamine-Intense Pulsed Light in Facial Rejuvenation: A Randomized Controlled Trial.,"Objective:  This randomized controlled trial aims to verify the efficacy of a combined fractional CO 2  laser and rhodamine-intense pulsed-light (r-IPL) protocol in the photoaging therapy.  Background:  Skin aging is related to multiple environmental and genetic factors that give rise to different manifestations. In recent years many techniques have been proposed for the rejuvenation of the skin of the face such as ablative and nonablative procedures. Combination of laser or light sources with different wavelengths represents a safe and effective treatment method. r-IPL is a new pulsed-light technique capable to generate wavelengths varying from 550 to 650 nm proposed in nonablative photorejuvenation with a good efficacy and safety profile.  Methods:  Twenty-two patients (skin phototypes II-III, aged 46-67 years) were randomly allocated into two groups: group A was treated only with a therapeutic standard dose of the fractional CO 2  laser, whereas group B was treated with a combined therapy of r-IPL and fractional CO 2  laser. All patients were treated up to three times at a 2-month interval. Efficacy of the procedures was assessed thanks to the Fitzpatrick Wrinkle Severity Scale (scores 1-9) before treatment and at a 4-month follow-up from the last treatment.  Results:  Patients treated with the combination of r-IPL and fractional CO 2  laser showed better results in terms of wrinkle reduction according to the Fitzpatrick Wrinkle Severity score (2.82 ± 0.87 vs. 3.09 ± 1.14), with a statistically significant reduction in healing times (7.82 ± 0.75 vs. 13.82 ± 1.94 days,  p  ≤ 0.001) and duration of post-treatment erythema (3.55 ± 0.93 vs. 8.18 ± 1.47 days,  p  ≤ 0.001). Patient satisfaction was higher after combined fractional CO 2  laser and r-IPL treatment.  Conclusions:  Our data suggest that combined use of fractional CO 2  laser and r-IPL may lead to excellent results in terms of skin rejuvenation with a simple post-treatment management and an optimal tolerability.",2021,Efficacy of the procedures was assessed thanks to the Fitzpatrick Wrinkle Severity Scale (scores 1-9) before treatment and at a 4-month follow-up from the last treatment.  ,"['Methods:  Twenty-two patients (skin phototypes II-III, aged 46-67 years', 'Facial Rejuvenation']","['fractional CO 2  laser', 'combined therapy of r-IPL and fractional CO 2  laser', 'Fractional CO 2  Laser and Rhodamine-Intense Pulsed Light', 'combined fractional CO 2  laser and rhodamine-intense pulsed-light (r-IPL) protocol']","['Fitzpatrick Wrinkle Severity score', 'Patient satisfaction', 'duration of post-treatment erythema', 'Fitzpatrick Wrinkle Severity Scale', 'healing times', 'wrinkle reduction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0035483', 'cui_str': 'Rhodamines'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.035022,Efficacy of the procedures was assessed thanks to the Fitzpatrick Wrinkle Severity Scale (scores 1-9) before treatment and at a 4-month follow-up from the last treatment.  ,"[{'ForeName': 'Steven Paul', 'Initials': 'SP', 'LastName': 'Nistico', 'Affiliation': 'Department of Health Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Silvestri', 'Affiliation': 'Department of Health Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Zingoni', 'Affiliation': 'Unit of Dermatology, University of Rome, Tor Vergata, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tamburi', 'Affiliation': 'Department of Health Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bennardo', 'Affiliation': 'Department of Health Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cannarozzo', 'Affiliation': 'Unit of Dermatology, University of Rome, Tor Vergata, Rome, Italy.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2020.4876']
982,33452438,Beta-adrenergic blockade blunts inflammatory and antiviral/antibody gene expression responses to acute psychosocial stress.,"Dysregulation of the immune system is one potential mechanism by which acute stress may contribute to downstream disease etiology and psychopathology. Here, we tested the role of β-adrenergic signaling as a mediator of acute stress-induced changes in immune cell gene expression. In a randomized, double-blind, and placebo-controlled trial, 90 healthy young adults (44% female) received a single 40 mg dose of the β-blocker propranolol (n = 43) or a placebo (n = 47) and then completed the Trier Social Stress Test (TSST). Pre- and post-stress blood samples were assayed for prespecified sets of pro-inflammatory and antiviral/antibody gene transcripts. Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol. Bioinformatics identified natural killer cells and dendritic cells as the primary cellular context for transcriptional upregulation, and monocytes as the primary cellular carrier of genes downregulated by the TSST. These effects were in part explained by acute changes in circulating cell types. Results suggest that acute psychosocial stress can induce an ""acute defense"" molecular phenotype via β-adrenergic signaling that involves mobilization of natural killer cells and dendritic cells at the expense of monocytes. This may represent an adaptive response to the risk of acute injury. These findings offer some of the first evidence in humans that β-blockade attenuates psychosocial stress-induced increases in inflammatory gene expression, offering new insights into the molecular and immunologic pathways by which stress may confer risks to health and well-being.",2021,"Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol.",['90 healthy young adults (44% female'],"['propranolol', 'single 40\u2009mg dose of the β-blocker propranolol', 'placebo (n\u2009=\u200947) and then completed the Trier Social Stress Test (TSST', 'placebo']",['expression of both inflammatory and antiviral/antibody-related genes in response to the TSST'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",90.0,0.140392,"Analyses revealed increased expression of both inflammatory and antiviral/antibody-related genes in response to the TSST, and these effects were blocked by pre-treatment with propranolol.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'MacCormack', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. maccormack@pitt.edu.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Gaudier-Diaz', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Armstrong-Carter', 'Affiliation': 'Graduate School of Education, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jesusa M G', 'Initials': 'JMG', 'LastName': 'Arevalo', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Sloan', 'Affiliation': 'Monash Institute of Pharmaceutical Sciences, Drug Discovery Biology Theme, Monash University, Parkville, VIC, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00897-0']
983,33444934,Longitudinal investigation of the relationship between omega-3 polyunsaturated fatty acids and neuropsychological functioning in recent-onset psychosis: A randomized clinical trial.,"Alterations in polyunsaturated fatty acids (PUFAs), including omega-3 and omega-6, have been implicated in the pathophysiology of psychotic disorders, but little is known about their associations with neuropsychological functioning. The present study includes 46 recent-onset psychosis patients who participated in a larger (n = 50) double blind, placebo-controlled randomized clinical trial comparing 16 weeks of treatment with either risperidone + fish oil (FO) (EPA 740 mg and DHA 400 mg daily) or risperidone + placebo and completed neuropsychological assessments at the baseline timepoint. We investigated the relationship between baseline omega-3 (i.e., eicosapentaenoic acid, EPA; docosapentaenoic acid, DPA and docosahexaenoic acid, DHA) and omega-6 (i.e., arachidonic acid, AA) PUFA with baseline MATRICS Consensus Cognitive Battery (MCCB) and Brief Psychiatric Rating Scale (BPRS) scores. Twenty-five patients had neuropsychological data available at 16 weeks following participation in the clinical trial, which included 12 patients assigned to risperidone + FO and 13 patients assigned to risperidone + placebo. At baseline both higher DHA and EPA correlated significantly with better social cognition after controlling for functioning on other neuropsychological domains, total BPRS score, AA level and substance use. Also, at baseline higher AA correlated significantly with hostility/uncooperativeness after controlling for DHA + EPA + DPA, overall neuropsychological functioning and substance use. Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo. DHA also correlated significantly with social cognition at the 16-week timepoint. This study provides novel evidence for a differential role of omega-3 vs. omega-6 PUFA in neuropsychological deficits and symptoms in recent-onset psychosis and its treatment.",2021,Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo.,"['46 recent-onset psychosis patients who participated in a larger (n\xa0=\xa050) double blind', 'Twenty-five patients had neuropsychological data available at 16\xa0weeks following participation in the clinical trial, which included 12 patients assigned to', 'recent-onset psychosis']","['omega-3 vs. omega-6 PUFA', 'EPA 740\xa0mg and DHA 400\xa0mg daily) or risperidone\xa0+\xa0placebo', 'placebo', 'omega-3 polyunsaturated fatty acids', 'risperidone\xa0+\xa0placebo', 'risperidone\xa0+\xa0fish oil (FO', 'risperidone\xa0+\xa0FO']","['baseline omega-3 (i.e., eicosapentaenoic acid, EPA; docosapentaenoic acid, DPA and docosahexaenoic acid, DHA) and omega-6 (i.e., arachidonic acid, AA) PUFA with baseline MATRICS Consensus Cognitive Battery (MCCB) and Brief Psychiatric Rating Scale (BPRS) scores', 'social cognition', 'total BPRS score, AA level and substance use']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0133860', 'cui_str': 'Fatty Acids, Omega-6'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",12.0,0.434911,Patients treated with risperidone + FO demonstrated a significant longitudinal increase in social cognition that was significantly higher at 16 weeks compared to patients treated with risperidone + placebo.,"[{'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Szeszko', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; James J. Peters VA Medical Center, Mental Illness Research, Education and Clinical Center, Bronx, NY, United States of America. Electronic address: philip.szeszko@mssm.edu.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Lipidomics Research Program, University of Cincinnati, Cincinnati, OH, United States of America.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Gallego', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Malhotra', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Govindarajulu', 'Affiliation': 'Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, NY, NY, United States of America.'}, {'ForeName': 'Bart D', 'Initials': 'BD', 'LastName': 'Peters', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States of America; Departments of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2020.11.050']
984,33460575,Unilateral Strength Training of the Less Affected Hand Improves Cortical Excitability and Clinical Outcomes in Patients With Subacute Stroke: A Randomized Controlled Trial.,"OBJECTIVES


To investigate whether unilateral strength training helps improve cortical excitability and clinical outcomes after stroke.
DESIGN


Randomized controlled trial.
SETTING


Rehabilitation sciences research center.
PARTICIPANTS


Patients with subacute stroke (N=26) were randomly assigned to a control group (n=13) or the experimental group (n=13).
INTERVENTIONS


Participants in both groups received conventional physiotherapy. The experimental group also received unilateral strength training of the less affected wrist extensors. Interventions were applied for 4 weeks (12 sessions, 3 d/wk).
MAIN OUTCOME MEASURES


Cortical excitability in both the ipsilesional hemisphere (ipsiH) and contralesional hemisphere (contraH) was assessed by measuring resting motor threshold (RMT), active motor threshold (AMT), motor evoked potential (MEP), and cortical silent period (CSP) at baseline and after the 4-week intervention period. Clinical outcomes were obtained by evaluating wrist extension strength in both the more affected and less affected hands, upper extremity motor function, activities of daily living (ADL), and spasticity.
RESULTS


The experimental group showed greater MEP amplitude (P=.001) in the ipsiH and shorter CSP duration in both the ipsiH (P=.042) and contraH (P=.038) compared with the control group. However, the reductions in RMT and AMT in both hemispheres were not significantly different between groups. Improvements in wrist extension strength in the more affected (P=.029) and less affected (P=.001) hand, upper extremity motor function (P=.04), and spasticity (P=.014) were greater in the experimental group. No significant difference in ADLs was detected between groups.
CONCLUSIONS


A combination of unilateral strength training and conventional physiotherapy appears to be a beneficial therapeutic modality for improving cortical excitability and some clinical outcomes in patients with stroke.",2021,The experimental group showed greater MEP amplitude (p=0.001) in the ipsiH and shorter CSP duration in both the ipsiH (p=0.042) and contraH (p=0.038) compared to the control group.,"['patients with subacute stroke', 'patients with stroke', ' 26 patients with subacute stroke']","['conventional physiotherapy', 'Unilateral strength training', 'unilateral strength training', 'unilateral strength training and conventional physiotherapy']","['upper extremity motor function', 'cortical excitability and clinical outcomes', 'hands, upper extremity motor function, activities of daily living (ADLs) and spasticity', 'MEP amplitude', 'CSP duration', 'spasticity', 'wrist extension strength', 'RMT and AMT', 'resting motor threshold (RMT), active motor threshold (AMT), motor evoked potential (MEP) and cortical silent period (CSP', 'ADLs', 'cortical excitability in both the ipsilesional hemisphere (ipsiH) and contralesional hemisphere (contraH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",26.0,0.162157,The experimental group showed greater MEP amplitude (p=0.001) in the ipsiH and shorter CSP duration in both the ipsiH (p=0.042) and contraH (p=0.038) compared to the control group.,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Salehi Dehno', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Kamali', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Fahimehkamali@hotmail.com.'}, {'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Shariat', 'Affiliation': 'Clinical Neurology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.12.012']
985,33464557,Effects of Femtosecond Laser-Assisted Cataract Surgery on Macular and Choroidal Thickness in Diabetic Patients.,"INTRODUCTION


This study aimed to compare the short-term changes in retinal and choroid thickness in diabetic patients after femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification (PE) surgery.
METHODS


A total of 47 eyes in the PE group and 44 eyes in the FLACS group were included. All patients underwent measurement of central macular thickness (CMT) and subfoveal choroidal thickness (SFCT) before and after surgery using optical coherence tomography (OCT).
RESULTS


The effective phaco time (EPT) in the FLACS group was significantly reduced. The BCVA differed significantly between the two groups at 1 week and 1 month after surgery. The CMT in both groups increased at 1 week after the operation. It did not return to the preoperative level until month 12 in the PE group. In the FLACS group, the CMT began to decrease at month 3 and recovered to the preoperative level at month 12. The SFCT of the two groups increased at week 1; it began to decrease at month 6 in the PE group but did not recover to the preoperative level until month 12. The SFCT in the FLACS group recovered to preoperative levels at month 6. In the PE group, baseline CMT values predicted CMT change at week 1 and months 1, 3 and 12 after surgery. In the FLACS group, baseline CMT predicted CMT changes at week 1, month 1 and month 3. In the FLACS group, EPT predicted SFCT change at month 3.
CONCLUSION


FLACS is safe and effective in patients with no fundus change or mild diabetic retinopathy. It has advantages in effectively reducing EPT, achieving good vision earlier and promoting faster recovery of the retinal and choroidal thickness. Preoperative CMT is a significant predictor of CMT changes in the early period after FLACS.",2021,The SFCT of the two groups increased at week 1; it began to decrease at month 6 in the PE group but did not recover to the preoperative level until month 12.,"['Diabetic Patients', 'A total of 47 eyes in the PE group and 44 eyes in the FLACS group were included', 'diabetic patients after', 'patients with no fundus change or mild diabetic retinopathy']","['FLACS', 'femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification (PE) surgery', 'Femtosecond Laser-Assisted Cataract Surgery']","['effective phaco time (EPT', 'BCVA', 'central macular thickness (CMT) and subfoveal choroidal thickness (SFCT', 'Macular and Choroidal Thickness', 'CMT changes', 'baseline CMT predicted CMT changes', 'EPT predicted SFCT change']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",47.0,0.0203637,The SFCT of the two groups increased at week 1; it began to decrease at month 6 in the PE group but did not recover to the preoperative level until month 12.,"[{'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Ma', 'Affiliation': 'Department of Ophthalmology, Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China.'}, {'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Rong', 'Affiliation': 'Department of Ophthalmology, Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China. rongao@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Xin Shi Jie Eye Hospital, Shanghai, 200050, China.'}, {'ForeName': 'Shu-Ya', 'Initials': 'SY', 'LastName': 'Deng', 'Affiliation': 'Department of Ophthalmology, Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00326-x']
986,33470341,"Codeine plus acetaminophen improve sleep quality, daily activity level, and food intake in the early postoperative period after photorefractive keratectomy: a secondary analysis.","PURPOSE


To determine whether codeine plus acetaminophen after photorefractive keratectomy (PRK) have beneficial effects on sleep quality, activity levels, and food intake, beyond their effect of pain relief.
METHODS


We enrolled 40 patients (80 eyes) in this randomized, double-blind, paired-eye, placebo-controlled, add-on trial. Each eye was treated 2 weeks apart, and the patients were randomly allocated to receive either the placebo or the intervention (30 mg codeine and 500 mg acetaminophen) (4 times a day for 4 days). Outcomes were sleep quality, daily activity level, and food intake within 24-72 h post-photorefractive keratectomy, as measured by the McGill Pain Questionnaire.
RESULTS


Sleep quality and daily activity level were inversely associated with pain scores within the first 48 h post-photorefractive keratectomy. During the intervention, patients were significantly more likely to score their sleep quality as good at 24 h (relative risk=2.5; 95% confidence interval 1.48-4.21, p<0.001) and 48 h compared to during placebo (relative risk=1.37; 95% confidence interval: 1.03-1.84, p=0.023). The probability of reporting good daily activity level at 24 and 72 hours post-photorefractive keratectomy was three times higher when patients received the intervention compared to the placebo (relative risk=3.0; 95% confidence interval: 1.49-6.15, p=0.006 and relative risk=1.31; 95% confidence interval: 1.02-1.67, p=0.021, respectively). No difference was observed in food intake.
CONCLUSION


The oral combination of codeine and acetaminophen significantly improves sleep quality and daily activity level within the first 24-72 h post-photorefractive keratectomy compared to a placebo.",2021,The oral combination of codeine and acetaminophen significantly improves sleep quality and daily activity level within the first 24-72 h post-photorefractive keratectomy compared to a placebo.,['40 patients (80 eyes'],"['codeine and acetaminophen', 'placebo', 'codeine and 500 mg acetaminophen', 'codeine plus acetaminophen', 'Codeine plus acetaminophen']","['Sleep quality and daily activity level', 'sleep quality, activity levels, and food intake', 'food intake', 'pain scores', 'score their sleep quality', 'sleep quality and daily activity level', 'sleep quality, daily activity level, and food intake within 24-72 h post-photorefractive keratectomy, as measured by the McGill Pain Questionnaire', 'probability of reporting good daily activity level', 'sleep quality, daily activity level, and food intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",40.0,0.695298,The oral combination of codeine and acetaminophen significantly improves sleep quality and daily activity level within the first 24-72 h post-photorefractive keratectomy compared to a placebo.,"[{'ForeName': 'Vinicius B P', 'Initials': 'VBP', 'LastName': 'Pereira', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'André A M', 'Initials': 'AAM', 'LastName': 'Torriceli', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Garcia', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Samir J', 'Initials': 'SJ', 'LastName': 'Bechara', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Milton R', 'Initials': 'MR', 'LastName': 'Alves', 'Affiliation': 'Departamento de Oftalmologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20210008']
987,33445133,Anakinra compared to prednisone in the treatment of acute CPPD crystal arthritis: A randomized controlled double-blinded pilot study.,,2020,,['acute CPPD crystal arthritis'],['prednisone'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1739045', 'cui_str': ""N-CYCLOHEXYL-N'-PHENYL-1,4-PHENYLENEDIAMINE""}, {'cui': 'C0152087', 'cui_str': 'Crystal arthropathy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],,0.551721,,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumusc', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland. Electronic address: alexandre.dumusc@chuv.ch.'}, {'ForeName': 'Borbala', 'Initials': 'B', 'LastName': 'Pazar Maldonado', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benaim', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Lausanne University Hospital, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Zufferey', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Bérengère', 'Initials': 'B', 'LastName': 'Aubry-Rozier', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'So', 'Affiliation': 'Rheumatology Department, Lausanne University Hospital, avenue Pierre-Decker 4, 1005 Lausanne, Switzerland.'}]",Joint bone spine,['10.1016/j.jbspin.2020.105088']
988,33422596,Enjoyment of watching pimple popping videos: An fMRI investigation.,"BACKGROUND


Millions of people enjoy watching videos of pimple treatments. The underlying neural mechanisms of this enjoyment have not been investigated so far.
METHOD


We administered a total of 96 video clips from three categories: Pimple Popping (PP), Water Fountains (WF), and Steam Cleaning (SC). The PP videos showed a pimple or blackhead that was opened to squeeze out the pus or sebum. The female participants (mean age: 24 years) were assigned to one of two groups: females who reported to enjoy watching PP (PPE_high; n = 38) and those with little enjoyment (PPE_low; n = 42). We analyzed brain activity in regions of interest (ROI) involved in the encoding of pleasure and aversion (e.g., nucleus accumbens (NAc), insula).
RESULTS


The PPE_high group showed less deactivation of the NAc (ROI finding), more frontopolar activation (whole-brain finding), and stronger accumbens-insula coupling than the PPE_low group.
CONCLUSIONS


A specific pattern of brain activity and connectivity that involves the NAc and insula (coding of aversion/pleasure) and the frontopolar region (prediction of outcomes of motor decisions) is associated with the enjoyment of PP videos.",2021,"The PPE_high group showed less deactivation of the NAc (ROI finding), more frontopolar activation (whole-brain finding), and stronger accumbens-insula coupling than the PPE_low group.
",['female participants (mean age: 24 years) were assigned to one of two groups: females who reported to enjoy watching PP (PPE_high; n = 38) and those with little enjoyment (PPE_low; n = 42'],"['PPE_high', '96 video clips from three categories: Pimple Popping (PP), Water Fountains (WF), and Steam Cleaning (SC']","['deactivation of the NAc (ROI finding), more frontopolar activation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",96.0,0.0517452,"The PPE_high group showed less deactivation of the NAc (ROI finding), more frontopolar activation (whole-brain finding), and stronger accumbens-insula coupling than the PPE_low group.
","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Wabnegger', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMedGraz, Universitätsplatz 2, 8010, Graz, Austria.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Höfler', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMedGraz, Universitätsplatz 2, 8010, Graz, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zussner', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMedGraz, Universitätsplatz 2, 8010, Graz, Austria.'}, {'ForeName': 'Harald H', 'Initials': 'HH', 'LastName': 'Freudenthaler', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMedGraz, Universitätsplatz 2, 8010, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Institute of Psychology, University of Graz, BioTechMedGraz, Universitätsplatz 2, 8010, Graz, Austria. Electronic address: anne.schienle@uni-graz.at.'}]",Behavioural brain research,['10.1016/j.bbr.2021.113129']
989,33462450,Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: the randomized phase II SAFIR02-BREAST IMMUNO trial.,"The impact of single-agent antibodies against programmed death-ligand 1 (PD-L1) as maintenance therapy is unknown in patients with metastatic breast cancer. The SAFIR02-BREAST IMMUNO substudy included patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after six to eight cycles of chemotherapy. Patients (n = 199) were randomized to either durvalumab (10 mg kg -1  every 2 weeks) or maintenance chemotherapy. In the overall population, durvalumab did not improve progression-free survival (adjusted hazard ratio (HR): 1.40, 95% confidence interval (CI): 1.00-1.96; P = 0.047) or overall survival (OS; adjusted HR: 0.84, 95% CI: 0.54-1.29; P = 0.423). In an exploratory subgroup analysis, durvalumab improved OS in patients with triple-negative breast cancer (TNBC; n = 82; HR: 0.54, 95% CI: 0.30-0.97, P = 0.0377). Exploratory analysis showed that the HR of death was 0.37 (95% CI: 0.12-1.13) for patients with PD-L1 +  TNBC (n = 32) and 0.49 (95% CI: 0.18-1.34) for those with PD-L1 -  TNBC (n = 29). In patients with TNBC, exploratory analyses showed that the HR for durvalumab efficacy (OS) was 0.18 (95% CI: 0.05-0.71; log-rank test, P = 0.0059) in patients with CD274 gain/amplification (n = 23) and 1.12 (95% CI: 0.42-2.99; log-rank test, P = 0.8139) in patients with CD274 normal/loss (n = 32). Tumor infiltration by lymphocytes (CD8, FoxP3 and CD103 expressions) and homologous recombination deficiency did not predict sensitivity to durvalumab in exploratory analyses. This latter finding should be interpreted with caution since only one patient presented a germline BRCA mutation. The present study provides a rationale to evaluate single-agent durvalumab in maintenance therapy in patients with TNBC. Exploratory analyses identified CD274 amplification as a potential biomarker of sensitivity. Maintenance chemotherapy was more effective than durvalumab in patients with hormone receptor-positive and Her2-negative disease.",2021,"Tumor infiltration by lymphocytes (CD8, FoxP3 and CD103 expressions) and homologous recombination deficiency did not predict sensitivity to durvalumab in exploratory analyses.","['Patients (n\u2009=\u2009199', 'patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer', 'metastatic breast cancer', 'patients with metastatic breast cancer', 'patients with TNBC', 'patients with hormone receptor-positive and Her2-negative disease']","['durvalumab', 'Maintenance chemotherapy', 'single-agent antibodies against programmed death-ligand 1 (PD-L1', 'chemotherapy', 'maintenance chemotherapy', 'Durvalumab']","['HR of death', 'progression-free survival', 'Tumor infiltration by lymphocytes (CD8, FoxP3 and CD103 expressions) and homologous recombination deficiency', 'durvalumab efficacy (OS', 'durvalumab improved OS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C1141628', 'cui_str': 'Lymphocyte antigen CD103'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",199.0,0.0687527,"Tumor infiltration by lymphocytes (CD8, FoxP3 and CD103 expressions) and homologous recombination deficiency did not predict sensitivity to durvalumab in exploratory analyses.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Filleron', 'Affiliation': 'Department of Biostatistics, Institut Claudius-Regaud, IUCT Oncopole, Toulouse, France.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bieche', 'Affiliation': 'Department of Genetics, Institut Curie and Paris-Descartes University, Paris, France.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Arnedos', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest - René Gauducheau, Saint Herblain et Angers, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Dalenc', 'Affiliation': 'Department of Medical Oncology, Institut Claudius-Regaud, IUCT Oncopole and University of Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Coussy', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Sablin', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debled', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lefeuvre-Plesse', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Goncalves', 'Affiliation': 'Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Marie-Ange Mouret', 'Initials': 'MM', 'LastName': 'Reynier', 'Affiliation': 'Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': 'Department of Medical Oncology, Institut de Cancérologie de Montpellier, Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194 and Montpellier Université, Montpellier, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL); Centre d'Investigation de Thérapeutiques en Oncologie et Hématologie de Lyon (CITOHL); Univ Lyon, Université Claude Bernard Lyon 1; EMR UCBL/HCL 3738; GINECO, Lyon, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthelemy', 'Affiliation': 'Institut de Cancérologie Strasbourg, Strasbourg, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Verret', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Department of Medical Oncology, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Tchiknavorian', 'Affiliation': 'Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer, Hôpital Sainte Musse, Toulon, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Thery', 'Affiliation': 'Department of Medical Oncology, Centre Henri Becquerel, University of Medicine of Rouen, Rouen, France.'}, {'ForeName': 'Tifenn', 'Initials': 'T', 'LastName': ""L'Haridon"", 'Affiliation': 'Centre Hospitalier Départemental de Vendée, La Roche Sur Yon, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': ""Department of Medical Oncology, Centre Antoine Lacassagne, University Côte d'Azur, Nice, France.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mege', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Del Piano', 'Affiliation': 'Hôpitaux du Leman, Thonon Les Bains, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Rouleau', 'Affiliation': 'Cancer Genetics Laboratory, Department of Pathology and Medical Biology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Tran-Dien', 'Affiliation': 'INSERM UMR981 and Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Adam', 'Affiliation': 'Department of Pathology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Lusque', 'Affiliation': 'Department of Biostatistics, Institut Claudius-Regaud, IUCT Oncopole, Toulouse, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jimenez', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jacquet', 'Affiliation': 'Unicancer, Paris, France.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Garberis', 'Affiliation': 'INSERM UMR981 and Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Andre', 'Affiliation': 'Department of Medical Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France. fabrice.andre@gustaveroussy.fr.'}]",Nature medicine,['10.1038/s41591-020-01189-2']
990,33464215,Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed.
OBJECTIVE


In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP).
METHODS


We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data.
RESULTS


The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020.
CONCLUSIONS


Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/25291.",2021,We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition.,"['Chronic Low Back Pain', '180 individuals with cLBP to 1 of 2 VR programs: (1', 'people with chronic low back pain (cLBP', '186 participants were recruited']","['self-administered behavioral skills-based VR program', 'Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy', 'Behavioral skills-based VR', 'EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition', 'Virtual reality (VR', 'VR headset', 'nonpharmacological home-based pain management treatment']","['patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction', 'average pain intensity and pain-related interference with activity, stress, mood, and sleep', '2D neutral content']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",186.0,0.13119,We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition.,"[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Garcia', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'C T Bauer College of Business, Houston, TX, United States.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Mackey', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Sackman', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Louis', 'Affiliation': 'Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, CA, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Maddox', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Birckhead', 'Affiliation': 'Division of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.'}]",JMIR research protocols,['10.2196/25291']
991,33470281,ETDRS panretinal photocoagulation combined with intravitreal ranibizumab versus PASCAL panretinal photocoagulation with intravitreal ranibizumab versus intravitreal ranibizumab alone for the treatment of proliferative diabetic retinopathy.,"PURPOSE


To compare visual acuity, macular thickness, and the area of active neovascularization based on fluorescein angiography outcomes associated with standard single-spot panretinal photocoagulation in the Early Treatment Diabetic Retinopathy Study (ETDRS) pattern combined with intravitreal ranibizumab injection versus multiple-spot full scatter (PASCAL) panretinal photocoagulation combined with intravitreal ranibizumab injection versus intravitreal injection alone in patients with proliferative diabetic retinopathy.
METHODS


Patients with proliferative diabetic retinopathy and no prior laser treatment were randomly assigned to receive three different types of treatment. Panretinal photocoagulation in the ETDRS group was administered in two sessions (weeks 0 and 2), and panretinal photocoagulation in the PASCAL group was administered in one session (week 0). Intravitreal injection of ranibizumab was administered at the end of the first laser session in both the ETDRS and PASCAL groups and at week 0 in the intravitreal injection group. Comprehensive ophthalmic evaluations were performed at baseline and every 4 weeks through week 48.
RESULTS


Thirty patients (n=40 eyes) completed the 48-week study period. After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group. A significant decrease in central subfield macular thickness was observed in the PASCAL group at weeks 4, 8, and 48; only at week 48 in the intravitreal injection group; and never in the ETDRS group. There was no significant difference among the three treatment groups with respect to change from baseline to week 48 in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization.
CONCLUSIONS


Intravitreal injection alone or combined with single- or multiple-spot panretinal photocoagulation yielded similar outcomes with respect to mean change in best-corrected visual acuity, central subfield macular thickness, and fluorescein leakage from active neovascularization at up to one-year of follow-up. All subjects provided written informed consent to participate (NCT02005432 in clinicaltrials.gov).",2020,"After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group.","['patients with proliferative diabetic retinopathy', 'Thirty patients (n=40 eyes) completed the 48-week study period', 'proliferative diabetic retinopathy', 'Patients with proliferative diabetic retinopathy and no prior laser treatment']","['intravitreal ranibizumab injection versus multiple-spot full scatter (PASCAL) panretinal photocoagulation combined with intravitreal ranibizumab injection', 'Panretinal photocoagulation', 'Intravitreal injection alone or combined with single- or multiple-spot panretinal photocoagulation', 'intravitreal ranibizumab', 'intravitreal injection alone', 'intravitreal ranibizumab alone', 'ranibizumab', 'standard single-spot panretinal photocoagulation']","['best-corrected visual acuity', 'mean change in best-corrected visual acuity, central subfield macular thickness, and fluorescein leakage from active neovascularization', 'corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization', 'central subfield macular thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}]",,0.0359353,"After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group.","[{'ForeName': 'Rafael de Montier P', 'Initials': 'RMP', 'LastName': 'Barroso', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Messias', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Denny Marcos', 'Initials': 'DM', 'LastName': 'Garcia', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'José Augusto', 'Initials': 'JA', 'LastName': 'Cardillo', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Messias', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Department of Ophthalmology, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200096']
992,33470278,Novel low-cost approach to the treatment of ocular surface squamous neoplasia using pattern scanning laser photocoagulation.,"PURPOSE


To evaluate the safety and 12-month effect of treatment with pattern scanning laser photocoagulation for ocular surface squamous neoplasia in a low-resource setting with extremely limited access to an operating room.
METHODS


Adult patients with a clinical diagnosis of ocular surface squamous neoplasia underwent a complete ophthalmologic examination. After topical anesthesia and instillation of toluidine blue 1%, the lesion was treated using pattern scanning photocoagulation for a duration time that varied from 20 to 100 ms and power from 600 to 1,800 mW. Patients were examined on a weekly basis for the first month and underwent weekly retreatment of the remaining lesions, as necessary. Patients had a minimum follow-up of 12 months.
RESULTS


Thirty-eight patients (38 eyes) were included. All patients had clinical ocular surface squamous neoplasia that was confirmed by impression cytology. The age of patients ranged from 40 to 83 years (average: 65.5 years) and 28 of them were males (74%). The patients were divided into two groups: group I (immunocompetent) and group II (immuno-suppressed). In group I, 23 patients (74%) presented complete response with lesion control after laser treatment alone. In group II, two of seven patients (28%) showed treatment response during the follow-up. The average number of treatments was 2.5 (one to six laser treatments). Procedures were well tolerated.
CONCLUSION


Short-term results of the laser photocoagulation approach for the treatment of ocular surface squamous neoplasia conjunctival lesions were favorable, with a 74% success rate observed in immunocompetent patients. This novel strategy is a less resource-intensive alternative that could demonstrate its usefulness in settings with shortages in operating rooms and in recurrent cases. Studies with longer follow-ups and larger sample sizes are warranted to confirm our findings and evaluate the effectiveness of laser treatment in association with topical chemotherapy.",2020,"Short-term results of the laser photocoagulation approach for the treatment of ocular surface squamous neoplasia conjunctival lesions were favorable, with a 74% success rate observed in immunocompetent patients.","['All patients had clinical ocular surface squamous neoplasia that was confirmed by impression cytology', 'Thirty-eight patients (38 eyes) were included', 'Adult patients with a clinical diagnosis of ocular surface squamous neoplasia underwent a complete ophthalmologic examination', 'ocular surface squamous neoplasia using pattern', 'The age of patients ranged from 40 to 83 years (average: 65.5 years) and 28 of them were males (74']","['pattern scanning photocoagulation', 'scanning laser photocoagulation', 'pattern scanning laser photocoagulation', 'laser photocoagulation approach']","['tolerated', 'complete response with lesion control', 'ocular surface squamous neoplasia conjunctival lesions']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4761284', 'cui_str': 'Ocular surface squamous neoplasia'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4761284', 'cui_str': 'Ocular surface squamous neoplasia'}, {'cui': 'C1393738', 'cui_str': 'Lesion of conjunctiva'}]",,0.0128663,"Short-term results of the laser photocoagulation approach for the treatment of ocular surface squamous neoplasia conjunctival lesions were favorable, with a 74% success rate observed in immunocompetent patients.","[{'ForeName': 'Ever Ernesto Caso', 'Initials': 'EEC', 'LastName': 'Rodriguez', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Karlos Frederico Castelo Branco', 'Initials': 'KFCB', 'LastName': 'Sancho', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Patricia Mencaroni', 'Initials': 'PM', 'LastName': 'Kange', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Jeison de Nadai', 'Initials': 'JN', 'LastName': 'Barros', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Aline Sutili', 'Initials': 'AS', 'LastName': 'Toledo', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Morales', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort Neto', 'Affiliation': 'Ophthalmology and Visual Sciences Department, Universidade Federal de São Paulo, Brazil.'}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200094']
993,33470276,Swept-source optical coherence tomography findings in premature children with a history of retinopathy of prematurity at 5 years of age.,"PURPOSE


To compare central foveal thickness, retinal nerve fiber layer thickness, and subfoveal choroidal thickness using swept-source optical coherence tomography in premature children with a history of treated retinopathy of prematurity (either with intravitreal bevacizumab or laser photocoagulation) or spontaneously regressed retinopathy of prematurity versus age-matched healthy children at the age of 5 years.
METHODS


A total of 79 children were divided into four groups: group 1, children who received intravitreal bevacizumab treatment; group 2, children who received laser photocoagulation treatment; group 3, children who had spontaneously regressed retinopathy of prematurity; and group 4, age matched, full-term healthy children. At the age of 5 years, visual functions and refractive status were assessed. The optical coherence tomography analysis was performed using swept-source optical coherence tomography (DRI-OCT Triton; Topcon, USA).
RESULTS


There were 12 (15.2%), 23 (29.1%), 30 (38%), and 14 (17.7%) children in groups 1, 2, 3, and 4, respectively. Sex distribution was similar between the groups (p=0.420). Best corrected visual acuity was significantly better in group 4 compared with groups 1, 2, and 3 (p=0.035, p=0.001, and p=0.001, respectively). Refractive error results were similar between the groups (p=0.119). Central foveal thickness was significantly higher in group 2 than in group 1 (p=0.023). There were no significant differences observed between the groups in retinal nerve fiber layer thickness and subfoveal choroidal thickness (p>0.05).
CONCLUSIONS


Visual functional outcomes were better in term-born healthy children compared with those noted in children with a history of treated retinopathy of prematurity and spontaneously regressed retinopathy of prematurity. Laser treatment exerted a signifi-cant effect on central foveal thickness in premature children at the age of 5 years, as revealed by swept-source optical coherence tomography.",2020,"There were no significant differences observed between the groups in retinal nerve fiber layer thickness and subfoveal choroidal thickness (p>0.05).
","['group 3, children who had spontaneously regressed retinopathy of prematurity; and group 4, age matched, full-term healthy children', 'spontaneously regressed retinopathy of prematurity versus age-matched healthy children at the age of 5 years', 'premature children at the age of 5 years', 'premature children with a history of treated retinopathy of prematurity (either with', 'premature children with a history of retinopathy of prematurity at 5 years of age', '79 children']","['intravitreal bevacizumab treatment', 'intravitreal bevacizumab or laser photocoagulation', 'swept-source optical coherence tomography', 'Swept-source optical coherence tomography findings', 'laser photocoagulation treatment']","['Best corrected visual acuity', 'Sex distribution', 'Central foveal thickness', 'Visual functional outcomes', 'Refractive error results', 'central foveal thickness, retinal nerve fiber layer thickness, and subfoveal choroidal thickness', 'central foveal thickness', 'retinal nerve fiber layer thickness and subfoveal choroidal thickness (p>0.05']","[{'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C5192531', 'cui_str': 'History of retinopathy of prematurity'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]",79.0,0.02513,"There were no significant differences observed between the groups in retinal nerve fiber layer thickness and subfoveal choroidal thickness (p>0.05).
","[{'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Celik', 'Affiliation': ""Department of Ophthalmology, Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gunay', 'Affiliation': 'Department of Ophthalmology, Trabzon Fatih State Hospital, Trabzon, Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Kizilay', 'Affiliation': ""Department of Ophthalmology, Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital, Istanbul, Turkey.""}]",Arquivos brasileiros de oftalmologia,['10.5935/0004-2749.20200090']
994,33476973,Investigating the efficacy of fluoxetine vs. fluoxetine plus alprazolam (single therapy vs. combination therapy) in treatment of chronic tinnitus: A placebo-controlled study.,"OBJECTIVE


To investigate the effect of combination therapy (fluoxetine + alprazolam) and fluoxetine alone in treatment of tinnitus.
MATERIAL AND METHODS


147 participants with chronic tinnitus were divided into three groups (fluoxetine, fluoxetine+ alprazolam, and placebo). Tinnitus Handicap Inventory (THI), Visual Analogue Scale (VAS), Tinnitus Severity Index (TSI), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) used to assess tinnitus. Effect size according to partial Eta square calculated and level of significance was considered as P < 0.05.
RESULTS


Fluoxetine reduced VAS, THI, BDI, and increased BAI. The combination therapy significantly reduced VAS, THI, BAI, and BDI. None of them reduced the TSI. The effect size for BAI and BDI were 0.135 (medium) and 0.075 (small), respectively. There was no significant difference between combination and single-drug therapy.
CONCLUSION


Both groups improved THI and VAS. Combination therapy was not significantly different from single-drug treatment. Combination therapy can be considered only according to the psychiatric needs of patients.",2021,"The effect size for BAI and BDI were 0.135 (medium) and 0.075 (small), respectively.","['147 participants with chronic tinnitus', 'chronic tinnitus']","['Fluoxetine', 'placebo', 'combination therapy (fluoxetine + alprazolam', 'fluoxetine, fluoxetine+ alprazolam, and placebo', 'fluoxetine', 'fluoxetine vs. fluoxetine plus alprazolam (single therapy vs. combination therapy']","['Tinnitus Handicap Inventory (THI), Visual Analogue Scale (VAS), Tinnitus Severity Index (TSI), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) used to assess tinnitus', 'THI and VAS', 'VAS, THI, BAI, and BDI', 'VAS, THI, BDI, and increased BAI', 'BAI and BDI']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",147.0,0.0252857,"The effect size for BAI and BDI were 0.135 (medium) and 0.075 (small), respectively.","[{'ForeName': 'Alia', 'Initials': 'A', 'LastName': 'Saberi', 'Affiliation': 'Neuroscience Research Center, Department of Neurology, Poursina Hospital, Guilan University of Medical Sciences, Rasht, Iran; Oto-Rhinolaryngology Research Center, Department of Otolaryngology Head & Neck Surgery, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Oto-Rhinolaryngology Research Center, Department of Otolaryngology Head & Neck Surgery, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: drshadmannemati_ent@yahoo.com.'}, {'ForeName': 'Ehsan Kazemnejad', 'Initials': 'EK', 'LastName': 'Lili', 'Affiliation': 'Oto-Rhinolaryngology Research Center, Department of Otolaryngology Head & Neck Surgery, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Esmaeilpour', 'Affiliation': 'Oto-Rhinolaryngology Research Center, Department of Otolaryngology Head & Neck Surgery, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Panahi', 'Affiliation': 'Cellular and Molecular Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102898']
995,33465681,Palbociclib and cetuximab in cetuximab-resistant human papillomavirus-related oropharynx squamous-cell carcinoma: A multicenter phase 2 trial.,"OBJECTIVES


We previously reported that palbociclib, a selective CDK4/6 inhibitor, given with cetuximab, resulted in an objective response rate (ORR) of 19% in cetuximab-resistant human papillomavirus (HPV)-unrelated head and neck squamous-cell carcinoma (HNSCC). In this study, we aimed to determine the proportion of patients with cetuximab-resistant HPV-related oropharynx (OP)SCC who achieved an objective response to palbociclib and cetuximab.
MATERIALS AND METHODS


We performed a multicenter phase 2 trial. Key eligibility requirements included measurable HPV-related OPSCC that progressed on a cetuximab-containing regimen. Palbociclib 125 mg po was administered on Days 1-21 of 28 day cycles, with weekly cetuximab. The primary endpoint was objective response (RECIST1.1). The study design had a probability of 0.70 of accepting the alternative hypothesis (ORR ≥ 20%) and rejecting the null hypothesis (ORR ≤ 5%). Two or more tumor responses among 24 patients were needed to accept the alternative hypothesis.
RESULTS


Twenty-four patients enrolled. The median interval from prior cetuximab to study enrollment was 0.7 months (IQR 0.2-6.1). Disease progression on a platinum agent occurred in 23 patients (96%). An objective response occurred in one patient (ORR 4%). The duration of response was 4 months. Stable disease with ≥ 10% decrease in target lesions occurred in 2 patients (8%). Median follow-up was 8.9 (IQR 3.7-16.8) months. The median progression-free survival was 1.9 months (95% CI 1.8-2.1) and the median overall survival was 17.1 months (95%CI: 5.8-21.5).
CONCLUSION


The trial did not meet its primary endpoint. Further investigation of palbociclib and cetuximab in cetuximab-resistant HPV-related OPSCC is not warranted.",2021,"The median progression-free survival was 1.9 months (95% CI 1.8-2.1) and the median overall survival was 17.1 months (95%CI: 5.8-21.5).
","['resistant human papillomavirus (HPV)-unrelated head and neck squamous-cell carcinoma (HNSCC', 'patients with cetuximab-resistant HPV-related oropharynx (OP)SCC who achieved an objective response to palbociclib and cetuximab', 'cetuximab-resistant human papillomavirus-related oropharynx squamous-cell carcinoma', 'Twenty-four patients enrolled', '24 patients']","['Palbociclib and cetuximab', 'cetuximab', 'Palbociclib']","['Disease progression', 'objective response', 'duration of response', 'median progression-free survival', 'median overall survival', 'target lesions', 'objective response rate (ORR', 'objective response (RECIST1.1', 'median interval']","[{'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",24.0,0.0556483,"The median progression-free survival was 1.9 months (95% CI 1.8-2.1) and the median overall survival was 17.1 months (95%CI: 5.8-21.5).
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Division of Medical Oncology and Alvin J Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology and Alvin J Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Division of Medical Oncology and Alvin J Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maggiore', 'Affiliation': 'Wilmot Cancer Institute at the University of Rochester, Rochester, NY, United States.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Public Health Sciences, Washington University School of Medicine, St Louis, MO, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Division of Medical Oncology and Alvin J Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States. Electronic address: dadkins@wustl.edu.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105164']
996,33470602,Efficacy of Rest Redistribution During Squats: Considerations for Strength and Sex.,"ABSTRACT


Boffey, D, Clark, NW, and Fukuda, DH. Efficacy of rest redistribution during squats: Considerations for strength and sex. J Strength Cond Res 35(3): 586-595, 2021-This study examined the kinematic, perceptual, and heart rate responses to rest redistribution (RR) and traditional sets (TS) during the barbell back squat for men and women possessing a wide range of strength levels. Forty-five resistance-trained subjects (30 men and 15 women) performed 40 repetitions of the barbell squat with 65% 1RM load with TS (4 × 10 repetitions, 3-minute rest) or RR (10 × 4 repetitions, 1-minute rest), in a randomized order on days separated by ≥72 hours. The significance was set at p ≤ 0.05 for all statistical analyses. The mean velocity (MV) maintenance was significantly higher for RR compared with TS (87.70 ± 4.50% vs. 84.07 ± 4.48%, respectively; p < 0.01, d = 0.35). Rating of perceived exertion (active muscles) was significantly lower for RR compared with TS (5.38 ± 1.42 vs. 6.08 ± 1.43, respectively; p = 0.02, d = -0.35). Rating of perceived exertion (overall) was also significantly lower for RR compared with TS (5.60 ± 1.40 vs. 6.48 ± 1.49, respectively; p = 0.02, d = -0.37). The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02). No sex-based differences (p > 0.05) were found for any dependent variables. Rest redistribution produced significantly higher mean HR (143.25 ± 21.11 vs. 135.05 ± 20.74, p < 0.01) and minimum HR (102.77 ± 19.58 vs. 95.97 ± 22.17, p < 0.01). Subjects were better able to maintain velocity with RR compared with TS, while experiencing less perceived effort. Rest redistribution can be recommended for both men and women, but very strong individuals may not improve their velocity maintenance with RR to the same extent as less strong individuals.",2021,"The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02).",['Forty-five resistance-trained subjects (30 men and 15 women) performed'],"['Rest Redistribution', '40 repetitions of the barbell squat with 65% 1RM load with TS (4 × 10 repetitions, 3-minute rest) or RR', 'J Strength Cond Res XX(X']","['Rating of perceived exertion (overall', 'relative strength ratio', 'kinematic, perceptual, and heart rate responses to rest redistribution (RR) and traditional sets (TS', 'mean velocity (MV) maintenance', 'Rating of perceived exertion (active muscles', 'MV maintenance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0969138,"The relative strength ratio (relative strength ratio; squat 1RM: body mass) was significantly correlated with the difference in MV maintenance between RR and TS (r = -0.34, p = 0.02).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boffey', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}, {'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'Physiology of Work and Exercise Response (POWER) Laboratory, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida; and.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003893']
997,33444489,Comparison of the marginal discrepancy of PFM crowns in the CAD/CAM and lost-wax fabrication techniques by triple scanning.,"BACKGROUND


Computer-aided design/computer-aided manufacturing (CAD/CAM) systems are widely used for the fabrication of porcelain-fused-to-metal (PFM) crowns.
OBJECTIVES


This study was conducted to compare PFM crowns through triple scanning in terms of marginal discrepancy between the CAD/CAM and lost-wax fabrication techniques.
MATERIAL AND METHODS


Twenty uniform resin dies of a prepared maxillary first molar were randomly divided into 2 groups: conventional lost-wax; and milling. Marginal discrepancy was evaluated at the framework and porcelain steps through triple scanning and direct visualization under a stereomicroscope. Then, the crowns were cemented to the related die and the marginal gap was measured with triple scanning, direct visualization under a stereomicroscope and scanning electron microscopy (SEM). The data was analyzed using the independent t test and the one-way analysis of variance (ANOVA). The significance level was set at 0.05.
RESULTS


Differences in the mean marginal gap were measured by the various evaluation methods. Triple scanning and stereomicroscopy identified increasing discrepancy during the fabrication process. According to the results of the independent t test, stereomicroscopy showed no difference after cementation between the CAD/CAM and lost-wax groups (p > 0.05), triple scanning showed higher fitness in the CAD/CAM group (p < 0.05), and SEM showed better adaptation in the lost-wax group (p < 0.05); however, there was a positive correlation between the findings of stereomicroscopy and SEM (p < 0.05).
CONCLUSIONS


The cobalt-chromium crowns had clinically acceptable marginal fitness from both the CAD/CAM and lost-wax techniques; however, the lost-wax group showed lower marginal discrepancy after cementation according to SEM.",2020,"According to the results of the independent t test, stereomicroscopy showed no difference after cementation between the CAD/CAM and lost-wax groups (p > 0.05), triple scanning showed higher fitness in the CAD/CAM group (p < 0.05), and SEM showed better adaptation in the lost-wax group (p < 0.05); however, there was a positive correlation between the findings of stereomicroscopy and SEM (p < 0.05).
",['Twenty uniform resin dies of a prepared maxillary first molar'],['conventional lost-wax; and milling'],"['Marginal discrepancy', 'marginal discrepancy', 'mean marginal gap']","[{'cui': 'C0205375', 'cui_str': 'Uniform'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0043076', 'cui_str': 'Wax'}, {'cui': 'C0599997', 'cui_str': 'Mill'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]",20.0,0.0219968,"According to the results of the independent t test, stereomicroscopy showed no difference after cementation between the CAD/CAM and lost-wax groups (p > 0.05), triple scanning showed higher fitness in the CAD/CAM group (p < 0.05), and SEM showed better adaptation in the lost-wax group (p < 0.05); however, there was a positive correlation between the findings of stereomicroscopy and SEM (p < 0.05).
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Masoumeh Hasani', 'Initials': 'MH', 'LastName': 'Tabatabaei', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Sina Mohammadi', 'Initials': 'SM', 'LastName': 'Sadr', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Atri', 'Affiliation': 'Dental Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Iran.'}]",Dental and medical problems,['10.17219/dmp/125532']
998,33476803,Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial.,"INTRODUCTION


In the Phase 3, placebo-controlled PACIFIC trial of patients with unresectable, stage III NSCLC without disease progression after concurrent chemoradiotherapy, consolidative durvalumab was associated with significant improvements in the primary end points of overall survival (OS) (hazard ratio [HR] = 0.68; 95% confidence interval [CI]: 0.53-0.87; p = 0.00251; data cutoff, March 22, 2018) and progression-free survival (PFS) (blinded independent central review; Response Evaluation Criteria in Solid Tumors version 1.1) (HR = 0.52; 95% CI: 0.42-65; p < 0.0001; February 13, 2017) with manageable safety. Here, we report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.
METHODS


Patients with WHO performance status of 0 or 1 (and any tumor programmed death-ligand 1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg) or placebo, administered every 2 weeks (≤12 months), stratified by age, sex, and smoking history. OS and PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS and PFS rates were estimated by the Kaplan-Meier method.
RESULTS


Overall, 709 of 713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of March 20, 2020 (median follow-up = 34.2 months; range: 0.2-64.9), updated OS (HR = 0.71; 95% CI: 0.57-0.88) and PFS (HR = 0.55; 95% CI: 0.44-0.67) remained consistent with the primary analyses. The median OS for durvalumab was reached (47.5 mo; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.
CONCLUSION


These updated exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab after chemoradiotherapy. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression-free (placebo, 19.5%).",2021,"Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.
","['Patients with WHO PS 0/1 (any tumor PD-L1 status', 'patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent chemoradiotherapy (CRT']","['durvalumab', 'intravenous durvalumab', 'durvalumab after chemoradiotherapy', 'placebo']","['Median OS for durvalumab', 'progression-free survival', 'overall survival (OS', 'OS/PFS', 'Estimated 4-year OS rates', 'Medians and 4-year OS/PFS rates', '4-year PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.769376,"Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.
","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester, Manchester, United Kingdom; The Christie NHS Foundation Trust, Manchester, United Kingdom. Electronic address: corinne.finn@nhs.net.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Internal Medicine, Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Department of Medical Oncology, Thoracic Unit, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'CiberOnc, Universidad Complutense, Madrid, Spain; Centro Nacional De Investigaciones Oncologicas (CNIO), Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Chronic Disease and Metabolism, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Division of Medical Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jarushka', 'Initials': 'J', 'LastName': 'Naidoo', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland; Bloomberg-Kimmel Institute for Cancer Immunotherapy at John Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rimner', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa School of Medicine, Istanbul University - Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Ki H', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Byoung C', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Department of Hematology, Oncology, and Palliative Medicine, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Newton', 'Affiliation': 'Department of Clinical Oncology, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Oncology, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Piruntha', 'Initials': 'P', 'LastName': 'Thiyagarajah', 'Affiliation': 'Department of Clinical Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.12.015']
999,33476675,Endocrinological effects of social exclusion and inclusion: Experimental evidence for adaptive regulation of female fecundity.,"When current conditions are probabilistically less suitable for successful reproduction than future conditions, females may prevent or delay reproduction until conditions improve. Throughout human evolution, social support was likely crucial to female reproductive success. Women may thus have evolved fertility regulation systems sensitive to cues from the social environment. However, current understanding of how psychological phenomena might affect female ovarian function is limited. In this study, we examined whether cues of reduced social support-social ostracism-impact women's hormone production. Following an in-lab group bonding task, women were randomly assigned to a social exclusion (n = 88) or social inclusion (n = 81) condition. After social exclusion, women with low background levels of social support experienced a decrease in estradiol relative to progesterone. In contrast, socially-included women with low background social support experienced an increase in estradiol relative to progesterone. Hormonal changes in both conditions occurred specifically when women were in their mid-to-late follicular phase, when baseline estradiol is high and progesterone is low. Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone. Results offer support for a potential mechanism by which fecundity could respond adaptively to the loss or lack of social support.",2021,"Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone.",['female fecundity'],['social exclusion (n\u202f=\u202f88) or social inclusion'],['estradiol relative to progesterone'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]",,0.0216004,"Follow-up analyses revealed that these changes were primarily driven by changes in progesterone, consistent with existing evidence for disruption of ovarian function following adrenal release of follicular-phase progesterone.","[{'ForeName': 'Tran', 'Initials': 'T', 'LastName': 'Dinh', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: trandinh@unm.edu.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Gangestad', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Melissa Emery', 'Initials': 'ME', 'LastName': 'Thompson', 'Affiliation': 'Department of Anthropology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Bedari Kindness Institute, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Daniel M T', 'Initials': 'DMT', 'LastName': 'Fessler', 'Affiliation': 'Department of Anthropology, University of California, Los Angeles, Los Angeles, CA, USA; Bedari Kindness Institute, University of California, Los Angeles, Los Angeles, CA, USA; Center for Behavior, Evolution, & Culture, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Theresa E', 'Initials': 'TE', 'LastName': 'Robertson', 'Affiliation': 'Department of Management, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Martie G', 'Initials': 'MG', 'LastName': 'Haselton', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Communication, University of California, Los Angeles, CA, USA.'}]",Hormones and behavior,['10.1016/j.yhbeh.2021.104934']
1000,33461782,Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial.,"Most studies indicate no benefit of adjuvant therapy with VEGFR tyrosine kinase inhibitors in advanced renal cell carcinoma (RCC). PROTECT (NCT01235962) was a randomized, double-blind, placebo-controlled phase 3 study to evaluate adjuvant pazopanib in patients with locally advanced RCC at high risk of relapse after nephrectomy (pazopanib, n = 769; placebo, n = 769). The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo. Here we report the final overall survival (OS) analysis (median follow-up: pazopanib, 76 mo, interquartile range [IQR] 66-84; placebo, 77 mo, IQR 69-85). There was no significant difference in OS between the pazopanib and placebo arms (hazard ratio 1.0, 95% confidence interval 0.80-1.26; nominal p > 0.9). OS was worse for patients with T4 disease compared to those with less advanced disease and was better for patients with body mass index (BMI) ≥30 kg/m 2  compared to those with lower BMI. OS was significantly better for patients who remained diseasefree at 2 yr after treatment compared with those who relapsed within 2 yr. These findings are consistent with the primary outcomes from PROTECT, indicating that adjuvant pazopanib does not confer a benefit in terms of OS for patients following resection of locally advanced RCC. PATIENT SUMMARY: In the randomized, double-blind, placebo-controlled phase 3 PROTECT study, overall survival was similar for patients with locally advanced renal cell carcinoma (RCC) at high risk of relapse after nephrectomy who received adjuvant therapy with pazopanib or placebo. Pazopanib is not recommended as adjuvant therapy following resection of locally advanced RCC. This trial is registered at Clinicaltrials.gov as NCT01235962.",2021,The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo.,"['patients with locally advanced renal cell carcinoma (RCC) at high risk of relapse after nephrectomy who received adjuvant therapy with', 'patients with locally advanced RCC at high risk of relapse after nephrectomy (pazopanib, n\u2009=\u2009769; placebo, n\u2009=\u2009769', 'Patients With Localized or Locally Advanced Renal Cell Carcinoma', 'advanced renal cell carcinoma (RCC', 'patients following resection of locally advanced RCC']","['Pazopanib', 'placebo', 'pazopanib or placebo', 'VEGFR tyrosine kinase inhibitors', 'pazopanib', 'Adjuvant Pazopanib Versus Placebo']","['OS', 'final overall survival (OS) analysis', 'disease-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.790081,The results of the primary analysis showed no difference in disease-free survival between pazopanib 600 mg and placebo.,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: motzerr@mskcc.org.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Haas', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Doehn', 'Affiliation': 'University of Lubeck Medical School and Urologikum Lubeck, Lubeck, Germany.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Varlamov', 'Affiliation': 'Altai Regional Cancer Center, Barnaul, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': 'State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Zemanova', 'Affiliation': 'Charles University and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rini', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wood', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'M Neil', 'Initials': 'MN', 'LastName': 'Reaume', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'University Hospital Tubingen, Tubingen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's and St Thomas' National Health Service Foundation, St. Thomas' Hospital, London, UK.""}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'McDermott', 'Affiliation': 'Tallaght University Hospital and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'University of Surrey, Guildford, UK.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Aimone', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.12.029']
1001,33475701,Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Coronavirus disease 2019 (COVID-19) continues to spread rapidly worldwide. Neutralizing antibodies are a potential treatment for COVID-19.
Objective


To determine the effect of bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load in mild to moderate COVID-19.
Design, Setting, and Participants


The BLAZE-1 study is a randomized phase 2/3 trial at 49 US centers including ambulatory patients (N = 613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms. Patients who received bamlanivimab monotherapy or placebo were enrolled first (June 17-August 21, 2020) followed by patients who received bamlanivimab and etesevimab or placebo (August 22-September 3). These are the final analyses and represent findings through October 6, 2020.
Interventions


Patients were randomized to receive a single infusion of bamlanivimab (700 mg [n = 101], 2800 mg [n = 107], or 7000 mg [n = 101]), the combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n = 112]), or placebo (n = 156).
Main Outcomes and Measures


The primary end point was change in SARS-CoV-2 log viral load at day 11 (±4 days). Nine prespecified secondary outcome measures were evaluated with comparisons between each treatment group and placebo, and included 3 other measures of viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29).
Results


Among the 577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29). The change in log viral load from baseline at day 11 was -3.72 for 700 mg, -4.08 for 2800 mg, -3.49 for 7000 mg, -4.37 for combination treatment, and -3.80 for placebo. Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment. Among the secondary outcome measures, differences between each treatment group vs the placebo group were statistically significant for 10 of 84 end points. The proportion of patients with COVID-19-related hospitalizations or ED visits was 5.8% (9 events) for placebo, 1.0% (1 event) for 700 mg, 1.9% (2 events) for 2800 mg, 2.0% (2 events) for 7000 mg, and 0.9% (1 event) for combination treatment. Immediate hypersensitivity reactions were reported in 9 patients (6 bamlanivimab, 2 combination treatment, and 1 placebo). No deaths occurred during the study treatment.
Conclusions and Relevance


Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11; no significant difference in viral load reduction was observed for bamlanivimab monotherapy. Further ongoing clinical trials will focus on assessing the clinical benefit of antispike neutralizing antibodies in patients with COVID-19 as a primary end point.
Trial Registration


ClinicalTrials.gov Identifier: NCT04427501.",2021,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","['Patients', 'patients with COVID-19 as a primary end point', '577 patients who were randomized and received an infusion (mean age, 44.7 [SD, 15.7] years; 315 [54.6%] women), 533 (92.4%) completed the efficacy evaluation period (day 29', 'mild to moderate COVID-19', '49 US centers including ambulatory patients (N\u2009=\u2009613) who tested positive for SARS-CoV-2 infection and had 1 or more mild to moderate symptoms']","['placebo', 'combination treatment (2800 mg of bamlanivimab and 2800 mg of etesevimab [n\u2009=\u2009112]), or placebo', 'Bamlanivimab', 'bamlanivimab monotherapy or placebo', 'bamlanivimab monotherapy and combination therapy with bamlanivimab and etesevimab', 'bamlanivimab', 'bamlanivimab and etesevimab or placebo']","['log viral load', 'viral load reduction', 'viral load, 5 on symptoms, and 1 measure of clinical outcome (the proportion of patients with a COVID-19-related hospitalization, an emergency department [ED] visit, or death at day 29', 'Immediate hypersensitivity reactions', 'SARS-CoV-2 viral load', 'change in SARS-CoV-2 log viral load', 'deaths', 'proportion of patients with COVID-19-related hospitalizations or ED visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517680', 'cui_str': '2800'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.45133,"Compared with placebo, the differences in the change in log viral load at day 11 were 0.09 (95% CI, -0.35 to 0.52; P = .69) for 700 mg, -0.27 (95% CI, -0.71 to 0.16; P = .21) for 2800 mg, 0.31 (95% CI, -0.13 to 0.76; P = .16) for 7000 mg, and -0.57 (95% CI, -1.00 to -0.14; P = .01) for combination treatment.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas, Texas.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles, California.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': 'Vitalink Research, Union, South Carolina.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Imperial Health, Lake Charles, Louisiana.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': 'Indago Research, Hialeah, Florida.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': 'Las Vegas Medical Research Center, Las Vegas, Nevada.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': 'Franciscan Health, Greenwood, Indiana.'}, {'ForeName': 'Princy', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Holzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Ebert', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Higgs', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Kallewaard', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA,['10.1001/jama.2021.0202']
1002,33469832,"Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in Patients Aged ≥65 and ≥75 Years: Subpopulation Analysis from the EMPOWUR Randomized, International, Phase III Study.","BACKGROUND


Overactive bladder (OAB) is common among older adults. The efficacy and safety of vibegron for the treatment of OAB were demonstrated in the international, phase III EMPOWUR trial. This subpopulation analysis from EMPOWUR assessed the efficacy and safety of vibegron in patients aged ≥ 65 and ≥ 75 years.
METHODS


In EMPOWUR, patients with OAB were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, once daily for 12 weeks. Coprimary efficacy endpoints were change from baseline at week 12 in average daily number of micturitions and urge urinary incontinence (UUI) episodes; a key secondary efficacy endpoint was change from baseline at week 12 in average daily number of urgency episodes. Safety was assessed through adverse events (AEs). Efficacy analyses compared vibegron with placebo; no efficacy comparisons were made between vibegron and tolterodine.
RESULTS


Of the 1463 patients with evaluable efficacy data, 628 patients were aged ≥ 65 years, and 179 were aged ≥ 75 years. After 12 weeks, patients treated with once-daily vibegron 75 mg in both age subgroups showed significant improvements from baseline versus placebo in all three symptoms of OAB: daily micturitions (≥ 65 years, P < 0.0001; ≥75 years, P < 0.05), UUI episodes (≥ 65 years, P < 0.001; ≥ 75 years, P < 0.0001), and urgency episodes (≥ 65 years, P < 0.01; ≥ 75 years, P < 0.01). Significant reductions from baseline versus placebo in daily micturitions, UUI episodes, and urgency episodes were observed beginning at week 2 for patients aged ≥ 65 years treated with vibegron. In patients aged ≥ 65 years, 50.0% of those receiving vibegron versus 29.8% receiving placebo experienced a ≥ 75% reduction in UUI episodes at week 12 (P < 0.0001). Rates of cardiovascular-associated AEs were low for patients receiving vibegron (<2% of patients in either age subgroup) and similar to rates in patients receiving placebo. In patients aged ≥ 65 years, hypertension was reported by 1.2%, 3.1%, and 2.9% of patients receiving vibegron, placebo, and tolterodine, respectively; in patients aged ≥ 75 years, hypertension was reported by 1.3%, 3.3%, and 2.1%, respectively.
CONCLUSIONS


In this subpopulation analysis of patients with OAB aged ≥ 65 and ≥ 75 years from the EMPOWUR study, once-daily vibegron 75 mg showed rapid onset and robust efficacy versus placebo and was generally safe and well tolerated, consistent with results from the overall population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT03492281; registered April 10, 2018.",2021,"Significant reductions from baseline versus placebo in daily micturitions, UUI episodes, and urgency episodes were observed beginning at week 2 for patients aged ≥ 65 years treated with vibegron.","['Patients Aged ≥65 and ≥75 Years', 'older adults', '1463 patients with evaluable efficacy data', 'patients aged ≥ 65 and ≥ 75 years', '628 patients were aged ≥ 65 years, and 179 were aged ≥ 75 years', 'patients with OAB', 'patients with OAB aged ≥ 65 and ≥ 75 years']","['vibegron 75 mg, placebo, or tolterodine', 'placebo', 'Once-Daily Vibegron']","['symptoms of OAB: daily micturitions', 'daily micturitions, UUI episodes, and urgency episodes', 'Efficacy and Safety', 'Rates of cardiovascular-associated AEs', 'urgency episodes', 'hypertension', 'efficacy and safety of vibegron', 'UUI episodes', 'average daily number of micturitions and urge urinary incontinence (UUI) episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0150045', 'cui_str': 'Urge incontinence of urine'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",628.0,0.435217,"Significant reductions from baseline versus placebo in daily micturitions, UUI episodes, and urgency episodes were observed beginning at week 2 for patients aged ≥ 65 years treated with vibegron.","[{'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Geriatric Medicine, Clinical Research Consulting, 2080 Bridgeport Avenue, Suite D, Milford, CT, 06460, USA. varanos2@yahoo.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Department of Surgery, Division of Urology, Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Urology, Seattle Urology Research Center, Seattle, WA, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Biostatistics, Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Clinical Development, Urovant Sciences, Irvine, CA, USA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Clinical Development, Urovant Sciences, Irvine, CA, USA.'}]",Drugs & aging,['10.1007/s40266-020-00829-z']
1003,33472925,Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke.,"OBJECTIVE


To test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.
METHODS


In this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.
RESULTS


A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range 28-83) years, and mean interval between stroke onset to randomization was 20.2 (range 5-89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months ( p  = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index,  p  = 0.023), which was notable among patients with low predicted recovery potential. There were no serious treatment-related adverse events.
CONCLUSIONS


IV application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that autologous MSCs do not improve 90-day outcomes in patients with chronic stroke.
CLINICALTRIALSGOV IDENTIFIER


NCT01716481.",2021,There was no significant difference between the groups in the mRS score shift at 3 months ( p  = 0.732).,"['patients with chronic major stroke', 'Mean age of patients was 68 (range, 28-83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5-89) days', 'patients with chronic stroke', 'patients with severe middle cerebral artery territory infarct within 90 days of symptom onset', 'Ischemic Stroke', 'A total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis']","['autologous modified mesenchymal stem cells (MSCs', 'MSC', 'preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group', 'Intravenous Mesenchymal Stem Cells']","['mRS score shift', 'motor recovery', '3-month mRS score', 'lower extremity motor function', 'score on the modified Rankin Scale (mRS', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.262044,There was no significant difference between the groups in the mRS score shift at 3 months ( p  = 0.732).,"[{'ForeName': 'Jong-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Won Hyuk', 'Initials': 'WH', 'LastName': 'Chang', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Bang', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. ohyoung.bang@samsung.com.'}, {'ForeName': 'Gyeong Joon', 'Initials': 'GJ', 'LastName': 'Moon', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Suk Jae', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Soo-Kyoung', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (J.-W.C., O.Y.B., S.J.K.), Samsung Medical Center, Sungkyunkwan University; Translational and Stem Cell Research Laboratory on Stroke (J.-W.C., O.Y.B., G.J.M.) and Stem Cell and Regenerative Medicine Institute (G.J.M.), Samsung Medical Center; Department of Physical and Rehabilitation Medicine (W.H.C., Y.-H.K.), Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; School of Life Sciences (G.J.M.), BK21 plus KNU Creative BioResearch Group, Kyungpook National University, Daegu; Department of Neurology (S.-K.K.), Gyeongsang National University School of Medicine, Jinju; Department of Neurology (J.S.L.), Ajou University Hospital, School of Medicine, Suwon; and Department of Neurology (S.-I.S.), Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, South Korea. Dr. Moon is currently affiliated with the Stem Cell Center, Asan Institute for Life Science and the Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011440']
1004,33472913,Phase I Trial of DNA Methyltransferase Inhibitor Guadecitabine Combined with Cisplatin and Gemcitabine for Solid Malignancies Including Urothelial Carcinoma (SPIRE).,"PURPOSE


Preclinical data indicate that DNA methyltransferase inhibition will circumvent cisplatin resistance in various cancers.
PATIENT AND METHODS


SPIRE comprised a dose-escalation phase for incurable metastatic solid cancers, followed by a randomized dose expansion phase for neoadjuvant treatment of T2-4a N0 M0 bladder urothelial carcinoma. The primary objective was a recommended phase II dose (RP2D) for guadecitabine combined with gemcitabine and cisplatin. Treatment comprised 21-day gemcitabine and cisplatin cycles (cisplatin 70 mg/m 2 , i.v., day 8 and gemcitabine 1,000 mg/m 2 , i.v., days 8 + 15). Guadecitabine was injected subcutaneously on days 1-5, within escalation phase cohorts, and to half of 20 patients in the expansion phase. Registration ID: ISRCTN 16332228.
RESULTS


Within the escalation phase, dose-limiting toxicities related predominantly to myelosuppression requiring G-CSF prophylaxis from cohort 2 (guadecitabine 20 mg/m 2 , days 1-5). The most common grade ≥3 adverse events in 17 patients in the dose-escalation phase were neutropenia (76.5%), thrombocytopenia (64.7%), leukopenia (29.4%), and anemia (29.4%). Addition of guadecitabine to gemcitabine and cisplatin in the expansion phase resulted in similar rates of severe hematologic adverse events, similar cisplatin dose intensity, but modestly reduced gemcitabine dose intensity. Radical treatment options after chemotherapy were not compromised. Pharmacodynamics evaluations indicated guadecitabine maximal target effect at the point of cisplatin administration. Pharmacokinetics were consistent with prior data. No treatment-related deaths occurred.
CONCLUSIONS


The guadecitabine RP2D was 20 mg/m 2 , days 1-5, in combination with gemcitabine and cisplatin and required GCSF prophylaxis. Gene promoter methylation pharmacodynamics are optimal with this schedule. Addition of guadecitabine to gemcitabine and cisplatin was tolerable, despite some additional myelosuppression, and warrants further investigation to assess efficacy.",2021,"Addition of guadecitabine to GC in the expansion phase resulted in similar rates of severe haematological adverse events, similar cisplatin dose intensity, but modestly reduced gemcitabine dose intensity.","['Registration', 'solid malignancies including urothelial carcinoma']","['DNA methyltransferase inhibitor guadecitabine combined with cisplatin and gemcitabine', 'gemcitabine', 'guadecitabine combined with gemcitabine and cisplatin (GC', '21-day GC cycles (cisplatin', 'Guadecitabine', 'guadecitabine RP2D', 'guadecitabine']","['thrombocytopenia', 'anaemia', 'severe haematological adverse events', 'neutropenia', 'leukopenia']","[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C0012873', 'cui_str': 'DNA Modification Methyltransferases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3899005', 'cui_str': 'guadecitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",,0.0426359,"Addition of guadecitabine to GC in the expansion phase resulted in similar rates of severe haematological adverse events, similar cisplatin dose intensity, but modestly reduced gemcitabine dose intensity.","[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Crabb', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom. S.J.Crabb@southampton.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Danson', 'Affiliation': 'Sheffield Experimental Cancer Medicine Centre, Weston Park Hospital, University of Sheffield, Sheffield, England, United Kingdom.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, England, United Kingdom.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Sheffield Experimental Cancer Medicine Centre, Weston Park Hospital, University of Sheffield, Sheffield, England, United Kingdom.'}, {'ForeName': 'Danna', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, California.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dunkley', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Downs', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Ellice', 'Initials': 'E', 'LastName': 'Marwood', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Saunders', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Light', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Whitehead', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ellis', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sarwar', 'Affiliation': 'Department of Oncology, Charing Cross Hospital, London, England, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Enting', 'Affiliation': ""Department of Oncology, Guy's and St Thomas' NHS Foundation Trust, London, England, United Kingdom.""}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Lancashire Teaching Hospitals NHS Foundation Trust, Preston, England, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'The Institute of Cancer Research, Sutton, England, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'The Institute of Cancer Research, Sutton, England, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3946']
1005,33479499,"Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake.","The carbohydrate-insulin model of obesity posits that high-carbohydrate diets lead to excess insulin secretion, thereby promoting fat accumulation and increasing energy intake. Thus, low-carbohydrate diets are predicted to reduce ad libitum energy intake as compared to low-fat, high-carbohydrate diets. To test this hypothesis, 20 adults aged 29.9 ± 1.4 (mean ± s.e.m.) years with body mass index of 27.8 ± 1.3 kg m -2  were admitted as inpatients to the National Institutes of Health Clinical Center and randomized to consume ad libitum either a minimally processed, plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with high glycemic load (85 g 1,000 kcal -1 ) or a minimally processed, animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with low glycemic load (6 g 1,000 kcal -1 ) for 2 weeks followed immediately by the alternate diet for 2 weeks. One participant withdrew due to hypoglycemia during the low-carbohydrate diet. The primary outcomes compared mean daily ad libitum energy intake between each 2-week diet period as well as between the final week of each diet. We found that the low-fat diet led to 689 ± 73 kcal d -1  less energy intake than the low-carbohydrate diet over 2 weeks (P < 0.0001) and 544 ± 68 kcal d -1  less over the final week (P < 0.0001). Therefore, the predictions of the carbohydrate-insulin model were inconsistent with our observations. This study was registered on ClinicalTrials.gov as NCT03878108 .",2021,We found that the low-fat diet led to 689 ± 73 kcal d -1  less energy intake than the low-carbohydrate diet over 2 weeks (P < 0.0001) and 544 ± 68 kcal d -1  less over the final week (P < 0.0001).,"['2  were admitted as inpatients to the National Institutes of Health Clinical Center and randomized to', 'years with body mass index of 27.8\u2009±\u20091.3\u2009kg\u2009m', '20 adults aged 29.9\u2009±\u20091.4 (mean\u2009±\u2009s.e.m']","['consume ad libitum either a minimally processed, plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with high glycemic load (85\u2009g\u20091,000\u2009kcal -1 ) or a minimally processed, animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with low glycemic load', 'plant-based, low-fat diet versus an animal-based, ketogenic diet']",['mean daily ad libitum energy intake'],"[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",20.0,0.0154974,We found that the low-fat diet led to 689 ± 73 kcal d -1  less energy intake than the low-carbohydrate diet over 2 weeks (P < 0.0001) and 544 ± 68 kcal d -1  less over the final week (P < 0.0001).,"[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hall', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA. kevinh@niddk.nih.gov.'}, {'ForeName': 'Juen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Courville', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Boring', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brychta', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Darcey', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Ciaran G', 'Initials': 'CG', 'LastName': 'Forde', 'Affiliation': 'Singapore Institute for Food and Biotechnology Innovation, Singapore, Singapore.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Gharib', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gallagher', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Paule V', 'Initials': 'PV', 'LastName': 'Joseph', 'Affiliation': 'National Institute of Nursing Research, Bethesda, MD, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Milley', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ouwerkerk', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Raisinger', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rozga', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Schick', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stagliano', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Torres', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Chung', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}]",Nature medicine,['10.1038/s41591-020-01209-1']
1006,33499668,Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial.,"BACKGROUND


Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).
METHODS


CABANA randomized patients with AF age ≥65 years or <65 years with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence.
RESULTS


CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) ( P <0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men,  P =0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62-1.65) in women and 0.73 (95% CI, 0.51-1.05) in men (interaction  P  value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51-0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40-0.58] for men; interaction  P  value=0.060).
CONCLUSIONS


Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.",2021,"The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (HR 0.64, 95% CI 0.51-0.82 for women vs. HR 0.48, 95% CI 0.40-0.58 for men, interaction p value=0.060).  ","['patients with AF age ≥65 or <65 with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents', 'patients with atrial fibrillation (AF', 'randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690', 'women and men']","['catheter ablation', 'Atrial Fibrillation Ablation Versus Drug Therapy', '2204-patient Catheter Ablation vs. Antiarrhythmic Drug Therapy']","['death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence', 'hazard ratio (HR', 'risk of recurrent AF', 'adverse events', 'symptomatic heart failure', 'paroxysmal AF pattern']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.254495,"The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (HR 0.64, 95% CI 0.51-0.82 for women vs. HR 0.48, 95% CI 0.40-0.58 for men, interaction p value=0.060).  ","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Russo', 'Affiliation': 'Division of Cardiovascular Disease, Cooper Medical School of Rowan University, Camden, NJ (A.M.R.).'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Zeitler', 'Affiliation': 'The Geisel School of Medicine at Dartmouth, Hanover, NH, Division of Cardiology, Dartmouth-Hitchcock Medical Center, and The Dartmouth Institute, Lebanon, NH (E.P.Z.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Silverstein', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Yong-Mei', 'Initials': 'YM', 'LastName': 'Cha', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Kristi H', 'Initials': 'KH', 'LastName': 'Monahan', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Tristram D', 'Initials': 'TD', 'LastName': 'Bahnson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (A.G., A.P.S., H.R.A.-K., T.D.B., D.B.M.).'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Packer', 'Affiliation': ""Mayo Clinic, St Mary's Campus, Rochester, MN (Y.-M.C., K.H.M., D.L.P.).""}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'University of Washington Medical Center, Seattle (J.E.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051558']
1007,33497850,Does cognitive training improve attention/working memory in persons with MS? A pilot study using the Cogmed Working Memory Training program.,"BACKGROUND


Cognitive deficits, especially in attention, are common in persons with MS (PwMS) and are associated with clinically meaningful outcomes, such as work disability and lower quality of life (QOL). In this study, we aimed to determine whether Cogmed Working Memory Training (CWMT) improves attention/working memory in PwMS displaying impairment in these domains.
METHODS


This single blind, randomized controlled, pilot study compared the effects of CWMT, a five-week evidenced-based computer-assisted training program that is supported by weekly meetings with a coach, to standard medical care (treatment as usual). We recruited PwMS from one MS center (London (ON) Canada), aged 18-64, with an Expanded Disability Status Scale (EDSS) score of ≤ 7.0, and a visual acuity (corrected) of at least 20/70. Potential subjects had to demonstrate impaired attention on at least two of three measures (Paced Auditory Serial Addition Test [PASAT], Symbol Digit Modalities Test [SDMT], and/or DKEFS Color-Word Interference Test); these measures also served as the primary study outcomes. Subjects were randomized to either the CWMT or treatment as usual. Secondary cognitive outcomes included other measures of attention, memory, as well as a self-reported cognitive function measure. Self-reported measures of mood (depression and anxiety), pain, and QOL were also included as other secondary outcomes. Subjects received assessments at baseline, post-treatment, and 6-month follow-up, or an equivalent time period for the treatment as usual group. The two groups were compared at baseline on background measures using independent samples t-tests, Chi-Square tests, and Mann-Whitney U tests. To analyze primary and secondary outcomes, a non-parametric approach was used due the small sample size and that many of our outcomes did not meet assumptions for parametric analyses. Friedman's test was conducted followed by post hoc pairwise comparisons within each group using Wilcoxon Signed-Rank tests with Bonferroni corrected post hoc contrasts, which allowed us to examine for differences between time points.
RESULTS


Of 30 subjects, 15 were assigned to CWMT. Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025. No significant changes were observed in the treatment as usual group.
CONCLUSION


This pilot study demonstrates that cognitive training with CWMT has the potential to improve attention/working memory in PwMS, as well as a potential positive effect on mood, in PwMS. Further exploration of this intervention in PwMS with attention/working memory impairment is warranted.",2021,"Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025.","['We recruited PwMS from one MS center (London (ON) Canada), aged 18-64, with an Expanded Disability Status Scale (EDSS) score of ≤ 7.0, and a visual acuity (corrected) of at least 20/70', 'persons with MS (PwMS', '30 subjects', 'persons with MS']","['CWMT', 'cognitive training with CWMT', 'cognitive training', 'Cogmed Working Memory Training program', 'Cogmed Working Memory Training (CWMT']","['measures (Paced Auditory Serial Addition Test [PASAT], Symbol Digit Modalities Test [SDMT], and/or DKEFS Color-Word Interference Test', '3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale', 'measures of attention, memory, as well as a self-reported cognitive function measure', 'mood (depression and anxiety), pain, and QOL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0461683,"Significant training effects were noted in 1 of 3 primary attentional outcomes (DKEFS Color-Word Interference Test), 2 of 3 secondary attentional outcomes (Letter-Number Sequencing, Digit Span), and 1 mood scale (Hospital Anxiety and Depression scale (HADS) - Depression Subscale), ps < .025.","[{'ForeName': 'Mervin', 'Initials': 'M', 'LastName': 'Blair', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Goveas', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Ajmal', 'Initials': 'A', 'LastName': 'Safi', 'Affiliation': 'Lawson Health Research Institute, Clinical Neuropsychiatry & Therapeutic Brain Stimulation Research, Ontario Shores Centre for Mental Health Sciences, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marshall', 'Affiliation': 'Parkwood Institute, Rehabilitation Program, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rosehart', 'Affiliation': 'Western University, Department of Clinical Neurological Sciences and, Parkwood Institute, Department of Cognitive Neurology London Health Sciences Center, London, ON Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Orenczuk', 'Affiliation': 'Parkwood Institute, Veterans Care Program, 550 Wellington Rd, London, ON, Canada.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Morrow', 'Affiliation': 'Western University, Department of Clinical Neurological Sciences and, Parkwood Institute, Department of Cognitive Neurology London Health Sciences Center, London, ON Canada. Electronic address: Sarah.morrow@lhsc.on.ca.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102770']
1008,33497809,Interleukin-6 and Outcomes in Acute Heart Failure: An ASCEND-HF Substudy.,"BACKGROUND


The inflammatory cytokine IL-6 has been previously implicated in the pathophysiology of acute decompensated heart failure (HF). Prior observations in acute HF patients have suggested that IL-6 may be associated with outcomes and modulated by nesiritide. We aimed to evaluate the associations between serial IL-6 measurements, mortality and rehospitalization in acute HF.
METHODS AND RESULTS


We analyzed the associations between IL-6 in acute HF, readmission, and mortality (30 and 180 days) using a cohort of 883 hospitalized patients from the ASCEND-HF trial (nesiritide vs placebo). Plasma IL-6 was measured at randomization (baseline), 48-72 hours, and 30 days. The median IL-6 was highest at baseline (14.1 pg/mL) and decreased at subsequent time points (7.6 pg/mL at 30 days). In a univariable Cox regression analysis, the baseline IL-6 was associated with 30- and 180-day mortality (hazard ratio per log 1.74, 95% confidence interval 1.09-2.78, P = .021; hazard ratio 3.23, confidence interval 1.18-8.86, P = .022, respectively). However, there was no association after multivariable adjustment. IL-6 at 48-72 hours was found to be independently associated with 30-day mortality (hazard ratio 8.2, confidence interval 1.2-57.5, P= .03), but not 180-day mortality in multivariable analysis that included the ASCEND-HF risk model and amino terminal pro-B-type natriuretic peptide as covariates. In comparison with placebo, nesiritide therapy was not associated with differences in serial IL-6 levels.
CONCLUSIONS


Although elevated IL-6 levels were associated with higher all-cause mortality in acute HF, no independent association with this outcome was identified at baseline or 30-day measurements. In contrast with prior reports, we did not observe any impact of nesiritide over placebo on serial IL-6 levels.",2021,"Contrary to prior reports, we did not observe any impact of nesiritide over placebo on serial IL-6 levels.","['Acute Heart Failure', '30 and 180 days) using a cohort of hospitalized 883 patients from the ASCEND-HF trial (nesiritide vs', 'acute HF patients']","['placebo, nesiritide therapy', 'placebo']","['Interleukin-6 and Outcomes', '30-day mortality', 'Median IL-6', 'serial IL-6 levels', 'Plasma IL-6', 'elevated IL-6 levels', 'serial IL-6 measurements, mortality and rehospitalization', 'IL-6', 'acute HF, readmission and mortality']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0919829', 'cui_str': 'IL-6 assay'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}]",883.0,0.464955,"Contrary to prior reports, we did not observe any impact of nesiritide over placebo on serial IL-6 levels.","[{'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Perez', 'Affiliation': 'Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Thanat', 'Initials': 'T', 'LastName': 'Chaikijurajai', 'Affiliation': 'Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Mathematics & Statistics, Cleveland State University, Cleveland, Ohio.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Cardiology, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart & Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: tangw@ccf.org.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2021.01.006']
1009,33434727,"Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial.","BACKGROUND


A Growing body of literature indicates therapeutic effectiveness of mindfulness for mental disorders. Only few trials have been conducted with schizophrenia spectrum disorders (SSD), mostly in outpatient settings. Primary objective was to assess feasibility, acceptability, and preliminary outcomes of mindfulness-based group therapy (MBGT) for in-patients with SSD.
METHODS


A pre-registered randomized controlled trial was conducted to assess feasibility and acceptability of the MBGT. The primary outcome was mindfulness measured with the Southampton Mindfulness Questionnaire (SMQ). Secondary outcomes were rater-blinded positive- and negative symptoms, depression, social functioning, and self-reported mindfulness, depression, anxiety, psychological flexibility, quality of life, and medication regime at baseline, post-intervention, and follow-up (Clinical Trails NCT03671005).
RESULTS


40 participants received either treatment-as-usual (TAU; n=19) or (MBGT+TAU; n = 21) for four weeks. At post-intervention, protocol adherence was 95.2%, and retention rate was 95%. ANCOVA revealed significant improvements in the MBGT+TAU for the primary outcome SMQ as well as negative symptoms at post-intervention between groups. In exploratory analyses, secondary outcomes showed medium-to-large pre-to-post-intervention effects on mindfulness, positive-, negative-, and depressive symptoms, psychological flexibility, quality of life, and social functioning for MBGT+TAU and small-to-moderate changes on positive symptoms and social functioning for TAU. No serious adverse effects were reported.
CONCLUSIONS


MBGT appears feasible and acceptable for in-patient settings, with high protocol adherence and retention rates. Preliminary findings highlight a proof of concept of MBGT and various improvements in clinical- and process dimensions. A fully powered trial is warranted to determine efficacy, cost-efficiency, and longitudinal changes based on these promising outcomes.",2021,ANCOVA revealed significant improvements in the MBGT+TAU for the primary outcome SMQ as well as negative symptoms at post-intervention between groups.,"['patients with SSD', 'patients with schizophrenia spectrum disorders']","['MBGT', 'mindfulness-based group therapy (MBGT', 'Mindfulness-based group therapy']","['feasibility and acceptability', 'mindfulness measured with the Southampton Mindfulness Questionnaire (SMQ', 'retention rate', 'rater-blinded positive- and negative symptoms, depression, social functioning, and self-reported mindfulness, depression, anxiety, psychological flexibility, quality of life, and medication regime at baseline, post-intervention, and follow-up (Clinical Trails NCT03671005', 'serious adverse effects', 'medium-to-large pre-to-post-intervention effects on mindfulness, positive-, negative-, and depressive symptoms, psychological flexibility, quality of life, and social functioning for MBGT+TAU and small-to-moderate changes on positive symptoms and social functioning for TAU', 'feasibility, acceptability', 'negative symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.214651,ANCOVA revealed significant improvements in the MBGT+TAU for the primary outcome SMQ as well as negative symptoms at post-intervention between groups.,"[{'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Böge', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: kerem.boege@charite.de.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Hahne', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: inge.hahne@charite.de.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Bergmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: niklas.bergmann@charite.de.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: katja.wingenfeld@charite.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zierhut', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: marco.zierhut@charite.de.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Centre for Mental Health, Swinburne University of Technology, Melbourne, Australia. Electronic address: neilthomas@swin.edu.au.'}, {'ForeName': 'Thi Minh Tam', 'Initials': 'TMT', 'LastName': 'Ta', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: thi-minh-tam.ta@charite.de.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Bajbouj', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: malek.bajbouj@charite.de.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Germany. Electronic address: eric.hahn@charite.de.'}]",Schizophrenia research,['10.1016/j.schres.2020.12.008']
1010,33460884,"Cosmetic outcomes after transoral robotic thyroidectomy: Comparison with transaxillary, postauricular, and conventional approaches.","OBJECTIVES


Transoral thyroidectomy does not involve neck incision, and its postoperative cosmetic outcome is thought to be superior to that of conventional thyroidectomy and other remote-access procedures. This study aimed to compare the cosmetic outcomes between transoral robotic thyroidectomy (TORT) and conventional transcervical thyroidectomy and two common remote-access robotic thyroidectomies via the transaxillary and postauricular approaches.
MATERIALS AND METHODS


We analyzed 160 patients who underwent TORT, robotic thyroidectomies via the transaxillary or postauricular approach, or conventional transcervical thyroidectomy (40 patients in each group). The postoperative cosmetic outcomes, including cosmetic satisfaction and scar consciousness scores, were evaluated using self-assessment cosmesis questionnaires at 3 months and 1 year postoperatively. The cosmesis index was defined as the sum of the percentage scores for cosmetic satisfaction and scar consciousness.
RESULTS


Cosmetic satisfaction scores, scar consciousness scores, and cosmesis indexes were significantly higher for the transoral, transaxillary, and postauricular approaches than the conventional approach at 3 months and 1 year postoperatively. There was a trend of better cosmetic outcomes, especially regarding scar consciousness, for the transoral and transaxillary approaches than for the postauricular approach, but the difference was not statistically significant.
CONCLUSION


Postoperative cosmesis of TORT, as well as the transaxillary and postauricular approaches, is superior to that of conventional thyroidectomy. The cosmetic outcomes of the transoral and transaxillary approaches seem to be better than those of the postauricular approach.",2021,"There was a trend of better cosmetic outcomes, especially regarding scar consciousness, for the transoral and transaxillary approaches than for the postauricular approach, but the difference was not statistically significant.
","['We analyzed 160 patients who underwent', '40 patients in each group']","['Transoral thyroidectomy', 'transoral robotic thyroidectomy (TORT', 'transoral robotic thyroidectomy', 'transaxillary, postauricular, and conventional approaches', 'conventional transcervical thyroidectomy and two common remote-access robotic thyroidectomies', 'TORT, robotic thyroidectomies via the transaxillary or postauricular approach, or conventional transcervical thyroidectomy']","['cosmesis index', 'scar consciousness', 'cosmetic satisfaction and scar consciousness', 'Cosmetic satisfaction scores, scar consciousness scores, and cosmesis indexes', 'cosmetic outcomes', 'postoperative cosmetic outcomes, including cosmetic satisfaction and scar consciousness scores', 'self-assessment cosmesis questionnaires', 'Cosmetic outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0442341', 'cui_str': 'Transaxillary approach'}, {'cui': 'C0442168', 'cui_str': 'Postauricular'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",160.0,0.0257118,"There was a trend of better cosmetic outcomes, especially regarding scar consciousness, for the transoral and transaxillary approaches than for the postauricular approach, but the difference was not statistically significant.
","[{'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Catholic University of Daegu, 33 Duryugongwon-ro 17-gil, Nam-Gu, Daegu 42472, Republic of Korea; Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. Electronic address: neck@cu.ac.kr.'}, {'ForeName': 'Hyang Sook', 'Initials': 'HS', 'LastName': 'Bang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. Electronic address: deresa3000@hyumc.com.'}, {'ForeName': 'Jin Hyeok', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. Electronic address: ent@hanyang.ac.kr.'}, {'ForeName': 'Sang Gyu', 'Initials': 'SG', 'LastName': 'Kwak', 'Affiliation': 'Department of Medical Statistics, School of Medicine, Catholic University of Daegu, 33 Duryugongwon-ro 17-gil, Nam-Gu, Daegu 42472, Republic of Korea. Electronic address: sanggyu39@naver.com.'}, {'ForeName': 'Yun Young', 'Initials': 'YY', 'LastName': 'Choi', 'Affiliation': 'Department of Nuclear Medicine, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. Electronic address: yychoi@hanyang.ac.kr.'}, {'ForeName': 'Kyung', 'Initials': 'K', 'LastName': 'Tae', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. Electronic address: kytae@hanyang.ac.kr.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105139']
1011,33497075,"Comparison of Intravenous and Periarticular Administration of Corticosteroids in Total Knee Arthroplasty: A Prospective, Randomized Controlled Study.","BACKGROUND


Corticosteroids are widely used in total knee arthroplasty (TKA) to relieve postoperative pain and prevent postoperative nausea. The aim of this prospective, randomized controlled study was to compare the effects of intravenous and periarticular administration of corticosteroids on pain control, prevention of postoperative nausea, and inflammation and thromboembolism markers following TKA.
METHODS


One hundred patients undergoing TKA were randomly allocated to either the intravenous administration or periarticular injection group. The intravenous administration group received 10 mg dexamethasone 1 hour before and 24 hours after the surgical procedure, as well as a periarticular injection placebo during the procedure. The periarticular injection group received a 40-mg injection of triamcinolone acetonide during the surgical procedure, as well as an intravenous administration placebo 1 hour before and 24 hours after the procedure. Postoperative pain scores at rest and during walking and nausea scores were recorded according to the 0-to-10 Numerical Rating Scale. Interleukin-6 (IL-6), C-reactive protein (CRP), and prothrombin fragment 1.2 (PF1.2) were measured preoperatively and postoperatively.
RESULTS


Pain scores at rest and during walking 24 hours postoperatively were significantly lower in the periarticular injection group than in the intravenous administration group. Nausea scores showed no significant difference between groups. IL-6 at 24 and 48 hours postoperatively also showed no significant difference between groups. CRP at 24 and 48 hours postoperatively was significantly lower in the intravenous administration group than in the periarticular injection group. In contrast, CRP at 1 week postoperatively was significantly higher in the intravenous administration group than in the periarticular injection group. The mean PF1.2 was significantly lower in the intravenous administration group than in the periarticular injection group at 4 hours postoperatively. Two cases of deep venous thrombosis in each group were detected with use of ultrasonographic examination.
CONCLUSIONS


Periarticular injection of corticosteroids showed a better pain-control effect at 24 hours postoperatively than did intravenous administration, whereas the antiemetic effect was similar between treatments. Although intravenous administration had a better anti-thromboembolic effect than periarticular injection, the incidence of deep venous thrombosis was low in both groups.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2021,"RESULTS


Pain scores at rest and during walking 24 hours postoperatively were significantly lower in the periarticular injection group than in the intravenous administration group.","['Total Knee Arthroplasty', 'One hundred patients undergoing TKA', 'total knee arthroplasty (TKA']","['corticosteroids', 'intravenous administration or periarticular injection', 'triamcinolone acetonide', 'dexamethasone', 'Intravenous and Periarticular Administration of Corticosteroids']","['pain-control effect', 'pain control, prevention of postoperative nausea, and inflammation and thromboembolism markers', 'antiemetic effect', 'deep venous thrombosis', 'incidence of deep venous thrombosis', 'Postoperative pain scores at rest and during walking and nausea scores', 'CRP', 'Nausea scores', 'IL-6', 'mean PF1.2', 'Pain scores', '0-to-10 Numerical Rating Scale. Interleukin-6 (IL-6), C-reactive protein (CRP), and prothrombin fragment 1.2 (PF1.2']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1516011', 'cui_str': 'Antiemetic Effects'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.0746397,"RESULTS


Pain scores at rest and during walking 24 hours postoperatively were significantly lower in the periarticular injection group than in the intravenous administration group.","[{'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Hatayama', 'Affiliation': 'Department of Orthopaedic Surgery, Japan Community Health Care Organization Gunma Central Hospital, Maebashi, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terauchi', 'Affiliation': 'Department of Orthopaedic Surgery, Japan Community Health Care Organization Gunma Central Hospital, Maebashi, Japan.'}, {'ForeName': 'Atsufumi', 'Initials': 'A', 'LastName': 'Oshima', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Hibiki', 'Initials': 'H', 'LastName': 'Kakiage', 'Affiliation': 'Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Orthopaedic Sports Surgery, Asakura Sports Rehabilitation Clinic, Maebashi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Higuchi', 'Affiliation': 'Department of Orthopaedic Sports Surgery, Asakura Sports Rehabilitation Clinic, Maebashi, Japan.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01153']
1012,33493652,Philosophy for children and mindfulness during COVID-19: Results from a randomized cluster trial and impact on mental health in elementary school students.,"BACKGROUND


Preliminary evidence suggests that the COVID-19 pandemic has had a negative impact on children's mental health. Given these problems can have significant impacts throughout the lifespan, preventing the negative repercussions of COVID-19 on children's mental health is essential. Philosophy for children (P4C) and mindfulness-based interventions (MBIs) show promise in this regard.
OBJECTIVE


The goal of the present study was to compare the impact of online MBI and P4C interventions on mental health, within the context of the COVID-19 pandemic. We used a randomized cluster trial to assess and compare the impact of both interventions on elementary school students' (N = 37) anxiety and inattention symptoms as well as on their basic psychological need satisfaction (BPN).
RESULTS


ANCOVAs revealed a significant effect of the P4C intervention on mental health difficulties, controlling for baseline levels. Participants in the P4C group showed lower scores on the measured symptoms at post-test than participants in the MBI group. Significant effects of the MBI on levels of BPN were also found. Participants in the MBI intervention reported greater BPN satisfaction at post-test than participants in the P4C intervention.
CONCLUSION


Results from this study suggest that, in the current context of the COVID-19 pandemic, a P4C intervention centered around COVID-19 related themes may be helpful to reduce mental health difficulties, that a MBI may be useful to satisfy BPN, and that both interventions were easy to offer online to elementary school students. Future work including a larger sample size and follow-up measures is warranted.
PUBLIC SIGNIFICANCE


Practice: Philosophy for children (P4C) and mindfulness-based interventions (MBIs) can be used to foster mental health in elementary school students, in the current COVID-19 context. Policy: As we do not anticipate that facilitators will be allowed in schools during the 2020-2021 school year and that children will, most likely, be attending school in the current COVID-19 context, policymakers who want to implement psychological support measures in elementary schools should consider an online modality, which has shown in this study to work well, be feasible, and yield positive results on youth mental health.",2021,"Participants in the MBI intervention reported greater BPN satisfaction at post-test than participants in the P4C intervention.
","[""elementary school students' (N\u202f=\u202f37) anxiety and inattention symptoms as well as on their basic psychological need satisfaction (BPN"", 'elementary school students', ""children's mental health"", 'Practice', 'children and mindfulness during COVID-19']","['MBI intervention', 'online MBI and a P4C interventions', 'P4C intervention', 'MBI', 'mindfulness-based interventions (MBIs']","['mental health difficulties', 'levels of BPN', 'BPN satisfaction']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.105048,"Participants in the MBI intervention reported greater BPN satisfaction at post-test than participants in the P4C intervention.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Malboeuf-Hurtubise', 'Affiliation': ""Department of Psychology, Bishop's University, 2600 College St., Sherbrooke, Quebec J1M 1Z7, Canada. Electronic address: catherine.malboeuf-hurtubise@ubishops.ca.""}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Léger-Goodes', 'Affiliation': 'Faculty of Medicine and Health Sciences, Université de Sherbrooke, Canada.'}, {'ForeName': 'Geneviève A', 'Initials': 'GA', 'LastName': 'Mageau', 'Affiliation': 'Department of Psychology, Université de Montréal, Canada.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Joussemet', 'Affiliation': 'Department of Psychology, Université de Montréal, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Herba', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Chadi', 'Affiliation': 'Department of Paediatrics, Sainte-Justine University Hospital Centre, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lefrançois', 'Affiliation': 'Department of Educational Sciences, Université du Québec en Outaouais, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Camden', 'Affiliation': 'School of rehabilitation sciences, Université de Sherbrooke, Canada.'}, {'ForeName': 'Ève-Line', 'Initials': 'ÈL', 'LastName': 'Bussières', 'Affiliation': 'Department of psychology, Université du Québec à Trois-Rivières, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Taylor', 'Affiliation': 'Department of Education and Pedagogy, Université du Québec à Montréal, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Éthier', 'Affiliation': 'Department of Didactics, Université de Montréal, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gagnon', 'Affiliation': 'Department of Education, Preschool and Primary school teaching, Université de Sherbrooke, Canada.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2021.110260']
1013,33493624,A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression.,"OBJECTIVE


To investigate whether a four-week course of neuronavigated intermittent theta burst stimulation (iTBS) of the left dorsolateral prefrontal cortex is superior to the non-neuronavigated F3-EEG method of positioning.
METHODS


We conducted a single-center, two-arm, randomized and double-blinded study (clinicaltrials.gov NCT03953521). 37 inpatients with an at least moderate depressive episode were randomized to receive either neuronavigated or 10-20-EEG-system based F3 guided iTBS. Both groups received twenty week daily sessions of iTBS while continuing to receive standard-of-care treatment by their ward physicians. For navigated iTBS, we used magnetic resonance imaging to target the border between the anterior and middle third of the middle frontal gyrus considered to represent the left dorsolateral prefrontal cortex (lDLPFC). Differences in the treatment arms were blinded by completely mimicking the procedures of the respective other treatment group. Rating physicians were not involved in the treatment procedure. Primary outcome was defined as the change of the 21-item version of the Hamilton Depression Score (HAMD) from baseline to end of treatment at week 4. Secondary outcomes included HAMD score during the treatment, Patient Health Questionnaire-9, WHO Quality of Life-BREF and Clinical Global Impression. For primary outcome, we used a planned group comparison for the absolute change in the HAMD. For secondary outcome measures we calculated analyses of variance (ANOVAs) with the within-subjects factor time (primary: baseline vs. week 4; secondary: all visits) and the between-subjects factor group (navigated vs. F3 guided group). We also did planned contrasts between both groups for all variables and all treatment and follow-up visits with the aim not to oversee any group differences. For group contrasts we used Student T-tests for metric and chi-square tests for categorial variables. Significance threshold was set to 5% uncorrected for multiple comparisons.
RESULTS


Enrolment of 80 patients with interim analysis was planned. Interim analysis was performed after 37 patients (intention to treat). 6 patients dropped out, leaving 31 for analysis. With respect to primary outcome criteria, absolute change in the HAMD did not differ significantly between groups. In accordance, relative change and number of responders and remitters were not significantly different. Overall number of responders was 53% and of remitters was 60%. On a descriptive level, the results favor the clinical effects of the F3 group for the absolute and relative change in the HAMD and the number of responders. Number of remitters were exactly the same for both groups. Therefore, we decided to stop the trial due to the added burden of magnetic resonance imaging and neuronavigated treatment in relation to the effect. Secondary outcomes did also not differ significantly between groups. Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
CONCLUSION


We noticed a high antidepressive effect of add-on iTBS treatment to standard inpatient treatment but failed to demonstrate a clinical superiority of neuronavigated localization. The non-navigated, F3 guided iTBS treatment used as a control group may be sophisticated enough to dilute potential added benefits, and the difference between the localization approaches is either negligible or too small to justify the additional efforts of navigation. The effects of concomitant treatment may mask effects, but our patient population reflects clinical reality in an inpatient setting. Further prospective studies are warranted to compare neuronavigated with surface-based approaches.",2021,"Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
","['80 patients with interim analysis was planned', '37 inpatients with an at least moderate depressive episode']","['neuronavigated or 10-20-EEG-system based F3 guided iTBS', 'neuronavigated intermittent theta burst stimulation', 'neuronavigated and non-neuronavigated intermittent theta burst stimulation', 'intermittent theta burst stimulation while continuing to receive standard-of-care treatment by their ward physicians']","['absolute change in the HAMD', 'Overall number of responders', 'HAMD score during the treatment, Patient Health Questionnaire-9, WHO Quality of Life-BREF and Clinical Global Impression', 'change of the 21-item version of the Hamilton Depression Score (HAMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0494398', 'cui_str': 'Moderate depressive episode'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",80.0,0.0960668,"Patients did not differ in their baseline characteristics nor with respect to intake of medication during the trial period and all had access to the same therapeutic interventions.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: tobias.hebel@medbo.de.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Göllnitz', 'Affiliation': 'Faculty of Medicine, University of Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schoisswohl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Franziska C', 'Initials': 'FC', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelnaim', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Wetter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2021.01.013']
1014,33493608,Friends are not to be eaten: Children are reluctant to eat cookies that share physical and psychological human features due to their desire to relate to the food.,"Children's food marketers very often use anthropomorphism in advertising as if it is an effective technique aimed at increasing food consumption. However, the evidence supporting this effect is mixed. In this research, we propose that while a food product's humanlike appearance (physical anthropomorphism) may increase consumption, attribution of mental states and emotions (psychological anthropomorphism) to a physically anthropomorphized food product discourages consumption because it facilitates the formation of a social-like relationship with the food. In two studies, we tested this prediction on samples of children. Preschoolers (N = 91 and N = 97) were randomly assigned to one of three conditions in which they were presented with a cookie that was both physically and psychologically anthropomorphized, physically anthropomorphized only, or not anthropomorphized. In two studies, we observed whether children left alone with the cookie would consume it and how quickly it would happen. Additionally, in Study 2, we asked children about their desire to relate to the cookie. The results confirmed that physical anthropomorphism accompanied by psychological anthropomorphism considerably reduced consumption of the cookies compared to both mere physical anthropomorphism and non-anthropomorphism. Moreover, the reduced appetite for cookies that were physically and psychologically anthropomorphized was mediated by the desire to relate to them. We discuss the implications of these results.",2021,Children's food marketers very often use anthropomorphism in advertising as if it is an effective technique aimed at increasing food consumption.,['Preschoolers (N = 91 and N = 97'],"['cookie that was both physically and psychologically anthropomorphized, physically anthropomorphized only, or not anthropomorphized']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C3853210', 'cui_str': 'Cookie'}]",[],97.0,0.0189432,Children's food marketers very often use anthropomorphism in advertising as if it is an effective technique aimed at increasing food consumption.,"[{'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Niemyjska', 'Affiliation': 'SWPS University of Social Sciences and Humanities, Social Behavior Research Center, Poland. Electronic address: aniemyjska@swps.edu.pl.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Myślińska-Szarek', 'Affiliation': 'SWPS University of Social Sciences and Humanities, Sopot Campus, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Cantarero', 'Affiliation': 'SWPS University of Social Sciences and Humanities, Social Behavior Research Center, Poland; University of Essex, Department of Psychology, UK.'}]",Appetite,['10.1016/j.appet.2021.105121']
1015,33497765,Transcranial direct current stimulation of the right dorsolateral prefrontal cortex improves response inhibition.,"BACKGROUND


A number of functional magnetic resonance imaging studies have shown that the dorsolateral prefrontal cortex (dlPFC) is a critical brain region for response inhibition. However, how it exerts this function remains unclear. This study investigated whether stimulating the right dlPFC by transcranial direct current stimulation (tDCS) affects performance on stop signal task.
METHODS


A total of 92 healthy subjects were enrolled in the study and randomly divided into three groups. The anode group received anodal stimulation over the right dlPFC and cathodal stimulation over the left supraorbital; the cathode group received cathodal stimulation over the right dlPFC and anodal stimulation over the left supraorbital; and the sham group received sham tDCS. All subjects performed a computer-based stop-signal task before and after tDCS.
RESULT


Performance on the response inhibition task after tDCS was improved in groups with both anodal and cathodal stimulation. Specifically, there was a decrease in the stop-signal reaction time in these subjects, whereas no difference was observed in the sham group. Consistent with signal detection theory, discrimination and decision bias was improved by anode tDCS relative to the sham group, while discrimination was also improved in the cathode group.
CONCLUSION


Anode and cathode tDCS of the right dlPFC improves response inhibition, with the right dlPFC may playing a key role in this process.",2021,"Consistent with signal detection theory, discrimination and decision bias was improved by anode tDCS relative to the sham group, while discrimination was also improved in the cathode group.
",['92 healthy subjects'],"['transcranial direct current stimulation (tDCS', 'Transcranial direct current stimulation', 'anodal stimulation over the right dlPFC and cathodal stimulation over the left supraorbital; the cathode group received cathodal stimulation over the right dlPFC and anodal stimulation over the left supraorbital; and the sham group received sham tDCS']","['stop-signal reaction time', 'response inhibition task']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",92.0,0.0209275,"Consistent with signal detection theory, discrimination and decision bias was improved by anode tDCS relative to the sham group, while discrimination was also improved in the cathode group.
","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Department of Neurology, the First Affiliated Hospital of Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, China; Collaborative Innovation Centre of Neuropsychiatric Disorder and Mental Health, Anhui Province, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei, China; Anhui Mental Health Center, Hefei, China. Electronic address: yufengqin1@163.com.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.01.014']
1016,33506629,Treatment of benign hyperpigmentations and pigmented scars by 755 alexandrite laser comparing the Single Pass versus MultiPass (MoveoPL) emission in skin types I-IV.,"Lasers are effective treatments for benign hyperpigmentations but may be difficult especially in darker skin type. In this randomized split-face controlled study on benign hyperpigmentations and pigmented scars, we compare the standard Single Pass (SP) emission with the MultiPass emission (MoveoPL) 755 alexandrite laser. Patients, skin types I-IV, with solar lentigines and ephelides of the face, chest, and hands and patients with pigmented scars of the legs, underwent laser treatment, by treating one side of the body or half scar using the SP and the other side using MoveoPL. Improvements according to a grading score system, side effects, and patient satisfaction were recorded. About 63 patients were enrolled. An overall improvement of benign hyperpigmentations and pigmented scars was recorded, with a grading score (±SD) of 2.8 ± 0.8 for SP and 3.6 ± 0.5 for MoveoPL (range, 0-4). SP emission showed best results in skin types I-II whereas MotusPL obtained successfully results in all the phototypes analyzed (types I-IV). Patients preferred MoveoPL as it was associated with fewer side effects. Both standard SP and MoveoPL emission are effective and safe. MoveoPL showed a higher efficacy and safety profile for the treatment of hyperpigmentations.",2021,SP emission showed best results in skin type I-II whereas MotusPL obtained successfully results in all the phototypes analysed (type I-IV).,"['63 patients were enrolled', 'Patients, skin types I-IV, with solar lentigines and ephelides of the face, chest and hands and patients with pigmented scars of the legs, underwent laser treatment, by treating one side of the body or half scar using the SP and the other side using MoveoPL', 'benign hyperpigmentations and pigmented scars']","['standard SP and MoveoPL emission', 'standard Single Pass (SP) emission with the MultiPass emission (MoveoPL) 755 alexandrite laser', '755 Alexandrite Laser comparing the Single Pass Versus MultiPass (MoveoPL) emission', 'MoveoPL']","['efficacy and safety profile', 'side effects', 'grading score system, side effects, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0036651', 'cui_str': 'Solar lentigo'}, {'cui': 'C0016689', 'cui_str': 'Ephelis'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0406842', 'cui_str': 'Pigmented scar'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",63.0,0.0291998,SP emission showed best results in skin type I-II whereas MotusPL obtained successfully results in all the phototypes analysed (type I-IV).,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonan', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Troiano', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bruscino', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Verdelli', 'Affiliation': 'Laser Cutaneous Cosmetic & Plastic Surgery Unit, Villa Donatello Clinic, Florence, Italy.'}]",Dermatologic therapy,['10.1111/dth.14819']
1017,33476880,Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years.,"BACKGROUND


Alemtuzumab significantly improved clinical and MRI outcomes vs. subcutaneous interferon beta-1a (SC IFNB-1a) in the CARE-MS trials (NCT00530348, NCT00548405), with sustained efficacy in 2 consecutive extensions (NCT00930553, NCT02255656 [TOPAZ]).
METHODS


Post hoc analysis of 8-year alemtuzumab efficacy and safety in pooled CARE-MS patients (N=811) stratified by baseline age (≥18 to ≤25, >25 to ≤35, >35 to ≤45, >45 to ≤55 years).
RESULTS


Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87% vs. -0.50% to -1.39%). Through Year 2, the treatment effect with alemtuzumab did not significantly differ among age groups for ARR (p-interaction=0.6325), 6-month CDW-free (p-interaction=0.4959), 6-month CDI (p-interaction=0.9268), MRI disease activity-free (p-interaction=0.6512), and BVL (p-interaction=0.4970). Alemtuzumab remained effective on outcomes through Year 8 across age groups. Age-related increases in malignancies (≤45 years: 0.9%-2.2% vs. >45 years: 8.1%) and deaths (0%-1.7% vs. 7.0%) were observed. Serious infections also increased from the youngest (5.1%) to oldest (12.8%) age cohorts.
CONCLUSIONS


Alemtuzumab had greater efficacy than SC IFNB-1a over 2 years across comparable age groups, with no significant differences between alemtuzumab-treated age groups. Efficacy on relapse, disability, and MRI outcomes continued through Year 8 across age groups. Age-related increases in serious infections, malignancies, and deaths were observed.",2020,"Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87%","['pooled CARE-MS patients (N=811) stratified by baseline age (≥18 to ≤25, >25 to ≤35, >35 to ≤45, >45 to ≤55 years', 'age']","['Alemtuzumab', 'alemtuzumab']","['serious infections, malignancies, and deaths', 'MRI disease activity', 'Serious infections', 'slowed brain volume loss', 'deaths', 'MRI disease activity-free', 'annualized relapse rates', '6-month CDW-free', 'stabilized disability', 'relapse, disability, and MRI outcomes']","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0452673,"Compared with SC IFNB-1a over 2 years across age cohorts, alemtuzumab lowered annualized relapse rates (ARR; 0.22-0.24 vs. 0.38-0.51), improved or stabilized disability (freedom from 6-month confirmed disability worsening [CDW]: 85%-92% vs. 62%-88%; achievement of 6-month confirmed disability improvement [CDI]: 20%-31% vs. 13%-25%), increased proportions free of MRI disease activity (70%-86% vs. 42%-63% per year), and slowed brain volume loss (BVL; -0.45% to -0.87%","[{'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Bass', 'Affiliation': 'Neurology Center of San Antonio, 1314 East Sonterra Blvd #601, San Antonio, TX, USA. Electronic address: annofb@hotmail.com.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Arroyo', 'Affiliation': 'Hospital Universitario Quirónsalud Madrid (RA), c/ Diego de Velázquez, 1 28223 Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Boster', 'Affiliation': 'Boster MS Center, 8000 Ravines Edge Court, Suite 200, Columbus, OH, USA.'}, {'ForeName': 'Alexey N', 'Initials': 'AN', 'LastName': 'Boyko', 'Affiliation': 'Pirogov Russian National Research University, Department of Neuroimmunology of the Federal Center of Brain and Neurosciences, Moscow, Russia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Eichau', 'Affiliation': 'Hospital Universitario Virgen Macarena, Avda. Dr. Fedriani, No. 3. 41009, Seville, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ionete', 'Affiliation': 'University of Massachusetts Memorial Medical Center, 55 Lake Avenue North, Worcester, MA, USA.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Limmroth', 'Affiliation': 'Klinik für Neurologie und Palliativmedizin, Ostmerheimer Str. 200, 51109 Cologne, Germany.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Navas', 'Affiliation': 'Clínica Universitaria Colombia, Cl. 22b ## 66-46, Bogota, Colombia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pelletier', 'Affiliation': 'Keck School of Medicine of University of Southern California, 1520 San Pablo St, Los Angeles, CA, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Pozzilli', 'Affiliation': 'Department of Human Neuroscience, Sapienza University, University Avenue 30, Rome, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ravenscroft', 'Affiliation': 'Kansas City MS Center, 10600 Mastin Street, Entrance C, Overland Park, KS, USA.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Sousa', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3000-075, Coimbra, Portugal.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tintoré', 'Affiliation': ""University Hospital Vall d'Hebron, Passeig de la Vall d'Hebron, 119, 129, 08035 Barcelona, Spain.""}, {'ForeName': 'Bernard M J', 'Initials': 'BMJ', 'LastName': 'Uitdehaag', 'Affiliation': 'Amsterdam University Medical Centers, PO Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Baker', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Choudhry', 'Affiliation': 'Sanofi, 50 Binney Street, Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rog', 'Affiliation': 'Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102717']
1018,33493803,Coffee and cigarette smoking interactions with lamotrigine.,"The objective of this analysis was to determine possible interactions between lamotrigine (LTG) and coffee or cigarette use. As part of the statistical analysis of factors influencing LTG pharmacokinetics (PK) in the Equigen chronic dose study, we collected prospective data from enrolled patients on their use of coffee and cigarettes. Subjects were part of a crossover replication study of generic LTG products with rigorous blood sampling and were instructed to not change their typical consumption of these products for the duration of the study. A total of 35 subjects were enrolled, with 33 subjects having sufficient data for analysis. Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG). Higher cigarette use did not result in a significant change in AUC or Cmax. Coffee, but not cigarette use, either induces LTG metabolism or inhibits LTG absorption.",2021,Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG).,"['35 subjects were enrolled, with 33 subjects having sufficient data for analysis', 'enrolled patients on their use of coffee and cigarettes']","['lamotrigine (LTG', 'generic LTG products with rigorous blood sampling', 'lamotrigine']","['AUC or Cmax', 'lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG', 'Higher consumption of coffee']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]",35.0,0.0222585,Higher consumption of coffee was associated with a significantly lower area under the curve (AUC) and maximum concentration (Cmax) of lamotrigine (LTG).,"[{'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Welty', 'Affiliation': 'College of Pharmacy and Health Sciences, Drake University, Des Moines, IA, USA. Electronic address: timothy.welty@drake.edu.'}, {'ForeName': 'Barry E', 'Initials': 'BE', 'LastName': 'Gidal', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Privitera', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Michel J', 'Initials': 'MJ', 'LastName': 'Berg', 'Affiliation': 'School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Krebill', 'Affiliation': 'School of Medicine, University of Kansas Medical Center, Kansas City, KA, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Szaflarski', 'Affiliation': 'School of Medicine, University of Alabama Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'School of Medicine, University of Kansas Medical Center, Kansas City, KA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107741']
1019,33493954,Effects of light-to-moderate intensity aerobic exercise on objectively measured sleep parameters among community-dwelling older people.,"OBJECTIVES


Although exercise improves sleep parameters in older people, most studies have been designed for people with insomnia or sleep complaints. Little is known of the effects of exercise among older people without sleep problems. We investigated the effects of 3-month light-to-moderate intensity aerobic exercise intervention on objectively measured sleep quantity and quality among community-dwelling older people.
METHODS


Fifty-eight community-dwelling older people were assigned into an exercise (EX) or control (CON) groups, and 49 participants (65.7 ± 5.7 years. BMI 24.4 ± 3.9 kg/m 2 ) were enrolled in the analysis. EX group members attended 60 min/week group-based exercise program and performed ≥140 min of home-based exercise, at ≥50% of maximum heart rate to exceed 200 min of total exercise per week. Sleep was assessed by an accelerometer and the Pittsburgh Sleep Quality Index (PSQI) before and after intervention.
RESULTS


In the EX group, total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10 min (WE≥10 min) significantly improved (p<0.05). EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05). The subgroup analyses in the EX group according to baseline PSQI cutoff value showed no differences in changes between subgroups.
CONCLUSIONS


Three-month aerobic exercise improved objectively measured sleep quality in community-dwelling older people. Baseline sleep conditions did not significantly influence the magnitude of changes in sleep quality and quantity. These results suggest that light aerobic exercise can improve sleep among community-dwelling older people, regardless of baseline sleep status, but the effect may be small.",2021,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"['older people without sleep problems', 'older people', 'people with insomnia or sleep complaints', 'community-dwelling older people', 'Fifty-eight community-dwelling older people', 'groups, and 49 participants (65.7\xa0±\xa05.7 years']","['exercise (EX) or control (CON', 'light aerobic exercise', 'EX group members attended 60\xa0min/week group-based exercise program and performed ≥140\xa0min of home-based exercise, at ≥50% of maximum heart rate to exceed 200\xa0min of total exercise per week', 'light-to-moderate intensity aerobic exercise', 'light-to-moderate intensity aerobic exercise intervention', 'CON', 'aerobic exercise']","['sleep quality and quantity', 'Pittsburgh Sleep Quality Index (PSQI', 'Sleep', 'sleep quality', 'sleep parameters', 'sleep quantity and quality', 'total sleep time, hours in waking after sleep onset, sleep efficiency and consecutive wake episodes ≥10']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.0335926,EX group showed a significantly greater reduction in WE≥10 min than the CON group (p<0.05).,"[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Miyazaki', 'Affiliation': 'Faculty of Human Sciences, Shimane University, 1060 Nishikawatsu, Matsue, Shimane 690-8504, Japan. Electronic address: miyazaki@hmn.shimane-u.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayabe', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: ayabe@ss.oka-pu.ac.jp.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kumahara', 'Affiliation': 'Faculty of Nutritional Sciences, Nakamura Gakuen University, 5-7-1 Befu, Jounan-ku, Fukuoka 814-0198, Japan. Electronic address: kumahara@nakamura-u.ac.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Morimura', 'Affiliation': 'Faculty of Education, Shujitsu University, 1-6-1 Nishigawara, Naka-ku, Okayama-shi, Okayama 703-8516, Japan. Electronic address: k_morimura@shujitsu.ac.jp.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Faculty of Computer Science and Systems Engineering, Okayama Prefectural University, 111 Kuboki, Soja, Okayama, 719-1197, Japan. Electronic address: Inukaiyoshihide@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104336']
1020,33500115,Home Management Versus Primary Care Physician Follow-up of Patients With Distal Radius Buckle Fractures: A Randomized Controlled Trial.,"STUDY OBJECTIVE


In patients with a distal radius buckle fracture, we determine whether home removal of a splint and physician follow-up as needed (home management) is noninferior to primary care physician follow-up in 1 to 2 weeks with respect to functional recovery. We also compare groups with respect to health care and patient-level costs.
METHODS


This was a noninferiority randomized controlled trial conducted at a tertiary care children's hospital. Eligible patients were randomized to home management versus primary care physician follow-up and received telephone contact at 3 and 6 weeks after the index ED visit. Functional recovery was measured with the Activities Scale for Kids-performance, and participants reported wrist-injury-related health care interventions and expenses. The primary outcome was a comparison of the performance score between groups at 3 weeks.
RESULTS


We enrolled 149 patients with mean age 9.5 years (SD 2.7 years), and 81 (54.4%) were male patients. Of the 133 patients (89.3%) with completed 3-week follow-up, the mean Activities Scale for Kids-performance score was 95.4% in the home management group (n=66) and 95.9% in the primary care physician follow-up group (n=67) (mean difference -0.4%; lower bound of the 95% confidence interval -2.4%). There was a mean costs savings of -$100.10 (95% confidence interval -$130.0 to -$70.20) in health care and -$28.2 (95% confidence interval -$49.6 to -$7.0) in patient costs in the home management versus primary care physician follow-up group.
CONCLUSION


In patients with distal radius buckle fractures, home management is at least as good as primary care physician follow-up with respect to functional recovery. Implementation of the home management strategy also demonstrated significant cost savings.",2021,"In patients with distal radius buckle fractures, home management is at least as good as primary care physician follow-up with respect to functional recovery.","[""tertiary care children's hospital"", 'Eligible patients', 'patients with a distal radius buckle fracture', 'Patients With Distal Radius Buckle Fractures', 'patients with distal radius buckle fractures', '149 patients with mean age 9.5 years (SD 2.7 years), and 81 (54.4%) were male patients']",['home management versus primary care physician follow-up and received telephone contact'],"['Functional recovery', 'mean Activities Scale for Kids-performance score', 'performance score', 'mean costs savings', 'cost savings']","[{'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0347847', 'cui_str': '[Q] Buckle'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",149.0,0.0696191,"In patients with distal radius buckle fractures, home management is at least as good as primary care physician follow-up with respect to functional recovery.","[{'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Colaco', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Research Institute at the Hospital for Sick Children and Dalla Lana School of Public Health at the University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stimec', 'Affiliation': 'Department of Diagnostic Imaging, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Barra', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Division of Orthopedics, Department of Surgery, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Boutis', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada. Electronic address: kathy.boutis@sickkids.ca.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.039']
1021,33497874,Mindfulness intervention for mild cognitive impairment led to attention-related improvements and neuroplastic changes: Results from a 9-month randomized control trial.,"Mindfulness-based interventions can enhance cognitive abilities among older adults, thereby effectively delaying cognitive decline. These cognitive enhancements are theorized to accompany neuroplastic changes in the brain. However, this mindfulness-associated neuroplasticity has yet to be documented adequately. A randomized controlled trial was carried out among participants with mild cognitive impairment (MCI) to examine the effects of a mindfulness-based intervention on various cognitive outcomes and cortical thickness (CT) in the context of age-related cognitive impairment. Participants were assigned to a mindfulness awareness program (MAP)(n = 27) and an active control condition - health education program (n = 27). In both, they attended weekly sessions for three months and subsequently, monthly sessions for six months. Cognitive assessments and structural scans were carried out across three time-points. Whole brain analyses on CT were carried out and were supplemented with region of interest-based analyses. ROI values and cognitive outcomes were analyzed with mixed MANOVAs and followed up with univariate ANOVAs. Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed. Three-month MAP-associated CT increase was observed in the left inferior temporal gyrus but did not sustain thereafter. MAP led to significant cognitive gains and various CT changes. Most of these neurobehavioral changes, may require sustained effort across nine months, albeit at a reduced intensity. MAP can remediate certain cognitive impairments and engender neuroplastic effects even among those with MCI.",2021,"Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed.","['participants with mild cognitive impairment (MCI', 'older adults']","['mindfulness awareness program (MAP)(n\xa0=\xa027) and an active control condition - health education program', 'Mindfulness-based interventions', 'Mindfulness intervention', 'mindfulness-based intervention']","['Cognitive assessments and structural scans', 'cognitive gains and various CT changes', 'ROI values and cognitive outcomes', 'cognitive abilities', 'CT increase', 'various cognitive outcomes and cortical thickness (CT']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",27.0,0.0197236,"Nine-month MAP-associated gains in working memory span and divided attention, along with an increased CT in the right frontal pole and decreased CT in the left anterior cingulate were observed.","[{'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: pcmyj@nus.edu.sg.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Rawtaer', 'Affiliation': 'Department of Psychiatry, Sengkang General Hospital, Singhealth Duke-Nus Academic Medical Centre, Singapore.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'Fam', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alan Prem', 'Initials': 'AP', 'LastName': 'Kumar', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore, And Medical Science Cluster, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Kee-Mun Cheah', 'Affiliation': 'Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Honer', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Yuan Kun', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology and Immunology, Yong Loo Lin School of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Ene Choo', 'Initials': 'EC', 'LastName': 'Tan', 'Affiliation': ""KK Research Laboratory, KK Women's and Children's Hospital, Singapore; SingHealth Duke-NUS Paediatrics Academic Clinical Program, Singapore.""}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, Mind Science Centre, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Academic Development Department, Duke-NUS Medical School, 8 College Road, Singapore. Electronic address: pcmrathi@nus.edu.sg.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.032']
1022,33497862,LDL-cholesterol lowering and clinical outcomes in hypercholesterolemic subjects with and without a familial hypercholesterolemia phenotype: Analysis from the secondary prevention 4S trial.,"BACKGROUND AND AIMS


Trial evidence for the benefits of cholesterol-lowering is limited for familial hypercholesterolemia (FH) patients, since they have not been the focus of large outcome trials. We assess statin use in coronary artery disease (CAD) subjects with low-density lipoprotein cholesterol (LDL-C) ≥4.9 mmol/L with or without an FH phenotype.
METHODS


The 4S trial randomized hypercholesterolemic CAD patients to simvastatin or placebo. We first stratified participants into baseline LDL-C <4.9 and ≥ 4.9 mmol/L; next, based on the DLCN criteria for FH, the latter group was stratified into four subgroups by presence of none, one or both of ""premature CAD"" and ""family history of CAD"". Participants having both are defined as having an FH phenotype.
RESULTS


2267 and 2164 participants had LDL-C <4.9 and ≥ 4.9 mmol/L, respectively. Mortality endpoints and major coronary events (MCE) were significantly reduced with simvastatin versus placebo in both groups over 5.4 years, but the latter derived greater absolute risk reductions (ARR) (4.1-4.3% for mortality endpoints, versus 2.5-2.8%). LDL-C reductions were similar among the 4 subgroups with levels ≥4.9 mmol/L. Participants with FH phenotype (n = 152) appeared to derive greater relative benefits with simvastatin than the other three subgroups (all-cause death: 84% relative risk reduction, p = 0.046; MCE: 55% reduction, p = 0.0297); statistical interaction was non-significant. Participants with FH phenotype derived greater ARR than any other group with simvastatin versus placebo (all-cause mortality: 6.6% ARR; MCE 13.2%; versus 3.8% and 8.3%, respectively, among participants with LDL-C ≥4.9 mmol/L but without features suggestive of FH).
CONCLUSIONS


The FH phenotype appeared to be associated with greater clinical benefits from a given magnitude of LDL-C reduction as compared to individuals without FH phenotype.",2021,"Mortality endpoints and major coronary events (MCE) were significantly reduced with simvastatin versus placebo in both groups over 5.4 years, but the latter derived greater absolute risk reductions (ARR) (4.1-4.3% for mortality endpoints, versus 2.5-2.8%).","['2267 and 2164 participants had LDL-C <4.9 and\xa0≥\xa04.9\xa0mmol/L, respectively', 'Participants having both are defined as having an FH phenotype', 'coronary artery disease (CAD) subjects with low-density lipoprotein cholesterol (LDL-C) ≥4.9\xa0mmol/L with or without an FH phenotype', 'hypercholesterolemic subjects with and without a familial hypercholesterolemia phenotype', 'familial hypercholesterolemia (FH) patients']","['simvastatin or placebo', 'simvastatin', 'placebo']","['LDL-C reductions', 'LDL-cholesterol lowering and clinical outcomes', 'Mortality endpoints and major coronary events (MCE', 'ARR', 'absolute risk reductions (ARR']","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0020445', 'cui_str': 'Familial hypercholesterolemia'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.235919,"Mortality endpoints and major coronary events (MCE) were significantly reduced with simvastatin versus placebo in both groups over 5.4 years, but the latter derived greater absolute risk reductions (ARR) (4.1-4.3% for mortality endpoints, versus 2.5-2.8%).","[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Vallejo-Vaz', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom. Electronic address: a.vallejo-vaz@imperial.ac.uk.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Packard', 'Affiliation': 'College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Ference', 'Affiliation': 'Centre for Naturally Randomized Trials, School of Clinical Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of São Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Evan A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Lipid Clinic, Department of Medicine, Cardiology University of Chicago School of Medicine, Chicago, USA.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, Università degli Studi di Milano and IRCCS Multimedica, Milan, Italy.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gerald F', 'Initials': 'GF', 'LastName': 'Watts', 'Affiliation': 'Lipid Disorders Clinic, Department of Cardiology, Royal Perth Hospital, School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2021.01.003']
1023,33497854,A thousand years of crash experience in three hours: An online hazard perception training course for drivers.,"A key goal of driver training is to teach drivers to avoid crashes. However, in traditional driver training, drivers are unlikely to see even a single example of the class of event that we want them to learn to avoid. We developed a six-session automated online hazard perception training course for drivers, which incorporates a range of evidence-based strategies and employs extensive video footage of real crashes. We evaluated this course in a randomized control trial by examining its effects on previously-validated computer-based measures of hazard perception, hazard prediction, speed choice, following distance, and gap acceptance propensity, as well as self-rated measures of driver skill, safety, and real world transfer. We found that the course resulted in significant improvements in hazard perception response time and hazard prediction scores, and significantly longer vehicle following distances. Additionally, all participants in the trained group reported that their real world driving behaviour had improved. No significant training effects were found for the other measures. The results suggest that the course can improve key behaviours associated with crash risk.",2021,"We found that the course resulted in significant improvements in hazard perception response time and hazard prediction scores, and significantly longer vehicle following distances.",['course for drivers'],"['driver training', 'online hazard perception training']","['real world driving behaviour', 'hazard perception, hazard prediction, speed choice, following distance, and gap acceptance propensity, as well as self-rated measures of driver skill, safety, and real world transfer', 'hazard perception response time and hazard prediction scores']","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]","[{'cui': 'C0336490', 'cui_str': 'Underground or elevated train driver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0217665,"We found that the course resulted in significant improvements in hazard perception response time and hazard prediction scores, and significantly longer vehicle following distances.","[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Horswill', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4072, Australia. Electronic address: m.horswill@psy.uq.edu.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4072, Australia; Minerals Industry Safety and Health Centre, Sustainable Minerals Institute, The University of Queensland, St. Lucia, Brisbane, QLD, 4072, Australia.'}, {'ForeName': 'Likitha', 'Initials': 'L', 'LastName': 'Silapurem', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4072, Australia.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Watson', 'Affiliation': 'School of Psychology, The University of Queensland, St Lucia, Brisbane, QLD, 4072, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105969']
1024,33512754,"Glucosuric, renal and haemodynamic effects of licogliflozin, a dual inhibitor of sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2, in patients with chronic kidney disease: A randomized trial.","AIM


To investigate the glucosuric, renal and haemodynamic effects of licogliflozin, a dual sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2 inhibitor, in patients with chronic kidney disease (CKD).
METHODS


This multiple-dose, parallel-group, phase II mechanistic study randomized 53 participants (aged 18-78 years, body mass index ≤ 50 kg/m 2  ) with varying degrees of CKD or normal renal function to treatment with licogliflozin (50 mg once daily) or placebo for 7 days. The effects of licogliflozin on 24-h urinary glucose excretion (UGE 24  ), renal function, haemodynamics, pharmacokinetics and safety were assessed.
RESULTS


Licogliflozin treatment for 7 days significantly (p < .01) increased UGE 24  from baseline in participants with normal renal function (adjusted mean change: 41.8 [33.6, 49.9] g) or with mild (32.6 [24.1, 41.0] g), moderate A (35.7 [28.6, 42.9] g) or moderate B (20.3 [13.1, 27.5] g) CKD, but not in severe (6.2 [-0.71, 13.18] g) CKD. Licogliflozin reduced urinary electrolytes (sodium, potassium and chloride), blood pressure and urinary volume to varying extents among different groups. Significant increases in renin (p < .05), angiotensin II (p < .05) and aldosterone (p < .01) levels were observed. Adverse events were generally mild, and most commonly included diarrhoea (94%), flatulence (68%) and abdominal pain (21%).
CONCLUSION


Licogliflozin treatment results in significantly increased UGE and favourable changes in urinary electrolytes and haemodynamics in patients with varying degrees of CKD (estimated glomerular filtration rate ≥ 45 mL/min/1.73 m 2  ).",2021,"Significant increases in renin (p<0.05), angiotensin II (p<0.05) and aldosterone (p<0.01) levels were observed.","['patients with chronic kidney disease', 'patients with CKD', '53 participants (18-78\u2009years, body mass index ≤50kg/m 2  ) with varying degrees of CKD or normal renal function to treatment with', 'patients with chronic kidney disease (CKD']","['SGLT2 inhibitors', 'placebo', 'dual inhibitor of SGLT1 and SGLT2, licogliflozin', 'SGLT1 and SGLT2', 'dual SGLT1/2 inhibitor, licogliflozin', 'licogliflozin', 'Licogliflozin']","['24 h urinary glucose excretion (UGE 24  ), renal function, hemodynamics, pharmacokinetics, and safety', 'normal renal function', 'urinary electrolytes (sodium, potassium and chloride), blood pressure (BP) and urinary volume', 'Glucosuric, renal and hemodynamic effects', 'flatulence', 'UGE', 'urinary electrolytes and hemodynamics', 'Adverse events (AEs', 'abdominal pain', 'renin (p<0.05), angiotensin II (p<0.05) and aldosterone (p<0.01) levels', 'diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1564997', 'cui_str': 'SLC5A1 protein, human'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",53.0,0.0496648,"Significant increases in renin (p<0.05), angiotensin II (p<0.05) and aldosterone (p<0.01) levels were observed.","[{'ForeName': 'YanLing', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Pachori', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Anisha E', 'Initials': 'AE', 'LastName': 'Mendonza', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Amer', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Marbury', 'Affiliation': 'Orlando Clinical Research Center, Orlando, Florida, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hinder', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14327']
1025,33513520,Improving MS patients' understanding of treatment risks and benefits in clinical consultations: A randomised crossover trial.,"BACKGROUND


Multiple Sclerosis (MS) patients find it difficult to understand the complex risk-benefit profiles of disease-modifying drugs. An evidence-based protocol was designed to improve patient's understanding of treatment information: Benefit and Risk Information for Medication in Multiple Sclerosis (BRIMMS).
OBJECTIVE


A feasibility study to evaluate whether the BRIMMS protocol can improve MS patients' treatment understanding and reduce conflict in treatment decisions compared to consultation as usual.
DESIGN


Single-blind 4-condition 4-period randomised crossover trial. Hypothetical treatment information was presented to MS patients in a faux 20 minute consultation session using the BRIMMS protocol (aural and visual) or as a usual consultation (aural and visual). Patients were randomised to the order in which they received the four consultation styles.
PARTICIPANTS


24 patients diagnosed with relapsing-remitting MS.
MEASURES


Patients were assessed on their comprehension of treatment information, decisional conflict and feedback on consultation styles. Disease and demographic information was also collected.
RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format. Similarly, BRIMMS visual and BRIMMS aural reduced decisional conflict compared to usual consultations in visual or aural formats. All comparisons were p<0.001. Cognitive status was not related to understanding in the BRIMMS protocol, but was negatively related with usual consultation. Conversely, mood influenced understanding on the BRIMMS protocol but not for usual consultation.
CONCLUSIONS


BRIMMS protocol offers an effective, evidence-based tool for presenting treatment information in consultations with MS patients and is not influenced by cognition.
TRIAL REGISTRATION


ISRCTN17318966.",2021,"RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format.",['24 patients diagnosed with relapsing-remitting MS'],[],"['comprehension of treatment information, decisional conflict and feedback on consultation styles', 'Cognitive status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]",[],"[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",24.0,0.0803882,"RESULTS


Treatment understanding was greater for both BRIMMS visual and BRIMMS aural, compared to usual consultations in visual or aural format.","[{'ForeName': 'Gurpreet K', 'Initials': 'GK', 'LastName': 'Reen', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Experimental Psychology, University of Oxford, Oxford, UK. Electronic address: Gurpreet.reen@psy.ox.ac.uk.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Silber', 'Affiliation': ""Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Neurology, King's College Hospital NHS Foundation Trust, Denmark Hill, London, UK.""}, {'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychology, Royal Holloway, University of London, Egham, UK; Department of Experimental Psychology, University of Oxford, Oxford, UK.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102737']
1026,33515972,Birth choices after caesarean in Taiwan: A mixed methods pilot study of a decision aid for shared decision making.,"BACKGROUND


Taiwan has a high national caesarean rate coupled with a low vaginal birth after caesarean (VBAC) rate. Studies suggest that women do not receive sufficient information about birth choices after caesarean in Taiwan and shared decision making (SDM) is not an expectation. This pilot study aimed to test the feasibility of using a birth choices decision aid to improve women's opportunity for engagement in SDM about birth after cesarean.
METHODS


A two-phase sequential mixed methods pilot study was conducted in a regional hospital in northern Taiwan. Phase I involved a randomized pre-test and post-test experimental design. Participants with one previous caesarean section (CS) were recruited at 14-24 weeks. A total of 65 women completed a baseline survey and were randomly allocated to either the intervention (birth choice decision aid booklet) or usual care (general maternal health booklet) group. A follow up survey at 37-38 weeks measured change in decisional conflict, knowledge, and birth mode preference. Birth outcomes and satisfaction were assessed one month after birth. Phase II consisted of postnatal interviews with women at one month after birth, to explore women's decision making experiences, using a constant comparative analytic technique and thematic analysis.
RESULTS


Decisional conflict was relatively low at baseline for all women. Although there were reductions in decisional conflict at follow up, differences between groups were not statistically significant. Women's early preferences regarding mode of birth influenced their knowledge-seeking behaviors and expectations or intention for engaging in SDM during pregnancy. Improvements in knowledge for the decision aid group were larger than for the usual care group, although differences between groups were not statistically significant. Four themes related to key factors in decision making were clarity, safety and risk, consistency, and support.
CONCLUSION


A cultural shift is needed to align expectations and relationships towards SDM for birth in Taiwan. Simulation-based strategies and tailored communication skills should be explored to enhance skills in decision coaching for providers. Use of interactive multimedia technology may provide opportunities to increase engagement with tools and support women during decision consultations. Midwife-led continuity of care models may also be beneficial in empowering women to actively share decisions and achieve the birth that is best for them.",2021,"Improvements in knowledge for the decision aid group were larger than for the usual care group, although differences between groups were not statistically significant.","['65 women completed a baseline survey', 'A two-phase sequential mixed methods pilot study was conducted in a regional hospital in northern Taiwan', 'Birth choices after caesarean in Taiwan', 'Participants with one previous caesarean section (CS) were recruited at 14-24 weeks']","['intervention (birth choice decision aid booklet) or usual care (general maternal health booklet', 'interactive multimedia technology']","['decisional conflict', 'clarity, safety and risk, consistency, and support', 'decisional conflict, knowledge, and birth mode preference', 'Birth outcomes and satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0269733', 'cui_str': 'Previous caesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",65.0,0.11666,"Improvements in knowledge for the decision aid group were larger than for the usual care group, although differences between groups were not statistically significant.","[{'ForeName': 'Shu Wen', 'Initials': 'SW', 'LastName': 'Chen', 'Affiliation': 'National Taipei University of Nursing and Health Science, School of Nursing, Taiwan. Electronic address: shuwen@ntunhs.edu.tw.'}, {'ForeName': 'Cherg Chia', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': ""Saint Paul's Hospital, Taiwan.""}, {'ForeName': 'Jimmy C', 'Initials': 'JC', 'LastName': 'Te', 'Affiliation': ""Saint Paul's Hospital, Taiwan.""}, {'ForeName': 'Yi Ling', 'Initials': 'YL', 'LastName': 'Tsai', 'Affiliation': ""Saint Paul's Hospital, Taiwan.""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Shorten', 'Affiliation': 'Freelance Statistical Consultant, Vestavia, Alabama, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Shorten', 'Affiliation': 'University of Alabama at Birmingham, Alabama, School of Nursing, USA.'}]",Midwifery,['10.1016/j.midw.2020.102920']
1027,33517233,Acute subjective sensory perceptions predict relative reinforcing effects of smoked nicotine.,"INTRODUCTION


Smoking is believed partially reinforcing via immediate sensory perceptions. Yet, unknown is whether a cigarette's relative reinforcing efficacy can be predicted by these perceptions and whether this relationship may vary due to constituents known to alter those perceptions.
METHODS


Sensory perceptions of acute smoking were examined as predictors of subsequent cigarette choice behavior. Also tested was whether nicotine content or menthol affected this relationship. Adult dependent smokers (N = 37) participated in five sessions comparing cigarettes varying in nicotine contents (NIC; 1.3, 2.3, 5.5, 11.2, and 17.4 mg/g), relative to the very lowest nicotine content, 0.4 mg/g (VLNC). Non-menthol (n = 17) and menthol (n = 20) cigarettes-matched on nicotine-were provided based on participant preference. One NIC was compared versus VLNC per session (single-blinded); NIC content order was randomized across sessions on separate days. Perceptions (e.g., ""liking"", ""satisfying"") were measured immediately after initial sampling of NIC or VLNC, followed by a validated puff-by-puff choice procedure to determine preference for each NIC versus VLNC.
RESULTS


NIC perceptions (difference from VLNC) and puff choices increased with nicotine. Menthol moderated associations between perceptions and nicotine; and between puff choices and nicotine. Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices. When testing perceptions' prediction of puff choices, neither the main effect of menthol or interaction of Perceptions X Nicotine Condition were significant.
CONCLUSIONS


Consistent with assumed-but rarely tested-causes of smoking reinforcement, sensory perceptions from a cigarette predict its relative reinforcing efficacy.",2021,Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices.,"['n\xa0=\xa017) and menthol (n\xa0=\xa020', 'Adult dependent smokers (N\xa0=\xa037']","['menthol', 'nicotine content, 0.4\xa0mg/g (VLNC', 'nicotine', 'smoked nicotine']",[],"[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",[],37.0,0.0296367,Perceptions were predictive of puff choice-greater magnitude of difference in perceptions between VLNC and NIC led to more NIC puff choices.,"[{'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Karelitz', 'Affiliation': 'Division of Cancer Control and Population Sciences, UPMC Hillman Cancer Center, Pittsburgh, PA, USA; Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA; Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: karelitzjl@upmc.edu.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106835']
1028,33517182,Fostering leadership competence and satisfaction in nursing undergraduates through a student-led conference: A quasi-experimental pre-post study.,"BACKGROUND


Numerous benefits have been reported for student-led conferences, such as increased leadership. This competence has been recognized as important for nurses so as to ensure the provision of safe and high-quality care in complex environments. However, research has yet to examine empirically the impact of student-led conferences on students' leadership behaviours.
OBJECTIVES


To examine the impact that participation in a student-led conference had on the self-perceived leadership competence of nursing undergraduates.
DESIGN


Quasi-experimental single group pre-post intervention study.
SETTING


Faculty of Medicine and Health Sciences at the Universitat Internacional de Catalunya.
PARTICIPANTS


31 students enrolled in two elective modules offered during the final year (fourth year) of a nursing degree programme.
METHODS


Pre-post assessment of self-perceived leadership behaviours among nursing students involved in planning and organizing a scientific conference. In addition to carrying out the tasks of organizing the Conference, all students participated as co-authors of an oral communication, thus being able to develop both cognitive and non-cognitive domains. Leadership was measured using ES_SALI scale, the Spanish version of the Self-Assessment Leadership Instrument.
RESULTS


Involvement in the student-led conference led to a statistically significant increase in self-perceived leadership competence among nursing undergraduates (p < .001). Both the total ES_SALI score and scores on each of its four dimensions (Strategic thinking, Emotional intelligence, Impact and influence, and Teamwork skills) increased significantly, and the percentage change was above 8% in all cases (p < .01). The greatest increase (10.99%) corresponded to the 'Impact and influence' dimension of leadership.
CONCLUSIONS


The results suggest that student-led conferences are an effective way of helping nursing undergraduates to develop their leadership competence.",2021,"RESULTS


Involvement in the student-led conference led to a statistically significant increase in self-perceived leadership competence among nursing undergraduates (p < .001).","['nursing students', 'Faculty of Medicine and Health Sciences at the Universitat Internacional de Catalunya', '31 students enrolled in two elective modules offered during the final year (fourth year) of a nursing degree programme']",[],"['self-perceived leadership competence', 'total ES_SALI score and scores on each of its four dimensions (Strategic thinking, Emotional intelligence, Impact and influence, and Teamwork skills']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",31.0,0.0199099,"RESULTS


Involvement in the student-led conference led to a statistically significant increase in self-perceived leadership competence among nursing undergraduates (p < .001).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'De Juan Pardo', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain. Electronic address: mdejuan@uic.es.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fuster', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gallart', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rodríguez', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wennberg', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Martin-Ferreres', 'Affiliation': 'Nursing Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Vallès, Spain.'}]",Nurse education today,['10.1016/j.nedt.2021.104748']
1029,33517179,A telehealth intervention to promote weight loss and physical activity in overweight primary care patients.,"INTERVENTION


This pilot study was a 16-week Telehealth intervention using wearable devices, automated text messaging, and trained health coaching, in primary care clinics of an academic medical center. Thirty patients were enrolled in three cohorts, ages 18-64, BMI > 27, and MVPA < 150 minutes per week. The primary outcome was weight loss per week.
RESULTS


Twenty-two participants had a significant median weight loss of -0.29 kg per week and mean change of -3.9 kg in total weight, -1.8 in BMI, and -3.8% of total bodyweight (all P<.001). MVPA increased 67 min per week (P=.003).
CONCLUSION


This pilot telehealth intervention suggests that, when combined, these tools may be used effectively by primary care teams to promote weight loss and physical activity in their patients.",2021,"MVPA increased 67 min per week (P=.003).
","['primary care clinics of an academic medical center', 'Thirty patients were enrolled in three cohorts, ages 18-64, BMI > 27, and MVPA < 150 minutes per week', 'overweight primary care patients']","['MVPA', 'telehealth intervention', 'wearable devices, automated text messaging, and trained health coaching']","['weight loss per week', 'median weight loss', 'weight loss and physical activity']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",30.0,0.0213644,"MVPA increased 67 min per week (P=.003).
","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hurst', 'Affiliation': 'University of Virginia, School of Law, Charlottesville, Virginia, US.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bixenstine', 'Affiliation': 'CareMore Health, Cerritos, California, US.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Casillas', 'Affiliation': 'University of Cincinnati, School of Medicine, Cincinnati, Ohio, US.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Sondra', 'Initials': 'S', 'LastName': 'Grossman', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Le', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ogren', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Severin', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tawfik', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Wei-Hsuan', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Alice A', 'Initials': 'AA', 'LastName': 'Kuo', 'Affiliation': 'Division of Medicine-Pediatrics, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Croymans', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, California, US. Electronic address: DCroymans@mednet.ucla.edu.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100509']
1030,33498165,Effectiveness of the Quadrivalent HPV Vaccine in Preventing Anal ≥ HSILs in a Spanish Population of HIV+ MSM Aged > 26 Years.,"Anal squamous cell carcinoma is the most frequent virus-related non-AIDS-defining neoplasia among HIV-infected individuals, especially MSM. The objectives of this study were to analyze the effectiveness of the quadrivalent HPV (qHPV) vaccine to prevent anal ≥ high-grade squamous intraepithelial lesions (≥HSILs), external ano-genital lesions (EAGLs), and infection by qHPV vaccine genotypes in HIV+ MSM, and to study the immunogenicity of the vaccine and risk factors for ≥ HSILs. This study is nested within a randomized, double-blind, placebo-controlled trial of the qHPV vaccine, which enrolled participants between May 2012 and May 2014, with a 48-month follow-up. A vaccine or placebo was administered at 0, 2, and 6 months, and vaccine antibody titers were evaluated at 7, 12, 24, 36, and 48 months. Data were gathered at 12, 24, 36, and 48 months on sexual habits, CD4/CD8 cell/counts, HIV viral load, and the results of cytology (Thin Prep ®  Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc ©  colposcope). The study included 129 patients (mean age of 38.8 years, 40 [31%] with a history of AIDS, 119 [92.2%] receiving ART, and 4 [3.3%] with virological failure), 66 (51.2%) in vaccine arm and 63 (48.4%) in placebo arm. The vaccine and placebo groups did not differ in ≥ HSILs (14.1 vs. 13.1%, respectively,  p  = 0.98) or EAGL (11.1 vs. 6.8%,  p  = 0.4) rates during follow-up; however, a protective effect against HPV 6 was observed during the first year of follow-up in the vaccine  versus  placebo group (7.5% vs. 23.4%;  p  = 0.047). A between-arm difference ( p  = 0.0001) in antibodies against qHPV vaccine genotypes was observed at 7 months (76.9% in vaccine arm vs. 30.2% in placebo arm), 12 months (68.1% vs. 26.5%), 24 months (75% vs. 32.5%), 36 months (90% vs. 24.4%), and 48 months (87.2% vs. 30%). Finally, the factor associated with the risk of anal ≥ HSIL onset during the four-year follow-up was the receipt of the last dose of the vaccine less than 6 months earlier in comparison to those vaccinated for a longer period (82.4% vs. 17.6% (OR 0.869 [95% CI, 0.825-0.917]). Vaccine and placebo arms did not significantly differ in ≥ HSIL or EAGL rates or in protection against infection by HPV genotype vaccine except for HPV6 at 12 months after the first dose. A long-lasting immune response was observed in almost all the vaccinated men. The main protective factor against ≥ HSIL was to have completed the vaccination regimen more than 6 months earlier.",2021,"A between-arm difference ( p  = 0.0001) in antibodies against qHPV vaccine genotypes was observed at 7 months (76.9% in vaccine arm vs. 30.2% in placebo arm), 12 months (68.1% vs. 26.5%), 24 months (75% vs. 32.5%), 36 months (90% vs. 24.4%), and 48 months (87.2% vs. 30%).","['HSILs in a Spanish Population of HIV', 'MSM Aged > 26 Years', '129 patients (mean age of 38.8 years, 40 [31%] with a history of AIDS, 119 [92.2%] receiving ART, and 4 [3.3%] with virological failure), 66 (51.2%) in vaccine arm and 63 (48.4%) in placebo arm', 'enrolled participants between May 2012 and May 2014, with a 48-month follow-up', 'Anal squamous cell carcinoma']","['placebo', 'quadrivalent HPV (qHPV) vaccine', 'Quadrivalent HPV Vaccine', 'vaccine or placebo', 'qHPV vaccine', 'Vaccine and placebo']","['protective effect against HPV 6', 'HSIL or EAGL rates', 'antibodies against qHPV vaccine genotypes', 'HSIL onset', 'sexual habits, CD4/CD8 cell/counts, HIV viral load, and the results of cytology (Thin Prep ®  Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy', 'vaccine antibody titers', 'risk of anal ≥']","[{'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0349534', 'cui_str': 'Carcinoma of anal margin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1005556', 'cui_str': 'Human papillomavirus type 6'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0193158', 'cui_str': 'Anoscopy'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}]",129.0,0.45878,"A between-arm difference ( p  = 0.0001) in antibodies against qHPV vaccine genotypes was observed at 7 months (76.9% in vaccine arm vs. 30.2% in placebo arm), 12 months (68.1% vs. 26.5%), 24 months (75% vs. 32.5%), 36 months (90% vs. 24.4%), and 48 months (87.2% vs. 30%).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Hidalgo-Tenorio', 'Affiliation': 'Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pasquau', 'Affiliation': 'Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Omar-Mohamed', 'Affiliation': 'Infectious Disease Unit, Complejo Hospitalario Jaén, 23007 Jaén, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sampedro', 'Affiliation': 'Microbiology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'López-Ruz', 'Affiliation': 'Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'López Hidalgo', 'Affiliation': 'Pathology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ramírez-Taboada', 'Affiliation': 'Infectious Disease Department, Hospital Universitario Virgen de las Nieves Granada, 18014 Granada, Spain.'}]",Viruses,['10.3390/v13020144']
1031,33508354,Randomised study of intra-oral kinetics of fluoride-containing toothpastes.,"OBJECTIVES


This randomised, controlled, analyst blind, crossover study aimed to evaluate and compare salivary fluoride and calcium ion concentration over 60 min following brushing with an assigned treatment and following an orange juice (OJ) or deionised (DI) water rinse 60 min post-brushing.
METHODS


Study treatments, both containing 1150 ppm fluoride as NaF and 5% w/w KNO 3 , were the Test (including 1.2 % w/w cocamidopropyl betaine) and Comparator (including tetrasodium pyrophosphate and sodium lauryl sulphate) toothpastes. Twenty nine participants were randomised to treatment.
RESULTS


A sharp increase in salivary fluoride ion concentration immediately post-brushing with either toothpaste decreased over time. Fluoride concentration following Test toothpaste use was numerically higher than the Comparator at all timepoints, with a significant difference from 10 min post-brushing (p < .05). Following the 60 min rinse, there were no significant differences between the Test or Comparator + OJ groups in salivary fluoride concentration but the Test + DI water group was significantly lower than Test (p < .001) or Comparator (p < .001) + OJ groups. A reduction in salivary calcium ion concentration was seen immediately post-brushing and after the OJ rinse with both toothpastes. Significant differences were observed in favour of the Test toothpaste at all timepoints (p < .05) and for Test and Comparator + OJ group (p < .001) compared with Test + DI water rinse. Both treatments were generally well-tolerated.
CONCLUSIONS


This study demonstrated that toothpaste formulations with identical declared fluoride concentrations and the same fluoride source give rise to differing intraoral fluoride concentrations over time, which are potentially related to different formulation excipient effects.
CLINICAL SIGNIFICANCE


By understanding the interaction of toothpaste formulation excipients in the oral environment, formulations can be developed that maximise retention of fluoride in the oral environment.",2021,Significant differences were observed in favour of the Test toothpaste at all timepoints (p < .05) and for Test and Comparator + OJ group (p < .001) compared with Test + DI water rinse.,['Twenty nine participants'],"['containing 1150\u2009ppm fluoride as NaF and 5% w/w KNO 3 , were the Test (including 1.2% w/w cocamidopropyl betaine) and Comparator (including tetrasodium pyrophosphate and sodium lauryl sulphate) toothpastes', 'orange juice (OJ) or deionised (DI) water rinse 60\u2009min post-brushing', 'fluoride-containing toothpastes']","['salivary calcium ion concentration', 'Fluoride concentration', 'salivary fluoride ion concentration', 'salivary fluoride concentration', 'tolerated']","[{'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]",29.0,0.0501118,Significant differences were observed in favour of the Test toothpaste at all timepoints (p < .05) and for Test and Comparator + OJ group (p < .001) compared with Test + DI water rinse.,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Parkinson', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, Surrey, United Kingdom. Electronic address: charlie.x.parkinson@gsk.com.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Burnett', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, Surrey, United Kingdom. Electronic address: gary.r.burnett@gsk.com.'}, {'ForeName': 'Gavin V', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Ellesmere Port, Cheshire, United Kingdom. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Davies', 'Affiliation': 'Intertek Clinical Research Services, Ellesmere Port, Cheshire, United Kingdom. Electronic address: luke.davies@intertek.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Payne', 'Affiliation': 'Intertek Clinical Research Services, Ellesmere Port, Cheshire, United Kingdom. Electronic address: dpayne109@aol.com.'}]",Journal of dentistry,['10.1016/j.jdent.2021.103587']
1032,33508334,Acute aerobic exercise enhances cortical connectivity between structures involved in shaping mood and improves self-reported mood: An EEG effective-connectivity study in young male adults.,"There seems to be a general consensus among researchers that acute aerobic exercise (exercise hereafter) improves mood, but the neural mechanisms which drive these effects are far from being clear. The current study investigated the cortical connectivity patterns that underlie changes in mood after exercise. Twenty male adults underwent three different experimental protocols that were carefully controlled in terms of underlying metabolism and were administered in a randomized order: moderate-intensity continuous exercise, high-intensity interval exercise, and seated rest condition. Before and after each experimental protocol, we collected data on the participants' mood using the UMACL questionnaire and recorded their resting-state EEG. We focused on the effective connectivity patterns exerted by the dorso-lateral prefrontal cortex (dlPFC) over the temporal region (TMP), as these are important cortical structures involved in shaping mood. The cortical connectivity patterns in the resting-state EEG were evaluated using the directed transfer function (DTF), which is an autoregressive effective connectivity method. The results showed that both moderate-intensity exercise and high-intensity interval exercise improved participants' self-reported mood. Crucially, this improvement was accompanied by stronger influences of dlPFC over TMP. The observed changes in the effective connectivity patterns between dlPFC and TMP might help to better understand the effects of exercise on mood.",2021,The observed changes in the effective connectivity patterns between dlPFC and TMP might help to better understand the effects of exercise on mood.,"['Twenty male adults', 'young male adults']","['Acute aerobic exercise', 'moderate-intensity continuous exercise, high-intensity interval exercise, and seated rest condition']","[""moderate-intensity exercise and high-intensity interval exercise improved participants' self-reported mood"", 'self-reported mood']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",20.0,0.0283666,The observed changes in the effective connectivity patterns between dlPFC and TMP might help to better understand the effects of exercise on mood.,"[{'ForeName': 'Tomasz S', 'Initials': 'TS', 'LastName': 'Ligeza', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland. Electronic address: tomasz.ligeza@uj.edu.pl.'}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Nowak', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Szygula', 'Affiliation': 'Department of Sports Medicine and Human Nutrition, Faculty of Physical Education and Sport, University of Physical Education, Kraków, Poland.'}, {'ForeName': 'Miroslaw', 'Initials': 'M', 'LastName': 'Wyczesany', 'Affiliation': 'Psychophysiology Laboratory, Institute of Psychology, Jagiellonian University, Kraków, Poland.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2021.01.016']
1033,33516082,Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation.,"BACKGROUND


Behavioral activation is ideal for embedded behavioral health providers (BHPs) working in primary care settings treating patients reporting a range of depressive symptoms. The current study tested whether a brief version of Behavioral Activation (two 30-minute appointments, 2 boosters) designed for primary care (BA-PC) was more effective than primary care behavioral health treatment-as-usual (TAU) in reducing depressive symptoms and improving quality of life and functioning.
METHODS


Parallel-arm, multi-site randomized controlled trial. 140 Veterans were randomized to BA-PC or TAU and completed assessments at baseline, 6 weeks, 12 weeks, and 24 weeks.
RESULTS


Reductions in depressive symptoms were observed in both groups between baseline and 3-weeks prior to any treatment, with continued reductions among those in the BA-PC condition through 12-weeks. However, there was no significant condition X time interaction at 12-weeks. Quality of life and mental health functioning were significantly improved for those in the BA-PC condition, compared to TAU, at 12 weeks.
LIMITATIONS


Generalizability to a broader population may be limited as this sample consisted of veterans. Although engagement in TAU matched other prior work, it was lower than engagement in BA-PC, which also may compromise results.
CONCLUSIONS


Although this study found that both TAU and BA-PC participants showed a decline in depressive symptoms, improvements in functioning and quality of life within those assigned to BA-PC, strong treatment retention and feasibility of BA-PC, and significant reductions in depressive symptoms among those with more severe baseline depressive symptoms are encouraging and support continued research on BA-PC. This trial was registered in clinicaltrials.gov as Improving Mood in Veterans in Primary Care (NCT02276807).",2021,"Quality of life and mental health functioning were significantly improved for those in the BA-PC condition, compared to TAU, at 12 weeks.
","['140 Veterans', 'veterans in primary care']","['Behavioral Activation (two 30-minute appointments, 2 boosters) designed for primary care (BA-PC', 'primary care behavioral health treatment-as-usual (TAU']","['Quality of life and mental health functioning', 'depressive symptoms and improving quality of life and functioning', 'depressive symptoms', 'functioning and quality of life']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",140.0,0.246093,"Quality of life and mental health functioning were significantly improved for those in the BA-PC condition, compared to TAU, at 12 weeks.
","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Funderburk', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA; Department of Psychology, Syracuse University, Syracuse, NY, USA; Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA. Electronic address: Jennifer.Funderburk@va.gov.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA; VA VISN 2 Center of Excellence for Suicide Prevention, Finger Lakes VA Medical Center, Canandaigua, NY, USA.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Shepardson', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA; Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Acker', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Fivecoat', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laura O', 'Initials': 'LO', 'LastName': 'Wray', 'Affiliation': 'VA Center for Integrated Healthcare, Western New York VA Medical Center, Buffalo, NY, USA; Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'VA Center for Integrated Healthcare, Syracuse VA Medical Center, Syracuse, NY, USA; Department of Psychology, Syracuse University, Syracuse, NY, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.01.033']
1034,33517168,Transition of care for pediatric and adult patients with venous thromboembolism: A National Quality Improvement Project from the American Thrombosis and Hemostasis Network (ATHN).,"BACKGROUND


Transition of care (TOC) for management of anticoagulation from inpatient to outpatient setting for patients with acute venous thromboembolism (VTE) poses serious safety concerns. We implemented a national quality improvement educational initiative to address this issue.
METHODS


Pediatric and adult patients admitted for their first VTE were prospectively enrolled at 16 centers from January 2016 to December 2018. Patient demographics, VTE diagnosis, risk factors, and treatment characteristics were collected. There were two phases: pre-intervention (PI) and quality intervention (QI). The PI phase assessed the quality and patient understanding and satisfaction of anticoagulation instructions given at hospital discharge and adherence to these instructions via a patient and/or caregiver feedback questionnaire (PFQ) and a patient knowledge questionnaire (PKQ) at 30 days. The QI phase provided patient and/or caregiver enhanced education regarding anticoagulation therapy and VTE at hospital discharge using a comprehensive discharge instruction module and a phone call follow-up at one week. Patient and/or caregiver knowledge at 7 and 30 days was assessed with the same PFQ and PKQ and compared to the PI baseline measures.
RESULTS


Of the 409 study patients, 210 (51%) were adults, 218 (53%) females, and 316 (77%) White. Deep vein thrombosis (62.8%) and pulmonary embolism (47.9%) were the most common VTE in children and adults, respectively. Day 30 PFQ scores were significantly higher in the QI phase compared to the PI phase by 11% (p < 0.01). Day 30 PKQ demonstrated enhanced teaching (93.7% vs. 83.5%, p-value 0.004) and disease recognition (89.6% vs. 84.6% p = 0.03) in the QI phase than the PI phase.
CONCLUSION


Comprehensive VTE discharge instructions followed by a 1-week post-discharge phone call strengthen patient and caregiver knowledge, satisfaction of education given and care provided, and disease recognition.",2021,"Day 30 PKQ demonstrated enhanced teaching (93.7% vs. 83.5%, p-value 0.004) and disease recognition (89.6% vs. 84.6% p = 0.03) in the QI phase than the PI phase.
","['Of the 409 study patients, 210 (51%) were adults, 218 (53%) females, and 316 (77', 'Pediatric and adult patients admitted for their first VTE were prospectively enrolled at 16 centers from January 2016 to December 2018', 'patients with acute venous thromboembolism (VTE', 'pediatric and adult patients with venous thromboembolism']",['Transition of care (TOC'],"['disease recognition', 'Day 30 PFQ scores', 'Patient and/or caregiver knowledge', 'pulmonary embolism', 'enhanced teaching', 'pre-intervention (PI) and quality intervention (QI', 'Deep vein thrombosis']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C3266241', 'cui_str': 'Transition of care'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",,0.0305355,"Day 30 PKQ demonstrated enhanced teaching (93.7% vs. 83.5%, p-value 0.004) and disease recognition (89.6% vs. 84.6% p = 0.03) in the QI phase than the PI phase.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'DeSancho', 'Affiliation': 'Weill Cornell University, New York Presbyterian Hospital, New York, NY, United States of America. Electronic address: mtd2002@med.cornell.edu.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Munn', 'Affiliation': 'Michigan Medicine, Ann Arbor, MI, United States of America.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Billett', 'Affiliation': 'Montefiore Medical Center & The Albert Einstein College of Medicine, Bronx, NY, United States of America.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'American Thrombosis and Hemostasis Network, Rochester, NY, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Holmes', 'Affiliation': 'University of Vermont, Burlington, VT, United States of America.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jaffray', 'Affiliation': ""Children's Hospital Los Angeles, University of Southern California, Keck School of Medicine, Los Angeles, CA, United States of America.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malone', 'Affiliation': 'Dartmouth Hitchcock Comprehensive Hemophilia & Thrombosis Center, Lebanon, NH, United States of America.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': ""Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta, Emory University, Atlanta, GA, United States of America.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharathkumar', 'Affiliation': ""Stead Family Department of Pediatrics, University of Iowa Children's Hospital, University of Iowa Carver College of Medicine, Iowa City, IA, United States of America.""}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Thornburg', 'Affiliation': ""Hemophilia and Thrombosis Treatment Center, Rady Children's Hospital San Diego, UC San Diego School of Medicine, San Diego, CA, United States of America.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hemophilia and Thrombosis Center, University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'American Thrombosis and Hemostasis Network, Rochester, NY, United States of America.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rajpurkar', 'Affiliation': ""Wayne State University, Children's Hospital of Michigan, Detroit, MI, United States of America.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thrombosis research,['10.1016/j.thromres.2021.01.001']
1035,33517104,"The comparative effects of spinal manipulation, myofascial release and exercise in tension-type headache patients with neck pain: A randomized controlled trial.","OBJECTIVES


To evaluate the effects of two manual treatment methods on pain, disability, and pressure pain threshold (PPT) in tension-type headache (TTH) patients with and neck pain.
METHODS


Forty-five patients with TTH were randomly assigned to one of three groups and received eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control). Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively) were measured at baseline, posttreatment, and at the third month follow-up. PPT was also evaluated on the temporalis muscle.
RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores. Also, manipulation group showed statistically significant improvements in all outcome criteria when compared control group.
CONCLUSIONS


Manipulation and exercise, in addition to pharmacologic treatment in TTH patients with cervical dysfunction appear to be a promising approach.",2021,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","['Forty-five patients with TTH', 'tension-type headache (TTH) patients with and neck pain', 'TTH patients with cervical dysfunction', 'tension-type headache patients with neck pain']","['spinal manipulation, myofascial release and exercise', 'eight sessions treatment: manipulation plus exercise (manipulation), suboccipital inhibition plus exercise (myofascial release), and exercise only (control']","['Headache frequency, pain severity (VAS-headache, VAS-neck pain) and headache and neck disability (HIT-6 and NDI, respectively', 'pain, disability, and pressure pain threshold (PPT', 'headache frequency, headache severity, and PPT scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0458596,"RESULTS


Manipulation group was statistically better than myofascial release group in terms of headache frequency, headache severity, and PPT scores.","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Corum', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: mustafacorum@gmail.com.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: drtugbaaydin@gmail.com.'}, {'ForeName': 'Cansın', 'Initials': 'C', 'LastName': 'Medin Ceylan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: cansinmedin@hotmail.com.'}, {'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, Turkey. Electronic address: nur.kesiktas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101319']
1036,33517103,Green tea extract for mild-to-moderate diabetic peripheral neuropathy A randomized controlled trial.,"BACKGROUND AND AIM


This randomized study aimed to evaluate the effect of green tea extract (GTE) intake on clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy (DPN).
PATIENTS AND METHODS


The present study included 194 patients with DPN. Patients were randomized into two treatment arms: GTE (n = 96) and placebo (n = 98) arms who received allocated treatment for 16 weeks. Symptoms of DPN were assessed using Toronto Clinical Scoring System (TCSS). Sensorineural pain was assessed using visual analog scale (VAS). Neural dysfunction was evaluated using the vibration perception thresholds (VPT). Assessments were made at baseline and after 4, 8, and 16 weeks of starting treatment.
RESULTS


At baseline and after 4 weeks of treatment, VAS, TCSS and VPT were comparable in the studied groups. However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT. As treatment continued, the differences between groups regarding the outcome parameters became more evident at 16 weeks.
CONCLUSIONS


GTE intake may have a beneficial value in treatment of DPN.",2021,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","['194 patients with DPN', 'mild-to-moderate diabetic peripheral neuropathy', 'patients with mild-to-moderate diabetic peripheral neuropathy (DPN']","['GTE', 'placebo', 'green tea extract (GTE) intake', 'Green tea extract']","['Sensorineural pain', 'VAS, TCSS and VPT', 'vibration perception thresholds (VPT', 'Symptoms of DPN', 'Neural dysfunction', 'VAS scores', 'visual analog scale (VAS', 'TCSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",194.0,0.185216,"However, after 8 weeks of treatment, patients in GTE group expressed lower VAS scores, significantly lower TCSS scores and significantly lower VPT.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Essmat', 'Affiliation': 'Department of Neurology, Al-Azhar University, Faculty of Medicine, Cairo, Egypt. Electronic address: ahmadesmat81@yahoo.com.'}, {'ForeName': 'Mohammed Salah', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Internal Medicine Department, Al-Azhar University, Faculty of Medicine, Cairo, Egypt.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101317']
1037,33517038,Exercise effects on backward walking speed in people with dementia: A randomized controlled trial.,"BACKGROUND


Multidirectional walking, including backward walking, is integral to daily activities, and seems particularly challenging in older age, and in people with pathology affecting postural control such as dementia.
RESEARCH QUESTION


Does exercise influence backward walking speed in people with dementia, when tested using habitual walking aids and without, and do effects differ according to walking aid use?
METHODS


This study included 141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden. Participants were randomized to a High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity. Blinded assessors measured 2.4-meter usual backward walking speed, at baseline, 4 - (intervention completion) and 7-month follow-up; tested 1) with habitual walking aids allowed, and 2) without walking aids.
RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P = .788 and -0.006 m/s, P = .754 and test 2) 0.030 m/s, P = .231 and 0.015 m/s, P = .569, respectively. In interaction analyses, exercise effects differed significantly between participants who habitually walked unaided compared with those that used a walking aid at 7 months (0.094 m/s, P = .027).
SIGNIFICANCE


In this study of older people with dementia living in nursing homes, the effects of exercise had no overall effects on backwards walking speed. Nevertheless, some benefit was indicated in participants who habitually walked unaided, which is promising and merits further investigation in future studies.",2021,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","['141 women and 45 men (mean age 85 years) with dementia from the Umeå Dementia and Exercise (UMDEX), a cluster-randomized controlled trial study set in 16 nursing homes in Umeå, Sweden', 'older people with dementia living in nursing homes', 'people with dementia']","['High-Intensity Functional Exercise (HIFE) program targeting lower limb strength-, balance and mobility exercise or to a seated attention control activity', 'habitual walking aids allowed, and 2) without walking aids']","['backward walking speed', 'exercise effects', 'backward walking speed test']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0557834', 'cui_str': 'Walking aid'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",141.0,0.208358,"RESULTS


Linear mixed models showed no between-group effect in either backward walking speed test at 4 or 7 months; test 1) 0.005 m/s, P","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Toots', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden. Electronic address: annika.toots@umu.se.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, 901 87, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå University, 901 87, Umeå, Sweden.'}]",Gait & posture,['10.1016/j.gaitpost.2020.12.028']
1038,33497912,Longitudinal impact and effects of booster sessions in a cognitive training program for healthy older adults.,"This paper reports the results from a 3-year follow-up study to measure the long-term efficacy of a cognitive training for healthy older adults and investigates the effects of booster sessions using an entropy-based metric.
DESIGN


semi-randomized quasi-experimental controlled design.
PARTICIPANTS


50 older adults, (M = 73.3, SD = 7.77) assigned into experimental (N = 25; Mean age = 73.9; SD = 8.62) and control groups (N = 25; mean age = 72.9; SD = 6.97).
INSTRUMENTS


six subtests of WAIS and two episodic memory tasks.
PROCEDURES


the participants were assessed on four occasions: after the end of the original intervention, pre-booster sessions (three years after the original intervention), immediately after the booster sessions and three months after the booster sessions.
RESULTS


the repeated measures ANOVA showed that two of the cognitive gains reported in the original intervention were also identified in the follow-up: Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = 0.73, p = .003, eta squared = 0.060). After the booster sessions, all variables presented a significant interaction between group and time favorable to the experimental group (moderate to high effect sizes). To compare the level of cohesion of the cognitive variables between the groups, an entropy-based metric was used. The experimental group presented a lower level of cohesion on three of the four measurement occasions, suggesting a differential impact of the intervention with immediate and short-term effects, but without long-term effects.",2021,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","['50 older adults, (M\xa0=\xa073.3, SD\xa0=\xa07.77) assigned into experimental (N\xa0', 'healthy older adults', '25; Mean age\xa0=\xa073.9; SD\xa0=\xa08.62) and control groups (N\xa0=\xa025; mean age\xa0']","['cognitive training', 'cognitive training program', 'booster sessions']",['cognitive gains'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]",[],50.0,0.0388754,"Coding (F(1, 44) = 11.79, MSE = 0.77, p = .001, eta squared = 0.084) and Picture Completion (F(1, 47) = 10.01, MSE = ","[{'ForeName': 'Lucas Matias', 'Initials': 'LM', 'LastName': 'Felix', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Mansur-Alves', 'Affiliation': 'Universidade Federal de Minas Gerais, Department of Psychology: 6627 Antonio Carlos avenue, Belo Horizonte, Minas Gerais, 31270-901, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Teles', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.. Electronic address: mt2yq@virginia.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jamison', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}, {'ForeName': 'Hudson', 'Initials': 'H', 'LastName': 'Golino', 'Affiliation': 'University of Virginia, Deparment of Psychology: 485, McCormick Road, Gilmer Hall, Charlottesville, VA 22903, U.S.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2021.104337']
1039,33503527,Periodized versus classic exercise therapy in Multiple Sclerosis: a randomized controlled trial.,"BACKGROUND


Periodizing exercise interventions in Multiple Sclerosis (MS) shows good high intensity exercise training adherence. Whether this approach induces comparable training adaptations with respect to exercise capacity, body composition and muscle strength compared to conventional, linear progressive training programs however is not known.
METHODS


Thirty-one persons with MS (all phenotypes, mean EDSS 2.3±1.3) were randomized into a twelve-week periodized (MS PER , n=17) or a classic endurance (MS CLA , n=14) training program. At baseline (PRE), exercise capacity (maximal exercise test, VO 2max ), body composition (DEXA) and muscle strength (Biodex®) were assessed. Classic, moderate intensity endurance training (60-80% HR max , 5 training sessions/2w, 60min/session) was performed on a stationary bicycle. Periodized exercise included 4 recurrent 3-week cycles of alternated endurance training (week 1: endurance training as described above), high intense exercise (week 2: 3 sessions/w, 3 × 20s all-out sprints, 10min/session) and recovery weeks (week 3: one sprint session as described above). POST measurements were performed similar to baseline. Total exercise volume of both programs was expressed as total peak-effort training minutes.
RESULTS


For MS CLA , total exercise volume included 1728 total peak-effort training minutes, whereas MS PER  included only 736. Despite this substantially reduced training volume, twelve weeks of periodized training significantly (p<0.05) improved VO 2max  (+14%, p=0.001), workload (+20%) and time until exhaustion (+25%). Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131). Pre-post improvements for VO 2max  were significantly higher in MS PER  compared to MS CLA  (p=0.046).
CONCLUSION


These data show that despite substantially lower training time (57% less peak-effort training minutes), 12 weeks of periodized exercise training in persons with MS seems to induce larger improvements in parameters of exercise capacity compared to classic endurance training. We therefore recommend to further investigate the effect of training periodization on various functional rehabilitation measures in MS.",2021,"Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131)","['Multiple Sclerosis', 'Thirty-one persons with MS (all phenotypes, mean EDSS 2.3±1.3', 'Multiple Sclerosis (MS']","['Classic, moderate intensity endurance training', 'classic endurance (MS CLA , n=14) training program', 'Periodized versus classic exercise therapy', 'training periodization', 'MS CLA', 'alternated endurance training (week 1: endurance training as described above), high intense exercise', 'Classic training', 'Periodizing exercise interventions', 'Periodized exercise', 'periodized exercise training']","['time until exhaustion', 'Total exercise volume', 'workload', 'At baseline (PRE), exercise capacity (maximal exercise test, VO 2max ), body composition (DEXA) and muscle strength (Biodex®', 'VO 2max']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",31.0,0.0124644,"Classic training significantly (p<0.05) improved workload (+10%) and time until exhaustion (+17%), but not VO 2max  (+5%, p=0.131)","[{'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Keytsman', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium. Electronic address: charly.keytsman@uhasselt.be.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Van Noten', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Verboven', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Bert O', 'Initials': 'BO', 'LastName': 'Eijnde', 'Affiliation': 'BIOMED Biomedical Research Institute, Hasselt University, Agoralaan Building A, B-3590, Diepenbeek, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102782']
1040,33511963,Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT.,"BACKGROUND


Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps.
OBJECTIVES


To compare FLACS with phacoemulsification cataract surgery (PCS).
DESIGN


Multicentre, outcome-masked, randomised controlled non-inferiority trial.
SETTING


Three collaborating NHS hospitals.
PARTICIPANTS


A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017.
INTERVENTION


FLACS ( n  = 392 participants) or PCS ( n  = 393 participants).
MAIN OUTCOME MEASURES


The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention.
RESULTS


A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of -0.01 logMAR (95% confidence interval -0.05 to 0.03 logMAR;  p  = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (-0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS;  p  = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR;  p  = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR;  p  = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR (95% confidence interval -0.05 to 0.00 logMAR) ( p  = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between -£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between -0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620.
LIMITATIONS


Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked.
CONCLUSIONS


The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months' follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months' follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective.
FUTURE WORK


To explore the possible differences in vision in patients without ocular co-pathology.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN77602616.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).",2021,"There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR","['A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the', ' n  = 392 participants) or PCS ( n  = 393 participants', 'Three collaborating NHS hospitals', 'A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017', 'patients without ocular co-pathology']","['phacoemulsification', 'FLACS', 'Femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond laser-assisted cataract surgery', 'PCS', 'FLACS with phacoemulsification cataract surgery (PCS']","['mean corrected distance visual acuity', 'corrected distance visual acuity, refractive outcomes (within 0.5\u2009dioptre and 1.0\u2009dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use', 'mean cost difference', 'health and safety outcomes', 'mean QALY difference (FLACS minus PCS', 'mean uncorrected distance visual acuity', 'uncorrected distance visual acuity', 'binocular corrected distance visual acuity', 'health, social care or societal costs', 'logarithm of the minimum angle of resolution (logMAR', 'mean binocular corrected distance visual acuity', 'mean corrected distance visual acuity values', 'incremental cost-effectiveness ratio']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",785.0,0.376002,"There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Day', 'Affiliation': 'The National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Department of Primary Care and Public Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit (CCTU), London, UK.'}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': 'Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Kamaljit S', 'Initials': 'KS', 'LastName': 'Balaggan', 'Affiliation': 'Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilkins', 'Affiliation': 'The National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta25060']
1041,33515786,Improving care coordination for patients with cardiac disease: Study protocol of the randomised controlled new healthcare programme (Cardiolotse).,"INTRODUCTION


A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system.
MATERIAL AND METHODS


The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation.
DISCUSSION


The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes.
TRIAL REGISTRATION


German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.",2021,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"['patients with cardiac disease', 'patients suffering from cardiac disease']",[],"['12-month rehospitalisation rate', 'length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}]",[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.137016,Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Geiger', 'Affiliation': 'LMU Munich, Department of Health Services Management, Schackstraße 4, 80539 Munich, Germany. Electronic address: geiger@bwl.lmu.de.'}, {'ForeName': 'Katrin C', 'Initials': 'KC', 'LastName': 'Reber', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Holzgreve', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Karmann', 'Affiliation': 'Vivantes - Netzwerk für Gesundheit GmbH, Aroser Allee 72-76, 13407 Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Liersch', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Anica', 'Initials': 'A', 'LastName': 'Stürtz', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Riesner', 'Affiliation': 'AOK - Die Gesundheitskasse, Health Services Management, Wilhelmstr. 1, 10963 Berlin, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Sundmacher', 'Affiliation': 'Chair of Health Economics, Technical University of Munich, Georg-Brauchle-Ring 60/62, 80992, Germany.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106297']
1042,33515785,"A randomized, controlled trial of the safety planning intervention: Research design and methods.","BACKGROUND


Brief interventions for suicide risk among patients treated in acute care settings like the emergency department are needed. The Safety Planning Intervention is a promising approach but has yet to undergo a high quality, individual level randomized controlled trial.
PURPOSE


This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
METHODS


The sample comprised patients 18 years and older presenting to one of three different emergency departments with suicide related emergencies (target n = 484). Eligible patients were approached, consented, and randomized to the intervention (Safety Planning Intervention) or control (risk factors and warning signs). They were assessed at 1, 3 and 6 months after their index visit. The primary outcome is suicidal behavior. The study also assessed mechanisms of action. Data analyses are pending.
CONCLUSIONS


We identified and addressed key challenges to studying suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit, ascertaining outcomes in patients that are historically very difficult to follow, and addressing the ambiguity of suicidal behavior. ClinicalTrials.gov Identifier: NCT03227991.",2021,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","['Eligible patients', 'patients 18\u202fyears and older presenting to one of three different emergency departments with suicide related emergencies (target n\u202f=\u202f484', 'suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit']","['Safety Planning Intervention', 'intervention (Safety Planning Intervention) or control (risk factors and warning signs']",['suicidal behavior'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",484.0,0.148182,"This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs.
","[{'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Boudreaux', 'Affiliation': 'Departments of Emergency Medicine, Psychiatry, and Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA. Electronic address: Edwin.Boudreaux@umassmed.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: kelgreen@pennmedicine.upenn.edu.'}, {'ForeName': 'Hanga', 'Initials': 'H', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA. Electronic address: hanga.galfalvy@nyspi.columbia.edu.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. Electronic address: gregbrow@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106291']
1043,33515784,Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial.,"INTRODUCTION


Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive. Few physical activity interventions have been designed specifically for YACS.
PURPOSE


To describe the rationale and design of the IMPACT (IMproving Physical Activity after Cancer Treatment) trial, which tests the efficacy of a theory-based, mobile physical activity intervention for YACS.
METHODS


A total of 280 physically inactive YACS (diagnosed at ages 18-39) will be randomized to a self-help control or intervention condition. All participants will receive an activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group. Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques. The program includes: behavioral lessons; adaptive goal-setting in response to individuals' changing activity patterns; tailored feedback based on objective data and self-report measures; tailored text messages; and Facebook prompts encouraging peer support. Assessments occur at baseline, 3, 6, and 12 months. The primary outcome is total physical activity min/week at 6 months (assessed via accelerometry); secondary outcomes include total physical activity at 12 months, sedentary behavior, weight, and psychosocial measures.
CONCLUSIONS


IMPACT uniquely focuses on physical activity in YACS using an automated tailored mHealth program. Study findings could result in a high-reach, physical activity intervention for YACS that has potential to be adopted on a larger scale and reduce cancer-related morbidity. ClinicalTrials.gov Identifier: NCT03569605.",2021,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","['young adult cancer survivors', '280 physically inactive YACS (diagnosed at ages 18-39']","['mobile intervention based on social cognitive theory', 'activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group', 'self-help control or intervention condition', 'theory-based, mobile physical activity intervention']","['behavioral capability, self-regulation, self-efficacy, and social support', 'total physical activity minutes/week at 6\u202fmonths (assessed via accelerometry); secondary outcomes include total physical activity at 12\u202fmonths, sedentary behavior, weight, and psychosocial measures']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",280.0,0.0428451,"Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques.","[{'ForeName': 'Carmina G', 'Initials': 'CG', 'LastName': 'Valle', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: carmina.valle@unc.edu.'}, {'ForeName': 'Bernardine M', 'Initials': 'BM', 'LastName': 'Pinto', 'Affiliation': 'School of Nursing, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Diamond', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lindsey N', 'Initials': 'LN', 'LastName': 'Horrell', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Brooke T', 'Initials': 'BT', 'LastName': 'Nezami', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Hatley', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Coffman', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Polzien', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Derek P', 'Initials': 'DP', 'LastName': 'Hales', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Rini', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Departments of Psychiatry and Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106293']
1044,33517032,The Effects of Combining Transcranial Direct Current Stimulation and Gait Training with Functional Electrical Stimulation on Trunk Acceleration During Walking in Patients with Subacute Stroke.,"OBJECTIVES


This study aimed to investigate whether the combination of transcranial direct current stimulation (tDCS) and gait training with FES affected walking speed and trunk accelerometry-based gait characteristics in patients with subacute stroke, compared with FES or tDCS gait training only.
MATERIALS AND METHODS


Stroke patients (n = 34; female 15; mean age, 72.5 ± 11.2 years; mean days poststroke, 38.7) with resultant paresis in the lower extremity (mean Fugl-Meyer score, 25.5) were enrolled. Patients were randomly assigned to one of three groups: combined anodal tDCS and gait training with FES (tDCS+FES, n = 11), anodal tDCS with gait training (tDCS, n = 11), or combined sham tDCS and gait training with FES (FES, n = 12). Participants received the intervention for 20 minutes and a 40-minute conventional rehabilitative intervention daily for a week. Patients' walking ability was evaluated using walking speed, harmonic ratio (HR), autocorrelation coefficient (AC), and root mean square (RMS) along each axis using a wearable trunk accelerometer.
RESULTS


The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively. There were no significant effects on walking speed or other parameters (HR and RMS) among the groups.
CONCLUSIONS


The combination of anodal tDCS and gait training with FES improved the post-stroke patients' gait regularity than FES gait training intervention only. Thus, combined tDCS and FES gait training, as a novel intervention, could be an important therapeutic tool in improving walking performance.",2021,"The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively.","['patients with subacute stroke, compared with FES or tDCS gait training only', 'Patients with Subacute Stroke', 'mean days poststroke, 38.7) with resultant paresis in the lower extremity (mean Fugl-Meyer score, 25.5) were enrolled', 'Stroke patients (n\u202f=\u202f34; female 15; mean age, 72.5 ± 11.2 years']","['combined anodal tDCS and gait training with FES (tDCS+FES, n\u202f=\u202f11), anodal tDCS with gait training (tDCS, n\u202f=\u202f11), or combined sham tDCS and gait training with FES (FES, n\u202f=\u202f12', 'anodal tDCS and gait training with FES', 'tDCS+FES', 'transcranial direct current stimulation (tDCS) and gait training with FES affected walking speed and trunk accelerometry-based gait characteristics', 'Transcranial Direct Current Stimulation and Gait Training with Functional Electrical Stimulation', '40-minute conventional rehabilitative intervention']","['walking speed or other parameters (HR and RMS', 'Trunk Acceleration', 'change in AC in the anteroposterior axis and mediolateral axis', 'walking speed, harmonic ratio (HR), autocorrelation coefficient (AC), and root mean square (RMS) along each axis using a wearable trunk accelerometer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}]",,0.0204706,"The tDCS+FES group had a significantly greater change in AC in the anteroposterior axis and mediolateral axis than the FES and tDCS groups and FES group, respectively.","[{'ForeName': 'Tsubasa', 'Initials': 'T', 'LastName': 'Mitsutake', 'Affiliation': 'Department of Physical Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan; Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan. Electronic address: mitutuba1012@gmail.com.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Sakamoto', 'Affiliation': 'Education and Research Centre for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Nakazono', 'Affiliation': 'Department of Occupational Therapy, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan.'}, {'ForeName': 'Etsuo', 'Initials': 'E', 'LastName': 'Horikawa', 'Affiliation': 'Department of Orthoptics, Faculty of Medical Science, Fukuoka International University of Health and Welfare, Fukuoka, Japan.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2021.105635']
1045,33516964,Heartrate variability biofeedback for migraine using a smartphone application and sensor: A randomized controlled trial.,"INTRODUCTION


Although hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine.
METHODS


2-arm randomized trial comparing an 8-week app-based HRV biofeedback (HeartMath) to waitlist control. Feasibility/acceptability outcomes included number and duration of sessions, satisfaction, barriers and adverse events. Primary clinical outcome was Migraine-Specific Quality of Life Questionnaire (MSQv2).
RESULTS


There were 52 participants (26/arm). On average, participants randomized to the Hearthmath group completed 29 sessions (SD = 29, range: 2-86) with an average length of 6:43 min over 36 days (SD = 27, range: 0, 88) before discontinuing. 9/29 reported technology barriers. 43% said that they were likely to recommend Heartmath to others. Average MSQv2 decreases were not significant between the Heartmath and waitlist control (estimate = 0.3, 95% CI = -3.1 - 3.6). High users of Heartmath reported a reduction in MSQv2 at day 30 (-12.3 points, p = 0.010) while low users did not (p = 0.765).
DISCUSSION


App-based HRV biofeedback was feasible and acceptable on a time-limited basis for people with migraine. Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.",2021,"Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.","['people with migraine', '52 participants (26/arm']","['smartphone application and sensor', 'electromyograph biofeedback', 'App-based HRV biofeedback', '8-week app-based HRV biofeedback (HeartMath) to waitlist control']","['MSQv2', 'Average MSQv2 decreases', 'number and duration of sessions, satisfaction, barriers and adverse events', 'Migraine-Specific Quality of Life Questionnaire (MSQv2']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.159473,"Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA; Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA. Electronic address: Minenmd@gmail.com.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Corner', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berk', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Valeriya', 'Initials': 'V', 'LastName': 'Levitan', 'Affiliation': 'Department of Neurology, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Friedman', 'Affiliation': 'Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, 550 1st Avenue, New York, NY 10016, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Seng', 'Affiliation': 'Department of Neurology, Yeshiva University Albert Einstein College of Medicine, 1300 Morris Park Ave, The Bronx, NY 10461, United States.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.12.008']
1046,33516859,Pinging the brain with transcranial magnetic stimulation reveals cortical reactivity in time and space.,"BACKGROUND


Single-pulse transcranial magnetic stimulation (TMS) elicits an evoked electroencephalography (EEG) potential (TMS-evoked potential, TEP), which is interpreted as direct evidence of cortical reactivity to TMS. Thus, combining TMS with EEG can be used to investigate the mechanism underlying brain network engagement in TMS treatment paradigms. However, controversy remains regarding whether TEP is a genuine marker of TMS-induced cortical reactivity or if it is confounded by responses to peripheral somatosensory and auditory inputs. Resolving this controversy is of great significance for the field and will validate TMS as a tool to probe networks of interest in cognitive and clinical neuroscience.
OBJECTIVE


Here, we delineated the cortical origin of TEP by spatially and temporally localizing successive TEP components, and modulating them with transcranial direct current stimulation (tDCS) to investigate cortical reactivity elicited by single-pulse TMS and its causal relationship with cortical excitability.
METHODS


We recruited 18 healthy participants in a double-blind, cross-over, sham-controlled design. We collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS targeting the left primary motor cortex (M1). To causally test cortical and corticospinal excitability, we applied tDCS to the left M1.
RESULTS


We found that the earliest TEP component (P25) was localized to the left M1. The following TEP components (N45 and P60) were largely localized to the primary somatosensory cortex, which may reflect afferent input by hand-muscle twitches. The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex. As hypothesized, tDCS selectively modulated cortical and corticospinal excitability by modulating the pre-stimulus mu-rhythm oscillatory power.
CONCLUSION


Together, our findings provide causal evidence that the early TEP components reflect cortical reactivity to TMS.",2021,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","['18 healthy participants in a double-blind, cross-over, sham-controlled design']","['collected motor-evoked potentials (MEPs) and TEPs elicited by suprathreshold single-pulse TMS', 'Transcranial Magnetic Stimulation', 'TEP', 'transcranial direct current stimulation (tDCS', 'pulse transcranial magnetic stimulation (TMS']",['cortical and corticospinal excitability'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",18.0,0.0660331,"The later TEP components (N100, P180, and N280) were largely localized to the auditory cortex.","[{'ForeName': 'Sangtae', 'Initials': 'S', 'LastName': 'Ahn', 'Affiliation': 'School of Electronics Engineering, Kyungpook National University, Daegu, 41566, South Korea; School of Electronic and Electrical Engineering, Kyungpook National University, Daegu, 41566, South Korea; Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. Electronic address: flavio_frohlich@med.unc.edu.'}]",Brain stimulation,['10.1016/j.brs.2021.01.018']
1047,33524489,The use of personal protection equipment does not impair the quality of cardiopulmonary resuscitation: A prospective triple-cross over randomised controlled non-inferiority trial.,"AIM


Prior studies suggest that the use of personal protective equipment might impair the quality of critical care. We investigated the influence of personal protective equipment on out-of-hospital cardiopulmonary resuscitation.
METHODS


Randomised controlled non-inferiority triple-crossover study. Forty-eight emergency medical service providers, randomized into teams of two, performed 12 min of basic life support (BLS) on a manikin after climbing 3 flights of stairs. Three scenarios were completed in a randomised order: Without personal protective equipment, with personal protective equipment including a filtering face piece (FFP) 2 mask with valve, and with personal protective equipment including an FFP2 mask without valve. The primary outcome was mean depth of chest compressions with a pre-defined non-inferiority margin of 3.5 mm. Secondary outcomes included other measurements of CPR quality, providers' subjective exhaustion levels, and providers' vital signs, including end-tidal CO 2 .
RESULTS


Differences regarding the primary outcome were well below the pre-defined non-inferiority margins for both control vs. personal protective equipment without valve (absolute difference 1 mm, 95% CI [-1, 2]) and control vs. personal protective equipment with valve (absolute difference 1 mm, [-0.2, 2]). This was also true for secondary outcomes regarding quality of chest compressions and providers' vital signs including etCO 2 . Subjective physical strain after BLS was higher in the personal protective equipment groups (Borg 4 (SD 3) without valve, 4 (SD 2) with valve) than in the control group (Borg 3 (SD 2)).
CONCLUSION


PPE including masks with and without expiration valve is safe for use without concerns regarding the impairment of CPR quality.",2021,"Subjective physical strain after BLS was higher in the personal protective equipment groups (Borg 4 (SD 3) without valve, 4 (SD 2) with valve) than in the control group (Borg 3 (SD 2)).
",['Forty-eight emergency medical service providers'],"['personal protective equipment', 'personal protective equipment, with personal protective equipment including a filtering face piece (FFP) 2 mask with valve, and with personal protective equipment including an FFP2 mask without valve', 'personal protection equipment', 'basic life support (BLS']","['mean depth of chest compressions with a pre-defined non-inferiority margin of 3.5\u2009mm', 'pre-defined non-inferiority margins', 'Subjective physical strain after BLS', 'quality of cardiopulmonary resuscitation', ""measurements of CPR quality, providers' subjective exhaustion levels, and providers' vital signs, including end-tidal CO 2 ""]","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444930', 'cui_str': 'End'}]",3.0,0.0946687,"Subjective physical strain after BLS was higher in the personal protective equipment groups (Borg 4 (SD 3) without valve, 4 (SD 2) with valve) than in the control group (Borg 3 (SD 2)).
","[{'ForeName': 'Calvin Lukas', 'Initials': 'CL', 'LastName': 'Kienbacher', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Grafeneder', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Tscherny', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Krammel', 'Affiliation': 'Emergency Medical Services Vienna, Radetzkystraße 1, 1030 Vienna, Austria; PULS-Austrian Cardiac Arrest Awareness Association, Lichtentaler Gasse 4/1/R03, 1090 Vienna, Austria.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Niederer', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Neudorfsky', 'Affiliation': 'Emergency Medical Services Vienna, Radetzkystraße 1, 1030 Vienna, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Herbich', 'Affiliation': 'Emergency Medical Services Vienna, Radetzkystraße 1, 1030 Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schreiber', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria; PULS-Austrian Cardiac Arrest Awareness Association, Lichtentaler Gasse 4/1/R03, 1090 Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Herkner', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria. Electronic address: harald.herkner@meduniwien.ac.at.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.'}]",Resuscitation,['10.1016/j.resuscitation.2021.01.021']
1048,33524488,Long term outcomes of participants in the PARAMEDIC2 randomised trial of adrenaline in out-of-hospital cardiac arrest.,"AIMS


We recently reported early outcomes in patients enrolled in a randomised trial of adrenaline in out-of-hospital cardiac arrest: the PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) trial. The purpose of the present paper is to report long-term survival, quality of life, functional and cognitive outcomes at 3, 6 and 12-months.
METHODS


PARAMEDIC2 was a pragmatic, individually randomised, double blind, controlled trial with an economic evaluation. Patients were randomised to either adrenaline or placebo. This paper reports results on the modified Rankin Scale scores at 6-months, survival at 6 and 12-months, as well as other cognitive, functional and quality of life outcomes collected at 3 and 6 months (Two Simple Questions, the Mini Mental State Examination, the Informant Questionnaire on Cognitive Decline Evaluation for Cardiac Arrest, Hospital Anxiety and Depression Scale, the Post Traumatic Stress Disorder Checklist - Civilian Version, Short-Form 12-item Health Survey and the EuroQoL EQ-5D-5L).
RESULTS


8014 patients were randomised with confirmed trial drug administration. At 6-months, 78 (2.0%) of the patients in the adrenaline group and 58 (1.5%) of patients in the placebo group had a favourable neurological outcome (adjusted odds ratio 1.35 [95% confidence interval: 0.93, 1.97]). 117 (2.9%) patients were alive at 6-months in the adrenaline group compared with 86 (2.2%) in the placebo group (1.43 [1.05, 1.96], reducing to 107 (2.7%) and 80 (2.0%) respectively at 12-months (1.38 [1.00, 1.92]). Measures of 3 and 6-month cognitive, functional and quality of life outcomes were reduced, but there was no strong evidence of differences between groups.
CONCLUSION


Adrenaline improved survival through to 12-months follow-up. The study did not find evidence of improvements in favourable neurological outcomes. (ISCRTN 73485024).",2021,"Measures of 3 and 6-month cognitive, functional and quality of life outcomes were reduced, but there was no strong evidence of differences between groups.
","['in out-of-hospital cardiac arrest', '8,014 patients']","['placebo', 'adrenaline or placebo', 'adrenaline', 'Adrenaline']","['survival', 'Mini Mental State Examination, the Informant Questionnaire on Cognitive Decline Evaluation for Cardiac Arrest, Hospital Anxiety and Depression Scale, the Post Traumatic Stress Disorder Checklist - Civilian Version, Short-Form 12-item Health Survey and the EuroQoL EQ-5D-5L', 'modified Rankin Scale scores', 'Measures of 3 and 6-month cognitive, functional and quality of life outcomes', 'cognitive, functional and quality of life outcomes', 'favourable neurological outcome', 'survival, quality of life, functional and cognitive outcomes']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",8014.0,0.437838,"Measures of 3 and 6-month cognitive, functional and quality of life outcomes were reduced, but there was no strong evidence of differences between groups.
","[{'ForeName': 'Kirstie L', 'Initials': 'KL', 'LastName': 'Haywood', 'Affiliation': 'Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, London SW17 0RE, UK.""}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; Royal United Hospital, Bath BA1 3NG, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne SO21 2RU, UK; NIHR Southampton Respiratory Biomedical Research Unit, Southampton SO16 6YD, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.'}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': ""Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; Kingston University and St George's, University of London, London SW17 0RE, UK; London Ambulance Service NHS Trust, London SE1 8SD, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; South Central Ambulance Service NHS Foundation Trust, Otterbourne SO21 2RU, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Service NHS Trust, Institute of Life Sciences, Swansea University, Swansea, Wales SA2 8PP, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Service NHS Trust, Institute of Life Sciences, Swansea University, Swansea, Wales SA2 8PP, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham B91 2JL, UK. Electronic address: g.d.perkins@warwick.ac.uk.'}]",Resuscitation,['10.1016/j.resuscitation.2021.01.019']
1049,33524439,General and specific graphic health warning labels reduce willingness to consume sugar-sweetened beverages.,"Sugar-sweetened beverage (SSB) consumption is associated with obesity and other severe negative health consequences. The present study examined the effectiveness of two types of health warning labels (HWLs) in modulating dietary choices for SSBs: specific HWLs, presenting health consequences associated with consuming SSBs, and general HWLs, presenting health consequences of an unhealthy diet and obesity. While electroencephalography (EEG) was recorded, 63 participants completed a computer-based task in which they were first randomly allocated to view either SBB-specific, general, or non-warning control HWLs. They then viewed images of a range of SSB products, varying on perceived healthiness and tastiness, and rated their willingness to consume (WTC) each one. Linear mixed-effect model analyses revealed that general and specific HWLs both decreased WTC SSBs perceived as tasty, compared to the control condition. For general HWLs, this effect was reduced for SSBs perceived to be healthy, suggesting that specific HWLs may be more effective at reducing SSB consumption. The EEG data showed that SSBs considered unhealthy elicited greater N1 amplitudes, and tasty SSBs elicited greater late positive potential (LPP) amplitudes, possibly reflecting attentional allocation and craving responses, respectively. However, no strong differences between HWL types were found. Taken together, the results suggest that graphic HWLs, both general and specific, have the potential to reduce SSB consumption, but they do not strongly modulate craving-related neural responses to SSBs.",2021,"Linear mixed-effect model analyses revealed that general and specific HWLs both decreased WTC SSBs perceived as tasty, compared to the control condition.",['63 participants completed a computer-based task in which they'],"['health warning labels (HWLs', 'Sugar-sweetened beverage (SSBs) consumption']","['WTC SSBs', 'N1 amplitudes, and tasty SSBs elicited greater late positive potential (LPP) amplitudes, possibly reflecting attentional allocation and craving responses']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",63.0,0.0402445,"Linear mixed-effect model analyses revealed that general and specific HWLs both decreased WTC SSBs perceived as tasty, compared to the control condition.","[{'ForeName': 'Elektra', 'Initials': 'E', 'LastName': 'Schubert', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Brydevall', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Lynch', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Elysha', 'Initials': 'E', 'LastName': 'Ringin', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Australia.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kashima', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bode', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Australia. Electronic address: sbode@unimelb.edu.au.'}]",Appetite,['10.1016/j.appet.2021.105141']
1050,33529810,"Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.","INTRODUCTION


Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.
AIM


The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.
METHODS


Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.
MAIN OUTCOME MEASURE


Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.
RESULTS


Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.
CONCLUSION


The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2020;XX:XXX-XXX.",2021,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","['patients with PE', 'Chinese men with PE', '1,252 patients with PE', 'Chinese Men With Premature Ejaculation', 'premature ejaculation (PE) management in China']","['dapoxetine', 'Dapoxetine']","['safety and effectiveness', 'Adverse events (AEs), such as nausea, thirst, headache, and dizziness', 'overall effectiveness rates', 'treatment-emergent AEs rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",1252.0,0.0218966,"The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, North Theater General Hospital, Shenyang, China.'}, {'ForeName': 'Renyuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ningchen', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yongguang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuqiang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Urology, Second Hospital of Shandong University, Ji'nan, China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ""Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Suyog', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Medical Department, A Menarini Asia Pacific, Singapore.'}, {'ForeName': 'Emmanuele A', 'Initials': 'EA', 'LastName': 'Jannini', 'Affiliation': 'Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China. Electronic address: zhangzhichao@bjmu.edu.cn.'}]",Sexual medicine,['10.1016/j.esxm.2020.100296']
1051,33538199,DORADA adherence study: full view into RebiSmart subdomains parameters in multiple sclerosis treatment.,"PURPOSE


The aim of this article is to provide unique and detailed data on how patients rate the RebiSmart 2.0 in the specific User Study Questionnaire (USQ) domains, and the relationship between their rating and individual level of disability, baseline demographic/socioeconomic factors, and adherence.
PATIENTS AND METHODS


Twelve-month, phase IV, observational, multicenter study (no placebo or comparator) to evaluate the ease of use of the RebiSmart autoinjector for self-injection during treatment of CIS/RRMS subjects with Rebif 44 mcg sc three times a week by USQ. A total of 290 subjects participated in the study, with 249 (85.86%) completing the entire study period.
RESULTS


The endpoint results demonstrated a very high proportion (>95%) of patients with a positive evaluation of the overall convenience of RebiSmart at each study visit. At the end of the study, all patients would recommend the device to others who need Rebif therapy. The proportion of patients rating the RebiSmart ease of use by individual domains (self-injection steps, changing the cartridge, using the device away from home) as ""very easy to use"" or ""easy to use"" and the proportion of patients rating the RebiSmart functions as ""helpful"" or ""very helpful"" were more than 80% for each domain at each study visit.
CONCLUSION


These findings are in line with the potential benefits of RebiSmart to treatment adherence. They demonstrate an overall, very good perception of the device by patients and its individual functions.",2021,The endpoint results demonstrated a very high proportion (>95%) of patients with a positive evaluation of the overall convenience of RebiSmart at each study visit.,"['Twelve-month, phase IV, observational, multicenter study (no', '290 subjects participated in the study, with 249 (85.86%) completing the entire study period']",['placebo or comparator'],[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],290.0,0.0146237,The endpoint results demonstrated a very high proportion (>95%) of patients with a positive evaluation of the overall convenience of RebiSmart at each study visit.,"[{'ForeName': 'Zbyšek', 'Initials': 'Z', 'LastName': 'Pavelek', 'Affiliation': 'Department of Neurology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Novotný', 'Affiliation': 'Department of Neurology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Klímová', 'Affiliation': 'Department of Neurology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Peterka', 'Affiliation': 'Department of Neurology, University Hospital Plzen, Plzen, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Potužník', 'Affiliation': 'Department of Neurology, University Hospital Plzen, Plzen, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kövári', 'Affiliation': 'Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vališ', 'Affiliation': 'Department of Neurology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.'}]",Current medical research and opinion,['10.1080/03007995.2021.1880886']
1052,33539993,The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa.,"BACKGROUND


Adolescents with anorexia nervosa have set-shifting inefficiencies that can be exacerbated by starvation and that may interfere with outcomes of treatment interventions. Cognitive Remediation Therapy (CRT), an adjunctive treatment focused on improving set-shifting, can target inefficiencies and may augment treatment effectiveness. The best way to add CRT to the standard of care (Family Based Treatment, FBT) for adolescents with anorexia remains understudied.
METHODS/DESIGN


This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents. Participants are adolescents 12-18 years old with anorexia and their parents. 54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study.
DISCUSSION


This is the first study of its kind to apply CRT to parents. All forms of CRT in the context of anorexia have targeted the individual with anorexia's thinking style. We propose that it may be impactful to target the parent of the adolescent with anorexia as parents carry the burden of treatment and re-nourishment of their child during FBT and may have similar thinking styles.
CONCLUSION


This study takes an experimental therapeutics approach to further our understanding of the mechanisms of treatment for adolescents with anorexia. It focuses on increasing cognitive flexibility in patients or their parents and determining the appropriate dose of CRT needed to achieve positive change.
TRIAL REGISTRATION


ClinicalTrails.gov Identifier NCT03928028.",2021,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","['adolescents with anorexia and/or their parents', 'Adolescents with anorexia nervosa', 'Participants are adolescents 12-18\u202fyears old with anorexia and their parents', 'adolescents with anorexia remains understudied', 'adolescents with anorexia', 'adolescents with anorexia nervosa']","['CRT', 'Cognitive remediation therapy', 'Cognitive Remediation Therapy (CRT', 'FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT']","['Psychosocial, neurocognitive, and behavioral measures', 'cognitive flexibility']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0465957,"54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT.","[{'ForeName': 'C Alix', 'Initials': 'CA', 'LastName': 'Timko', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: timkoc@email.chop.edu.""}, {'ForeName': 'Anushua', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kathleen Kara', 'Initials': 'KK', 'LastName': 'Fitzpatrick', 'Affiliation': 'Private Practice, Palo Alto, CA, United States of America.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Howe', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'School of Nursing and Health Sciences and Public Health, La Salle University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Mears', 'Affiliation': ""Eating Disorder Assessment and Treatment Program, Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Heckert', 'Affiliation': ""Deptartment of Clinical Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ubel', 'Affiliation': 'The Fuqua School of Business, Duke University, Durham, NC, United States of America; Sanford School of Policy, Duke University, Durham, NC, United States of America; School of Medicine, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'Psychology Department, University of Miami, Miami, FL, United States of America.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Peebles', 'Affiliation': ""Craig Dalsimer Division of Adolescent Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, United States of America; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2021.106313']
1053,33539991,The active workplace study: Protocol for a randomized controlled trial with sedentary workers.,"OBJECTIVES


Sedentary behavior is pervasive in the workplace and is harmful to health. Research on the effectiveness of comprehensive workplace interventions to reduce sedentary behavior and improve worker health and safety is crucial as sedentary jobs become more common.
METHODS


We developed a Total Worker Health intervention targeting sedentary behavior in call centers, and are evaluating intervention effectiveness in a randomized controlled trial. Four worksites will be randomly assigned to an intervention or control condition. The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels. Control worksites will receive active workstations with no additional support, following common organizational practices.
RESULTS


Outcomes include objectively measured physical activity, biological markers of health, and self-report survey data at baseline, after the 6-month intervention or control period, and at a 12-month follow-up.
CONCLUSIONS


The aims of the study are to determine whether a Total Worker Health intervention has stronger impacts on workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety compared to a usual practice control condition. The study will inform future workplace sedentary behavior intervention and dissemination research, along with organizational best practices for reducing sedentary behavior in the workplace.",2021,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.",['sedentary workers'],"['Total Worker Health intervention', 'comprehensive workplace interventions', 'Total Worker Health intervention targeting sedentary behavior']","['physical activity, biological markers of health, and self-report survey data', 'workplace sedentary behavior, uninterrupted bouts of sitting, and worker health and safety', 'worker health and safety']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4.0,0.104672,"The intervention condition includes the provision of active workstations along with programs and procedures at environmental, organizational, and individual levels.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wipfli', 'Affiliation': 'OHSU-PSU School of Public Health, Portland State University, PO Box 751, SCH, Portland, OR 97207-0751, United States of America; Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: bwipfli@pdx.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wild', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: wilsa@ohsu.edu.'}, {'ForeName': 'Ginger C', 'Initials': 'GC', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Johns Hopkins University, 525 N. Wolfe Street, Baltimore, MD 21205, United States of America. Electronic address: ghanson4@jhu.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Shea', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: sheast@ohsu.edu.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Winters-Stone', 'Affiliation': ""OHSU School of Nursing, Oregon Health & Science University, 3455 SW US Veteran's Hospital Rd, Portland, OR 97239, United States of America. Electronic address: wintersk@ohsu.edu.""}, {'ForeName': 'Saurabh S', 'Initials': 'SS', 'LastName': 'Thosar', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, 3222 SW Research Drive L606 Portland, Oregon 97239, United States of America. Electronic address: thosar@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106311']
1054,33512323,"Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19-Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial.","BACKGROUND


The COVID-19 pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions that aim to improve the elevated levels of psychological distress due to the COVID-19 pandemic.
OBJECTIVE


This study aimed to comparatively assess the efficacy of therapist-guided online therapy with that of self-help, internet-based therapy focusing on COVID-19-induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic.
METHODS


This was a 6-week-long pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety or depression among the Omani public amid the COVID-19 pandemic. Participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman; these sessions were conducted in Arabic or English. The psychotherapists utilized cognitive behavioral therapy and acceptance and commitment therapy interventions. Participants in the control group received an automatic weekly newsletter via email containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of cognitive behavioral therapy and acceptance and commitment therapy. The primary outcome was measured by comparing the change in the mean scores of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scale from the baseline to the end of the study (ie, after 6 sessions) between the two groups. The secondary outcome was to compare the proportions of participants with depression and anxiety between the two groups.
RESULTS


Data from 46 participants were analyzed (intervention group n=22, control group n=24). There was no statistical difference in the baseline characteristics between both groups. Analysis of covariance indicated a significant reduction in the GAD-7 scores (F 1,43 =7.307; P=.01) between the two groups after adjusting for baseline scores. GAD-7 scores of participants in the intervention group were considerably more reduced than those of participants in the control group (β=-3.27; P=.01). Moreover, a greater reduction in mean PHQ-9 scores was observed among participants in the intervention group (F 1,43 =8.298; P=.006) than those in the control group (β=-4.311; P=.006). Although the levels of anxiety and depression reduced in both study groups, the reduction was higher in the intervention group (P=.049) than in the control group (P=.02).
CONCLUSIONS


This study provides preliminary evidence to support the efficacy of online therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist-guided online therapy was found to be superior to self-help, internet-based therapy; however, both therapies could be considered as viable options.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04378257; https://clinicaltrials.gov/ct2/show/NCT04378257.",2021,"The intervention arm had a greater reduction in PHQ-9 mean scores (F(1,43) = 8.298; P=.006) when compared to the control arm (B = -4.311; P=.006).","['60 participants who were recruited from a study sample surveyed for symptoms of anxiety/depression among the public in Oman amid the COVID-19 pandemic', '46 participants were analyzed (22 in intervention arm and 24 in control arm', 'Individuals in Oman', 'individuals living in Oman during the COVID-19 pandemic']","['Six-Week Therapist-Guided Online Therapy', '1 online session per week for 6 weeks from certified psychotherapists in Oman in Arabic or English', 'Psychotherapists utilized Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) interventions', 'automatic weekly newsletter via e-mail containing self-help information and tips to cope with distress associated with COVID-19', 'Online-Therapy', 'Self-Help Internet-Based Therapy', 'Therapist guided Online-Therapy', 'therapist guided Online-Therapy versus self-help, e-mail delivered, therapy']","['proportions of participants with depression and anxiety', 'COVID-19 Invoked Anxiety and Depression', 'PHQ-9 mean scores', 'GAD scores', 'mean Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scores', 'levels of anxiety and depression']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0557555', 'cui_str': 'Psychotherapist'}, {'cui': 'C0028971', 'cui_str': 'Oman'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.0951274,"The intervention arm had a greater reduction in PHQ-9 mean scores (F(1,43) = 8.298; P=.006) when compared to the control arm (B = -4.311; P=.006).","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Alawi', 'Affiliation': 'Department of Behavioral Medicine, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Roopa K', 'Initials': 'RK', 'LastName': 'McCall', 'Affiliation': 'Al Harub Medical Center, Muscat, Oman.'}, {'ForeName': 'Alya', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Euonia Clinic, Muscat, Oman.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Al Balushi', 'Affiliation': 'Department of Behavioral Medicine, Sultan Qaboos University Hospital, Muscat, Oman.'}, {'ForeName': 'Tamadhir', 'Initials': 'T', 'LastName': 'Al-Mahrouqi', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al Ghailani', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Al Sabti', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al-Maniri', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Sathiya M', 'Initials': 'SM', 'LastName': 'Panchatcharam', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Al Sinawi', 'Affiliation': 'Department of Behavioral Medicine, Sultan Qaboos University Hospital, Muscat, Oman.'}]",JMIR mental health,['10.2196/26683']
1055,33508735,Efficacy of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach with and without parental coaching on activity and participation for children with developmental coordination disorder: A randomized clinical trial.,"BACKGROUND


Cognitive Orientation to daily Occupational Performance (CO-OP) is recommended for its effectiveness in improving activity performance in children with Developmental Coordination Disorder (DCD). Since parental support is a key element in CO-OP, parental coaching seems relevant to be investigated.
AIMS


Compare the efficacy of the CO-OP Approach with and without additional parental coaching to improve activity and participation in children with DCD.
METHODS AND PROCEDURES


Randomized clinical trial with 7-12-years-old children with DCD, randomly assigned to experimental (E-group) or active control (AC-group) groups, with 11 children each. Both groups received traditional CO-OP, E-group received four additional parental group-coaching sessions. Occupational performance and satisfaction on intervention goals were measured at baseline, post-intervention, and follow-up. Participation, motor performance and executive function were assessed at baseline and post-intervention.
OUTCOMES AND RESULTS


CO-OP with and without additional parental coaching resulted in improved occupational performance according to children, parents, and external evaluators. Children showed statistically significant gains in motor performance and cognitive flexibility. Participation measures did not change.
CONCLUSIONS AND IMPLICATIONS


As coaching did not add additional gains, parent's required participation in CO-OP might be enough to support children's occupational performance.",2021,"OUTCOMES AND RESULTS


CO-OP with and without additional parental coaching resulted in improved occupational performance according to children, parents, and external evaluators.","['children with developmental coordination disorder', 'children with DCD', '7-12-years-old children with DCD', 'children with Developmental Coordination Disorder (DCD']","['CO-OP Approach with and without additional parental coaching', 'active control (AC-group', 'traditional CO-OP, E-group received four additional parental group-coaching sessions', 'Cognitive Orientation to daily Occupational Performance (CO-OP) approach with and without parental coaching', 'Cognitive Orientation to daily Occupational Performance (CO-OP']","['Participation, motor performance and executive function', 'occupational performance', 'activity performance', 'motor performance and cognitive flexibility', 'Occupational performance and satisfaction on intervention goals']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",11.0,0.0713272,"OUTCOMES AND RESULTS


CO-OP with and without additional parental coaching resulted in improved occupational performance according to children, parents, and external evaluators.","[{'ForeName': 'Clarice Ribeiro Soares', 'Initials': 'CRS', 'LastName': 'Araujo', 'Affiliation': 'Rehabilitation Science Graduate Program, Universidade Federal de Minas Gerais (UFMG), Brazil; Occupational Therapy Department, Universidade Federal da Paraíba (UFPB), Health Sciences Center, Cidade Universitária, 58051-900, João Pessoa, PB, Brazil. Electronic address: clarice.araujo@academico.ufpb.br.'}, {'ForeName': 'Ana Amélia', 'Initials': 'AA', 'LastName': 'Cardoso', 'Affiliation': 'Occupation Studies Graduate Program, UFMG, Brazil; Occupational Therapy Department, Escola de Educação Física, Fisioterapia e Terapia Ocupacional (UFMG), Av. Antônio Carlos, 6627, Pampulha, 31270-901, Belo Horizonte, MG, Brazil. Electronic address: anaameliacardoso@gmail.com.'}, {'ForeName': 'Helene J', 'Initials': 'HJ', 'LastName': 'Polatajko', 'Affiliation': 'Occupational Science and Occupational Therapy Department, Rehabilitation Sciences Institute, University of Toronto, 160 - 500 University Avenue, M5G 1V7, Toronto, ON, Canada. Electronic address: h.polatajko@utoronto.ca.'}, {'ForeName': 'Lívia', 'Initials': 'L', 'LastName': 'de Castro Magalhães', 'Affiliation': 'Rehabilitation Science Graduate Program, Universidade Federal de Minas Gerais (UFMG), Brazil; Occupation Studies Graduate Program, UFMG, Brazil. Electronic address: liviacmag@gmail.com.'}]",Research in developmental disabilities,['10.1016/j.ridd.2021.103862']
1056,33508718,The effect of physical training modality on exercise performance with police-related personal protective equipment.,"PURPOSE


To investigate the influence of aerobic capacity, muscle strength, and body composition on performance and metabolic demands of men wearing personal protective equipment (PPE).
METHODS


45 men were assigned to one of four groups which significantly differed in upright pull isometric strength (MVC ≤ 1325 N or ≥ 1531 N) and maximum oxygen uptake (VO 2 max ≤ 51.9 mL min -1 ·kg -1  or ≥ 56.0 mL min -1 ·kg -1 ): endurance-trained (low MVC, high VO 2 max), strength-trained (high MVC, low VO 2 max), endurance- and strength-trained (high MVC, high VO 2 max), and untrained (low MVC, low VO 2 max). Each participant underwent two test series consisting of a repeated 10 m dummy drag and a graded exercise test wearing either sportswear or PPE of a German riot police unit weighing 20.9 kg (statistics: two-way repeated measures ANOVA, stepwise multiple linear regressions).
RESULTS


With PPE, dummy drag and running performance were impaired by 14 ± 9% and 58 ± 7%. Groups with high MVC dragged the dummy significantly faster than groups with low MVC (17.5 ± 1.8 s/17.6 ± 1.4 s vs. 23.4 ± 5.6 s/22.3 ± 3.5 s). Running distance was significantly higher in groups with high VO 2 max (4.5 ± 0.8 km/4.4 ± 0.7 km vs. 3.1 ± 0.5 km/2.8 ± 0.5 km). Body composition variables partially correlated with performance (R ranging from -0.70 to 0.41), but were not significant predictors of the regression models in PPE.
CONCLUSIONS


Individuals who showed a certain degree of aerobic endurance, as well as muscle strength, performed consistently well during the test series. Therefore, none of these variables should be trained in isolation but optimized in combination to be capable in a variety of operational tasks.",2021,Running distance was significantly higher in groups with high VO 2 max (4.5 ± 0.8 km/4.4 ± 0.7 km vs. 3.1 ± 0.5 km/2.8 ± ,"['51.9', 'men wearing personal protective equipment (PPE', 'exercise performance with police-related personal protective equipment', '45 men']","['physical training modality', 'N or\xa0≥', 'upright pull isometric strength (MVC\xa0≤\xa01325', 'repeated 10\xa0m dummy drag and a graded exercise test wearing either sportswear or PPE']","['Running distance', 'maximum oxygen uptake (VO 2 max\xa0≤', '·kg -1 ): endurance-trained (low MVC, high VO 2 max), strength-trained (high MVC, low VO 2 max), endurance- and strength-trained (high MVC, high VO 2 max), and untrained (low MVC, low VO 2 max']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085098', 'cui_str': 'Police'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1562415', 'cui_str': 'Skin drag'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",45.0,0.0351362,Running distance was significantly higher in groups with high VO 2 max (4.5 ± 0.8 km/4.4 ± 0.7 km vs. 3.1 ± 0.5 km/2.8 ± ,"[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Zwingmann', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiology and Sports Medicine, German Sport University Cologne, Germany; The German Research Centre of Elite Sport Cologne, German Sport University Cologne, Germany. Electronic address: L.Zwingmann@dshs-koeln.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Hoppstock', 'Affiliation': 'The German Research Centre of Elite Sport Cologne, German Sport University Cologne, Germany.'}, {'ForeName': 'Jan-Peter', 'Initials': 'JP', 'LastName': 'Goldmann', 'Affiliation': 'Institute of Biomechanics and Orthopaedics, German Sport University Cologne, Germany; The German Research Centre of Elite Sport Cologne, German Sport University Cologne, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wahl', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiology and Sports Medicine, German Sport University Cologne, Germany; The German Research Centre of Elite Sport Cologne, German Sport University Cologne, Germany.'}]",Applied ergonomics,['10.1016/j.apergo.2021.103371']
1057,33515781,Transplant regimen adherence for kidney recipients by engaging information technologies (TAKE IT): Rationale and methods for a randomized controlled trial of a strategy to promote medication adherence among transplant recipients.,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence. We describe a multifaceted, evidence-based, medication adherence monitoring strategy ('TAKE IT') that leverages available transplant center resources to identify potential medication non-adherence and other concerns earlier to prevent complications that could result from inadequate IS adherence.
METHODS


The TAKE IT strategy includes: 1) medication adherence mobile application; 2) routine, online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators; 4) quarterly adherence reports to monitor IS values and summarize adherence trends; 5) deployment of adherence support tools tailored to specific adherence concerns. To test the TAKE IT intervention, we will conduct a two-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n = 225 per site) within 2 years of transplantation and 2 years of follow-up. Study assessments will take place at baseline, 6 weeks, 6, 12, 18 and 24 months. The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process outcomes and cost-effectiveness will also be examined.
CONCLUSION


The TAKE IT trial presents an innovative approach to monitoring and optimizing medication adherence among a population taking complex medication regimens. This trial seeks to evaluate the effectiveness and feasibility of this strategy compared to usual care.",2021,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","['kidney transplant recipients (KTRs', 'transplant recipients', 'kidney recipients', 'diverse transplant centers (Northwestern University, Mayo Clinic, AZ) with planned recruitment of 450 KTRs (n\u202f=\u202f225 per site) within 2\u202fyears of transplantation and 2\u202fyears of follow-up']",['online patient self-reported adherence assessments; 3) care alert notifications via the electronic health record (EHR) directed to transplant coordinators'],"['cost-effectiveness', 'medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.106032,"BACKGROUND


Several studies report a high prevalence of non-adherence to prescribed immunosuppressive (IS) medications among kidney transplant recipients (KTRs), yet few interventions have been effective for helping patients sustain appropriate post-transplant adherence.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Serper', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America. Electronic address: marinas2@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniela P', 'Initials': 'DP', 'LastName': 'Ladner', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Department of Surgery, Northwestern Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Sumi S', 'Initials': 'SS', 'LastName': 'Nair', 'Affiliation': 'Mayo Clinic Arizona Transplant Center, Mayo Clinic, Phoenix, AZ, United States of America.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Ho', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Friedewald', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America; Division of Organ Transplantation, Division of Nephrology/Hypertension Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States of America; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Renal-Electrolyte and Hypertension Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States of America.'}, {'ForeName': 'Michael M I', 'Initials': 'MMI', 'LastName': 'Abecassis', 'Affiliation': 'Northwestern University Transplant Outcomes Research Collaborative (NUTORC), Comprehensive Transplant Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106294']
1058,33515770,"Experiences, expectations and preferences regarding MRI and mammography as breast cancer screening tools in women at familial risk.","BACKGROUND


Several studies have investigated MRI breast cancer screening in women at increased risk, but little is known about their preferences. In this study, experiences, expectations and preferences for MRI and mammography were evaluated among women undergoing screening with MRI and/or mammography in the randomized FaMRIsc trial.
METHODS


A 17-item questionnaire was sent to 412 women in the FaMRIsc trial. Participants were aged 30-55 years, had a ≥20% cumulative lifetime risk, but no BRCA1/2 or TP53 gene variant, and were screened outside the population-based screening program. Women received annual mammography (mammography-group), or annual MRI and biennial mammography (MRI-group). We asked whether women trust the screening outcome, what they consider as (dis)advantages, which screening they prefer and what they expect of the early detection by the screening tools.
RESULTS


255 (62%) women completed our questionnaire. The high chance of early cancer detection was the most important advantage of MRI screening (MRI-group: 95%; mammography-group: 74%), while this was also the main advantage of mammography (MRI-group: 57%; mammography-group: 72%). Most important disadvantages of MRI were the small tunnel and the contrast fluid (for 23-36%), and of mammography were its painfulness and X-radiation (for 48-60%). Almost the whole MRI-group and half the mammography-group preferred screening with MRI (either alone or with mammography).
DISCUSSION


Most women would prefer screening with MRI. The way women think of MRI and mammography is influenced by the screening strategy they are undergoing. Our outcomes can be used for creating information brochures when MRI will be implemented for more women.",2021,"Almost the whole MRI-group and half the mammography-group preferred screening with MRI (either alone or with mammography).
","['Participants were aged 30-55 years, had a ≥20% cumulative lifetime risk, but no BRCA1/2 or TP53 gene variant, and were screened outside the population-based screening program', 'A 17-item questionnaire was sent to 412 women in the FaMRIsc trial', '255 (62%) women completed our questionnaire', 'women undergoing screening with MRI and/or mammography in the randomized FaMRIsc trial', 'women at familial risk']","['mammography-group preferred screening with MRI (either alone or with mammography', 'annual mammography (mammography-group), or annual MRI and biennial mammography (MRI-group']",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0050288', 'cui_str': 'A 17'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]",[],412.0,0.0596367,"Almost the whole MRI-group and half the mammography-group preferred screening with MRI (either alone or with mammography).
","[{'ForeName': 'H Amarens', 'Initials': 'HA', 'LastName': 'Geuzinge', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: h.geuzinge@erasmusmc.nl.'}, {'ForeName': 'Eveline A M', 'Initials': 'EAM', 'LastName': 'Heijnsdijk', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: e.heijnsdijk@erasmusmc.nl.'}, {'ForeName': 'Inge-Marie', 'Initials': 'IM', 'LastName': 'Obdeijn', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands. Electronic address: a.obdeijn@erasmusmc.nl.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'de Koning', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: h.dekoning@erasmusmc.nl.'}, {'ForeName': 'Madeleine M A', 'Initials': 'MMA', 'LastName': 'Tilanus-Linthorst', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: madeleinetilanus@hotmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2021.01.002']
1059,33517741,A prospective double-blind randomized trial on ultrasound-guided versus blind intra-articular corticosteroid injections for primary frozen shoulder.,"AIMS


Ultrasound (US)-guided injections are widely used in patients with conditions of the shoulder in order to improve their accuracy. However, the clinical efficacy of US-guided injections compared with blind injections remains controversial. The aim of this study was to compare the accuracy and efficacy of US-guided compared with blind corticosteroid injections into the glenohumeral joint in patients with primary frozen shoulder (FS).
METHODS


Intra-articular corticosteroid injections were administered to 90 patients primary FS, who were randomly assigned to either an US-guided (n = 45) or a blind technique (n = 45), by a shoulder specialist. Immediately after injection, fluoroscopic images were obtained to assess the accuracy of the injection. The outcome was assessed using a visual analogue scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the subjective shoulder value (SSV) and range of movement (ROM) for all patients at the time of presentation and at three, six, and 12 weeks after injection.
RESULTS


The accuracy of injection in the US and blind groups was 100% (45/45) and 71.1% (32/45), respectively; this difference was significant (p < 0.001). Both groups had significant improvements in VAS pain score, ASES score, SSV, forward flexion, abduction, external rotation, and internal rotation throughout follow-up until 12 weeks after injection (all p < 0.001). There were no significant differences between the VAS pain scores, the ASES score, the SSV and all ROMs between the two groups at the time points assessed (all p > 0.05). No injection-related adverse effects were noted in either group.
CONCLUSION


We found no significant differences in pain and functional outcomes between the two groups, although an US-guided injection was associated with greater accuracy. Considering that it is both costly and time-consuming, an US-guided intra-articular injection of corticosteroid seems not always to be necessary in the treatment of FS as it gives similar outcomes as a blind injection. Cite this article:  Bone Joint J  2021;103-B(2):353-359.",2021,"Both groups had significant improvements in VAS pain score, ASES score, SSV, forward flexion, abduction, external rotation, and internal rotation throughout follow-up until 12 weeks after injection (all p < 0.001).","['90 patients primary FS', 'primary frozen shoulder', 'patients with primary frozen shoulder (FS', 'patients with conditions of the shoulder']","['Ultrasound (US)-guided injections', 'US-guided compared with blind corticosteroid injections', 'ultrasound-guided versus blind intra-articular corticosteroid injections', 'US-guided (n = 45) or a blind technique']","['VAS pain score, ASES score, SSV, forward flexion, abduction, external rotation, and internal rotation', 'accuracy and efficacy', 'pain and functional outcomes', 'VAS pain scores, the ASES score, the SSV and all ROMs', 'visual analogue scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the subjective shoulder value (SSV) and range of movement (ROM', 'adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0442775', 'cui_str': 'Blind technique'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.0937229,"Both groups had significant improvements in VAS pain score, ASES score, SSV, forward flexion, abduction, external rotation, and internal rotation throughout follow-up until 12 weeks after injection (all p < 0.001).","[{'ForeName': 'Chul-Hyun', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Dongsan Medical Center, Keimyung University School of Medicine, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Byung-Woo', 'Initials': 'BW', 'LastName': 'Min', 'Affiliation': 'Department of Orthopedic Surgery, Dongsan Medical Center, Keimyung University School of Medicine, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Ki-Cheor', 'Initials': 'KC', 'LastName': 'Bae', 'Affiliation': 'Department of Orthopedic Surgery, Dongsan Medical Center, Keimyung University School of Medicine, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Kyung-Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Dongsan Medical Center, Keimyung University School of Medicine, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Du Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea.'}]",The bone & joint journal,['10.1302/0301-620X.103B2.BJJ-2020-0755.R1']
1060,33517740,Coronal Plane Alignment of the Knee (CPAK) classification.,"AIMS


A comprehensive classification for coronal lower limb alignment with predictive capabilities for knee balance would be beneficial in total knee arthroplasty (TKA). This paper describes the Coronal Plane Alignment of the Knee (CPAK) classification and examines its utility in preoperative soft tissue balance prediction, comparing kinematic alignment (KA) to mechanical alignment (MA).
METHODS


A radiological analysis of 500 healthy and 500 osteoarthritic (OA) knees was used to assess the applicability of the CPAK classification. CPAK comprises nine phenotypes based on the arithmetic HKA (aHKA) that estimates constitutional limb alignment and joint line obliquity (JLO). Intraoperative balance was compared within each phenotype in a cohort of 138 computer-assisted TKAs randomized to KA or MA. Primary outcomes included descriptive analyses of healthy and OA groups per CPAK type, and comparison of balance at 10° of flexion within each type. Secondary outcomes assessed balance at 45° and 90° and bone recuts required to achieve final knee balance within each CPAK type.
RESULTS


There was similar frequency distribution between healthy and arthritic groups across all CPAK types. The most common categories were Type II (39.2% healthy vs 32.2% OA), Type I (26.4% healthy vs 19.4% OA) and Type V (15.4% healthy vs 14.6% OA). CPAK Types VII, VIII, and IX were rare in both populations. Across all CPAK types, a greater proportion of KA TKAs achieved optimal balance compared to MA. This effect was largest, and statistically significant, in CPAK Types I (100% KA vs 15% MA; p < 0.001), Type II (78% KA vs 46% MA; p = 0.018). and Type IV (89% KA vs 0% MA; p < 0.001).
CONCLUSION


CPAK is a pragmatic, comprehensive classification for coronal knee alignment, based on constitutional alignment and JLO, that can be used in healthy and arthritic knees. CPAK identifies which knee phenotypes may benefit most from KA when optimization of soft tissue balance is prioritized. Further, it will allow for consistency of reporting in future studies. Cite this article:  Bone Joint J  2021;103-B(2):329-337.",2021,"This effect was largest, and statistically significant, in CPAK Types","['healthy and arthritic knees', 'total knee arthroplasty (TKA', '500 healthy and 500 osteoarthritic (OA) knees']",['CPAK'],"['balance at 45° and 90° and bone recuts required to achieve final knee balance within each CPAK type', 'Intraoperative balance', 'descriptive analyses of healthy and OA groups per CPAK type, and comparison of balance at 10° of flexion within each type']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}]",500.0,0.0383124,"This effect was largest, and statistically significant, in CPAK Types","[{'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'CPAK Research Group, Sydney, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Griffiths-Jones', 'Affiliation': 'CPAK Research Group, Sydney, Australia.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'Orthopaedic Surgery, University of New South Wales, South Western Sydney Clinical School, Liverpool, NSW, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bellemans', 'Affiliation': 'CPAK Research Group, Sydney, Australia.'}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Chen', 'Affiliation': 'CPAK Research Group, Sydney, Australia.'}]",The bone & joint journal,['10.1302/0301-620X.103B2.BJJ-2020-1050.R1']
1061,33524284,A multidisciplinary ED-based fall prevention intervention reduced subsequent ED visits in older adults.,"SOURCE CITATION


Goldberg EM, Marks SJ, Resnik LJ, et al.  Can an emergency department-initiated intervention prevent subsequent falls and health care use in older adults? A randomized controlled trial.  Ann Emerg Med. 2020;76:739-50. 32854965.",2021,Can an emergency department-initiated intervention prevent subsequent falls and health care use in older adults?,['older adults'],['multidisciplinary ED-based fall prevention intervention'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0227397,Can an emergency department-initiated intervention prevent subsequent falls and health care use in older adults?,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'Sentara Norfolk General Hospital/Eastern Virginia Medical School, Norfolk, Virginia USA (B.L.).'}]",Annals of internal medicine,['10.7326/ACPJ202102160-019']
1062,33528914,"The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial.","AIM


To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis.
MATERIALS AND METHODS


A double-blind, randomized, placebo-controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once-daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale.
RESULTS


Seven hundred and ninety-nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study-specific medication and protocol (n = 50). Forty-seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference -6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group.
CONCLUSIONS


This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.",2021,The commonest reasons for exclusion were ineligibility (44%) and inability to make contact (28%).,"['Setting Mental health centres and primary care within Southern Health NHS Foundation Trust', 'people with severe mental illness', '47 participants', 'People with severe mental illness', '799 individuals were screened for eligibility', 'Participants Adults with schizophrenia, schizoaffective, or first-episode psychosis prescribed antipsychotic medication who were overweight or obese', 'people with schizophrenia, schizoaffective disorder and first episode psychosis']","['liraglutide', 'liraglutide or placebo', 'placebo']","['feasibility and acceptability', 'consent, retention and adherence', 'weight change', 'acceptance rate', 'BMI, waist circumference and HbA 1c  reduced', 'weight, HbA 1c  and Brief Psychiatric Rating Scale']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}]",47.0,0.632749,The commonest reasons for exclusion were ineligibility (44%) and inability to make contact (28%).,"[{'ForeName': 'Clare A', 'Initials': 'CA', 'LastName': 'Whicher', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Hermione C', 'Initials': 'HC', 'LastName': 'Price', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Barnard-Kelly', 'Affiliation': 'Barnard Health Research Limited, Fareham, UK.'}, {'ForeName': 'Kandala', 'Initials': 'K', 'LastName': 'Ngianga', 'Affiliation': 'Faculty of Science and Health, School of Health and Care Professions, Portsmouth, UK.'}, {'ForeName': 'Kerensa', 'Initials': 'K', 'LastName': 'Thorne', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Asher', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Peveler', 'Affiliation': 'Academic Department of Psychiatry, College Keep, Southampton, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McCarthy', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Dept. Tom Rudd Unit, Moorgreen Hospital, West End Southampton, UK.'}, {'ForeName': 'Richard I G', 'Initials': 'RIG', 'LastName': 'Holt', 'Affiliation': 'Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14334']
1063,33525270,Treatment of hypoglycemia during prolonged physical activity in adolescents with type 1 diabetes mellitus.,"BACKGROUND


management of children with type 1 diabetes (T1DM) during physical activity includes intensive blood glucose monitoring and proper insulin and nutritional adjustments in order to prevent hypoglycemia. Regarding the treatment of hypoglycemia during physical activity, different types of rapid acting carbohydrate (CHO) can be used and recommendations are still debated.
AIM OF THE WORK


compare the response to three types of frequently used rapid acting CHO to correct hypoglycemia during prolonged aerobic exercise.  Subjects and Methods: 21 subjects with T1DM, aged 12-16 years, agreed to be recruited in the study. All participants took part in a trekking camp for 5 days, with 70 Km itinerary. A ""flash monitoring"" device was put on every participant and insulin and nutritional adjustments were done according to a protocol. Subjects have been randomized into three different groups: group 1 had to correct hypoglycemia with 0.3g/Kg of a glucose preparation; group 2 used sugar fondant candies; group 3 used fruit juice.
RESULTS


no significant differences were highlighted among the three treatments in terms of time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events after correction of hypoglycemia.
CONCLUSIONS


our results suggest that 0.3g pro Kg of rapidly acting CHO in the form of glucose, sugar fondant or orange juice, effectively resolve hypoglycemia in children during aerobic prolonged physical activity.",2020,"RESULTS


no significant differences were highlighted among the three treatments in terms of time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events after correction of hypoglycemia.
","['Subjects and Methods: 21 subjects with T1DM, aged 12-16 years, agreed to be recruited in the study', 'children with type 1 diabetes (T1DM', 'adolescents with type 1 diabetes mellitus']","['correct hypoglycemia with 0.3g/Kg of a glucose preparation; group 2 used sugar fondant candies; group 3 used fruit juice', 'rapid acting carbohydrate (CHO']","['time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0452453', 'cui_str': 'Fruit juice'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",21.0,0.0213492,"RESULTS


no significant differences were highlighted among the three treatments in terms of time spent in hypoglycemia, rise in blood glucose levels and number of hypoglycemic events after correction of hypoglycemia.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fumanelli', 'Affiliation': '. jenmed87@hotmail.it.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Franceschi', 'Affiliation': 'S.Chiara Hospital of Trento. robertofranceschi@yahoo.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bonani', 'Affiliation': '. monica.bonani@apss.tn.it.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Orrasch', 'Affiliation': '. massimo.orrasch@apss.tn.it.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cauvin', 'Affiliation': '. vittoria.cauvin@apss.tn.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i4.8437']
1064,33533669,"Development and validation of nomograms for epithelial ovarian cancer: a SEER population-based, real-world study.","Aim:  To develop and internally validate nomograms to predict the overall survival (OS) and the cancer-specific survival (CSS) of patients with epithelial ovarian cancer (EOC).  Methods:  A total of 9001 EOC patients diagnosed between 2010 and 2013 were randomly divided into the training (n = 6301) and validation (n = 2700) cohorts. Nomogram and bootstrap validation were used to assess the predictive values of the models, including discrimination, calibration and clinical benefit.  Results:  In the validation cohort, the concordance statistic values were 0.733 for OS and 0.747 for CSS. Calibration plots and decision curve analyses demonstrated moderate accuracy and clinical applicability.  Conclusion:  Nomograms were user-friendly tools for guiding clinical treatment and estimating prognosis.",2021,"In the validation cohort, the concordance statistic values were 0.733 for OS and 0.747 for CSS.","['9001 EOC patients diagnosed between 2010 and 2013', 'patients with epithelial ovarian cancer (EOC', 'epithelial ovarian cancer']",[],"['overall survival (OS) and the cancer-specific survival (CSS', 'concordance statistic values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9001.0,0.0490873,"In the validation cohort, the concordance statistic values were 0.733 for OS and 0.747 for CSS.","[{'ForeName': 'Ruiqi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Guilan', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Cuifang', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Liren', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, PR\xa0China.""}, {'ForeName': 'Wenfang', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics & Gynecology, Maternal & Child Health Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, PR\xa0China.""}]","Future oncology (London, England)",['10.2217/fon-2020-0531']
1065,33524659,Clinical efficacy of adductor canal block in medial open wedge high tibial osteotomy.,"BACKGROUND


To evaluate the effect of adductor canal block (ACB) on short-term postoperative outcomes in patients who underwent medial open-wedge high tibial osteotomy (MOWHTO) compared to that of a placebo.
METHODS


35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a single-shot ACB and 16 patients who received a saline injection (a placebo group). Primary outcomes were (1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications.
RESULTS


The pain score was lower in the ACB group than in the placebo group in the first 12 h (p = 0.04). ACB did not exhibit significantly less quadriceps strength weakness postoperatively. There was no statistical difference in the time to SLR (23.5 ± 17.7 h in ACB vs. 27.6 ± 11.4 in placebo, p = 0.520). The opioid consumption rate within postoperative 12 h was significantly decreased after ACB (16.7% in ACB, 70% in placebo, p = 0.017). The proportion of patients with more than 5 opioid injections within 72 h postoperatively was lower in the ACB group (8.3% in ACB, 50% in placebo, p = 0.043). Both groups did not show any localized and systemic complications.
CONCLUSION


ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
LEVEL OF EVIDENCE


II, Prospectively comparative study.",2021,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","['35 patients who underwent unilateral MOWHTO between 2017 and 2019 were prospectively reviewed and randomly divided into two groups: 19 patients who received a', 'patients who underwent medial open-wedge high tibial osteotomy (MOWHTO', 'medial open wedge high tibial osteotomy']","['ACB', 'placebo', 'saline injection (a placebo', 'adductor canal block (ACB', 'single-shot ACB', 'adductor canal block']","['pain score', 'opioid consumption rate', '1) pain measured using the visual analog scale and range of motion, (2) patient satisfaction, (3) postoperative need for additional opioids, (3) quadriceps strength (the time to straight leg raising [SLR]), (4) clinical outcomes, and (5) complications', 'time to SLR', 'quadriceps strength and complications', 'quadriceps strength weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0445153', 'cui_str': 'Opening wedge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",35.0,0.218775,"ACB following MOWHTO exhibited better outcomes than a placebo with respect to opioid consumption with no changes in the quadriceps strength and complications.
","[{'ForeName': 'Jae Ang', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: sim_ja@gilhospital.com.'}, {'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: mikeum2@gilhospital.com.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: cherish@gilhospital.com.'}, {'ForeName': 'Beom Koo', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: knee@gilhospital.com.'}, {'ForeName': 'Byung Hoon', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedics Surgery, Gachon University College of Medicine, Incheon, Republic of Korea. Electronic address: oselite@naver.com.'}]",The Knee,['10.1016/j.knee.2020.12.017']
1066,33540223,The role of social isolation in physical and emotional outcomes among patients with chronic pain.,"OBJECTIVE


Social isolation negatively impacts early-disease processes and long-term health. Individuals with chronic pain are more vulnerable to social isolation, which exacerbates symptoms. It is currently unclear whether: 1. group-based programs for chronic pain improve social isolation, 2. improvements in social isolation account for improvements in outcomes. This study involved secondary data analysis of participants in a 10-week mind-body physical activity program. We examined whether social isolation improved during treatment, and whether such improvements accounted for improvements in emotional and physical functioning.
METHODS


Participants (N = 82) with chronic pain were randomized to a group-based mind-body physical activity intervention with (GetActive-Fitbit; n = 41) or without a Fitbit device (GetActive; n = 41). Participants completed self-reported measures of social isolation, emotional functioning (depression and anxiety symptoms), and multimodal physical functioning (self-report, performance-based, and objective). We used linear mixed effects modeling to examine pre-post treatment changes in social isolation and whether these changes accounted for improvements in emotional and physical functioning.
RESULTS


Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in accounted for significant improvements in self-reported emotional and physical functioning.
CONCLUSION


Interventions may target social isolation in chronic pain to optimize treatment outcomes.",2021,"Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in accounted for significant improvements in self-reported emotional and physical functioning.
","['Participants (N\xa0=\xa082) with chronic pain', 'participants in a 10-week mind-body physical activity program', 'Individuals with chronic pain', 'patients with chronic pain']",['group-based mind-body physical activity intervention with (GetActive-Fitbit; n\xa0=\xa041) or without a Fitbit device (GetActive; n\xa0=\xa041'],"['self-reported emotional and physical functioning', 'social isolation, emotional functioning (depression and anxiety symptoms), and multimodal physical functioning (self-report, performance-based, and objective', 'social isolation', 'emotional and physical functioning']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",82.0,0.0385238,"Both interventions were associated with significant and comparable improvements in social isolation from baseline to end of treatment, and improvements in accounted for significant improvements in self-reported emotional and physical functioning.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bannon', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: avranceanu@mgh.harvard.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2021.01.009']
1067,33540157,Differences in maternal characteristics and their associations with breastfeeding attitudes among primiparous mothers.,"BACKGROUND


The benefits of breastfeeding are well documented, yet substantially below half of all mothers globally meet the recommendation to exclusively breast-feed for 6 months.
OBJECTIVE


This study aimed to examine whether there were differences in maternal factors, including maternal characteristics and breastfeeding attitudes, between those who were eligible versus non-eligible to be included in a randomised trial, as exclusive breastfeeding was the eligibility criteria for the trial. It also aimed to investigate associations between maternal factors and breastfeeding attitudes.
METHOD


Primiparous pregnant mothers (n=88) completed questionnaires on demographic factors including maternity care and breastfeeding attitude using self-administered questionnaire and Iowa Infant Feeding Attitude Scale (IIFAS). Two weeks post-birth, mothers were screened for eligibility to be included in a randomised trial including assessing for exclusive breastfeeding (EBF). Findings were compared between inclusion (all EBF mothers) and exclusion groups (non-EBF).
RESULTS


Inclusion group mothers were significantly younger than those in the exclusion group (26.7±2.8 v 28.5±2.5, p=0.007) and the majority had their husband as the primary maternity care person after birth (X 2 =12.8, p=0.01). Inclusion group mothers had a more positive perception toward breastfeeding in public and at work on the IIFAS scale (p<0.05). The overall IIFAS score was positively associated with higher breastfeeding confidence (r=0.285, p=0.008), education levels (r=0.31, p=0.003), household income (r=0.32, p=0.003), and age (r=0.28, p=0.008).
CONCLUSION


EBF mothers (inclusion group) tend to be younger, had husband as primary care, and have more positive perception towards breastfeeding outside home. Overall, maternal characteristics and paternal support could influence breastfeeding practices and should be targeted for future intervention. Maternal attitude and perceptions about breastfeeding in public could be improved to encourage exclusive breastfeeding.",2021,Inclusion group mothers had a more positive perception toward breastfeeding in public and at work on the IIFAS scale (p<0.05).,"['Primiparous pregnant mothers (n=88) completed questionnaires on', 'primiparous mothers']",[],"['maternal characteristics and breastfeeding attitudes', 'overall IIFAS score', 'education levels', 'household income', 'positive perception toward breastfeeding in public and at work on the IIFAS scale', 'breastfeeding confidence', 'demographic factors including maternity care and breastfeeding attitude using self-administered questionnaire and Iowa Infant Feeding Attitude Scale (IIFAS']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0728705,Inclusion group mothers had a more positive perception toward breastfeeding in public and at work on the IIFAS scale (p<0.05).,"[{'ForeName': 'Nurul Husna', 'Initials': 'NH', 'LastName': 'Mohd Shukri', 'Affiliation': 'Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Malaysia; UCL Great Ormond Street Institute of Child Health, University College London, UK. Electronic address: n_husna@upm.edu.my.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wells', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, UK.'}]",Midwifery,['10.1016/j.midw.2021.102931']
1068,33545494,Cost-effectiveness analysis of housing first intervention with an independent housing and team support for homeless people with severe mental illness: A Markov model informed by a randomized controlled trial.,,2021,,['homeless people with severe mental illness'],['housing first intervention'],[],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.21877,,"[{'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Lemoine', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France; Department of Clinical Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, 27 Boulevard Jean Moulin, 13385, Marseille, France. Electronic address: coralie-lemoine@orange.fr.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Loubière', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France; Department of Clinical Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, 27 Boulevard Jean Moulin, 13385, Marseille, France. Electronic address: sandrine.loubiere@univ-amu.fr.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Boucekine', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France; Department of Clinical Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, 27 Boulevard Jean Moulin, 13385, Marseille, France. Electronic address: boucekine.mohamed@gmail.com.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Girard', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France. Electronic address: vincent.girard.46@gmail.com.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Tinland', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France; Department of Psychiatry, Sainte-Marguerite University Hospital, Boulevard Sainte Marguerite, 13009, Marseille, France. Electronic address: aurelie.tinland@gmail.com.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Auquier', 'Affiliation': 'Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, 27 Boulevard Jean Moulin, 13005, Marseille, France; Department of Clinical Research and Innovation, Support Unit for Clinical Research and Economic Evaluation, Assistance Publique - Hôpitaux de Marseille, 27 Boulevard Jean Moulin, 13385, Marseille, France. Electronic address: pascal.auquier@univ-amu.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Social science & medicine (1982),['10.1016/j.socscimed.2021.113692']
1069,33547665,Photobiomodulation Therapy by 820 nm Diode Laser on Nonsurgical Periodontal Treatment of Smoker and Nonsmoker Patients: A Single-Blind Parallel Randomized Clinical Trial.,"The effect of smoking on nonsurgical periodontal treatment (SRP) is known, but the adjunct use of photobiomodulation (PBMT) to SRP has not been fully investigated in smokers. This study aimed to assess the effect of 820 nm diode laser on SRP in smoker/nonsmoker. Sixty patients (smokers/n = 30, nonsmokers/n = 30) were enrolled in this parallel-arm clinical study. All patients were divided into two main groups: SRP and PBMT + SRP. In PMBT + SRP groups, 7.96 J cm -2  energy was applied by 820nm diode laser at baseline and first, second and third weeks after SRP. Periodontal pocket depth (PPD), gingival index (GI), plaque index (PI) and clinical attachment level (CAL) were recorded, and also gingival crevicular fluid (GCF) samples were collected at baseline and 6w after SRP. Total antioxidant capacity (TAOC) and total oxidative status (TOS) in GCF were analyzed. PBMT + SRP groups showed a statistically significant decrease in PPD and CAL, not in GI and PI compared with SRP alone. There were no statistically significant differences between smokers and nonsmokers in clinical data at six weeks after treatment. Although TAOC levels were increased in PMBT groups, TOS levels were decreased in all groups at the comparison of baseline and 6w after SRP. Adjunct use of 820 nm diode laser on SRP may improve the clinical parameters in smoker or nonsmoker patient with periodontitis.",2021,"Periodontal pocket depth(PPD), gingival index(GI), plaque index(PI), clinical attachment level(CAL) were recorded, and also gingival crevicular fluid(GCF) samples were collected at baseline and 6w after SRP.","['on Non-Surgical Periodontal Treatment of Smoker and Non-Smoker Patients', 'smoker or non-smoker patient with periodontitis', 'Sixty patients(smokers/n=30,non-smokers/n=30', 'smoker/non-smoker']","['PBMT+SRP', '820 nm diode laser', 'PMBT+SRP', 'SRP and PBMT+SRP', 'Photobiomodulation Therapy by 820 nm Diode Laser', '820 nm diode laser on SRP']","['TOS levels', 'Periodontal pocket depth(PPD), gingival index(GI), plaque index(PI), clinical attachment level(CAL', 'gingival crevicular fluid(GCF) samples', 'PPD and CAL', 'Total antioxidant capacity(TAOC) and Total oxidative status(TOS', 'TAOC levels']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}]","[{'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",30.0,0.0363473,"Periodontal pocket depth(PPD), gingival index(GI), plaque index(PI), clinical attachment level(CAL) were recorded, and also gingival crevicular fluid(GCF) samples were collected at baseline and 6w after SRP.","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Özdemir', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Osmangazi, Eskişehir, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Gündoğar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Gaziantep, Gaziantep, Turkey.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Akpınar', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Uludağ, Bursa, Turkey.'}]",Photochemistry and photobiology,['10.1111/php.13394']
1070,33509804,The Effect of Metformin in Treatment of Adenomas in Patients with Familial Adenomatous Polyposis.,"Familial adenomatous polyposis (FAP) is a hereditary disease characterized by the development of numerous colorectal adenomas in young adults. Metformin, an oral diabetic drug, has been shown to have antineoplastic effects and a favorable safety profile. We performed a randomized, double-blind, controlled trial to evaluate the efficacy of metformin on the regression of colorectal and duodenal adenoma in patients with FAP. Thirty-four FAP patients were randomly assigned in a 1:2:2 ratio to receive placebo, 500 mg metformin, or 1,500 mg metformin per day orally for 7 months. The number and size of polyps and the global polyp burden were evaluated before and after the intervention. This study was terminated early based on the results of the interim analysis. No significant differences were determined in the percentage change of colorectal and duodenal polyp number over the course of treatment among the three treatment arms ( P  = 0.627 and  P  = 1.000, respectively). We found no significant differences in the percentage change of colorectal or duodenal polyp size among the three groups ( P  = 0.214 and  P  = 0.803, respectively). The overall polyp burdens of the colorectum and duodenum were not significantly changed by metformin treatment at either dosage. Colon polyps removed from the metformin-treated patients showed significantly lower mTOR signal (p-S6) expression than those from patients in the placebo arm. In conclusion, 7 months of treatment with 500 mg or 1,500 mg metformin did not reduce the mean number or size of polyps in the colorectum or duodenum in FAP patients (ClinicalTrials.gov ID: NCT01725490). PREVENTION RELEVANCE: A 7-month metformin treatment (500 mg or 1,500 mg) did not reduce the number or size of polyps in the colorectum or duodenum of FAP patients as compared to placebo. These results do not support the use of metformin to promote regression of intestinal adenomas in FAP patients.",2021,"No significant differences were determined in the percentage change of colorectal and duodenal polyp number over the course of treatment among the three treatment arms(P=0.627 and P=1.000, respectively).","['patients with FAP', 'Familial adenomatous polyposis(FAP', 'patients with familial adenomatous polyposis', 'Thirty-four FAP patients']","['metformin', 'Metformin', 'placebo, 500 mg metformin, or 1500 mg metformin']","['mean number or size of polyps', 'percentage change of colorectal and duodenal polyp number', 'overall polyp burdens of the colorectum and duodenum', 'mTOR signal', 'percentage change of colorectal or duodenal polyp size', 'number and size of polyps and the global polyp burden']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0347266', 'cui_str': 'Polyp of duodenum'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",34.0,0.0957006,"No significant differences were determined in the percentage change of colorectal and duodenal polyp number over the course of treatment among the three treatment arms(P=0.627 and P=1.000, respectively).","[{'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Byung Chang', 'Initials': 'BC', 'LastName': 'Kim', 'Affiliation': 'Center for Colorectal Cancer, Center for Cancer Prevention & Detection, Division of Cancer Epidemiology and Management, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Sung Pil', 'Initials': 'SP', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoojeong', 'Initials': 'Y', 'LastName': 'Seo', 'Affiliation': 'Institute of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji University Hospital, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Soo-Young', 'Initials': 'SY', 'LastName': 'Na', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Sung Chul', 'Initials': 'SC', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Jongha', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jae Hak', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Chang Mo', 'Initials': 'CM', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Ewha Womans University, Seoul, Korea.'}, {'ForeName': 'Kyu Chan', 'Initials': 'KC', 'LastName': 'Huh', 'Affiliation': 'Department of Internal Medicine, Konyang University College of Medicine, Konyang University Hospital, Daejeon, Korea.'}, {'ForeName': 'Soo Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Il', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. taeilkim@yuhs.ac.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0580']
1071,33515536,Modulation of control: Can HD-tDCS targeting the dACC reduce impulsivity?,"BACKGROUND


The dorsal anterior cingulate cortex (dACC) and its neurocircuits are central in impulsivity, and maladaptive dACC activity has been implicated in psychological disorders characterized by high trait impulsivity. High-Definition transcranial Direct Current Stimulation (HD-tDCS) is a non-invasive neuromodulation tool that, with certain electrode configurations, can be optimized for targeting deeper subcorticalbrainstructures, such as the dACC.
OBJECTIVES


Using behavioural and electrophysiological measures we investigated whether HD-tDCS targeting the dACC could modulate two key components of impulsivity, inhibitory control and error processing.
METHODS


Twenty-three healthy adults with high trait impulsivity participated in two experimental sessions. Participants received active or sham HD-tDCS in counterbalanced order with a wash-out period of at least 3 days, as part of a single-blind, cross-over design. EEG was recorded during the Go-NoGo task before, directly after, and 30 min after HD-tDCS.
RESULTS


HD-tDCS targeting the dACC did not affect inhibitory control performance on the Go-NoGo task, but there was evidence for a delayed change in underlying neurophysiological components of motor inhibition (NoGo P3) and error processing (error related negativity; ERN) after one session of HD-tDCS.
CONCLUSION


HD-tDCS has potential to modulate underlying neurophysiological components of impulsivity. Future studies should further explore to what degree the dACC was affected and whether multi-session HD-tDCS has the capacity to also induce behavioural changes, particularly in clinical samples characterized by high trait impulsivity.",2021,"RESULTS


HD-tDCS targeting the dACC did not affect inhibitory control performance on the Go-NoGo task, but there was evidence for a delayed change in underlying neurophysiological components of motor inhibition (NoGo P3) and error processing (error related negativity; ERN) after one session of HD-tDCS.
CONCLUSION


",['Twenty-three healthy adults with high trait impulsivity participated in two experimental sessions'],"['active or sham HD-tDCS', 'High-Definition transcranial Direct Current Stimulation (HD-tDCS']","['EEG', 'motor inhibition (NoGo P3) and error processing (error related negativity; ERN']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",23.0,0.0296015,"RESULTS


HD-tDCS targeting the dACC did not affect inhibitory control performance on the Go-NoGo task, but there was evidence for a delayed change in underlying neurophysiological components of motor inhibition (NoGo P3) and error processing (error related negativity; ERN) after one session of HD-tDCS.
CONCLUSION


","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Aron T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Cognitive Neuroscience Unit, School of Psychology, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Yücel', 'Affiliation': 'BrainPark, Turner Institute for Brain and Mental Health, School of Psychological Sciences, and Monash Biomedical Imaging Facility, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Josanne D M', 'Initials': 'JDM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Segrave', 'Affiliation': 'BrainPark, Turner Institute for Brain and Mental Health, School of Psychological Sciences, and Monash Biomedical Imaging Facility, Monash University, Melbourne, Victoria, Australia.'}]",Brain research,['10.1016/j.brainres.2021.147282']
1072,33528901,An evaluation of a prenatal individualised mixed management intervention addressing breastfeeding outcomes and postpartum depression: A ramdomised controlled trial.,"AIMS AND OBJECTIVES


To determine the effects of an individualised mixed management combined lactation education and psychoeducation intervention on breastfeeding outcomes and postpartum depression (PPD) at 3 and 42 days postpartum.
BACKGROUND


Pregnant women with antenatal depression are prone to postpartum depression and failure in breastfeeding.
DESIGN


Eligible women participated in a randomised single-blind controlled trial. Results are reported as per the CONSORT 2010 statement.
METHODS


Participants were recruited from December 2017-August 2018 at a major teaching hospital located in Shanghai. Primiparous women (n = 182) with an Edinburgh Postnatal Depression Scale score ≥9 were randomly enrolled in the intervention group (n = 91) or the control group (n = 91). The intervention group participated in a 4-session face-to-face mixed management intervention targeting perinatal depression and breastfeeding. The control group received usual care. Breastfeeding and psychological outcomes were measured during the third trimester (≥28 weeks and <35 weeks), and at 3 and 42 days postpartum.
RESULTS


There were statistically significant differences in rates of overall and exclusive breastfeeding, initial breastfeeding experience, breastfeeding behaviour and self-efficacy between the two groups at 3 and 42 days postpartum (p < .05). Intention-to-treat linear mixed model analysis showed that EPDS scores were statistically significantly different between groups over time (F = 20.42, p < .001). Intervention group were more satisfied with their husbands' care and care received during the first month postpartum (p < .05).
CONCLUSIONS


The results demonstrate the effectiveness and feasibility of delivering an individualised mixed management intervention combining lactation guidance with psychological support during pregnancy.
RELEVANCE TO CLINICAL PRACTICE


This study supports the need to identify pregnant women at risk of perinatal depression and indicates that the prenatal individualised mixed management intervention has the potential to reduce PPD and help achieve better breastfeeding outcomes.",2021,"There were statistically significant differences in rates of overall and exclusive breastfeeding, initial breastfeeding experience, breastfeeding behavior and self-efficacy between the two groups at 3 and 42 days postpartum (p < .05).","['Pregnant women with antenatal depression', 'Eligible women participated', 'postpartum depression', 'Participants were recruited from December 2017 to August 2018 at a major teaching hospital located in Shanghai', 'Primiparous women (n = 182) with an Edinburgh Postnatal Depression Scale score ≥ 9', 'pregnant women at risk of perinatal depression']","['prenatal individualized mixed management intervention', 'individualized mixed management combined lactation education and psychoeducation intervention', 'usual care', '4-session face-to-face mixed management intervention targeting perinatal depression and breastfeeding']","['EPDS scores', 'rates of overall and exclusive breastfeeding, initial breastfeeding experience, breastfeeding behavior and self-efficacy', 'Breastfeeding and psychological outcomes', 'breastfeeding outcomes and postpartum depression (PPD']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1319304', 'cui_str': 'Breastfeeding performance'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",182.0,0.057517,"There were statistically significant differences in rates of overall and exclusive breastfeeding, initial breastfeeding experience, breastfeeding behavior and self-efficacy between the two groups at 3 and 42 days postpartum (p < .05).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Qiping', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Obstetrics and Gynecology Hospital of Fudan University, Shanghai, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Obstetrics and Gynecology Hospital of Fudan University, Shanghai, PR China.'}]",Journal of clinical nursing,['10.1111/jocn.15684']
1073,33529664,Influence of age on the relationship between apixaban concentration and anti-factor Xa activity in older patients with non-valvular atrial fibrillation.,"BACKGROUND/OBJECTIVES


Despite lower major bleeding rates associated with direct oral anticoagulants (DOACs) as compared to conventional warfarin therapy, bleeding rates remain higher in older patients compared to younger patients suggesting a potential role for DOAC measurements. The objective of this study is to examine the effect of age on the relationship between apixaban concentrations and anti-Factor Xa activity in patients with non-valvular atrial fibrillation (NVAF).
METHODS


This is a retrospective analysis based on a database created using data from the ARISTOTLE study. Outpatient, stable adult patients with NVAF receiving apixaban were included in this study. Data collection consisted of apixaban concentration, anti-Factor Xa activity, age, weight, creatinine, and co-medications.
RESULTS


The database composed of 2058 patients receiving apixaban. Distribution of race, NVAF subtype, and aspirin use was fairly similar across each age quantile. Older patients received a higher number of co-medications and received the 2.5 mg apixaban dose more often as compared to younger patients (22% vs. < 1%). Linear regression demonstrated that the unadjusted slope for apixaban concentration effect on anti-Factor Xa activity was similar across each age quantile. Although, the overall adjusted linear regression analysis demonstrated that the age by concentration interaction was statistically significant, relative differences in anti-Factor Xa activity (< 8%) were not clinically meaningful.
CONCLUSION


Data on apixaban concentrations and anti-Factor Xa activity from a pivotal randomized double-blind study of apixaban for the prevention of stroke in NVAF patients have confirmed that the chromogenic anti-Factor Xa activity assay can accurately assess apixaban concentrations in patients regardless of age. Age was not associated with a clinically relevant change in the apixaban vs. anti-Factor Xa activity response relationship and target ranges are unchanged.",2021,Age was not associated with a clinically relevant change in the apixaban vs. anti-Factor Xa activity response relationship and target ranges are unchanged.,"['Outpatient, stable adult patients with NVAF receiving apixaban', '2058 patients receiving', 'Older patients', 'older patients with non-valvular atrial fibrillation', 'NVAF patients', 'patients with non-valvular atrial fibrillation (NVAF']","['direct oral anticoagulants (DOACs', 'apixaban']","['apixaban concentration, anti-Factor Xa activity, age, weight, creatinine, and', 'apixaban concentrations and anti-Factor Xa activity', 'anti-Factor Xa activity', 'apixaban concentrations', 'apixaban concentration and anti-factor Xa activity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",2058.0,0.110415,Age was not associated with a clinically relevant change in the apixaban vs. anti-Factor Xa activity response relationship and target ranges are unchanged.,"[{'ForeName': 'Shamir N', 'Initials': 'SN', 'LastName': 'Kalaria', 'Affiliation': 'Center for Translational Medicine, University of Maryland, School of Pharmacy, Baltimore, MD, United States of America.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Office of Clinical Pharmacology, US Food and Drug Administration, White Oak, MD, United States of America.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Office of Clinical Pharmacology, US Food and Drug Administration, White Oak, MD, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Florian', 'Affiliation': 'Office of Clinical Pharmacology, US Food and Drug Administration, White Oak, MD, United States of America.'}, {'ForeName': 'Yaning', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Office of Clinical Pharmacology, US Food and Drug Administration, White Oak, MD, United States of America.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Department of Medicine, University of California San Francisco, School of Medicine, San Francisco, CA, United States of America. Electronic address: Janice.Schwartz@ucsf.edu.'}]",International journal of cardiology,['10.1016/j.ijcard.2021.01.025']
1074,33535141,Culture moderates the relationship between self-control ability and free will beliefs in childhood.,"We investigate individual, developmental, and cultural differences in self-control in relation to children's changing belief in ""free will"" - the possibility of acting against and inhibiting strong desires. In three studies, 4- to 8-year-olds in the U.S., China, Singapore, and Peru (N = 441) answered questions to gauge their belief in free will and completed a series of self-control and inhibitory control tasks. Children across all four cultures showed predictable age-related improvements in self-control, as well as changes in their free will beliefs. Cultural context played a role in the timing of these emerging free will beliefs: Singaporean and Peruvian children's beliefs changed at later ages than Chinese and U.S. children. Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru. There was also evidence of a causal influence of self-control performance on free will beliefs in our U.S. sample. In Study 2, a randomly assigned group of U.S. 4- and 5-year-olds who failed at two self-control tasks showed reduced belief in free will, but a group of children who completed free will questions first did not show changes to self-control. Together these results suggest that culturally-acquired causal-explanatory frameworks for action, along with observations of one's own abilities, might influence children's emerging understanding of free will.",2021,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.",['childhood'],['U.S. 4- and 5-year-olds who failed at two self-control tasks'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",[],,0.0150515,"Critically, culture moderated the link between self-control abilities and free will beliefs: Individual differences in self-control behaviors were linked to individual differences in free will beliefs in U.S. children, but not in children from China, Singapore or Peru.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'East China Normal University, China.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Wente', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'María Fernández', 'Initials': 'MF', 'LastName': 'Flecha', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Denise Segovia', 'Initials': 'DS', 'LastName': 'Galvan', 'Affiliation': 'Pontificia Universidad Católica del Perú, Peru.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Gopnik', 'Affiliation': 'University of California, Berkeley, USA.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kushnir', 'Affiliation': 'Cornell University, USA. Electronic address: tk397@cornell.edu.'}]",Cognition,['10.1016/j.cognition.2021.104609']
1075,33545575,"The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases.","PURPOSE


This study was carried out to find out the effects of yoga applied to chronic respiratory disease patients on dyspnea, sleep quality and fatigue.
MATERIAL AND METHOD


The study was conducted between May and August 2020 as a randomized controlled study. 'Personal Information Form', 'Respiratory Functions Monitoring Form', 'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC) were used in data collection.
RESULTS


When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
CONCLUSION


Yoga has been found to reduce the severity of dyspnea and fatigue and improve sleep quality in chronic respiratory diseases.",2021,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
",['chronic respiratory diseases'],[],"['severity of dyspnea and fatigue and improve sleep quality', 'dyspnea, sleep and fatigue', 'dyspnea, sleep quality and fatigue', 'CAFS, CASIS and mMRC mean scores', 'Personal Information Form\', \'Respiratory Functions Monitoring Form\', \'COPD and Asthma Fatigue Scale (CAFS), ""Asthma and COPD Sleep Impact Scale (CASIS)"" and Modified Medical Research Council Dyspnea Scale (mMRC']","[{'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0106463,"When the post-test mean scores of the patients in the experimental and control group were compared, it was found that CAFS, CASIS and mMRC mean scores of the patients in the experimental group decreased positively compared to the patients in the control group and the difference between was found to be statistically significant (p < 0.05).
","[{'ForeName': 'Zülfünaz', 'Initials': 'Z', 'LastName': 'Özer', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Istanbul Sabahattin Zaim University, Istanbul, Turkey. Electronic address: zulfinazozer@gmail.com.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bahçecioğlu Turan', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Firat University, Elazıg, Turkey. Electronic address: glcnbah@hotmail.com.'}, {'ForeName': 'Meyreme', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Department of Nursing, Faculty of Health Science Siirt University, Siirt, Turkey. Electronic address: meryeme_072@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101306']
1076,33545574,The effect of compound Da-Cheng-Qi Decoction on the treatment of malignant bowel obstruction with transnasal ileus tube.,"OBJECTIVE


To study the effect of compound Da-Cheng-Qi Decoction (CDCQD) on the treatment of malignant bowel obstruction (MBO) with transnasal ileus tube (TIT).
METHODS


We observed 30 cases of MBO from July 2018 to August 2019. The patients were divided into the control group (n = 15) and the CDCQD group (n = 15) according to a random number table. All patients were inserted the TIT after admission. Twenty-four hours later, the CDCQD group began to take 100 ml CDCQD twice a day for 7 days. The control group took the plain boiled water instead. Other treatment was the same in the two groups. The waistline reduction, the release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT were observed and compared between the two groups.
RESULTS


Three days after insertion of TIT, the abdominal plain film was re-examined in the two groups. Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05). The effective rate of CDCQD group (86.7%) was significantly higher than that of control group (53.3%). The recovery time of exhaust and defecation in the CDCQD group was earlier than that in the control group (P < 0.05). The daily drainage volume of TIT in the CDCQD group was less than that in the control group, especially from the fourth day to the sixth day after insertion of TIT, with a significant difference (P < 0.05).
CONCLUSION


TIT is an effective treatment for patients with MBO. With the basis of TIT treatment, CDCQD therapy can improve the curative effect of MBO. It can promote intestinal exhaust and defecation and improves the curative effect of palliative treatment of MBO. It is an effective method to assist Tit in the treatment for MBO patients.",2021,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"['30 cases of MBO from July 2018 to August 2019', 'malignant bowel obstruction (MBO) with transnasal ileus tube (TIT', 'patients with MBO', 'malignant bowel obstruction with transnasal ileus tube', 'MBO patients']","['compound Da-Cheng-Qi Decoction', 'plain boiled water instead', 'TIT', 'compound Da-Cheng-Qi Decoction (CDCQD', 'CDCQD']","['curative effect of MBO', 'recovery time of exhaust and defecation', 'effective rate', 'release time of abdominal pain and distention, recovery of exhaust and defecation time, drainage volume of TIT', 'daily drainage volume of TIT', 'gas-liquid level']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2935869', 'cui_str': 'Da-Cheng-Qi'}, {'cui': 'C0439892', 'cui_str': 'Boiled water'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0162882,Most of the patients' gas-liquid level disappeared and there was no significant difference between the two groups (P > 0.05).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Nutrition, Tianjin Nankai Hospital, 300100, Tianjin, China. Electronic address: xiangqixiangqi@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shimin', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Tianjin Nankai Hospital, 300100, Tianjin, China.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101316']
1077,33545548,"A chinese herbal formula ameliorates COPD by inhibiting the inflammatory response via downregulation of p65, JNK, and p38.","BACKGROUND


Bufei Yishen formula (BYF), a traditional Chinese medicine (TCM), is an effective therapeutic strategy for patients with chronic obstructive pulmonary disease (COPD).
PURPOSE


To evaluate the efficacy of BYF and investigate its therapeutic mechanisms.
METHODS


A total of 134 patients completed the study: 68 patients treated by BYF combined with conventional Western medicine in the trial group; and 66 patients treated using conventional Western medicine in the control group. The efficacy of BYF was evaluated by a subgroup analysis of data obtained from a four-center, open-label, randomized controlled trial of comprehensive TCM interventions. A rat model of COPD was treated with the key active molecules (KAM) of BYF for 8 weeks. An in vitro model of COPD was also treated with KAM.
RESULTS


Patients treated with BYF had reduced frequency of acute exacerbation of COPD (p < 0.001) and duration (p = 0.028), dyspnea scale (p = 0.007), 6-min walking distance (p = 0.048). There were no differences observed in forced vital capacity in one second (FVC), forced expiratory volume in one second (FEV1), and FEV1 percentage of the predicted value (FEV1%). The five KAM of BYF (KAM-BYF) improved lung function, including tidal volume, minute ventilation, peak expiratory flow, FVC, FEV0.1, and FEV0.3, and pathological changes in COPD rats. Treatment with KAM-BYF markedly decreased the levels of interleukin 6 (IL6), tumor necrosis factor-α (TNF-α), matrix metalloproteinase 9 (MMP9), and MMP12 in serum and bronchial alveolar lavage fluid. In airway epithelial cells, KAM-BYF decreased the levels of TNF-α-induced IL8 and IL6. Finally, we discovered that the anti-inflammatory effects of KAM-BYF in COPD rats and BEAS-2Bs were mediated through inhibition of nuclear factor-kappaB (NF-κB) p65, c-Jun NH2-terminal kinase (JNK), and p38 mitogen-activated protein kinase signaling.
CONCLUSIONS


BYF exerts beneficial effects in patients with COPD via inhibition of inflammation.",2021,"There were no differences observed in forced vital capacity in one second (FVC), forced expiratory volume in one second (FEV1), and FEV1 percentage of the predicted value (FEV1%).","['134 patients completed the study: 68 patients treated by', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD via inhibition of inflammation']","['comprehensive TCM interventions', 'KAM-BYF', 'Yishen formula (BYF), a traditional Chinese medicine (TCM', 'BYF combined with conventional Western medicine', 'conventional Western medicine']","['6-min walking distance', 'frequency of acute exacerbation of COPD', 'levels of interleukin 6 (IL6), tumor necrosis factor-α (TNF-α), matrix metalloproteinase 9 (MMP9), and MMP12 in serum and bronchial alveolar lavage fluid', 'five KAM of BYF (KAM-BYF) improved lung function, including tidal volume, minute ventilation, peak expiratory flow, FVC, FEV0.1, and FEV0.3, and pathological changes in COPD rats', 'forced vital capacity in one second (FVC), forced expiratory volume in one second (FEV1), and FEV1 percentage of the predicted value (FEV1', 'dyspnea scale', 'levels of TNF-α-induced IL8 and IL6']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C3501660', 'cui_str': 'Bu-Fei-Yi-Shen'}, {'cui': 'C2003492', 'cui_str': 'yishen'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C3501660', 'cui_str': 'Bu-Fei-Yi-Shen'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",134.0,0.0629934,"There were no differences observed in forced vital capacity in one second (FVC), forced expiratory volume in one second (FEV1), and FEV1 percentage of the predicted value (FEV1%).","[{'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China. Electronic address: li_js8@163.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Oliver', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; School of Life Sciences, Faculty of Science, University of Technology Sydney, Sydney, New South Wales 2007, Australia; Woolcock Institute of Medical Research, Respiratory Cellular and Molecular Biology, The University of Sydney, New South Wales 2037, Australia.'}, {'ForeName': 'Yange', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China.'}, {'ForeName': 'Suyun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China.'}, {'ForeName': 'Minghang', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153475']
1078,33545542,"Effect of cacao polyphenol-rich chocolate on postprandial glycemia, insulin, and incretin secretion in healthy participants.","OBJECTIVES


There is substantial interest in using dark chocolate to prevent postprandial hyperglycemia. We investigated the effects of cacao polyphenol-rich chocolate on postprandial glycemic and insulinemic responses and whether cacao polyphenol-rich chocolate increases glucagon-like peptide-1 (GLP-1) secretion.
METHODS


In a stratified, randomized, crossover study, 48 healthy participants ingested either water (W) or cacao polyphenol-rich chocolate plus water (C) 15 min before a 50 g oral glucose tolerance test (OGTT). Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated.
RESULTS


Peak plasma glucose concentrations did not differ significantly between groups W and C; however, plasma glucose concentrations at 120 min in group C were significantly lower than those in group W (P < .01). Postprandial serum insulin and plasma GLP-1 concentrations and incremental serum insulin and plasma GLP-1 area under the curve (AUC) - 15-180 min  for group C were significantly higher than those for group W (P < .05). When comparing the changes after the OGTT, the incremental plasma glucose AUC 0-180 min  for group C was significantly lower than that for group W (P < .05), but the incremental serum insulin and plasma GLP-1 AUC 0-180 min  did not differ significantly between groups W and C.
CONCLUSIONS


This study indicated that the intake of cacao polyphenol-rich chocolate before a 50 g OGTT could enhance early insulin and GLP-1 secretion in healthy participants, and illustrates the potential of cacao polyphenol-rich chocolate in managing postprandial glucose excursions.",2021,"Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated.
","['48 healthy participants ingested either', 'healthy participants']","['cacao polyphenol-rich chocolate', 'water (W) or cacao polyphenol-rich chocolate plus water (C) 15 min before a 50 g oral glucose tolerance test (OGTT', 'GLP-1']","['postprandial glycemic and insulinemic responses', 'Postprandial serum insulin and plasma GLP-1 concentrations and incremental serum insulin and plasma GLP-1 area under the curve (AUC', 'Peak plasma glucose concentrations', 'postprandial hyperglycemia', 'Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1', 'early insulin and GLP-1 secretion', 'postprandial glycemia, insulin, and incretin secretion', 'incremental plasma glucose AUC', 'incremental serum insulin and plasma', 'plasma glucose concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",48.0,0.0188671,"Pre- and postprandial concentrations of blood glucose, insulin, free fatty acid, glucagon, and GLP-1 were evaluated.
","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kawakami', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan. Electronic address: kawakami@u-shizuoka-ken.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Mazuka', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Yagi', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Sawazaki', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Koganei', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Natsume', 'Affiliation': 'Food Microbiology and Function Research Laboratories, R&D Division, Meiji Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kiyonori', 'Initials': 'K', 'LastName': 'Kuriki', 'Affiliation': 'Laboratory of Public Health, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Division of Molecular Medicine, Graduate Division of Pharmaceutical Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Asai', 'Affiliation': 'Asai Clinic, Shizuoka, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Laboratory of Clinical Nutrition and Management, Graduate Division of Nutritional and Environmental Sciences, and Graduate School of Integrated Pharmaceutical and Nutritional Sciences, The University of Shizuoka, Shizuoka, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111128']
1079,33545934,"Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study [CONSORT Compliant].","GOALS


To evaluate safety and efficacy of Bacillus coagulans LBSC [DSM17654] in irritable bowel syndrome (IBS) through a prospective, interventional, randomized, double-blind, and placebo-controlled, CONSORT compliant clinical trial.
BACKGROUND


Bacteriotherapy shows promising impact on alleviating clinical conditions of IBS and associated functional gastrointestinal disorders. B coagulans LBSC is a genetically and phenotypically safe probiotic strain used in this study to study its impact on ameliorating IBS symptoms and improving quality of life.
METHODS


In this interventional, randomized, double-blind, placebo-controlled clinical study, total 40 subjects (18-65 years) were screened through Rome IV criteria and randomized into 2 groups, that is, interventional and placebo arm (n = 20/arm). Similar dosages were received by both the arm, that is, placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. Study completed with per protocol subjects (n = 38) and results were considered to evaluate the primary and secondary endpoints.
RESULTS


Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety. Maximum of ""no symptoms"" cases and mild to moderate gastrointestinal symptoms along with improved stool consistency were from interventional arm tested following IBS severity scoring system and Bristol stool form scale. Upper gastrointestinal endoscopy revealed no clinical difference of gastrointestinal mucosa between both the arms. B coagulans LBSC was well tolerated with no serious adverse events.
CONCLUSIONS


B coagulans LBSC was safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life evaluated.",2021,"RESULTS


Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety.","['total 40 subjects (18-65 years', 'irritable bowel syndrome (IBS', 'irritable bowel syndrome']","['Bacillus coagulans LBSC', 'Bacillus coagulans LBSC [DSM17654', 'interventional and placebo', 'placebo']","['bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety', 'Efficacy and safety', 'gastrointestinal mucosa', 'IBS symptoms and improving quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0314931', 'cui_str': 'Bacteroides coagulans'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226876', 'cui_str': 'Structure of gastrointestinal tract mucous membrane'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.604795,"RESULTS


Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety.","[{'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Probiotics Laboratory, Advanced Enzyme Technologies Ltd., Sun Magnetica, Louiswadi, Thane (W), Maharashtra, India.'}, {'ForeName': 'Chiranjit', 'Initials': 'C', 'LastName': 'Maity', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023641']
1080,33548860,"Nanoparticle albumin-bound paclitaxel with cetuximab and carboplatin as first-line therapy for recurrent or metastatic head and neck cancer: A single-arm, multicenter, phase 2 trial.","OBJECTIVES


Macropinocytosis promotes internalization of albumin into cells to serve as a nutrient supply and is constitutively driven by signaling pathways frequently hyperactivated in head and neck squamous-cell carcinoma (HNSCC). In this way, drugs bound to albumin may selectively target HNSCC. nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel that improves drug delivery into tumor compared to paclitaxel. The primary aim of this single-arm, multicenter, phase 2 trial was to determine if nab-paclitaxel, cetuximab, and carboplatin (CACTUX regimen) would result in longer progression-free survival (PFS) than the historical regimen (EXTREME: 5-fluorouracil, cetuximab, and a platinum).
MATERIALS AND METHODS


Patients with untreated recurrent or metastatic HNSCC received six, three-week cycles of nab-paclitaxel, cetuximab, and carboplatin, followed by maintenance nab-paclitaxel and cetuximab until progression. We hypothesized the median PFS with CACTUX would be 35% longer than with EXTREME (corresponding to 7.6 vs 5.6 months; power 0.80, α = 0.05, one-sided test, n = 70). Secondary outcomes included objective response rate (ORR) and overall survival (OS).
RESULTS


Seventy-four patients enrolled into the trial; seventy were evaluable. The median PFS was 6.1 months (95% CI, 4.1-7.4). The ORR was 60%. Median follow-up was 18 months (IQR: 4.7-23). The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
CONCLUSION


Among patients with recurrent or metastatic HNSCC, CACTUX did not result in a longer PFS than historical EXTREME. However, CACTUX did result in a more favorable ORR and OS.",2021,"The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
","['patients with recurrent or metastatic HNSCC', 'Seventy-four patients enrolled into the trial; seventy were evaluable', 'recurrent or metastatic head and neck cancer', 'head and neck squamous-cell carcinoma (HNSCC', 'Patients with untreated recurrent or metastatic HNSCC received six, three-week cycles of']","['CACTUX', 'nab-paclitaxel', 'Nanoparticle albumin-bound paclitaxel with cetuximab and carboplatin', 'nab-paclitaxel, cetuximab, and carboplatin, followed by maintenance nab-paclitaxel and cetuximab until progression', '5-fluorouracil, cetuximab, and a platinum', 'nab-paclitaxel, cetuximab, and carboplatin (CACTUX regimen']","['longer progression-free survival (PFS', 'median PFS with CACTUX', 'ORR', 'median PFS', 'objective response rate (ORR) and overall survival (OS', 'median OS', 'favorable ORR and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0744619', 'cui_str': 'Head and neck cancer metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",74.0,0.086168,"The median OS was 17.8 months (95% CI, 8.5-21.7) for all patients, and 19.8 months (95% CI, 10.9-22.0) for human papillomavirus (HPV)-related oropharynx SCC and 14.0 months (95% CI, 4.6-23.3) for HPV-unrelated HNSCC.
","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States. Electronic address: dadkins@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Atiq', 'Affiliation': 'Winthrop P. Rockefeller Cancer Institute, University of Arkansas Medical System, Little Rock, AR, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Powell', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, United States.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Spanos', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Sioux Falls, SD, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gitau', 'Affiliation': 'Sanford Cancer Center, Sanford Health, Fargo, ND, United States.'}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Rigden', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Biostatistics Shared Resource, Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, United States; Division of Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105173']
1081,33548749,Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial.,"PURPOSE


In this study, it was aimed to determine the effect of deep tissue massage (DTM) applied by midwife on pain and comfort after cesarean section.
MATERIAL AND METHODS


This study was designed as a randomized controlled trial conducted with experimental and control groups. The data were collected using a personal information form, visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ). DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean. No applications were performed in the control group.
RESULTS


According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
CONCLUSIONS


It was indicated that DTM application decreased the levels of pain and increased the comfort levels of the women who had cesarean sections.",2021,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
",['after cesarean'],"['DTM', 'deep tissue massage (DTM', 'deep tissue massage']","['pain and comfort', 'visual analogue scale (VAS), the Postpartum Comfort Questionnaire (PPCQ', 'levels of pain', 'PPCQ total and sub-dimension mean scores', 'mean VAS score']",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0341934,"According to the measurements, the mean VAS score of the mother in the experimental group was lower than that of the control group (17.51 ± 6.15, 56.16 ± 9.53; respectively) and PPCQ total and sub-dimension mean scores were found to be statistically significant in favor of the experimental group (p < 0.001).
","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Güney', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: esra.guney@inonu.edu.tr.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Uçar', 'Affiliation': 'Inonu University, Department of Midwifery, 44280 Malatya, Turkey. Electronic address: tuba.ucar@inonu.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101320']
1082,33548748,Clinical and phytochemical studies of Plantago major in pressure ulcer treatment: A randomized controlled trial.,"BACKGROUND


Plantago major L. is used by local people to improve various wounds and lesions such as pressure ulcer. In this study, the therapeutic effects of P. major topical formulation on the stage 1 pressure ulcer in patients have been investigated.
MATERIALS AND METHODS


This randomized triple blind clinical trial study was performed on 130 patients. During the 14 days of study, each of the test and control groups was checked according to check list. Also the topical formulation was standardized by HPLC based on the amount of quercetin.
RESULTS


The findings of this study indicated a significant difference in resolution of the damage between the test and control groups. Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
CONCLUSION


The results confirmed the traditional use of P. major in resolution of the damage. CLINICAL TRIAL ID: (IRCT201609209014N117).",2021,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
",['130 patients'],[],[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],130.0,0.0438995,"Topical formulation was standardized by HPLC based on the quercetin (1.88 mg/100g) and no side effects associated with this topical formulation was found.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Ghiasian', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Niroomandi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Dastan', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Zare', 'Affiliation': 'Department of Neurology, School of Medicine, Hamadan University of Medical Science, Hamadan, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ataei', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Medicinal Plants and Natural Products Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: s.ataei@umsha.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101325']
1083,33548747,"Effect of therapeutic touch on daytime sleepiness, stress and fatigue among students of nursing and midwifery: A randomized sham-controlled trial.","OBJECTIVES


This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among students of nursing and midwifery.
METHODS


96 students were randomized into three groups: the therapeutic touch (TT) group, the sham therapeutic touch (STT) group, and the control group. In this randomized sham-controlled study, the TT group was subjected to therapeutic touch twice a week for four weeks with each session lasting 20 min.
RESULTS


When the TT group was compared to the STT and control groups following the intervention, the decrease in the levels of stress (p < 0.001), fatigue (p < 0.001) and daytime sleepiness (p < 0.001), and the increase in the sleep quality (p < 0.001) were found to be significant.
CONCLUSION


It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.",2021,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","['students of nursing and midwifery', '96 students']","['STT', 'therapeutic touch', 'therapeutic touch (TT) group, the sham therapeutic touch (STT']","['stress, daytime sleepiness, sleep quality and fatigue', 'daytime sleepiness', 'levels of stress, fatigue and daytime sleepiness', 'sleep quality', 'fatigue', 'daytime sleepiness, stress and fatigue', 'levels of stress']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",96.0,0.0270069,"It was found that TT, which is one form of complementary therapy, was relatively effective in decreasing the levels of stress, fatigue and daytime sleepiness, and in increasing the sleep quality of university students of nursing and midwifery.","[{'ForeName': 'Birgül', 'Initials': 'B', 'LastName': 'Vural Doğru', 'Affiliation': 'Mersin University, Faculty of Nursing, Internal Nursing Department, Mersin, Turkey. Electronic address: bvuraldogru@gmail.com.'}, {'ForeName': 'Hediye', 'Initials': 'H', 'LastName': 'Utli', 'Affiliation': 'Mardin Artuklu University, Elderly Care Department, Mardin, Turkey. Electronic address: hediyeutli@gmail.com.'}, {'ForeName': 'Fisun', 'Initials': 'F', 'LastName': 'Şenuzun Aykar', 'Affiliation': 'Izmir Tinaztepe University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: fisunsenuzun@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101322']
1084,33548743,Effects of a phonics-based intervention on the reading skills of students with intellectual disability.,"BACKGROUND


To date, only a few studies with randomized controlled trials have been published on the effectiveness of phonics-based reading interventions to teach decoding and spelling skills to students with intellectual disability.
AIMS


This study evaluated the effects of a phonics-based reading intervention program on the progress of French-speaking elementary students with intellectual disability.
METHODS


A total of 48 non decoding elementary students with intellectual disability were randomly assigned to either a treatment group or a control group. Most of the participants (75 %) had nonverbal IQs below 55. The reading intervention program was implemented for seven months by the students' teachers and mainly in a small-group format (two to four students).
RESULTS


Students from the treatment group made significantly more progress in word and nonword reading measured by a researcher-designed test with a medium effect size. An almost significant difference was also found on spelling (p = .058) and on word and nonword reading measured with a standardized test (p = .060) with medium effect sizes.
CONCLUSIONS


These findings suggest that students with ID benefit from phonics-based programs integrating research-based approaches and techniques.",2021,"RESULTS


Students from the treatment group made significantly more progress in word and nonword reading measured by a researcher-designed test with a medium effect size.","['students with intellectual disability', '48 non decoding elementary students with intellectual disability', 'French-speaking elementary students with intellectual disability']","['phonics-based reading intervention program', 'phonics-based intervention']","['nonverbal IQs', 'progress in word and nonword reading']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",48.0,0.0593137,"RESULTS


Students from the treatment group made significantly more progress in word and nonword reading measured by a researcher-designed test with a medium effect size.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sermier Dessemontet', 'Affiliation': 'University of Teacher Education of the State of Vaud, Special Needs Education Unit, Av. de Cour 33, 1014, Lausanne, Switzerland. Electronic address: rachel.sermier@hepl.ch.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'de Chambrier', 'Affiliation': 'University of Teacher Education of the State of Vaud, Special Needs Education Unit, Av. de Cour 33, 1014, Lausanne, Switzerland. Electronic address: anne-francoise.de-chambrier@hepl.ch.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Martinet', 'Affiliation': 'University of Teacher Education of the State of Vaud, Special Needs Education Unit, Av. de Cour 33, 1014, Lausanne, Switzerland. Electronic address: catherine.martinet@hepl.ch.'}, {'ForeName': 'Natalina', 'Initials': 'N', 'LastName': 'Meuli', 'Affiliation': 'University of Teacher Education of the State of Vaud, Special Needs Education Unit, Av. de Cour 33, 1014, Lausanne, Switzerland. Electronic address: natalina.meuli@hepl.ch.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Linder', 'Affiliation': 'University of Teacher Education of the State of Vaud, Special Needs Education Unit, Av. de Cour 33, 1014, Lausanne, Switzerland. Electronic address: anne-laure.linder@hepl.ch.'}]",Research in developmental disabilities,['10.1016/j.ridd.2021.103883']
1085,33516143,"The effects of KaiXinSan on depression and its association with lipid profiles: A randomized, double-blinded, placebo-controlled trial.","BACKGROUND


Traditional Chinese medicine (TCM) KaiXinSan (KXS) has been used to treat depressed patients for a long time, but its potential underlying mechanisms have not been fully understood.
HYPOTHESIS


KXS could mitigate symptoms of patients with atypical depression at least partly via regulating lipid equilibrium.
METHODS


Patients meeting DSM-IV criteria for mild or moderate depression were assigned into placebo (N = 68) or KXS 3.2 g/day (N = 66) groups in a randomized, double-blinded, placebo-controlled, parallel clinical trial to investigate the anti-depressive efficacy of KXS and its association with serum lipid profile.
RESULTS


The HAMD score and SDS score at 8 weeks were significantly improved in KXS-treated patients the N-BACK accuracy rate was also increased after 8 weeks of KXS treatment compared with baseline. These results indicated that KXS not only improved the specific symptoms of depression, but also had a beneficial effect on cognitive function related working memory. More importantly, KXS treatment improved patients' lipid profile by reducing the ratios of LDL/HDL and ApoB/ApoA1 (p < 0.05), as well as ApoC3 level. Moreover, subgroup analysis found that HAMD score was significantly higher in patients with high lipid profile than in those with normal lipid profile, and lipid improvement after 8 weeks of KXS treatment was more obvious in depressed patients with high lipid profile than with normal lipid profile.
CONCLUSION


KXS could mitigate symptoms of patients with minor and modest depression at least partly via regulating lipid equilibrium. Its might shed light that KXS may likely contributes to depressed patients with other cardio-metabolic diseases.",2021,The HAMD score and SDS score at 8 weeks were significantly improved in KXS-treated patients the N-BACK accuracy rate was also increased after 8 weeks of KXS treatment compared with baseline.,"['patients with atypical depression at least partly via regulating lipid equilibrium', 'Patients meeting DSM-IV criteria for mild or moderate depression']","['placebo', 'KaiXinSan', 'KaiXinSan (KXS', 'KXS', 'Traditional Chinese medicine (TCM']","['BACK accuracy rate', 'specific symptoms of depression', 'HAMD score and SDS score', 'ratios of LDL/HDL and ApoB/ApoA1', 'HAMD score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154437', 'cui_str': 'Atypical depressive disorder'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3491954', 'cui_str': 'Kai-Xin-San'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}]",,0.285605,The HAMD score and SDS score at 8 weeks were significantly improved in KXS-treated patients the N-BACK accuracy rate was also increased after 8 weeks of KXS treatment compared with baseline.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Wenshan', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Yuanbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Basic Theory of TCM, College of Basic Medicine Sciences, Guangzhou University of Chinese Medicine. Electronic address: yancan999@sina.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Medical Supplier Center, Chinese PLA General Hospital, Beijing 100853, China. Electronic address: liupingpla@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2021.153467']
1086,33516092,Baseline red blood cell and breast milk DHA levels affect responses to standard dose of DHA in lactating women on a controlled feeding diet.,"BACKGROUND


The importance of providing the newborn infant with docosahexaenoic acid (DHA) from breast milk is well established. However, women in the United States, on average, have breast milk DHA levels of 0.20%, which is below the worldwide average (and proposed target) of >0.32%. Additionally, the relationship between maternal red blood cell (RBC) and breast milk DHA levels may provide insight into the sufficiency of DHA recommendations during lactation. Whether the standard recommendation of at least 200 mg/day of supplemental DHA during lactation is sufficient for most women to achieve a desirable RBC and breast milk DHA status is unknown.
METHODS


Lactating women (n = 27) at about 5 weeks postpartum were enrolled in a 10-12 week controlled feeding study that included randomization to 480 or 930 mg choline/d (diet plus supplementation). As part of the intervention, all participants were required to consume a 200 mg/d of microalgal DHA. RBC and breast milk DHA levels were measured by capillary gas chromatography in an exploratory analysis.
RESULTS


Median RBC DHA was 5.0% (95% CI: 4.3, 5.5) at baseline and 5.1% (4.6, 5.4) after 10 weeks of supplementation (P = 0.6). DHA as a percent of breast milk fatty acids increased from 0.19% (0.18, 0.33) to 0.34% (0.27, 0.38) after supplementation (P<0.05). The proportion of women meeting the target RBC DHA level of >5% was unchanged (52% at baseline and week 10). The proportion of women achieving a breast milk DHA level of >0.32% approximately doubled from 30% to 56% (p = 0.06). Baseline RBC and breast milk DHA levels affected their responses to supplementation. Those with baseline RBC and breast milk DHA levels above the median (5% and 0.19%, respectively) experienced no change or a slight decrease in levels, while those below the median had a significant increase. Choline supplementation did not significantly influence final RBC or breast milk DHA levels.
CONCLUSIONS


On average, the standard prenatal DHA dose of 200 mg/d did not increase RBC DHA but did increase breastmilk DHA over 10 weeks in a cohort of lactating women in a controlled-feeding study. Baseline DHA levels in RBC and breast milk affected the response to DHA supplementation, with lower levels being associated with a greater increase and higher levels with no change or a slight decrease. Additional larger, dose-response DHA trials accounting for usual intakes and baseline DHA status are needed to determine how to best achieve target breast milk DHA levels and to identify additional modifiers of the variable breast milk DHA response to maternal DHA supplementation.",2021,The proportion of women achieving a breast milk DHA level of >0.32% approximately doubled from 30% to 56% (p = 0.06).,"['Lactating women (n\xa0=\xa027) at about 5 weeks postpartum were enrolled in a 10-12 week controlled feeding study that included randomization to 480 or 930\xa0mg', 'lactating women on a controlled feeding diet']","['Choline supplementation', 'docosahexaenoic acid (DHA', 'choline/d (diet plus supplementation']","['RBC DHA', 'Median RBC DHA', 'final RBC or breast milk DHA levels', 'proportion of women meeting the target RBC DHA level', 'breastmilk DHA', 'proportion of women achieving a breast milk DHA level', 'Baseline DHA levels', 'RBC and breast milk DHA levels', 'breast milk DHA levels', 'breast milk fatty acids', 'Baseline RBC and breast milk DHA levels', 'maternal red blood cell (RBC) and breast milk DHA levels']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0556089', 'cui_str': 'Choline supplementation'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",,0.0482707,The proportion of women achieving a breast milk DHA level of >0.32% approximately doubled from 30% to 56% (p = 0.06).,"[{'ForeName': 'Kristina Harris', 'Initials': 'KH', 'LastName': 'Jackson', 'Affiliation': 'OmegaQuant Analytics, LLC. Sioux Falls, SD, 57105, USA; Sanford School of Medicine, University of South Dakota, Sioux Falls, SD, 57105, USA. Electronic address: kristina@omegaquant.com.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Klatt', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, TX, 77030, USA.""}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Caudill', 'Affiliation': 'Division of Nutritional Science, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Melissa Q', 'Initials': 'MQ', 'LastName': 'McDougall', 'Affiliation': 'Division of Nutritional Science, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Allyson A', 'Initials': 'AA', 'LastName': 'West', 'Affiliation': 'Division of Nutritional Science, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Cydne A', 'Initials': 'CA', 'LastName': 'Perry', 'Affiliation': 'Division of Nutritional Science, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Malysheva', 'Affiliation': 'Division of Nutritional Science, Cornell University, Ithaca, NY, 14853, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'Sanford School of Medicine, University of South Dakota, Sioux Falls, SD, 57105, USA; Fatty Acid Research Institute, Sioux Falls, SD, 57105, USA.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2021.102248']
1087,33517738,The PINS Trial: a prospective randomized clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames.,"AIMS


Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.
METHODS


Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system.
RESULTS


Out of 116 patients who were enrolled in the study, 23 patients (40%) in the CHX group and 26 (44%) in the DML group had at least one bad or ugly pin-site infection. This difference was not statistically significant (p = 0.71). There was no significant relationship between pH or hydration of the skin and pin-site infection. The epidermal thickness was found to be significantly greater in patients who had a pin-site infection compared with those who did not (p = 0.01). Skin irritation requiring a change of treatment occurred in four patients (7%) using CHX, and none using DML.
CONCLUSION


We found no significant difference in the incidence of pin-site infection between the CHX and DML treatment groups. Dermol appeared to offer a small but significant advantage in terms of tolerability. We did not find a significant association between patient or treatment related factors and pin-site infection. It is therefore difficult to make specific recommendations based upon these results. The use of either cleaning agent appears to be appropriate. Cite this article:  Bone Joint J  2021;103-B(2):279-285.",2021,The epidermal thickness was found to be significantly greater in patients who had a pin-site infection compared with those who did not (p = 0.01).,"['Patients', 'patients with circular frames', 'patients with a tibial fracture treated with a circular frame', 'patients treated by external fixation', 'Out of 116 patients who were enrolled in the study']","['emollient skincare regimen', 'CHX', 'DML', 'alcoholic chlorhexidine (CHX', '0.5% CHX or Dermol (DML) 500 emollient pin-site care']","['pH or hydration of the skin and pin-site infection', 'incidence of pin-site infection', 'tolerability', 'Skin irritation', 'epidermal thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013983', 'cui_str': 'Emollient'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0578491', 'cui_str': 'Infection by site'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",23.0,0.0480186,The epidermal thickness was found to be significantly greater in patients who had a pin-site infection compared with those who did not (p = 0.01).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ferguson', 'Affiliation': 'Trauma & Orthopaedics, James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harwood', 'Affiliation': 'Limb Reconstruction Unit, Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Orthopaedics, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'United Lincolnshire Hospitals NHS Trust, Lincoln, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Foster', 'Affiliation': 'Limb Reconstruction Unit, Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Limb Reconstruction Unit, Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Moulder', 'Affiliation': 'Orthopaedics, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Sharma', 'Affiliation': 'Orthopaedics, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.'}]",The bone & joint journal,['10.1302/0301-620X.103B2.BJJ-2020-0680.R1']
1088,33517727,Capsular resection versus capsular repair in direct anterior approach for total hip arthroplasty: a randomized controlled trial.,"AIMS


Optimal exposure through the direct anterior approach (DAA) for total hip arthroplasty (THA) conducted on a regular operating theatre table is achieved with a standardized capsular releasing sequence in which the anterior capsule can be preserved or resected. We hypothesized that clinical outcomes and implant positioning would not be different in case a capsular sparing (CS) technique would be compared to capsular resection (CR).
METHODS


In this prospective trial, 219 hips in 190 patients were randomized to either the CS (n = 104) or CR (n = 115) cohort. In the CS cohort, a medial based anterior flap was created and sutured back in place at the end of the procedure. The anterior capsule was resected in the CR cohort. Primary outcome was defined as the difference in patient-reported outcome measures (PROMs) after one year. PROMs (Harris Hip Score (HHS), Hip disability and Osteoarthritis Outcome Score (HOOS), and Short Form 36 Item Health Survey (SF-36)) were collected preoperatively and one year postoperatively. Radiological parameters were analyzed to assess implant positioning and implant ingrowth. Adverse events were monitored.
RESULTS


At one year, there was no difference in HSS (p = 0.728), HOOS (Activity Daily Life, p = 0.347; Pain, p = 0.982; Quality of Life, p = 0.653; Sport, p = 0.994; Symptom, p = 0.459), or SF-36 (p = 0.338). Acetabular component inclination (p = 0.276) and anteversion (p = 0.392) as well as femoral component alignment (p = 0.351) were similar in both groups. There were no dislocations, readmissions, or reoperations in either group. The incidence of psoas tendinitis was six cases in the CS cohort (6%) and six cases in the CR cohort (5%) (p = 0.631).
CONCLUSION


No clinical differences were found between resection or preservation of the anterior capsule when performing a primary THA through the DAA on a regular theatre table. In case of limited visibility during the learning curve, it might be advisable to resect a part of the anterior capsule. Cite this article:  Bone Joint J  2021;103-B(2):321-328.",2021,No clinical differences were found between resection or preservation of the anterior capsule when performing a primary THA through the DAA on a regular theatre table.,"['total hip arthroplasty (THA', '219 hips in 190 patients', 'n = 104) or CR (n = 115) cohort', 'total hip arthroplasty']","['Capsular resection versus capsular repair in direct anterior approach', 'CS', 'direct anterior approach (DAA']","['Harris Hip Score (HHS), Hip disability and Osteoarthritis Outcome Score (HOOS), and Short Form 36 Item Health Survey (SF-36', 'HOOS (Activity Daily Life', 'femoral component alignment', 'dislocations, readmissions, or reoperations', 'incidence of psoas tendinitis', 'Adverse events', 'Acetabular component inclination', 'PROMs ', 'HSS']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0263926', 'cui_str': 'Psoas tendinitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}]",190.0,0.0830577,No clinical differences were found between resection or preservation of the anterior capsule when performing a primary THA through the DAA on a regular theatre table.,"[{'ForeName': 'Frans-Jozef', 'Initials': 'FJ', 'LastName': 'Vandeputte', 'Affiliation': 'Hip Unit, Limburg Orthopaedic Center, East Limburg Hospital, Genk, Belgium.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Vanbiervliet', 'Affiliation': 'Hip Unit, Limburg Orthopaedic Center, East Limburg Hospital, Genk, Belgium.'}, {'ForeName': 'Cigdem', 'Initials': 'C', 'LastName': 'Sarac', 'Affiliation': 'Hip Unit, Limburg Orthopaedic Center, East Limburg Hospital, Genk, Belgium.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Driesen', 'Affiliation': 'Hip Unit, Limburg Orthopaedic Center, East Limburg Hospital, Genk, Belgium.'}, {'ForeName': 'Kristoff', 'Initials': 'K', 'LastName': 'Corten', 'Affiliation': 'Hip Unit, Limburg Orthopaedic Center, East Limburg Hospital, Genk, Belgium.'}]",The bone & joint journal,['10.1302/0301-620X.103B2.BJJ-2020-0529.R2']
1089,33517725,Cast immobilization is non-inferior to volar locking plates in relation to QuickDASH after one year in patients aged 65 years and older: a randomized controlled trial of displaced distal radius fractures.,"AIMS


To compare operative and nonoperative treatment for displaced distal radius fractures in patients aged over 65 years.
METHODS


A total of 100 patients were randomized in this non-inferiority trial, comparing cast immobilization with operation with a volar locking plate. Patients with displaced AO/OTA A and C fractures were eligible if one of the following were found after initial closed reduction: 1) dorsal angulation > 10°; 2) ulnar variance > 3 mm; or 3) intra-articular step-off > 2 mm. Primary outcome measure was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) after 12 months. Secondary outcome measures were the Patient-Rated Wrist and Hand Evaluation (PRWHE), EuroQol-5 dimensions 5-level questionnaire (EQ-5D-5L), range of motion (ROM), grip strength, ""satisfaction with wrist function"" (score 0 to 10), and complications.
RESULTS


In all, 89 women and 11 men were included. Mean age was 74 years (65 to 91). Nonoperative treatment was non-inferior to operation with a five-point difference in median QuickDASH after 12 months (p = 0.206). After three and six months QuickDASH favoured the operative group (p = 0.010 and 0.030). Median values for PRWHE were 19 (interquartile range (IRQ) 10 to 32) in the operative group versus ten (IQR 1 to 31) in the nonoperative group at three months (p = 0.064), nine (IQR 2 to 20) versus five (IQR 0 to 13) (p = 0.020) at six months, and two (IQR 0 to 12) versus zero (IQR 0 to 8) (p = 0.019) after 12 months. Range of motion was similar between the groups. The EQ-5D-5L index score was better (mean difference 0.07) in the operative group at three and 12 months (p = 0.008 and 0.020). The complication rate was similar (p = 0.220). The operated patients were more satisfied with wrist function (median 8 (IQR 6 to 9) vs 6 (IQR 5 to 7) at three months, p = 0.002; 9 (IQR 7 to 9) vs 8 (IQR 6 to 8) at six months, p = 0.002; and 10 (IQR 8 to 10) vs 8 (IQR 7 to 9) at 12 months, p < 0.001).
CONCLUSION


Nonoperative treatment was non-inferior to operative treatment based on QuickDASH after one year. Patients in the operative group had a faster recovery and were more satisfied with wrist function. Results from previous trials comparing operative and nonoperative treatment for displaced distal radius fractures in the elderly vary between favouring the operative group and showing similar results between the treatments. This randomized trial suggests that most elderly patients may be treated nonoperatively. Cite this article:  Bone Joint J  2021;103-B(2):247-255.",2021,Nonoperative treatment was non-inferior to operation with a five-point difference in median QuickDASH after 12 months (p = 0.206).,"['patients aged 65 years and older', '100 patients', 'Mean age was 74 years (65 to 91', '89 women and 11 men were included', 'displaced distal radius fractures in patients aged over 65 years', 'Patients with displaced AO/OTA A and C fractures were eligible if one of the following were found after initial closed reduction: 1) dorsal angulation > 10°; 2) ulnar variance > 3 mm; or 3) intra-articular step-off > 2 mm', 'elderly patients']","['Cast immobilization', 'cast immobilization with operation with a volar locking plate']","['satisfied with wrist function', 'complication rate', 'median QuickDASH', 'EQ-5D-5L index score', 'abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH', 'Patient-Rated Wrist and Hand Evaluation (PRWHE), EuroQol-5 dimensions 5-level questionnaire (EQ-5D-5L), range of motion (ROM), grip strength, ""satisfaction with wrist function"" (score 0 to 10), and complications', 'Median values for PRWHE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0231627', 'cui_str': 'Step-off'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",100.0,0.115125,Nonoperative treatment was non-inferior to operation with a five-point difference in median QuickDASH after 12 months (p = 0.206).,"[{'ForeName': 'Sondre Stafsnes', 'Initials': 'SS', 'LastName': 'Hassellund', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'John Håkon', 'Initials': 'JH', 'LastName': 'Williksen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Marit Mjelde', 'Initials': 'MM', 'LastName': 'Laane', 'Affiliation': 'Department for Radiology and Nuclear Medicine, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Are', 'Initials': 'A', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Carina Paulsen', 'Initials': 'CP', 'LastName': 'Rosales', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Karlsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ullevaal, Oslo, Norway.'}]",The bone & joint journal,['10.1302/0301-620X.103B2.BJJ-2020-0192.R2']
1090,33524515,"Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.","OBJECTIVE


This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA).
DESIGN


120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed.
RESULTS


The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY.
CONCLUSIONS


The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.",2021,"The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group.","['120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV', 'medial knee osteoarthritis (OA', 'medial knee osteoarthritis']","['UCA', 'custom-made knee brace versus usual care', 'ODRA plus usual care (ODRA group) and usual care alone (UCA group', 'ODRA', 'knee brace']","['Drug consumption, compliance, safety of the knee brace, and cost-utility', 'KOOS subscales', 'Effectiveness, safety, and cost-utility', 'changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores', 'VAS pain', 'physical activities', 'change in VAS pain between M0 and M12', 'quality of life', 'analgesics consumption', 'effectiveness, safety, and cost-utility', 'function in activities of daily living']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C1017304', 'cui_str': 'Uca'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",120.0,0.186727,"The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gueugnon', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France. Electronic address: mathieu.gueugnon@chu-dijon.fr.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fournel', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France. Electronic address: isabelle.fournel@chu-dijon.fr.""}, {'ForeName': 'A-L', 'Initials': 'AL', 'LastName': 'Soilly', 'Affiliation': 'Department of Clinical Research, Clinical Research Unit-Methodological Support Network CHU Dijon-Bourgogne, F-21000, Dijon, France. Electronic address: anne-laure.soilly@chu-dijon.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France. Electronic address: harmonie.diaz@chu-dijon.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baulot', 'Affiliation': 'Department of Orthopedic Surgery, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: emmanuel.baulot@chu-dijon.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bussière', 'Affiliation': 'Department of Orthopedic Surgery, Centre Orthopédique Medico-chirugical, Dracy-Le-Fort, France. Electronic address: christophe.bussiere@dracy.fr.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Casillas', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport; Department of Physical Medicine and Rehabilitation, CHU Dijon Bourgogne, F-2100 Dijon, France. Electronic address: jean-marie.casillas@chu-dijon.fr.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cherasse', 'Affiliation': 'Department of Rheumatology, Hospital Center Mâcon, Mâcon, France. Electronic address: AnCHERASSE@ch-macon.fr.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Conrozier', 'Affiliation': 'Department of Rheumatology, Hospital Nord Franche-Comté, Belfort, France. Electronic address: tconrozier@chbm.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Loeuille', 'Affiliation': 'Department of Rheumatology, CHU Nancy, F-54500 Vandoeuvre-lès-Nancy, France INSERM, CIC-EC CIE6, Nancy, France University Hospital of Nancy, Epidemiology and Clinical Evaluation, F-54500 Vandoeuvre-lès-Nancy, France. Electronic address: d.loeuille@chu-nancy.fr.'}, {'ForeName': 'J-F', 'Initials': 'JF', 'LastName': 'Maillefert', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: jean-francis.maillefert@chu-dijon.fr.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mazalovic', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France; Department of General Medicine, Bourgogne Franche-Comté University, UFR des Sciences de Santé, Dijon, France. Electronic address: katia.mazalovic@u-bourgogne.fr.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Timsit', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clinique de Provence Bourbonne, F-13400 Aubagne, France. Electronic address: m.timsit@ramsaygds.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Department of Rheumatology, CHU Besançon EA4266 Bourgogne Franche-Comté University, F-25030 Besançon, France. Electronic address: dwendling@chu-besancon.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramon', 'Affiliation': 'Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France. Electronic address: andre.ramon@chu-dijon.fr.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Binquet', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module EC, CHU Dijon-Bourgogne, Dijon, France. Electronic address: christine.binquet@chu-dijon.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Morisset', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France. Electronic address: claire.morisset@chu-dijon.fr.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ornetti', 'Affiliation': ""INSERM, CIC 1432, Centre D'Investigation Clinique, Module Plurithématique, Plateforme D'Investigation Technologiques, Dijon, France CHU Dijon-Bourgogne, Dijon, France; Department of Rheumatology, CHU Dijon Bourgogne, F-21000 Dijon, France; INSERM UMR 1093-CAPS, Bourgogne Franche-Comté University, UFR des Sciences et Du Sport. Electronic address: paul.ornetti@chu-dijon.fr.""}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.11.009']
1091,33538104,Effect of a new cryotherapy device on an itchy sensation in patients with mild atopic dermatitis.,"BACKGROUND


The existence of an itchy sensation is a common complaint in patients with atopic dermatitis. More therapeutic modalities to address the itchy sensation in atopic dermatitis are still required.
OBJECTIVE


We sought to assess the effect of a new cryotherapy device on the itchy sensation experienced by patients with atopic dermatitis.
METHODS


A total of 28 patients with mild to moderate atopic dermatitis participated in this study. A split-body clinical trial was conducted for 2 months, where one side of each participant was treated with the novel cryotherapy device, and the other side of each participant was observed as a control. The cryotherapy device was set to -5°C and applied for five seconds. We evaluated the visual analog scale (VAS) score for itch at 10, 30, and 60 minutes and at 1, 2 and 8 weeks after cryotherapy application. In addition, the level of patient satisfaction and adverse events were evaluated every visit.
RESULTS


On the day immediately after treatment, the VAS score for itch in the treated-side group was lower following cryotherapy application than as compared within the control-side group. Further, the VAS score for itch in the treated-side group at baseline (before treatment) was higher than at 1, 2 and 8 weeks after treatment. The proportion of patients reporting good or excellent satisfaction was 14.3%. No serious adverse events were recorded.
CONCLUSIONS


The novel cryotherapy tested herein may be a valuable antipruritic therapeutic remedy in patients with atopic dermatitis.",2021,"On the day immediately after treatment, the VAS score for itch in the treated-side group was lower following cryotherapy application than as compared with in the control-side group.","['28 patients with mild to moderate atopic dermatitis', 'patients with mild atopic dermatitis', 'patients with atopic dermatitis']",['new cryotherapy device'],"['VAS score for itch', 'serious adverse events', 'itchy sensation', 'level of patient satisfaction and adverse events', 'proportion of patients reporting good or excellent satisfaction', 'visual analog scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",28.0,0.0206491,"On the day immediately after treatment, the VAS score for itch in the treated-side group was lower following cryotherapy application than as compared with in the control-side group.","[{'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Hyun Ji', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Kyung Duck', 'Initials': 'KD', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Weon Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13975']
1092,33539971,Smoking Behavior in Patients With Early-Stage NSCLC: A Report From ECOG-ACRIN 1505 Trial.,"INTRODUCTION


Smoking cessation has been reported to benefit patients even after a diagnosis of lung cancer. We studied the smoking behavior of patients who participated in a phase 3 trial of adjuvant therapy following resection of stages IB-IIIA NSCLC.
METHODS


The ECOG-ACRIN 1505 was conducted to determine whether the addition of bevacizumab to adjuvant chemotherapy would improve overall survival (OS) for patients with early-stage NSCLC. Studying the association between smoking status and OS was a secondary end point. Patients completed a questionnaire on their smoking habits at baseline, 3, 6, 9, and 12 months.
RESULTS


A total of 1501 patients were enrolled, and 99.8%, 95%, 94%, 93%, and 93% responded to the questionnaire at baseline, 3, 6, 9, and 12 months, respectively. A total of 90% reported a current or previous history of cigarette smoking. In addition, 60% of nonsmokers at enrollment reported smoking after diagnosis (before randomization); however, 1% of them reported smoking at 12 months. Furthermore, 94% of the respondents smoked none/fewer cigarettes daily at 12 months. The incidence of grades 3-5 toxicity on treatment was 68%, 76%, and 72% in never, former, and current smokers, respectively (p = 0.05). The disease-free survival for never-smokers relative to current and former smokers was (hazard ratio [HR] 0.93, p = 0.64 and HR 1.05, p = 0.72), and OS was (adjusted HR for death 0.54, p = 0.005 and adjusted HR for death 0.68, p = 0.03), respectively.
CONCLUSIONS


This is the first comprehensive, prospective report of smoking habits in patients with NSCLC patients from a phase III early-stage trial. There was a high rate of smoking reduction and cessation following study entry. The disease-free survival did not differ significantly between smokers and never smokers, though there were less grade 3-5 toxicities and more favorable OS in never-smokers.",2021,"DFS did not differ significantly between smokers and never smokers, though there were less grade 3-5 toxicities and more favorable OS in never-smokers.","['1501 patients', 'patients who participated in a phase 3 trial of adjuvant therapy following resection of stages IB-IIIA non-small cell lung cancer (NSCLC', 'Patients with Early Stage NSCLC', 'patients with early stage NSCLC']",['bevacizumab to adjuvant chemotherapy'],"['Smoking Behavior', 'overall survival (OS', 'DFS', 'incidence of grades 3-5 toxicity', 'grade 3-5 toxicities', 'disease-free survival (DFS', 'current or previous history of cigarette smoking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",1501.0,0.0482112,"DFS did not differ significantly between smokers and never smokers, though there were less grade 3-5 toxicities and more favorable OS in never-smokers.","[{'ForeName': 'Conor E', 'Initials': 'CE', 'LastName': 'Steuer', 'Affiliation': 'Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia. Electronic address: csteuer@emory.edu.'}, {'ForeName': 'Opeyemi A', 'Initials': 'OA', 'LastName': 'Jegede', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Wakelee', 'Affiliation': 'Stanford University School of Medicine and Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Keller', 'Affiliation': 'Merck, Kenilworth, New Jersey.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Tester', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, California.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Graziano', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Butts', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Schar Cancer Institute, Falls Church, Virginia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.12.017']
1093,33539945,Ibrutinib in Combination with Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients with Metastatic Pancreatic Adenocarcinoma: Phase 3 RESOLVE Study.,"BACKGROUND


First-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) includes nab-paclitaxel/gemcitabine. Ibrutinib, a Bruton's tyrosine kinase inhibitor, exhibits antitumor activity through tumor microenvironment modulation. The safety and efficacy of first-line ibrutinib plus nab-paclitaxel/gemcitabine treatment in patients with PDAC was evaluated.
PATIENTS AND METHODS


RESOLVE (NCT02436668) was a phase 3, randomized, double-blind, placebo-controlled study. Patients (histologically-confirmed PDAC; stage IV diagnosis ≥6 weeks of randomization; Karnofsky performance score ≥70) were randomized to once-daily oral ibrutinib (560 mg) or placebo plus nab-paclitaxel (125 mg/m 2 ) and gemcitabine (1,000 mg/m 2 ). Primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate (ORR) and safety were assessed.
RESULTS


In total, 424 patients were randomized (ibrutinib arm, n=211; placebo arm, n=213). Baseline characteristics were balanced across arms. After median follow-up of 25 months, there was no significant difference in OS between ibrutinib plus nab-paclitaxel/gemcitabine vs placebo plus nab-paclitaxel/gemcitabine (median of 9.7 vs 10.8 months; P=0.3225). PFS was shorter for ibrutinib plus nab-paclitaxel/gemcitabine compared with placebo plus nab-paclitaxel/gemcitabine (median 5.3 vs 6.0 months; P<0.0001). ORRs were 29% and 42%, respectively (P=0.0058). Patients in the ibrutinib arm had less time on treatment and received lower cumulative dose for all agents compared to placebo arm. Most common grade ≥3 adverse events (AEs) for ibrutinib vs placebo arms included neutropenia (24% vs 35%), peripheral sensory neuropathy (17% vs 8%), and anemia (16% vs 17%). Primary reasons for any treatment discontinuation were disease progression and AEs.
CONCLUSIONS


Ibrutinib plus nab-paclitaxel/gemcitabine did not improve OS or PFS for patients with PDAC. Safety was consistent with known profiles for these agents.",2021,Patients in the ibrutinib arm had less time on treatment and received lower cumulative dose for all agents compared to placebo arm.,"['metastatic pancreatic ductal adenocarcinoma (PDAC', '424 patients were randomized (ibrutinib arm, n=211; placebo arm, n=213', 'Patients (histologically-confirmed PDAC; stage IV diagnosis ≥6 weeks of randomization; Karnofsky performance score ≥70', 'patients with PDAC was evaluated', 'Patients with Metastatic Pancreatic Adenocarcinoma', 'patients with PDAC']","['gemcitabine', 'first-line ibrutinib plus nab-paclitaxel/gemcitabine', 'placebo plus nab-paclitaxel', 'placebo', 'Ibrutinib in Combination with Nab-Paclitaxel and Gemcitabine', 'Ibrutinib plus nab-paclitaxel/gemcitabine', 'placebo plus nab-paclitaxel/gemcitabine', 'paclitaxel/gemcitabine vs placebo plus nab-paclitaxel/gemcitabine', 'paclitaxel/gemcitabine']","['PFS', 'disease progression and AEs', 'ORRs', 'anemia', 'OS or PFS', 'OS', 'safety and efficacy', 'peripheral sensory neuropathy', 'overall survival (OS) and investigator-assessed progression-free survival (PFS); overall response rate (ORR) and safety', 'neutropenia']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",424.0,0.392036,Patients in the ibrutinib arm had less time on treatment and received lower cumulative dose for all agents compared to placebo arm.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tempero', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA. Electronic address: Margaret.Tempero@ucsf.edu.'}, {'ForeName': 'D-Y', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UICC, CIBERONC Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reni', 'Affiliation': 'San Raffaele Hospital Scientific Institute, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Gasthuisberg/Leuven & KU Leuven, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'D-T', 'Initials': 'DT', 'LastName': 'Waldschmidt', 'Affiliation': 'University of Cologne, Köln, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'The Royal Marsden, London, United Kingdom.'}, {'ForeName': 'J-B', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'UPMC, Sorbonne University, Pitié Salpêtrière Hospital, APHP, Paris, France.'}, {'ForeName': 'H-M', 'Initials': 'HM', 'LastName': 'Chang', 'Affiliation': 'University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': 'Translational Genomics and Targeted Therapeutics in Solid Tumors Group, IDIBAPS, Hospital Clinic Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': 'Hospital Universitario Doce de Octubre, Imas12, UCM, CNIO, CIBERONC, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Department of Cell, Developmental & Cancer Biology, Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Tsao', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cole', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UICC, CIBERONC Barcelona, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2021.01.070']
1094,33549682,Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial.,"INTRODUCTION


Although African Americans have the highest colorectal cancer (CRC) incidence and mortality rates of any racial group, their screening rates remain low.
STUDY DESIGN/PURPOSE


This randomized controlled trial compared efficacy of two clinic-based interventions for increasing CRC screening among African American primary care patients.
METHODS


African American patients from 11 clinics who were not current with CRC screening were randomized to receive a computer-tailored intervention (n = 335) or a non-tailored brochure (n = 358) designed to promote adherence to CRC screening. Interventions were delivered in clinic immediately prior to a provider visit. Univariate and multivariable logistic regression models analyzed predictors of screening test completion. Moderators and mediators were determined using multivariable linear and logistic regression analyses.
RESULTS


Significant effects of the computer-tailored intervention were observed for completion of a stool blood test (SBT) and completion of any CRC screening test (SBT or colonoscopy). The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant. Predictors of SBT completion were: receipt of the computer-tailored intervention; being seen at a Veterans Affairs Medical Center clinic; baseline stage of adoption; and reason for visit. Mediators of intervention effects were changes in perceived SBT barriers, changes in perceived colonoscopy benefits, changes in CRC knowledge, and patient-provider discussion. Moderators of intervention effects were age, employment, and family/friend recommendation of screening.
CONCLUSION


This one-time computer-tailored intervention significantly improved CRC screening rates among low-income African American patients. This finding was largely driven by increasing SBT but the impact of the intervention on colonoscopy screening was strong. Implementation of a CRC screening quality improvement program in the VA site that included provision of stool blood test kits and follow-up likely contributed to the strong intervention effect observed at that site. The trial is registered at ClinicalTrials.gov as NCT00672828.",2021,The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant.,"['African American primary care patients', 'low-income African Americans in primary care', 'low-income African American patients', 'African American patients from 11 clinics who were not current with CRC screening']","['clinic-based interventions', 'computer-tailored intervention (n\u202f=\u202f335) or a non-tailored brochure (n\u202f=\u202f358) designed to promote adherence to CRC screening', 'Computer-tailored intervention']","['completion of a stool blood test (SBT) and completion of any CRC screening test (SBT or colonoscopy', 'colonoscopy screening rate', 'SBT barriers, changes in perceived colonoscopy benefits, changes in CRC knowledge, and patient-provider discussion', 'colorectal cancer screening', 'CRC screening rates', 'highest colorectal cancer (CRC) incidence and mortality rates']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0272823,The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States of America; Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, United States of America. Electronic address: srawl@iu.edu.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Christy', 'Affiliation': 'Division of Population Science, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, United States of America; Morsani College of Medicine, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Perkins', 'Affiliation': 'Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, United States of America; Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Krier', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States of America.'}, {'ForeName': 'Hsiao-Lan', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, United States of America.'}, {'ForeName': 'Amelia M', 'Initials': 'AM', 'LastName': 'Huang', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Laury', 'Affiliation': 'Villanova University M. Louise Fitzpatrick College of Nursing, Villanova, PA, United States of America.'}, {'ForeName': 'Broderick', 'Initials': 'B', 'LastName': 'Rhyant', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lloyd', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Deanna R', 'Initials': 'DR', 'LastName': 'Willis', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Imperiale', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America; Roudebush Veterans Affairs Medical Center, Indianapolis, IN, United States of America.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, United States of America; Roudebush Veterans Affairs Medical Center, Indianapolis, IN, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Springston', 'Affiliation': 'Grady College of Journalism and Mass Communication, University of Georgia, Athens, Georgia.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'University of Texas Southwestern Medical Center & Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States of America; Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2021.106449']
1095,33546069,"CONSORT the effect of a bolus dose of dexmedetomidine on postoperative pain, agitation, and quality of recovery after laparoscopic cholecystectomy.","BACKGROUND


The perioperative administration of dexmedetomidine may improve the quality of recovery (QoR) after major abdominal and spinal surgeries. We evaluated the effect of an intraoperative bolus of dexmedetomidine on postoperative pain, emergence agitation, and the QoR after laparoscopic cholecystectomy.
METHODS


Patients undergoing elective laparoscopic cholecystectomy were randomized to receive dexmedetomidine 0.5 μg/kg 5 minutes after anesthesia induction (dexmedetomidine group, n = 45) or normal saline (control group, n = 45). The primary outcome was the QoR at the first postoperative day using a 40-item scoring system (QoR-40). Secondary outcomes included intraoperative hemodynamic parameters, postoperative agitation, pain, and nausea and vomiting.
RESULTS


The heart rate and the mean blood pressure were significantly lower in the dexmedetomidine group than in the control group (P < .001 and .007, respectively). During extubation, emergence agitation was significantly lower in the dexmedetomidine group than in the control group (23% vs 64%, P < .001). The median pain scores in the post-anesthetic care unit were significantly lower in the dexmedetomidine group than in the control group (4 [2-7] vs 5 [4-7], P = .034). The incidence of postoperative agitation, pain, and nausea and vomiting was not different between the groups. On the first postoperative day, recovery profile was similar between the groups. However, the scores on the emotional state and physical comfort dimensions were significantly higher in the dexmedetomidine group than in the control group (P = .038 and .040, respectively).
CONCLUSIONS


A bolus dose of dexmedetomidine after anesthesia induction may improve intraoperative hemodynamics, emergence agitation, and immediate postoperative analgesia. However, it does not affect overall QoR-40 score after laparoscopic cholecystectomy.",2021,"The heart rate and the mean blood pressure were significantly lower in the dexmedetomidine group than in the control group (P < .001 and .007, respectively).",['Patients undergoing elective laparoscopic cholecystectomy'],"['dexmedetomidine', 'dexmedetomidine 0.5\u200aμg/kg 5 minutes after anesthesia induction (dexmedetomidine group, n\u200a=\u200a45) or normal saline (control group, n\u200a=\u200a45']","['heart rate and the mean blood pressure', 'median pain scores', 'postoperative agitation, pain, and nausea and vomiting', 'intraoperative hemodynamic parameters, postoperative agitation, pain, and nausea and vomiting', 'emergence agitation', 'QoR at the first postoperative day using a 40-item scoring system (QoR-40', 'overall QoR-40 score', 'emotional state and physical comfort dimensions', 'quality of recovery (QoR', 'postoperative pain, agitation, and quality of recovery', 'intraoperative hemodynamics, emergence agitation, and immediate postoperative analgesia', 'postoperative pain, emergence agitation, and the QoR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0857125', 'cui_str': 'Immediate postoperative analgesia'}]",,0.221171,"The heart rate and the mean blood pressure were significantly lower in the dexmedetomidine group than in the control group (P < .001 and .007, respectively).","[{'ForeName': 'Jung Ju', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}, {'ForeName': 'Kyungmi', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}, {'ForeName': 'Kwan Yeong', 'Initials': 'KY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center, Incheon.'}]",Medicine,['10.1097/MD.0000000000024353']
1096,33544989,Antimicrobial effects of silver diamine fluoride: An in vivo study.,"PURPOSE


To compare the antimicrobial effect of treating dentin caries lesions with silver diamine fluoride (SDF) in different concentrations and chlorhexidine (CHX).
METHODS


Children aged 7-10 years presenting one occlusal dentin carious lesion in primary molars were selected, totaling 40 teeth. The sample was randomly divided into four groups: (G1) 38%-SDF + potassium iodide (KI); (G2) 30%-SDF; (G3) 2%-CHX; and (G4) control group. After cleaning the cavity up to firm dentin, a sample of dentin from the pulp wall was collected; the cavity was then treated with the antimicrobial agent tested and, immediately after, another dentin sample was collected. Cavities were restored with high viscosity glass ionomer cement. Microorganisms were counted, and species from the Streptococcus genus were analyzed for susceptibility to antimicrobial agents. Shapiro-Wilk and Levene's tests were used to assess normality and homogeneity, respectively. Student's t-test, two-way ANOVA, and Bonferroni post-test were applied for multiple comparisons.
RESULTS


For the overall microorganisms count, it was observed that G1 and G2 presented a statistically lower number of microorganisms following treatment in comparison to G3 and G4 (P< 0.05). When analyzing the Streptococcus spp. and Enterococcus sp. separately, a statistical reduction in the microorganism count before and after the treatment was observed for all groups (P< 0.05), excluding the control group. Among the species tested, S. mutans were the least susceptible to SDF treatments compared to the other species. The treatments with SDF were more effective in reducing microorganisms when compared to CHX. Similarly, the susceptibility of Streptococcus to CHX was lower than that observed for SDF.
CLINICAL SIGNIFICANCE


In cases where the dental professional decides to apply an antimicrobial agent prior to the placement of a restoration, silver diamine fluoride proved to be more effective than chlorhexidine, slowing the progression of carious lesions, and possibly preventing future restorative interventions thus improving children's quality of life. It is important to note that clinicians should consider the type of restorative material that will be used due to the possibility that the use of SDF may influence adhesion of the subsequent restoration.",2021,"For the overall microorganisms count, it was observed that G1 and G2 presented a statistically lower number of microorganisms following treatment in comparison to G3 and G4 (P< 0.05).","['Children aged 7-10 years presenting one occlusal dentin carious lesion in primary molars were selected, totaling 40 teeth']","['SDF', '38%-SDF + potassium iodide (KI); (G2) 30%-SDF; (G3) 2%-CHX; and (G4) control group', 'chlorhexidine (CHX', 'chlorhexidine', 'desensitizing products', 'silver diamine fluoride (SDF']","['number of microorganisms', 'microorganism count', 'susceptibility of Streptococcus to CHX']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0032831', 'cui_str': 'Potassium Iodide'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]",,0.0230757,"For the overall microorganisms count, it was observed that G1 and G2 presented a statistically lower number of microorganisms following treatment in comparison to G3 and G4 (P< 0.05).","[{'ForeName': 'Érica TdeA', 'Initials': 'ÉT', 'LastName': 'Piovesan', 'Affiliation': 'Department of Dentistry, Faculty of Health Science, University of Brasilia, Brasilia, Brazil, ericatorresa@hotmail.com.'}, {'ForeName': 'Marly Vs', 'Initials': 'MV', 'LastName': 'Silva', 'Affiliation': 'Department of Dentistry, Faculty of Health Science, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Tatiana A', 'Initials': 'TA', 'LastName': 'de Campos', 'Affiliation': 'Department of Cellular Biology, Institute of Biological Sciences, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Vicente deP', 'Initials': 'VD', 'LastName': 'Martins', 'Affiliation': 'Department of Cellular Biology, Institute of Biological Sciences, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Ana Cristina B', 'Initials': 'ACB', 'LastName': 'Bezzerra', 'Affiliation': 'Department of Dentistry, Faculty of Health Science, University of Brasilia, Brasilia, Brazil.'}]",American journal of dentistry,[]
1097,33550718,"Treatment of periorbital and perioral wrinkles with fractional Er:YAG laser: What are the effects of age, smoking, and Glogau stage?","BACKGROUND


Dynamic and static wrinkling are observed on the facial skin as a result of aging. Previously, it was showed that fractional Er:YAG laser was effective in the treatment of facial wrinkles.
AIMS


The aims of this study are to determine the effects of age, Glogau stage, and smoking status on the treatment efficacy of fractional Er:YAG laser; and to compare the success of laser treatment on periorbital wrinkles with perioral wrinkles.
MATERIAL/METHOD


Periorbital and perioral wrinkles of the same patient were treated with fractional Er:YAG laser (2940 nm) for 4 sessions with monthly intervals. Treatment parameters were affluence of 1.5J, a spot size of 7 mm, and a frequency of 5 Hz. Treatment efficacy was evaluated by a blinded physician evaluation scale and patient satisfaction scale 2 months after the final treatment session.
RESULTS


Fifteen patients completed the study. The mean age of the patients was 42.8 years. The blinded physician evaluation of the improvement in the periorbital wrinkles decreased (P =.034) and the patient satisfaction in perioral wrinkles decreased (P =.049) with increasing age. The relationship between smoking and patient satisfaction in the treatment of periorbital wrinkles was also statistically significant (P =.014). No difference in terms of treatment efficacy was found between periorbital and perioral regions.
CONCLUSION


Fractional Er:YAG laser (2940 nm) is equally successful in the treatment of periorbital and perioral wrinkles. The treatment success decreases with smoking and increasing age.",2021,The blinded physician evaluation of the improvement in the periorbital wrinkles decreased (p= 0.034) and the patient satisfaction in perioral wrinkles decreased (p=0.049) with increasing age.,"['Periorbital and perioral wrinkles of the same patient were treated with', 'Fifteen patients completed the study']","['fractional er', 'fractional Er:YAG laser', 'Fractional Er:YAG laser (2940 nm', 'yag laser']","['periorbital wrinkles', 'spot size of 7 mm and a frequency of 5 Hz', 'treatment efficacy', 'patient satisfaction in perioral wrinkles']","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}]","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}]",,0.0209911,The blinded physician evaluation of the improvement in the periorbital wrinkles decreased (p= 0.034) and the patient satisfaction in perioral wrinkles decreased (p=0.049) with increasing age.,"[{'ForeName': 'Defne', 'Initials': 'D', 'LastName': 'Özkoca', 'Affiliation': 'Cerrahpaşa Medical Faculty, Department of Dermatology and Venerology, İstanbul University-Cerrahpaşa, İstanbul, Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Aşkın', 'Affiliation': 'Cerrahpaşa Medical Faculty, Department of Dermatology and Venerology, İstanbul University-Cerrahpaşa, İstanbul, Turkey.'}, {'ForeName': 'Burhan', 'Initials': 'B', 'LastName': 'Engin', 'Affiliation': 'Cerrahpaşa Medical Faculty, Department of Dermatology and Venerology, İstanbul University-Cerrahpaşa, İstanbul, Turkey.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13984']
1098,33550716,Analgesic effect of topical lidocaine is enhanced by cold atmospheric plasma pretreatment in facial CO 2  laser treatments.,"BACKGROUND


Topical anesthesia is widely used in many dermatological and cosmetic procedures. Nevertheless, the stratum corneum serves as the skin barrier, impedes the transdermal drug delivery greatly, and results in insufficient analgesia. Cold atmospheric plasma (CAP) has been researched as a transdermal drug delivery promoter with ex vivo experiments for a few years, while clinical trials are scarce.
AIMS


To assess the efficacy and safety of CAP as a pretreatment to improve the transdermal absorption of topical anesthetic cream before the CO 2  laser treatment for postacne scars in the human body.
PATIENTS/METHODS


Twenty patients, seeking full facial laser treatment for atrophic acne scars, underwent a randomized split-face study. One side of the face was pretreated by CAP before topical anesthetic cream was applied, and the other side was applied with topical anesthetic cream only as control. After that, the subjects went through full-face fractional CO 2  laser treatment of postacne scars. They were asked to score the pain on a visual analogue scale (VAS) after the laser treatment to measure the anesthesia effects which indicates the transdermal absorption of the cream. Possible adverse effects of the plasma were recorded during the pretreatment including associated pain, heat, erythema, and edema.
RESULTS


The VAS score of the treated side was statistically lower (5.1 ± 2.1) compared with the nontreated side (6.3 ± 1.9), with a mean difference of 1.3 (95% confidence interval [CI], 0.6-1.9; P < .0001). No severe adverse event was reported, and all the disturbing sensations and symptoms (pain, heat, and edema) were evaluated as mild with no mean score surpassing 4.0.
CONCLUSION


Plasma pretreatment of 5 minutes before topical anesthetic cream application gives significant pain reduction during the laser procedures, showing the potential effects of CAP on promoting transdermal drug delivery, with no obvious adverse effects reported.",2021,"No severe adverse event was reported and all the disturbing sensations and symptoms (pain, heat, and edema) were evaluated as mild with no mean score surpassing 4.0.
","['Twenty patients, seeking full facial laser treatment for atrophic acne scars', 'post acne scars in the human body', 'Facial CO 2  Laser Treatments']","['CAP', 'Cold atmospheric plasma (CAP', 'Topical Lidocaine']","['disturbing sensations and symptoms (pain, heat, and edema', 'associated pain, heat, erythema, and edema', 'pain reduction', 'severe adverse event', 'visual analogue scale (VAS', 'VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0242821', 'cui_str': 'Body, Human'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0321887,"No severe adverse event was reported and all the disturbing sensations and symptoms (pain, heat, and edema) were evaluated as mild with no mean score surpassing 4.0.
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatovenereology, West China Hospital, Sichuan University, Chengdu, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13983']
1099,33560633,Sleep and Activity Patterns Are Altered During Early Critical Illness in Mechanically Ventilated Adults.,"BACKGROUND


Mechanically ventilated (MV) patients in the intensive care unit (ICU) often experience disturbed sleep and profound inactivity.
OBJECTIVES


The aim of this study was to report 5 consecutive days' descriptive analyses on sleep efficiency (SE), total sleep time (TST), daytime activity ratio (DAR), and hourly activity counts among critically ill MV adults from 9 ICUs across 2 hospitals.
METHODS


A secondary analysis was undertaken from our parent National Institutes of Health-funded randomized controlled trial (NIH R01 NR016702). Subjects included 31 critically ill patients from multiple ICUs. Wrist actigraphy estimated SE and TST. Mean DAR, an indicator of altered sleep-wake cycles, was calculated. Continuous 24-hour activity counts over 5 consecutive days were summarized. Descriptive analyses were used.
RESULTS


A total of 31 subjects with complete actigraphy data were included. Mean age was 59.6 (SD, 17.3) years; 41.9% were male; 83.9% were White, and 67.7% were Hispanic/Latino; and the mean APACHE III (Acute Physiology and Chronic Health Evaluation III) severity of illness score was 74.5 (SD, 25.5). The mean nighttime SE and TST over the 5-day ICU period were 83.1% (SD, 16.14%) and 6.6 (SD, 1.3) hours, respectively. The mean DAR over the 5-day ICU period was 66.5% (SD, 19.2%). The DAR surpassed 80% on only 17.5% of subject days. The majority of subjects' activity level was low, falling below 1000 activity counts per hour.
CONCLUSION


Our study revealed poor rest-activity cycle consolidation among critically ill MV patients during the early ICU period. Future interventional studies should promote quality sleep at nighttime and promote mobilization during the daytime.",2021,The DAR surpassed 80% on only 17.5% of subject days.,"['Mechanically Ventilated Adults', 'critically ill MV patients during the early ICU period', '31 subjects with complete actigraphy data were included', 'Subjects included 31 critically ill patients from multiple ICUs', 'critically ill MV adults from 9 ICUs across 2 hospitals', 'Mean age was 59.6 (SD, 17.3) years; 41.9% were male; 83.9% were White, and 67.7% were Hispanic/Latino; and the', 'Mechanically ventilated (MV) patients in the intensive care unit (ICU) often experience disturbed sleep and profound inactivity']",[],"['mean nighttime SE and TST', ""majority of subjects' activity level"", 'mean APACHE III (Acute Physiology and Chronic Health Evaluation III) severity of illness score', 'sleep efficiency (SE), total sleep time (TST), daytime activity ratio (DAR), and hourly activity counts', 'Continuous 24-hour activity counts', 'mean DAR', 'Mean DAR']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439808', 'cui_str': 'Profound'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243029', 'cui_str': 'APACHE III'}, {'cui': 'C0450980', 'cui_str': 'Acute physiology and chronic health evaluation III'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",31.0,0.0724768,The DAR surpassed 80% on only 17.5% of subject days.,"[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Munro', 'Affiliation': ''}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Maya N', 'Initials': 'MN', 'LastName': 'Elías', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Xusheng', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Calero', 'Affiliation': ''}]",Dimensions of critical care nursing : DCCN,['10.1097/DCC.0000000000000455']
1100,33524283,"In women aged 40 to 48 y, annual mammography vs. usual care reduced breast cancer mortality at 10 but not 23 y.","SOURCE CITATION


Duffy SW, Vulkan D, Cuckle H, et al.  Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.  Lancet Oncol. 2020;21:1165-72. 32800099.",2021,"SOURCE CITATION


Duffy SW, Vulkan D, Cuckle H, et al.  ","['women aged 40 to 48 y, annual mammography vs. usual care reduced breast cancer mortality at 10 but not 23', 'from age 40 years on breast cancer mortality (UK Age trial']",['mammographic screening'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",[],,0.0522119,"SOURCE CITATION


Duffy SW, Vulkan D, Cuckle H, et al.  ","[{'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Batur', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA (P.B.).'}]",Annals of internal medicine,['10.7326/ACPJ202102160-018']
1101,33540298,"The effect on gastrointestinal system functions, pain and anxiety of acupressure applied following laparoscopic cholecystectomy operation: A randomised, placebo-controlled study.","The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 min, as 3 min at each of the ST25, CV12, TH6, and HT7 acupuncture points, at 0, 4 and 8 h after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 h postoperatively. The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05). The application of acupressure can be recommended in the nursing interventions following laparoscopic cholecystectomy to reduce acute pain and shorten the time to defecation.",2021,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,[],"['laparoscopic cholecystectomy operation', 'placebo', 'acupressure']","['acute postoperative pain', 'gastrointestinal system functions, pain and anxiety of acupressure', 'Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory', 'GIS symptoms, pain and anxiety of acupressure', 'time to first flatus and defecation, pain and the State-Trait Anxiety points']",[],"[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.05456,The application of acupressure was determined to have signficantly reduced acute postoperative pain and shortened the time to defecation (p < 0.05).,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Soylu', 'Affiliation': 'Erciyes University, Institute of Health Sciences, Surgical Nursing, Kayseri, Turkey. Electronic address: dsoylu@ksu.edu.tr.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Tekinsoy Kartın', 'Affiliation': 'Erciyes University, Faculty of Health Sciences, Nursing Department, Kayseri, Turkey. Electronic address: ptekinsoy@erciyes.edu.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101304']
1102,33545096,"Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.","BACKGROUND


Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.
METHODS


In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
FINDINGS


Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0·97, 95% CI 0·87-1·07; p=0·50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98-1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0·95, 95% CI 0·87-1·03; p=0·24).
INTERPRETATION


In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication.
FUNDING


UK Research and Innovation (Medical Research Council) and National Institute of Health Research.",2021,"No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98-1·10; p=0·19).","['mean age of these study participants was 65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763', 'patients admitted to hospital with COVID-19 (RECOVERY', 'Eligible and consenting patients', 'Between April 7 and Nov 27, 2020, of 16\u2008442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of', '176 hospitals in the UK', 'and 5181 patients', '2582 patients', 'patients admitted to hospital with COVID-19', 'patients admitted to hospital with COVID-19 in the UK']","['Azithromycin', 'usual standard of care alone or usual standard of care plus azithromycin', 'azithromycin', 'usual care alone']","['survival', 'invasive mechanical ventilation or death', 'safety and efficacy', 'duration of hospital stay', '28-day all-cause mortality, assessed in the intention-to-treat population']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",2582.0,0.197866,"No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98-1·10; p=0·19).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00149-5']
1103,33524440,"Watching, keeping and squeezing time to lose weight: Implications of time-restricted eating in daily life.","Time-restricted eating (TRE) is a novel intervention that allows eating and drinking within a certain time window and has shown positive effects on body weight in few studies. Weight loss strategies that easily can be integrated into daily life are needed, but knowledge about how TRE affects daily life is lacking. This study examined how individuals having overweight or obesity at high risk of type 2 diabetes performed TRE in daily life, with a focus on how the timing of eating changed the organisation and rhythms of daily activities. Semi-structured interviews were conducted with participants enrolled in a randomised controlled trial studying the effect of a 12-week TRE intervention focusing on a self-selected daily 10-h window between 6 AM and 8 PM. Seventeen participants from the intervention group were interviewed at baseline and end of intervention, and data were analysed using a thematic analysis approach. Participants found TRE simple and appealing due to the unrestricted dietary intake. In general, participants did not change their food preferences and continued to eat three main daily meals. However, participants had to increase their awareness of the time of day, reshuffle ordinary daily activities and plan their intake more carefully. Two participants reported fully adherence every day, whereas all other participants reported one to several episodes of intake outside their window during the 12 weeks. Social evening activities and collective rhythms were largest barriers. Our findings suggest that TRE interventions would benefit from a broader perspective on daily life and an expanded view on families and friends as joint units of intervention. TRE interventions should consider individuals' daily rhythms and help them develop practical solutions to integrating new eating practices.",2021,Semi-structured interviews were conducted with participants enrolled in a randomised controlled trial studying the effect of a 12-week TRE intervention focusing on a self-selected daily 10-h window between 6 AM and 8 PM.,['individuals having overweight or obesity at high risk of type 2 diabetes performed'],"['Time-restricted eating (TRE', 'TRE interventions', 'TRE', 'TRE intervention focusing on a self-selected daily 10-h window between 6 AM and 8 PM']","['awareness of the time of day, reshuffle ordinary daily activities and plan their intake more carefully', 'several episodes of intake outside their window', 'Social evening activities and collective rhythms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439548', 'cui_str': 'Temporal periods of day'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205172', 'cui_str': 'More'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0494298,Semi-structured interviews were conducted with participants enrolled in a randomised controlled trial studying the effect of a 12-week TRE intervention focusing on a self-selected daily 10-h window between 6 AM and 8 PM.,"[{'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Bjerre', 'Affiliation': 'Health Promotion Research Unit, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, Gentofte, Denmark; Department of Food and Resource Economics, University of Copenhagen, Rolighedsvej 25, Frederiksberg, Denmark. Electronic address: Natasja.bjerre.martinsen@regionh.dk.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Holm', 'Affiliation': 'Department of Food and Resource Economics, University of Copenhagen, Rolighedsvej 25, Frederiksberg, Denmark. Electronic address: Loho@ifro.ku.dk.'}, {'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Clinical Research Unit, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, Gentofte, Denmark. Electronic address: Jonas.salling.quist@regionh.dk.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Clinical Research Unit, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, Gentofte, Denmark; Department of Biomedical Sciences, University of Copenhagen, Blegdamsvej 3B, Copenhagen, Denmark. Electronic address: Kristine.faerch@regionh.dk.'}, {'ForeName': 'Nana Folmann', 'Initials': 'NF', 'LastName': 'Hempler', 'Affiliation': 'Health Promotion Research Unit, Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, Gentofte, Denmark. Electronic address: Nana.folmann.hempler@regionh.dk.'}]",Appetite,['10.1016/j.appet.2021.105138']
1104,33550193,"The effect of rosemary essential oil inhalation on sleepiness and alertness of shift-working nurses: A randomized, controlled field trial.","BACKGROUND


Sleepiness during the night shift is a common complaint of shift workers, including the nurses. This study investigated the effects of inhaled rosemary oil on sleepiness and alertness of shift-working nurses.
METHODS


Eighty shift-working nurses were selected and assigned randomly into control (n = 40) and intervention (n = 40) groups. Both groups completed the Karolinska Sleep Questionnaire and Epworth Sleepiness Survey before the intervention. The intervention group received one drop of rosemary essential oil using a mask. The control group received a drop of distilled water instead, after which the questionnaires were completed for a second time.
RESULTS


The sleepiness mean score in the intervention group reduced from 12.15 to 8.3, while it increased from 11.41 to 13.76 in the control group (P < 0.001). The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
CONCLUSION


Rosemary aroma decreased sleepiness and increased alertness in shift-working nurses.",2021,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","['sleepiness and alertness of shift-working nurses', 'Eighty shift-working nurses', 'n\xa0=\xa040) and intervention (n\xa0=\xa040']","['Rosemary aroma', 'rosemary essential oil using a mask', 'rosemary essential oil inhalation', 'inhaled rosemary oil']","['sleepiness mean score', 'Karolinska Sleep Questionnaire and Epworth Sleepiness Survey', 'alertness mean scores', 'sleepiness and increased alertness']","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0939869', 'cui_str': 'rosemary extract'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304114', 'cui_str': 'rosemary oil'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0394962,"The alertness mean scores changed from 4.45 to 3.25 and from 4.41 to 5.34 in intervention and control groups, respectively (P < 0.001).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Nasiri', 'Affiliation': 'Medical Toxicology and Drug Abuse Research Center (MTDRC), Birjand University of Medical Sciences, Birjand, Iran. Electronic address: nasiri2006@bums.ac.ir.'}, {'ForeName': ""Masoomeh Mo'tamed"", 'Initials': 'MM', 'LastName': 'Boroomand', 'Affiliation': 'MScN, Department of Nursing, Nursing and Midwifery Faculty, Birjand University of Medical Sciences, Birjand, Iran. Electronic address: motamed@bums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2021.101326']
1105,33550146,Effects of mechanical thrombectomy for post-stroke patients with upper limb hemiparesis: Use of Propensity Score Matching.,"BACKGROUND


Mechanical Thrombectomy (MT) is a recommended approach for post-cerebral ischemia in acute settings. Although a large amount of evidence suggests the use of MT, existing evidence has primarily focused on assessing lower limb performance or gait performance as an outcome measure.
METHODS


This study was to investigate whether MT would be an effective approach for improving upper limb performance in post-stroke patients.This case control was divided into two groups: 154 patients as a control group only given conventional rehabilitation; and 25 patients as an intervention group given MT and conventional rehabilitation. Outcome variables were measured by calculating the change of Fugl-Meyer Assessment score at the last intervention compared with the beginning of the intervention.
RESULT


By comparing the FMA scores after, the propensity matching compared between before receiving therapy intervention and after, the intervention group showed as follows: 30.4 ± 26.4-44.3 ± 25.4, p = 0.0019, r = 0.59. The control group showed as follows: 39.9 ± 24.1-49.1 ± 21.3, p = 0.002, r = 0.69. Lastly, a comparison of the intervention group with the control group about their FMA score change indicates as follows: intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
CONCLUSION


This study indicated that there was no significant difference between MT and a conventional approach for improving UE function. However, this is the first study to investigate the course of recovery of UE function in the acute phase after MT, and this finding supports the need for further research.",2021,"intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
","['post-stroke patients with upper limb hemiparesis', 'post-stroke patients']","['Mechanical Thrombectomy (MT', 'mechanical thrombectomy', 'MT', 'intervention group given MT and conventional rehabilitation', 'control group only given conventional rehabilitation']","['change of Fugl-Meyer Assessment score', 'FMA score change', 'UE function', 'upper limb performance', 'FMA scores']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",,0.0525222,"intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15.
","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Tokuda', 'Affiliation': 'Department of Rehabilitation, Hanwa Memorial Hospital, Osaka, Japan. Electronic address: tkdka3377@gmail.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takebayashi', 'Affiliation': 'School of Comprehensive Rehabilitation, College of Health and Human Science, Osaka Prefecture University, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Koyama', 'Affiliation': 'Department of Cranial Nerve Surgery, Hanwa Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cranial Nerve Surgery, Hanwa Memorial Hospital, Osaka, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hanada', 'Affiliation': 'Department of Rehabilitation, Suisyokai Murata Hospital, Osaka, Japan.'}, {'ForeName': 'Yuho', 'Initials': 'Y', 'LastName': 'Okita', 'Affiliation': 'Soaring Health Sports, Wellness & Community Centre, Melbourne, Australia.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106520']
1106,33549862,Influence of Thermal and Gustatory Stimulus in the Initiation of the Pharyngeal Swallow and Bolus Location Instroke.,"INTRODUCTION/OBJECTIVE


The aim of this study is to analyze the influence of sour taste and cold temperature in the initiation of the pharyngeal swallow (IPS) and bolus location at pharyngeal swallow onset in individuals after stroke.
METHODS


Cross-sectional prospective study. The study included 52 individuals with unilateral ischemic stroke. Each individual was assessed by videofluoroscopic swallowing study with 5ml of paste bolus offering four different stimuli (natural, cold, sour, and sour-cold). The individuals were divided into two groups according to the offer sequence. Group 1 (G1) - received a randomized sequence of stimuli (24 individuals), and Group 2 (G2) -the stimuli were offered in the following order: natural, cold, sour, and sour-cold(28 individuals). The IPS time and bolus location at pharyngeal swallow onset were analyzed. The bolus location at pharyngeal swallow onset was defined using six different levels.
RESULTS


Individuals in G1 did not show a significant difference in IPS time between stimuli. However, individuals in G2 presented a significantly shorter IPS time with the sour and sour-cold stimuli than with natural or cold stimuli. The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups. On the other hand, in the G2 it was observed higher frequency of swallowing with sour-cold stimulus at level 1 (the bolus head was located in any region between the fauces pillar and the point where the tongue crosses the inferior border of the mandible).
CONCLUSION


The sour and sour-cold stimuli influenced the IPS time when they were offered in a sequential order. Moreover, both the IPS time and bolus location at pharyngeal swallow onset were not influenced by the sour and sour cold-bolus when offered in a random sequence.",2021,The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups.,"['individuals after stroke', '52 individuals with unilateral ischemic stroke']",[],"['IPS time', 'IPS time and bolus location at pharyngeal swallow onset']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",52.0,0.0197181,The bolus location at pharyngeal swallow onset did not show significant difference between stimuli in both groups.,"[{'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Gatto', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP, Botucatu SP, Brazil. Electronic address: rg.silva@unesp.br.'}, {'ForeName': 'Paula Cristina', 'Initials': 'PC', 'LastName': 'Cola', 'Affiliation': 'Department of Medicine, Marilia University - UNIMAR, Marilia SP, Brazil.'}, {'ForeName': 'Roberta Gonçalves', 'Initials': 'RG', 'LastName': 'da Silva', 'Affiliation': 'Department of Speech and Language Therapy, Sao Paulo State University - UNESP, Marília SP,Brazil.'}, {'ForeName': 'Priscila Watson', 'Initials': 'PW', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP,Botucatu SP, Brazil.'}, {'ForeName': 'André Augusto', 'Initials': 'AA', 'LastName': 'Spadotto', 'Affiliation': 'Department of Neurology and Psiquiatry, Sao Paulo State University-UNESP,Botucatu SP, Brazil.'}, {'ForeName': 'Maria Aparecida de Arruda Coelho', 'Initials': 'MAAC', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, Sao Paulo State University - UNESP, Botucatu SP, Brazil.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105349']
1107,33554391,Adaptation of the working alliance inventory for the assessment of the therapeutic alliance in genetic counseling.,"The concept of therapeutic alliance is central to genetic counseling as the mechanism through which the outcomes of empowerment and effective coping are likely to be achieved. To date, there have been no published systematic assessments of the therapeutic relationship in genetic counseling. We adapted a previously validated measure of the therapeutic alliance to genetic counseling and assessed its reliability and validity. Participants were enrolled in a clinical genomic study where they were randomized to receive education about carrier results via a Web platform or via a genetic counselor and then further randomized to receive genetic counseling (without additional education) or not. We rated the therapeutic alliance from audio recordings of 120 genetic counseling sessions. We modified the observer version of the Working Alliance Inventory (WAI-O), initially designed to assess therapeutic relationships in psychotherapy. We examined internal consistency reliability by calculating Cronbach's alpha and inter-rater reliability through both percent agreement and Gwet's alternative agreement coefficient (AC). Regression analyses were used to evaluate the relationship of WAI-O scores with session length and with the designation of the session as one in which prior education was delivered by the genetic counselor or not. The adapted scale had high-reliability characteristics with agreement of 88%-93%, Gwet's AC of 0.84-0.90, and Cronbach's alpha of 0.89-0.93 for the three WAI-O subscales (bonds, goals, and tasks). Although there was no difference in alliance based on whether prior education was provided by the genetic counselor, the total WAI-O score significantly increased with increasing session length (beta =0.667, p<.001), providing preliminary evidence of construct validity. The WAI-O that we have adapted can be used reliably with two independent raters to assess the therapeutic alliance in studies of genetic counseling. The initial evidence for construct validity is promising and should be reassessed in future genetic counseling studies using the WAI-O.",2021,The WAI-O that we have adapted can be used reliably with two independent raters to assess the therapeutic alliance in studies of genetic counseling.,['genetic counseling'],['education about carrier results via a Web platform or via a genetic counselor and then further randomized to receive genetic counseling (without additional education) or not'],['total WAI-O score'],"[{'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0431855,The WAI-O that we have adapted can be used reliably with two independent raters to assess the therapeutic alliance in studies of genetic counseling.,"[{'ForeName': 'Lori H', 'Initials': 'LH', 'LastName': 'Erby', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Wisniewski', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hernandez', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leslie G', 'Initials': 'LG', 'LastName': 'Biesecker', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1378']
1108,33550634,Comparison between the use of intense pulsed light and Q-switched neodymium-doped yttrium aluminum garnet laser for the treatment of axillary hyperpigmentation.,"BACKGROUND


Axillary hyperpigmentation (AH) is a condition in which axillary skin is darker than the adjacent areas. To date, there is no standard treatment for AH. The Q-switched neodymium-doped yttrium aluminum garnet 1064-nm(QS) laser and intense pulsed light (IPL) are two effective modalities for the treatment of pigmentary disorders; however, the efficacy and safety levels of both treatments for AH have not yet been compared in a controlled study.
AIMS


To evaluate and compare the efficacy and safety of the QS laser and IPL in the treatment of AH.
METHODS


A randomized, split-side study was conducted on 22 subjects; all subjects received a total of five split-side treatments every 2 weeks. The efficacy was determined using the melanin index (MI), color chart level using the Pantone SkinTone™ Guide, improvement grading scale (IGS), and patient satisfaction scores at weeks 2, 4, 6, 8, and 10.
RESULTS


The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments. Both treatments significantly improved AH after three sessions. However, the pain score was lower for IPL treatment. The adverse effects were transient and were found after IPL treatment in one participant (4.45%) who developed hyperpigmentation and another participant (4.45%) who developed erythema.
CONCLUSIONS


Intense pulsed light therapy is safe and effective for the treatment of AH, with no significant difference in the outcome compared with QS laser treatment.",2021,"The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments.","['axillary hyperpigmentation', '22 subjects; all subjects']","['QS laser and IPL', 'intense pulsed light and Q-switched neodymium-doped yttrium aluminum garnet laser', 'neodymium-doped yttrium aluminum garnet 1064-nm(QS', 'laser and intense pulsed light (IPL', 'IPL therapy']","['efficacy and safety levels', 'pain score', 'melanin index (MI), color chart level using the Pantone Skintone™ Guide, improvement grading scale (IGS), and patient satisfaction scores', 'MI, color chart level, IGS, and patient satisfaction scores', 'efficacy and safety', 'adverse effects']","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}]","[{'cui': 'C1289832', 'cui_str': 'Q-switching laser device'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",22.0,0.0205367,"The results showed that there was no significant difference in MI, color chart level, IGS, and patient satisfaction scores between the two treatments.","[{'ForeName': 'Watinee', 'Initials': 'W', 'LastName': 'Amornpetkul', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsri', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Nanticha', 'Initials': 'N', 'LastName': 'Kamanamool', 'Affiliation': 'Department of Preventive and Social Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Montree', 'Initials': 'M', 'LastName': 'Udompataikul', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}, {'ForeName': 'Salinee', 'Initials': 'S', 'LastName': 'Rojhirunsakool', 'Affiliation': 'Skin Center, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13981']
1109,33556861,Feasibility of telephone-delivered therapy for common mental health difficulties embedded in pediatric epilepsy clinics.,"BACKGROUND


Mental and physical health treatment should be delivered together for children and young people with epilepsy. Training healthcare professionals (HCPs) in epilepsy services to deliver mental health interventions is an important way to facilitate integrated care.
OBJECTIVE


To determine the feasibility of remotely delivered assessment and psychological treatment for mental health difficulties delivered by HCPs in pediatric epilepsy clinics with limited formal training in psychological interventions. We hypothesized that it would be (i) feasible to train HCPs to deliver the psychological intervention and (ii) that participants receiving the psychological therapy would report reductions in symptoms of mental health difficulties including anxiety, depression, and behavior difficulties and improve quality of life.
METHODS


Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma) were allocated to receive 6 months of a modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience. Thirteen HCPs were trained in delivery of the intervention. Healthcare professional competence was assessed in a two-stage process. Parent-reported measures of mental health symptoms and quality of life were completed at baseline and following the intervention. Paired t-tests were used to analyze changes in symptoms over time.
RESULTS


All thirteen HCPs who participated in the training were considered competent in therapeutic delivery by the end of the training period. Twenty-three patients completed pre- and post-intervention measures and were included in the analysis. There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy. Health-related Quality of Life also improved over the duration of treatment. A randomized controlled trial (RCT) is needed to demonstrate efficacy of the intervention.",2021,"There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy.","['children and young people with epilepsy', 'Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma', 'pediatric epilepsy clinics with limited formal training in psychological interventions', 'pediatric epilepsy clinics']","['modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience', 'telephone-delivered therapy', 'psychological therapy']","['mental health problems', 'anxiety, depression, and behavior difficulties and improve quality of life', ' symptoms of mental health problems', 'Health-related Quality of Life', 'Healthcare professional competence', 'anxiety and depression symptoms', 'total impact of mental health problems', 'mental health symptoms and quality of life', 'quality of life', 'therapeutic delivery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1320526', 'cui_str': 'Formal psychological therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}]","[{'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",34.0,0.0761899,"There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57).
CONCLUSION


A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy.","[{'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Bennett', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK. Electronic address: sophie.bennett.10@ucl.ac.uk.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Au', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Coughtrey', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dalrymple', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lewins', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, UK.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107743']
1110,33556765,Closed-loop programming using external responses for deep brain stimulation in Parkinson's disease.,"INTRODUCTION


Deep brain stimulation (DBS) is an established treatment for Parkinson's disease (PD). Clinicians face various challenges in adjusting stimulation parameters and configurations in clinical DBS settings owing to inexperience, time constraints, and recent advances in DBS technology that have expanded the number of possible contact configurations. We aimed to assess the efficacy of a closed-loop algorithm (CLA) for the DBS-programming method using external motion sensor-based motor assessments in patients with PD.
METHODS


In this randomized, double-blind, crossover study, we enrolled 12 patients who underwent eight-ring-contact DBS lead implantations bilaterally in the subthalamic nucleus. The DBS settings of the participants were programmed using a standard of care (SOC) and CLA method. The clinical effects of both programming methods were assessed in a randomized crossover fashion. The outcomes were evaluated using the Unified Parkinson's Disease Scale part III (UPDRS-III) and sensor-based scores for baseline (medication-off/stimulation-off) and both programming methods. The number of programming steps required for each programming method was also recorded.
RESULTS


The UPDRS-III scores and sensor-based scores were significantly improved by SOC and CLA settings compared to the baseline. No statistical difference was observed between SOC and CLA. The programming steps were significantly reduced in the CLA settings compared to those in the SOC. No serious adverse events were observed.
CONCLUSION


CLA can optimize DBS settings prospectively with similar therapeutic benefits as that of the SOC and reduce the number of programming steps. Automated optimization of DBS settings would reduce the burden of programming for both clinicians and patients.",2021,The UPDRS-III scores and sensor-based scores were significantly improved by SOC and CLA settings compared to the baseline.,"[""Parkinson's disease (PD"", ""Parkinson's disease"", 'patients with PD', '12 patients who underwent eight-ring-contact DBS lead implantations bilaterally in the subthalamic nucleus']","['CLA', 'Deep brain stimulation (DBS', 'DBS-programming method using external motion sensor-based motor assessments', 'Closed-loop programming using external responses', 'closed-loop algorithm (CLA']","['UPDRS-III scores and sensor-based scores', ""Unified Parkinson's Disease Scale part III (UPDRS-III) and sensor-based scores for baseline (medication-off/stimulation-off) and both programming methods"", 'serious adverse events']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",12.0,0.0510667,The UPDRS-III scores and sensor-based scores were significantly improved by SOC and CLA settings compared to the baseline.,"[{'ForeName': 'Fuyuko', 'Initials': 'F', 'LastName': 'Sasaki', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Genko', 'Initials': 'G', 'LastName': 'Oyama', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: g_oyama@juntendo.ac.jp.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Maierdanjiang', 'Initials': 'M', 'LastName': 'Nuermaimaiti', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Iwamuro', 'Affiliation': 'Department of Research and Therapeutics for Movement Disorders, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Neurosurgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimo', 'Affiliation': 'Department of Research and Therapeutics for Movement Disorders, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Neurology, Juntendo University Nerima Hospital, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Umemura', 'Affiliation': 'Department of Research and Therapeutics for Movement Disorders, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Neurosurgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan; Department of Research and Therapeutics for Movement Disorders, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2021.01.023']
1111,33556737,Efficacy and safety of eslicarbazepine acetate as a first or later adjunctive therapy in patients with focal seizures.,"INTRODUCTION


We report outcomes from an open-label, non-randomized, 24-week study of eslicarbazepine acetate (ESL) in adults at earlier and later stages of their treatment history for focal seizures, conducted in a real-world clinical setting.
METHODS


ESL was taken as the first adjunctive therapy to levetiracetam (LEV) or lamotrigine (LTG) monotherapy (Arm 1), or as a later adjunctive therapy in treatment-resistant patients (Arm 2). The primary objective was to evaluate the effectiveness of ESL (by retention rates). Secondary objectives were to evaluate efficacy (seizure frequency), safety, tolerability, behavioral changes, mood, and health-related quality of life (HRQoL) associated with ESL treatment.
RESULTS


The modified intent-to-treat population included 96 patients (Arm 1: n = 41; Arm 2: n = 55) and the safety population included 102 patients (Arm 1: n = 44; Arm 2: n = 58). Overall, 81.8 % of patients in Arm 1 and 63.8 % of patients in Arm 2 completed the 24-week maintenance period. Median reductions in standardized seizure frequency (SSF) were markedly higher in Arm 1 (72.8 %) than Arm 2 (22.8 %), as were responder rates (≥50 % reduction in SSF; Arm 1: 62.5 %; Arm 2: 38.5 %) and rates of seizure freedom (Arm 1: 25.0 %; Arm 2: 9.6 %). Efficacy outcomes were generally more favorable in patients taking ESL in combination with LEV versus other anti-seizure medications (ASMs). Treatment-emergent adverse events (TEAEs; 81 % vs 73 %) and TEAEs leading to discontinuation (16 % vs 2 %) were reported more frequently in Arm 2 than Arm 1, respectively. Serious adverse events were reported infrequently (Arm 1: 0; Arm 2: 7 %). The most common TEAEs were dizziness, nausea, headache, somnolence, fatigue, nasopharyngitis, vomiting, and anxiety. There were no notable changes in depressive symptoms, mood status, or aggression throughout the study. Health and HRQoL scores were generally high at baseline and did not change throughout the study. However, on average, both clinicians and patients perceived improvement in illness over the course of the study.
CONCLUSIONS


ESL was effective and well tolerated both as the first adjunctive therapy to either of the most prescribed first-line ASMs, LEV or LTG, and as a later adjunctive therapy in treatment-resistant patients.",2021,"Median reductions in standardized seizure frequency (SSF) were markedly higher in Arm 1 (72.8 %) than Arm 2 (22.8 %), as were responder rates (≥50 % reduction in SSF;","['patients with focal seizures', '96 patients (Arm 1: n = 41; Arm 2: n = 55) and the safety population included 102 patients (Arm 1: n = 44; Arm 2: n = 58', 'adults at earlier and later stages of their treatment history for focal seizures, conducted in a real-world clinical setting']","['eslicarbazepine acetate', 'LTG) monotherapy', 'SSF', 'LEV', 'ESL', 'eslicarbazepine acetate (ESL', 'levetiracetam (LEV) or lamotrigine']","['effective and well tolerated', 'efficacy (seizure frequency), safety, tolerability, behavioral changes, mood, and health-related quality of life (HRQoL) associated with ESL treatment', 'dizziness, nausea, headache, somnolence, fatigue, nasopharyngitis, vomiting, and anxiety', 'Median reductions in standardized seizure frequency (SSF', 'Efficacy and safety', 'depressive symptoms, mood status, or aggression', 'Health and HRQoL scores', 'rates of seizure freedom', 'Serious adverse events', 'Efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",102.0,0.0848638,"Median reductions in standardized seizure frequency (SSF) were markedly higher in Arm 1 (72.8 %) than Arm 2 (22.8 %), as were responder rates (≥50 % reduction in SSF;","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hixson', 'Affiliation': 'University of California, San Francisco, CA, United States. Electronic address: John.Hixson@ucsf.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Gidal', 'Affiliation': 'University of Wisconsin, Madison, WI, United States. Electronic address: Barry.Gidal@wisc.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States. Electronic address: Andrei.Pikalov@sunovion.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States. Electronic address: Ian.Zhang@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States. Electronic address: davideblum@gmail.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cantu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Fort Lee, NJ, United States. Electronic address: David.Cantu@sunovion.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Epilepsy research,['10.1016/j.eplepsyres.2021.106561']
1112,33524887,"Effects of glucose intake on stress reactivity in young, healthy men.","The psychobiological stress response has a broad impact on energy metabolism, while the availability of energy may, in turn, affect the stress response. Specifically, a reduced cortisol response has been found after 8-11 hours of fasting, while glucose intake has led to an increase in cortisol reactivity. We compared the effects of standardized glucose or artificial sweetener drinks, as well as water, ingested prior to a physical (cold pressor test, CPT) or a psychosocial stressor (Trier Social Stress Test, TSST) after four hours of fasting. Healthy male subjects (N = 151) were randomized to one of six groups (either glucose, sweetener or water group and stress induction with the CPT or TSST). Thirty minutes after ingestion, participants were exposed to the stressor. Repeated measures of the subjective stress response, salivary cortisol and alpha amylase as well as continuous heart rate recordings were taken to capture the psychobiological stress response. Capillary blood glucose levels were measured four times. We found significant psychobiological stress responses for all variables and both stressors, but significantly stronger responses for the TSST. Moreover, we found a significant but small effect for a slightly stronger cortisol response to stress after glucose ingestion, which is presumably driven by a more pronounced effect in the TSST compared to the CPT condition. Responder rates did not differ for the three conditions in either the TSST or in the CPT. Our results demonstrate that even after a short fasting timeframe of four hours, higher glucose availability results in slightly higher cortisol stress responses in men.",2020,"Repeated measures of the subjective stress response, salivary cortisol and alpha amylase as well as continuous heart rate recordings were taken to capture the psychobiological stress response.","['men', 'Healthy male subjects (N\u2009=\u2009151', 'young, healthy men']","['glucose intake', 'glucose, sweetener or water group and stress induction with the CPT or TSST', 'TSST', 'standardized glucose or artificial sweetener drinks, as well as water, ingested prior to a physical (cold pressor test, CPT) or a psychosocial stressor (Trier Social Stress Test, TSST']","['cortisol reactivity', 'subjective stress response, salivary cortisol and alpha amylase as well as continuous heart rate recordings', 'Capillary blood glucose levels', 'psychobiological stress responses', 'stress reactivity', 'reduced cortisol response', 'Responder rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0556133', 'cui_str': 'Glucose intake'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0038998', 'cui_str': 'Sweeteners'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0457578', 'cui_str': 'Capillary blood glucose measurement'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",151.0,0.0144522,"Repeated measures of the subjective stress response, salivary cortisol and alpha amylase as well as continuous heart rate recordings were taken to capture the psychobiological stress response.","[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'von Dawans', 'Affiliation': 'Department of Biological and Clinical Psychology, University of Trier, D-54290, Trier, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department of Biological and Clinical Psychology, University of Trier, D-54290, Trier, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Biological and Clinical Psychology, University of Trier, D-54290, Trier, Germany. Electronic address: domes@uni-trier.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.105062']
1113,33524646,Negative pressure wound therapy in grade 1 and 2 diabetic foot ulcers: A randomized controlled study.,"BACKGROUND AND AIMS


Foot ulcers are one of the major causes of morbidity and mortality among diabetics in India. Early diagnosis and timely management is vital in preventing the progression of the disease which may require amputation. Conventional methods take a long time for healing. This study aims to compare negative pressure wound therapy (NPWT) and conventional saline dressings in diabetic foot ulcer (DFU) healing.
METHODS


This prospective randomized study was conducted in 45 patients with grade 1 and 2 DFUs. 22 patients in group A received NPWT and 23 patients in group B received saline dressings. The formation of granulation tissue, reduction in ulcer size, duration of hospital stay and time for complete healing of wounds were assessed.
RESULTS


The formation of granulation tissue (91.14 vs 52.61%, p < 0.001) and reduction in ulcer size (40.78 vs 21.18%, p = 0.008) at 14 days was significantly more in group A. The duration of hospital stay (15.68 vs 29.00 days, p < 0.001) and time for 100% coverage of the wound with granulation tissue (14.82 ± 7.30 vs 44.57 ± 7.11 days, p < 0.001) was significantly less in group A. Complete healing of wounds at 3 months was observed in 20 patients (90.9%) in group A and 6 patients (26.1%) in group B (p = 0.006).
CONCLUSION


In our study NPWT led to early reduction in ulcer size, more granulation tissue formation, shorter hospital stay and complete wound healing. In lower and middle income countries like India with high prevalence of DFUs, early recovery is a boon to the patients to resume their daily activities.",2021,"The formation of granulation tissue (91.14 vs 52.61%, p < 0.001) and reduction in ulcer size (40.78 vs 21.18%, p = 0.008) at 14 days was significantly more in group A.","['diabetic foot ulcer (DFU) healing', '45 patients with grade 1 and 2 DFUs', 'diabetics in India', 'grade 1 and 2 diabetic foot ulcers']","['NPWT', 'Negative pressure wound therapy', 'saline dressings', 'negative pressure wound therapy (NPWT) and conventional saline dressings']","['Complete healing of wounds', 'ulcer size, more granulation tissue formation, shorter hospital stay and complete wound healing', 'duration of hospital stay', 'formation of granulation tissue, reduction in ulcer size, duration of hospital stay and time for complete healing of wounds', 'formation of granulation tissue', 'ulcer size']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C2721313', 'cui_str': 'Sodium chloride dressing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",45.0,0.030466,"The formation of granulation tissue (91.14 vs 52.61%, p < 0.001) and reduction in ulcer size (40.78 vs 21.18%, p = 0.008) at 14 days was significantly more in group A.","[{'ForeName': 'Haraesh', 'Initials': 'H', 'LastName': 'Maranna', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: haraesh92@yahoo.co.in.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Lal', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: pawanlal@yahoo.com.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: lovenishbains@gmail.com.'}, {'ForeName': 'Gaurish', 'Initials': 'G', 'LastName': 'Sawant', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: gaurish1311@outlook.com.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: rahulbhatianinetyone@gmail.com.'}, {'ForeName': 'Pritesh', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: pkn644@gmail.com.'}, {'ForeName': 'Mohd Yasir', 'Initials': 'MY', 'LastName': 'Beg', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: begyasir99@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2021.01.014']
1114,33535835,"A phase I study of fluzoparib tablet formulation, an oral PARP inhibitor: effect of food on the pharmacokinetics and metabolism after oral dosing in healthy Chinese volunteers.","OBJECTIVE


To evaluate the effect of food on the pharmacokinetics (PK) of fluzoparib capsule.
METHODS


PK data were obtained after fluzoparib treatment in a crossover design study. Single-dose fluzoparib (120 mg) was administered under fasted and fed conditions to 16 healthy subjects. Metabolism and transformation fluzoparib were analyzed by liquid chromatograph-tandem mass spectrometry in the first period. Safety was also assessed.
RESULTS


The absorption rate of fluzoparib was slower in the fed group (t max  delayed by 3 h), and peak exposure (C max ) of fluzoparib in plasma decreased by 19.8% ( p  < 0.05) compared with the fasted group. The area under the curve (AUC) of fluzoparib was not statistically different between the fasted and fed conditions. The 90% confidence intervals for the C max  and AUC 0-∞  were 69.77-92.24% and 84.88-102.26%, respectively. Five, seven, and five fluzoparib metabolites were isolated from plasma, urine, and feces samples, respectively. Most treatment-emergent adverse events were grade I or II.
CONCLUSIONS


The presence of food decreased the absorption rate and peak exposure time of fluzoparib; however, the AUC did not significantly change compared with the fasted condition. Therefore, oral administration does not alter the efficacy and safety profile of fluzoparib.",2021,"The absorption rate of fluzoparib was slower in the fed group (t max  delayed by 3 h), and peak exposure (C max ) of fluzoparib in plasma decreased by 19.8% ( p  < 0.05) compared with the fasted group.","['healthy Chinese volunteers', '16 healthy subjects']",['fluzoparib'],"['Metabolism and transformation fluzoparib', 'absorption rate and peak exposure time of fluzoparib', 'area under the curve (AUC) of fluzoparib', 'absorption rate of fluzoparib', 'Safety', 'peak exposure (C max ) of fluzoparib in plasma', 'pharmacokinetics and metabolism', 'efficacy and safety profile of fluzoparib']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",16.0,0.0484886,"The absorption rate of fluzoparib was slower in the fed group (t max  delayed by 3 h), and peak exposure (C max ) of fluzoparib in plasma decreased by 19.8% ( p  < 0.05) compared with the fasted group.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University , Changchun, Jilin, China.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2021.1881480']
1115,33530006,A Clinical Trial of a Video Intervention Targeting Opioid Disposal After General Surgery: A Feasibility Study.,"BACKGROUND


The opioid epidemic continues and although some initiatives have shown promise in reducing the number of opiates prescribed, few studies have focused on education of general surgery patients about home storage and safe disposal. The purpose of this feasibility study was to explore the use of an online video intervention to prepare surgical patients to properly dispose of unused opioids.
METHODS


Eligible patients undergoing elective general surgery between August and October 2019 were enrolled into this prospective randomized controlled feasibility study. Patients with reported opioid use preoperatively were excluded from the study. The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills. Measures were collected at baseline and 2 wk postoperatively.
RESULTS


A total of 40 participants were enrolled in the study; average age was 44.7 (range 21-75 y); most were Caucasian, educated, and employed. Recruitment took 11 wk, and the retention rate was excellent at 85%. Differences in opioid disposal were not significantly different by age, sex, education, or type of surgery. The video intervention was positively received, but the majority (80%) still stored their pills unsecured.
CONCLUSIONS


Results demonstrate that a video intervention addressing safe storage and disposal practices of unused opioids is feasible, and more research is needed to determine efficacy in increasing rates of secure storage and disposal of unused opioid pills.",2021,"The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills.","['Patients with reported opioid use preoperatively were excluded from the study', 'surgical patients to properly dispose of unused opioids', 'A total of 40 participants were enrolled in the study; average age was 44.7 (range 21-75\xa0y); most were Caucasian, educated, and employed', 'Eligible patients undergoing elective general surgery between August and October 2019']","['control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills', 'Video Intervention Targeting Opioid Disposal', 'online video intervention']","['retention rate', 'opioid disposal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",40.0,0.0885486,"The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lewis', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts. Electronic address: Joanne.lewis@umassmed.edu.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sullivan-Boylai', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Poza', 'Affiliation': 'University of Massachusetts Medical School, Graduate School of Nursing, Worcester, Massachusetts.'}]",The Journal of surgical research,['10.1016/j.jss.2020.12.010']
1116,33548689,Sobriety Treatment and Recovery Teams for families with co-occurring substance use and child maltreatment: A randomized controlled trial.,"BACKGROUND


Co-occurring parental substance use and child maltreatment has increased in recent years and is associated with poor child welfare outcomes. The Sobriety Treatment and Recovery Teams (START) program was developed to meet the needs of these families.
OBJECTIVE


A randomized controlled trial was implemented to compare START to usual child welfare services on three outcomes: out-of-home care (OOHC) placements; reunification; and subsequent child maltreatment.
PARTICIPANTS AND SETTING


Families reported to child welfare services in Jefferson County, Kentucky, were eligible if they had a current finding of child maltreatment or services needed, substance use as a primary risk factor, a child under six years of age, and no other open child welfare cases.
METHODS


Biased coin randomization was used for a control: treatment randomization ratio of 1:2. Analyses were conducted using intent-to-treat (ITT), though a subsample of families receiving services was also analyzed. Differences were assessed using t-tests, chi-square, and risk ratios.
RESULTS


A total of 348 families including 526 children were randomized to START (n = 346) and usual services (n = 180). There were no significant differences between groups on the three outcomes in the ITT sample or the subsample that received services, though the START OOHC rate was 7 percentage points lower (relative difference: 21.6 %) and the reunification rate was 13 percentage points higher (relative difference: 27.6 %) in the subsample.
CONCLUSIONS


Although differences between groups were not significantly different, the relative differences were meaningful and this is the third study showing lower rates of OOHC among START relative to usual services. Additionally, the START reunification rate is higher than the overall U.S. average in spite of notable risk factors.",2021,"There were no significant differences between groups on the three outcomes in the ITT sample or the subsample that received services, though the START OOHC rate was 7 percentage points lower (relative difference: 21.6 %) and the reunification rate was 13 percentage points higher (relative difference: 27.6 %) in the subsample.
","['A total of 348 families including 526 children were randomized to START (n = 346) and usual services (n = 180', 'Families reported to child welfare services in Jefferson County, Kentucky, were eligible if they had a current finding of child maltreatment or services needed, substance use as a primary risk factor, a child under six years of age, and no other open child welfare cases', 'families with co-occurring substance use and child maltreatment']",[],"['reunification rate', 'START OOHC rate', 'START reunification rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}]",[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}]",526.0,0.104645,"There were no significant differences between groups on the three outcomes in the ITT sample or the subsample that received services, though the START OOHC rate was 7 percentage points lower (relative difference: 21.6 %) and the reunification rate was 13 percentage points higher (relative difference: 27.6 %) in the subsample.
","[{'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Hall', 'Affiliation': 'University of Louisville, Louisville, KY, United States. Electronic address: martin.hall@louisville.edu.'}, {'ForeName': 'Aimee B', 'Initials': 'AB', 'LastName': 'Kelmel', 'Affiliation': 'University of Louisville, Louisville, KY, United States.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Huebner', 'Affiliation': 'Children and Family Futures, Lake Forest, CA, United States.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Walton', 'Affiliation': 'University of Louisville, Louisville, KY, United States.'}, {'ForeName': 'Anita P', 'Initials': 'AP', 'LastName': 'Barbee', 'Affiliation': 'University of Louisville, Louisville, KY, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2021.104963']
1117,33548586,"Research on intervention methods for children's street-crossing behaviour: Application and expansion of the theory of ""behaviour spectrums"".","Due to immaturity in their physical and cognitive development, children are particularly vulnerable to road traffic injuries as pedestrians. Child pedestrian injury primarily occurs in urban areas, with a significant share at crosswalks. The aim of this study is to explore whether an intervention programme based on the theory of ""behaviour spectrums"" can improve the street-crossing skills of primary school children. Children were recruited near a local primary school through invitation letters and were randomly divided into two groups: a control group (n = 10, no intervention) and an experimental group (n = 10, intervention). The children in the experimental group received 30-45 min of training. The child participants were asked to wear an eye tracker and performed a crossing test in a real-world street environment; in this test, they were required to successively pass through an unsignalised intersection, an unsignalised T-intersection and a signalised intersection on a designated test route. A high-definition camera was used to record the children's crossing behaviour, and the Tobii Pro Glasses 2 eye tracker was used to derive indicators of the children's visual behaviour in the areas of interest (AOIs) in the street. The evaluation was conducted on children's crossing behaviour in the control group (which received no intervention) and the experimental group (tested at two time points after the intervention: children tested immediately after the intervention and children retested one month after the intervention). The results showed that compared with the control group, the children in the experimental group no longer focused on the small area around the body (e.g., the zebra crossing area) and the area in front of the eyes (e.g., the sidewalk area), which increased their visual attention to the traffic areas on the left and right sides of the zebra crossing; thus, unsafe crossing behaviour was reduced in the experimental group. Compared with the experimental group immediately after the intervention, the intervention effect on some indicators showed a significant weakening trend in the retest of the experimental group one month later. Overall, the results show that an intervention programme based on the theory of ""behaviour spectrums"" can improve children's crossing skills. This study provides valuable information for the development and evaluation of intervention programmes to improve children's street-crossing skills.",2021,"The results showed that compared with the control group, the children in the experimental group no longer focused on the small area around the body (e.g., the zebra crossing area) and the area in front of the eyes (e.g., the sidewalk area), which increased their visual attention to the traffic areas on the left and right sides of the zebra crossing; thus, unsafe crossing behaviour was reduced in the experimental group.","['Children were recruited near a local primary school through invitation letters', 'primary school children', ""children's street-crossing behaviour""]","['control group (n = 10, no intervention']","['visual attention', 'unsafe crossing behaviour']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0155427,"The results showed that compared with the control group, the children in the experimental group no longer focused on the small area around the body (e.g., the zebra crossing area) and the area in front of the eyes (e.g., the sidewalk area), which increased their visual attention to the traffic areas on the left and right sides of the zebra crossing; thus, unsafe crossing behaviour was reduced in the experimental group.","[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Jiang', 'Affiliation': 'Affiliation: School of Automobile and Traffic Engineering, Hefei University of Technology, Hefei, 230009, Anhui, PR China. Electronic address: kangj@hfut.edu.cn.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Affiliation: School of Automobile and Traffic Engineering, Hefei University of Technology, Hefei, 230009, Anhui, PR China. Electronic address: 335269316@qq.com.'}, {'ForeName': 'Zhongxiang', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Affiliation: School of Automobile and Traffic Engineering, Hefei University of Technology, Hefei, 230009, Anhui, PR China. Electronic address: fzx@hfut.edu.cn.'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'School of Environment and Science, Griffith University, Brisbane, Queensland, Australia. Electronic address: jj.cui@griffith.edu.au.'}, {'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Affiliation: School of Automobile and Traffic Engineering, Hefei University of Technology, Hefei, 230009, Anhui, PR China. Electronic address: traffic_h@hfut.edu.cn.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'School of Mechanical Engineering, Hefei University of Technology, Hefei, 230009, Anhui, PR China. Electronic address: Yuzhenhua@hfut.edu.cn.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Sze', 'Affiliation': 'Department of Civil and Environmental Engineering, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong. Electronic address: tony.nn.sze@polyu.edu.hk.'}]",Accident; analysis and prevention,['10.1016/j.aap.2021.105979']
1118,33476838,Impact of an antimicrobial stewardship and monitoring of infection control bundle in a surgical intensive care unit of a tertiary-care hospital in India.,"OBJECTIVES


Antimicrobial stewardship (AMS) in resource-limited settings lacks models that can be readily adapted to their settings. Here we discuss the impact of a combined strategy of AMS and monitoring of infection control practices in a tertiary-care centre of a developing country.
METHODS


This study was undertaken in the surgical unit of a tertiary-care hospital over an 8-month period. In the first 2 months (baseline phase), prospective audit and feedback alone was undertaken, while in the next 6 months (intervention phase) this was supplemented with strategies such as antimicrobial timeout, correction of doses and bundle approach for prevention of hospital-acquired infections.
RESULTS


A total of 337 patients were included (94 in the baseline phase and 243 in the intervention phase). There was a decrease in days of therapy per 1000 patient-days (1000PD) (1112.3 days vs. 1048.6 days), length of therapy per 1000PD (956 days vs. 936.3 days) and defined daily doses (DDD) per 1000PD for most antimicrobials. A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed. There was a decrease in the incidence of ventilator-associated pneumonia per 1000 ventilator-days in the intervention phase (46.4 vs. 35.4), whereas central line-associated bloodstream infections per 1000 central line-days remained the same (14.7 vs. 14.8).
CONCLUSION


This study shows that implementation of routine AMS activities with monitoring of infection control practices can help decrease overall antimicrobial use. With furtherance of measures to control infection, antimicrobial use may be further curtailed.",2021,A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed.,"['surgical unit of a tertiary-care hospital over an 8-month period', 'a tertiary-care centre of a developing country', 'A total of 337 patients were included (94 in the baseline phase and 243 in the intervention phase', 'surgical intensive care unit of a tertiary-care hospital in India']","['Antimicrobial stewardship (AMS', 'antimicrobial stewardship']","['double anaerobic cover', 'incidence of ventilator-associated pneumonia', 'central line-associated bloodstream infections', 'double cover for Gram-negative infections']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",337.0,0.0379005,A decrease in double cover for Gram-negative infections (9.6% vs. 2.9%) but an increase in double anaerobic cover (4.2% vs. 7.4%) was observed.,"[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Panditrao', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Shafiq', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India. Electronic address: shafiq.nusrat@pgimer.edu.in.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar-M', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Amritpal Kaur', 'Initials': 'AK', 'LastName': 'Sekhon', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Biswal', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Kulbeer', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Infection Control, PGIMER, Chandigarh, India.'}, {'ForeName': 'Pallab', 'Initials': 'P', 'LastName': 'Ray', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gautam', 'Affiliation': 'Department of Medical Microbiology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Yadav', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Laroiya', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Hemanth', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Salvania', 'Affiliation': 'Department of General Surgery, PGIMER, Chandigarh, India.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2021.01.003']
1119,33559485,"Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction.","Background Ticagrelor reduces ischemic risk but increases bleeding in patients with prior myocardial infarction. Identification of patients at lower bleeding risk is important in selecting patients who are likely to derive more favorable outcomes versus risk from this strategy. Methods and Results PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) randomized 21 162 patients with prior myocardial infarction in a 1:1:1 fashion to ticagrelor 60 mg or 90 mg twice daily or placebo, with ticagrelor 60 mg approved for long-term use. TIMI major or minor bleeding was the primary end point for this analysis. Causes of bleeding were categorized by site and etiology, and independent predictors were identified. At 3 years, ticagrelor 60 mg increased the rate of TIMI major or minor bleeding by 2.0% versus placebo (1.4% placebo versus 3.4% ticagrelor). The bleeding excess was driven primarily by spontaneous gastrointestinal bleeds. A history of spontaneous bleeding requiring hospitalization and the presence of anemia were independent predictors of bleeding but not of ischemic risk. Patients with at least 1 risk predictor had 3-fold higher rates of bleeding with ticagrelor 60 mg versus those who had neither (absolute risk increase, 4.4% versus 1.5%;  P =0.01). Patients with neither predictor had a more favorable benefit profile with ticagrelor 60 mg versus placebo including lower mortality (hazard ratio, 0.79; 95% CI, 0.65-0.96;  P  interaction = 0.03). Conclusions In patients with prior myocardial infarction, bleeding with ticagrelor 60 mg twice daily is predominantly spontaneous gastrointestinal. A history of spontaneous bleeding requiring hospitalization or the presence of anemia identifies patients at higher risk of bleeding, and the absence of either identifies patients likely to have a more favorable net benefit with ticagrelor. Registration URL https://www.clinicaltrials.gov/. Unique identifier: NCT01225562.",2021,"Patients with neither predictor had a more favorable benefit profile with ticagrelor 60 mg versus placebo including lower mortality (hazard ratio, 0.79; 95% CI, 0.65-0.96;  P  interaction = 0.03).","['Patients With Prior Heart Attack Using', 'Stable Patients With Prior Myocardial Infarction', 'patients with prior myocardial infarction', 'patients with prior myocardial infarction, bleeding with', 'Myocardial Infarction 54) randomized 21\xa0162 patients with prior myocardial infarction in a 1:1:1 fashion to ticagrelor 60']","['placebo', ' Ticagrelor', 'Ticagrelor', 'Aspirin-Thrombolysis', 'placebo, with ticagrelor', 'ticagrelor', 'Placebo']","['rate of TIMI major or minor bleeding', 'rates of bleeding', 'bleeding excess', 'TIMI major or minor bleeding', 'lower mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21162.0,0.0570614,"Patients with neither predictor had a more favorable benefit profile with ticagrelor 60 mg versus placebo including lower mortality (hazard ratio, 0.79; 95% CI, 0.65-0.96;  P  interaction = 0.03).","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Magnani', 'Affiliation': 'Parma University Hospital Parma Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ardissino', 'Affiliation': 'Parma University Hospital Parma Italy.'}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study GroupBrigham and Women's Hospital Boston MA.""}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Grochowski Hospital Warsaw Poland.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield Sheffield UK.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Dept de Cardiologie Hôpital BichatHôpitaux de Paris Paris France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study GroupBrigham and Women's Hospital Boston MA.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical CenterRutgers Medical school Newark NJ.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Oude Ophius', 'Affiliation': 'Canisius Wilhelmina Ziekenhuis Nijmegen the Netherlands.'}, {'ForeName': 'Assen', 'Initials': 'A', 'LastName': 'Goudev', 'Affiliation': 'Queen Giovanna University Hospital St Sofia Bulgaria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Institute of Cardiology Kiev Ukraine.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kamensky', 'Affiliation': 'University Hospital Bratislava Bratislava Slovakia.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of FloridaCollege of Medicine Jacksonville FL.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': 'Hosp Univrio La Paz Madrid Spain.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Mölndal Sweden.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study GroupBrigham and Women's Hospital Boston MA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study GroupBrigham and Women's Hospital Boston MA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'University of ColoradoSchool of Medicine Aurora CO.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017008']
1120,33556669,Predictors of consent and engagement to participate in telephone delivered continuing care following specialist residential alcohol and other drug treatment.,"INTRODUCTION AND AIMS


Although continuing care programs have been shown to improve alcohol and other drug (AOD) treatment outcomes, uptake of continuing care has been low. The current study aimed to determine predictors of participants' who both re-confirmed consent to engage in telephone-based continuing care and commenced continuing care once they left residential AOD treatment. These participants had initially consented to partake in continuing care during the course of their residential stay.
METHODS


Participants were 391 individuals (232 males, 59% and 158 females, 40%) accessing therapeutic communities for AOD treatment provided by The Australian Salvation Army and We Help Ourselves (WHOS). Measures at baseline, collected during residential treatment, included demographics, primary substance of concern, abstinence goal, refusal self-efficacy, cravings for substances, mental health diagnoses, psychological distress, quality of life and feelings of loneliness. All measures were used as predictor variables to determine characteristics of participants who re-confirmed consent to engage in continuing care and commenced continuing care following residential AOD treatment.
RESULTS


Completing residential treatment, being unmarried, and higher levels of loneliness predicted re-confirmation of consent to participate in continuing care following discharge from residential treatment. Participants who were Aboriginal and/or Torres Strait Islander were less likely to provide re-confirmation of consent. Participants were more likely to commence continuing care if they completed residential treatment, were older, and had longer years of substance use.
CONCLUSIONS


Tailoring continuing care programs to reach a broader array of individuals such as Indigenous populations and persons who exit treatment services early is needed to ensure these programs can reach all individuals who might need them.",2021,"Participants were more likely to commence continuing care if they completed residential treatment, were older, and had longer years of substance use.
","['Participants who were Aboriginal and/or Torres', ""participants' who both re-confirmed consent to engage in telephone-based continuing care and commenced continuing care once they left residential AOD treatment"", 'participants had initially consented to partake in continuing care during the course of their residential stay', 'Participants were 391 individuals (232 males, 59% and 158 females, 40%) accessing therapeutic communities for AOD treatment provided by The Australian Salvation Army and We Help Ourselves (WHOS', 'Participants were more likely to commence continuing care if they completed residential treatment, were older, and had longer years of substance use']",[],"['demographics, primary substance of concern, abstinence goal, refusal self-efficacy, cravings for substances, mental health diagnoses, psychological distress, quality of life and feelings of loneliness']","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039786', 'cui_str': 'Community, Therapeutic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}]",391.0,0.0556413,"Participants were more likely to commence continuing care if they completed residential treatment, were older, and had longer years of substance use.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia. Electronic address: pkelly@uow.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Ingram', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'University of Newcastle, University Drive, School of Medicine and Public Health, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'University of Pennsylvania, Market Street, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Robinson', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Byrne', 'Affiliation': 'We Help Ourselves, Rozelle, New South Wales 2039, Australia.'}, {'ForeName': 'Tayla J', 'Initials': 'TJ', 'LastName': 'Degan', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Osborne', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Camilla J', 'Initials': 'CJ', 'LastName': 'Townsend', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Nunes', 'Affiliation': 'University of Wollongong, Northfields Avenue, School of Psychology, Wollongong, New South Wales 2500, Australia; Illawarra Health and Medical Research Institute, Wollongong, New South Wales 2500, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lunn', 'Affiliation': 'We Help Ourselves, Rozelle, New South Wales 2039, Australia.'}]",Addictive behaviors,['10.1016/j.addbeh.2021.106840']
1121,33561756,Startup and implementation costs of a colorectal cancer screening tailored navigation research study.,"BACKGROUND


Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States. Despite improvements in screening, testing for CRC is underutilized in some populations, suggesting a need to identify efficient test promotion strategies.
METHODS


Our intervention guided individuals from low-income, underserved communities into primary care clinics to receive CRC screening referrals. Community sites were randomized to education or education plus navigation. The Phase I community-to-clinic navigation outcome was clinic attendance; the Phase II clinic-to-screening navigation outcome was screening completion. We used micro-costing to determine costs necessary to replicate our project in a similar, non-research setting.
RESULTS


Over the 4-year project, startup costs tended to decrease as implementation costs increased. The largest component of startup costs (32 % of total) was community site recruitment. Implementation costs per class attendee were higher in the navigation group ($1084) than control ($798). But costs per participant who made a clinic appointment ($3573 versus $6292) and per participant who completed screening ($4083 versus $7640) were lower in the navigation group.
CONCLUSIONS


Our description of startup and implementation costs for this intervention provides decision makers with information needed to plan and budget for a similar project to guide individuals from community into clinics.",2021,Implementation costs per class attendee were higher in the navigation group ($1084) than control ($798).,"['Colorectal cancer (CRC', 'Our intervention guided individuals from low-income, underserved communities into primary care clinics to receive CRC screening referrals']",['education or education plus navigation'],"['Implementation costs per class attendee', 'startup costs']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.0213385,Implementation costs per class attendee were higher in the navigation group ($1084) than control ($798).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bucho-Gonzalez', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, USA. Electronic address: Julie.Bucho-Gonzalez@asu.edu.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Herman', 'Affiliation': 'RAND Health Care, RAND Corporation, 776 Main Street, Santa Monica, CA, 90401-3208, USA. Electronic address: pherman@rand.org.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, USA. Electronic address: Linda.Larkey@asu.edu.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Menon', 'Affiliation': 'College of Nursing, University of South Florida, 12901 Bruce B. Downs Blvd, Tampa, FL, 33612, USA. Electronic address: umenon@usf.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Szalacha', 'Affiliation': 'Morsani College of Medicine and College of Nursing, University of South Florida, 12901 Bruce B. Downs Blvd, Tampa, FL, 33612, USA. Electronic address: lszalacha@usf.edu.'}]",Evaluation and program planning,['10.1016/j.evalprogplan.2021.101907']
1122,33561725,Scaffolding the attention-deficit/hyperactivity disorder brain using transcranial direct current and random noise stimulation: A randomized controlled trial.,"OBJECTIVE


Improving symptomology and cognitive deficits in neurodevelopmental disorders is a crucial challenge. We examined whether neurostimulation protocols, which have been shown to yield long-term effects when combined with cognitive training, could benefit children with Attention-deficit/hyperactivity-disorder (ADHD), the most common neurodevelopmental disorder in childhood.
METHODS


We used a randomized double-blind active-controlled crossover study of 19 unmedicated children with ADHD, who received either anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (dlPFC) or random noise stimulation (tRNS) over the bilateral dlPFC, while completing executive functions training.
RESULTS


For our primary outcome, tRNS yielded a clinical improvement as indicated by the reduced ADHD rating-scale score from baseline, and in comparison to the changes observed in tDCS. The effect of brain stimulation one week after completion of treatment yielded further improvement, suggesting a neuroplasticity-related effect. Finally, tRNS improved working memory compared to tDCS, and a larger tRNS effect on ADHD rating-scale was predicted for those who showed the greatest improvement in working memory.
CONCLUSIONS


We found that our intervention can have a lasting effect, rather than a merely immediate effect as was shown for in previous medical interventions in ADHD.
SIGNIFICANCE


Our results provide a promising direction toward a novel intervention in ADHD.",2021,"For our primary outcome, tRNS yielded a clinical improvement as indicated by the reduced ADHD rating-scale score from baseline, and in comparison to the changes observed in tDCS.","['19 unmedicated children with ADHD, who received either']","['transcranial direct current and random noise stimulation', 'cognitive training', 'anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (dlPFC) or random noise stimulation (tRNS) over the bilateral dlPFC, while completing executive functions training']","['reduced ADHD rating-scale score', 'ADHD rating-scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",19.0,0.249495,"For our primary outcome, tRNS yielded a clinical improvement as indicated by the reduced ADHD rating-scale score from baseline, and in comparison to the changes observed in tDCS.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Berger', 'Affiliation': 'Pediatric Neurology Unit, Hadassah-Hebrew University Medical Center, Israel; School of Social Work and Social Welfare, Hebrew University of Jerusalem, Israel. Electronic address: itai.berger@mail.huji.ac.il.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Dakwar-Kawar', 'Affiliation': 'School of Occupational Therapy, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Ephraim S', 'Initials': 'ES', 'LastName': 'Grossman', 'Affiliation': 'Pediatric Neurology Unit, Hadassah-Hebrew University Medical Center, Israel.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Nahum', 'Affiliation': 'School of Occupational Therapy, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Roi', 'Initials': 'R', 'LastName': 'Cohen Kadosh', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, UK. Electronic address: roi.cohenkadosh@psy.ox.ac.uk.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2021.01.005']
1123,33561724,Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial.,"BACKGROUND


The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR). POUR is a common complication of abdominal surgery, leading to the use of urinary catheters, which are a risk factor for urinary tract infection. Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms.
MATERIALS AND METHODS


A randomized, double-blind, placebo-controlled trial was undertaken from August 2015 to May 2018. Adults undergoing elective inpatient abdominal surgery were randomized to receive either tamsulosin 0.4 mg or placebo daily for 7 d before surgery and continuing for up to 7 d postoperatively. The primary outcome was need for at least a single intermittent catheterization postoperatively. Secondary outcomes included first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30 d of surgery.
RESULTS


A total of 158 participants were enrolled, with a final analytic cohort of 141 participants. The two groups had similar baseline characteristics, operative characteristics, and timing of catheter removal. There was no difference in the incidence of POUR between the two groups (26% in tamsulosin versus 31% in placebo, P = 0.49). There was also no difference in any of the secondary outcomes between the two groups. Epidural usage, open surgery, and age <50 were identified as risk factors for POUR.
CONCLUSIONS


Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.",2021,"CONCLUSIONS


Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.","['Adults undergoing elective inpatient abdominal surgery', 'August 2015 to May 2018', 'patients undergoing elective abdominal surgery', '158 participants were enrolled, with a final analytic cohort of 141 participants']","['tamsulosin', 'tamsulosin 0.4\xa0mg or placebo', 'placebo', 'Preoperative Tamsulosin', 'Tamsulosin']","['need for at least a single intermittent catheterization postoperatively', 'Postoperative Urinary Retention', 'operative characteristics, and timing of catheter removal', 'incidence of POUR', 'postoperative urinary retention (POUR', 'first postvoid residual volume, number of catheterizations, need for replacement of an indwelling catheter, hospital length of stay, and urinary tract infection within 30\xa0d of surgery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",158.0,0.345461,"CONCLUSIONS


Perioperative prophylaxis with tamsulosin is not effective in reducing the incidence of POUR in patients undergoing elective abdominal surgery.","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Papageorge', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Howington', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Leverson', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Kennedy', 'Affiliation': 'Department of Surgery, University of Alabama-Birmingham, Gardendale, Alabama.'}, {'ForeName': 'Evie H', 'Initials': 'EH', 'LastName': 'Carchman', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Electronic address: carchman@surgery.wisc.edu.'}]",The Journal of surgical research,['10.1016/j.jss.2020.12.055']
1124,33570548,Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial.,"Importance


Decipher (Decipher Biosciences Inc) is a genomic classifier (GC) developed to estimate the risk of distant metastasis (DM) after radical prostatectomy (RP) in patients with prostate cancer.
Objective


To validate the GC in the context of a randomized phase 3 trial.
Design, Setting, and Participants


This ancillary study used RP specimens from the phase 3 placebo-controlled NRG/RTOG 9601 randomized clinical trial conducted from March 1998 to March 2003. The specimens were centrally reviewed, and RNA was extracted from the highest-grade tumor available in 2019 with a median follow-up of 13 years. Clinical-grade whole transcriptomes from samples passing quality control were assigned GC scores (scale, 0-1). A National Clinical Trials Network-approved prespecified statistical plan included the primary objective of validating the independent prognostic ability of GC for DM, with secondary end points of prostate cancer-specific mortality (PCSM) and overall survival (OS). Data were analyzed from September 2019 to December 2019.
Intervention


Salvage radiotherapy (sRT) with or without 2 years of bicalutamide.
Main Outcomes and Measures


The preplanned primary end point of this study was the independent association of the GC with the development of DM.
Results


In this ancillary study of specimens from a phase 3 randomized clinical trial, GC scores were generated from 486 of 760 randomized patients with a median follow-up of 13 years; samples from a total of 352 men (median [interquartile range] age, 64.5 (60-70) years; 314 White [89.2%] participants) passed microarray quality control and comprised the final cohort for analysis. On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm. Although the original planned analysis was not powered to detect a treatment effect interaction by GC score, the estimated absolute effect of bicalutamide on 12-year OS was less when comparing patients with lower vs higher GC scores (2.4% vs 8.9%), which was further demonstrated in men receiving early sRT at a prostate-specific antigen level lower than 0.7 ng/mL (-7.8% vs 4.6%).
Conclusions and Relevance


This ancillary validation study of the Decipher GC in a randomized trial cohort demonstrated association of the GC with DM, PCSM, and OS independent of standard clinicopathologic variables. These results suggest that not all men with biochemically recurrent prostate cancer after surgery benefit equally from the addition of hormone therapy to sRT.
Trial Registration


ClinicalTrials.gov identifier: NCT00002874.",2021,"On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm.","['With Recurrent Prostate Cancer', '486 of 760 randomized patients with a median follow-up of 13 years; samples from a total of 352 men (median [interquartile range] age, 64.5 (60-70) years; 314 White [89.2%] participants) passed microarray quality control and comprised the final cohort for analysis', 'Patients', 'patients with prostate cancer']","['radical prostatectomy (RP', 'Intervention\n\n\nSalvage radiotherapy (sRT) with or without 2 years of bicalutamide', 'bicalutamide']",['prostate cancer-specific mortality (PCSM) and overall survival (OS'],"[{'cui': 'C0278838', 'cui_str': 'Prostate cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",760.0,0.230703,"On multivariable analysis, the GC (continuous variable, per 0.1 unit) was independently associated with DM (hazard ratio [HR], 1.17; 95% CI, 1.05-1.32; P = .006), PCSM (HR, 1.39; 95% CI, 1.20-1.63; P < .001), and OS (HR, 1.17; 95% CI, 1.06-1.29; P = .002) after adjusting for age, race/ethnicity, Gleason score, T stage, margin status, entry prostate-specific antigen, and treatment arm.","[{'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'Huei-Chung', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Shuang George', 'Initials': 'SG', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Jeffry P', 'Initials': 'JP', 'LastName': 'Simko', 'Affiliation': 'NRG Biorepository, Department of Pathology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': ""Department of Radiation Oncology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Dicker', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Todorovic', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Margrave', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Yang Seagle', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Dabbas', 'Affiliation': 'Decipher Biosciences, San Diego, California.'}, {'ForeName': 'Darby J S', 'Initials': 'DJS', 'LastName': 'Thompson', 'Affiliation': 'Emmes Canada, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Department of Radiation Oncology, UCSF Medical Center, San Francisco, California.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sweeney', 'Affiliation': 'Department of Medicine, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'Department of Oncology, University College London, London, United Kingdom.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bahary', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal-Notre Dame, Montreal, Quebec, Canada.""}, {'ForeName': 'Himanshu R', 'Initials': 'HR', 'LastName': 'Lukka', 'Affiliation': 'Department of Radiation Oncology, Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Froedtert and the Medical College of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Amit B', 'Initials': 'AB', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, WellSpan Health-York Cancer Center accruals under Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.7671']
1125,33570516,Effects of Training on the Execution of Complete-Arch Scans. Part 1: Scanning Time.,"PURPOSE


To investigate the effect of training on scanning times of complete-arch scans (CAS) performed by first-time users, with a distinction made between specific training (repeated practice of CAS) and nonspecific training (simple use of an intraoral scanner for a sextant scan in the context of a student CAD/CAM course).
METHODS


Thirty-six students with no experience in intraoral scanning were randomized into three groups (n = 12 per group) according to the number of specific CAS training sessions: three sessions (3S), two sessions (2S), and one session (1S). Each student performed 10 CAS per scanning session. These sessions were scheduled at baseline (T 0 ), T 1  (2 weeks after T 0 ), and T 2  (4 weeks after T 0 ) for group 3S; at T 0  and T 2  for group 2S; and at T 2  for group 1S. Before the final scanning session in each group (ie, the first scanning session in group 1S), the students participated in a CAD/CAM course (3 weeks after T0) in which a monolithic crown was fabricated in a fully digital chairside workflow. The scanning time was measured as the time between the activation and termination of the scanning mode of the intraoral device. Data were analyzed using SPSS Statistics 25 (IBM). The level of significance was set to α = .05.
RESULTS


A continual decrease in scanning time was observed for all groups as experience in intraoral scanning increased. The mean scanning times were as follows: for group 3S, 305 seconds at T 0 , 246 seconds at T 1 , and 233 seconds at T 2 ; for group 2S, 380 seconds at T 0  and 303 seconds at T 2 ; and for group 1S, 355 seconds at T 2 . When compared to group 1S after it had received nonspecific training only, the effect of a single specific training session in groups 3S and 2S was not significant (P = .4428). However, two specific training sessions had a significant effect on scanning time compared to nonspecific training only (P = .0005).
CONCLUSION


Training does affect the scanning time required for CAS. To perform such scans in a time-efficient manner, dental practitioners should undertake training that comprises at least 12 CAS.",2021,"However, two specific training sessions had a significant effect on scanning time compared to nonspecific training only (P = .0005).
",['Thirty-six students with no experience in intraoral scanning'],"['single specific training session', 'specific training (repeated practice of CAS) and nonspecific training (simple use of an intraoral scanner', 'nonspecific training']","['mean scanning times', 'scanning time', 'scanning time required for CAS']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}]",36.0,0.0142708,"However, two specific training sessions had a significant effect on scanning time compared to nonspecific training only (P = .0005).
","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Waldecker', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Trebing', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rues', 'Affiliation': ''}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.6903']
1126,33570517,Effects of Training on the Execution of Complete-Arch Scans. Part 2: Scanning Accuracy.,"PURPOSE


To investigate the effect of training on scanning accuracy of complete arch scans (CAS) performed by first-time users, with a distinction made between specific training (repeated performance of CAS) and nonspecific training (simple use of an intraoral optical scanner for a sextant scan in the context of a CAD/CAM teaching module).
MATERIALS AND METHODS


A total of 36 students with no experience in intraoral scanning were randomized into three groups (n = 12 per group) according to the number of CAS sessions: three sessions (3S), two sessions (2S), and one session (1S). Each student had to perform 10 CAS per scanning session. Sessions were scheduled at T 0 , T 1 , and T 2  for group 3S; at T 0  and T 2  for group 2S; and at T 2  for group 1S. Before the final scanning session in each group (ie, the first scanning session in group 1S), the students completed a CAD/CAM teaching module, which included fabrication of a monolithic crown in a fully digital chairside workflow.
RESULTS


In all groups, repeated CAS resulted in improved scanning accuracy. Participation in the CAD/CAM module had a positive effect on initial accuracy for CAS. Mean absolute deviations in cross-arch distance were 84 μm (T 0 ), 68 μm (T 1 ), and 63 μm (T 2 ) for group 3S; 79 μm (T 0 ) and 61 μm (T 2 ) for group 2S; and 67 μm (T 2 ) for group 1S.
CONCLUSION


To perform CAS with the best possible accuracy, specific training is highly recommended. In addition, nonspecific training leads to an improvement in initial scanning accuracy.",2021,"Mean absolute deviations in cross-arch distance were 84 μm (T 0 ), 68 μm (T 1 ), and 63 μm (T 2 ) for group 3S; 79 μm (T 0 ) and 61 μm (T 2 ) for group 2S; and 67 μm (T 2 ) for group 1S.
CONCLUSION


",['36 students with no experience in intraoral scanning'],"['CAS', 'nonspecific training', 'CAD/CAM teaching module', 'nonspecific training (simple use of an intraoral optical scanner']","['scanning accuracy', 'initial scanning accuracy', 'Mean absolute deviations']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]",36.0,0.0150608,"Mean absolute deviations in cross-arch distance were 84 μm (T 0 ), 68 μm (T 1 ), and 63 μm (T 2 ) for group 3S; 79 μm (T 0 ) and 61 μm (T 2 ) for group 2S; and 67 μm (T 2 ) for group 1S.
CONCLUSION


","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Waldecker', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rues', 'Affiliation': ''}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Trebing', 'Affiliation': ''}, {'ForeName': 'Rouven', 'Initials': 'R', 'LastName': 'Behnisch', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rammelsberg', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bömicke', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.6940']
1127,33579931,The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer.,"Obesity has been associated with poor breast cancer (BC) outcomes. We investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact BC outcomes. We conducted a multicenter trial randomizing women 1:1 to mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity, and behavior and involved 19 calls over 2 years to achieve up to 10% weight loss. In all, 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI) ≥24 kg/m 2  receiving adjuvant letrozole were randomized (enrolment ended due to funding loss). The primary outcome was disease-free survival (DFS); secondary outcome was Overall Survival (OS). At 8 years' median follow-up, in a planned analysis, DFS and OS were compared using the Kaplan-Meier method. Baseline BMI and other characteristics were similar between study arms. In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71 (95% confidence interval [CI]: 0.41-1.24, p = 0.23). Although loss of funding reduced sample size, we view these hypothesis generating results as compatible with our hypothesis of a potential beneficial effect of a lifestyle intervention on DFS. They provide support for completion of ongoing randomized controlled trials of the effect of lifestyle interventions in BC outcomes.",2020,"In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71",['postmenopausal breast cancer'],"['weight loss intervention', 'adjuvant letrozole', 'mail-based educational material alone (control) or combined with a standardized, telephone-based lifestyle intervention', 'telephone-based weight loss lifestyle intervention']",['disease-free survival (DFS); secondary outcome was Overall Survival (OS'],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.177849,"In all, 22 of 171 (12.9%) in the lifestyle intervention arm versus 30 of 167 (18.0%) in the education had DFS events; the hazard ratio (HR) was 0.71","[{'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Goodwin', 'Affiliation': 'Department of Medicine, Division of Clinical Epidemiology at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada. Pamela.Goodwin@sinaihealth.ca.'}, {'ForeName': 'Roanne J', 'Initials': 'RJ', 'LastName': 'Segal', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Ottawa Hospital Regional Cancer Center, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vallis', 'Affiliation': 'Primary Care, Capital Health, Department of Family Medicine, Dalhousie University, Halifax, Nova Scotia, UK.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Pond', 'Affiliation': 'Department of Oncology, Ontario Clinical Oncology Group, Juravinski Hospital and Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': ""Faculty of Medicine, Department of Nutrition, Research Center, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Findlay', 'Affiliation': 'Department of Oncology, Niagara Health System, Walker Family Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Som D', 'Initials': 'SD', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Kathleen I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Division of Medical Oncology & Hematology, Sunnybrook Odette Cancer Center, Ontario Clinical Oncology Group, University of Toronto, Toronto, ON, Canada.'}]",NPJ breast cancer,['10.1038/s41523-020-0149-z']
1128,33579349,"Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial.","BACKGROUND


Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally regarded as the Wei-Pi syndrome, and Banxia Xiexin decoction (BXD) has been used in the empirical treatment of the same for a long time. The current study aims to evaluate the efficacy of modified BXD in the management of Wei-Pi syndrome.
METHODS/DESIGN


A randomized, waitlist-controlled trial will be conducted. A total of 84 patients with Wei-Pi syndrome will be randomized into the BXD or waitlist control group in a ratio of 1:1. The patients in the BXD group will receive the semi-individualized BXD on the basis of the syndrome differentiation in CM, for a duration of 3 weeks and will be under follow-up for further 3 weeks after the completion of therapy. Conversely, the patients in the waitlist control group will undergo the same intervention and follow-up after a 3-week waiting period. In the current study, the primary outcome will be the variation in the scores pertaining to the global scale of the Quality of Life Questionnaire for Functional Digestive Disorders after 3 weeks. The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests.
DISCUSSION


This trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering from Wei-Pi syndrome.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04398888 . Registered on May 21, 2020.",2021,"The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests.
","['84 patients with Wei-Pi syndrome', 'Wei-Pi syndrome (postprandial distress syndrome', 'patients suffering from Wei-Pi syndrome']","['modified BXD', 'BXD', 'modified Banxia Xiexin decoction', 'semi-individualized BXD']","['quality of life', 'global scale of the Quality of Life Questionnaire for Functional Digestive Disorders', 'variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C5198102', 'cui_str': 'banxia xiexin decoction'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0012242', 'cui_str': 'Disorder of digestive system'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",84.0,0.0466159,"The secondary outcomes include the variations in the scores pertaining to the Hospital Anxiety and Depression Scale and the EuroQoL 5-dimension 5-level Questionnaire and the results of the liver and kidney function tests.
","[{'ForeName': 'Sai Ho', 'Initials': 'SH', 'LastName': 'Sin', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Kar Hung Kevin', 'Initials': 'KHK', 'LastName': 'Yip', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Ngo Suet', 'Initials': 'NS', 'LastName': 'Kong', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Hei', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'The Hong Kong Buddhist Association - The University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Wong Tai Sin District), Hong Kong, China.'}, {'ForeName': 'Bacon Fung Leung', 'Initials': 'BFL', 'LastName': 'Ng', 'Affiliation': 'Department of Chinese Medicine, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. haiyong@hku.hk.'}]",Trials,['10.1186/s13063-021-05078-y']
1129,33579345,Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial.,"BACKGROUND


Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effective treatment for patients with cirrhosis. However, post-LDLT patients are prone to muscle atrophy and sarcopenia. Therefore, physiotherapy of post-LDLT patients is essential for preventing the progression of sarcopenia. Recently, rehabilitation using neuromuscular electrical stimulation (NMES) has been reported to be useful for preventing the progression of sarcopenia. Similarly, nutrition therapy is essential for post-LDLT patients because these patients frequently experience malnutrition. However, the effects of combined NMES and nutrition therapy on post-LDLT patients remain unknown.
METHODS/DESIGN


This open-label, randomized, parallel-group study will compare the effects of combined therapy with NMES and branched-chain amino acids (BCAA) with those of NMES alone in patients with decompensated cirrhosis after LDLT. After LDLT, 50 patients with decompensated cirrhosis will be randomly assigned to receive NMES with BCAA or NMES without BCAA. The duration of the intervention will be 3 months. To analyze the change in skeletal muscle mass, InBody 770 body composition and body water analysis and ultrasonography will be performed before LDLT and 4 weeks and 12 weeks post-LDLT. The primary endpoint is changes in the skeletal muscle mass from baseline to 3 months. Important secondary endpoints are the changes in the skeletal muscle mass from baseline to 1 month and changes in the quadriceps strength from baseline to 1 month.
DISCUSSION


The results of this study are expected to provide evidence regarding the effect of NMES combined with BCAA therapy on the skeletal muscle of post-LDLT patients.
TRIAL REGISTRATION


Japan Registry of Clinical Research jRCTs071190051 . Registered on February 26, 2020.",2021,"Important secondary endpoints are the changes in the skeletal muscle mass from baseline to 1 month and changes in the quadriceps strength from baseline to 1 month.
","['patients with decompensated cirrhosis after LDLT', 'patients after living-donor liver transplantation', 'patients with cirrhosis', '50 patients with decompensated cirrhosis']","['neuromuscular electrical stimulation (NMES', 'combined NMES and nutrition therapy', 'NMES alone', 'neuromuscular electrical stimulation and oral administration of branched-chain amino acid', 'Living donor liver transplantation (LDLT', 'NMES with BCAA or NMES without BCAA', 'NMES and branched-chain amino acids (BCAA', 'NMES combined with BCAA therapy', 'nutrition therapy']","['skeletal muscle mass', 'quadriceps strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",50.0,0.103505,"Important secondary endpoints are the changes in the skeletal muscle mass from baseline to 1 month and changes in the quadriceps strength from baseline to 1 month.
","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Haraguchi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Ichinose', 'Affiliation': 'Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan.'}, {'ForeName': 'Hisamitsu', 'Initials': 'H', 'LastName': 'Miyaaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. miyaaki-hi@nagasaki-u.ac.jp.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hanada', 'Affiliation': 'Cardiorespiratory Division, Department of Rehabilitation Medicine, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fukushima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Sasaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miuma', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Hara', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Tota', 'Initials': 'T', 'LastName': 'Kugiyama', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Soyama', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Hidaka', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Nurse, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Yano', 'Affiliation': 'Division of Intensive Care, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Sekino', 'Affiliation': 'Division of Intensive Care, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahata', 'Affiliation': 'Cardiorespiratory Division, Department of Rehabilitation Medicine, Nagasaki University Hospital, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Eguchi', 'Affiliation': 'Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, 852-8501, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.'}]",Trials,['10.1186/s13063-021-05086-y']
1130,33579340,Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial.,"BACKGROUND


Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence rates but the efficacy of this strategy has not been definitely established. As treatment tolerability is more favorable with preoperative radiotherapy, normofractionated neoadjuvant treatment is the current approach. The final results of the prospective, randomized STRASS (EORTC 62092) trial, which compared the efficacy of this combined treatment to that of surgery alone, are still awaited; preliminary results presented at the 2019 ASCO Annual Meeting indicated that combined treatment is associated with better local control in patients with liposarcoma (74.5% of the cohort, 11% benefit in abdominal progression free survival after 3 years, p = 0.049). Particles allow better sparing of surrounding tissues at risk, e.g., bowel epithelium, and carbon ions additionally offer biologic advantages and are preferred in slow growing tumors. Furthermore, hypofractionation allows for a significantly shorter treatment interval with a lower risk of progression during radiotherapy.
METHODS AND DESIGN


We present a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the retroperitoneum will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the safety and feasibility based on the proportion of grade 3-5 toxicity (CTCAE, version 5.0) in the first 12 months after surgery or discontinuation of treatment for any reason related to the treatment. Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study.
DISCUSSION


The aim of this study is to confirm that hypofractionated, accelerated preoperative radiotherapy is safe and feasible. The rationale for the use of particle therapy is the potential for reduced toxicity. The data will lay the groundwork for a randomized phase III trial comparing hypofractionated proton and carbon ion irradiation with regard to local control.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04219202 . Retrospectively registered on January 6, 2020.",2021,"Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study.
","['Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the retroperitoneum']","['neoadjuvant proton or neoadjuvant carbon ion radiotherapy', 'Radiotherapy', 'hypofractionated proton and carbon ion irradiation', 'Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion']","['Local control, local progression-free survival, disease-free survival, overall survival, and quality of life', 'safety and feasibility', 'recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C3494442', 'cui_str': 'Carbon Ion Therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.112082,"Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seidensaal', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. katharina.seidensaal@med.uni-heidelberg.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hommertgen', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jaekel', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Harrabi', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Herfarth', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mechtesheimer', 'Affiliation': 'Institute of Pathology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lehner', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Paraplegiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nienhueser', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fröhling', 'Affiliation': 'Department of Translational Medical Oncology, National Center for Tumor Diseases Heidelberg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Egerer', 'Affiliation': 'Department of Hematology, Oncology and Rheumatology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhl', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-021-05069-z']
1131,33579336,Isometric blood flow restriction exercise: acute physiological and neuromuscular responses.,"BACKGROUND


Numerous studies have demonstrated that the addition of blood flow restriction (BFR) to low-load (LL) resistance exercise leads to elevated levels of muscle hypertrophy and strength gains. In terms of main underlying mechanisms, metabolic accumulation and increased neuromuscular adaptations seem to play a primary role. However, this evidence is largely based on dynamic exercise conditions. Therefore, the main objective was to investigate the acute physiological adaptations following isometric LL-BFR exercise.
METHODS


Fifteen males participated in this cross-over trial and completed the following sessions in a random and counterbalanced order: isometric LL-BFR exercise (20% maximum voluntary contraction, MVC) and load matched LL exercise without BFR. Lactate levels, muscle activation as well as muscle swelling were recorded during the whole exercise and until 15 min post completion. Additionally, changes in maximal voluntary torque and ratings of perceived exertion (RPE) were monitored.
RESULTS


During exercise, EMG amplitudes (72.5 ± 12.7% vs. 46.3 ± 6.7% of maximal EMG activity), muscle swelling and RPE were significantly higher during LL-BFR compared to LL (p < 0.05). Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05). Additionally, MVC torque significantly decreased immediately post exercise only in LL-BFR (~ - 11%) (p < 0.05) but recovered after 15 min.
CONCLUSIONS


The present results demonstrate that isometric LL-BFR causes increased metabolic, neuromuscular as well as perceptual responses compared to LL alone. These adaptations are similar to dynamic exercise and therefore LL-BFR represents a valuable type of exercise where large joint movements are contraindicated (e.g. rehabilitation after orthopedic injuries).",2021,"Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05).",['Fifteen males participated in this cross-over trial and completed the following sessions in a random and counterbalanced order'],"['isometric LL-BFR exercise (20% maximum voluntary contraction, MVC) and load matched LL exercise without BFR', 'isometric LL-BFR exercise', 'Isometric blood flow restriction exercise']","['maximal voluntary torque and ratings of perceived exertion (RPE', 'MVC torque', 'Lactate levels', 'LL-BFR', 'maximal EMG activity), muscle swelling and RPE', 'Lactate levels, muscle activation as well as muscle swelling']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0281913', 'cui_str': 'Swelling of skeletal muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",15.0,0.0420079,"Lactate levels did not show significant group differences during exercise but revealed higher increases 15 min after completion in the LL-BFR condition (LL-BFR: + 69%, LL: + 22%) (p < 0.05).","[{'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Lauber', 'Affiliation': 'Department of Neurosciences and Movement Sciences, University of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'König', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gollhofer', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Centner', 'Affiliation': 'Department of Sport and Sport Science, University of Freiburg, Schwarzwaldstraße 175, 79117, Freiburg, Germany. christoph.centner@sport.uni-freiburg.de.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-021-00239-7']
1132,33578911,Effects of Percutaneous Electrical Nerve Stimulation on Countermovement Jump and Squat Performance Speed in Male Soccer Players: A Pilot Randomized Clinical Trial.,"It has been suggested that Percutaneous Electrical Nerve Stimulation (PENS) can increase muscle strength. No previous study has investigated changes in performance in semiprofessional soccer players. This study compares the effects of adding two sessions of PENS to a training program versus the single training program over sport performance attributes (e.g., jump height and squat speed) in healthy soccer players. A cluster-randomized controlled trial was conducted on twenty-three semiprofessional soccer players who were randomized into an experimental (PENS + training program) or control (single training program) group. The training program consisted of endurance and strength exercises separated by 15-min recovery period, three times/week. The experimental group received two single sessions of PENS one-week apart. Flight time and vertical jump height during the countermovement jump and squat performance speed were assessed before and after each session, and 30 days after the last session. Male soccer players receiving the PENS intervention before the training session experienced greater increases in the flight time, and therefore, in vertical jump height, after both sessions, but not one month after than those who did not receive the PENS intervention (F = 4.289,  p  = 0.003, η 2 p: 0.170). Similarly, soccer players receiving the PENS intervention experienced a greater increase in the squat performance speed after the second session, but not after the first session or one month after (F = 7.947,  p  < 0.001, η 2 p: 0.275). Adding two sessions of ultrasound-guided PENS before a training strength program improves countermovement jump and squat performance speed in soccer players.",2021,Adding two sessions of ultrasound-guided PENS before a training strength program improves countermovement jump and squat performance speed in soccer players.,"['soccer players', 'healthy soccer players', 'Male Soccer Players', 'Male soccer players', 'twenty-three semiprofessional soccer players', 'semiprofessional soccer players']","['Percutaneous Electrical Nerve Stimulation', 'experimental (PENS + training program) or control (single training program', 'Percutaneous Electrical Nerve Stimulation (PENS', 'endurance and strength exercises']","['flight time, and therefore, in vertical jump height', 'squat performance speed', 'Countermovement Jump and Squat Performance Speed', 'Flight time and vertical jump height during the countermovement jump and squat performance speed', 'countermovement jump and squat performance speed']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450348', 'cui_str': '23'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0132773,Adding two sessions of ultrasound-guided PENS before a training strength program improves countermovement jump and squat performance speed in soccer players.,"[{'ForeName': 'Gracia María', 'Initials': 'GM', 'LastName': 'Gallego-Sendarrubias', 'Affiliation': 'Department of Physical Therapy, Universidad Camilo José Cela, Villanueva de la Cañada, 28692 Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28922 Alcorcón, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': ""Úbeda-D'Ocasar"", 'Affiliation': 'Department of Physical Therapy, Universidad Camilo José Cela, Villanueva de la Cañada, 28692 Madrid, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Hervás-Pérez', 'Affiliation': 'Department of Physical Therapy, Universidad Camilo José Cela, Villanueva de la Cañada, 28692 Madrid, Spain.'}, {'ForeName': 'Manuel Antonio', 'Initials': 'MA', 'LastName': 'Rubio-Palomino', 'Affiliation': 'Private Professional Practice, 28008 Madrid, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28922 Alcorcón, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Valera-Calero', 'Affiliation': 'Department of Physical Therapy, Universidad Camilo José Cela, Villanueva de la Cañada, 28692 Madrid, Spain.'}]",Journal of clinical medicine,['10.3390/jcm10040690']
1133,33578854,Active Game-Based Solutions for the Treatment of Childhood Obesity.,"Obesity is one of the biggest health problems globally that, together with sedentarism, requires solutions that increase the enthusiasm towards physical activity. Therefore, this paper describes two solutions based on active games using the Kinect sensor and biometric sensors, designed for the outpatient treatment of childhood obesity. The solutions were applied in an intervention program based on active video games and motor games, developed with children in treatment for childhood obesity. An ad hoc questionnaire was used to assess the level of satisfaction, fun, learning, and behavior changes in the children of the experimental group that developed the intervention. The results showed a high index of satisfaction with the intervention program, as well as with the games developed. It is concluded that active video games and group games are highly motivating and can promote behavior change towards healthier life habits in children.",2021,"The solutions were applied in an intervention program based on active video games and motor games, developed with children in treatment for childhood obesity.","['children', 'Childhood Obesity']",['Active Game-Based Solutions'],"['level of satisfaction, fun, learning, and behavior changes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",,0.0163123,"The solutions were applied in an intervention program based on active video games and motor games, developed with children in treatment for childhood obesity.","[{'ForeName': 'Carina S', 'Initials': 'CS', 'LastName': 'González-González', 'Affiliation': 'Grupo ITED, Universidad de La Laguna, 38200 San Cristóbal de La Laguna, Spain.'}, {'ForeName': 'Nazaret', 'Initials': 'N', 'LastName': 'Gómez Del Río', 'Affiliation': 'Grupo GRIAL, Universidad de Salamanca, 37008 Salamanca, Spain.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Toledo-Delgado', 'Affiliation': 'Grupo ITED, Universidad de La Laguna, 38200 San Cristóbal de La Laguna, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'García-Peñalvo', 'Affiliation': 'Grupo GRIAL, Universidad de Salamanca, 37008 Salamanca, Spain.'}]","Sensors (Basel, Switzerland)",['10.3390/s21041266']
1134,33578807,"Effects of Integrated Indirect Forest Experience on Emotion, Fatigue, Stress and Immune Function in Hemodialysis Patients.","BACKGROUND


Most hemodialysis patients may experience physiological and psychological stress. Exposure to nature has been reported to reduce psychological and physiological stress levels and improve immune function. This study aimed to investigate psychological and physiological effects of integrated indirect forest experience on chronic renal failure patients undergoing hemodialysis.
METHODS


As a quasi-experiment, this study employed a nonequivalent control group, repeated measurements, and a non-synchronized design. In total, 54 participants were included: 26 and 28 patients in the experimental and control groups, respectively. During hemodialysis, five types of forest therapy stimuli (visual, auditory, olfactory, tactile, and motor) were applied 3 times per week for 4 weeks during 15 min sessions.
RESULTS


Positive, but not negative, emotion measures differed between the groups after the intervention. Fatigue and physiological stress levels were significantly reduced in the experimental group, whereas no significant difference was found between the groups with respect to measures of psychological stress. Activation of both the parasympathetic and sympathetic nervous systems was similar in both groups, as was the number of natural killer cells.
CONCLUSION


Integrated indirect forest experience may help increase positive emotions and reduce fatigue and stress levels during hemodialysis in patients with chronic renal failure.",2021,"Fatigue and physiological stress levels were significantly reduced in the experimental group, whereas no significant difference was found between the groups with respect to measures of psychological stress.","['patients with chronic renal failure', 'chronic renal failure patients undergoing hemodialysis', '54 participants were included: 26 and 28 patients in the experimental and control groups, respectively', 'Hemodialysis Patients']","['Integrated Indirect Forest Experience', 'integrated indirect forest experience']","['forest therapy stimuli (visual, auditory, olfactory, tactile, and motor', 'positive emotions and reduce fatigue and stress levels', 'negative, emotion measures', 'Fatigue and physiological stress levels', 'psychological stress', 'Emotion, Fatigue, Stress and Immune Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}]",54.0,0.0132793,"Fatigue and physiological stress levels were significantly reduced in the experimental group, whereas no significant difference was found between the groups with respect to measures of psychological stress.","[{'ForeName': 'Hyoyoung', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Kangwon National University, Chuncheon 24341, Korea.'}, {'ForeName': 'Youngran', 'Initials': 'Y', 'LastName': 'Chae', 'Affiliation': 'Department of Nursing, Kangwon National University, Chuncheon 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph18041701']
1135,33578767,AN-VR-BE. A Randomized Controlled Trial for Reducing Fear of Gaining Weight and Other Eating Disorder Symptoms in Anorexia Nervosa through Virtual Reality-Based Body Exposure.,"In vivo body exposure therapy is considered an effective and suitable intervention to help patients with anorexia nervosa (AN) reduce their body image disturbances (BIDs). However, these interventions have notable limitations and cannot effectively reproduce certain fears usually found in AN, such as the fear of gaining weight (FGW). The latest developments in virtual reality (VR) technology and embodiment-based procedures could overcome these limitations and allow AN patients to confront their FGW and BIDs. This study aimed to provide further evidence of the efficacy of an enhanced (by means of embodiment) VR-based body exposure therapy for the treatment of AN. Thirty-five AN patients (16 in the experimental group, 19 in the control group) participated in the study. FGW, BIDs, and other body-related and ED measures were assessed before and after the intervention and three months later. The experimental group received treatment as usual (TAU) and five additional sessions of VR-based body exposure therapy, while the control group received only TAU. After the intervention, ED symptoms were clearly reduced in both groups, with most of the changes being more noticeable in the experimental group. Specifically, after the intervention and at follow-up, significant group differences were found in the FGW and BIDs, with the experimental group showing significantly lower values than the control group. The current study provides new insights and encouraging findings in the field of exposure-based therapies in AN. VR technology might improve research and clinical practice in AN by providing new tools to help patients confront their core fears (i.e., food- or weight-related cues) and improve their emotional, cognitive, and behavioral responses to their body image.",2021,"VR technology might improve research and clinical practice in AN by providing new tools to help patients confront their core fears (i.e., food- or weight-related cues) and improve their emotional, cognitive, and behavioral responses to their body image.","['Thirty-five AN patients (16 in the experimental group, 19 in the control group) participated in the study', 'patients with anorexia nervosa (AN']","['treatment as usual (TAU) and five additional sessions of VR-based body exposure therapy, while the control group received only TAU', 'embodiment) VR-based body exposure therapy']","['ED symptoms', 'FGW and BIDs', 'FGW, BIDs, and other body-related and ED measures']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0558116', 'cui_str': 'Distorted body image'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0147545,"VR technology might improve research and clinical practice in AN by providing new tools to help patients confront their core fears (i.e., food- or weight-related cues) and improve their emotional, cognitive, and behavioral responses to their body image.","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Porras-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrer-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Serrano-Troncoso', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Sant Joan de Déu of Barcelona, Passeig de Sant Joan de Déu, 2, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Carulla-Roig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Sant Joan de Déu of Barcelona, Passeig de Sant Joan de Déu, 2, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Soto-Usera', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Sant Joan de Déu of Barcelona, Passeig de Sant Joan de Déu, 2, Esplugues de Llobregat, 08950 Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Miquel-Nabau', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Laura Fernández-Del Castillo', 'Initials': 'LFC', 'LastName': 'Olivares', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Marnet-Fiol', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}, {'ForeName': 'Isabel de la Montaña', 'Initials': 'IM', 'LastName': 'Santos-Carrasco', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Clínico San Carlos, Madrid, Calle del Prof Martín Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Borszewski', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Clínico San Carlos, Madrid, Calle del Prof Martín Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Díaz-Marsá', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Clínico San Carlos, Madrid, Calle del Prof Martín Lagos, s/n, 28040 Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Sánchez-Díaz', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Universitario de Bellvitge-IDIBELL and CIBEROBN, Barcelona, Carrer Feixa Llarga s/n, Hospitalet del Llobregat, 08907 Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fernández-Aranda', 'Affiliation': 'Department of Psychiatry and Mental Health, Hospital Universitario de Bellvitge-IDIBELL and CIBEROBN, Barcelona, Carrer Feixa Llarga s/n, Hospitalet del Llobregat, 08907 Barcelona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gutiérrez-Maldonado', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, University of Barcelona, Passeig de la Vall d'Hebron 171, 08035 Barcelona, Spain.""}]",Journal of clinical medicine,['10.3390/jcm10040682']
1136,33578226,Early vs. late enoxaparin for the prevention of venous thromboembolism in patients with ICH: A double blind placebo controlled multicenter study.,"BACKROUND


Venous thromboembolism (VTE) after primary intracerebral hemorrhage (ICH) worsens patient prognosis. Administering low-molecular weight heparins (LMWH) to prevent VTE early (24 h) may increase the risk of hematoma enlargement, whereas administering late (72 h) after onset may decrease its effect on VTE prevention. The authors investigated when it is safe and effective to start LMWH in ICH patients.
METHODS


In the setting of double blinded, placebo controlled randomization, patients >18 years of age with paretic lower extremity, and admitted to the emergency room within 12 h of the onset of ICH, were randomized into two groups. Patients in the enoxaparin group received 20 mg twice a day 24 h (early) after the onset of ICH and in the placebo group 72 h (late) after onset respectively. Both groups immediately received intermittent pneumatic compression stockings at the ER. Patients were prospectively and routinely screened for VTE and hemorrhagic complications 1 day after entering the study and again before discharge.
RESULTS


139 patients were included for randomization in this study. Only 3 patients developed VTE, 2 in the early enoxaparin group and one in the late enoxaparin group. No patients developed PE. Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
CONCLUSION


Administering 40 mg/d LMWH for prevention of VTE to a spontaneous ICH patient is safe regardless of whether it is started 24 h (early) or 72 h (late) after the hemorrhage. Risk of hemorrhage enlargement is not associated with early LMWH treatment. Administering LMWH late did not increase VTEs.",2021,"Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
","['139 patients were included for randomization in this study', 'patients with ICH', 'primary intracerebral hemorrhage (ICH) worsens patient prognosis', 'patients >18 years of age with paretic lower extremity, and admitted to the emergency room within 12 h of the onset of ICH']","['Administering low-molecular weight heparins (LMWH', 'intermittent pneumatic compression stockings', 'enoxaparin', 'placebo']","['risk of hematoma enlargement', 'PE', 'overall outcome', 'Thromboembolic events', 'VTEs', 'venous thromboembolism']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1287404', 'cui_str': 'Prognosis/outlook finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C2711456', 'cui_str': 'Intermittent pneumatic compression stockings'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",139.0,0.311758,"Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Neurosurgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huhtakangas', 'Affiliation': 'Department of Neurology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Juvela', 'Affiliation': 'Department of Clinical Neurosciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Bode', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tatlisumak', 'Affiliation': 'Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland; Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Savolainen', 'Affiliation': 'Department of Clinical Neurosciences, University of Helsinki, Helsinki, Finland; Department of Neurology, South Karelian Central Hospital, Lappeenranta, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Numminen', 'Affiliation': 'Department of Neurology, Tampere University Hospital, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ollikainen', 'Affiliation': 'Department of Neurology, Tampere University Hospital, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luostarinen', 'Affiliation': 'Department of Neurology, Päijät-Häme Central Hospital, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kupila', 'Affiliation': 'Department of Neurology, Päijät-Häme Central Hospital, Finland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tetri', 'Affiliation': 'Department of Neurosurgery, Oulu University Hospital, Oulu, Finland. Electronic address: sami.tetri@ppshp.fi.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2021.106534']
1137,33578224,The development and efficacy of a mobile phone application to improve medication adherence for persons with epilepsy in limited resource settings: A preliminary study.,"OBJECTIVE


Persons with epilepsy (PWE), especially those with limited education backgrounds from developing countries, are challenged by complicated medication regimens, debilitating seizures, and stigmatization in their daily life. Consequently, it is difficult for physicians to ensure medication adherence. This study validates a novel mobile application which was hypothesized to increase medication adherence and self-management skills in PWE. Created by medical professionals, the application included behavioral and educational components and was built to be easy-to-understand for those of socio-economically disadvantaged backgrounds.
METHODS


This was a parallel, two-armed randomized controlled trial in which a total of 96 participants were enrolled from a Neurology Outpatient Department into a control standard care group and a mobile application group that used the smartphone application (app) in addition to the standard medical treatment. The app was intuitive and easy to understand for those coming from a socio-economically disadvantaged background. Medication adherence and self-efficacy were assessed with the Morisky Green and Levine Scale (MGLS) and the Epilepsy Self Efficacy Scale (ESES). Patients were reassessed 12 weeks later. Change in seizure frequency following administration of the application was a secondary outcome.
RESULTS


In an intent-to-treat analysis, the mobile application interventional group showed over a 60% increase in the proportion of medication adherence (P < 0.0001). The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75 (P < 0.0001). The control group showed no statistically significant increases in either the proportion adherent or mean self-efficacy scores.
SIGNIFICANCE


This study demonstrated the statistically significant performance of a mobile application in improving medication adherence and self-management skills in Indian persons with epilepsy.",2021,The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75,"['Indian persons with epilepsy', 'Persons with epilepsy (PWE', 'persons with epilepsy in limited resource settings', '96 participants were enrolled from a Neurology Outpatient Department into a']","['mobile phone application', 'control standard care group and a mobile application group that used the smartphone application (app) in addition to the standard medical treatment']","['mean self-efficacy score', 'proportion adherent or mean self-efficacy scores', 'medication adherence and self-management skills', 'Medication adherence and self-efficacy', 'seizure frequency', 'medication adherence', 'Morisky Green and Levine Scale (MGLS) and the Epilepsy Self Efficacy Scale (ESES', 'proportion of medication adherence']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]",96.0,0.0382893,The mean self-efficacy score for the mobile application group was increased from 269.5 to 289.75,"[{'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Mirpuri', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'P Prarthana', 'Initials': 'PP', 'LastName': 'Chandra', 'Affiliation': 'Hamdard Institute of Medical Sciences and Research, New Delhi, India.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Samala', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Doddamani', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kirandeep', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India; MEG Facility, National Brain Research Centre, Manesar, Haryana, India.'}, {'ForeName': 'Bhargavi', 'Initials': 'B', 'LastName': 'Ramanujan', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'P Sarat', 'Initials': 'PS', 'LastName': 'Chandra', 'Affiliation': 'Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: mantriaiims@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2021.107794']
1138,33578191,Subgroup analysis of clinical and MRI outcomes in participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study.,"BACKGROUND


In the Phase 3, 96-week ORACLE-MS study, cladribine 10 mg tablets (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years) significantly reduced the rate of conversion to clinically definite multiple sclerosis (CDMS) per the Poser criteria (henceforth referred to as CDMS), multiple sclerosis (MS) per the 2005 McDonald criteria, and the number of new or persisting T1 gadolinium-enhancing (Gd+), new or enlarging T2, and combined unique active (CUA) lesions versus placebo in participants with a first clinical demyelinating event (FCDE). Patient demographic and disease characteristics may be predictors of disease progression. The current study analyzed the effect of cladribine tablets in subgroups of participants in the ORACLE-MS study by baseline demographics and disease characteristics.
METHODS


This analysis retrospectively examined data collected from 616 participants enrolled in the ORACLE-MS study (placebo, n=206; cladribine tablets 3.5 mg/kg, n=206; cladribine tablets 5.25 mg/kg, n=204). Five subgroups were predetermined by baseline demographics, including sex, age (<30 or ≥30 years), classification of FCDE, and lesion characteristics, including absence or presence of T1 Gd+ lesions and number of T2 lesions (<9 or ≥9). Selected endpoints of the ORACLE-MS study were re-analyzed for these subgroups. The primary and main secondary endpoints were time to conversion to CDMS and MS (2005 McDonald criteria), respectively. Secondary magnetic resonance imaging (MRI) endpoints included cumulative T1 Gd+ and new or enlarging T2 lesions. Cox proportional hazards models were used to evaluate time to conversion to CDMS and MS (2005 McDonald criteria). This analysis focused primarily on the results for the cladribine tablets 3.5 mg/kg group because this dosage is approved for relapsing forms of MS.
RESULTS


In the overall intent-to-treat (ITT) population, cladribine tablets 3.5 mg/kg significantly reduced the risk of conversion to CDMS (hazard ratio [HR]=0.326; P<0.0001) and MS (2005 McDonald criteria; HR=0.485; P<0.0001) versus placebo. Similar effects of cladribine tablets on risk of conversion were observed in post hoc analyses of subgroups defined by various baseline characteristics. In both the ITT population and across subgroups, cladribine tablets 3.5 mg/kg reduced the numbers of cumulative T1 Gd+ (range of rate ratios: 0.106-0.399), new or enlarging T2 (range of rate ratios: 0.178-0.485), and CUA (range of rate ratios: 0.154-0.384) lesions versus placebo (all nominal P<0.03). Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
CONCLUSION


In this post hoc analysis of the ORACLE-MS study, cladribine tablets reduced the risk of conversion to multiple sclerosis and lesion burden in participants with an FCDE in the overall ITT population and multiple subgroups defined by baseline demographics and lesion characteristics.",2020,"Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
","['participants with a first clinical demyelinating event at risk of multiple sclerosis in the ORACLE-MS study', '616 participants enrolled in the ORACLE-MS study (placebo, n=206; cladribine tablets 3.5 mg/kg, n=206', 'participants with a first clinical demyelinating event (FCDE', 'Five subgroups were predetermined by baseline demographics, including sex, age (<30 or ≥30 years), classification of FCDE, and lesion characteristics, including absence or presence of T1 Gd+ lesions and number of T2 lesions (<9 or ≥9', 'subgroups of participants in the ORACLE-MS study by baseline demographics and disease characteristics']","['placebo', 'cladribine tablets', 'Secondary magnetic resonance imaging (MRI', 'cladribine']","['FCDE classification', 'number of T2 lesions', 'risk of conversion to CDMS', 'risk of conversion', 'rate of conversion', 'numbers of cumulative T1 Gd', 'risk of conversion to multiple sclerosis and lesion burden', 'presence of T1 Gd+ lesions', 'cumulative T1 Gd+ and new or enlarging T2 lesions', 'time to conversion to CDMS and MS']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",616.0,0.133533,"Multivariate Cox proportional hazards models revealed that age (HR=0.577, nominal P<0.0001), FCDE classification (HR=0.738, nominal P=0.0043), presence of T1 Gd+ lesions (HR=0.554, nominal P<0.0001), and number of T2 lesions (HR=0.417, nominal P<0.0001) at baseline were factors associated with risk of conversion to MS (2005 McDonald criteria), whereas no baseline factors examined were associated with risk of conversion to CDMS.
","[{'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, San Francisco, CA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bowen', 'Affiliation': 'Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, University Hospital of Düsseldorf, Medical Faculty, Heinrich-Heine-Universität, Düsseldorf, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'University of Lille, INSERM U1172, Lille Neurosciences and Cognition, CHU Lille, FHU Imminent, F-59000 Lille, France.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Hughes', 'Affiliation': 'MercyOne Ruan Multiple Sclerosis Center, Des Moines, IA, USA.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Hyvert', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Galazka', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Grosso', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Leist', 'Affiliation': 'Comprehensive Multiple Sclerosis Center, Jefferson University, Philadelphia, PA, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102695']
1139,33580803,Benefits of Adding Gluteal Dry Needling to a Four-Week Physical Exercise Program in a Chronic Low Back Pain Population. A Randomized Clinical Trial.,"OBJECTIVE


To determine if adding dry needling to a four-week exercise program has an additional benefit compared with adding sham dry needling to the same exercise program in subjects with chronic low back pain.
DESIGN


Randomized clinical trial.
SETTING


Physiotherapy and Pain Clinic of Alcala University.
SUBJECTS


Forty-six patients with chronic low back pain.
METHODS


Subjects were randomized to two groups: the dry needling group (N = 23) or sham dry needling group (N = 23). Both groups received a four-week exercise program and before the exercise started a session of dry needling or sham dry needling. Pain (visual analog scale), disability (Roland-Morris Questionnaire), and fear avoidance beliefs (Fear Avoidance Beliefs Questionnaire) were assessed at baseline, after treatment, and at three-month follow-up. Pressure pain thresholds (algometer) were measured at baseline, after the dry needling or the sham dry needling, and after treatment.
RESULTS


Both groups showed significant improvements for all variables. In the between-group comparison, the dry needling group improved significantly in pain at three-month follow-up and pressure pain thresholds at the end of treatment for all measures, and at three-month follow-up there was no improvement in gluteus medium.
CONCLUSIONS


In chronic low back patients, adding dry needling to a four-week exercise program has an additional benefit in pain and sensitivity compared with adding sham dry needling to the same exercise program.",2020,"In the between-group comparison, the dry needling group improved significantly in pain at three-month follow-up and pressure pain thresholds at the end of treatment for all measures, and at three-month follow-up there was no improvement in gluteus medium.
","['subjects with chronic low back pain', 'Subjects', 'Chronic Low Back Pain Population', 'Physiotherapy and Pain Clinic of Alcala University', 'Forty-six patients with chronic low back pain']","['exercise started a session of dry needling or sham dry needling', 'dry needling group (N\u2009=\u200923) or sham dry needling group', 'Gluteal Dry Needling to a Four-Week Physical Exercise Program']","['pressure pain thresholds', 'Pressure pain thresholds (algometer', 'Pain (visual analog scale), disability (Roland-Morris Questionnaire), and fear avoidance beliefs (Fear Avoidance Beliefs Questionnaire', 'gluteus medium', 'pain']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]",46.0,0.0681849,"In the between-group comparison, the dry needling group improved significantly in pain at three-month follow-up and pressure pain thresholds at the end of treatment for all measures, and at three-month follow-up there was no improvement in gluteus medium.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín-Corrales', 'Affiliation': 'Bonn Center, Madrid, Spain.'}, {'ForeName': 'Irene Victoria', 'Initials': 'IV', 'LastName': 'Bautista', 'Affiliation': 'Meblanc Center, Madrid, Spain.'}, {'ForeName': 'José Enrique', 'Initials': 'JE', 'LastName': 'Méndez-Mera', 'Affiliation': 'Binomio Center, Madrid, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Fernández-Matías', 'Affiliation': 'Research Institute of Physiotherapy and Pain. Universidad de Alcalá, Alcalá, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Universidad de Jaén, Jaén, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Research Institute of Physiotherapy and Pain. Universidad de Alcalá, Alcalá, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Nuñez-Nagy', 'Affiliation': 'Department of Physical Therapy and Nursing, Universidad de Alcalá, Alcalá, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Research Institute of Physiotherapy and Pain. Universidad de Alcalá, Alcalá, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa279']
1140,33580636,Vitamin D supplementation protects against reductions in plasma 25-hydroxyvitamin D induced by open-heart surgery: Assess-d trial.,"Low vitamin D (serum or plasma 25-hydroxyvitamin D (25(OH)D)) is a global pandemic and associates with a greater prevalence in all-cause and cardiovascular mortality and morbidity. Open-heart surgery is a form of acute stress that decreases circulating 25(OH)D concentrations and exacerbates the preponderance of low vitamin D in a patient population already characterized by low levels. Although supplemental vitamin D increases 25(OH)D, it is unknown if supplemental vitamin D can overcome the decreases in circulating 25(OH)D induced by open-heart surgery. We sought to identify if supplemental vitamin D protects against the acute decrease in plasma 25(OH)D propagated by open-heart surgery during perioperative care. Participants undergoing open-heart surgery were randomly assigned (double-blind) to one of two groups: (a) vitamin D (n = 75; cholecalciferol, 50,000 IU/dose) or (b) placebo (n = 75). Participants received supplements on three separate occasions: orally the evening before surgery and either orally or per nasogastric tube on postoperative days 1 and 2. Plasma 25(OH)D concentrations were measured at baseline (the day before surgery and before the first supplement bolus), after surgery on postoperative days 1, 2, 3, and 4, at hospital discharge (5-8 days after surgery), and at an elective outpatient follow-up visit at 6 months. Supplemental vitamin D abolished the acute decrease in 25(OH)D induced by open-heart surgery during postoperative care. Moreover, plasma 25(OH)D gradually increased from baseline to day 3 and remained significantly increased thereafter but plateaued to discharge with supplemental vitamin D. We conclude that perioperative vitamin D supplementation protects against the immediate decrease in plasma 25(OH)D induced by open-heart surgery. ClinicalTrials.gov Identifier: NCT02460211.",2021,"Moreover, plasma 25(OH)D gradually increased from baseline to day 3 and remained significantly increased thereafter but plateaued to discharge with supplemental vitamin D. We conclude that perioperative vitamin D supplementation protects against the immediate decrease in plasma 25(OH)D induced by open-heart surgery.",['Participants undergoing open-heart surgery'],"['vitamin D (n\xa0=\xa075; cholecalciferol', 'Vitamin D supplementation', 'placebo', 'supplemental vitamin D', 'Supplemental vitamin D']","['plasma 25-hydroxyvitamin D', 'plasma 25(OH)D', 'Low vitamin D (serum or plasma 25-hydroxyvitamin D (25(OH)D', 'Plasma 25(OH)D concentrations']","[{'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4285871', 'cui_str': 'Vitamin D low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.32917,"Moreover, plasma 25(OH)D gradually increased from baseline to day 3 and remained significantly increased thereafter but plateaued to discharge with supplemental vitamin D. We conclude that perioperative vitamin D supplementation protects against the immediate decrease in plasma 25(OH)D induced by open-heart surgery.","[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Barker', 'Affiliation': 'Precision Genomics, Intermountain Healthcare, St. George, Utah, USA.'}, {'ForeName': 'Heidi T', 'Initials': 'HT', 'LastName': 'May', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Doty', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Lappe', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Kirk U', 'Initials': 'KU', 'LastName': 'Knowlton', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Carlquist', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Konery', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Inglet', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Chisum', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Oxana', 'Initials': 'O', 'LastName': 'Galenko', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Muhlestein', 'Affiliation': 'Heart Institute, Intermountain Healthcare, Salt Lake City, Utah, USA.'}]",Physiological reports,['10.14814/phy2.14747']
1141,33581464,Can increased cognitive load help people with subthreshold depression to forget negative information?,"BACKGROUND


Given that major depression is a global public health problem, and that sub-threshold depression (SD) has been shown to be a significant risk indicator of major depression disorder, the awareness of SD interventions has increased. The current study explored the effect of increasing cognitive load on the forgetting of unwanted and negative memories of sub-threshold depression individuals (SDs) (Study 1) and proposed a cognitive load intervention (CLI) (study 2).
METHODS


53 SDs and 52 normal participants were recruited to explore the effect of cognitive load on the directed forgetting of negative items (Study 1). The treatment effect of CLI on 62 SDs was investigated. SDs completed up to 8 CLI/control sessions over an 8-week period while regularly recording their depression symptoms (Study 2).
RESULTS


The results showed that it is more difficult for SDs to forget negative 'to-be-forgotten' items than normal controls (F (1, 99) = 27.98, p < 0.001, η 2  = 0.22). In study 1, increasing cognitive load promoted directed forgetting for negative items in SDs. Study 2 showed that there were significant reductions in depression symptoms of SDs over the 8-week CLI (e.g. BDI-Ⅱ scores: F (1, 60) = 99.93, p < 0.001, η 2  = 0.63).
LIMITATIONS


Small sample size and lack of verification by neuroimaging may limit the generalizability of these results.
CONCLUSIONS


The study revealed that increasing cognitive load can promote SDs to forget negative information, while the CLI project effectively reduced the depression level of SDs, thus providing encouraging initial support for its use in the treatment of SD.",2021,"The results showed that it is more difficult for SDs to forget negative 'to-be-forgotten' items than normal controls (F (1, 99) = 27.98, p < 0.001, η 2  = 0.22).",['53 SDs and 52 normal participants'],"['CLI', 'cognitive load intervention (CLI']",['depression symptoms of SDs'],"[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0347911,"The results showed that it is more difficult for SDs to forget negative 'to-be-forgotten' items than normal controls (F (1, 99) = 27.98, p < 0.001, η 2  = 0.22).","[{'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Psychology, Shandong Normal University, China. Electronic address: huyixin2005@163.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shandong Normal University, China. Electronic address: 1076784206@qq.com.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Shandong Normal University, China. Electronic address: 940917373@qq.com.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Maguire', 'Affiliation': 'Department of Computer Science, National University of Ireland. Electronic address: pmaguire@cs.nuim.ie.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'School of Psychology, Shandong Normal University, China. Electronic address: wdw112@163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2021.01.062']
1142,33581146,Take-Home Kits to Detect Respiratory Viruses among Healthcare Personnel: Lessons Learned from a Cluster Randomized Clinical Trial.,"BACKGROUND


Healthcare personnel (HCP) working in outpatient settings routinely interact with patients with acute respiratory illnesses. Absenteeism following symptom development and lack of staff trained to obtain samples limit efforts to identify pathogens among infected HCP.
METHODS


The Respiratory Protection Effectiveness Clinical Trial assessed respiratory infection incidence among HCP between 2011 and 2015. Research assistants (RAs) obtained anterior nasal and oropharyngeal swabs from HCP in the workplace following development of respiratory illness symptoms and randomly while asymptomatic. Participants received take-home kits to self-collect swabs when absent from work. Samples mailed to a central laboratory were tested for respiratory viruses by reverse transcription polymerase chain reaction.
RESULTS


Among 2,862 participants, 3,467 swabs were obtained from symptomatic participants. Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples. Self-collected samples by symptomatic HCP at home had higher rates of viral detection (40.3%) compared to 24% obtained by trained RAs in the workplace (P < 0.001).
CONCLUSIONS


In this randomized clinical trial, take-home kits were an easily implemented, effective method to self-collect samples by HCP. Other studies have previously shown relative equivalence of self-collected samples to those obtained by trained healthcare workers. Take-home kit self-collection could diminish workforce exposures and decrease the demand for personnel protective equipment worn to protect workers who collect respiratory samples.",2021,"Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples.","['2,862 participants, 3,467 swabs were obtained from symptomatic participants', 'patients with acute respiratory illnesses', 'Healthcare Personnel']",[],['viral detection'],"[{'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",[],"[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",3467.0,0.15521,"Among symptomatic HCP, respiratory virus was detected in 904 of 3,467 (26.1%) samples.","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Los', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: jlos1@jhmi.edu.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Geoffrey J', 'Initials': 'GJ', 'LastName': 'Gorse', 'Affiliation': 'VA St. Louis Health Care System and Saint Louis University School of Medicine St. Louis, MO, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Lykken', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Nyquist', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA; University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Price', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; Denver Health and Hospital, Denver, CO, USA.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Radonovich', 'Affiliation': 'Respiratory Health Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rattigan', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Reich', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Simberkoff', 'Affiliation': 'New York Harbor Healthcare System, New York, NY, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Bessesen', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; VA-Eastern Colorado Healthcare System, Denver, CO, USA.'}, {'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'University of Massachusetts, Amherst, MA, USA.'}, {'ForeName': 'Derek A T', 'Initials': 'DAT', 'LastName': 'Cummings', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Trish M', 'Initials': 'TM', 'LastName': 'Perl', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of infection control,['10.1016/j.ajic.2021.02.001']
1143,33581023,Tranexamic acid in joint replacement : a randomized trial comparing intravenous oral and topical routes.,"Various plating systems are available to fix distal radius fractures, each with a specific design. The purpose of this study was to compare radiological outcome and complications of the Variable Angle LCP Plate 2.4-mm (DePuy Synthes) with the VariAx volar locking plate (Stryker). One hundred patients (103 wrists) operated on for a distal radius fracture were retrospectively reviewed with a mean follow-up of 3.5 years. Seventy-three wrists were treated with a DePuy Synthes plate and 30 with a VariAx plate. The overall complication rate was 32%. Nineteen cases underwent revision surgery, 18 had malunion and 3 complex regional pain syndrome. Complicaton rate was 43% with DePuy Synthes plates and 27% with Variax plates, but the difference was not significant.",2020,"Complicaton rate was 43% with DePuy Synthes plates and 27% with Variax plates, but the difference was not significant.","['Nineteen cases underwent revision surgery, 18 had malunion and 3 complex regional pain syndrome', 'Seventy-three wrists were treated with a', 'joint replacement ', 'One hundred patients (103 wrists) operated on for a distal radius fracture were retrospectively reviewed with a mean follow-up of 3.5 years']","['DePuy Synthes plate and 30 with a VariAx plate', 'VariAx volar locking plate (Stryker', 'Tranexamic acid']","['overall complication rate', 'Complicaton rate']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185317', 'cui_str': 'Implantation of joint prosthesis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0264329,"Complicaton rate was 43% with DePuy Synthes plates and 27% with Variax plates, but the difference was not significant.","[{'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Othman', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Melebeck', 'Affiliation': ''}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Daubresse', 'Affiliation': ''}]",Acta orthopaedica Belgica,[]
1144,33581015,Effects of metformin and insulin therapy regimens on postpartum oral glucose tolerance test results in pregnant women with gestational diabetes mellitus: a comparative study.,"OBJECTIVES


The main purpose of this study was to compare the effects of two regimens of metformin and insulin therapy on postpartum oral glucose tolerance test (OGTT) results in pregnant women with gestational diabetes mellitus (GDM).
METHODS


In this single-blind randomized clinical trial (RCT), a total number of 60 pregnant women meeting the inclusion criteria were assigned to two groups with a randomized block design (RBD): insulin therapy (IT) group (30 patients) and metformin therapy (MT) group (30 patients). At baseline, the data were comprised of prenatal maternal age, gestational age, GDM diagnosis, and maternal weight/height. During the postpartum period, 5-cc blood samples were taken from the pregnant women concerned to analyze their fasting blood sugar (FBS) levels. Then, the patients were asked to come back four days and six weeks later after delivery to check the OGTT results. At six weeks postpartum, in addition to OGTT, the glycated hemoglobin (HbA 1 C) test was performed for all mothers. Finally, six weeks after delivery, these mothers were evaluated with regard to weight loss and body mass index (BMI).
RESULTS


Six weeks postpartum, the maternal weight and BMI significantly decreased in the MT group compared with the IT one, while there was no significant difference between both groups at baseline. On the fourth day, the OGTT results in the MT group were significantly lower in comparison with those in the IT group (p=0.012). At sixth weeks postpartum, the OGTT results were comparably lower in the MT group than those reported for the IT one; however, such a difference was not statistically significant (p=0.087).
CONCLUSIONS


According to the study results, metformin could be an effective and safe treatment for pregnant women suffering from GDM instead of insulin therapy.",2020,"On the fourth day, the OGTT results in the MT group were significantly lower in comparison with those in the IT group (p=0.012).","['pregnant women suffering from GDM instead of insulin therapy', 'pregnant women with gestational diabetes mellitus (GDM', 'pregnant women with gestational diabetes mellitus', '60 pregnant women meeting the inclusion criteria']","['metformin', 'metformin and insulin therapy', 'metformin and insulin therapy regimens', 'randomized block design (RBD): insulin therapy (IT) group (30 patients) and metformin therapy (MT']","['weight loss and body mass index (BMI', 'postpartum oral glucose tolerance test', 'fasting blood sugar (FBS) levels', 'postpartum oral glucose tolerance test (OGTT', 'glycated hemoglobin', 'maternal weight and BMI']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",60.0,0.0386487,"On the fourth day, the OGTT results in the MT group were significantly lower in comparison with those in the IT group (p=0.012).","[{'ForeName': 'Moghadaseh', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sayyad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Islamic Republic of Iran.'}, {'ForeName': 'Arash Rezaei', 'Initials': 'AR', 'LastName': 'Shahmirzadi', 'Affiliation': 'Student Research Committee, Golestan University of Medical Sciences, Gorgan, Islamic Republic of Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kashani', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sayyad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Islamic Republic of Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alipoor', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Islamic Republic of Iran.'}, {'ForeName': 'Shoreh', 'Initials': 'S', 'LastName': 'Vosough', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sayyad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Islamic Republic of Iran.'}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2020-0018']
1145,30102683,Endothelial Vasodilation After a High-Volume Training Load and Tapered Training in Collegiate Female Swimmers.,"ABSTRACT


Weihl, FM and Van Guilder, GP. Endothelial vasodilation after a high-volume training load and tapered training in collegiate female swimmers. J Strength Cond Res 35(3): 811-818, 2021-High-volume endurance training loads have been linked to adverse remodeling of the heart and large arteries; yet, data on the vascular endothelial function are unclear. Moreover, although collegiate-level endurance athletes often perform high-volumes of vigorous endurance training and resistance training as part of their strength and conditioning programs, it is unknown whether they also experience vascular abnormalities, particularly changes in endothelial function. The aim of this study was to verify the impact of a high-volume training load phase followed by low-volume tapered training on endothelial vasodilator function in National Collegiate Athletic Association (NCAA) Division I competitive female swimmers. Microvascular endothelial vasodilation was assessed by pulse arterial tonometry that provides a reactive hyperemia index in 10 female NCAA Division 1 swimmers after 4 weeks of a high-volume training load, and subsequently, after 3 weeks of low-volume tapered training as part of preparation for annual conference championships. The reactive hyperemia index was calculated as the ratio of the pulse volume amplitude after 5 minutes of left-arm brachial artery ischemia to the baseline amplitude, divided by same ratio in the contralateral arm. The high-volume training load included a 4-week block of dual-day sessions (120 minutes per practice) consisting of vigorous intensity endurance and high-intensity interval/sprint swim training, coupled with 5K running, resistance training, and Olympic weightlifting. Tapered training consisted of 3 weeks of 3-5 swims per week at ∼50% V̇o2max for 60 minutes per practice (∼4,000 minutes per practice). The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction. However, after tapered training, the reactive hyperemia index was ∼33% higher (2.29 ± 0.43; 95% confidence interval [CI]: 1.98-2.60, p = 0.0223 vs. the high-volume training load). Effect size, as expressed by the partial eta2 (0.46) and Cohen's dz (1.1923; 95% CI: 0.1687-2.4643) with tapered training, was large. These results demonstrate distinct differences in endothelial vasodilation after 4 weeks of a high-volume training load compared with a 3-week taper in NCAA Division I female swimmers.",2021,The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction.,"['Collegiate Female Swimmers', 'I competitive female swimmers', 'J Strength Cond Res 35(3', 'I female swimmers', 'National Collegiate Athletic Association (NCAA', 'collegiate female swimmers']","['NCAA Division', 'vigorous intensity endurance and high-intensity interval/sprint swim training, coupled with 5K running, resistance training, and Olympic weightlifting', 'Division', 'high-volume training load phase followed by low-volume tapered training']","['reactive hyperemia index', 'Microvascular endothelial vasodilation', 'Endothelial Vasodilation', 'endothelial vasodilation', 'Endothelial vasodilation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}]","[{'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}]",,0.0247808,The reactive hyperemia index (1.73 ± 0.50) was low in athletes after the high-volume training load with 8 athletes demonstrating endothelial dysfunction.,"[{'ForeName': 'Fawn M', 'Initials': 'FM', 'LastName': 'Weihl', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health & Nutritional Sciences, South Dakota State University, Brookings, South Dakota.'}, {'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Van Guilder', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002769']
1146,33586058,Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS.,"AIMS


The Italian Titration Approach Study (ITAS) demonstrated comparable HbA 1c  reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed.
METHODS


This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA 1c  change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration.
RESULTS


HbA 1c  change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00-pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05).
CONCLUSIONS


Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM.
CLINICAL TRIAL REGISTRATION


EudraCT 2015-001167-39.",2021,Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population.,['across subgroups of patients with T2DM'],"['insulin glargine 300 U/mL', 'Gla-300 self-titration']","['low hypoglycaemia risk', 'incidence of hypoglycaemia (any type) and nocturnal rates', 'rates of 00:00-pre-breakfast and anytime hypoglycaemia', 'Hypoglycaemia rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]",,0.039526,Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy. Andrea.Giaccari@unicatt.it.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma, Parma, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Sapienza University of Rome, Piazzale Aldo Moro, 5, 00185, Rome, RM, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Perseghin', 'Affiliation': ""University of Milan Bicocca, Piazza dell'Ateneo Nuovo, 1, 20126, Milan, MI, Italy.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': 'University of Messina, Piazza Pugliatti, 1, 98122, Messina, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fanelli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Piazzale Gambuli, 1, 06129, Perugia, PG, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'University of Padua, Via 8 Febbraio 1848, 2, 35122, Padua, PD, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aimaretti', 'Affiliation': 'University of the Eastern Piedmont, Via del Duomo, 6, 13100, Vercelli, VC, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Larosa', 'Affiliation': 'Sanofi, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pagano', 'Affiliation': 'OPIS s.r.l., Palazzo Aliprandi, Via Matteotti, 10, 20832, Desio, Italy.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Piazzale Gambuli, 1, 06129, Perugia, PG, Italy.'}]",Acta diabetologica,['10.1007/s00592-021-01675-0']
1147,33586034,The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.,"PURPOSE


We previously reported the first evidence of oncological benefits from a Japanese phase II trial of oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer (the FACOS study). We herein report the long-term survival and persistent oxaliplatin-related peripheral sensory neuropathy (PSN) for patients enrolled in this trial.
METHODS


Patients were scheduled to receive the mFOLFOX6 or CAPOX regimen in the adjuvant setting. The five-year overall survival (OS) rate and persistent PSN were evaluated.
RESULTS


A total of 130 patients (mFOLFOX6, n = 73; CAPOX, n = 57) were eligible. The 5-year OS rate was 91.4%. No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25). The incidence of PSN during adjuvant treatment was 55.4% in grade 1 (G1), 30.0% in G2, and 4.6% in G3. No patients showed G3 PSN at 12 months, but G1 or G2 residual PSN after 5 years was observed in 21.8% (G1, 20%; G2, 1.8%).
CONCLUSIONS


Updated results from the FACOS study support the benefits of oxaliplatin-based adjuvant chemotherapy in terms of the long-term survival among Japanese patients with stage III colon cancer. However, long-term persistent PSN occurs in about 20% of survivors, counterbalancing the favorable OS.",2021,"No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25).","['Japanese patients with stage III colon cancer', 'patients enrolled in this trial', 'patients with stage III colon cancer (the FACOS study', 'Patients were scheduled to receive the', '130 patients (mFOLFOX6, n\u2009=\u200973; CAPOX, n\u2009=\u200957) were eligible']","['mFOLFOX6 or CAPOX', 'oxaliplatin-based adjuvant chemotherapy', 'oxaliplatin-related peripheral sensory neuropathy (PSN']","['incidence of PSN', 'G3 PSN', 'OS rate', 'five-year overall survival (OS) rate and persistent PSN', '5-year OS rate']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",130.0,0.153689,"No significant difference in the OS rate was observed between regimens (mFOLFOX6, 94.4%; CAPOX, 87.4%; P = 0.25).","[{'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Takeshita', 'Affiliation': 'Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Koda', 'Affiliation': 'Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Oda', 'Affiliation': 'Colo-Proctological Institute, Matsuda Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yoshimatsu', 'Affiliation': ""Department of Surgery, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Oya', 'Affiliation': 'Department of Surgery, Saitama Medical Center, Dokkyo University, Kosihgaya, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'First Department of Surgery, Dokkyo Medical University, Mibu, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Nakajima', 'Affiliation': 'Department of Oncology, Ageo Central General Hospital, Ageo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Momma', 'Affiliation': 'Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Maekawa', 'Affiliation': 'Department of Surgery, Juntendo University Shizuoka Hospital, Izunokuni, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsubaki', 'Affiliation': 'Department of Surgery, Yuai Memorial Hospital, Koga, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Tanakaya', 'Affiliation': 'Department of Surgery, Iwakuni Clinical Center, Iwakuni, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan. 05hishi@saitama-med.ac.jp.'}]",Surgery today,['10.1007/s00595-021-02230-8']
1148,33586012,The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study.,"PURPOSE


We aim to compare the efficiency and toxicity of three different 5-fluorouracil (5-FU) administration types in 5-FU, leucovorin, and oxaliplatin (FOLFOX) combination treatment for adjuvant therapy in colorectal cancer (CRC).
METHODS


Five hundred and seventy patients with stage III colorectal carcinoma who received different FOLFOX regimens after curative resection were included. Patients were divided into three groups as FOLFOX-4, modified FOLFOX-6 (mFOLFOX-6), and mFOLFOX-4 for comparison of toxicity and disease-free survival (DFS) and overall survival (OS) times.
RESULTS


Three-year DFS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 65%, 72%, and 72%, respectively. Five-year OS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 69%, 75%, and 67%, respectively. There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively). Among grade 1-2 adverse events (AE), thrombocytopenia, neuropathy, and stomatitis were more common in the mFOLFOX-6-treated group. The frequency of grade 1-2 nausea and vomiting were similar in mFOLFOX-6 (36.3% and 24%, respectively) and mFOLFOX-4 (32.4% and 24.7%, respectively) groups but were higher than that in the FOLFOX-4 (19.5% and 11.3%, respectively) group. Among the most common grade 3-4 AE, neutropenia (53.4%, 9%, and 13.5%, respectively) and diarrhea (10.5%, 2.2%, and 2.4, respectively) were more common in FOLFOX-4. The rate of anemia and febrile neutropenia was similar in treatment groups (p = 0.063, and p = 0.210, respectively).
CONCLUSION


In the adjuvant treatment of stage III CRC patients, three different 5-FU administration types in FOLFOX combination treatment can be used with similar efficiency and manageable toxicity.",2021,"There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively).","['colorectal cancer', 'Five hundred and seventy patients with stage III colorectal carcinoma who received different FOLFOX regimens after curative resection were included', 'stage III CRC patients', 'colorectal cancer (CRC']","['5-FU, leucovorin, and oxaliplatin (FOLFOX) combination treatment', '5-fluorouracil (5-FU', '5-FU']","['adverse events (AE), thrombocytopenia, neuropathy, and stomatitis', 'rate of anemia and febrile neutropenia', 'efficiency and manageable toxicity', 'frequency of grade 1-2 nausea and vomiting', 'DFS rates', 'toxicity and disease-free survival (DFS) and overall survival (OS) times', 'DFS and OS', 'neutropenia', 'efficiency and toxicity', 'diarrhea']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0915342', 'cui_str': 'Folinic acid-fluororuracil-oxaliplatin regimen'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0677949', 'cui_str': 'Colorectal cancer stage III'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",570.0,0.0284344,"There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively).","[{'ForeName': 'Nadiye', 'Initials': 'N', 'LastName': 'Akdeniz', 'Affiliation': 'Department of Medical Oncology, Adiyaman Training and Research Hospital, 02100, Adiyaman, Turkey. nadiyeakdeniz21@gmail.com.'}, {'ForeName': 'Muhammet Ali', 'Initials': 'MA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Medical Oncology, Dicle University Faculty of Medicine, Diyarbakır, Turkey.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Uncu', 'Affiliation': 'Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Mevlüde', 'Initials': 'M', 'LastName': 'İnanç', 'Affiliation': 'Department of Medical Oncology, Erciyes University Faculty of Medicine, Kayseri, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Kaya', 'Affiliation': 'Department of Medical Oncology, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Faysal', 'Initials': 'F', 'LastName': 'Dane', 'Affiliation': 'Department of Medical Oncology, Marmara University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Küçüköner', 'Affiliation': 'Department of Medical Oncology, Dicle University Faculty of Medicine, Diyarbakır, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Demirci', 'Affiliation': 'Department of Medical Oncology, Sakarya University Faculty of Medicine, Sakarya, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Bilici', 'Affiliation': 'Department of Medical Oncology, Atatürk University Faculty of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ayşe Gök', 'Initials': 'AG', 'LastName': 'Durnalı', 'Affiliation': 'Department of Medical Oncology, Ankara Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Lokman', 'Initials': 'L', 'LastName': 'Koral', 'Affiliation': 'Department of Medical Oncology, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale, Turkey.'}, {'ForeName': 'Mehmet Ali Nahit', 'Initials': 'MAN', 'LastName': 'Şendur', 'Affiliation': 'Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Erol', 'Affiliation': 'Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Türkmen', 'Affiliation': 'Department of Medical Oncology, Derince Training and Research Hospital, Izmit, Turkey.'}, {'ForeName': 'Ömer Fatih', 'Initials': 'ÖF', 'LastName': 'Ölmez', 'Affiliation': 'Department of Medical Oncology, Medipol University Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Açıkgöz', 'Affiliation': 'Department of Medical Oncology, Medipol University Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Şahin', 'Initials': 'Ş', 'LastName': 'Laçin', 'Affiliation': 'Department of Medical Oncology, Yeditepe University Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Hayriye', 'Initials': 'H', 'LastName': 'Şahinli', 'Affiliation': 'Department of Medical Oncology, Diskapi Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Zuhat', 'Initials': 'Z', 'LastName': 'Urakçı', 'Affiliation': 'Department of Medical Oncology, Dicle University Faculty of Medicine, Diyarbakır, Turkey.'}, {'ForeName': 'Abdurrahman', 'Initials': 'A', 'LastName': 'Işıkdoğan', 'Affiliation': 'Department of Medical Oncology, Dicle University Faculty of Medicine, Diyarbakır, Turkey.'}]",International journal of colorectal disease,['10.1007/s00384-021-03888-9']
1149,33586003,A mouth rinse based on a tea solution of Salvia officinalis for oral discomfort in palliative cancer care: a randomized controlled trial.,"BACKGROUND


Few clinical studies evaluate interventions to reduce oral discomfort among patients in palliative care.
AIM


This study examines the efficacy of a Salvia officinalis (SO) based herbal mouth rinse compared to conventional normal saline (NS) in order to improve oral health.
DESIGN


A block-randomized controlled trial. Data were collected before and after a 4-day intervention with either SO (n=44) or NS (n=44). Numerical rating scales (NRS, 0-10) and 12 items from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oral Health 17 (EORTC QLQ-OH17) measured patient-reported oral symptoms. An oral examination was performed before and after the intervention.
SETTING/PARTICIPANTS


This study included adult patients with late-stage cancer in an inpatient hospice unit.
RESULTS


Of the 88 patients included (mean age=63.9 years, SD=10.6), 73 (83%) completed the study. At baseline, 78% reported dry mouth on the EORTC QLQ-OH17, and 80% rated dry mouth ≥4 on the NRS. Total oral health scores based on the 12 EORTC QLQ-OH17 items improved similarly in both groups (p<0.001). However, dry mouth ratings on both the EORTC QLQ-OH17 (p=0.036) and NRS (p=0.045) improved more in the SO group than in the NS group. Plaque on the teeth improved in both the SO (p=0.008) and NS (p=0.018) groups, but plaque on the tongue and erythema only improved with NS.
CONCLUSIONS


This study did not detect an overall significant difference between SO and NS. Both mouth rinses improved oral health parameters, indicating that systematic assessment and oral care may reduce oral discomfort.
TRIAL REGISTRATION


NCT02067572.",2021,"However, dry mouth ratings on both the EORTC QLQ-OH17 (p=0.036) and NRS (p=0.045) improved more in the SO group than in the NS group.","['palliative cancer care', 'patients in palliative care', 'adult patients with late-stage cancer in an inpatient hospice unit', 'Of the 88 patients included (mean age=63.9 years, SD=10.6), 73 (83%) completed the study']","['tea solution of Salvia officinalis', 'conventional normal saline (NS', 'Salvia officinalis (SO) based herbal mouth rinse']","['Quality of Life Questionnaire-Oral Health 17 (EORTC QLQ-OH17', 'oral health parameters', 'Numerical rating scales (NRS, 0-10) and 12 items from the European Organisation for Research and Treatment of Cancer (EORTC', 'Total oral health scores']","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0453265', 'cui_str': 'Sage Plant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",88.0,0.271212,"However, dry mouth ratings on both the EORTC QLQ-OH17 (p=0.036) and NRS (p=0.045) improved more in the SO group than in the NS group.","[{'ForeName': 'Ragnhild Elisabeth', 'Initials': 'RE', 'LastName': 'Monsen', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway. ragnhm@uio.no.'}, {'ForeName': 'Bente Brokstad', 'Initials': 'BB', 'LastName': 'Herlofson', 'Affiliation': 'Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Caryl', 'Initials': 'C', 'LastName': 'Gay', 'Affiliation': 'Department of Research, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Katrine Gahre', 'Initials': 'KG', 'LastName': 'Fjeld', 'Affiliation': 'Department of Cariology and Gerodontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lene Hystad', 'Initials': 'LH', 'LastName': 'Hove', 'Affiliation': 'Department of Cariology and Gerodontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Karl Egil', 'Initials': 'KE', 'LastName': 'Malterud', 'Affiliation': 'Department of Pharmacy, Section Pharmaceutical Chemistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Saghaug', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Joran', 'Initials': 'J', 'LastName': 'Slaaen', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Sundal', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Tollisen', 'Affiliation': 'Department of Medicine, Lovisenberg Diaconal Hospital, Oslo, Norway.'}, {'ForeName': 'Anners', 'Initials': 'A', 'LastName': 'Lerdal', 'Affiliation': 'Department for Interdisciplinary Health Sciences, Institute of Health and Society, Faculty of Medicine, University of Oslo, Postboks 1089 Blindern, 0317, Oslo, Norway.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-021-06021-2']
1150,33585998,Carvedilol Does Not Improve Exercise Performance in Fontan Patients: Results of a Crossover Trial.,"Increased circulating catecholamines are associated with worse exercise performance in adult heart failure patients. Patients with Fontan physiology have increased circulating catecholamines and theoretically could benefit from beta blockade. We hypothesized that carvedilol would improve exercise performance in Fontan patients. A double-blind, placebo-controlled, crossover trial of carvedilol was performed. Single ventricle patients between the ages of 10 and 35 years with a previous Fontan operation who were able to complete a maximal exercise test (respiratory exchange ratio > 1.0) were included. Two 12-week treatment arms were separated by a 6-week washout period. Exercise testing was performed at beginning and end of each treatment arm. Primary endpoint was improvement in peak oxygen consumption/kg (pVO 2 ) from baseline. Of the 26 subjects enrolled, 23 completed the study. Four subjects did not reach goal maximum carvedilol dose, vs. 1 for placebo (p = 0.14). The mean change in pVO 2  between treatments was not different (carvedilol = - 2.1 mL/kg/min v. placebo = - 1.42, p = 0.28). Carvedilol therapy decreased peak heart rate by 4.2 ± 20.2 bpm, (p < 0.01) leading to an increase in peak oxygen pulse (p < 0.01). Serum N-terminal-proBNP increased with carvedilol therapy (mean change of + 23.77 pg/mL) compared to placebo (mean change of - 5.37 pg/mL, p = 0.03). There were no serious adverse events related to study drug. Carvedilol was not associated with improved exercise performance and was associated with mildly increased N-terminal-proBNP. This study does not support the routine administration of carvedilol to healthy Fontan patients.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT02946892. Registered October 27, 2016. Retrospectively Registered. https://clinicaltrials.gov/ct2/show/NCT02946892.",2021,Carvedilol was not associated with improved exercise performance and was associated with mildly increased N-terminal-proBNP.,"['Fontan Patients', 'Fontan patients', 'Single ventricle patients between the ages of 10 and 35\xa0years with a previous Fontan operation who were able to complete a maximal exercise test (respiratory exchange ratio\u2009>\u20091.0) were included', 'adult heart failure patients', 'healthy Fontan patients', '26 subjects enrolled, 23 completed the study']","['placebo', 'carvedilol', 'carvedilol therapy', 'Carvedilol']","['Serum N-terminal-proBNP', 'peak oxygen consumption/kg (pVO 2 ', 'peak oxygen pulse', 'peak heart rate', 'Exercise Performance', 'circulating catecholamines', 'exercise performance', 'mean change in pVO 2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0190010', 'cui_str': 'Fontan procedure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C3697711', 'cui_str': 'Carvedilol therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",26.0,0.215432,Carvedilol was not associated with improved exercise performance and was associated with mildly increased N-terminal-proBNP.,"[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Butts', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Texas Southwestern, Dallas, TX, USA. rjh3001@med.cornell.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Nathanya', 'Initials': 'N', 'LastName': 'BaezHernandez', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sutcliffe', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Reisch', 'Affiliation': 'Division of Biostatistics, Department of Population and Data Sciences, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Mahony', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Texas Southwestern, Dallas, TX, USA.'}]",Pediatric cardiology,['10.1007/s00246-021-02565-6']
1151,33585943,"Effectiveness of robotic balance training on postural instability in patients with mild Parkinson's disease: A pilot, single blind, randomized controlled trial.","OBJECTIVE


To examine whether tailored robotic platform training could improve postural stability compared with conventional balance treatment in patients with mild Parkinson's disease.  Design: Randomized single-blind pilot study.
SUBJECTS


Twenty-two patients with mild Parkinson's disease (Hoehn and Yahr scale; H-Y 1-2).
METHODS


Patients were randomly assigned to an experimental group for robotic balance training and to a control group for conventional balance training. Each patient received 20 treatments (45 min/session, 5 times/week). Blinded evaluations were conducted before and after the treatment and 1 month post-treatment. Primary outcome measures were Mini BESTest, and Berg Balance Scale; secondary outcome measures were 10-Meter Walk Test, Five Times Sit to Stand Test, and Parkinson's Disease Questionnaire 39.
RESULTS


Primary outcome measures in patients in both the experimental and control groups improved significantly after the balance treatment. Similar results were found for all the secondary outcome measures. The experimental group performed significantly better than the control group at both post-intervention and follow-up evaluation in the primary outcomes (p < 0.05). No significant differences between groups were found in secondary outcomes.
CONCLUSION


Robot-assisted balance training may be a promising tool to improve postural stability in patients with mild Parkinson's disease.",2021,The experimental group performed significantly better than the control group at both post-intervention and follow-up evaluation in the primary outcomes (p < 0.05).,"[""Twenty-two patients with mild Parkinson's disease (Hoehn and Yahr scale; H-Y 1-2"", 'patients with mild Parkinsonâs disease', 'Patients', ""patients with mild Parkinson's disease""]","['robotic balance training', 'robotic platform training', 'Robot-assisted balance training', 'conventional balance treatment', 'robotic balance training and to a control group for conventional balance training']","['postural instability', ""Mini BESTest, and Berg Balance Scale; secondary outcome measures were 10-Meter Walk Test, Five Times Sit to Stand Test, and Parkinson's Disease Questionnaire 39"", 'postural stability']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4274667', 'cui_str': 'Hoehn and Yahr Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",22.0,0.0792623,The experimental group performed significantly better than the control group at both post-intervention and follow-up evaluation in the primary outcomes (p < 0.05).,"[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Spina', 'Affiliation': 'Physical Medicine and Rehabilitation Section, Policlinico Riuniti, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Facciorusso', 'Affiliation': ''}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Cinone', 'Affiliation': ''}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Armiento', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Avvantaggiato', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ciritella', 'Affiliation': ''}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Fiore', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santamato', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2793']
1152,33585918,Ratings of Perceived Exertion during Walking: Predicting Major Mobility Disability and Effect of Structured Physical Activity in Mobility-Limited Older Adults.,"BACKGROUND


This study evaluated the association between ratings of perceived exertion (RPE) of walking and major mobility disability (MMD), as well as their transitions in response to a physical activity (PA) compared to a health education (HE) program.
METHODS


Older adults (n=1633) at risk for mobility impairment were randomized to structured PA or HE programs. During a 400m walk, participants rated exertion as ""light"" or ""hard"". An MMD event was defined as the inability to walk 400m. MMD events and RPE values were assessed every 6-months for an average of 2.6 years.
RESULTS


Participants rating their exertion as ""hard"" had a nearly 3-fold higher risk of MMD compared with those rating their exertion as ""light"" (HR: 2.61, 95%CI: 2.19-3.11). The association held after adjusting for disease conditions, depression, cognitive function and walking speed (HR: 2.24, 95%CI: 1.87-2.69). The PA group was 25% more likely to transition from ""light"" to ""hard"" RPE than the HE group (1.25, 1.05-1.49). Additionally, the PA group was 27% (0.73, 0.55 - 0.97) less likely to transition from a ""hard"" RPE to inability to walk 400m and was more likely to recover their ability to walk 400m by transitioning to a ""hard"" RPE (2.10, 1.39-3.17) than the HE group.
CONCLUSIONS


Older adults rating ""hard"" effort during a standardized walk test were at increased risk of subsequent MMD. A structured PA program enabled walking recovery, but was more likely to increase transition from ""light"" to ""hard"" effort, which may reflect greater capacity to perform the test.",2021,"Additionally, the PA group was 27% (0.73, 0.55 - 0.97) less likely to transition from a ""hard"" RPE to inability to walk 400m and was more likely to recover their ability to walk 400m by transitioning to a ""hard"" RPE (2.10, 1.39-3.17) than the HE group.
","['Older adults (n=1633) at risk for mobility impairment', 'Mobility-Limited Older Adults']","['structured PA or HE programs', 'Structured Physical Activity']","['MMD events and RPE values', 'risk of MMD', 'ratings of perceived exertion (RPE) of walking and major mobility disability (MMD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0362057,"Additionally, the PA group was 27% (0.73, 0.55 - 0.97) less likely to transition from a ""hard"" RPE to inability to walk 400m and was more likely to recover their ability to walk 400m by transitioning to a ""hard"" RPE (2.10, 1.39-3.17) than the HE group.
","[{'ForeName': 'Erta', 'Initials': 'E', 'LastName': 'Cenko', 'Affiliation': 'Department of Epidemiology, University of Florida.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric Medicine, Yale School of Medicine.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Henderson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research and Policy, Stanford University.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Qiu', 'Affiliation': 'Department of Biostatistics, University of Florida.'}, {'ForeName': 'Alvito', 'Initials': 'A', 'LastName': 'Rego', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Reid', 'Affiliation': 'Nutrition, Exercise Physiology and Sarcopenia Lab, Tufts University.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Tudor-Locke', 'Affiliation': 'College of Human and Health Services, UNC Charlotte.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Valiani', 'Affiliation': 'Department of Interdisciplinary Medicine, Università degli Studi di Bari Aldo Moro.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'You', 'Affiliation': 'Department of Biostatistics, University of Florida.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glab036']
1153,33585896,Daily Caffeine Intake Induces Concentration-Dependent Medial Temporal Plasticity in Humans: A Multimodal Double-Blind Randomized Controlled Trial.,"Caffeine is commonly used to combat high sleep pressure on a daily basis. However, interference with sleep-wake regulation could disturb neural homeostasis and insufficient sleep could lead to alterations in human gray matter. Hence, in this double-blind, randomized, cross-over study, we examined the impact of 10-day caffeine (3 × 150 mg/day) on human gray matter volumes (GMVs) and cerebral blood flow (CBF) by fMRI MP-RAGE and arterial spin-labeling sequences in 20 habitual caffeine consumers, compared with 10-day placebo (3 × 150 mg/day). Sleep pressure was quantified by electroencephalographic slow-wave activity (SWA) in the previous nighttime sleep. Nonparametric voxel-based analyses revealed a significant reduction in GMV in the medial temporal lobe (mTL) after 10 days of caffeine intake compared with 10 days of placebo, voxel-wisely adjusted for CBF considering the decreased perfusion after caffeine intake compared with placebo. Larger GMV reductions were associated with higher individual concentrations of caffeine and paraxanthine. Sleep SWA was, however, neither different between conditions nor associated with caffeine-induced GMV reductions. Therefore, the data do not suggest a link between sleep depth during daily caffeine intake and changes in brain morphology. In conclusion, daily caffeine intake might induce neural plasticity in the mTL depending on individual metabolic processes.",2021,"Nonparametric voxel-based analyses revealed a significant reduction in GMV in the medial temporal lobe (mTL) after 10 days of caffeine intake compared with 10 days of placebo, voxel-wisely adjusted for CBF considering the decreased perfusion after caffeine intake compared with placebo.","['20 habitual caffeine consumers', 'Humans']","['Daily Caffeine Intake', 'placebo', '10-day caffeine', 'paraxanthine', 'Caffeine']","['neural plasticity', 'Sleep SWA', 'electroencephalographic slow-wave activity (SWA', 'human gray matter volumes (GMVs) and cerebral blood flow (CBF) by fMRI MP-RAGE and arterial spin-labeling sequences', 'Sleep pressure']","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0044060', 'cui_str': '1,7-dimethylxanthine'}]","[{'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034634', 'cui_str': 'Rage'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.327439,"Nonparametric voxel-based analyses revealed a significant reduction in GMV in the medial temporal lobe (mTL) after 10 days of caffeine intake compared with 10 days of placebo, voxel-wisely adjusted for CBF considering the decreased perfusion after caffeine intake compared with placebo.","[{'ForeName': 'Yu-Shiuan', 'Initials': 'YS', 'LastName': 'Lin', 'Affiliation': 'Centre for Chronobiology, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Weibel', 'Affiliation': 'Centre for Chronobiology, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zurich, 8057 Zurich, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Santini', 'Affiliation': 'Department of Radiology, Division of Radiological Physics, University Hospital Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Centre for Chronobiology, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brunmair', 'Affiliation': 'Department of Analytical Chemistry, University of Vienna, 1090 Vienna A, Austria.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Meier-Menches', 'Affiliation': 'Department of Analytical Chemistry, University of Vienna, 1090 Vienna A, Austria.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gerner', 'Affiliation': 'Department of Analytical Chemistry, University of Vienna, 1090 Vienna A, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Neuropsychiatry and Brain Imaging, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cajochen', 'Affiliation': 'Centre for Chronobiology, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Reichert', 'Affiliation': 'Centre for Chronobiology, University Psychiatric Clinics, University of Basel, 4002 Basel, Switzerland.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhab005']
1154,33585890,A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy.,"BACKGROUND


Currently, there is no specific drug for the treatment of COVID-19. Therapeutic benefits of intravenous immunoglobin (IVIG) have been demonstrated in wide range of diseases. The present study is conducted to evaluate the safety and efficacy of IVIG in the treatment of COVID-19 patients with moderate pneumonia.
METHODS


An open-label, multicenter, comparative, randomized study was conducted on COVID-19 patients with moderate pneumonia. 100 eligible patients were randomized in 1:1 ratio either to receive IVIG + standard of care (SOC) or SOC.
RESULTS


Duration of hospital stay was significantly shorter in IVIG group to that of SOC alone (7.7 Vs. 17.5 days). Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to SOC. Percentages of patients on mechanical ventilation in two groups were not significantly different (24% Vs. 38%). Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days). There were only mild to moderate adverse events in both groups except for one patient (2%), who died in SOC.
CONCLUSIONS


IVIG was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19. The trial was registered under Clinical Trial Registry, India (CTRI/2020/06/026222).",2021,Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days).,"['100 eligible patients', 'COVID-19 patients with moderate pneumonia', 'COVID-19 patients with Regular Intravenous Immunoglobulin Therapy']","['intravenous immunoglobin (IVIG', 'IVIG + standard of care (SOC) or SOC', 'SOC', 'IVIG']","['safety and efficacy', 'mechanical ventilation', 'Duration for normalization of body temperature, oxygen saturation and mechanical ventilation', 'moderate adverse events', 'Median time to RT-PCR negativity', 'Duration of hospital stay']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1513374', 'cui_str': 'Common terminology criteria for adverse events grade 2'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",100.0,0.065347,Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days).,"[{'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'R S', 'Affiliation': 'Department of Medicine, Maharaja Agrasen Hospital, New Delhi, India.'}, {'ForeName': 'Vijaykumar Bhagwan', 'Initials': 'VB', 'LastName': 'Barge', 'Affiliation': 'Department of Medicine, Rajshree Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, Maharashtra, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Darivenula', 'Affiliation': 'Department of General Medicine, Gandhi Medical College and Hospital, Hyderabad, Telangana, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Dandu', 'Affiliation': ""Department of Medicine, King George's Medical College, Lucknow, Uttar Pradesh, India.""}, {'ForeName': 'Rakesh R', 'Initials': 'RR', 'LastName': 'Kartha', 'Affiliation': 'Department of Medicine, Maharaja Agrasen Hospital, New Delhi, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Bafna', 'Affiliation': 'Department of Medicine, Rajshree Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, Maharashtra, India.'}, {'ForeName': 'Vishaly T', 'Initials': 'VT', 'LastName': 'Aravinda', 'Affiliation': 'Department of Medical Affairs, Virchow Biotech Pvt. Ltd., Hyderabad, Telangana, India.'}, {'ForeName': 'Thummala C', 'Initials': 'TC', 'LastName': 'Raghuram', 'Affiliation': 'Department of Medical Affairs, Virchow Biotech Pvt. Ltd., Hyderabad, Telangana, India.'}]",The Journal of infectious diseases,['10.1093/infdis/jiab098']
1155,33585885,Impact of Current Pain Status on Low-Barrier Buprenorphine Treatment Response among Patients with Opioid Use Disorder.,"OBJECTIVE


Chronic non-cancer pain (CNCP) is prevalent among individuals with opioid use disorder (OUD). However, the impact of CNCP on buprenorphine treatment outcomes is largely unknown. In this secondary analysis, we examined treatment outcomes among individuals with and without CNCP who received a low-barrier buprenorphine maintenance regimen during waitlist delays to more comprehensive opioid treatment.
METHODS


Participants were 28 adults with OUD who received 12 weeks of buprenorphine treatment involving bimonthly clinic visits, computerized medication dispensing, and phone-based monitoring. At intake and monthly follow-up assessments, participants completed the Brief Pain Inventory, Beck Anxiety Inventory, Beck Depression Inventory (BDI-II), Brief Symptom Inventory (BSI), Addiction Severity Index and staff-observed urinalysis.
RESULTS


Participants with CNCP (n = 10) achieved comparable rates of illicit opioid abstinence as those without CNCP (n = 18) at weeks 4 (90% vs. 94%), 8 (80% vs. 83%), and 12 (70% vs. 67%)(p's = 0.99). Study retention was also similar, with 90% and 83% of participants with and without CNCP completing the 12-week study, respectively (p = 0.99). Furthermore, individuals with CNCP demonstrated significant improvements on the BDI-II and Global Severity Index subscale of the BSI (p's < 0.05). However, those with CNCP reported more severe medical problems and smaller reductions in legal problems relative to those without CNCP (p's = 0.03).
CONCLUSIONS


Despite research suggesting that chronic pain may influence OUD treatment outcomes, participants with and without CNCP achieved similar rates of treatment retention and significant reductions in illicit opioid use and psychiatric symptomatology during low-barrier buprenorphine treatment.",2021,"However, those with CNCP reported more severe medical problems and smaller reductions in legal problems relative to those without CNCP (p's = 0.03).
","['individuals with and without CNCP who received a', 'Participants were 28 adults with OUD who received 12\u2009weeks of', 'individuals with opioid use disorder (OUD', 'Patients with Opioid Use Disorder']","['buprenorphine treatment involving bimonthly clinic visits, computerized medication dispensing, and phone-based monitoring', 'buprenorphine', 'CNCP', 'low-barrier buprenorphine maintenance regimen']","['BDI-II and Global Severity Index subscale of the BSI ', 'rates of illicit opioid abstinence', 'legal problems', 'illicit opioid use and psychiatric symptomatology', 'severe medical problems', 'Brief Pain Inventory, Beck Anxiety Inventory, Beck Depression Inventory (BDI-II), Brief Symptom Inventory (BSI), Addiction Severity Index and staff-observed urinalysis']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0362060', 'cui_str': 'Legal problem'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}]",28.0,0.0955046,"However, those with CNCP reported more severe medical problems and smaller reductions in legal problems relative to those without CNCP (p's = 0.03).
","[{'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Peck', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Ochalek', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Badger', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnab058']
1156,33585833,Virtual Reality Analgesia for Children With Large Severe Burn Wounds During Burn Wound Debridement.,"The objective of this study was to compare the effect of adjunctive virtual reality vs. standard analgesic pain medications during burn wound cleaning/debridement. Participants were predominantly Hispanic children aged 6-17 years of age, with large severe burn injuries (TBSA = 44%) reporting moderate or higher baseline pain during burn wound care. Using a randomized between-groups design, participants were randomly assigned to one of two groups, (a) the Control Group = pain medications only or (b) the VR Group = pain medications + virtual reality. A total of 50 children (88% Hispanic) with large severe burns (mean TBSA > 10%) received severe burn wound cleaning sessions. For the primary outcome measure of worst pain (intensity) on Study Day 1, using a between groups ANOVA, burn injured children in the group that received virtual reality during wound care showed significantly less pain intensity than the No VR control group, [mean worst pain ratings for the No VR group = 7.46 (SD = 2.93) vs. 5.54 (SD = 3.56),  F   (1,48)  = 4.29, <0.05, MSE = 46.00]. Similarly, one of the secondary pain measures, ""lowest pain during wound care"" was significantly lower in the VR group, No VR = 4.29 (SD = 3.75) vs. 1.68 (2.04) for the VR group,  F ( 147 ) = 9.29, < 0.005, MSE = 83.52 for Study Day 1. The other secondary pain measures showed the predicted pattern on Study Day 1, but were non-significant. Regarding whether VR reduced pain beyond Study Day 1, absolute change in pain intensity (analgesia = baseline pain minus the mean of the worst pain scores on Study days 1-10) was significantly greater for the VR group,  F   (148)  = 4.88,  p <  0.05, MSE = 34.26, partial eta squared = 0.09, but contrary to predictions, absolute change scores were non-significant for all secondary measures.",2020,"Similarly, one of the secondary pain measures, ""lowest pain during wound care"" was significantly lower in the VR group, No VR = 4.29 (SD = 3.75) vs. 1.68 (2.04) for the VR group,  F ( 147 ) =","['Children', '50 children (88% Hispanic) with large severe burns (mean TBSA > 10%) received severe burn wound cleaning sessions', 'Participants were predominantly Hispanic children aged 6-17 years of age, with large severe burn injuries (TBSA = 44%) reporting moderate or higher baseline pain during burn wound care']","['adjunctive virtual reality vs. standard analgesic pain medications', 'Virtual Reality Analgesia', 'Control Group = pain medications only or (b) the VR Group = pain medications + virtual reality']","['pain intensity (analgesia = baseline pain minus the mean of the worst pain scores', 'pain ratings', 'pain intensity', 'secondary pain measures, ""lowest pain during wound care', 'worst pain (intensity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",50.0,0.0711951,"Similarly, one of the secondary pain measures, ""lowest pain during wound care"" was significantly lower in the VR group, No VR = 4.29 (SD = 3.75) vs. 1.68 (2.04) for the VR group,  F ( 147 ) =","[{'ForeName': 'Hunter G', 'Initials': 'HG', 'LastName': 'Hoffman', 'Affiliation': 'Department of Mechanical Engineering, College of Engineering, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Patterson', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rodriguez', 'Affiliation': 'University of Texas Medical Branch at Galveston, Galveston, TX, United States.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Peña', 'Affiliation': 'University of Texas Medical Branch at Galveston, Galveston, TX, United States.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Beck', 'Affiliation': 'Shriners Hospitals for Children Galveston, Galveston, TX, United States.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, WA, United States.'}]",Frontiers in virtual reality,['10.3389/frvir.2020.602299']
1157,33585723,Effects of neuromuscular electrical stimulation therapy on physical function in patients with COVID-19 associated pneumonia: Study protocol of a randomized controlled trial.,"Purpose


Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients during and/or after intensive care unit (ICU) stay. The overall objective of this study is to evaluate the NMES effectiveness to counteract the post-ICU impairment in physical function of COVID-19 patients. The specific aim of this manuscript is to describe the study design, protocol, content of interventions, primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results.
Methods


This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance are assessed once (after the intervention), while all other outcomes are assessed twice (before and after the intervention).
Conclusion


NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.",2021,"Conclusion


NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive.","['patients with COVID-19 associated pneumonia', 'COVID-19 patients', 'patients presenting with post-intensive care syndrome', '80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure', 'patients during and/or after intensive care unit (ICU) stay']","['NMES group (routine physical therapy plus NMES', 'NMES therapy', 'control group (routine physical therapy', 'NMES', 'neuromuscular electrical stimulation therapy', 'Neuromuscular electrical stimulation (NMES']","['SPBB and walking performance', 'physical function', 'physical performance assessed through the Short Physical Performance Battery (SPPB', 'independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",80.0,0.112478,"Conclusion


NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive.","[{'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Minetto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Sabrina Dal', 'Initials': 'SD', 'LastName': 'Fior', 'Affiliation': 'Division of Physical Medicine and NeuroRehabilitation, San Luigi Hospital, Orbassano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Busso', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Caironi', 'Affiliation': 'Department of Anesthesia and Critical Care, San Luigi Hospital, Department of Oncology, University of Turin, Turin, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Massazza', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Maffiuletti', 'Affiliation': 'Human Performance Lab, Schulthess Clinic, Zurich, Switzerland.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Gamna', 'Affiliation': 'Division of Physical Medicine and NeuroRehabilitation, San Luigi Hospital, Orbassano, Italy.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2021.100742']
1158,33585721,Comparison of fentanil and remifentanil for coronary artery surgery with low ejection fraction.,"Introduction


In this study, we evaluated patient response and haemodynamic parameters in patients with low ejection fraction undergoing coronary bypass surgery with either fentanil or remifentanil in conjunction with etomidate.
Material and methods


We evaluated 30 cases of coronary artery surgery, which were divided into two treatment groups ( n  = 15 each). In group F (fentanil group), the following regimen was employed for anaesthesia induction: 1 mg/kg lidocaine, 0.3 mg/kg etomidate, and, following a 1 µg/kg 60 s bolus dose of fentanil, a 0.1 µg/kg/min fentanil infusion was initiated, after which 0.6 mg/kg rocuronium was administered. In group R (remifentanil group), the following regimen was employed for anaesthesia induction: 1 mg/kg lidocaine, 0.3 mg/kg etomidate and, following a 1 µg/kg 60 s bolus dose of remifentanil, a 0.1 µg/kg/min remifentanil infusion was initiated, after which 0.6 mg/kg rocuronium was administered. Systolic artery pressure, diastolic artery pressure, mean arterial pressure, heart rate, SPO 2  (saturation), cardiac output, stroke volume variance, central venous pressure, and systemic vascular resistance values were recorded for all study patients at five minutes before anaesthetic induction (T1), immediately following induction (T2), and immediately following intubation (T3).
Results


The demographic values obtained for both groups were similar. We found that remifentanil use was associated with decreased cardiac output and increased fluctuations in both heart rate and mean values of arterial pressure.
Conclusions


Although many studies have demonstrated remifentanil to be as safe as fentanil when titrated to an appropriate dose, our study suggests that fentanil may be a more appropriate choice during the induction of anaesthesia in patients with a low ejection fraction.",2020,The demographic values obtained for both groups were similar.,"['patients with a low ejection fraction', '30 cases of coronary artery surgery', 'patients with low ejection fraction undergoing coronary bypass surgery with either fentanil or remifentanil in conjunction with etomidate', 'coronary artery surgery with low ejection fraction']","['rocuronium', 'fentanil and remifentanil', 'remifentanil', 'lidocaine, 0.3 mg/kg etomidate', 'remifentanil, a 0.1 µg/kg/min remifentanil infusion']","['Systolic artery pressure, diastolic artery pressure, mean arterial pressure, heart rate, SPO 2  (saturation), cardiac output, stroke volume variance, central venous pressure, and systemic vascular resistance values', 'cardiac output', 'heart rate and mean values of arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}]",,0.15514,The demographic values obtained for both groups were similar.,"[{'ForeName': 'Nukhet', 'Initials': 'N', 'LastName': 'Baddal', 'Affiliation': 'Department of Anaesthesiology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Conkbayir', 'Affiliation': 'Department of Cardiology, Near East University, Nicosia (north), Cyprus.'}, {'ForeName': 'Ozcan', 'Initials': 'O', 'LastName': 'Erdemli', 'Affiliation': 'Department of Anaesthesiology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Karadeniz', 'Affiliation': 'Department of Anaesthesiology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Tezcan', 'Affiliation': 'Department of Anaesthesiology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}, {'ForeName': 'Didem Melis', 'Initials': 'DM', 'LastName': 'Oztas', 'Affiliation': 'Department of Cardiovascular Surgery, Bagcilar Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin Onur', 'Initials': 'MO', 'LastName': 'Beyaz', 'Affiliation': 'Department of Cardiovascular Surgery, Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Ugurlucan', 'Affiliation': 'Department of Cardiovascular Surgery, Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Yildiz', 'Affiliation': 'Department of Anaesthesia, Medipol University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Soner', 'Initials': 'S', 'LastName': 'Yavas', 'Affiliation': 'Department of Anaesthesiology, Yuksek Ihtisas Hospital, Ankara, Turkey.'}]",Archives of medical sciences. Atherosclerotic diseases,['10.5114/amsad.2020.93528']
1159,33585705,Therapeutic plasma exchange for persistent encephalopathy associated with Covid-19.,"Patients infected with COVID-19 virus, show a highly variable symptomatology which can include central nervous system (CNS) dysfunction. One of the most disabling CNS manifestations is persistent severe encephalopathy seen for weeks after the resolution of the acute viral pneumonia and associated acute systemic illnesses. The precise pathophysiology of this persistent Post COVID Encephalopathy is unknown but may involve direct viral invasion of microvascular endothelium, microvascular thrombosis, toxic neuronal effects of inflammatory products, vasoactive pathology at arteriolar level or leptomeningeal inflammation. Currently, there are no established specific treatments for Post COVID -19 encephalopathy. We present a case series of three patients that underwent Therapeutic Plasma Exchange (TPE) with salinized albumin that suggests a positive therapeutic effect. We believe that the results warrant further evaluation for the role of TPE with a prospective randomized trial in persistent Post COVID -19 encephalopathy syndrome.",2021,"Patients infected with COVID-19 virus, show a highly variable symptomatology which can include central nervous system (CNS) dysfunction.",[],['Therapeutic Plasma Exchange (TPE) with salinized albumin'],['central nervous system (CNS) dysfunction'],[],"[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",3.0,0.205719,"Patients infected with COVID-19 virus, show a highly variable symptomatology which can include central nervous system (CNS) dysfunction.","[{'ForeName': 'Chakrapani', 'Initials': 'C', 'LastName': 'Ranganathan', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Neurology, USA.'}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Fusinski', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Neurology, USA.'}, {'ForeName': 'Imad M', 'Initials': 'IM', 'LastName': 'Obeid', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Pulmonary/Critical Care Medicine, USA.'}, {'ForeName': 'Khaled M', 'Initials': 'KM', 'LastName': 'Ismail', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Nephrology, USA.'}, {'ForeName': 'Derrick T', 'Initials': 'DT', 'LastName': 'Ferguson', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Pulmonary/Critical Care Medicine, USA.'}, {'ForeName': 'Mindy F', 'Initials': 'MF', 'LastName': 'Raminick', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Nephrology, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Dawes', 'Affiliation': 'Ascension Macomb-Oakland Hospital, Pulmonary/Critical Care Medicine, USA.'}]",eNeurologicalSci,['10.1016/j.ensci.2021.100327']
1160,33585685,Anesthetic efficacy of single buccal infiltration of 4% articaine compared to routine inferior alveolar nerve block with 2% lidocaine during bilateral extraction of mandibular primary molars: a randomized controlled trial.,"Background


Inferior alveolar nerve block (IANB) using lidocaine 2% is commonly used for anesthetizing primary mandibular molars; however, this technique has the highest level of patient discomfort compared to other local anesthesia techniques. Therefore, alternative anesthesia techniques are necessary. The aim of this study was to evaluate the efficacy of a single buccal infiltration of 4% articaine with IANB using 2% lidocaine, for the bilateral extraction of primary mandibular molars.
Methods


The present study was conducted on 30 patients aged between 6 and 9 years, who required the extraction of bilateral primary mandibular molars. The patients were randomly divided into two groups as follows: In the first session, Group A received IANB with lidocaine 2% and group B received infiltration with articaine 4%. In the second session, another injection method was performed on the opposite side. The Wong-Baker Facial Pain scale (WBFPS), Face Leg Activity Cry, and Consolability (FLACC), and physiologic parameters were used to assess pain perception.
Results


The independent t-test showed no statistically significant difference in blood pressure and heart rate before and after extraction (P > 0.05). The mean FLACC index in the lidocaine and articaine groups was 0.89 and 1.36, respectively; there was no statistically significant difference between them (P > 0.05). According to the results of the chi-square test, there was no statistically significant difference between the groups for WBFPS (P > 0.05).
Conclusion


The articaine infiltration technique may be an alternative to the IANB for the extraction of primary mandibular molars.",2021,"According to the results of the chi-square test, there was no statistically significant difference between the groups for WBFPS (P > 0.05).
","['30 patients aged between 6 and 9 years, who required the extraction of bilateral primary mandibular molars', 'primary mandibular molars', 'anesthetizing primary mandibular molars', 'bilateral extraction of mandibular primary molars']","['articaine with IANB', 'articaine', 'IANB with lidocaine', 'lidocaine', '\n\n\nInferior alveolar nerve block (IANB']","['mean FLACC index', 'blood pressure and heart rate', 'pain perception', 'Anesthetic efficacy', 'Baker Facial Pain scale (WBFPS), Face Leg Activity Cry, and Consolability (FLACC), and physiologic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0382663,"According to the results of the chi-square test, there was no statistically significant difference between the groups for WBFPS (P > 0.05).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bahrololoomi', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2021.21.1.61']
1161,33585684,Efficacy of phentolamine mesylate in reducing the duration of various local anesthetics.,"Background


To evaluate changes in the effectiveness of phentolamine mesylate in combination with different local anesthetics (LAs) and vasoconstrictors. A prospective randomized double-blind study was conducted with 90 patients divided into three groups, with each group being administered one of three different LAs: lidocaine 2% 1/80,000, articaine 4% 1/200,000, and bupivacaine 0.5% 1/200,000.
Methods


We compared treatments administered to the mandible involving a LA blockade of the inferior alveolar nerve. Results were assessed by evaluating reduction in total duration of anesthesia, self-reported patient comfort using the visual analog pain scale, incidence rates of the most common adverse effects, overall patient satisfaction, and patient feedback.
Results


The differences among the three groups were highly significant (P < 0.001); time under anesthesia was especially reduced for both the lip and tongue with bupivacaine. The following adverse effects were reported: pain at the site of the anesthetic injection (11.1%), headaches (6.7%), tachycardia (1.1%), and heavy bleeding after treatment (3.3%). The patients' feedback and satisfaction ratings were 100% and 98.9%, respectively.
Conclusions


Efficient reversal of LAs is useful in dentistry as it allows patients to return to normal life more readily and avoid common self-injuries sometimes caused by anesthesia. Phentolamine mesylate reduced the duration of anesthesia in the three studied groups, with the highest reduction reported in the bupivacaine group (from 460 min to 230 min for the lip and 270 min for the tongue [P < 0.001]).",2021,The differences among the three groups were highly significant (P < 0.001); time under anesthesia was especially reduced for both the lip and tongue with bupivacaine.,"['90 patients divided into three groups, with each group being administered one of three different LAs']","['phentolamine mesylate', 'bupivacaine', 'articaine', 'lidocaine', 'Phentolamine mesylate']","['time under anesthesia', 'feedback and satisfaction ratings', 'tachycardia', 'duration of various local anesthetics', 'total duration of anesthesia, self-reported patient comfort using the visual analog pain scale, incidence rates of the most common adverse effects, overall patient satisfaction, and patient feedback', 'headaches', 'heavy bleeding', 'pain', 'duration of anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0733398', 'cui_str': 'Phentolamine mesylate'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0822832,The differences among the three groups were highly significant (P < 0.001); time under anesthesia was especially reduced for both the lip and tongue with bupivacaine.,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Gago-García', 'Affiliation': 'University of León, León, Spain.'}, {'ForeName': 'Cayetana', 'Initials': 'C', 'LastName': 'Barrilero-Martin', 'Affiliation': 'University of León, León, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Alobera-Gracia', 'Affiliation': 'University of León, León, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Del Canto-Pingarrón', 'Affiliation': 'University of León, León, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Seco-Calvo', 'Affiliation': 'Institute of Biomedicine (IBIOMED), University of León, León, Spain; Visiting Researcher of University of the Basque Country (UPV/EHU), Leoia, Spain.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2021.21.1.49']
1162,33585683,DentalVibe reduces pain during the administration of local anesthetic injection in comparison to 2% lignocaine gel: results from a clinical study.,"Background


This study was designed to compare the efficacy of DentalVibe against 2% lidocaine gel in reducing pain during the administration of local anesthetic injection in the adult population.
Methods


This was a split-mouth open-label, randomized, controlled clinical study conducted in the Department of Oral and Maxillofacial Surgery of a dental institute. Fifty patients who were scheduled for bilateral dental extractions requiring an inferior alveolar nerve block were enrolled in the study. Site A (n = 50) was coated with 2% lidocaine gel followed by a local anesthetic injection, and DentalVibe with local anesthetic injection was used for Site B (n = 50). The primary outcome was pain, which was recorded immediately after the administration of anesthetic injection using the Visual Analogue Scale [VAS 0 - 10].
Results


The VAS pain scores ranged from 4 to 10 for site A and 0 to 6 for site B. Comparison between the two sites showed a statistically significant difference [Mann-Whitney U test value = 51.50, P < 0.001] favoring site B.
Conclusion


This study showed that DentalVibe reduces pain during injection of local anesthesia compared to topical anesthetic gel.",2021,"The VAS pain scores ranged from 4 to 10 for site A and 0 to 6 for site B. Comparison between the two sites showed a statistically significant difference [Mann-Whitney U test value = 51.50, P < 0.001] favoring site B.
Conclusion


","['adult population', 'Fifty patients who were scheduled for bilateral dental extractions requiring an inferior alveolar nerve block were enrolled in the study', 'Department of Oral and Maxillofacial Surgery of a dental institute']","['lignocaine gel', 'lidocaine gel followed by a local anesthetic injection, and DentalVibe with local anesthetic injection', 'topical anesthetic gel', 'lidocaine gel']","['Visual Analogue Scale [VAS 0 - 10', 'pain', 'VAS pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",50.0,0.105279,"The VAS pain scores ranged from 4 to 10 for site A and 0 to 6 for site B. Comparison between the two sites showed a statistically significant difference [Mann-Whitney U test value = 51.50, P < 0.001] favoring site B.
Conclusion


","[{'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Dr. D. Y. Patil Vidyapeeth. Pimpri, Pune, India.'}, {'ForeName': 'Kalyani', 'Initials': 'K', 'LastName': 'Bhate', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Dr. D. Y. Patil Vidyapeeth. Pimpri, Pune, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Kshirsagar', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, D. Y. Patil Dental School, Charoli Bk, Lohegaon, Pune, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Pawar', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Dr. D. Y. Patil Vidyapeeth. Pimpri, Pune, India.'}, {'ForeName': 'Pradnya', 'Initials': 'P', 'LastName': 'Kakodkar', 'Affiliation': 'Deputy Research Director, Dr. D. Y. Patil Vidyapeeth. Pimpri, Pune, India.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2021.21.1.41']
1163,33585682,Comparative efficiency of the preoperative pterygomandibular space injection of two doses of dexamethasone in mandibular third molar surgery.,"Background


Impacted mandibular third molar removal is one of the most commonly performed oral surgical procedures. This procedure can lead to several postoperative complications, such as trismus, facial swelling, and pain, which occur as a result of the inflammatory responses to surgery. This study compared the efficiency of preoperative injections of 4 mg versus 8 mg dexamethasone into the pterygomandibular space to reduce postoperative sequelae.
Methods


This was a randomized, prospective, split-mouth, controlled study, including 52 mandibular third molar surgeries in 26 patients. Each patient was randomized to either the 4 mg or 8 mg dexamethasone injection group. Dexamethasone was injected into the pterygomandibular space after numbness from local anesthesia. Data were collected for trismus, facial swelling, visual analog scale (VAS) pain score, and the number of analgesics taken during the evaluation period. The level of significance was set at P < 0.05.
Results


Statistically significant differences in postoperative facial swelling (P = 0.031, diff = 1.4 mm) and pain (P = 0.012, diff = 0.020) were found between the 8 mg and 4 mg dexamethasone groups. However, there were no significant differences between the groups for trismus and the total number of analgesics consumed (P > 0.05).
Conclusion


Compared to the 4 mg preoperative dexamethasone injection, the 8 mg preoperative dexamethasone injection into the pterygomandibular space was more effective in reducing postoperative swelling and pain following the surgical removal of the impacted mandibular third molar. However, the difference in trismus could not be evaluated clinically. Therefore, the recommendation of administering the 4 mg dexamethasone preoperative injection is optimal in the third molar surgical procedure.",2021,"Statistically significant differences in postoperative facial swelling (P = 0.031, diff = 1.4 mm) and pain (P = 0.012, diff = 0.020) were found between the 8 mg and 4 mg dexamethasone groups.","['mandibular third molar surgery', '52 mandibular third molar surgeries in 26 patients']","['dexamethasone preoperative injection', 'dexamethasone injection', 'Dexamethasone', 'dexamethasone']","['postoperative swelling and pain', 'postoperative facial swelling', 'trismus, facial swelling, visual analog scale (VAS) pain score, and the number of analgesics taken', 'trismus and the total number of analgesics', 'pain']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.106893,"Statistically significant differences in postoperative facial swelling (P = 0.031, diff = 1.4 mm) and pain (P = 0.012, diff = 0.020) were found between the 8 mg and 4 mg dexamethasone groups.","[{'ForeName': 'Pavita', 'Initials': 'P', 'LastName': 'Wanithanont', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeranut', 'Initials': 'T', 'LastName': 'Chaiyasamut', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kadkao', 'Initials': 'K', 'LastName': 'Vongsavan', 'Affiliation': 'Walailak University International College of Dentistry, Bangkok, Thailand.'}, {'ForeName': 'Bishwa Prakash', 'Initials': 'BP', 'LastName': 'Bhattarai', 'Affiliation': 'Walailak University International College of Dentistry, Bangkok, Thailand.'}, {'ForeName': 'Verasak', 'Initials': 'V', 'LastName': 'Pairuchvej', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sirichai', 'Initials': 'S', 'LastName': 'Kiattavorncharoen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'Walailak University International College of Dentistry, Bangkok, Thailand.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2021.21.1.29']
1164,33585673,"A Multilevel Model of Alcohol Outlet Density, Individual Characteristics and Alcohol-Related Injury in Argentinean Young Adults.","Objectives


Previous research from high-income countries has consistently shown an association between alcohol-related harms and neighborhood characteristics such as alcohol outlet density, but this research has not been extended to middle- and low-income countries. We assessed the role of neighborhood characteristics such as alcohol outlet density, overcrowding and crime rates, and individual characteristics including gender, age, alcohol and marijuana use, and geographic mobility associated with alcohol-related injuries in university students in Argentina.
Methods


Data were collected from a randomized sample of students attending a national public university (n = 1346). Descriptive, bivariable, and multilevel logistic regression analyses were performed.
Results


In the final model, on-premises alcohol outlet density-but not off-premises outlet density, overcrowding or crime-was associated with past-year and lifetime alcohol-related injury (median odds ratio=1.16). At the individual level, quantity (odds ratio (OR)=1.05, 95% CI=(1.01, 1.10)) and frequency (OR=1.66, 95% CI=(1.41,1.97)) of alcohol consumption and age (OR=0.81, 95% CI=(0.74, 0.88)) were associated with past-year and lifetime alcohol-related injury.
Conclusions


This study contributes to an area with a paucity of information from non-high-income countries, finding differences with previous literature.",2020,"At the individual level, quantity (odds ratio (OR)=1.05, 95% CI=(1.01, 1.10)) and frequency (OR=1.66, 95% CI=(1.41,1.97)) of alcohol consumption and age (OR=0.81, 95% CI=(0.74, 0.88)) were associated with past-year and lifetime alcohol-related injury.
","['Argentinean Young Adults', 'students attending a national public university (n = 1346', 'university students in Argentina']",[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}]",[],[],1346.0,0.0630183,"At the individual level, quantity (odds ratio (OR)=1.05, 95% CI=(1.01, 1.10)) and frequency (OR=1.66, 95% CI=(1.41,1.97)) of alcohol consumption and age (OR=0.81, 95% CI=(0.74, 0.88)) were associated with past-year and lifetime alcohol-related injury.
","[{'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Conde', 'Affiliation': 'Institute of Basic, Applied Psychology and Technology (IPSIBAT-CONICET-UNMDP-CIC), Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Nesoff', 'Affiliation': 'Department of Epidemiology, Columbia University Mailman School of Public Health, 722 W168th St, 5th floor, New York, NY.'}, {'ForeName': 'Raquel I', 'Initials': 'RI', 'LastName': 'Peltzer', 'Affiliation': 'Institute of Basic, Applied Psychology and Technology (IPSIBAT-CONICET-UNMDP-CIC), Mar del Plata, Buenos Aires, Argentina.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Cremonte', 'Affiliation': 'Institute of Basic, Applied Psychology and Technology (IPSIBAT-CONICET-UNMDP-CIC), Mar del Plata, Buenos Aires, Argentina.'}]",The Canadian journal of addiction,['10.1097/cxa.0000000000000097']
1165,33585626,Biliary stent combined with iodine-125 seed strand implantation in malignant obstructive jaundice.,"BACKGROUND


Malignant obstructive jaundice is mainly caused by cholangiocarcinoma. Only a few patients are indicated for surgical resection, and the 3-year survival rate is < 50%. For patients who are not eligible for surgery, biliary stent placement can relieve biliary obstruction and improve liver function and quality of life. However, restenosis after biliary stents has a poor prognosis and is a clinical challenge. Biliary stent combined with iodine-125 ( 125 I) seed implantation can prolong stent patency and improve survival.
AIM


To evaluate the safety and efficacy of biliary stent combined with  125 I seed strand implantation in malignant obstructive jaundice.
METHODS


We enrolled 67 patients between January 2016 and June 2018 with malignant obstructive jaundice and randomized them into a biliary stent combined with  125 I seed strand treatment (combined) group  (n =  32) and biliary stent (control) group ( n  = 35). All patients underwent enhanced computed tomography and magnetic resonance imaging and were tested for biochemical and cancer markers. Twelve patients underwent pathological examination before surgery. All patients were followed up by telephone or clinical visit. Postoperative liver function improvement, postoperative complications, stent patency time, and survival time were compared between the two groups. Prognostic risk factors were evaluated.
RESULTS


Technical success was achieved in all patients in both groups. Postoperative liver function improved significantly in all patients (total bilirubin, direct bilirubin, alanine aminotransferase, and aspartate aminotransferase decreased significantly in all patients, the  P  values were less than 0.05). There was no significant difference in preoperative or postoperative indexes between the two groups for changes in total bilirubin ( P  = 0.147), direct bilirubin ( P  = 0.448), alanine aminotransferase ( P  = 0.120), and aspartate aminotransferase ( P  = 0.387) between the two groups. The median stent patency time of the combined group was 9.0 ± 1.4 mo [95% confidence interval (CI): 6.3-11.8 mo], which was significantly longer than the that of the control group (6.0 ± 0.3 mo, 95%CI: 5.5-6.5 mo,  P  = 0.000). The median survival time of the combined group was 11.0 ± 1.4 mo (95%CI: 8.2-13.7 mo), which was significantly longer than that of the control group (7.0 ± 0.3 mo, 95%CI: 6.4-7.6 mo,  P  = 0.000). Location of obstruction and number of stents were independent risk factors affecting prognosis.
CONCLUSION


Biliary stent combined with  125 I seed strand implantation is safe and effective in malignant obstructive jaundice and improves stent patency time and median survival time.",2021,I seed strand implantation is safe and effective in malignant obstructive jaundice and improves stent patency time and median survival time.,"['Twelve patients underwent pathological examination before surgery', '125', 'malignant obstructive jaundice', '67 patients between January 2016 and June 2018 with malignant obstructive jaundice']","['Biliary stent combined with', 'I seed strand treatment (combined) group  (n =  32) and biliary stent (control', 'I seed strand implantation', 'biliary stent combined with', 'Biliary stent combined with iodine-125 ( 125 I) seed implantation', 'enhanced computed tomography and magnetic resonance imaging', 'biliary stent combined with  125', 'Biliary stent combined with iodine-125 seed strand implantation']","['Prognostic risk factors', 'Technical success', 'median stent patency time', 'Postoperative liver function', 'Postoperative liver function improvement, postoperative complications, stent patency time, and survival time', 'safety and efficacy', 'total bilirubin', 'direct bilirubin', 'alanine aminotransferase', '3-year survival rate', 'liver function and quality of life', 'aspartate aminotransferase', 'median survival time', 'stent patency time and median survival time', 'stent patency and improve survival', 'total bilirubin, direct bilirubin, alanine aminotransferase, and aspartate aminotransferase', 'preoperative or postoperative indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}]","[{'cui': 'C0183512', 'cui_str': 'Biliary stent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449591', 'cui_str': 'Stent patency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0201916', 'cui_str': 'Bilirubin, direct measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",67.0,0.0825156,I seed strand implantation is safe and effective in malignant obstructive jaundice and improves stent patency time and median survival time.,"[{'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Li', 'Affiliation': 'Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China.'}, {'ForeName': 'Shi-Jie', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China.'}, {'ForeName': 'Jun-Rong', 'Initials': 'JR', 'LastName': 'Lu', 'Affiliation': 'Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China.'}, {'ForeName': 'Dong-Feng', 'Initials': 'DF', 'LastName': 'He', 'Affiliation': 'Department of Interventional, Harbin Medical University Cancer Hospital, Harbin 150081, Heilongjiang Province, China. 13644578588@139.com.'}]",World journal of clinical cases,['10.12998/wjcc.v9.i4.801']
1166,33585624,Effect of biofeedback combined with high-quality nursing in treatment of functional constipation.,"BACKGROUND


Functional constipation (FC) is a common functional gastrointestinal disease with various clinical manifestations. It is a physical and mental disease, which seriously affects patient physical and mental health and quality of life. Biofeedback therapy is the treatment of choice for FC, especially outlet obstructive constipation caused by pelvic floor dysfunction. High-quality nursing is a new nursing model in modern clinical work and a new concept of modern nursing service.
AIM


To explore the effect of biofeedback combined with high-quality nursing in the treatment of FC.
METHODS


A total of 100 patients with FC admitted to our hospital from March 2015 to July 2019 were selected for clinical observation. These patients were randomly divided into two groups of 50: Experimental group (biofeedback combined with high-quality nursing treatment group) and control group (biofeedback group).
RESULTS


The constipation symptom score of the experimental group was significantly lower than that of the control group, and the difference was statistically significant ( P  < 0.05). The anal canal resting pressure and initial defecation threshold of the experimental group were significantly lower than those of the control group, and the maximum squeeze systolic pressure of the anal canal of the experimental group was significantly higher than that of the control group ( P  < 0.05). The Self-Rating Anxiety Scale and Zung's Self-Rating Depression Scale scores of the two groups were significantly lower than before treatment. The Self-Rating Anxiety Scale and Self-Rating Depression Scale scores of the experimental group were significantly lower than those of the control group ( P  < 0.05). The patient satisfaction score of the experimental group was significantly higher than that of the control group ( P  < 0.05).
CONCLUSION


The application of biofeedback combined with high-quality nursing in the treatment of FC has significant advantages over pure biofeedback treatment, and it is worthy of promotion in clinical work.",2021,"The anal canal resting pressure and initial defecation threshold of the experimental group were significantly lower than those of the control group, and the maximum squeeze systolic pressure of the anal canal of the experimental group was significantly higher than that of the control group ( P  < 0.05).",['100 patients with FC admitted to our hospital from March 2015 to July 2019 were selected for clinical observation'],"['Biofeedback therapy', 'Experimental group (biofeedback combined with high-quality nursing treatment group) and control group (biofeedback group', 'biofeedback combined with high-quality nursing']","[""Self-Rating Anxiety Scale and Zung's Self-Rating Depression Scale scores"", 'constipation symptom score', 'patient satisfaction score', 'Self-Rating Anxiety Scale and Self-Rating Depression Scale scores', 'anal canal resting pressure and initial defecation threshold', 'functional constipation', 'maximum squeeze systolic pressure of the anal canal']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",100.0,0.0125593,"The anal canal resting pressure and initial defecation threshold of the experimental group were significantly lower than those of the control group, and the maximum squeeze systolic pressure of the anal canal of the experimental group was significantly higher than that of the control group ( P  < 0.05).","[{'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anorectal Disease, Shenyang Coloproctology Hospital, Shenyang 110000, Liaoning Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Department of Anorectal Disease, Shenyang Coloproctology Hospital, Shenyang 110000, Liaoning Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Department of Constipation, Shenyang Coloproctology Hospital, Shenyang 110000, Liaoning Province, China.'}, {'ForeName': 'Zhi-Tao', 'Initials': 'ZT', 'LastName': 'Yin', 'Affiliation': 'Department of Anorectal Disease, Shenyang Hospital of Traditional Chinese Medicine, Shenyang 110000, Liaoning Province, China. yinzitao@163.com.'}]",World journal of clinical cases,['10.12998/wjcc.v9.i4.784']
1167,33585623,"Effect of hospital discharge plan for children with type 1 diabetes on discharge readiness, discharge education quality, and blood glucose control.","BACKGROUND


Type 1 diabetes is one of the most common chronic diseases in childhood. The number of type 1 diabetes patients in China still ranks fourth in the world. Therefore, children with type 1 diabetes in China are a group that needs attention. The management of type 1 diabetes mellitus (T1DM) involves many aspects of daily life. It is extremely challenging for children and their families. T1DM children have complex medical care needs. Despite the continuous development of therapeutic medicine and treatment technologies, blood glucose control in children with T1DM is still not ideal. They and their parents need to acquire more knowledge and skills before being discharged.
AIM


To explore the influence of hospital discharge plan based on parental care needs of children with T1DM on discharge readiness, quality of discharge education and blood glucose control level.
METHODS


In total, 102 parents of children with type 1 diabetes were divided into control group and intervention group according to admission time. Fifty cases from February to June 2019 were selected as the control group, and 52 cases from July to October 2019 were selected as the intervention group to implement the discharge plan. The Readiness for Hospital Discharge Scale, Hospital Discharged Education Quality Scale and children's blood glucose metabolism indicators were used to compare the differences in discharge preparation, discharge education quality and blood glucose control between the two groups of children and their parents.
RESULTS


On the day of discharge, the two groups of children had the following scores of readiness for discharge: The intervention group score was 225.34 ± 32.47, and the control group score was 208.68 ± 29.31. The  P  value was 0.007, and the difference was statistically significant. The discharge education quality scores were as follows: The intervention group score was 135.11 ± 19.86, the control group score was 124.13 ± 15.56, the  P  value was 0.002 and the difference was statistically significant. Three months after discharge, the blood glucose metabolism indicator showed that the glycosylated hemoglobin value of the two groups was (7.45% ± 1.04%), and that of the control group was (8.04% ± 1.27%),  P  = 0.012. Therefore, the improvement of parents' readiness for discharge, quality of discharge education and blood glucose metabolism indicators (glycosylated hemoglobin, fasting blood glucose and postprandial blood glucose) in the intervention group were better than those in the control group ( P  < 0.05), and the difference was statistically significant.
CONCLUSION


The discharge plan for children with T1DM can help the children and their families realize the transition from hospital care to home self-management and improve the parents' readiness for discharge, thereby improving children's blood glucose control levels.",2021,"The intervention group score was 135.11 ± 19.86, the control group score was 124.13 ± 15.56, the  P  value was 0.002 and the difference was statistically significant.","['102 parents of children with type 1 diabetes', 'children with T1DM on', 'children with T1DM', 'children with type 1 diabetes', 'children with type 1 diabetes in China', 'Fifty cases from February to June 2019 were selected as the control group, and 52 cases from July to October 2019']",['hospital discharge plan'],"['discharge readiness, discharge education quality, and blood glucose control', 'discharge education quality scores', ""parents' readiness for discharge, quality of discharge education and blood glucose metabolism indicators (glycosylated hemoglobin, fasting blood glucose and postprandial blood glucose"", ""Readiness for Hospital Discharge Scale, Hospital Discharged Education Quality Scale and children's blood glucose metabolism indicators"", 'discharge preparation, discharge education quality and blood glucose control', 'discharge readiness, quality of discharge education and blood glucose control level', 'blood glucose metabolism indicator', 'glycosylated hemoglobin value', 'scores of readiness for discharge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0237506,"The intervention group score was 135.11 ± 19.86, the control group score was 124.13 ± 15.56, the  P  value was 0.002 and the difference was statistically significant.","[{'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Tong', 'Affiliation': 'Department of Nursing, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': ""Department of Ophthalmology, Shenyang Fourth People's Hospital, Shenyang 110034, Liaoning Province, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China. fanl_sj0512@163.com.'}]",World journal of clinical cases,['10.12998/wjcc.v9.i4.774']
1168,33585533,Power Comparisons and Clinical Meaning of Outcome Measures in Assessing Treatment Effect in Cancer Cachexia: Secondary Analysis From a Randomized Pilot Multimodal Intervention Trial.,"Background:  New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention.  Methods:  The study was a multicenter, open-label, randomized pilot study investigating the feasibility of a 6-week multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids ( n -3 PUFAs)] vs. standard cancer care in non-operable non-small-cell lung cancer and advanced pancreatic cancer. Body composition measures from computerized tomography scans and circulating biomarkers were analyzed.  Results:  Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively. The between-group ESs were high for body weight (ES = 1.2,  p  < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64-1.37,  p  < 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53,  p  = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86,  p  = 0.001) and n-3 PUFAs (ES > 0.8,  p  < 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49,  p  = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = -0.84,  p  = 0.002) and muscle mass (ES = -0.67,  p  = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = -0.88,  p  = 0.002) were found.  Conclusion:  Demonstrating high sensitivity to change and between treatment ES and body composition measures, body weight still stands out as a clinical and relevant outcome measure in cancer cachexia. Body composition and physical function measures clearly are important to address but demand large sample sizes to detect treatment group differences.  Trial registration:  ClinicalTrials.gov identifier: NCT01419145.",2020,"The between-group ESs were high for body weight (ES = 1.2,  p  < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64-1.37,  ","['Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively', 'cancer cachexia', 'Cancer Cachexia', 'non-operable non-small-cell lung cancer and advanced pancreatic cancer']","['multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids ( n -3 PUFAs', 'standard cancer care']","['high for body weight', 'small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D', 'moderate sensitivity to change for body weight', 'n-3 PUFAs', 'plasma levels of 25-OH vitamin D', 'body composition measures', 'high sensitivity to change for adiponectin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1391732', 'cui_str': 'Cancer cachexia'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1285593', 'cui_str': 'Body composition measure'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",46.0,0.0869756,"The between-group ESs were high for body weight (ES = 1.2,  p  < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64-1.37,  ","[{'ForeName': 'Trude R', 'Initials': 'TR', 'LastName': 'Balstad', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Brunelli', 'Affiliation': 'Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Caroline H', 'Initials': 'CH', 'LastName': 'Pettersen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Svanhild A', 'Initials': 'SA', 'LastName': 'Schønberg', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Skorpen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fallon', 'Affiliation': 'Edinburgh Cancer Research Centre (IGMM), University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Kaasa', 'Affiliation': 'Department of Oncology, European Palliative Care Research Centre (PRC), Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Bye', 'Affiliation': 'Department of Oncology, European Palliative Care Research Centre (PRC), Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Barry J A', 'Initials': 'BJA', 'LastName': 'Laird', 'Affiliation': ""St. Columba's Hospice, Edinburgh, United Kingdom.""}, {'ForeName': 'Guro B', 'Initials': 'GB', 'LastName': 'Stene', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Tora S', 'Initials': 'TS', 'LastName': 'Solheim', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU-Norwegian University of Science and Technology, Trondheim, Norway.'}]",Frontiers in nutrition,['10.3389/fnut.2020.602775']
1169,33585378,Development and Implementation of Liposomal Encapsulated Micronutrient Fortified Body Oil Intervention for Infant Massage: An Innovative Concept to Prevent Micronutrient Deficiencies in Children.,"Indian communities have the ancient cultural practice of gentle oil massage for infants which has been shown to play a beneficial role in neuro-motor development. The concept of incorporating nanosized liposomes of micronutrients (i.e., iron, folate, vitamin B12, and vitamin D) in the body oil leverages this practice for transdermal supplementation of essential micro-nutrients. This paper describes the experience of developing an intervention in the form of body oil containing nanosized liposomes of iron and micro-nutrients built on the social context of infant oil massage using a theory of change approach. The process of development of the intervention has been covered into stages such as design, decide and implement. The design phase describes how the idea of nanosized liposomal encapsulated micronutrient fortified (LMF) body oil was conceptualized and how its feasibility was assessed through initial formative work in the community. The decide phase describes steps involved while scaling up technology from laboratory to community level. The implementation phase describes processes while implementing the intervention of LMF oil in a community-based randomized controlled study. Overall, the theory of change approach helps to outline the various intermediate steps and challenges while translating novel technologies for transdermal nutrient fortification to community level. In our experience, adaptation in the technology for large scale up, formative work and pilot testing of innovation at community level were important processes that helped in shaping the innovation. Meticulous mapping of these processes and experiences can be a useful guide for translating similar innovations.",2020,"In our experience, adaptation in the technology for large scale up, formative work and pilot testing of innovation at community level were important processes that helped in shaping the innovation.","['Children', 'Infant Massage']","['Liposomal Encapsulated Micronutrient Fortified Body Oil Intervention', 'LMF oil']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0695595', 'cui_str': 'Infant massage'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C1166870', 'cui_str': 'Oil Bodies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]",[],,0.0209893,"In our experience, adaptation in the technology for large scale up, formative work and pilot testing of innovation at community level were important processes that helped in shaping the innovation.","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Apte', 'Affiliation': 'Vadu Rural Health Program, King Edward Memorial Hospital Research Centre, Pune, India.'}, {'ForeName': 'Himangi', 'Initials': 'H', 'LastName': 'Lubree', 'Affiliation': 'Vadu Rural Health Program, King Edward Memorial Hospital Research Centre, Pune, India.'}, {'ForeName': 'Mudra', 'Initials': 'M', 'LastName': 'Kapoor', 'Affiliation': 'Nanomedicine Laboratory, Department of Biosciences and Bioengineering, Indian Institute of Technology Bombay, Mumbai, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Juvekar', 'Affiliation': 'Vadu Rural Health Program, King Edward Memorial Hospital Research Centre, Pune, India.'}, {'ForeName': 'Rinti', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Nanomedicine Laboratory, Department of Biosciences and Bioengineering, Indian Institute of Technology Bombay, Mumbai, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'Vadu Rural Health Program, King Edward Memorial Hospital Research Centre, Pune, India.'}]",Frontiers in public health,['10.3389/fpubh.2020.567689']
1170,33585359,Look Upstream: Measurement for Innovation on the Upper Rio Negro of the Amazon Basin.,"The growth of the randomized controlled trial (RCT) as the ""gold standard"" for evaluation has justly been praised as an advance in the professionalization of social programs and projects, an ""adoption of science"" - in the words of the Lancet. None the less, the emphasis on the RCT biases funding for projects that distribute private goods and which focus on ""low hanging fruit"" in health, nutrition, and sanitation, simply because those areas lend themselves to the sort of measurement that works with RCTs. As a result, many project developers in the government and NGO sectors lament that a hegemonic focus on RCTs impedes creativity or new models that challenge traditional paradigms. This case study of CanalCanoa, a community video coaching project for indigenous parents of young children in the Rio Negro region of the Amazon Basin, offers techniques to measure for innovation. Instead of developing a new RCT for an extremely diverse population (27 ethnic groups) where traditional childcare methods are in historical flux because of urbanization, CanalCanoa measured variables shown by previous RCTs to be causally connected with positive development results. By researching the impact of the intervention on nutrition, language (multilingualism, use of traditional songs and stories), and social network expansion, CanalCanoa measured upstream indicators, thus mixing scientific rigor with an opportunity for innovation and providing important insight and reform of a theory of change.",2020,"This case study of CanalCanoa, a community video coaching project for indigenous parents of young children in the Rio Negro region of the Amazon Basin, offers techniques to measure for innovation.",['indigenous parents of young children in the Rio Negro region of the Amazon Basin'],['CanalCanoa'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0445581', 'cui_str': 'Rio'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0179226', 'cui_str': 'Basin'}]",[],[],,0.0264141,"This case study of CanalCanoa, a community video coaching project for indigenous parents of young children in the Rio Negro region of the Amazon Basin, offers techniques to measure for innovation.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Shaw', 'Affiliation': 'Usina da Imaginação, Florianópolis, Brazil.'}, {'ForeName': 'Rita de Cácia Oenning', 'Initials': 'RCO', 'LastName': 'da Silva', 'Affiliation': 'Usina da Imaginação, Florianópolis, Brazil.'}]",Frontiers in pediatrics,['10.3389/fped.2020.567257']
1171,33585354,The usefulness of transanal tube for reducing anastomotic leak in mid rectal cancer: compared to diverting stoma.,"Purpose


Diverting stoma (DS) and transanal tube (TAT) are the 2 main procedures for reducing anastomotic leak (AL) in rectal cancer surgery. However, few studies have compared the protective effect of the 2 modalities against AL.
Methods


Total of 165 patients with mid rectal cancer, who underwent curative resection from 2012 to 2017, were included. Clinical characteristics and outcomes were compared. Risk factors for AL were identified using multivariate analysis.
Results


The DS group had lower tumor location, higher rates of neoadjuvant concurrent chemoradiotherapy, and longer operative time than the TAT group. However, the level of the anastomosis did not show statistically significant differences (DS: 4.6 cm  vs.  TAT: 4.9 cm, P = 0.061). AL occurred in 14 of the 165 patients (8.5%), with 10 (10.2%) in the DS group and 4 (6.0%) in the TAT group (P = 0.405). On multivariate analysis, only low body mass index (BMI) and smoking were significantly related to AL. Neither the protection method nor neoadjuvant chemoradiotherapy demonstrated statistical differences in AL. Seven of 10 patients in the DS group who experienced AL were treated conservatively, while all 4 in the TAT group underwent reoperation.
Conclusion


TAT seems to have comparable protective effect against AL to DS. However, in AL, DS appeared to be more effective in preventing reoperation. Therefore, DS is recommended in patients with low BMI or smoking, and with an expected higher probability of morbidity or mortality in case of reoperation. In other cases, TAT may be considered as an alternative to DS.",2021,Neither the protection method nor neoadjuvant chemoradiotherapy demonstrated statistical differences in AL.,"['rectal cancer surgery', '165 patients with mid rectal cancer, who underwent curative resection from 2012 to 2017, were included', 'mid rectal cancer']","['TAT', 'transanal tube', 'Diverting stoma (DS) and transanal tube (TAT']","['lower tumor location, higher rates of neoadjuvant concurrent chemoradiotherapy, and longer operative time', 'anastomotic leak', 'AL', 'low body mass index (BMI) and smoking']","[{'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0589371', 'cui_str': 'Transanal approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",165.0,0.0196485,Neither the protection method nor neoadjuvant chemoradiotherapy demonstrated statistical differences in AL.,"[{'ForeName': 'Seok Hyeon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'In Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Min Ki', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.'}]",Annals of surgical treatment and research,['10.4174/astr.2021.100.2.100']
1172,33585197,Automatic Detection and Classification of Focal Liver Lesions Based on Deep Convolutional Neural Networks: A Preliminary Study.,"With the increasing daily workload of physicians, computer-aided diagnosis (CAD) systems based on deep learning play an increasingly important role in pattern recognition of diagnostic medical images. In this paper, we propose a framework based on hierarchical convolutional neural networks (CNNs) for automatic detection and classification of focal liver lesions (FLLs) in multi-phasic computed tomography (CT). A total of 616 nodules, composed of three types of malignant lesions (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and metastasis) and benign lesions (hemangioma, focal nodular hyperplasia, and cyst), were randomly divided into training and test sets at an approximate ratio of 3:1. To evaluate the performance of our model, other commonly adopted CNN models and two physicians were included for comparison. Our model achieved the best results to detect FLLs, with an average test precision of 82.8%, recall of 93.4%, and F1-score of 87.8%. Our model initially classified FLLs into malignant and benign and then classified them into more detailed classes. For the binary and six-class classification, our model achieved average accuracy results of 82.5 and73.4%, respectively, which were better than the other three classification neural networks. Interestingly, the classification performance of the model was placed between a junior physician and a senior physician. Overall, this preliminary study demonstrates that our proposed multi-modality and multi-scale CNN structure can locate and classify FLLs accurately in a limited dataset, and would help inexperienced physicians to reach a diagnosis in clinical practice.",2020,"Our model achieved the best results to detect FLLs, with an average test precision of 82.8%, recall of 93.4%, and F1-score of 87.8%.","['A total of 616 nodules, composed of three types of malignant lesions (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and metastasis) and benign lesions (hemangioma, focal nodular hyperplasia, and cyst']",['multi-phasic computed tomography (CT'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345905', 'cui_str': 'Intrahepatic bile duct carcinoma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}, {'cui': 'C0333980', 'cui_str': 'Focal nodular hyperplasia'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],616.0,0.0161456,"Our model achieved the best results to detect FLLs, with an average test precision of 82.8%, recall of 93.4%, and F1-score of 87.8%.","[{'ForeName': 'Jiarong', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Wenzhe', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'College of Computer Science and Technology, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Biwen', 'Initials': 'B', 'LastName': 'Lei', 'Affiliation': 'College of Computer Science and Technology, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Ge', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Linshi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yingcai', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Dongkai', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Computer Science and Technology, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Weilin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.581210']
1173,33585008,The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients.,"Aim


The main complication of Endoscopic retrograde cholangiopancreatography (ERCP) is post-ERCP pancreatitis (PEP).
Background


Based on demographic characteristics and underlying issues and ERCP indication, patients are categorized as high risk or low risk. There have been no studies on the synergistic effects of NSAIDS and hydration therapy, separately sorted by the risk assessment of PEP in different groups of patients.
Methods


This study included 281 eligible participants after exclusion. According to demographic characteristics and co-morbidities, the patients were divided to high risk and low risk. The high-risk group was divided randomly into two subgroups and both of them received NSAIDs (100 mg rectal Diclofenac). One group received standard hydration (1.5mg/kg/hr), another the other received aggressive hydration (3mg/kg/h). The low-risk group received standard hydration. One of its subgroups received NSAIDs, while others did not. The efficacy of these preventions was compared across 4 subgroups.
Results


The mean age was 59.85±17.17. Eight hours after ERCP, the amylase and lipase were significantly higher in the high-risk group with standard hydration (P=0.00). Amylase, lipase 8 hours, between two low risk subgroups, NSAIDs had no significant effect (P=0.38, P=0.95, respectively). After adjustment based on cannulation, manipulation and duration of time, the results had no change (P=0.64, P=0.19, P=0.61).
Conclusion


The aggressive hydration could significantly decrease the risk of PEP. However, the low-risk group was exposed to the lowest risk of PEP. NSAIDs could not help to decrease the rate PEP in the low-risk groups alone. Overall, it seems hydration and NSAIDs therapy had synergistic outcome in high-risk patients.",2020,"Eight hours after ERCP, the amylase and lipase were significantly higher in the high-risk group with standard hydration (P=0.00).","['high-risk patients', '281 eligible participants after exclusion', 'high -risk and low -risk patients']","['Endoscopic retrograde cholangiopancreatography (ERCP', 'NSAIDs and aggressive hydration therapy', 'standard hydration', 'NSAIDs (100 mg rectal Diclofenac']","['rate of post-ERCP pancreatitis', 'rate PEP', 'risk of PEP', 'amylase and lipase']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0360480', 'cui_str': 'Diclofenac-containing product in rectal dose form'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",281.0,0.0256027,"Eight hours after ERCP, the amylase and lipase were significantly higher in the high-risk group with standard hydration (P=0.00).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Aghajanpoor Pasha', 'Affiliation': 'Gastroenterology and Hepatobiliary Research Center, AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Eslami', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Dooghaie Moghadam', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bobak', 'Initials': 'B', 'LastName': 'Moazzami', 'Affiliation': 'Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Shojaee', 'Affiliation': 'Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Almasi', 'Affiliation': 'Department of Internal Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Tavakolikia', 'Affiliation': 'Social and Preventive Medicine Specialist, Head of Family, Population Health Department, Tehran University of Medical science, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Norouzinia', 'Affiliation': 'Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Radinnia', 'Affiliation': 'Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Gastroenterology and hepatology from bed to bench,[]
1174,33584959,"A Split-face, Controlled Study to Assess the Compatibility of Tretinoin 0.05% Acne Lotion with Facial Foundation Makeup.","OBJECTIVE:  This study was conducted to assess compatibility of tretinoin 0.05% acne lotion with foundation makeup.  DESIGN:  This was a single-center, evaluator-blinded, randomized, controlled clinical trial. Participants were randomized to apply tretinoin 0.05% lotion to either the right or left side of the face before applying full-face foundation makeup.  SETTING:  Participants were enrolled at a single center in the United States.  PARTICIPANTS:  Female individuals aged 18 to 50 years who used facial foundation makeup ≥5 days per week were included.  MEASUREMENTS:  Investigator-assessed grading for foundation coverage and participant evaluations of makeup appearance were conducted at post-makeup application (Post-Makeup) and Hour 6 (6H) timepoints. Antera 3D® images were taken for skin texture roughness analysis and tolerability evaluations were performed at baseline, post-tretinoin application, Post-Makeup, and 6H timepoints.  RESULTS:  A total of 30 participants were enrolled and 29 completed the study. There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness). There was a small but statistically significant worsening in percent coverage at 6H versus Post-Makeup on the untreated side, but not the treated side. As rated by participants, even/full coverage and skin smoothness were significantly better on the tretinoin-lotion treated versus the untreated side. Three-dimensional imaging showed there were no significant differences in skin roughness between the treated and untreated sides. Participants reported overall satisfaction with the tretinoin lotion-treated side.  CONCLUSION:  Tretinoin 0.05% lotion did not interfere with facial makeup application or wearability and was well tolerated.",2020,"There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness).","['A total of 30 participants were enrolled and 29 completed the study', '  Female individuals aged 18 to 50 years who used facial foundation makeup ≥5 days per week were included', 'Participants were enrolled at a single center in the United States']","['tretinoin-lotion', 'tretinoin 0.05% lotion', 'tretinoin lotion-treated side', 'tretinoin', 'Tretinoin']","['skin texture roughness analysis and tolerability evaluations', 'full coverage and skin smoothness', 'Investigator-assessed grading for foundation coverage and participant evaluations of makeup appearance', 'overall satisfaction', 'facial makeup application or wearability and was well tolerated', 'investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness', 'skin roughness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037290', 'cui_str': 'Skin pigmentation'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}]",30.0,0.044501,"There were no significant differences between tretinoin treated and untreated sides for any outcomes of investigator-assessed grading of foundation (percentage coverage, blotchiness, overall coverage, skin tone evenness, visual smoothness).","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Bhatia', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}, {'ForeName': 'Leon H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Shamban', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Bhatt', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Guenin', 'Affiliation': 'Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California.'}]",The Journal of clinical and aesthetic dermatology,[]
1175,33584955,"An Herbal Extract Combination (Biochanin A, Acetyl tetrapeptide-3, and Ginseng Extracts) versus 3% Minoxidil Solution for the Treatment of Androgenetic Alopecia: A 24-week, Prospective, Randomized, Triple-blind, Controlled Trial.","OBJECTIVE : We sought to evaluate the efficacy and safety profile of an herbal extract combination comprising biochanin A, acetyl tetrapeptide-3, and ginseng extracts, and compare this to 3% minoxidil solution for the treatment of andogenetic alopecia (AGA).  METHODS : A 24-week, triple-blinded, randomized controlled study was conducted in male and female subjects (N=32) with mild to moderate AGA. All were randomized to receive twice-daily, 1mL applications of the herbal extract combination or 3% minoxidil solution. Clinical efficacy from photographic assessment and adverse reactions were evaluated.  RESULTS : There were thirty-two subjects (16 male, mean age 41.3±13.8 years), with AGA onset and duration of 35.5±13.6 and 6.5±5.1 years, respectively. The herbal extract combination demonstrated a comparable efficacy to 3% minoxidil solution. Expert panel photographic assessment observed a response to both treatments in most patients at 24 weeks, with no statistically significant difference in an increase of terminal hair counts (8.3% [ P =0.009] and 8.7% [ P =0.002] at 24 weeks in the herbal extract combinations and the 3% minoxidil solution groups, respectively). No local adverse reactions from the herbal extract combination were observed, but one subject developed scalp eczema after using the 3% minoxidil solution.  CONCLUSION : The non-significant difference in clinical efficacy and safety to 3% minoxidil solution suggests that the herbal extract combination evaluated here could potentially be an alternative treatment with for AGA. Further studies with larger groups and longer follow-up periods are recommended to verify our results.",2020,"Expert panel photographic assessment observed a response to both treatments in most patients at 24 weeks, with no statistically significant difference in an increase of terminal hair counts (8.3% [ P =0.009] and 8.7% [ P =0.002] at 24 weeks in the herbal extract combinations and the 3% minoxidil solution groups, respectively).","['Androgenetic Alopecia', 'andogenetic alopecia (AGA', 'There were thirty-two subjects (16 male, mean age 41.3±13.8 years), with AGA onset and duration of 35.5±13.6 and 6.5±5.1 years, respectively', 'male and female subjects (N=32) with mild to moderate AGA']","['herbal extract combination comprising biochanin A, acetyl tetrapeptide-3, and ginseng extracts', 'Herbal Extract Combination (Biochanin A, Acetyl tetrapeptide-3, and Ginseng Extracts) versus 3% Minoxidil Solution', 'minoxidil solution', 'herbal extract combination or 3% minoxidil solution', 'minoxidil']","['scalp eczema', 'local adverse reactions', 'clinical efficacy and safety', 'terminal hair counts']","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0053622', 'cui_str': 'Biochanin A'}, {'cui': 'C4555695', 'cui_str': 'acetyl tetrapeptide-3'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221960', 'cui_str': 'Structure of terminal hair'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",32.0,0.0416928,"Expert panel photographic assessment observed a response to both treatments in most patients at 24 weeks, with no statistically significant difference in an increase of terminal hair counts (8.3% [ P =0.009] and 8.7% [ P =0.002] at 24 weeks in the herbal extract combinations and the 3% minoxidil solution groups, respectively).","[{'ForeName': 'Suparuj', 'Initials': 'S', 'LastName': 'Lueangarun', 'Affiliation': 'Dr. Lueangarun is with the Division of Dermatology at Chulabhorn International College of Medicine at Thammasat University in Pathumthani, Thailand.'}, {'ForeName': 'Ratchathorn', 'Initials': 'R', 'LastName': 'Panchaprateep', 'Affiliation': 'Dr. Lueangarun is with the Division of Dermatology at Chulabhorn International College of Medicine at Thammasat University in Pathumthani, Thailand.'}]",The Journal of clinical and aesthetic dermatology,[]
1176,33584952,Early Treatment Targets for Predicting Long-term Dermatology Life Quality Index Response in Patients with Moderate-to-Severe Plaque Psoriasis: A  Post-hoc  Analysis from a Long-term Clinical Study.,"BACKGROUND : Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody.  OBJECTIVE : We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]).  METHODS : The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index.  RESULTS : Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher.  CONCLUSION : Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.",2020,"Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody.  ",['Patients with Moderate-to-Severe Plaque Psoriasis'],"['UST', 'IXE or IL-12/23 (ustekinumab [UST', 'ixekizumab (IXE', 'IXE']","['health-related quality of life (HRQoL) and psoriasis severity', 'early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI', 'PASI response', 'skin clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0982226,"Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody.  ","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shrom', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Lotus', 'Initials': 'L', 'LastName': 'Mallbris', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain.'}]",The Journal of clinical and aesthetic dermatology,[]
1177,33584665,"Probiotics, Anticipation Stress, and the Acute Immune Response to Night Shift.","Introduction


Sleep disturbance and sleep disruption are associated with chronic, low grade inflammation and may underpin a range of chronic diseases in night shift workers. Through modulation of the intestinal microbiota, probiotic supplements may moderate the effects of sleep disruption on the immune system. The aim of this study was to examine 14 days of daily probiotic supplementation on the acute response of acute phase proteins and immune markers to sleep disruption associated with night shift work (Australia and New Zealand Clinical Trials Registry: 12617001552370).
Methods


Individuals (mean age 41 ± 11 yrs; 74% female) performing routine night shift were randomly assigned to a probiotic group (1 × 10 10  colony forming units (CFU)  Lactobacillus acidophilus  DDS-1 or 1 × 10 10  CFU  Bifidobacterium animalis  subsp.  lactis  UABla-12) or placebo (n= 29 per group). Participants undertook a 14-day supplementation period that coincided with a period of no night shifts followed by two consecutive night shifts. Blood samples were collected prior to the start of supplementation (V1), prior to commencing the first night shift (V2), after the first night shift (V3) and after the second night shift (V4). Serum was assessed for markers of stress (cortisol), acute phase response (C reactive protein (CRP), erythrocyte sedimentation rate, pentraxin), adhesion markers (serum E-selectin, mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1), and serum cytokines (interleukin (IL)-1ra, IL-1β, IL-6, tumor necrosis factor (TNF)-α, IL-10). Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI) and a Fitbit activity tracker.
Results


The groups were well balanced on key markers and the probiotic strains were well tolerated. The 14-day supplementation period that coincided with typical night-day sleep-wake cycles leading up to night shift (V1 to V2) was associated with significant changes in the placebo group in the concentration of serum cortisol (p = 0.01), pentraxin (p = 0.001), MAdCAM-1 (p = 0.001), and IL-1ra (p=0.03). In contrast, probiotic supplementation moderated changes in these serum markers from V1 to V2. No significant interaction effects (time by group) were observed for the serum markers prior to and after night shift work following probiotic supplementation due to the substantial changes in the serum markers that occurred during the normal sleep period from V1 to V2.
Conclusions


Probiotics may moderate the effects of anticipatory stress on the immune system in the lead up to night shift.",2020,"No significant interaction effects (time by group) were observed for the serum markers prior to and after night shift work following probiotic supplementation due to the substantial changes in the serum markers that occurred during the normal sleep period from V1 to V2.
",['Methods\n\n\nIndividuals (mean age 41 ± 11 yrs; 74% female) performing routine night shift'],"['placebo', 'daily probiotic supplementation', 'probiotic supplementation', 'probiotic group (1 × 10 10  colony forming units (CFU)  Lactobacillus acidophilus  DDS-1 or 1 × 10 10  CFU  Bifidobacterium animalis  subsp']","['Sleep quality', 'Pittsburgh Sleep Quality Index (PSQI) and a Fitbit activity tracker', 'concentration of serum cortisol', 'markers of stress (cortisol), acute phase response (C reactive protein (CRP), erythrocyte sedimentation rate, pentraxin), adhesion markers (serum E-selectin, mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1), and serum cytokines (interleukin (IL)-1ra, IL-1β, IL-6, tumor necrosis factor (TNF)-α, IL-10', 'typical night-day sleep-wake cycles leading up to night shift', 'tolerated']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001349', 'cui_str': 'Acute phase reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1309370', 'cui_str': 'CADM1 protein, human'}, {'cui': 'C1138490', 'cui_str': 'MADCAM1 protein, human'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0557861', 'cui_str': 'Night and day'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",,0.0204761,"No significant interaction effects (time by group) were observed for the serum markers prior to and after night shift work following probiotic supplementation due to the substantial changes in the serum markers that occurred during the normal sleep period from V1 to V2.
","[{'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'West', 'Affiliation': 'School of Medical Science and Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Hughes', 'Affiliation': 'School of Medical Science and Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ramsey', 'Affiliation': 'School of Medical Science and Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Martoni', 'Affiliation': 'United Agricultural Services (UAS) Laboratories, Windsor, WI, United\xa0States.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Leyer', 'Affiliation': 'United Agricultural Services (UAS) Laboratories, Windsor, WI, United\xa0States.'}, {'ForeName': 'Allan W', 'Initials': 'AW', 'LastName': 'Cripps', 'Affiliation': 'School of Medicine and Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cox', 'Affiliation': 'School of Medical Science and Menzies Health Institute QLD, Griffith University, Gold Coast, QLD, Australia.'}]",Frontiers in immunology,['10.3389/fimmu.2020.599547']
1178,33584534,Using Health Information Technology to Engage African American Women on Nutrition and Supplement Use During the Preconception Period.,"Importance


Healthy nutrition and appropriate supplementation during preconception have important implications for the health of the mother and newborn. The best way to deliver preconception care to address health risks related to nutrition is unknown.
Methods


We conducted a secondary analysis of data from a randomized controlled trial designed to study the impact of conversational agent technology in 13 domains of preconception care among 528 non-pregnant African American and Black women. This analysis is restricted to those 480 women who reported at least one of the ten risks related to nutrition and dietary supplement use.
Interventions


An online conversational agent, called ""Gabby"", assesses health risks and delivers 12 months of tailored dialogue for over 100 preconception health risks, including ten nutrition and supplement risks, using behavioral change techniques like shared decision making and motivational interviewing. The control group received a letter listing their preconception risks and encouraging them to talk to a health care provider.
Results


After 6 months, women using Gabby (a) reported progressing forward on the stage of change scale for, on average, 52.9% (SD, 35.1%) of nutrition and supplement risks compared to 42.9% (SD, 35.4) in the control group (IRR 1.22, 95% CI 1.03-1.45, P = 0.019); and (b) reported achieving the action and maintenance stage of change for, on average, 52.8% (SD 37.1) of the nutrition and supplement risks compared to 42.8% (SD, 37.9) in the control group (IRR 1.26, 96% CI 1.08-1.48, P = 0.004). For subjects beginning the study at the contemplation stage of change, intervention subjects reported progressing forward on the stage of change scale for 75.0% (SD, 36.3%) of their health risks compared to 52.1% (SD, 47.1%) in the control group (P = 0.006).
Conclusion


The scalability of Gabby has the potential to improve women's nutritional health as an adjunct to clinical care or at the population health level. Further studies are needed to determine if improving nutrition and supplement risks can impact clinical outcomes including optimization of weight.
Clinical Trial Registration


ClinicalTrials.gov, identifier NCT01827215.",2020,"An online conversational agent, called ""Gabby"", assesses health risks and delivers 12 months of tailored dialogue for over 100 preconception health risks, including ten nutrition and supplement risks, using behavioral change techniques like shared decision making and motivational interviewing.","['13 domains of preconception care among 528 non-pregnant African American and Black women', '480 women who reported at least one of the ten risks related to nutrition and dietary supplement use']","['behavioral change techniques like shared decision making and motivational interviewing', 'letter listing their preconception risks and encouraging them to talk to a health care provider', 'conversational agent technology']",['health risks'],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",528.0,0.0272583,"An online conversational agent, called ""Gabby"", assesses health risks and delivers 12 months of tailored dialogue for over 100 preconception health risks, including ten nutrition and supplement risks, using behavioral change techniques like shared decision making and motivational interviewing.","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gardiner', 'Affiliation': 'Department of Family Medicine, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Bickmore', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Yinusa-Nyahkoon', 'Affiliation': 'College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Reichert', 'Affiliation': 'Department of Government, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Clevanne', 'Initials': 'C', 'LastName': 'Julce', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Nireesha', 'Initials': 'N', 'LastName': 'Sidduri', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Martin-Howard', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Woodhams', 'Affiliation': 'Department of Obstetrics and Gynecology, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Jumana', 'Initials': 'J', 'LastName': 'Aryan', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Fernandez', 'Affiliation': 'Khoury College of Computer Sciences, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Loafman', 'Affiliation': 'Department of Family Medicine, Cook County Health System, Chicago, IL, United States.'}, {'ForeName': 'Jayakanth', 'Initials': 'J', 'LastName': 'Srinivasan', 'Affiliation': 'Institute for Health Systems Innovation and Policy, Boston University, Boston, MA, United States.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cabral', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, MA, United States.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Jack', 'Affiliation': 'Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.571705']
1179,33584510,"2D Virtual Reality-Based Exercise Improves Spatial Navigation in Institutionalized Non-robust Older Persons: A Preliminary Data Report of a Single-Blind, Randomized, and Controlled Study.","Background:  Spatial navigation is a prodromal dementia marker. Exercise used alongside virtual reality improves many cognitive functions, but effects on spatial navigation are still unclear.  Objective:  To investigate the effect of virtual reality-based physical exercise with 2D exergames on spatial navigation in institutionalized non-robust older persons.  Method:  A total of 14 older persons (aged ≧ 60) were randomly allocated to the exergame (EG) and active control (ACG) groups. EG performed exercises with 2D exergames, while the ACG used the same movements as the EG, but without the use of virtual reality. Spatial navigation was assessed through the Floor Maze Test, where the immediate maze time (IMT) and delayed maze time (DMT) were recorded.  Results:  Spatial navigation was enhanced in EG participants compared to ACG individuals. A significant ( p  = 0.01) IMT reduction between groups was observed, while DMT time without prior planning was significantly different at the significance threshold ( p  = 0.07).  Conclusions:  Virtual reality-based exercise improves the spatial navigation of institutionalized non-robust older persons. This study should be replicated to confirm the findings reported herein.  Clinical Trial Registration:  This study was registered in the Brazilian Registry of Clinical Trials (Protocol RBR-8dv3kg - https://ensaiosclinicos.gov.br/rg/RBR-8dv3kg).",2020,"IMT reduction between groups was observed, while DMT time without prior planning was significantly different at the significance threshold ( p  = 0.07).  ","['institutionalized non-robust older persons', 'Institutionalized Non-robust Older Persons', '14 older persons (aged ≧ 60']","['Exercise used alongside virtual reality', '2D Virtual Reality-Based Exercise Improves Spatial Navigation', 'Spatial navigation', 'Virtual reality-based exercise', 'virtual reality-based physical exercise with 2D exergames', 'exergame (EG) and active control (ACG']","['spatial navigation', 'DMT time without prior planning', 'Spatial navigation', 'IMT reduction', 'immediate maze time (IMT) and delayed maze time (DMT']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3850152', 'cui_str': 'Spatial Navigation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0050397', 'cui_str': 'acceleratory factor from growth hormone'}]","[{'cui': 'C3850152', 'cui_str': 'Spatial Navigation'}, {'cui': 'C0027183', 'cui_str': 'N,-N-dimethyltryptamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0083355', 'cui_str': 'MAZE protocol'}]",60.0,0.0308334,"IMT reduction between groups was observed, while DMT time without prior planning was significantly different at the significance threshold ( p  = 0.07).  ","[{'ForeName': 'Luciana Mendes', 'Initials': 'LM', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program of Medicine (Neurology/Neurosciences), Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Eric Hudson', 'Initials': 'EH', 'LastName': 'Evangelista E Souza', 'Affiliation': 'Graduate Program of Health Sciences, Montes Claros State University, Montes Claros, Brazil.'}, {'ForeName': 'Mariana Rocha', 'Initials': 'MR', 'LastName': 'Alves', 'Affiliation': 'Graduate Program of Medicine (Neurology/Neurosciences), Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Carneiro', 'Affiliation': 'Universitary Institute of Maia, Maia, Portugal.'}, {'ForeName': 'Daniel Ferreira', 'Initials': 'DF', 'LastName': 'Fagundes', 'Affiliation': 'Graduate Program of Medicine (Neurology/Neurosciences), Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Alfredo Maurício Batista', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Graduate Program of Health Sciences, Montes Claros State University, Montes Claros, Brazil.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Engedal', 'Affiliation': 'Norwegian Advisory Unit for Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Osvaldo J M', 'Initials': 'OJM', 'LastName': 'Nascimento', 'Affiliation': 'Graduate Program of Medicine (Neurology/Neurosciences), Federal Fluminense University, Niterói, Brazil.'}, {'ForeName': 'Renato Sobral', 'Initials': 'RS', 'LastName': 'Monteiro-Junior', 'Affiliation': 'Graduate Program of Medicine (Neurology/Neurosciences), Federal Fluminense University, Niterói, Brazil.'}]",Frontiers in neurology,['10.3389/fneur.2020.609988']
1180,33584491,Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial.,"Background:  Stenting treatment for refractory symptomatic patients with vertebral artery origin stenosis (VAOS) is safe; however, there is a high rate of in-stent restenosis. Although drug-eluting stents can reduce the incidence of restenosis to some extent, there is still a risk caused by stent fracture. Drug-coated balloon (DCB) has been proven to reduce the rate of restenosis in peripheral and coronary artery disease. DCB can prevent inflammation caused by extraneous material stimulation and allow the subsequent treatment that is characteristic of ""leave nothing behind."" The purpose of this trial is to compare the efficacy and safety of DCB and bare metal stent (BMS) in the treatment of VAOS.  Method/Design:  This trial is a 1:1 randomized, controlled, multicenter, non-inferiority trial that compares the DCB to BMS in terms of angiographically assessed target lesion binary restenosis (≥50%) at 12 months in endovascular treatment of symptomatic patients with VAOS.  Discussion:  A total of 180 patients with symptomatic VAOS who match the trial eligibility criteria will be randomized 1:1 to treatment with DCB ( n  = 90) or BMS ( n  = 90). An angiographic core laboratory-adjudicated target lesion binary restenosis (≥50%) at 12 months of follow-up was selected as primary efficacy endpoint to assess the DCB treatment effect. A clinical events committee will assess the safety endpoints of all-cause death, target vessel related transient ischemic attack and ischemic or hemorrhagic stroke events. A data safety monitoring board will periodically review safety data for subject safety, the study conduct, and progress. In this trial, randomization is only allowed after successful pre-dilatation. We anticipate that this trial will provide rigorous data to clarify whether DCBs are beneficial in patients with symptomatic VAOS.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT03910166.",2020,Drug-coated balloon (DCB) has been proven to reduce the rate of restenosis in peripheral and coronary artery disease.,"['patients with symptomatic VAOS', 'Symptomatic Vertebral Artery Origin Stenosis Patients', '180 patients with symptomatic VAOS who match the trial eligibility criteria', 'symptomatic patients with VAOS', 'refractory symptomatic patients with vertebral artery origin stenosis (VAOS']","['DCB', 'Paclitaxel Coated Balloon vs. Bare Metal Stent', ':  Stenting treatment', 'DCB and bare metal stent (BMS', 'Drug-coated balloon (DCB', 'BMS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]",[],180.0,0.255017,Drug-coated balloon (DCB) has been proven to reduce the rate of restenosis in peripheral and coronary artery disease.,"[{'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.579238']
1181,33584485,Defensive Functioning Moderates the Effects of Nondirective Meditation.,"We have recently found that nondirective meditation facilitates stress reduction. This supplementary study investigated whether defensive functioning would moderate these beneficial effects. We explored the occurrence of defense mechanisms and the impact of defensive functioning on the outcome of companies' stress management programs regarding worries nervousness, mental distress, sleep problems, and muscle pain. The sample was a population of active, working professionals recruited from Norwegian companies ( n  = 105). The intervention group obtained significant benefits on all outcome measures, but there were no effects in the control group. We analyzed defensive functioning with the self-report questionnaire, Life Style Index, at four time points. The healthy adults who participated had a low level of defense scores at the outset. There was a significant reduction in the level of defenses in both groups over the study period, 6 months. Defensive functioning significantly moderated the change of the outcome measures from baseline to follow-up in the intervention group, but not in the control group.",2021,"Defensive functioning significantly moderated the change of the outcome measures from baseline to follow-up in the intervention group, but not in the control group.","['healthy adults who participated had a low level of defense scores at the outset', 'sample was a population of active, working professionals recruited from Norwegian companies ( n  = 105']","['Nondirective Meditation', 'nondirective meditation']","['level of defenses', 'worries nervousness, mental distress, sleep problems, and muscle pain']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C4319547', 'cui_str': '105'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0235109', 'cui_str': 'Mental distress'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",,0.0403798,"Defensive functioning significantly moderated the change of the outcome measures from baseline to follow-up in the intervention group, but not in the control group.","[{'ForeName': 'Anne Grete', 'Initials': 'AG', 'LastName': 'Hersoug', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Wærsted', 'Affiliation': 'National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.629784']
1182,33584484,Does Social Exclusion Improve Detection of Real and Fake Smiles? A Replication Study.,"Research on social exclusion suggests an increased attention of excluded persons to subtle social cues. In one study ( N  = 32), published in  Psychological Science , Bernstein et al. (2008) provided evidence for this idea by showing that participants in the social exclusion condition were better in correctly categorizing a target person's smile as real or fake. Although highly cited, this finding has never been directly replicated. The present study aimed to fill that gap. 201 participants (79.1% female) were randomly assigned to a social exclusion, social inclusion or control condition. Next, participants watched 20 videos of smiling persons and rated whether they show a real or a fake smile. In line with the original study, results showed that participants in the exclusion condition performed better than in the control condition. However, the performance did not differ between the exclusion and inclusion condition-although the pattern was in the predicted direction. In sum, the findings of our study increase rather than decrease confidence in the validity of the investigated idea, but results point to a substantially smaller effect.",2021,"However, the performance did not differ between the exclusion and inclusion condition-although the pattern was in the predicted direction.",['201 participants (79.1% female'],"['social exclusion, social inclusion or control condition']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],,0.0286204,"However, the performance did not differ between the exclusion and inclusion condition-although the pattern was in the predicted direction.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schindler', 'Affiliation': 'Department of Psychology, University of Kassel, Kassel, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Trede', 'Affiliation': 'Department of Psychology, University of Kassel, Kassel, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.626087']
1183,33584480,Effects of a Coordinative Ability Training Program on Adolescents' Cognitive Functioning.,"The purpose of this randomized controlled study was to investigate the effects of a 12-week coordinative ability training program on adolescents' cognitive functioning, using evaluation tests of visuospatial perception, attention, and working memory. We randomly assigned 60 public school students (14-15 years) to either an experimental coordinative abilities training (∼40 min twice/week) group ( n  = 30) or a control group ( n  = 30) who received general psycho-physical wellness training (∼40 min., twice a week). At baseline and after training we used two standardized motor tests and a single cognitive measure (Corsi's Block-tapping test) to assess students' visuospatial perception, attention, and working memory. We found a significant Time x Group interaction for the Throwing and Catching Test and Corsi's Block-Tapping test, reflecting a meaningful experimental group improvement ( p  < 0.001), and there were no significant pre-post changes found in the control group. Thus, a 12-week program of coordinative abilities was able to improve not only coordination skills but aspects of cognitive functioning relevant to academic achievement.",2021,"We found a significant Time x Group interaction for the Throwing and Catching Test and Corsi's Block-Tapping test, reflecting a meaningful experimental group improvement ( p  < 0.001), and there were no significant pre-post changes found in the control group.","[""Adolescents' Cognitive Functioning"", '60 public school students (14-15 years) to either an']","['coordinative ability training program', 'experimental coordinative abilities training (∼40 min twice/week) group ( n  = 30) or a control group ( n  = 30) who received general psycho-physical wellness training', 'Coordinative Ability Training Program']","['visuospatial perception, attention, and working memory', ""students' visuospatial perception, attention, and working memory"", ""adolescents' cognitive functioning"", ""significant Time x Group interaction for the Throwing and Catching Test and Corsi's Block-Tapping test""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]",60.0,0.0183176,"We found a significant Time x Group interaction for the Throwing and Catching Test and Corsi's Block-Tapping test, reflecting a meaningful experimental group improvement ( p  < 0.001), and there were no significant pre-post changes found in the control group.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Latino', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari, Bari, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Cataldi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fischetti', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari, Bari, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.620440']
1184,33584479,Ambivalent Food Craving and Psychobiological Characteristics in Individuals With Weight Suppression.,"This study investigated the effects of psychobiological characteristics of non-obese women with a high level of weight suppression (H-WS) on explicit-implicit and approach-avoidance response toward food cues, depending on hunger-satiety states. The 634 participants were divided into two groups according to their weight history. If the difference between their highest weight over the last year and their current weight (a difference sustained at least for 1 year) was more than 5%, they were assigned to the ""H-WS"" group ( N  = 25). If the difference in weight was less than 5%, they were assigned to the ""low level of weight suppression"" (L-WS) group ( N  = 29). Explicit approach and avoidance toward food were measured by self-report questionnaires. Implicit approach and avoidance toward food cues were measured using an eye-tracker. Fasting blood samples were obtained to measure fasting serum leptin levels. After this, participants consumed a standard breakfast to control the satiety level. After breakfast, explicit-implicit approach-avoidance responses were repeatedly measured at the satiety states. Self-reported body shape concerns, drive for thinness, ambivalent food craving, and bulimic behavior were also assessed. The results showed that the H-WS group had lower leptin levels, and higher body shape concerns, drive for thinness, ambivalent food craving, and bulimic behaviors compared to the L-WS group. At the explicit level, the H-WS group reported lower approach and higher avoidance to food compared to the L-WS group, regardless of hunger-satiety state. Whereas, at the implicit level, the H-WS group showed higher approach during satiety rather than during hunger states. Regardless of the hunger-satiety state, there were no significant group differences with regard to implicit avoidance between the two groups. Thus, we confirmed that a high level of avoidance toward foods was observed in the H-WS group at the explicit level but not at the implicit level. Moreover, in contrast with a high level of explicit avoidance toward palatable foods, inhibition for implicit approach toward high-calorie foods seemed to be blunted after food consumption in the H-WS group. These inconsistencies may be associated with ambivalent food craving and vulnerability to bulimic behavior among H-WS individuals.",2021,"At the explicit level, the H-WS group reported lower approach and higher avoidance to food compared to the L-WS group, regardless of hunger-satiety state.","['non-obese women with a high level of weight suppression (H-WS', '634 participants', 'Individuals With Weight Suppression']",[],"['Implicit approach and avoidance toward food cues', 'fasting serum leptin levels', 'Self-reported body shape concerns, drive for thinness, ambivalent food craving, and bulimic behavior', 'hunger-satiety state', 'lower leptin levels, and higher body shape concerns, drive for thinness, ambivalent food craving, and bulimic behaviors', 'implicit avoidance', 'Fasting blood samples']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0039870', 'cui_str': 'Thin build'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",634.0,0.0219122,"At the explicit level, the H-WS group reported lower approach and higher avoidance to food compared to the L-WS group, regardless of hunger-satiety state.","[{'ForeName': 'Mooah', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Chung-Ang University, Seoul, South Korea.'}, {'ForeName': 'Jang-Han', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Chung-Ang University, Seoul, South Korea.'}]",Frontiers in psychology,['10.3389/fpsyg.2021.619025']
1185,33584452,Impact of Adverse Childhood Events on the Psychosocial Functioning of Children Affected by Parental HIV in Rural China.,"Introduction : Children affected by parental HIV are more likely than unaffected peers to experience trauma and are at-risk for negative psychological and social outcomes. This study aimed to examine the relationship between adverse childhood events and psychosocial functioning among children affected by parental HIV.  Methods : A total of 790 children ages 6-17 from Henan, China were enrolled in a longitudinal, randomized controlled trial of a resilience-based psychosocial intervention. At baseline, children reported on numerous psychosocial factors, including trauma exposure, symptoms of anxiety and depression, and peer social functioning. We used linear regression analysis to test the direct effect of trauma exposure on peer social functioning. We then tested whether depression and anxiety symptoms served as two potential parallel mediators in the association between trauma exposure and peer social functioning.  Results : Trauma exposure was significantly associated with poor peer social functioning ( β  = -0.10,  p  = 0.005) when controlling for key covariates. When depression and anxiety symptoms were added to the model, the association between trauma exposure and peer social functioning became nonsignificant. Instead, there were significant indirect effects from trauma exposure to peer social functioning  via  depression ( β  = -0.06, 95%CI[-0.09, -0.03]) and anxiety ( β  = -0.02, 95%CI[-0.04, -0.00]).  Conclusion : This study is among the first to link trauma exposure to peer social functioning deficits for children affected by parental HIV and demonstrates that symptoms of anxiety and depression mediate this relationship. Findings underscore the need for comprehensive psychosocial support for children affected by HIV, including screening for trauma exposure and mental health disorders.",2020,Trauma exposure was significantly associated with poor peer social functioning ( β  ,"['children affected by parental HIV', '790 children ages 6-17 from Henan, China', 'Children Affected by Parental HIV in Rural China']",['resilience-based psychosocial intervention'],"['poor peer social functioning ( β', 'trauma exposure, symptoms of anxiety and depression, and peer social functioning', 'depression and anxiety symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",790.0,0.0567155,Trauma exposure was significantly associated with poor peer social functioning ( β  ,"[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Ezell', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Sayward E', 'Initials': 'SE', 'LastName': 'Harrison', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, MI, United States.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, University of South Carolina, Columbia, SC, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.617048']
1186,33584433,No Effects of Acute Psychosocial Stress on Working Memory in Older People With Type 2 Diabetes.,"Type 2 diabetes (T2D) has been considered a public health threat due to its growing prevalence, particularly in the older population. It is important to know the effects of psychosocial stress and its potential consequences for some basic cognitive processes that are important in daily life. Currently, there is very little information about how people with T2D face acute psychosocial stressors, and even less about how their response affects working memory (WM), which is essential for their functionality and independence. Our aim was to characterize the response to an acute laboratory psychosocial stressor and its effects on WM in older people with T2D. Fifty participants with T2D from 52 to 77 years old were randomly assigned to a stress (12 men and 12 women) or control (12 men and 14 women) condition. Mood and physiological (cortisol, C, and salivary alpha-amylase, sAA) responses to tasks were measured. In addition, participants completed a WM test before and after the stress or control task. Our results showed that the TSST elicited higher negative affect and greater C and sAA responses than the control task. No significant differences in WM were observed depending on the exposure to stress or the control task. Finally, participants who showed higher C and sAA responses to the stressor had lower WM performance. Our results indicate that medically treated older adults with T2D show clear, typical mood and physiological responses to an acute psychosocial stressor. Finally, the lack of acute psychosocial stress effects on WM suggests that it could be related to aging and not to this disease, at least when T2D is adequately treated.",2020,"Mood and physiological (cortisol, C, and salivary alpha-amylase, sAA) responses to tasks were measured.","['Older People With Type 2 Diabetes', 'medically treated older adults with T2D', 'older people with T2D. Fifty participants with T2D from 52 to 77 years old were randomly assigned to a stress (12 men and 12 women) or control (12 men and 14 women) condition']","['Acute Psychosocial Stress', 'TSST']","['Working Memory', 'WM', 'C and sAA responses', 'Mood and physiological (cortisol, C, and salivary alpha-amylase, sAA) responses', 'WM performance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",50.0,0.0304805,"Mood and physiological (cortisol, C, and salivary alpha-amylase, sAA) responses to tasks were measured.","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Vallejo', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology and University Institute for Research in Psychology of Human Resources, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Zapater-Fajarí', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology and University Institute for Research in Psychology of Human Resources, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Montoliu', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology and University Institute for Research in Psychology of Human Resources, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Puig-Perez', 'Affiliation': 'Department of Health Sciences, Valencian International University, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Nacher', 'Affiliation': 'Valencian (VLC) Campus Research Microcluster ""Technologies of Information and Control Applied to the Pathophysiology and Treatment of Diabetes,"" University of Valencia, Valencia, Spain.'}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Hidalgo', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology and University Institute for Research in Psychology of Human Resources, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Salvador', 'Affiliation': 'Laboratory of Social Cognitive Neuroscience, Department of Psychobiology and University Institute for Research in Psychology of Human Resources, Organizational Development and Quality of Work Life (IDOCAL), University of Valencia, Valencia, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.596584']
1187,33584422,Study Protocol for the Evaluation of Individual Psychological Interventions for Family Caregivers of Advanced Cancer Patients.,"Background:  Both anxiety and depression in family caregivers (FCs) of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST) in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.  Methods and Analysis:  A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Distress Thermometer (DT), Zarit Burden Interview (ZBI), Chinese version of the Medical Outcomes Study 12-item Short Form (C-SF-12), and Family Carer Satisfaction with Palliative Care scale (FAMCARE-2).  Dissemination:  The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations.",2020,The validity of mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST) in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.  ,"['family caregivers (FCs) of advanced cancer patients', 'Family Caregivers of Advanced Cancer Patients', 'advanced cancer patients', 'Fifty eligible FCs of advanced cancer patients', 'Cancer Hospital, Chinese Academy of Medical Sciences', 'advanced cancer patients in China']","['Individual Psychological Interventions', 'mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST', 'psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST', 'MBSR and psychological consultation guided by the NST']","['Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Distress Thermometer (DT), Zarit Burden Interview (ZBI), Chinese version of the Medical Outcomes Study 12-item Short Form (C-SF-12), and Family Carer Satisfaction with Palliative Care scale (FAMCARE-2']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0558005', 'cui_str': 'Assessment of needs'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",50.0,0.0355741,The validity of mindfulness-based stress reduction (MBSR) and psychological consultation guided by the needs assessment tool (NST) in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.  ,"[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Zou', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Cong', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Internal Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tinglin', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': 'Division of Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.587627']
1188,33584328,PET Imaging of Dopamine Neurotransmission During EEG Neurofeedback.,"Neurofeedback (NFB) is a brain-based training method that enables users to control their own cortical oscillations using real-time feedback from the electroencephalogram (EEG). Importantly, no investigations to date have directly explored the potential impact of NFB on the brain's key neuromodulatory systems. Our study's objective was to assess the capacity of NFB to induce dopamine release as revealed by positron emission tomography (PET). Thirty-two healthy volunteers were randomized to either EEG-neurofeedback (NFB) or EEG-electromyography (EMG), and scanned while performing self-regulation during a single session of dynamic PET brain imaging using the high affinity D 2/3  receptor radiotracer, [ 18 F]Fallypride. NFB and EMG groups down-regulated cortical alpha power and facial muscle tone, respectively. Task-induced effects on endogenous dopamine release were estimated in the frontal cortex, anterior cingulate cortex, and thalamus, using the linearized simplified reference region model (LSRRM), which accounts for time-dependent changes in radiotracer binding following task initiation. Contrary to our hypothesis of a differential effect for NFB vs. EMG training, significant dopamine release was observed in both training groups in the frontal and anterior cingulate cortex, but not in thalamus. Interestingly, a significant negative correlation was observed between dopamine release in frontal cortex and  pre-to-post  NFB change in spontaneous alpha power, suggesting that intra-individual changes in brain state (i.e., alpha power) could partly result from changes in neuromodulatory tone. Overall, our findings constitute the first direct investigation of neurofeedback's effect on the endogenous release of a key neuromodulator, demonstrating its feasibility and paving the way for future studies using this methodology.",2020,"NFB and EMG groups down-regulated cortical alpha power and facial muscle tone, respectively.",['Thirty-two healthy volunteers'],"['PET Imaging of Dopamine Neurotransmission', 'EEG-neurofeedback (NFB) or EEG-electromyography (EMG), and scanned while performing self-regulation', 'Neurofeedback (NFB']","['endogenous dopamine release', 'dopamine release']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0027793', 'cui_str': 'Synaptic transmission'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",32.0,0.0258551,"NFB and EMG groups down-regulated cortical alpha power and facial muscle tone, respectively.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ros', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kwiek', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Andriot', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Abele', 'Initials': 'A', 'LastName': 'Michela', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Vuilleumier', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Garibotto', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Medical Imaging, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Ginovart', 'Affiliation': 'Department of Basic Neurosciences, University of Geneva, Geneva, Switzerland.'}]",Frontiers in physiology,['10.3389/fphys.2020.590503']
1189,33584327,Neuromuscular Adaptations and Enhancement of Physical Performance in Female Basketball Players After 8 Weeks of Plyometric Training.,"The aim of this study was to examine the effects of an 8-week in-season plyometric training (PT) program on the physical performance and neuromuscular adaptations of female basketball players. Twenty-seven elite female basketball players (aged 21.0 ± 2.6 years) were assigned between an experimental group ( n  = 15) who substituted a part of their usual training with biweekly PT, and a control group ( n  = 12) who maintained their standard basketball training. Analyses of variance and co-variance assessed changes in 10, 20, and 30 m sprint times, ability to change direction ( T -test) and jumping ability [squat jump (SJ) and countermovement jump (CMJ)] with electromyographic assessment of the vastus lateralis, vastus medialis, and rectus femoris muscles during jumping and meassurement of the isokinetic strength of the knee muscles. After 8 weeks of the plyometric program the experimental group enhanced change of direction performance (Δ = -3.90%,  d  = 0.67) and showed a greater thigh cross sectional area (Δ = 9.89%,  d  = 0.95) relative to controls. Neural adaptations included significant improvements of EMG parameters for the vastus medialis muscle during Squat Jumping (Δ = 109.3%,  d  = 0.59). However, trends to improvements of sprinting times and jumping performances did not reach statistical significance. In addition, there were no gains in the peak torque and the average power of the quadriceps and hamstring muscles at either slow or moderate test speeds. We conclude that 8-weeks of PT (72-126 jumps) was insufficient to improve many of the variables associated with basketball performance in our subject-group. Further studies of female basketball players, extending the program period and increasing the intensity and speed of jumps are recommended in the search for more significant results.",2020,"In addition, there were no gains in the peak torque and the average power of the quadriceps and hamstring muscles at either slow or moderate test speeds.","['Twenty-seven elite female basketball players (aged 21.0 ± 2.6 years', 'female basketball players', 'Female Basketball Players']","['substituted a part of their usual training with biweekly PT, and a control group ( n  = 12) who maintained their standard basketball training', 'season plyometric training (PT) program', 'Plyometric Training']","['greater thigh cross sectional area', '30 m sprint times, ability to change direction ( T -test) and jumping ability [squat jump (SJ) and countermovement jump (CMJ)] with electromyographic assessment of the vastus lateralis, vastus medialis, and rectus femoris muscles during jumping and meassurement of the isokinetic strength of the knee muscles', 'direction performance', 'peak torque and the average power of the quadriceps and hamstring muscles', 'EMG parameters for the vastus medialis muscle during Squat Jumping']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0126378,"In addition, there were no gains in the peak torque and the average power of the quadriceps and hamstring muscles at either slow or moderate test speeds.","[{'ForeName': 'Yosser', 'Initials': 'Y', 'LastName': 'Cherni', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"", Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", Tunis, Tunisia.'}, {'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"", Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", Tunis, Tunisia.'}, {'ForeName': 'Mohamed Chedly', 'Initials': 'MC', 'LastName': 'Jelid', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"", Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", Tunis, Tunisia.'}, {'ForeName': 'Ghaith', 'Initials': 'G', 'LastName': 'Aloui', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"", Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", Tunis, Tunisia.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Japan.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'Research Unit (UR17JS01) ""Sport Performance, Health & Society"", Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba"", Tunis, Tunisia.'}]",Frontiers in physiology,['10.3389/fphys.2020.588787']
1190,33584289,A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza ® ) in Healthy Male Subjects.,"Objective:  Pharmacokinetic (PK) similarity between biosimilar candidate LRG201902 and European Union-sourced liraglutide reference product (Victoza ® ) was evaluated. Safety and immunogenicity were also assessed.  Methods:  This single-dose, randomized, open-label, 2-period crossover study (CTR20192342) was conducted in thirty-eight healthy adult male subjects. Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza ®  or LRG201902 by subcutaneous injection during the first period. Following 8 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration. The primary pharmacokinetic endpoints were AUC 0-t , AUC 0-∞ , and C max . Pharmacokinetic similarity was achieved if 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0-t, AUC 0-∞ , and C max  were within the range of 80-125%. Other pharmacokinetic parameters including T max , t ½ , and λ z  were also measured. Safety profile and immunogenicity data were collected from each subject.  Results:  C max , AUC 0-t , and AUC 0-∞  were similar between the two groups. GMRs of Cmax, AUC 0-t , and AUC 0-∞  were 113.50%, 107.21%, and 106.97% between LRG201902 and Victoza ®  respectively. The 90% CIs for the GMRs of C max , AUC 0-t , and AUC 0-∞  were all within the PK equivalence criteria. Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T max , t ½ , and λ z ) were comparable between groups. Treatment-related adverse events were reported by 27.8% and 23.7% subjects in the LRG201902 and Victoza ®  arms, respectively. All post-dose samples were detected negative for anti-drug antibodies.  Conclusion:  This study demonstrates pharmacokinetic similarity of LRG201902 to Victoza ®  in healthy subjects. The safety and immunogenicity profiles were similar for the two products.",2020,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T max , t ½ , and λ z ) were comparable between groups.","['healthy subjects', 'Healthy Male Subjects', 'thirty-eight healthy adult male subjects']","['Liraglutide (Victoza ® ', 'Potential Biosimilar LRG201902', 'Victoza ®  or LRG201902']","['Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T max , t ½ , and λ z ', 'safety and immunogenicity profiles', 'Results:  C max , AUC 0-t , and AUC 0-∞', 'GMRs of C max , AUC 0-t , and AUC 0-∞', 'geometric mean ratios (GMRs) of AUC0-t, AUC 0-∞ , and C max', 'AUC 0-t , AUC 0-∞ , and C max ', 'Safety and immunogenicity', 'Safety profile and immunogenicity data', 'GMRs of Cmax, AUC 0-t , and AUC 0-∞', 'Pharmacokinetic similarity', 'adverse events', 'T max , t ½ , and λ z', 'Blood samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C2732208', 'cui_str': 'Victoza'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",38.0,0.0285879,"Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T max , t ½ , and λ z ) were comparable between groups.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Mai', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Mupeng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Gan', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Shentu', 'Affiliation': ""Phase 1 Clinical Trial Center, People's Hospital of Deyang City, Deyang, China.""}]",Frontiers in pharmacology,['10.3389/fphar.2020.610880']
1191,33584232,The Effects of Priming Intermittent Theta Burst Stimulation on Movement-Related and Mirror Visual Feedback-Induced Sensorimotor Desynchronization.,"The potential benefits of priming intermittent theta burst stimulation (iTBS) with continuous theta burst stimulation (cTBS) have not been examined in regard to sensorimotor oscillatory activities recorded in electroencephalography (EEG). The objective of this study was to investigate the modulatory effect of priming iTBS (cTBS followed by iTBS) delivered to the motor cortex on movement-related and mirror visual feedback (MVF)-induced sensorimotor event-related desynchronization (ERD), compared with iTBS alone, on healthy adults. Twenty participants were randomly allocated into Group 1: priming iTBS-cTBS followed by iTBS, and Group 2: non-priming iTBS-sham cTBS followed by iTBS. The stimulation was delivered to the right primary motor cortex daily for 4 consecutive days. EEG was measured before and after 4 sessions of stimulation. Movement-related ERD was evaluated during left-index finger tapping and MVF-induced sensorimotor ERD was evaluated by comparing the difference between right-index finger tapping with and without MVF. After stimulation, both protocols increased movement-related ERD and MVF-induced sensorimotor ERD in high mu and low beta bands, indicated by significant time effects. A significant interaction effect favoring Group 1 in enhancing movement-related ERD was observed in the high mu band [ F   (1,18)  = 4.47,  p  = 0.049], compared with Group 2. Our experiment suggests that among healthy adults priming iTBS with cTBS delivered to the motor cortex yields similar effects with iTBS alone on enhancing ERD induced by MVF-based observation, while movement-related ERD was more enhanced in the priming iTBS condition, specifically in the high mu band.",2021,"After stimulation, both protocols increased movement-related ERD and MVF-induced sensorimotor ERD in high mu and low beta bands, indicated by significant time effects.","['Twenty participants', 'healthy adults']","['priming iTBS (cTBS followed by iTBS', 'iTBS alone', 'Priming Intermittent Theta Burst Stimulation', 'iTBS-cTBS followed by iTBS, and Group 2: non-priming iTBS-sham cTBS followed by iTBS', 'priming intermittent theta burst stimulation (iTBS) with continuous theta burst stimulation (cTBS', 'iTBS']","['Movement-Related and Mirror Visual Feedback-Induced Sensorimotor Desynchronization', 'enhancing movement-related ERD', 'EEG', 'movement-related ERD and MVF-induced sensorimotor ERD']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",20.0,0.0267532,"After stimulation, both protocols increased movement-related ERD and MVF-induced sensorimotor ERD in high mu and low beta bands, indicated by significant time effects.","[{'ForeName': 'Jack Jiaqi', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Kenneth N K', 'Initials': 'KNK', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2021.626887']
1192,33584074,Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean ® ) with a polyethylene glycol/bisacodyl kit.,"BACKGROUND


Efficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.
AIM


To compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean ® ) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax ® ) under identical dietary recommendations.
METHODS


This multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean ®  = 222 and Klean-Prep/Dulcolax ®  = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.
RESULTS


Success rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% ( n  = 205) and 97.6% ( n  = 204) in the Quiklean ®  and Klean-Prep/Dulcolax ®  groups, respectively. Quiklean ®  demonstrated noninferiority over Klean-Prep/Dulcolax ®  in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0%  vs  17.2%;  P  = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1%  vs  13.4%;  P  < 0.0001) than Klean-Prep/Dulcolax ® . Safety profiles did not differ between the two groups. Our data indicate that Quiklean ®  is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax ® .
CONCLUSION


Quiklean ®  is sodium phosphate tablets available on Taiwan's market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.",2021,Quiklean ®  demonstrated noninferiority over Klean-Prep/Dulcolax ®  in colon cleansing efficacy.,"['472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean ®  = 222 and Klean-Prep/Dulcolax ®  = 220']","['sodium phosphate tablets (Quiklean ® ', '32-tablet sodium phosphate (Quiklean ® ) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax ® ', 'sodium phosphate tablets', 'polyethylene glycol/bisacodyl kit']","['bowel cleansing quality by Aronchick Scale', 'bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events', 'Safety profiles', 'tolerability and acceptability', 'bowel cleansing quality using the Aronchick Scale']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0674963', 'cui_str': 'klean prep'}, {'cui': 'C0591416', 'cui_str': 'Dulco-Lax'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0591416', 'cui_str': 'Dulco-Lax'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",472.0,0.0597772,Quiklean ®  demonstrated noninferiority over Klean-Prep/Dulcolax ®  in colon cleansing efficacy.,"[{'ForeName': 'Shih-Ya', 'Initials': 'SY', 'LastName': 'Hung', 'Affiliation': 'Graduate Institute of Acupuncture Science, China Medical University, Taichung 40402, Taiwan.'}, {'ForeName': 'Hung-Chang', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Tao-Wei', 'Initials': 'TW', 'LastName': 'Ke', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Jiann-Hwa', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan.'}, {'ForeName': 'Koung-Hung', 'Initials': 'KH', 'LastName': 'Hsiao', 'Affiliation': 'Division of Colorectal Surgery, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan.'}, {'ForeName': 'Hwei-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Hua-Che', 'Initials': 'HC', 'LastName': 'Chiang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Sheng-Chi', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Yi-Chang', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Ming-Hao', 'Initials': 'MH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Yuan-Yao', 'Initials': 'YY', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'Yo-Wen', 'Initials': 'YW', 'LastName': 'Hsieh', 'Affiliation': 'Department of Pharmacy, China Medical University Hospital, Taichung 40447, Taiwan.'}, {'ForeName': 'William Tzu-Liang', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, China Medical University Hsinchu Hospital, Zhubei 30272, Taiwan. wtchen@mail.cmuh.org.tw.'}]",World journal of gastroenterology,['10.3748/wjg.v27.i5.428']
1193,33584067,Effect of remote ischemic preconditioning among donors and recipients following pediatric liver transplantation: A randomized clinical trial.,"BACKGROUND


Studies suggested that remote ischemic preconditioning (RIPC) may effectively lessen the harmful effects of ischemia reperfusion injury during organ transplantation surgery.
AIM


To investigate the protective effects of RIPC on living liver donors and recipients following pediatric liver transplantation.
METHODS


From January 2016 to January 2019 at Renji Hospital Affiliated with Shanghai Jiao Tong University School of Medicine, 208 donors were recruited and randomly assigned to four groups: S-RIPC group (no intervention;  n  = 55), D-RIPC group (donors received RIPC;  n  = 51), R-RIPC group (recipients received RIPC,  n  = 51) and DR-RIPC group (both donors and recipients received RIPC;  n  = 51). We primarily evaluated postoperative liver function among donors and recipients and incidences of early allograft dysfunction, primary nonfunction and postoperative complications among recipients.
RESULTS


RIPC did not significantly improve alanine transaminase and aspartate aminotransferase levels among donors and recipients or decrease the incidences of early allograft dysfunction, primary nonfunction, and postoperative complications among recipients. Limited protective effects were observed, including a lower creatinine level in the D-RIPC group than in the S-RIPC group on postoperative day 0 ( P  < 0.05). However, no significant improvements were found in donors who received RIPC. Furthermore, RIPC had no effects on the overall survival of recipients.
CONCLUSION


The protective effects of RIPC were limited for recipients who received living liver transplantation, and no significant improvement of the prognosis was observed in recipients.",2021,"The protective effects of RIPC were limited for recipients who received living liver transplantation, and no significant improvement of the prognosis was observed in recipients.","['From January 2016 to January 2019 at Renji Hospital Affiliated with Shanghai Jiao Tong University School of Medicine, 208 donors', 'donors and recipients and incidences of early allograft dysfunction, primary nonfunction and postoperative complications among recipients', 'living liver donors and recipients following pediatric liver transplantation', 'donors and recipients following pediatric liver transplantation']","['remote ischemic preconditioning (RIPC', 'remote ischemic preconditioning', 'S-RIPC group (no intervention;  n  = 55), D-RIPC group (donors received RIPC;  n  = 51), R-RIPC group (recipients received RIPC,  n  = 51) and DR-RIPC group (both donors and recipients received RIPC', 'RIPC']","['postoperative liver function', 'lower creatinine level', 'alanine transaminase and aspartate aminotransferase levels', 'incidences of early allograft dysfunction, primary nonfunction, and postoperative complications', 'overall survival']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0239150', 'cui_str': 'Creatinine low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0836535,"The protective effects of RIPC were limited for recipients who received living liver transplantation, and no significant improvement of the prognosis was observed in recipients.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Xiao-Qiang', 'Initials': 'XQ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Pan', 'Affiliation': 'Clinical Center for Investigation, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Pei-Ying', 'Initials': 'PY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Ling-Ke', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Transplantation and Hepatic Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200120, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Wei-Feng', 'Initials': 'WF', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China. ywf808@yeah.net.'}]",World journal of gastroenterology,['10.3748/wjg.v27.i4.345']
1194,33584054,Clinical Post-operative Bleeding During Minor Oral Surgical Procedure and In Vitro Platelet Aggregation in Patients on Aspirin Therapy: Are they Coherent?,"Aim


The risk of excessive bleeding prompts physicians to discontinue aspirin in patients on low-dose, long-term therapy which in turn puts them at the risk from adverse cardiovascular and thrombotic events. Effect of low-dose aspirin therapy on platelet function was assessed using platelet aggregation method. The aim was to correlate the laboratory platelet function with cutaneous and clinical oral bleeding time (BT).
Materials and Methods


One hundred one patients were enrolled in this prospective trial and were allocated into two groups. Interventional or test group consisted of patients who were on aspirin therapy (75 mg/100 mg) for primary or secondary prevention of angina, myocardial infarction and stroke. Minor oral surgical procedure was performed in this group without discontinuing aspirin therapy. Control group consisted of healthy patients (under no medication) undergoing minor oral surgical procedure. Cutaneous and clinical oral BT were recorded in both the groups. Venous blood sample was drawn, and percentage platelet aggregation function was analysed using adenosine diphosphate (ADP) and arachidonic acid (AA) reagents. The percentage of platelet aggregation was then correlated with cutaneous and clinical oral BT.
Results


A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed. However, there were no significant difference in mean cutaneous BT (aspirin-1.5 0.65 min; control-1.6 0.71 min) and clinical oral BT (aspirin-5.0 2.48 min; control-4.8 2.60 min) in aspirin and control groups.
Conclusion


Majority of the minor oral surgical procedures can be carried out safely without discontinuing aspirin in patients on low-dose long-term therapy. This is possible because despite significant platelet aggregation evident in laboratory evaluation there is lack of its clinical corroboration owing to aspirin resistance.
Clinical Trial Registration


CTRI/2018/02/012055.",2021,A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed.,"['Patients on', 'One hundred one patients']","['Aspirin Therapy', 'healthy patients (under no medication) undergoing minor oral surgical procedure', 'low-dose aspirin therapy', 'aspirin', 'aspirin therapy', 'discontinue aspirin']","['laboratory platelet function with cutaneous and clinical oral bleeding time (BT', 'platelet function', 'percentage of platelet aggregation', 'mean cutaneous BT', 'percentage platelet aggregation', 'Cutaneous and clinical oral BT', 'adenosine diphosphate (ADP) and arachidonic acid (AA) reagents']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0524861', 'cui_str': 'Oral surgery'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0034760', 'cui_str': 'Reagents'}]",101.0,0.0221892,A significant decrease in percentage platelet aggregation using ADP (aspirin-74.7 21.39; control-89.2 13.70) and AA (aspirin-47.6 23.11; control-82.3 20.17) was observed.,"[{'ForeName': 'Surjit', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Saptarshi', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': 'Department of Transfusion Medicine, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Ankita', 'Initials': 'A', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Deora', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Md Atik', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Department of Transfusion Medicine, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}, {'ForeName': 'Vinay Kumar', 'Initials': 'VK', 'LastName': 'Chugh', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Jodhpur, Jodhpur, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01438-4']
1195,33584049,"Body Weight Loss After Orthognathic Surgery: Comparison Between Postoperative Intermaxillary Fixation with Metal Wire and Elastic Traction, Factors Related to Body Weight Loss.","Introduction


The aim of this study was to compare body weight loss between postoperative intermaxillary fixation with metal wire and elastic traction and to investigate factors related to body weight loss after orthognathic surgery.
Materials and methods


Subjects were 59 patients with dentofacial deformity, comprising 31 patients treated with intermaxillary fixation (IMF) and 28 patients treated with elastic traction without IMF (ELT) just after surgery. Body weight loss was measured at 1 week (T1) and 2 weeks (T2) after surgery. Body weight loss was compared between IMF and ELT, and factors related to body weight loss were statistically analyzed.
Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference. Body weight loss ratio was significantly increased at T2 compared to T1 in both groups. Body weight loss was significantly greater at T2 than at T1.
Conclusion


Both IMF and ELT cause body weight loss after orthognathic surgery, but IMF causes body weight loss earlier than ELT and increased early body weight loss increases continuous body weight loss after orthognathic surgery.",2021,"Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference.","['59 patients with dentofacial deformity, comprising 31 patients treated with']","['postoperative intermaxillary fixation with metal wire and elastic traction', 'Postoperative Intermaxillary Fixation with Metal Wire and Elastic Traction', 'elastic traction without IMF (ELT', 'intermaxillary fixation (IMF']","['body weight loss', 'Body weight loss', 'Body weight loss ratio', 'Body Weight Loss', 'IMF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494419', 'cui_str': 'Dentofacial Deformities'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",59.0,0.014282,"Results


Body weight loss ratio was significantly increased in IMF (2.6%) rather than in ELT (1.4%) at T1, but only tended to be increased in both groups at T2, showing no statistical difference.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ooi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641 Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Gerodontology, Department of Oral Health Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mikoya', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kawashiri', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641 Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tei', 'Affiliation': 'Oral and Maxillofacial Surgery, Department of Oral Patho-biological Science, Graduate School of Dental Medicine, Hokkaido University, Kita 13 Nishi 7 Kita-ku, Sapporo, Hokkaido 060-8586 Japan.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01318-6']
1196,33584044,"Comparison of Safety, Efficacy, Patient Compliance and Cost-Effectiveness of Transdermal, Oral and Intramuscular Diclofenac for Pain Control Following Oral Surgical Procedures.","Purpose


To evaluate transdermal diclofenac in terms of analgesic efficacy, safety, compliance and cost-effectiveness and to compare it with oral tablets and intramuscular (IM) injections following surgical removal of impacted mandibular third molars.
Subjects and Methods


A prospective, single-centre, multi-arm parallel, randomized study on subjects undergoing extraction of impacted mandibular third molars was conducted between January 2016 and December 2017. The study included 90 participants, 30 in each group. Participants received the standard once daily (OD) dosages of diclofenac in each group for three post-operative days and were advised to consume paracetamol 500 mg as rescue analgesics if the pain was not alleviated. Outcome measures such as demographics, duration of surgery, post-operative pain, the number of rescue analgesics taken, adverse drug reactions experienced and overall global assessment for three post-operative days were recorded by the participants on a questionnaire.
Results


Transdermal and oral forms achieved similar analgesia on all 3 days. Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac. A higher number of rescue analgesics was consumed in oral group on day 1. Gastritis and vomiting were seen in 36.66% and 10% cases, respectively, in oral group. 100% of those in IM group had pain on injection. 6.6% complained of dry skin due to patch, while 3.33% had rash and pruritus. Transdermal group had better overall global assessment by patients with 16.67%, 46.67% and 20% participants reporting excellent, very good and good pain control, respectively. The cost in INR was maximum for the transdermal group.
Conclusion


Transdermal diclofenac is an excellent alternative to oral and parenteral routes of drug administration in oral surgical procedures with adequate analgesic efficacy, good compliance and fewer side effects.",2021,Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac.,"['Pain Control Following Oral Surgical Procedures', 'surgical removal of impacted mandibular third molars', '90 participants, 30 in each group', 'subjects undergoing extraction of impacted mandibular third molars was conducted between January 2016 and December 2017']","['diclofenac', 'Injectable diclofenac', 'oral tablets and intramuscular (IM) injections', 'Transdermal, Oral and Intramuscular Diclofenac', 'paracetamol', 'transdermal diclofenac', 'Transdermal diclofenac']","['pain on injection', 'Gastritis and vomiting', 'overall global assessment', 'demographics, duration of surgery, post-operative pain, the number of rescue analgesics taken, adverse drug reactions experienced and overall global assessment for three post-operative days', 'cost in INR', 'analgesic efficacy, safety, compliance and cost-effectiveness', 'pain control', 'rash and pruritus', 'Safety, Efficacy, Patient Compliance and Cost-Effectiveness']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0524861', 'cui_str': 'Oral surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0993159', 'cui_str': 'Oral tablet'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}]",90.0,0.0424232,Injectable diclofenac had significantly better pain control on the second and third post-operative days compared to tablets and on the third day compared to transdermal diclofenac.,"[{'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Samal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Brundabati', 'Initials': 'B', 'LastName': 'Meher', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Indu Bhusan', 'Initials': 'IB', 'LastName': 'Kar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'Rosalin', 'Initials': 'R', 'LastName': 'Kar', 'Affiliation': 'Department of Prosthetic Dentistry, SCB Dental College and Hospital, Cuttack, Odisha India.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Saipooja', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SCB Dental College and Hospital, Cuttack, Odisha India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01260-7']
1197,33584043,Abdominal Dermis-Fat Graft Versus Conventional Temporalis Myofascial Flap Interposition in Temporomandibular Joint Ankylosis: A Prospective Clinical Comparative Study.,"Introduction


Temporomandibular joint (TMJ) ankylosis is an extremely disabling condition with almost complete inability to open the jaws causing difficulty in chewing, speech, poor oral hygiene and cosmetic disfigurement. Temporalis myofascial flap still remains the most common interpositional material used; however, patients usually complain of pain during movement, unesthetic bulging in the temporal region and trismus due to scar contracture. The main aim of the study was to evaluate the efficacy of abdominal dermis-fat graft and compare it with temporalis myofascial flap as to see which of the two grafts offers more advantages and provides better postoperative results following TMJ ankylosis surgery.
Materials and Methods


A total of 30 diagnosed cases of TMJ ankylosis were randomly divided into two groups of 15 patients each. All the patients underwent TMJ ankylosis release under general anesthesia followed by abdominal dermis-fat interposition in Group A and temporalis muscle in Group B. The patients were assessed for pre-operative and postoperative mouth opening (immediate and 6 month postoperative), pain during physiotherapy, donor and surgical site complications and recurrence of ankylosis.
Results


The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001). Physiotherapy was less painful in dermis-fat group than in temporalis group, and the differences in VAS scores among the 2 groups showed high statistical significance ( p  < 0.001). Hypertrophic scar developed at the donor site in 2 patients in dermis-fat group; however, it was located below the beltline and hardly noticeable. A total of 9 patients (4 in Group A and 5 in Group B) developed temporary facial nerve weakness, and no case of re-ankylosis was noted in either group.
Conclusion


Dermis-fat graft in temporomandibular joint ankylosis showed better results than conventional temporalis myofascial flap in terms of postoperative mouth opening, physiotherapy and jaw function with esthetically acceptable results.",2021,"The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001).","['Temporomandibular Joint Ankylosis', '30 diagnosed cases of TMJ ankylosis']","['Conventional Temporalis Myofascial Flap Interposition', 'abdominal dermis-fat graft', 'conventional temporalis myofascial flap', 'Abdominal Dermis-Fat Graft', 'TMJ ankylosis release under general anesthesia followed by abdominal dermis-fat interposition in Group A and temporalis muscle in Group B']","['temporary facial nerve weakness', 'pre-operative and postoperative mouth opening (immediate and 6\xa0month postoperative), pain during physiotherapy, donor and surgical site complications and recurrence of ankylosis', 'mean maximum inter-incisal opening', 'Hypertrophic scar', 'VAS scores']","[{'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0388244,"The mean maximum inter-incisal opening in dermis-fat group was significantly higher than temporalis group both at immediate and 6 month postoperative periods ( p  = 0.041, 0.001).","[{'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Younis', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Elite Mission Hospital, Thrissur, Kerala India.'}, {'ForeName': 'Ajaz Ahmed', 'Initials': 'AA', 'LastName': 'Shah', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Muneet', 'Initials': 'M', 'LastName': 'Kapoor', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital Srinagar, Srinagar, Jammu and Kashmir India.'}, {'ForeName': 'Abina', 'Initials': 'A', 'LastName': 'Rashid', 'Affiliation': 'SKIMS Medical College and Hospital, Srinagar, Jammu and Kashmir India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01455-3']
1198,33583887,Effects of Isometric Handgrip Training on Home Blood Pressure Measurements in Hypertensive Patients: A Randomized Crossover Study.,"Objective We aimed to examine the effects of isometric handgrip (IHG) training on home blood pressure (BP) levels in hypertensive Japanese patients undergoing treatment. Methods Fifty-three hypertensive patients (mean age, 61.7 years; 56.6% men) with a home systolic BP ≥135 mmHg and/or a home diastolic BP ≥85 mmHg were randomly assigned to either group A or B. As per the crossover design, group A performed 8 weeks of IHG training, followed by an equivalent training-free, control period, while the reverse protocol was performed by group B. The baseline characteristics were similar between both groups. The individualized daily IHG training comprised four sets of 2-min isometric contractions at 30% of the individual's maximum voluntary contraction capacity, including 1 min of rest between sets, for ≥3 days/week. The outcome measure was morning and evening home BP readings taken over the last 2 weeks of the training and control periods. Results A combined data analysis for both groups showed that IHG training was significantly associated with the lowering of both systolic and diastolic BP in the morning (137.9±9.3 vs. 135.3±9.5 mmHg, p=0.007 and 83.0±9.5 vs. 81.2±9.3 mmHg, p<0.001, respectively) and evening (130.0±10.7 vs. 127.6±10.1 mmHg, p=0.003 and 75.8±10.4 vs. 73.8±9.2 mmHg, p<0.001, respectively), while no significant change was observed after the control period. A larger increase in the maximum grip strength due to IHG training was associated with greater BP reductions. Conclusion An 8-week period of IHG training significantly lowered both the morning and evening home BP in hypertensive Japanese patients undergoing treatment.",2021,"A combined data analysis for both groups showed that IHG training was significantly associated with the lowering of both systolic and diastolic BP in the morning (137.9±9.3 vs. 135.3±9.5 mmHg, p=0.007 and 83.0±9.5 vs. 81.2±9.3 mmHg, p<0.001, respectively) and evening (130.0±10.7 vs. 127.6±10.1","['Methods Fifty-three hypertensive patients (mean age, 61.7 years; 56.6% men) with a home systolic BP ≥135 mmHg', 'and/or a home diastolic BP ≥85 mmHg', 'Hypertensive Patients', 'hypertensive Japanese patients undergoing treatment']","['IHG training, followed by an equivalent training-free, control period, while the reverse protocol was performed by group B', 'Isometric Handgrip Training', 'isometric handgrip (IHG) training', 'IHG training']","['morning and evening home BP readings taken', 'BP reductions', 'lowering of both systolic and diastolic BP', 'maximum grip strength', 'home blood pressure (BP) levels', 'Home Blood Pressure Measurements']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",53.0,0.0281135,"A combined data analysis for both groups showed that IHG training was significantly associated with the lowering of both systolic and diastolic BP in the morning (137.9±9.3 vs. 135.3±9.5 mmHg, p=0.007 and 83.0±9.5 vs. 81.2±9.3 mmHg, p<0.001, respectively) and evening (130.0±10.7 vs. 127.6±10.1","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nemoto', 'Affiliation': 'Research Center for the Promotion of Health and Employment Support, Tohoku Rosai Hospital, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Research Center for the Promotion of Health and Employment Support, Tohoku Rosai Hospital, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Research Center for the Promotion of Health and Employment Support, Tohoku Rosai Hospital, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Hattori', 'Affiliation': 'Research Center for Lifestyle-related Disease, Tohoku Rosai Hospital, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Konno', 'Affiliation': 'Research Center for Lifestyle-related Disease, Tohoku Rosai Hospital, Japan.'}, {'ForeName': 'Shigefumi', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Fukushima Rosai Hospital, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sakihara', 'Affiliation': 'Division of Diabetes and endocrinology, Aomori Rosai Hospital, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Munakata', 'Affiliation': 'Research Center for the Promotion of Health and Employment Support, Tohoku Rosai Hospital, Japan.'}]","Internal medicine (Tokyo, Japan)",['10.2169/internalmedicine.5865-20']
1199,33583877,Effects of Chewing Gum Base on Oral Hygiene and Mental Health: A Pilot Study.,"The purpose of the present study was to clarify the long-term effects of frequent chewing of unflavored and odorless gum (hereafter, gum base) on oral hygiene and mental health. This single-arm study, which started with a 4-week control and ended with a 4-week intervention period, was conducted in two phases: one in 2017 and one in 2018. The participants comprised 36 dental hygiene students (17 in 2017, 19 in 2018). During the intervention period, all participants were required to chew a piece of gum base 7 times a day for 10 min each time. The unstimulated salivary flow rate and masticatory efficiency were measured and chewing number counted. Two questionnaires －the Profile of Mood States, second edition (POMS2) and the 30-item General Health Questionnaire (GHQ-30)－ were administered to assess mental health. In both phases, the unstimulated salivary flow rate showed a significant increase after the intervention period (p<0.05). In 2017, the GHQ-30 scores and masticatory efficiency showed a tendency toward a negative correlation after the intervention period (r=－0.4647, p=0.06). In 2018, a significant negative correlation was observed between chewing number and the POMS2 scores after the intervention period (r=－0.6296, p<0.01). These findings suggest that frequent chewing of gum base increases unstimulated salivary flow rate. However, no significant change was observed in the mental health.",2021,"In 2018, a significant negative correlation was observed between chewing number and the POMS2 scores after the intervention period (r=－0.6296, p<0.01).","['Oral Hygiene and Mental Health', '36 dental hygiene students (17 in 2017, 19 in 2018']","['frequent chewing of unflavored and odorless gum (hereafter, gum base', 'Chewing Gum']","['Mood States, second edition (POMS2) and the 30-item General Health Questionnaire (GHQ-30)－', 'oral hygiene and mental health', 'unstimulated salivary flow rate and masticatory efficiency', 'mental health', 'POMS2 scores', 'GHQ-30 scores and masticatory efficiency', 'unstimulated salivary flow rate']","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C4273686', 'cui_str': '30 item General Health Questionnaire'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0175764,"In 2018, a significant negative correlation was observed between chewing number and the POMS2 scores after the intervention period (r=－0.6296, p<0.01).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takenouchi', 'Affiliation': 'Dental Hygiene Course, Shinjuku Medical Career College.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saeki', 'Affiliation': 'Central Laboratory, Lotte Co., Ltd.'}, {'ForeName': 'Etsuyo', 'Initials': 'E', 'LastName': 'Otani', 'Affiliation': 'Dental Hygiene Course, Shinjuku Medical Career College.'}, {'ForeName': 'Minji', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Central Laboratory, Lotte Co., Ltd.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Fushimi', 'Affiliation': 'Taiyo School of Dental Hygiene.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Satoh', 'Affiliation': 'Taiyo School of Dental Hygiene.'}, {'ForeName': 'Yumiko', 'Initials': 'Y', 'LastName': 'Kakegawa', 'Affiliation': 'Taiyo School of Dental Hygiene.'}, {'ForeName': 'Hiroe', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': 'Taiyo School of Dental Hygiene.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Taguchi', 'Affiliation': 'Department of Dental Hygiene, Mejiro University College.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukubo', 'Affiliation': 'Tokyo Dental College.'}]",The Bulletin of Tokyo Dental College,['10.2209/tdcpublication.2020-0009']
1200,33583799,Pharmacokinetics and vasodilating effect study of beraprost sodium in healthy volunteers.,"Currently beraprost sodium (BPS) is widely proposed to ameliorate the symptoms caused by chronic arterial occlusive disease. The objective of this study is to investigate the BPS pharmacokinetic characteristics, its vasodilating effect and the relationship between plasma concentration vs response effect. 12 healthy Chinese volunteers (6 male, 6 female) were chosen to participate in a single center, random, and open design study. After overnight fasting, BPS (dose = 40μg) was administrated orally to each volunteer. The blood samples were collected at different time points (from 0 to 5 h after administration) and BPS concentration was analyzed by LC-MS/MS method. The vasodilating effect was evaluated by detecting the skin microcirculation blood flow of volunteers' fingers with laser Doppler fluxmetry. The C max  of BPS was (601.14 ± 214.81) pg/mL, the T max  was (0.58 ± 0.48) h, and AUC0-t was (1020.41±214.63) pg/mL•h. BPS exhibited significant vasodilating effect since the skin microcirculation blood flow increased definitely at 0.25, 0.5, and 0.75 h (all p&lt;0.05) after drug administration, and a positive correlation was presented between the pharmacokinetics and the vasodilating effect, which would be beneficial for guiding BPS dosage in clinical.",2020,"BPS exhibited significant vasodilating effect since the skin microcirculation blood flow increased definitely at 0.25, 0.5, and 0.75 h (all p&lt;0.05) after drug administration, and a positive correlation was presented between the pharmacokinetics and the vasodilating effect, which would be beneficial for guiding BPS dosage in clinical.","['healthy volunteers', '12 healthy Chinese volunteers (6 male, 6 female']","['beraprost sodium', 'laser Doppler fluxmetry', 'beraprost sodium (BPS']","['BPS pharmacokinetic characteristics', 'blood samples', 'BPS concentration', 'skin microcirculation blood flow', 'C max  of BPS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0526064', 'cui_str': 'beraprost sodium'}, {'cui': 'C0430489', 'cui_str': 'Laser doppler'}]","[{'cui': 'C0526064', 'cui_str': 'beraprost sodium'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",12.0,0.0172731,"BPS exhibited significant vasodilating effect since the skin microcirculation blood flow increased definitely at 0.25, 0.5, and 0.75 h (all p&lt;0.05) after drug administration, and a positive correlation was presented between the pharmacokinetics and the vasodilating effect, which would be beneficial for guiding BPS dosage in clinical.","[{'ForeName': 'Pingli', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Guiyan', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Keguang', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Huanjun', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Abdul Sami', 'Initials': 'AS', 'LastName': 'Shaikh', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Benjie', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ruichen', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China.'}]",Pakistan journal of pharmaceutical sciences,[]
1201,33583759,"A comparison of the efficacy of autologous fibrin glue/platelet-poor plasma versus suction drainage in preventing hematoma and seroma in rhytidectomy: A randomized, double-blind, controlled study.","BACKGROUND


One of the most feared complications of rhytidectomy is the formation of hematoma and seroma, which may harm patients' health and compromise the surgical outcome.
OBJECTIVE


To compare the efficacy of autologous fibrin glue/platelet-poor plasma versus suction drainage in preventing surgical complications such as hematoma and seroma following rhytidectomy procedures.
METHODS


A prospective, randomized, double-blind, controlled study was conducted to compare the efficacy of the two interventions. Seventy-two patients were selected and divided into two groups of 36 (autologous fibrin glue versus suction drainage). Forty-eight hours after the procedures, all patients underwent ultrasound examination, always by the same radiologist, to measure the volume of exudate under the facial skin flaps.
RESULTS


The mean total volume of exudate was 3.21 mL in the suction drainage group and 1.02 mL in the fibrin glue group, with effect size of 68.1% and confidence interval of 55.3 to 77.2 (P < 0.001).
CONCLUSIONS


Results significantly favor the use of fibrin glue and show that it was 68.1% more effective than suction drainage in preventing hematoma or seroma in rhytidectomy procedures.",2021,"The mean total volume of exudate was 3.21 mL in the suction drainage group and 1.02 mL in the fibrin glue group, with effect size of 68.1% and confidence interval of 55.3 to 77.2 (P < 0.001).
","['Seventy-two patients', 'hematoma and seroma in rhytidectomy']","['fibrin glue', 'suction drainage', '36 (autologous fibrin glue versus suction drainage', 'autologous fibrin glue/platelet-poor plasma versus suction drainage']","['volume of exudate under the facial skin flaps', 'mean total volume of exudate', 'hematoma or seroma']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0035519', 'cui_str': 'Facial rhytidoplasty'}]","[{'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370219', 'cui_str': 'Platelet poor plasma'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}]",72.0,0.0666734,"The mean total volume of exudate was 3.21 mL in the suction drainage group and 1.02 mL in the fibrin glue group, with effect size of 68.1% and confidence interval of 55.3 to 77.2 (P < 0.001).
","[{'ForeName': 'Antonio Roberto da Rosa', 'Initials': 'ARDR', 'LastName': 'Rezende', 'Affiliation': 'Coordinator, Department of Plastic Surgery, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil. Electronic address: arrrezende@hotmail.com.'}, {'ForeName': 'Kátia Lúcia', 'Initials': 'KL', 'LastName': 'Rezende', 'Affiliation': 'Plastic surgeon, Department of Plastic Surgery, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Gibram Busatto', 'Initials': 'GB', 'LastName': 'Chedid', 'Affiliation': 'Plastic surgeon, Department of Plastic Surgery, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'João Maximiliano Pedron', 'Initials': 'JMP', 'LastName': 'Martins', 'Affiliation': 'Plastic surgeon, Department of Plastic Surgery, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marcus Vinicius Martins', 'Initials': 'MVM', 'LastName': 'Collares', 'Affiliation': 'Head of the Department of Plastic Surgery, HCPA, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.12.098']
1202,33583722,The safety and efficacy of SLIT compared to placebo or standard care for children with asthma.,,2021,,['children with asthma'],"['SLIT', 'placebo']",['safety and efficacy'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0193794,,"[{'ForeName': 'Marco Shiu Tsun', 'Initials': 'MST', 'LastName': 'Leung', 'Affiliation': ""St George's, University of London, London, UK; Cochrane Airways, Population Health Research Institute, St George's, University of London, UK. Electronic address: marcostleung@hotmail.com.""}, {'ForeName': 'Parker', 'Initials': 'P', 'LastName': ""O'Neill"", 'Affiliation': ""St George's, University of London, London, UK; Cochrane Airways, Population Health Research Institute, St George's, University of London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dennett', 'Affiliation': ""Cochrane Airways, Population Health Research Institute, St George's, University of London, UK.""}, {'ForeName': 'Kayleigh M', 'Initials': 'KM', 'LastName': 'Kew', 'Affiliation': 'Cochrane Editorial and Methods Department, Cochrane, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fortescue', 'Affiliation': ""Cochrane Airways, Population Health Research Institute, St George's, University of London, UK.""}]",Paediatric respiratory reviews,['10.1016/j.prrv.2021.01.002']
1203,33583683,"A Group Randomized Trial Evaluating High School FLASH, a Comprehensive Sexual Health Curriculum.","PURPOSE


To evaluate the effectiveness of a school-based comprehensive sexual health curriculum (FLASH) on high-school students' sexual behavior and related outcomes.
METHODS


A cohort of 1,597 9th and 10th grade students representing 20 schools from two regions in the U.S. (Midwest and South) were enrolled and completed the baseline survey. Following baseline, the 20 schools were randomly assigned to receive FLASH (n = 10 schools, five per region) or a knowledge-based sexual health curriculum (n = 10 schools, five per region). Follow-up surveys were administered at 3 months and 12 months after the instruction period.
RESULTS


There were no statistically significant differences between conditions for the overall sample on rates of vaginal sex in the past 3 months or the rates of vaginal sex without a condom or other birth control. In supplementary subgroup analyses of students who were not sexually experienced at baseline, FLASH showed a statistically significant protective impact at the 3-month follow-up on vaginal sex without a condom or birth control (p = .04). FLASH also showed statistically significant gains in psychosocial outcomes, such as refusal and condom use self-efficacy, attitudes toward birth control and condoms, and perceived norms.
CONCLUSIONS


FLASH demonstrated consistent short-term and long-term impacts on key behavioral determinants. It also showed a significant impact on vaginal sex without a condom or other birth control for the subgroup of students who were not sexually experienced at baseline. Behavioral impacts were not evident for the entire study population.",2021,There were no statistically significant differences between conditions for the overall sample on rates of vaginal sex in the past 3 months or the rates of vaginal sex without a condom or other birth control.,"['A cohort of 1,597 9th and 10th grade students representing 20 schools from two regions in the U.S. (Midwest and South) were enrolled and completed the baseline survey', '20 schools']","['FLASH', 'school-based comprehensive sexual health curriculum (FLASH', 'High School FLASH', 'knowledge-based sexual health curriculum']","['vaginal sex', 'psychosocial outcomes, such as refusal and condom use self-efficacy, attitudes toward birth control and condoms, and perceived norms', 'rates of vaginal sex', 'Behavioral impacts']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0586013,There were no statistically significant differences between conditions for the overall sample on rates of vaginal sex in the past 3 months or the rates of vaginal sex without a condom or other birth control.,"[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Coyle', 'Affiliation': 'Education-Training-Research, Services Department, Scotts Valley, California. Electronic address: karin.coyle@etr.org.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Education-Training-Research, Services Department, Scotts Valley, California.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Laris', 'Affiliation': 'Education-Training-Research, Services Department, Scotts Valley, California.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': 'Education-Training-Research, Services Department, Scotts Valley, California.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Unti', 'Affiliation': 'Education-Training-Research, Services Department, Scotts Valley, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Baumler', 'Affiliation': 'Behavioral Health and Research Department of Obstetrics & Gynecology, University of Texas Medical Branch, Galveston, Texas.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.12.005']
1204,33583493,A comparison of two visual methods for classifying obstructive versus central hypopneas.,"STUDY OBJECTIVES


Rules for classifying apneas as obstructive, central, or mixed are well established. Although hypopneas are given equal weight when calculating the apnea-hypopnea index, classification is not standardized. Visual methods for classifying hypopneas have been proposed by the American Academy of Sleep Medicine (AASM) and by Randerath, et al., but never compared. We evaluated the clinical suitability of the two visual methods for classifying hypopneas as central or obstructive.
METHODS


Fifty hypopnea containing polysomnographic segments (HCPS) were selected from patients with clear obstructive or clear central physiology to serve as standard obstructive or central hypopneas. These 100 HCPS were de-identified, randomized, and scored by 2 groups. We assigned one group to use the AASM criteria, and the other the Randerath algorithm. After a washout period, re-randomized HCPS were scored using the alternate method. We determined the accuracy (agreement with standard), inter-rater (Fleiss' kappa), and intra-rater agreement (Cohen's kappa) for obtained scores.
RESULTS


Accuracy of the two methods was similar-67 vs 69.3% for Randerath and AASM respectively. Cohen's kappa was 0.01 to 0.75, showing some raters scored similarly using the two methods, while others scored them markedly differently. Fleiss' kappa for the AASM algorithm was 0.32 (95% CI 0.29 to 0.36) and for the Randerath algorithm was 0.27 (95% CI 0.23 to 0.30).
CONCLUSIONS


More work is needed to discover a non-invasive way to accurately characterize hypopneas. Studies like ours may lay the foundation for discovering the full spectrum of physiologic consequences of OSA and CSA.",2021,"RESULTS


Accuracy of the two methods was similar-67 vs 69.3% for Randerath and AASM respectively.","['classifying obstructive versus central hypopneas', 'Fifty hypopnea containing polysomnographic segments (HCPS) were selected from patients with clear obstructive or clear central physiology to serve as standard obstructive or central hypopneas']",[],[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],[],,0.0546929,"RESULTS


Accuracy of the two methods was similar-67 vs 69.3% for Randerath and AASM respectively.","[{'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Dupuy-McCauley', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Harsha V', 'Initials': 'HV', 'LastName': 'Mudrakola', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Colaco', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Vichaya', 'Initials': 'V', 'LastName': 'Arunthari', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Katarzyna A', 'Initials': 'KA', 'LastName': 'Slota', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Morgenthaler', 'Affiliation': 'Mayo Clinic, Rochester MN, Mayo Clinic, Jacksonville, FL.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,[]
1205,33583462,Family Minds: A randomized controlled trial of a group intervention to improve foster parents' reflective functioning.,"Family Minds is a brief group psychoeducational parenting intervention designed to increase the reflective functioning (RF) and mentalization skills of foster parents. RF is important for foster parents who have to build relationships with children whose adverse experiences increase their risk for psychosocial challenges. A randomized controlled trial (RCT) for Family Minds was conducted in Texas with 89 foster parents. The main aims of this study were to examine whether the intervention could significantly increase the RF/mentalization skills of the foster parents and decrease their parenting stress. After 6 weeks, compared with the control group, intervention foster parents improved their RF via a lowering of pre-mentalizing and also significantly decreased parenting stress related to parent-child dysfunctional interactions. Other measures of RF and parenting stress showed no significant differences between groups. Foster child behavior was not significantly different between groups, although data at 6 months showed a possible lowering of internalizing symptoms for children of intervention parents. This RCT provides some encouraging evidence that Family Minds may increase RF in foster parents, improve parental sensitivity and their ability to emotionally regulate, decrease parenting stress related to challenging interactions with their foster children, and possibly decrease children's internalizing behavior.",2021,"Foster child behavior was not significantly different between groups, although data at 6 months showed a possible lowering of internalizing symptoms for children of intervention parents.","['foster parents', ""foster parents' reflective functioning"", 'Family Minds was conducted in Texas with 89 foster parents', 'Family Minds']",['psychoeducational parenting intervention'],"['Foster child behavior', 'internalizing symptoms', 'RF/mentalization skills', 'parenting stress', 'RF and parenting stress']","[{'cui': 'C0337468', 'cui_str': 'Foster parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0337544', 'cui_str': 'Foster child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",89.0,0.0714292,"Foster child behavior was not significantly different between groups, although data at 6 months showed a possible lowering of internalizing symptoms for children of intervention parents.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Adkins', 'Affiliation': 'Steve Hicks School of Social Work, Texas Institute for Child & Family Wellbeing, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Reisz', 'Affiliation': 'Department of Human Development, Washington State University-Vancouver, Vancouver, WA, USA.'}, {'ForeName': 'Dilara', 'Initials': 'D', 'LastName': 'Hasdemir', 'Affiliation': 'Steve Hicks School of Social Work, Texas Institute for Child & Family Wellbeing, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}]",Development and psychopathology,['10.1017/S095457942000214X']
1206,33583424,Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial.,"INTRODUCTION


Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.
METHODS


The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle.
DISCUSSION


We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients' relapse management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020.",2021,The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment.,"['people with multiple sclerosis', '188 people with possible or relapsing-remitting multiple sclerosis with ≥\u20091 relapse within the last year and/or ≥\u20092 relapses within the last 2\xa0years']","['placebo', 'web-based relapse management programme', 'web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum', 'oral corticosteroids', 'interactive web-based decision-making programme']","['annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness', 'proportion of relapses not treated or treated with oral corticosteroids']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",188.0,0.153948,The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment.,"[{'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. anne.christin.rahn@uni-oldenburg.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stahmann', 'Affiliation': 'MS Forschungs- und Projektentwicklungs-gGmbH, Hannover, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Scheiderbauer', 'Affiliation': 'Stiftung für Selbstbestimmung und Selbstvertretung von MS-Betroffenen, Trier, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Grentzenberg', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Montalbo', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical, Göttingen, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Institute of Nursing Science, University Hospital Cologne and Faculty of Medicine, University of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-021-05059-1']
1207,33583416,A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension.,"BACKGROUND


To investigate whether pharmacist health coaching improves progression through the stages of change (SOC) for three modifiable health behaviours; diet, exercise, and medication management in participants with poorly controlled hypertension.
METHODS


In this four-month controlled group study two community-based pharmacists provided three health coaching sessions to 20 participants with poorly controlled hypertension at monthly intervals. Changes in participants' stages of change with respect to the modifiable health behaviours; diet, exercise, and medication management were assessed. To confirm the behaviour change outcomes, SOC were also assessed in a control group over the same period.
RESULTS


Statistically significant changes in the modifiable health behaviours- medication management (d = 0.19; p = 0.03) and exercise (d = 0.85; p = 0.01) were apparent in participants who received health coaching and were evident through positive changes in the SOC charts. The participants in the control group did not experience significant changes with respect to the SOC. This was parallel to a decrease in mean systolic blood pressure from session one to session four by 7.53 mmHg (p < 0.05, d = - 0.42) in participants who received health coaching. Improvements to medication adherence was also apparent in these participants, evident from the mean scores for the Adherence to Refills and Medications Scale (ARMS), which decreased significantly from a mean of 15.60 to 13.05 (p < 0.05) from session one to four.
CONCLUSIONS


Pharmacist health coaching produced promising health outcomes in participants with poorly controlled hypertension. Pharmacists were able to facilitate a positive behaviour change in participants. However, larger participant cohorts are needed to explore these findings further.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry ACTRN12618001839291 . Date of registration 12/11/2018.",2021,Statistically significant changes in the modifiable health behaviours- medication management (d = 0.19; p = 0.03) and exercise (d = 0.85; p = 0.01) were apparent in participants who received health coaching and were evident through positive changes in the SOC charts.,"['participants with poorly controlled hypertension', '20 participants with poorly controlled hypertension at monthly intervals']","['pharmacist health coaching', 'community-based pharmacists provided three health coaching sessions', 'Pharmacist health coaching', 'health coaching']","['modifiable health behaviours- medication management', 'mean systolic blood pressure', 'health outcomes', 'Adherence to Refills and Medications Scale (ARMS', 'medication adherence']","[{'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",20.0,0.0668138,Statistically significant changes in the modifiable health behaviours- medication management (d = 0.19; p = 0.03) and exercise (d = 0.85; p = 0.01) were apparent in participants who received health coaching and were evident through positive changes in the SOC charts.,"[{'ForeName': 'Harjit K', 'Initials': 'HK', 'LastName': 'Singh', 'Affiliation': 'Discipline of Pharmacy, The School of Health and Biomedical Sciences, RMIT University VIC, Bundoora, VIC, 3083, Australia. harjitks@live.com.au.'}, {'ForeName': 'Gerard A', 'Initials': 'GA', 'LastName': 'Kennedy', 'Affiliation': 'Discipline of Pharmacy, The School of Health and Biomedical Sciences, RMIT University VIC, Bundoora, VIC, 3083, Australia.'}, {'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Stupans', 'Affiliation': 'Discipline of Pharmacy, The School of Health and Biomedical Sciences, RMIT University VIC, Bundoora, VIC, 3083, Australia.'}]",BMC family practice,['10.1186/s12875-021-01385-0']
1208,33583390,Effect of Direct-Acting Antiviral Drugs on Erectile Functions among Hepatitis C Patients: A Prospective Interventional Study.,"BACKGROUND & OBJECTIVE


Erectile dysfunction (ED) is one of the extrahepatic manifestations of hepatitis C virus infection that greatly affects patients' quality of life. Unfortunately, some of the drugs used for HCV treatment may have a negative impact on the patient's erectile function such as the pegylated interferon. Currently, with the introduction of directacting antiviral drugs, there are scarce data in the literature about its potential impact on erectile function. In these settings, we aimed to assess the impact of sofosbuvir-based therapy on male erectile function.
METHODS


This prospective interventional study was carried out in Benha University hospitals between January 2019 and May 2020. The study included all consecutive HCV patients with simultaneous ED coming to the hepatology outpatient clinic. Patients were divided into a study group who received sofosbuvir-based therapy (group A) or a control group who received silymarin therapy (group B). The International Index of Erectile Function-5 (IIEF-5) was used for assessment of erectile function at different time points (pretreatment, 6 months, and 12 months after treatment). Different variables in both groups have been statistically analyzed.
RESULTS


Overall, 75 patients who received sofosbuvir-based therapy and a control group (n = 35) matched for age and pretreatment variables (Child-Turcotte-Pugh score and Fibrosis- 4 score). There was no significant difference between both groups in the pretreatment data. On the other hand, the posttreatment IIEF-5 was significantly higher in the sofosbuvir arm compared to the silymarin arm both at six months (p<0.001) and at 12 months (p<0.001). Furthermore, the age and the stage of liver fibrosis were negatively correlated with IIEF-5 at all-time points.
CONCLUSION


The age and the stage of liver fibrosis are significantly correlated with the degree of ED. Furthermore, sofosbuvir-based therapy may be associated with significant improvement in the patients' erectile function.",2021,"Furthermore, the age and the stage of liver fibrosis were negatively correlated with IIEF-5 at all-time points.
","['consecutive HCV patients with simultaneous ED coming to the hepatology outpatient clinic', 'Benha University hospitals between January 2019 and May 2020', '75 patients who received sofosbuvir-based therapy and a control group (n = 35) matched for age and pretreatment variables (Child-Turcotte-Pugh score and Fibrosis- 4 score', 'Hepatitis C Patients']","['sofosbuvir-based therapy', 'control group who received silymarin therapy', 'Direct-Acting Antiviral Drugs']","['posttreatment IIEF-5', 'Erectile Functions', 'liver fibrosis']","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0086403', 'cui_str': 'Hepatology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3854424', 'cui_str': 'Child-Pugh-Turcotte score'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",35.0,0.0189591,"Furthermore, the age and the stage of liver fibrosis were negatively correlated with IIEF-5 at all-time points.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alhefnawy', 'Affiliation': 'Urology Department, Faculty of Medicine, Benha University, Benha. Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mohey', 'Affiliation': 'Urology Department, Faculty of Medicine, Benha University, Benha. Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Urology Department, Faculty of Medicine, Benha University, Benha. Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': 'Internal Medicine Department, Faculty of Medicine, Benha University, Benha. Egypt.'}, {'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Tanta University, Tanta. Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eissa', 'Affiliation': 'Urology Department; Faculty of Medicine; Tanta University; Tanta. Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hagras', 'Affiliation': 'Urology Department; Faculty of Medicine; Tanta University; Tanta. Egypt.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Puliatti', 'Affiliation': 'Urology Department, University of Modena and Reggio Emilia, Modena. Italy.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Almekaty', 'Affiliation': 'Urology Department; Faculty of Medicine; Tanta University; Tanta. Egypt.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530321666210212143932']
1209,33583347,The effects of the activation of hostile and non-hostile schemas on intent attribution processes in non-aggressive individuals: An ERP study.,"We investigated the influences of hostile and non-hostile schemas activations in non-aggressive individuals on their intent attribution processes in various social contexts. 38 non-aggressive participants were randomly assigned to one of two groups, one primed with negative words, to be conditioned as temporarily hostile (TH), and the other with positive words, be conditioned as temporarily non-hostile (TNH). They were asked to read social scenarios composed of positive or negative behaviors of others whose intentions are ambiguous followed by a disambiguation of others' real intentions (hostile vs non-hostile) behind their behaviors. Neural activity related to spontaneous intent attribution processes was measured using electroencephalography (EEG). Event-related potentials (ERPs) associated with the presentation of unexpected intentions produced an N400 component. The results showed that when non-hostile intentions were revealed following ambiguous-negative behaviors of others, the N400 effect was observed only in the TH group and not in the TNH group. Similarly, when hostile intentions were revealed following ambiguous-positive behaviors of others, the N400 effect was observed only in the TNH group and not in the TH group. In other words, non-aggressive individuals were led to attribute either hostile or non-hostile intentions to the same ambiguous behaviors of others depending on which concepts or thoughts (hostile vs non hostile) were activated and accessible in memory by priming at the time of social interactions.",2021,"Similarly, when hostile intentions were revealed following ambiguous-positive behaviors of others, the N400 effect was observed only in the TNH group and not in the TH group.","['non-aggressive individuals', '38 non-aggressive participants', 'non-aggressive individuals on their intent attribution processes in various social contexts']","['activation of hostile and non-hostile schemas', 'TNH', 'negative words, to be conditioned as temporarily hostile (TH), and the other with positive words, be conditioned as temporarily non-hostile (TNH']",[],"[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",[],38.0,0.0260507,"Similarly, when hostile intentions were revealed following ambiguous-positive behaviors of others, the N400 effect was observed only in the TNH group and not in the TH group.","[{'ForeName': 'Wan Seo', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, University of Montreal , Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Jolicœur', 'Affiliation': 'Department of Psychology, University of Montreal , Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gagnon', 'Affiliation': 'Department of Psychology, University of Montreal , Canada.'}]",Social neuroscience,['10.1080/17470919.2021.1888790']
1210,33583341,"Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial.","BACKGROUND


Suicidal patients often present to the emergency department, where specific anti-suicidal treatment is lacking. Ketamine, a Glutamate modulator and a rapidly acting antidepressant with anti-suicidal properties, might offer relief.
AIMS


Evaluation of single, fixed-dosed intranasal ketamine for acute suicidal ideation in the emergency department.
METHODS


Between August 2016 and April 2018, 30 eligible suicidal subjects, scheduled for psychiatric hospitalization, independently of their psychiatric diagnosis, were randomized to intranasal ketamine 40 mg or saline placebo. Safety and efficacy evaluations were scheduled for 30, 60, 120 and 240 min post administration and on days 1, 2, 3, 4, 5, 7, 21 and 28. Primary outcome was suicidal ideation.
RESULTS


Fifteen subjects were randomized for each study group. All were analyzed for primary and secondary outcomes. Four hours post administration, the mean difference in suicidal symptoms between the groups, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) item of suicidal thoughts (MADRS-SI), was 1.267 (95% confident interval 0.1-2.43,  p  < 0.05) favoring treatment. Remission from suicidal ideation was evident in 80% for the ketamine group compared with 33% for the controls ( p  < 0.05). The mean difference in depressive symptoms, measured by MADRS, at the same time was 9.75 (95% confident interval 0.72-18.79,  p  < 0.05) favoring ketamine. Treatment was safe and well-tolerated. Conclusions: Single, fixed-dose, intranasal ketamine alleviated suicidal ideation and improved depressive symptoms four hours post administration. We present here an innovative paradigm for emergency department management of suicidal individuals. Future larger-scale studies are warranted. ClinicalTrials.gov Identifier: NCT02183272.",2021,Remission from suicidal ideation was evident in 80% for the ketamine group compared with 33% for the controls ( p  < 0.05).,"['Fifteen subjects', 'emergency department management of suicidal individuals', 'Suicidal patients', 'Between August 2016 and April 2018, 30 eligible suicidal subjects, scheduled for psychiatric hospitalization, independently of their psychiatric diagnosis', 'acute suicidal ideation in the emergency department']","['ketamine', 'intranasal ketamine', 'Ketamine', 'intranasal ketamine 40\u2009mg or saline placebo', 'single, fixed-dosed intranasal ketamine', 'Placebo']","['safe and well-tolerated', 'suicidal ideation', 'depressive symptoms', 'suicidal symptoms', 'Acute Suicidal Ideation', 'Remission from suicidal ideation', 'suicidal ideation and improved depressive symptoms', 'Safety and efficacy evaluations', 'Montgomery-Åsberg Depression Rating Scale (MADRS) item of suicidal thoughts (MADRS-SI']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",15.0,0.459431,Remission from suicidal ideation was evident in 80% for the ketamine group compared with 33% for the controls ( p  < 0.05).,"[{'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Domany', 'Affiliation': ''}, {'ForeName': 'Cheryl B', 'Initials': 'CB', 'LastName': 'McCullumsmith', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2021.1878078']
1211,33583335,The Effect of Custom-Fitted Compression Garments Worn Overnight for Recovery from Judo Training in Elite Athletes.,"This study investigated the effects of custom-fitted compression garments (CG) worn during recovery over a multi-day training camp in elite judo players (judoka). A single blind, placebo-controlled study was carried out in 11 elite judoka, using a two-way crossover design. Two three-day training camps were completed in CG and placebo conditions in a random order. Changes in performance and physiological markers were compared between conditions. Judoka were assessed before training for (maximal) isometric knee extension and grip strength, countermovement jump performance and bench-press velocity, alongside soreness, limb circumferences, plasma creatine kinase activity (CK) and perceived bruising. Measurements were repeated after 12 h, 36 h and 43 h of training, whereupon judoka rated the effectiveness of each intervention. Knee extension and bench-press performance demonstrated significant familiarization ( p  < 0.001), and were excluded from subsequent analysis. Jump performance was unaffected by training ( p  > 0.05). Grip strength declined throughout training ( p  < 0.001), with peak decrements of - 9.7 % indicating mild muscle damage. Increases in bruising, CK and soreness demonstrated highly variable, if significant ( p  < 0.001) responses. Although CG were perceived as significantly more effective than placebo for recovery ( p  = 0.046), no effects were observed for any other outcome ( p  > 0.05). Compression conferred no statistically significant impact upon recovery markers in elite judoka throughout training. Muscle damage responses were inconsistent in this population. Individual athletes would be advised to monitor habitually-used performance measures while using CG to ascertain whether perceptual benefits translate into enhanced recovery.",2021,"Increases in bruising, CK and soreness demonstrated highly variable, if significant ( p  < 0.001) responses.","['elite judo players (judoka', '11 elite judoka', 'Elite Athletes']","['placebo', 'Custom-Fitted Compression Garments', 'custom-fitted compression garments (CG']","['isometric knee extension and grip strength, countermovement jump performance and bench-press velocity, alongside soreness, limb circumferences, plasma creatine kinase activity (CK) and perceived bruising', 'Jump performance', 'Grip strength', 'Muscle damage responses', 'bruising, CK and soreness', 'Changes in performance and physiological markers']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.17479,"Increases in bruising, CK and soreness demonstrated highly variable, if significant ( p  < 0.001) responses.","[{'ForeName': 'Freddy C W', 'Initials': 'FCW', 'LastName': 'Brown', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, Twickenham, UK.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Hill', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, Twickenham, UK.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'van Someren', 'Affiliation': 'Sports Lab North West, Letterkenny Institute of Technology, Ireland.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Faculty of Health and Life of Sciences, Northumbria University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Pedlar', 'Affiliation': ""Faculty of Sport, Health and Applied Science, St Mary's University, Twickenham, UK.""}]",European journal of sport science,['10.1080/17461391.2021.1891294']
1212,33583304,Continuous Endotracheal Tube Cuff Pressure Control Decreases Incidence of Ventilator-Associated Pneumonia in Patients with Traumatic Brain Injury.,"BACKGROUND


Ventilator-associated pneumonia (VAP) is a common cause of morbidity and mortality in intensive care unit (ICU), and among the several preventative strategies described to reduce the incidence of VAP, the most important is the endotracheal tube cuff (ETC) pressure. The present study was conducted on 60 patients who required mechanical ventilation (MV) in the ICU with traumatic brain injury (TBI).
METHODS


The patients were randomized into two groups of 30, in which ETC pressure was regulated using a smart cuff manager (SCM) (Group II), or manual measurement approach (MMA) (Group I). Demographic data, MV duration, length of ICU stay and mortality rates were recorded. The clinical pulmonary infection scores (CPISs), C-reactive protein (CRP) values, and the fraction of inspired oxygen (FiO2) and positive end-expiratory pressure (PEEP) values of the groups were compared at baseline, and at hours 48, 72 and 96.
RESULTS


In Group I, CPIS values significantly higher than Group II in 48th, 72nd and 96th hours ( p  < 0.05). In Group I, PEEP values and deep tracheal aspirate (DTA) culture growth rates significantly higher than Group II in 72nd and 96th hours ( p  < 0.05).
CONCLUSION


The continuous maintenance of ETC pressure using SCM reduced the incidence of VAP.",2021,"In Group I, PEEP values and deep tracheal aspirate (DTA) culture growth rates significantly higher than Group II in 72nd and 96th hours ( p  < 0.05).
","['60 patients who required mechanical ventilation (MV) in the ICU with traumatic brain injury (TBI', 'Patients with Traumatic Brain Injury']","['Continuous Endotracheal Tube Cuff Pressure Control', 'smart cuff manager (SCM) (Group II), or manual measurement approach (MMA']","['clinical pulmonary infection scores (CPISs), C-reactive protein (CRP) values, and the fraction of inspired oxygen (FiO2) and positive end-expiratory pressure (PEEP) values', 'PEEP values and deep tracheal aspirate (DTA) culture growth rates', 'Demographic data, MV duration, length of ICU stay and mortality rates', 'incidence of VAP', 'CPIS values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C2919642', 'cui_str': 'Specimen from trachea obtained by aspiration'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",60.0,0.0360511,"In Group I, PEEP values and deep tracheal aspirate (DTA) culture growth rates significantly higher than Group II in 72nd and 96th hours ( p  < 0.05).
","[{'ForeName': 'Mehmet Salih', 'Initials': 'MS', 'LastName': 'Sevdi', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Demirgan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Erkalp', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul University-Cerrahpasa, Institute of Cardiology, Istanbul, Turkey.'}, {'ForeName': 'Onat', 'Initials': 'O', 'LastName': 'Akyol', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Funda Gumus', 'Initials': 'FG', 'LastName': 'Ozcan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan Cem', 'Initials': 'HC', 'LastName': 'Guneyli', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Can', 'Initials': 'MC', 'LastName': 'Tunali', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysin', 'Initials': 'A', 'LastName': 'Selcan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul Bagcilar Training and Research Hospital, Istanbul, Turkey.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2021.1881190']
1213,33583253,"Effects of 8 Weeks of Balance Training, Virtual Reality Training, and Combined Exercise on Lower Limb Muscle Strength, Balance, and Functional Mobility Among Older Men: A Randomized Controlled Trial.","BACKGROUND


Poor muscle strength, balance, and functional mobility have predicted falls in older adults. Fall prevention guidelines recommend highly challenging balance training modes to decrease falls; however, it is unclear whether certain modes are more effective. The purpose of this study was to determine whether traditional balance training (BT), virtual reality balance training (VR), or combined exercise (MIX) relative to a waitlist control group (CON) would provoke greater improvements in strength, balance, and functional mobility as falls risk factor proxies for falls in older men.
HYPOTHESIS


We hypothesized that 8 weeks of MIX will provoke the greatest improvements in falls risk factors, followed by similar improvements after BT and VR, relative to the CON.
STUDY DESIGN


Single-blinded randomized controlled trial NCT02778841 (ClinicalTrials.gov identifier).
LEVEL OF EVIDENCE


Level 2.
METHODS


In total, 64 community-dwelling older men (age 71.8 ± 6.09 years) were randomly assigned into BT, VR, MIX, and CON groups and tested at baseline and at the 8-week follow-up. The training groups exercised for 40 minutes, 3 times per week, for 8 weeks. Isokinetic quadriceps and hamstrings strength on the dominant and nondominant legs were primary outcomes measured by the Biodex Isokinetic Dynamometer. Secondary outcomes included 1-legged stance on firm and foam surfaces, tandem stance, the timed-up-and-go, and gait speed. Separate one-way analyses of covariance between groups were conducted for each outcome using baseline scores as covariates.
RESULTS


(1) MIX elicited greater improvements in strength, balance, and functional mobility relative to BT, VR, and CON; (2) VR exhibited better balance and functional mobility relative to BT and CON; and (3) BT demonstrated better balance and functional mobility relative to CON.
CONCLUSION


The moderate to large effect sizes in strength and large effect sizes for balance and functional mobility underline that MIX is an effective method to improve falls risk among older adults.
CLINICAL RELEVANCE


This study forms the basis for a larger trial powered for falls.",2021,"(1) MIX elicited greater improvements in strength, balance, and functional mobility relative to BT, VR, and CON; (2) VR exhibited better balance and functional mobility relative to BT and CON; and (3) BT demonstrated better balance and functional mobility relative to CON.
","['Older Men', 'older men', 'older adults', '64 community-dwelling older men (age 71.8 ± 6.09 years']","['Balance Training, Virtual Reality Training, and Combined Exercise', 'traditional balance training (BT), virtual reality balance training (VR), or combined exercise (MIX) relative to a waitlist control group (CON']","['strength, balance, and functional mobility relative to BT, VR, and CON; (2) VR exhibited better balance and functional mobility relative to BT and CON', 'Biodex Isokinetic Dynamometer', 'strength, balance, and functional mobility', 'falls risk factors', '1-legged stance on firm and foam surfaces, tandem stance, the timed-up-and-go, and gait speed', 'balance and functional mobility relative to CON', 'Lower Limb Muscle Strength, Balance, and Functional Mobility', 'Isokinetic quadriceps and hamstrings strength']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205233', 'cui_str': 'Firm'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",64.0,0.0368323,"(1) MIX elicited greater improvements in strength, balance, and functional mobility relative to BT, VR, and CON; (2) VR exhibited better balance and functional mobility relative to BT and CON; and (3) BT demonstrated better balance and functional mobility relative to CON.
","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Biomechanics and Sports Injuries, Faculty of Physical Education and Sports Sciences, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Jehu', 'Affiliation': 'Aging, Mobility and Cognitive Neuroscience Laboratory, Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Abdolhamid', 'Initials': 'A', 'LastName': 'Daneshjoo', 'Affiliation': 'Department of Sports Injuries and Corrective Exercises, Faculty of Sports Sciences, Shahid Bahonar University of Kerman, Kerman, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shakoor', 'Affiliation': 'Department of Physical Education and Sport Sciences, School of Education and Psychology, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Razeghi', 'Affiliation': 'School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Amani', 'Affiliation': 'Faculty of Sports Science, Shomal University, Amol, Iran.'}, {'ForeName': 'Muhammad Nazrul', 'Initials': 'MN', 'LastName': 'Hakim', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Universiti Putra, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Ashril', 'Initials': 'A', 'LastName': 'Yusof', 'Affiliation': 'Centre for Sports and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia.'}]",Sports health,['10.1177/1941738120986803']
1214,33583250,An Eight-Week Mindful Eating Program Applied in a Mediterranean Population With Overweight or Obesity: The EATT Intervention Study.,"BACKGROUND


Overweight and obesity are important public health priorities. Mindful eating can contribute in preventing automatic eating behavior and emotional dysregulation, both being primary causes of overeating and negative body image. This research outlines an eight-week mindful eating intervention (i.e., project EATT) focusing on people with overweight or obesity in assisting positive behavioral, psychological and physiological change.
METHODS


Fifty-seven people residing in Athens were recruited to participate in this research, where participants were allocated to either an experimental or a waitlist condition. Changes in body weight, and eating attitude, mindfulness, self-compassion, anxiety questionnaires were administered at baseline and post-intervention, and at a 14-month follow-up.
RESULTS


Results indicated that mindfulness and self-compassion increased significantly, while anxiety symptoms decreased. Significance was also observed in reduction of overeating symptoms and oral control. While a negative relationship was observed between anxiety and mindfulness, and anxiety and self-compassion, self-compassion was negatively associated with overeating episodes.
CONCLUSIONS


The intervention improved participants' relationship with food and enabled changes towards successful weight regulation.",2021,"Changes in body weight, and eating attitude, mindfulness, self-compassion, anxiety questionnaires were administered at baseline and post-intervention, and at a 14-month follow-up.
","['Mediterranean Population With Overweight or Obesity', 'people with overweight or obesity in assisting positive behavioral, psychological and physiological change', 'Fifty-seven people residing in Athens']",[],"['body weight, and eating attitude, mindfulness, self-compassion, anxiety questionnaires', 'automatic eating behavior and emotional dysregulation', 'successful weight regulation', 'anxiety and mindfulness, and anxiety and self-compassion, self-compassion', 'overeating symptoms and oral control', 'anxiety symptoms', 'mindfulness and self-compassion']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4517815', 'cui_str': '57'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",57.0,0.014229,"Changes in body weight, and eating attitude, mindfulness, self-compassion, anxiety questionnaires were administered at baseline and post-intervention, and at a 14-month follow-up.
","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zervos', 'Affiliation': 'Center for Health Services Research, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Koletsi', 'Affiliation': 'Department of Psychology, 121340New York College, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mantzios', 'Affiliation': 'School of Social Sciences, 1725Birmingham City University, Birmingham, UK.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Skopeliti', 'Affiliation': 'Center for Health Services Research, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsitsas', 'Affiliation': 'Counselling Center, 68996Harokopio University, Athens, Greece.'}, {'ForeName': 'Androniki', 'Initials': 'A', 'LastName': 'Naska', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Psychological reports,['10.1177/0033294120988104']
1215,33583208,Telephonic Nurse Guidance for Colonoscopy: A Clinical Trial.,"This study aims to analyze the effectiveness of nurse-conducted telephone guidance for bowel preparation before a colonoscopy after patients have received routine recommendations. A randomized, controlled, colonoscopist-blinded clinical trial was conducted at a Brazilian teaching hospital. Participants included patients aged ≥ 18, who were available via telephone (the intervention group was given guidance over telephone). Of the 109 total participants, 55 were placed into the intervention group (IG) and 54 into the control group (CG). Outcomes included Boston Bowel Preparation Scale (BBPS) scores, adenoma detection, and cecal intubation. Total BBPS scores showed a statistically significant reduction for the IG when compared to the CG ( p  < .001) (all colon segments were evaluated thus). Cecal intubation occurred in all exams for those in the IG ( p  = .027). No significant differences were found regarding adenoma detection. The examined educational intervention was an effective strategy for reeducating patients about bowel preparation.",2021,Total BBPS scores showed a statistically significant reduction for the IG when compared to the CG ( p  < .001) (all colon segments were evaluated thus).,"['109 total participants, 55 were placed into the intervention group (IG) and 54 into the control group (CG', 'Brazilian teaching hospital', 'Colonoscopy', 'Participants included patients aged ≥ 18, who were available via telephone (the intervention group was given guidance over telephone']",['nurse-conducted telephone guidance'],"['adenoma detection', 'Total BBPS scores', 'Cecal intubation', 'Boston Bowel Preparation Scale (BBPS) scores, adenoma detection, and cecal intubation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",109.0,0.0503661,Total BBPS scores showed a statistically significant reduction for the IG when compared to the CG ( p  < .001) (all colon segments were evaluated thus).,"[{'ForeName': 'Tatiane Santa Rosa', 'Initials': 'TSR', 'LastName': 'Diniz', 'Affiliation': 'São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Suzimar de Fátima Benato', 'Initials': 'SFB', 'LastName': 'Fusco', 'Affiliation': 'São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Maria Elizandre Camilo de', 'Initials': 'MEC', 'LastName': 'Oliveira', 'Affiliation': 'São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Hélio Rubens de Carvalho', 'Initials': 'HRC', 'LastName': 'Nunes', 'Affiliation': 'São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Marla Andréia Garcia de', 'Initials': 'MAG', 'LastName': 'Avila', 'Affiliation': 'São Paulo State University - UNESP, Botucatu, Brazil.'}]",Clinical nursing research,['10.1177/1054773821995015']
1216,33583203,The Potential of Personalized Virtual Reality in Palliative Care: A Feasibility Trial.,"BACKGROUND


Virtual Reality can help alleviate symptoms in a non-palliative care population. Personalized therapy can further alleviate these symptoms. There is little evidence in a palliative care population.
AIM


To understand the feasibility of repeated personalized virtual reality sessions in a palliative care population.
DESIGN


A feasibility randomized control trial. Intervention: personalized virtual reality, Control: non-personalized virtual reality. All participants completed a 4-minute virtual reality session for 4 weeks. At each point, the Edmonton Symptom Assessment System-Revised (scored 0 = none up to 100 = worst) was completed pre- and post- each session. A time-series regression analysis was completed for the overall effect.
SETTING/PARTICIPANTS


The research took place in one hospice. The main inclusion criteria was: (1) under the care of the hospice (2) advanced disease (3) over 18 years (4) physically able to use virtual reality set (5) capacity (6) proficient English.
RESULTS


Twenty-six participants enrolled, of which 20 (77%) completed all sessions. At baseline, the intervention group had a mean pre- score of 26.3 (SD 15.1) which reduced to 11.5 (SD 12.6) after the first session. At the same time point, the control group had a mean pre- score of 37.9 (SD 21.6) which reduced to 25.5 (SD 17.4) post-session. The mean scores dropped following each session, however this was not significant (mean difference = -1.3, 95% CI: -6.4 to 3.7, p = 0.601).
CONCLUSIONS


It is feasible to complete repeated virtual reality sessions within a palliative care population. Future research should explore the structure and effectiveness of virtual reality in a fully powered trial.",2021,"The mean scores dropped following each session, however this was not significant (mean difference = -1.3","['Twenty-six participants enrolled, of which 20 (77%) completed all sessions', 'The main inclusion criteria was: (1) under the care of the hospice (2) advanced disease (3) over 18 years (4) physically able to use virtual reality set (5) capacity (6) proficient English']",['personalized virtual reality sessions'],"['mean pre- score', 'mean scores']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.210577,"The mean scores dropped following each session, however this was not significant (mean difference = -1.3","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Perna MSc Msw', 'Affiliation': '9098Royal Trinity Hospice, London, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Lund', 'Affiliation': '9098Royal Trinity Hospice, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Marie Curie Palliative Care Research Department, 4919UCL, London, UK.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Minton', 'Affiliation': ""4968St George's University Hospitals NHS Foundation Trust, London, UK.""}]",The American journal of hospice & palliative care,['10.1177/1049909121994299']
1217,33583202,Treatment of Primary Aldosteronism Increases Plasma Epoxyeicosatrienoic Acids.,"Epoxyeicosatrienoic acids (EETs) are lipid signaling molecules formed from arachidonic acid by the action of CYP450s. EETs cause vasodilation, exert anti-inflammatory effects, and enhance insulin secretion and sensitivity in rodents. EETs are metabolized to less active dihydroxyeicosatrienoic acids (DHETs) by sEH (soluble epoxide hydrolase), and 14,15-DHET has been reported to be increased in patients with primary aldosteronism, but the effects of aldosterone on EET concentrations and sEH activity are unknown. We tested the hypothesis that treatment of primary aldosteronism would alter EET concentrations in humans. We studied 9 patients with primary aldosteronism before and at least 3 months after unilateral adrenalectomy (6) or treatment with a mineralocorticoid antagonist (3). Circulating total EET concentrations increased to 18.5±12.6 from 11.9±5.9 nmol/L with treatment of primary aldosteronism ( P= 0.027). Among the regioisomers of EETs, 14,15-EET significantly increased after treatment, whereas 11,12-EET and 8,9 EET were unaltered. Total DHET concentrations and specific regioisomers of DHET did not change significantly. Circulating total EETs (ρ=-0.52,  P= 0.026), 14,15-EET ( ρ =-0.56,  P= 0.015), and 11,12-EET ( ρ =-0.48,  P= 0.042) correlated inversely with aldosterone. We also assessed EETs after a 12-hour aldosterone or vehicle infusion in a randomized cross-over study in healthy volunteers. Plasma EETs were similar after 12-hour aldosterone or vehicle infusion. Lastly, 3-day infusion of aldosterone in mice decreased EET concentrations in adipose and muscle and increased sEH expression as determined by molar ratio of DHETs to EETs and soluble epoxide hydrolase ( Ephx2 ) mRNA expression in adipose tissue. These studies suggest that prolonged exposure to increased aldosterone decreases EET concentrations.",2021,Circulating total EET concentrations increased to 18.5±12.6 from 11.9±5.9 nmol/L with treatment of primary aldosteronism ( P= 0.027).,"['patients with primary aldosteronism', '9 patients with primary aldosteronism before and at least 3 months after unilateral adrenalectomy (6) or treatment with a', 'healthy volunteers', 'rodents']","['mineralocorticoid antagonist (3', 'aldosterone', 'aldosterone or vehicle infusion']","['EET concentrations', '14,15-EET', 'Total DHET concentrations and specific regioisomers of DHET', 'Plasma Epoxyeicosatrienoic Acids', 'EET concentrations in adipose and muscle and increased sEH expression', 'Circulating total EETs', 'Circulating total EET concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035804', 'cui_str': 'Order Rodentia'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0044845', 'cui_str': '14,15-epoxy-5,8,11-eicosatrienoic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",9.0,0.0316789,Circulating total EET concentrations increased to 18.5±12.6 from 11.9±5.9 nmol/L with treatment of primary aldosteronism ( P= 0.027).,"[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Luther', 'Affiliation': 'From the Division of Clinical Pharmacology, Vanderbilt University Medical Center (J.M.L., D.S.W., D.P., N.J.B.).'}, {'ForeName': 'Dawei S', 'Initials': 'DS', 'LastName': 'Wei', 'Affiliation': 'From the Division of Clinical Pharmacology, Vanderbilt University Medical Center (J.M.L., D.S.W., D.P., N.J.B.).'}, {'ForeName': 'Kakali', 'Initials': 'K', 'LastName': 'Ghoshal', 'Affiliation': 'Division of Nephrology and Hypertension, Vanderbilt University Medical Center (K.G., A.P.).'}, {'ForeName': 'Dungeng', 'Initials': 'D', 'LastName': 'Peng', 'Affiliation': 'From the Division of Clinical Pharmacology, Vanderbilt University Medical Center (J.M.L., D.S.W., D.P., N.J.B.).'}, {'ForeName': 'Gail K', 'Initials': 'GK', 'LastName': 'Adler', 'Affiliation': ""Division of Endocrinology and Hypertension, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School (G.K.A.).""}, {'ForeName': 'Adina F', 'Initials': 'AF', 'LastName': 'Turcu', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of Michigan (A.F.T.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Nian', 'Affiliation': 'Department of Biostatistics, Vanderbilt University (H.N., C.Y.).'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University (H.N., C.Y.).'}, {'ForeName': 'Carmen C', 'Initials': 'CC', 'LastName': 'Solorzano', 'Affiliation': 'Department of Medicine and Department of Surgery, Vanderbilt University Medical Center (C.C.S.).'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Pozzi', 'Affiliation': 'Division of Nephrology and Hypertension, Vanderbilt University Medical Center (K.G., A.P.).'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Brown', 'Affiliation': 'From the Division of Clinical Pharmacology, Vanderbilt University Medical Center (J.M.L., D.S.W., D.P., N.J.B.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14808']
1218,33583199,Effect of Intensive Versus Standard Blood Pressure Control on Stroke Subtypes.,"In the SPRINT (Systolic Blood Pressure Intervention Trial), the number of strokes did not differ significantly by treatment group. However, stroke subtypes have heterogeneous causes that could respond differently to intensive blood pressure control. SPRINT participants (N=9361) were randomized to target systolic blood pressures of <120 mm Hg (intensive treatment) compared with <140 mm Hg (standard treatment). We compared incident hemorrhage, cardiac embolism, large- and small-vessel infarctions across treatment arms. Participants randomized to the intensive arm had mean systolic blood pressures of 121.4 mm Hg in the intensive arm (N=4678) and 136.2 mm Hg in the standard arm (N=4683) at one year. Sixty-nine strokes occurred in the intensive arm and 78 in the standard arm when SPRINT was stopped. The breakdown of stroke subtypes across treatment arms included hemorrhagic (intensive treatment, n=6, standard treatment, n=7) and ischemic stroke subtypes (large artery atherosclerosis: intensive treatment n=11, standard treatment, n=13; cardiac embolism: intensive treatment n=11, standard treatment n=15; small artery occlusion: intensive treatment n=8, standard treatment n=8; other ischemic stroke: intensive treatment n=3, standard treatment n=1). Fewer strokes occurred among participants without prior cardiovascular disease in the intensive (n=43) than the standard arm (n=61), but the difference did not reach predefined statistical significance level of 0.05 ( P =0.09). The interaction between baseline cardiovascular risk factor status and treatment arm on stroke risk did not reach significance ( P =0.05). Similar numbers of stroke subtypes occurred in the intensive BP control and standard control arms of SPRINT.",2021,"In the SPRINT (Systolic Blood Pressure Intervention Trial), the number of strokes did not differ significantly by treatment group.","['stroke subtypes across treatment arms included hemorrhagic (intensive treatment, n=6, standard treatment, n=7) and ischemic stroke subtypes (large artery atherosclerosis: intensive treatment n=11, standard treatment, n=13; cardiac embolism', 'SPRINT participants (N=9361', 'of 121.4 mm Hg in the intensive arm (N=4678) and', 'Stroke Subtypes']","['intensive treatment n=11, standard treatment n=15; small artery occlusion: intensive treatment n=8, standard treatment n=8; other ischemic stroke: intensive treatment n=3, standard treatment n=1', 'Intensive Versus Standard Blood Pressure Control']","['stroke subtypes', 'mean systolic blood pressures', 'number of strokes', 'Fewer strokes']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0442840', 'cui_str': 'Cardiac embolism'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226001', 'cui_str': 'Structure of small artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",9361.0,0.0817278,"In the SPRINT (Systolic Blood Pressure Intervention Trial), the number of strokes did not differ significantly by treatment group.","[{'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'From the Division of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (C.B.W.).'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Auchus', 'Affiliation': 'Department of Neurology, University of Mississippi Medical Center, Jackson (A.P.A.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH (A.L.).'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (W.T.A., J.J.W.).'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ay', 'Affiliation': 'Departments of Neurology and Radiology, Massachusetts General Hospital, Harvard Medical School, Boston (H.A.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX (J.T.B.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Tulane School of Medicine, New Orleans, LA (J.C.).'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M.).'}, {'ForeName': 'Suchita', 'Initials': 'S', 'LastName': 'Pancholi', 'Affiliation': 'Department of Medicine, University of South Carolina School of Medicine, Columbia (S.P.).'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, DC (V.P.).'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, UCLA School of Medicine, Los Angeles, CA (A.R.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sweeney', 'Affiliation': 'Department of Medicine, Emory University School of Medicine, Atlanta, GA (M.S.).'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Willard', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC (W.T.A., J.J.W.).'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI (J.Y.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham (S.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16027']
1219,33583168,Somatocognitive therapy of women with provoked vulvodynia: a pilot study.,"BACKGROUND AND AIMS


Provoked vestibulodynia (PVD) is a common persistent pain state among women in the Western world, causing dyspareunia, psychological distress and challenges against fertility. Therapies aimed at relieving pain (physiotherapy) and psychological distress (psychotherapy) are often recommended, sometimes in multimodal combinations. We have previously developed somatocognitive therapy (SCT) as a multimodal intervention, administered by a physiotherapist, to a different group of patients with gynecological pain, i.e. chronic (unprovoked) pelvic pain (CPP, also referred to as low abdominal pain). In a randomized, controlled study this intervention was shown to reduce pain experience and improve motor function or body awareness. Here we present the results of a clinical follow-up pilot study with 30 women with PVD, applying SCT administered by third year bachelor students in physiotherapy. Main outcome was pain experience, secondary outcomes were psychological distress and motor functions of the patients.
METHODS


Thirty women diagnosed with PVD were recruited from a tertiary university hospital clinic of gynecology, and included in the follow-up pilot study at an out-patient physiotherapy clinic. Each patient participated in 10-14 therapy sessions over 6 weeks. The students were supervised by an experienced physiotherapist with extensive background in this clinical area, who also performed two clinical sessions with each of the patients at the end of the treatment period. Before therapy, the patients were evaluated for pain experience (visual analogue scale of pain, VAS), psychological distress (Tampa scale of kinesiophobia, TSK) and General Health Questionnaire (GHQ-30) as well as body function (standardized Mensendieck test, SMT). Statistical analyzes were performed by using the average ± standard deviation, statistical significance of changes calculated by means of the  t -test.
RESULTS


Average pain score before therapy were 7.77 ± 1.98, after 6 weeks of intervention 4.17 ± 2.07 and at 6 months' follow-up 1.66 ± 1.08 (average ± standard deviation), changes being significant below  p  < 0.01 level. Secondary outcome variables assessing psychological distress and sub optimal motor patterns were also significantly improved. For example, anxiety and depression scores were reduced by approximately 40%, and respiration pattern score improved by almost 80%.
CONCLUSIONS


Multimodal somatocognitive therapy reduced levels of pain and psychological distress, and improved motor functions in women with PVD after 6 weeks of interventions. All variables were further improved at 6 months' follow-up. Thus, somatocognitive therapy may be a useful treatment option for patients with PVD. However, there are limitations to this study, since there was no control group, and suboptimal blinding during assessment of the data.
IMPLICATIONS


Somatocognitive therapy may be a useful tool when treating PVD patients. More studies, in particular RCTs, should be performed to further evaluate this intervention and corroborate the results from this pilot study.",2019,"For example, anxiety and depression scores were reduced by approximately 40%, and respiration pattern score improved by almost 80%.
","['patients with PVD', '30 women with PVD, applying SCT administered by third year bachelor students in physiotherapy', 'PVD patients', 'women with provoked vulvodynia', 'Thirty women diagnosed with PVD were recruited from a tertiary university hospital clinic of gynecology, and included in the follow-up pilot study at an out-patient physiotherapy clinic', 'patients with gynecological pain, i.e. chronic (unprovoked) pelvic pain (CPP, also referred to as low abdominal pain']","['somatocognitive therapy (SCT', 'Somatocognitive therapy', 'Multimodal somatocognitive therapy']","['psychological distress and motor functions of the patients', 'motor functions', 'levels of pain and psychological distress', 'psychological distress and sub optimal motor patterns', 'pain experience and improve motor function or body awareness', 'anxiety and depression scores', 'pain experience (visual analogue scale of pain, VAS), psychological distress (Tampa scale of kinesiophobia, TSK) and General Health Questionnaire (GHQ-30) as well as body function (standardized Mensendieck test, SMT', 'respiration pattern score', 'Average pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0232495', 'cui_str': 'Lower abdominal pain'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",30.0,0.043882,"For example, anxiety and depression scores were reduced by approximately 40%, and respiration pattern score improved by almost 80%.
","[{'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Kirschner', 'Affiliation': 'Department of Gynecology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Unni', 'Initials': 'U', 'LastName': 'Kirste', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Lilleheie', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tor S', 'Initials': 'TS', 'LastName': 'Haugstad', 'Affiliation': 'Pain Study Group, Sunnaas Rehabilitation Hospital, Oslo, Norway.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0011']
1220,33583165,Okada Purifying Therapy in combination with duloxetine vs. duloxetine alone in patients with TMD and fibromyalgia: a randomized clinical study.,"OBJECTIVES


This randomized study was aimed at evaluating the additional analgesic effect of Okada Purifying Therapy (OPT) when administered in combination with duloxetine in patients with Temporomandibular Disorders (TMDs) and Fibromyalgia (FM).
METHODS


Patients with TMDs visited at Department of Oral and Maxillofacial Sciences, Sapienza University of Rome who were diagnosed with FM were selected for the study. The final sample was composed of 31 patients: 15 patients were treated only with duloxetine (Group I) and 16 patients underwent also OPT treatment (Group II), for eight weeks. Craniomandibular index, total tenderness score, Brief Pain Inventory Modified Short Form, Fibromyalgia Impact Questionnaire, Beck Depression Inventory and State and Trait Anxiety Inventory-1 were assessed at the beginning (T0), during the course (T1) and after therapy (T2). Descriptive and inferential statistics were performed.
RESULTS


In all the data analyzed, both groups showed an improvement in particular between T0 and T1. No statistically significant differences were observed between the two groups during the trial, except for the interaction between treatment and time as to the ability of walking at the BPI-I (F=7.57, p=0.002). No side effects due to the duloxetine were recorded in group II compared to group I.
CONCLUSION


The additional complementary treatment (OPT) did not appear to give the patients with TMDs and FM any further benefit but it might improve pharmacological tolerability of the traditional medication.",2020,The additional complementary treatment (OPT) did not appear to give the patients with TMDs and FM any further benefit,"['patients with TMD and fibromyalgia', 'patients with Temporomandibular Disorders (TMDs) and Fibromyalgia (FM', 'Patients with TMDs visited at Department of Oral and Maxillofacial Sciences, Sapienza University of Rome who were diagnosed with FM were selected for the study', '31 patients: 15 patients were treated only with']","['OPT treatment', 'duloxetine', 'Okada Purifying Therapy (OPT', 'duloxetine vs. duloxetine']","['ability of walking at the BPI-I', 'Craniomandibular index, total tenderness score, Brief Pain Inventory Modified Short Form, Fibromyalgia Impact Questionnaire, Beck Depression Inventory and State and Trait Anxiety Inventory-1', 'pharmacological tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]",31.0,0.029827,The additional complementary treatment (OPT) did not appear to give the patients with TMDs and FM any further benefit,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Bruti', 'Affiliation': '""Sapienza"" University of Rome and Eurekacademy ETS, Rome (RM), Italy.'}, {'ForeName': 'Manuela Ramos', 'Initials': 'MR', 'LastName': 'Atencio', 'Affiliation': 'Mokichi Okada Association (MOA), Rome (RM), Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': ""D'Urso"", 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Gnathologic Division ""Sapienza"" University of Rome, Rome (RM), Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Di Giacomo', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Gnathologic Division ""Sapienza"" University of Rome, Rome (RM), Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Paolo', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Gnathologic Division ""Sapienza"" University of Rome, Rome (RM), Italy.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2020-0116']
1221,33583158,"Effects of  Artemisia  supplementation on anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial.","OBJECTIVES


One of the most important problems of hemodialysis (HD) patients is anorexia due to the lack of proper treatment for it and on the other hand kidney disease is increasing. We designed a randomized controlled clinical trial to investigate the effects of  Artemisia  supplementation on anorexia in HD patients.
MATERIALS AND METHODS


This randomized, double-blind, placebo-controlled trial was carried out on 58 subjects with HD, aged 55-65 years old. Participants were randomly divided into two groups. One group received 250 mg/day of Artemisia supplement capsule for six weeks (n=26), and the other group was given placebo for the same time duration and dosage (n=32). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically using commercial kits. Anorexia score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ). Independent t-test analysis were applied to evaluate the data.
RESULTS


The results showed that the  Artemisia  supplementation significantly improved the anorexia in HD patients, for six weeks (p<0.05). However, it did not significantly effect on the albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05).
CONCLUSION


According to the outcomes of this study, Artemisia supplementation can be effective as an adjunct therapy for improve anorexia in HD patients.",2021,"However, it did not significantly effect on the albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05).
","['HD patients', 'hemodialysis patients', '58 subjects with HD, aged 55-65 years old']","['Artemisia  supplementation', 'placebo']","['Simplified Nutritional Appetite Questionnaire (SNAQ', 'anorexia', 'albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05', 'serum concentrations of urea, creatinine, albumin and hemoglobin', 'Anorexia score']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0331308', 'cui_str': 'Artemisia'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",58.0,0.1653,"However, it did not significantly effect on the albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05).
","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohajeranirad', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Saeidi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mohammad Kamali', 'Initials': 'MK', 'LastName': 'Nejad', 'Affiliation': 'School of Pharmacy, Shaheed Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Seyed Abdullah', 'Initials': 'SA', 'LastName': 'Mahmoodi', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Almasi-Hashiani', 'Affiliation': 'Department of Epidemiology, School of Health, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Seyed Amirhossein', 'Initials': 'SA', 'LastName': 'Latifi', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of basic and clinical physiology and pharmacology,['10.1515/jbcpp-2020-0250']
1222,33583149,Topical tretinoin in chronic rhinosinusitis with nasal polyps: a randomized clinical trial.,"BACKGROUND


Chronic rhinosinusitis with nasal polyps (CRSwNP) is usually treated with corticosteroids, given their anti-inflammatory effects. Unlike the nasal administration, the oral and ocular use of tretinoin, an immunoregulatory drug, is well established. Therefore, tretinoin was thought to act on nasal polyps, and possible adverse and/or therapeutic effects were investigated.
METHODS


A first-in-human open-label trial was conducted enrolling patients with CRSwNP randomized into: a control group (CTR, n = 15), treated with budesonide for 24 weeks; and an intervention group (TRT, n = 15), who received budesonide and 0.1% tretinoin in the last 12 weeks. Primary endpoint included histopathological analysis and tissue immunoassay (Multiplex) for tumor necrosis factor α (TNF-α), interleukin (IL)-1β, IL-4, IL-5, IL-13, and matrix metalloproteinase 9 (MMP-9) at 12 and 24 weeks. Secondary endpoints were: adverse events report, endoscopy (modified Lund-Kennedy scoring system [LKS]), quality of life (22-item Sino-Nasal Outcome Test [SNOT-22]), and olfactory test (Connecticut Chemosensory Clinical Research Center) at baseline, at 12 weeks, and at 24 weeks, in addition to serum biochemistry and tomographic findings (Lund-Mackay computed tomography [CT] staging system [LMS]) at baseline and 24 weeks.
RESULTS


TRT showed less microscopic edema (2/13 [15.4%] vs 8/13 [61.5%]; p = 0.044) as well as no increase in cytokines levels. All adverse events were categorized as ""grade 1"" (asymptomatic; mild). The most interesting part of this study was the improvement in smell between baseline (T0) and week 24 (T2) in TRT only (p = 0.041).
CONCLUSION


Transnasal tretinoin associated with budesonide was safe and well tolerated, and it should be investigated as a treatment option for some CRSwNP endotypes. ©2021 ARSAAOA, LLC.",2021,"RESULTS


TRT showed less microscopic edema (2/13 [15.4%] vs 8/13 [61.5%]; p = 0.044) as well as no increase in cytokines levels.","['chronic rhinosinusitis with nasal polyps', 'Chronic rhinosinusitis with nasal polyps (CRSwNP', 'A first-in-human open-label trial was conducted enrolling patients with CRSwNP randomized into: a control group (CTR, n = 15), treated with']","['Topical tretinoin', 'budesonide and 0.1% tretinoin', 'Transnasal tretinoin', 'tretinoin', 'budesonide']","['cytokines levels', 'serum biochemistry and tomographic findings (Lund-Mackay computed tomography [CT] staging system [LMS', 'safe and well tolerated', 'histopathological analysis and tissue immunoassay (Multiplex) for tumor necrosis factor α (TNF-α), interleukin (IL)-1β, IL-4, IL-5, IL-13, and matrix metalloproteinase 9 (MMP-9', 'adverse events report, endoscopy (modified Lund-Kennedy scoring system [LKS]), quality of life (22-item Sino-Nasal Outcome Test [SNOT-22]), and olfactory test (Connecticut Chemosensory Clinical Research Center', 'microscopic edema']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C3212626', 'cui_str': 'Tretinoin-containing product in cutaneous dose form'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0430621', 'cui_str': 'Olfaction test'}, {'cui': 'C0009778', 'cui_str': 'Connecticut'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",,0.0607093,"RESULTS


TRT showed less microscopic edema (2/13 [15.4%] vs 8/13 [61.5%]; p = 0.044) as well as no increase in cytokines levels.","[{'ForeName': 'Marcelo Augusto', 'Initials': 'MA', 'LastName': 'Antonio', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, University of Campinas (Unicamp), Campinas, São Paulo, Brazil.'}, {'ForeName': 'Fernando Augusto Lima', 'Initials': 'FAL', 'LastName': 'Marson', 'Affiliation': 'Department of Medical Genetics and Genomic Medicine, Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Mariana Dalbo Contrera', 'Initials': 'MDC', 'LastName': 'Toro', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, University of Campinas (Unicamp), Campinas, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Hamilton', 'Initials': 'MH', 'LastName': 'Sampaio', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, University of Campinas (Unicamp), Campinas, São Paulo, Brazil.'}, {'ForeName': 'Icleia Siqueira', 'Initials': 'IS', 'LastName': 'Barreto', 'Affiliation': 'Department of Pathological Anatomy, Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Sérgio San Juan', 'Initials': 'SSJ', 'LastName': 'Dertkigil', 'Affiliation': 'Department of Radiology, Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Emerson Taro Inoue', 'Initials': 'ETI', 'LastName': 'Sakuma', 'Affiliation': 'Department of Radiology, Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Dioze', 'Initials': 'D', 'LastName': 'Guadagnini', 'Affiliation': 'Department of Internal Medicine, Faculty of Medical Sciences, Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Sakano', 'Affiliation': 'Department of Ophthalmology and Otorhinolaryngology, University of Campinas (Unicamp), Campinas, São Paulo, Brazil.'}]",International forum of allergy & rhinology,['10.1002/alr.22778']
1223,33583120,"Every two-month belatacept maintenance therapy in kidney transplant recipients greater than one-year post-transplant: a randomized, non-inferiority trial.","Belatacept results in improved kidney transplant outcomes, but utilization has been limited by logistical barriers related to monthly (q1m) intravenous infusions. Every 2-month (q2m) belatacept has potential to increase utilization, therefore we conducted a randomized non-inferiority trial in low immunologic risk renal transplant recipients greater than one-year post-transplant. Patients on belatacept were randomly assigned to q1m or q2m therapy. The primary objective was a non-inferiority comparison of renal function (eGFR) at 12 months with a non-inferiority margin (NIM) of 6.0 ml/min/1.73m 2  . 166 participants were randomized to q1m (n=82) or q2m (n=84) belatacept, 163 patients received treatment, and 76 q1m and 77 q2m subjects completed the 12-month study period. Every 2-month belatacept was non-inferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM. Two-month dosing was safe and well tolerated, with no patient deaths or graft losses. Four rejection episodes and three cases of donor-specific antibodies (DSA) occurred amongst q2m subjects; however, only one rejection and one instance of DSA was observed in subjects adherent to the study protocol. Every two-month belatacept therapy may facilitate long-term utilization of costimulation blockade, but future multicenter studies with longer-term follow-up will further elucidate immunologic risk.",2021,"Every 2-month belatacept was non-inferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM.","['kidney transplant recipients greater than one-year post-transplant', 'low immunologic risk renal transplant recipients greater than one-year post-transplant', '166 participants were randomized to q1m (n=82) or q2m (n=84) belatacept, 163 patients received treatment, and 76 q1m and 77 q2m subjects completed the 12-month study period']",[],"['renal function (eGFR', 'safe and well tolerated, with no patient deaths or graft losses', 'mean eGFR adjusted for baseline renal function', 'donor-specific antibodies (DSA']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3887292', 'cui_str': 'Greater than one year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C1880609', 'cui_str': 'Every two months'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}]",166.0,0.0239052,"Every 2-month belatacept was non-inferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM.","[{'ForeName': 'I Raul', 'Initials': 'IR', 'LastName': 'Badell', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Parsons', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Karadkhele', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Octav', 'Initials': 'O', 'LastName': 'Cristea', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Mead', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Shine', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Robertson', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Grace S', 'Initials': 'GS', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Hanfelt', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephen O', 'Initials': 'SO', 'LastName': 'Pastan', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16538']
1224,33583066,"Prophylactic norepinephrine infusion for postspinal anesthesia hypotension in patients undergoing cesarean section: a randomized, controlled, dose-finding trial.","BACKGROUND


Prophylactic norepinephrine infusion effectively lowers the incidence of postspinal anesthesia hypotension. The optimal prophylactic dose of norepinephrine remains undefined. The purpose of this study was to investigate the optimal prophylactic dose of norepinephrine to prevent postspinal anesthesia hypotension in patients undergoing cesarean section.
METHODS


Patients were randomly assigned into groups to receive normal saline (NS) or one of four different prophylactic doses (0.025 [NE25], 0.05 [NE50], 0.075 [NE75], and 0.1 [NE100] ug/kg/min) of norepinephrine. The primary end point was the incidence of postspinal anesthesia hypotension (systolic blood pressure [SBP] < 80% of baseline) within 15 minutes after spinal anesthesia. Secondary outcomes included the overall stability of SBP control versus baseline (median performance error [MDPE] and median absolute performance error [MDAPE]), the dose that would be effective in preventing postspinal anesthesia hypotension in 50% (effective dose, ED 50) and 90% (ED90) of patients, other adverse events (bradycardia, nausea, vomiting, hypertension, and the total additional bolus of norepinephrine and atropine), and neonatal outcomes (blood gas values and Apgar scores).
RESULTS


The incidence of postspinal anesthesia hypotension in NS, NE25, NE50, NE75, and NE100 groups was 68.42% (13/19), 40.00% (8/20), 20.00% (4/20), 15.00% (3/20), and 10.00% (2/20), respectively. With increasing prophylactic doses of norepinephrine, the incidence of postspinal anesthesia hypotension decreased (p < 0.001), SBP was maintained closer to the baseline (MDPE, p < 0.001; MDAPE, p = 0.001), and the total additional bolus of norepinephrine decreased (p < 0.001). The ED50 and ED90 values of norepinephrine were 0.016 (95% CI: -0.014 - 0.033) and 0.088 (95% CI: 0.068 - 0.133) ug/kg/min, respectively. Other adverse effects, neonatal outcomes, and the total additional bolus of atropine did not differ among the five groups.
CONCLUSION


A prophylactic dose of 0.05 or 0.075 μg/kg/min norepinephrine prevents postspinal anesthesia hypotension in patients undergoing cesarean section.",2021,"With increasing prophylactic doses of norepinephrine, the incidence of postspinal anesthesia hypotension decreased (p < 0.001), SBP was maintained closer to the baseline (MDPE, p < 0.001; MDAPE, p = 0.001), and the total additional bolus of norepinephrine decreased (p < 0.001).","['patients undergoing cesarean section', 'Patients']","['norepinephrine', 'Prophylactic norepinephrine infusion', 'normal saline (NS']","['ED50 and ED90 values of norepinephrine', 'postspinal anesthesia hypotension', 'total additional bolus of norepinephrine', 'SBP', 'overall stability of SBP control versus baseline (median performance error [MDPE] and median absolute performance error [MDAPE', 'total additional bolus of atropine', 'incidence of postspinal anesthesia hypotension (systolic blood pressure [SBP', 'adverse events (bradycardia, nausea, vomiting, hypertension, and the total additional bolus of norepinephrine and atropine), and neonatal outcomes (blood gas values and Apgar scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}]",,0.240481,"With increasing prophylactic doses of norepinephrine, the incidence of postspinal anesthesia hypotension decreased (p < 0.001), SBP was maintained closer to the baseline (MDPE, p < 0.001; MDAPE, p = 0.001), and the total additional bolus of norepinephrine decreased (p < 0.001).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Zhenzhou', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China.'}]",Pharmacotherapy,['10.1002/phar.2514']
1225,33583034,Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: protocol and statistical analysis plan.,"BACKGROUND


The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear.
METHODS


The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol.
DISCUSSION


The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.",2021,"The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28.","['enrol 1,000 patients in Denmark, Sweden, Switzerland and India', 'adults with COVID-19 and severe hypoxia', 'patients with severe COVID-19', 'COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society']","['Systemic low-dose corticosteroids', 'corticosteroids', 'Dexamethasone', 'dexamethasone']","['days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy', 'Kryger Jensen and Lange test adjusted for stratification variables', 'serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.290557,"The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Munch', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Bharath Kumar Tirupakuzhi', 'Initials': 'BKT', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India and Chennai Critical Care Consultants, Chennai, India.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases, Dept. of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Denmark.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Micallef', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Bassi', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Oommen', 'Initials': 'O', 'LastName': 'John', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle Kristiansen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Smitt', 'Affiliation': 'Department of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesiology Intensive Care, Copenhagen University Hospital, Nordsjaelland, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Mohd Saif', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Padmanaban', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India and Chennai Critical Care Consultants, Chennai, India.'}, {'ForeName': 'Jigeeshu Vasishtha', 'Initials': 'JV', 'LastName': 'Divatia', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sanjith', 'Initials': 'S', 'LastName': 'Saseedharan', 'Affiliation': 'Department of Intensive Care, SL Raheja Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Borawake', 'Affiliation': 'Department of Intensive Care, Vishwaraj Hospital, Pune, India.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Kapadia', 'Affiliation': 'Section of Critical Care, Department of Medicine, Hinduja Hospital, Mahim, Mumbai, India.'}, {'ForeName': 'Subhal', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Critical Care Medicine, Sanjeevan Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Indraprastha Apollo Hospital, New Delhi, India.'}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Intensive Care Unit and Emergency Services, Symbiosis University Hospital and Research Centre, Lavale, Pune, India.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Amin', 'Affiliation': 'Department of Critical Care Medicine, Bombay Hospital Institute of Medical Sciences, Mumbai, India.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13795']
1226,33583027,Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: protocol for a secondary Bayesian analysis.,"BACKGROUND


Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs. lower doses of dexamethasone (12 vs. 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia.
METHODS


This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors.
DISCUSSION


This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results.",2021,Corticosteroids decrease mortality in severely or critically ill patients with COVID-19.,"['severely or critically ill patients with COVID-19', '1,000 adult patients with COVID-19 and severe hypoxia']","['Dexamethasone', 'dexamethasone']",['Corticosteroids decrease mortality'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1000.0,0.24484,Corticosteroids decrease mortality in severely or critically ill patients with COVID-19.,"[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Munch', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Bharath Kumar Tirupakuzhi', 'Initials': 'BKT', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India and Chennai Critical Care Consultants, Chennai, India.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases, Dept. of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Denmark.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Micallef', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Bassi', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Oommen', 'Initials': 'O', 'LastName': 'John', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle Kristiansen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Smitt', 'Affiliation': 'Department of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesiology Intensive Care, Copenhagen University Hospital, Nordsjaelland, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology, Zealand University Hospital, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Mohd Saif', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Padmanaban', 'Affiliation': 'Department of Critical Care, Apollo Hospitals, Chennai, India and Chennai Critical Care Consultants, Chennai, India.'}, {'ForeName': 'Jigeeshu', 'Initials': 'J', 'LastName': 'Vasishtha Divatia', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sanjith', 'Initials': 'S', 'LastName': 'Saseedharan', 'Affiliation': 'Department of Intensive Care, SL Raheja Hospital, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Borawake', 'Affiliation': 'Department of Intensive Care, Vishwaraj Hospital, Pune, India.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Kapadia', 'Affiliation': 'Section of Critical Care, Department of Medicine, Hinduja Hospital, Mahim, Mumbai, India.'}, {'ForeName': 'Subhal', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Critical Care Medicine, Sanjeevan Hospital, Pune, Maharashtra, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Chawla', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Indraprastha Apollo Hospital, New Delhi, India.'}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Intensive Care Unit and Emergency Services, Symbiosis University Hospital and Research Centre, Lavale, Pune, India.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Amin', 'Affiliation': 'Department of Critical Care Medicine, Bombay Hospital Institute of Medical Sciences, Mumbai, India.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Chew', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, University of Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13793']
1227,33583000,The sarcopenia and physical frailty in older people: multi-component treatment strategies (SPRINTT) project: description and feasibility of a nutrition intervention in community-dwelling older Europeans.,"BACKGROUND


The ""Sarcopenia and Physical Frailty in Older People: Multicomponent Treatment Strategies"" (SPRINTT) project sponsored a multi-center randomized controlled trial (RCT) with the objective to determine the effect of physical activity and nutrition intervention for prevention of mobility disability in community-dwelling frail older Europeans. We describe here the design and feasibility of the SPRINTT nutrition intervention, including techniques used by nutrition interventionists to identify those at risk of malnutrition and to carry out the nutrition intervention.
METHODS


SPRINTT RCT recruited older adults (≥ 70 years) from 11 European countries. Eligible participants (n = 1517) had functional limitations measured with Short Physical Performance Battery (SPPB score 3-9) and low muscle mass as determined by DXA scans, but were able to walk 400 m without assistance within 15 min. Participants were followed up for up to 3 years. The nutrition intervention was carried out mainly by individual nutrition counseling. Nutrition goals included achieving a daily protein intake of 1.0-1.2 g/kg body weight, energy intake of 25-30 kcal/kg of body weight/day, and serum vitamin D concentration ≥ 75 mmol/L. Survey on the method strategies and feasibility of the nutrition intervention was sent to all nutrition interventionists of the 16 SPRINTT study sites.
RESULTS


Nutrition interventionists from all study sites responded to the survey. All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority. The identification of participants at nutritional risk was accomplished by combining information from interviews, questionnaires, clinical and laboratory data. Although the nutrition intervention was mainly carried out using individual nutritional counselling, other assisting methods were used as appropriate.
CONCLUSION


The SPRINTT nutrition intervention was feasible and able to adapt flexibly to varying needs of this heterogeneous population. The procedures adopted to identify older adults at risk of malnutrition and to design the appropriate intervention may serve as a model to deliver nutrition intervention for community-dwelling older people with mobility limitations.",2021,"All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority.","['Eligible participants (n\u2009=\u20091517) had functional limitations measured with Short Physical Performance Battery (SPPB score 3-9) and low muscle mass as determined by DXA scans, but were able to walk 400\xa0m without assistance within 15\xa0min', 'Older People', 'SPRINTT RCT recruited older adults (≥\u200970\xa0years) from 11 European countries', 'older people', 'community-dwelling older Europeans', 'older adults at risk of malnutrition', 'community-dwelling frail older Europeans', 'community-dwelling older people with mobility limitations']","['physical activity and nutrition intervention', 'nutrition intervention', 'SPRINTT nutrition intervention']",['mobility disability'],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0195684,"All responders found that the SPRINTT nutrition intervention was feasible for the target population, and it was well received by the majority.","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland. satu.jyvakorpi@gery.fi.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramel', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Strandberg', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Piotrowicz', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Błaszczyk-Bębenek', 'Affiliation': 'Department of Nutrition and Drug Research, Institute of Public Health, Faculty of Health Science, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Urtamo', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Rempe', 'Affiliation': 'Institute for Biomedicine of Aging, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Ó', 'Initials': 'Ó', 'LastName': 'Geirsdóttir', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vágnerová', 'Affiliation': '1St Faculty of Medicine, Department of Gerontology & Geriatrics, Charles University in Prague, General University Hospital Prague, Nové Město, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Billot', 'Affiliation': 'PRISMATICS Lab (Predictive Research In Spine/Neuromodulation Management And Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Larreur', 'Affiliation': 'Department of Geriatrics, University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Savera', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Soriano', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Picauron', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tagliaferri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sanchez-Puelles', 'Affiliation': 'University Hospital Getafe, Madrid, Spain.'}, {'ForeName': 'V Sánchez', 'Initials': 'VS', 'LastName': 'Cadenas', 'Affiliation': 'University Hospital Ramon Y Cajal Madrid, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perl', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tirrel', 'Affiliation': 'Diabetes Frail, Medici Medical Practice, Luton, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Öhman', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Weling-Scheepers', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ambrosi', 'Affiliation': 'IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Costantini', 'Affiliation': 'IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pavelková', 'Affiliation': 'Silesian Hospital, Opava, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klimkova', 'Affiliation': 'Silesian Hospital, Opava, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Freiberger', 'Affiliation': '1St Faculty of Medicine, Department of Gerontology & Geriatrics, Charles University in Prague, General University Hospital Prague, Nové Město, Czech Republic.'}, {'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Jonsson', 'Affiliation': 'The Icelandic Gerontological Research Center, The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Clinicum, Department of General Practice, Helsinki University Central Hospital, University of Helsinki, Tukholmankatu 8 B, 00014, Helsinki, Finland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Landi', 'Affiliation': 'Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Fondazione Policlinico Universitario ""A. Gemelli"" IRCCS, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European geriatric medicine,['10.1007/s41999-020-00438-4']
1228,33582875,The usefulness of Smart Pilot View for fast recovery from desflurane general anesthesia.,"INTRODUCTION


Smart Pilot View (SPV) (Dräger Medical) provide information about the estimated drug effect of anesthetic drugs. We conducted a prospective randomized trial to evaluated the recovery time in SPV-guided general anesthesia compared with usual practice in patients with desflurane general anesthesia.
METHOD


Thirty-four American Society of Anesthesiologist's physical status I-II patients scheduled for elective surgery under general anesthesia were enrolled in the study. The patients were allocated to one of the following two groups: the Smart Pilot View group (group SPV) or the control group (group C). General anesthesia was induced by propofol and maintained by desflurane end-tidal concentration of 4.2%. During the procedure, desflurane concentration was adjusted to maintain BIS values between 40 and 60 and above MAC 90. In group SPV, desflurane concentration and infusion rate of remifentanil were decreased to achieve MAC 90 about 10 min before the end of the procedure. In group C, the desflurane concentration and infusion rate of remifentanil were maintained unchanged until the end of the procedure.
RESULTS


Fifteen patients were enrolled in group C, and seventeen of these were enrolled in group SPV. The time taken for the opening of the patient's eyes was 292 ± 53 s in group C and 218 ± 44 s in group SPV. The time taken for recovery of orientation was 451 ± 100 s in group C and 316 ± 57 s in group SPV. Both times were significantly faster in the group SPV.
CONCLUSION


Smart Pilot View guided anesthesia enabled faster recovery from desflurane general anesthesia.",2021,"Both times were significantly faster in the group SPV.
CONCLUSION


Smart Pilot View guided anesthesia enabled faster recovery from desflurane general anesthesia.","['patients with desflurane general anesthesia', ""Thirty-four American Society of Anesthesiologist's physical status"", 'I-II patients scheduled for elective surgery under general anesthesia were enrolled in the study', 'Fifteen patients were enrolled in group C, and seventeen of these were enrolled in group SPV']","['Smart Pilot View group (group SPV', 'SPV-guided general anesthesia', 'usual practice']",['desflurane concentration and infusion rate of remifentanil'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",15.0,0.0173576,"Both times were significantly faster in the group SPV.
CONCLUSION


Smart Pilot View guided anesthesia enabled faster recovery from desflurane general anesthesia.","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan. yasumorimo@gmail.com.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Shiramoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}]",Journal of anesthesia,['10.1007/s00540-021-02905-z']
1229,33582852,Outcome comparison of submucous resection versus combined submucous diathermy and outfracture for treatment of inferior turbinate hypertrophy.,"OBJECTIVES


The aim of this study was to compare the outcome of submucous resection and combined submucous diathermy with outfracture technique in treatment of nasal obstruction caused by inferior turbinate hypertrophy.
METHODS


This study is a prospective randomized clinical trial involving 90 patients with hypertrophied inferior turbinate not responding to medical treatment. All patients were selected with equal or near equal mucosal and bony turbinate components using computed tomography (CT) and then randomly allocated into two groups; group A (n = 45): underwent submucous resection in both sides and group B (n = 45): underwent combined submucous diathermy and outfracture in both sides. Subjective (NOSE score) and objective (4-grades endoscopic classification system and PNIF evaluation) measures of nasal airflow were done preoperatively and postoperatively.
RESULTS


Subjective assessment using NOSE scale proved that both techniques were effective in relieving nasal obstruction as it improved in both groups postoperatively compared to the preoperative data. However, resection technique was better than diathermy technique with a statistically significant difference (p < 0.05), while objective assessment of nasal obstruction showed better results in resection group than diathermy group, but with no statistically significant difference.
CONCLUSION


Both techniques are effective in relief of nasal obstruction due to inferior turbinate hypertrophy. However, submucous resection showed marked improvement compared to diathermy technique especially at long-term follow-up.",2021,"However, resection technique was better than diathermy technique with a statistically significant difference (p < 0.05), while objective assessment of nasal obstruction showed better results in resection group than diathermy group, but with no statistically significant difference.
","['90 patients with hypertrophied inferior turbinate not responding to medical treatment', 'inferior turbinate hypertrophy', 'All patients were selected with equal or near equal mucosal and bony turbinate components using']","['submucous resection in both sides and group B (n\u2009=\u200945): underwent combined submucous diathermy and outfracture in both sides', 'computed tomography (CT', 'submucous resection and combined submucous diathermy with outfracture technique', 'submucous resection versus combined submucous diathermy and outfracture']","['objective assessment of nasal obstruction', 'relieving nasal obstruction', 'Subjective (NOSE score) and objective (4-grades endoscopic classification system and PNIF evaluation) measures of nasal airflow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0225434', 'cui_str': 'Inferior nasal turbinate bone structure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C1266928', 'cui_str': 'Nasal turbinate bone structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0188993', 'cui_str': 'Submucous resection of nasal septum'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}]",90.0,0.0175953,"However, resection technique was better than diathermy technique with a statistically significant difference (p < 0.05), while objective assessment of nasal obstruction showed better results in resection group than diathermy group, but with no statistically significant difference.
","[{'ForeName': 'Nariman Abdel-Salam', 'Initials': 'NA', 'LastName': 'Elshipli', 'Affiliation': 'Manzala General Hospital, Al Manzalah, 35511, Dakahlia, Egypt. nariman_elshipli@yahoo.com.'}, {'ForeName': 'Hossam Elsayed', 'Initials': 'HE', 'LastName': 'El-Sisi', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed Musaad Abd', 'Initials': 'AMA', 'LastName': 'El-Fattah', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed Abd El-Halem', 'Initials': 'MAE', 'LastName': 'Al-Saddeik', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-021-06663-2']
1230,33582788,Effective recruitment strategies for African-American men and women: the Nutritious Eating with Soul study.,"Previous studies have found it challenging to recruit African-American (AA) participants into health education research studies. The goal of this article is to describe the recruitment methods used for the Nutritious Eating with Soul (NEW Soul) study, a 2-year randomized behavioral health education intervention, conducted in two cohorts, with emphasis on methods used for reaching men. Participants indicated how they learned about the study on an online screening questionnaire from a list of the recruitment strategies we employed. Due to limited recruitment of men in Cohort 1, recruitment strategies for Cohort 2 focused on reaching men. Across the two cohorts, a total of 568 (23% men) participants completed the online screener and 159 (21% men) completed all baseline assessments and enrolled in the study. The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events. Men were primarily recruited via radio ads, whereas women were more often recruited through TV and social media. Radio was an effective way to recruit AA adults into nutrition interventions, particularly men. In addition, low-cost methods, such as personal referrals, social media posts and community events were also effective strategies.",2021,"The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events.","['African-American men and women', 'Nutritious Eating with Soul (NEW Soul) study, a 2-year randomized behavioral health education intervention, conducted in two cohorts, with emphasis on methods used for reaching men', 'Men were primarily recruited via radio ads, whereas women were more often recruited through TV and social media', 'two cohorts, a total of 568 (23% men) participants completed the online screener and 159 (21% men) completed all baseline assessments and enrolled in the study']",[],[],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],[],568.0,0.0294487,"The most effective methods for completing screening questionnaires were radio ads, referrals from friends and family, TV interviews, social media posts and community events.","[{'ForeName': 'Gabrielle M', 'Initials': 'GM', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Wilson', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Shiba', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bernhart', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Columbia, SC 29208, USA.'}, {'ForeName': 'E Angela', 'Initials': 'EA', 'LastName': 'Murphy', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, School of Medicine, University of South Carolina, 6439 Garners Ferry Rd, Columbia, SC 29209, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': 'Prevention Research Center, Arnold School of Public Health, University of South Carolina, 921 Assembly Street, Columbia, SC 29208, USA.'}]",Health education research,['10.1093/her/cyab003']
1231,33582693,Investigating the Efficacy of Triple Drug Therapy and Sequential Drug Therapy in the Eradication of Helicobacter Pylori with Respect to Antigen Stool test: A Pilot Study.,"Background Helicobacter pylori is one of the most prevalent infectious disease worldwide. The treatment regimens involve mainly two therapies: Standard Triple drug therapy and Sequential drug therapy. Several studies have shown that the sequential therapy has higher eradication rates of H. pylori than the standard triple drug therapy and since proper study on sequential drug therapy and standard triple drug therapy is still lacking in Nepal, this study is attempted to compare efficacy of Sequential Drug Therapy in the eradication of H. pylori in gastritis with respect to the Standard triple drug therapy. Objective To investigate the efficacy of Triple Drug Therapy and Sequential Drug Therapy in the eradication of Helicobacter pylori with respect to Antigen Stool test. Method This study was the prospective study conducted in 62 patients attending the Department of Gastroenterology, Dhulikhel Hospital, meeting the inclusion criteria who were confirmed as H. pylori positive by histopathology and stool antigen test. Patients were randomized into two groups. One group prescribed with Standard triple drug regimen and another group with Sequential drug regimen. Eradication of H. pylori infection was confirmed by repeating the stool antigen test at least five weeks after the completion of the regimen. Result Among the 62 participants included in this study, 54.5% of them were males. Among the study population, the eradication achieved by standard triple drug therapy was 87.8% and 89.6% with Sequential drug therapy. Higher numbers (82.3%) of patients were compliant to the prescribed medication. Forgetfulness was the main reason for missing the dose (91%) of the non-compliant patients. Conclusion The study revealed an equal efficacy of both Standard Triple drug regimen and Sequential drug regimen in the eradication of H. pylori infection. Further, Stool antigen test can be preferred as a non-invasive test, for diagnosis of H. pylori infection, monitoring the response to treatment and in epidemiological studies.",2020,The study revealed an equal efficacy of both Standard Triple drug regimen and Sequential drug regimen in the eradication of H. pylori infection.,"['62 participants included in this study, 54.5% of them were males', '62 patients attending the Department of Gastroenterology, Dhulikhel Hospital, meeting the inclusion criteria who were confirmed as H. pylori positive by histopathology and stool antigen test']",['Triple Drug Therapy and Sequential Drug Therapy'],"['eradication of H. pylori infection', 'eradication rates', 'Eradication of H. pylori infection', 'Forgetfulness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0243140', 'cui_str': 'histopathology'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0729856', 'cui_str': 'Antigen test'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0542476', 'cui_str': 'Forgetful'}]",,0.0196704,The study revealed an equal efficacy of both Standard Triple drug regimen and Sequential drug regimen in the eradication of H. pylori infection.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Department of Pharmacology, Pharmacovigillance Unit/ Research and Development Division, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Poudel', 'Affiliation': 'Department of Pharmacology, Nepal Medical, College, Jorpati, Kathmandu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shakya', 'Affiliation': 'Department of Pharmacology, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Gurung', 'Affiliation': 'Department of Internal Medicine, Kathmandu University School of Medical Sciences, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Makaju', 'Affiliation': 'Department of Pathology, Kathmandu University School of Medical Sciences, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koju', 'Affiliation': 'Pharmacovigillance Unit/ Research and Development Division, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre.'}]",Kathmandu University medical journal (KUMJ),[]
1232,33582692,Study of Dexmedetomidine in Caudal Block for Children Undergoing Inguino-scrotal Surgery.,"Background Caudal block is the most common anaesthetic technique employed in children for managing perioperative pain of inguino-scrotal surgery. However, despite using longacting local anaesthetics, caudal analgesia lasts relatively shorter. Dexmedetomidine, an alpha-2 agonist, augments local anaesthetic action. Objective To assess the analgesic effect of caudal Dexmedetomidine. Method This is a randomized, double-blinded study conducted on otherwise healthy children (one to five years) undergoing elective inguino-scrotal surgery. General anaesthesia was administered and a laryngeal mask airway was inserted for assisting ventilation. The caudal block was applied using 0.8 milliliters/kilogram drug volume comprising either two milligrams/kilogram Bupivacaine in group A (n=42) or two milligrams/ kilogram Bupivacaine mixed with 0.75 micrograms/kilogram Dexmedetomidine in group B (n=42). Intraoperatively, inhaled Halothane, intravenous Fentanyl, fluids, and ventilation were titrated to maintain monitored hemodynamic variables within 15% from baseline values. The primary endpoint comprised the duration of analgesia, defined by a time when postoperative pain score (face, legs, activity, cry, consolability; FLACC scale) reached four out of ten. Perioperative events were studied for 24 hours. Student's t-test and Chi-square test were used for analysis, with p-value less than 0.05 considered as significant. Result Demographic, surgical, and anaesthetic characteristics were similar between the groups. Duration of analgesia was significantly prolonged in group B (group B, 413±101 minutes; group A, 204±40 minutes). The intraoperative requirement for supplement Fentanyl was significantly reduced in group B. Adverse events were comparable between the groups. Conclusion Dexmedetomidine prolongs the duration of analgesia when mixed with caudal Bupivacaine, without increasing adverse events.",2020,"Duration of analgesia was significantly prolonged in group B (group B, 413±101 minutes; group A, 204±40 minutes).","['Children Undergoing Inguino-scrotal Surgery', 'otherwise healthy children (one to five years) undergoing elective inguino-scrotal surgery']","['Dexmedetomidine', 'Halothane, intravenous Fentanyl, fluids, and ventilation', 'caudal Dexmedetomidine', 'milligrams/ kilogram Bupivacaine mixed with 0.75 micrograms/kilogram Dexmedetomidine', 'Bupivacaine']","['Result Demographic, surgical, and anaesthetic characteristics', 'duration of analgesia', 'duration of analgesia, defined by a time when postoperative pain score (face, legs, activity, cry, consolability; FLACC scale', 'Perioperative events', 'Adverse events', 'Duration of analgesia', 'adverse events', 'intraoperative requirement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036471', 'cui_str': 'Scrotal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0018549', 'cui_str': 'Halothane'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1627892', 'cui_str': 'ug/kg'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",,0.130329,"Duration of analgesia was significantly prolonged in group B (group B, 413±101 minutes; group A, 204±40 minutes).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gautam', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Kathmandu Medical College Teaching Hospital, Sinamangal, Kathmandu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Piya', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Kathmandu Medical College Teaching Hospital, Sinamangal, Kathmandu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Karki', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Kathmandu Medical College Teaching Hospital, Sinamangal, Kathmandu.'}]",Kathmandu University medical journal (KUMJ),[]
1233,33582687,An Open Label Prospective Study on Evaluation of Safety and Efficacy of Cilnidipine Over Amlodipine in Stage 1 Hypertensive Patients.,"Background Calcium channel blockers are considered the first line drug over renin-angiotensinaldosterone system inhibitor in black population and with renin-angiotensinaldosterone system inhibitor in non-black population with Hypertension. Amlodipine has longer biological half life and lower potential to stimulate SNS. But, is associated with reflex tachycardia and pedal oedema. Cilnidipine has potent inhibitory both on voltage gated L-type and N-type calcium channels with better anti-proteinuric effect and good tolerability. Hence, our study compared the efficacy, safety and compliance of cilnidipine over amlodipine in Stage 1 hypertensive subjects. Objective To find out antihypertensive and renoprotective effect of cilnidipine. Method The study was open-label, single centre, prospective, parallel design, randomized controlled was done in Outdoor Patient Department (OPD) of Medicine and Department of Pharmacology in Burdwan Medical College and Hospital (BMCH). Patients with stage 1 HTN received cilnidipine while the other group received amlodipine. There were 4 follow-up visits for each participant consisting of baseline, 1 week, 6 weeks and after 12 weeks. Clinical parameters including pulse rate, blood pressure and ankle oedema noted also laboratory investigations were done. Safety parameters with adverse events and compliance by traditional pill count method. Result Blood pressure was effectively decreased by both amlodipine and cilnidipine. Cilnidipine significantly decreased Pulse Rate while amlodipine increased it and the difference in Pulse Rate comparing both the groups was statistically significant. None of the ADRs were statistically significant except pedal oedema. Pedal oedema was noted only in amlodipine arm and was statistically significant. Compliance to both the drugs was excellent. Total cost of therapy was higher with cilnidipine. Conclusion Though amlodipine is preferred drug, cilnidipine should be a better alternative when we consider subjects with sympathetic over activity, proteinuria or pedal oedema.",2020,None of the ADRs were statistically significant except pedal oedema.,"['Outdoor Patient Department (OPD) of Medicine and Department of Pharmacology in Burdwan Medical College and Hospital (BMCH', 'Stage 1 Hypertensive Patients', 'Stage 1 hypertensive subjects', 'subjects with sympathetic over activity, proteinuria or pedal oedema']","[' Calcium channel blockers', 'Cilnidipine', 'cilnidipine', 'Cilnidipine Over Amlodipine', 'cilnidipine over amlodipine', 'Amlodipine', 'amlodipine']","['Result Blood pressure', 'Pulse Rate', 'pedal oedema', 'pulse rate, blood pressure and ankle oedema', 'reflex tachycardia and pedal oedema', 'Pedal oedema', 'Total cost of therapy', 'efficacy, safety and compliance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0574002', 'cui_str': 'Edema of foot'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0378675', 'cui_str': 'cilnidipine'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0574002', 'cui_str': 'Edema of foot'}, {'cui': 'C0235439', 'cui_str': 'Ankle edema'}, {'cui': 'C1328539', 'cui_str': 'Reflex tachycardia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0190351,None of the ADRs were statistically significant except pedal oedema.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Harlalka', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College and Hospital, India.'}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'Roy', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College and Hospital, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Majumdar', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College and Hospital, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Das', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College and Hospital, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mandal', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College and Hospital, India.'}]",Kathmandu University medical journal (KUMJ),[]
1234,33582688,"Outcome of Uretero Renoscopic Lithotripsy (URSL) with Holmium LASER Vs Pneumatic Lithotripter for Lower Ureteric Stones, Experience from University Hospital of Nepal.","Background There are various methods of endoluminal ureteral stone fragmentation. Among various modalities Laser lithotripsy and Pneumatic lithotripsy are commonly used and have shown comparable outcomes. Objective To compare the efficacy and outcome of laser and pneumatic lithotripsy in a patient with lower ureteric calculi. The comparison will be done in stone free rate, migration of stone and complication of the procedure. Method This is a prospective comparative study in a cohort of patients at University Hospital with Lower Ureteric stone. Ninety patients were randomized in to two groups (Laser Lithotripsy Vs Pneumatic Lithotripsy) during the study period. The purpose of this study was to measure the immediate stone free rate, intra-operative complications, mean operative time, post-operative complication and if any stone retention after six weeks follow up. Result Both the groups were similar in Age and Gender. Immediate stone free rate was slightly higher in Laser lithotripsy group (97.77%) in comparison to Pneumatic lithotripter group (84.44%) with p=0.507 which is not statistically significant. There was statistical difference in terms of stone migration rate, mean operation time in favor of Laser Lithotripsy group (p<0.01, in both parameters). There were no immediate complications in both the group however there were three cases of short segment ureteric strictures (6.66%) in case of Pneumatic lithotripsy on six weeks follow up which was managed conservatively. Conclusion Both LASER lithotripter and Pneumatic lithotripter are equally efficacious modality of endoluminal URSL in lower ureteric stone with similar Stone Free Rate. Laser lithotripsy showed lower frequency of stone migration and had shorter procedure time.",2020,Immediate stone free rate was slightly higher in Laser lithotripsy group (97.77%) in comparison to Pneumatic lithotripter group (84.44%) with p=0.507 which is not statistically significant.,"['patient with lower ureteric calculi', 'Ninety patients', 'Lower Ureteric Stones, Experience from University Hospital of Nepal', 'patients at University Hospital with Lower Ureteric stone']","['Pneumatic lithotripter', 'Uretero Renoscopic Lithotripsy (URSL) with Holmium LASER Vs Pneumatic Lithotripter', 'Laser Lithotripsy Vs Pneumatic Lithotripsy', 'Laser lithotripsy', 'Laser lithotripsy and Pneumatic lithotripsy', 'Pneumatic lithotripsy', 'Laser Lithotripsy', 'LASER lithotripter and Pneumatic lithotripter', 'laser and pneumatic lithotripsy']","['frequency of stone migration', 'immediate stone free rate, intra-operative complications, mean operative time, post-operative complication and if any stone retention', 'Immediate stone free rate', 'stone migration rate, mean operation time', 'short segment ureteric strictures', 'immediate complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0181670', 'cui_str': 'Lithotripter'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0181676', 'cui_str': 'Laser lithotripter'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]",90.0,0.0332332,Immediate stone free rate was slightly higher in Laser lithotripsy group (97.77%) in comparison to Pneumatic lithotripter group (84.44%) with p=0.507 which is not statistically significant.,"[{'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Joshi', 'Affiliation': 'Department of Surgery, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Koirala', 'Affiliation': 'Department of Surgery, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Karmacharya', 'Affiliation': 'Department of Surgery, Dhulikhel Hospital, Kathmandu University Hospital, Dhulikhel, Kavre, Nepal.'}]",Kathmandu University medical journal (KUMJ),[]
1235,33582682,Comparative Efficacy of Fexofenadine Versus Levocetrizine Versus Desloratadine via 1% Histamine Wheal Suppression Test.,"Background Urticaria and allergic dermatoses remains a great challenge to treating dermatologist. Histamine is the major mediator in such disorders. Antihistamines as levocetrizine, fexofenadine and desloratadine are often used to treat such conditions. Ability of antihistamines to suppress the allergic response helps to evaluate the efficacy of the medicine. Objective To compare the efficacy of levocetrizine versus fexofenadine versus desloratadine in suppressing histamine induced wheals in adults. Method One hundred and two healthy adult volunteers completed the study. Subjects were randomized into 3 groups using an envelope method. First group received fexofenadine (N=36), second group received levocetrizine (N =37), and third group received desloratadine (N=29). Pretesting was performed by skin prick test with histamine 1% (positive control) and normal saline (negative control). Wheal size was recorded before and after the treatment (at 0.5, 1, 2, 4 and 24 hours). Result At 30 minutes and 1 hour fexofenadine showed statistically significant wheal suppression than levocetrizine and desloratadine (p=0.0016). However by 2 and 4 hours all three antihistamines; fexofenadine, levocetirizine and desloratadine showed significant suppression of wheal. Whereas at 24 hours desloratadine showed greater wheal suppression than levocetrizine and fexofenadine (p= 0.014). Conclusion The results of the present study showed that fexofenadine presented early onset of action but longer suppression of wheal size was seen with desloratadine as compared to other antihistamines. These potentials could be employed in clinical aspects; depending upon the response needed.",2020,At 30 minutes and 1 hour fexofenadine showed statistically significant wheal suppression than levocetrizine and desloratadine (p=0.0016).,"['adults', 'Method One hundred and two healthy adult volunteers completed the study']","['Fexofenadine Versus Levocetrizine Versus Desloratadine', 'levocetrizine', 'fexofenadine', 'desloratadine', 'antihistamines; fexofenadine, levocetirizine', 'levocetrizine and fexofenadine', 'histamine 1% (positive control) and normal saline (negative control', 'levocetrizine and desloratadine', 'levocetrizine, fexofenadine and desloratadine', 'Antihistamines', 'Histamine', 'antihistamines']","['wheal size', 'suppression of wheal', 'Wheal size', 'wheal suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0296800', 'cui_str': 'fexofenadine'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C0252352', 'cui_str': 'des(ethoxycarbonyl)loratadine'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",102.0,0.0232201,At 30 minutes and 1 hour fexofenadine showed statistically significant wheal suppression than levocetrizine and desloratadine (p=0.0016).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kc', 'Affiliation': 'Department of Dermatology, Kathmandu University School of Medical Sciences, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aryal', 'Affiliation': 'Department of Dermatology, Kathmandu University School of Medical Sciences, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Adhikary', 'Affiliation': 'Department of Dermatology, Kathmandu University School of Medical Sciences, Dhulikhel, Kavre, Nepal.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Karn', 'Affiliation': 'Department of Dermatology, Kathmandu University School of Medical Sciences, Dhulikhel, Kavre, Nepal.'}]",Kathmandu University medical journal (KUMJ),[]
1236,33582664,"Colchicine for Left Ventricular Infarct Size Reduction in Acute Myocardial Infarction: A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Protocol - The COVERT-MI Study.","Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI). They add damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. Colchicine is a well-known alkaloid with potent anti-inflammatory properties. In a proof-of-concept phase II trial, colchicine has been associated with a significant 50% reduction of infarct size (assessed by creatine kinase levels) in comparison to placebo in acute STEMI patients referred for primary percutaneous coronary intervention (PPCI). The Colchicine in STEMI Patients Study (COVERT-MI) is an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether a short course oral treatment with colchicine versus placebo decreases myocardial injury in patients presenting with STEMI referred for PPCI. Adult patients, with a first STEMI episode and an initial TIMI flow ≤1, referred for PPCI, will be randomized (n = 194) in a 1:1 ratio to receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. treatment during 5 days or matching placebo. The primary endpoint will be the reduction in infarct size as assessed by cardiac magnetic resonance at 5 ± 2 days between both groups. The main secondary endpoints will be tested between groups in hierarchical order with left ventricular ejection fraction at 5 days, microvascular obstruction presence at 5 days, and absolute adverse left ventricular remodeling between 5 days and 3 months. This academic study is being financed by a grant from the French Ministry of Health (PHRCN-16-0357). Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present study describes the rationale, design, and methods of the trial.",2021,Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI).,"['acute STEMI patients referred for primary percutaneous coronary intervention (PPCI', 'patients presenting with STEMI referred for PPCI', 'Acute Myocardial Infarction', 'Adult patients, with a first STEMI episode and an initial TIMI flow ≤1, referred for PPCI']","['placebo', 'colchicine versus placebo', 'Colchicine', 'colchicine of 2 mg followed by 0.5 mg b.i.d', 'Placebo', 'colchicine']","['hierarchical order with left ventricular ejection fraction at 5 days, microvascular obstruction presence at 5 days, and absolute adverse left ventricular remodeling', 'infarct size', 'reduction in infarct size as assessed by cardiac magnetic resonance']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]",,0.668017,Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI).,"[{'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Bresson', 'Affiliation': 'University Hospital of Mulhouse, Hôpital Emile Muller, Mulhouse, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Cardiology Department, PhyMedExp, INSERM, CNRS, CHU de Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Prieur', 'Affiliation': 'Coronary Care Unit, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Biere', 'Affiliation': ""Institut MITOVASC, CNRS 6015 INSERM U1083, CHU Angers, Service de Cardiologie, Angers Cedex, Université d'Angers, Angers, France.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Ivanes', 'Affiliation': 'Cardiology Department CHRU de Tours & EA4245 T2i Tours University, Tours, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bouleti', 'Affiliation': 'CIC Inserm 1402n CHU de Poitiers, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dubreuil', 'Affiliation': 'Invasive Cardiology Department, Centre Hospitalier Saint-Joseph Saint-Luc, Lyon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rioufol', 'Affiliation': 'Coronary Care Unit, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Biostatistical Department - Bioinformatique, Pôle de Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Sideris', 'Affiliation': 'Cardiology Department, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Interventional Cardiology Department, CHU de Rangueil, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bochaton', 'Affiliation': ""Centre d'Investigation Clinique, Inserm 1407, CarMeN Unit Inserm 1060, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'De Bourguignon', 'Affiliation': ""Centre d'Investigation Clinique, Inserm 1407, CarMeN Unit Inserm 1060, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.""}, {'ForeName': 'Naoual', 'Initials': 'N', 'LastName': 'El Jonhy', 'Affiliation': ""Centre d'Investigation Clinique, Inserm 1407, CarMeN Unit Inserm 1060, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Dufay', 'Affiliation': 'NeuroBioTec, Centre de Ressources Biologiques des HCL, Hôpital Neurologique, Bron, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Dhelens', 'Affiliation': 'Pharmacy Department, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Croisille', 'Affiliation': 'Department Radiology, CREATIS CNRS 5220 INSERM U1206 Research Lab, Hôpital Nord University Hospital/CHU Saint Etienne, Avenue Albert Raimond, Saint-Priest en Jarez, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Prunier', 'Affiliation': ""Institut MITOVASC, CNRS 6015 INSERM U1083, CHU Angers, Service de Cardiologie, Angers Cedex, Université d'Angers, Angers, France.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': 'Cardiology Department CHRU de Tours & EA4245 T2i Tours University, Tours, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': ""Centre d'Investigation Clinique, Inserm 1407, CarMeN Unit Inserm 1060, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Biostatistical Department - Bioinformatique, Pôle de Santé Publique, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': ""Centre d'Investigation Clinique, Inserm 1407, CarMeN Unit Inserm 1060, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Bron, France, nathan.mewton@chu-lyon.fr.""}]",Cardiology,['10.1159/000512772']
1237,33582621,Effects of additional action observation to an exercise program in patients with chronic pain due to knee osteoarthritis: A randomized-controlled trial.,"BACKGROUND


Knee osteoarthritis (OA) leads to pain, stiffness, and functional impairment and eventually decreased level of the quality of life. Although several treatment methods have been used to achieve pain relief, patients still complain of pain.
OBJECTIVE


The aim of this study was to investigate the effects of the addition of action observation therapy to an exercise program on pain severity, pressure pain threshold, kinesiphobia functionality, and pain catastrophization in knee OA patients with chronic pain.
METHODS


This prospective, randomized-controlled, superiority trial included a total of 36 patients with knee OA. The patients were randomly divided into two groups as the treatment group (n = 18) receiving action observation therapy in addition to exercise and control group (n = 18) receiving exercise alone. The interventions were performed three times weekly for six weeks. The primary outcomes were pain and pressure pain threshold. Secondary outcomes were kinesiphobia, functionality, and pain catastrophization. All participants were assessed at baseline (pre-intervention) and after the six-week treatment (post-intervention).
RESULTS


There was no significant difference in the primary and secondary outcome measures before and after the intervention between the groups (p > 0.05). Both groups showed a significant improvement in all outcome measures after the intervention (p < 0.01).
CONCLUSION


Our study results suggest that action observation therapy in addition to an exercise program does not contribute any additional benefits to pain, pressure pain threshold, kinesiophobia, pain catastrophization, and functionality in knee OA patients with chronic pain. Nonetheless, further large-scale, long-term, prospective studies are needed to gain a better understanding on this subject.",2021,There was no significant difference in the primary and secondary outcome measures before and after the intervention between the groups (p > 0.05).,"['36 patients with knee OA', 'patients with chronic pain due to knee osteoarthritis', 'knee OA patients with chronic pain']","['exercise program', 'action observation therapy in addition to exercise and control group (n\xa0=\xa018) receiving exercise alone', 'action observation therapy', 'additional action observation']","['pain relief', 'pain and pressure pain threshold', 'pain, pressure pain threshold, kinesiophobia, pain catastrophization, and functionality', 'pain severity, pressure pain threshold, kinesiphobia functionality, and pain catastrophization', 'kinesiphobia, functionality, and pain catastrophization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0563150', 'cui_str': 'Catastrophization'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",36.0,0.0612731,There was no significant difference in the primary and secondary outcome measures before and after the intervention between the groups (p > 0.05).,"[{'ForeName': 'Özgül', 'Initials': 'Ö', 'LastName': 'Öztürk', 'Affiliation': 'Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. Electronic address: ozgul.ozturk@acibadem.edu.tr.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Bombacı', 'Affiliation': 'University of Health Sciences, Haydarpaşa Numune Research and Training Hospital, Department of Orthopedics and Traumatology, Istanbul, Turkey.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Keçeci', 'Affiliation': 'Ordu University, Faculty of Medicine, Department of Orthopedics and Traumatology, Ordu, Turkey.'}, {'ForeName': 'Zeliha Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Istanbul Medipol University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2021.102334']
1238,33582575,Exercise-induced euphoria and anxiolysis do not depend on endogenous opioids in humans.,"A runner's high describes a sense of well-being during endurance exercise characterized by euphoria and anxiolysis. It has been a widespread belief that the release of endogenous opioids, such as endorphins, underlie a runner's high. However, exercise leads to the release of two classes of rewarding molecules, endocannabinoids (eCBs) and opioids. In mice, we have shown that core features of a runner's high depend on cannabinoid receptors but not opioid receptors. In the present study, we aimed to corroborate in humans that endorphins do not play a significant role in the underlying mechanism of a runner's high. Thus, we investigated whether the development of two core features of a runner's high, euphoria and reduced anxiety levels, depend on opioid signaling by using the opioid receptor antagonist naltrexone (NAL) in a double-blind, randomized, placebo (PLA)-controlled experiment. Participants (N = 63) exhibited increased euphoria and decreased anxiety after 45 min of running (RUN) on a treadmill in a moderate-intensity range compared to walking (WALK). RUN led to higher plasma levels of the eCBs anandamide (AEA) and 2-arachidonoglycerol (2-AG). Opioid blockade did not prevent the development of euphoria and reduced anxiety as well as elevation of eCB levels following exercise. Moreover, the fraction of participants reporting a subjective runner's high was comparable in the NAL and PLA-treated group. Therefore, this study indicates that the development of a runner's high does not depend on opioid signaling in humans, but makes eCBs strong candidates in humans, as previously shown in mice.",2021,RUN led to higher plasma levels of the eCBs anandamide (AEA) and 2-arachidonoglycerol (2-AG).,['humans'],"['Exercise-induced euphoria and anxiolysis', 'placebo (PLA)-controlled experiment', 'opioid receptor antagonist naltrexone (NAL']","['plasma levels of the eCBs anandamide (AEA) and 2-arachidonoglycerol (2-AG', 'development of euphoria and reduced anxiety', 'euphoria and decreased anxiety']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.174883,RUN led to higher plasma levels of the eCBs anandamide (AEA) and 2-arachidonoglycerol (2-AG).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Siebers', 'Affiliation': 'Human Behavior Laboratory, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sarah V', 'Initials': 'SV', 'LastName': 'Biedermann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bindila', 'Affiliation': 'Institute of Physiological Chemistry, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Lutz', 'Affiliation': 'Institute of Physiological Chemistry, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fuss', 'Affiliation': 'Human Behavior Laboratory, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: jo.fuss@uke.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2021.105173']
1239,33582566,Associations between fatigue impact and lifestyle factors in people with multiple sclerosis - The Danish MS hospitals rehabilitation study.,"BACKGROUND


The lack of medical treatment options to reduce fatigue in patients with multiple sclerosis (MS) emphasize the importance of identifying potential non-pharmacological modifiable factors, as this may help advance current treatment strategies. The aim of this study was to identify potential modifiable lifestyle factors as well as patient- and disease-related characteristics, that are associated with fatigue in a large sample of clinically well-characterized patients with MS.
METHODS


This study was a secondary analysis of a pragmatic randomized controlled trial of inpatient multidisciplinary rehabilitation in Denmark. MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated. Data on patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity), were collected at baseline. A linear mixed model was used to compare MFIS total, physical, cognitive, and psychosocial scores across subgroups of selected characteristics. Regression analyses were used to examine associations between lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores.
RESULTS


In the sample of 417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS. Higher MFIS total scores were observed in MS patients with shorter time since diagnosis, being a tobacco smoker, and not undertaking regular physical activity. Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores. In the multivariate analyses, physical activity was significantly associated with fatigue impact on total, physical and psychosocial functioning. Tobacco smoking was significantly associated with fatigue impact on psychosocial functioning. Alcohol intake was not associated with fatigue impact. None of the lifestyle factors were associated with fatigue impact on cognitive functioning. In the adjusted models time since diagnosis was significantly associated with fatigue impact on total, physical and cognitive functioning, as was disease severity with fatigue impact on physical and cognitive functioning.
CONCLUSION


Physical activity showed the most pronounced associations with fatigue impact on physical and psychosocial functioning, while the impact on cognitive functioning showed a trend. Tobacco smoking contributed significantly to impact on psychosocial functioning, while alcohol intake did not contribute to fatigue impact. Introducing or supporting maintenance of physical activity/exercise and cessation of tobacco smoking seems to be a useful approach for rehabilitation services to help patients with MS manage fatigue.",2021,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","['patients with multiple sclerosis (MS', 'MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated', '417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS', 'people with multiple sclerosis - The Danish MS hospitals rehabilitation study', 'inpatient multidisciplinary rehabilitation in Denmark']",['physical activity/exercise and cessation of tobacco smoking'],"['Alcohol intake', 'fatigue impact on cognitive functioning', 'Tobacco smoking', 'MFIS total, physical, cognitive, and psychosocial scores', 'lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores', 'physical and psychosocial functioning', 'Higher MFIS total scores', 'fatigue impact on total, physical and cognitive functioning', 'MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores', 'patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity', 'fatigue impact on total, physical and psychosocial functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",417.0,0.0213903,"Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores.","[{'ForeName': 'Sverker', 'Initials': 'S', 'LastName': 'Johansson', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Allied Health Professionals Function, Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden. Electronic address: sverker.johansson@ki.se.'}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Skjerbæk', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Boesen', 'Affiliation': 'MS Hospitals in Denmark, Ry and Haslev, Denmark.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Hvid', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102799']
1240,33582533,Efficacy of low glycemic index diet therapy (LGIT) in children aged 2-8 years with drug-resistant epilepsy: A randomized controlled trial.,"BACKGROUND


A classic ketogenic diet, even though effective in children with drug-resistant epilepsy is not tolerated well by them and cumbersome to prepare. Low glycemic index therapy (LGIT), the least restrictive with minimal adverse effects among ketogenic dietary therapies has been proven effective in uncontrolled trials, but a placebo-controlled trial in this regard is still lacking.
METHODS


In this open-label randomized controlled study, we randomized children above age two years with drug-resistant epilepsy into two groups (LGIT and control groups). Patients in the LGIT group received an add-on low glycemic index diet for 3 months along with the ongoing antiepileptic drugs and the patients in the control group did not receive any dietary intervention. Seizure frequency was assessed from the seizure diary maintained by the parents. Diet compliance was assessed using the diet diary that was maintained by the parents for three days just before the scheduled monthly visits of the patients.
RESULTS


Forty children with drug-refractory epilepsy (20 in each group) were enrolled. While 6/20 children in the LGIT arm have >50 % reduction in seizure frequency, none achieved this in the control arm (p = 0.02). The overall compliance with the low glycemic diet in the intervention group was 88.5 %. Out of six responders to LGIT, one child achieved seizure freedom and one achieved >90 % seizure reduction. Five continued LGIT further for a median duration of 8 months (range-4-12 months) successfully. The number needed to treat for more than 50 % seizure reduction was 3 and for more than 90 % seizure reduction was 10. The mean frequency of seizures for the intervention and control groups at three months of follow-up was not significantly different (p = 0.16), but the change in seizure frequency as compared to baseline was better in the intervention arm (p = 0.01). Three patients in the LGIT arm had non-serious adverse events (lethargy in two, vomiting in one).
CONCLUSION


In children aged 2-8 years with drug-refractory epilepsy, the administration of LGIT along with ongoing anti-seizure medications (ASM) is more efficacious in reducing seizure frequency as compared to ASM alone.",2021,"The mean frequency of seizures for the intervention and control groups at three months of follow-up was not significantly different (p = 0.16), but the change in seizure frequency as compared to baseline was better in the intervention arm (p = 0.01).","['children aged 2-8 years with drug-resistant epilepsy', 'children with drug-resistant epilepsy', 'children above age two years with drug-resistant epilepsy into two groups (LGIT and control groups', 'children aged 2-8 years with drug-refractory epilepsy, the administration of LGIT along with ongoing anti-seizure medications (ASM', 'Forty children with drug-refractory epilepsy (20 in each group) were enrolled']","['control group did not receive any dietary intervention', 'LGIT', 'low glycemic index diet therapy (LGIT', 'add-on low glycemic index diet', 'Low glycemic index therapy (LGIT']","['mean frequency of seizures', 'seizure freedom', 'non-serious adverse events (lethargy', 'Diet compliance', 'seizure frequency', 'overall compliance with the low glycemic diet', 'Seizure frequency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C1272406', 'cui_str': 'Encouragement of dietary compliance'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]",40.0,0.0688035,"The mean frequency of seizures for the intervention and control groups at three months of follow-up was not significantly different (p = 0.16), but the change in seizure frequency as compared to baseline was better in the intervention arm (p = 0.01).","[{'ForeName': 'Kannan', 'Initials': 'K', 'LastName': 'Lakshminarayanan', 'Affiliation': 'Paediatric Neurologist and Epileptologist, Gleneagles Global Hospital, Chennai, Tamilnadu, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarawal', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Prateek Kumar', 'Initials': 'PK', 'LastName': 'Panda', 'Affiliation': 'Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India; Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'Department of Neurology, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Sheffali', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India. Electronic address: sheffaligulati@gmail.com.'}]",Epilepsy research,['10.1016/j.eplepsyres.2021.106574']
1241,33582525,Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study.,"Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD). Citing orbito-frontal cortex (OFC) hyper-connectivity with striatum as the most consistent finding implicated in patho-physiologically of OCD, we aimed to study the effect of novel continuous Theta Burst Stimulation (cTBS) targeting OFC in OCD subjects on a randomized placebo control design. Thirty-three patients were randomly allocated to active cTBS (n= 18) and sham (n= 15) groups. They received 10 TBS sessions, 2 per day (total of 1200 pulses; intensive protocol) for 5 days in a week. The Yale Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores were assessed at baseline, after last session and at 2 weeks post-rTMS. On repeated measures-ANOVA, a significant group*time effect (from pretreatment to 2 weeks post TBS) for obsessions, compulsions, HAM-A, HAM-D, and CGI scores was found. But when controlled for confounding variables, only HAM-A scores and CGI effect retained statistical significance. We conclude that intensive OFC cTBS (iOFcTBS) in OCD is well tolerated with clinically significant improvements in anxiety symptoms and global severity. This improvement in anxiety symptoms could be due to modulations of state dependent dysregulation in OCD.",2021,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"['Obsessive-compulsive disorder (OCD', 'Obsessive Compulsive Disorder', 'Thirty-three patients']","['Transcranial magnetic stimulation (TMS', 'active cTBS', 'intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS', 'Placebo', 'intensive OFC cTBS']","['obsessions, compulsions, HAM-A, HAM-D, and CGI scores', 'anxiety symptoms and global severity', 'Yale Brown Obsessive Compulsive Scale\xa0(Y-BOCS), Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression-Severity (CGI-S) scores', 'anxiety symptoms']","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}]","[{'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",33.0,0.0778492,Transcranial magnetic stimulation (TMS) can non-invasively modulate specific brain regions in Obsessive-compulsive disorder (OCD).,"[{'ForeName': 'Parth', 'Initials': 'P', 'LastName': 'Dutta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Dhyani', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Shobit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India. Electronic address: shobit.garg@gmail.com.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Khattri', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, 248001 Uttarakhand, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mishra', 'Affiliation': 'Clinical Psychology, Government Medical College and Hospital, Chandigarh, India.'}]",Psychiatry research,['10.1016/j.psychres.2021.113784']
1242,33582490,Effects of acute distress and tobacco cues on tobacco demand.,"INTRODUCTION


Cigarette demand, or relative value, can be assessed via analysis of performance on a hypothetical behavioral economic cigarette purchase task (CPT). Substance purchase tasks are highly amenable to manipulation, namely, external stimuli, instructional changes, or acute stressors. In this regard, the current secondary analysis evaluates the role a novel, computerized stress induction paradigm, the Contextual-Frustration Intolerance Typing Task (C-FiTT), plays in eliciting varying levels of stress and resulting demand.
METHOD


Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions: combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group. Tobacco demand was assessed immediately following the distress task using the hypothetical CPT.
RESULTS


The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint). Moreover, demand increased with severity of C-FiTT condition, with the high-difficulty condition resulting in significantly higher breakpoint and P max , compared to other conditions. C-FiTT condition was not related to a significant increase in O max , intensity, or elasticity.
DISCUSSION


The novel C-FiTT paradigm produced comparable effects on tobacco demand relative to in vivo withdrawal induction, indicating that the C-FiTT is a viable procedure by which to influence demand. Reduction of internal and external stressors may be effective in lowering motivation for tobacco. These results highlight the importance of state distress in tobacco demand, and offer a potential avenue for intervention.",2021,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).",['Daily smokers (n = 484) completed the C-FiTT wherein they were randomly assigned to one of five distress conditions'],"['combination of task difficulty (low or high difficulty) with neutral or withdrawal cues, and a neutral control group']","['price at maximum expenditure (P max ) and first price where consumption', 'O max , intensity, or elasticity']","[{'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0441704', 'cui_str': 'Typings'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",484.0,0.0173953,"The C-FiTT distress-induction task significantly increased key cigarette demand indices, including price at maximum expenditure (P max ) and first price where consumption was suppressed to zero (breakpoint).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Aston', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA. Electronic address: Elizabeth_Aston@Brown.edu.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Brown University School of Public Health, Center for Alcohol and Addiction Studies, Providence, RI USA; City University of New York (CUNY), Brooklyn College, Brooklyn, NY USA.'}, {'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Rutgers, the State University of New Jersey, Piscataway, NJ, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108522']
1243,33582379,Health-related quality of life after laparoscopic hysterectomy following Enhanced Recovery After Surgery (ERAS) or a conventional recovery protocol.,"STUDY OBJECTIVE


To compare the health-related quality of life (HRQoL) and psychological distress after laparoscopic hysterectomy (LH) following enhanced recovery after surgery (ERAS) and conventional recovery protocols.
DESIGN


A secondary analysis of a single-center randomized controlled trial SETTING: University hospital.
PATIENTS


Women assigned to laparoscopic hysterectomy were randomly divided into two groups: the intervention (enhanced recovery protocol) group (IG; n = 60) and the control (conventional protocol) group (CG; n = 60).
INTERVENTION


Women in the intervention group were treated according to the ERAS protocol.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was a change in HRQoL assessed by the 15D questionnaire and a change in psychological distress assessed by the GHQ12 questionnaire at baseline before surgery and one month later. One month after surgery, the HRQoL was clinically and statistically better compared to baseline, but with no difference between groups. Following the ERAS protocol, the improvement of HRQoL was clinically greater, the difference in the dimension of sleeping was statistically better (p< .05), and the dimensions of discomfort and symptoms (+0.028), depression (+0.282), distress (+ 0.018) and vitality (+0.040) were clinically better than when following the conventional protocol. No differences were found in psychological distress scores either preoperatively or 1 month after surgery (24 in IG vs 25 in CG (p= .85) and 9 vs 12 (p= .47), respectively).
CONCLUSION


The HRQoL improved after LH with no significant difference between ERAS and the conventional recovery protocols. However, clinically the change of HRQoL was greater and the dimensions of sleeping, discomfort and symptoms, depression, distress and vitality were better after ERAS. Psychological distress was equal in both groups. ERAS seems to have a positive impact on recovery after LH.",2021,"No differences were found in psychological distress scores either preoperatively or 1 month after surgery (24 in IG vs 25 in CG (p= .85) and 9 vs 12 (p= .47), respectively).
","['Women assigned to', ' University hospital']","['laparoscopic hysterectomy', 'laparoscopic hysterectomy following Enhanced Recovery', 'intervention (enhanced recovery protocol) group (IG; n\u202f=\u202f60) and the control (conventional protocol) group (CG; n\u202f=\u202f60', 'laparoscopic hysterectomy (LH']","['Psychological distress', 'dimension of sleeping', 'psychological distress scores', 'dimensions of discomfort and symptoms', 'health-related quality of life (HRQoL) and psychological distress', 'distress', 'HRQoL', 'change in HRQoL assessed by the 15D questionnaire and a change in psychological distress assessed by the GHQ12 questionnaire', 'vitality', 'depression', 'dimensions of sleeping, discomfort and symptoms, depression, distress and vitality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.104294,"No differences were found in psychological distress scores either preoperatively or 1 month after surgery (24 in IG vs 25 in CG (p= .85) and 9 vs 12 (p= .47), respectively).
","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kilpiö', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Kilpiö, Härkki, Mentula and Pakarinen), University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: olga.kilpio@hus.fi.'}, {'ForeName': 'Päivi S M', 'Initials': 'PSM', 'LastName': 'Härkki', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Kilpiö, Härkki, Mentula and Pakarinen), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Maarit J', 'Initials': 'MJ', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Kilpiö, Härkki, Mentula and Pakarinen), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi I', 'Initials': 'PI', 'LastName': 'Pakarinen', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Kilpiö, Härkki, Mentula and Pakarinen), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2021.02.008']
1244,33582306,Novel device versus manual examinations for the measurement of cervical dilation in labor: a randomized controlled trial.,"BACKGROUND


Cervical dilation and changes in cervical dilation inform the management of labor, including decisions to admit a patient to the hospital, augment labor, or perform a cesarean section. Practitioners routinely measure cervical dilation subjectively using two fingers on manual examination; however, agreement ≤1cm between two observers has been reported as 60-91% previously in laboring women.
METHODS


Women admitted in labor to a Labor & Delivery service were randomized to receive two cervical examinations from trained providers, either using a novel device (DilaCheck®) or the standard manual examination. This randomized controlled trial compares a novel device with the standard method of manual examination for the measurement of cervical dilation. The novel device consisted of a string measuring tape suspended between two soft plastic rings worn on the index and middle fingertips. Inter-observer agreement, defined as the agreement (exact, ≤1cm - primary outcome - or ≤2cm) in the numerical cervical dilation measurement obtained by two different examiners, was compared between the two groups.
RESULTS


A total of 42 women in labor were randomized, 21 to the novel device and 21 to the standard manual examination groups. The two device examinations agreed in 19% of cases, while manual examinations agreed exactly in 42.9% of cases (p=0.10). Inter-observer agreement ≤1cm was 61.9% vs. 95.2%, respectively (p=0.008). Inter-observer agreement ≤2cm was 90.5% vs. 100%, respectively (p=0.15). Most inter-observer disagreement was seen at 5-7cm of cervical dilation.
CONCLUSION


A novel device, DilaCheck, intended for more objective cervical assessment of women in labor, did not improve inter-observer agreement; in fact, it decreased it. Standard cervical dilation examinations result in poor inter-examiner exact agreement, usually at best 50% or less. Clinical management should be based on clinical differences of >1cm because, in general, 90% of cervical examinations will agree within 1cm of each other. Given the importance of dilation measurements in the management of labor, continued innovation in this field would benefit women in labor and the providers caring for them; however, the puzzle remains unsolved.",2021,"Inter-observer agreement ≤2cm was 90.5% vs. 100%, respectively (p=0.15).","['Women admitted in labor to a Labor & Delivery service', '42 women in labor', 'labor']","['Novel device versus manual examinations', 'cervical examinations from trained providers, either using a novel device (DilaCheck®) or the standard manual examination']",['numerical cervical dilation measurement'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",42.0,0.0915295,"Inter-observer agreement ≤2cm was 90.5% vs. 100%, respectively (p=0.15).","[{'ForeName': 'Eva L', 'Initials': 'EL', 'LastName': 'Martin', 'Affiliation': 'Elm Tree Medical Inc., San Francisco, CA, USA.'}, {'ForeName': 'Brandy', 'Initials': 'B', 'LastName': 'Firman', 'Affiliation': 'Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, USA. Electronic address: vincenzo.berghella@jefferson.edu.'}]",American journal of obstetrics & gynecology MFM,['10.1016/j.ajogmf.2021.100328']
1245,33582295,Harnessing mobile technology to reduce mental health disorders in college populations: A randomized controlled trial study protocol.,"About a third of college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach to detect mental health problems and engage college students in services. We have developed a transdiagnostic, low-cost mobile mental health targeted prevention and intervention platform that uses population-level screening to engage college students in tailored services that address common mental health problems. We will test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20+ colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N = 7884) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning. We will also test mediators, predictors, and moderators of improved mental health outcomes, as well as stakeholder-relevant outcomes, including cost-effectiveness and academic performance. This population-level approach to service engagement has the potential to improve mental health outcomes for the millions of students enrolled in U.S. colleges and universities.",2021,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","['college students struggle with anxiety, depression, or an eating disorder, and only 20-40% of college students with mental disorders receive treatment', 'students enrolled in U.S. colleges and universities', 'Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N\u202f=\u202f7884', 'college populations']","['Harnessing mobile technology', 'intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center']","['cost-effectiveness and academic performance', 'mental health disorders']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",7884.0,0.257177,"We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases and disorder-specific symptoms, and improved quality of life and functioning.","[{'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: fitzsimmonse@wustl.edu.'}, {'ForeName': 'C Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: btaylor@stanford.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: mgn1@psu.edu.'}, {'ForeName': 'Nur Hani', 'Initials': 'NH', 'LastName': 'Zainal', 'Affiliation': 'Department of Psychology, Penn State University, University Park, PA, USA. Electronic address: nvz5057@psu.edu.'}, {'ForeName': 'Elsa E', 'Initials': 'EE', 'LastName': 'Rojas-Ashe', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA. Electronic address: erojas@paloaltou.edu.'}, {'ForeName': 'Sarah Ketchen', 'Initials': 'SK', 'LastName': 'Lipson', 'Affiliation': 'Department of Health Law Policy and Management, Boston University School of Public Health, Boston, MA, USA. Electronic address: sklipson@bu.edu.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Firebaugh', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: mcallewaert@wustl.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA. Electronic address: peterceg@umich.edu.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Center for m(2)Health, Palo Alto University, Palo Alto, CA, USA; Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden. Electronic address: naira.topooco@liu.se.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Departments of Biomedical Data Science and Psychiatry, Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA. Electronic address: andrea.graham@northwestern.edu.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA. Electronic address: myrakim@umich.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Health Policy and Management, Fielding School of Public Health, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: daniel.eisenberg@ucla.edu.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, Mailstop 8134-29-2100, 660 S. Euclid Ave., St. Louis, MO 63110, USA. Electronic address: wilfleyd@wustl.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106320']
1246,33582285,"Double-dose cefuroxime concentrations in bone, synovial fluid of the knee joint and subcutaneous adipose tissue-A randomised porcine microdialysis study.","This study evaluated target tissue concentrations of double dose cefuroxime administered intravenously as either one 15 min infusion of 3,000 mg (Group 1) or two single 15 min infusions of 1,500 mg administered 4 h apart (Group 2). Sixteen pigs were randomised into two groups of eight. Cortical and cancellous bone, synovial fluid of the knee joint and subcutaneous adipose tissue concentrations were measured based on sampling via microdialysis. Plasma samples were collected as a reference. Comparison of the groups was based on time with concentrations above relevant minimal inhibitory concentrations (fT>MIC) of 4 μg/mL. The mean time fT>MIC (4 μg/mL) across compartments was longer for Group 2 (280-394 min) than for Group 1 (207-253 min) (p<0.01). Cortical bone showed a tendency towards longer fT>MIC (4 μg/mL) in Group 2 (280 min) than in Group 1 (207 min) (p=0.053). Within 50 min after administration, the mean concentration of 4 μg/mL was reached in all compartments for both groups. The mean concentrations decreased below 4 μg/mL after approximately 4 h (Group 1) and 3 h (Group 2) from initiation of administration (time zero). During an 8 h interval, double-dose cefuroxime administered as 2 × 1,500 mg with a 4 h interval provides longer time above MIC breakpoint for Staphylococcus aureus (4 μg/mL) than a single bolus of 3,000 mg cefuroxime. To maintain sufficient tissue concentrations during longer surgeries, re-administration of cefuroxime (1,500 mg) should be considered 3 h after the first administration.",2021,Cortical bone showed a tendency towards longer fT>MIC (4 μg/mL) in Group 2 (280 min) than in Group 1 (207 min) (p=0.053).,['Sixteen pigs'],"['Double-dose cefuroxime', 'cefuroxime']","['tendency towards longer fT>MIC', 'mean concentrations', 'mean time fT>MIC', 'Cortical and cancellous bone, synovial fluid of the knee joint and subcutaneous adipose tissue concentrations', 'mean concentration of 4 μg/mL']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0066256', 'cui_str': 'Methyl isocyanate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0039097', 'cui_str': 'Synovial fluid'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}]",16.0,0.234312,Cortical bone showed a tendency towards longer fT>MIC (4 μg/mL) in Group 2 (280 min) than in Group 1 (207 min) (p=0.053).,"[{'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Jørgensen', 'Affiliation': 'Aarhus Microdialysis Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: anjo@clin.au.dk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hanberg', 'Affiliation': 'Aarhus Microdialysis Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus N, Denmark; Department of Orthopaedic Surgery, Horsens Regional Hospital, Horsens, Denmark. Electronic address: pellehanberg@clin.au.dk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bue', 'Affiliation': 'Aarhus Microdialysis Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: matsbue@clin.au.dk.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Thomassen', 'Affiliation': 'Aarhus Microdialysis Research Group, Orthopaedic Research Unit, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: majathma@rm.dk.'}, {'ForeName': 'N Pedersen', 'Initials': 'NP', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: nisjoerg@rm.dk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stilling', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: maiken.stilling@clin.au.dk.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2021.105754']
1247,33582249,Induction Chemotherapy plus Concomitant Chemoradiotherapy in Nasopharyngeal Carcinoma: an Updated Network Meta-Analysis.,"BACKGROUND


Induction chemotherapy (IC) added to concurrent chemoradiotherapy (CCRT) appears to be superior to CCRT alone for locally-advanced nasopharyngeal carcinoma (NPC). The main objective of this network meta-analysis (NMA) was to assess the impact of different IC regimens on patient outcome.
PATIENTS AND METHODS


We systematically searched and extracted data from randomized, controlled trials involving stage III-IV NPC patients randomly assigned to receive IC + CCRT vs. CCRT alone. Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs).
RESULTS


Eight clinical trials were identified including 2362 patients. OS-benefit from doublet IC regimens, in particular platinum-docetaxel and platinum-gemcitabine regimens, was seen. With regard to LRFS, docetaxel-platinum-5FU regimen showed a greater impact than the others. An indirect comparison between taxane- and gemcitabine-based IC regimens showed a benefit of the latter in terms of OS and DMFS.
CONCLUSIONS


Although CCRT with cisplatin has been the gold standard of treatment in NPC for several years. Docetaxel + cisplatin-IC and cisplatin + gemcitabine-IC regimens have a positive impact on survival in locally-advanced NPC and should be considered the new standard option.",2021,"Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs).
","['stage III-IV NPC patients', 'Nasopharyngeal Carcinoma', '2362 patients', 'locally-advanced nasopharyngeal carcinoma (NPC']","['CCRT with cisplatin', 'platinum-docetaxel and platinum-gemcitabine', 'taxane- and gemcitabine-based IC regimens', 'LRFS, docetaxel-platinum-5FU regimen', 'Induction Chemotherapy plus Concomitant Chemoradiotherapy', 'IC\u2009+\u2009CCRT vs. CCRT alone', 'CCRT alone', 'Docetaxel\u2009+\u2009cisplatin-IC and cisplatin\u2009+\u2009gemcitabine-IC regimens', 'Induction chemotherapy (IC) added to concurrent chemoradiotherapy (CCRT']","['Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.124424,"Overall survival (OS), locoregional recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) in the two arms were compared using hazard ratios (HRs).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bongiovanni', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address: alberto.bongiovanni@irst.emr.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Vagheggini', 'Affiliation': 'Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Fausti', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mercatali', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Calpona', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giandomenico', 'Initials': 'G', 'LastName': 'Di Menna', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Miserocchi', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Ibrahim', 'Affiliation': 'Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Critical reviews in oncology/hematology,['10.1016/j.critrevonc.2021.103244']
1248,33582039,"Effect of Diabetes Health Coaching on Glycemic Control and Quality of Life in Adults Living With Type 2 Diabetes: A Community-Based, Randomized, Controlled Trial.","OBJECTIVES


Health coaching for type 2 diabetes (T2DM) represents a promising addition toward efforts to improve clinical health outcomes and quality of life. The purpose of this study was to evaluate the effect of a 12-month telephone diabetes health coaching (DHC) intervention on glycemic control in persons living with T2DM.
METHODS


In this community-based, randomized, controlled trial, adults with T2DM, glycated hemoglobin (A1C) ≥7.5% and telephone access were assigned to either usual diabetes education (DE) or DHC and access to DE. The primary outcome was change in A1C after 1 year, and secondary outcomes included score on the 19-item Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) instrument and self-care behaviours. Safety was assessed in all participants (NCT02128815 at www.clinicaltrials.gov).
RESULTS


Three hundred sixty-five participants (50% females; mean age, 57 years; mean A1C, 8.98%) were randomized to control (DE, n=177) or intervention (DHC, n=188) groups. The A1C level decreased by an absolute amount of 1.8% and 1.3% in the intervention and control groups, respectively. DHC plus DE reduced A1C by 0.49% more than DE alone (95% confidence interval, -0.80 to -0.18; p<0.01) and improved ADDQoL-19 scores, with between-group differences for the average weighted score of 0.28 (95% confidence interval, 0.04 to 0.52; p=0.02). There were no differences between groups for proportion of participants having an emergency department visit or hospitalization.
CONCLUSIONS


Providing frequent telephone-based DHC and access to DE to adults living with T2DM for 1 year supports improvements in glycemic control and quality of life.",2020,"DHC plus DE reduced A1C by 0.49% more than DE alone (95% confidence interval, -0.80 to -0.18; p<0.01) and improved ADDQoL-19 scores, with between-group differences for the average weighted score of 0.28 (95% confidence interval, 0.04 to 0.52; p=0.02).","['Three hundred sixty-five participants (50% females; mean age, 57 years; mean A1C, 8.98%) were randomized to control (DE, n=177) or intervention (DHC, n=188) groups', 'persons living with T2DM', 'adults with T2DM, glycated hemoglobin (A1C) ≥7.5% and telephone access', 'Adults Living With Type 2 Diabetes']","['Diabetes Health Coaching', 'telephone diabetes health coaching (DHC) intervention', 'usual diabetes education (DE) or DHC and access to DE']","['ADDQoL-19 scores', 'A1C level', 'glycemic control and quality of life', 'Safety', 'change in A1C', 'DHC plus DE reduced A1C', 'Glycemic Control and Quality of Life', 'score on the 19-item Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) instrument and self-care behaviours', 'emergency department visit or hospitalization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",365.0,0.150667,"DHC plus DE reduced A1C by 0.49% more than DE alone (95% confidence interval, -0.80 to -0.18; p<0.01) and improved ADDQoL-19 scores, with between-group differences for the average weighted score of 0.28 (95% confidence interval, 0.04 to 0.52; p=0.02).","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sherifali', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, Ontario, Canada; Diabetes Care and Research Program, Hamilton Health Sciences, Hamilton, Ontario, Canada; McMaster Evidence Review and Synthesis Team, McMaster University, Hamilton, Ontario, Canada. Electronic address: dsherif@mcmaster.ca.'}, {'ForeName': 'Anka', 'Initials': 'A', 'LastName': 'Brozic', 'Affiliation': 'Kitchener Downtown Community Health Centre, Kitchener, Ontario, Canada.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Agema', 'Affiliation': 'Langs Community Health Centre, Cambridge, Ontario, Canada.'}, {'ForeName': 'Zubin', 'Initials': 'Z', 'LastName': 'Punthakee', 'Affiliation': 'Diabetes Care and Research Program, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'McInnes', 'Affiliation': 'Diabetes Care and Research Program, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': ""Programs for Assessment of Technology in Health, The Research Institute of St. Joe's Hamilton, St. Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'R Muhammad', 'Initials': 'RM', 'LastName': 'Usman Ali', 'Affiliation': 'McMaster Evidence Review and Synthesis Team, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada; Centre for Interprofessional Education, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Diabetes Care and Research Program, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.11.012']
1249,33581997,Physiologic Voice Rehabilitation Based on Water Resistance Therapy With Connected Speech in Subjects With Vocal Fatigue.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on water resistance therapy (WRT) exercises including connected speech in a group of subjects with voice complaints (vocal effort and fatigue).
METHODS


Twenty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: (1) voice treatment with WRT plus vocal hygiene program (n = 12), and (2) vocal hygiene program only (n = 12). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic and electroglottographic assessment. The Voice Handicap Index (VHI) and self-assessment of resonant voice were also performed. The treatment included six voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with two different voice training devices (PocketVox and MaskVox). Comparison for all variables was performed between experimental group and control group.
RESULTS


Significant differences were found for experimental group for VHI physical subscale, and self-perceived resonant voice when comparing pre-post conditions. A strong negative correlation between self-perceived resonant voice and VHI physical sub-score was also reported. No significant differences were found for instrumented variables.
CONCLUSION


Physiologic voice therapy based on WRT exercises including connected speech seems to be an effective tool to improve self-perceived voice in subjects diagnosed with voice complaints. Apparently, changes are more prone to occur in perceptual variables related with physical discomfort associate with voice production. A reduction in phonatory effort and perceptual aspects of vocal fatigue are the main improvements.",2021,"RESULTS


Significant differences were found for experimental group for VHI physical subscale, and self-perceived resonant voice when comparing pre-post conditions.","['subjects diagnosed with voice complaints', 'connected speech in a group of subjects with voice complaints (vocal effort and fatigue', 'Subjects With Vocal Fatigue', 'Twenty-four participants with behavioral dysphonia']","['physiologic voice therapy program based on water resistance therapy (WRT) exercises', 'voice training devices (PocketVox and MaskVox', 'voice treatment with WRT plus vocal hygiene program (n\xa0=\xa012), and (2) vocal hygiene program', 'Physiologic voice therapy based on WRT exercises', 'Physiologic Voice Rehabilitation Based on Water Resistance Therapy With Connected Speech']","['resonant voice and VHI physical sub-score', 'Voice Handicap Index (VHI) and self-assessment of resonant voice', 'VHI physical subscale, and self-perceived resonant voice', 'Laryngoscopic assessment']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0241700', 'cui_str': 'Vocal fatigue'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042944', 'cui_str': 'Voice training'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",24.0,0.0114603,"RESULTS


Significant differences were found for experimental group for VHI physical subscale, and self-perceived resonant voice when comparing pre-post conditions.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Ilter', 'Initials': 'I', 'LastName': 'Denizoglu', 'Affiliation': 'EgeSante Vocology Center, Izmir, Turkey.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fridman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile, Santiago, Chile.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Loncon', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile, Santiago, Chile.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile, Santiago, Chile.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'García', 'Affiliation': 'Department of Otolaryngology, Clínica Universidad de los Andes, Santiago, Chile.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Morán', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de Chile, Santiago, Chile.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Otolaryngology, Clínica Universidad de los Andes, Santiago, Chile.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.12.022']
1250,33581975,Randomized Trial of Static and Articulating Spacers for Treatment of the Infected Total Hip Arthroplasty.,"BACKGROUND


The purpose of this randomized clinical trial is to compare perioperative and postoperative variables between static and articulating spacers for the treatment of chronic periprosthetic joint infection (PJI) complicating total hip arthroplasty (THA).
METHODS


Fifty-two patients undergoing resection arthroplasty as part of a 2-stage exchange for PJI at 3 centers were randomized to either a static (n = 23) or articulating spacer (n = 29). The primary endpoint was operative time of the second-stage reimplantation and power analysis determined that 22 patients per cohort were necessary to detect a 20-minute difference. Seven patients were lost to follow-up, 4 were never reimplanted, and one died before discharge after reimplantation. Forty patients were followed for a mean 3.2 years (range 2.0-7.1).
RESULTS


There were no differences in operative time at second-stage reimplantation (143 minutes static vs 145 minutes articulating, P = .499). Length of hospital stay was longer in the static cohort after stage 1 (8.6 vs 5.4 days, P = .006) and stage 2 (6.3 vs 3.6 days, P < .001). Although it did not reach statistical significance with the numbers available for study, nearly twice as many patients in the static cohort were discharged to an extended care facility after stage 1 (65% vs 30%, P = .056).
CONCLUSION


This randomized trial demonstrated that the outcomes of static and articulating spacers are similar in the treatment of THA PJI undergoing 2-stage exchange arthroplasty. The significantly longer length of hospital stay associated with the use of static spacers may have important economic implications for the health care system.",2021,There were no differences in operative time at second-stage reimplantation (143 minutes,"['Forty patients were followed for a mean 3.2 years (range 2.0-7.1', 'THA PJI undergoing 2-stage exchange arthroplasty', 'Fifty-two patients undergoing resection arthroplasty as part of a 2-stage exchange for PJI at 3 centers', 'Infected Total Hip Arthroplasty', 'chronic periprosthetic joint infection (PJI) complicating total hip arthroplasty (THA']","['Static and Articulating Spacers', 'static and articulating spacers', 'articulating spacer']","['operative time', 'Length of hospital stay', 'longer length of hospital stay', 'operative time of the second-stage reimplantation and power analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",52.0,0.0947578,There were no differences in operative time at second-stage reimplantation (143 minutes,"[{'ForeName': 'Cindy R', 'Initials': 'CR', 'LastName': 'Nahhas', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Chalmers', 'Affiliation': 'Department of Orthopaedic Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Parvizi', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Deirmengian', 'Affiliation': 'Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Moric', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2021.01.031']
1251,33581971,A Web-Based Interactive Patient-Provider Software Platform Does Not Increase Patient Satisfaction or Decrease Hospital Resource Utilization in Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System.,"BACKGROUND


Web-based platforms used to enhance patient-provider communication are being explored to improve patient satisfaction and care delivery, and decrease cost. This study tested a web-based interactive patient-provider software platform (IPSP), JointCOACH, which enabled patient communication with their care team and preparatory/recovery guidance. The aims of this study are to compare (1) patient satisfaction and (2) healthcare resource utilization by patients who underwent total knee and hip replacements and added IPSP to standard of care (SOC).
METHODS


This study is a prospective, randomized clinical trial at a single large academic healthcare system. Between May 2018 and March 2020, 399 patients undergoing elective total hip or knee arthroplasty were randomized to SOC arm (n = 204) or SOC + IPSP arm (n = 195). Patient demographics, surgical details, and comorbidities were collected. Patient satisfaction was assessed using Visual Analog Scale and the Picker Patient Experience-15. Healthcare utilization was measured using length of stay, emergency department and office visits, office calls, readmissions, and reoperations at 30 and 90 days after surgery.
RESULTS


No difference was found in length of stay between SOC and SOC + IPSP. No differences were found in 30-day or 90-day satisfaction or in healthcare resource utilization (P > .05) including number of office and emergency department visits, phone calls, and readmissions.
CONCLUSION


Statistical differences were not found in satisfaction and healthcare utilization with the addition of IPSP to SOC. IPSP can be used to reinforce patient education and communication between the patient and provider, and should be evaluated as an element of virtual care rather than supplementing traditional in-office follow-up. CLINICALTRIALS.GOV: More information on this study can be found at clinicaltrials.gov NCT03499028.",2021,"No differences were found in 30-day or 90-day satisfaction or in healthcare resource utilization (P > .05) including number of office and emergency department visits, phone calls, and readmissions.
","['Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System', 'patients who underwent total knee and hip replacements and added IPSP to standard of care (SOC', 'Between May 2018 and March 2020, 399 patients undergoing elective total hip or knee arthroplasty']","['SOC\xa0+ IPSP', 'SOC', 'IPSP']","['length of stay, emergency department and office visits, office calls, readmissions, and reoperations', 'Healthcare utilization', 'satisfaction and healthcare utilization', 'length of stay between SOC and SOC\xa0+ IPSP', 'Visual Analog Scale', 'Patient satisfaction', 'number of office and emergency department visits, phone calls, and readmissions', '30-day or 90-day satisfaction or in healthcare resource utilization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0392806', 'cui_str': 'Insertion of hip prosthesis'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",399.0,0.0811636,"No differences were found in 30-day or 90-day satisfaction or in healthcare resource utilization (P > .05) including number of office and emergency department visits, phone calls, and readmissions.
","[{'ForeName': 'Anabelle T', 'Initials': 'AT', 'LastName': 'Visperas', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Viktor E', 'Initials': 'VE', 'LastName': 'Krebs', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Klika', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Nicolas S', 'Initials': 'NS', 'LastName': 'Piuzzi', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Higuera-Rueda', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, FL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2021.01.037']
1252,33581958,Use of modified 3D digital surgical guides in the treatment of complex mandibular fractures.,"The objective of this study was to evaluate the use of 3D modified digital surgical guide plates combined with preformed titanium plates in the treatment of complex mandibular fractures. Patients with complex mandibular fractures were randomized into three groups. Group A was treated with a combination of 3D modified digital surgical guide plates and preformed titanium plates, Group B was treated with preformed titanium plates only, and Group C was treated conventionally. The key design point of the guide plates is the ""slot"" structure, which is crucial for accurately locating the preformed titanium plate. Clinical outcomes, including facial symmetry, surgical accuracy, and maximum deviation were quantitatively assessed postoperatively. Twenty-two patients were recruited for this study, eight for Group A, six for Group B, and eight for Group C. Group A exhibited better postoperative clinical outcomes. Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P < 0.001], S5 [0.47 ± 0.16 mm, P = 0.042], S6 [0.35 ± 0.04 mm, P = 0.001], S10 [0.50 ± 0.31 mm, P = 0.048], S11 [0.97 ± 0.29 mm, P = 0.018]) and surgical accuracy (T1 [R, 0.56 ± 0.18 mm, P = 0.021], T1 [L, 0.60 ± 0.30 mm, P = 0.022], T2 [L, 0.76 ± 0.21 mm, P = 0.006], T4 [R, 0.37 ± 0.15 mm, P < 0.001], T4 [L, 0.40 ± 0.15 mm, P = 0.001], T8 [R, 0.40 ± 0.15 mm, P = 0.007], T8 [L, 0.31 ± 0.29 mm, P = 0.001], T9 [L, 0.51 ± 0.33 mm, P = 0.042], T10 [R, 0.58 ± 0.28 mm, P = 0.049], T10 [L, 0.53 ± 0.34 mm, P = 0.046], T11 [R, 0.54 ± 0.13 mm, P = 0.021], T12 [0.45 ± 0.16 mm, P = 0.003]). The ideal postoperative effect was found in Group A with maximum deviation analysis. 3D printed modified digital surgical guide plates can effectively improve treatment outcomes in complex mandibular fractures.",2021,"Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P ","['Patients with complex mandibular fractures', 'complex mandibular fractures']","['3D modified digital surgical guide plates combined with preformed titanium plates', 'modified 3D digital surgical guides', '3D modified digital surgical guide plates and preformed titanium plates, Group B was treated with preformed titanium plates']","['facial symmetry', 'facial symmetry, surgical accuracy, and maximum deviation', 'surgical accuracy', 'postoperative clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0424480', 'cui_str': 'Facial symmetry'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",22.0,0.0624845,"Among three groups, significant improvements were found in Group A for facial symmetry (S1 [0.74 ± 0.17 mm, P < 0.001], S2 [0.86 ± 0.21 mm, P = 0.004], S3 [0.92 ± 0.26 mm, P < 0.001], S4 [0.32 ± 0.09 mm, P ","[{'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; National Engineering Laboratory for Oral Regenerative Medicine, Chengdu, 610041, PR China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Stomatology Hospital, Zhejiang University School of Medicine, 310000, PR China.'}, {'ForeName': 'Zeyou', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; National Engineering Laboratory for Oral Regenerative Medicine, Chengdu, 610041, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'The State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, 610041, PR China; Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University, Chengdu, 610041, PR China; Engineering Research Center of Oral Translational Medicine, Ministry of Education, Chengdu, 610041, PR China. Electronic address: dr.jielong@hotmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2021.01.016']
1253,33581954,Randomised controlled trial of arthrocentesis with or without PRF for internal derangement of the TMJ.,"This prospective randomised clinical study aims to evaluate different treatments in patients with temporomandibular disorder. Control group (C) patients underwent arthrocentesis and experimental group (E) patients underwent injectable platelet-rich fibrin (İ-PRF) in addition to arthrocentesis. Helkimo Clinical Dysfunction Score (HCDS) examinations and VAS scores of the patients were recorded at the end of the 10th day, 1 month and 3 months. 36 patients (17 females, 19 males), 18 in the experimental and 18 in the control group, aged between 18 and 64 years and in groups 3, 4 and 5 according to Wilke's classification were included in this study. Improvement of VAS (E mean: 5,83, E standard deviation: 2,550, C mean: 2,94, C standard deviation: 2,043, p<0.001) and HCDS (E mean: 13,61, E standard deviation: 5,158, C mean: 9,22, C standard deviation: 6,916, p:0.039) of the experimental group patients was significantly higher than control group at the end of the third month. As a result of this study, the combination of i-PRF with arthrocentesis gave a much better outcome than arthrocentesis alone. Additional PRF injection should be preferred for severe dysfunction. Further studies with long-term follow-up are needed to better understand the effects of i-PRF.",2021,"9,22, C standard deviation: 6,916, p:0.039) of the experimental group patients was significantly higher than control group at the end of the third month.","[""36 patients (17 females, 19 males), 18 in the experimental and 18 in the control group, aged between 18 and 64 years and in groups 3, 4 and 5 according to Wilke's classification were included in this study"", 'patients with temporomandibular disorder', 'C mean']","['arthrocentesis with or without PRF', 'arthrocentesis and experimental group (E) patients underwent injectable platelet-rich fibrin (İ-PRF']","['HCDS (E mean', 'Helkimo Clinical Dysfunction Score (HCDS) examinations and VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.030858,"9,22, C standard deviation: 6,916, p:0.039) of the experimental group patients was significantly higher than control group at the end of the third month.","[{'ForeName': 'Ugur', 'Initials': 'U', 'LastName': 'Karadayi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Aydın Adnan Menderes University, Aydın, Turkiye.'}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Gursoytrak', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Aydın Adnan Menderes University, Aydın, Turkiye. Electronic address: dt_burcupoyraz@hotmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2021.01.018']
1254,33581920,Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age.,"BACKGROUND


The global reliance on eggs to produce most influenza vaccines has several limitations and new approaches to influenza vaccine production are needed. Herein we describe a phase 3, lot-to-lot consistency trial (NCT03321968) of a quadrivalent, recombinant, virus-like particle (VLP) influenza vaccine produced in plants. This platform is based on transient expression of proteins in Nicotiana benthamiana and yields VLPs bearing hemagglutinin (HA) protein trimers that are combined in a quadrivalent vaccine (QVLP).
METHODS


The HAs targeted in this study were A/California/07/2009 H1N1, A/Hong Kong/4801/2014 H3N2, B/Brisbane/60/08 and B/Phuket/3073/2013: recommended for the 2016-2017 Northern Hemisphere season. Healthy adults 18-49 years of age (n = 1200) were randomized 1:1:1 to receive a 0.5 mL intramuscular injection of QVLP (30 μg HA/strain) from three sequential lots. Local and systemic reactions were monitored for 21 days post-vaccination and blood was collected pre-vaccination and at day 21 (D21) after vaccination to measure hemagglutination inhibition (HI) antibodies.
RESULTS


Subject demographics were similar between groups and compliance with study procedures was 96.3%. The study population was 54.8% female, the mean age (±SD) was 29.9 ± 9.01 and the racial distribution was 77.8% Caucasian, 15.6% Asian, 5.8% Black/African American and 0.8% other. The HI responses met the Center for Biologics Evaluation and Research criteria for seroconversion (SCR ≥ 40%) and seroprotection rates (SPR ≥ 70%). The geometric mean fold rise in HI titers was ≥ 2.5 for all 4 strains for each lot. Lot-to-lot consistency was met with the 95% confidence intervals of the D21 mean geometric titre ratios falling between 0.67 and 1.5 for all four strains. No safety concerns were identified. Solicited adverse events were generally mild and transient: typical for what is reported after inactivated influenza vaccines.
CONCLUSIONS


This study supported earlier findings of the safety profile and immunogenicity of the plant-derived QVLP and demonstrated the consistency with which it can be produced.",2021,Lot-to-lot consistency was met with the 95% confidence intervals of the D21 mean geometric titre ratios falling between 0.67 and 1.5 for all four strains.,"['The study population was 54.8% female, the mean age (±SD) was 29.9\xa0±\xa09.01 and the racial distribution was 77.8% Caucasian, 15.6% Asian, 5.8% Black/African American and 0.8% other', 'Healthy adults 18-49\xa0years of age (n\xa0=\xa01200', 'adults 18-49\xa0years of age']","['0.5\xa0mL intramuscular injection of QVLP', 'new plant-derived quadrivalent virus like particle influenza vaccine', 'quadrivalent, recombinant, virus-like particle (VLP) influenza vaccine']","['Solicited adverse events', 'Local and systemic reactions', 'D21 mean geometric titre ratios falling', 'geometric mean fold rise in HI titers', 'seroprotection rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}]",1200.0,0.0467914,Lot-to-lot consistency was met with the 95% confidence intervals of the D21 mean geometric titre ratios falling between 0.67 and 1.5 for all four strains.,"[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ward', 'Affiliation': ""Medicago Inc., 1020 route de l'Église office 600, Québec, QC G1V 3V9, Canada; Research Institute of the McGill University Health Centre, 1001 Decarie Street, EM3-3248, Montreal, QC H4A 3J1, Canada.""}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Séguin', 'Affiliation': ""Medicago Inc., 1020 route de l'Église office 600, Québec, QC G1V 3V9, Canada.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Couillard', 'Affiliation': ""Medicago Inc., 1020 route de l'Église office 600, Québec, QC G1V 3V9, Canada.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Trépanier', 'Affiliation': ""Medicago Inc., 1020 route de l'Église office 600, Québec, QC G1V 3V9, Canada.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Landry', 'Affiliation': ""Medicago Inc., 1020 route de l'Église office 600, Québec, QC G1V 3V9, Canada. Electronic address: landryn@medicago.com.""}]",Vaccine,['10.1016/j.vaccine.2021.01.004']
1255,33581874,The Magnificent MASTER Trial: A Randomised Controlled Trial of Surgery After Postprostatectomy Incontinence.,,2021,,[],['Surgery'],[],[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.28645,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Urology, Maastricht University Medical Centre, Maastricht, The Netherlands. Electronic address: john.heesakkers@mumc.nl.'}]",European urology,['10.1016/j.eururo.2021.01.040']
1256,33581821,"Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial.","BACKGROUND


We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.
METHODS


In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing.
FINDINGS


Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17·9-not evaluable) with cemiplimab (n=283) versus 14·2 months (11·2-17·5) with chemotherapy (n=280; hazard ratio [HR] 0·57 [0·42-0·77]; p=0·0002). Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p<0·0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy.
INTERPRETATION


Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population.
FUNDING


Regeneron Pharmaceuticals and Sanofi.",2021,Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%).,"['HR 0·54', 'Between June 27, 2017 and Feb 27, 2020', 'patients with advanced non-small-cell lung cancer', '710 patients', 'eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible']","['Cemiplimab monotherapy', 'chemotherapy', 'chemotherapy ', 'cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy']","['intention-to-treat population and in a prespecified PD-L1', 'Grade 3-4 treatment-emergent adverse events', 'median overall survival', 'Adverse events', 'overall survival and progression-free survival per masked independent review committee', 'overall survival and progression-free survival', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}]","[{'cui': 'C4724806', 'cui_str': 'cemiplimab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}]",710.0,0.497287,Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%).,"[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sezer', 'Affiliation': 'Department of Medical Oncology, Başkent University, Adana, Turkey. Electronic address: drasezer@hotmail.com.tr.'}, {'ForeName': 'Saadettin', 'Initials': 'S', 'LastName': 'Kilickap', 'Affiliation': 'Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Department of Medical Oncology, School of Medicine, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Department of Oncology and Medical Radiology; Dnipropetrovsk Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Gogishvili', 'Affiliation': 'High Technology Medical Centre, University Clinic, Tbilisi, Georgia.'}, {'ForeName': 'Haci M', 'Initials': 'HM', 'LastName': 'Turk', 'Affiliation': 'Department of Medical Oncology, Bezmialem Vakif University, Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Department of Medical Oncology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Bentsion', 'Affiliation': 'Radiotherapy Department, Sverdlovsk Regional Oncology Centre, Sverdlovsk, Russia.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Gladkov', 'Affiliation': 'LLC, ""EVIMED"", Chelyabinsk, Russia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clingan', 'Affiliation': 'Southern Medical Day Care Centre and Illawarra Health and Medical Research Institute, University of Wollongong-Illawarra Cancer Centre, Wollongong Hospital, Wollongong, NSW, Australia.'}, {'ForeName': 'Virote', 'Initials': 'V', 'LastName': 'Sriuranpong', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Naiyer', 'Initials': 'N', 'LastName': 'Rizvi', 'Affiliation': 'Division of Hematology-Oncology, Columbia University Medical Center, New York, New York, NY, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Regeneron Pharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Regeneron Pharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'McGuire', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'Chieh-I', 'Initials': 'CI', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Tamta', 'Initials': 'T', 'LastName': 'Makharadze', 'Affiliation': 'High Technology Hospital Medcenter, Batumi, Georgia.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Paydas', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Nechaeva', 'Affiliation': 'Arkhangelsk Clinical Oncology Center, Arkhangelsk, Russia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Seebach', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gullo', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Lowy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rietschel', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00228-2']
1257,33581820,Transdermal oestradiol for androgen suppression in prostate cancer: long-term cardiovascular outcomes from the randomised Prostate Adenocarcinoma Transcutaneous Hormone (PATCH) trial programme.,"BACKGROUND


Androgen suppression is a central component of prostate cancer management but causes substantial long-term toxicity. Transdermal administration of oestradiol (tE2) circumvents first-pass hepatic metabolism and, therefore, should avoid the cardiovascular toxicity seen with oral oestrogen and the oestrogen-depletion effects seen with luteinising hormone releasing hormone agonists (LHRHa). We present long-term cardiovascular follow-up data from the Prostate Adenocarcinoma Transcutaneous Hormone (PATCH) trial programme.
METHODS


PATCH is a seamless phase 2/3, randomised, multicentre trial programme at 52 study sites in the UK. Men with locally advanced or metastatic prostate cancer were randomly allocated (1:2 from August, 2007 then 1:1 from February, 2011) to either LHRHa according to local practice or tE2 patches (four 100 μg patches per 24 h, changed twice weekly, reducing to three patches twice weekly if castrate at 4 weeks [defined as testosterone ≤1·7 nmol/L]). Randomisation was done using a computer-based minimisation algorithm and was stratified by several factors, including disease stage, age, smoking status, and family history of cardiac disease. The primary outcome of this analysis was cardiovascular morbidity and mortality. Cardiovascular events, including heart failure, acute coronary syndrome, thromboembolic stroke, and other thromboembolic events, were confirmed using predefined criteria and source data. Sudden or unexpected deaths were attributed to a cardiovascular category if a confirmatory post-mortem report was available and as other relevant events if no post-mortem report was available. PATCH is registered with the ISRCTN registry, ISRCTN70406718; the study is ongoing and adaptive.
FINDINGS


Between Aug 14, 2007, and July 30, 2019, 1694 men were randomly allocated either LHRHa (n=790) or tE2 patches (n=904). Overall, median follow-up was 3·9 (IQR 2·4-7·0) years. Respective castration rates at 1 month and 3 months were 65% and 93% among patients assigned LHRHa and 83% and 93% among those allocated tE2. 157 events from 145 men met predefined cardiovascular criteria, with a further ten sudden deaths with no post-mortem report (total 167 events in 153 men). 26 (2%) of 1694 patients had fatal cardiovascular events, 15 (2%) of 790 assigned LHRHa and 11 (1%) of 904 allocated tE2. The time to first cardiovascular event did not differ between treatments (hazard ratio 1·11, 95% CI 0·80-1·53; p=0·54 [including sudden deaths without post-mortem report]; 1·20, 0·86-1·68; p=0·29 [confirmed group only]). 30 (34%) of 89 cardiovascular events in patients assigned tE2 occurred more than 3 months after tE2 was stopped or changed to LHRHa. The most frequent adverse events were gynaecomastia (all grades), with 279 (38%) events in 730 patients who received LHRHa versus 690 (86%) in 807 patients who received tE2 (p<0·0001) and hot flushes (all grades) in 628 (86%) of those who received LHRHa versus 280 (35%) who received tE2 (p<0·0001).
INTERPRETATION


Long-term data comparing tE2 patches with LHRHa show no evidence of a difference between treatments in cardiovascular mortality or morbidity. Oestrogens administered transdermally should be reconsidered for androgen suppression in the management of prostate cancer.
FUNDING


Cancer Research UK, and Medical Research Council Clinical Trials Unit at University College London.",2021,Respective castration rates at 1 month and 3 months were 65% and 93% among patients assigned LHRHa and 83% and 93% among those allocated tE2.,"['52 study sites in the UK', 'prostate cancer', 'Men with locally advanced or metastatic prostate cancer', 'Between Aug 14, 2007, and July 30, 2019', '157 events from 145 men met predefined cardiovascular criteria, with a further ten sudden deaths with no post-mortem report (total 167 events in 153 men', '1694 men']","['Oestrogens', 'Transdermal oestradiol', 'LHRHa', 'oestradiol (tE2', 'LHRHa according to local practice or tE2 patches']","['Cardiovascular events, including heart failure, acute coronary syndrome, thromboembolic stroke, and other thromboembolic events', 'cardiovascular mortality or morbidity', 'Respective castration rates', 'hot flushes', 'time to first cardiovascular event', 'cardiovascular morbidity and mortality', 'fatal cardiovascular events', 'Sudden or unexpected deaths', 'sudden deaths']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0580205', 'cui_str': 'Postmortem period'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0450699', 'cui_str': 'TE2'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1112433', 'cui_str': 'Thromboembolic stroke'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0277591', 'cui_str': 'Unexpected death'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",1694.0,0.182213,Respective castration rates at 1 month and 3 months were 65% and 93% among patients assigned LHRHa and 83% and 93% among those allocated tE2.,"[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK. Electronic address: ruth.langley@ucl.ac.uk.'}, {'ForeName': 'Duncan C', 'Initials': 'DC', 'LastName': 'Gilbert', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Trinh', 'Initials': 'T', 'LastName': 'Duong', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'The Christie and Salford Royal Hospitals, Manchester, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Stuart D', 'Initials': 'SD', 'LastName': 'Rosen', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mangar', 'Affiliation': 'Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Archie', 'Initials': 'A', 'LastName': 'Macnair', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Subramanian Kanaga', 'Initials': 'SK', 'LastName': 'Sundaram', 'Affiliation': 'Mid Yorkshire NHS Trust, Wakefield, UK.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Laniado', 'Affiliation': 'Wexham Park Hospital, Frimley Health Foundation Trust, Slough, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Scunthorpe General Hospital, Scunthorpe, UK.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Department of Urology & Nephrology, Dartford and Gravesham NHS Trust, Dartford, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Manetta', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Alvan', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'The Hillingdon Hospitals NHS Foundation Trust and Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Scrase', 'Affiliation': 'Ipswich Hospital, East Suffolk North Essex NHS Foundation Trust, Ipswich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mckay', 'Affiliation': 'Forth Valley Royal Hospital, Larbert, UK; Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Iqtedar A', 'Initials': 'IA', 'LastName': 'Muazzam', 'Affiliation': 'Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Cottingham, UK.'}, {'ForeName': 'Gerald N', 'Initials': 'GN', 'LastName': 'Collins', 'Affiliation': 'Macclesfield District General Hospital, East Cheshire NHS Trust, Macclesfield, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Worlding', 'Affiliation': 'University Hospital Coventry, Coventry, UK.'}, {'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Williams', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Newcastle Urology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Sussex Cancer Centre, Brighton, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'McFarlane', 'Affiliation': 'Royal United Hospitals, Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Deighan', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Forcat', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, Cardiff University Medical School, Cardiff, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Units at University College London (UCL), London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(21)00100-8']
1258,33581798,"[ 177 Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial.","BACKGROUND


Lutetium-177 [ 177 Lu]Lu-PSMA-617 is a radiolabelled small molecule that delivers β radiation to cells expressing prostate-specific membrane antigen (PSMA), with activity and safety in patients with metastatic castration-resistant prostate cancer. We aimed to compare [ 177 Lu]Lu-PSMA-617 with cabazitaxel in patients with metastatic castration-resistant prostate cancer.
METHODS


We did this multicentre, unblinded, randomised phase 2 trial at 11 centres in Australia. We recruited men with metastatic castration-resistant prostate cancer for whom cabazitaxel was considered the next appropriate standard treatment. Participants were required to have adequate renal, haematological, and liver function, and an Eastern Cooperative Oncology Group performance status of 0-2. Previous treatment with androgen receptor-directed therapy was allowed. Men underwent gallium-68 [ 68 Ga]Ga-PSMA-11 and 2-flourine-18[ 18 F]fluoro-2-deoxy-D-glucose (FDG) PET-CT scans. PET eligibility criteria for the trial were PSMA-positive disease, and no sites of metastatic disease with discordant FDG-positive and PSMA-negative findings. Men were randomly assigned (1:1) to [ 177 Lu]Lu-PSMA-617 (6·0-8·5 GBq intravenously every 6 weeks for up to six cycles) or cabazitaxel (20 mg/m 2  intravenously every 3 weeks for up to ten cycles). The primary endpoint was prostate-specific antigen (PSA) response defined by a reduction of at least 50% from baseline. This trial is registered with ClinicalTrials.gov, NCT03392428.
FINDINGS


Between Feb 6, 2018, and Sept 3, 2019, we screened 291 men, of whom 200 were eligible on PET imaging. Study treatment was received by 98 (99%) of 99 men randomly assigned to [ 177 Lu]Lu-PSMA-617 versus 85 (84%) of 101 randomly assigned to cabazitaxel. PSA responses were more frequent among men in the [ 177 Lu]Lu-PSMA-617 group than in the cabazitaxel group (65 vs 37 PSA responses; 66% vs 37% by intention to treat; difference 29% (95% CI 16-42; p<0·0001; and 66% vs 44% by treatment received; difference 23% [9-37]; p=0·0016). Grade 3-4 adverse events occurred in 32 (33%) of 98 men in the [ 177 Lu]Lu-PSMA-617 group versus 45 (53%) of 85 men in the cabazitaxel group. No deaths were attributed to [ 177 Lu]Lu-PSMA-617.
INTERPRETATION


[ 177 Lu]Lu-PSMA-617 compared with cabazitaxel in men with metastatic castration-resistant prostate cancer led to a higher PSA response and fewer grade 3 or 4 adverse events. [ 177 Lu]Lu-PSMA-617 is a new effective class of therapy and a potential alternative to cabazitaxel.
FUNDING


Prostate Cancer Foundation of Australia, Endocyte (a Novartis company), Australian Nuclear Science and Technology Organization, Movember, The Distinguished Gentleman's Ride, It's a Bloke Thing, and CAN4CANCER.",2021,Grade 3-4 adverse events occurred in 32 (33%) of 98 men in the [ 177 Lu]Lu-PSMA-617 group versus 45 (53%) of 85 men in the cabazitaxel group.,"['Between Feb 6, 2018, and Sept 3, 2019, we screened 291 men, of whom 200 were eligible on PET imaging', 'men with metastatic castration-resistant prostate cancer for whom cabazitaxel was considered the next appropriate standard treatment', 'patients with metastatic castration-resistant prostate cancer (TheraP', 'patients with metastatic castration-resistant prostate cancer', 'Participants were required to have adequate renal, haematological, and liver function, and an Eastern Cooperative Oncology Group performance status of 0-2', '11 centres in Australia', 'men with metastatic castration-resistant prostate cancer', 'Men underwent', 'Study treatment was received by 98 (99%) of 99 men randomly assigned to [ 177']","['androgen receptor-directed therapy', '177 Lu]Lu-PSMA-617 with cabazitaxel', 'Lu]Lu-PSMA-617', 'F]fluoro-2-deoxy-D-glucose (FDG) PET-CT scans', 'PSMA-617 versus cabazitaxel', '2-flourine-18', 'gallium-68', 'cabazitaxel']","['Grade 3-4 adverse events', 'prostate-specific antigen (PSA) response', 'PSA responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}, {'cui': 'C0011501', 'cui_str': '2-Desoxy-D-glucose'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",99.0,0.212597,Grade 3-4 adverse events occurred in 32 (33%) of 98 men in the [ 177 Lu]Lu-PSMA-617 group versus 45 (53%) of 85 men in the cabazitaxel group.,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: michael.hofman@petermac.org.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Emmett', 'Affiliation': ""Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia.""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Mallinckrodt Institute of Radiology, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Medical Oncology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Pattison', 'Affiliation': ""Department of Nuclear Medicine & Specialised PET Services, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; School of Medicine, University of Queensland, St Lucia, Brisbane, QLD, Australia.""}, {'ForeName': 'Thean Hsiang', 'Initials': 'TH', 'LastName': 'Tan', 'Affiliation': 'Department of Oncology, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Oncology, Royal Adelaide Hospital, Adelaide, SA, Australia; Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'Department of Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Gedye', 'Affiliation': 'Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Natalie K', 'Initials': 'NK', 'LastName': 'Rutherford', 'Affiliation': 'Department of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Weickhardt', 'Affiliation': 'Olivia Newton-John Cancer and Wellness Centre, Austin Health, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Scott', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia; Olivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Sze-Ting', 'Initials': 'ST', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia; Olivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Edmond M', 'Initials': 'EM', 'LastName': 'Kwan', 'Affiliation': 'Department of Medical Oncology, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Arun A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Shakher', 'Initials': 'S', 'LastName': 'Ramdave', 'Affiliation': 'Monash Health Imaging, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Redfern', 'Affiliation': 'Medical School, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Macdonald', 'Affiliation': 'Department of Nuclear Medicine, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Guminski', 'Affiliation': 'Department of Medical Oncology, Royal North Shore Hospital, Sydney, NSW, Australia; Northern Clinical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chua', 'Affiliation': 'Department of Medical Oncology, Liverpool Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia; Department of Nuclear Medicine and PET, Liverpool Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Alison Y', 'Initials': 'AY', 'LastName': 'Zhang', 'Affiliation': ""NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia; Department of Medical Oncology, Macquarie University Hospital, Sydney, NSW, Australia; Department of Medical Oncology, Chris O'Brien Lifehouse, Sydney, NSW, Australia.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'McJannett', 'Affiliation': 'Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, NSW, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': ""NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia; Department of Medical Oncology, Chris O'Brien Lifehouse, Sydney, NSW, Australia.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Violet', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Williams', 'Affiliation': 'Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia; Eastern Health, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(21)00237-3']
1259,33581774,"Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial.","BACKGROUND


Despite therapeutic advances in HER2-positive metastatic breast cancer, resistance to trastuzumab inevitably develops. In the PHOEBE study, we aimed to assess the efficacy and safety of pyrotinib (an irreversible pan-HER inhibitor) plus capecitabine after previous trastuzumab.
METHODS


This is an open-label, randomised, controlled, phase 3 trial done at 29 hospitals in China. Patients with pathologically confirmed HER2-positive metastatic breast cancer, aged 18-70 years, who had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had been previously treated with trastuzumab and taxanes were randomly assigned (1:1) to receive oral pyrotinib 400 mg or lapatinib 1250 mg once daily plus oral capecitabine 1000 mg/m 2  twice daily on days 1-14 of each 21-day cycle. Randomisation was done via a centralised interactive web-response system with a block size of four or six and stratified by hormone receptor status and previous lines of chemotherapy for metastatic disease. The primary endpoint was progression-free survival according to masked independent central review. Efficacy and safety were assessed in all patients who received at least one dose of the study drugs. Results presented here are from a prespecified interim analysis. This study is registered with ClinicalTrials.gov, NCT03080805.
FINDINGS


Between July 31, 2017, and Oct 30, 2018, 267 patients were enrolled and randomly assigned. 134 patients received pyrotinib plus capecitabine and 132 received lapatinib plus capecitabine. At data cutoff of the interim analysis on March 31, 2019, median progression-free survival was significantly longer with pyrotinib plus capecitabine (12·5 months [95% CI 9·7-not reached]) than with lapatinib plus capecitabine (6·8 months [5·4-8·1]; hazard ratio 0·39 [95% CI 0·27-0·56]; one-sided p<0·0001). The most common grade 3 or worse adverse events were diarrhoea (41 [31%] in the pyrotinib group vs 11 [8%] in the lapatinib group) and hand-foot syndrome (22 [16%] vs 20 [15%]). Serious adverse events were reported for 14 (10%) patients in the pyrotinib group and 11 (8%) patients in the lapatinib group. No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
INTERPRETATION


Pyrotinib plus capecitabine significantly improved progression-free survival compared with that for lapatinib plus capecitabine, with manageable toxicity, and can be considered an alternative treatment option for patients with HER2-positive metastatic breast cancer after trastuzumab and chemotherapy.
FUNDING


Jiangsu Hengrui Medicine and National Key R&D Program of China.",2021,"No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
","['Patients with pathologically confirmed HER2-positive metastatic breast cancer, aged 18-70 years, who had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had been previously treated with', '134 patients received', 'all patients who received at least one dose of the study drugs', 'patients with HER2-positive metastatic breast cancer after trastuzumab and chemotherapy', 'HER2-positive metastatic breast cancer (PHOEBE', '29 hospitals in China', 'Between July 31, 2017, and Oct 30, 2018, 267 patients were enrolled and randomly assigned']","['pyrotinib plus capecitabine', 'oral pyrotinib 400 mg or lapatinib 1250 mg once daily plus oral capecitabine', 'capecitabine', 'lapatinib plus capecitabine', 'Pyrotinib plus capecitabine versus lapatinib plus capecitabine', 'trastuzumab and taxanes']","['sudden death', 'progression-free survival', 'median progression-free survival', 'Efficacy and safety', 'deaths', 'efficacy and safety', 'Serious adverse events', 'diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242755', 'cui_str': 'Phoebe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3828434', 'cui_str': 'pyrotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",267.0,0.376178,"No treatment-related deaths were reported in the pyrotinib group and one sudden death in the lapatinib group was considered treatment related.
","[{'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: xubinghe@medmail.com.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xichun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Fudan University Cancer Hospital, Shanghai, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Quchang', 'Initials': 'Q', 'LastName': 'Ouyang', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': 'Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Liaoning Cancer Hospital & Institute, Shenyang, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The First Bethune Hospital of Jilin University, Changchun, China; The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qianjun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Wuhan Union Hospital, Wuhan, China.'}, {'ForeName': 'Cuizhi', 'Initials': 'C', 'LastName': 'Geng', 'Affiliation': 'The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Centre of Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sun Yat-Sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'The Third Hospital of Nanchang, Nanchang, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Luo', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yudong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Shandong Tumor Hospital, Jinan, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Jiangsu Hengrui Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30702-6']
1260,33581737,Role of Canagliflozin on function of CD34+ve endothelial progenitor cells (EPC) in patients with type 2 diabetes.,"BACKGROUND


Endothelial progenitor cells (EPCs) has been shown to be dysfunctional in both type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) leading to poor regeneration of endothelium and renal perfusion. EPCs have been shown to be a robust cardiovascular disease (CVD) risk indicator. Effect of sodium glucose channel inhibitors (SGLT2i) such as Canagliflozin (CG) on a cellular biomarker such as CD34+ve progenitor cells, which may help predict CVD risk, in patients with T2DM with established CKD has not been explored.
METHODS


This is a pilot study where 29 subjects taking metformin and/or Insulin were enrolled in a 16 week, double blind, randomized placebo matched trial, with a low dose 100 mg CG as the intervention group compared to matched placebo. Type 2 diabetes subjects (30-70 years old), with hemoglobin A1c (HbA1c) of 7-10%, were enrolled. CD34+ve cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, serum biochemistry pertaining to cardio-metabolic health, resting energy expenditure and body composition were measured. Data were collected at week 0, 8 and 16. A mixed model regression analysis was done and p value less than 0.05 was considered statistically significant.
RESULTS


A significant expression of CXCR4 receptor with a concomittant increase in migratory function of CD34+ve cells was observed in CG treated group as compared to placebo group. Gene expression analysis of CD34+ve cells showed an increase in expression of antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and notable endothelial markers (PECAM1, VEGF-A, and NOS3). A significant reduction in glucose and HbA1c levels were observed along with improved systolic and diastolic blood pressure in the CG group. A significant increase in adiponectin (p = 0.006) was also noted in treatment group. Urinary exosomal protein leak in urine, examining podocyte health (podocalyxin, Wilm's tumor and nephrin) showed reduction with CG CONCLUSION: Low dose Canagliflozin has a beneficial effect on CD34+ cell function, serum biochemistry and urinary podocyte specific exosomes in type 2 diabetes.",2021,"Gene expression analysis of CD34+ve cells showed an increase in expression of antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and notable endothelial markers (PECAM1, VEGF-A, and NOS3).","['29 subjects taking metformin and/or Insulin were enrolled in a 16\xa0week', 'patients with T2DM with established CKD', 'patients with type 2 diabetes', 'Type 2 diabetes subjects (30-70\xa0years old), with hemoglobin A1c (HbA1c) of 7-10%, were enrolled']","['Endothelial progenitor cells (EPCs', 'Canagliflozin', 'placebo', 'sodium glucose channel inhibitors (SGLT2i) such as Canagliflozin (CG']","['expression of antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and notable endothelial markers (PECAM1, VEGF-A, and NOS3', 'adiponectin', 'CD34+ve cell number, migratory function, gene expression along with vascular parameters such as arterial stiffness, serum biochemistry pertaining to cardio-metabolic health, resting energy expenditure and body composition', 'migratory function of CD34+ve cells', 'function of CD34+ve endothelial progenitor cells (EPC', 'glucose and HbA1c levels', 'systolic and diastolic blood pressure']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0968147', 'cui_str': 'superoxide dismutase 2'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0232901', 'cui_str': 'Migratory'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0511653,"Gene expression analysis of CD34+ve cells showed an increase in expression of antioxidants (superoxide dismutase 2 or SOD2, Catalase and Glutathione Peroxidase or GPX) and notable endothelial markers (PECAM1, VEGF-A, and NOS3).","[{'ForeName': 'Seshagiri Rao', 'Initials': 'SR', 'LastName': 'Nandula', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 Eye Street, SMHS, Room 462,, Washington, DC, 20037, USA.'}, {'ForeName': 'Nabanita', 'Initials': 'N', 'LastName': 'Kundu', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 Eye Street, SMHS, Room 462,, Washington, DC, 20037, USA.'}, {'ForeName': 'Hassan B', 'Initials': 'HB', 'LastName': 'Awal', 'Affiliation': 'The GW Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Beda', 'Initials': 'B', 'LastName': 'Brichacek', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 Eye Street, SMHS, Room 462,, Washington, DC, 20037, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fakhri', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 Eye Street, SMHS, Room 462,, Washington, DC, 20037, USA.'}, {'ForeName': 'Nikhila', 'Initials': 'N', 'LastName': 'Aimalla', 'Affiliation': 'Department of Medicine, The George Washington University, 2300 Eye Street, SMHS, Room 462,, Washington, DC, 20037, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Elzarki', 'Affiliation': 'The GW Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Amdur', 'Affiliation': 'The GW Medical Faculty Associates, Washington, DC, USA.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'The GW Medical Faculty Associates, Washington, DC, USA. ssen1@gwu.edu.'}]",Cardiovascular diabetology,['10.1186/s12933-021-01235-4']
1261,33581727,"Penehyclidine mitigates postoperative nausea and vomiting and intraoperative oculocardiac reflex in patients undergoing strabismus surgery: a prospective, randomized, double-blind comparison.","BACKGROUND


Postoperative nausea and vomiting (PONV) is one of the most frequent complications following strabismus surgery. Penehyclidine, an anticholinergic agent, is widely used as premedication. This study investigated the effect of preoperative penehyclidine on PONV in patients undergoing strabismus surgery.
METHODS


In this prospective, randomized, double-blind study, patients scheduled for strabismus surgery under general anesthesia were randomly assigned to either penehyclidine (n = 114) or normal saline (n = 104) group. Penehyclidine was administrated immediately after anesthesia induction, and normal saline was substituted as control. PONV was investigated from 0 to 48 h after surgery. Intraoperative oculocardiac reflex (OCR) was also recorded.
RESULTS


Compared with normal saline, penehyclidine significantly reduced PONV incidence (30.7% vs. 54.8%, P < 0.01) and mitigated PONV severity as indicated by severity scoring (P < 0.01). Compared with normal saline, penehyclidine also significantly reduced OCR incidence (57.9% vs. 77.9%, P < 0.01) and mitigated OCR severity, as indicated by the requirement for atropine rescue (77.3% vs. 90.1%, P < 0.05) and the maximum decrease of heart rate during OCR (23.1 ± 9.4 bpm vs. 27.3 ± 12.4 bpm, P < 0.05). The recovery course did not differ between groups.
CONCLUSIONS


Penehyclidine administrated after anesthesia induction significantly reduced the incidence of PONV and alleviated intraoperative OCR in patients undergoing strabismus surgery.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT04054479 ). Retrospectively registered August 13, 2019.",2021,"Compared with normal saline, penehyclidine significantly reduced PONV incidence (30.7% vs. 54.8%, P ","['patients undergoing strabismus surgery', 'patients scheduled for strabismus surgery under general anesthesia']","['penehyclidine', 'normal saline, penehyclidine', 'preoperative penehyclidine', 'Penehyclidine', 'normal saline']","['incidence of PONV and alleviated intraoperative OCR', 'OCR incidence', 'PONV', 'mitigated PONV severity', 'heart rate during OCR', 'mitigated OCR severity', 'atropine rescue', 'postoperative nausea and vomiting and intraoperative oculocardiac reflex', 'Intraoperative oculocardiac reflex (OCR', 'PONV incidence', 'recovery course']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C1451872', 'cui_str': 'penehyclidine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0034938', 'cui_str': 'Oculocardiac reflex'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",,0.592675,"Compared with normal saline, penehyclidine significantly reduced PONV incidence (30.7% vs. 54.8%, P ","[{'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Xinxu', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Zhengnian', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing, 210029, China. zhengnianding@njmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-021-01266-0']
1262,33581721,Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.,"BACKGROUND


The Analgesia Nociception Index (ANI) has been suggested as a non-invasive guide for analgesia. Our objective was to compare the efficacy of ANI vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration.
METHODS


This was a prospective, randomized, controlled study of adult female patients undergoing elective mastectomy under general anesthesia. The patients were randomized to the ANI-guided group receiving a loading dose of 75 μg of fentanyl followed by 25 μg when the ANI score was under 50. The Control group received the same loading dose followed by 25 μg every 30 min with additional doses when there were signs of inadequate analgesia (viz., tachycardia or hypertension).
RESULTS


Sixty patients-30 in each group-were recruited. Although the actual mean ANI score was higher in the ANI-guided than in the Control group (mean difference 2.2; 95% CI: 0.3 to 4.0, P = 0.022), there was no difference in the primary outcome-i.e., intraoperative fentanyl consumption (mean difference - 4.2 μg; 95% CI: - 24.7 to 16.4, P = 0.686 and - 0.14 μg·kg - 1 ·h - 1 ; 95% CI: - 0.31 to 0.03, P = 0.105). No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit.
CONCLUSIONS


Intraoperative fentanyl administration guided by ANI was equivalent to that guided by a modified pharmacologic pattern. In a surgical model of mastectomy, the ANI-guided intraoperative administration of fentanyl had no impact on clinical outcomes.
TRIAL REGISTRATION


The study was registered with ClinicalTrials.gov ( NCT03716453 ) on 21/10/2018.",2021,"No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit.
","['adult female patients undergoing elective mastectomy under general anesthesia', 'mastectomy patients', 'Sixty patients-30 in each group-were recruited']","['ANI-guided group receiving a loading dose of 75\u2009μg of fentanyl', 'fentanyl', 'analgesia nociception index (ANI) vs. standard pharmacokinetic pattern']","['intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores', 'actual mean ANI score', 'intraoperative fentanyl consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",,0.233908,"No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit.
","[{'ForeName': 'Sirirat', 'Initials': 'S', 'LastName': 'Tribuddharat', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Thepakorn', 'Initials': 'T', 'LastName': 'Sathitkarnmanee', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand. thepakorns@gmail.com.'}, {'ForeName': 'Pornlada', 'Initials': 'P', 'LastName': 'Sukhong', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Maneerat', 'Initials': 'M', 'LastName': 'Thananun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Parinda', 'Initials': 'P', 'LastName': 'Promkhote', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.'}, {'ForeName': 'Duangthida', 'Initials': 'D', 'LastName': 'Nonlhaopol', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.'}]",BMC anesthesiology,['10.1186/s12871-021-01272-2']
1263,33581715,The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol.,"BACKGROUND


Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as patients with a history of coronary or cerebrovascular disease. Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease. Atherosclerotic risk factor identification and modification play an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. In this study, we aim to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors.
METHODS


This is a randomised, parallel group, active-control trial to compare the effectiveness of the risk factor modification intervention programme to standard healthcare in a tertiary vascular care centre, in the reduction of modified risk factors in PAD patients. The primary outcome of this study is to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors at 3 and 12 months. The secondary outcomes are to compare the impact of the programme on clinical outcomes in PAD patients at 12 months. Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.
DISCUSSION


This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high-quality, well-powered clinical trial.
TRIAL REGISTRATION


This trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov ( NCT03935776 ) which was registered on 02 May 2019.",2021,"Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.
","['patients with a history of coronary or cerebrovascular disease', 'patients with atherosclerosis', 'PAD patients', 'patients with PAD']","['lifestyle and risk factor modification', 'lifestyle and risk factor modification intervention programme', 'risk factor modification intervention programme', 'Risk reduction therapy']","['amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events', 'cardiovascular mortality and morbidity', 'PAD risk factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",,0.158693,"Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elfghi', 'Affiliation': 'School of Medicine, National University of Ireland, University Road, Galway, Ireland. marahelfghi@gmail.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Jordan', 'Affiliation': 'School of Nursing and Midwifery, National University of Ireland, University Road, Galway, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dunne', 'Affiliation': 'National Institute for Prevention and Cardiovascular Health, Croi Heart and Stroke Centre, Mayola Lane, Newcastle, Galway, Ireland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gibson', 'Affiliation': 'School of Medicine, National University of Ireland, University Road, Galway, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'National Institute for Prevention and Cardiovascular Health, Croi Heart and Stroke Centre, Mayola Lane, Newcastle, Galway, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Flaherty', 'Affiliation': 'School of Medicine, National University of Ireland, University Road, Galway, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University College Hospital, Galway (UCHG), Newcastle Road, Galway, Ireland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tawfick', 'Affiliation': 'School of Medicine, National University of Ireland, University Road, Galway, Ireland.'}]",Trials,['10.1186/s13063-021-05087-x']
1264,33587431,Association of HHV-6 With Outcomes in CMV-Seronegative Liver Transplant Recipients With CMV-Seropositive Donors Receiving Preemptive Antiviral Therapy.,"BACKGROUND


Risk factors, virologic parameters and outcomes associated with HHV-6 viremia in high-risk donor CMV-seropositive and recipient CMV-seronegative (D+R-) liver transplant recipients in the current era are incompletely defined.
METHODS


The study population consisted of patients in the preemptive therapy (PET) arm of a randomized, controlled trial of PET versus valganciclovir prophylaxis for CMV prevention in D+R- liver transplant recipients. Weekly blood samples through 100 days in the PET group were tested for HHV-6 viremia using a real-time quantitative PCR. Assessments included virologic characteristics and relationship with CMV, risk factors and impact of HHV-6 viremia with outcomes through 12 months post-transplant.
RESULTS


HHV-6 viremia at any level developed in 42% (40/96). Older patient age (p=0.03), longer hospitalization (p=0.015), and ICU stay at transplantation (p=0.029) were significantly associated with high-grade viremia. Concurrent HHV-6 and CMV viremia was associated with earlier onset of HHV-6 viremia (p=0.004), higher HHV-6 AUC (p=0.043), and higher peak HHV-6 viral load (p=0.006) vs HHV-6 viremia alone. High-grade viremia was independently associated with biopsy-proven rejection within 12 months (p=0.045) post-transplant.
CONCLUSIONS


Among D+R- liver transplant recipients receiving valganciclovir as PET, high-grade HHV-6 viremia was associated with increased age and critical-illness in ICU at time of transplant and was independently associated with allograft rejection.",2020,"High-grade viremia was independently associated with biopsy-proven rejection within 12 months (p=0.045) post-transplant.
","['D+R- liver transplant recipients', 'CMV-Seronegative Liver Transplant Recipients With CMV-Seropositive Donors Receiving Preemptive Antiviral Therapy']","['HHV-6', 'preemptive therapy (PET', 'PET', 'valganciclovir prophylaxis']","['High-grade viremia', 'longer hospitalization', 'Concurrent HHV-6 and CMV viremia', 'virologic characteristics and relationship with CMV, risk factors and impact of HHV-6 viremia', 'higher HHV-6 AUC', 'HHV-6 viremia', 'peak HHV-6 viral load', 'ICU stay at transplantation']","[{'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}]","[{'cui': 'C0019381', 'cui_str': 'Human herpesvirus 6'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0909381', 'cui_str': 'valganciclovir'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0019381', 'cui_str': 'Human herpesvirus 6'}, {'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",,0.0191758,"High-grade viremia was independently associated with biopsy-proven rejection within 12 months (p=0.045) post-transplant.
","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'University of Pittsburgh, and VA Pittsburgh Healthcare System, Pittsburgh, PA University of California Los Angeles Medical Center, Los Angeles, CA Mayo Clinic, Rochester, MN Emory University, Atlanta, GA University of Pittsburgh and University of Pittsburgh Medical Center, Pittsburgh PA Fred Hutchinson Cancer Research Center, Seattle, WA University of Washington, Seattle, WA.'}, {'ForeName': 'Drew J', 'Initials': 'DJ', 'LastName': 'Winston', 'Affiliation': ''}, {'ForeName': 'Raymund R', 'Initials': 'RR', 'LastName': 'Razonable', 'Affiliation': ''}, {'ForeName': 'G Marshall', 'Initials': 'GM', 'LastName': 'Lyon', 'Affiliation': ''}, {'ForeName': 'Meei-Li', 'Initials': 'ML', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Jerome', 'Affiliation': ''}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Silveira', 'Affiliation': ''}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Wagener', 'Affiliation': ''}, {'ForeName': 'Ajit P', 'Initials': 'AP', 'LastName': 'Limaye', 'Affiliation': ''}]",Transplantation,['10.1097/TP.0000000000003604']
1265,33587407,The Effect of Nutritional Therapy on Bone Mineral Density and Bone Metabolism in Pediatric Crohn's Disease.,"OBJECTIVES


Both the inflammatory burden of Crohn's disease (CD) and corticosteroids have a negative effect on bone density. Exclusive enteral nutrition (EEN) avoids corticosteroids and promotes endoscopic healing. We thus aimed to explore the effect of nutritional therapy on bone health in pediatric CD.
METHODS


This was a planned sub-study of a clinical trial enrolling children with new-onset mild-moderate CD. Children were randomized to either 6 weeks EEN followed by 6 weeks 25% partial enteral nutrition (PEN) or 6 weeks of 50% PEN with a CD exclusion diet followed by 6 weeks of 25% PEN + exclusion diet. Bone formation and resorption were measured at baseline, week 12 and week 24 by serum C-Propeptide of Type I Procollagen (CICP) and type I Collagen N-Telopeptide (NTX), respectively. Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24.
RESULTS


Median CICP improved from 130 ng/mL (106-189) at baseline to 223 (143-258) at week 12 and 193 (143-252) at week 24 (p = 0.016 for both, n = 29 children). Median NTX remained unchanged (p = 0.45 and p = 0.45). Thirty six children had DXA scans performed at diagnosis; 81% and 33% had z-scores of <-1 and <-2, respectively. DXA z-scores did not improve from baseline (adjusted total body less head BMD -1.62 ± 0.87) to week 24 (-1.76 ± 0.75; p = 0.30, n = 21 with both scans).
CONCLUSION


Low bone density is common in new-onset mild-moderate pediatric CD. CICP, a sensitive marker of bone formation, improved following dietary intervention but this was not associated with improved BMD.",2021,"DXA z-scores did not improve from baseline (adjusted total body less head BMD -1.62 ± 0.87) to week 24 (-1.76 ± 0.75; p = 0.30, n = 21 with both scans).
","['pediatric CD', 'children with new-onset mild-moderate CD', ""Pediatric Crohn's Disease""]","['Exclusive enteral nutrition (EEN) avoids corticosteroids', 'I Procollagen (CICP) and type', 'Nutritional Therapy', 'I Collagen N-Telopeptide (NTX', 'nutritional therapy', '6\u200aweeks EEN followed by 6\u200aweeks 25% partial enteral nutrition (PEN) or 6\u200aweeks of 50% PEN with a CD exclusion diet followed by 6\u200aweeks of 25% PEN + exclusion diet']","['bone health', 'Bone formation and resorption', 'BMD', 'DXA z-scores', 'Bone Mineral Density and Bone Metabolism', 'Median NTX', 'Median CICP', 'Bone mineral density (BMD', 'DXA scans']","[{'cui': 'C2931133', 'cui_str': ""Pediatric Crohn's disease""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0452376', 'cui_str': 'Elimination diet'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}]",36.0,0.135288,"DXA z-scores did not improve from baseline (adjusted total body less head BMD -1.62 ± 0.87) to week 24 (-1.76 ± 0.75; p = 0.30, n = 21 with both scans).
","[{'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': ""Juliet Keidan Institute of Pediatric Gastroenterology & Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel The Hebrew University of Jerusalem, Jerusalem, Israel Pediatric Health Center, Clalit Health Services, Hadera, Israel The Ruth and Bruce Rappaport School of Medicine, Technion - Israel Institute of Technology, Haifa, Israel Hadassah Medical Center, Jerusalem, Israel Rambam Medical Center, Haifa, Israel Kaplan Medical Center, Rehovot, Israel The Institute of Gastroenterology, Hepatology and Nutrition, Schneider Children's Hospital, Petach Tikva, Israel Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel Edith Wolfson Medical Center, Holon, Israel.""}, {'ForeName': 'Tehila', 'Initials': 'T', 'LastName': 'Ben-Moshe', 'Affiliation': ''}, {'ForeName': 'Guila', 'Initials': 'G', 'LastName': 'Abitbol', 'Affiliation': ''}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': ''}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Peleg', 'Affiliation': ''}, {'ForeName': 'Peri', 'Initials': 'P', 'LastName': 'Millman', 'Affiliation': ''}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Shaoul', 'Affiliation': ''}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kori', 'Affiliation': ''}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Assa', 'Affiliation': ''}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Strich', 'Affiliation': ''}, {'ForeName': 'Shoshana', 'Initials': 'S', 'LastName': 'Revel-Vilk', 'Affiliation': ''}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Tiomkin', 'Affiliation': ''}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'Rotem Sigall', 'Initials': 'RS', 'LastName': 'Boneh', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000003073']
1266,33587403,Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Lisdexamfetamine in Healthy Adults.,"BACKGROUND


Viloxazine extended-release is a novel nonstimulant under investigation as a potential treatment for attention-deficit/hyperactivity disorder (ADHD). Given the potential for viloxazine extended-release to be co-administered with stimulant ADHD pharmacotherapies, this trial investigated the pharmacokinetics and safety of combination viloxazine extended-release + lisdexamfetamine dimesylate (lisdexamfetamine) versus viloxazine extended-release and lisdexamfetamine alone.
METHODS


In this single-center, cross-over, open-label trial, healthy, non-ADHD adults received single oral doses of 700 mg viloxazine extended-release alone, 50 mg lisdexamfetamine alone, and a combination of viloxazine extended-release (700 mg) + lisdexamfetamine (50 mg), with blood samples collected over 4 days postadministration. The active drug in viloxazine extended-release (viloxazine) and primary metabolite of lisdexamfetamine (D-amphetamine) were measured using chromatographic tandem mass spectrometry. Safety assessments included adverse events, vital signs, echocardiograms, and clinical laboratory evaluations.
RESULTS


Thirty-six adults were enrolled, and 34 completed the trial. The least squares geometric mean ratios are reported as [combination / single drug (90% confidence intervals)]. Viloxazine extended-release: Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) = 99.23% (96.61-101.93). Lisdexamfetamine: Cmax = 112.78% (109.93-115.71), AUC0-t = 109.64% (105.25-114.22), and AUCinf = 109.52% (105.19-114.03). All reported adverse events, except 1 (moderate vomiting), were mild in severity.
CONCLUSIONS


Co-administration of viloxazine extended-release and lisdexamfetamine did not impact the pharmacokinetics of viloxazine or D-amphetamine relative to administration of either drug alone. After single dose administration, the combination appeared to be safe and well tolerated.",2021,"Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) =","['Thirty-six adults were enrolled, and 34 completed the trial', 'Healthy Adults']","['viloxazine extended-release alone, 50 mg lisdexamfetamine alone, and a combination of viloxazine extended-release (700 mg) + lisdexamfetamine', 'lisdexamfetamine (D-amphetamine', 'viloxazine', 'Lisdexamfetamine', 'Coadministered Viloxazine Extended-Release', 'Viloxazine extended-release', 'lisdexamfetamine', 'lisdexamfetamine dimesylate (lisdexamfetamine']","['adverse events, vital signs, echocardiograms, and clinical laboratory evaluations', 'area under the concentration-time curve', 'safe and well tolerated', 'adverse events, except 1 (moderate vomiting']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1873633', 'cui_str': 'Lisdexamfetamine'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}, {'cui': 'C1739826', 'cui_str': 'Lisdexamfetamine dimesylate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",36.0,0.0712771,"Cmax = 95.96% (91.33-100.82), area under the concentration-time curve from 0 to the last measurable time (AUC0-t) = 99.19% (96.53-101.91), and area under the concentration-time curve from 0 to infinity (AUCinf) =","[{'ForeName': 'Shamia L', 'Initials': 'SL', 'LastName': 'Faison', 'Affiliation': 'From the Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD Department of Psychiatry/Behavioral Science, University of South Carolina School of Medicine, Greenville, SC.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fry', 'Affiliation': ''}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': ''}, {'ForeName': 'Oyinkansola', 'Initials': 'O', 'LastName': 'Odebo', 'Affiliation': ''}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Maletic', 'Affiliation': ''}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001361']
1267,33587402,Effects of Oral Administration of Alprazolam and Lorazepam as Hypnotics on Cardiovascular Parameters in Hypertensive Patients.,"BACKGROUND


Previous studies have suggested that evening intake of benzodiazepine affects blood pressure (BP) and/or heart rate (HR) in healthy and hypertensive subjects. The aim of this study was to compare the effect of chronic oral administration of alprazolam and lorazepam as hypnotics on ambulatory BP and HR in patients with mild hypertension.
METHODS


Consecutive outpatients of both sexes with newly diagnosed, never-treated mild hypertension were randomized, after a 4-week placebo run-in period, to receive alprazolam 0.5 mg plus placebo, lorazepam 1 mg plus placebo, or placebo plus placebo for 2 weeks in 3 crossover periods, each separated by a 1-week placebo wash-out period. At the end of the initial placebo run-in and of each treatment period, 24-hour ambulatory BP and HR monitoring was performed using a noninvasive device.
RESULTS


In the 32 patients, no treatment had any effect on 24-hour and daytime systolic BP (SBP), diastolic BP (DBP), and HR, which remained unchanged. During the nighttime, SBP and DBP values were unaffected by alprazolam, as compared with placebo, whereas DBP was significantly higher after treatment with lorazepam (+3.7%, P < 0.05 vs placebo). Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
CONCLUSIONS


In patients with mild hypertension, oral intake of alprazolam or lorazepam as hypnotics did not affect ambulatory BP or HR values. A slight increase in nighttime DBP was observed with lorazepam, whereas alprazolam showed no effect on nocturnal BP and HR, probably reflecting a stimulating effect of the drug on central α2-receptors.",2021,"Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
","['patients with mild hypertension, oral intake of', 'Consecutive outpatients of both sexes with newly diagnosed, never-treated mild hypertension', 'healthy and hypertensive subjects', 'Hypertensive Patients', 'patients with mild hypertension']","['placebo', 'Alprazolam and Lorazepam', 'alprazolam', 'alprazolam or lorazepam', 'alprazolam 0.5 mg plus placebo, lorazepam 1 mg plus placebo, or placebo plus placebo', 'benzodiazepine', 'lorazepam', 'alprazolam and lorazepam']","['nighttime DBP', 'nighttime, SBP and DBP values', 'DBP', 'blood pressure (BP) and/or heart rate (HR', '24-hour and daytime systolic BP (SBP), diastolic BP (DBP), and HR, which remained unchanged', 'ambulatory BP or HR values', 'ambulatory BP and HR', '24-hour ambulatory BP and HR monitoring', 'Nocturnal HR mean values', 'Cardiovascular Parameters', 'nocturnal BP and HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0991957', 'cui_str': 'Alprazolam 0.5 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0987272', 'cui_str': 'Lorazepam 1 MG'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0199637', 'cui_str': 'Cardiotachometry'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.328406,"Nocturnal HR mean values were significantly increased by lorazepam (+10.1%, P < 0.01 vs placebo), whereas they did not change after alprazolam.
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': 'From the Unit of Behavioral Neurology, IRCCS Mondino Foundation Departments of Brain and Behavior Internal Medicine and Therapeutics, University of Pavia Laboratory of Neurosonology, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': ''}, {'ForeName': 'Matteo Cotta', 'Initials': 'MC', 'LastName': 'Ramusino', 'Affiliation': ''}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Perini', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bosone', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Fogari', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001362']
1268,33587397,Effects of Oxytocin on Emotion Recognition in Schizophrenia: A Randomized Double-Blind Pilot Study.,"BACKGROUND


Schizophrenia (SCZ) is a neurodevelopmental disorder that leads to poor social function. Oxytocin (OXT), a neuropeptide involved in social cognition, is a potential therapeutic agent for alleviating social dysfunction. Therefore, we investigated the effects of intranasal oxytocin (IN-OXT) on emotional processes in experimental interactive social contexts in individuals with SCZ.
METHODS


In a male-only parallel randomized placebo-controlled double-blind trial, we investigated the effects of IN-OXT (24 IU) on visual fixation on pictures of faces and emotion recognition in an interactive ball-tossing game that probed processing of social and nonsocial stimuli.
RESULTS


Intranasal oxytocin enhanced the recognition of emotions during an emotion-based ball-tossing game. This improvement was specific to the game that included social cue processing. Intranasal oxytocin did not affect eye gaze duration or gaze dwell time on faces in these patients.
CONCLUSIONS


An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition. Higher doses and long-term trials targeting emotional processing in SCZ may lead to improved social function.",2021,An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition.,"['individuals with SCZ', 'Schizophrenia']","['placebo', 'Intranasal oxytocin', 'intranasal oxytocin (IN-OXT', 'Oxytocin (OXT', 'IN-OXT', 'Oxytocin']","['visual fixation on pictures of faces and emotion recognition', 'eye gaze duration or gaze dwell time', 'Emotion Recognition', 'social cue processing', 'recognition of emotions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0016183', 'cui_str': 'Ocular fixation observable'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.298628,An acute low dose of IN-OXT had a modest effect on social cue processing and was limited to emotion recognition.,"[{'ForeName': 'Elissar', 'Initials': 'E', 'LastName': 'Andari', 'Affiliation': 'From the Department of Psychiatry, College of Medicine and Life Sciences, University of Toledo, Toledo, OH Atlanta Veterans Affairs Health Care System, Decatur Rollins School of Public Health, Emory University Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA Department of Psychology, University of California at Los Angeles, Los Angeles, CA Center for Translational Social Neuroscience, Emory University School of Medicine Silvio O. Conte Center for Oxytocin and Social Cognition, Yerkes National Primate Research Center, Emory University, Atlanta, GA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Massa', 'Affiliation': ''}, {'ForeName': 'Molly D', 'Initials': 'MD', 'LastName': 'Fargotstein', 'Affiliation': ''}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Halverson', 'Affiliation': ''}, {'ForeName': 'Andrew V', 'Initials': 'AV', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Currin', 'Affiliation': ''}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': ''}, {'ForeName': 'Dmitriy', 'Initials': 'D', 'LastName': 'Gitman', 'Affiliation': ''}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Cuthbert', 'Affiliation': ''}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Erica J', 'Initials': 'EJ', 'LastName': 'Duncan', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001367']
1269,33587394,"Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial.","PURPOSE/BACKGROUND


There are few efficacious pharmacological treatments for posttraumatic stress disorder (PTSD) and many patients fail to benefit from existing treatments. Vortioxetine, a recently developed antidepressant, acts as a serotonin modulator through inhibition of the serotonin transporter and actions at multiple types of serotonin receptors. Its unique pharmacodynamic profile suggests it may have efficacy for the treatment of PTSD.
METHODS/PROCEDURES


We conducted a 12-week placebo-controlled, randomized clinical trial of vortioxetine (flexibly dosed from 10 to 20 mg/d) versus placebo in adults with PTSD. The primary outcome was change from baseline in the past-month version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), analyzed using a mixed-model repeated-measures analysis of variance.
FINDINGS/RESULTS


Forty-one patients were randomized, and 32 (78%) completed the 12 weeks of treatment. The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29. However, at week 8, the drug-placebo difference was d = 0.78, which met the multivariate criteria for statistical significance, P = 0.014.
IMPLICATIONS/CONCLUSIONS


In this study of 41 patients, vortioxetine did not demonstrate superiority over placebo for adults with PTSD. Future PTSD trials may benefit from stratifying the randomization based on number of years since the index traumatic event and a history of failure to respond to treatment.",2021,The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29.,"['Forty-one patients', 'Posttraumatic Stress Disorder', 'adults with PTSD', '41 patients']","['placebo', 'vortioxetine and placebo', 'vortioxetine', 'Placebo', 'Vortioxetine Monotherapy', 'Vortioxetine']","['CAPS-5 total scores', 'change from baseline in the past-month version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), analyzed using a mixed-model repeated-measures analysis of variance', 'mean reduction in CAPS-5 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",41.0,0.267323,The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29.,"[{'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'From the Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA Department of Psychiatry and Behavioral Sciences, Institute for Early Life Adversity Research, University of Texas at Austin Dell Medical School, Austin, TX University of Miami Miller School of Medicine Bruce W. Carter VA Medical Center, Miami FL.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Rakofsky', 'Affiliation': ''}, {'ForeName': 'D Jeffrey', 'Initials': 'DJ', 'LastName': 'Newport', 'Affiliation': ''}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Mletzko-Crowe', 'Affiliation': ''}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Barone', 'Affiliation': ''}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Nemeroff', 'Affiliation': ''}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001363']
1270,33587381,Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program.,"BACKGROUND


Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented.
OBJECTIVE


To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines.
METHODS


Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments.
RESULTS


In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status.
CONCLUSION


Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice.",2021,Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups.,"['Adults with moderate or severe glabellar lines treated with', '609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated']","['Botulinum Toxin Treatment', 'DaxibotulinumtoxinA for Injection (DAXI) or placebo', 'DAXI and placebo', 'botulinum toxin type A (BoNTA) formulations', 'DaxibotulinumtoxinA']","['Efficacy', 'Efficacy and tolerability', 'efficacy, duration of response, and tolerability', 'mild glabellar lines and duration of response', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0442019', 'cui_str': 'Glabellar'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3.0,0.179842,Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups.,"[{'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Cohen', 'Affiliation': 'AboutSkin Dermatology and DermSurgery PC, Greenwood Village, Colorado; Department of Dermatology, George Washington University School of Medicine, Washington, District of Columbia; Beer Dermatology, West Palm Beach, Florida; Revance Therapeutics, Inc., Newark, California.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Beer', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Gallagher', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002877']
1271,33587369,"A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study of Hyaluronic Acid Filler Effectiveness and Safety in Lip Fullness Augmentation.","BACKGROUND


HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids.
OBJECTIVE


To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids.
METHODS AND MATERIALS


Treatment with HARK or control (randomized 2:1) was administered on Day 1 in this 48-week, evaluator-blinded study with optional touch-up at Week 4. Primary endpoint was change from baseline to Week 8 in lip fullness. Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries).
RESULTS


The primary objective was met; HARK was noninferior to control in lip fullness augmentation at Week 8. Lip fullness and wrinkle severity improvement persisted at Week 48, and was accompanied by high aesthetic improvement and subject satisfaction scores. The mean volume of HARK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient.
CONCLUSION


HARK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.",2021,"Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries).
",['Lip Fullness Augmentation'],"['Hyaluronic Acid', 'HARK', 'HARK versus a control (HAJV']","['lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries', 'aesthetic improvement and subject satisfaction scores', 'Lip fullness and wrinkle severity improvement', 'adverse events and local tolerability symptoms', 'change from baseline to Week 8 in lip fullness', 'mean volume of HARK', 'effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids']","[{'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0277938', 'cui_str': 'Circumoral rhytides'}]",,0.103697,"Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries).
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Maryland Dermatology, Laser, Skin and Vein Institute, Hunt Valley, Maryland; Research Institute of SouthEast, West Palm Beach, Florida; Aesthetic Solutions, Chapel Hill, North Carolina; Art of Skin Maryland, Solana Beach, California; Skin Research Institute, LLC, Coral Gables, Florida; Center for Advanced Clinical Research, Dallas, Texas; Brian S. Biesman, Nashville, Tennessee; Clinical Testing of Beverly Hills, Encino, California; Galderma Aesthetics, Clinical Development, Uppsala, Sweden; Galderma Aesthetics, Global Medical Affairs, Uppsala, Sweden.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Beer', 'Affiliation': ''}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Palm', 'Affiliation': ''}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bassichis', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Biesman', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': ''}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Almegård', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Edwartz', 'Affiliation': ''}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002856']
1272,33587340,Effect of exercise intensity on metabolic responses on combined application of electrical stimulation and voluntary exercise.,"The combined application of voluntary exercises and neuromuscular electrical stimulation (NMES) has been developed as a new type of exercise that can recruit motor units contributing to both aerobic and anaerobic energy metabolisms. We aimed to investigate the effect of voluntary exercise intensity on metabolic responses on the combination of voluntary exercise and NMES. In 13 volunteers, oxygen consumption and the blood lactate concentration were measured during (1) voluntary pedaling exercise at four different intensities: 50%, 75%, 100%, and 125% of the ventilatory threshold (VT) (VOL), (2) these voluntary exercises with superimposed NMES applied to the gluteus and thigh muscles (VOL+NMES), and (3) NMES only (NMES). Oxygen consumption and the blood lactate concentration in VOL+NMES were significantly greater than VOL at each exercise intensity (p < 0.05). Differences in oxygen consumption between VOL+NMES and VOL decreased with exercise intensity, and that at 125% VT was significantly lower than the net gain in oxygen consumption following NMES (p < 0.05). Differences in the blood lactate concentration between VOL+NMES and VOL increased with exercise intensity, and that at 50% VT was significantly lower than the net gain in the blood lactate concentration following NMES (p < 0.05). Our results suggest that voluntary exercise intensity has a critical impact on metabolic responses during the combined application of voluntary exercises and NMES. Superimposing NMES onto voluntary exercises at high exercise intensities may induce overlapping recruitment of motor units, leading to a markedly reduced benefit of additional metabolic responses on its superimposition.",2021,Oxygen consumption and the blood lactate concentration in VOL+NMES were significantly greater than VOL at each exercise intensity (p < 0.05).,[],"['voluntary exercise and NMES', 'exercise intensity', 'voluntary exercises with superimposed NMES applied to the gluteus and thigh muscles (VOL+NMES), and (3) NMES only (NMES', 'voluntary exercise intensity', 'voluntary exercises and neuromuscular electrical stimulation (NMES', 'electrical stimulation and voluntary exercise']","['metabolic responses', 'blood lactate concentration', 'oxygen consumption and the blood lactate concentration', 'Oxygen consumption and the blood lactate concentration', 'oxygen consumption']",[],"[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",13.0,0.0478675,Oxygen consumption and the blood lactate concentration in VOL+NMES were significantly greater than VOL at each exercise intensity (p < 0.05).,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Neuromuscular Biomechanics, Faculty of Liberal Arts and Sciences and School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Takada', 'Affiliation': 'MTG Co., Ltd., Nagoya, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Kawade', 'Affiliation': 'MTG Co., Ltd., Nagoya, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Moritani', 'Affiliation': 'School of Health and Sport Sciences, Chukyo University, Toyota, Japan.'}]",Physiological reports,['10.14814/phy2.14758']
1273,33587286,Evaluation of the Pharmacokinetics and Exposure-Response Relationship of Dapagliflozin in Patients without Diabetes and with Chronic Kidney Disease.,"BACKGROUND AND OBJECTIVE


Dapagliflozin, a sodium-glucose co-transporter inhibitor, was originally developed as an oral glucose-lowering drug for the treatment of type 2 diabetes mellitus. Emerging data suggest that cardiovascular and kidney benefits extend to patients without diabetes. Limited pharmacological data are, however, available in patients without diabetes. We aimed to characterise the pharmacokinetic profile of dapagliflozin in patients with chronic kidney disease without type 2 diabetes.
METHODS


Plasma samples were collected in a randomised, placebo-controlled, double-blind, cross-over trial (DIAMOND, NCT03190694, n = 53) that assessed the effects of 10 mg of dapagliflozin in patients with a glomerular filtration rate ≥ 25 mL/min/1.73 m 2  and proteinuria > 500 mg/day. Mixed-effects models were used to develop a pharmacokinetic model and to evaluate the association between plasma exposure and response.
RESULTS


Plasma concentrations (n = 430 observations) from 48 patients (mean age 50.8 years, mean glomerular filtration rate 57.9 mL/min/1.73 m 2 , median proteinuria 1115 mg/24 h) were best described using a two-compartment model with first-order elimination. Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9 (95% confidence interval 39.0-50.9) L, respectively. Median dapagliflozin plasma exposure was 740.9 ng h/mL (2.5th-97.5th percentiles: 434.0-1615.3). Plasma exposure increased with decreasing kidney function. Every 100-ng h/mL increment in dapagliflozin plasma exposure was associated with a decrease in the urinary albumin:creatinine ratio (β = - 2.8%, p = 0.01), glomerular filtration rate (β = - 0.5 mL/min/1.73 m 2 , p < 0.01) and systolic blood pressure (β = - 0.4 mmHg, p = 0.03).
CONCLUSIONS


The dapagliflozin plasma concentration-time profile in patients with non-diabetic kidney disease appears similar to the profile of patients with diabetic kidney disease described in the literature. Furthermore, the plasma exposure was associated with changes in risk markers for kidney disease.",2021,Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9,"['patients with a glomerular filtration rate ≥\xa025', 'patients without diabetes', 'Patients without Diabetes and with Chronic Kidney Disease', 'patients with non-diabetic kidney disease', 'type 2 diabetes mellitus', 'patients with chronic kidney disease without type 2 diabetes']","['Dapagliflozin', 'dapagliflozin', 'placebo']","['mean glomerular filtration rate', 'proteinuria', 'systolic blood pressure', 'glomerular filtration rate', 'urinary albumin:creatinine ratio', 'Apparent clearance and volume of distribution', 'dapagliflozin plasma exposure', 'Median dapagliflozin plasma exposure', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.161272,Apparent clearance and volume of distribution were 11.7 (95% confidence interval 10.7-12.7) L/h and 44.9,"[{'ForeName': 'Annemarie B', 'Initials': 'AB', 'LastName': 'van der Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, The Netherlands.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands. h.j.lambers.heerspink@umcg.nl.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00956-1']
1274,33587220,Health measures and long-term care use in the European frail population.,"This paper explores the association between health measures and long-term care (LTC) use in the 70+ old population. We examine how different measures of health-subjective versus objective-predict LTC use, provided either formally or informally. We consider an absolute measure of subjective health, the grade given by the individual to his/her health status, and additionally construct a relative measure capturing the difference between this grade and the average grade given to health by individuals sharing the same characteristics. Conceptually, this difference comes from the perception of the individual, corresponding to both the private health information and the reporting behavior affecting self-rated health. We use the baseline data from the SPRINTT study, an ongoing randomized control trial on 1519 subjects facing physical frailty and sarcopenia (PF&S) in 11 European countries. Our sample population is older than 70 (mean: 79 years) and comprises a majority (71%) of women. Results show that self-rated health indicators correlate to formal care even when objective health measures are included, while it is not the case for informal care. Formal care consumption thus appears to be more sensitive to the individual's perception of health than informal care.",2021,"Results show that self-rated health indicators correlate to formal care even when objective health measures are included, while it is not the case for informal care.","['European frail population', '70+\u2009old population', 'Our sample population is older than 70 (mean: 79\xa0years) and comprises a majority (71%) of women', '1519 subjects facing physical frailty and sarcopenia (PF&S) in 11 European countries']",[],[],"[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0454713', 'cui_str': 'European country'}]",[],[],1519.0,0.022459,"Results show that self-rated health indicators correlate to formal care even when objective health measures are included, while it is not the case for informal care.","[{'ForeName': 'Quitterie', 'Initials': 'Q', 'LastName': 'Roquebert', 'Affiliation': 'Université de Strasbourg, Université de Lorraine, CNRS, BETA, 67000, Strasbourg, France. roquebert@unistra.fr.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sicsic', 'Affiliation': 'LIRAES (EA4470), Université de Paris, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rapp', 'Affiliation': 'LIRAES (EA4470), Université de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01263-z']
1275,33543484,Daily Brazilian green propolis intake elevates blood artepillin C levels in humans.,"BACKGROUND


Propolis is a natural product collected by worker bees from a variety of plant species. As a type of propolis, Brazilian green propolis contains a large amount of artepillin C. Artepillin C is a cinnamic acid derivative and has been shown to have a wide variety of biological functions, including anti-inflammatory, antiviral and antitumor activities, in both cell culture and animal models. However, how propolis is digested and absorbed remains to be elucidated. Moreover, blood artepillin C levels after propolis intake have not been shown in human studies.
RESULTS


A randomized, single-blind placebo-controlled study on the effect of Brazilian green propolis on serum artepillin C levels was conducted with healthy volunteers. The participants (n = 133) were randomly allocated in an approximately 2:1 ratio to two groups: propolis (n = 91) and placebo (n = 42). The participants took daily propolis or placebo, and blood tests were performed on day 0 (before propolis intake) and days 1, 3 and 7. Artepillin C was detected in serum in almost all individuals in the propolis groups. No serum artepillin C was detected in the placebo group. Serum artepillin C levels in the female group tended to be higher than those in the male group. In the female group, menstrual status was unrelated to serum artepillin C levels.
CONCLUSION


These results suggested that propolis intake might be more effective for females than for males. © 2021 Society of Chemical Industry.",2021,No serum artepillin C was detected in the placebo group.,"['healthy volunteers', 'humans', 'participants (n=133']","['Daily Brazilian green propolis intake', 'Brazilian green propolis', 'placebo']","['serum artepillin C', 'serum artepillin C levels', 'blood artepillin C levels', 'Serum artepillin C levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0531492', 'cui_str': 'artepillin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",133.0,0.0543055,No serum artepillin C was detected in the placebo group.,"[{'ForeName': 'Jiangli', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Tomoh', 'Initials': 'T', 'LastName': 'Matsumiya', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Hayakari', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shiba', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Seya', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ueno', 'Affiliation': 'Department of Pharmaceutical Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Tadaatsu', 'Initials': 'T', 'LastName': 'Imaizumi', 'Affiliation': 'Department of Vascular Biology, Institute of Brain Science, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}]",Journal of the science of food and agriculture,['10.1002/jsfa.11132']
1276,33548897,Functional evaluation of NK 1  antagonism on cue reactivity in opiate dependence; An fMRI study.,"BACKGROUND


Opiate addiction is a major health challenge with substantial societal cost. Though harm minimisation strategies have been effective, there is a growing need for new treatments for detoxification and relapse prevention. Preclinical research has found neurokinin 1 (NK 1 ) receptors have prominent effects on opiate reward and reinforcement, and human studies have found NK 1  antagonism led to reductions in craving and withdrawal. However, its effect on brain mechanisms in opiate addiction has not yet been examined.
METHODS


This study aims to assess the impact of NK 1  antagonist aprepitant on heroin cue-elicited changes in blood-oxygenation level dependent (BOLD) signal in opiate dependent individuals undergoing detoxification. Participants will attend two scanning sessions and receive a single dose of aprepitant (320 mg) and a placebo in a randomised, cross-over design. During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion. We hypothesise that NK 1  antagonism will attenuate the BOLD response to drug cues in the caudate nucleus and amygdala. Regions of interest were selected based on NK 1  receptor density and their role in cue reactivity and craving.",2021,"During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion.","['opiate dependence', 'opiate dependent individuals undergoing detoxification']",['placebo'],['blood-oxygenation level dependent (BOLD) signal'],"[{'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0567241,"During functional magnetic resonance imaging participants will undergo two runs of a cue reactivity task, which consists of passive viewing of drug cues or neutral cues in a block design fashion.","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fonville', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom. Electronic address: l.fonville@imperial.ac.uk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Paterson', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Herlinger', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hayes', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Hill', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nutt', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lingford-Hughes', 'Affiliation': 'Division of Psychiatry, Department of Brain Sciences, Imperial College London, United Kingdom.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2021.108564']
1277,33545941,Comparative effectiveness of herb-partitioned moxibustion plus lifestyle modification treatment for patients with simple obesity: A study protocol for a randomized controlled trial.,"INTRODUCTION


Obesity is a global public health issue, which results in many health complications. Moxibustion may serve as an alternative management for simple obesity, where pharmacological therapy is always difficult to be accepted by the majority of obese patients based on its safety. However, the effects of herb-partitioned moxibustion as obesity intervention have not been confirmed. This study is designed as a single-blinded, 3-dummy randomized controlled trial to evaluate the efficacy and safety of herb-partitioned moxibustion plus lifestyle modification treatment in patients with simple obesity.
METHODS AND ANALYSIS


This study will be a randomized, controlled trial conducted from April, 2019 to April, 2021 that includes 108 participants who have simple obesity and meet the eligibility criteria. The participants will be randomly divided into 3 treatment groups: heat application group, medicated plaster group, or herb-partitioned moxibustion group. Each treatment will last 4 weeks. The primary outcomes will be the clinical effectiveness. The secondary outcome measures include participants' obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine. Adverse events will be recorded during the intervention period.
ETHICS AND DISSEMINATION


Ethical approval of this study was granted by the Ethics Committee of Hubei Provincial Hospital of Traditional Chinese Medicine on 15 November 2018 (Ethics Reference No: HBZY2018-C24-01). Written informed consents will be provided by all participants before they were enrolled in this study.
TRIAL REGISTRATION NUMBER


NCT04606680.",2021,"The secondary outcome measures include participants' obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine.","['Hubei Provincial Hospital of Traditional Chinese Medicine on 15 November 2018 (Ethics Reference', 'from April, 2019 to April, 2021 that includes 108 participants who have simple obesity and meet the eligibility criteria', 'patients with simple obesity']","['herb-partitioned moxibustion', 'Moxibustion', 'herb-partitioned moxibustion plus lifestyle modification treatment', 'heat application group, medicated plaster group, or herb-partitioned moxibustion group']","['clinical effectiveness', ""participants' obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine"", 'Adverse events', 'efficacy and safety']","[{'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0451819', 'cui_str': 'Simple obesity'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2021.0,0.137828,"The secondary outcome measures include participants' obesity-related indicators, the IWQOL-Lite scale, and the syndrome score of Traditional Chinese Medicine.","[{'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion.'}, {'ForeName': 'Si-Ying', 'Initials': 'SY', 'LastName': 'Lv', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Yi-Ran', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Jia-Jie', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion.'}, {'ForeName': 'Zhong-Yu', 'Initials': 'ZY', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}]",Medicine,['10.1097/MD.0000000000023758']
1278,33558721,Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma.,"Neoadjuvant ipilimumab plus nivolumab showed high pathologic response rates (pRRs) in patients with macroscopic stage III melanoma in the phase 1b OpACIN ( NCT02437279 ) and phase 2 OpACIN-neo ( NCT02977052 ) studies 1,2 . While the results are promising, data on the durability of these pathologic responses and baseline biomarkers for response and survival were lacking. After a median follow-up of 4 years, none of the patients with a pathologic response (n = 7/9 patients) in the OpACIN study had relapsed. In OpACIN-neo (n = 86), the 2-year estimated relapse-free survival was 84% for all patients, 97% for patients achieving a pathologic response and 36% for nonresponders (P < 0.001). High tumor mutational burden (TMB) and high interferon-gamma-related gene expression signature score (IFN-γ score) were associated with pathologic response and low risk of relapse; pRR was 100% in patients with high IFN-γ score/high TMB; patients with high IFN-γ score/low TMB or low IFN-γ score/high TMB had pRRs of 91% and 88%; while patients with low IFN-γ score/low TMB had a pRR of only 39%. These data demonstrate long-term benefit in patients with a pathologic response and show the predictive potential of TMB and IFN-γ score. Our findings provide a strong rationale for a randomized phase 3 study comparing neoadjuvant ipilimumab plus nivolumab versus standard adjuvant therapy with antibodies against the programmed cell death protein-1 (anti-PD-1) in macroscopic stage III melanoma.",2021,"In OpACIN-neo (n = 86), the 2-year estimated relapse-free survival was 84% for all patients, 97% for patients achieving a pathologic response and 36% for nonresponders (P < 0.001).","['macroscopic stage III melanoma', 'patients with macroscopic stage III melanoma']",[],"['high pathologic response rates (pRRs', '2-year estimated relapse-free survival', 'TMB and IFN-γ score', 'pathologic response', 'High tumor mutational burden (TMB) and high interferon-gamma-related gene expression signature score (IFN-γ score', 'pathologic response and low risk of relapse; pRR']","[{'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.120376,"In OpACIN-neo (n = 86), the 2-year estimated relapse-free survival was 84% for all patients, 97% for patients achieving a pathologic response and 36% for nonresponders (P < 0.001).","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Rozeman', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Hoefsmit', 'Affiliation': 'Department of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'I L M', 'Initials': 'ILM', 'LastName': 'Reijers', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'R P M', 'Initials': 'RPM', 'LastName': 'Saw', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Versluis', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Krijgsman', 'Affiliation': 'Department of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Dimitriadis', 'Affiliation': 'Department of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sikorska', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'van de Wiel', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eriksson', 'Affiliation': 'Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gonzalez', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Torres Acosta', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Grijpink-Ongering', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shannon', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'J B A G', 'Initials': 'JBAG', 'LastName': 'Haanen', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stretch', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""Ch'ng"", 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'O E', 'Initials': 'OE', 'LastName': 'Nieweg', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Mallo', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adriaansz', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Kerkhoven', 'Affiliation': 'Genomics Core Facility, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cornelissen', 'Affiliation': 'Core Facility Molecular Pathology and Biobanking, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Broeks', 'Affiliation': 'Core Facility Molecular Pathology and Biobanking, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'W M C', 'Initials': 'WMC', 'LastName': 'Klop', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Zuur', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'van Houdt', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Peeper', 'Affiliation': 'Department of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Spillane', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'A C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Scolyer', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'T N M', 'Initials': 'TNM', 'LastName': 'Schumacher', 'Affiliation': 'Department of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Menzies', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'C U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. c.blank@nki.nl.'}]",Nature medicine,['10.1038/s41591-020-01211-7']
1279,33556409,Effect of tDCS on well-being and autonomic function in professional male players after official soccer matches.,"This study aimed to examine the effect of transcranial direct current stimulation (tDCS) used as a recovery strategy, on heart rate (HR) measures and perceived well-being in 12 male professional soccer players. tDCS was applied in the days after official matches targeting the left dorsolateral prefrontal cortex (DLPFC) with 2 mA for 20 min (F3-F4 montage). Participants were randomly assigned to anodal tDCS (a-tDCS) or sham tDCS sessions. Players completed the Well-Being Questionnaire (WBQ) and performed the Submaximal Running Test (SRT) before and after tDCS. HR during exercise (HRex) was determined during the last 30 s of SRT. HR recovery (HRR) was recorded at 60 s after SRT. The HRR index was calculated from the absolute difference between HRex and HRR. A significant increase was observed for WBQ (effect of time; p<0.001; η p 2 =0.417) with no effect for condition or interaction. A decrease in HRR (p = 0.014; η p 2 =0.241), and an increase in HRR index were observed (p = 0.045; η p 2 =0.168), with no effect for condition or interaction. No change for HRex was evident (p>0.05). These results suggest that a-tDCS over the DLPFC may have a positive effect on enhancing well-being and parasympathetic autonomic markers, which opens up a possibility for testing tDCS as a promising recovery-enhancing strategy targeting the brain in soccer players. The findings suggest that brain areas related to emotional and autonomic control might be involved in these changes with a possible interaction effect of tDCS by placebo-related effects, but more research is needed to verify this effect.",2021,"A decrease in HRR (p=0.014; η p 2 =0.241), and an increase in HRR index were observed (p=0.045; η p 2 =0.168), with no effect for condition or interaction.","['professional male players after official soccer matches', '12 male professional soccer players']","['anodal tDCS (a-tDCS) or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['WBQ (effect of time', 'heart rate (HR) measures', 'well-being and autonomic function', 'Well-Being Questionnaire (WBQ) and performed the Submaximal Running Test (SRT', 'HRR', 'HRR index', 'HRex', 'HR recovery (HRR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",12.0,0.0437313,"A decrease in HRR (p=0.014; η p 2 =0.241), and an increase in HRR index were observed (p=0.045; η p 2 =0.168), with no effect for condition or interaction.","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Moreira', 'Affiliation': 'Department of Sport, School of Physical Education and Sport, University of São Paulo, São Paulo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology. Research, Innovation and Dissemination Centers - The São Paulo Research Foundation (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, Brazil. Electronic address: alemoreira@usp.br.'}, {'ForeName': 'Daniel Gomes da Silva', 'Initials': 'DGDS', 'LastName': 'Machado', 'Affiliation': 'Graduate Program in Collective Health, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Luciane', 'Initials': 'L', 'LastName': 'Moscaleski', 'Affiliation': 'Center of Mathematics, Computation, and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology. Research, Innovation and Dissemination Centers - The São Paulo Research Foundation (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York of CUNY, New York, NY, United States.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Unal', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York of CUNY, New York, NY, United States.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Bradley', 'Affiliation': 'Research Institute of Sport & Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Abrahão F', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Center of Mathematics, Computation, and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology. Research, Innovation and Dissemination Centers - The São Paulo Research Foundation (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Morya', 'Affiliation': 'Santos Dumont Institute (Instituto Internacional de Neurociências Edmond e Lily Safra), Natal, Rio Grande do Norte, Brazil; Brazilian Institute of Neuroscience and Neurotechnology. Research, Innovation and Dissemination Centers - The São Paulo Research Foundation (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Cevada', 'Affiliation': 'Sport Science Program (PPGCEE), State University of Rio de Janeiro (UERJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Marques', 'Affiliation': 'Red Bull Brazil, São Paulo, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Zanetti', 'Affiliation': 'Red Bull Brazil, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Hideki', 'Initials': 'AH', 'LastName': 'Okano', 'Affiliation': 'Center of Mathematics, Computation, and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP, Brazil; Brazilian Institute of Neuroscience and Neurotechnology. Research, Innovation and Dissemination Centers - The São Paulo Research Foundation (BRAINN/CEPID-FAPESP), University of Campinas, Campinas, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113351']
1280,33571839,Hysteroscopic morcellation versus bipolar resection for removal of type 0 and 1 submucous myomas: A randomized trial.,"OBJECTIVES


To compare hysteroscopic morcellation with bipolar resection for the removal of submucous type 0 and 1 myomas, in terms of procedure time (primary outcome), adverse events, tissue availability, short term effectiveness and postoperative adhesion formation (secondary outcomes).
STUDY DESIGN


The study was performed from May 2011 to May 2018 in the Catharina hospital (Eindhoven, the Netherlands) and the Ghent University hospital (Ghent, Belgium). Women with type 0 and 1 submucous myomas up to 3 cm were randomized to hysteroscopic morcellation with the TruClear TM  8.0 Tissue Removal System or to bipolar resection with a rigid 8.5-mm resectoscope. Skewed time variables were log-transformed and analyzed with the Student t-test. Multiple linear regression analysis was performed to assess the effect of myoma diameter on operating time.
RESULTS


Forty-five and 38 women were included in the hysteroscopic morcellation and resection group, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with resection (9.2 min [interquartile range 5.6-14.4] versus 13.4 min [interquartile range 8.6-17.5], P = .04). In the morcellation group, operating time, corrected for the myoma diameter, was reduced by 26 % (95 % CI 5-43%; P = .02). The median setup time was significantly longer in the morcellation group (5.2 min [interquartile range 4.2-6.9] versus 3.8 min [interquartile range 3.3-5.3], P = .006). The median total procedure time was not significantly different between the two techniques (14.4 min [interquartile range 11.4-19.2] versus 17.3 [interquartile range 12.7-23.8], P = .18). Two procedures of the morcellation group were converted to bipolar resection because of the myoma hardness. Complete resection was found in 89 % of the morcellation group and 95 % of the resection group. Adverse events occurred in 3 patients of the morcellation group, namely a fluid deficit > 2500 mL with the need of potassium suppletion, an asystolic vasovagal response after conversion to resection and postoperative fever requiring antibiotics. Tissue was available for pathology analysis in all cases. Routine second-look hysteroscopy performed in one center showed no intrauterine adhesions.
CONCLUSION


Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas. Although hysteroscopic morcellation is faster, its setup time is longer. Calcified myomas can be challenging and fluid deficit remains a limiting factor.",2021,"Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas.","['Women with type 0 and 1 submucous myomas up to 3 cm', '2011 to May 2018 in the Catharina hospital (Eindhoven, the Netherlands) and the Ghent University hospital (Ghent, Belgium', 'Forty-five and 38 women were included in the hysteroscopic morcellation and resection group, respectively']","['Routine second-look hysteroscopy', 'Hysteroscopic morcellation versus bipolar resection', 'hysteroscopic morcellation with the TruClear TM  8.0 Tissue Removal System or to bipolar resection with a rigid 8.5-mm resectoscope', 'hysteroscopic morcellation', 'hysteroscopic morcellation with bipolar resection']","['median operating time', 'Complete resection', 'median setup time', 'adverse events, tissue availability, short term effectiveness and postoperative adhesion formation (secondary outcomes', 'asystolic vasovagal response', 'total procedure time', 'operating time, corrected for the myoma diameter', 'Adverse events', 'median total procedure time', 'intrauterine adhesions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C4042900', 'cui_str': 'Morcellation'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001510', 'cui_str': 'Postoperative adhesion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]",,0.120602,"Overall, there is no difference in total procedure time between hysteroscopic morcellation using the TruClear TM  system compared to bipolar resection for the removal of smaller type 0 and 1 submucous myomas.","[{'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'van Wessel', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium. Electronic address: steffi.vanwessel@ugent.be.""}, {'ForeName': 'Hubertus A A M', 'Initials': 'HAAM', 'LastName': 'van Vliet', 'Affiliation': 'Department of Obstetrics and Gynecology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Benedictus C', 'Initials': 'BC', 'LastName': 'Schoot', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium; Department of Obstetrics and Gynecology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Weyers', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.""}, {'ForeName': 'Tjalina W O', 'Initials': 'TWO', 'LastName': 'Hamerlynck', 'Affiliation': ""Women's Clinic, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2021.01.050']
1281,33571736,"Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: A double-blind, randomized, phase 2 trial.","OBJECTIVES


This study examined whether palbociclib and cetuximab prolonged overall survival (OS) versus placebo and cetuximab.
MATERIALS AND METHODS


In this double-blind, randomized, phase 2 trial (PALATINUS), patients with platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent/metastatic head and neck squamous-cell carcinoma received cetuximab and either palbociclib (arm A) or placebo (arm B). The primary endpoint was OS; 120 patients were required to have ≥80% power to detect a hazard ratio (HR) of 0.6 (median OS of 10 months in arm A and 6 months in arm B) using a one-sided, log-rank test (P = 0.10).
RESULTS


125 patients were randomized (arm A: 65, arm B: 60). Median follow-up was 15.9 months (IQR, 11.3-22.7). Median OS was 9.7 months in arm A and 7.8 months in arm B (HR, 0.82; 95% CI, 0.54-1.25; P = 0.18). Median progression-free survival was 3.9 months in arm A and 4.6 months in arm B (HR, 1.00; 95% CI, 0.67-1.5; P = 0.50). The most common treatment-related adverse events in arm A were rash (39 patients, 60.9%) and neutropenia (26, 40.6%; three febrile) and in arm B was rash (32, 53.3%).
CONCLUSION


There was no significant difference in median OS with palbociclib and cetuximab versus placebo and cetuximab.
FUNDING


Pfizer Inc (NCT02499120).",2021,"Median progression-free survival was 3.9 months in arm A and 4.6 months in arm B (HR, 1.00; 95% CI, 0.67-1.5; P = 0.50).","['patients with platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent/metastatic head and neck squamous-cell carcinoma received', 'platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma', '125 patients were randomized (arm']","['placebo', 'Palbociclib and cetuximab', 'palbociclib and cetuximab', 'cetuximab and either palbociclib (arm A) or placebo', 'placebo and cetuximab']","['overall survival (OS', 'Median OS', 'hazard ratio (HR', 'median OS', 'neutropenia', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",125.0,0.192058,"Median progression-free survival was 3.9 months in arm A and 4.6 months in arm B (HR, 1.00; 95% CI, 0.67-1.5; P = 0.50).","[{'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Adkins', 'Affiliation': 'Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA. Electronic address: dadkins@wustl.edu.'}, {'ForeName': 'Jin-Ching', 'Initials': 'JC', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan.'}, {'ForeName': 'Assuntina', 'Initials': 'A', 'LastName': 'Sacco', 'Affiliation': 'Infusion Center, University of California San Diego Moores Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Vyacheslay', 'Initials': 'V', 'LastName': 'Vanchenko', 'Affiliation': 'Department of Microsurgery of Otolaryngology Organs, Ivano-Frankivsk Regional Clinical Hospital, Ukraine.'}, {'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Komashko', 'Affiliation': 'Department of Microsurgery of Otolaryngology Organs, Ivano-Frankivsk Regional Clinical Hospital, Ukraine.'}, {'ForeName': 'Chia-Jui', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Haemtology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Wise-Draper', 'Affiliation': 'Division of Hematology Oncology, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Picazo Gonzalez', 'Affiliation': 'Department of Oncology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Radulovic', 'Affiliation': 'Department of Experimental Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thurm', 'Affiliation': 'Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Lekarska fakulta Univerzity Palackeho a Fakultni nemocnice, Olomouc, Czech Republic.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Head and Neck Oncology Division, Japanese National Cancer Center, Chiba, Japan.'}]",Oral oncology,['10.1016/j.oraloncology.2021.105192']
1282,33571687,"Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov.","BACKGROUND


Choosing the right recruitment strategy has implications for the successful conduct of a trial. Our objective was to compare a novel peer recruitment strategy to four other recruitment strategies for a large randomized trial testing a digital tobacco intervention.
METHODS


We compared enrollment rates, demographic and baseline smoking characteristics, and odds of completing the 6-month study by recruitment strategy. Cost of recruitment strategies per retained participant was calculated using staff personnel time and advertisement costs.
FINDINGS


We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n = 273 (18.4%), Facebook Ads n = 505 (34%), Google Ads = 200 (13.4%), ResearchMatch n = 356 (23.9%) and Smokefree.govn = 153 (10.3%). Mean enrollment rate per active recruitment month: 1) Peer recruitment, n = 13.9, 2) Facebook ads, n = 25.3, 3) Google ads, n = 10.51, 4) Research Match, n = 59.3, and 5) Smokefree.gov, n = 13.9. Peer recruitment recruited the greatest number of males (n = 110, 40.3%), young adults (n = 41, 14.7%), participants with a high school degree or less (n = 24, 12.5%) and smokers within one's social network. Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%). Peer recruitment was moderate in cost per retained participant ($47.18) and substantially less costly than Facebook ($173.60).
CONCLUSIONS


Though peer recruitment had lower enrollment than other strategies, it may provide greater access to harder to reach populations and possibly others who smoke within one's social network while being moderately cost-effective. ClinicalTrials.gov: NCT03224520.",2021,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[""Peer recruitment recruited the greatest number of males (n\u202f=\u202f110, 40.3%), young adults (n\u202f=\u202f41, 14.7%), participants with a high school degree or less (n\u202f=\u202f24, 12.5%) and smokers within one's social network"", 'We enrolled 1487 participants between August 2017 and March 2019 from: Peer recruitment n\u202f=\u202f273 (18.4']","['digital tobacco intervention', 'Facebook Ads']","['Mean enrollment rate per active recruitment month: 1) Peer recruitment, n\u202f=\u202f13.9, 2']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517562', 'cui_str': '13.9'}]",1487.0,0.147848,"Compared to peer recruitment (retention rate = 57%), participants from Facebook were less likely (OR 0.46, p < 0.01, retention rate = 40%), and those from ResearchMatch were more likely to complete the study (OR 1.90, p < 0.01, retention rate = 70%).","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Faro', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States. Electronic address: Jamie.faro@umassmed.edu.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Nagawa', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Orvek', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Bridget M', 'Initials': 'BM', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation for Complex Chronic Healthcare (CINCCH), Spinal Cord Injury Quality Enhancement Research Initiative (QUERI), Hines VAMC, Chicago, IL, United States; Department of Pediatrics and Center for Community Health, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Blok', 'Affiliation': 'Department of Systems, Populations and Leadership, University of Michigan School of Nursing, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, United States.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Kamberi', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Sharina D', 'Initials': 'SD', 'LastName': 'Person', 'Affiliation': 'Division of Biostatistics and Health Services Research, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Rajani S', 'Initials': 'RS', 'LastName': 'Sadasivam', 'Affiliation': 'Division of Health Informatics and Implementation Science, Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106314']
1283,33580174,Effectiveness of e-Health cardiac rehabilitation program on quality of life associated with symptoms of anxiety and depression in moderate-risk patients.,"Exploring new models of medical care requires evaluating the impact of new care strategies not only on physiological parameters but also on the quality of life of the patient. On the other hand the presence of anxiety together with depression requires further consideration when planning appropriate management strategies. The aim of this study was to examine the effectiveness of a home-based cardiac rehabilitation program incorporating an e-Health technology on health-related quality of life associated with symptoms of anxiety and depression in moderate-risk patients. A multicenter, randomized controlled clinical trial was designed to compare a traditional hospital based cardiac rehabilitation program (n = 38, 35 male) with a mixed home surveillance program where patients exercised at home with a remote electrocardiographic monitoring device (n = 33, 31 male). The Short Form-36 (SF-36) Health Survey and the Goldberg questionnaire were used to evaluate quality of life and the presence of symptoms of anxiety and depression respectively. The results of this study show that the type of cardiac rehabilitation program did not influence the improvement in quality of life (p = 0.854), but the presence of symptoms of anxiety and depression did (p = 0.001). Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021). Trial registration: Retrospectively registered NCT02796404 (10/06/2016) in clinialtrials.gov.",2021,"Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021).","['n\u2009=\u200933, 31 male', 'moderate-risk patients', 'n\u2009=\u200938, 35 male) with a']","['e-Health cardiac rehabilitation program', 'mixed home surveillance program where patients exercised at home with a remote electrocardiographic monitoring device', 'home-based cardiac rehabilitation program', 'traditional hospital based cardiac rehabilitation program']","['bodily pain dimension', 'quality of life and the presence of symptoms of anxiety and depression respectively', 'presence of symptoms of anxiety and depression', 'quality of life', 'anxiety and depression symptoms and improved functional capacity', 'quality of life associated with symptoms of anxiety and depression']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1444530', 'cui_str': 'Housing surveillance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",,0.0318719,"Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021).","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Bravo-Escobar', 'Affiliation': 'Cardiac Rehabilitation Unit, Virgen de La Victoria University Hospital of Malaga, Campus de Teatinos s/n, 29010, Malaga, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'González-Represas', 'Affiliation': 'Department of Functional Biology and Health Sciences, Physical Therapy Faculty, University of Vigo, Campus A Xunqueira s/n, 36005, Pontevedra, Spain. alicia@uvigo.es.'}, {'ForeName': 'Adela María', 'Initials': 'AM', 'LastName': 'Gómez-González', 'Affiliation': 'Cardiac Rehabilitation Unit, Virgen de La Victoria University Hospital of Malaga, Campus de Teatinos s/n, 29010, Malaga, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Heredia-Torres', 'Affiliation': 'Cardiac Rehabilitation Unit, Reina Sofía University Hospital of Córdoba, Avda. Menéndez Pidal, s/n, 14004, Córdoba, Spain.'}]",Scientific reports,['10.1038/s41598-021-83231-y']
1284,33580103,"Multiple micronutrient supplementation improves micronutrient status in primary school children in Hai Phong City, Vietnam: a randomised controlled trial.","We aimed to determine the efficacy of multiple micronutrient supplementation on the biomarkers of iron, zinc, and vitamin A status across anthropometric status categories in Vietnamese school children. In this 22-week randomised controlled trial, 347 undernourished, normal weight, or overweight/obese children aged 6-9 years were allocated to receive every school day a multiple micronutrient supplement (10 mg iron, 10 mg zinc, 400 µg vitamin A) or a placebo. Haematological indices; circulating ferritin, zinc, and retinol (corrected for inflammation); and C-reactive protein were measured at baseline and 22 weeks. At week 22, linear mixed models showed that mean corpuscular volume increased by 0.3 fL, serum ferritin by 9.1 µg/L, plasma zinc by 0.9 µmol/L, and plasma retinol by 15%, and the prevalence of zinc deficiency decreased by 17.3% points in the intervention group compared to placebo. No intervention effects were found for other haematological indices, or the prevalence of anaemia. Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.Trial registration: This trial was registered on 06/09/2016 at www.anzctr.org.au as ACTRN12616001245482.",2021,"Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.","['347 undernourished, normal weight, or overweight/obese children aged 6-9\xa0years', 'Vietnamese school children', 'primary school children in Hai Phong City, Vietnam']","['placebo', 'multiple micronutrient supplement (10\xa0mg iron, 10\xa0mg zinc, 400\xa0µg vitamin A) or a placebo', 'Multiple micronutrient supplementation', 'multiple micronutrient supplementation']","['prevalence of zinc deficiency', 'biomarkers of zinc and vitamin A status and some biomarkers of iron status', 'micronutrient status', 'plasma zinc', 'biomarkers of iron, zinc, and vitamin A status across anthropometric status categories', 'plasma retinol', 'prevalence of anaemia', 'mean corpuscular volume', 'Haematological indices; circulating ferritin, zinc, and retinol (corrected for inflammation); and C-reactive protein', 'serum ferritin']","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0235950', 'cui_str': 'Zinc deficiency'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0524587', 'cui_str': 'Mean cell volume - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}]",347.0,0.354741,"Multiple micronutrient supplementation for 22 weeks improved the biomarkers of zinc and vitamin A status and some biomarkers of iron status, and reduced the prevalence of zinc deficiency in Vietnamese school children.","[{'ForeName': 'Ngan T D', 'Initials': 'NTD', 'LastName': 'Hoang', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Gibson', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tuyen D', 'Initials': 'TD', 'LastName': 'Le', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Worsley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nghien T T', 'Initials': 'NTT', 'LastName': 'Hoang', 'Affiliation': 'Hanoi Medical University, Hanoi, Vietnam.'}, {'ForeName': 'Ewa A', 'Initials': 'EA', 'LastName': 'Szymlek-Gay', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia. ewa.szymlekgay@deakin.edu.au.'}]",Scientific reports,['10.1038/s41598-021-83129-9']
1285,33579288,Dual versus monotherapy with bronchodilators in GOLD group B COPD patients according to baseline FEV 1  level: a patient-level pooled analysis of phase-3 randomized clinical trials.,"BACKGROUND


Which patients should receive dual therapy as initial treatment for chronic obstructive pulmonary disease (COPD) is only loosely defined. We evaluated if a lower forced expiratory volume in 1 s (FEV 1 ) identifies a population more likely to benefit from dual therapy than monotherapy among group B COPD patients in whom Global initiative for Chronic Obstructive Pulmonary Disease (GOLD) recommends monotherapy as initial treatment.
METHODS


This was a patient-level pooled analysis of phase-3 randomized controlled trials involving dual bronchodilators. Study patients were classified into two groups based on the FEV 1  of 50% of the predicted value (GOLD I/II versus GOLD III/IV). We evaluated the efficacy of dual versus monotherapy (long-acting beta-2 agonist [LABA] or long-acting muscarinic antagonist [LAMA]) between these two groups in the following outcomes: changes in trough FEV 1 , the St. George's Respiratory Questionnaire (SGRQ) score, the proportion of SGRQ responders, time to first exacerbation, and risk of adverse events.
RESULTS


A total of 14,449 group B patients from 12 studies were divided into GOLD III/IV (n = 8043) or GOLD I/II group (n = 6406). In the GOLD III/IV group, dual therapy was significantly more effective in improving FEV 1 , reducing SGRQ scores, and achieving a higher proportion of SGRQ responders compared with either LABA or LAMA. Dual therapy also showed a significantly longer time to first exacerbation compared with LABA in the GOLD III/IV group. In contrast, in the GOLD I/II group, the benefits of dual therapy over monotherapy were less consistent. Although dual therapy resulted in significantly higher FEV 1  than either LABA or LAMA, it did not show significant differences in the SGRQ score and proportion of SGRQ responders as compared with LABA. The time to first exacerbation was also not significantly different between dual therapy and either LABA or LAMA in the GOLD I/II group.
CONCLUSIONS


Dual therapy demonstrated benefits over monotherapy more consistently in patients with lower FEV 1  than those with higher FEV 1 .",2021,"In the GOLD III/IV group, dual therapy was significantly more effective in improving FEV 1 , reducing SGRQ scores, and achieving a higher proportion of SGRQ responders compared with either LABA or LAMA.","['14,449 group B patients from 12 studies', 'chronic obstructive pulmonary disease (COPD', 'GOLD group B COPD patients according to baseline FEV 1  level', 'group B COPD patients in whom Global initiative for Chronic Obstructive Pulmonary Disease (GOLD']",['dual versus monotherapy'],"['SGRQ score and proportion of SGRQ responders', 'effective in improving FEV 1 , reducing SGRQ scores', ""trough FEV 1 , the St. George's Respiratory Questionnaire (SGRQ) score, the proportion of SGRQ responders, time to first exacerbation, and risk of adverse events"", 'time to first exacerbation', 'longer time to first exacerbation']","[{'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.0330077,"In the GOLD III/IV group, dual therapy was significantly more effective in improving FEV 1 , reducing SGRQ scores, and achieving a higher proportion of SGRQ responders compared with either LABA or LAMA.","[{'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Seoul, Republic of Korea.'}, {'ForeName': 'Sei Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Bok', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, 88 Olympic-ro 43-gil, Seoul, Republic of Korea. jungbok.lee@gmail.com.'}, {'ForeName': 'Yeon-Mok', 'Initials': 'YM', 'LastName': 'Oh', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Seoul, Republic of Korea. yeonmok.oh@gmail.com.'}]",Respiratory research,['10.1186/s12931-021-01648-5']
1286,33579279,Staff experiences of implementing Dementia Care Mapping to improve the quality of dementia care in care homes: a qualitative process evaluation.,"BACKGROUND


Dementia Care Mapping™ (DCM) is a widely used, staff-led, psychosocial intervention to support the implementation of person-centred care. Efficacy evaluations in care homes have produced mixed outcomes, with implementation problems identified. Understanding the experiences of staff trained to lead DCM implementation is crucial to understanding implementation challenges, yet this has rarely been formally explored. This study aimed to examine the experiences of care home staff trained to lead DCM implementation, within a large cluster randomised controlled trial.
METHODS


Process evaluation including, semi-structured interviews with 27 trained mappers from 16 intervention allocated care homes. Data were analysed using template variant of thematic analysis.
RESULTS


Three main themes were identified 1) Preparedness to lead - While mappers overwhelmingly enjoyed DCM training, many did not have the personal attributes required to lead practice change and felt DCM training did not adequately equip them to implement it in practice. For many their expectations of the mapper role at recruitment contrasted with the reality once they began to attempt implementation; 2) Transferring knowledge into practice - Due to the complex nature of DCM, developing mastery required regular practice of DCM skills, which was difficult to achieve within available time and resources. Gaining engagement of and transferring learning to the wider staff team was challenging, with benefits of DCM largely limited to the mappers themselves, rather than realised at a care home level; and 3) Sustaining DCM - This required a perception of DCM as beneficial, allocation of adequate resources and support for the process which was often not able to be provided, for the mapper role to fit with the staff member's usual duties and for DCM to fit with the home's ethos and future plans for care.
CONCLUSIONS


Many care homes may not have staff with the requisite skills to lead practice change using DCM, or the requisite staffing, resources or leadership support required for sustainable implementation. Adaptations to the DCM tool, process and training may be required to reduce its complexity and burden and increase chances of implementation success. Alternatively, models of implementation not reliant on care home staff may be required.",2021,"RESULTS


Three main themes were identified 1)","['Process evaluation including, semi-structured interviews with 27 trained mappers from 16 intervention allocated care homes', 'care homes']",[],[],"[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],[],,0.0493385,"RESULTS


Three main themes were identified 1)","[{'ForeName': 'Alys Wyn', 'Initials': 'AW', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK.'}, {'ForeName': 'Olivia C', 'Initials': 'OC', 'LastName': 'Robinson', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shoesmith', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Kelley', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK.'}, {'ForeName': 'Claire A', 'Initials': 'CA', 'LastName': 'Surr', 'Affiliation': 'Centre for Dementia Research, Leeds Beckett University, City Campus, Leeds, LS1 3HE, UK. c.a.surr@leedsbeckett.ac.uk.'}]",BMC health services research,['10.1186/s12913-021-06152-6']
1287,33579265,A randomized placebo-controlled phase I clinical trial to evaluate the immunomodulatory activities of Atractylodes lancea (Thunb) DC. in healthy Thai subjects.,"BACKGROUND


Atractylodes lancea (Thunb) DC. (AL) and bioactive compounds β-eudesmol and atractylodin have been demonstrated in the in vitro and in vivo studies for their potential clinical use in cholangiocarcinoma. The study was a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the immunomodulatory effect of AL in human subjects.
METHODS


The modulatory effects of AL and β-eudesmol and atractylodin on TNFα and IL6 expression in PBMCs were measured using real-time PCR. Blood samples were collected from forty-eight healthy subjects following oral administration of a single or multiple dosing of capsule formulation of the standardized AL extract or placebo. Serum cytokine profiles, lymphocyte subpopulations (B lymphocytes, CD8 +  cytotoxic T lymphocytes, CD4 +  T-helper lymphocytes, and NK cells), and cytotoxic activity of PBMCs against the cholangiocarcinoma cell line CL-6 were evaluated using cytometric bead array (CBA) with flow cytometry analysis.
RESULTS


AL extract at almost all concentrations significantly inhibited both TNFα and IL6 expression in Con A-mediated inflammation in PBMCs. β-Eudesmol at all concentrations significantly inhibited only IL6 expression. Atractylodin at the lowest concentration significantly inhibited the expression of both cytokines, while the highest concentration significantly inhibited only IL6 expression. The administration of AL at a single oral dose of 1000 mg appeared to decrease IFNγ and IL10 and increase B cell, while significantly increase NK and CD4 +  and CD8 +  cells. A trend of increasing (compared with placebo) in the cytotoxic activity of PBMCs at 24 h of dosing was observed. AL at multiple dosing of 1000 mg for 21 days tended to decrease the production of all cytokines, while significantly inhibited IL17A production at 24 h of dosing. In addition, a significant increase in CD4 +  and CD8 +  cells was observed. A trend of increase in the cytotoxic activity of PBMCs was observed at 24 h but terminated at 48 h of dosing.
CONCLUSIONS


The results confirm the immunomodulatory activity of AL in humans. This activity, in complementary with the direct action of AL on inducing cholangiocarcinoma cell apoptosis, suggests its potential role for CCA control.
TRIAL REGISTRATION


Retrospectively registered on 17 October 2020 [Thai Clinical Trials Registry (TCTR: www.clinical trials.in.th ) Number TCTR20201020001 #].",2021,"RESULTS


AL extract at almost all concentrations significantly inhibited both TNFα and IL6 expression in Con A-mediated inflammation in PBMCs.","['17 October 2020', 'human subjects', 'healthy Thai subjects']","['Atractylodes lancea (Thunb) DC', 'AL and β-eudesmol and atractylodin', 'placebo', 'standardized AL extract or placebo']","['IL6 expression', 'IL17A production', 'NK and CD4 +  and CD8 +  cells', 'IFNγ and IL10 and increase B cell', 'TNFα and IL6 expression in PBMCs', 'Serum cytokine profiles, lymphocyte subpopulations (B lymphocytes, CD8 +  cytotoxic T lymphocytes, CD4 +  T-helper lymphocytes, and NK cells), and cytotoxic activity of PBMCs against the cholangiocarcinoma cell line CL-6', 'cytotoxic activity of PBMCs', 'CD4 +  and CD8 +  cells', 'TNFα and IL6 expression', 'production of all cytokines']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C1009530', 'cui_str': 'Jutsu'}, {'cui': 'C0540883', 'cui_str': 'atractylodin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0007600', 'cui_str': 'Cell Line'}]",48.0,0.0935717,"RESULTS


AL extract at almost all concentrations significantly inhibited both TNFα and IL6 expression in Con A-mediated inflammation in PBMCs.","[{'ForeName': 'Inthuon', 'Initials': 'I', 'LastName': 'Kulma', 'Affiliation': 'Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand.'}, {'ForeName': 'Luxsana', 'Initials': 'L', 'LastName': 'Panrit', 'Affiliation': 'Drug Discovery and Development Center, Office of Advanced Science and Technology, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand.'}, {'ForeName': 'Tullayakorn', 'Initials': 'T', 'LastName': 'Plengsuriyakarn', 'Affiliation': 'Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand.'}, {'ForeName': 'Wanna', 'Initials': 'W', 'LastName': 'Chaijaroenkul', 'Affiliation': 'Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand.'}, {'ForeName': 'Siriprapa', 'Initials': 'S', 'LastName': 'Warathumpitak', 'Affiliation': 'Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand.'}, {'ForeName': 'Kesara', 'Initials': 'K', 'LastName': 'Na-Bangchang', 'Affiliation': 'Graduate Program in Bioclinical Sciences, Chulabhorn International College of Medicine, Thammasat University (Rangsit Campus), Pathumthani, 12121, Thailand. kesaratmu@yahoo.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03199-6']
1288,33579257,Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial.,"BACKGROUND


The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial.
METHODS


The participants were women aged 20-69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups.
RESULTS


After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87-3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.
CONCLUSIONS


Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer.
TRIAL REGISTRATION


UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.",2021,"After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87-3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.
","['women who screen positive for cervical cancer', 'participants were women aged 20-69\xa0years who were about to undergo cervical cancer screening at health centers']",[],"['Alleviating psychological distress', 'psychological distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]",[],"[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.199347,"After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87-3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.
","[{'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan. s1530359@u.tsukuba.ac.jp.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Hori', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Ichikawa', 'Affiliation': 'Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",BMC women's health,['10.1186/s12905-021-01207-6']
1289,33586924,"Effect of mental fatigue on performance, perceptual and physiological responses in Orienteering athletes.","BACKGROUND


Mental fatigue seems to impair the athletes' performance; however, in sports with high cognitive demand, such as Orienteering, this negative effect could be attenuated during the race. Therefore, this study investigated mental fatigue's effect on performance, perceptual, and physiological responses in orienteers.
METHODS


Fifteen male orienteers (30 ± 8 years) participated in the study. Two conditions of cognitive tasks preceded the Orienteering performance, performed randomly: 30-min of mental exertion (experimental condition, EXP) by Stroop Task, or 30-min without mental exertion (control condition, CON). Orienteering performance was determined by the time required to perform the Orienteering race. The perceived recovery and motivation were evaluated in each condition, pre-cognitive task, and heart rate during the task. Perceived exertion (RPE) were measured pre and post Orienteering race. Orienteering performance and perceived performance were measured immediately after the race.
RESULTS


Orienteering performance and remain variables showed no significant differences between conditions (EXP versus CON) (p >.05). Although a slight increase in performance-time was found in EXP (40.8 ± 11.4-min) versus CON (38.4 ± 13-min) (p = 0.4; ES = 0.20). RPE increase post-EXP (p <.05; ES = 0.96) but not post-Orienteering race (p >.05).
CONCLUSIONS


30-minute of the cognitive task did not significantly affect the perceptual and physiological responses but demonstrates the addition of 2.4-min to Orienteering performance. Orienteers may cope with mental effort due to the cognitive demands and physical conditions required in Orienteering.",2021,Orienteering performance and remain variables showed no significant differences between conditions (EXP versus CON) (p >.05).,"['orienteers', 'Orienteering athletes', 'Fifteen male orienteers (30 ± 8 years) participated in the study']","['mental exertion (experimental condition, EXP) by Stroop Task, or 30-min without mental exertion (control condition, CON']","['performance, perceptual, and physiological responses', 'pre-cognitive task, and heart rate during the task', 'Orienteering performance', 'RPE increase post-EXP', 'Orienteering performance and perceived performance', 'performance-time', 'perceptual and physiological responses', 'mental fatigue on performance, perceptual and physiological responses', 'Perceived exertion (RPE']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}]",15.0,0.094963,Orienteering performance and remain variables showed no significant differences between conditions (EXP versus CON) (p >.05).,"[{'ForeName': 'Mayara M', 'Initials': 'MM', 'LastName': 'Batista', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil - mayamb2@hotmail.com.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Paludo', 'Affiliation': 'Department of Physical Education, State University of Midwestern Paraná, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, State University of Midwestern Paraná, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Marcos V', 'Initials': 'MV', 'LastName': 'Martins', 'Affiliation': 'Department of Physical Education, State University of Midwestern Paraná, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Pauli', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': ""Dal'maz"", 'Affiliation': 'Department of Physical Education, State University of Midwestern Paraná, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Joice Mf', 'Initials': 'JM', 'LastName': 'Stefanello', 'Affiliation': 'Department of Physical Education, State University of Midwestern Paraná, Guarapuava, Paraná, Brazil.'}, {'ForeName': 'Marcus P', 'Initials': 'MP', 'LastName': 'Tartaruga', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.21.11334-9']
1290,33586923,"The sub-acute effects of high-intensity interval training in healthy young adults: respiratory parameters, aerobic capacity and perceived stress.","PURPOSE


Although the effects of sub-maximal continuous aerobic training (SCT) and high-intensity interval training (HIIT) are well studied in performance athletes and in several patient groups, there is not much evidence about the effects of these exercises in sedentary healthy young population. The aim of study was to compare the effects of these two different types of aerobic exercises on respiratory parameters, aerobic capacity and perceived stress in healthy university students.
METHODS


Thirty-six healthy, young subjects with a mean age of 20.83±0.97 years were included in the study (n=19 in HIIT and n=17 in SCT). Pulmonary function tests (PFTs) and respiratory muscle strength (RMS) assessments were done using a desktop spirometer. Aerobic capacity was estimated with the Bruce treadmill exercise test. The Perceived Stress Scale(PSS) was used for the assessment of stress perception. All participants exercised 3 times per week for 4 weeks (a total of 12 sessions).
RESULTS


After 12 sessions, the peak expiratory flow parameter (a PFT value) of both groups showed significant increases, but there was no difference between the groups. The RMS of the subjects increased significantly in both the groups (p<0.05), but there was no significant difference between the groups. Both groups showed significant increases in terms of aerobic capacity (p>0.05), and the improvement was significantly higher in the HIIT group. Perceived stress values showed a significant increase in the SCT group.
CONCLUSIONS


On the basis of the results of this study, the two exercise types were found to have similar effects on RMS. Also, when compared with SCT, HIIT was found to have more effect on aerobic capacity.",2021,"Both groups showed significant increases in terms of aerobic capacity (p>0.05), and the improvement was significantly higher in the HIIT group.","['healthy university students', 'healthy young adults', 'Thirty-six healthy, young subjects with a mean age of 20.83±0.97 years were included in the study (n=19 in HIIT and n=17 in SCT', 'sedentary healthy young population']","['sub-maximal continuous aerobic training (SCT) and high-intensity interval training (HIIT', 'high-intensity interval training', 'aerobic exercises']","['aerobic capacity', 'Perceived stress values', 'Aerobic capacity', 'peak expiratory flow parameter', 'Pulmonary function tests (PFTs) and respiratory muscle strength (RMS) assessments', 'respiratory parameters, aerobic capacity and perceived stress']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",36.0,0.0153868,"Both groups showed significant increases in terms of aerobic capacity (p>0.05), and the improvement was significantly higher in the HIIT group.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey - yalman_ali@yahoo.com.'}, {'ForeName': 'Orçin', 'Initials': 'O', 'LastName': 'Tellİ Atalay', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ünver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Şenol', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'TaŞkin', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.21.10897-7']
1291,33586920,A pilot study of the effect of a home-based multimodal symptom-management program in children and adolescents undergoing chemotherapy.,"BACKGROUND


Prevalent symptoms that affect children and adolescents throughout the process of cancer diagnosis and treatment include nausea and vomiting, fatigue, pain, mucositis, and anxiety.
AIM


To examine the effect of a home-based multimodal symptom-management program for alleviation of nausea and vomiting, fatigue, pain, mucositis, and anxiety in children and adolescents undergoing chemotherapy for hematological malignancies or solid tumors.
METHODS


In an exploratory pilot randomized study with qualitative interview, patients between 10 and 18 years of age were randomly assigned to either the symptom-management program plus usual care (intervention group) or usual care (control group). The program consisted of multiple nonpharmacological interventional components. The targeted symptoms were measured at baseline (after diagnosis), at the first 2 weeks of each cycle of chemotherapy, and at 6 months after baseline, using the Memorial Symptom Assessment Scale 10-18 and the State Anxiety Scale for Children.
RESULTS


Fifty children (31 boys; mean age, 13.7 years) were randomized either to the intervention group or the control group (25 each) and underwent baseline assessment. A comparison between the groups showed that the intervention group had a significant less fatigue over time (P < .05). However, no differences were found with respect to nausea and vomiting, pain, mucositis, and anxiety between groups. Both children and parents reported a positive experience with the symptom-management program.
CONCLUSION


The home-based symptom-management program may have helped to reduce fatigue in children and adolescents undergoing chemotherapy. In addition, qualitative data support the importance of improving children and parents' knowledge, coping skills, and psychological preparation for symptoms associated with chemotherapy.",2021,A comparison between the groups showed that the intervention group had a significant less fatigue over time (P < .05).,"['Fifty children (31 boys; mean age, 13.7\u2009years', 'children and adolescents undergoing chemotherapy', 'patients between 10 and 18\u2009years of age', 'children and adolescents undergoing chemotherapy for hematological malignancies or solid tumors']","['symptom-management program plus usual care (intervention group) or usual care (control group', 'home-based multimodal symptom-management program']","['nausea and vomiting, pain, mucositis, and anxiety', 'fatigue over time', 'Memorial Symptom Assessment Scale 10-18 and the State Anxiety Scale for Children', 'nausea and vomiting, fatigue, pain, mucositis, and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",50.0,0.0303488,A comparison between the groups showed that the intervention group had a significant less fatigue over time (P < .05).,"[{'ForeName': 'Karis Kin-Fong', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Laura Mei Lian', 'Initials': 'LML', 'LastName': 'Tan', 'Affiliation': ""Paediatric Oncology, Department of Paediatrics, Khoo Teck Puat National University Children's Medical Institute, Singapore, Singapore.""}]","Cancer reports (Hoboken, N.J.)",['10.1002/cnr2.1336']
1292,33586911,Home-Based Intervention to Test and Start (HITS): a community-randomized controlled trial to increase HIV testing uptake among men in rural South Africa.,"INTRODUCTION


The uptake of HIV testing and linkage to care remains low among men, contributing to high HIV incidence in women in South Africa. We conducted the ""Home-Based Intervention to Test and Start"" (HITS) in a 2x2 factorial cluster randomized controlled trial in one of the World's largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing.
METHODS


Between February and December 2018, in the uMkhanyakude district of KwaZulu-Natal, we randomly assigned 45 communities (clusters) (n = 13,838 residents) to one of the four arms: (i) financial incentives for home-based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male-targeted HIV-specific decision support application, called EPIC-HIV; (iii) both financial incentives and male-targeted HIV-specific decision support application and (iv) standard of care (SoC). EPIC-HIV was developed to encourage and serve as an intrinsic motivator for HIV testing and linkage to care, and individually offered to men via a tablet device. Financial incentives were offered to both men and women. Here we report the effect of the interventions on uptake of home-based HIV testing among men. Intention-to-treat (ITT) analysis was performed using modified Poisson regression with adjustment for clustering of standard errors at the cluster levels.
RESULTS


Among all 13,838 men ≥ 15 years living in the 45 communities, the overall population coverage during a single round of home-based HIV testing was 20.7%. The uptake of HIV testing was 27.5% (683/2481) in the financial incentives arm, 17.1% (433/2534) in the EPIC-HIV arm, 26.8% (568/2120) in the arm receiving both interventions and 17.8% in the SoC arm. The probability of HIV testing increased substantially by 55% in the financial incentives arm (risk ratio (RR)=1.55, 95% CI: 1.31 to 1.82, p < 0.001) and 51% in the arm receiving both interventions (RR = 1.51, 95% CI: 1.21 to 1.87 p < 0.001), compared to men in the SoC arm. The probability of HIV testing did not significantly differ in the EPIC-HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70).
CONCLUSIONS


The provision of a small financial incentive acted as a powerful extrinsic motivator substantially increasing the uptake of home-based HIV testing among men in rural South Africa. In contrast, the counselling and testing application which was designed to encourage and serve as an intrinsic motivator to test for HIV did not increase the uptake of home-based testing.",2021,"The probability of HIV testing did not significantly differ in the EPIC-HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70).
","['Between February and December 2018, in the uMkhanyakude district of KwaZulu-Natal', 'women in South Africa', 'men', ""one of the World's largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing"", '13,838 men\xa0≥', 'men in rural South Africa']","['Home-Based Intervention to Test and Start"" (HITS', 'Home-Based Intervention to Test and Start (HITS', 'financial incentives for home-based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male-targeted HIV-specific decision support application, called EPIC-HIV; (iii) both financial incentives and male-targeted HIV-specific decision support application and (iv) standard of care (SoC']","['overall population coverage', 'probability of HIV testing', 'uptake of HIV testing']","[{'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0392342', 'cui_str': 'Extrinsic motivation'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.111082,"The probability of HIV testing did not significantly differ in the EPIC-HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70).
","[{'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Thulile', 'Initials': 'T', 'LastName': 'Mathenjwa', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Phillippa', 'Initials': 'P', 'LastName': 'Matthews', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Oluwafemi', 'Initials': 'O', 'LastName': 'Adeagbo', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Benn', 'Initials': 'B', 'LastName': 'Sartorius', 'Affiliation': 'School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Handurugamage Manisha', 'Initials': 'HM', 'LastName': 'Yapa', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Thembelihle', 'Initials': 'T', 'LastName': 'Zuma', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Zeitlin', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Blandford', 'Affiliation': 'University College London Interaction Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dobra', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25665']
1293,33586696,Optimal number of needle passes during EUS-guided fine-needle biopsy of solid pancreatic lesions with 22G ProCore needles and different suction techniques: A randomized controlled trial.,"Background and Objectives


The sensitivity of EUS-guided fine-needle biopsy (EUS-FNB) varies considerably. The optimal number of passes through a solid pancreatic lesion with a 22G FNB needle during EUS-FNB is controversial. This prospective randomized controlled study aimed to determine the optimal number of needle passes during EUS-FNB of solid pancreatic lesions, with 22G FNB needles and different sampling techniques.
Methods


Pancreatic masses were sampled using 22G FNB needles with either the stylet slow-pull (SP) technique or the standard-suction (SS) technique. We determined the number of needle passes required to obtain a diagnostic accuracy of >90%. Differences between the two techniques in terms of technical success rate, cytological acquisition, core tissue acquisition, sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and complications were analyzed.
Results


A total of 120 patients were randomly assigned to either SP or SS group. Three patients who were lost to follow-up and one who did not complete 5 passes due to bent needle head were excluded from the study. Fifty-six cases in the SP group and 60 cases in the SS group were included in the analysis. For SP technique, the cumulative accuracy of passes 1, 2, 3, 4, and 5 was 44.83%, 76.79%, 87.50%, 92.86%, and 94.64%, respectively. For SS technique, the cumulative accuracy of passes 1, 2, 3, 4, and 5 was 71.67%, 85.0%, 90.0%, 93.33%, and 95.0%, respectively. For each group, there was no statistically significant difference in accuracy after 3 and 4 passes. After 4 passes, the pooled sensitivity (92.59% vs. 93.10%), accuracy (92.86% vs. 93.10%), and specificity (100% vs. 100%) were similar (P > 0.05) in the SP and SS groups, respectively. In addition, positive cytological diagnoses (83.9% vs. 85.0%) and positive histological diagnoses (71.4% vs. 78.3%) were comparable (P > 0.05) in the SP and SS groups, respectively. No statistically significant factor was found associated with diagnostic sensitivity for each group.
Conclusion


When on-site cytological evaluation is unavailable, we recommend that at least 3 passes with 22G ProCore needles be performed during EUS-FNB using the SS technique, at least 4 passes when using SP technique. The SS technique showed potential advantages over SP technique in tissue acquisition and diagnostic capabilities.",2021,"After 4 passes, the pooled sensitivity (92.59% vs. 93.10%), accuracy (92.86% vs. 93.10%), and specificity (100% vs. 100%) were similar (P > 0.05) in the SP and SS groups, respectively.","['A total of 120 patients', 'Three patients who were lost to follow-up and one who did not complete 5 passes due to bent needle head were excluded from the study']","['EUS-guided fine-needle biopsy of solid pancreatic lesions with 22G ProCore needles and different suction techniques', 'stylet slow-pull (SP) technique or the standard-suction (SS) technique', 'SP or SS']","['positive cytological diagnoses', 'diagnostic sensitivity', 'accuracy', 'technical success rate, cytological acquisition, core tissue acquisition, sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and complications', 'pooled sensitivity', 'specificity', 'positive histological diagnoses']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0085846', 'cui_str': 'Fine needle biopsy'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}]",120.0,0.0499155,"After 4 passes, the pooled sensitivity (92.59% vs. 93.10%), accuracy (92.86% vs. 93.10%), and specificity (100% vs. 100%) were similar (P > 0.05) in the SP and SS groups, respectively.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Shi-Yu', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Pathology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xiang-Yu', 'Initials': 'XY', 'LastName': 'Kong', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Ai-Qiao', 'Initials': 'AQ', 'LastName': 'Fang', 'Affiliation': 'Digestive Endoscopy Center, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}, {'ForeName': 'Kai-Xuan', 'Initials': 'KX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China.'}]",Endoscopic ultrasound,['10.4103/EUS-D-20-00147']
1294,33586647,Non-invasive vagus nerve stimulation boosts mood recovery after effort exertion.,"BACKGROUND


Mood plays an important role in our life which is illustrated by the disruptive impact of aberrant mood states in depression. Although vagus nerve stimulation (VNS) has been shown to improve symptoms of depression, the exact mechanism is still elusive, and it is an open question whether non-invasive VNS could be used to swiftly and robustly improve mood.
METHODS


Here, we investigated the effect of left- and right-sided transcutaneous auricular VNS (taVNS) v. a sham control condition on mood after the exertion of physical and cognitive effort in 82 healthy participants (randomized cross-over design) using linear mixed-effects and hierarchical Bayesian analyses of mood ratings.
RESULTS


We found that 90 min of either left-sided or right-sided taVNS improved positive mood [b = 5.11, 95% credible interval, CI (1.39-9.01), 9.6% improvement relative to the mood intercept, BF10 = 7.69, pLME = 0.017], yet only during the post-stimulation phase. Moreover, lower baseline scores of positive mood were associated with greater taVNS-induced improvements in motivation [r = -0.42, 95% CI (-0.58 to -0.21), BF10 = 249].
CONCLUSIONS


We conclude that taVNS boosts mood after a prolonged period of effort exertion with concurrent stimulation and that acute motivational effects of taVNS are partly dependent on initial mood states. Collectively, our results show that taVNS may help quickly improve affect after a mood challenge, potentially by modulating interoceptive signals contributing to the reappraisal of effortful behavior. This suggests that taVNS could be a useful add-on to current behavioral therapies.",2021,"Moreover, lower baseline scores of positive mood were associated with greater taVNS-induced improvements in motivation [r = -0.42, 95% CI (-0.58 to -0.21), BF10 = 249].
",['82 healthy participants'],"['left- and right-sided transcutaneous auricular VNS (taVNS) v. a sham control condition', 'vagus nerve stimulation (VNS']",['positive mood'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",82.0,0.0844172,"Moreover, lower baseline scores of positive mood were associated with greater taVNS-induced improvements in motivation [r = -0.42, 95% CI (-0.58 to -0.21), BF10 = 249].
","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Ferstl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Wy Ming', 'Initials': 'WM', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kräutlein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Klaus', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",Psychological medicine,['10.1017/S0033291720005073']
1295,33586626,A clinical trial: Aqualizer ™ therapy and its effects on myopathies or temporomandibular dysfunctions. Part II: Subjective parameters.,"Objective : Temporomandibular dysfunction (TMD) reduces patients' quality of life (QoL). The aim was to assess the effects of initial Aqualizer™ therapy.  Methods : Group 1 (initial Aqualizer™ therapy) before definitive splint therapy or Group 2 (no initial therapy). Patients with arthrosis, partial/total prosthesis, or were undergoing splint therapy were excluded. Subjective parameters were evaluated: duration and intensity of pain, influence on wellbeing, changes in the head/neck area, handling and improvement of the Aqualizer™, improvement in QoL. The statistical significance level was 5% (p < 0.05).  Results : In 53 patients (Group 1 n = 25; Group 2 n = 28), the improvement in patients' well-being and intensity of pain in both groups was significant (p < 0.001). An improvement in QoL was found in 84% of patients in Group 1 and 75% in Group 2.  Conclusion : Initial Aqualizer™ therapy can decrease the intensity of pain and increase patients'.",2021,An improvement in QoL was found in 84% of patients in Group 1 and 75% in Group 2.  ,"['Patients with arthrosis, partial/total prosthesis, or were undergoing splint therapy were excluded']",['Methods : Group 1 (initial Aqualizer™ therapy) before definitive splint therapy or Group 2 (no initial therapy'],"['duration and intensity of pain, influence on wellbeing, changes in the head/neck area, handling and improvement of the Aqualizer™, improvement in QoL', ' quality of life (QoL', 'QoL', 'intensity of pain', ""patients' well-being and intensity of pain"", 'myopathies or temporomandibular dysfunctions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",,0.0205497,An improvement in QoL was found in 84% of patients in Group 1 and 75% in Group 2.  ,"[{'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Buchbender', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen- Nuremberg , Erlangen, Germany.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Keplinger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen- Nuremberg , Erlangen, Germany.'}, {'ForeName': 'Marco R', 'Initials': 'MR', 'LastName': 'Kesting', 'Affiliation': 'Head of the Department of Oral and Maxillofacial Surgery, University of Erlangen- Nuremberg , Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Adler', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen Nuremberg , Erlangen, Germany.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen- Nuremberg , Erlangen, Germany.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2021.1885887']
1296,33586606,Efficacy and safety evaluation of avatrombopag in immune thrombocytopenia: analyses of a phase III study and long-term extension.,"Avatrombopag is an oral thrombopoietin receptor agonist approved for chronic immune thrombocytopenia (ITP). This is a post hoc analysis of the pivotal phase III study (NCT01438840) evaluating additional endpoints not previously described. Thirty-two ITP patients were randomized to avatrombopag and 17 were randomized to placebo during a 26-week core study period (with 21 study visits), followed by an open-label extension period, in which all patients received avatrombopag for varying lengths of time. In this analysis, we evaluated previously unreported response rates at the study visit level, durability of response, and reduction in corticosteroid use with avatrombopag treatment. In the core study, more avatrombopag-treated patients achieved either response (Plt ≥50 000/µL) or complete response (Plt ≥100 000/µL) than placebo-treated patients by day 8 (65.6% vs. 0%;  P  < .0001 for response; 37.5% vs. 0%;  P  < .0001 for complete response), day 28 (84.4% vs. 0%;  P  < .0001 for response; 71.9% vs. 0%;  P  < .0001 for complete response), and month 6 (87.5% vs. 5.9%;  P  < .0001 for response; 81.3% vs. 5.9%;  P  < .0001 for complete response). Durable responders from the core study achieved response and complete response at 96.1% and 60.1% of extension phase visits, respectively. Durable clinically relevant response (Plt ≥30 000/µL for 6 of the final 8 weeks of the core study) occurred in 64.0% of avatrombopag-treated patients versus 0% of placebo-treated patients. More than half (57.1%) of patients on chronic corticosteroids reduced or discontinued corticosteroids. In conclusion, avatrombopag enabled most patients with ITP to achieve clinically meaningful and durable platelet count improvements.",2021,"< .0001 for complete response), and month 6 (87.5% vs. 5.9%;  P  < .0001 for response; 81.3% vs. 5.9%;  P  < .0001 for complete response).",['Thirty-two ITP patients'],"['avatrombopag', 'placebo']",['response and complete response'],"[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3886460', 'cui_str': 'avatrombopag'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}]",32.0,0.13996,"< .0001 for complete response), and month 6 (87.5% vs. 5.9%;  P  < .0001 for response; 81.3% vs. 5.9%;  P  < .0001 for complete response).","[{'ForeName': 'Hanny', 'Initials': 'H', 'LastName': 'Al-Samkari', 'Affiliation': 'Division of Hematology, Massachusetts General Hospital, Harvard Medical School , Boston, MA, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Nagalla', 'Affiliation': 'Division of Benign Hematology, Miami Cancer Institute , Miami, FL, USA.'}]",Platelets,['10.1080/09537104.2021.1881952']
1297,33586596,Treating alcohol use disorders in primary care - a qualitative evaluation of a new innovation: the 15-method.,"OBJECTIVE


This study aims to explore how the characteristics of an innovation, the 15-method, a stepped care model for treatment of alcohol use disorders in primary care was perceived.
METHODS/DESIGN/SETTING/SUBJECT


General practitioners and heads of primary care units ( n  = 10) that delivered the 15-method in a randomized controlled trial participated in individual interviews at two occasions in Stockholm, Sweden. Data were analyzed with theoretical thematic analysis, using Diffusion of Innovation Theory.
RESULTS


The participants described that offering the 15-method met a need among their patients. Participants were positive towards the training and the manual for the method. They mentioned a previous lack of routines to work with alcohol use disorders. The 15-method was described as easy to use. It would however be more feasible to implement in a team of different professions, rather than among general practitioners only. Priorities made by regional health care managers were described as important for the implementation, as well as financial incentives. A barrier to implementation was that alcohol screening was perceived as difficult. While the 15-method was perceived as effective in reducing the patients' alcohol use and cost effective, participants expressed uncertainty about the long-term effects.
CONCLUSIONS


The 15-method provides structure for treatment of alcohol use disorders and is described by general practitioners and heads as a promising approach. Being able to offer treatment for alcohol dependence may increase the uptake of alcohol interventions in primary care. KEY POINTS Little attention has been given to develop treatment models for alcohol use disorders that are adapted to primary care settings. This study describes how an innovation, the 15-method, a stepped care model for treatment of alcohol use disorders in primary care was perceived. The 15-method provides structure for treatment of alcohol use disorders in primary care and is described by general practitioners and heads as a promising approach. Being able to offer treatment for alcohol dependence may increase the uptake of alcohol interventions in primary care.",2021,Participants were positive towards the training and the manual for the method.,['General practitioners and heads of primary care units ( n \u2009=\u200910'],[],[],"[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],[],,0.0169017,Participants were positive towards the training and the manual for the method.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallhed Finn', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hammarberg', 'Affiliation': 'Department of Clinical Neurosciences, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andreasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jirwe', 'Affiliation': 'Department of Health Science, Red Cross University College, Stockholm, Sweden.'}]",Scandinavian journal of primary health care,['10.1080/02813432.2021.1882079']
1298,33586583,Effectiveness of the piperine-supplemented  Curcuma longa  L. in metabolic control of patients with type 2 diabetes: a randomised double-blind placebo-controlled clinical trial.,"There is robust evidence of using  Curcuma longa  L. in reducing metabolic levels in people with diabetes. This study analysed the effectiveness of  Curcuma longa  L. in the metabolic control of patients with type 2 diabetes in Brazil. A randomised double-blind placebo-controlled clinical trial was conducted with 71 participants divided into a  Curcuma longa  L. group (500 mg/day with piperine 5 mg) and a placebo group, for 120 days. Anthropometric, clinical and biochemical variables were evaluated at baseline, 60 and 120 days after the beginning of the intervention. Paired and independent Student's  t -test and chi-square test were used for statistical analysis. The curcuma group presented a significantly decreased glycaemia ( p =.013), glycated haemoglobin ( p =.015), HOMA index ( p =.037) and triglycerides (TGs) ( p =.002). The use of piperine-added  Curcuma longa  L. was effective in the glycaemic and TG control of patients with type 2 diabetes.",2021,"The curcuma group presented a significantly decreased glycaemia ( p =.013), glycated haemoglobin ( p =.015), HOMA index ( p =.037) and triglycerides (TGs) ( p =.002).","['patients with type 2 diabetes in Brazil', 'people with diabetes', '71 participants divided into a  Curcuma longa  L. group (500\u2009mg/day with', 'patients with type 2 diabetes']","['placebo', 'piperine-supplemented  Curcuma longa  L', 'piperine 5\u2009mg) and a placebo', 'Curcuma longa  L', 'piperine-added  Curcuma longa  L']","['glycaemia', 'triglycerides (TGs', 'glycated haemoglobin', 'HOMA index', 'metabolic levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071112', 'cui_str': 'piperine'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",71.0,0.339246,"The curcuma group presented a significantly decreased glycaemia ( p =.013), glycated haemoglobin ( p =.015), HOMA index ( p =.037) and triglycerides (TGs) ( p =.002).","[{'ForeName': 'Joana Furtado de Figueiredo', 'Initials': 'JFF', 'LastName': 'Neta', 'Affiliation': 'Oswaldo Cruz Foundation, Eusébio, Brazil.'}, {'ForeName': 'Vivian Saraiva', 'Initials': 'VS', 'LastName': 'Veras', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro Brazilian Lusophony, Redenção, Brazil.'}, {'ForeName': 'Danilo Ferreira de', 'Initials': 'DF', 'LastName': 'Sousa', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro Brazilian Lusophony, Redenção, Brazil.'}, {'ForeName': 'Maria da Conceição Dos Santos Oliveira', 'Initials': 'MDCDSO', 'LastName': 'Cunha', 'Affiliation': 'Department of Nursing, State University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Maria Veraci Oliveira', 'Initials': 'MVO', 'LastName': 'Queiroz', 'Affiliation': 'Department of Nursing, State University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'José Claudio Garcia Lira', 'Initials': 'JCGL', 'LastName': 'Neto', 'Affiliation': 'Department of Nursing, Federal University of Piauí, Floriano, Brazil.'}, {'ForeName': 'Marta Maria Coelho', 'Initials': 'MMC', 'LastName': 'Damasceno', 'Affiliation': 'Department of Nursing, Dentist and Pharmacy Faculty, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Márcio Flávio Moura de', 'Initials': 'MFM', 'LastName': 'Araújo', 'Affiliation': 'Oswaldo Cruz Foundation, Eusébio, Brazil.'}, {'ForeName': 'Roberto Wagner Júnior Freire de', 'Initials': 'RWJF', 'LastName': 'Freitas', 'Affiliation': 'Oswaldo Cruz Foundation, Eusébio, Brazil.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2021.1885015']
1299,33586453,Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.,"Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH antiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01-1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32-1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25-2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). Conclusions Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. Registration URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.",2021,"Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248).","['Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy', 'patients with spontaneous ICH within 8\xa0hours of onset', '40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6\xa0mL) than the no-antiplatelet group', 'intracerebral hemorrhage (ICH']","['TICH-2 (Tranexamic Acid', 'tranexamic acid', 'placebo', 'Tranexamic acid']","['24-hour hematoma expansion and day 90 modified Rankin Scale score', 'intraventricular hemorrhage', 'modified Rankin Scale', 'Intracerebral Hemorrhage', 'ischemic heart disease', 'ischemic stroke', 'risk of hematoma expansion', 'higher risk of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2325.0,0.304542,"Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248).","[{'ForeName': 'Zhe Kang', 'Initials': 'ZK', 'LastName': 'Law', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience University of Nottingham United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Desborough', 'Affiliation': ""Haemophilia and Thrombosis Centre Guy's and St Thomas' NHS Foundation Trust London United Kingdom.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit London School of Hygiene & Tropical Medicine London United Kingdom.'}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences University of Edinburgh United Kingdom.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine Division of Medical Sciences & GEM Royal Derby Hospital CentreUniversity of Nottingham United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Centre UCL Queen Square Institute of Neurology London United Kingdom.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and National Institute for Health Research Biomedical Research Centre University of Leicester United Kingdom.'}, {'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Nottingham University Hospitals NHS Trust Nottingham United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dineen', 'Affiliation': 'Radiological Sciences University of Nottingham United Kingdom.'}, {'ForeName': 'Ann Charlotte', 'Initials': 'AC', 'LastName': 'Laska', 'Affiliation': 'Department of Clinical Sciences Karolinska InstitutetDanderyd Hospital Sweden.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Peters', 'Affiliation': 'Neurology and Stroke Center Klinik Hirslanden Zürich Switzerland.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Egea-Guerrero', 'Affiliation': 'NeuroCritical Care Unit Virgen del Rocio University Hospital Seville Spain.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Karlinski', 'Affiliation': 'Institute of Psychiatry and Neurology Warsaw Poland.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Department of Neurology Bispebjerg Hospital and University of Copenhagen Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roffe', 'Affiliation': 'Stroke Research Faculty of Medicine and Health Sciences Keele University Stoke-on-Trent United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology Semmelweis University Budapest Hungary.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology Selcuk University Faculty of Medicine Konya Turkey.'}, {'ForeName': 'Jegan', 'Initials': 'J', 'LastName': 'Thanabalan', 'Affiliation': 'Division of Neurosurgery Department of Surgery National University of Malaysia Kuala Lumpur Malaysia.'}, {'ForeName': 'Rónán', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Tallaght University Hospital Dublin Republic of Ireland.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Beridze', 'Affiliation': 'The First University Clinic of Tbilisi State Medical University Tbilisi Georgia.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience University of Nottingham United Kingdom.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit Division of Clinical Neuroscience University of Nottingham United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.019130']
1300,33586367,Elevated urate does not alter bone turnover markers. Randomized controlled trial of inosine supplementation in post-menopausal women.,"OBJECTIVE


Observational studies have consistently reported that serum urate positively correlates with bone mineral density (BMD). The aim of this study was to determine whether moderate hyperuricaemia induced by inosine supplements influences bone turnover markers in post-menopausal women over a six-month period.
METHODS


One hundred and twenty post-menopausal women were recruited into a six-month randomised, double-blind, placebo-controlled trial. Key exclusion criteria were osteoporosis, previous fragility fracture, bisphosphonate therapy, gout, kidney stones, and urine pH ≤5.0. Participants were randomised 1:1 to placebo or inosine. The co-primary endpoints were change in procollagen type-I N-terminal propeptide (PINP) and change in β-C-terminal telopeptide of type I collagen (β-CTX). Change in BMD measured by dual-energy x-ray absorptiometry was an exploratory endpoint.
RESULTS


Administration of inosine led to a significant increase in serum urate over the study period (P<0.0001 for all follow-up time-points). At week 26, the mean change in serum urate was +0.13 mmol/L (+2.2mg/dL) in the inosine group and 0.00mmol/L (0mg/dL) in the placebo group. There was no difference in PINP or β-CTX between groups over the six months. There were no significant changes in bone density between groups over the six months. Adverse events and serious adverse events were similar between the two groups.
CONCLUSION


This clinical trial shows that although inosine supplementation leads to sustained increases in serum urate over a six month period, it does not alter markers of bone turnover in post-menopausal women. These findings do not support the concept that urate has direct biological effects on bone turnover.",2021,"RESULTS


Administration of inosine led to a significant increase in serum urate over the study period (P<0.0001 for all follow-up time-points).","['post-menopausal women', 'post-menopausal women over a six-month period', 'One hundred and twenty post-menopausal women']","['placebo or inosine', 'inosine supplements', 'placebo', 'inosine supplementation']","['PINP or β-CTX', 'Adverse events and serious adverse events', 'bone mineral density (BMD', 'bone density', 'mean change in serum urate', 'Change in BMD', 'change in procollagen type-I N-terminal propeptide (PINP) and change in β-C-terminal telopeptide of type I collagen (β-CTX', 'bone turnover markers', 'bone turnover', 'serum urate']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.534384,"RESULTS


Administration of inosine led to a significant increase in serum urate over the study period (P<0.0001 for all follow-up time-points).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Horne', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Mihov', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tony R', 'Initials': 'TR', 'LastName': 'Merriman', 'Affiliation': 'Department of Biochemistry, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Stamp', 'Affiliation': 'Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41691']
1301,33586360,Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial.,"BACKGROUND


Currently, there are no randomized trials on the effect of antiangiogenic therapy in patients with esophageal squamous cell carcinoma (ESCC). The following study investigated the efficacy and safety of anlotinib in patients with advanced ESCC who were previously treated with chemotherapy.
METHODS


This randomized, placebo-controlled, double-blind phase 2 trial (NCT02649361) was conducted in 13 Chinese hospitals. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC who were previously treated with chemotherapy, and were randomly assigned (2:1) to receive oral anlotinib 12 mg or placebo on days 1-14 (repeated every 21 days). The primary endpoint was progression-free survival (PFS).
RESULTS


One hundred and sixty-five patients were randomly assigned to the anlotinib (n = 110) or the placebo (n = 55) arm. Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001). The most common treatment-related adverse events of grade 3 or 4 were hypertension (17 [16%] patients), decreased appetite (6 [6%] patients), and hyponatremia (4 [4%] patients) in the anlotinib group and decreased appetite (2 [4%] patients) in the placebo group. Three (3%) deaths in the anlotinib group were considered as drug related, while there were no treatment-related deaths in the placebo group.
CONCLUSIONS


The use of anlotinib in previously treated, recurrent, or metastatic ESCC patients significantly improved PFS compared with placebo. Our findings suggest that antiangiogenesis might be an important therapeutic target in advanced ESCC.
CLINICAL TRIALS REGISTRATION


Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102), NCT02649361.",2021,Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001).,"['Patients With Esophageal Squamous Cell Carcinoma (ALTER1102', 'One hundred and sixty-five patients', 'Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC who were previously treated with', 'previously treated advanced or metastatic esophageal squamous cell carcinoma', 'patients with esophageal squamous cell carcinoma (ESCC', 'patients with advanced ESCC who were previously treated with chemotherapy', '13 Chinese hospitals']","['oral anlotinib 12\xa0mg or placebo', 'antiangiogenic therapy', 'placebo', 'chemotherapy']","['PFS', 'appetite', 'efficacy and safety', 'decreased appetite', 'Median PFS', 'progression-free survival (PFS', 'hyponatremia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1142025', 'cui_str': 'Oesophageal squamous cell carcinoma stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",165.0,0.728124,Median PFS was 3.02 months (95% CI 2.63-3.65) in the anlotinib group and 1.41 months (95% CI 1.38-1.41) in the placebo group (hazard ratio 0.46 [95% CI 0.32-0.66]; p < 0.001).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Juxiang', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Qingxia', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ba', 'Affiliation': 'Department of Medical Oncology, Tianjin Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Affiliated Tumor Hospital, Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Cancer medicine,['10.1002/cam4.3771']
1302,33586283,Introducing mindfulness and compassion-based interventions to improve verbal creativity in students of clinical and health psychology.,"OBJECTIVES


In the field of psychotherapy, verbal creativity has been suggested as an important aspect in psychotherapists' training. In the present study, the effects of a mindfulness and compassion-based intervention (MCBI) on verbal creativity are analysed in students of clinical and health psychology (N = 90).
DESIGN


Students were randomly assigned to an experimental group (n = 37), in which an MCBI was applied, and a waiting list group (n = 26) with no intervention. We also assessed a non-randomized active control group (n = 27), in which students received training in basic psychotherapy skills.
METHODS


Verbal creativity (fluency, flexibility, and originality) was evaluated in a pre-, post-, and follow-up assessment.
RESULTS


Results indicated a significant increase in fluency (p = .001, d = .64), flexibility (p = .017, d = .67), and originality (p = .004, d = .72) in the experimental group, relative to the waiting list group, in the post-assessment. Fluency (p = .010, d = .64) and flexibility (p = .033, d = .62) were also found to be higher in the follow-up assessment. In addition, results indicated a significant increase in flexibility (p = .034, d = .74) in the experimental group, relative to the active control group, in the follow-up assessment.
CONCLUSIONS


Introducing MCBI in the university education of psychotherapists seems to be a useful strategy to improve their verbal creativity, which could positively influence their ability to explore and appropriately respond to their patients' needs.
PRACTITIONER POINTS


Mindfulness and compassion-based interventions (MCBIs) could be a useful strategy to improve verbal creativity in the university education of psychotherapists. After the MCBI, students of clinical and health psychology increased the number of ideas they produced when facing a specific situation, as well as their variety and originality.",2021,"RESULTS


Results indicated a significant increase in fluency (p = .001, d = .64), flexibility (p = .017, d = .67), and originality (p = .004, d = .72) in the experimental group, relative to the waiting list group, in the post-assessment.","['Students', 'students of clinical and health psychology']","['training in basic psychotherapy skills', 'mindfulness and compassion-based intervention (MCBI', 'Mindfulness and compassion-based interventions (MCBIs']","['flexibility', 'Fluency', 'fluency', 'Verbal creativity (fluency, flexibility, and originality', 'verbal creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0302827', 'cui_str': 'Psychology, Health'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",,0.0242308,"RESULTS


Results indicated a significant increase in fluency (p = .001, d = .64), flexibility (p = .017, d = .67), and originality (p = .004, d = .72) in the experimental group, relative to the waiting list group, in the post-assessment.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bellosta-Batalla', 'Affiliation': 'El Arte de Escuchar, Psychotherapy and Mindfulness, Valencia, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, University of Valencia, Spain.'}, {'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Pérez-Blasco', 'Affiliation': 'Department of Evolutionary and Educational Psychology, University of Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Moya-Albiol', 'Affiliation': 'Department of Psychobiology, University of Valencia, Spain.'}]",Psychology and psychotherapy,['10.1111/papt.12329']
1303,33586254,Improving the prognosis of renal patients: the role of blood flow-restriction resistance training on redox balance and cardiac autonomic function.,"NEW FINDINGS


What is the central question of this study? Resistance training with and without blood flow-restriction can improve redox balance and positively impact the autonomic cardiac modulation in chronic kidney disease patients? What is the main finding and its importance? Resistance training with and without blood flow-restriction improved antioxidant defense (PON-1) and decreases the pro-oxidative MPO, improved cardiac autonomic function and slowing the decrease in renal function. We draw attention to the important clinical implications for the management of redox balance and autonomic cardiac function in CKD patients.
ABSTRACT


Background : Patients with chronic kidney disease (CKD) are prone to cardiovascular diseases secondary to abnormalities in both autonomic cardiac function and redox balance (myeloperoxidase/paraoxonase-1 ratio). Although aerobic training improves both autonomic and redox balance in patients with CKD, the cardio-protective effects of resistance training (RT) with and without blood flow-restriction (BFR) remains unknown. We aimed to compare the effects of RT and RT+BFR on antioxidant defense (PON-1), pro-oxidative status (MPO), cardiac autonomic function (quantified by HRV analysis), and renal function (assessed by estimated glomerular filtration rate).
METHODS


Conservative CKD patients (n = 105/33♀) from both gender were randomized into three groups: control (CTL; 57.6±5.2yrs; BMI 33.23±1.62), RT (58.09±6.26yrs; BMI 33.63±2.05) and RT+BFR (58.06±6.47yrs; BMI 33.32±1.87). Patients completed six months of RT or RT+BFR on three nonconsecutive days per week under the supervision of strength and conditioning professional. Training loads were adjusted every two months. Heart rate variability (HRV) was recorded with a Polar-RS800® and data were analyzed for time and frequency domains using Kubios software. Redox balance markers were paraoxonase-1 and myeloperoxidase which were analyzed in the plasma samples. Renal function was estimated through glomerular filtration rate.
RESULTS


RT and RT+BFR decreased pro-oxidative MPO (RT, ∼34ng/mL and RT+BFR, ∼27ng/mL), improved both antioxidant defense PON-1(RT, ∼23U/L and RT+BFR, ∼31U/L) and cardiac autonomic function {RR (ms): RT, ∼120.4ms and RT+BFR, ∼117.7ms)}, and slowed the deterioration of renal function (p<0.0001). Redox balance markers were inversely correlated with HRV time-domain indexes.
CONCLUSIONS


Our data indicated that both training models were effective as non-pharmacological tools to increase the antioxidant defenses, decrease oxidative stress, and thus improving the cardiac autonomic function of CKD patients. This article is protected by copyright. All rights reserved.",2021,"Resistance training with and without blood flow-restriction improved antioxidant defense (PON-1) and decreases the pro-oxidative MPO, improved cardiac autonomic function and slowing the decrease in renal function.","['renal patients', 'chronic kidney disease patients', 'patients with CKD', 'CKD patients', 'Conservative CKD patients (n = 105/33♀) from both gender', 'Patients with chronic kidney disease (CKD']","['Resistance training with and without blood flow-restriction', 'RT or RT+BFR', 'aerobic training', 'blood flow-restriction resistance training', 'RT and RT+BFR']","['redox balance and cardiac autonomic function', 'autonomic and redox balance', 'glomerular filtration rate', 'antioxidant defenses, decrease oxidative stress', 'cardiac autonomic function', 'Heart rate variability (HRV', 'antioxidant defense PON-1(RT, ∼23U/L and RT+BFR, ∼31U/L) and cardiac autonomic function {RR (ms): RT, ∼120.4ms and RT+BFR, ∼117.7ms)}, and slowed the deterioration of renal function', 'antioxidant defense (PON-1', 'renal function', 'antioxidant defense (PON-1), pro-oxidative status (MPO), cardiac autonomic function (quantified by HRV analysis), and renal function', 'Redox balance markers', 'redox balance', 'RT and RT+BFR decreased pro-oxidative MPO', 'Renal function', 'HRV time-domain indexes']","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032639', 'cui_str': 'Pontine structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1257646', 'cui_str': 'PON1 protein, human'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0125561,"Resistance training with and without blood flow-restriction improved antioxidant defense (PON-1) and decreases the pro-oxidative MPO, improved cardiac autonomic function and slowing the decrease in renal function.","[{'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Hugo de Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Fernando Sousa', 'Initials': 'FS', 'LastName': 'Honorato', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Thaís Branquinho', 'Initials': 'TB', 'LastName': 'de Araújo', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Bouve College of Health Sciences, Northeastern University, Boston, USA.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'de Moraes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Luiz Sinésio', 'Initials': 'LS', 'LastName': 'Silva Neto', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Palmas, Tocantins, Brazil.'}, {'ForeName': 'Cláudio Avelino', 'Initials': 'CA', 'LastName': 'Rodrigues Santos', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Palmas, Tocantins, Brazil.'}, {'ForeName': 'Gislane Ferreira', 'Initials': 'GF', 'LastName': 'Melo', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Whitley Jo', 'Initials': 'WJ', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology, Recreation, and Sport, Western Kentucky University, Kentucky, USA.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, Brasília, DF, Brazil.'}]",Experimental physiology,['10.1113/EP089341']
1304,33586201,Changes in utilization of axillary dissection in women with invasive breast cancer and sentinel node metastasis after the ACOSOG Z0011 trial.,"The American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial demonstrated no survival advantage for women with clinical T1-T2 invasive breast cancer with 1-2 positive sentinel lymph nodes (SLN) who received whole-breast radiation, and no further axillary surgery when compared to women who did undergo axillary lymph node dissection (ALND). We used the National Cancer Database (NCDB) to study changes in utilization of ALND after the publication of this trial. NCDB was queried for female patients from 2012 to 2015 who met Z0011 criteria. Patients were divided into four groups based on Commission on Cancer facility accreditation. Outcome measures include the rate of ALND (nonadherence to Z0011) and the average number of nodes retrieved with ALND. 27,635 patients were identified, with no significant differences in T stage and receptor profiles between groups. Overall rate of ALND decreased from 34.0% in 2012 to 22.7% in 2015. Nonadherence was lowest in Academic Programs (decreasing from 30.1% in 2012 to 20.5% in 2015) and was highest in Community Cancer Programs (41.2% in 2012 to 29.1% in 2015). Median number of positive SLN did not differ between groups (p = .563). Median number of nodes retrieved on ALND decreased from 9 (IQR 5-14) in 2012 to 7 (IQR 4-12) in 2015 (p < .001). In patients who met the ACOSOG Z11 trial guidelines, rates of ALND have decreased over time. However, rates of nonadherence to Z0011 are significantly higher in Community Cancer Programs compared to Academic Programs.",2021,Median number of positive SLN did not differ between groups (p = .563).,"['women with clinical T1-T2 invasive breast cancer with 1-2 positive sentinel lymph nodes (SLN', 'women who did undergo axillary lymph node dissection (ALND', 'women with invasive breast cancer and sentinel node metastasis after the ACOSOG Z0011 trial', 'female patients from 2012 to 2015 who met Z0011 criteria', '27,635 patients', 'American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011']",['NCDB'],"['Median number of nodes retrieved on ALND', 'Median number of positive SLN', 'Overall rate of ALND', 'Nonadherence', 'T stage and receptor profiles', 'survival advantage', 'rates of ALND', 'rate of ALND (nonadherence to Z0011) and the average number of nodes retrieved with ALND']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",27635.0,0.0411383,Median number of positive SLN did not differ between groups (p = .563).,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Tseng', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Rodrigo F', 'Initials': 'RF', 'LastName': 'Alban', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Siegel', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Chung', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Armando E', 'Initials': 'AE', 'LastName': 'Giuliano', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Farin F', 'Initials': 'FF', 'LastName': 'Amersi', 'Affiliation': 'Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}]",The breast journal,['10.1111/tbj.14191']
1305,33586178,The effect of an online psychoeducational stress management program on international students' ability to cope and adapt.,"PURPOSE


To assess the effect of an online psychoeducational program on international students' abilities to cope with and adapt to stress.
DESIGN AND METHOD


The study had an experimental design with a pre- and posttest and a control group. The sample consisted of 60 participants randomly assigned to the control and experimental groups.
FINDING


The psychoeducational stress management program was effective in decreasing the stress levels and improving the capacity to cope with the participants in the experimental group.
IMPLICATIONS FOR PRACTICE


The study provides information to psychiatric nurses and student support services about how to assist international nursing students in coping with stress.",2021,"The psychoeducational stress management program was effective in decreasing the stress levels and improving the capacity to cope with the participants in the experimental group.
","[""international students' abilities to cope with and adapt to stress"", 'international nursing students in coping with stress']","['online psychoeducational stress management program', 'psychoeducational stress management program', 'online psychoeducational program']",['stress levels'],"[{'cui': 'C3472518', 'cui_str': 'International student'}, {'cui': 'C0424097', 'cui_str': 'Ability to cope'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1319127', 'cui_str': 'Level of stress'}]",60.0,0.0191619,"The psychoeducational stress management program was effective in decreasing the stress levels and improving the capacity to cope with the participants in the experimental group.
","[{'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Bani Ahmad', 'Affiliation': 'Faculty of Nursing, Near East University, Mersin, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Meriç', 'Affiliation': 'Faculty of Nursing, Near East University, Mersin, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12735']
1306,33586160,COVID-19 convalescent plasma: interim recommendations from the AABB.,"BACKGROUND


COVID-19 convalescent plasma (CCP) has emerged as a potential treatment for COVID-19. However, efficacy data and recommendations for its use are limited.
METHODS


AABB commissioned a panel of experts to develop interim recommendations based on limited data to guide use of this scarce resource. The panel performed a literature review using the search terms ""COVID-19,"" ""SARS-CoV-2"" and ""convalescent plasma."" The interim recommendations reflect a consensus of expert opinion. INTERIM RECOMMENDATION 1: When making risk benefit decisions, one should consider the risk of CCP as comparable to standard (SARS-CoV-2 non-immune) plasma. INTERIM RECOMMENDATION 2: CCP is optimally effective when transfused as close to symptom onset as possible. CCP is unlikely to provide benefit for patients with late-stage disease or on mechanical ventilation. INTERIM RECOMMENDATION 3: The effectiveness of CCP is related to the antibody quantity within a unit; high-titer CCP is superior to low-titer CCP. A single high-titer unit should be sufficient for most patients. INTERIM RECOMMENDATION 4: If group B or group AB CCP is unavailable, transfusion of group A or group O CCP with low anti-A/B titer may be acceptable for group B and group AB patients. INTERIM RECOMMENDATION 5: Additional randomized controlled trial (RCT) data are needed to fully assess CCP efficacy and to identify which specific patient populations and unit characteristics might confer the greatest benefit.
CONCLUSIONS


These interim recommendations are based on the best-available evidence at the time of writing. Additional data from on-going RCTs will lead to clinical practice guidelines in the future.",2021,The effectiveness of CCP is related to the antibody quantity within a unit; high-titer CCP is superior to low-titer CCP.,['patients with late-stage disease or on mechanical ventilation'],['CCP'],['CCP efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0404344,The effectiveness of CCP is related to the antibody quantity within a unit; high-titer CCP is superior to low-titer CCP.,"[{'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Cohn', 'Affiliation': 'University of Minnesota, Department of Laboratory Medicine and Pathology, Minneapolis, Minnesota.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Estcourt', 'Affiliation': 'NHS Blood and Transplant, Oxford, UK & Radcliffe Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Brenda J', 'Initials': 'BJ', 'LastName': 'Grossman', 'Affiliation': 'Washington University in St. Louis School of Medicine, Department of Pathology and Immunology, St Louis, Missouri.'}, {'ForeName': 'Monica B', 'Initials': 'MB', 'LastName': 'Pagano', 'Affiliation': 'University of Washington, Department of Laboratory Medicine and Pathology, Seattle, Washington.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Allen', 'Affiliation': 'University of California San Diego, Department of Pathology, La Jolla, CA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'The Johns Hopkins University School of Medicine, Department of Pathology, Baltimore, MD.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'The Johns Hopkins University School of Public Health, Department of Molecular Microbiology and Immunology, Baltimore, Maryland.'}, {'ForeName': 'Dana V', 'Initials': 'DV', 'LastName': 'Devine', 'Affiliation': 'Canadian Blood Services, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Dunbar', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Department of Pathology, Lebanon, New Hampshire.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Foroutan', 'Affiliation': 'University Health Network, Ted Rogers Centre for Heart Research, Toronto, ON, Canada.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Gniadek', 'Affiliation': 'NorthShore University HealthSystem, Department of Pathology and Laboratory Medicine, Evanston, IL.'}, {'ForeName': 'Ruchika', 'Initials': 'R', 'LastName': 'Goel', 'Affiliation': 'Mississippi Valley Regional Blood Center, Springfield, IL, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Gorlin', 'Affiliation': 'Innovative Blood Resources, Division of New York Blood Center enterprises, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Mayo Clinic, Department of Anesthesiology and Perioperative Medicine, Rochester, MN.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Metcalf', 'Affiliation': 'University of Utah, Department of Pathology, Salt Lake City, Utah, USA.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Raval', 'Affiliation': 'University of New Mexico, Department of Pathology, Albuquerque, NM, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Vanderbilt University Medical Center, Division of Allergy, Pulmonary, and Critical Care Medicine, Nashville, Tennessee.'}, {'ForeName': 'Beth H', 'Initials': 'BH', 'LastName': 'Shaz', 'Affiliation': 'Duke University, Department of Pathology, Durham, NC.'}, {'ForeName': 'Ralph R', 'Initials': 'RR', 'LastName': 'Vassallo', 'Affiliation': 'Vitalant, Scottsdale, AZ.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Winters', 'Affiliation': 'Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, Minnesota.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Beaudoin', 'Affiliation': 'Patient Representative, Minneapolis, Minnesota.'}, {'ForeName': 'Aaron A R', 'Initials': 'AAR', 'LastName': 'Tobian', 'Affiliation': 'The Johns Hopkins University School of Medicine, Department of Pathology, Baltimore, MD.'}]",Transfusion,['10.1111/trf.16328']
1307,33586143,Long-term Safety and Efficacy of Eculizumab in Aquaporin-4 IgG-Positive NMOSD.,"OBJECTIVE


During PREVENT (NCT01892345), eculizumab significantly reduced relapse risk versus placebo in patients with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG+ NMOSD). We report an interim analysis of PREVENT's ongoing open-label extension (OLE; NCT02003144) evaluating eculizumab's long-term safety and efficacy.
METHODS


Patients who completed PREVENT could enroll in the OLE to receive eculizumab (maintenance dose, 1200 mg/2 weeks, after a blinded induction phase). Safety and efficacy data from PREVENT and its OLE (interim data cut, July 31, 2019) were combined for this analysis.
RESULTS


Across PREVENT and the OLE, 137 patients received eculizumab and were monitored for a median (range) of 133.3 (5.1-276.9) weeks, for a combined total of 362.3 patient-years (PY). Treatment-related adverse event (AE) and serious adverse event (SAE) rates were 183.5/100 PY and 8.6/100 PY, respectively. Serious infection rates were 10.2/100 PY in eculizumab-treated patients versus 15.1/100 PY in the PREVENT placebo group. No patient developed a meningococcal infection. At 192 weeks (3.7 years), 94.4% (95% confidence interval [CI], 88.6-97.3) of patients remained adjudicated relapse-free. The adjudicated annualized relapse rate was 0.025 (95% CI, 0.013-0.048) in all eculizumab-treated patients versus 0.350 (95% CI, 0.199-0.616) in the PREVENT placebo group. During the OLE, 37% of patients (44/119) stopped or decreased background immunosuppressive therapy use.
INTERPRETATION


This analysis demonstrates that eculizumab's long-term safety profile in NMOSD is consistent with its established profile across other indications. This analysis also demonstrated the sustained ability of long-term eculizumab treatment to reduce relapse risk in patients with AQP4-IgG+ NMOSD. This article is protected by copyright. All rights reserved.",2021,Serious infection rates were 10.2/100 PY in eculizumab-treated patients versus 15.1/100 PY in the PREVENT placebo group.,"['Patients who completed PREVENT could enroll in the OLE to receive', 'patients with AQP4-IgG+ NMOSD', 'patients with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG+ NMOSD']","['eculizumab', 'placebo', 'Eculizumab']","['Treatment-related adverse event (AE) and serious adverse event (SAE) rates', 'relapse risk', 'Serious infection rates', 'annualized relapse rate', 'meningococcal infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0292777', 'cui_str': 'Aquaporin-4'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}]",,0.550354,Serious infection rates were 10.2/100 PY in eculizumab-treated patients versus 15.1/100 PY in the PREVENT placebo group.,"[{'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Tohoku University, Sendai, Japan.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Palace', 'Affiliation': 'John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Berthele', 'Affiliation': 'Technical University of Munich, School of Medicine, Department of Neurology, Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Tohoku University, Sendai, Japan.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Oreja-Guevara', 'Affiliation': 'Hospital Universitario Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Kai-Chen', 'Initials': 'KC', 'LastName': 'Wang', 'Affiliation': 'Cheng-Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Alexion Pharmaceuticals, Boston, Massachusetts.'}, {'ForeName': 'Shulian', 'Initials': 'S', 'LastName': 'Shang', 'Affiliation': 'Alexion Pharmaceuticals, Boston, Massachusetts.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Sabatella', 'Affiliation': 'Alexion Pharmaceuticals, Boston, Massachusetts.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Yountz', 'Affiliation': 'Alexion Pharmaceuticals, Boston, Massachusetts.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Pittock', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.26049']
1308,33586144,Speed of electroconvulsive therapy for depression: effects of electrode placement.,"OBJECTIVE


Electroconvulsive therapy (ECT) is a rapidly effective treatment for severe depression. Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness. There is limited evidence for demographic and clinical factors that predict speed of response and remission with ECT. We aimed to investigate differences in speed of improvement as well as achieving response and remission between twice-weekly brief-pulse high-dose (6 x seizure threshold) RUL ECT and moderate-dose (1.5 x seizure threshold) BT ECT. We also explored demographic and clinical characteristics that predict speed of response and remission.
METHODS


Weekly 24-item Hamilton Depression Rating Scale scores were assessed among patients with severe depression who participated in the EFFECT-Dep trial (ISRCTN23577151). Speed of improvement in patients randomized to RUL ECT (n = 69) or BT ECT (n = 69) was compared using independent sample t-tests. Pearson's chi-square and Fisher's exact tests compared proportions of responders and remitters at each weekly assessment. Predictors of speed of response and remission were explored using Cox regression analyses.
RESULTS


There were no significant differences between RUL and BT ECT in speed of improvement, response or remission. Exploratory analyses indicated that speed of response and remission were not predicted by a wide variety of demographic and clinical characteristics.
CONCLUSION


ECT electrode placement did not have predictive value when determining speed of improvement, response and remission with ECT. Other clinical factors, such as cognitive side-effects, may be more relevant when making the clinical choice between RUL and BT ECT.",2021,Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness.,['patients with severe depression who participated in the EFFECT-Dep trial (ISRCTN23577151'],"['electroconvulsive therapy', 'RUL ECT', 'ECT electrode placement', 'right unilateral (RUL) or bitemporal (BT) ECT', 'BT ECT', 'electrode placement', 'Electroconvulsive therapy (ECT']","['RUL and BT ECT in speed of improvement, response or remission', '24-item Hamilton Depression Rating Scale scores', 'speed of response and remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}]","[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",69.0,0.107202,Treatment with right unilateral (RUL) or bitemporal (BT) ECT may explain individual differences in speed of ECT effectiveness.,"[{'ForeName': 'Celine A', 'Initials': 'CA', 'LastName': 'Fox', 'Affiliation': ""Dept. of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Declan M', 'Initials': 'DM', 'LastName': 'McLoughlin', 'Affiliation': ""Dept. of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland.""}]",Acta psychiatrica Scandinavica,['10.1111/acps.13286']
1309,33586120,"Empagliflozin Improves Liver Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","INTRODUCTION


To evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).
METHODS


In this prospective randomized, double-blind, placebo-controlled trial, we assigned 106 patients with NAFLD and T2DM to receive empagliflozin 10 mg (n = 35), pioglitazone 30 mg (n = 34), or placebo (n = 37) for 24 weeks. Liver fat content and liver stiffness were measured using fibroscans. Body composition assessment was performed by dual-energy x-ray absorptiometry (DEXA) scans. The primary end point was change from baseline in liver steatosis, using the controlled attenuation parameter (CAP) score.
RESULTS


A borderline significant decrease in CAP score was observed with empagliflozin compared to placebo, mean difference: - 29.6 dB/m (- 39.5 to - 19.6) versus - 16.4 dB/m (- 25.0 to - 7.8), respectively; p = 0.05. Using multivariate analysis, we observed a significant reduction in the placebo-corrected change in liver stiffness measurement (LSM) with empagliflozin compared to pioglitazone: - 0.77 kPa (- 1.45, - 0.09), p  = 0.02, versus 0.01 kPa (95% CI - 0.70, 0.71, p  = 0.98), p for comparison = 0.03. Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group (p  < 0.001 and p  = 0.01, respectively) and both were increased in the placebo and pioglitazone groups. There were no serious adverse events in either group.
CONCLUSION


Treatment for 24 weeks with empagliflozin, in contrast to pioglitazone, was associated with improvement of liver steatosis and fibrosis in patients with NAFLD and T2DM. In addition, body weight and abdominal fat area were decreased in the empagliflozin group.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.",2021,"Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group (p  < 0.001 and p  = 0.01, respectively) and both were increased in the placebo and pioglitazone groups.","['106 patients with NAFLD and T2DM to receive', 'patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM', 'Patients with Non', 'Alcoholic Fatty Liver Disease and Type 2 Diabetes']","['empagliflozin', 'placebo', 'pioglitazone 30\xa0mg (n\u2009=\u200934), or placebo', 'Empagliflozin', 'pioglitazone', 'Placebo']","['Liver Steatosis and Fibrosis', 'CAP score', 'serious adverse events', 'serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI', 'liver steatosis and fibrosis', 'liver stiffness measurement (LSM', 'Liver fat content and liver stiffness', 'body weight and visceral fat area', 'body weight and abdominal fat area', 'change from baseline in liver steatosis, using the controlled attenuation parameter (CAP) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1127433', 'cui_str': 'pioglitazone 30 MG'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4304377', 'cui_str': 'Fibrosis-4 index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4722043', 'cui_str': 'NAFLD (Non-Alcoholic Fatty Liver Disease) fibrosis score'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0201837', 'cui_str': 'Albumin/Globulin ratio'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",106.0,0.476591,"Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group (p  < 0.001 and p  = 0.01, respectively) and both were increased in the placebo and pioglitazone groups.","[{'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Chehrehgosha', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoud Reza', 'Initials': 'MR', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ajdarkosh', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Khoonsari', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Afshin Eshghi', 'Initials': 'AE', 'LastName': 'Fallah', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. khamseh.m@iums.ac.ir.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-021-01011-3']
1310,33586112,Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners.,"OBJECTIVES


Point-of-care ultrasound (POCUS) has become increasingly integrated into medical education given the growing role of evaluative and procedural techniques in practice today. Tele-ultrasound is a new and promising venture that aims to expand medical knowledge and education to previously unreached or underserved areas. This study aimed to determine the non-inferiority of teaching ultrasound remotely using tele-ultrasound via the Philips Lumify (Philips Medical Systems, Bothell, WA) system, which utilizes video conferencing technology and real-time imaging that can be viewed by the operator and educator simultaneously.
METHODS


Three commonly used ultrasound exams were taught and evaluated in 56 ultrasound-naive medical participants: Focused Assessment with Sonography in Trauma (FAST), Lower Extremity Deep Venous Thrombosis (LEDVT) screening, and ultrasound-guided vascular access. The participants were randomized into either in-person traditional learning or tele-ultrasound learning with the Philips Lumify (Philips Medical Systems, Bothell, WA) units. The primary outcome of interest was the ability to perform certain tasks for each exam RESULTS: Competency on each exam was tested across all exams and no inferiority was found between in-person and remote learning (p < 0.05).
CONCLUSIONS


Our findings support the use of tele-ultrasound in beginner ultrasound education.",2021,"Competency on each exam was tested across all exams and no inferiority was found between in-person and remote learning (p < 0.05).
",[],"['care ultrasound (POCUS', 'tele-ultrasound in education sonography', '56 ultrasound-naive medical participants: Focused Assessment with Sonography in Trauma (FAST), Lower Extremity Deep Venous Thrombosis (LEDVT) screening, and ultrasound-guided vascular access', 'person traditional learning or tele-ultrasound learning with the Philips Lumify (Philips Medical Systems, Bothell, WA) units']",[],[],"[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C4550793', 'cui_str': 'Lumify'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],,0.0303031,"Competency on each exam was tested across all exams and no inferiority was found between in-person and remote learning (p < 0.05).
","[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Drake', 'Affiliation': 'Case Western Reserve University School of Medicine, Health Education Campus, 9501 Euclid Ave, Cleveland, OH, 44106, USA. aed65@case.edu.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hy', 'Affiliation': 'Case Western Reserve University School of Medicine, Health Education Campus, 9501 Euclid Ave, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'MacDougall', 'Affiliation': 'Case Western Reserve University School of Medicine, Health Education Campus, 9501 Euclid Ave, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Holmes', 'Affiliation': 'Case Western Reserve University School of Medicine, Health Education Campus, 9501 Euclid Ave, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Icken', 'Affiliation': 'Case Western Reserve University School of Medicine, Health Education Campus, 9501 Euclid Ave, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Jon W', 'Initials': 'JW', 'LastName': 'Schrock', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'MetroHealth Medical Center, Cleveland, OH, USA.'}]",The ultrasound journal,['10.1186/s13089-021-00210-0']
1311,33586090,Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study.,"PURPOSE


Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children.
STUDY DESIGN


Multicenter (7 university hospitals), randomized, double-masked, placebo-controlled trial.
METHODS


Participants were 171 Japanese schoolchildren aged 6 to 12 years, with progressive myopia, spherical equivalence (SE) of -1.00 to -6.00 diopters (D), and astigmatism of ≤1.5 D. They were randomized to receive either 0.01% atropine (n=85) or placebo (n=86) eye drops once nightly OU for 24 months. Primary and secondary efficacy endpoints were changes in SE and axial length (AL), respectively, from baseline to month 24.
RESULTS


Data from 168 subjects were analyzed. At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%). The least squares mean change in SE and AL from baseline were, respectively, -1.26 D (95% confidence interval [CI]: -1.35, -1.17) and 0.63 mm (0.59, 0.67) for atropine and -1.48 D (- 1.57, -1.39) and 0.77 mm (0.73, 0.81) for placebo. Inter-group differences were 0.22 D (95% CI: 0.09, 0.35; P < 0.001) for SE and - 0.14 mm (-0.20, -0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients).
CONCLUSION


With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.",2021,"At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%).","['Data from 168 subjects were analyzed', 'Participants were 171 Japanese schoolchildren aged 6 to 12\xa0years, with progressive myopia, spherical equivalence (SE) of\u2009-1.00 to\u2009-6.00 diopters (D), and astigmatism of\u2009≤1.5 D', 'Multicenter (7 university hospitals', 'Japanese schoolchildren population', 'Japanese children']","['atropine eye drops', 'Atropine', 'atropine', 'placebo']","['changes in SE and axial length (AL', 'efficacy and safety', 'Efficacy and safety', 'mild allergic conjunctivitis side effects']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1449744', 'cui_str': 'Myopia, Progressive'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009766', 'cui_str': 'Allergic conjunctivitis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",171.0,0.761791,"At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%).","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hieda', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tusukuba, Ibaraki, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujikado', 'Affiliation': 'Graduate School of Frontier Biosciences, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ishiko', 'Affiliation': 'Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hasebe', 'Affiliation': 'Department of Ophthalmology 2, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Hidemasa', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Ophthalmology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Yo', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Sotozono', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Oshika', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tusukuba, Ibaraki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Advanced Visual Neuroscience, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Nishida', 'Affiliation': 'Department of Ophthalmology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Tokutake', 'Affiliation': 'Department of Ophthalmology, Kawasaki Medical School General Medical Center, Okayama, Okayama, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Nishi', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Shigeno', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Kurihara', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Negishi', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tsubota', 'Affiliation': 'Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Ophthalmology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Nakai', 'Affiliation': 'Clinical Biostatistics Course, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Clinical Biostatistics Course, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Frontier Medical Science and Technology for Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, 602-0841, Japan. shigeruk@koto.kpu-m.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of ophthalmology,['10.1007/s10384-021-00822-y']
1312,33586087,"Electrical, taste, and temperature stimulation in patients with chronic dysphagia after stroke: a randomized controlled pilot trial.","The objective of present study was compare a traditional swallowing therapy program with a new combined swallowing therapy program including neuromuscular electrical stimulation in patients with oropharyngeal dysphagia after stroke. This pilot study included eight patients with chronic oropharyngeal dysphagia after stroke. These patients underwent traditional therapy with gustative-thermic-tactile stimulation (group A), or a new combined program adding neuromuscular electrical stimulation (group B). Study participants were evaluated before and after the intervention using fiberoptic endoscopic evaluation of swallowing with temporal measures of posterior oral spillage and whiteout time, functional oral intake scale and a visual analog scale classifies an individual's swallowing ability. The two groups did not differ in terms of posterior oral spillage time, whiteout time and functional oral intake scale. Subjects in group B exhibited significant increases in visual analog scale scores. However, both groups demonstrated improvement with decreases in posterior oral spillage time, increased whiteout time, and increased functional oral intake scale and visual analog scale scores. There was no difference in the parameters studied in both therapeutic programs in individuals with chronic oropharyngeal dysphagia after stroke.",2021,"The two groups did not differ in terms of posterior oral spillage time, whiteout time and functional oral intake scale.","['individuals with chronic oropharyngeal dysphagia after stroke', 'patients with oropharyngeal dysphagia after stroke', 'patients with chronic dysphagia after stroke', 'eight patients with chronic oropharyngeal dysphagia after stroke']","['traditional therapy with gustative-thermic-tactile stimulation', 'new combined program adding neuromuscular electrical stimulation', 'traditional swallowing therapy program with a new combined swallowing therapy program']","['posterior oral spillage time, increased whiteout time, and increased functional oral intake scale and visual analog scale scores', ""fiberoptic endoscopic evaluation of swallowing with temporal measures of posterior oral spillage and whiteout time, functional oral intake scale and a visual analog scale classifies an individual's swallowing ability"", 'Electrical, taste, and temperature stimulation', 'visual analog scale scores', 'posterior oral spillage time, whiteout time and functional oral intake scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0589274', 'cui_str': 'Swallowing promotion therapy'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234438', 'cui_str': 'Whiteout'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0589408', 'cui_str': 'Fiberoptic endoscopic evaluation of swallowing'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",8.0,0.0159659,"The two groups did not differ in terms of posterior oral spillage time, whiteout time and functional oral intake scale.","[{'ForeName': 'Paula Cristina', 'Initials': 'PC', 'LastName': 'Cola', 'Affiliation': 'Medicine Department, Marília University-UNIMAR, Av. Hygino Muzzi Filho, 1001, Mirante, Cep: 17.525-902, Marília,, São Paulo, Brazil. paccola@hotmail.com.'}, {'ForeName': 'Suely Mayumi Motonaga', 'Initials': 'SMM', 'LastName': 'Onofri', 'Affiliation': 'Dysphagia Research Rehabilitation Center, Graduate of Speech, Language and Hearing Sciences Department, Paulista State University-UNESP, Marília, São Paulo, Brazil.'}, {'ForeName': 'Claudio José', 'Initials': 'CJ', 'LastName': 'Rubira', 'Affiliation': 'Medicine Department, Marília University-UNIMAR, Av. Hygino Muzzi Filho, 1001, Mirante, Cep: 17.525-902, Marília,, São Paulo, Brazil.'}, {'ForeName': 'Cristiane Rodrigues', 'Initials': 'CR', 'LastName': 'Pedroni', 'Affiliation': 'Graduate of Physiotherapy Department, Paulista State University-UNESP, Marília, São Paulo, Brazil.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Roberta Gonçalves', 'Initials': 'RG', 'LastName': 'da Silva', 'Affiliation': 'Dysphagia Research Rehabilitation Center, Graduate of Speech, Language and Hearing Sciences Department, Paulista State University-UNESP, Marília, São Paulo, Brazil.'}]",Acta neurologica Belgica,['10.1007/s13760-021-01624-2']
1313,33586072,The Landmark Series: Locally Advanced Pancreatic Cancer and Ablative Therapy Options.,"Locally advanced pancreatic cancer (LAPC) is a challenging disease to treat. There is consensus that systemic chemotherapy should be the first line of therapy for most patients. However, there is no consensus on how to manage those patients who do not have sufficient response to become candidates for resection but also do not have distant progression after weeks or months of systemic therapy. Radiation therapy is the most commonly used and best-studied local ablative therapy. One recent randomized controlled trial (LAP-07) failed to demonstrate an overall survival benefit for conventional chemoradiation therapy after induction chemotherapy versus chemotherapy alone. This study had several limitations, and ongoing studies are re-evaluating the role of chemoradiation after more effective chemotherapy regimens as well as more advanced radiation techniques. In parallel, there has been increasing interest in other thermal and non-thermal methods of ablation. In particular, irreversible electroporation has gained traction for treatment of LAPC, with at least one ongoing randomized controlled trial designed to address its role compared with systemic chemotherapy alone. Multiple preclinical and clinical studies are investigating combinations of local ablation and immunotherapy with the goal of generating immune responses that will meaningfully improve outcomes.",2021,One recent randomized controlled trial (LAP-07) failed to demonstrate an overall survival benefit for conventional chemoradiation therapy after induction chemotherapy versus chemotherapy alone.,['Locally advanced pancreatic cancer (LAPC'],['Radiation therapy'],['overall survival benefit'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1.0,0.0845893,One recent randomized controlled trial (LAP-07) failed to demonstrate an overall survival benefit for conventional chemoradiation therapy after induction chemotherapy versus chemotherapy alone.,"[{'ForeName': 'Rebekah R', 'Initials': 'RR', 'LastName': 'White', 'Affiliation': 'Department of Surgery, University of California San Diego Moores Cancer Center, La Jolla, CA, USA. rewhite@health.ucsd.edu.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Murphy', 'Affiliation': 'Department of Radiation Oncology, University of California San Diego Moores Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Robert C G', 'Initials': 'RCG', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, University of Louisville, Louisville, KY, USA.'}]",Annals of surgical oncology,['10.1245/s10434-021-09662-z']
1314,32371517,Implementation of care managers for patients with depression: a cross-sectional study in Swedish primary care.,"OBJECTIVES


To perform an analysis of collaborative care with a care manager implementation in a primary healthcare setting. The study has a twofold aim: (1) to examine clinicians' and directors' perceptions of implementing collaborative care with a care manager for patients with depression at the primary care centre (PCC), and (2) to identify barriers and facilitators that influenced this implementation.
DESIGN


A cross-sectional study was performed in 2016-2017 in parallel with a cluster-randomised controlled trial.
SETTING


36 PCCs in south-west Sweden.
PARTICIPANTS


PCCs' directors and clinicians.
OUTCOME


Data regarding the study's aims were collected by two web-based questionnaires (directors, clinicians). Descriptive statistics and qualitative content analysis were used for analysis.
RESULTS


Among the 36 PCCs, 461 (59%) clinicians and 36 (100%) directors participated. Fifty-two per cent of clinicians could cooperate with the care manager without problems. Forty per cent regarded to their knowledge of the care manager assignment as insufficient. Around two-thirds perceived that collaborating with the care manager was part of their duty as PCC staff. Almost 90% of the PCCs' directors considered that the assignment of the care manager was clearly designed, around 70% considered the priority of the implementation to be high and around 90% were positive to the implementation. Facilitators consisted of support from colleagues and directors, cooperative skills and positive attitudes. Barriers were high workload, shortage of staff and extensive requirements and demands from healthcare management.
CONCLUSIONS


Our study confirms that the care manager puts collaborative care into practice. Facilitators and barriers of the implementation, such as time, information, soft values and attitudes, financial structure need to be considered when implementing care managers at PCCs.",2020,"Almost 90% of the PCCs' directors considered that the assignment of the care manager was clearly designed, around 70% considered the priority of the implementation to be high and around 90% were positive to the implementation.","['patients with depression', 'A cross-sectional study was performed in 2016-2017 in parallel with a cluster-randomised controlled trial', 'patients with depression at the primary care centre (PCC), and (2', '36 PCCs in south-west Sweden', ""PCCs' directors and clinicians""]",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]",[],[],,0.0439952,"Almost 90% of the PCCs' directors considered that the assignment of the care manager was clearly designed, around 70% considered the priority of the implementation to be high and around 90% were positive to the implementation.","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Augustsson', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden pia.augustsson_olsson@vgregion.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Holst', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Svenningsson', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva-Lisa', 'Initials': 'EL', 'LastName': 'Petersson', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Björkelund', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Björk Brämberg', 'Affiliation': 'Primary Health Care, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-035629']
1315,31364472,Video interpretation and diagnosis of pediatric amblyopia and eye disease.,"AIM


The aim of this study was to assess the potential of using video screening to interpret the results of paediatric eye examinations.
DESIGN


Prospective multi-centred, blinded study.
METHODS


Children aged 5 months to 11 years referred to a paediatric ophthalmology centre were enrolled in the study. Outcome measures included the degree of agreement between examiners for assessment of various aspects of paediatric eye examination. In Phase 1, children were individually assessed in the clinic by three different examiners to determine the level of agreement. In Phase 2 a video recording was made of the first ophthalmologist examining the children. The other two examiners viewed the video recordings to make their diagnoses. Areas of assessment included lid function, pupillary function, ocular motility, strabismus, nystagmus, torticollis and facial asymmetry. Agreement between examiners was measured using Gwet's agreement coefficient (AC1).
RESULTS


A total of 27 patients in Phase 1 (mean age 4.0 years) and 160 children in Phase 2 (mean age 4.8 years) underwent clinical and video-recorded screening. In Phase 1, all but one area of ocular examination (heterotropia) achieved ≥84% agreement between three examiners. In Phase 2, there was greater variation between direct clinical examination and interpretation of video findings, ranging from 55-100% agreement.
CONCLUSION


Using experienced clinicians and changing only one variable in Phase 2 (the method of assessment - direct examination versus video interpretation), the results show the possible usefulness of video-recorded screening as a means of assessing children. Further research is indicated to assess the accuracy of ophthalmologists interpreting video recordings of eye examinations performed by trained non-eye-care professionals.",2021,"In Phase 1, all but one area of ocular examination (heterotropia) achieved ≥84% agreement between three examiners.","['27 patients in Phase 1 (mean age 4.0 years) and 160 children in Phase 2 (mean age 4.8 years) underwent clinical and video-recorded screening', 'Children aged 5 months to 11 years referred to a paediatric ophthalmology centre were enrolled in the study']",[],"['degree of agreement between examiners for assessment of various aspects of paediatric eye examination', 'lid function, pupillary function, ocular motility, strabismus, nystagmus, torticollis and facial asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1628978', 'cui_str': 'Pediatric ophthalmology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234667', 'cui_str': 'Pupillary function'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}, {'cui': 'C0546952', 'cui_str': 'Congenital facial asymmetry'}]",,0.0329603,"In Phase 1, all but one area of ocular examination (heterotropia) achieved ≥84% agreement between three examiners.","[{'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Sabri', 'Affiliation': 'Department of Surgery, Division of Ophthalmology, McMaster University, Canada.'}, {'ForeName': 'Prima', 'Initials': 'P', 'LastName': 'Moinul', 'Affiliation': 'Department of Surgery, Division of Ophthalmology, McMaster University, Canada.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Tehrani', 'Affiliation': 'Department of Surgery, Division of Ophthalmology, University of Toronto, Canada.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Wiggins', 'Affiliation': 'Department of Optometry, University of Waterloo, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Fleming', 'Affiliation': 'Department of Surgery, McMaster Pediatric Surgery Research Collaborative, Canada.'}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': 'Department of Surgery, McMaster Paediatric Eye Research Group, Canada.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19864823']
1316,31414842,"Internalized stigma, sense of belonging, and suicidal ideation among veterans with serious mental illness.","OBJECTIVE


There is emerging evidence that internalized stigma increases risk for suicide among individuals with serious mental illness. The purpose of the current study was to evaluate whether sense of belonging moderates the relationship between internalized stigma and suicidal ideation.
METHOD


Two hundred forty-two veterans with serious mental illness completed measures of internalized stigma, belongingness, and depression. Moderation analysis was used to determine whether sense of belonging interacts with internalized stigma to predict suicidal ideation when accounting for individual differences in depression and relevant demographic variables.
RESULTS


Consistent with our hypothesis, sense of belonging significantly moderated the relationship between internalized stigma and suicidal ideation. Specifically, the relationship between internalized stigma and suicidal ideation was strongest when sense of belonging was low.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


Internalized stigma and belongingness interact to increase risk for suicide. Both constructs should be assessed and included in interventions to reduce suicide risk among veterans with serious mental illness. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Consistent with our hypothesis, sense of belonging significantly moderated the relationship between internalized stigma and suicidal ideation.","['veterans with serious mental illness', 'individuals with serious mental illness', 'Two hundred forty-two veterans with serious mental illness completed measures of internalized stigma, belongingness, and depression']",[],"['Internalized stigma, sense of belonging, and suicidal ideation', 'internalized stigma and suicidal ideation', 'suicide risk']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}]",,0.0767642,"Consistent with our hypothesis, sense of belonging significantly moderated the relationship between internalized stigma and suicidal ideation.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wastler', 'Affiliation': 'Veterans Affairs VISN 5 Mental Illness Research, Education, and Clinical Center (MIRECC).'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'Veterans Affairs VISN 5 Mental Illness Research, Education, and Clinical Center (MIRECC).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phalen', 'Affiliation': 'Veterans Affairs VISN 5 Mental Illness Research, Education, and Clinical Center (MIRECC).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Drapalski', 'Affiliation': 'Veterans Affairs VISN 5 Mental Illness Research, Education, and Clinical Center (MIRECC).'}]",Psychiatric rehabilitation journal,['10.1037/prj0000386']
1317,32354681,A trajectory analysis of daily step counts during a physician-delivered intervention.,"OBJECTIVES


Higher steps are associated with lower mortality and cardiovascular event rates. We previously demonstrated that tailored physician-delivered step count prescriptions successfully increased steps/day in adults with type 2 diabetes mellitus (T2DM) and/or hypertension. In the present analysis, we examined patterns of step count change and the factors that influence different responses.
DESIGN


Longitudinal observational study METHODS: Active arm participants (n=118) recorded steps/day. They received a step count prescription from their physician every 3-4 months. We computed mean steps/day and changes from baseline for sequential 30-day periods. Group-based trajectory modeling was applied.
RESULTS


Four distinct trajectories of mean steps/day emerged, distinguishable by differences in baseline steps/day: sedentary (19%), low active (40%), somewhat active (30%) and active (11%). All four demonstrated similar upward slopes. Three patterns emerged for the change in steps from baseline: gradual decrease (30%), gradual increase with late decline (56%), and rapid increase with midpoint decline (14%); thus 70% had an increase from baseline. T2DM (odd ratios [OR]: 3.7, 95% CI 1.7, 7.7) and age (OR per 10-year increment: 2, 95% CI 1.3, 2.8) were both associated with starting at a lower baseline but participants from these groups were no less likely than others to increase steps/day.
CONCLUSIONS


T2DM and older age were associated with lower baseline values but were not indicators of likelihood of step count increases. A physician-delivered step count prescription and monitoring strategy has strong potential to be effective in increasing steps irrespective of baseline counts and other clinical and demographic characteristics.",2020,A physician-delivered step count prescription and monitoring strategy has strong potential to be effective in increasing steps irrespective of baseline counts and other clinical and demographic characteristics.,['adults with type 2 diabetes mellitus (T2DM) and/or hypertension'],[],['T2DM (odd ratios '],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",[],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",118.0,0.107369,A physician-delivered step count prescription and monitoring strategy has strong potential to be effective in increasing steps irrespective of baseline counts and other clinical and demographic characteristics.,"[{'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Cooke', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, McGill University Health Centre, McGill University, Canada.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rahme', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Alvin Kuate', 'Initials': 'AK', 'LastName': 'Defo', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, McGill University Health Centre, McGill University, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stella S', 'Initials': 'SS', 'LastName': 'Daskalopoulou', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, McGill University Health Centre, McGill University, Canada; Division of Internal Medicine, Department of Medicine, McGill University Health Centre, McGill University, Canada.'}, {'ForeName': 'Kaberi', 'Initials': 'K', 'LastName': 'Dasgupta', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada; Division of Internal Medicine, Department of Medicine, McGill University Health Centre, McGill University, Canada. Electronic address: kaberi.dasgupta@mcgill.ca.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.04.010']
1318,32086352,"Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study.","OBJECTIVES


We investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST).
DESIGN AND SETTING


This study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ 2  tests (categorical variables) and t-tests (continuous variables).
PRIMARY OUTCOME MEASURE


Primary outcome was psychosocial status.
PARTICIPANTS


All control persons participating in the third screening round in the DLCST were included.
RESULTS


Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales: 'behaviour' 0.77 (99% CI 0.18 to 1.36), 'self-blame' 0.59 (99% CI 0.14 to 1.04), 'focus on airway symptoms' 0.22 (99% CI 0.08 to 0.36), 'stigmatisation' 0.51 (99% CI 0.16 to 0.86), 'introvert' 0.56 (99% CI 0.23 to 0.89) and 'harms of smoking' 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline.
CONCLUSIONS


Non-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov Protocol Registration System (NCT00496977).",2020,Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales:,['All control persons participating in the third screening round in the DLCST were included'],[],"['Did psychosocial status, sociodemographics and smoking status affect non-attendance', 'psychosocial status', 'sociodemographics and smoking status']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0337459', 'cui_str': 'Psychosocial status'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0642868,Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales:,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Thorsen', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Heleno', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-030871']
1319,31954775,A role for early oral exposure to house dust mite allergens through breast milk in IgE-mediated food allergy susceptibility.,"BACKGROUND


Successful prevention of food allergy requires the identification of the factors adversely affecting the capacity to develop oral tolerance to food antigen in early life.
OBJECTIVES


This study sought to determine whether oral exposure to Dermatophagoides pteronyssinus through breast milk affects gut mucosal immunity with long-term effects on IgE-mediated food allergy susceptibility.
METHODS


Gut immunity was explored in 2-week-old mice breast-fed by mothers exposed to D pteronyssinus, protease-inactivated D pteronyssinus, or to PBS during lactation. We further analyzed oral tolerance to a bystander food allergen, ovalbumin (OVA). In a proof-of-concept study, Der p 1 and OVA levels were determined in 100 human breast milk samples and the association with prevalence of IgE-mediated egg allergy at 1 year was assessed.
RESULTS


Increased permeability, IL-33 levels, type 2 innate lymphoid cell activation, and T h 2 cell differentiation were found in gut mucosa of mice nursed by mothers exposed to D pteronyssinus compared with PBS. This pro-T h 2 gut mucosal environment inhibited the induction of antigen-specific FoxP3 regulatory T cells and the prevention of food allergy by OVA exposure through breast milk. In contrast, protease-inactivated D pteronyssinus had no effect on offspring gut mucosal immunity. Based on the presence of Der p 1 and/or OVA in human breast milk, we identified groups of lactating mothers, which mirror the ones found in mice to be responsible for different egg allergy risk.
CONCLUSIONS


This study highlights an unpredicted potential risk factor for the development of food allergy, that is, D pteronyssinus allergens in breast milk, which disrupt gut immune homeostasis and prevents oral tolerance induction to bystander food antigen through their protease activity.",2020,"RESULTS


Increased permeability, IL-33 levels, type 2 innate lymphoid cell activation, and T h 2 cell differentiation were found in gut mucosa of mice nursed by mothers exposed to D pteronyssinus compared with PBS.","['2-week-old mice breast-fed by mothers exposed to', 'early oral exposure to house dust mite allergens through breast milk in IgE-mediated food allergy susceptibility']","['D pteronyssinus, protease-inactivated D pteronyssinus, or to PBS during lactation', 'Dermatophagoides pteronyssinus']","['OVA levels', 'permeability, IL-33 levels, type 2 innate lymphoid cell activation, and T h 2 cell differentiation', 'gut mucosal immunity']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0057489', 'cui_str': 'Allergens, House Dust Mites'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C1122992', 'cui_str': 'Dermatophagoides pteronyssimus'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}]","[{'cui': 'C0029923', 'cui_str': 'Ovalbumin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1667752', 'cui_str': 'IL33 protein, human'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086574', 'cui_str': 'Lymphoid Cells'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}]",100.0,0.029553,"RESULTS


Increased permeability, IL-33 levels, type 2 innate lymphoid cell activation, and T h 2 cell differentiation were found in gut mucosa of mice nursed by mothers exposed to D pteronyssinus compared with PBS.","[{'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Rekima', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Bonnart', 'Affiliation': 'Institut National de la Santé et de la Recherche Médicale, U1220, Toulouse, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Macchiaverni', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Metcalfe', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Meri K', 'Initials': 'MK', 'LastName': 'Tulic', 'Affiliation': 'EA6302 Immune Tolerance, Université de Nice Sophia-Antipolis, Nice, France; Institut National de la Santé et de la Recherche Médicale, U1065, Mediterranean Centre for Molecular Medicine, Team 12, Nice, France; inVIVO Global Network, Research Group of the Worldwide Universities Network, West New York, NJ.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Halloin', 'Affiliation': 'EA6302 Immune Tolerance, Université de Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Samah', 'Initials': 'S', 'LastName': 'Rekima', 'Affiliation': ""Institut Biologie Valrose, Université Côte d'Azur, Institut National de la Santé et de la Recherche Medicale, Centre National de la Recherche Scientifique, Nice, France.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Genuneit', 'Affiliation': 'inVIVO Global Network, Research Group of the Worldwide Universities Network, West New York, NJ; Pediatric Epidemiology, Department of Pediatrics, University of Leipzig Medical Center, Leipzig, Germany.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Zanelli', 'Affiliation': 'EA6302 Immune Tolerance, Université de Nice Sophia-Antipolis, Nice, France.'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Medeiros', 'Affiliation': 'EA6302 Immune Tolerance, Université de Nice Sophia-Antipolis, Nice, France; Departamento de Bioquímica e Imunologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Palmer', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia; inVIVO Global Network, Research Group of the Worldwide Universities Network, West New York, NJ.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Prescott', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Perth, Australia; inVIVO Global Network, Research Group of the Worldwide Universities Network, West New York, NJ; Perth Childrens Hospital, Perth, Australia; School of Medicine, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Verhasselt', 'Affiliation': 'School of Molecular Sciences, University of Western Australia, Perth, Australia; inVIVO Global Network, Research Group of the Worldwide Universities Network, West New York, NJ. Electronic address: valerie.verhasselt@uwa.edu.au.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.12.912']
1320,33482134,An Exploratory Analysis of Tamsulosin for Overactive Bladder (OAB) in Men With Varying Voiding Symptom Burden.,"OBJECTIVE


To evaluate tamsulosin (α-blocker therapy) for male overactive bladder (OAB) and to examine if indicators of concomitant benign prostatic hyperplasia are associated with OAB symptom improvement.
MATERIALS AND METHODS


This was a planned, exploratory analysis of a 4-week, α-blocker (tamsulosin 0.4 mg) run-in phase of the Male Overactive Bladder Trial in Veterans (MOTIVE). Participants with urinary urgency and urinary frequency (> 8 voids/24 hours) completed bladder diaries, answered symptom questionnaires (AUA-7 SI), and had post-void residual and noninvasive uroflowmetry measurement.
RESULTS


A total of 116 male Veterans aged 42-88 years with OAB participated. There were statistically significant reductions in voiding frequency (11.3 > 10.0 voids/24 hours, P < .0001), urgency scores (mean 2.5-2.2 points, P < .0001), and nightly nocturia (2.1 > 1.8, P < .001). Only baseline AUA-7 SI total and voiding subscale categories (mild, moderate, severe) were associated with significant reduction in AUA-7 SI total score. For continuous variables, only AUA-7 SI baseline total score was associated with AUA-7 SI storage symptom changes. No other baseline measures were associated with changes in urgency, frequency, or nocturia.
CONCLUSION


Initiation of short course tamsulosin therapy in men was associated with statistical reduction in OAB symptoms. Baseline post-void residual, uroflow rate, and the voiding symptom subscore of the AUA-7 SI were not predictive of OAB symptom improvement with tamsulosin. These findings merits further exploration.",2021,"There were statistically significant reductions in voiding frequency (11.3 > 10.0 voids/24 hours, P < .0001), urgency scores (mean 2.5-2.2 points, P < .0001), and nightly nocturia (2.1 > 1.8, P < .001).","['male overactive bladder (OAB', '116 male Veterans aged 42-88 years with OAB participated', 'in phase of the Male Overactive Bladder Trial in Veterans (MOTIVE', 'Participants with urinary urgency and urinary frequency (> 8 voids/24 hours) completed', 'Men With Varying Voiding Symptom Burden']","['tamsulosin', 'tamsulosin (α-blocker therapy', 'α-blocker (tamsulosin 0.4 mg) run', 'Tamsulosin']","['bladder diaries, answered symptom questionnaires (AUA-7 SI), and had post-void residual and noninvasive uroflowmetry measurement', 'Overactive Bladder (OAB', 'OAB symptom improvement', 'AUA-7 SI baseline total score', 'AUA-7 SI storage symptom changes', 'voiding frequency', 'baseline AUA-7 SI total and voiding subscale categories (mild, moderate, severe', 'urgency, frequency, or nocturia', 'voiding symptom subscore of the AUA-7 SI', 'AUA-7 SI total score', 'nightly nocturia', 'urgency scores', 'OAB symptoms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}]",116.0,0.084533,"There were statistically significant reductions in voiding frequency (11.3 > 10.0 voids/24 hours, P < .0001), urgency scores (mean 2.5-2.2 points, P < .0001), and nightly nocturia (2.1 > 1.8, P < .001).","[{'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; Emory University, Atlanta, GA. Electronic address: tmjohns@emory.edu.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Hammontree', 'Affiliation': 'Urology Centers of Alabama, AL.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; Emory University, Atlanta, GA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Ouslander', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Miami, FL.'}, {'ForeName': 'Kerac', 'Initials': 'K', 'LastName': 'Falk', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'McGwin', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Birmingham/Atlanta Department of Veterans Affairs Geriatric Research, Education, and Clinical Center (GRECC), Birmingham, AL, and Decatur, GA; University of Alabama at Birmingham, Birmingham, AL.'}]",Urology,['10.1016/j.urology.2021.01.022']
1321,33587993,Understanding the Role of Knowledge in Advance Care Planning Engagement.,"CONTEXT


Advance care planning remains underutilized. A better understanding of the role of education in promoting engagement is needed.
OBJECTIVES


To examine advance care planning knowledge and its relationship to engagement in middle-aged and older adults.
METHODS


This cross-sectional study utilized baseline data from 921 participants age ≥55 years enrolled in the STAMP randomized controlled trial, including a knowledge scale consisting of seven questions regarding the purpose and mechanisms of advance care planning and measures of participation.
RESULTS


Only 11.9% of participants answered all 7 questions correctly, and 25.6% of participants answered ≤ 3 correctly (defined as ""low knowledge""). Low knowledge was independently associated with male gender (OR 2.1, 95% CI: 1.5, 3.0), non-white race (OR 1.5, 95% CI: 1.1, 2.2), older age (OR 2.2, 95% CI: 1.4, 3.4), lower income (OR 1.5, 95% CI: 1.1, 2.1), and lower education level (OR 2.9, 95% CI: 2.0, 4.1). Higher knowledge was independently associated with communicating with a loved one about quality versus quantity of life (OR 1.7, 95% CI: 1.2, 2.4) and with living will completion (OR 1.6, 95% CI: 1.0, 2.5), but not with healthcare agent assignment. Factors including race and education remained associated with engagement after accounting for knowledge.
CONCLUSION


Knowledge deficits regarding advance care planning are common and associated with the same sociodemographic factors linked to other healthcare disparities. While improving knowledge is an important component of intervention, it is unlikely sufficient in and of itself to increase engagement.",2021,"Low knowledge was independently associated with male gender (OR 2.1, 95% CI: 1.5, 3.0), non-white race (OR 1.5, 95% CI: 1.1, 2.2), older age (OR 2.2, 95% CI: 1.4, 3.4), lower income (OR 1.5, 95% CI: 1.1, 2.1), and lower education level (OR 2.9, 95% CI: 2.0, 4.1).","['middle-aged and older adults', '921 participants age ≥55 years enrolled in the']",['STAMP'],"['lower education level', 'Low knowledge']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",921.0,0.0577878,"Low knowledge was independently associated with male gender (OR 2.1, 95% CI: 1.5, 3.0), non-white race (OR 1.5, 95% CI: 1.1, 2.2), older age (OR 2.2, 95% CI: 1.4, 3.4), lower income (OR 1.5, 95% CI: 1.1, 2.1), and lower education level (OR 2.9, 95% CI: 2.0, 4.1).","[{'ForeName': 'Laura I', 'Initials': 'LI', 'LastName': 'van Dyck', 'Affiliation': 'Department of Medicine, School of Medicine, Yale University, New Haven, Connecticut, USA. Electronic address: laura.vandyck@yale.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Cancer Prevention Research Center, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island, USA; Psychology Department, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Redding', 'Affiliation': 'Cancer Prevention Research Center, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island, USA; Psychology Department, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Terri R', 'Initials': 'TR', 'LastName': 'Fried', 'Affiliation': 'Department of Medicine, School of Medicine, Yale University, New Haven, Connecticut, USA; Clinical Epidemiology Research Center, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.02.011']
1322,33587901,"Do blue-blocking lenses reduce eye strain from extended screen time? A double-masked, randomized controlled trial.","PURPOSE


To investigate if blue-blocking lenses are effective in reducing the ocular signs and symptoms of eye strain associated with computer use.
DESIGN


Double-masked, randomized controlled trial.
METHODS


120 symptomatic computer users were randomly assigned (1:1) into a 'positive' or 'negative' advocacy arm (i.e., a clinician either advocating, or not advocating, for the intervention via a pre-recorded video). Participants were further sub-randomized (1:1) to receive either clear (placebo) or blue-blocking spectacles. All participants were led to believe they had received an active intervention. Participants performed a two-hour computer task whilst wearing their assigned spectacle intervention. The pre-specified primary outcome measures were the mean change (post- minus pre-computer task) in eye strain symptom score and critical flicker-fusion frequency (CFF, an objective measure of eye strain). The study also investigated whether clinician advocacy of the intervention (in a positive or negative light) modulated clinical outcomes.
RESULTS


All participants completed the study. In the primary analysis, for CFF, no significant effect was found for advocacy type (positive or negative, p=0.164) and spectacle intervention type (blue-blocking or clear lens, p=0.304). Likewise, for eye strain symptom score, no differences were found for advocacy (p=0.410) or spectacle lens types (p=0.394). No adverse events were documented.
CONCLUSIONS


Blue-blocking lenses did not alter signs or symptoms of eye strain with computer use relative to standard clear lenses. Clinician advocacy type had no bearing on clinical outcomes.
ABBREVIATIONS AND ACRONYMS


CVS = computer vision syndrome; RCT = randomized controlled trial; CFF = critical flicker-fusion frequency; SD = standard deviation; IQR = inter quartile range; ANOVA = analysis of variance.",2021,"Likewise, for eye strain symptom score, no differences were found for advocacy (p=0.410) or spectacle lens types (p=0.394).",['120 symptomatic computer users'],"['blue-blocking lenses', 'clear (placebo) or blue-blocking spectacles', ""positive' or 'negative' advocacy arm (i.e., a clinician either advocating, or not advocating, for the intervention via a pre-recorded video"", 'Blue-blocking lenses']","['mean change (post- minus pre-computer task) in eye strain symptom score and critical flicker-fusion frequency (CFF, an objective measure of eye strain', 'eye strain symptom score', 'adverse events']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0150446', 'cui_str': 'Advocacy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016236', 'cui_str': 'Flicker Fusion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.467133,"Likewise, for eye strain symptom score, no differences were found for advocacy (p=0.410) or spectacle lens types (p=0.394).","[{'ForeName': 'Sumeer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia 3010.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Downie', 'Affiliation': 'Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia 3010.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Anderson', 'Affiliation': 'Department of Optometry and Vision Sciences, The University of Melbourne, Parkville, Victoria, Australia 3010. Electronic address: aaj@unimelb.edu.au.'}]",American journal of ophthalmology,['10.1016/j.ajo.2021.02.010']
1323,33587897,"QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial.","BACKGROUND


Bedaquiline and delamanid are the first drugs of new classes registered for tuberculosis treatment in 40 years. Each can prolong the QTc interval, with maximum effects occurring weeks after drug initiation. The cardiac safety and microbiological activity of these drugs when co-administered are not well-established. Our aim was to characterise the effects of bedaquiline, delamanid, or both on the QTc interval, longitudinally over 6 months of multidrug treatment, among patients with multidrug-resistant or rifampicin-resistant tuberculosis taking multidrug background therapy.
METHODS


ACTG A5343 is a phase 2, open-label, randomised, controlled trial in which adults with multidrug-resistant or rifampicin-resistant tuberculosis receiving multidrug background treatment were randomly assigned 1:1:1 by centrally, computer-generated randomisation, by means of permuted blocks to receive bedaquiline, delamanid, or both for 24 weeks. Participants were enrolled at TASK in Cape Town and the South African Tuberculosis Vaccine Initiative in Worcester, both in South Africa, and Hospital Maria Auxiliadora in Peru. Individuals with QTc greater than 450 ms were excluded. HIV-positive participants received dolutegravir-based antiretroviral therapy. Clofazimine was disallowed, and levofloxacin replaced moxifloxacin. ECG in triplicate and sputum cultures were done fortnightly. The primary endpoint was mean QTcF change from baseline (averaged over weeks 8-24); cumulative culture conversation at week 8-24 was an exploratory endpoint. Analyses included all participants who initiated study tuberculosis treatment (modified intention-to-treat population). This trial is registered with ClinicalTrials.gov, NCT02583048 and is ongoing.
FINDINGS


Between Aug 26, 2016 and July 13, 2018, of 174 screened, 84 participants (28 in each treatment group, and 31 in total with HIV) were enrolled. Two participants did not initiate study treatment (one in the delamanid group withdrew consent and one in the bedaquiline plus delamanid group) did not meet the eligibility criterion). Mean change in QTc from baseline was 12·3 ms (95% CI 7·8-16·7; bedaquiline), 8·6 ms (4·0-13·1; delamanid), and 20·7 ms (16·1-25·3) (bedaquiline plus delamanid). There were no grade 3 or 4 adverse QTc prolongation events and no deaths during study treatment. Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
INTERPRETATION


Combining bedaquiline and delamanid has a modest, no more than additive, effect on the QTc interval, and initial microbiology data are encouraging. This study provides supportive evidence for use of these agents together in patients with multidrug-resistant or rifampicin-resistant tuberculosis with normal baseline QTc values.
FUNDING


Division of AIDS, National Institutes of Health.",2021,"Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
","['patients with multidrug-resistant or rifampicin-resistant tuberculosis with normal baseline QTc values', 'Between Aug 26, 2016 and July 13, 2018, of 174 screened, 84 participants (28 in each treatment group, and 31 in total with HIV) were enrolled', 'participants who initiated study tuberculosis treatment (modified intention-to-treat population', 'adults with multidrug-resistant or rifampicin-resistant tuberculosis receiving multidrug background treatment', 'patients with multidrug-resistant or rifampicin-resistant tuberculosis taking multidrug background therapy', 'patients with rifampicin-resistant tuberculosis', 'Participants were enrolled at TASK in Cape Town and the South African Tuberculosis Vaccine Initiative in Worcester, both in South Africa, and Hospital Maria Auxiliadora in Peru', 'Individuals with QTc greater than 450 ms were excluded']","['dolutegravir-based antiretroviral therapy', 'Clofazimine', 'bedaquiline, delamanid, or both for 24 weeks', 'levofloxacin replaced moxifloxacin']","['mean QTcF change', 'cardiac safety and microbiological activity', 'Mean change in QTc', 'cumulative culture conversation', 'Cumulative culture conversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis vaccine'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C3489682', 'cui_str': 'delamanid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",84.0,0.331246,"Cumulative culture conversion by week 8 was 21 (88%) of 24 (95% CI 71-97; bedaquiline), 20 (83%) of 24 (65-95; delamanid), and 19 (95%) of 20 (79-100; bedaquiline plus delamanid) and was 92% (77-99) for bedaquiline, 91% (76-99), for delamanid, and 95% (79-100) for bedaquiline plus delamanid at 24 weeks.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Frontier Science Foundation, Brookline, MA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems, Silver Spring, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Shenje', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, Cape Town, South Africa; Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'De Los Rios', 'Affiliation': 'Asociación Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Comins', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Morganroth', 'Affiliation': 'ERT, Philadelphia, PA, USA.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa; Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Yoninah S', 'Initials': 'YS', 'LastName': 'Cramer', 'Affiliation': 'Frontier Science Foundation, Brookline, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Cape Town, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30770-2']
1324,33587893,"Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial.","BACKGROUND


Whether extended lymphadenectomy for right colon cancer leads to increased perioperative complications or improves survival is still controversial. This trial aimed to compare the efficacy and safety of complete mesocolic excision (CME) versus D2 dissection in laparoscopic right hemicolectomy for patients with right colon cancer. This article reports the early safety results from the trial.
METHODS


This randomised, controlled, phase 3, superiority, trial was done at 17 hospitals in nine provinces of China. Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the right third of the transverse colon, without evidence of distant metastases. Central randomisation was done by means of the Clinical Information Management-Central Randomisation System via block randomisation (block size of four). Patients were randomly assigned (1:1) to CME or D2 dissection during laparoscopic right colectomy. Central lymph nodes were dissected in the CME but not in the D2 procedure. Neither investigators nor patients were masked to their group assignment but the quality control committee were masked to group assignment. The primary endpoint was 3-year disease-free survival, but the data for this endpoint are not yet mature; thus, only the secondary outcomes-intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death from any cause within 30 days of surgery), and central lymph node metastasis rate in the CME group only-are reported in this Article. This early analysis of safety was preplanned. The outcomes were analysed according to a modified intention-to-treat principle (excluding patients who no longer met inclusion criteria after surgery or who did not have surgery). This study is registered with ClinicalTrials.gov, NCT02619942. Study recruitment is complete, and follow-up is ongoing.
FINDINGS


Between Jan 11, 2016, and Dec 26, 2019, 1072 patients were enrolled and randomly assigned. After exclusion of 77 patients, 995 patients were included in the modified intention-to-treat population (495 in the CME group and 500 in the D2 dissection group). The postoperative surgical complication rate was 20% (97 of 495 patients) in the CME group versus 22% (109 of 500 patients) in the D2 group (difference, -2·2% [95% CI -7·2 to 2·8]; p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group. Of the intraoperative complications, vascular injury was significantly more common in the CME group than in the D2 group (15 [3%] vs six [1%], difference, 1·8 [95% CI 0·04 to 3·6]; p=0·045). Metastases in the central lymph nodes were detected in 13 (3%) of 394 patients who underwent central lymph node biopsy in the CME group; no patient had isolated metastases to central lymph nodes.
INTERPRETATION


Although the CME procedure might increase the risk of intraoperative vascular injury, it generally seems to be safe and feasible for experienced surgeons.
FUNDING


The Capital Characteristic Clinical Project of Beijing and the Chinese Academy of Medical Sciences.",2021,"p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group.","['17 hospitals in nine provinces of China', '77 patients, 995 patients were included in the modified intention-to-treat population (495 in the CME group and 500 in the D2 dissection group', 'Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the right third of the transverse colon, without evidence of distant metastases', 'Between Jan 11, 2016, and Dec 26, 2019, 1072 patients were enrolled and randomly assigned', '394 patients who underwent central lymph node biopsy in the CME group; no patient had isolated metastases to central lymph nodes', 'patients undergoing laparoscopic colectomy for right colon cancer (RELARC', 'patients who no longer met inclusion criteria after surgery or who did not have surgery', 'patients with right colon cancer']","['CME or D2 dissection during laparoscopic right colectomy', 'CME', 'complete mesocolic excision (CME) versus D2 dissection', 'complete mesocolic excision versus D2 dissection']","['central lymph node metastasis rate', 'Clavien-Dindo grade III-IV complications', 'postoperative surgical complication rate', 'intraoperative complications, vascular injury', 'deaths', 'efficacy and safety', 'frequency of Clavien-Dindo grade I-II complications', '3-year disease-free survival', 'intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0227386', 'cui_str': 'Transverse colon structure'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0193842', 'cui_str': 'Biopsy of lymph node'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1072.0,0.36714,"p=0·39); the frequency of Clavien-Dindo grade I-II complications were similar between groups (91 [18%] vs 92 [18%], difference, -0·0% [95% CI -4·8 to 4·8]; p=1·0) but Clavien-Dindo grade III-IV complications were significantly less frequent in the CME group than in the D2 group (six [1%] vs 17 [3%], -2·2% [-4·1 to -0·3]; p=0·022); no deaths occurred in either group.","[{'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Surgery IV, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Chenghai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Surgery IV, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Junyang', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Guannan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Colorectal Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""Department of General Surgery, Chinese General Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fujian, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Aiwen', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Unit III & Ostomy Service, Gastrointestinal Cancer Centre, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Anlong', 'Initials': 'A', 'LastName': 'Zhu', 'Affiliation': 'Department of Colorectal Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yingjiang', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': ""Department of Gastroenterological Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kefeng', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Colorectal Surgery and Oncology, Key Laboratory of Cancer Prevention and Intervention (Ministry of Education), The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China; School of Basic Medicine, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongtao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Beijing Friendship Hospital, Capital Medical University and National Clinical Research Centre for Digestive Diseases, Beijing, China.'}, {'ForeName': 'Minhua', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of General Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Division of Colorectal Surgery, Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing, China. Electronic address: xiaoy@pumch.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30685-9']
1325,33587894,Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study.,"BACKGROUND


Melanoma lacks validated blood-based biomarkers for monitoring and predicting treatment efficacy. Cell-free circulating tumour DNA (ctDNA) is a promising biomarker; however, various detection methods have been used, and, to date, no large studies have examined the association between serial changes in ctDNA and survival after BRAF, MEK, or BRAF plus MEK inhibitor therapy. We aimed to evaluate whether baseline ctDNA concentrations and kinetics could predict survival outcomes.
METHODS


In this clinical validation study, we used analytically validated droplet digital PCR assays to measure BRAF V600 -mutant ctDNA in pretreatment and on-treatment plasma samples from patients aged 18 years or older enrolled in two clinical trials. COMBI-d (NCT01584648) was a double-blind, randomised phase 3 study of dabrafenib plus trametinib versus dabrafenib plus placebo in previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. COMBI-MB (NCT02039947) was an open-label, non-randomised, phase 2 study evaluating dabrafenib plus trametinib in patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases. Patients in cohort A of COMBI-MB had asymptomatic brain metastases, no previous local brain-directed therapy, and an ECOG performance status of 0 or 1. Biomarker analysis was a prespecified exploratory endpoint in both trials and performed in the intention-to-treat populations in COMBI-d and COMBI-MB. We investigated the association between mutant copy number (baseline or week 4 or zero conversion status) and efficacy endpoints (progression-free survival, overall survival, and best overall response). We used Cox models, Kaplan-Meier plots, and log-rank tests to explore the association of pretreatment ctDNA concentrations with progression-free survival and overall survival. The effect of additional prognostic variables such as lactate dehydrogenase was also investigated in addition to the mutant copy number.
FINDINGS


In COMBI-d, pretreatment plasma samples were available from 345 (82%) of 423 patients and on-treatment (week 4) plasma samples were available from 224 (53%) of 423 patients. In cohort A of COMBI-MB, pretreatment and on-treatment samples were available from 38 (50%) of 76 patients with intracranial and extracranial metastatic melanoma. ctDNA was detected in pretreatment samples from 320 (93%) of 345 patients (COMBI-d) and 34 (89%) of 38 patients (COMBI-MB). When assessed as a continuous variable, elevated baseline BRAF V600  mutation-positive ctDNA concentration was associated with worse overall survival outcome (hazard ratio [HR] 1·13 [95% CI 1·09-1·18], p<0·0001 by univariate analysis), independent of treatment group and baseline lactate dehydrogenase concentrations (1·08 [1·03-1·13], p=0·0020), in COMBI-d. A ctDNA cutoff point of 64 copies per mL of plasma stratified patients enrolled in COMBI-d as high risk or low risk with respect to survival outcomes (HR 1·74 [95% CI 1·37-2·21], p<0·0001 for progression-free survival; 2·23 [1·73-2·87], p<0·0001 for overall survival) and was validated in the COMBI-MB cohort (3·20 [1·39-7·34], p=0·0047 for progression-free survival; 2·94 [1·18-7·32], p=0·016 for overall survival). In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
INTERPRETATION


Pretreatment and on-treatment BRAF V600 -mutant ctDNA measurements could serve as independent, predictive biomarkers of clinical outcome with targeted therapy.
FUNDING


Novartis.",2021,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","['1·13', 'previously untreated patients with BRAF V600  mutation-positive unresectable or metastatic melanoma', 'patients with advanced melanoma treated with', '76 patients with intracranial and extracranial metastatic melanoma', 'patients aged 18 years or older enrolled in two clinical trials', 'Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', 'patients with BRAF V600  mutation-positive metastatic melanoma and brain metastases']","['dabrafenib or dabrafenib plus trametinib', 'dabrafenib plus trametinib versus dabrafenib plus placebo']","['extended progression-free and overall survival', 'survival outcomes', 'elevated lactate dehydrogenase concentrations', 'efficacy endpoints (progression-free survival, overall survival, and best overall response', 'ctDNA', 'overall survival outcome (hazard ratio [HR', 'overall survival', 'baseline lactate dehydrogenase concentrations']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}]","[{'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",423.0,0.610155,"In COMBI-d, undetectable ctDNA at week 4 was significantly associated with extended progression-free and overall survival, particularly in patients with elevated lactate dehydrogenase concentrations (HR 1·99 [95% CI 1·08-3·64], p=0·027 for progression-free survival; 2·38 [1·24-4·54], p=0·0089 for overall survival).
","[{'ForeName': 'Mahrukh M', 'Initials': 'MM', 'LastName': 'Syeda', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wiggins', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Broderick C', 'Initials': 'BC', 'LastName': 'Corless', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Dana-Farber Cancer Institute/Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'East and North NHS Trust, Northwood, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institute Gustave Roussy and Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Davies', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancer Department, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Squires', 'Affiliation': 'Novartis Institute for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Marker', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garrett', 'Affiliation': 'Novartis Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'NYU Langone Health, New York, NY, USA. Electronic address: david.polsky@nyulangone.org.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30726-9']
1326,33587856,Clinical relevance of massage therapy and abdominal hypopressive gymnastics on chronic nonspecific low back pain: a randomized controlled trial.,"PURPOSE


To determine the clinical relevance of the effects that Massage-Therapy (MT) and Abdominal-Hypopressive-Gymnastics (AHG) and the combination of both procedures have on the disability, pain intensity, quality of life, and lumbar mobility of patients with chronic nonspecific low back pain (CNSLBP).
METHODS


A randomized controlled-trial with parallel-groups, concealed allocation, assessor blinding, and intention-to-treat analysis was carried out. The sample included 60 adults with CNSLBP. The participants received MT ( n  = 20), AHG ( n  = 20), or MT + AHG ( n  = 20). Each group received 8 interventions.
RESULTS


The ODI change scores were significantly higher ( p  < 0.05) in the MT + AHG group than in the other two groups. Significant differences were found in the results of NRS, Schober's test, and SF-12 PCS ( p  < 0.05) in each group. There were significant differences ( p  < 0.05) between the values of SF-12 MCS in AHG and MT + AHG groups.
CONCLUSIONS


Massage Therapy and Abdominal Hypopressive Gymnastics reduce pain levels, increase the mobility of the lumbar spine, and improve disability and quality of life (PCS) in patients with CNSLBP in the short term. Likewise, AHG and MT + AHG improve quality of life (MCS). The combination of both therapies provides more benefits in terms of lumbar disability in patients with CNSLBP in the short term. This improvement is clinically relevant.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02721914).
IMPLICATIONS FOR REHABILITATION Massage Therapy (MT) and Abdominal Hypopressive Gymnastics (AHG), reduce pain, improve mobility and quality of life, and reduce disability in the short term. These results are clinically relevant. The combination of manual and active therapy (MT + AHG) seems to be more effective and produces clinically relevant changes.",2021,The combination of both therapies provides more benefits in terms of lumbar disability in patients with CNSLBP in the short term.,"['chronic nonspecific low back pain', 'patients with chronic nonspecific low back pain (CNSLBP', 'patients with CNSLBP in the short term', '60 adults with CNSLBP']","['Massage Therapy', 'Massage-Therapy (MT) and Abdominal-Hypopressive-Gymnastics (AHG', 'MT', 'massage therapy and abdominal hypopressive gymnastics', 'MT\u2009+\u2009AHG', 'manual and active therapy (MT\u2009+\u2009AHG']","['mobility of the lumbar spine, and improve disability and quality of life (PCS', ""NRS, Schober's test, and SF-12 PCS"", 'MT) and Abdominal Hypopressive Gymnastics (AHG), reduce pain, improve mobility and quality of life, and reduce disability', 'quality of life (MCS', 'ODI change scores', 'disability, pain intensity, quality of life, and lumbar mobility', 'lumbar disability', 'pain levels']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0430750', 'cui_str': 'Modified Schober test'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",60.0,0.1086,The combination of both therapies provides more benefits in terms of lumbar disability in patients with CNSLBP in the short term.,"[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Bellido-Fernández', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain.'}, {'ForeName': 'José-Jesús', 'Initials': 'JJ', 'LastName': 'Jiménez-Rejano', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Chillón-Martínez', 'Affiliation': 'Department of Health and Sports, Pablo de Olavide University, Seville, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Lorenzo-Muñoz', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rebollo-Salas', 'Affiliation': 'Department of Physiotherapy, University of Seville, Seville, Spain.'}]",Disability and rehabilitation,['10.1080/09638288.2021.1884903']
1327,33587831,Recitation of quran and music to reduce chemotherapy-induced anxiety among adult patients with cancer: A clinical trial.,"AIM


The aim of this study was to assess the effectiveness of listening to music or Quran in reducing cancer patients' anxiety before chemotherapy administration. Reducing anxiety in people with cancer, prior to chemotherapy administration, is a crucial goal in nursing care.
DESIGN


An experimental comparative study was conducted.
METHODS


A simple randomization sampling method was applied. Two hundred thirty-eight people with cancer who underwent chemotherapy were participated. They are assigned as Quran, music and control groups.
RESULTS


The overall score of Arabic State Anxiety Inventory in all groups revealed that there was a significant difference between pre-test and post-test among participants. Listening to Quran or music reduced the chemotherapy-induced anxiety. There was no difference between these two ways to reduce anxiety in people with cancer. Listening to Quran or music can be added in nursing care plans prior chemotherapy administrations to reduce cancer patients' anxiety.",2021,The overall score of Arabic State Anxiety Inventory in all groups revealed that there was a significant difference between pre-test and post-test among participants.,"['people with cancer', 'adult patients with cancer', 'Two hundred thirty-eight people with cancer who underwent chemotherapy were participated', ""cancer patients' anxiety"", ""cancer patients' anxiety before chemotherapy administration""]","['Listening to Quran or music', 'listening to music or Quran', 'Recitation of quran and music to reduce chemotherapy-induced anxiety']","['overall score of Arabic State Anxiety Inventory', 'anxiety', 'Reducing anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",238.0,0.0825134,The overall score of Arabic State Anxiety Inventory in all groups revealed that there was a significant difference between pre-test and post-test among participants.,"[{'ForeName': 'Mohammed Baqer Abbas', 'Initials': 'MBA', 'LastName': 'Al-Jubouri', 'Affiliation': 'University of Baghdad, College of Nursing, Baghdad, Iraq.'}, {'ForeName': 'Safad Riyadh', 'Initials': 'SR', 'LastName': 'Isam', 'Affiliation': 'University of Baghdad, College of Nursing, Baghdad, Iraq.'}, {'ForeName': 'Shaymaa Mohammed', 'Initials': 'SM', 'LastName': 'Hussein', 'Affiliation': 'University of Baghdad, College of Nursing, Baghdad, Iraq.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Machuca-Contreras', 'Affiliation': 'Universidad Autónoma de Chile, Chile, Chile.'}]",Nursing open,['10.1002/nop2.781']
1328,33587827,'It reshaped how I will do research': A qualitative exploration of team members' experiences with youth and family engagement in a randomized controlled trial.,"BACKGROUND


Engaging youth and family members as active partners in research and service design offers great promise in improving projects. In youth mental health, recent research has highlighted the value of youth and family engagement. However, research on the experience and impacts of engagement is sparse.
OBJECTIVE


This study explores the project team's experience of youth and family engagement in the design and development of the YouthCan IMPACT randomized controlled trial and clinical service pathway design.
DESIGN


Qualitative data collected using semi-structured interviews and a focus group as part of the YouthCan IMPACT clinical trial were analysed to understand the impacts of engagement. Twenty-eight team members were interviewed, including youth and family members. A qualitative content analysis was conducted, with a member checking process.
RESULTS


Team members reported facilitators, barriers and impacts of youth and family engagement. Facilitators included a safe environment and strong procedures conducive to inclusion in co-design. Barriers included logistical, structural and institutional constraints. Overall, team members found youth and family engagement to be valuable and to positively impact the research and service design process.
DISCUSSION AND CONCLUSIONS


Youth and family engagement played a critical role in research and clinical service pathway design. The team found that their involvement improved the quality of the research and service pathway through sustained and multifaceted engagement. Facilitators and barriers to engagement may serve to guide future engagement initiatives. Future research should evaluate the long-term impact of early engagement and further focus on family engagement.
PATIENT/PUBLIC CONTRIBUTION


Youth and family members were engaged in the data analysis and interpretation process.",2021,"Overall, team members found youth and family engagement to be valuable and to positively impact the research and service design process.
","['Twenty-eight team members were interviewed, including youth and family members']",[],"['facilitators, barriers and impacts of youth and family engagement']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]",[],"[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",28.0,0.069196,"Overall, team members found youth and family engagement to be valuable and to positively impact the research and service design process.
","[{'ForeName': 'Natasha Y', 'Initials': 'NY', 'LastName': 'Sheikhan', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Hawke', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Karleigh', 'Initials': 'K', 'LastName': 'Darnay', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Courey', 'Affiliation': 'Sashbear Foundation, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szatmari', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13206']
1329,33587781,Cluster randomized control trial of nursing home residents' oral hygiene following the Mouth Care Matters education program for certified nursing assistants.,"AIMS


The purpose of this study was to determine if the number of certified nursing assistants (CNAs) trained with the Mouth Care Matters (MCM) oral health educational program had an impact on nursing facility (NF) resident oral health.
MATERIALS AND METHODS


Three NFs participated in a cluster randomized control trial. In NF-A: all CNAs were offered the MCM program, NF-B: 3 CNAs were offered the MCM program, and NF-C: Control (no CNAs were offered the MCM program). Demographic information, systemic health data, and oral health data at baseline, 3-month, and 6-month intervals were collected and analyzed using Kruskal-Wallis, Wilcoxon signed-rank and Wilcoxon rank-sum tests. A total of 24 dentate residents participated in this study. Plaque control record scores for NF-A were significantly reduced compared to NF-B and NF-C (P < .001 and P = .002 respectively) and gingival bleeding index for NF-A were significantly reduced compared to NF-B and NF-C (P = .002 and P < .001 respectively).
CONCLUSION


Increasing the number of CNA's trained in the Mouth Care Matters educational program positively impacted NF residents' oral hygiene.",2021,"Plaque control record scores for NF-A were significantly reduced compared to NF-B and NF-C (P < .001 and P = .002 respectively) and gingival bleeding index for NF-A were significantly reduced compared to NF-B and NF-C (P = .002 and P < .001 respectively).
","['Three NFs participated in a cluster randomized control trial', ""nursing home residents' oral hygiene following the Mouth Care Matters education program for certified nursing assistants"", '24 dentate residents participated in this study']",['certified nursing assistants (CNAs) trained with the Mouth Care Matters (MCM) oral health educational program'],"['Demographic information, systemic health data, and oral health data', 'gingival bleeding index for NF-A']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028663', 'cui_str': 'Nursing aid'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",3.0,0.0346093,"Plaque control record scores for NF-A were significantly reduced compared to NF-B and NF-C (P < .001 and P = .002 respectively) and gingival bleeding index for NF-A were significantly reduced compared to NF-B and NF-C (P = .002 and P < .001 respectively).
","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Hartshorn', 'Affiliation': 'Preventive and Community Dentistry, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Cowen', 'Affiliation': 'Preventive and Community Dentistry, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Carissa L', 'Initials': 'CL', 'LastName': 'Comnick', 'Affiliation': 'Division of Biostatistics and Computational Biology, University of Iowa, Iowa City, Iowa.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12577']
1330,33587782,The effect of motor and cognitive placebos on the serial reaction time task.,"Motor learning is a key component of human motor functions. Repeated practice is essential to gain proficiency over time but may induce fatigue. The aim of this study was to determine whether motor performance and motor learning (as assessed with the serial reaction time task, SRTT) and perceived fatigability (as assessed with subjective scales) are improved after two types of placebo interventions (motor and cognitive). A total of 90 healthy volunteers performed the SRTT with the right hand in three sessions (baseline, training, final). Before the training and the final session, one group underwent a motor-related placebo intervention in which inert electrical stimulation (TENS) was applied over the hand and accompanied by verbal suggestion that it improves movement execution (placebo-TENS). The other group underwent a cognitive-related placebo intervention in which sham transcranial direct current stimulation (tDCS) was delivered to the supraorbital area and accompanied by verbal suggestion that it increases attention (placebo-tDCS). A control group performed the same task without receiving treatment. Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level. The same was observed in a subgroup tested 24 hours later. The placebo-tDCS group reported less perceived fatigability, both at the mental and physical level. These findings indicate that motor- and cognitive-related placebo effects differently shape motor performance and perceived fatigability on a repeated motor task.",2021,"Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level.",['90 healthy volunteers'],"['Motor learning', 'motor-related placebo intervention in which inert electrical stimulation (TENS) was applied over the hand and accompanied by verbal suggestion that it improves movement execution (placebo-TENS', 'placebo-tDCS', 'cognitive-related placebo intervention in which sham transcranial direct current stimulation (tDCS', 'motor and cognitive placebos']","['motor performance and motor learning', 'serial reaction time task', 'serial reaction time task, SRTT) and perceived fatigability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",90.0,0.108468,"Overall better performance on the SRTT (not ascribed to sequence-specific learning) was noted for the placebo-TENS group, which also reported less perceived fatigability at the physical level.","[{'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Villa-Sánchez', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Emadi Andani', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cesari', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Fiorio', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",The European journal of neuroscience,['10.1111/ejn.15148']
1331,33587726,Comparison of Arthroscopic Surgery Versus Open Surgical Repair of the Anterior Talofibular Ligament: A Retrospective Study of 80 Patients from a Single Center.,"BACKGROUND This retrospective study from a single center aimed to compare the safety and clinical outcomes of arthroscopic surgery vs open surgical repair of the anterior talofibular ligament (ATFL). MATERIAL AND METHODS We randomly divided 80 patients with ATFL injury divided into 2 groups: an open surgery group and an arthroscopic group. The operation time, intraoperative bleeding volume, and the postoperative recovery time of all patients were analyzed. The anterior displacement and talus tilt angle, the American Orthopedic Foot and Ankle Society Ankle-Hindfoot Score (AOFAS), the Jersey Shore Science Fair (JSSF) ankle-hindfoot scale score, and the Karlsson Ankle Functional Score (KAFS) were compared at 6 months, 1 year, and 2 years after surgery. We collected data on the incidence of postoperative complications during follow-up. All significant results were supported with a P value. RESULTS The operation time, intraoperative bleeding volume, and postoperative recovery time in the arthroscopic group were better than in the open group (P<0.05). The AOFAS, JSSF, and KAFS in the arthroscopic group were better than in the open group at 6 months after the operation (P<0.05). The AOFAS, JSSF, and KAFS scale scores were not significantly different between the 2 groups at 1 year and 2 years after the operation (P<0.05). CONCLUSIONS The findings from this retrospective study showed that the use of arthroscopic surgical repair of the ATFL is a safe minimally invasive technique with reduced blood loss and surgical duration and good clinical outcomes.",2021,"The AOFAS, JSSF, and KAFS scale scores were not significantly different between the 2 groups at 1 year and 2 years after the operation (P<0.05).","['80 patients with ATFL injury divided into 2 groups: an', '80 Patients from a Single Center']","['ATFL', 'arthroscopic surgery vs open surgical repair of the anterior talofibular ligament (ATFL', 'open surgery group and an arthroscopic group', 'Arthroscopic Surgery Versus Open Surgical Repair of the Anterior Talofibular Ligament']","['operation time, intraoperative bleeding volume, and postoperative recovery time', 'AOFAS, JSSF, and KAFS scale scores', 'anterior displacement and talus tilt angle, the American Orthopedic Foot and Ankle Society Ankle-Hindfoot Score (AOFAS), the Jersey Shore Science Fair (JSSF) ankle-hindfoot scale score, and the Karlsson Ankle Functional Score (KAFS', 'postoperative complications', 'operation time, intraoperative bleeding volume, and the postoperative recovery time', 'AOFAS, JSSF, and KAFS', 'blood loss and surgical duration and good clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225166', 'cui_str': 'Structure of anterior talofibular ligament'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0225166', 'cui_str': 'Structure of anterior talofibular ligament'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0454673', 'cui_str': 'Jersey'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0333043', 'cui_str': 'Anterior displacement'}, {'cui': 'C0039277', 'cui_str': 'Bone structure of talus'}, {'cui': 'C0454235', 'cui_str': 'Tilt angle'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.0253688,"The AOFAS, JSSF, and KAFS scale scores were not significantly different between the 2 groups at 1 year and 2 years after the operation (P<0.05).","[{'ForeName': 'Bo-Yuan', 'Initials': 'BY', 'LastName': 'Su', 'Affiliation': 'Department of Orthopedics, Dongguan Hospital of Traditional Chinese Medicine, Dongguan, Guangdong, China (mainland).'}, {'ForeName': 'Shu-Yun', 'Initials': 'SY', 'LastName': 'Yi', 'Affiliation': 'Department of Orthopedics, Zengcheng Branch of South Hospital of Southern Medical University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Peng', 'Affiliation': 'Clinical Medical College of Southwest Medical University, Luzhou, Sichuan, China (mainland).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Yi', 'Affiliation': 'Department of Orthopedics, Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan, China (mainland).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.928526']
1332,33587687,"A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine.","BACKGROUND


Zika virus (ZIKV) may cause severe congenital disease after maternal-fetal transmission. No vaccine is currently available.
OBJECTIVE


To assess the safety and immunogenicity of Ad26.ZIKV.001, a prophylactic ZIKV vaccine candidate.
DESIGN


Phase 1 randomized, double-blind, placebo-controlled clinical study. (ClinicalTrials.gov: NCT03356561).
SETTING


United States.
PARTICIPANTS


100 healthy adult volunteers.
INTERVENTION


Ad26.ZIKV.001, an adenovirus serotype 26 vector encoding ZIKV M-Env, administered in 1- or 2-dose regimens of 5 × 10 10  or 1 × 10 11  viral particles (vp), or placebo.
MEASUREMENTS


Local and systemic adverse events; neutralization titers by microneutralization assay (MN50) and T-cell responses by interferon-γ enzyme-linked immunospot and intracellular cytokine staining; and protectivity of vaccine-induced antibodies in a subset of participants through transfer in an exploratory mouse ZIKV challenge model.
RESULTS


All regimens were well tolerated, with no safety concerns identified. In both 2-dose regimens, ZIKV neutralizing titers peaked 14 days after the second vaccination, with geometric mean MN50 titers (GMTs) of 1065.6 (95% CI, 494.9 to 2294.5) for 5 × 10 10  vp and 956.6 (595.8 to 1535.8) for 1 × 10 11  vp. Titers persisted for at least 1 year at a GMT of 68.7 (CI, 26.4-178.9) for 5 × 10 10  vp and 87.0 (CI, 29.3 to 258.6) for 1 × 10 11  vp. A 1-dose regimen of 1 × 10 11  vp Ad26.ZIKV.001 induced seroconversion in all participants 56 days after the first vaccination (GMT, 103.4 [CI, 52.7 to 202.9]), with titers persisting for at least 1 year (GMT, 90.2 [CI, 38.4 to 212.2]). Env-specific cellular responses were induced. Protection against ZIKV challenge was observed after antibody transfer from participants into mice, and MN50 titers correlated with protection in this model.
LIMITATION


The study was conducted in a nonendemic area, so it did not assess safety and immunogenicity in a flavivirus-exposed population.
CONCLUSION


The safety and immunogenicity profile makes Ad26.ZIKV.001 a promising candidate for further development if the need reemerges.
PRIMARY FUNDING SOURCE


Janssen Vaccines and Infectious Diseases.",2021,"Titers persisted for at least 1 year at a GMT of 68.7 (CI, 26.4-178.9) for 5 × 10 10  vp and 87.0 (CI, 29.3 to 258.6) for 1 × 10 11  vp.","['United States', '100 healthy adult volunteers', 'participants through transfer in an exploratory mouse ZIKV challenge model']","['Placebo', 'placebo.\nMEASUREMENTS', 'microneutralization assay (MN50) and T-cell responses by interferon-γ enzyme-linked immunospot and intracellular cytokine staining', 'placebo']","['seroconversion', 'safety and immunogenicity', 'ZIKV neutralizing titers']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",100.0,0.415103,"Titers persisted for at least 1 year at a GMT of 68.7 (CI, 26.4-178.9) for 5 × 10 10  vp and 87.0 (CI, 29.3 to 258.6) for 1 × 10 11  vp.","[{'ForeName': 'Nadine C', 'Initials': 'NC', 'LastName': 'Salisch', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Janssen Research and Development, Spring House, Pennsylvania (K.W.).'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Cox', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'van der Fits', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heerwegh', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium (D.H., C.T.).'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium (D.H., C.T.).'}, {'ForeName': 'Marrit N', 'Initials': 'MN', 'LastName': 'Habets', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Larocca', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Abbink', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fierro', 'Affiliation': 'Johnson County Clin-Trials, Lenexa, Kansas (C.F.).'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'and Walter Reed Army Institute of Research, Silver Spring, Maryland (R.A.D., K.M.).'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'and Walter Reed Army Institute of Research, Silver Spring, Maryland (R.A.D., K.M.).'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Conor P', 'Initials': 'CP', 'LastName': 'Cahill', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Leyssen', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'van Hoof', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines and Prevention, Leiden, the Netherlands (N.C.S., F.C., L.V., M.N.H., R.C.Z., J.H., C.P.C., M.L., M.D., J.V., H.S.).'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts (K.E.S., D.G.K., R.A.L., P.A., J.L., L.P., D.H.B.).'}]",Annals of internal medicine,['10.7326/M20-5306']
1333,33587674,"Preoperative Management of MGD with Vectored Thermal Pulsation before Cataract Surgery: A Prospective, Controlled Clinical Trial.","Purpose : To investigate the efficacy of preoperative monocular treatment in elderly cataract patients with Meibomian Gland Dysfunction (MGD) utilizing vectored thermal pulsation treatment.  Materials and Methods : This study was a prospective, examiner-masked contralateral eye clinical trial. Patients previously diagnosed with MGD undergoing uncomplicated cataract surgery in two eyes were enrolled. The eye perceived by the patient to be more symptomatic of MGD received a 12 min vectored thermal pulsation treatment using the LipiFlow Thermal Pulsation System, and was referred to as the LipiFlow-surgery eye. The contralateral eye then served as the nonLipiFlow-surgery eye. Patients with MGD not undergoing cataract surgery were enrolled as the control group. Within the control group, the eye that received LipiFlow treatment was considered the LipiFlow-nonsurgery eye, while the contralateral eye served as the nonLipiFlow-nonsurgery eye. All patients were examined before treatment and at one-week, one-month, and three-month intervals after treatment. Clinical parameters included dry eye symptoms, average lipid layer thickness (LLT-ave), tear breakup time (TBUT), corneal staining, Schirmer I tests, Meibomian glands yielding liquid secretion (MGYLS), and meibomian gland dropout.  Results : A total of 32 patients (64 eyes) were examined during the three-month follow-up. There was a significant reduction in dry eye symptoms in non-surgery patients with monocular treatment of MGD, while no change in surgery patients was observed. Significant improvement of MGYLS in LipiFlow-surgery and LipiFlow-nonsurgery eyes during the follow-up time ( p  < .001) was reported, while no difference was observed in nonLipiFlow-surgery and nonLipiFlow-nonsurgery eyes. A statistically significant difference was seen in TBUT between LipiFlow-surgery and nonLipiFlow-surgery eyes at one-week and one-month intervals ( p  = .019 and 0.019, respectively). Differences in other clinical parameters were not statistically significant.  Conclusions : Our findings suggest that although subjective symptoms were not alleviated, a single application of LipiFlow treatment before cataract surgery is effective in alleviating blockage of meibomian glands and preventing the decline of TBUT after cataract surgery.",2021,"A statistically significant difference was seen in TBUT between LipiFlow-surgery and nonLipiFlow-surgery eyes at one-week and one-month intervals ( p  = .019 and 0.019, respectively).","['Patients previously diagnosed with MGD undergoing uncomplicated cataract surgery in two eyes were enrolled', 'Patients with MGD not undergoing cataract surgery', '32 patients (64 eyes', 'elderly cataract patients with Meibomian Gland Dysfunction (MGD) utilizing vectored thermal pulsation treatment']","['MGD with Vectored Thermal Pulsation before Cataract Surgery', 'LipiFlow treatment was considered the LipiFlow-nonsurgery eye, while the contralateral eye served as the nonLipiFlow-nonsurgery eye', 'preoperative monocular treatment', 'Materials and Methods ']","['dry eye symptoms, average lipid layer thickness (LLT-ave), tear breakup time (TBUT), corneal staining, Schirmer I tests, Meibomian glands yielding liquid secretion (MGYLS), and meibomian gland dropout', 'TBUT', 'dry eye symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",32.0,0.0171743,"A statistically significant difference was seen in TBUT between LipiFlow-surgery and nonLipiFlow-surgery eyes at one-week and one-month intervals ( p  = .019 and 0.019, respectively).","[{'ForeName': 'Yinying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Keyun', 'Initials': 'K', 'LastName': 'Xue', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Jialu', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Gongpei', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Gu', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}, {'ForeName': 'Yune', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University , Wenzhou, Zhejiang, China.'}]",Seminars in ophthalmology,['10.1080/08820538.2021.1881567']
1334,33587659,Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial.,"BACKGROUND


Female sex is an independent risk factor for stroke and systemic embolic events in patients with atrial fibrillation. This study aimed to examine the efficacy and safety profile of edoxaban in women versus men.
METHODS


The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) randomly assigned 21 105 patients (8040 women) with atrial fibrillation and CHADS 2  score ≥2 either to a higher-dose edoxaban regimen, a lower-dose edoxaban regimen, or warfarin. The primary end points of the trial were the composite of stroke or systemic embolic events (efficacy), and International Society on Thrombosis and Haemostasis-defined major bleeding (safety).
RESULTS


In comparison with men, women were older, had lower body weight, were more likely to have hypertension and renal dysfunction, but less likely to smoke, drink alcohol, or have diabetes or coronary artery disease. Pretreatment endogenous factor Xa activity was significantly higher in women than in men (92.5% versus 86.1%,  P <0.001). Treatment with edoxaban in women resulted in greater peak edoxaban concentration and inhibition of endogenous factor Xa in comparison with men, resulting in similar endogenous factor Xa activity between the sexes 2 to 4 hours after dose. Treatment with higher-dose edoxaban regimen (versus warfarin) resulted in similar reduction in the risk of stroke/systemic embolic events (women: hazard ratio [HR], 0.87 [0.69-1.11], men: HR, 0.87 [0.71-1.06];  P -interaction=0.97) and major bleeding (women: HR, 0.74 [0.59-0.92], men: HR, 0.84 [0.72-0.99];  P -interaction=0.34) in women and men. However, women assigned to higher-dose edoxaban regimen experienced greater reductions in hemorrhagic stroke (HR, 0.30 [95% CI, 0.15-0.59] versus HR, 0.70 [95% CI, 0.46-1.06]), intracranial bleeding (HR, 0.20 [95% CI, 0.10-0.39] versus HR, 0.63 [95% CI, 0.44-0.89]), and life-threatening or fatal bleeding (HR, 0.25 [95% CI, 0.15-0.42] versus HR, 0.72 [95% CI, 0.54-0.96]) than men (each  P -interaction<0.05).
CONCLUSIONS


Despite many differences in baseline characteristics between women and men and higher baseline endogenous factor Xa levels in women, the intensity of anticoagulation achieved with edoxaban between the sexes was similar. Treatment with higher-dose edoxaban regimen resulted in an even greater reduction in hemorrhagic stroke and several serious bleeding outcomes in women than in men, whereas the efficacy profile was similar between sexes.",2021,"Treatment with edoxaban in women resulted in greater peak edoxaban concentration and inhibition of endogenous factor Xa in comparison with men, resulting in similar endogenous factor Xa activity between the sexes 2 to 4 hours after dose.","['women versus men', 'patients with atrial fibrillation', 'Myocardial Infarction 48) randomly assigned 21\u2009105 patients (8040 women) with atrial fibrillation and CHADS 2  score ≥2 either to a higher-dose', '8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial']","['edoxaban regimen (versus warfarin', 'edoxaban', 'edoxaban regimen, a lower-dose edoxaban regimen, or warfarin', 'Edoxaban', 'Factor Xa Next Generation']","['efficacy profile', 'efficacy and safety profile', 'composite of stroke or systemic embolic events (efficacy), and International Society on Thrombosis and Haemostasis-defined major bleeding (safety', 'Xa activity', 'peak edoxaban concentration and inhibition of endogenous factor Xa', 'hypertension and renal dysfunction', 'hemorrhagic stroke', 'life-threatening or fatal bleeding', 'risk of stroke/systemic embolic events', 'intracranial bleeding', 'endogenous factor Xa activity', 'hemorrhagic stroke and several serious bleeding outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0007928', 'cui_str': 'Chad'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",21105.0,0.309706,"Treatment with edoxaban in women resulted in greater peak edoxaban concentration and inhibition of endogenous factor Xa in comparison with men, resulting in similar endogenous factor Xa activity between the sexes 2 to 4 hours after dose.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': 'Division of Cardiology, Medical University of Vienna, Austria (T.A.Z.).'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Ardissino', 'Affiliation': 'Department of Medicine, Imperial College, London, United Kingdom (M.A.).'}, {'ForeName': 'Felicita', 'Initials': 'F', 'LastName': 'Andreotti', 'Affiliation': 'Fondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy (F.A.).'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Ophelia', 'Initials': 'O', 'LastName': 'Yin', 'Affiliation': 'Daiichi Sankyo Inc, Basking Ridge, NJ (O.Y.).'}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany (H.J.L.).'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Piera Angelica', 'Initials': 'PA', 'LastName': 'Merlini', 'Affiliation': 'Department of Cardiology, Niguarda Hospital, Milan, Italy (P.A.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.052216']
1335,33587654,"Sex, Permanent Drug Discontinuation, and Study Retention in Clinical Trials: Insights From the TIMI trials.","BACKGROUND


Women are underrepresented across cardiovascular clinical trials. Whether women are more likely than men to prematurely discontinue study drug or withdraw consent once enrolled in a clinical trial is unknown.
METHODS


Eleven phase 3/4 TIMI (Thrombolysis in Myocardial Infarction) trials were included (135 879 men and 51 812 women [28%]). The association between sex and premature study drug discontinuation and withdrawal of consent were examined by multivariable logistic regression after adjusting for potential confounders in each individual trial and combining the individual point estimates in random effects models.
RESULTS


After adjusting for baseline differences, women had 22% higher odds of premature drug discontinuation (adjusted odds ratio [OR adj ], 1.22 [95% CI, 1.16-1.28];  P <0.001) compared with men. Qualitatively consistent results were observed for women versus men in the placebo arms (OR adj , 1.20 [95% CI, 1.13-1.27]) and active therapy arms (OR adj , 1.23 [95% CI, 1.17-1.30)]; there was some evidence for regional heterogeneity ( P  interaction <0.001). Of those who stopped study drug prematurely, a similar proportion of men and women in the active arm stopped because of an adverse event (36% for both;  P =0.60). Women were also more likely to withdraw consent compared with men (OR adj , 1.26 [95% CI, 1.17-1.36];  P <0.001).
CONCLUSIONS


Women were more likely than men to prematurely discontinue study drug and withdraw consent across cardiovascular outcome trials. Premature study drug discontinuation was not explained by baseline differences by sex or a higher proportion of adverse events. Future trials should better capture reasons for drug discontinuation and withdrawal of consent to understand barriers to continued study drug use and clinical trial participation, particularly among women.",2021,"Women were also more likely to withdraw consent compared with men (OR adj , 1.26 [95% CI, 1.17-1.36];  P <0.001).
","['135 879 men and 51 812 women [28', 'Eleven phase 3/4 TIMI (Thrombolysis in Myocardial Infarction']",['placebo'],"['adverse event', 'regional heterogeneity', 'premature drug discontinuation', 'withdraw consent']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",135879.0,0.261518,"Women were also more likely to withdraw consent compared with men (OR adj , 1.26 [95% CI, 1.17-1.36];  P <0.001).
","[{'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lau', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, MA (E.S.L.).'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': ''}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (D.L.B., C.P.C.).""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Denver, CO (M.P.B.).'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (D.L.B., C.P.C.).""}, {'ForeName': 'KyungAh', 'Initials': 'K', 'LastName': 'Im', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (E.B., D.A.M., R.P.G., E.M.A., B.M.S., E.A.B., S.D.W., K.I., J.G., M.S.S., M.O.D.).""}]",Circulation,['10.1161/CIRCULATIONAHA.120.052339']
1336,33587552,Predicting Cardiorespiratory Fitness Using the 20-m Shuttle Run Test: New Insights Using Nonlinear Allometry.,"PURPOSE


Recently, doubts have been raised concerning the validity of the 20-m shuttle run test (20mSRT) to predict cardiorespiratory fitness (CRF) in youth. Despite these doubts, authors continue to provide powerful evidence that CRF can be predicted reliably using the 20mSRT albeit using contrasting models. Therefore, we aimed to compare a new linear model with an alternative allometric model to predict CRF (peak oxygen uptake, V˙O2peak) using 20mSRT.
METHODS


The study included 148 adolescents (43% girls), aged 13.37 ± 1.84 years. Adolescents were randomly assigned to validation (n = 91) and cross-validation (n = 57) groups. V˙O2peak was measured using a gas analyser in both maximal exercise tests in the laboratory as well as 20mSRT. Multiple linear regression methods were applied to develop the linear models using 20mSRT (laps), BMI and body fat percentage. Alternative allometric models were also proposed/fitted using 20mSRT (laps), height and body mass.
RESULTS


The criterion validity of both the linear and the allomeric models were found to be acceptable R2=82.5% and 82.7% respectively, providing reassuring evidence that the 20mSRT can be used with confidence to predict CRF. However, the allometric model identified a height-to-mass ratio, not dissimilar to the inverse BMI (known to be a measure of leanness), to be associated with CRF. The allometric model also revealed that the rise in energy cost (V˙O2peak) with increasing laps was exponential. This will more accurately reflect the non-linear rise in energy demand of shuttle running as the test progresses to exhaustion.
CONCLUSIONS


These observations provided powerful evidence that allometric models are more than satisfactory in terms of both criterion AND construct validity when predicting CRF (V˙O2peak) using the 20mSRT.",2021,"Despite these doubts, authors continue to provide powerful evidence that CRF can be predicted reliably using the 20mSRT albeit using contrasting models.","['Adolescents', '148 adolescents (43% girls), aged 13.37 ± 1.84 years']",[],"['V˙O2peak', 'energy cost (V˙O2peak']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}]",148.0,0.0166482,"Despite these doubts, authors continue to provide powerful evidence that CRF can be predicted reliably using the 20mSRT albeit using contrasting models.","[{'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Nevill', 'Affiliation': 'Faculty of Education, Health and Wellbeing, University of Wolverhampton, Walsall Campus, Walsall, United Kingdom Department of Physical Education, Federal University of Paraná, Curitiba, Brazil Department of Centro de Investigação em Actividade Fìsica, Saúde e Lazer (CIAFEL), University of Porto, Porto, Portugal.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'de Menezes-Junior', 'Affiliation': ''}, {'ForeName': 'Íncare Correa', 'Initials': 'ÍC', 'LastName': 'de Jesus', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Fatima Aguiar Lopes', 'Affiliation': ''}, {'ForeName': 'Patricia Ribeiro Paes', 'Initials': 'PRP', 'LastName': 'Corazza', 'Affiliation': ''}, {'ForeName': 'Maiara Cristina', 'Initials': 'MC', 'LastName': 'Tadiotto', 'Affiliation': ''}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Mota', 'Affiliation': ''}, {'ForeName': 'Neiva', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002637']
1337,33587549,Continuous versus Intermittent Dieting for Fat Loss and Fat-free Mass Retention in Resistance-trained Adults: The ICECAP Trial.,"INTRODUCTION


Can intermittent energy restriction (IER) improve fat loss and fat-free mass retention compared with continuous energy restriction (CER) in resistance-trained adults?
METHODS


Sixty-one adults (32 women) with mean (SD) age 28.7 (6.5) years, body weight 77.2 (16.1) kg and body fat 25.5 (6.1)% were randomized to 12 weeks of (1) 4 x 3-weeks of moderate (m) energy restriction interspersed with 3 x 1-weeks of energy balance (mIER; n=30; 15 weeks total), or (2) 12 weeks of continuous moderate energy restriction (mCER; n=31). Analyses of all outcome measures were by intention-to-treat.
RESULTS


After accounting for baseline differences, mIER did not result in lower fat mass or body weight, or greater fat-free mass, compared to mCER after energy restriction. Mean (and 97.5% confidence interval, CI) for fat mass at the end of mIER versus mCER was 15.3 (12.5 to 18.0) kg versus 18.0 (14.3 to 21.7) kg (P=0.321), for fat-free mass was 56.7 (51.5 to 61.9) kg versus 56.7 (51.4 to 62.0) kg (P=0.309), and for body weight (with 95% CI) was 72.1 (66.4 to 77.9) versus 74.6 (69.3 to 80.0) (P=0.283). There were no differences between interventions in muscle strength or endurance or in resting energy expenditure, leptin, testosterone, insulin like growth factor-1, free 3,3',5-triiodothyronine or active ghrelin, nor in sleep, muscle dysmorphia or eating disorder behaviours. However, participants in mIER exhibited lower hunger (P=0.002) and desire to eat (P=0.014) compared to those in mCER, and greater satisfaction (P=0.016) and peptide YY (P=0.034).
CONCLUSIONS


Similar fat loss and fat-free mass retention are achieved with mIER and mCER during 12 weeks of energy restriction; however, mIER is associated with reduced appetite.
TRIAL REGISTRATION


ACTRN12618000638235p.",2021,"There were no differences between interventions in muscle strength or endurance or in resting energy expenditure, leptin, testosterone, insulin like growth factor-1, free 3,3',5-triiodothyronine or active ghrelin, nor in sleep, muscle dysmorphia or eating disorder behaviours.","['Resistance-trained Adults', 'Sixty-one adults (32 women) with mean (SD) age 28.7 (6.5) years, body weight 77.2 (16.1) kg and body fat 25.5 (6.1']","['Can intermittent energy restriction (IER', 'Continuous versus Intermittent Dieting for Fat Loss and Fat-free Mass Retention', 'moderate (m) energy restriction interspersed with 3 x 1-weeks of energy balance', 'continuous energy restriction (CER']","['intention-to-treat', 'lower fat mass or body weight, or greater fat-free mass', 'desire to eat', 'body weight', 'Similar fat loss and fat-free mass retention', ""muscle strength or endurance or in resting energy expenditure, leptin, testosterone, insulin like growth factor-1, free 3,3',5-triiodothyronine or active ghrelin, nor in sleep, muscle dysmorphia or eating disorder behaviours"", 'lower hunger', 'greater satisfaction', 'fat-free mass']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517663', 'cui_str': '25.5'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1737329', 'cui_str': 'Dysmorphism'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",61.0,0.151607,"There were no differences between interventions in muscle strength or endurance or in resting energy expenditure, leptin, testosterone, insulin like growth factor-1, free 3,3',5-triiodothyronine or active ghrelin, nor in sleep, muscle dysmorphia or eating disorder behaviours.","[{'ForeName': 'Jackson J', 'Initials': 'JJ', 'LastName': 'Peos', 'Affiliation': 'School of Human Sciences (Exercise and Sports Science), Faculty of Science, The University of Western Australia, Crawley, Western Australia, Australia Auckland University of Technology, Sports Performance Institute New Zealand (SPRINZ), Auckland, New Zealand Weightology LLC, Issaquah, WA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Helms', 'Affiliation': ''}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Fournier', 'Affiliation': ''}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Ong', 'Affiliation': ''}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Krieger', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002636']
1338,33587510,A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa: baseline findings.,"BACKGROUND


HIV Vaccine Trials Network (HVTN) 703/HIV Prevention Trials Network (HPTN) 081 is a phase 2b randomized, double-blind placebo-controlled trial to assess the safety and efficacy of passively infused monoclonal antibody (mAb) VRC01 in preventing HIV acquisition in heterosexual women between the ages of 18 and 50 at risk of HIV. Participants were enrolled at 20 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe. It is one of two Antibody Mediated Prevention (AMP) efficacy trials, with HVTN 704/HPTN 085, evaluating VRC01 for HIV prevention.
METHODS


Intense community engagement was utilized to optimize participant recruitment and retention. Participants were randomly assigned to receive intravenous (IV) VRC01 10 mg/kg, VRC01 30 mg/kg, or placebo in a 1:1:1 ratio. Infusions were given every eight weeks with a total of 10 infusions and 104 weeks of follow-up after the first infusion.
RESULTS


Between May 2016 and September 2018, 1924 women from sub-Saharan Africa were enrolled. The median age was 26 (IQR: 22-30) and 98.9% were Black. Sexually transmitted infection prevalence at enrollment included chlamydia (16.9%), trichomonas (7.2%), gonorrhea (5.7%) and syphilis (2.2%). External condoms (83.2%) and injectable contraceptives (61.1%) were the methods of contraception most frequently used by participants. In total, through April 3, 2020, 38,490 clinic visits were completed with a retention rate of 96% and 16,807 infusions administered with an adherence rate of 98%.
CONCLUSIONS


This proof-of-concept, large-scale mAb study demonstrates the feasibility of conducting complex trials involving IV infusions in high-incidence populations in sub-Saharan Africa.",2021,"Sexually transmitted infection prevalence at enrollment included chlamydia (16.9%), trichomonas (7.2%), gonorrhea (5.7%) and syphilis (2.2%).","['women in sub-Saharan Africa', 'Between May 2016 and September 2018, 1924 women from sub-Saharan Africa were enrolled', 'Participants were enrolled at 20 sites in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe', 'high-incidence populations in sub-Saharan Africa', 'heterosexual women between the ages of 18 and 50 at risk of HIV']","['placebo', 'VRC01', 'injectable contraceptives', 'intravenous (IV) VRC01 10 mg/kg, VRC01 30 mg/kg, or placebo', 'passively infused monoclonal antibody (mAb) VRC01']","['HIV acquisition', 'safety and efficacy', 'acquisition of HIV-1 infection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]",1924.0,0.506411,"Sexually transmitted infection prevalence at enrollment included chlamydia (16.9%), trichomonas (7.2%), gonorrhea (5.7%) and syphilis (2.2%).","[{'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, Georgia, United States of America Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, North Carolina, USA Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa. Botswana Harvard AIDS Institute, Gaborone, Botswana Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, Boston, USA Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Takuva', 'Affiliation': ''}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Karuna', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': ''}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Lazarus', 'Affiliation': ''}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Garnett', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shava', 'Affiliation': ''}, {'ForeName': 'Pamela G', 'Initials': 'PG', 'LastName': 'Mukwekwerere', 'Affiliation': ''}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rudnicki', 'Affiliation': ''}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juraska', 'Affiliation': ''}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Karg', 'Affiliation': ''}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Tindale', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Nandisile', 'Initials': 'N', 'LastName': 'Luthuli', 'Affiliation': ''}, {'ForeName': 'Kagisho', 'Initials': 'K', 'LastName': 'Baepanye', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': ''}, {'ForeName': 'Margarita M', 'Initials': 'MM', 'LastName': 'Gomez Lorenzo', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ledgerwood', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': ''}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002649']
1339,33587505,"Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.","BACKGROUND


The Antibody Mediated Prevention (AMP) trials (HVTN 704/HPTN 085 & HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody (mAb) targeting the CD4 binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2,701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland and the United States.
METHODS


Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of ten infusions. Participants were followed for 104 weeks after first infusion.
RESULTS


The median HVTN 704/HPTN 085 participant age was 28; 99% were assigned male sex; 90% identified as cisgender male, 5% as TG female and the remaining as other genders. Thirty-two percent were White, 15% Black and 57% Hispanic/Latinx. Twenty-eight percent had a sexually transmitted infection at enrollment. Over 23,000 infusions were administered with no serious IV administration complications. Overall retention and adherence to the study schedule exceeded 90%, and the drop-out rate was below 10% annually (7.3 per 100-person years) through Week 80, the last visit for the primary endpoint.
CONCLUSIONS


HVTN 704/HPTN 085 exceeded accrual and retention expectations. With exceptional safety of IV administration and operational feasibility, it paves the way for future large-scale mAb trials for HIV prevention and/or treatment.",2021,"Overall retention and adherence to the study schedule exceeded 90%, and the drop-out rate was below 10% annually (7.3 per 100-person years) through Week 80, the last visit for the primary endpoint.
","['The median HVTN 704/HPTN 085 participant age was 28; 99% were assigned male sex; 90% identified as cisgender male, 5% as TG female and the remaining as other genders', 'Twenty-eight percent had a sexually transmitted infection at enrollment', 'Participants were recruited and retained through early, extensive community engagement', 'Thirty-two percent were White, 15% Black and 57', 'HVTN 704/HPTN 085 enrolled 2,701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland and the United States', 'Eligible participants']","['HVTN', 'VRC01 or saline placebo']",['Overall retention and adherence'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2701.0,0.166727,"Overall retention and adherence to the study schedule exceeded 90%, and the drop-out rate was below 10% annually (7.3 per 100-person years) through Week 80, the last visit for the primary endpoint.
","[{'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, Georgia, United States of America University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill, North Carolina, USA Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos, Lima, Peru Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo, Lima University of Pennsylvania, Pennsylvania, PA Columbia University, New York, NY Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA Department of Biostatistics, Univeristy of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nyaradzo', 'Initials': 'N', 'LastName': 'Mgodi', 'Affiliation': ''}, {'ForeName': 'Shelly T', 'Initials': 'ST', 'LastName': 'Karuna', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rudnicki', 'Affiliation': ''}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': ''}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'deCamp', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'De La Grecca', 'Affiliation': ''}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Carissa', 'Initials': 'C', 'LastName': 'Karg', 'Affiliation': ''}, {'ForeName': 'India', 'Initials': 'I', 'LastName': 'Tindale', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Gail B', 'Initials': 'GB', 'LastName': 'Broder', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': ''}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Gallardo-Cartagena', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sobieszczyk', 'Affiliation': ''}, {'ForeName': 'Margarita M', 'Initials': 'MM', 'LastName': 'Gomez Lorenzo', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Maurine D', 'Initials': 'MD', 'LastName': 'Miner', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ledgerwood', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': ''}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': ''}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002639']
1340,33587490,Correction to: Cap-Assisted Endoscopic Sclerotherapy vs Ligation in the Long-Term Management of Medium Esophageal Varices: A Randomized Trial.,,2021,,['Medium Esophageal Varices'],['Cap-Assisted Endoscopic Sclerotherapy vs Ligation'],[],"[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0014867', 'cui_str': 'Esophageal varices'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]",[],,0.146568,,"[{'ForeName': 'An-Jiang', 'Initials': 'AJ', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xue-Lian', 'Initials': 'XL', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Jun-Bo', 'Initials': 'JB', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Jia-Wei', 'Initials': 'JW', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Hui-Qiang', 'Initials': 'HQ', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Hai-Ying', 'Initials': 'HY', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Gan', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Gui-Hai', 'Initials': 'GH', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Bu-Shan', 'Initials': 'BS', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Bi-Min', 'Initials': 'BM', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000318']
1341,33587443,"A randomized, placebo-controlled, double-blinded clinical trial of colchicine to improve vascular health in people living with HIV.","OBJECTIVES


People living with HIV (PLWH) experience an increased burden of coronary artery disease (CAD) believed to be related, in part, to an interplay of chronically increased inflammation and traditional risk factors. Recent trials suggest cardiovascular benefits of the anti-inflammatory, colchicine, in HIV-seronegative CAD patients. However, the impact of colchicine on impaired vascular health, as measured by coronary endothelial function (CEF), an independent contributor to CAD, has not been studied in PLWH. We tested the hypothesis that colchicine improves vascular health in PLWH.
DESIGN


This was a randomized, placebo-controlled, double-blinded trial in 81 PLWH to test whether low-dose colchicine (0.6 mg daily) improves CEF over eight- to twenty four-weeks.
METHODS


Coronary and systemic endothelial function and serum inflammatory markers were measured at baseline, and at 8 and 24 weeks. The primary endpoint was CEF, measured as the change in coronary blood flow from rest to that during isometric handgrip exercise, an endothelial-dependent stressor, measured with noninvasive MRI at 8 weeks.
RESULTS


Colchicine was well tolerated and not associated with increased adverse events. However, there were no significant improvements in coronary or systemic endothelial function or reductions in serum inflammatory markers at 8 or 24 weeks with colchicine as compared to placebo.
CONCLUSIONS


In PLWH with no history of CAD, low-dose colchicine was well tolerated but did not improve impaired coronary endothelial function, a predictor of cardiovascular events. These findings suggest that an anti-inflammatory approach using colchicine in PLWH does not improve vascular health, the central, early driver of coronary atherosclerosis.",2021,"However, there were no significant improvements in coronary or systemic endothelial function or reductions in serum inflammatory markers at 8 or 24 weeks with colchicine as compared to placebo.
","['People living with HIV (PLWH', 'people living with HIV', 'HIV-seronegative CAD patients']","['colchicine', 'placebo', 'Colchicine']","['vascular health', 'coronary endothelial function (CEF', 'coronary or systemic endothelial function', 'systemic endothelial function and serum inflammatory markers', 'coronary endothelial function', 'CEF', 'coronary artery disease (CAD', 'CEF, measured as the change in coronary blood flow from rest to that during isometric handgrip exercise, an endothelial-dependent stressor', 'cardiovascular events', 'adverse events', 'tolerated', 'serum inflammatory markers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",81.0,0.664562,"However, there were no significant improvements in coronary or systemic endothelial function or reductions in serum inflammatory markers at 8 or 24 weeks with colchicine as compared to placebo.
","[{'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Hays', 'Affiliation': 'From the Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD Division of Magnetic Resonance Research, Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD Division of Infectious Diseases, Department of Medicine, University of Maryland School of Medicine, Baltimore MD Analytical Pharmacology Core, Sidney Kimmel Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, 615\u200aN Wolfe St. Baltimore, Maryland Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415\u200aN Washington St. Baltimore, Maryland, 21205 USA Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schär', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Barditch-Crovo', 'Affiliation': ''}, {'ForeName': 'Shashwatee', 'Initials': 'S', 'LastName': 'Bagchi', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Bonanno', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': ''}, {'ForeName': 'Yohannes', 'Initials': 'Y', 'LastName': 'Afework', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Streeb', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stradley', 'Affiliation': ''}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Anders', 'Affiliation': ''}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Margolick', 'Affiliation': ''}, {'ForeName': 'Shenghan', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Gerstenblith', 'Affiliation': ''}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Weiss', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002845']
1342,33587439,"Efficacy, safety and CNS effects after switch from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine in a randomized controlled trial.","OBJECTIVE


Doravirine is an alternative treatment option for individuals who do not tolerate efavirenz. We assessed efficacy, safety, and CNS effects in adults with HIV-1 and CNS complaints who switched from an efavirenz-based regimen to a doravirine-based regimen.
DESIGN


Multicenter, double-blind, randomized trial.
METHODS


Virologically suppressed adults receiving efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF), or its components, with ongoing EFV-associated CNS toxicity Grade 2 or higher (DAIDS Criteria) were switched to doravirine/lamivudine/tenofovir (DOR/3TC/TDF) on Day 1 (immediate switch group [ISG]) or after 12 weeks (deferred switch group [DSG]). CNS toxicity data were collected by self-administered questionnaire. The primary endpoint was the proportion of participants with any Grade 2 or higher CNS toxicity at Week 12. Secondary endpoints included virologic response and effect on fasting lipids.
RESULTS


86 participants (58% male, 56% black, median age 41 years, median 4 years on prior EFV regimen) were enrolled (43 ISG, 43 DSG) and included in the analyses. At Week 12, 42% of ISG and 37% of DSG had ≥1 Grade 2 or higher CNS toxicity (difference 4.7%, 95% CI [-16%, 25%]; p = 0.33). At 24 weeks post-switch, HIV-1 RNA < 50 copies/mL was maintained in 95.3% of participants, and fasting lipids were significantly decreased (LDL-cholesterol -11.0, non-HDL-cholesterol -13.2, HDL-cholesterol -7.7, total cholesterol -20.9, and triglycerides -13.0 mg/dL).
CONCLUSIONS


In participants who had CNS complaints while receiving EFV/FTC/TDF, improvement in CNS toxicities attributable to EFV was not significantly different after switching to DOR/3TC/TDF compared with remaining on EFV/FTC/TDF. Virologic efficacy was maintained and lipid profiles improved after switching to DOR/3TC/TDF.",2021,"At 24 weeks post-switch, HIV-1 RNA < 50 copies/mL was maintained in 95.3% of participants, and fasting lipids were significantly decreased (LDL-cholesterol -11.0, non-HDL-cholesterol -13.2, HDL-cholesterol -7.7, total cholesterol -20.9, and triglycerides -13.0 mg/dL).
","['86 participants (58% male, 56% black, median age 41 years, median 4 years on prior EFV regimen) were enrolled (43 ISG, 43 DSG) and included in the analyses', 'adults with HIV-1 and CNS complaints who switched from an efavirenz-based regimen to a doravirine-based regimen', 'Virologically suppressed adults receiving', ' or its components, with ongoing EFV-associated CNS toxicity Grade 2 or higher (DAIDS Criteria', 'individuals who do not tolerate efavirenz']","['efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF', 'doravirine/lamivudine/tenofovir (DOR/3TC/TDF) on Day 1 (immediate switch group [ISG]) or after 12 weeks (deferred switch group [DSG', 'efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine']","['efficacy, safety, and CNS effects', 'CNS toxicities attributable to EFV', 'virologic response and effect on fasting lipids', 'CNS toxicity', 'proportion of participants with any Grade 2 or higher CNS toxicity', 'fasting lipids', 'Efficacy, safety and CNS effects', 'Virologic efficacy', 'CNS toxicity data']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3160947', 'cui_str': 'CNS toxicity'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C1725746', 'cui_str': 'Efavirenz- and emtricitabine- and tenofovir-containing product'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3160947', 'cui_str': 'CNS toxicity'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.288309,"At 24 weeks post-switch, HIV-1 RNA < 50 copies/mL was maintained in 95.3% of participants, and fasting lipids were significantly decreased (LDL-cholesterol -11.0, non-HDL-cholesterol -13.2, HDL-cholesterol -7.7, total cholesterol -20.9, and triglycerides -13.0 mg/dL).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Department of Infectious Disease, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK Imperial College London, London, UK Department of Translational Medicine, University of Liverpool, Liverpool, UK Enhancing Care Foundation, Durban, South Africa Mzansi Ethical Research Centre, Middleburg, South Africa Queen Mary University of London, London, UK University of Witwatersrand, Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa Merck & Co., Inc., Kenilworth, NJ, USA. co-lead authors.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Winston', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': ''}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Bassa', 'Affiliation': ''}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': ''}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Rassool', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Teal', 'Affiliation': ''}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Teppler', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002804']
1343,33591621,Liraglutide Hospital Discharge Trial: A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide versus Glargine Insulin for the Management of Patients with Type 2 Diabetes After Hospital Discharge.,"BACKGROUND


Few studies have focused on pharmacologic diabetes therapy adjustments at hospital discharge. This randomized clinical trial compared a GLP-1 receptor analog with basal insulin at hospital discharge in patients with uncontrolled type 2 diabetes.
METHODS


A total of 273 patients with HbA1c 7-10% were randomised to liraglutide (n = 136) or glargine (n = 137) at hospital discharge. The primary endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included hypoglycaemia, changes in body weight, and achievement of HbA1c <7% without hypoglycaemia or weight gain.
RESULTS


Between-group HbA1c difference at 12 weeks and 26 weeks was -0.28%, 95%CI: (-0.64, 0.09), and 26 weeks was -0.55%, 95%CI (-1.01, -0.09) in favour of liraglutide. Liraglutide treatment resulted in lower frequency of hypoglycaemia <3.9 mmol/L (13% vs 23% p = 0.04), but there was no difference in the rate of clinically significant hypoglycaemia <3.0 mmol/L. Compared to glargine, liraglutide treatment was associated with greater weight loss at 26 weeks (-4.7 ± 7.7 Kg vs. -0.6 ± 11.5 kg, p < 0.001) and in the proportion of patients with HbA1c <7% without hypoglycaemia was 48% vs 33% (p = 0.05) at 12 weeks and 45% vs 33% (p = 0.14) at 26 weeks in liraglutide vs glargine insulin. The proportion of patients with HbA1c <7% without hypoglycaemia and no weight gain were higher with liraglutide at 12 (41% vs 24%, p = 0.005) and 26 weeks (39% vs 22%, p = 0.014). The incidence of gastrointestinal adverse events was higher with liraglutide than with glargine (p < 0.001).
CONCLUSION


Compared to insulin glargine, treatment with liraglutide at hospital discharge resulted in better glycaemic control and greater weight loss, but increased gastrointestinal adverse events. This article is protected by copyright. All rights reserved.",2021,"The incidence of gastrointestinal adverse events was higher with liraglutide than with glargine (p < 0.001).
","['273 patients with HbA1c 7-10', 'Patients with Type 2 Diabetes After Hospital Discharge', 'patients with uncontrolled type 2 diabetes']","['glargine', 'liraglutide', 'liraglutide vs glargine insulin', 'glargine, liraglutide', 'Liraglutide', 'Liraglutide versus Glargine Insulin', 'GLP-1 receptor analog with basal insulin', 'insulin glargine']","['hypoglycaemia and no weight gain', 'weight loss', 'hypoglycaemia, changes in body weight, and achievement of HbA1c <7% without hypoglycaemia or weight gain', 'incidence of gastrointestinal adverse events', 'gastrointestinal adverse events', 'rate of clinically significant hypoglycaemia', 'frequency of hypoglycaemia', 'hypoglycaemia', 'glycaemic control and greater weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",273.0,0.179486,"The incidence of gastrointestinal adverse events was higher with liraglutide than with glargine (p < 0.001).
","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'K Walkiria', 'Initials': 'KW', 'LastName': 'Zamudio Coronado', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'M Citlalli', 'Initials': 'MC', 'LastName': 'Perez-Guzman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Iacobellis', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami, Florida, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Palacios', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami, Florida, USA.'}, {'ForeName': 'Javier M', 'Initials': 'JM', 'LastName': 'Farias', 'Affiliation': 'Division of Endocrinology Sanatorio Guemes, Ciudad Autonoma de Buenos Aires, Argentina.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Anzola', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Georgia M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Migdal', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Deartment of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14347']
1344,33591620,Thirty-six-month results of laparoscopic-based renal denervation plus unilateral laparoscopic adrenalectomy for the treatment of patients with resistant hypertension caused by unilateral aldosterone-producing adenoma.,"The aim of this study was to explore the long-term clinical results of Renal denervation (RDN) from the adventitia of the renal artery plus unilateral laparoscopic adrenalectomy to treat patients with resistant hypertension caused by unilateral aldosterone-producing adenoma (APA). Sixty patients with resistant hypertension caused by APA who were treated at Henan Provincial People's Hospital from December 2016 to March 2018 were selected and randomly assigned to undergo RDN from the adventitia of the renal artery plus adrenalectomy (RDN group, n = 30) or adrenalectomy alone (control group, n = 30). Office blood pressure (BP), antihypertensive medication usage and other laboratory characteristics were followed every 6 months through 36 months. Follow-up data were available at 36 months for 23 of 30 subjects in the RDN group and for 21 of 30 subjects who were in the control group. At 36 months postprocedure, the reduction in the RDN group was 42.2 ± 21.6 mmHg and that in the control group was 29.8 ± 13.5 mmHg (p = .029 between the groups). During the follow-up to 36 months postprocedure, no patients in either the RDN group or the control group died due to surgical complications, and the RDN group had no procedural complications, including renal artery dissection, perforation, and renal artery stenosis. There was no change in the mean eGFR of the two groups, and no serious adverse events were reported. In conclusion, RDN from the adventitia of the renal artery plus unilateral laparoscopic adrenalectomy resulted in sustained lowering of BP at 3 years in a selected population of subjects with resistant hypertension caused by unilateral APA without serious safety concerns.",2021,"During the follow-up to 36 months postprocedure, no patients in either the RDN group or the control group died due to surgical complications, and the RDN group had no procedural complications, including renal artery dissection, perforation, and renal artery stenosis.","['patients with resistant hypertension caused by unilateral aldosterone-producing adenoma', 'patients with resistant hypertension caused by unilateral aldosterone-producing adenoma (APA', ""Sixty patients with resistant hypertension caused by APA who were treated at Henan Provincial People's Hospital from December 2016 to March 2018 were selected and randomly assigned to undergo RDN from the adventitia of the renal artery plus""]","['renal artery plus unilateral laparoscopic adrenalectomy', 'RDN', 'laparoscopic-based renal denervation plus unilateral laparoscopic adrenalectomy', 'adrenalectomy (RDN group, n\xa0=\xa030) or adrenalectomy alone (control group, n\xa0=\xa030', 'Renal denervation (RDN']","['Office blood pressure (BP), antihypertensive medication usage and other laboratory characteristics', 'surgical complications', 'mean eGFR', 'procedural complications, including renal artery dissection, perforation, and renal artery stenosis', 'sustained lowering of BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0009777', 'cui_str': 'Aldosterone-producing adenoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0225342', 'cui_str': 'Tunica adventitia'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0919563', 'cui_str': 'Dissection of renal artery'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0035067', 'cui_str': 'Renal artery stenosis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",60.0,0.0186846,"During the follow-up to 36 months postprocedure, no patients in either the RDN group or the control group died due to surgical complications, and the RDN group had no procedural complications, including renal artery dissection, perforation, and renal artery stenosis.","[{'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Urinary Surgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Degang', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': ""Department of Urinary Surgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Urinary Surgery, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Datun', 'Initials': 'D', 'LastName': 'Qi', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, The Shanghai Institute of Hypertension, Shanghai, China.'}, {'ForeName': 'Chuanyu', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.""}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14223']
1345,33591618,"Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: a randomized, double-blind trial in healthy subjects.","This double-blind, randomized, single-site, crossover trial (NCT04189848; EudraCT: 2019-83003844-57) compared the injection-site experience with the starting doses of semaglutide and dulaglutide. Healthy subjects (18-75 years; body mass index ≥25 kg/m 2  ; n=104) were randomized 1:1, using a pre-generated list, to semaglutide 0.25 mg as the first injection and dulaglutide 0.75 mg as the second injection or vice versa; each was administered using their proprietary pen-injectors, according to Instructions for Use. The primary endpoint was intensity of injection-site pain, measured using a visual analogue scale (VAS; 0 mm=no pain, 100 mm=unbearable pain). Exploratory endpoints included: intensity category, duration and quality of injection-site pain, and comparative assessment of injection-site pain with the two injections. The point estimate of the VAS score for injection-site pain intensity was 11.5 mm with dulaglutide vs 5.6 mm with semaglutide; mean [95% confidence interval] estimated treatment difference 5.9 mm [3.6;8.2]; P<0.0001. Other endpoints corroborated a less painful injection experience with semaglutide vs dulaglutide. Safety was consistent with reported data for the drugs. In conclusion, injection-site experience with semaglutide was rated less painful than that with dulaglutide. This article is protected by copyright. All rights reserved.",2021,The point estimate of the VAS score for injection-site pain intensity was 11.5 mm with dulaglutide vs 5.6 mm with semaglutide; mean,"['Healthy subjects (18-75\u2009years; body mass index ≥25 kg/m 2  ; n=104', 'healthy subjects']","['semaglutide 0.25 mg as the first injection and dulaglutide 0.75 mg as the second injection or vice versa; each was administered using their proprietary pen-injectors', 'semaglutide and dulaglutide']","['intensity category, duration and quality of injection-site pain, and comparative assessment of injection-site pain', 'painful injection experience', 'intensity of injection-site pain, measured using a visual analogue scale (VAS; 0\u2009mm=no pain, 100\u2009mm=unbearable pain', 'VAS score for injection-site pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.489856,The point estimate of the VAS score for injection-site pain intensity was 11.5 mm with dulaglutide vs 5.6 mm with semaglutide; mean,"[{'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Snitker', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Andersen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Berg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'van Marle', 'Affiliation': 'PRA Health Sciences, Groningen, the Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sparre', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14349']
1346,33591613,Metformin and carotid intima media thickness in never smokers with type 1 diabetes: the REMOVAL trial.,,2021,,['never smokers with type'],['Metformin'],[],"[{'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.0223947,,"[{'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Timmons', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Greenlaw', 'Affiliation': 'Robertson Centre for Biostatistics University of Glasgow, Glasgow, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Boyle', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Chaturvedi', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics University of Glasgow, Glasgow, UK.'}, {'ForeName': 'McGj', 'Initials': 'M', 'LastName': 'Brouwers', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tillin', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': ""St Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Hughes', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'Bek', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Ooi', 'Affiliation': 'Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen and the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cda', 'Initials': 'C', 'LastName': 'Stehouwer', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, UK.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Petrie', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14350']
1347,33591553,Long-term safety and efficacy of hydroxychloroquine in patients with IgA nephropathy: a single-center experience.,"BACKGROUND


Hydroxychloroquine (HCQ) has been used as a supportive therapy for IgA nephropathy (IgAN). We aimed to determine the long-term efficacy and safety of HCQ therapy in patients with IgAN.
METHODS


A total of 180 patients with IgAN who had received HCQ therapy for at least 1 year were enrolled in this study. The changes in proteinuria and the estimated glomerular filtration rate (eGFR) were analyzed during the follow-up period.
RESULTS


The level of proteinuria decreased from 1.69 [1.24, 2.30] to 1.01 [0.59, 1.74] g/day (- 37.58 [- 57.52, 8.24] %, P < 0.001) at 12 months and to 1.00 [0.59, 1.60] g/day (- 55.30 [- 71.09, - 3.44] %, P < 0.001) at 24 months. There was no significant change in the eGFR of these patients at 12 months (65.82 ± 25.22 vs. 63.93 ± 25.96 ml/min/1.73 m 2 , P = 0.411); however, the eGFR decreased from 65.82 ± 25.22 to 62.15 ± 25.81 ml/min/1.73 m 2  at 24 months (P = 0.003). The cumulative frequency of all patients with a 50% decrease in proteinuria was 72.78% at 12 months. Sixty (33.3%) patients changed to corticosteroid therapy during the follow-up period. No serious adverse effects were documented during HCQ treatment.
CONCLUSIONS


HCQ effectively and safely reduces proteinuria in IgAN patients with different levels of eGFR, supporting the maintenance of stable kidney function in the long term.",2021,"No serious adverse effects were documented during HCQ treatment.
","['180 patients with IgAN who had received HCQ therapy for at least 1\xa0year were enrolled in this study', 'patients with IgAN', 'patients with IgA nephropathy']","['Hydroxychloroquine (HCQ', 'HCQ therapy', 'hydroxychloroquine']","['changes in proteinuria and the estimated glomerular filtration rate (eGFR', 'level of proteinuria', 'cumulative frequency', 'eGFR', 'serious adverse effects', 'proteinuria']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C5190549', 'cui_str': 'Hydroxychloroquine therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C5190549', 'cui_str': 'Hydroxychloroquine therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",180.0,0.0373412,"No serious adverse effects were documented during HCQ treatment.
","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China.""}, {'ForeName': 'Ji-Cheng', 'Initials': 'JC', 'LastName': 'Lv', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China.""}, {'ForeName': 'Su-Fang', 'Initials': 'SF', 'LastName': 'Shi', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China.""}, {'ForeName': 'Yu-Qing', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China.""}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Liu', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China. lijun.liu@aliyun.com.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, 100034, People's Republic of China.""}]",Journal of nephrology,['10.1007/s40620-021-00988-1']
1348,33591489,The effects of short-term L2 training on components of executive control in Indian bilinguals.,"This study investigated whether a short training (8 weeks) in the second-language (English) has any facilitative effect on components of executive functions in young adults. A pre-post design was used with two groups of participants: one group (experimental group) of students received English language training for eight weeks, and another group (control group) matched on age and background did not. Executive function tasks (Flanker, Stroop, and color-shape switching task) along with the object naming and working memory tasks were administered before and after the training. We observed that the experimental group demonstrated significant improvement in task switching, working memory capacity, and language skills. Findings from the study provide evidence that short training in second-language can enhance some components of executive functions besides improving language skills in young adult students. This finding contributes to a better understanding of language training and executive function among young adult bilinguals.",2021,"Executive function tasks (Flanker, Stroop, and color-shape switching task) along with the object naming and working memory tasks were administered before and after the training.","['young adult students', 'young adults', 'Indian bilinguals', 'young adult bilinguals']","['English language training', 'short-term L2 training', 'short training (8\xa0weeks) in the second-language (English']","['task switching, working memory capacity, and language skills', 'Executive function tasks (Flanker, Stroop, and color-shape switching task']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0557074', 'cui_str': 'Second language'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",,0.015324,"Executive function tasks (Flanker, Stroop, and color-shape switching task) along with the object naming and working memory tasks were administered before and after the training.","[{'ForeName': 'Riya', 'Initials': 'R', 'LastName': 'Rafeekh', 'Affiliation': 'Centre for Neural and Cognitive Sciences, University of Hyderabad, Hyderabad, Telangana, 500046, India.'}, {'ForeName': 'P Phani', 'Initials': 'PP', 'LastName': 'Krishna', 'Affiliation': 'Centre for Neural and Cognitive Sciences, University of Hyderabad, Hyderabad, Telangana, 500046, India.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Kapiley', 'Affiliation': 'Centre for Neural and Cognitive Sciences, University of Hyderabad, Hyderabad, Telangana, 500046, India.'}, {'ForeName': 'Ramesh Kumar', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Centre for Neural and Cognitive Sciences, University of Hyderabad, Hyderabad, Telangana, 500046, India. rkmishra@uohyd.ac.in.'}]",Cognitive processing,['10.1007/s10339-021-01014-9']
1349,33591484,The FamilyTalk randomized controlled trial: patient-reported outcomes in clinical genetic sequencing for colorectal cancer.,"As genetics gains favor in clinical oncology, it is important to address patient concerns around confidentiality, privacy, and security of genetic information that might otherwise limit its utilization. We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening. Of 208 randomized participants, 149 (71.6%) returned six-month surveys. Overall, there was no difference in CRC screening between the study arms. Privacy and confidentiality concerns about medical and genetic information, reactions to genetic test results, and lifestyle changes did not differ between arms. Participants with pathogenic or likely pathogenic (P/LP) and variant of uncertain significance (VUS) results were more likely than those with negative results to report that the results accurately predicted their disease risks (OR 5.37, p = 0.02 and OR 3.13, p = 0.02, respectively). This trial demonstrated no evidence that FamilyTalk impacted patient-reported outcomes. Low power, due to the limited number of participants with P/LP results in the overall sample, as well as the short follow-up period, could have contributed to the null findings.",2021,We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening.,"['Of 208 randomized participants, 149 (71.6%) returned six-month surveys']",['online educational tool (FamilyTalk'],"['CRC screening', 'disease risks']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}]",208.0,0.0857292,We designed a randomized controlled trial to assess the social impact of an online educational tool (FamilyTalk) to increase family communication about colorectal cancer (CRC) risk and screening.,"[{'ForeName': 'Sukh', 'Initials': 'S', 'LastName': 'Makhnoon', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Bowen', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA. dbowen@uw.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Shirts', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Fullerton', 'Affiliation': 'Department of Bioethics and Humanities, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Larson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Leppig', 'Affiliation': 'Genetic Services, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Crosslin', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Veenstra', 'Affiliation': 'Department of Pharmacy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gail P', 'Initials': 'GP', 'LastName': 'Jarvik', 'Affiliation': 'Departments of Medicine (Medical Genetics) and Genome Sciences, University of Washington Medical Center, Seattle, WA, USA.'}]",Cancer causes & control : CCC,['10.1007/s10552-021-01398-1']
1350,33591469,Long-term outcome of (neo)adjuvant zoledronic acid therapy in locally advanced breast cancer.,"PURPOSE


The role of zoledronic acid (ZOL), a bone-targeted bisphosphonate, in the treatment of patients with breast cancer remains an active area of study. Here, we report the long-term outcomes of a randomized placebo-controlled phase II clinical trial in which ZOL treatment was added to neoadjuvant chemotherapy in women with locally advanced breast cancer.
METHODS


120 women with clinical stage II-III (≥ T2 and/or ≥ N1) newly diagnosed breast cancer were randomized to receive either 4 mg intravenous ZOL every 3 weeks for 1 year (17 total doses) beginning with the first dose of neoadjuvant chemotherapy, or chemotherapy alone. Clinical endpoints included time to recurrence (TTR), time to bone recurrence (TTBR), time to non-bone recurrence (TTNBR), breast cancer survival (BCS) and overall survival (OS).
RESULTS


With a median follow-up interval of 14.4 years, there were no significant differences in any of the clinical endpoints studied between the control and ZOL groups in the overall study population. However, ER+/HER2- patients younger than age 45 who were treated with ZOL had significantly worse TTR and TTNBR with a trend towards worse TTBR, BCS and OS (TTR: P = 0.024, HR 6.05 [1.26-29.1]; TTNBR: P = 0.026, HR 6.94 [1.26-38.1]; TTBR: P = 0.054, HR 6.01 [0.97-37.1]; BCS: P = 0.138, HR 4.43 [0.62-31.7]; OS: P = 0.138, HR 4.43 [0.62-31.7]). These differences were not seen in older ER+/HER2- patients or triple-negative patients of any age.
CONCLUSION


Addition of ZOL to neoadjuvant therapy did not significantly affect clinical outcomes in the overall study population but was associated with increased extra-skeletal recurrence and a trend towards worse survival in ER+/HER2- patients younger than age 45. These findings suggest caution when using zoledronic acid in young, premenopausal women with locally advanced breast cancer and warrant further investigation. Clinical Trial Registration Number NCT00242203, Date of Registration: 10/17/2005.",2021,", there were no significant differences in any of the clinical endpoints studied between the control and ZOL groups in the overall study population.","['young, premenopausal women with locally advanced breast cancer', 'women with locally advanced breast cancer', '≥\u2009T2 and/or\u2009≥\u2009N1) newly diagnosed breast cancer', 'With a median follow-up interval of 14.4\xa0years', 'patients with breast cancer remains an active area of study', 'patients younger than age 45 who were treated with', 'locally advanced breast cancer', '120 women with clinical stage II-III']","['neoadjuvant chemotherapy, or chemotherapy alone', 'placebo', 'ER+/HER2', '4\xa0mg intravenous ZOL', 'ZOL treatment', 'neoadjuvant chemotherapy', 'zoledronic acid', 'zoledronic acid (ZOL', 'ZOL', 'zoledronic acid therapy']","['time to recurrence (TTR), time to bone recurrence (TTBR), time to non-bone recurrence (TTNBR), breast cancer survival (BCS) and overall survival (OS', 'TTBR, BCS and OS', 'survival', 'extra-skeletal recurrence', 'TTR and TTNBR']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3839933', 'cui_str': 'Zoledronic acid therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}]",120.0,0.366053,", there were no significant differences in any of the clinical endpoints studied between the control and ZOL groups in the overall study population.","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jallouk', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Paravastu', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Weilbaecher', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Aft', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, St. Louis, MO, 63110, USA. aftr@wustl.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-021-06100-2']
1351,33591459,Transcapillary escape rate of  125 I-albumin in relation to timing of blood sampling: the need for standardization.,"BACKGROUND


Increased vascular permeability is an early sign of vascular damage and can be measured with the transcapillary escape rate of albumin (TER alb ). Although TER alb  has a multi-exponential kinetic model, most published TER alb  data are based on mono-exponential kinetic models with variation in blood sampling schemes. Aim of this posthoc study was to evaluate the influence of variation in blood sampling schemes and the impact of mono- or bi-exponential analyses on the calculation of TER alb . Study participants were part of a cross-over intervention study protocol, investigating effects of sodium loading on blood pressure, endothelial surface layer and microcirculation. Multiple blood samples were drawn between 3 and 60 min after injection of radioactive iodide labeled human serum albumin (rHSA).
RESULTS


In total 27 male participants with 54 measurements were included. For all participants the maximum serum radioactivity was reached within 20 min, while 85% of the participants had their maximum serum activity within 10 min. The TER alb  calculated with the subsequently chosen T 20-60 min  reference scheme (6.19 ± 0.49%/h) was significantly lower compared to the TER alb  of the T 3-60 min , T 5-60 min , and T max - 60 min  schemes. There was no significant difference between the T 20-60 min  reference scheme and the T 10-60 min  and T 15-60 min  schemes. Bi-exponential kinetic modeling did not result in significant different observations compared to the mono-exponential kinetic analysis.
CONCLUSIONS


As there is variation in the timing of the maximum serum radioactivity of rHSA, blood sampling schemes starting before 10 min after administration of rHSA will result in a significant overestimation of TER alb . In addition, variation in kinetic modeling did not result in significant changes in TER alb . Therefore, we emphasize the need to standardize TER alb  and for practical and logistical reasons advocate the use of a mono-exponential model with blood sampling starting 20 min after rHSA administration.",2021,There was no significant difference between the T 20-60 min  reference scheme and the T 10-60 min  and T 15-60 min  schemes.,['In total 27 male participants with 54 measurements were included'],"['rHSA', 'sodium loading']","['maximum serum activity', 'blood pressure, endothelial surface layer and microcirculation', 'Transcapillary escape rate of', 'maximum serum radioactivity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}]",27.0,0.0714367,There was no significant difference between the T 20-60 min  reference scheme and the T 10-60 min  and T 15-60 min  schemes.,"[{'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Chahid', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. y.chahid@amsterdamumc.nl.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam University Medical Centers, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Soufian', 'Initials': 'S', 'LastName': 'El Boujoufi', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ron A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Department of Clinical Pharmacy, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam University Medical Centers, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}]",EJNMMI radiopharmacy and chemistry,['10.1186/s41181-021-00125-0']
1352,33591439,Influence of dynamic neck motion on the clinical usefulness of multi-positional MRI in cervical degenerative spondylosis.,"PURPOSE


The purpose of this study was to find out additional indications for multi-positional MRI in cervical degenerative spondylosis (CDS) patients.
MATERIAL AND METHODS


A total of 63 patients with cervical spondylotic myelopathy that underwent multi-positional MRI and X-ray were included. Muhle's grade, C2-7 angle, and C7 slope were measured. Patients were assigned to the stenosis group (Group S) when Muhle's grades were increased by more than two or maximum grade was reached. Other patients were assigned to the maintenance group (Group M). Receiver operating characteristic (ROC) analysis was performed. Statistical significance was accepted for p values of < 0.05.
RESULTS


A total of 24 patients were assigned to the S group and 39 patients to the M group. Mean C2-7 angle difference in extension (eC27A) between S and M groups was 10.97° (p = 0.002). The mean inter-group difference between C2-7 angle in extension and neutral positions (e-nC27A) was 14.39° (p = 0.000). Mean C7 slope difference in neutral position was  - 6.53° (p = 0.002). Based on areas under ROC curves (AUCs), e-nC27A, eC27A, and negative C7 slope had AUCs of 0.934 (95% CI 0.876-0.992), 0.752 (95% CI 0.624-0.880), and 0.720 (95% CI 0.588-0.851), respectively. The optimal cutoff value of e-nC27A was 15.4 degrees, which had a diagnostic accuracy of 88.9%.
CONCLUSION


Multi-positional MRI helps to find dynamic cord compressive lesion in CDS patients. The higher eC27A, e-nC27A values and smaller C7 slope were found to increase the likelihood of cervical dynamic stenosis. Among other factors, we recommend multi-positional MRI before surgery especially when a patient's e-nC27A is > 15.4 degrees.
LEVEL OF EVIDENCE I


Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.",2021,Mean C2-7 angle difference in extension (eC27A) between S and M groups was 10.97° (p = 0.002).,"['CDS patients', 'cervical degenerative spondylosis (CDS) patients', '63 patients with cervical spondylotic myelopathy that underwent multi-positional\xa0MRI and X-ray\xa0were included', '24 patients were assigned to the S group and 39 patients to the M group', 'cervical degenerative spondylosis']","['dynamic neck motion', 'multi-positional MRI']","['likelihood of cervical dynamic stenosis', 'higher eC27A, e-nC27A values and smaller C7 slope', ""Muhle's grade, C2-7 angle, and C7 slope"", 'Mean\xa0C2-7 angle\xa0difference in extension (eC27A', 'Mean C7 slope\xa0difference in neutral position', 'areas under ROC curves (AUCs), e-nC27A, eC27A, and\xa0negative C7 slope']","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0038019', 'cui_str': 'Spondylosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",63.0,0.0567535,Mean C2-7 angle difference in extension (eC27A) between S and M groups was 10.97° (p = 0.002).,"[{'ForeName': 'Jong Beom', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Chungbuk National University of Korea, Cheongju, Korea.'}, {'ForeName': 'Jong- Hyeok', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ""Department of Neurosurgery, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Gangneung Asan Hospital, The Ulsan University, Gangneung, Korea.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ""Department of Neurosurgery, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Il Sup', 'Initials': 'IS', 'LastName': 'Kim', 'Affiliation': ""Department of Neurosurgery, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Jung-Woo', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': ""Department of Neurosurgery, Eunpyung St. Mary's Hospital, The Catholic University of Korea, Tongil-ro, Eunpyeng-Gu, Seoul, 102103312, Korea.""}, {'ForeName': 'Jae Taek', 'Initials': 'JT', 'LastName': 'Hong', 'Affiliation': ""Department of Neurosurgery, Eunpyung St. Mary's Hospital, The Catholic University of Korea, Tongil-ro, Eunpyeng-Gu, Seoul, 102103312, Korea. jatagi15@gmail.com.""}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-021-06760-0']
1353,33591390,Diet- and sex-related changes of gut microbiota composition and functional profiles after 4 months of weight loss intervention.,"PURPOSE


Obesity has been related to intestinal dysbiosis and the modification of gut microbiota composition by dietary strategies becomes a promising strategy to help manage obesity. The aim of the current study was to evaluate the effect of two weight-loss diets on the composition and functional profile of gut microbiota.
METHODS


55 men and 124 women with BMI > 25 kg/m 2  were randomly assigned to moderately high-protein (MHP) or low-fat (LF) diet. Differences in fecal bacteria abundance (based on 16 s rRNA sequencing) between before and after 4 months of calorie restriction was analyzed using EdgeR tool in MicrobiomeAnalyst platform. Bacterial functional profile was predicted using Tax4Fun and metagenomeSeq analysis. Significant KEGG Orthology (KO) terms were selected for the metabolomic study using chromatography.
RESULTS


After the intervention, MHP-men showed a significant decrease in Negativicutes, Selenomonadales, Dielma and Dielma fastidiosa. LF-men showed a significant increase in Bacilli, Lactobacillales, Christensenellaceae, Peptococcaceae, and Streptococcaceae, Peptococcus, Streptococcus and Christensenella, Duncaniella dubosii_CP039396_93.49%, Roseburia sp_AB744234_98.96% and Alistipes inops_KJ572413_99.57%. MHP-women increased Pasteurellales, Phascolarctobacterium succinatutens, Ruthenibacterium lactatiformans_LR215981_99.55% and decreased in Phascolarctobacterium succinatutens_NR112902_99.56%. Finally, LF-women presented a significant decrease in Bacteroides clarus and Erysipelothrix inopinata_CP060715_84.4%. Surprisingly, no matching bacterial changes were found between these four groups. A total of 42 KO, 10 metabolic pathways and 107 related metabolites related were found implicated in these bacterial changes. Seven metabolites were confirmed in plasma.
CONCLUSION


Weight-loss-related-changes in gut microbiome composition and the functional profile occur in a sex- and diet-related manner, showing that women and men could differentially benefit from the consumption of MHP and LF diets.
TRIAL REGISTRATION


NCT02737267, 10th March 2016 retrospectively registered.",2021,"Finally, LF-women presented a significant decrease in Bacteroides clarus and Erysipelothrix inopinata_CP060715_84.4%.",['55 men and 124 women with BMI\u2009>\u200925\xa0kg/m 2'],"['weight-loss diets', 'moderately high-protein (MHP) or low-fat (LF) diet']","['Bacterial functional profile', 'Bacilli, Lactobacillales, Christensenellaceae, Peptococcaceae, and Streptococcaceae, Peptococcus, Streptococcus and Christensenella', 'fecal bacteria abundance', 'Bacteroides clarus', 'Negativicutes, Selenomonadales, Dielma and Dielma fastidiosa', 'composition and functional profile of gut microbiota']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0030964', 'cui_str': 'Peptococcaceae'}, {'cui': 'C0038394', 'cui_str': 'Streptococcaceae'}, {'cui': 'C0030965', 'cui_str': 'Peptococcus'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C3131019', 'cui_str': 'Genus Christensenella'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C3473406', 'cui_str': 'Clarus'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",55.0,0.0408434,"Finally, LF-women presented a significant decrease in Bacteroides clarus and Erysipelothrix inopinata_CP060715_84.4%.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cuevas-Sierra', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Romo-Hualde', 'Affiliation': 'Center for Nutrition Research, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Aranaz', 'Affiliation': 'Center for Nutrition Research, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Goni', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cuervo', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, 31008, Pamplona, Spain.'}, {'ForeName': 'Fermín I', 'Initials': 'FI', 'LastName': 'Milagro', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, 31008, Pamplona, Spain. fmilagro@unav.es.'}, {'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Riezu-Boj', 'Affiliation': 'Department of Nutrition, Food Sciences and Physiology, University of Navarra, 31008, Pamplona, Spain.'}]",European journal of nutrition,['10.1007/s00394-021-02508-0']
1354,33591381,Olfactory dysfunction and oxidative stress in pregnant women with hyperemesis gravidarum.,"PURPOSE


This study aimed to compare the first-trimester pregnancy serum total oxidative status (TOS), total antioxidant status (TAS), and serum estradiol levels as well as the olfactory functions assessed using the brief smell identification test (BSIT) of women with healthy pregnancies and those with hyperemesis gravidarum (HG).
METHODS


In this prospective study, 60 pregnant women in the first trimester of their pregnancies were divided into two groups: 30 pregnant women with HG (study group) and 30 healthy pregnant women (control group). The following parameters were compared in the HG group and the healthy controls: TOS, TAS, serum levels of estradiol (E2), and olfactory function, which was measured using BSIT.
RESULTS


Both groups were similar in terms of age, gravida, and parity. The mean total smell score was lower in the HG group than the healthy control group (p < 0.05). TOS was significantly higher in the HG group than the control group. TAS was significantly higher in the control group than the HG group (p < 0.05).
CONCLUSION


The removal of sharp odors that will trigger the perception of odor in pregnant women with HG can contribute to the effective control of this disease; moreover, adding fetal-safe antioxidants to the treatment can contribute to the effective control of this disease.",2021,The mean total smell score was lower in the HG group than the healthy control group (p < 0.05).,"['pregnant women with hyperemesis gravidarum', 'women with healthy pregnancies and those with hyperemesis gravidarum (HG', '60 pregnant women in the first trimester of their pregnancies were divided into two groups: 30 pregnant women with HG (study group) and 30 healthy pregnant women (control group', 'pregnant women with HG']",[],"['TAS', 'TOS', 'first-trimester pregnancy serum total oxidative status (TOS), total antioxidant status (TAS), and serum estradiol levels', 'Olfactory dysfunction and oxidative stress', 'mean total smell score', 'TAS, serum levels of estradiol (E2), and olfactory function']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",60.0,0.0321579,The mean total smell score was lower in the HG group than the healthy control group (p < 0.05).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Şimşek', 'Affiliation': 'Faculty of Medicine, Obstetrics and Gynecology Department, Biruni University, Istanbul, Turkey.'}, {'ForeName': 'Gökçe', 'Initials': 'G', 'LastName': 'Şimşek', 'Affiliation': 'Faculty of Medicine, ENT Department, Kırıkkale University, Kırıkkale, Turkey.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Bayar Muluk', 'Affiliation': 'Faculty of Medicine, ENT Department, Kırıkkale University, Kırıkkale, Turkey. nuray.bayar@yahoo.com.'}, {'ForeName': 'Osman Kürşat', 'Initials': 'OK', 'LastName': 'Arıkan', 'Affiliation': 'Adana Ortadoğu Hospital, ENT Clinics, Adana, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-021-05998-9']
1355,33591346,Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial.,"Importance


Thigh muscle weakness is associated with knee discomfort and osteoarthritis disease progression. Little is known about the efficacy of high-intensity strength training in patients with knee osteoarthritis or whether it may worsen knee symptoms.
Objective


To determine whether high-intensity strength training reduces knee pain and knee joint compressive forces more than low-intensity strength training and more than attention control in patients with knee osteoarthritis.
Design, Setting, and Participants


Assessor-blinded randomized clinical trial conducted at a university research center in North Carolina that included 377 community-dwelling adults (≥50 years) with body mass index (BMI) ranging from 20 to 45 and with knee pain and radiographic knee osteoarthritis. Enrollment occurred between July 2012 and February 2016, and follow-up was completed September 2017.
Interventions


Participants were randomized to high-intensity strength training (n = 127), low-intensity strength training (n = 126), or attention control (n = 124).
Main Outcomes and Measures


Primary outcomes at the 18-month follow-up were Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) knee pain (0 best-20 worst; minimally clinically important difference [MCID, 2]) and knee joint compressive force, defined as the maximal tibiofemoral contact force exerted along the long axis of the tibia during walking (MCID, unknown).
Results


Among 377 randomized participants (mean age, 65 years; 151 women [40%]), 320 (85%) completed the trial. Mean adjusted (sex, baseline BMI, baseline outcome values) WOMAC pain scores at the 18-month follow-up were not statistically significantly different between the high-intensity group and the control group (5.1 vs 4.9; adjusted difference, 0.2; 95% CI, -0.6 to 1.1; P = .61) or between the high-intensity and low-intensity groups (5.1 vs 4.4; adjusted difference, 0.7; 95% CI, -0.1 to 1.6; P = .08). Mean knee joint compressive forces were not statistically significantly different between the high-intensity group and the control group (2453 N vs 2512 N; adjusted difference, -58; 95% CI, -282 to 165 N; P = .61), or between the high-intensity and low-intensity groups (2453 N vs 2475 N; adjusted difference, -21; 95% CI, -235 to 193 N; P = .85). There were 87 nonserious adverse events (high-intensity, 53; low-intensity, 30; control, 4) and 13 serious adverse events unrelated to the study (high-intensity, 5; low-intensity, 3; control, 5).
Conclusions and Relevance


Among patients with knee osteoarthritis, high-intensity strength training compared with low-intensity strength training or an attention control did not significantly reduce knee pain or knee joint compressive forces at 18 months. The findings do not support the use of high-intensity strength training over low-intensity strength training or an attention control in adults with knee osteoarthritis.
Trial Registration


ClinicalTrials.gov Identifier: NCT01489462.",2021,"WOMAC pain scores at the 18-month follow-up were not statistically significantly different between the high-intensity group and the control group (5.1 vs 4.9; adjusted difference, 0.2; 95% CI, -0.6 to 1.1; P = .61) or between the high-intensity and low-intensity groups (5.1 vs 4.4; adjusted difference, 0.7; 95% CI, -0.1 to 1.6; P = .08).","[' 151 women [40%]), 320 (85%) completed the trial', 'adults with knee osteoarthritis', '377 randomized participants (mean age, 65 years', 'patients with knee osteoarthritis', 'Adults With Knee Osteoarthritis', 'university research center in North Carolina that included 377 community-dwelling adults (≥50 years) with body mass index (BMI) ranging from 20 to 45 and with knee pain and radiographic knee osteoarthritis']","['low-intensity strength training', 'High-Intensity Strength Training', 'low-intensity strength training (n\u2009=\u2009126), or attention control', 'high-intensity strength training over low-intensity strength training', 'high-intensity strength training']","['knee pain or knee joint compressive forces', 'knee joint compressive force', 'Knee Pain and Knee Joint Compressive Forces', '18-month follow-up were Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) knee pain (0', 'Mean adjusted (sex, baseline BMI, baseline outcome values', 'Mean knee joint compressive forces', 'WOMAC pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",377.0,0.0944637,"WOMAC pain scores at the 18-month follow-up were not statistically significantly different between the high-intensity group and the control group (5.1 vs 4.9; adjusted difference, 0.2; 95% CI, -0.6 to 1.1; P = .61) or between the high-intensity and low-intensity groups (5.1 vs 4.4; adjusted difference, 0.7; 95% CI, -0.1 to 1.6; P = .08).","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'J.B. Snow Biomechanics Laboratory, Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mihalko', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DeVita', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'J Jeffery', 'Initials': 'JJ', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology and Radiologic Science, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Rheumatology Department, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lyles', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, VA Boston Healthcare System, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'Department of Physiotherapy, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Loeser', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina School of Medicine, Chapel Hill.'}]",JAMA,['10.1001/jama.2021.0411']
1356,33591324,A randomized phase 2/3 study of R-CHOP vs CHOP combined with dose-dense rituximab for DLBCL: the JCOG0601 trial.,"Rituximab plus cyclophosphamide-doxorubicin-vincristine-prednisone (R-CHOP) is the standard of care for untreated diffuse large B-cell lymphoma (DLBCL). However, the schedule for rituximab administration has not been optimized. To compare standard R-CHOP with CHOP plus dose-dense weekly rituximab (RW-CHOP) in patients with untreated DLBCL, we conducted a phase 2/3 study (JCOG0601, jRCTs031180139). Patients were randomly assigned to R-CHOP (CHOP-21 with 8 doses of rituximab once every 3 weeks [375 mg/m2]) or RW-CHOP (CHOP-21 with 8 doses of weekly rituximab [375 mg/m2]) groups. The primary end point of the phase 2 component was percent complete response (%CR) of the RW-CHOP arm, whereas that of the phase 3 component was progression-free survival (PFS). Between December 2007 and December 2014, 421 untreated patients were randomly assigned to R-CHOP (213 patients) or RW-CHOP (208 patients). The %CR in the RW-CHOP arm was 85.3% and therefore met the prespecified decision criteria for the phase 2 component. With a median follow-up of 63.4 months, the 3-year PFS and overall survival were 79.2% and 88.7% in the R-CHOP arm and 80.3% and 90.4% in the RW-CHOP arm, respectively. There was no significant difference in PFS (hazard ratio, 0.95; 90.6% confidence interval, 0.68-1.31). Although the safety profile and efficacy of RW-CHOP was comparable with R-CHOP and its tolerability was acceptable, weekly rituximab in combination with CHOP during the early treatment period did not improve PFS in untreated patients with DLBCL. This trial was registered at jrct.niph.go.jp as #jRCTs031180139.",2021,"There was no significant difference in PFS (hazard ratio, 0.95; 90.6% confidence interval, 0.68-1.31).","['untreated patients with DLBCL', 'patients with untreated DLBCL', 'Between December 2007 and December 2014, 421 untreated patients']","['R-CHOP (CHOP-21 with 8 doses of rituximab', 'Rituximab plus cyclophosphamide-doxorubicin-vincristine-prednisone (R-CHOP', 'standard R-CHOP with CHOP plus dose-dense weekly rituximab (RW-CHOP', 'R-CHOP vs CHOP combined with dose-dense rituximab', 'R-CHOP', 'RW-CHOP (CHOP-21 with 8 doses of weekly rituximab', 'RW-CHOP']","['3-year PFS and overall survival', 'progression-free survival (PFS', 'percent complete response', 'PFS']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",421.0,0.106965,"There was no significant difference in PFS (hazard ratio, 0.95; 90.6% confidence interval, 0.68-1.31).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ohmachi', 'Affiliation': 'Department of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology and.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Hematology and Oncology, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Norifumi', 'Initials': 'N', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Hematology, Gunma University Hospital, Gunma, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Utsumi', 'Affiliation': 'Department of Hematology, Shiga General Hospital, Shiga, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Imaizumi', 'Affiliation': 'Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Masaki', 'Affiliation': 'Department of Hematology and Immunology, Medicine, Kanazawa Medical University, Ishikawa, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Murayama', 'Affiliation': 'Department of Hematology, Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yakushijin', 'Affiliation': 'First Department of Internal Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Youko', 'Initials': 'Y', 'LastName': 'Suehiro', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Kisato', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Dobashi', 'Affiliation': 'Department of Clinical Oncology and Hematology, The Jikei University Daisan Hospital, Tokyo, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan; and.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology and.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Hematology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Pathology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Tomomitsu', 'Initials': 'T', 'LastName': 'Hotta', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Blood advances,['10.1182/bloodadvances.2020002567']
1357,33591313,Personalising heart failure management in CKD patients.,"CKD in heart failure patients is common, present in 49%, associated with higher mortality [Hazard ratio, 2.34 (95% CI2.20-2.50, P < 0.001) and multiple hospital admissions. The management of heart failure in CKD can be challenging due to drug induced electrolyte and creatinine changes; resistance to diuretics and infections related to device therapy. Evidence for improvement in mortality and heart failure hospitalisations exists in HFrEF stage 3 CKD patients from randomised controlled trials of ACE-inhibitor and mineralocorticoid receptor antagonist therapy; but not in dialysis patients where higher doses can cause hyperkalaemia. Evidence on improvement of cardiovascular death and heart failure hospitalisations has emerged with angiotensin blocker-neprilysin inhibitor, ivabradine and more recently with sodium-glucose cotransporter inhibitors in HFrEF patients with CKD stages 1,2, and 3. However these studies have excluded CKD 4,5 patients. Evidence for betablocker therapy exists in CKD stages 1,2 and 3 and separately in haemodialysis patients. Cardiac resynchronisation therapy reduces heart failure hospitalisations and mortality in patients with CKD 1,2,3 but not in CKD stages 4,5 or dialysis patients. Internal cardioverter and defibrillator therapy in HFrEF patients have been shown to be beneficial in CKD 3 patients, not in dialysis patients where it is associated with high rates of infection. For HFpEF patients with CKD therapy is symptomatic as there is no proven therapy for improvement in survival or hospitalisations. Heart failure patients with end-stage-kidney disease with fluid overload may benefit from peritoneal dialysis. A multidisciplinary, personalised approach has been associated with better care and improved patient satisfaction.",2021,"CKD in heart failure patients is common, present in 49%, associated with higher mortality [Hazard ratio, 2.34 (95% CI2.20-2.50, P < 0.001) and multiple hospital admissions.","['HFrEF stage 3 CKD patients', 'haemodialysis patients', 'patients with CKD 1,2,3 but not in CKD stages 4,5 or dialysis patients', 'HFrEF patients', 'CKD patients', 'Heart failure patients with end-stage-kidney disease with fluid overload may benefit from peritoneal dialysis']","['Cardiac resynchronisation therapy', 'ACE-inhibitor and mineralocorticoid receptor antagonist therapy', 'Internal cardioverter and defibrillator therapy']",['cardiovascular death and heart failure hospitalisations'],"[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0300821,"CKD in heart failure patients is common, present in 49%, associated with higher mortality [Hazard ratio, 2.34 (95% CI2.20-2.50, P < 0.001) and multiple hospital admissions.","[{'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals NHS Foundation Trust; Cardiovascular Clinical Academic Group, Molecular and Clinical Sciences Research Institute; St George's, University of London; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.""}, {'ForeName': 'Angela Yee-Moon', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals NHS Foundation Trust; Cardiovascular Clinical Academic Group, Molecular and Clinical Sciences Research Institute; St George's, University of London; Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.""}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfab026']
1358,33591291,"The Impact of Nonpharmacological Interventions on Patient Experience, Opioid Use, and Health Care Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study.","BACKGROUND


Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated comfort coach has not been evaluated in an adult surgical setting.
OBJECTIVE


This trial aims to assess whether nonpharmacological interventions administered by a trained comfort coach affect patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. This study has 3 specific aims: assess the effect of a comfort coach on patient experience, measure differences in inpatient and outpatient opioid use and postoperative health care utilization, and qualitatively evaluate the comfort coach intervention.
METHODS


To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at 6 points: preoperative outpatient clinic, preoperative care unit on the day of surgery, extubation, chest tube removal, hospital discharge, and 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up. For aim 2, we will record inpatient opioid use and collect postdischarge opioid use and pain-related outcomes through an 11-item questionnaire administered at the 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 days after surgery. For aim 3, we will perform semistructured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis.
RESULTS


This trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020.
CONCLUSIONS


Data generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study's findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/21350.",2021,"To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up.","['154 adult cardiac surgery patients at Michigan Medicine', 'patients undergoing cardiac surgery experience severe anxiety and pain', 'adult cardiac surgery patient experience', 'Adult Cardiac Surgery Patients', 'enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020', 'naive patients undergoing first-time, elective cardiac surgery via sternotomy', 'adult cardiac surgery patients']","['comfort coach', 'Opioid', 'comfort coach (intervention) versus usual care (control', 'Nonpharmacological Interventions', 'nonpharmacological interventions']","['Patient Experience, Opioid Use, and Health Care Utilization', 'perioperative anxiety, self-reported pain, functional status, and patient satisfaction', ""Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and an unplanned doctor's office visit""]","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}]",154.0,0.127237,"To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at preoperative outpatient clinic, discharge, 30-day follow-up, and 90-day follow-up.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Brescia', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Piazza', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jessica N', 'Initials': 'JN', 'LastName': 'Jenkins', 'Affiliation': ""Department of Child and Family Life, CS Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Lindsay K', 'Initials': 'LK', 'LastName': 'Heering', 'Affiliation': ""Department of Child and Family Life, CS Mott Children's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Ivacko', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Piazza', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Dwyer-White', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Stefanie L', 'Initials': 'SL', 'LastName': 'Peters', 'Affiliation': 'Frankel Cardiovascular Center, Michigan Medicine, Ann Arbor, MI, United States.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Cepero', 'Affiliation': ""Children and Women's Hospital, Michigan Medicine, Ann Arbor, MI, United States.""}, {'ForeName': 'Bailey H', 'Initials': 'BH', 'LastName': 'Brown', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Faraz N', 'Initials': 'FN', 'LastName': 'Longi', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Katelyn P', 'Initials': 'KP', 'LastName': 'Monaghan', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Bauer', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Varun G', 'Initials': 'VG', 'LastName': 'Kathawate', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Jafri', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Webster', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kasperek', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Nickole L', 'Initials': 'NL', 'LastName': 'Garvey', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schwenzer', 'Affiliation': 'Office of Patient Experience, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Kiran H', 'Initials': 'KH', 'LastName': 'Lagisetty', 'Affiliation': 'Department of Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Osborne', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Waljee', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Riba', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Likosky', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Byrnes', 'Affiliation': 'Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/21350']
1359,33591290,Acceptability of a Mobile Health Behavior Change Intervention for Cancer Survivors With Obesity or Overweight: Nested Mixed Methods Study Within a Randomized Controlled Trial.,"BACKGROUND


A significant proportion of cancer survivors have overweight or obesity. Although this has negative implications for health, weight management is not a standard component of oncology aftercare. Mobile health (mHealth) technology, in combination with behavior change techniques (BCTs), has the potential to support positive lifestyle changes. Few studies have been carried out with cancer survivors; therefore, the acceptability of these tools and techniques requires further investigation.
OBJECTIVE


The aim of this study is to examine the acceptability of a behavior change intervention using mHealth for cancer survivors with a BMI of 25 or more and to gather constructive feedback from participants.
METHODS


The intervention consisted of educational sessions and an 8-week physical activity goal setting intervention delivered using mobile technology (ie, Fitbit activity monitor plus SMS contact). In the context of a two-arm randomized controlled trial, semistructured interviews were conducted to assess the retrospective acceptability of the intervention from the perspective of the recipients. The theoretical framework for the acceptability of health care interventions was used to inform a topic guide. The interviews were transcribed and analyzed using thematic analysis. A quantitative survey was also conducted to determine the acceptability of the intervention. A total of 13 participants were interviewed, and 36 participants completed the quantitative survey.
RESULTS


The results strongly support the acceptability of the intervention. The majority of the survey respondents held a positive attitude toward the intervention (35/36, 97%). In qualitative reports, many of the intervention components were enjoyed and the mHealth components (ie, Fitbit and goal setting through text message contact) were rated especially positively. Responses were mixed as to whether the burden of participating in the intervention was high (6/36, 17%) or low (5/36, 14%). Participants perceived the intervention as having high efficacy in improving health and well-being (34/36, 94%). Most respondents said that they understood how the intervention works (35/36, 97%), and qualitative data show that participants' understanding of the aim of the intervention was broader than weight management and focused more on moving on psychologically from cancer.
CONCLUSIONS


On the basis of the coherence of responses with theorized aspects of intervention acceptability, we are confident that this intervention using mHealth and BCTs is acceptable to cancer survivors with obesity or overweight. Participants made several recommendations concerning the additional provision of social support. Future studies are needed to assess the feasibility of delivery in clinical practice and the acceptability of the intervention to those delivering the intervention.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/13214.",2021,"Participants perceived the intervention as having high efficacy in improving health and well-being (34/36, 94%).","['Cancer Survivors With Obesity or Overweight', 'cancer survivors with obesity or overweight', 'A total of 13 participants were interviewed, and 36 participants completed the quantitative survey', 'cancer survivors with a BMI of 25 or more and to gather constructive feedback from participants']","['behavior change intervention', 'Mobile health (mHealth) technology, in combination with behavior change techniques (BCTs', 'Mobile Health Behavior Change Intervention', 'educational sessions and an 8-week physical activity goal setting intervention delivered using mobile technology (ie, Fitbit activity monitor plus SMS contact']",[],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4042837', 'cui_str': 'Constructive Feedback'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",[],13.0,0.0637157,"Participants perceived the intervention as having high efficacy in improving health and well-being (34/36, 94%).","[{'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'Groarke', 'Affiliation': ""Centre for Improving Health-Related Quality of Life, School of Psychology, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Richmond', 'Affiliation': 'Letterkenny University Hospital, Donegal, Ireland.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Mc Sharry', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'AnnMarie', 'Initials': 'A', 'LastName': 'Groarke', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Owen M', 'Initials': 'OM', 'LastName': 'Harney', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Kelly', 'Affiliation': 'Letterkenny University Hospital, Donegal, Ireland.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Walsh', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Galway, Ireland.'}]",JMIR mHealth and uHealth,['10.2196/18288']
1360,33591279,"Effect of a Parent-Focused eHealth Intervention on Children's Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial.","BACKGROUND


In Western countries, children's diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family's diet.
OBJECTIVE


In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers' diets by shaping their food and eating environment.
METHODS


The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed.
RESULTS


At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (P=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (P<.001), regardless of group.
CONCLUSIONS


A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420.",2021,A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2.,"['Parent-child dyads were recruited through social media', 'Food4toddlers', '298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2', 'Norway in 2017-2018']","['Parent-Focused eHealth Intervention', 'Food4toddlers eHealth intervention']","['dietary changes', ""Children's Fruit, Vegetable, and Discretionary Food Intake"", 'frequency of vegetable intake', 'changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",298.0,0.0881134,A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2.,"[{'ForeName': 'Margrethe', 'Initials': 'M', 'LastName': 'Røed', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Anine C', 'Initials': 'AC', 'LastName': 'Medin', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Frøydis N', 'Initials': 'FN', 'LastName': 'Vik', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Elisabet R', 'Initials': 'ER', 'LastName': 'Hillesund', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Van Lippevelde', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nina C', 'Initials': 'NC', 'LastName': 'Øverby', 'Affiliation': 'Department of Nutrition and Public Health, University of Agder, Kristiansand, Norway.'}]",Journal of medical Internet research,['10.2196/18311']
1361,33591141,A randomized clinical trial comparing six techniques of postoperative analgesia for elective total hip arthroplasty under subarachnoid anesthesia with opioids.,"BACKGROUND


Optimal control of acute postoperative pain and prevention of chronic persistent pain in total hip arthroplasty (THA) remain a challenge. The main hypothesis was that peripheral nerve blocks improve postoperative analgesia.
METHODS


Immediate postoperative pain (24 hours) was evaluated every hour in 510 patients using a verbal rating 11-point scale for patient self-reporting of pain (VRS-11). All patients received subarachnoid anesthesia (SA) and were randomly allocated in six groups: SA with morphine 0.1 (SA0.1) or 0.2 mg (SA0.2), fascia iliaca compartment block with dexamethasone 4 mg + levobupivacaine 0.375% 20 (FICB20) or 30 mL (FICB30), lateral femoral cutaneous nerve block with levobupivacaine 0.25% 5 ml (LFCNB) and FICB20+LFCNB. Standardized analgesia included intravenous metamizole magnesium, dexketoprofen and rescue with paracetamol and morphine, and/or regional rescue (FICB, LFCNB, femoral and sciatic nerve blocks).
RESULTS


37.5% of patients had at least one episode of pain, 31.3% of them needed rescue analgesia while the remaining 6.2% did not request analgesia. There were no significant differences between the groups in paracetamol, morphine and rescue nerve blocks requirements. There was pain only in 5.4% of the total PACU pain records: 3.1% mild pain, 1.7% moderate pain and 0.6% severe pain.
CONCLUSIONS


Combined with a multimodal analgesic approach, infra-inguinal FICB and LFCNB did not improve immediate postoperative analgesia for THA in our hospital. Other options and longer-term studies should be more extensively investigated to determine the role of peripheral blocks in postoperative pain treatment protocols.",2021,"There were no significant differences between the groups in paracetamol, morphine and rescue nerve blocks requirements.",['elective total hip arthroplasty under subarachnoid anesthesia with opioids'],"['subarachnoid anesthesia (SA', 'paracetamol and morphine', 'metamizole magnesium, dexketoprofen', 'postoperative analgesia', 'morphine 0.1 (SA0.1) or 0.2 mg (SA0.2), fascia iliaca compartment block with dexamethasone 4 mg + levobupivacaine 0.375% 20 (FICB20) or 30 mL (FICB30), lateral femoral cutaneous nerve block with levobupivacaine 0.25% 5 ml (LFCNB) and FICB20+LFCNB']","['postoperative analgesia', 'episode of pain', 'immediate postoperative analgesia', 'regional rescue (FICB, LFCNB, femoral and sciatic nerve blocks', 'verbal rating 11-point scale for patient self-reporting of pain (VRS-11', 'rescue analgesia', 'paracetamol, morphine and rescue nerve blocks requirements', 'pain']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0610271', 'cui_str': 'Metamizole magnesium'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C4517443', 'cui_str': '0.25'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0857125', 'cui_str': 'Immediate postoperative analgesia'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]",510.0,0.215716,"There were no significant differences between the groups in paracetamol, morphine and rescue nerve blocks requirements.","[{'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Ortiz-GÓmez', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain - j.r.ortiz.gomez.md.phd@gmail.com.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'PerepÉrez-Candel', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'PavÓn-Benito', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'TorrÓn-Abad', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Dorronsoro-Auzmendi', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'MartÍnez-GarcÍa', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Zabaleta-ZÚÑiga', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Azcona-Calahorra', 'Affiliation': 'Department of Anesthesiology, Hospital Complex of Navarra, Section D (Orthopedic Surgery Center), Elcano, Spain.'}, {'ForeName': 'Inocencia', 'Initials': 'I', 'LastName': 'Fornet-Ruiz', 'Affiliation': 'Department of Anesthesiology, Puerta de Hierro Majadahonda Hospital, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ortiz-DomÍnguez', 'Affiliation': 'School of Medicine, University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Palacio-Abizanda', 'Affiliation': 'Department of Anesthesiology, Gregorio Marañón Hospital, Madrid, Spain.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.14957-0']
1362,33591139,Superficial cervical plexus block alone or combined with interscalene brachial plexus block in surgery for clavicle fractures: a randomized clinical trial.,"BACKGROUND


The regional anesthesia technique which is suitable for fracture clavicle is a matter of debate. This study aimed to compare the use of superficial cervical plexus alone or in combination with interscalene block in patients undergoing internal fixation of fractured clavicle.
METHODS


Seventy patients undergoing internal fixation of fractured clavicle were enrolled in this clinical trial and randomly distributed into two groups; superficial cervical plexus block (CPB) group and combined superficial cervical plexus block and interscalene block (ISB) group. The regional anesthesia techniques were performed before induction of general anesthesia. The intraoperative fentanyl and isoflurane consumption, the postoperative morphine consumption, the postoperative pain score, the duration of postoperative analgesia, the incidence of perioperative complications, and the patient's satisfaction were recorded.
RESULTS


In comparison to the use of combined CPB and ISB, the use of CPB alone did not significantly change the postoperative morphine consumption (8.4±3.3 mg versus 7.3±3.2 mg (P = 0.2)), the time to the first request of postoperative analgesia (396.7 193.4 min versus 407.7±150.0 min (P = 0.8)), or the postoperative pain score (P ˃ 0.05). Also, it did not change the intraoperative fentanyl consumption (P = 0.3), the intraoperative isoflurane consumption (P = 0.7), the incidence of perioperative complication, or the degree of patient's satisfaction (P ˃ 0.05). It significantly decreased the incidence of phrenic nerve palsy (P = 0.03).
CONCLUSIONS


In patients undergoing internal fixation of clavicular fracture, the perioperative analgesic effect of SCP alone is equally effective to its use in combination with ISB.",2021,"Also, it did not change the intraoperative fentanyl consumption (P = 0.3), the intraoperative isoflurane consumption (P = 0.7), the incidence of perioperative complication, or the degree of patient's satisfaction (P ˃ 0.05).","['Seventy patients undergoing internal fixation of fractured clavicle', 'patients undergoing internal fixation of fractured clavicle', 'patients undergoing internal fixation of clavicular fracture', 'clavicle fractures']","['SCP', 'Superficial cervical plexus block alone or combined with interscalene brachial plexus block', 'superficial cervical plexus block (CPB) group and combined superficial cervical plexus block and interscalene block (ISB', 'superficial cervical plexus alone or in combination with interscalene block']","['postoperative morphine consumption', 'postoperative pain score', 'time to the first request of postoperative analgesia', 'incidence of phrenic nerve palsy', 'intraoperative isoflurane consumption', ""postoperative morphine consumption, the postoperative pain score, the duration of postoperative analgesia, the incidence of perioperative complications, and the patient's satisfaction"", 'intraoperative fentanyl consumption', ""incidence of perioperative complication, or the degree of patient's satisfaction""]","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0159658', 'cui_str': 'Fracture of clavicle'}]","[{'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228825', 'cui_str': 'Superficial branch of cervical plexus'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0238371', 'cui_str': 'Phrenic nerve lesion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0281221,"Also, it did not change the intraoperative fentanyl consumption (P = 0.3), the intraoperative isoflurane consumption (P = 0.7), the incidence of perioperative complication, or the degree of patient's satisfaction (P ˃ 0.05).","[{'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sameh A', 'Initials': 'SA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt - samehabdelkhalik1982@gmail.com.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Afandy', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.14865-5']
1363,33591137,Comparison of the analgesic effect of quadratus lumborum block and epidural block in open uterine surgery: a randomized controlled trial.,"BACKGROUND


Effective regional analgesia during open surgery could reduce opioid consumption and enhance early recovery. We compared the effects of the newly developed quadratus lumborum block (QLB) and the traditional epidural block (EB) in open uterine surgery.
METHODS


In this randomized controlled trial, we included patients scheduled for elective open uterine surgery during May-September 30, 2019. Patients received QLB or EB for perioperative pain relief before general anesthesia. Perioperative opioid consumption, and numeric rating scale (NRS, 0-10) pain scores after surgery, heart rate (HR), mean arterial pressure (MAP), ephedrine and urapidil use during surgery, lower limb muscle strength, timing of first flatus and defecation, nausea, vomiting, and other complications within 24 h post-surgery, were the primary and secondary outcomes, respectively.
RESULTS


Data of 72 (86%; 36/group) of 83 eligible patients were analyzed. Remifentanil consumption during surgery was higher in the QLB than in the EB group, while cumulative sufentanil consumption within 24 h post-surgery was similar between both groups. NRS pain scores at rest and during activity were higher at 1 h post-surgery, and MAP was higher at 5, 15, and 30 min post-incision in the QLB than in the EB group; HR was similar between groups. Lower ephedrine requirements, higher lower limb muscle strength at 1 h post-surgery, and lower nausea incidence were observed in the QLB group.
CONCLUSIONS


QLB produces a less intense but longer block and fewer side effects in the first 24 h after open uterine surgery than those produced by EB.",2021,"NRS pain scores at rest and during activity were higher at 1 h post-surgery, and MAP was higher at 5, 15, and 30 min post-incision in the QLB than in the EB group; HR was similar between groups.","['open uterine surgery', 'patients scheduled for elective open uterine surgery during May-September 30, 2019', 'Data of 72 (86%; 36/group) of 83 eligible patients were analyzed']","['quadratus lumborum block and epidural block', 'newly developed quadratus lumborum block (QLB) and the traditional epidural block (EB', 'QLB or EB']","['Remifentanil consumption', 'side effects', 'cumulative sufentanil consumption', 'perioperative pain relief', 'NRS pain scores', 'limb muscle strength', 'nausea incidence', 'Perioperative opioid consumption, and numeric rating scale (NRS, 0-10) pain scores after surgery, heart rate (HR), mean arterial pressure (MAP), ephedrine and urapidil use during surgery, lower limb muscle strength, timing of first flatus and defecation, nausea, vomiting, and other complications within 24 h post-surgery']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3665370', 'cui_str': 'Operation on uterus'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0077857', 'cui_str': 'urapidil'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",83.0,0.249226,"NRS pain scores at rest and during activity were higher at 1 h post-surgery, and MAP was higher at 5, 15, and 30 min post-incision in the QLB than in the EB group; HR was similar between groups.","[{'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'She', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Surgery, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Mingxiu', 'Initials': 'M', 'LastName': 'Kan', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Jiangsu University, Zhenjiang, China - wujin914@hotmail.com.'}]",Minerva anestesiologica,['10.23736/S0375-9393.21.14800-X']
1364,33591125,Low Molecular-weight Hyaluronic Acid Versus Physiotherapy for the Treatment of Supraspinatus Tendinopathy: A Randomized Comparative Clinical Trial.,"INTRODUCTION


The tendons of the rotator cuff are major sources of shoulder pain. This study aimed to compare the effects of low molecular-weight hyaluronic acid with physiotherapy (PT) in patients with supraspinatus tendinopathy (ST).
METHODS


We carried out a parallel two-group randomized comparative clinical trial in an outpatient clinic of physical medicine and rehabilitation at a teaching hospital. In total, 51 patients (31 women) aged 20 to 55 years with ST were randomly allocated to subacromial hyaluronate injection (n = 28) and PT (n = 23) groups. For the hyaluronate group, we administered a single injection of 2 mL (20 mg) hyaluronate 1% (500 to 700 kDa). For PT, we prescribed three sessions of treatment per week for 12 weeks, totaling 36 sessions including rotator cuff activation exercises. The primary outcome was shoulder pain in the visual analog scale. The secondary outcomes included the range of movement and the disability score of the shoulder, and a World Health Organization questionnaire on quality of life. We did the measurements at the baseline and at one, four, and 12 weeks after intervention.
RESULTS


The results showed that both interventions were beneficial in the management of ST. However, hyaluronate was more effective in reducing shoulder pain at rest and during activities (both P < 0.001, effect size = 0.52 and 0.68, respectively). The two interventions similarly decreased patients' disability (P = 0.196). Hyaluronate improved shoulder motion and the quality of life better than PT.
CONCLUSION


In the treatment of ST, low molecular-weight hyaluronate is more effective than PT, at least for three months. Particularly, hyaluronate is more successful in alleviating pain.",2021,"However, hyaluronate was more effective in reducing shoulder pain at rest and during activities (both P < 0.001, effect size = 0.52 and 0.68, respectively).","['Supraspinatus Tendinopathy', 'patients with supraspinatus tendinopathy (ST', '51 patients (31 women) aged 20 to 55 years with ST', 'outpatient clinic of physical medicine and rehabilitation at a teaching hospital']","['low molecular-weight hyaluronic acid with physiotherapy (PT', 'subacromial hyaluronate injection', 'Low Molecular-weight Hyaluronic Acid Versus Physiotherapy', 'rotator cuff activation exercises']","[""patients' disability"", 'range of movement and the disability score of the shoulder, and a World Health Organization questionnaire on quality of life', 'shoulder motion and the quality of life better', 'shoulder pain in the visual analog scale', 'shoulder pain']","[{'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C4307026', 'cui_str': 'hyaluronate Injection [Hyalgan]'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",51.0,0.0695729,"However, hyaluronate was more effective in reducing shoulder pain at rest and during activities (both P < 0.001, effect size = 0.52 and 0.68, respectively).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': 'From the Clinical Biomechanics and Ergonomics Research Center (Rezasoltani, Dadarkhah, Rousta, Vashaei), Faculty of Medicine, Aja University of Medical Sciences, Department of Clinical Pharmacy (Esmaily), School of Pharmacy, Shahid Beheshti University of Medical Sciences, and Pharmaceutical Sciences Research Center (Mohebbi), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': ''}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': ''}, {'ForeName': 'Mansoure', 'Initials': 'M', 'LastName': 'Rousta', 'Affiliation': ''}, {'ForeName': 'Rezvaneh', 'Initials': 'R', 'LastName': 'Mohebbi', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Vashaei', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-01014']
1365,33591115,Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study.,"BACKGROUND


Tools for the evaluation of gastric emptying have evolved over time. The purpose of this study was to show that the risk of pulmonary aspiration is not increased with carbohydrate drink, by demonstrating that the gastric antral cross-sectional area (CSA) of the NO-NPO group is either equivalent to or less than that of the NPO (nil per os) group.
METHODS


Sixty-four patients scheduled for elective laparoscopic benign gynecologic surgery were enrolled and randomly assigned to the NPO group (n = 32) or the NO-NPO group (n = 32). After having a regular meal until midnight before surgery, the NPO group fasted until surgery, while the NO-NPO group ingested 400 mL of a carbohydrate drink at midnight and freely up to 2 hours before anesthesia. The primary outcome was the gastric antral CSA by gastric ultrasound in right lateral decubitus position (RLDP). Noninferiority was defined as a mean difference of CSA <2.8 cm2. Secondary outcomes included CSA in supine position, gastric volume (GV), GV per weight (GV/kg), GV/kg >1.5 mL/kg, and Perlas grade.
RESULTS


CSA in RLDP was not different between the NPO group (6.25 ± 3.79 cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P = .959). The mean difference of CSA in RLDP (NO-NPO group - NPO group) was 0.04 (95% confidence interval [CI], -1.56 to 1.64), which was within the noninferiority margin of 2.8 cm2. CSA was not different between the 2 groups (4.17 ± 2.34 cm2 in NPO group versus 4.28 ± 1.23 cm2 in NO-NPO group; P = .828). GV in NPO group (70 ± 56 mL) was not different from NO-NPO group (66 ± 36 mL; mean difference, 3.66; 95% CI, -20 to 27; P = .756). GV/kg in the NPO group (1.25 ± 1.00 mL/kg) was not different from the NO-NPO group (1.17 ± 0.67 mL/kg; P = .694). The incidence of GV/kg > 1.5 mL/kg was not different between NPO (31.3%) and NO-NPO group (21.9%; P = .768). The median (interquartile range) of the Perlas grade was 1 (0-1) in NPO group and 0.5 (0-1) in NO-NPO group (P = .871).
CONCLUSIONS


Preoperative carbohydrates ingested up to 2 hours before anesthesia do not delay gastric emptying compared to midnight fasting, as evaluated with gastric ultrasound.",2021,"RESULTS


CSA in RLDP was not different between the NPO group (6.25 ± 3.79 cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P = .959).",['Sixty-four patients scheduled for elective laparoscopic benign gynecologic surgery'],"['Preoperative Carbohydrate Drinks', 'RLDP', 'NPO group fasted until surgery, while the NO-NPO group ingested 400 mL of a carbohydrate drink', 'NPO', 'NO-NPO']","['gastric antral CSA by gastric ultrasound in right lateral decubitus position (RLDP', 'delay gastric emptying', 'CSA in supine position, gastric volume (GV), GV per weight (GV/kg), GV/kg >1.5 mL/kg, and Perlas grade', 'CSA']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0029247', 'cui_str': 'Non-profit organization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",64.0,0.0873844,"RESULTS


CSA in RLDP was not different between the NPO group (6.25 ± 3.79 cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P = .959).","[{'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, College of Medicine, Kangwon National University, Chuncheon, Gangwon, Republic of Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huh', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, College of Medicine, Kangwon National University, Chuncheon, Gangwon, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine.'}, {'ForeName': 'Mi Sung', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology.'}, {'ForeName': 'Taejong', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Obstetrics & Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005411']
1366,33591032,Corneal Stromal Regeneration Therapy for Advanced Keratoconus: Long-term Outcomes at 3 Years.,"PURPOSE


To report the 3-year clinical outcomes of corneal stromal cell therapy consisting of the intrastromal implantation with autologous adipose-derived adult stem cells (ADASCs), and decellularized or ADASC-recellularized human donor corneal laminas in advanced keratoconus.
METHODS


Fourteen patients were enrolled in 3 experimental groups. Group 1 (G-1) patients underwent implantation of ADASCs alone (3 × 106 cells/1 mL) (n = 5). Group 2 (G-2) patients received a 120-μm decellularized corneal stroma lamina (n = 5). Group 3 (G-3) patients received a 120-μm lamina recellularized with ADASCs (1 × 106 cells/1 mL) (n = 4). ADASCs were obtained by elective liposuction. Implantation was performed into a femtosecond pocket under topical anesthesia.
RESULTS


At 3 years, a significant improvement of 1 to 2 logMAR lines in uncorrected distance visual acuity was observed in all groups. A statistically significant decrease in corrected distance visual acuity was obtained in G-2 and G-3 (P < 0.001) when compared with that of G-1. Rigid contact lens distance visual acuity showed a statistically significant worsening in G-2 (P < 0.001) compared with that of G-1. A statistically significant increase in central corneal thickness was observed in G-2 (P = 0.012) and G-3 (P < 0.001); in the Scheimpflug corneal topography, the thinnest point was observed in G-2 (P = 0.007) and G-3 (P = 0.001) when compared with that of G-1.
CONCLUSIONS


Intrastromal implantation of ADASCs and decellularized or ADASC-recellularized human corneal stroma laminas did not have complications at 3 years. The technique showed a moderate improvement in (uncorrected distance visual acuity) and (corrected distance visual acuity) in advanced keratoconus.",2021,Rigid contact lens distance visual acuity showed a statistically significant worsening in G-2 (P < 0.001) compared with that of G-1.,"['Advanced Keratoconus', 'Fourteen patients were enrolled in 3 experimental groups']","['implantation of ADASCs alone', 'corneal stromal cell therapy', 'intrastromal implantation with autologous adipose-derived adult stem cells (ADASCs), and decellularized or ADASC-recellularized human donor corneal laminas', '120-μm lamina recellularized with ADASCs', '120-μm decellularized corneal stroma lamina', 'Corneal Stromal Regeneration Therapy']","['corrected distance visual acuity', 'central corneal thickness', 'G-2', 'uncorrected distance visual acuity', 'moderate improvement in (uncorrected distance visual acuity) and (corrected distance visual acuity', 'Rigid contact lens distance visual acuity']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1636199', 'cui_str': 'Adipose derived adult stem cell'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0010040', 'cui_str': 'Structure of substantia propria of cornea'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730374', 'cui_str': 'Rigid contact lens'}]",14.0,0.0870047,Rigid contact lens distance visual acuity showed a statistically significant worsening in G-2 (P < 0.001) compared with that of G-1.,"[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'El Zarif', 'Affiliation': 'Lebaneese university Hadath: EDST of Biotechnology, Optica General, Saida, Lebanon; Division of Ophthalmology, Universidad Miguel Hernández University, Alicante, Spain; Lebaneese university Hadath: EDST of Biotechnology, Doctoral School of Sciences and Technology, Lebanese University, Hadath, Lebanon; GSBT Genomic Surveillance and Biotherapy Team, Faculty of Sciences, Lebanese University, Hadath, Lebanon. Cornea, Cataract and Refractive Surgery Unit, Vissum Instituto Oftalmologico de Alicante, Grupo Miranza, Alicante, Spain; Department of Clinical Medicine, Miguel Hernández University, Alicante, Spain; and Cell Engineering Laboratory, IdiPAZ, La Paz Hospital Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió', 'Affiliation': ''}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió Del Barrio', 'Affiliation': ''}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Abdul Jawad', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': ''}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Abdul Jawad', 'Affiliation': ''}, {'ForeName': 'María P', 'Initials': 'MP', 'LastName': 'De Miguel', 'Affiliation': ''}, {'ForeName': 'Nehman', 'Initials': 'N', 'LastName': 'Makdissy', 'Affiliation': ''}]",Cornea,['10.1097/ICO.0000000000002646']
1367,33548380,Post-prandial effects of high-polyphenolic extra virgin olive oil on endothelial function in adults at risk for type 2 diabetes: A randomized controlled crossover trial.,"BACKGROUND


Effects of olive oil on cardiovascular risk have been controversial. We compared the effects of high-polyphenolic extra virgin olive oil (EVOO) and refined olive oil without polyphenols on endothelial function (EF) in adults at risk for Type 2 diabetes mellitus (T2DM).
METHODS


Randomized, controlled, double-blind, crossover trial of 20 adults (mean age 56.1 years; 10 women, 10 men) at risk for T2DM (i.e., as defined by either prediabetes or metabolic syndrome) assigned to one of two possible sequence permutations of two different single dose treatments (50 mL of high-polyphenolic EVOO or 50 mL of refined olive oil without polyphenols), with 1-week washout. Participants received their olive oils in a smoothie consisting of ½ cup frozen blueberries and 1 cup (8 oz) low-fat vanilla yogurt blended together. Primary outcome measure was EF measured as flow-mediated dilatation. Participants were evaluated before and 2 h after ingestion of their assigned olive oil treatment.
RESULTS


EVOO acutely improved EF as compared to refined olive oil (1.2 ± 6.5% versus -3.6 ± 3.8%; p = 0.0086). No significant effects on systolic or diastolic blood pressure were observed.
CONCLUSIONS


High-polyphenolic EVOO acutely enhanced EF in the study cohort, whereas refined olive oil did not. Blood pressure effects were not observed. Reports on the vascular effects of olive oil ingestion should specify the characteristics of the oil.
CLINICAL TRIAL REGISTRATION NUMBER


NCT04025281.",2021,"RESULTS


EVOO acutely improved EF as compared to refined olive oil (1.2 ± 6.5% versus -3.6 ± 3.8%; p = 0.0086).","['adults at risk for Type 2 diabetes mellitus (T2DM', 'adults at risk for type 2 diabetes', '20 adults (mean age 56.1\u202fyears; 10 women, 10 men) at risk for T2DM (i.e., as defined by either prediabetes or metabolic syndrome']","['olive oil treatment', 'high-polyphenolic extra virgin olive oil', 'olive oil', 'olive oils', 'olive oil ingestion', 'high-polyphenolic EVOO or 50\u202fmL of refined olive oil without polyphenols', 'high-polyphenolic extra virgin olive oil (EVOO) and refined olive oil without polyphenols']","['endothelial function (EF', 'systolic or diastolic blood pressure', 'endothelial function', 'Blood pressure effects', 'EF measured as flow-mediated dilatation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}]",20.0,0.369544,"RESULTS


EVOO acutely improved EF as compared to refined olive oil (1.2 ± 6.5% versus -3.6 ± 3.8%; p = 0.0086).","[{'ForeName': 'Valentine Y', 'Initials': 'VY', 'LastName': 'Njike', 'Affiliation': 'Yale-Griffin Prevention Research Center, United States of America; Griffin Hospital, Derby, CT (VN, RA, JT, KD, DK), United States of America. Electronic address: valentine.njike@yalegriffinprc.org.'}, {'ForeName': 'Rockiy', 'Initials': 'R', 'LastName': 'Ayettey', 'Affiliation': 'Yale-Griffin Prevention Research Center, United States of America; Griffin Hospital, Derby, CT (VN, RA, JT, KD, DK), United States of America. Electronic address: rockiy.ayettey@yalegriffinprc.org.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Treu', 'Affiliation': 'Yale-Griffin Prevention Research Center, United States of America; Griffin Hospital, Derby, CT (VN, RA, JT, KD, DK), United States of America.'}, {'ForeName': 'Kimberly N', 'Initials': 'KN', 'LastName': 'Doughty', 'Affiliation': 'Yale-Griffin Prevention Research Center, United States of America; Griffin Hospital, Derby, CT (VN, RA, JT, KD, DK), United States of America.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Katz', 'Affiliation': 'Yale-Griffin Prevention Research Center, United States of America.'}]",International journal of cardiology,['10.1016/j.ijcard.2021.01.062']
1368,33540351,The role of psychological variables in improving resilience: Comparison of an online intervention with a face-to-face intervention. A randomised controlled clinical trial in students of health sciences.,"BACKGROUND


Most studies on improving resilience lack representative samples and pre- and post-intervention assessments. Results regarding the effectiveness of online interventions versus face-to-face interventions are mixed.
OBJECTIVES


To evaluate the effectiveness of online and face-to-face programmes for the improvement of coping strategies to develop resilience to stressful situations, and to assess their relationship with personality traits, mood, and academic stressors.
DESIGN


Randomised controlled clinical trial. Three-armed parallel design.
PARTICIPANTS


245 students of the Nursing and Physical Therapy Degree.
METHODS


Students were randomly assigned to the control group (CG), intervention group 1 (IG-1, face-to-face) or intervention group 2 (IG-2, online). They were assessed after the intervention with the following instruments: the Positive and Negative Affect Schedule (PANAS), the Academic Stressors Scale, the Coping Orientation to Problems Experienced (COPE), the Connor-Davidson Resilience Scale, and the NEO-FFI scale.
RESULTS


Negative affect was higher in IG-1 (p = 0.12). The greatest stressors were methodological deficiencies of the teaching staff, academic overload, and beliefs about academic performance. The most widely used coping strategies were ""Active Problem-Focused Coping"" and ""Seeking Social Support"". There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086). On the Resilience scale, ""Persistence, Tenacity, and Self-Efficacy"" was higher in the CG, and there were differences with IG-1 (p = 0.06). With respect to the traits measured by the NEO-FFI questionnaire, higher levels of emotional instability (neuroticism) were observed in IG-1 than in the CG (p = 0.06).
CONCLUSIONS


The results of both interventions are similar, with increased self-awareness of negative personality traits, which is useful for those ignoring their areas for improvement. In addition, these factors are further increased in individuals with high levels of neuroticism and low levels of extraversion. The online intervention was as effective as the face-to-face intervention.",2021,"There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086).","['Students', 'students of health sciences', '245 students of the Nursing and Physical Therapy Degree']","['control group (CG), intervention group 1 (IG-1, face-to-face) or intervention group 2 (IG-2, online', 'online intervention with a face-to-face intervention']","['methodological deficiencies of the teaching staff, academic overload, and beliefs about academic performance', 'Resilience scale, ""Persistence, Tenacity, and Self-Efficacy', 'NEO-FFI questionnaire, higher levels of emotional instability (neuroticism', 'IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions', 'Positive and Negative Affect Schedule (PANAS), the Academic Stressors Scale, the Coping Orientation to Problems Experienced (COPE), the Connor-Davidson Resilience Scale, and the NEO-FFI scale']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",245.0,0.0251234,"There were differences between IG-1 and IG-2 only regarding ""Focus on and Venting of Emotions"" (p = 0.086).","[{'ForeName': 'Luis Iván', 'Initials': 'LI', 'LastName': 'Mayor-Silva', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: limayors@ucm.es.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Romero-Saldaña', 'Affiliation': 'Grupo Asociado de Investigación Estilos de vida, innovación y salud. Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC). Faculty of Nursing, University of Cordoba. Avda. Menéndez Pidal, s/n 14071, Córdoba, Spain. Electronic address: z92rosam@uco.es.'}, {'ForeName': 'Antonio Gabriel', 'Initials': 'AG', 'LastName': 'Moreno-Pimentel', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: antomo05@ucm.es.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Álvarez-Melcón', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: angela.alvarez@ucm.es.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Molina-Luque', 'Affiliation': 'Grupo Asociado de Investigación Estilos de vida, innovación y salud. Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC). Faculty of Nursing, University of Cordoba. Avda. Menéndez Pidal, s/n 14071, Córdoba, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Meneses-Monroy', 'Affiliation': 'Faculty of Nursing, Physical Therapy, and Podiatry, Complutense University of Madrid, Faculty of Medicine Building, 3.ª Planta, Plaza de Ramón y Cajal, 3, CP: 28040 Madrid, Spain. Electronic address: ameneses@ucm.es.'}]",Nurse education today,['10.1016/j.nedt.2021.104778']
1369,33540180,"Role of active cycle of breathing technique for patients with chronic obstructive pulmonary disease: A pragmatic, randomized clinical trial.","BACKGROUND


While active cycle of breathing technique for chronic obstructive pulmonary disease patients with more sputum can improve clinic outcomes, less is known about sputum viscosity and sputum production of the intervention.
OBJECTIVE


The purpose of our study was to explore the effect of active cycle of breathing technique on sputum viscosity and production among patients with chronic obstructive pulmonary disease.
DESIGN


This was a two-arms, parallel, randomized clinical trial.
SETTING


Study enrollment, randomization and implementation were conducted in the department of respiratory medicine inpatient at the Medical Center in Changchun, China.
PARTICIPANTS


Hospitalized patients due to chronic obstructive pulmonary disease who met additional eligibility criteria were randomized to active cycle of breathing technique (n = 50) or usual care group (n = 50).
METHODS


Patients in the intervention group received a week-long intervention from an experienced physical therapist. Patients in the usual care group received usual care as well as information and advice in the light of their health plan from respiratory medicine. The primary outcome was the changes on sputum viscosity and production.
RESULTS


Among one hundred patients who were randomized (mean [SD] age, 54.89 [12.06] years; females, 58%), ninety-six participants completed the study. No significant differences were found between two groups on the changes of sputum viscosity (t = 0.277, P = 0.782). And there were insignificant differences between groups in the average amount of sputum among 1 h (Z=-1.848, P = 0.065) and significant differences in the average amount of sputum among 24 h (Z=-2.236, P = 0.025). From admission to one week recovery, the changes in ratio of forced expiratory volume in 1 s to forced vital capacity (Z=-4.511, P<0.0001) and arterial oxygen saturation (Z=-2.997, P = 0.003) were better in active cycle breathing technique group. Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069). No adverse events occurred during the study.
CONCLUSION


For patients with chronic obstructive pulmonary disease, active cycle of breathing technique can significantly result in sputum production and respiratory function, especially those of Global Initiative for Chronic Obstructive Lung Disease classification level 3, but did not result in the short-term improvement of sputum viscosity, quality of life and cost effectiveness. Registration number: ChiCTR2000033068.",2021,"Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069).","['chronic obstructive pulmonary disease patients with more sputum', 'one hundred patients who were randomized (mean [SD] age, 54.89 [12.06] years; females, 58%), ninety-six participants completed the study', 'Hospitalized patients due to chronic obstructive pulmonary disease who met additional eligibility criteria', 'Patients in the intervention group received a', 'Study enrollment, randomization and implementation were conducted in the department of respiratory medicine inpatient at the Medical Center in Changchun, China', 'patients with chronic obstructive pulmonary disease']","['usual care as well as information and advice in the light of their health plan from respiratory medicine', 'breathing technique', 'week-long intervention from an experienced physical therapist', 'active cycle of breathing technique (n\xa0=\xa050) or usual care group (n\xa0=\xa050']","['average amount of sputum', 'arterial oxygen saturation', 'changes in ratio of forced expiratory volume in 1\xa0s to forced vital capacity', 'sputum viscosity and production', 'adverse events', 'Total Chronic Obstructive Pulmonary Disease Assessment Test scale', 'changes of sputum viscosity', 'sputum viscosity, quality of life and cost effectiveness']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0454503', 'cui_str': 'Active cycle of breathing technique'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4758039', 'cui_str': 'Chronic Obstructive Pulmonary Disease Assessment Test scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",100.0,0.175681,"Total Chronic Obstructive Pulmonary Disease Assessment Test scale were similar among two groups (Z=-1.818, P = 0.069).","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: shenmy18@jlu.edu.cn.'}, {'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: yuewei@jlu.edu.cn.'}, {'ForeName': 'L Q', 'Initials': 'LQ', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: xulq18@jlu.edu.cn.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: shihy18@jlu.edu.cn.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: niyy18@jlu.edu.cn.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Lin', 'Affiliation': 'The First Hospital of Jilin University, No 71, Xinmin Street, 130000 Changchun, Jilin Province, China. Electronic address: 2571807028@qq.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, No 965, Xin Jiang Avenue, 130000 Changchun, Jilin Province, China. Electronic address: fli@jlu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2021.103880']
1370,33556493,Examining Adherence and Dose Effect of an Early Palliative Care Intervention for Advanced Heart Failure Patients.,"CONTEXT


Research priority guidelines highlight the need for examining the ""dose"" components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes.
OBJECTIVES


Examine the ""dose"" effect of PC intervention completion vs. non-completion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks.
METHODS


Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. 'Completers' defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. 'Non-completers' were defined as either not attending the OPCC or completing < 6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for 'completers' vs 'non-completers' over 32 weeks.
RESULTS


Of 208 intervention group participants, 81 (38.9%) were classified as 'completers' with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. 'Completers' vs. 'non-completers' groups were well-balanced at baseline; however 'non-completers' did report higher anxiety (6.0 vs 7.0, p<0.05, d=0.28). Moderate, clinically-significant, improved QoL differences were found at 16-weeks in 'completers' vs. 'non-completers' (between-group difference: -9.71 (3.18), d=0.47, p=0.002) but not healthcare use.
CONCLUSION


Higher intervention completion rates of an early PC intervention was associated with QoL improvements in patients with advanced HF. Future work should focus on identifying the most efficacious ""dose"" of intervention components and increasing adherence to them.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02505425 KEY MESSAGE: Higher intervention completion of a HF early PC intervention (ENABLE CHF-PC) was associated with QoL improvements in patients with advanced HF. Future work should seek to enhance adherence to early PC interventions and identify other efficacious intervention ""dose"" components.",2021,Higher intervention completion of a HF early PC intervention (ENABLE CHF-PC) was associated with QoL improvements in patients with advanced HF.,"['patients with advanced heart failure (HF) over 32 weeks', 'Advanced Heart Failure Patients', 'patients with advanced HF', 'patients with New York Heart Association (NYHA) Class III/IV HF. ', ""Of 208 intervention group participants, 81 (38.9%) were classified as 'completers' with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. ""]","['PC intervention completion vs. non-completion', 'Early Palliative Care Intervention', ""palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. 'Non-completers' were defined as either not attending the OPCC or completing < 6 telehealth sessions"", 'HF early PC intervention']","['anxiety', 'QoL differences', 'QoL improvements', 'quality of life (QoL) and healthcare use', 'QoL and healthcare resource use (hospital days; emergency department visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3714595', 'cui_str': 'Palliative care nurse'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0559294', 'cui_str': 'Did not attend'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",,0.0747557,Higher intervention completion of a HF early PC intervention (ENABLE CHF-PC) was associated with QoL improvements in patients with advanced HF.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, AL, NB 352 │ 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: raduncan@uab.edu.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, AL, NB 485J │ 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: dionneod@uab.edu.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, NB 485H │ 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: andreo@uab.edu.'}, {'ForeName': 'Harleah', 'Initials': 'H', 'LastName': 'Buck', 'Affiliation': 'Csomay Center for Gerontological Excellence, College of Nursing, University of Iowa Iowa City, 50 Newton Road | Iowa City, IA 52242-1121. Electronic address: harleah-buck@uiowa.edu.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, NB 573 │ 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: tejem@uab.edu.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Department of Medicine, Division of Gerontology, Geriatrics, Palliative Care, University of Alabama at Birmingham, Birmingham, AL; Birmingham VA Medical Center, VAMC 11G | 700 19th St South| Birmingham, AL 35233-0001. Electronic address: kburgio@uabmc.edu.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, NB 306 | 1720 2nd Avenue South| Birmingham, AL 35294-1210. Electronic address: macylynn@uab.edu.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Tucker', 'Affiliation': 'Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, CH19 219T | 1720 2nd Avenue South| Birmingham, AL 35294-2041. Electronic address: rtucker@uab.edu.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Diseases, University of Alabama at Birmingham, THT 321 | 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: spamboukian@uabmc.edu.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Department of Medicine, Division of Cardiovascular Diseases, University of Alabama at Birmingham, THT 338 | 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: jtallaj@uabmc.edu.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, NB 352 | 1720 2nd Avenue South| Birmingham, AL 35294-1210. Electronic address: sengler@uab.edu.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, ALNB 348 | 1720 2nd Avenue South| Birmingham, AL 35294-1210. Electronic address: anakonda@uab.edu.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, CH 19 | 1720 2nd Avenue South| Birmingham, AL 35294-1210. Electronic address: nmii30@uab.edu.'}, {'ForeName': 'Raegan', 'Initials': 'R', 'LastName': 'Durant', 'Affiliation': 'Department of Medicine, Division of Preventative Medicine, University of Alabama at Birmingham, MT 625│ 1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: rdurant@uabmc.edu.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Department of Medicine, Division of Gerontology, Geriatrics and Palliative Care, University of Alabama, SRC 152A │1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: kswetz@uabmc.edu.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, and Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, NB 573D │1720 2nd Avenue South│ Birmingham, AL 35294-1210. Electronic address: mbakitas@uab.edu.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2021.01.136']
1371,33556410,Impact of saffron (Crocus Sativus Linn) supplementation and resistance training on markers implicated in depression and happiness levels in untrained young males.,"BACKGROUND


We aimed to assess the effects of six weeks of resistance training (RT) combined with saffron supplementation on markers implicated in depression as well as happiness levels in untrained young males.
MATERIALS AND METHODS


Untrained young male participants were randomly assigned to one of two groups: RT + saffron supplement (RS; n = 14) or RT + placebo (RP; n = 14). For 6 weeks, participants in the RS group took one 150 mg pill of pure saffron immediately after each RT session and at the same time on non-training days. Those assigned to the RP group took a dextrose pill. Concentrations of Anandamide (AEA), 2-Arachidonoylglycerol (2-AG), serotonin, dopamine, β-endorphin (beta-endorphin), tryptophan, happiness levels (via questionnaire), and body composition were assessed before and after the 6 weeks of whole-body supervised RT (4x/week, 3 sets using 60-70% of 1-repetition maximum [1-RM]).
RESULTS


AEA (0.5 ng/ml), 2-AG (0.04 ng/ml), dopamine (0.7 ng/ml), and β-endorphin (9.4 pg/ml) concentrations significantly increased in the RS group (P<0.05) while no changes were detected in the RP group. Serotonin (RS = 0.5 ng/mL and RP = 0.09 ng/mL) concentrations and happiness levels significantly increased in both groups with greater changes in RS group while tryptophan concentrations remained unchanged (P> 0.05). In addition, both groups significantly increased muscular endurance with greater changes in RS group (P<0.05).
CONCLUSION


Six weeks of RT combined with saffron supplementation improved AEA, 2-AG, dopamine, β-endorphin, and serotonin concentrations. Moreover, the addition of saffron supplement to chronic RT results in greater improvements in happiness levels than RT alone.",2021,"Six weeks of RT combined with saffron supplementation improved AEA, 2-AG, dopamine, β-endorphin, and serotonin concentrations.","['Untrained young male participants', 'untrained young males']","['resistance training (RT) combined with saffron supplementation', 'saffron (Crocus Sativus Linn) supplementation and resistance training', 'dextrose pill', '2-AG', 'dopamine', 'Serotonin', 'RT\u202f+\u202fsaffron supplement (RS; n\u2009=\u200914) or RT\u202f+\u202fplacebo']","['Concentrations of Anandamide (AEA), 2-Arachidonoylglycerol (2-AG), serotonin, dopamine, β-endorphin (beta-endorphin), tryptophan, happiness levels (via questionnaire), and body composition', 'muscular endurance', 'ng/mL) concentrations and happiness levels', 'tryptophan concentrations', 'depression and happiness levels', 'AEA, 2-AG, dopamine, β-endorphin, and serotonin concentrations', 'happiness levels']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0946614', 'cui_str': 'Saffron Crocus'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0299477', 'cui_str': 'glyceryl 2-arachidonate'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0299477', 'cui_str': 'glyceryl 2-arachidonate'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0005210', 'cui_str': 'Beta endorphin'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0600648,"Six weeks of RT combined with saffron supplementation improved AEA, 2-AG, dopamine, β-endorphin, and serotonin concentrations.","[{'ForeName': 'Babak Hooshmand', 'Initials': 'BH', 'LastName': 'Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran. Electronic address: Will.fivb@yahoo.com.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Roozbeh', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, University Hospital of Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, Clermont-Ferrand, France.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, United States. Electronic address: awong@marymount.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2021.113352']
1372,33565286,"""Big girls don't cry"": the effect of the experimenter's sex and pain catastrophising on pain.","OBJECTIVES


The expression of pain in males and females involves complex socio-psychological mechanisms. Males may report lower pain to a female experimenter to appear strong, whereas females may report higher pain to a male experimenter to appear weak and to seek protection. However, evidence to support these stereotypes is inconclusive. Individuals who catastrophise about pain rate higher pain than those who do not. How pain catastrophising interacts with the effect of the experimenter's sex on pain reports is yet to be explored. Thus, the aim of this study was to determine whether pain catastrophising moderated the effect of the experimenter's sex on pain reports in healthy males and females.
METHODS


Participants (n=60, 30 males) were assigned to one of four experimental conditions: males tested by male experimenters, males tested by female experimenters, females tested by male experimenters, and females tested by female experimenters. Participants completed the Pain Catastrophising Scale, and then sensitivity to heat and to blunt (pressure-pain threshold) and sharp stimuli was assessed on both forearms, and to high frequency electrical stimulation (HFS) administered to one forearm.
RESULTS


Females reported lower pressure-pain thresholds than males irrespective of the experimenters' sex. Females reported lower sharpness ratings to male than female experimenters only when the test stimuli were moderately or intensely sharp. Higher pain catastrophising scores were associated with higher sharpness ratings in females but not males. Additionally, higher pain catastrophising scores were associated with greater temporal summation of pain to HFS, and with lower pressure-pain thresholds in females who were tested by male experimenters.
CONCLUSIONS


These findings indicate that the experimenters' sex and the participant's pain catastrophising score influence pain reports, particularly in females. Awareness of these psychosocial factors is important in order to interpret pain responses in a meaningful way, especially when females are tested by male experimenters. A greater awareness of sex/gender role biases and their potential interaction with pain catastrophising may help researchers and clinicians to interpret pain reports in meaningful ways. In turn, this may help to improve delivery of treatments for patients with chronic pain.",2021,Females reported lower sharpness ratings to male than female experimenters only when the test stimuli were moderately or intensely sharp.,"['healthy males and females', 'Participants (n=60, 30 males) were assigned to one of four experimental conditions: males tested by male experimenters, males tested by female experimenters, females tested by male experimenters, and females tested by female experimenters', 'in females who were tested by male experimenters', 'patients with chronic pain']",[],"['higher pain catastrophising scores', 'sharpness ratings', 'pressure-pain thresholds', 'Higher pain catastrophising scores', 'Pain Catastrophising Scale, and then sensitivity to heat and to blunt (pressure-pain threshold) and sharp stimuli', 'expression of pain']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0246425,Females reported lower sharpness ratings to male than female experimenters only when the test stimuli were moderately or intensely sharp.,"[{'ForeName': 'Lechi', 'Initials': 'L', 'LastName': 'Vo', 'Affiliation': 'College of Science, Health, Education and Engineering, Discipline of Psychology, Murdoch University, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': 'College of Science, Health, Education and Engineering, Discipline of Psychology, Murdoch University, Perth, Western Australia, Australia.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0157']
1373,33568628,"Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial.","Treatment of severe Coronavirus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned at a 2:1 ratio to receive either UC-MSCs (4 × 10 7  cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test (6-MWT), maximum vital capacity, diffusing capacity, and adverse events were recorded and analyzed. In all, 100 COVID-19 patients were finally received either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was -13.31%, 95% CI -29.14%, 2.13%, P = 0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: -15.45%; 95% CI -30.82%, -0.39%; P = 0.043). The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057). The incidence of adverse events was similar in the two groups. These results suggest that UC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. A phase 3 trial is required to evaluate effects on reducing mortality and preventing long-term pulmonary disability. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.",2021,"The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057).","['COVID-19 patients with lung damage', '100 COVID-19 patients were finally received either', '101 severe COVID-19 patients with lung damage', 'severe COVID-19 patients with lung damage', 'severe COVID-19 patients']","['6-MWT', 'human umbilical cord-mesenchymal stem cells (UC-MSCs', 'placebo', 'UC-MSCs', 'human umbilical cord-derived mesenchymal stem cells']","['whole lung lesion volume', 'mortality and preventing long-term pulmonary disability', 'proportions of solid component lesion volume', 'altered proportion of whole lung lesion volumes', 'efficacy and safety', 'adverse events', '6-minute walk test (6-MWT), maximum vital capacity, diffusing capacity, and adverse events']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",100.0,0.741613,"The 6-MWT showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P = 0.057).","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory, Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xuechun', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Disease, General Hospital of Central Theater Command, Wuhan, China.'}, {'ForeName': 'Ruonan', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Jun-Liang', 'Initials': 'JL', 'LastName': 'Fu', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'VCANBIO Cell & Gene Engineering Corp., Ltd, Tianjin, China.'}, {'ForeName': 'Wei-Qi', 'Initials': 'WQ', 'LastName': 'Yao', 'Affiliation': 'National Industrial Base for Stem Cell Engineering Products, Tianjin, China.'}, {'ForeName': 'Tianyi', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Jinwen', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Optical Valley Branch of Maternal and Child Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, General Hospital of Central Theater Command, Wuhan, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Fanping', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yanning', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiqiu', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Wuhan Huoshenshan Hospital, Wuhan, China.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Maeurer', 'Affiliation': 'Immunotherapy Programme, Champalimaud Centre for the Unknown, Lisbon, Portugal.'}, {'ForeName': 'Alimuddin', 'Initials': 'A', 'LastName': 'Zumla', 'Affiliation': 'Center for Clinical Microbiology, Division of Infection and Immunity, University College London, and UCL Hospitals NIHR Biomedical Research Centre, London, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China. yaochen@hsc.pku.edu.cn.'}, {'ForeName': 'Wei-Fen', 'Initials': 'WF', 'LastName': 'Xie', 'Affiliation': 'Optical Valley Branch of Maternal and Child Hospital of Hubei Province, Wuhan, China. weifenxie@medmail.com.cn.'}, {'ForeName': 'Fu-Sheng', 'Initials': 'FS', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing, China. fswang302@163.com.'}]",Signal transduction and targeted therapy,['10.1038/s41392-021-00488-5']
1374,33571946,MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a.,"BACKGROUND


Subcutaneous (sc) interferon (IFN) β-1a reduces relapse rates and delays disability progression in patients with MS. We examined the association of the year 1 Magnetic Resonance Imaging in MS (MAGNIMS) score with long-term clinical disease activity (CDA) -free status and confirmed disability progression in patients treated with sc IFN β-1a in PRISMS.
METHODS


Patients treated with sc IFN β-1a three-times-weekly (22 or 44 μg; pooled data) were classified by MAGNIMS score (0, n = 129; 1, n = 108; 2, n = 130) at year 1. Hazard ratios (HR; 95% confidence intervals [CI]) for risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression were calculated by MAGNIMS score for up to 15 years of follow-up.
RESULTS


The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89], all p < 0.0001). The same outcome was observed with the risk of confirmed EDSS progression (1 versus 0: 1.93 [1.23-3.02]; 2 versus 0: 2.95 [1.95-4.46]; 2 versus 1: 1.53 [1.05-2.23]; all p < 0.0001).
CONCLUSION


In PRISMS, MAGNIMS score at Year 1 predicted risk of CDA and confirmed disability progression in sc IFN β-1a-treated patients over up to 15 years. PRISMS-15 clinicaltrial.gov identifier: NCT01034644.",2021,"The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89],","['Patients treated with sc IFN β-1a three-times-weekly (22 or 44\xa0μg; pooled data) were classified by MAGNIMS score (0, n\xa0=\xa0129; 1, n\xa0=\xa0108; 2, n\xa0=\xa0130) at year 1', 'patients treated with sc IFN β-1a in PRISMS', 'patients with MS']",['Subcutaneous (sc) interferon (IFN) β-1a'],"['risk of confirmed EDSS progression', 'disability progression', 'risk of CDA', 'relapse rates and delays disability progression', 'risk of CDA and confirmed Expanded Disability Status Score (EDSS) progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]",,0.115578,"The risk of CDA was higher with a year 1 MAGNIMS score of 1 versus 0 (HR 1.82 [1.38-2.41]), 2 versus 0 (2.63 [2.01-3.45]) and 2 versus 1 (1.45 [1.11-1.89],","[{'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa and Ospedale Policlinico San Martino IRCCS, Via Pastore 1, 16132, Genova, Italy. Electronic address: mariapia.sormani@unige.it.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, 501 Smyth Box 511, Ottawa, ON K1H 8L6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Aldridge', 'Affiliation': 'EMD Serono Research & Development Institute Inc., 45 Middlesex Turnpike, Billerica, MA 01821-3936, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Marhardt', 'Affiliation': 'Merck GmbH, Zimbagasse 5, 1147 Vienna, Austria.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Research Center Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'De Stefano', 'Affiliation': 'Department of Medicine, Surgery and Neuroscience, University of Siena, Viale Bracci 2, 53100, Siena, Italy.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2021.102790']
1375,33571868,"Body composition and weight changes after ivacaftor treatment in adults with cystic fibrosis carrying the G551 D cystic fibrosis transmembrane conductance regulator mutation: A double-blind, placebo-controlled, randomized, crossover study with open-label extension.","OBJECTIVES


In patients with cystic fibrosis (CF) who carry the G551D mutation, treatment with ivacaftor improves lung function and weight; however, short- and long-term impacts on body composition have not been well studied.
METHODS


Twenty adults with CF carrying the G551D mutation (mean ± standard deviation body mass index [BMI] 23.3 ± 4.3 kg/m 2 ) were recruited for a single-center, double-blind, placebo-controlled, 28-d, crossover study of ivacaftor, followed by an open-label extension (OLE) for 5 mo. Eleven patients underwent measurements 2 y later. The study variables included weight, BMI, and body composition (including fat-free mass [FFM] and fat mass).
RESULTS


After 28 d of treatment with ivacaftor, weight increased by 1.1 ± 1.3 kg, BMI by 0.4 ± 0.5 kg/m 2 , and FFM by 1.1 ± 1.2 kg (all P < .005) with no change in fat mass. Differences between 28-d changes on ivacaftor and placebo were not statistically significant. In the following 5 mo of the OLE, there were significant increases in weight (1.2 ± 1.9 kg; P < .05) and fat mass (1.5 ± 1.9 kg; P < .01), but not in FFM. Between baseline and the end of the OLE, the total weight gain was 2.5 ± 2.4 kg (P < .005), comprised of 0.9 ± 1.5 kg FFM (P < .05) and 1.6 ± 1.8 kg fat mass (P < .005). For the 11 participants who were followed for a further 2 y, no further changes in mean weight, BMI, or body composition parameters between 6 mo and 2 y later were observed.
CONCLUSIONS


Small gains were seen in FFM in the first month of ivacaftor treatment. Weight, BMI, and fat-mass gains in the first 6 mo on ivacaftor plateaued by 2.5 y. The metabolic and clinical consequences of weight and fat-mass gains remain to be determined.",2021,Differences between 28-d changes on ivacaftor and placebo were not statistically significant.,"['Twenty adults with CF carrying the G551D mutation (mean ± standard deviation body mass index', 'adults with cystic fibrosis carrying the G551 D cystic fibrosis transmembrane conductance regulator mutation', 'patients with cystic fibrosis (CF) who carry the G551D mutation, treatment with', 'Eleven patients underwent measurements 2']","['ivacaftor treatment', 'ivacaftor', 'placebo']","['weight', 'lung function and weight', 'fat mass', 'mean weight, BMI, or body composition parameters', 'weight, BMI, and body composition (including fat-free mass [FFM] and fat mass', 'Weight, BMI, and fat-mass gains', 'Body composition and weight changes', 'FFM', 'total weight gain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",20.0,0.0404613,Differences between 28-d changes on ivacaftor and placebo were not statistically significant.,"[{'ForeName': 'Susannah J', 'Initials': 'SJ', 'LastName': 'King', 'Affiliation': 'Nutrition Department, Alfred Hospital, Melbourne, Victoria, Australia; Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Dietetics, Nutrition and Sport, LaTrobe University, Victoria, Australia. Electronic address: s.king@alfred.org.au.'}, {'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Tierney', 'Affiliation': 'Nutrition Department, Alfred Hospital, Melbourne, Victoria, Australia; Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Dietetics, Nutrition and Sport, LaTrobe University, Victoria, Australia; School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Edgeworth', 'Affiliation': ""Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anesthesia and Intensive Care Medicine, St James' Hospital, Dublin, Ireland.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Keating', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elyssa', 'Initials': 'E', 'LastName': 'Williams', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kotsimbos', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Button', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia; Physiotherapy Department, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Wilson', 'Affiliation': 'Cystic Fibrosis Service, Department of Respiratory Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Medicine, Monash University, Melbourne, Victoria, Australia.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111124']
1376,33574371,A randomized controlled trial investigating the impact of maternal dietary supplementation with pomegranate juice on brain injury in infants with IUGR.,"Animal studies have demonstrated the therapeutic potential of polyphenol-rich pomegranate juice. We recently reported altered white matter microstructure and functional connectivity in the infant brain following in utero pomegranate juice exposure in pregnancies with intrauterine growth restriction (IUGR). This double-blind exploratory randomized controlled trial further investigates the impact of maternal pomegranate juice intake on brain structure and injury in a second cohort of IUGR pregnancies diagnosed at 24-34 weeks' gestation. Ninety-nine mothers and their eligible fetuses (n = 103) were recruited from Brigham and Women's Hospital and randomly assigned to 8 oz pomegranate (n = 56) or placebo (n = 47) juice to be consumed daily from enrollment to delivery. A subset of participants underwent fetal echocardiogram after 2 weeks on juice with no evidence of ductal constriction. 57 infants (n = 26 pomegranate, n = 31 placebo) underwent term-equivalent MRI for assessment of brain injury, volumes and white matter diffusion. No significant group differences were found in brain volumes or white matter microstructure; however, infants whose mothers consumed pomegranate juice demonstrated lower risk for brain injury, including any white or cortical grey matter injury compared to placebo. These preliminary findings suggest pomegranate juice may be a safe in utero neuroprotectant in pregnancies with known IUGR warranting continued investigation.Clinical trial registration: NCT04394910, https://clinicaltrials.gov/ct2/show/NCT04394910 , Registered May 20, 2020, initial participant enrollment January 16, 2016.",2021,"No significant group differences were found in brain volumes or white matter microstructure; however, infants whose mothers consumed pomegranate juice demonstrated lower risk for brain injury, including any white or cortical grey matter injury compared to placebo.","['57 infants (n\u2009=\u200926 pomegranate, n\u2009=\u200931', 'pregnancies with intrauterine growth restriction (IUGR', ""IUGR pregnancies diagnosed at 24-34\xa0weeks' gestation"", ""Ninety-nine mothers and their eligible fetuses (n\u2009=\u2009103) were recruited from Brigham and Women's Hospital and randomly assigned to 8\xa0oz pomegranate (n\u2009=\u200956) or"", 'infants with IUGR', 'https://clinicaltrials.gov/ct2/show/NCT04394910 , Registered May 20, 2020, initial participant enrollment January 16, 2016']","['maternal pomegranate juice intake', 'maternal dietary supplementation with pomegranate juice', 'placebo (n\u2009=\u200947) juice to be consumed daily from enrollment to delivery', 'placebo']",['brain volumes or white matter microstructure'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",,0.703843,"No significant group differences were found in brain volumes or white matter microstructure; however, infants whose mothers consumed pomegranate juice demonstrated lower risk for brain injury, including any white or cortical grey matter injury compared to placebo.","[{'ForeName': 'Madeline M', 'Initials': 'MM', 'LastName': 'Ross', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cherkerzian', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Mikulis', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': ""Department of Obstetrics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Terrie E', 'Initials': 'TE', 'LastName': 'Inder', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.""}, {'ForeName': 'Lillian G', 'Initials': 'LG', 'LastName': 'Matthews', 'Affiliation': ""Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA. lmatthews4@bwh.harvard.edu.""}]",Scientific reports,['10.1038/s41598-021-82144-0']
1377,33579766,"Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol.","INTRODUCTION


Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.
METHODS AND ANALYSIS


The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1-7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants' and caregivers' experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d'Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03784027.",2021,Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm.,"['72 children aged 1-7 years with type 1 diabetes on insulin pump therapy', 'very young children with type 1 diabetes (KidsAP02 study']","['closed-loop insulin delivery compared with sensor-augmented pump therapy', 'hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4\u2009weeks washout period before crossing over to the other arm', 'insulin pump and study continuous glucose monitoring devices']","['time spent above and below target glucose range, glycated haemoglobin and average sensor glucose', 'time spent in the target glucose range', 'efficacy, safety and utility', 'sensor glucose readings']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",72.0,0.102877,Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fuchs', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Allen', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Boughton', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Malgorzata E', 'Initials': 'ME', 'LastName': 'Wilinska', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Thankamony', 'Affiliation': 'Department of Paediatrics, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'de Beaufort', 'Affiliation': 'DECCP, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': ""Leeds Children's Hospital, Leeds, West Yorkshire, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Yong', 'Affiliation': ""Leeds Children's Hospital, Leeds, West Yorkshire, UK.""}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Froehlich-Reiterer', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Medical University of Graz, Graz, Steiermark, Austria.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Mader', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Steiermark, Austria.'}, {'ForeName': 'Sabine E', 'Initials': 'SE', 'LastName': 'Hofer', 'Affiliation': 'Department of Pediatrics I, Medical University of Innsbruck, Innsbruck, Tirol, Austria.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kapellen', 'Affiliation': 'Hospital for Children and Adolescents, University of Leipzig Faculty of Medicine, Leipzig, Sachsen, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Rami-Merhar', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tauschmann', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Endocrinology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kimbell', 'Affiliation': 'The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lawton', 'Affiliation': 'The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Roze', 'Affiliation': 'Vyoo Agency Sarl, Lyon, France.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sibayan', 'Affiliation': 'Jaeb Centre for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Centre for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, University of Cambridge School of Clinical Medicine, Cambridge, UK rh347@cam.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-042790']
1378,33579762,Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study.,"INTRODUCTION


Approximately one in three of all older adults fall each year, with wide ranging physical, psychosocial and healthcare-related consequences. Exercise-based interventions are the cornerstone for falls prevention programmes, yet these are not consistently provided, do not routinely address all components of the balance system and are often not well attended. The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system. The aims of this proof-of-concept study are to (1) determine the safety, acceptability and feasibility of providing HOLOBalance to community dwelling older adults at risk for falls and (2) provide data to support sample size estimates for a future trial.
METHODS


A single (assessor) blinded pilot randomised controlled proof of concept study. 120 participants will be randomised to receive an 8-week home exercise programme consisting of either: (1) HOLOBalance or (2) The OTAGO Home Exercise Programme. Participants will be required to complete their exercise programme independently under the supervision of a physiotherapist. Participants will have weekly telephone contact with their physiotherapist, and will receive home visits at weeks 0, 3 and 6. Outcome measures of safety, acceptability and feasibility, clinical measures of balance function, disability, balance confidence and cognitive function will be assessed before and immediately after the 8 week intervention. Acceptability and feasibility will be explored using descriptive statistics, and trends for effectiveness will be explored using general linear model analysis of variance.
ETHICS AND DISSEMINATION


This study has received institutional ethical approvals in Germany (reference: 265/19), Greece (reference: 9769/24-6-2019) and the UK (reference: 19/LO/1908). Findings from this study will be submitted for peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT04053829.
PROTOCOL VERSION


V.2, 20 January 2020.",2021,"The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system.","['older adults at risk for falls', '120 participants', 'community dwelling older adults at risk for falls and (2', 'VERSION\n\n\nV.2, 20 January 2020']","['HOLOBalance system', 'standard care', '8-week home exercise programme consisting of either: (1) HOLOBalance or (2']","['safety, acceptability and feasibility, clinical measures of balance function, disability, balance confidence and cognitive function', 'safety, acceptability and feasibility']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",120.0,0.140791,"The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Liston', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK matthew.liston@kcl.ac.uk.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Genna', 'Affiliation': 'The Ear Institute, University College London, London, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Maurer', 'Affiliation': 'Department of Neurology and Neuroscience, Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Kikidis', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Gatsios', 'Affiliation': 'Unit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Fotiadis', 'Affiliation': 'Unit of Medical Technology and Intelligent Information Systems, Department of Material Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Doris-Eva', 'Initials': 'DE', 'LastName': 'Bamiou', 'Affiliation': 'The Ear Institute, University College London, London, UK.'}, {'ForeName': 'Marousa', 'Initials': 'M', 'LastName': 'Pavlou', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2020-039254']
1379,33590739,"Occupational Therapists, Physiotherapists and Orthopaedic Surgeons Agree on the Decision for Carpal Tunnel Surgery.","BACKGROUND


Therapist-led pathways have been proposed as waitlist management strategies prior to surgery for conditions such as carpal tunnel syndrome (CTS) in public hospitals. These models of care typically shift the initial care of patients and decision-making from surgeons to therapists and, have been shown to reduce the number of patients requiring surgery and improve wait-times. This occurs despite limited evidence of surgeon-therapist agreement on key decisions, such as the need for surgery. The purpose of this was study was to assess the agreement between therapists and orthopaedic surgeons regarding the need for surgery for patients who have CTS.
METHODS


This blinded inter-rated agreement study was embedded in a multicentre randomised parallel groups trial of 105 patients with CTS referred to four orthopaedic departments and waitlisted for an appointment. The trial evaluated the effect of a therapist-led care pathway on the need for surgery and outcomes related to symptoms and function. Patients were randomised to either remain on the orthopaedic waitlist or receive group education, a splint and home exercises. The decision on the need for surgery at 6 months was made by a member of the orthopaedic consultant team or by one of the 14 participating therapists. The therapists and surgeons were blinded to each other's decision. Agreement was determined using percentage agreement, kappa coefficients (k), prevalence-adjusted and bias-adjusted kappa (PABAK), and Gwet's first-order agreement coefficient (AC1).
RESULTS


Substantial agreement was seen between therapists and surgeons regarding the need for surgery (PABAK=0.74 (0.60-0.88)). Agreement was significantly associated with experience (P=.02). Therapists with advanced experience and scope of practice demonstrated perfect agreement with surgeons (PABAK=1.00 (95% CI: 1.00-1.00)). Mid-career therapists demonstrated substantial agreement (PABAK=0.67 (95% CI: 0.42-0.91)) and early-career therapists demonstrated fair agreement (PABAK=0.43 (95% CI: -0.04-0.90)).
CONCLUSION


Therapists with advanced scope of practice make decisions that are consistent with orthopaedic surgeons.",2020,"RESULTS


Substantial agreement was seen between therapists and surgeons regarding the need for surgery (PABAK=0.74 (0.60-0.88)).","['105 patients with CTS referred to four orthopaedic departments and waitlisted for an appointment', 'patients who have CTS']","['orthopaedic waitlist or receive group education, a splint and home exercises', 'therapist-led care pathway']","[""kappa coefficients (k), prevalence-adjusted and bias-adjusted kappa (PABAK), and Gwet's first-order agreement coefficient (AC1""]","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",105.0,0.125461,"RESULTS


Substantial agreement was seen between therapists and surgeons regarding the need for surgery (PABAK=0.74 (0.60-0.88)).","[{'ForeName': 'Karina J', 'Initials': 'KJ', 'LastName': 'Lewis', 'Affiliation': 'Occupational Therapy Department, Gold Coast University Hospital, Southport, QLD, Australia.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Coppieters', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane and Gold Coast, QLD, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Vicenzino', 'Affiliation': 'School of Health and Rehabilitation Sciences: Physiotherapy, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hughes', 'Affiliation': 'Office of Research Governance and Development, Gold Coast University Hospital, Southport, QLD, Australia.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Division of Allied Health, Queen Elizabeth II Jubilee Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Annina B', 'Initials': 'AB', 'LastName': 'Schmid', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",International journal of health policy and management,['10.34172/ijhpm.2020.227']
1380,33590715,Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial.,"PURPOSE


Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient's blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability.
METHODS


In a prospective, double-blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one-month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre- and postoutcome measurements.
RESULTS


Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was -4.2 (-9.5 to 1.2) for autologous and -4.5 (-9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely.
CONCLUSION


Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.",2021,The estimated mean difference (95% confidence interval) was -4.2,"['Nineteen patients were enrolled, of whom 15 completed the trial', 'patients with severe dry eyes', 'patients who need SEDs but are clinically or logistically unable to donate blood']","['Autologous and allogeneic SEDs', 'Allogeneic SEDs', 'Allogeneic and autologous serum eye drops', 'autologous and allogeneic SEDs', 'autologous SEDs']","['Serum eye drops (SEDs', 'efficacy and tolerability', 'Ocular Surface Disease Index (OSDI', 'Adverse events', 'mean\xa0±\xa0SD OSDI']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0425264', 'cui_str': 'Willing to be donor of blood'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",19.0,0.0792957,The estimated mean difference (95% confidence interval) was -4.2,"[{'ForeName': 'Pieter F', 'Initials': 'PF', 'LastName': 'van der Meer', 'Affiliation': 'Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands.'}, {'ForeName': 'Sanne K', 'Initials': 'SK', 'LastName': 'Verbakel', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Áine', 'Initials': 'Á', 'LastName': 'Honohan', 'Affiliation': 'Department of Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Lorinser', 'Affiliation': 'Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands.'}, {'ForeName': 'Rogier M', 'Initials': 'RM', 'LastName': 'Thurlings', 'Affiliation': 'Department of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joannes F M', 'Initials': 'JFM', 'LastName': 'Jacobs', 'Affiliation': 'Department of Laboratory Medicine, Laboratory Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'de Korte', 'Affiliation': 'Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands.'}, {'ForeName': 'Catharina A', 'Initials': 'CA', 'LastName': 'Eggink', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Acta ophthalmologica,['10.1111/aos.14788']
1381,33590683,Outcomes of semantic feature analysis treatment for aphasia with and without apraxia of speech.,"BACKGROUND


To date, studies have not explored whether a dual diagnosis of aphasia plus apraxia of speech (AOS) versus aphasia alone (APH) affects the response to language-based naming treatments.
AIMS


To compare the effects of semantic feature analysis (SFA) treatment for individuals with APH versus aphasia plus AOS, and to test if the presence of AOS impacted the effects of treatment.
METHODS AND PROCEDURES


A non-randomized experimental group study was conducted to explore the treatment, generalization and maintenance effects between the AOS and APH groups. Participants included nine individuals with aphasia and 11 with concomitant aphasia and AOS. Dependent measures included lexical accuracy, number of sound-level distortions, and lexical stress and syllable segmentation errors.
OUTCOMES AND RESULTS


Both groups showed significantly improved naming accuracy of trained items for up to 2 months post-treatment. Improvement on naming accuracy of untrained items post-treatment, both semantically related and unrelated to trained items, was lower in magnitude. That this may have been due to effects of repeated probing (which included target repetition) or regression to the mean cannot be excluded. There was a tendency for the AOS group to respond slightly better to treatment than the APH group overall, which was not correlated with aphasia severity. Also, measures of phonetic accuracy and fluency improved for both groups, with no main effect of group. Treatment effects did not generalize to formal measures of (untrained) picture naming or expression of correct information units in discourse in a story retelling task.
CONCLUSIONS AND IMPLICATIONS


Findings indicate that individuals with aphasia plus AOS can gain equivalent benefits in word retrieval and production from the language-based SFA treatment as individuals with aphasia alone. This may be, in part, due to the tendency for SFA to incorporate principles of practice that are known to support motor learning in AOS, such as high intensity, random stimulus presentation and variable practice. Findings provide further support for high-intensity practice and use of self-generated features to facilitate maintenance of effects. What this paper adds What is already known on the subject SFA treatment is the most common intervention for word-finding difficulties for individuals with aphasia. AOS is a common concomitant disorder to aphasia. However, it is not clear whether the effects of language-based SFA treatment are mitigated by the presence of AOS, which tends to respond well to treatments focused on articulatory-kinematic aspects of speech movement. What this paper adds to the existing knowledge This study compares the effects of SFA in a group of individuals with aphasia alone and a group with similar severity of aphasia but with concomitant AOS, ranging from mild to moderate-severe. Overall, AOS did not have a negative effect on response to the treatment. What are the potential or actual clinical implications of this work? Individuals with aphasia plus AOS can be expected to benefit to a similar degree from SFA as people with aphasia alone. It is likely that the use of practice principles of high intensity, random stimulus presentation and varied practice are important components of the protocol.",2021,"Improvement on naming accuracy of untrained items post-treatment, both semantically related and unrelated to trained items, was lower in magnitude.","['aphasia with and without apraxia of speech', 'individuals with aphasia', 'individuals with APH versus aphasia plus AOS', 'individuals with aphasia alone and a group with similar severity of aphasia but with concomitant AOS, ranging from mild to moderate-severe', 'Participants included nine individuals with aphasia and 11 with concomitant aphasia and AOS']","['SFA', 'semantic feature analysis (SFA', 'aphasia alone (APH']","['naming accuracy of trained items', 'phonetic accuracy and fluency', 'lexical accuracy, number of sound-level distortions, and lexical stress and syllable segmentation errors']","[{'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0264611', 'cui_str': 'Apraxic aphonia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0632711', 'cui_str': ""N'-(3-aminopropyl)homospermidine""}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0632711', 'cui_str': ""N'-(3-aminopropyl)homospermidine""}]","[{'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0428754', 'cui_str': 'Sound level'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",9.0,0.0513453,"Improvement on naming accuracy of untrained items post-treatment, both semantically related and unrelated to trained items, was lower in magnitude.","[{'ForeName': 'Dominique I', 'Initials': 'DI', 'LastName': 'Scholl', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Nickels', 'Affiliation': 'Centre of Research Excellence in Aphasia Recovery and Rehabilitation, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12597']
1382,33590674,A bilingual dietary intervention early in treatment is feasible and prevents weight gain in childhood acute lymphoblastic leukemia.,"BACKGROUND


Childhood acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy. The onset of obesity during childhood ALL has been well established and is associated with inferior survival rates and increased treatment-related toxicities. This pilot study sought to determine if a dietary intervention is feasible and minimizes weight gain during the initial phases of treatment for ALL.
METHODS


Participants were recruited from four institutions, fluent in English or Spanish, between 5 and 21 years old, and enrolled within 3 days of starting induction therapy. Participants were counseled for 6 months to follow a low glycemic diet. Dietary and anthropometric data were collected at diagnosis, end of induction, and end of month 6 (NCT03157323).
RESULTS


Twenty-three of 28 participants (82.1%) were evaluable and included in the analysis. Dietary changes targeted by the nutrition intervention were successful; sugar intake declined (P = .003), whereas vegetable intake increased (P = .033). The majority of participants were able to adhere to the dietary principles prescribed: ≥70.0% reduced glycemic load and ≥60.0% increased fiber intake and decreased sugar intake. Importantly, we did not observe an increase in body mass index z-score during induction or over the 6-month intervention period. Most families found the nutrition intervention easy to follow (60%) and affordable (95%) despite simultaneous initiation of treatment for ALL.
CONCLUSIONS


A 6-month nutrition intervention initiated during the initial phase of treatment for childhood ALL is feasible and may prevent weight gain. Our preliminary findings need to be confirmed in a larger clinical trial.",2021,"Dietary changes targeted by the nutrition intervention were successful; sugar intake declined (P = .003), whereas vegetable intake increased (P = .033).","['childhood acute lymphoblastic leukemia', 'Twenty-three of 28 participants (82.1%) were evaluable and included in the analysis', 'Childhood acute lymphoblastic leukemia (ALL', 'Participants were recruited from four institutions, fluent in English or Spanish, between 5 and 21\xa0years old, and enrolled within 3\xa0days of starting induction therapy']",['dietary intervention'],"['successful; sugar intake', 'vegetable intake', 'weight gain', 'inferior survival rates', 'body mass index z-score', 'fiber intake and decreased sugar intake']","[{'cui': 'C0023452', 'cui_str': 'Lymphoblastic Leukemia, Acute, Childhood'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0549312,"Dietary changes targeted by the nutrition intervention were successful; sugar intake declined (P = .003), whereas vegetable intake increased (P = .033).","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Walters', 'Affiliation': 'Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Mowbray', 'Affiliation': ""Division of Oncology, Children's National Hospital, District of Columbia, Washington.""}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Jubelirer', 'Affiliation': ""Division of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': ""Division of Oncology, Children's National Hospital, District of Columbia, Washington.""}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics, Roswell Park Comprehensive Cancer Center and University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ""Division of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Biostatistics, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Zhezhen', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Biostatistics, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Elena J', 'Initials': 'EJ', 'LastName': 'Ladas', 'Affiliation': 'Division of Pediatric Hematology/Oncology/Stem Cell Transplant, Columbia University Irving Medical Center, New York, New York.'}]",Pediatric blood & cancer,['10.1002/pbc.28910']
1383,33590475,Adaptive intervention for prevention of adolescent suicidal behavior after hospitalization: a pilot sequential multiple assignment randomized trial.,"BACKGROUND


The need for effective interventions for psychiatrically hospitalized adolescents who have varying levels of postdischarge suicide risk calls for personalized approaches, such as adaptive interventions (AIs). We conducted a nonrestricted pilot Sequential, Multiple Assignment, Randomized Trial (SMART) to guide the development of an AI targeting suicide risk after hospitalization.
METHODS


Adolescent inpatients (N = 80; ages 13-17; 67.5% female) were randomized in Phase 1 to a Motivational Interview-Enhanced Safety Plan (MI-SP), delivered during hospitalization, alone or in combination with postdischarge text-based support (Texts). Two weeks after discharge, participants were re-randomized in Phase 2 to added telephone booster calls or to no calls. Mechanisms of change were assessed with daily diaries for four weeks and over a 1- and 3-month follow-up. This trial is registered with clinicaltrials.gov (identifier: NCT03838198).
RESULTS


Procedures were feasible and acceptable. Mixed effects models indicate that adolescents randomized to MI-SP + Texts (Phase 1) and those randomized to booster calls (Phase 2) experienced significant improvement in daily-level mechanisms, including safety plan use, self-efficacy to refrain from suicidal action, and coping by support seeking. Those randomized to MI-SP + Texts also reported significantly higher coping self-efficacy at 1 and 3 months. Although exploratory, results were in the expected direction for MI-SP + Texts, versus MI-SP alone, in terms of lower risk of suicide attempts (Hazard ratio = 0.30; 95% CI = 0.06, 1.48) and suicidal behavior (Hazard ratio = 0.36; 95% CI = 0.10, 1.37) three months after discharge. Moreover, augmentation with booster calls did not have an overall meaningful impact on suicide attempts (Hazard ratio = 0.65; 95% CI = 0.17, 3.05) or suicidal behavior (Hazard ratio = 0.78; 95% CI = 0.23, 2.67); however, boosters benefited most those initially assigned to MI-SP + Texts.
CONCLUSIONS


The current SMART was feasible and acceptable for the purpose of informing an AI for suicidal adolescents, warranting additional study. Findings also indicate that postdischarge text-based support offers a promising augmentation to safety planning delivered during hospitalization.",2021,"Moreover, augmentation with booster calls did not have an overall meaningful impact on suicide attempts (Hazard ratio = 0.65; 95% CI = 0.17, 3.05) or suicidal behavior (Hazard ratio = 0.78; 95% CI = 0.23, 2.67); however, boosters benefited most those initially assigned to MI-SP + Texts.
","['psychiatrically hospitalized adolescents who have varying levels of postdischarge suicide risk calls', 'adolescent suicidal behavior after hospitalization', 'Adolescent inpatients (N\xa0=\xa080; ages 13-17; 67.5% female']","['Motivational Interview-Enhanced Safety Plan (MI-SP), delivered during hospitalization, alone or in combination with postdischarge text-based support (Texts', 'telephone booster calls or to no calls', 'Adaptive intervention']","['daily-level mechanisms, including safety plan use, self-efficacy', 'suicidal behavior', 'coping self-efficacy']","[{'cui': 'C0001585', 'cui_str': 'Adolescent, Hospitalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.169264,"Moreover, augmentation with booster calls did not have an overall meaningful impact on suicide attempts (Hazard ratio = 0.65; 95% CI = 0.17, 3.05) or suicidal behavior (Hazard ratio = 0.78; 95% CI = 0.23, 2.67); however, boosters benefited most those initially assigned to MI-SP + Texts.
","[{'ForeName': 'Ewa K', 'Initials': 'EK', 'LastName': 'Czyz', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Prouty', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Micol', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Walton', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13383']
1384,33590471,Effects of levetiracetam and oxcarbazepine monotherapy on intellectual and cognitive development in children with benign epilepsy with centrotemporal spikes.,"Levetiracetam (LEV) and oxcarbazepine (OXC) are commonly used in the treatment of epilepsy, but their efficacy and safety have seldom been compared for the treatment of children with benign epilepsy with centrotemporal spikes (BECTS). We thus assessed the efficacy of LEV and OXC monotherapy in the treatment of children with BECTS, and the effect of this treatment on children's intelligence and cognitive development. This was a randomized, single-center trial. Children with BECTS were randomized (1:1) into LEV and OXC groups, and were assessed at 1, 3 and 6 months after treatment. The primary outcomes were the frequency of seizures and changes in intelligence and cognitive function. Secondary outcomes were electroencephalogram (EEG) results and safety. Seventy children were enrolled and randomized to the LEV group or the OXC group, and 32 of the 35 children in each group completed the study. After 6 months, the effective treatment rate of the OXC group was significantly higher than that of the LEV group (78.12 vs. 53.12%, p = 0.035). However, no significant inter-group difference was observed in EEG improvement (p = 0.211). In terms of intelligence and cognitive development, children in the OXC group exhibited significantly improved choice reaction time, mental rotation, and Wisconsin Card Sorting Test results (all p < 0.05). Both LEV and OXC were well tolerated, with 18.75 and 21.88% of children reporting mild adverse events (p = 0.756). OXC monotherapy was more effective than LEV for children with BECTS. In addition, children with OXC monotherapy had higher improvements in children's intelligence and cognitive function than those with LEV monotherapy.",2021,"In terms of intelligence and cognitive development, children in the OXC group exhibited significantly improved choice reaction time, mental rotation, and Wisconsin Card Sorting Test results (all p < 0.05).","['children with benign epilepsy with centrotemporal spikes', 'children with benign epilepsy with centrotemporal spikes (BECTS', 'Children with BECTS', 'Seventy children', 'group, and 32 of the 35 children in each group completed the study', 'children with BECTS']","['Levetiracetam (LEV) and oxcarbazepine (OXC', 'OXC', 'OXC monotherapy', 'LEV', 'levetiracetam and oxcarbazepine monotherapy', 'LEV and OXC monotherapy']","['frequency of seizures and changes in intelligence and cognitive function', 'choice reaction time, mental rotation, and Wisconsin Card Sorting Test results', 'mild adverse events', 'intellectual and cognitive development', 'EEG improvement', 'effective treatment rate', ""children's intelligence and cognitive function"", 'tolerated', 'electroencephalogram (EEG) results and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2363129', 'cui_str': 'Benign Rolandic epilepsy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.0416784,"In terms of intelligence and cognitive development, children in the OXC group exhibited significantly improved choice reaction time, mental rotation, and Wisconsin Card Sorting Test results (all p < 0.05).","[{'ForeName': 'Gui-Hai', 'Initials': 'GH', 'LastName': 'Suo', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Soochow University & Affiliated Hospital of Nantong University, No. 92 Zhongnan Street, Suzhou Industrial Park, 215025, Jiangsu, China.""}, {'ForeName': 'Yu-Qin', 'Initials': 'YQ', 'LastName': 'Zheng', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Soochow University & Affiliated Hospital of Nantong University, No. 92 Zhongnan Street, Suzhou Industrial Park, 215025, Jiangsu, China.""}, {'ForeName': 'You-Jia', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Nantong University, No.20 Xi Si Road, Nantong, 226001, Jiangsu, China.'}, {'ForeName': 'Ji-Hong', 'Initials': 'JH', 'LastName': 'Tang', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Soochow University, No. 92 Zhongnan Street, Suzhou Industrial Park 215025, Jiangsu, China. tekv494@126.com.""}]",Acta neurologica Belgica,['10.1007/s13760-021-01613-5']
1385,33590363,Randomised Controlled Trial Evidence Questions the Assumption that Pulmonary Metastasectomy Benefits Patients with Colorectal Cancer.,"Pulmonary metastasectomy for sarcoma is surgery without proven benefit, and in the light of a randomized controlled trial examining pulmonary metastasectomy in colorectal cancer, it should be questioned.",2021,"Pulmonary metastasectomy for sarcoma is surgery without proven benefit, and in the light of a randomized controlled trial examining pulmonary metastasectomy in colorectal cancer, it should be questioned.",['Patients with Colorectal Cancer'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.181757,"Pulmonary metastasectomy for sarcoma is surgery without proven benefit, and in the light of a randomized controlled trial examining pulmonary metastasectomy in colorectal cancer, it should be questioned.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Batchelor', 'Affiliation': 'Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Jurjees', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'The Christie Hospital, Manchester, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Shackcloth', 'Affiliation': 'Liverpool Heart and Chest, Liverpool, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College, London, UK. tom.treasure@gmail.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-09521-3']
1386,33590342,Recreational beach tennis reduces 24-h blood pressure in adults with hypertension: a randomized crossover trial.,"PURPOSE


To evaluate the effect of a beach tennis session on 24-h ambulatory blood pressure in adults with hypertension.
METHODS


In this randomized crossover trial, 24 participants (12 men and 12 women) randomly performed two experimental sessions: a beach tennis session and a non-exercise control session. The beach tennis session started with a standardized 5-min warm-up consisting of basic techniques, followed by three 12-min beach tennis matches with 2-min intervals between them. Heart rate was continuously recorded and rating of perceived exertion was assessed in the middle and at the end of each set during the beach tennis session. Enjoyment was also assessed after the beach tennis session. The control session was performed in seated rest. Both experimental sessions lasted 45 min. Ambulatory blood pressure was measured continuously for 24 h after sessions.
RESULTS


Systolic blood pressure (24-h: 6 mmHg, P = 0.008; daytime: 6 mmHg, P = 0.031; nighttime: 6 mmHg, P = 0.042) and diastolic blood pressure (24-h: 3 mmHg, P = 0.021; daytime: 3 mmHg, P = 0.036; nighttime: 4 mmHg, P = 0.076) decreased after beach tennis when compared with control. The participants presented a reserve heart rate of 59-68%, and a rating of perceived exertion score of 3.4-4.7 using Borg's CR10 Scale. The enjoyment scores after beach tennis session were higher than 90%.
CONCLUSION


A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension. Additionally, the participants can achieve a high physiological stress but perceive less effort during the practice.
TRIAL REGISTRATION


Date: April 10, 2019; identifier number NCT03909308 (Clinicaltrials.gov).",2021,A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension.,"['adults with hypertension', '24 participants (12 men and 12 women']","['Recreational beach tennis', 'beach tennis session', 'beach tennis session and a non-exercise control session', 'recreational beach tennis']","['diastolic blood pressure (24-h', '24-h blood pressure', 'daytime', 'Ambulatory blood pressure', 'Systolic blood pressure (24-h', 'enjoyment scores', '24-h ambulatory blood pressure', 'reserve heart rate', 'Heart rate', 'Enjoyment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",24.0,0.0343098,A single session of recreational beach tennis reduces 24-h ambulatory blood pressure in adults with hypertension.,"[{'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Carpes', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jacobsen', 'Affiliation': 'Sports and Exercise Training Study Group, Hospital de Clínicas de Porto Alegre, Rua Ramiro Barcelos 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Domingues', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Nathalia', 'Initials': 'N', 'LastName': 'Jung', 'Affiliation': 'Sports and Exercise Training Study Group, Hospital de Clínicas de Porto Alegre, Rua Ramiro Barcelos 2350, Porto Alegre, RS, 90035-903, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Graduate Program in Cardiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. rod.ferrari84@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-021-04617-4']
1387,33590330,Trajectories of change in symptom severity in patients with fibromyalgia: exploratory analyses of a randomised controlled trial.,"The clinical picture of fibromyalgia (FM) symptoms fluctuates, and the symptom severity varies within and between patients. The current study aimed to identify groups of PDS trajectories and to explore differences in baseline characteristics between the potential groups of trajectories. We included patients from a completed randomised controlled trial, in total 170 patients diagnosed with FM according to the ACR 2010 criteria. The mean age was 40 years, and 94% were women. Symptom severity was assessed by the Polysymptomatic distress scale (PDS) [range 0 (no symptoms) to 31] at four timepoints over 13-18 months. Latent class growth analysis was used to identify patient trajectories based on their response pattern on the PDS. Potential differences in baseline characteristics between the trajectories were compared using appropriate statistical tests. Two distinct PDS trajectories were identified with 110 patients (65%) classified as the ""no improvement"" group and 60 (35%) as the ""some improvement"" group. Mean PDS scores at pre-baseline were ≥ 20 in both groups. At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the ""some improvement"" group and 21 (4.12) in the ""no improvement"" group. There were no significant differences in baseline characteristics between the groups of PDS trajectories. We identified one group of FM patients that improved slightly during the study period and one group that not improved. There were no differences in baseline characteristics between the two groups.",2021,"At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the ""some improvement"" group and 21 (4.12) in the ""no improvement"" group.","['patients with fibromyalgia', '170 patients diagnosed with FM according to the ACR 2010 criteria', 'The mean age was 40\xa0years, and 94% were women']",[],"['Polysymptomatic distress scale (PDS', 'Mean PDS scores', 'mean (SD) PDS score', 'Symptom severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",170.0,0.0681025,"At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the ""some improvement"" group and 21 (4.12) in the ""no improvement"" group.","[{'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Haugmark', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Vinderen, PO Box 23, 0319, Oslo, Norway. trond.haugmark@diakonsyk.no.'}, {'ForeName': 'Kåre Birger', 'Initials': 'KB', 'LastName': 'Hagen', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Vinderen, PO Box 23, 0319, Oslo, Norway.'}, {'ForeName': 'Sella Aarrestad', 'Initials': 'SA', 'LastName': 'Provan', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Vinderen, PO Box 23, 0319, Oslo, Norway.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sexton', 'Affiliation': 'Department of Research and Innovation, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Zangi', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Vinderen, PO Box 23, 0319, Oslo, Norway.'}]",Rheumatology international,['10.1007/s00296-021-04801-x']
1388,33589758,Intensive blood pressure treatment in coronary artery disease: implications from the Systolic Blood Pressure Intervention Trial (SPRINT).,"To investigate the optimal blood pressure (BP) in patients with coronary artery disease (CAD), we conducted subgroup analysis using SPRINT data. The study sample included 1206 participants with CAD (of whom 692 underwent coronary revascularization) and 8127 participants without CAD. Participants were randomized into two groups (systolic BP target of 140 mm Hg vs. 120 mm Hg). The primary outcome was a composite of cardiovascular events. After a median follow-up of 3.9 years, the hazard ratios (HRs) for the primary outcome were 0.65 (95% confidence interval (CI) 0.53-0.79) and 1.05 (95% CI 0.76-1.46) among those in the non-CAD and CAD subgroups, respectively (P value for interaction 0.02). Intensive BP treatment was a protective factor for all-cause death (HR 0.60, 95% CI 0.37-0.96) in the CAD subgroup, compared with standard BP treatment. The HRs (95% CI) for stroke were 3.57 (1.17-10.85) and 1.03 (0.29-3.62) among those in the coronary revascularization and non-revascularization subgroups, respectively (P value for interaction 0.13). For safety events, intensive BP treatment increased the risk of hypotension (HR 2.00, 95% CI 1.06-3.79) and electrolyte abnormalities (HR 2.38, 95% CI 1.25-4.56) in the CAD subgroup, while the risk of serious adverse events did not increase (HR 1.03, 95% CI 0.88-1.20). These results suggest that positive benefits from intensive BP treatment might be attenuated in patients with CAD who are under better secondary prevention. The risk of stroke might increase at the systolic BP target of 120 mm Hg in case of coronary revascularization, although the confidence interval was wide.",2021,"For safety events, intensive BP treatment increased the risk of hypotension (HR 2.00, 95% CI 1.06-3.79) and electrolyte abnormalities (HR 2.38, 95% CI 1.25-4.56) in the CAD subgroup, while the risk of serious adverse events did not increase (HR 1.03, 95% CI 0.88-1.20).","['1206 participants with CAD (of whom 692 underwent coronary revascularization) and 8127 participants without CAD', 'patients with CAD who are under better secondary prevention', 'patients with coronary artery disease (CAD', 'coronary artery disease']",['Intensive blood pressure treatment'],"['optimal blood pressure (BP', 'risk of hypotension', 'electrolyte abnormalities', 'risk of serious adverse events', 'hazard ratios (HRs', 'composite of cardiovascular events']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0151613', 'cui_str': 'Electrolytes abnormal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1206.0,0.375488,"For safety events, intensive BP treatment increased the risk of hypotension (HR 2.00, 95% CI 1.06-3.79) and electrolyte abnormalities (HR 2.38, 95% CI 1.25-4.56) in the CAD subgroup, while the risk of serious adverse events did not increase (HR 1.03, 95% CI 0.88-1.20).","[{'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Zang', 'Affiliation': 'Department of Cardiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaozhao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China. liaoxinx@mail.sysu.edu.cn.'}, {'ForeName': 'Guifu', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong, China. wuguifu@mail.sysu.edu.cn.'}]",Journal of human hypertension,['10.1038/s41371-021-00494-8']
1389,33589725,Self-directed video versus instructor-based neonatal resuscitation training: a randomized controlled blinded non-inferiority multicenter international study.,"OBJECTIVE


To compare the efficacy of video-assisted self-directed neonatal resuscitation skills course with video-assisted facilitator-led course.
METHODS


This multicenter, randomized, blinded, non-inferiority-controlled trial compared two methods of teaching basic neonatal resuscitation skills using mask ventilation. Groups of novice providers watched an instructional video. One group received instructor facilitation (Ins-Video). The other group did not (Self-Video). An Objective Structured Clinical Exam (OSCE) measured skills performance, and a written test gauged knowledge.
RESULTS


One hundred and thirty-four students completed the study. Sixty-three of 68 in the Self-Video Group (92.6%) and 59 of 66 in the Ins-Video Group (89.4%) achieved post-training competency in positive pressure ventilation (primary outcome). OSCE passing rates were low in both groups. Knowledge survey scores were comparable between groups and non-inferior.
CONCLUSIONS


Video self-instruction taught novice providers positive pressure ventilation skills and theoretical knowledge, but it was insufficient for mastery of basic neonatal resuscitation in simulation environment.",2021,"Knowledge survey scores were comparable between groups and non-inferior.
CONCLUSIONS


Video self-instruction taught novice providers positive pressure ventilation skills and theoretical knowledge, but it was insufficient for mastery of basic neonatal resuscitation in simulation environment.",['One hundred and thirty-four students completed the study'],"['teaching basic neonatal resuscitation skills using mask ventilation', 'video-assisted self-directed neonatal resuscitation skills course with video-assisted facilitator-led course', 'Self-directed video versus instructor-based neonatal resuscitation training', 'instructor facilitation']","['Knowledge survey scores', 'OSCE passing rates']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204928', 'cui_str': 'CPR education'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",134.0,0.215681,"Knowledge survey scores were comparable between groups and non-inferior.
CONCLUSIONS


Video self-instruction taught novice providers positive pressure ventilation skills and theoretical knowledge, but it was insufficient for mastery of basic neonatal resuscitation in simulation environment.","[{'ForeName': 'Edgardo G', 'Initials': 'EG', 'LastName': 'Szyld', 'Affiliation': 'The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. edgardo-szyld@ouhsc.edu.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Aguilar', 'Affiliation': 'Sociedad Argentina de Pediatria, Buenos Aires, Argentina.'}, {'ForeName': 'Santiago Perez', 'Initials': 'SP', 'LastName': 'Lloret', 'Affiliation': 'Universidad Abierta Interamericana-Centro de Altos Estudios en Ciencias Humanas y de la Salud, Consejo Nacional de Investigaciones Cientificas y Tencnicas. (UAI-CAECICHS.CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Amorina', 'Initials': 'A', 'LastName': 'Pardo', 'Affiliation': 'Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Fabres', 'Affiliation': 'Department of Neonatology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Hospital Interzonal De Agudos Evita, Lanus, Buenos Aires, Argentina.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Purnahamsi V', 'Initials': 'PV', 'LastName': 'Desai', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Capelli', 'Affiliation': 'Hospital Universitario Austral, Pilar, Buenos Aires, Argentina.'}, {'ForeName': 'Clara H', 'Initials': 'CH', 'LastName': 'Song', 'Affiliation': 'The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Enriquez', 'Affiliation': 'Simulacion Medica Roemmers, Olivos, Buenos Aires, Argentina.'}, {'ForeName': 'Demian', 'Initials': 'D', 'LastName': 'Szyld', 'Affiliation': 'Center for Medical Simulation, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-021-00941-x']
1390,33589706,Randomized controlled study using text messages to help connect new medicaid beneficiaries to primary care.,"Accessing primary care is often difficult for newly insured Medicaid beneficiaries. Tailored text messages may help patients navigate the health system and initiate care with a primary care physician. We conducted a randomized controlled trial of tailored text messages with newly enrolled Medicaid managed care beneficiaries. Text messages included education about the importance of primary care, reminders to obtain an appointment, and resources to help schedule an appointment. Within 120 days of enrollment, we examined completion of at least one primary care visit and use of the emergency department. Within 1 year of enrollment, we examined diagnosis of a chronic disease, receipt of preventive care, and use of the emergency department. 8432 beneficiaries (4201 texting group; 4231 control group) were randomized; mean age was 37 years and 24% were White. In the texting group, 31% engaged with text messages. In the texting vs control group after 120 days, there were no differences in having one or more primary care visits (44.9% vs. 45.2%; difference, -0.27%; p = 0.802) or emergency department use (16.2% vs. 16.0%; difference, 0.23%; p = 0.771). After 1 year, there were no differences in diagnosis of a chronic disease (29.0% vs. 27.8%; difference, 1.2%; p = 0.213) or appropriate preventive care (for example, diabetes screening: 14.1% vs. 13.4%; difference, 0.69%; p = 0.357), but emergency department use (32.7% vs. 30.2%; difference, 2.5%; p = 0.014) was greater in the texting group. Tailored text messages were ineffective in helping new Medicaid beneficiaries visit primary care within 120 days.",2021,"In the texting vs control group after 120 days, there were no differences in having one or more primary care visits (44.9% vs. 45.2%; difference, -0.27%; p = 0.802) or emergency department use (16.2% vs. 16.0%; difference, 0.23%; p = 0.771).","['newly enrolled Medicaid managed care beneficiaries', '8432 beneficiaries (4201 texting group; 4231 control group) were randomized; mean age was 37 years and 24% were White']",[],"['emergency department use', 'primary care visits', 'diagnosis of a chronic disease']","[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0086583', 'cui_str': 'Managed Care'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]",8432.0,0.0916724,"In the texting vs control group after 120 days, there were no differences in having one or more primary care visits (44.9% vs. 45.2%; difference, -0.27%; p = 0.802) or emergency department use (16.2% vs. 16.0%; difference, 0.23%; p = 0.771).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Levine', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA. dmlevine@bwh.harvard.edu.""}, {'ForeName': 'Pragya', 'Initials': 'P', 'LastName': 'Kakani', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ateev', 'Initials': 'A', 'LastName': 'Mehrotra', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",NPJ digital medicine,['10.1038/s41746-021-00389-5']
1391,33589705,Associations of early pregnancy BMI with adverse pregnancy outcomes and infant neurocognitive development.,"The prevalence of overweight and obesity amongst reproductive women has been increasing worldwide. Our aim was to compare pregnancy outcomes and infant neurocognitive development by different BMI classifications and investigate whether early pregnancy BMI was associated with risks of adverse outcomes in a Southwest Chinese population. We analysed data from 1273 women enrolled in the Complex Lipids in Mothers and Babies (CLIMB) randomized controlled trial in Chongqing, China. Maternal BMI was classified as underweight, normal weight and overweight/obese according to the Chinese, WHO Asian, and WHO European standards. For the adverse pregnancy outcomes, after adjustment for potential confounders, an underweight BMI was associated with increased risk of small for gestational age (SGA) babies, and an overweight/obese BMI was associated with increased risk of maternal gestational diabetes mellitus (GDM), caesarean section (C-section), macrosomia and large for gestational age (LGA) babies. For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups. Our findings demonstrate that abnormal early pregnancy BMI were associated with increased risks of adverse pregnancy outcomes in Chinese women, while early pregnancy BMI had no significant influence on the infant neurocognitive development at 12 months of age.",2021,"For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups.","['1273 women enrolled in the Complex Lipids in Mothers and Babies (CLIMB) randomized controlled trial in Chongqing, China', 'a Southwest Chinese population', 'Chinese women']",[],"['infant neurocognitive development', 'Maternal BMI', 'risks of adverse pregnancy outcomes', 'risk of small for gestational age (SGA) babies', 'risk of maternal gestational diabetes mellitus (GDM), caesarean section (C-section), macrosomia and large for gestational age (LGA) babies', 'Mental Development Index (MDI) or the Psychomotor Development Index (PDI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}]",1273.0,0.0379047,"For infant neurocognitive development, 1017 mothers and their children participated; no significant differences were seen in the Mental Development Index (MDI) or the Psychomotor Development Index (PDI) between the three BMI groups.","[{'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Yin-Yin', 'Initials': 'YY', 'LastName': 'Xia', 'Affiliation': 'School of Public Health and Management, Chongqing Medical University, Chongqing, 400016, China. 100118@cqmu.edu.cn.'}, {'ForeName': 'Ting-Li', 'Initials': 'TL', 'LastName': 'Han', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Xu-Yang', 'Initials': 'XY', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zou', 'Affiliation': 'Institute of Life Sciences, Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Hong-Bo', 'Initials': 'HB', 'LastName': 'Qi', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.'}, {'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Albert', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Department of Psychology and Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Baker', 'Affiliation': 'College of Life Sciences, University of Leicester, Leicester, UK.'}]",Scientific reports,['10.1038/s41598-021-83430-7']
1392,33589674,Insights into the role of diet and dietary flavanols in cognitive aging: results of a randomized controlled trial.,"With the world's population aging, age-related memory decline is an impending cognitive epidemic. Assessing the impact of diet on cognitive aging, we conducted a controlled, randomized, parallel-arm dietary intervention with 211 healthy adults (50-75 years) investigating effects of either a placebo or 260, 510 and 770 mg/day of cocoa flavanols for 12-weeks followed by 8-weeks washout. The primary outcome was a newly-developed object-recognition task localized to the hippocampus' dentate gyrus. Secondary outcomes included a hippocampal-dependent list-learning task and a prefrontal cortex-dependent list-sorting task. The alternative Healthy Eating Index and a biomarker of flavanol intake (gVLM) were measured. In an MRI substudy, hippocampal cerebral blood volume was mapped. Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake. However, the hippocampal-dependent list-learning performance was directly associated with baseline diet quality and improved after flavanol intake, particularly in participants in the bottom tertile of baseline diet quality. In the imaging substudy, a region-of-interest analysis was negative but a voxel-based-analysis suggested that dietary flavanols target the dentate gyrus. While replication is needed, these findings suggest that diet in general, and dietary flavanols in particular, may be associated with memory function of the aging hippocampus and normal cognitive decline.",2021,Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake.,"['211 healthy adults (50-75\xa0years', 'cognitive aging']","['diet and dietary flavanols', 'placebo', 'cocoa flavanols']","['hippocampal-dependent list-learning task and a prefrontal cortex-dependent list-sorting task', 'Object-recognition and list-sorting performance', 'alternative Healthy Eating Index and a biomarker of flavanol intake (gVLM', 'hippocampal cerebral blood volume', ""newly-developed object-recognition task localized to the hippocampus' dentate gyrus""]","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042952', 'cui_str': 'Cognitive Aging'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0152314', 'cui_str': 'Structure of dentate gyrus'}]",211.0,0.12004,Object-recognition and list-sorting performance did not correlate with baseline diet quality and did not improve after flavanol intake.,"[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Sloan', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry, Columbia University Irving Medical Center, 622 West 168th St., New York, NY, 10032, USA. rps7@cumc.columbia.edu.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wall', 'Affiliation': 'New York State Psychiatric Institute, 1050 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Lok-Kin', 'Initials': 'LK', 'LastName': 'Yeung', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'New York State Psychiatric Institute, 1050 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Provenzano', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Schroeter', 'Affiliation': 'Mars Inc., 6885 Elm St, McLean, VA, 22101, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Lauriola', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry, Columbia University Irving Medical Center, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brickman', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Small', 'Affiliation': 'Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, 622 West 168th St., New York, NY, 10032, USA. sas68@cumc.columbia.edu.'}]",Scientific reports,['10.1038/s41598-021-83370-2']
1393,33589667,Effects of exercise on cervical muscle strength and cross-sectional area in patients with thoracic hyperkyphosis and chronic cervical pain.,"There is a lack of studies comparing the effects of different exercise types in patients with thoracic hyperkyphosis. Twenty-four subjects were divided into three groups: corrective exercise, resistance exercise, and physical therapy. The groups performed their respective interventions, two times per week for three months. Clinical outcomes, including the value of Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the cervical deep muscles were measured pre- and post-intervention. There was a significant difference in the changes in the thoracic Cobb's angle between the groups (P < 0.001). The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012). There was a significant difference in the cross-sectional area of the cervical deep muscles included longus capitis and multifidus between the groups (P < 0.036 and 0.007, respectively). The corrective exercise group showed the most significant increase in cross-sectional area between pre- and post-intervention (P < 0.012). A corrective exercise program is a more effective intervention than traditional resistance exercise and physical therapy for improving the thoracic Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the deep muscles in patients with thoracic hyperkyphosis.Trial registration: KCT0005292.",2021,The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012).,"['patients with thoracic hyperkyphosis and chronic cervical pain', 'patients with thoracic hyperkyphosis', 'Twenty-four subjects']","['corrective exercise, resistance exercise, and physical therapy', 'corrective exercise program', 'traditional resistance exercise and physical therapy', 'exercise']","['muscle strength and endurance', 'cross-sectional area of the cervical deep muscles included longus capitis and multifidus', 'cervical muscle strength', 'cross-sectional area', ""thoracic Cobb's angle"", ""value of Cobb's angle, cervical muscle strength and endurance, and the cross-sectional area of the cervical deep muscles""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0224107', 'cui_str': 'Structure of longus capitis muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",24.0,0.022271,The corrective exercise group revealed a significantly superior increase in muscle strength and endurance between pre- and post-intervention (P < 0.012).,"[{'ForeName': 'Hyunghun', 'Initials': 'H', 'LastName': 'Moon', 'Affiliation': 'Department of Sports Medicine, Cha University, 120, Haeryong-ro, Pocheon-si, Gyeonggi-do, 11160, Republic of Korea.'}, {'ForeName': 'Sung-Ki', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Sports Medicine, Cha University, 120, Haeryong-ro, Pocheon-si, Gyeonggi-do, 11160, Republic of Korea. sklee@cha.ac.kr.'}, {'ForeName': 'Won-Moon', 'Initials': 'WM', 'LastName': 'Kim', 'Affiliation': 'Department of Sports Science, Dongguk University, 123, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, Republic of Korea.'}, {'ForeName': 'Yong-Gon', 'Initials': 'YG', 'LastName': 'Seo', 'Affiliation': 'Division of Sports Medicine, Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea. yongon79@naver.com.'}]",Scientific reports,['10.1038/s41598-021-83344-4']
1394,33589644,Six degrees head-down tilt bed rest caused low-grade hemolysis: a prospective randomized clinical trial.,"This study aimed to measure hemolysis before, during and after 60 days of the ground-based spaceflight analog bed rest and the effect of a nutritional intervention through a prospective randomized clinical trial. Twenty male participants were hospitalized for 88 days comprised of 14 days of ambulatory baseline, 60 days of 6° head-down tilt bed rest and 14 days of reambulation. Ten participants each received a control diet or daily polyphenol associated with omega-3, vitamin E, and selenium supplements. The primary outcome was endogenous carbon monoxide (CO) elimination measured by gas chromatography. Hemolysis was also measured with serial bilirubin, iron, transferrin saturation blood levels and serial 3-day stool collections were used to measure urobilinoid excretion using photometry. Total hemoglobin mass (tHb) was measured using CO-rebreathing. CO elimination increased after 5, 11, 30, and 57 days of bed rest: +289 ppb (95% CI 101-477 ppb; p = 0.004), +253 ppb (78-427 ppb; p = 0.007), +193 ppb (89-298 ppb; p = 0.001) and +858 ppb (670-1046 ppb; p < 0.000), respectively, compared to baseline. Bilirubin increased after 20 and 49 days of bed rest +0.8 mg/l (p = 0.013) and +1.1 mg/l (p = 0.012), respectively; and iron increased after 20 days of bed rest +10.5 µg/dl (p = 0.032). The nutritional intervention did not change CO elimination. THb was lower after 60 days of bed rest -0.9 g/kg (p = 0.001). Bed rest enhanced hemolysis as measured through all three by-products of heme oxygenase. Ongoing enhanced hemolysis over 60 days contributed to a 10% decrease in tHb mass. Modulation of red blood cell control towards increased hemolysis may be an important mechanism causing anemia in astronauts.",2021,"Bilirubin increased after 20 and 49 days of bed rest +0.8 mg/l (p = 0.013) and +1.1 mg/l (p = 0.012), respectively; and iron increased after 20 days of bed rest +10.5 µg/dl (p = 0.032).","['Twenty male participants were hospitalized for 88 days comprised of 14 days of ambulatory baseline, 60 days of 6° head-down tilt bed rest and 14 days of reambulation', 'Six degrees head-down tilt bed rest caused low-grade hemolysis']","['control diet or daily polyphenol associated with omega-3, vitamin E, and selenium supplements']","['Total hemoglobin mass (tHb', 'serial bilirubin, iron, transferrin saturation blood levels and serial 3-day stool collections', 'endogenous carbon monoxide (CO) elimination measured by gas chromatography', 'Bilirubin', 'CO elimination', 'THb']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}]","[{'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}]",20.0,0.107232,"Bilirubin increased after 20 and 49 days of bed rest +0.8 mg/l (p = 0.013) and +1.1 mg/l (p = 0.012), respectively; and iron increased after 20 days of bed rest +10.5 µg/dl (p = 0.032).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Culliton', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Louati', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Laneuville', 'Affiliation': 'Department of Biology, Faculty of Science, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Trudel', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, Ottawa Hospital Research Institute, Ottawa, ON, Canada. gtrudel@toh.ca.'}]",NPJ microgravity,['10.1038/s41526-021-00132-0']
1395,33589575,Development and validation of RNA binding protein-applied prediction model for gastric cancer.,"RNA-binding proteins (RBPs) have been reported to be associated with the occurrence and progression of multiple cancers, but the role in gastric adenocarcinoma remains poorly understood. The present study aims to uncover potential RBPs associated with the survival of gastric adenocarcinoma, as well as corresponding biologic properties and signaling pathways of these RBPs. RNA sequencing and clinical data of GC were obtained from The Cancer Genome Atlas (n=373) and the Gene Expression Omnibus (GSE84437, n=433) database. Tumor samples in TCGA were randomly divided into the training and internal testing group by R software. A total of 238 DERBPs were selected for univariate and multivariate Cox regression analyses. Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model. Survival relevance and prediction accuracy of model were tested via Kaplan-Meier (K-M) curves and receiver operating characteristic (ROC) curves in internal and external testing groups. Further analysis has also showed that this model could serve as an independent prognosis-related parameter. A prognostic nomogram has been eventually developed, and presents a good performance of prediction.",2021,"Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model.","['gastric cancer', 'Tumor samples in TCGA']",[],"['Survival relevance', 'Kaplan-Meier (K-M) curves and receiver operating characteristic (ROC) curves']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",238.0,0.015527,"Five pivotal RBP genes (RNASE2, METTL1, ANG, YBX2 and LARP6) were screened out and were used to construct a new prognostic model.","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Zi-Han', 'Initials': 'ZH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Lung Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}, {'ForeName': 'Zhi-Wu', 'Initials': 'ZW', 'LastName': 'Wang', 'Affiliation': 'Department of Chemoradiotherapy, Tangshan People&#x2019;s Hospital, Tangshan 063000, P.R. China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, Lung Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, P.R. China.'}]",Aging,['10.18632/aging.202483']
1396,33589569,The joint effect of energy reduction with calcium supplementation on the risk factors of type 2 diabetes in the overweight population: a two-year randomized controlled trial.,"Both excessive energy intake and low calcium intake are inversely associated with the aging-related diseases, particularly for type 2 diabetes mellitus(T2DM). This study examined whether energy reduction coupled with calcium supplementation aided in the prevention of T2DM among the overweight population. A randomized controlled trial(RCT) of 1021 overweight participants was performed, in which participants were randomly assigned to 4 groups: 1) energy-reduction group(ERG), 2) calcium supplementation group(CSG), 3) energy-reduction with calcium supplementation group(ER-CSG), 4) control group(CG). Nutritional habits, anthropometric and diabetes-related indicators were measured at baseline and each follow-up time. To analyze the separate effects of dietary energy reduction and calcium supplementation, ERG and ER-CSG were integrated into ERGs. Similarly, CSG and ER-CSG were integrated into CSGs. Compared to the non-energy-reduction groups(NERGs), ERGs had lower values of ΔBMI(-0.9kg/m 2 ), ΔFSG (-0.34mmol/L), ΔHbA1c(0.16%), and ΔHOMA-IR(-0.13), and higher value of ΔGutt index(-5.82). Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease. Moreover, these risk factors for T2DM were most effectively ameliorated in ER-CSG group with the decreased values of ΔFSG(-0.42mmol/L), ΔGutt index(-0.73), and the slowest increasing rate value of Δ2h-glucose(0.37mmol/L). This RCT demonstrated that energy-reduction with calcium supplementation was a useful dietary intervention strategy for preventing the development of T2DM in the overweight population.",2021,"Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease.","['type 2 diabetes in the overweight population', '1021 overweight participants', 'T2DM among the overweight population']","['calcium supplementation', 'energy-reduction group(ERG), 2) calcium supplementation group(CSG), 3) energy-reduction with calcium supplementation group(ER-CSG), 4) control group(CG', 'dietary energy reduction and calcium supplementation, ERG and ER-CSG']",[],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]",[],1021.0,0.0235172,"Compared to the non-calcium supplementation groups(NCSGs), the ΔGutt index(-5.46) in CSGs showed a significant decrease.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Huanyu', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Qingrao', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Postgraduate, The Third Affiliated Hospital of Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Xuanyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Changhao', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, College of Public Health, Harbin Medical University, Harbin 150081, Heilongjiang Province, P. R. China.'}]",Aging,['10.18632/aging.202485']
1397,33589554,"A phase III randomized study of apremilast, an oral phosphodiesterase 4 inhibitor, for active ankylosing spondylitis.","OBJECTIVE


To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with active ankylosing spondylitis (AS).
METHODS


This phase III, multicenter, double-blind, placebo-controlled study (NCT01583374) randomized patients with active AS (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily for 24 weeks, followed by a long-term extension phase (up to 5 years). The primary endpoint was assessment of the SpondyloArthritis International Society 20 (ASAS 20) response at Week 16. The impact of treatment on radiographic outcomes after 104 weeks was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
RESULTS


In total, 490 patients with active AS were randomized in the study (placebo: n=164; apremilast 20 mg twice daily: n=163; apremilast 30 mg twice daily: n=163). The primary endpoint of ASAS 20 response at Week 16 was not met (placebo: 37%; apremilast 20 mg twice daily: 35%; apremilast 30 mg twice daily: 33%; p=0.44 vs placebo). At Week 104, mean (SD) changes from baseline in mSASSS were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg twice daily, and apremilast 30 mg twice daily, respectively. The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea.
CONCLUSION


No clinical benefit was observed with apremilast treatment in patients with active AS. The safety and tolerability of apremilast were consistent with its known profile.",2021,"The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea.
","['active ankylosing spondylitis', '490 patients with active AS', 'patients with active AS', 'patients with active ankylosing spondylitis (AS']",['placebo'],"['radiographic outcomes', 'safety and tolerability', 'ASAS 20 response', 'diarrhea, nasopharyngitis, upper respiratory infection, and nausea', 'SpondyloArthritis International Society 20 (ASAS 20) response', 'efficacy and safety', 'modified Stoke Ankylosing Spondylitis Spine Score (mSASSS']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",490.0,0.327195,"The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea.
","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Landewé', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McCue', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Boonen', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Amsterdam University Medical Centre & Zuyderland Medical Centre, Heerlen, The Netherlands; Celgene Corporation, Summit, New Jersey, USA; Amgen Inc., Thousand Oaks, California, USA; Division of Rheumatology, Department of Internal Medicine, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands. This study was funded by Celgene. Amgen Inc. acquired the worldwide rights to Otezla® (apremilast) on November 21, 2019. P.C. Taylor has received grant/research support from Celgene. D. van der Heijde has served as a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, and is a director of Imaging Rheumatology BV. R. Landewé has served as a consultant for AbbVie, Eli Lilly, Galapagos, Gilead, Merck, Novartis, Pfizer and UCB Pharma and received an honorarium from Celgene for reading films for this study. S. McCue is a former employee of Celgene. S. Cheng is an employee of Amgen Inc. and a former employee of Celgene. A. Boonen has received grant/research support from Celgene. Address correspondence to Dr. P.C. Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road Headington, Oxford, OX3 7LD, UK; Tel.: 01865 227323; E-mail: peter.taylor@kennedy.ox.ac.uk.'}]",The Journal of rheumatology,['10.3899/jrheum.201088']
1398,33589450,Protocol for a phase II randomised controlled trial of TKI alone versus TKI and local consolidative radiation therapy in patients with oncogene driver-mutated oligometastatic non-small cell lung cancer.,"INTRODUCTION


Tyrosine kinase inhibitors (TKIs) have significantly improved the progression-free survival (PFS) of metastatic non-small cell lung cancer (NSCLC) with oncogene mutations of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) compared with systemic therapy alone. However, the majority eventually develop resistance with a median PFS of 8-12 months. The pattern of failure studies showed disease relapse at the original sites of the disease-harbouring resistant tumour cells.
METHODS AND ANALYSIS


This study is designed as a phase II randomised controlled trial to evaluate the efficacy of local consolidative radiation therapy (LCRT) in addition to TKI in upfront oligometastatic NSCLC. Patients will be screened at presentation for oligometastases (≤5 sites) and will start on TKI after confirmation of EGFR or ALK mutation status. After initial TKI for 2-4 months, eligible patients will be randomised in a 1:1 ratio with stratification of oligometastatic sites (1-3 vs 4-5), performance status of 0-1 versus 2 and brain metastases. The standard arm will continue to receive TKI, and the intervention arm will receive TKI plus LCRT. Stereotactic body radiation therapy will be delivered to all the oligometastatic sites.The primary end point is PFS, and secondary end points are overall survival, local control of oligometastatic sites, toxicity and patient-reported outcomes. The sample size calculation took a median PFS of 10 months in the standard arm. To detect an absolute improvement of 7 months in the interventional arm, with a one-sided alpha of 5% and 80% power, a total of 106 patients will be accrued over a period of 48 months.
ETHICS AND DISSEMINATION


The study is approved by the Institutional Ethics Committee II of Tata Memorial Centre, Mumbai, and registered with Clinical Trials Registry-India, CTRI/2019/11/021872, dated 5 November 2019. All eligible participants will be provided with a participant information sheet and will be required to provide written informed consent for participation in the study. The study results will be presented at a national/international conference and will be published in a peer-reviewed journal.",2021,"The primary end point is PFS, and secondary end points are overall survival, local control of oligometastatic sites, toxicity and patient-reported outcomes.","['Patients will be screened at presentation for oligometastases (≤5 sites) and will start on TKI after confirmation of EGFR or ALK mutation status', 'patients with oncogene driver-mutated oligometastatic non-small cell lung cancer']","['TKI plus LCRT', 'Tyrosine kinase inhibitors (TKIs', 'local consolidative radiation therapy (LCRT', 'Stereotactic body radiation therapy', 'TKI alone versus TKI and local consolidative radiation therapy']","['overall survival, local control of oligometastatic sites, toxicity and patient-reported outcomes', 'disease relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0029016', 'cui_str': 'Oncogene'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}]",106.0,0.131521,"The primary end point is PFS, and secondary end points are overall survival, local control of oligometastatic sites, toxicity and patient-reported outcomes.","[{'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Tibdewal', 'Affiliation': 'Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India aniltibdewal@gmail.com.'}, {'ForeName': 'JaiPrakash', 'Initials': 'J', 'LastName': 'Agarwal', 'Affiliation': 'Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Mummudi', 'Affiliation': 'Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Nilendu', 'Initials': 'N', 'LastName': 'Purandare', 'Affiliation': 'Nuclear Medicine, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Janu', 'Affiliation': 'Radiodiagnosis, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Kaushal', 'Affiliation': 'Pathology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}, {'ForeName': 'Sadhna', 'Initials': 'S', 'LastName': 'Kannan', 'Affiliation': 'Clinical Research Secreariat, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India.'}]",BMJ open,['10.1136/bmjopen-2020-041345']
1399,33589406,"Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.","BACKGROUND


Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE


This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m 2 , and 24-hour proteinuria level of 0.5-3.0 g, were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups: SYKFT, losartan potassium 50 mg or 100 mg, SYKFT plus losartan potassium 50 mg or 100 mg.
MAIN OUTCOME MEASURES


The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS


A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION


SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER


NCT02063100 on ClinicalTrials.gov.",2021,"The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group.","['primary glomerulonephritis patients', 'Primary glomerulonephritis patients, aged 18-70\xa0years, with blood pressure\xa0≤', 'primary glomerulonephritis', '735 participants were enrolled', '41 hospitals across 19 provinces in China']","['SYKFT plus losartan potassium', 'SYKFT, losartan potassium 50\xa0mg or 100\xa0mg, SYKFT plus losartan potassium 50', 'losartan', 'losartan potassium', 'SYKFT', 'SYKFT plus losartan potassium therapy', 'Shenyankangfu Tablet (SYKFT', 'Shenyankangfu Tablet, a Chinese patent medicine']","['glomerular filtration rate (eGFR', '24-hour proteinuria level', 'Efficacy and safety', 'obvious adverse reactions', 'urine protein level', 'TCM syndrome scores', 'efficacy and safety', 'TCM syndrome score', 'eGFR, serum creatinine and serum albumin', 'urine protein', 'urine protein quantification']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C2912320', 'cui_str': 'Losartan Potassium 50 MG'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013231', 'cui_str': 'Drugs, Non-Prescription'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}]",735.0,0.24206,"The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China.""}, {'ForeName': 'Shu-Wei', 'Initials': 'SW', 'LastName': 'Duan', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China.""}, {'ForeName': 'Hong-Tao', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300192, China.'}, {'ForeName': 'Yue-Yi', 'Initials': 'YY', 'LastName': 'Deng', 'Affiliation': 'Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan 250011, Shandong Province, China.'}, {'ForeName': 'Ya-Ni', 'Initials': 'YN', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Daping Hospital, Army Medical University, Chongqing 400042, China.'}, {'ForeName': 'Zhao-Hui', 'Initials': 'ZH', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China.'}, {'ForeName': 'Yong-Li', 'Initials': 'YL', 'LastName': 'Zhan', 'Affiliation': ""Department of Nephrology, Guang'anmen Hospital, China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, Tianjin Medical University General Hospital, Tianjin 300052, China.'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Guo', 'Affiliation': 'Department of Nephrology, Changhai Hospital of Shanghai, Naval Medical University, Shanghai 200433, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Nephrology, West China Hospital, Chengdu 610083, Sichuan Province, China.'}, {'ForeName': 'Jing-Ai', 'Initials': 'JA', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Xu-Sheng', 'Initials': 'XS', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, Guangdong Province, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Shanxi Medical University Second Affiliated Hospital, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Shandong Provincial Hospital, Jinan 250021, Shandong Province, China.'}, {'ForeName': 'Nian-Song', 'Initials': 'NS', 'LastName': 'Wang', 'Affiliation': ""Department of Nephrology and Rheumatology, Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai 200233, China.""}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Cheng', 'Affiliation': ""Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi'an 710003, Shaanxi Province, China.""}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'Department of Nephrology, Jilin University Second Hospital, Changchun 130041, Jilin Province, China.'}, {'ForeName': 'Shi-Ren', 'Initials': 'SR', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, Xijing Hospital, Air Force Military Medical University, Xi'an 710032, Shaanxi Province, China.""}, {'ForeName': 'Ji-Feng', 'Initials': 'JF', 'LastName': 'Sun', 'Affiliation': ""Department of Nephrology, Tangdu Hospital, Air Force Military Medical University, Xi'an 710038, Shaanxi Province, China.""}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Yin', 'Affiliation': ""Department of Nephrology, the First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an 710061, Shaanxi Province, China.""}, {'ForeName': 'Geng-Ru', 'Initials': 'GR', 'LastName': 'Jiang', 'Affiliation': 'Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China.'}, {'ForeName': 'Hong-Yu', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou 310007, Zhejiang Province, China.'}, {'ForeName': 'Wen-Hu', 'Initials': 'WH', 'LastName': 'Liu', 'Affiliation': 'Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Hong-Li', 'Initials': 'HL', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': ""Department of Nephrology, the 174th Hospital of the People's Liberation Army, Xiamen 361003, Fujian Province, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Nephrology, 281th Hospital of Chinese People's Liberation Army, Qinhuangdao 066100, Hebei Province, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Song', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, Heilongjiang Province, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, 900th Hospital of the Joint Logistics Team of the Chinese People's Liberation Army, Fuzhou 350001, Fujian Province, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Nephrology, Henan Provincial People's Hospital, Zhengzhou 450003, Henan Province, China.""}, {'ForeName': 'Chang-Ying', 'Initials': 'CY', 'LastName': 'Xing', 'Affiliation': 'Department of Nephrology, Jiangsu Province Hospital, Nanjing 210029, Jiangsu Province, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Jiangxi Provincial People's Hospital, Nanchang 330006, Jiangxi Province, China.""}, {'ForeName': 'Ji-Ning', 'Initials': 'JN', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan 030001, Shanxi Province, China.'}, {'ForeName': 'Rong-Shan', 'Initials': 'RS', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanxi Provincial People's Hospital, Taiyuan 030012, Shanxi Province, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, the Third Xiangya Hospital of Central South University, Changsha 410000, Hunan Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Nephrology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province, China.'}, {'ForeName': 'Qiao-Ling', 'Initials': 'QL', 'LastName': 'Zhou', 'Affiliation': 'Department of Nephrology, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China.'}, {'ForeName': 'Jun-Zhou', 'Initials': 'JZ', 'LastName': 'Fu', 'Affiliation': ""Department of Nephrology, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou 310014, Zhejiang Province, China.""}, {'ForeName': 'Guang-Yan', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China. Electronic address: caiguangyan@sina.com.""}, {'ForeName': 'Xiang-Mei', 'Initials': 'XM', 'LastName': 'Chen', 'Affiliation': ""Department of Nephrology, Chinese People's Liberation Army General Hospital, Chinese People's Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China. Electronic address: xmchen301@126.com.""}]",Journal of integrative medicine,['10.1016/j.joim.2021.01.009']
1400,33589320,Putative metabolites involved in the beneficial effects of wholegrain cereal: Nontargeted metabolite profiling approach.,"BACKGROUND AND AIMS


Wholegrain cereals have been implicated in the reduction of lifestyle-related chronic diseases risk including cardiovascular diseases and type 2 diabetes. Molecular mechanisms responsible for the beneficial health effects are not entirely understood. The aims of this study were 1) to identify new potential plasma biomarker candidate metabolites of wholegrain cereal foods intake and 2) to examine whether some putative metabolites associated with wholegrain foods intake may play a role in the improvement of cardiometabolic risk factors.
METHODS AND RESULTS


Analysis have been conducted in 54 individuals with metabolic syndrome of both genders, age 40-65 years, randomly assigned to 2 dietary interventions lasting 12-week: 1) wholegrain enriched diet (n = 28), and 2) refined-wheat cereals diet (control diet) (n = 26). Nontargeted metabolite profiling analysis was performed on fasting plasma samples collected at baseline and at the end of the experimental diets. Our data show that, at the end of the intervention, a higher intake of wholegrain (tertile 3) was significantly associated with a marked increase in several lipid compounds, as PC (20:4/16:1), LPC (20:4), LPC (22:6), LPC (18:3), LPC (22:5), and a phenolic compound (P < .05 for all). In the wholegrain group, higher concentrations of these metabolites (tertile 3 vs tertile 1 of each metabolite) were significantly associated with lower postprandial insulin and triglyceride responses (P < .05) by 29% and 37%, respectively.
CONCLUSION


These observations suggest a possible role of lipid and polyphenol metabolites in the postprandial metabolic benefits of wholegrains in subjects at high risk of cardiovascular disease. In addition, they provide insight into the role of these metabolites as potential candidate biomarkers of wholegrain foods. The study was registered on ClinicalTrials.gov (identifier: NCT00945854).",2020,"In the wholegrain group, higher concentrations of these metabolites (tertile 3 vs tertile 1 of each metabolite) were significantly associated with lower postprandial insulin and triglyceride responses (P ","['54 individuals with metabolic syndrome of both genders, age 40-65 years', 'subjects at high risk of cardiovascular disease']","['Wholegrain cereals', 'wholegrain enriched diet (n\xa0=\xa028), and 2) refined-wheat cereals diet (control diet']",['postprandial insulin and triglyceride responses'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",54.0,0.0335291,"In the wholegrain group, higher concentrations of these metabolites (tertile 3 vs tertile 1 of each metabolite) were significantly associated with lower postprandial insulin and triglyceride responses (P ","[{'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University of Naples, Italy. Electronic address: marilena.vitale@unina.it.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Hanhineva', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland; Department of Biochemistry, Food Chemistry and Food Development Unit, University of Turku, Turku, Finland; Department of Biology and biological engineering, Division of food and nutrition science, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Koistinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Auriola', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Paananen', 'Affiliation': 'Institute of Biomedicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University of Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Della Pepa', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University of Naples, Italy.'}, {'ForeName': 'Angela A', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University of Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, ""Federico II"" University of Naples, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Institute of Food Sciences, National Research Council, Avellino, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.12.022']
1401,33589311,Nutritional intervention during maxillomandibular fixation of jaw fractures prevents weight loss and improves quality of life.,"Maxillomandibular fixation (MMF) for the management of jaw fractures leads to compromised nutritional intake and consequent weight loss and poor quality of life (QoL). The present study aimed to evaluate the effectiveness of a home-based dietary plan to prevent weight loss, and its effect on the QoL of patients who underwent four weeks of MMF for the treatment of maxillofacial fractures. A total of 50 patients were randomised into nutritional intervention (Group1) and non-intervention groups (Group 2). Patients in Group1 were counselled by a dietitian and given a diet plan. Patients in Group 2 were advised to take a liquid diet of their own choice in the form of shakes, juices, and milk, along with protein supplements. Patients in Group1 lost significantly less weight than those in Group 2 (p=0.001) at week four of follow up. Group1 patients had significantly better oral health-related QoL in the 'physical pain' domain during the two weeks of MMF, and in the 'physical discomfort' and 'psychological disability' domains two weeks after the release of MMF. They had significantly better nutrition-related QoL in all the domains during the two weeks of MMF and, except for the 'physical' domain, also during the two weeks after its release. Individual home-based diet plans effectively helped the patients maintain their weight and improved QoL.",2020,"Group1 patients had significantly better oral health-related QoL in the 'physical pain' domain during the two weeks of MMF, and in the 'physical discomfort' and 'psychological disability' domains two weeks after the release of MMF.",['50 patients'],"['home-based dietary plan', 'nutritional intervention (Group1) and non-intervention', 'Nutritional intervention', 'Maxillomandibular fixation (MMF', 'MMF']","['weight loss', 'weight', 'patients maintain their weight and improved QoL', 'weight loss and poor quality of life (QoL', 'oral health-related QoL', 'weight loss and improves quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",50.0,0.016231,"Group1 patients had significantly better oral health-related QoL in the 'physical pain' domain during the two weeks of MMF, and in the 'physical discomfort' and 'psychological disability' domains two weeks after the release of MMF.","[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Popat', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: drshyampopat@gmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rattan', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: drvidyarattan@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: drraisachin@gmail.com.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Jolly', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: satnamsurgeon@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Malhotra', 'Affiliation': 'Department of Dietetics, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. Electronic address: sunita_malhotra01@yahoo.co.in.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.10.009']
1402,33589269,On the synergistic effect of sulfonic functionalization and acidic adhesive conditioning to enhance the adhesion of PEEK to resin-matrix composites.,"OBJECTIVE


The objective of this study was to evaluate the combined effect of the sulfuric acid etching and an acidic adhesive conditioning on the shear bond strength of PEEK to a resin-matrix composite.
MATERIALS AND METHODS


Forty PEEK specimens were assigned randomly to 4 groups for H 2 SO 4  etching followed by universal adhesive (pH at 2.5) conditioning for 0, 1, 3, and 5 min. Thirty PEEK specimens were divided into 3 groups for only acidic adhesive conditioning for 0, 1, 3, and 5 min. After the light-curing of the adhesive, a nanohybrid resin composite was applied onto the surfaces and then light-cured following the manufacturer`s guidelines. All specimens were stored in distilled water at 37 °C for 24 h mechanical testing. Shear bond strength tests were performed using a universal testing machine. Surfaces were analyzed by SEM, light interferometry, FTIR, and liquid contact angle measurement. Statistical analysis was performed by one-way ANOVA and Tukey's post hoc tests (p < 0.05).
RESULTS


No adhesion was achieved between untreated PEEK a resin-matrix composite, regardless of the adhesive conditioning time points. Shear bond strength of H 2 SO 4 -etched PEEK to resin-matrix composite increased with time (0 mmin. 4.95 ± 2.86 MPa < 1 min: 9.35 ± 2.26 MPa < 3 min: 17.84 ± 2.82 MPa < 5 min: 21.43 ± 5.00 MPa). SEM images revealed a significant modification of PEEK surface topography after the H 2 SO 4  etching.
SIGNIFICANCE


The acidic adhesive was unable to modify the untreated PEEK surface to establish an effective adhesion although a synergistic effect was noticed when the universal (acidic) adhesive was applied over a H 2 SO 4 -etched PEEK surface, thus improving the PEEK to resin-matrix composite adhesion.",2021,"The acidic adhesive was unable to modify the untreated PEEK surface to establish an effective adhesion although a synergistic effect was noticed when the universal (acidic) adhesive was applied over a H 2 SO 4 -etched PEEK surface, thus improving the PEEK to resin-matrix composite adhesion.",['Forty PEEK specimens'],"['H 2 SO 4  etching followed by universal adhesive (pH at 2.5) conditioning for 0, 1, 3, and 5 min', 'sulfuric acid etching and an acidic adhesive conditioning']",['Shear bond strength'],"[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038784', 'cui_str': 'Sulfuric acid'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0163279,"The acidic adhesive was unable to modify the untreated PEEK surface to establish an effective adhesion although a synergistic effect was noticed when the universal (acidic) adhesive was applied over a H 2 SO 4 -etched PEEK surface, thus improving the PEEK to resin-matrix composite adhesion.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Escobar', 'Affiliation': 'Postgraduate Program in Dentistry (PPGO), Federal University of Santa Catarina (UFSC), 88040-900, Florianópolis, Brazil.'}, {'ForeName': 'Júlio C M', 'Initials': 'JCM', 'LastName': 'Souza', 'Affiliation': 'School of Dentistry, University Institute of Health Sciences (IUCS), CESPU, 4585-116 Gandra PRD, Portugal; Centre for MicroElectroMechanical Systems (CMEMS-UMinho), University of Minho, Campus Azurém, 4800-058 Guimarães, Braga, Portugal. Electronic address: jsouza@dem.uminho.pt.'}, {'ForeName': 'Guilherme M O', 'Initials': 'GMO', 'LastName': 'Barra', 'Affiliation': 'Department of Mechanical Engineering (EMC), Federal University of Santa Catarina (UFSC), Florianópolis 88040-900, SC, Brazil.'}, {'ForeName': 'Márcio C', 'Initials': 'MC', 'LastName': 'Fredel', 'Affiliation': 'Ceramic and Composite Materials Research Group (CERMAT), Federal University of Santa Catarina, (UFSC), Campus Trindade, 88040-900, Florianópolis, SC, Brazil.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Dental Materials Unit, Division of Dental Biomaterials, Center of Dental Medicine, Clinic for Reconstructive Dentistry, University of Zürich, 8032 Zürich, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Henriques', 'Affiliation': 'School of Dentistry, University Institute of Health Sciences (IUCS), CESPU, 4585-116 Gandra PRD, Portugal; Ceramic and Composite Materials Research Group (CERMAT), Federal University of Santa Catarina, (UFSC), Campus Trindade, 88040-900, Florianópolis, SC, Brazil. Electronic address: brunohenriques@dem.uminho.pt.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2021.01.017']
1403,33589246,Global versus task-specific postoperative feedback in surgical procedure learning.,"BACKGROUND


Task-specific checklists and global rating scales are both recommended assessment tools to provide constructive feedback on surgical performance. This study evaluated the most effective feedback tool by comparing the effects of the Observational Clinical Human Reliability Analysis (OCHRA) and the Objective Structured Assessment of Technical Skills (OSATS) on surgical performance in relation to the visual-spatial ability of the learners.
METHODS


In a randomized controlled trial, medical students were allocated to either the OCHRA (n = 25) or OSATS (n = 25) feedback group. Visual-spatial ability was measured by a Mental Rotation Test. Participants performed an open inguinal hernia repair procedure on a simulation model twice. Feedback was provided after the first procedure. Improvement in performance was evaluated blindly using a global rating scale (performance score) and hand-motion analysis (time and path length).
RESULTS


Mean improvement in performance score was not significantly different between the OCHRA and OSATS feedback groups (P = .100). However, mean improvement in time (371.0 ± 223.4 vs 274.6 ± 341.6; P = .027) and path length (53.5 ± 42.4 vs 34.7 ± 39.0; P = .046) was significantly greater in the OCHRA feedback group. When stratified by mental rotation test scores, the greater improvement in time (P = .032) and path length (P = .053) was observed only among individuals with low visual-spatial abilities.
CONCLUSION


A task-specific (OCHRA) feedback is more effective in improving surgical skills in terms of time and path length in novices compared to a global rating scale (OSATS). The effects of a task-specific feedback are present mostly in individuals with lower visual-spatial abilities.",2021,A task-specific (OCHRA) feedback is more effective in improving surgical skills in terms of time and path length in novices compared to a global rating scale (OSATS).,"['medical students', 'individuals with lower visual-spatial abilities']","['open inguinal hernia repair procedure', 'OCHRA', 'task-specific feedback', 'Technical Skills (OSATS', 'task-specific (OCHRA) feedback', 'OSATS (n\xa0= 25) feedback group', 'Global versus task-specific postoperative feedback']","['Mean improvement in performance score', 'global rating scale (performance score) and hand-motion analysis (time and path length', 'path length', 'Visual-spatial ability']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}]",25.0,0.0811879,A task-specific (OCHRA) feedback is more effective in improving surgical skills in terms of time and path length in novices compared to a global rating scale (OSATS).,"[{'ForeName': 'Tahmina', 'Initials': 'T', 'LastName': 'Nazari', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: t.nazari@erasmusmc.nl.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Bogomolova', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Center for Innovation of Medical Education, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marlike', 'Initials': 'M', 'LastName': 'Ridderbos', 'Affiliation': 'Incision Academy, Amsterdam, The Netherlands.'}, {'ForeName': 'Mary E W', 'Initials': 'MEW', 'LastName': 'Dankbaar', 'Affiliation': 'The Institute for Medical Education Research Rotterdam, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: https://twitter.com/marydankb.'}, {'ForeName': 'Jeroen J G', 'Initials': 'JJG', 'LastName': 'van Merriënboer', 'Affiliation': 'Department of Educational Development and Research, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Wiggers', 'Affiliation': 'Incision Academy, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos A', 'Initials': 'JA', 'LastName': 'van der Hage', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Center for Innovation of Medical Education, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: https://twitter.com/hage_jos.'}]",Surgery,['10.1016/j.surg.2020.12.038']
1404,33589135,Transcriptomic analysis of endometrial receptivity for a genomic diagnostics model of Chinese women.,"OBJECTIVE


To define the transcriptomic signature with respect to human endometrial receptivity in Chinese women by next-generation sequencing and to develop a more refined and customized bioinformatic predictive method for endometrial dating in Chinese women.
DESIGN


Randomized.
SETTING


A tertiary hospital-based reproductive medicine center.
PATIENT(S)


Ninety healthy, fertile Chinese women.
INTERVENTION(S)


Human endometrial biopsies.
MAIN OUTCOME MEASURE(S)


Gene expression of endometrial biopsies.
RESULT(S)


Ninety endometrial samples from healthy Chinese women during their menstrual cycles-including prereceptive (luteinizing hormone [LH] + 3 days/LH + 5 days), receptive (LH + 7 days), and post-receptive (LH + 9 days) phases-were subjected to transcriptomic analysis using messenger RNA (mRNA)-enriched RNA-Seq. Feature genes were obtained and used to train the predictor for endometrial dating, with 63 samples for the training set and 27 samples for the validation set. Differentially expressed genes (DEGs) were identified by comparing samples from different phases of the menstrual cycle. Based on the transcriptomic feature genes, we constructed a bioinformatic predictor for endometrial dating. The accuracy on assessment of the endometrium on days LH + 3, LH + 5, LH + 7, and LH + 9 was 100% in the training set and 85.19% in the validation set.
CONCLUSION(S)


Our transcriptomic profiling method can be used to monitor the window of implantation with regard to the endometrium in the Chinese population. This method potentially provides an evaluation of endometrial status, and can be used to predict a personal window of implantation by reproductive medicine clinicians.",2021,"This method potentially provides an evaluation of endometrial status, and can be used to predict a personal window of implantation by reproductive medicine clinicians.","['Ninety endometrial samples from healthy Chinese women during their menstrual cycles-including', 'A tertiary hospital-based reproductive medicine center', 'Ninety healthy, fertile Chinese women', 'Chinese women']","['prereceptive (luteinizing hormone [LH] + 3 days/LH + 5 days), receptive (LH + 7 days), and post-receptive (LH + 9 days) phases-were subjected to transcriptomic analysis using messenger RNA (mRNA)-enriched RNA-Seq']",['Gene expression of endometrial biopsies'],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]",,0.101786,"This method potentially provides an evaluation of endometrial status, and can be used to predict a personal window of implantation by reproductive medicine clinicians.","[{'ForeName': 'Wen-Bi', 'Initials': 'WB', 'LastName': 'Zhang', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Unimed Biotech (Shanghai) Co., Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Unimed Biotech (Shanghai) Co., Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Chen', 'Affiliation': ""Unimed Biotech (Shanghai) Co., Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Zhang', 'Affiliation': ""Unimed Biotech (Shanghai) Co., Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Chen', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Unimed Biotech (Shanghai) Co., Ltd., Shanghai, People's Republic of China.""}, {'ForeName': 'Xiao-Xi', 'Initials': 'XX', 'LastName': 'Sun', 'Affiliation': ""Shanghai Ji Ai Genetics and IVF Institute, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China; Key Laboratory of Female Reproductive Endocrine Related Diseases, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, People's Republic of China. Electronic address: steven3019@hotmail.com.""}]",Fertility and sterility,['10.1016/j.fertnstert.2020.11.010']
1405,33588974,Angiotensin-converting enzyme inhibition and pre-superior cavopulmonary connection haemodynamics in infants with single-ventricle physiology.,"INTRODUCTION


Preliminary animal and human data suggest that angiotensin-converting enzyme inhibition has a role in pulmonary vascular remodelling. We sought to assess the effect of ACEi versus placebo on pulmonary artery pressure and transpulmonary gradient amongst infants undergoing single-ventricle palliation.
MATERIALS AND METHODS


Using the publicly available Pediatric Heart Network Infant Single-Ventricle trial dataset, we compared mean PA pressure at pre-superior cavopulmonary connection catheterisation (primary outcome), transpulmonary gradient, pulmonary-to-systemic flow ratio, and post-SCPC oxygen saturation (secondary outcomes) in infants receiving enalapril versus placebo.
RESULTS


A total of 179 infants underwent pre-SCPC catheterisation, of which 85 (47%) received enalapril. There was no difference between the enalapril and placebo group in the primary and the secondary outcomes. Mean PA pressure in the enalapril group was 13.1 ± 2.9 compared to 13.7 ± 3.4 mmHg in the placebo group. The transpulmonary gradient was 6.7 ± 2.5 versus 6.9 ± 3.2 mmHg in the enalapril and placebo groups, respectively. The pulmonary-to-systemic flow ratio was 1.1 ± 0.5 in the enalapril group versus 1.0 ± 0.5 in the placebo group and the post-SCPC saturation was 83.1 ± 5.0% in the enalapril group versus 82.2 ± 5.3% in the placebo group. In the pre-specified subgroup analyses comparing enalapril and placebo according to ventricular morphology and shunt type, there was no difference in the primary and secondary outcomes.
CONCLUSION


ACEi did not impact mean pulmonary artery pressure or transpulmonary gradient amongst infants with single-ventricle physiology prior to SCPC palliation.",2021,The pulmonary-to-systemic flow ratio was 1.1 ± 0.5 in the enalapril group versus 1.0 ± 0.5 in the placebo group and the post-SCPC saturation was 83.1 ± 5.0% in the enalapril group versus 82.2 ± 5.3% in the placebo group.,"['infants with single-ventricle physiology', '179 infants underwent pre-SCPC catheterisation, of which 85 (47%) received', 'infants receiving', 'infants undergoing single-ventricle palliation']","['placebo', 'Angiotensin-converting enzyme inhibition and pre-superior cavopulmonary connection haemodynamics', 'ACEi versus placebo', 'enalapril and placebo', 'enalapril', 'ACEi', 'angiotensin-converting enzyme inhibition', 'enalapril versus placebo']","['pulmonary artery pressure and transpulmonary gradient', 'Mean PA pressure', 'mean PA pressure at pre-superior cavopulmonary connection catheterisation (primary outcome), transpulmonary gradient, pulmonary-to-systemic flow ratio, and post-SCPC oxygen saturation', 'pulmonary-to-systemic flow ratio']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428854', 'cui_str': 'Pulmonary to systemic flow ratio'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",179.0,0.204267,The pulmonary-to-systemic flow ratio was 1.1 ± 0.5 in the enalapril group versus 1.0 ± 0.5 in the placebo group and the post-SCPC saturation was 83.1 ± 5.0% in the enalapril group versus 82.2 ± 5.3% in the placebo group.,"[{'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Al Balushi', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Averin', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Daphne T', 'Initials': 'DT', 'LastName': 'Hsu', 'Affiliation': ""The Children's Hospital at Montefiore, Albert Einstein College of Medicine, New York, NY, USA.""}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Division of Cardiology, Stollery Children's Hospital, Department of Pediatrics, University of Alberta, Edmonton, Canada.""}]",Cardiology in the young,['10.1017/S1047951121000305']
1406,33588948,High intensity exercise during breast cancer chemotherapy - effects on long-term myocardial damage and physical capacity - data from the OptiTrain RCT.,"BACKGROUND


Adjuvant systemic breast cancer treatment improves disease specific outcomes, but also presents with cardiac toxicity. In this post-hoc exploratory analysis of the OptiTrain trial, the effects of exercise on cardiotoxicity were monitored by assessing fitness and biomarkers over the intervention and into survivorship. Methods; Women starting chemotherapy were randomized to 16-weeks of resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT), or usual care (UC). Outcome measures included plasma troponin-T (cTnT), Nt-pro-BNP and peak oxygen uptake (VO 2peak ), assessed at baseline, post-intervention, and at 1- and 2-years.
RESULTS


For this per-protocol analysis, 88 women met criteria for inclusion. Plasma cTnT increased in all groups post-intervention. At the 1-year follow-up, Nt-pro-BNP was lower in the exercise groups compared to UC. At 2-years there was a drop in VO 2peak  for patients with high cTnT and Nt-pro-BNP. Fewer patients in the RT-HIIT group fulfilled biomarker risk criteria compared to UC (OR 0.200; 95% CI = 0.055-0.734).
CONCLUSIONS


In this cohort, high-intensity exercise was associated with lower levels of NT-proBNP 1-year post-baseline, but not with cTnT directly after treatment completion. This may, together with the preserved VO 2peak  in patients with low levels of biomarkers, indicate a long-term cardioprotective effect of exercise.
TRIAL REGISTRATION


Clinicaltrials. govNCT02522260 , Registered 13th of august 2015 - Retrospectively Registered.",2021,At 2-years there was a drop in VO 2peak  for patients with high cTnT,"['govNCT02522260 , Registered 13th of august 2015', 'patients with high cTnT', '88 women met criteria for inclusion']","['resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT), or usual care (UC', 'High intensity exercise']","['disease specific outcomes', 'plasma troponin-T (cTnT), Nt-pro-BNP and peak oxygen uptake (VO 2peak ), assessed at baseline, post-intervention, and at 1- and', 'Plasma cTnT', 'cardiotoxicity']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]",,0.117787,At 2-years there was a drop in VO 2peak  for patients with high cTnT,"[{'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Ansund', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Bolam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'Altena', 'Affiliation': 'Cancer Theme, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullman', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rundqvist', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden. Helene.Rundqvist@ki.se.'}]","Cardio-oncology (London, England)",['10.1186/s40959-021-00091-1']
1407,33588938,Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial.,"BACKGROUND


The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants' survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy.
METHODS


One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects.
DISCUSSION


This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods.
TRIAL REGISTRATION


NCT04471103 . Registered on 14 July 2020.",2021,"By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process.","['One hundred and\xa0eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers']",['Multi-Round compared to Real-Time Delphi'],[],"[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],,0.153336,"By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process.","[{'ForeName': 'Fiona A', 'Initials': 'FA', 'LastName': 'Quirke', 'Affiliation': 'Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland. f.quirke1@nuigalway.ie.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Healy', 'Affiliation': 'College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Elaine Ní', 'Initials': 'EN', 'LastName': 'Bhraonáin', 'Affiliation': 'Family Support Liaison, Irish Neonatal Health Alliance, Wicklow, Ireland.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Daly', 'Affiliation': 'Advocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Biesty', 'Affiliation': 'College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hurley', 'Affiliation': 'Health Research Board Neonatal Encephalopathy PhD Training Network (NEPTuNE), Galway, Ireland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'RPA Newborn Care, Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Meher', 'Affiliation': ""Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': 'Indiana University School of Medicine Department of Obstetrics and Gynecology, Indianapolis, USA.'}, {'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Bloomfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Kirkham', 'Affiliation': 'Centre for Biostatistics, University of Manchester, Manchester, UK.'}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Molloy', 'Affiliation': 'Paediatrics and Child Health, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland.'}]",Trials,['10.1186/s13063-021-05074-2']
1408,33588932,Lessons learned from a randomized controlled trial on a home delivered meal service in advanced cancer patients undergoing chemotherapy: a pilot study.,"BACKGROUND


Performing a randomized controlled trial (RCT) in the field of nutrition is challenging and success highly depends on understanding the factors that influence recruitment and dropout of participants. Our aim was to assess the feasibility of a RCT that evaluated a home delivered meal service in advanced cancer patients while receiving chemotherapy.
METHODS


This pilot RCT aimed to enroll 20 participants who were randomized into the home delivered meal service group or usual care group. Study procedures took place before chemotherapy (T0), 3 weeks after T0 (T1), 6 weeks after T0 (T2) and 3 months after T2 (T3). All information regarding recruitment, dropout and study procedures was recorded. Patient satisfaction was assessed by in-depth interviews.
RESULTS


Over 7 months, 20 of 41 approached patients (49%) were included, followed by a dropout rate of 35%. At baseline, hand grip strength (n = 8/16), the Short Physical Performance Battery (n = 12/16) and nutritional intake (n = 8/16) had the highest rate of missing values. Study procedures were not experienced as burdensome and planning of these procedures in line with fixed hospital appointments contributed to this low burden. Keeping the symptom diary was mentioned as being burdensome.
CONCLUSIONS


It is feasible to conduct a RCT on a home delivered meal service in advanced cancer patients during chemotherapy, although recruitment is challenging. Close contact of patients with recruiting personnel is essential to sustain motivation. To increase compliance with the study protocol it is important to carefully instruct participants on how to complete questionnaires and to emphasize to use these in the communication with their practitioners.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03382171 .",2021,"At baseline, hand grip strength (n = 8/16), the Short Physical Performance Battery (n = 12/16) and nutritional intake (n = 8/16) had the highest rate of missing values.","['advanced cancer patients', 'advanced cancer patients undergoing', 'advanced cancer patients while receiving chemotherapy', 'enroll 20 participants who were randomized into the home delivered']","['chemotherapy', 'meal service group or usual care group']","['highest rate of missing values', 'Patient satisfaction', 'hand grip strength', 'Short Physical Performance Battery', 'nutritional intake']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",41.0,0.170832,"At baseline, hand grip strength (n = 8/16), the Short Physical Performance Battery (n = 12/16) and nutritional intake (n = 8/16) had the highest rate of missing values.","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'IJmker-Hemink', 'Affiliation': 'Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboudumc, Nijmegen, The Netherlands. Vera.IJmkerHemink@radboudumc.nl.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Lize', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Beijer', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.'}, {'ForeName': 'Natasja', 'Initials': 'N', 'LastName': 'Raijmakers', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Wanten', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboudumc, Nijmegen, The Netherlands.'}]",BMC nutrition,['10.1186/s40795-021-00407-5']
1409,33588930,"How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods.","BACKGROUND


Fixed orthodontic appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. Fifty to 70% of patients treated with braces encounter these problems. Their care in the USA represents an annual cost of five hundred million dollars. Initial education and motivation for oral hygiene depend on two categories of factors: firstly, practical prophylactic measures (instruments and medication, professional care) and secondly, the educational component: choice of communication technique, frequency, and nature of hygiene instructions. This trial aims to study this last component. Its main objective is to compare three methods' effectiveness of oral hygiene education in adolescent patients treated with braces in terms of biofilm (plaque) control. The secondary objectives are the evaluation of these methods' effectiveness regarding gingival inflammation and the maintenance of hygiene during the first 6 months of treatment.
METHODS


This study is a prospective randomized controlled trial of superiority. It evaluates the effectiveness of three hygiene education techniques. A total of 90 patients from the University Hospital Center of Rennes will be randomized into 3 parallel groups with a 1:1:1 ratio. Each will benefit from a different educational method: oral and/or practical. The main outcome will be the average plaque index for each group after 6 months of treatment. Additional outcomes will be the average gingival index for each group and the plaque and gingival indices over 6 months.
DISCUSSION


The effectiveness of preventive procedures for optimizing oral hygiene during orthodontics is based on ambiguous literature. As a result, it is difficult to draw conclusions and to translate them into everyday practice. Sixty-eight percent of the orthodontists support the development of guidelines for education. The aim of this study is to standardize methods of oral hygiene education during orthodontic fixed treatment. The purpose of this study would be to provide practitioners with a concrete education program through guidelines dedicated to the method having the best results.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04444154 . Registered on 22 June 2020. SI CNRIPH ID 8011N° 20.04.27.58337. Registered on 29 July 2020.",2021,"The secondary objectives are the evaluation of these methods' effectiveness regarding gingival inflammation and the maintenance of hygiene during the first 6 months of treatment.
","['adolescents undergoing orthodontic treatment', 'adolescent patients treated with braces in terms of biofilm (plaque) control', 'Fixed orthodontic appliances hamper oral hygiene procedures', '90 patients from the University Hospital Center of Rennes']",['oral hygiene education'],"['average plaque index', 'plaque and gingival indices', 'average gingival index']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0181113', 'cui_str': 'Hamper'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",90.0,0.0762163,"The secondary objectives are the evaluation of these methods' effectiveness regarding gingival inflammation and the maintenance of hygiene during the first 6 months of treatment.
","[{'ForeName': 'Alisée', 'Initials': 'A', 'LastName': 'Le Fouler', 'Affiliation': 'Univ Rennes, CHU Rennes, Pôle Odontologie, 2 av. du Professeur Léon Bernard, Bât. 15, 35043, Rennes Cedex, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Jeanne', 'Affiliation': 'Univ Rennes, ISCR, CNRS-UMR 6226, CHU Rennes, Pôle Odontologie, 2 av. du Professeur Léon Bernard, Bât. 15, 35043, Rennes Cedex, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sorel', 'Affiliation': 'Univ Rennes, CHU Rennes, Pôle Odontologie, 2 av. du Professeur Léon Bernard, Bât. 15, 35043, Rennes Cedex, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Brézulier', 'Affiliation': 'Univ Rennes, ISCR, CNRS-UMR 6226, CHU Rennes, Pôle Odontologie, 2 av. du Professeur Léon Bernard, Bât. 15, 35043, Rennes Cedex, France. damien.brezulier@univ-rennes1.fr.'}]",Trials,['10.1186/s13063-021-05093-z']
1410,33588908,MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion-study protocol for a randomized clinical trial.,"BACKGROUND


Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there is clinical equipoise concerning the added benefit of intravenous alteplase administration (IVT) prior to EVT. The aim of this study is to assess the efficacy and safety of omitting IVT before EVT in patients with AIS caused by an anterior circulation LVO.
METHODS


MR CLEAN-NO IV is a multicenter randomized open-label clinical trial with blinded outcome assessment (PROBE design). Patients ≥ 18 years of age with a pre-stroke mRS < 3 with an LVO confirmed on CT angiography/MR angiography eligible for both IVT and EVT are randomized to receive either IVT (0.9 mg/kg) followed by EVT, or direct EVT in a 1:1 ratio. The primary objective is to assess superiority of direct EVT. Secondarily, non-inferiority of direct EVT compared to IVT before EVT will be explored. The primary outcome is the score on the modified Rankin Scale at 90 days. Ordinal regression with adjustment for prognostic variables will be used to estimate treatment effect. Secondary outcomes include reperfusion graded with the eTICI scale after EVT and stroke severity (National Institutes of Health Stroke Scale) at 24 h. Safety outcomes include intracranial hemorrhages scored according to the Heidelberg criteria. A total of 540 patients will be included.
DISCUSSION


IVT prior to EVT might facilitate early reperfusion before EVT or improved reperfusion rates during EVT. Conversely, among other potential adverse effects, the increased risk of bleeding could nullify the beneficial effects of IVT. MR CLEAN-NO IV will provide insight into whether IVT is still of added value in patients eligible for EVT.
TRIAL REGISTRATION


www.isrctn.com : ISRCTN80619088 . Registered on 31 October 2017.",2021,"BACKGROUND


Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation.","['18\u2009years of age with a pre-stroke mRS <\u20093 with an LVO confirmed on CT angiography/MR angiography eligible for both IVT and EVT', 'patients with AIS caused by an anterior circulation LVO', '540 patients will be included', 'patients eligible for EVT', 'Patients ≥', 'acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation']","['endovascular treatment versus direct endovascular treatment', 'Endovascular treatment (EVT', 'IVT', 'omitting IVT before EVT', 'direct EVT', 'MR CLEAN', 'EVT, or direct EVT']","['intracranial hemorrhages scored according to the Heidelberg criteria', 'efficacy and safety', 'reperfusion graded with the eTICI scale after EVT and stroke severity (National Institutes of Health Stroke Scale', 'reperfusion rates', 'score on the modified Rankin Scale', 'acute ischemic stroke']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",540.0,0.142424,"BACKGROUND


Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation.","[{'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, Amsterdam, 1100DD, The Netherlands.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, Amsterdam, 1100DD, The Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, Amsterdam, 1100DD, The Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, Amsterdam, 1100DD, The Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jelis', 'Initials': 'J', 'LastName': 'Boiten', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Geert J', 'Initials': 'GJ', 'LastName': 'Lycklama', 'Affiliation': 'Department of Radiology, The Hague Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Keizer', 'Affiliation': 'Department of Neurology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Lonneke S F', 'Initials': 'LSF', 'LastName': 'Yo', 'Affiliation': 'Department of Radiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Department of Radiology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'de Ridder', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Amsterdam UMC, University of Amsterdam, P.O. Box 22660, Amsterdam, 1100DD, The Netherlands. c.b.majoie@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-021-05063-5']
1411,33588904,Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial.,"BACKGROUND


High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP.
METHODS/DESIGN


This prospective, randomized, and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 min, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12 weeks from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, body mass index, and waist circumference. Adverse events during the trial will be monitored.
DISCUSSION


This trial will explore the feasibility and provide potential evidence for the effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR 1900024982 . Registered on August 6, 2019.",2021,Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio.,"['high-normal blood pressure', 'Sixty participants with high-normal BP', 'community service center in China']","['TEAS', 'Transcutaneous electrical acupoint stimulation', 'Transcutaneous electrical acupoint stimulation (TEAS', 'TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group', 'TEAS combined with lifestyle modification', 'same lifestyle modification but no TEAS']","['mean systolic blood pressure', 'Adverse events', 'change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, body mass index, and waist circumference']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0009482', 'cui_str': 'Community Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",60.0,0.173114,Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Zhong-Xue', 'Initials': 'ZX', 'LastName': 'Tian', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Jun-Hong', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'You-Sheng', 'Initials': 'YS', 'LastName': 'Qi', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.'}, {'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. wangliqiongwork@163.com.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.'}]",Trials,['10.1186/s13063-021-05039-5']
1412,33588897,Long-term health-related quality of life in patients treated with subcutaneous C1-inhibitor replacement therapy for the prevention of hereditary angioedema attacks: findings from the COMPACT open-label extension study.,"BACKGROUND


Long-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE) was evaluated in an open-label extension follow-up study to the international, double-blind, placebo-controlled COMPACT study. The current analysis evaluated patient-reported health-related quality of life (HRQoL) data from 126 patients in the open-label extension study randomized to treatment with C1-INH(SC) 40 IU/kg (n = 63) or 60 IU/kg (n = 63) twice weekly for 52 weeks. HRQoL was evaluated at the beginning of the open-label study and at various time points using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the Hospital Anxiety and Depression Scale (HADS), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the Treatment Satisfaction Questionnaire for Medication. The disease-specific Angioedema Quality of Life Questionnaire (AE-QoL) and HAE quality of life questionnaire (HAE-QoL) instruments were administered in a subset of patients. Statistical significance was determined by change-from-baseline 95% confidence intervals (CIs) excluding zero. No adjustment for multiplicity was done.
RESULTS


Mean baseline EQ-5D scores (Health State Value, 0.90; Visual Analog Scale, 81.32) were slightly higher (better) than United States population norms (0.825, 80.0, respectively) and mean HADS anxiety (5.48) and depression (2.88) scores were within ""normal"" range (0-7). Yet, patients using C1-INH(SC) 60 IU/kg demonstrated significant improvement from baseline to end-of-study on the EQ-5D Health State Value (mean change [95% CI], 0.07 [0.01, 0.12] and Visual Analog Scale (7.45 [3.29, 11.62]). In the C1-INH(SC) 60 IU/kg group, there were significant improvements in the HADS anxiety scale (mean change [95% CI], - 1.23 [- 2.08, - 0.38]), HADS depression scale (- 0.95 [- 1.57, - 0.34]), and WPAI-assessed presenteeism (mean change [95% CI], - 23.33% [- 34.86, - 11.81]), work productivity loss (- 26.68% [- 39.92, - 13.44]), and activity impairment (- 16.14% [- 26.36, - 5.91]). Clinically important improvements were achieved in ≥ 25% of patients for all domains except WPAI-assessed absenteeism (which was very low at baseline). Mean AE-QoL total score by visit ranged from 13.39 to 17.89 (scale 0-100; lower scores = less impairment). Mean HAE-QoL global scores at each visit (115.7-122.3) were close to the maximum (best) possible score of 135.
CONCLUSIONS


Long-term C1-INH(SC) replacement therapy in patients with C1-INH-HAE leads to significant and sustained improvements in multiple measures of HRQoL. Trial registration A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema, NCT02316353. Registered December 12, 2014, https://clinicaltrials.gov/ct2/show/NCT02316353 .",2021,Clinically important improvements were achieved in ≥ 25% of patients for all domains except WPAI-assessed absenteeism (which was very low at baseline).,"['patients treated with', 'hereditary angioedema attacks', 'patients with C1-INH-HAE', 'patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE']","['subcutaneous C1-inhibitor (C1-INH[SC', 'subcutaneous C1-inhibitor replacement therapy', 'C1-INH(SC']","['EQ-5D Health State Value', 'European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the Hospital Anxiety and Depression Scale (HADS), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the Treatment Satisfaction Questionnaire for Medication', 'HADS anxiety scale', 'HADS depression scale', 'Visual Analog Scale', 'disease-specific Angioedema Quality of Life Questionnaire (AE-QoL) and HAE quality of life questionnaire (HAE-QoL', 'Mean baseline EQ-5D scores (Health State Value, 0.90; Visual Analog Scale', 'Mean AE-QoL total score', 'HRQoL', 'Mean HAE-QoL global scores', 'mean HADS anxiety', 'activity impairment', 'work productivity loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0009500', 'cui_str': 'Complement Component 1 Inactivator Proteins'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.100852,Clinically important improvements were achieved in ≥ 25% of patients for all domains except WPAI-assessed absenteeism (which was very low at baseline).,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, 10100 N. Central Expressway, Suite 100, Dallas, TX, 75231, USA. Lumrymd@AARAResearch.com.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Zuraw', 'Affiliation': 'Department of Medicine, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cicardi', 'Affiliation': 'University of Milan, Milan, Italy.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC, Cincinnati, OH, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Caballero', 'Affiliation': 'Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network On Rare Diseases (CIBERER U754), Madrid, Spain.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, 3Rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gower', 'Affiliation': 'Marycliff Clinical Research, Spokane, WA, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Keith', 'Affiliation': 'McMaster University, Hamilton, ON, USA.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Levy', 'Affiliation': 'UC Irvine, Orange, CA, USA.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Magerl', 'Affiliation': 'Department of Dermatology and Allergy, Charité, Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manning', 'Affiliation': 'Medical Research of Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'CSL Behring GmbH, Emil-von-Behring-Strasse 76, Marburg, Germany.'}, {'ForeName': 'Subhransu', 'Initials': 'S', 'LastName': 'Prusty', 'Affiliation': 'CSL Behring GmbH, Emil-von-Behring-Strasse 76, Marburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Machnig', 'Affiliation': 'CSL Behring GmbH, Emil-von-Behring-Strasse 76, Marburg, Germany.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Longhurst', 'Affiliation': 'University College Hospital, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01658-4']
1413,33588893,"Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial.","BACKGROUND


Anemia is a significant problem in patients on ICU. Its commonest cause, iron deficiency (ID), is difficult to diagnose in the context of inflammation. Hepcidin is a new marker of ID. We aimed to assess whether hepcidin levels would accurately guide treatment of ID in critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes.
METHODS


In a controlled, single-blinded, multicenter study, anemic (WHO definition) critically ill patients with an ICU stay ≥ 5 days were randomized when discharge was expected to either intervention by hepcidin treatment protocol or control. In the intervention arm, patients were treated with intravenous iron (1 g of ferric carboxymaltose) when hepcidin was < 20 μg/l and with intravenous iron and erythropoietin for 20 ≤ hepcidin < 41 μg/l. Control patients were treated according to standard care (hepcidin quantification remained blinded). Primary endpoint was the number of days spent in hospital 90 days after ICU discharge (post-ICU LOS). Secondary endpoints were day 15 anemia, day 30 fatigue, day 90 mortality and 1-year survival.
RESULTS


Of 405 randomized patients, 399 were analyzed (201 in intervention and 198 in control arm). A total of 220 patients (55%) had ID at discharge (i.e., a hepcidin < 41 μg/l). Primary endpoint was not different (medians (IQR) post-ICU LOS 33(13;90) vs. 33(11;90) days for intervention and control, respectively, median difference - 1(- 3;1) days, p = 0.78). D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04).
CONCLUSION


Treatment of ID diagnosed according to hepcidin levels did not reduce the post-ICU LOS, but was associated with a significant reduction in D90 mortality and with improved 1-year survival in critically ill patients about to be discharged after a prolonged stay.
TRIAL REGISTRATION


www.clinicaltrial.gov NCT02276690 (October 28, 2014; retrospectively registered).",2021,"D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04).
","['patients on ICU', 'critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes', 'anemic (WHO definition) critically ill patients with an ICU stay\u2009≥\u20095\xa0days', '220 patients (55%) had ID at discharge (i.e., a hepcidin', '405 randomized patients']","['Hepcidin', 'intravenous iron (1\xa0g of ferric carboxymaltose', 'hepcidin treatment protocol or control', 'hepcidin was\u2009<\u200920\xa0μg/l and with intravenous iron and erythropoietin for 20\u2009≤\u2009hepcidin\u2009<\u200941\xa0μg/l']","['year survival', 'number of days spent in hospital 90\xa0days after ICU discharge (post-ICU LOS', 'day 15 anemia, day 30 fatigue, day 90 mortality and 1-year survival', 'D90 mortality', '1-year survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C4517768', 'cui_str': '405'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",405.0,0.286186,"D90 mortality was significantly lower in intervention arm (16(8%) vs 33(16.6%) deaths, absolute risk difference - 8.7 (- 15.1 to - 2.3)%, p = 0.008, OR 95% IC, 0.46, 0.22-0.94, p = 0.035), and one-year survival was improved (p = 0.04).
","[{'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie Réanimation, CHU Angers, Université D'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France. sigismond@lasocki.com.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""Département Médecine Intensive Réanimation, CHU Angers, Université D'Angers, Angers, France.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Département Anesthésie Réanimation, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandiere', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Tours, Université de Tours, Tours, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kerforne', 'Affiliation': ""Service D'anesthésie-réanimation, CHU de Poitiers, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Montravers', 'Affiliation': 'Département Anesthésie Réanimation, APHP, HUPNSV, CHU Bichat, Université Paris Diderot Sorbonne, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Seguin', 'Affiliation': 'Département Anesthésie Réanimation, CHU de Rennes, Université de Rennes, Rennes, France.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': ""Peoc'h"", 'Affiliation': ""INSERM U1149, UFR de Médecine Bichat, Centre de Recherche Sur L'Inflammation, Université de Paris, Paris, France.""}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ""Département Anesthésie Réanimation, CHU Angers, Université D'Angers, 4 rue Larrey, 49933, Angers Cedex 9, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': ""Département D'information médicale, CHU Montpellier, Université de Montpellier, Montpellier, France.""}, {'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Lefebvre', 'Affiliation': ""INSERM U1149, UFR de Médecine Bichat, Centre de Recherche Sur L'Inflammation, Université de Paris, Paris, France.""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Lehmann', 'Affiliation': 'Laboratoire de Biochimie Protéomique Clinique Et IRMB INSERM, CHU de Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Critical care (London, England)",['10.1186/s13054-020-03430-3']
1414,33588872,Ergogenic effect of pre-exercise chicken broth ingestion on a high-intensity cycling time-trial.,"BACKGROUND


chicken meat extract is a popular functional food in Asia. It is rich in the bioactive compounds carnosine and anserine, two histidine-containing dipeptides (HCD). Studies suggest that acute pre-exercise ingestion of chicken extracts has important applications towards exercise performance and fatigue control, but the evidence is equivocal. This study aimed to evaluate the ergogenic potential of the pre-exercise ingestion of a homemade chicken broth (CB) vs a placebo soup on a short-lasting, high-intensity cycling exercise.
METHODS


fourteen men participated in this double-blind, placebo-controlled, crossover intervention study. Subjects ingested either CB, thereby receiving 46.4 mg/kg body weight of HCD, or a placebo soup (similar in taste without HCD) 40 min before an 8 min cycling time trial (TT) was performed. Venous blood samples were collected at arrival (fasted), before exercise and at 5 min recovery. Plasma HCD were measured with UPLC-MS/MS and glutathione (in red blood cells) was measured through HPLC. Capillary blood samples were collected at different timepoints before and after exercise.
RESULTS


a significant improvement (p = 0.033; 5.2%) of the 8 min TT mean power was observed after CB supplementation compared to placebo. Post-exercise plasma carnosine (p <  0.05) and anserine (p <  0.001) was significantly increased after CB supplementation and not following placebo. No significant effect of CB supplementation was observed either on blood glutathione levels, nor on capillary blood analysis.
CONCLUSIONS


oral CB supplementation improved the 8 min TT performance albeit it did not affect the acid-base balance or oxidative status parameters. Further research should unravel the potential role and mechanisms of HCD, present in CB, in this ergogenic approach.",2021,"RESULTS


a significant improvement (p = 0.033; 5.2%) of the 8 min",['fourteen men participated'],"['pre-exercise chicken broth ingestion', 'homemade chicken broth (CB) vs a placebo', 'placebo']","['Venous blood samples', 'acid-base balance or oxidative status parameters', 'Capillary blood samples', 'Plasma HCD', 'UPLC-MS/MS and glutathione (in red blood cells', 'blood glutathione levels', 'TT mean power']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008051', 'cui_str': 'Gallus gallus'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0419342', 'cui_str': 'Capillary specimen collection'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012512', 'cui_str': 'Dipeptide'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",14.0,0.428403,"RESULTS


a significant improvement (p = 0.033; 5.2%) of the 8 min","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Barbaresi', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, B-9000, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Blancquaert', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, B-9000, Ghent, Belgium.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Nikolovski', 'Affiliation': 'Faculty of Kinesiology, University of Split, Split, Croatia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'de Jager', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, B-9000, Ghent, Belgium.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Institute of Sport, Exercise and Health (ISEH), University College London, London, UK.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Everaert', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, B-9000, Ghent, Belgium.'}, {'ForeName': 'Siegrid', 'Initials': 'S', 'LastName': 'De Baere', 'Affiliation': 'Department of Pharmacology, Toxicology and Biochemistry, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Siska', 'Initials': 'S', 'LastName': 'Croubels', 'Affiliation': 'Department of Pharmacology, Toxicology and Biochemistry, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Laboratory for Animal Nutrition and Animal Product Quality, Ghent University, Ghent, Belgium.'}, {'ForeName': 'N Tim', 'Initials': 'NT', 'LastName': 'Cable', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Derave', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Watersportlaan 2, B-9000, Ghent, Belgium. wim.derave@ugent.be.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-021-00408-6']
1415,33588822,How supervision and educational supports impact medical students' preparation for future learning of endotracheal intubation skills: a non-inferiority experimental trial.,"BACKGROUND


Professional education cannot keep pace with the rapid advancements of knowledge in today's society. But it can develop professionals who can. 'Preparation for future learning' (PFL) has been conceptualized as a form of transfer whereby learners use their previous knowledge to learn about and adaptively solve new problems. Improved PFL outcomes have been linked to instructional approaches targeting learning mechanisms similar to those associated with successful self-regulated learning (SRL). We expected training that includes evidence-based SRL-supports would be non-inferior to training with direct supervision using the outcomes of a 'near transfer' test, and a PFL assessment of simulated endotracheal intubation skills.
METHOD


This study took place at the University of Toronto from October 2014 to August 2015. We randomized medical students and residents (n = 54) into three groups: Unsupervised, Supported; Supervised, Supported; and Unsupervised, Unsupported. Two raters scored participants' test performances using a Global Rating Scale with strong validity evidence. We analyzed participants' near transfer and PFL outcomes using two separate mixed effects ANCOVAs.
RESULTS


For the Unsupervised, Supported group versus the Supervised, Supported group, we found that the difference in mean scores was 0.20, with a 95% Confidence Interval (CI) of - 0.17 to 0.57, on the near transfer test, and was 0.09, with a 95% CI of - 0.28 to 0.46, on the PFL assessment. Neither mean score nor their 95% CIs exceeded the non-inferiority margin of 0.60 units. Compared to the two Supported groups, the Unsupervised, Unsupported group was non-inferior on the near transfer test (differences in mean scores were 0.02 and - 0.22). On the PFL assessment, however, the differences in mean scores were 0.38 and 0.29, and both 95% CIs crossed the non-inferiority margin.
CONCLUSIONS


Training with SRL-supports was non-inferior to training with a supervisor. Both interventions appeared to impact PFL assessment outcomes positively, yet inconclusively when compared to the Unsupervised and Unsupported group, By contrast, the Unsupervised, Supported group did not score well on the near transfer test. Based on the observed sensitivity of the PFL assessment, we recommend researchers continue to study how such assessments may measure learners' SRL outcomes  during structured learning experiences.",2021,"Compared to the two Supported groups, the Unsupervised, Unsupported group was non-inferior on the near transfer test (differences in mean scores were 0.02 and - 0.22).","['University of Toronto from October 2014 to August 2015', 'medical students and residents (n\u2009=\u200954) into three groups']","['Unsupervised, Supported; Supervised, Supported; and Unsupervised, Unsupported']","['mean scores', 'Global Rating Scale with strong validity evidence']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",,0.045109,"Compared to the two Supported groups, the Unsupervised, Unsupported group was non-inferior on the near transfer test (differences in mean scores were 0.02 and - 0.22).","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Manzone', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mylopoulos', 'Affiliation': 'Wilson Centre and Department of Pediatrics, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ringsted', 'Affiliation': 'Centre for Health Sciences Education, Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Brydges', 'Affiliation': ""Allan Waters Family Simulation Centre and Technology-Enabled Education, St. Michael's Hospital, Toronto, ON, Canada. ryan.brydges@utoronto.ca.""}]",BMC medical education,['10.1186/s12909-021-02514-0']
1416,33588808,"Cooking for Health: a healthy food budgeting, purchasing, and cooking skills randomized controlled trial to improve diet among American Indians with type 2 diabetes.","BACKGROUND


The prevalence of poor diet quality and type 2 diabetes are exceedingly high in many rural American Indian (AI) communities. Because of limited resources and infrastructure in some communities, implementation of interventions to promote a healthy diet is challenging-which may exacerbate health disparities by region (urban/rural) and ethnicity (AIs/other populations). It is critical to adapt existing evidence-based healthy food budgeting, purchasing, and cooking programs to be relevant to underserved populations with a high burden of diabetes and related complications. The Cooking for Health Study will work in partnership with an AI community in South Dakota to develop a culturally-adapted 12-month distance-learning-based healthy food budgeting, purchasing, and cooking intervention to improve diet among AI adults with type 2 diabetes.
METHODS


The study will enroll 165 AIs with physician-diagnosed type 2 diabetes who reside on the reservation. Participants will be randomized to an intervention or control arm. The intervention arm will receive a 12-month distance-learning curriculum adapted from Cooking Matters® that focuses on healthy food budgeting, purchasing, and cooking skills. In-person assessments at baseline, month 6 and month 12 will include completion of the Nutrition Assessment Shared Resources Food Frequency Questionnaire and a survey to assess frequency of healthy and unhealthy food purchases. Primary outcomes of interest are: (1) change in self-reported intake of sugar-sweetened beverages (SSBs); and (2) change in the frequency of healthy and unhealthy food purchases. Secondary outcomes include: (1) change in self-reported food budgeting skills; (2) change in self-reported cooking skills; and (3) a mixed-methods process evaluation to assess intervention reach, fidelity, satisfaction, and dose delivered/received.
DISCUSSION


Targeted and sustainable interventions are needed to promote optimal health in rural AI communities. If effective, this intervention will reduce intake of SSBs and the purchase of unhealthy foods; increase the purchase of healthy foods; and improve healthy food budgeting and cooking skills among AIs with type 2 diabetes - a population at high risk of poor health outcomes. This work will help inform future health promotion efforts in resource-limited settings.
TRIAL REGISTRATION


This study was registered on ClinicalTrials.gov on October 9, 2018 with Identifier NCT03699709 .",2021,"If effective, this intervention will reduce intake of SSBs and the purchase of unhealthy foods; increase the purchase of healthy foods; and improve healthy food budgeting and cooking skills among AIs with type 2 diabetes - a population at high risk of poor health outcomes.","['American Indians with type 2 diabetes', 'AI adults with type 2 diabetes', '165 AIs with physician-diagnosed type 2 diabetes who reside on the reservation', 'rural AI communities']",[],"['interest are: (1) change in self-reported intake of sugar-sweetened beverages (SSBs); and (2) change in the frequency of healthy and unhealthy food purchases', ' (1) change in self-reported food budgeting skills; (2) change in self-reported cooking skills; and (3) a mixed-methods process evaluation to assess intervention reach, fidelity, satisfaction, and dose delivered/received']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0039585', 'cui_str': 'Androgen resistance syndrome'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0561041,"If effective, this intervention will reduce intake of SSBs and the purchase of unhealthy foods; increase the purchase of healthy foods; and improve healthy food budgeting and cooking skills among AIs with type 2 diabetes - a population at high risk of poor health outcomes.","[{'ForeName': 'Caitlin N', 'Initials': 'CN', 'LastName': 'Hawley', 'Affiliation': 'Department of Medicine, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, USA.'}, {'ForeName': 'Corrine M', 'Initials': 'CM', 'LastName': 'Huber', 'Affiliation': 'Missouri Breaks Industries Research Inc, 118 S Willow St, Eagle Butte, SD, 57625, USA.'}, {'ForeName': 'Lyle G', 'Initials': 'LG', 'LastName': 'Best', 'Affiliation': 'Missouri Breaks Industries Research Inc, 118 S Willow St, Eagle Butte, SD, 57625, USA.'}, {'ForeName': 'Barbara V', 'Initials': 'BV', 'LastName': 'Howard', 'Affiliation': 'Medstar Health Research Institute, 6525 Belcrest Rd #700c, Hyattsville, MD, 20785, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Umans', 'Affiliation': 'Medstar Health Research Institute, 6525 Belcrest Rd #700c, Hyattsville, MD, 20785, USA.'}, {'ForeName': 'Shirley A A', 'Initials': 'SAA', 'LastName': 'Beresford', 'Affiliation': 'Department of Epidemiology, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McKnight', 'Affiliation': 'Department of Biostatistics, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, USA.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Hager', 'Affiliation': 'Cheyenne River Sioux Tribe Adult Diabetes Program, 24276 Airport Rd, Eagle Butte, SD, 57625, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': ""O'Leary"", 'Affiliation': 'Missouri Breaks Industries Research Inc, 118 S Willow St, Eagle Butte, SD, 57625, USA.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, 1410 NE Campus Parkway, Seattle, WA, 98195, USA.'}, {'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Fretts', 'Affiliation': 'Department of Epidemiology, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, USA. amfretts@uw.edu.'}]",BMC public health,['10.1186/s12889-021-10308-8']
1417,33588801,Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial.,"BACKGROUND


Antenatal corticosteroids (ACS) are increasingly used to improve prematurity-related neonatal outcome. A recognized and common adverse effect from administration of antenatal corticosteroid is maternal hyperglycemia. Even normal pregnancy is characterized by relative insulin resistance and glucose intolerance. Treatment of maternal hyperglycemia after ACS might be indicated due to the higher risk of neonatal acidosis which may coincide with premature birth. Metformin is increasingly used to manage diabetes mellitus during pregnancy as it is effective and more patient friendly. There is no data on prophylactic metformin to maintain euglycemia following antenatal corticosteroids administration.
METHODS


A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal ≥ 5.3 mmol/L or two-hour post prandial/meal ≥ 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids.
RESULTS


Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 ± 1.0 (metformin) vs. 1.2 ± 1.0 (placebo) p = 0.15 and further reduced to 0.6 ± 1.0 (metformin) vs. 0.7 ± 1.0 (placebo) p = 0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different.
CONCLUSIONS


In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids' hyperglycemic effect.
TRIAL REGISTRATION


The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier https://doi.org/10.1186/ISRCTN10156101 .",2021,"RESULTS


Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64.","['103 women scheduled to receive two doses of 12-mg intramuscular', 'gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1']","['prophylactic metformin or placebo', 'Metformin', 'Prophylactic metformin', 'dexamethasone', 'Antenatal corticosteroids (ACS', 'antenatal corticosteroid']","['Hypoglycemic episodes', 'magnitude of Day-1 hyperglycemia', 'Hyperglycemic episodes', 'hyperglycemic episodes']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",103.0,0.527944,"RESULTS


Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64.","[{'ForeName': 'Jesrine Gek Shan', 'Initials': 'JGS', 'LastName': 'Hong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. jesrine@um.edu.my.'}, {'ForeName': 'Peng Chiong', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Maherah', 'Initials': 'M', 'LastName': 'Kamarudin', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zawiah', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-03628-5']
1418,33588798,Acceptability of tDCS in treating stress-related mental health disorders: a mixed methods study among military patients and caregivers.,"BACKGROUND


Noninvasive brain stimulation techniques like transcranial direct current stimulation (tDCS) offer potential new approaches to treat stress-related mental health disorders. While the acceptability of tDCS as a treatment tool plays a crucial role in its development and implementation, little is known about tDCS acceptability for users in mental healthcare, especially in the context of stress-related disorders.
METHODS


Using a mixed-methods approach, we investigated tDCS acceptability among 102 active duty and post-active military patients with stress-related symptoms (posttraumatic stress disorder, anxiety and impulsive aggression) who participated in a 5-session tDCS intervention. Quantitative dropout and adverse effects data was collected for all patients involved in the sham-controlled tDCS intervention. We additionally explored perspectives on the acceptability of tDCS treatment via a theory-based semi-structured interview. A subgroup of patients as well as their caregivers were interviewed to include the views of both patients and mental healthcare professionals.
RESULTS


Quantitative outcomes showed minimal tDCS-related adverse effects (mild itching or burning sensations on the scalp) and high tDCS treatment adherence (dropout rate: 4% for active tDCS, 0% for sham). The qualitative outcomes showed predominantly positive attitudes towards tDCS interventions for stress-related disorders, but only as complementary to psychotherapy. Remarkably, despite the perception that sufficient explanation was provided, patients and caregivers stressed that tDCS treatment comprehension was limited and should improve. Also, the travel associated with frequent on-site tDCS sessions may produce a significant barrier to care for patients with stress-related disorders and active-duty military personnel.
CONCLUSIONS


Acceptability numbers and perspectives from military patients and caregivers suggest that tDCS is an acceptable complementary tool in the treatment of stress-related disorders. Critically, however, if tDCS is to be used beyond scientific studies, adequately educating users on tDCS working mechanisms is vital to further improve its acceptability. Also, the perceived potential barrier to care due to frequent travel may favor home-based tDCS solutions.
TRIAL REGISTRATION


The tDCS intervention was part of a sham-controlled trial registered on 05-18-2016 at the Netherlands Trial Register with ID NL5709 .",2021,"The qualitative outcomes showed predominantly positive attitudes towards tDCS interventions for stress-related disorders, but only as complementary to psychotherapy.","['102 active duty and post-active military patients with stress-related symptoms (posttraumatic stress disorder, anxiety and impulsive aggression) who participated in a 5-session tDCS intervention', 'military patients and caregivers', 'patients with stress-related disorders and active-duty military personnel', 'treating stress-related mental health disorders']","['tDCS intervention', 'Noninvasive brain stimulation techniques like transcranial direct current stimulation (tDCS', 'tDCS']","['minimal tDCS-related adverse effects (mild itching or burning sensations on the scalp) and high tDCS treatment adherence', 'tDCS acceptability', 'Quantitative dropout and adverse effects data']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0858853', 'cui_str': 'Impulsive aggression'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}]",,0.0727492,"The qualitative outcomes showed predominantly positive attitudes towards tDCS interventions for stress-related disorders, but only as complementary to psychotherapy.","[{'ForeName': 'Fenne M', 'Initials': 'FM', 'LastName': 'Smits', 'Affiliation': 'Brain Research & Innovation Centre, Ministry of Defence, Lundlaan 1, 3584 EZ, Utrecht, The Netherlands. f.m.smits-2@umcutrecht.nl.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'de Kort', 'Affiliation': 'Brain Research & Innovation Centre, Ministry of Defence, Lundlaan 1, 3584 EZ, Utrecht, The Netherlands.'}, {'ForeName': 'Elbert', 'Initials': 'E', 'LastName': 'Geuze', 'Affiliation': 'Brain Research & Innovation Centre, Ministry of Defence, Lundlaan 1, 3584 EZ, Utrecht, The Netherlands.'}]",BMC psychiatry,['10.1186/s12888-021-03086-5']
1419,33588784,Effects of foreign language learning on executive functions in healthy older adults: study protocol for a randomised controlled trial.,"BACKGROUND


With age, most cognitive functions decline. As the number of people aged 60 years and older is expected to rise rapidly within the next decades, identifying interventions that promote healthy cognitive ageing is of utmost importance. Promising research on bilingualism has led to the notion that learning a foreign language could protect against cognitive decline. Foreign language learning likely promotes executive functions, which are higher-order cognitive abilities particularly affected by age-related cognitive decline. However, evidence is still sparse and has produced contradictory results. This study aims to investigate the effects of short and intensive foreign language learning on executive functions in healthy older adults.
METHODS


In a randomised controlled trial, we will assign 60 native German-speaking monolingual healthy older adults, aged 65-80 years, to either a foreign language learning or a waiting list control group. Language learners will attend a face-to-face, group-based Spanish course for beginners for 1.5 h a day, 5 days a week, for a total of 3 weeks. Cognitive performance in executive functions will be assessed before and after the intervention or after a waiting period of 3 weeks (waiting list control group). Participants will be tested again after 3 months to evaluate longitudinal effects of foreign language learning. The waiting list control group will receive Spanish lessons only after the final assessment and will be invited to an additional voluntary evaluation after completion of the course.
DISCUSSION


To the best of our knowledge, we are conducting the first randomised controlled trial on the effects of short and intensive foreign language learning in older adulthood on executive functions. Enhanced cognitive performance after foreign language learning would indicate that learning a foreign language could enlarge cognitive reserve and thus promote healthy cognitive ageing in older adults.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00016552 . Registered on 11 February 2019.",2021,"Foreign language learning likely promotes executive functions, which are higher-order cognitive abilities particularly affected by age-related cognitive decline.","['older adulthood on executive functions', 'people aged 60\u2009years and older', 'healthy older adults', '60 native German-speaking monolingual healthy older adults, aged 65-80\u2009years, to either a foreign language learning or a waiting list control group']","['foreign language learning', 'short and intensive foreign language learning']","['cognitive performance', 'Cognitive performance in executive functions', 'executive functions']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376327', 'cui_str': 'Multinational Aspects'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0686418,"Foreign language learning likely promotes executive functions, which are higher-order cognitive abilities particularly affected by age-related cognitive decline.","[{'ForeName': 'Judith Alina', 'Initials': 'JA', 'LastName': 'Grossmann', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany. grossmann@nar.uni-heidelberg.de.'}, {'ForeName': 'Verena Magdalena', 'Initials': 'VM', 'LastName': 'Koelsch', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Merve Gul', 'Initials': 'MG', 'LastName': 'Degirmenci', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Aschenbrenner', 'Affiliation': 'Department of Clinical Psychology and Neuropsychology, SRH Clinic Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Teichmann', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Meyer', 'Affiliation': 'Network Aging Research, Heidelberg University, Heidelberg, Germany.'}]",BMC geriatrics,['10.1186/s12877-021-02051-x']
1420,33588777,Rivaroxaban for the treatment of cerebral venous thrombosis.,"BACKGROUND


New Oral Anticoagulants (NOACs) such as Rivaroxaban are introduced as alternatives to conventional vitamin-K antagonists in the long-term treatment of thrombotic events due to their lower bleeding risk. There is a lack of evidence on the effectiveness and safety of Rivaroxaban in Cerebral venous thrombosis (CVT). This study aims to assess the effectiveness and bleeding risk of Rivaroxaban in comparison with Warfarin for the treatment of CVT.
MATERIALS AND METHODS


36 patients with diagnosis of CVT were included. Clinical and background information was assessed on admission and patients were followed for at least 12 months. Measured outcomes were modified Rankin Scale (mRS), evidence of recanalization on contrast-enhanced Brain MR venography (MRV) and major or minor bleeding. Patients were divided into two groups according to the type of oral anticoagulant (Rivaroxaban vs Warfarin). Groups were compared in terms of final outcomes and side effects.
RESULT


Overall, 13 (36.11%) patients received Warfarin and 23 (63.89%) received Rivaroxaban. Optimal mRS score (0-1) was attained in 9 of 10 (90%) of patients treated with Rivaroxaban and 19 of 22 (86.36%) of patients received Warfarin. MRV showed complete or partial recanalization in 12 of 14 (85.71%) patients treated with Rivaroxaban and all patients in the Warfarin group. There was no significant difference between the two groups in terms of major and minor hemorrhage.
CONCLUSION


Rivaroxaban holds promise for the treatment of CVT.",2021,MRV showed complete or partial recanalization in 12 of 14 (85.71%) patients treated with Rivaroxaban and all patients in the Warfarin group.,"['cerebral venous thrombosis', '36 patients with diagnosis of CVT were included']","['oral anticoagulant (Rivaroxaban vs Warfarin', 'Rivaroxaban', 'Warfarin']","['effectiveness and bleeding risk', 'complete or partial recanalization', 'major and minor hemorrhage', 'Optimal mRS score', 'modified Rankin Scale (mRS), evidence of recanalization on contrast-enhanced Brain MR venography (MRV) and major or minor bleeding']","[{'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1690005', 'cui_str': 'MRI venography'}]",36.0,0.075804,MRV showed complete or partial recanalization in 12 of 14 (85.71%) patients treated with Rivaroxaban and all patients in the Warfarin group.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Esmaeili', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Abolmaali', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Aarabi', 'Affiliation': 'Department of Neurology, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Motamed', 'Affiliation': 'Department of Neurology, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Chaibakhsh', 'Affiliation': 'Eye Research Center, The Five Senses Institute Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Joghataei', 'Affiliation': 'Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mojtahed', 'Affiliation': 'School of Advanced Technologies in Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mirzaasgari', 'Affiliation': 'Department of Neurology, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran. Zahra.Mirzaasgari@gmail.com.'}]",BMC neurology,['10.1186/s12883-021-02091-1']
1421,33588770,Rapid component of excess post-exercise oxygen consumption of children of different weight status after playing active video games.,"BACKGROUND


Excess post-exercise oxygen consumption (EPOC) of children could indicate the potential of an exercise therapy to treat or prevent obesity. However, EPOC as a result of playing active video games (AVG) has been poorly investigated. Therefore, we aimed to investigate the rapid component of EPOC of children with healthy weight and overweight/obesity (according to their BMI percentile) after playing AVGs that feature predominately upper body (UB) and whole-body (WB) movement.
METHODS


Twenty-one children with healthy weight (BMI percentile < 85%) and with overweight/obesity (BMI percentile ≥ 85%) randomly underwent two 10-min AVG sessions (UB and WB). The heart rate (HR), minute ventilation (VE), oxygen consumption (VO 2 ) and carbon dioxide production (VCO 2 ) were recorded during exercise and post-exercise recovery period. For the rapid component of EPOC in each AVG session, measurements were recorded every 15 s for 5-min of post-exercise recovery. The rate of perceived exertion (RPE) was also measured immediately before and after each AVG play.
RESULTS


Children with overweight/obesity had a higher average of absolute VE, VO 2 , and VCO 2  than their healthy-weight counterparts (BMI percentile < 85%; n = 21) during post-exercise recovery. RPE, HR, and HR% were not different between the game sessions and weight groups. Children with overweight/obesity showed a higher absolute VO 2  during EPOC than healthy-weight children in both game sessions, but relative VO 2  was higher in healthy-weight children during EPOC. No differences were observed for EPOC between UB and WB sessions.
CONCLUSIONS


Children with overweight/obesity had a greater EPOC than healthy-weight children after AVG sessions in terms of absolute oxygen values, whereas healthy-weight children have higher EPOC considering relative VO 2  when controlling for body mass. UB and WB AVGs induced a similar EPOC among children with healthy weight and overweight/obesity. As UB and WB AVGs induce the rapid component of EPOC in children regardless their weight status, AVGs could be used as an exercise method to treat and prevent child obesity.",2021,"Children with overweight/obesity showed a higher absolute VO 2  during EPOC than healthy-weight children in both game sessions, but relative VO 2  was higher in healthy-weight children during EPOC.","['children of different weight status after playing active video games', 'children with healthy weight and overweight/obesity (according to their BMI percentile) after playing AVGs that feature predominately upper body (UB) and whole-body (WB) movement', 'Children with overweight/obesity', 'Twenty-one children with healthy weight (BMI percentile\xa0<\u200985%) and with overweight/obesity (BMI percentile\xa0≥\xa085%) randomly underwent', 'children with healthy weight and overweight/obesity']","['Excess post-exercise oxygen consumption (EPOC', 'two 10-min AVG sessions (UB and WB']","['heart rate (HR), minute ventilation (VE), oxygen consumption (VO 2 ) and carbon dioxide production (VCO 2 ', 'RPE, HR, and HR', 'rate of perceived exertion (RPE']","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332251', 'cui_str': 'Predominate'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0280558', 'cui_str': 'COPE regimen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",21.0,0.0296125,"Children with overweight/obesity showed a higher absolute VO 2  during EPOC than healthy-weight children in both game sessions, but relative VO 2  was higher in healthy-weight children during EPOC.","[{'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simoes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Sun', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Amy Shirong', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'Health Technology Lab, College of Arts, Media & Design; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA. a.lu@northeastern.edu.'}]",BMC pediatrics,['10.1186/s12887-021-02528-z']
1422,33588768,Placing assistive technology and telecare in everyday practices of people with dementia and their caregivers: findings from an embedded ethnography of a national dementia trial.,"BACKGROUND


Policy makers and care providers see assistive technology and telecare as potential products to support people with dementia to live independently in their homes and communities. Previous research rarely examined how people with dementia and their caregivers actually use such technology. The study examined how and why people living with dementia and their caregivers used assistive technology and telecare in their own homes.
METHODS


This study used an ethnographic design embedded within the NIHR-funded Assistive Technology and Telecare to maintain Independent Living At home for people with dementia (ATTILA) randomised controlled trial. We collected 208 h of observational data on situated practices of ten people with dementia and their ten caregivers. We used this data to construct extended cases to explain how technologies supported people with dementia in home and community settings.
RESULTS


We identified three themes: placing technology in care, which illustrates how people with dementia and caregivers 'fit' technology into their homes and routines; replacing care with technology, which shows how caregivers replaced normal care practices with ones mediated through technologies; and technology displacing care and everyday life, which highlights how technologies disrupted the everyday lives of people with dementia.
DISCUSSION


This study exemplifies unintended and unanticipated consequences for assistive technology and telecare uptake in 'real world' community-based dementia care. It underlines the need to identify and map the context of technological provision over time within the changing lives of people with dementia and their caregivers.",2021,"BACKGROUND


Policy makers and care providers see assistive technology and telecare as potential products to support people with dementia to live independently in their homes and communities.","['people with dementia', 'We collected 208\u2009h of observational data on situated practices of ten people with dementia and their ten caregivers', 'people with dementia in home and community settings', 'people living with dementia and their caregivers used assistive technology and telecare in their own homes', 'people with dementia and their caregivers']","['NIHR-funded Assistive Technology and Telecare to maintain Independent Living At home', 'Placing assistive technology and telecare']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}]","[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",[],208.0,0.0746126,"BACKGROUND


Policy makers and care providers see assistive technology and telecare as potential products to support people with dementia to live independently in their homes and communities.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lariviere', 'Affiliation': 'Centre for Research on Health and Social Care, School for Policy Studies, University of Bristol, Bristol, BS8 1TZ, UK. matthew.lariviere@bristol.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Poland', 'Affiliation': ""School of Health Sciences, University of East Anglia, Queen's Building, Norwich, NR4 7TJ, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Woolham', 'Affiliation': ""Health and Social Care Workforce Research Unit, King's College London, Kingsway, London, WC2R 2LS, UK.""}, {'ForeName': 'Stanton', 'Initials': 'S', 'LastName': 'Newman', 'Affiliation': 'School of Health Sciences, City University of London, Northampton Square, London, EC1V 0HB, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.'}]",BMC geriatrics,['10.1186/s12877-020-01896-y']
1423,33588758,The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE-A multicenter randomized controlled trial.,"BACKGROUND


The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT).
METHODS


This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention.
RESULTS


A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was - 18.8 mg/dl (95% confidence interval, - 30.8 to - 6.8) (p = 0.0064) for the MAGE (vildagliptin, - 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), - 22.8° (- 40.6° to - 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, - 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, - 15.1 ± 25.2 μm).
CONCLUSIONS


Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058.",2021,"The adjusted difference of mean changes between the groups was - 18.8 mg/dl (95% confidence interval, - 30.8 to - 6.8) (p = 0.0064) for the MAGE (vildagliptin, - 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), - 22.8° (- 40.6° to - 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, - 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, - 15.1 ± 25.2 μm).
","['coronary artery disease (CAD) patients with impaired glucose tolerance (IGT', 'CAD patients with IGT under lipid-lowering therapy receiving either', '20 participants with 47 lesions', 'impaired glucose tolerance patients with coronary artery disease', 'group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions']","['Vildagliptin', 'vildagliptin', 'vildagliptin (50\xa0mg once a day) or no medication (control group) regarding glycemic treatment', 'MAGE (vildagliptin']","['mean amplitude of glycemic excursion (MAGE', 'daily glucose profile and coronary plaque stability', 'Glycemic variability', 'minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",20.0,0.0816026,"The adjusted difference of mean changes between the groups was - 18.8 mg/dl (95% confidence interval, - 30.8 to - 6.8) (p = 0.0064) for the MAGE (vildagliptin, - 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), - 22.8° (- 40.6° to - 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, - 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, - 15.1 ± 25.2 μm).
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Konishi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. shinke@med.showa-u.ac.jp.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Osue', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Sawada', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Takaya', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Kawai', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ohara', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Hyogo Heart and Brain Center, Himeji, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sakaguchi', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Kobe University Hospital Clinical & Translational Research Center, Kobe, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Hirata', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",BMC cardiovascular disorders,['10.1186/s12872-021-01902-0']
1424,33588696,The impact of patient narratives on medical students' perceptions of shared decision making: A randomized controlled trial.,"Successful shared decision making (SDM) in clinical practice requires that future clinicians learn to appreciate the value of patient participation as early as they can in their medical training. Narratives, such as patient testimonials, have been successfully used to support patients' decision-making process. Previous research suggests that narratives may also be used for increasing clinicians' empathy and responsiveness in medical consultations. However, so far, no studies have investigated the benefits of narratives for conveying the relevance of SDM to medical students. In this randomized controlled experiment, N = 167 medical students were put into a scenario where they prepared for medical consultation with a patient having Parkinson disease. After receiving general information, participants read either a narrative testimonial of a Parkinson patient or a fact-based information text. We measured their perceptions of SDM, their control preferences (i.e., their priorities as to who should make the decision), and the time they intended to spend for the consultation. Participants in the narrative patient testimonial condition referred more strongly to the patient as the one who should make decisions than participants who read the information text. Participants who read the patient narrative also considered SDM in situations with several equivalent treatment options to be more important than participants in the information text condition. There were no group differences regarding their control preferences. Participants who read the patient testimonial indicated that they would schedule more time for the consultation. These findings show that narratives can potentially be useful for imparting the relevance of SDM and patient-centered values to medical students. We discuss possible causes of this effect and implications for training and future research.  Trial registration : The study was pre-registered on the pre-registration platform  AsPredicted  (aspredicted.org) before data collection began (registration number: #29,342). Date of registration: 17 October 2019.",2021,These findings show that narratives can potentially be useful for imparting the relevance of SDM and patient-centered values to medical students.,['N =\xa0167 medical students'],['narrative testimonial of a Parkinson patient or a fact-based information text'],[],"[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0652101,These findings show that narratives can potentially be useful for imparting the relevance of SDM and patient-centered values to medical students.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut Fuer Wissensmedien , Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut Fuer Wissensmedien , Tuebingen, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Korger', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut Fuer Wissensmedien , Tuebingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut Fuer Wissensmedien , Tuebingen, Germany.'}]",Medical education online,['10.1080/10872981.2021.1886642']
1425,33588644,Combining the Copenhagen Adduction Exercise and Nordic Hamstring Exercise Improves Dynamic Balance Among Male Athletes: A Randomized Controlled Trial.,"BACKGROUND


Copenhagen adduction exercise (CAE) and Nordic hamstring exercise (NHE) reduce the incidence of groin and hamstring injuries. Efficient dynamic balance can improve motor performance and reduce the risk of injuries in athletes. However, the effects of these exercises on dynamic balance have not been investigated.
HYPOTHESIS


CAE and NHE, as well as a combination of both exercises, would improve dynamic balance among amateur male athletes.
STUDY DESIGN


Randomized controlled trial.
LEVEL OF EVIDENCE


Level 1.
METHODS


A total of 200 male athletes aged 21.9 ± 2.4 years were included in the study and randomly assigned to 4 groups: CAE group (n = 50), NHE group (n = 50), CAE and NHE group (n = 50), and a control group (n = 50). A total of 177 male athletes completed the study. The primary outcome measure was the limit of stability (LoS), which was measured using the Biodex Stability System to assess the performance of the dynamic balance. The LoS of the athletes' performance was measured pre- and postintervention after 6 weeks.
RESULTS


The LoS significantly improved in all treatment groups, including CAE (44.5% ± 5.3%), NHE (43.2% ± 5.3%), and CAE + NHE (48.4% ± 5.1%) groups when compared with the control group (28.3% ± 4.8%) after 6 weeks (all  P s < 0.01). The improvement of LoS was significantly greater in the CAE + NHE group compared with other groups (CAE, NHE, and control groups).
CONCLUSION


There was a significant increase in dynamic balance performance postintervention among male athletes. CAE and NHE may improve injury prevention programs.
CLINICAL RELEVANCE


The results of this study provide evidence for athlete trainers and coaches to consider including the CAE and NHE as components of injury prevention programs to improve balance capacity and performance in athletes. Such improvements in balance may prevent injury risk and decrease absenteeism and injury-related financial burdens.",2021,"The LoS significantly improved in all treatment groups, including CAE (44.5% ± 5.3%), NHE (43.2% ± 5.3%), and CAE + NHE (48.4% ± 5.1%) groups when compared with the control group (28.3% ± 4.8%) after 6 weeks (all  P s < 0.01).","['male athletes', 'Male Athletes', '177 male athletes completed the study', 'amateur male athletes', 'athletes', '200 male athletes aged 21.9 ± 2.4 years']","['NHE', 'CAE and NHE', 'CAE', 'CAE + NHE', 'Copenhagen Adduction Exercise and Nordic Hamstring Exercise', 'Copenhagen adduction exercise (CAE) and Nordic hamstring exercise (NHE']","['improvement of LoS', 'dynamic balance performance postintervention', 'performance of the dynamic balance', 'LoS', 'limit of stability (LoS', 'motor performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",200.0,0.143492,"The LoS significantly improved in all treatment groups, including CAE (44.5% ± 5.3%), NHE (43.2% ± 5.3%), and CAE + NHE (48.4% ± 5.1%) groups when compared with the control group (28.3% ± 4.8%) after 6 weeks (all  P s < 0.01).","[{'ForeName': 'Wesam', 'Initials': 'W', 'LastName': 'Saleh A Al Attar', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Science, Umm Al Qura University, Makkah, Saudi Arabia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Faude', 'Affiliation': 'Department of Sport, Exercise and Health, Faculty of Medicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Husain', 'Affiliation': 'Department of Physiotherapy, College of Health and Sport Sciences, University of Bahrain, Manama, Bahrain.'}, {'ForeName': 'Najeebullah', 'Initials': 'N', 'LastName': 'Soomro', 'Affiliation': 'The Broken Hill University Department of Rural Health, Faculty of Medicine and Health, The University of Sydney, Broken Hill, Australia.'}, {'ForeName': 'Ross H', 'Initials': 'RH', 'LastName': 'Sanders', 'Affiliation': 'Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}]",Sports health,['10.1177/1941738121993479']
1426,33588639,Health Behavior Change Processes Among Adults With Serious Mental Illness Engaged in Illness Self-Management.,"Self-management interventions promote illness management among adults with chronic health conditions. Little is known regarding the processes by which these interventions have their effects. The present study examined how Living Well, an effective self-management intervention for adults with serious mental illness, led to health behavior change in a randomized controlled trial. A convenience subset ( N  = 15) of participants completed qualitative interviews regarding the feasibility/acceptability of Living Well. An inductive secondary qualitative analysis, using a combination of interpretive phenomenological and social constructivist approaches, was conducted to examine processes of change. Results indicate that Living Well provided information and knowledge, opportunities for learning from others and real-world practice, and an interpersonally supportive environment. These active ingredients led to enhanced self-awareness, confidence, sense of control, and behavior and health status changes among participants. These findings are considered in the context of prominent behavior change theories such as social cognitive theory and self-regulation.",2021,"These active ingredients led to enhanced self-awareness, confidence, sense of control, and behavior and health status changes among participants.","['adults with serious mental illness', 'adults with chronic health conditions', 'Adults With Serious Mental Illness']",['Self-management interventions'],"['Health Behavior Change Processes', 'enhanced self-awareness, confidence, sense of control, and behavior and health status changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021783', 'cui_str': 'External-Internal Control'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0544377,"These active ingredients led to enhanced self-awareness, confidence, sense of control, and behavior and health status changes among participants.","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5), Mental Illness Research Education and Clinical Center (MIRECC), Baltimore, Maryland, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Peeples', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5), Mental Illness Research Education and Clinical Center (MIRECC), Baltimore, Maryland, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5), Mental Illness Research Education and Clinical Center (MIRECC), Baltimore, Maryland, USA.'}]",Qualitative health research,['10.1177/1049732321992049']
1427,33588630,"Acute diet soda consumption alters brain responses to food cues in humans: A randomized, controlled, cross-over pilot study.","BACKGROUND


Diet soda consumption has frequently been linked to obesity and its comorbidities in epidemiological studies. Whether this link is causal and a potential mechanism remains to be determined.
AIM/METHODS


This randomized, cross-over, controlled pilot study sought to determine whether there may be changes in reward-related brain activations to visual food cues after acute consumption of diet soda versus regular soda or carbonated water using functional magnetic resonance imaging.
RESULTS


Diet soda as compared to carbonated water consumption increased activation of reward-related caudate to highly versus less desirable food cues. Diet soda as compared to regular soda increased reward-related insula and decreased activation of cognitive control-related dorsolateral prefrontal cortex to food cues versus non-food cues. No changes in ratings of hunger an hour after beverage consumption were observed.
CONCLUSIONS


These results may suggest a potential mechanism for diet soda to increase food palatability through activation of the reward system and suppression of inhibitory control that remains to be confirmed by future studies.",2021,Diet soda as compared to regular soda increased reward-related insula and decreased activation of cognitive control-related dorsolateral prefrontal cortex to food cues versus non-food cues.,['humans'],"['diet soda versus regular soda or carbonated water using functional magnetic resonance imaging', 'Acute diet soda consumption']",['ratings of hunger'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0683086', 'cui_str': 'Caffeinated soft drinks'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C3494193', 'cui_str': 'Soda Water'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}]",,0.0375891,Diet soda as compared to regular soda increased reward-related insula and decreased activation of cognitive control-related dorsolateral prefrontal cortex to food cues versus non-food cues.,"[{'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Farr', 'Affiliation': 'Division of Endocrinology, Beth-Israel Deaconess Medical Center/1811Harvard Medical School, Boston, MA, USA.'}]",Nutrition and health,['10.1177/0260106021993753']
1428,33588614,Practice Transformation in HIV Primary Care: Perspectives of Coaches and Champions in the Southeast United States.,"INTRODUCTION/OBJECTIVES


Across the United States, and particularly in the South, there is an urgent need to improve health outcomes for people with HIV. In response, the Southeast AIDS Education & Training Center (AETC) conducted a 4-year Practice Transformation (PT) initiative (2015-2018) in 12 mostly primary care clinics across 4 states in the region. Drawing on the leadership of PT facilitators (""coaches"") from AETC partner sites throughout the region and specific clinic staff members (""champions""), clinics worked toward self-selected organizational goals to increase their HIV care capacity and improve HIV health outcomes.
METHODS


To explore coaches' and champions' experiences and perspectives of PT, we conducted 2 focus group sessions, 1 tailored for coaches (n = 5) and another for champions (n = 9).
RESULTS


Content analysis of qualitative data revealed 4 major themes around coaches' and champions' experiences and perspectives of PT. These themes include Challenges, Facilitators, Successes, and Suggestions for PT Improvement.
CONCLUSION


Primary care and infectious diseases/HIV clinics can help improve HIV Care Continuum outcomes through increasing their capacity to serve the needs of their clients, as facilitated through coaches and clinic champions. Since no single clinic or clinic patient population is alike, it is important work within organizations to address specific needs and leverage unique skillsets. Future PT initiatives can learn from experiences of this PT program to optimize the effectiveness of their programs.",2021,"RESULTS


Content analysis of qualitative data revealed 4 major themes around coaches' and champions' experiences and perspectives of PT.","['people with HIV', '12 mostly primary care clinics across 4 states in the region']",[],['health outcomes'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",12.0,0.0130164,"RESULTS


Content analysis of qualitative data revealed 4 major themes around coaches' and champions' experiences and perspectives of PT.","[{'ForeName': 'Emma Sophia', 'Initials': 'ES', 'LastName': 'Kay', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Craft', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'McCormick', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Greer A', 'Initials': 'GA', 'LastName': 'Burkholder', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burdge', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Raffanti', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fifolt', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of primary care & community health,['10.1177/2150132720984429']
1429,33559636,Prevention of postoperative surgical wound complications in ankle and distal tibia fractures: results of Incisional Negative Pressure Wound Therapy.,"BACKGROUND AND AIM OF THE WORK


complications in surgical wound healing represent the main postoperative complication in ankle and distal tibia fractures. Whereas the use of Incisional Negative Pressure Wound Therapy (INPWT) is recognized to have a role in wound complications prevention in prosthetic surgery, literature about its use in trauma surgery is scarce. The aim of this study was to compare the effectiveness of INWPT with a conventional dressing in order to prevent surgical wound complications in ankle and distal tibia fractures.
METHODS


The study population included patients over 65 years as well as patients under 65 years considered at risk for wound complications (smokers, obese, affected by diabetes), who underwent ORIF for bi/tri-malleolar ankle fractures or distal tibia (pilon) fractures. After surgery, patients were randomized to receive a conventional dressing or INPWT. Complications in surgical wound healing were classified in major (requiring surgical intervention) and minor complications.
RESULTS


65 patients were included in the study. The rate of minor and major complications between the two groups was not significantly different, although a positive trend towards a lower minor complications rate was noted in the INPWT group (12.6% vs 34.7%). No complications or complaints were reported for the INPWT device.
CONCLUSIONS


INPWT proved to be safe, well-tolerated and showed promising results in preventing surgical wound complications in ankle and distal tibia fractures.",2020,"The rate of minor and major complications between the two groups was not significantly different, although a positive trend towards a lower minor complications rate was noted in the INPWT group (12.6% vs 34.7%).","['ankle and distal tibia fractures', '65 patients were included in the study', 'study population included patients over 65 years as well as patients under 65 years considered at risk for wound complications (smokers, obese, affected by diabetes), who underwent ORIF for bi/tri-malleolar ankle fractures or distal tibia (pilon) fractures']","['Incisional Negative Pressure Wound Therapy (INPWT', 'Incisional Negative Pressure Wound Therapy', 'conventional dressing or INPWT', 'INPWT', 'INWPT']","['complications rate', 'surgical wound complications', 'rate of minor and major complications']","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0262488', 'cui_str': 'Fracture of distal end of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",65.0,0.0605381,"The rate of minor and major complications between the two groups was not significantly different, although a positive trend towards a lower minor complications rate was noted in the INPWT group (12.6% vs 34.7%).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Canton', 'Affiliation': 'Orthopaedics and Traumatology Unit, Cattinara Hospital - ASUGI, Department of Medical, Surgical and Life Sciences, Trieste University, Trieste (Italy). gcanton84@gmail.com.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Fattori', 'Affiliation': 'Array. roberto.fattori@hotmail.com.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Pinzani', 'Affiliation': 'Orthopaedics and Traumatology Unit, Cattinara Hospital - ASUGI, Department of Medical, Surgical and Life Sciences, Trieste University, Trieste (Italy). emanuelepinzani@gmail.com.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Monticelli', 'Affiliation': 'Orthopaedics and Traumatology Unit, Cattinara Hospital - ASUGI, Department of Medical, Surgical and Life Sciences, Trieste University, Trieste (Italy). luca.monticelli93@gmail.com.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ratti', 'Affiliation': 'Orthopaedics and Traumatology Unit, Cattinara Hospital - ASUGI, Department of Medical, Surgical and Life Sciences, Trieste University, Trieste (Italy). chiara.ratti@asugi.sanita.fvg.it.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Murena', 'Affiliation': 'Orthopaedics and Traumatology Unit, Cattinara Hospital - ASUGI, Department of Medical, Surgical and Life Sciences, Trieste University, Trieste (Italy). luigi.murena@asuits.sanita.fvg.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i14-S.10784']
1430,33559621,Clinical and radiological outcomes with PEEK suture anchors used in rotator cuff repair: our experience confirm that a perianchor fluid signal on RM does not affect clinical outcome at one year of follow up.,"Introduction / objectives  Osteolytic-type reactions of the perianchor bone which in magnetic resonance are manifested as hyperintensity of the signal in T2 images are reported in many studies. T  The objective of the present study is to evaluate and compare to the literature data the clinical and radiological results of a group of patients who underwent arthroscopic suture of a rotator cuff tear using polyetherketone (PEEK) suture anchors. Materials and methods Twenty patients, aged between 44 and 73 years, who underwent arthroscopic repair of the rotator cuff for lesions smaller than 4 cm considered reparaible between August 2017 and January 2019, were enrolled in the present study. Patients were evaluated clinically with clinical examination, Constant scale and ASES scale pre and post surgery. MRI either pre and post operation at one year were evaluated to obtain data about tendon healing and evaluate bone reaction to PEEK anchors. Results: MRI analysis showed a tendon signal according to Sugaya classification of type 1 in the 25% of patients, type 2 in the 60% of cases and type 3 in the remaining 15% . Osteolysis was grade 0 in 65%, grade 1 in 30 % and grade 2 in 5% of cases. No anchors pull out or mobilization were reported. Conclusions: The presence of a T2 hyperintense signal osteolysis like on MRI control using PEEK anchors for the sutur of rotator cuff lesions does not find correlation whit the final clinical result of the procedure.",2020,"MRI analysis showed a tendon signal according to Sugaya classification of type 1 in the 25% of patients, type 2 in the 60% of cases and type 3 in the remaining 15% .","['rotator cuff repair', 'Twenty patients, aged between 44 and 73 years, who underwent arthroscopic repair of the rotator cuff for lesions smaller than 4 cm considered reparaible between August 2017 and January 2019, were enrolled in the present study']","['arthroscopic suture of a rotator cuff tear using polyetherketone (PEEK) suture anchors', 'PEEK suture anchors']","['Osteolysis', 'clinical examination, Constant scale and ASES scale pre and post surgery']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C4721411', 'cui_str': 'Osteolysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",20.0,0.0296789,"MRI analysis showed a tendon signal according to Sugaya classification of type 1 in the 25% of patients, type 2 in the 60% of cases and type 3 in the remaining 15% .","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Di Benedetto', 'Affiliation': 'clinic of orthopaedics, University Hospital of Udine. dibenedetto.paolo@aoud.sanita.fvg.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gorasso', 'Affiliation': 'Clinic of Orthopedics, Academic Hospital of Udine, Udine, Italy. giovanni.gorasso@gmail.com.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Beltrame', 'Affiliation': 'Clinic of Orthopedics, Academic Hospital of Udine, Udine, Italy. alessandro.beltrame@asufc.sanita.fvg.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mancuso', 'Affiliation': 'Clinic of Orthopedics, Academic Hospital of Udine, Udine, Italy. fra.mancuso@gmail.com.'}, {'ForeName': 'Michele Mario', 'Initials': 'MM', 'LastName': 'Buttironi', 'Affiliation': 'Clinic of Orthopedics, Academic Hospital of Udine, Udine, Italy. michelebuttironi@gmail.com.'}, {'ForeName': 'Araldo', 'Initials': 'A', 'LastName': 'Causero', 'Affiliation': 'Clinic of Orthopedics, Academic Hospital of Udine, Udine, Italy Medical Department, Universitiy of Udine, Italy. araldo.causero@asufc.sanita.fvg.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i14-S.10986']
1431,33577055,"Effect of omeprazole on symptoms of gastroesophageal reflux disease in children with cystic fibrosis. A randomized, double-blind, placebo-controlled trial.","OBJECTIVE


The incidence of gastroesophageal reflux disease (GERD) is higher in patients with cystic fibrosis (CF) than in the general population. While the relationship between GERD and its typical symptom, heartburn, is beyond doubt, its effect on cough or abdominal pain is unclear. In CF patients, in particular, it is often difficult to confirm the causal relationship between GERD and these symptoms. The aim of this trial was to evaluate the effect of omeprazole treatment of GERD on abdominal pain and cough, in children with CF.
PATIENTS AND METHODS


This was a multicentre, randomized, double-blind, placebo-controlled trial. All children aged 4-18 years underwent 24-hour multichannel intraluminal pH-impedance monitoring. The patients with diagnosed GERD were randomly assigned to receive omeprazole (20 mg twice daily for 12 weeks) or placebo. The severity of symptoms was assessed on visual analog scale.
RESULTS


22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled. A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups. However, there were no statistically significant differences between the groups in the degree of reduction. We did not observe any differences between the groups in terms of adverse reactions.
CONCLUSIONS


Treatment of GERD in children with CF seems not to have a stronger effect than a placebo on the severity of cough and abdominal pain. Considering this, as well as the previously raised concerns about the impact of chronic proton pump inhibitor treatment on the course of CF, perhaps one should be more careful in intensively treating suspected atypical GERD symptoms in patients with CF.",2021,"A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups.","['22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled', 'patients with diagnosed GERD', 'patients with CF', 'All children aged 4-18 years underwent', 'patients with cystic fibrosis (CF) than in the general population', 'children with CF', 'children with cystic fibrosis']","['24-hour multichannel intraluminal pH-impedance monitoring', 'GERD', 'placebo', 'omeprazole']","['abdominal pain and cough', 'abdominal pain and typical GERD symptoms', 'gastroesophageal reflux disease (GERD', 'visual analog scale', 'severity of cough and abdominal pain', 'gastroesophageal reflux disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",22.0,0.347657,"A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dziekiewicz', 'Affiliation': 'Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Poland. marcin.dziekiewicz@wum.edu.pl.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mielus', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sands', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Radzikowski', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Banaszkiewicz', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24669']
1432,33577011,"Changes of anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen and d-dimer in guiding venous thrombosis during pregnancy.","OBJECTIVE


This study provides a theoretical basis for the prevention, treatment and diagnosis of venous thrombosis during pregnancy.
PATIENTS AND METHODS


Sixty patients with venous thrombosis in gestation period were treated as the research group, including every 30 people in the middle and late pregnancy groups, and the control group randomly selected 33 healthy pregnant women during the same period. The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects.
RESULTS


Resistance-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and compared with the control group, D-dimer levels were significantly increased (p<0.05), but for the middle pregnancy group and late pregnancy group, the difference was not statistically significant (p>0.05). In the control group of pregnant women anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer no obvious correlation (p>0.05), Anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, D-dimer entry equation are closely related risk factors for venous thrombosis during pregnancy (p<0.05), and D-dimer is the most important.
CONCLUSIONS


Vein thrombosis during pregnancy patients anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer in pregnant women group increased significantly compared with the control group, suggesting these above indicators are closely related to Venous thrombosis in pregnant women and associated with the severity of the disease. Vascular endothelial injury plays an important role in phlebothrombosis in gestation period.",2021,"The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects.
","['pregnancy patients', 'Sixty patients with venous thrombosis in gestation period were treated as the research group, including every 30 people in the middle and late pregnancy groups, and the control group randomly selected 33 healthy pregnant women during the same period']",['anti-β2 glycoprotein'],"['anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels', 'anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen and d-dimer', 'Vein thrombosis', 'D-dimer levels', 'pregnant women anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer no obvious correlation (p>0.05), Anti-β2 glycoprotein Ⅰ antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, D-dimer entry equation', 'platelet aggregation rate, plasma fibrinogen, and D-dimer', 'Resistance-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}]","[{'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0221138', 'cui_str': 'Blood group antibody I'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",33.0,0.0279337,"The anti-β2 glycoprotein I antibody IgA/G/M, platelet aggregation rate, plasma fibrinogen, and D-dimer levels were measured in all subjects.
","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Operation Room, The Fifth Hospital of Wuhan, Wuhan, Hubei, China. whdwyykjk@163.com.'}, {'ForeName': 'H-P', 'Initials': 'HP', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'F-R', 'Initials': 'FR', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Q-Y', 'Initials': 'QY', 'LastName': 'Pan', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202101_24616']
1433,33579359,"Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: protocol for an open-label, parallel-group, superiority, randomized controlled trial.","BACKGROUND


Buprenorphine/naloxone (Suboxone) is a current first-line treatment for opioid use disorder (OUD). The standard induction method of buprenorphine/naloxone requires patients to be abstinent from opioids and therefore experience withdrawal symptoms prior to induction, which can be a barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of buprenorphine/naloxone and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone in patients with OUD.
METHODS


This is a randomized, open-label, two-arm, superiority, controlled trial comparing the safety and effectiveness of rapid micro-induction versus standard induction of buprenorphine/naloxone for the treatment of OUD. A total of 50 participants with OUD will be randomized at one Canadian hospital. The primary outcome is the completion of buprenorphine/naloxone induction with low levels of withdrawal. Secondary outcomes are treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction.
DISCUSSION


This is the first randomized controlled trial to compare the effectiveness and safety of rapid micro-induction versus standard induction of buprenorphine/naloxone. This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis. Trial registration ClinicalTrials.gov, NCT04234191; date of registration: January 21, 2020; https://clinicaltrials.gov/ct2/show/NCT04234191.",2021,This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis.,"['patients with OUD', '50 participants with OUD will be randomized at one Canadian hospital']","['Buprenorphine/naloxone (Suboxone', 'rapid micro-induction', 'buprenorphine/naloxone']","['completion of buprenorphine/naloxone induction with low levels of withdrawal', 'treatment retention, illicit drug use, self-reported drug use behaviour, craving, pain, physical health, safety, and client satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C1170625', 'cui_str': 'Suboxone'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0281875', 'cui_str': 'Illicit medication use'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",50.0,0.119058,This study will thereby generate evidence for a novel induction method which eliminates substantial barriers to the use of buprenorphine/naloxone in the midst of the ongoing opioid crisis.,"[{'ForeName': 'James S H', 'Initials': 'JSH', 'LastName': 'Wong', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada. james.wong@ubc.ca.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nikoo', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Jean N', 'Initials': 'JN', 'LastName': 'Westenberg', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Janet G', 'Initials': 'JG', 'LastName': 'Suen', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Jennifer Y C', 'Initials': 'JYC', 'LastName': 'Wong', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Reinhard M', 'Initials': 'RM', 'LastName': 'Krausz', 'Affiliation': 'Addictions and Concurrent Disorders Research Group, Institute of Mental Health, Department of Psychiatry, The University of British Columbia, 430-5950, David Strangway Building, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Schütz', 'Affiliation': 'Behavioral Reward Affect + Impulsivity Neuroscience Lab, Institute of Mental Health, Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vogel', 'Affiliation': 'Division of Addictive Disorders, University of Basel Psychiatric Hospital, Wilhelm Klein-Strasse 27, 4002, Basel, Switzerland.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Sidhu', 'Affiliation': 'Department of Psychiatry, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Moe', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Arishenkoff', 'Affiliation': 'Department of Medicine, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Griesdale', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Nickie', 'Initials': 'N', 'LastName': 'Mathew', 'Affiliation': 'Department of Psychiatry, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Azar', 'Affiliation': 'Department of Psychiatry, University of British Columbia & Vancouver General Hospital, Vancouver, BC, Canada.'}]",Addiction science & clinical practice,['10.1186/s13722-021-00220-2']
1434,33579256,One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol.,"BACKGROUND


A two-stage prosthesis exchange procedure has been the gold standard in surgical treatment of the chronically infected knee arthroplasty so far. This includes 2 surgeries/hospitalizations and an interim period of 2-3 months between surgeries with impaired health, functional status and quality of life of the patients. A one-stage exchange procedure holds many obvious advantages compared to the two-stage approach, but outcomes of a one-stage versus two-stage procedures have never been investigated in a randomized clinical trial. The purpose of this study is primarily to investigate time-adjusted differences in functional status of patients after one-stage versus two-stage revision. Secondary, to report time-adjusted differences in quality of life, complications (including re-revisions due to infection) and mortality.
METHODS


This study is a pragmatic, multi-center, randomized, non-inferiority trial comparing one-stage versus two-stage revision of the infected knee arthroplasty. Seven Danish hospitals are currently participating in the study, but additional hospitals can enter the study if adhering to protocol. Ninety-six patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 10 years. The patients who are not able to participate in the randomized trial are followed in a parallel cohort study.
PROM'S


Oxford Knee Score and EQ5D + EQ5D VAS questionnaires are completed preoperatively and sent out to the study participants at 6 weeks, 3, 6, 9, 12, 18 and 24 months as well as 5 and 10 years postoperatively. In addition a tailor made cost questionnaire on the non-treating hospital resource use, community health and social service use, travel costs, time off work and informal care are sent out.
DISCUSSION


If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted. Other outcomes will open informed discussions about treatment strategies for periprosthetic knee infections.
TRIAL REGISTRATION


The randomized trial is registered on ClinicalTrials.gov with ID NCT03435679 , initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020.",2021,"If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted.","['patients after one-stage versus two-stage revision', 'Ninety-six patients will be included prospectively', 'initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020']",[],"['quality of life', 'quality of life, complications (including re-revisions due to infection) and mortality', ""PROM'S\n\n\nOxford Knee Score and EQ5D\u2009+\u2009EQ5D VAS questionnaires""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439619', 'cui_str': 'Two stage revision'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",96.0,0.175395,"If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lindberg-Larsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark. martin.lindberg-larsen@rsyd.dk.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Odgaard', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fredborg', 'Affiliation': 'Intensive Care Unit, Copenhagen University Hospital Rigshospitalet-Glostrup, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Morville', 'Initials': 'HM', 'LastName': 'Schrøder', 'Affiliation': 'Department of Orthopaedic Surgery, Næstved Hospital, Næstved, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-021-04044-8']
1435,33579247,Cleaning the palate and tongue without nausea: a mixed methods study exploring the appropriate depth and direction of oral care.,"BACKGROUND


It is advisable to clean the palate and tongue thoroughly during oral care to protect against nosocomial infections. However, improper cleaning may cause nausea. To date, no robust data are available regarding how to implement this procedure properly. Furthermore, traditional cotton balls, forceps and normal saline are still used in clinical in China. This mixed methods study aimed to explore the appropriate depth and direction of cleaning methods for palates and tongues without causing nausea and the factors influencing cleaning depth and discomfort in traditional oral care.
METHODS


Our study recruited students (n = 276) from a medical university. The first phase was a quantitative study, in which forceps were slowly inserted into their throats until the gag reflex was triggered, and then, the insertion depth was measured. After that, participants were randomly divided into two groups. In group A, palates and tongues were cleaned coronally and then sagittally, with the converse order used for group B. The extent of nausea was measured. Additionally, the qualitative data were types of discomfort other than nausea reported by the participants.
RESULTS


The tolerable depths (without causing nausea) for cleaning the palate and tongue were 6.75 ± 1.07 cm and 6.92 ± 1.11 cm, respectively. Participants of male sex and with high BMI (overweight/obese) were associated with greater tolerable cleaning depth. The extent of nausea caused by cleaning both the palate and the tongue sagittally was higher than that elicited by coronal cleaning (p = 0.025 and p = 0.003, respectively). Other discomforts included itching, saltiness and coldness.
CONCLUSION


It is appropriate to increase the cleaning depth of the palate and tongue for adult males and overweight/obese individuals. Moreover, coronal cleaning causes lower levels of nausea, and traditional oral care appliances should be improved.",2021,"The extent of nausea caused by cleaning both the palate and the tongue sagittally was higher than that elicited by coronal cleaning (p = 0.025 and p = 0.003, respectively).","['Our study recruited students (n\u2009=\u2009276) from a medical university', 'adult males and overweight/obese individuals', 'Participants of male sex and with high BMI (overweight/obese']","['coronal cleaning', 'traditional cotton balls, forceps and normal saline']","['tolerable cleaning depth', 'itching, saltiness and coldness', 'tolerable depths', 'nausea']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0180134', 'cui_str': 'Cotton ball'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0812387', 'cui_str': 'Feels cold'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.035598,"The extent of nausea caused by cleaning both the palate and the tongue sagittally was higher than that elicited by coronal cleaning (p = 0.025 and p = 0.003, respectively).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China.""}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China. zhouyufeng_njmu@163.com.""}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Ding', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China. dingyp@njmu.edu.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China.""}, {'ForeName': 'Enfang', 'Initials': 'E', 'LastName': 'Shan', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""School of Nursing, Nanjing Medical University, 140 Hanzhong Road, Nanjing, 210000, Jiangsu, People's Republic of China.""}]",BMC oral health,['10.1186/s12903-021-01414-5']
1436,33579240,Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol.,"BACKGROUND


Exposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children. We describe herein the rationale for our specific approach, the adaption of the DPP-based curriculum for delivery to patients of a Federally Qualified Health Center (FQHC), and the study design and methodology.
METHODS


The effects of the intervention on reduction in excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk in mother-child dyads will be evaluated during a 13-week, group randomized trial wherein 60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations. Intervention participants (n = 30) will begin the group program immediately, whereas the wait-listed controls (n = 30) will receive a booklet describing self-guided strategies for behavior change. Associated program delivery costs, acceptability of the program to participants and FQHC staff, and potential for long-term sustainability will also be evaluated.
DISCUSSION


Successful completion in our aims will produce a scalable program with high potential for replication and dissemination, and estimated intervention effects to inform T2DM prevention efforts on families who use the FQHC system. The results from this study will be critical in developing a T2DM prevention model that can be implemented and scaled across FQHCs serving populations disproportionately burdened by T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03781102 ; Date of registration: 19 December 2018.",2021,Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children.,"['mothers with a history of GDM and their children', 'at-risk mothers and their 8- to 12-year-old children', 'gestational diabetes mellitus (GDM', 'at-risk mothers and children at a Federally Qualified Healthcare Center', '60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations']","['behavioral lifestyle intervention', 'type 2 diabetes prevention intervention', 'booklet describing self-guided strategies for behavior change']","['T2DM risk factors', 'excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2183115', 'cui_str': 'History of gestational diabetes mellitus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",60.0,0.0280564,Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children.,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Marrero', 'Affiliation': 'University of Arizona Health Sciences Center for Border Health Disparities, 1295 North Martin Ave., P.O. Box 210202, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Blew', 'Affiliation': 'Department of Nutritional Sciences, College of Agriculture & Life Sciences, The University of Arizona, 1177 E. 4th Street, Shantz Building, Room 328, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Kelly N B', 'Initials': 'KNB', 'LastName': 'Palmer', 'Affiliation': 'University of Arizona Health Sciences Center for Border Health Disparities, 1295 North Martin Ave., P.O. Box 210202, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Family and Child Wellness at El Rio Community Health Center, 450 W Paseo Redondo, Tucson, AZ, 85701, USA.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Roe', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, The University of Arizona, 1295 N. Martin Ave., P.O. Box 245210, Tucson, AZ, 85724, USA.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Hingle', 'Affiliation': 'Department of Nutritional Sciences, College of Agriculture & Life Sciences, The University of Arizona, 1177 E. 4th Street, Shantz Building, Room 328, Tucson, AZ, 85721, USA. hinglem@email.arizona.edu.'}]",BMC public health,['10.1186/s12889-021-10392-w']
1437,33579222,"Effects of health education on spousal knowledge and participation in birth preparedness in Farafenni Regional Hospital, The Gambia: a randomized trial.","BACKGROUND


The Gambia is a male-dominant society in which the cultural norms empower husbands to decide when and where their wives seek care, yet they are not always involved in maternal health care services. Therefore, the purpose of this study was to design and measure the effects of antenatal health education on spousal participation in birth preparedness in Farafenni and satellite villages.
METHODS


The study used a quasi-experimental design, and the participants were 300 spouses of pregnant women attending their antenatal care booking at Farafenni Hospital. A multistage sampling method was used to select the study participants who were then equally distributed to the intervention and comparison groups. Pre-test data were collected from both groups. Thereafter, the intervention group was exposed to two health education sessions on obstetric danger signs and birth preparedness. The post-test data were collected immediately before discharge of the participants' wives after institutional delivery or within 2 weeks post-delivery for those who did not accompany their wives to the health care institution, or whose wives delivered at home. IBM SPSS version 21 software was used to analyze the data.
RESULTS


The differences between the demographic characteristics of participants in the intervention and comparison groups were not statistically significant except for the highest level of education achieved. After controlling for the demographic variables, the health education administered to the intervention group effectively increased knowledge on birth preparedness among them (F (1, 255) = 376.108, p < .001). Every unit increase in the intervention led to a unit increase in the spouses' knowledge on birth preparedness (β = 0.789, p <  0.001). Furthermore, the participants in the intervention group had higher mean score (M = 4.4; SD = 0.8) on participation in birth preparedness than those in the comparison group (M = 0.9; SD = 0.8). The spouses in the intervention group were four times more likely to be prepared for the delivery of their wives after being exposed to the health education than those in the comparison group (F (1, 255) = 522.414, p < .001).
CONCLUSION


The study provides evidence that educating men on maternal health care can improve their level of participation in birth preparedness.
TRIAL REGISTRATION


Name of Registry: Pan African Clinical Trial Registry ( www.pactr.org ). Registry Number: PACTR202004752273171 . Date of Registration: 19th April 2020. Retrospectively Registered.",2021,The differences between the demographic characteristics of participants in the intervention and comparison groups were not statistically significant except for the highest level of education achieved.,"['participants were 300 spouses of pregnant women attending their antenatal care booking at Farafenni Hospital', 'birth preparedness in Farafenni and satellite villages', 'birth preparedness in Farafenni Regional\xa0Hospital, The Gambia']","['health education sessions', 'antenatal health education', 'health education']","['higher mean score', 'participation in birth preparedness', ""spouses' knowledge on birth preparedness"", 'knowledge on birth preparedness']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0016993', 'cui_str': 'The Gambia'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.033264,The differences between the demographic characteristics of participants in the intervention and comparison groups were not statistically significant except for the highest level of education achieved.,"[{'ForeName': 'Haddy', 'Initials': 'H', 'LastName': 'Tunkara-Bah', 'Affiliation': 'Department of Nursing, University of The Gambia, Serrekunda, Gambia. htbah@utg.edu.gm.'}, {'ForeName': 'Florence O', 'Initials': 'FO', 'LastName': 'Adeyemo', 'Affiliation': 'Department of Nursing, University of Benin, Benin City, Nigeria.'}, {'ForeName': 'Friday E', 'Initials': 'FE', 'LastName': 'Okonofua', 'Affiliation': 'Department of Obstetrics and Gynae, University of Benin, Benin City, Nigeria.'}]",BMC pregnancy and childbirth,['10.1186/s12884-021-03605-y']
1438,33580944,"A randomized, open-label study to evaluate the efficacy and safety of liposomal amphotericin B (AmBisome) versus miltefosine in patients with post-kala-azar dermal leishmaniasis.","BACKGROUND


Treatment of post-kala-azar dermal leishmaniasis cases is of paramount importance for kala-azar elimination; however, limited treatment regimens are available as of now.
AIM


To compare the effectiveness of liposomal amphotericin B vs miltefosine in post-kala-azar dermal leishmaniasis patients.
METHODOLOGY


This was a randomized, open-label, parallel-group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3rd, 6th and 12th months after the end of the treatment.
RESULTS


In the liposomal amphotericin B group, two patients were lost to follow-up, whereas four patients were lost to follow-up in the miltefosine group. The initial cure rate by ""intention to treat analysis"" was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by ""per protocol analysis"" was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events.
LIMITATIONS


Quantitative polymerase chain reaction was not performed at all the follow-up visits and sample sizes.
CONCLUSION


Efficacy of miltefosine was found to be better than liposomal amphotericin B, hence, the use of miltefosine as first-line therapy for post-kala-azar dermal leishmaniasis needs to be continued. However, liposomal amphotericin B could be considered as one of the treatment options for the elimination of kala-azar from the Indian subcontinent.",2021,"The initial cure rate by ""intention to treat analysis"" was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively.","['post-kala-azar dermal leishmaniasis patients', 'patients with post-kala-azar dermal leishmaniasis', '100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group']","['liposomal amphotericin', 'liposomal amphotericin B vs miltefosine', 'liposomal amphotericin B and miltefosine', 'A (liposomal amphotericin B) and B (miltefosine', 'liposomal amphotericin B', 'liposomal amphotericin B (AmBisome) versus miltefosine', 'miltefosine']","['efficacy and safety', 'serious adverse events', 'final cure rate', 'initial cure rate']","[{'cui': 'C0032749', 'cui_str': 'Post-kala-azar dermal leishmaniasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1145701', 'cui_str': 'amphotericin B liposomal'}, {'cui': 'C0068006', 'cui_str': 'miltefosine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",100.0,0.07207,"The initial cure rate by ""intention to treat analysis"" was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively.","[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Pandey', 'Affiliation': 'Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India.'}, {'ForeName': 'Biplab', 'Initials': 'B', 'LastName': 'Pal', 'Affiliation': 'Department of Pharmacology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Niyamat Ali', 'Initials': 'NA', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Biostatistics, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Chandra Shekhar', 'Initials': 'CS', 'LastName': 'Lal', 'Affiliation': 'Department of Biochemistry, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Vahab', 'Initials': 'V', 'LastName': 'Ali', 'Affiliation': 'Department of Microbiology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Sanjiva', 'Initials': 'S', 'LastName': 'Bimal', 'Affiliation': 'Department of Immunology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Molecular Biology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Department of Pathology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Vidya Nand Rabi', 'Initials': 'VNR', 'LastName': 'Das', 'Affiliation': 'Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India.'}, {'ForeName': 'Shubhankar Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Microbiology, Lovely Professional University, Phagwara, Punjab.'}, {'ForeName': 'Roshan Kamal', 'Initials': 'RK', 'LastName': 'Topno', 'Affiliation': 'Department of Epidemiology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Patna, Bihar, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Das', 'Affiliation': 'Department of Molecular Biology, Lovely Professional University, Phagwara, Punjab.'}]","Indian journal of dermatology, venereology and leprology",['10.25259/IJDVL_410_19']
1439,33580923,A randomized comparative study of the efficacy of topical latanoprost versus topical betamethasone diproprionate lotion in the treatment of localized alopecia areata.,"BACKGROUND


Topical corticosteroids are the standard therapy for the treatment of alopecia areata. Recently, topical latanoprost has been found effective in the treatment of eyelash alopecia areata.
OBJECTIVES


The objective of this study was to compare the efficacy of topical latanoprost ophthalmic solution (group 1) with that of topical betamethasone diproprionate lotion (group 2) in the treatment of localized alopecia areata.
METHODS


This was a single-centre, randomized, two-armed, parallel-group efficacy trial. Fifty consecutive patients with localized alopecia areata were randomized in a 1:1 ratio to receive either topical latanoprost 0.005% ophthalmic solution or topical betamethasone diproprionate 0.05% lotion. Of these 50 patients, 44 patients (21 in group 1 and 23 in group 2) completed the treatment protocol.
RESULTS


The percentage reduction in area involved with alopecia areata at 16 weeks (primary outcome) was lower in latanoprost vs. betamethasone group (median [interquartile range], 11.1 [0-99.1] vs. 100% [13.6-100], P = 0.02). Significantly lesser patients in the latanoprost group had a complete response to treatment as compared to the betamethasone group (6 [24%] vs. 14 [56%], P = 0.02). The median (interquartile range) hair regrowth score was significantly lower in the latanoprost vs. the betamethasone group (1 [0-4.5] vs. 5 [1-5], P = 0.02). Subjects in the betamethasone group showed a more rapid reduction in the involved area.
LIMITATIONS


Short duration of treatment and follow-up were limitations of this study.
CONCLUSION


Our results suggest that topical latanoprost 0.005% ophthalmic solution is less effective but safer than topical betamethasone dipropionate 0.05% lotion in the treatment of localized alopecia areata (clinicaltrials.gov: NCT02350023).",2021,"The percentage reduction in area involved with alopecia areata at 16 weeks (primary outcome) was lower in latanoprost vs. betamethasone group (median [interquartile range], 11.1 [0-99.1] vs. 100% [","['Fifty consecutive patients with localized alopecia areata', 'alopecia areata', 'localized alopecia areata']","['betamethasone', 'topical latanoprost', 'topical latanoprost ophthalmic solution', 'topical latanoprost 0.005% ophthalmic solution or topical betamethasone diproprionate 0.05% lotion', 'topical betamethasone diproprionate lotion', 'latanoprost vs. betamethasone', 'betamethasone diproprionate lotion', 'latanoprost', 'topical betamethasone dipropionate']","['rapid reduction', 'percentage reduction in area involved with alopecia areata', 'median (interquartile range) hair regrowth score', 'localized alopecia areata']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0090306', 'cui_str': 'latanoprost'}, {'cui': 'C1237748', 'cui_str': 'latanoprost Ophthalmic Solution [Xalatan]'}, {'cui': 'C0981551', 'cui_str': 'Latanoprost 50 microgram/mL eye drops'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.103744,"The percentage reduction in area involved with alopecia areata at 16 weeks (primary outcome) was lower in latanoprost vs. betamethasone group (median [interquartile range], 11.1 [0-99.1] vs. 100% [","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Bhat', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Handa', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Dipankar', 'Initials': 'D', 'LastName': 'De', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]","Indian journal of dermatology, venereology and leprology",['10.25259/IJDVL_787_19']
1440,33496532,Literature Commentary.,"In this issue of Journal of Neuro-Ophthalmology, M. Tariq Bhatti, MD, and Mark L. Moster, MD will discuss the following 6 articles: Giannoccaro MP, Paolucci M, Zenesini C, Di Stasi V, Donadio V, Avoni P, Liguori R. Comparison of ice pack test and single-fiber EMG diagnostic accuracy in patients referred for myasthenic ptosis. Neurology. 2020;95:e1800-e1806.Slonim CB, Foster S, Jaros M, Kannarr SR, Korenfeld MS, Smyth-Medina R, Wirta DL. Association of oxymetazoline hydrochloride, 0.1%, solution administration with visual field in acquired ptosis: a pooled analysis of 2 randomized clinical trials. JAMA Ophthalmol. 2020;138:1168-1175.Madhavan AA, Carr CM, Morris PP, Flanagan EP, Kotsenas AL, Hunt CH, Eckel LJ, Lindell EP, Diehn FE. Imaging review of paraneoplastic neurologic syndromes. AJNR Am J Neuroradiol. 2020;41:2176-2187.Nguyen AL, Vodehnalova K, Kalincik T, Signori A, Havrdova EK, Lechner-Scott J, Skibina OG, Eastaugh A, Taylor L, Baker J, McGuinn N, Rath L, Maltby V, Sormani MP, Butzkueven H, Van der Walt A, Horakova D, Jokubaitis VG. Association of pregnancy with the onset of clinically isolated syndrome. JAMA Neurol. 2020;77:1-9.Kurian A, Reghunadhan I, Thilak P, Soman I, Nair U. Short-term efficacy and safety of topical β-blockers (timolol maleate ophthalmic solution, 0.5%) in acute migraine: a randomized crossover trial. JAMA Ophthalmol. 2020;138:1160-1166.Hatt SR, Leske DA, Iezzi R Jr, Holmes JM. Binocular interference vs diplopia in patients with epiretinal membrane. JAMA Ophthalmol. 2020;138:1121-1127.",2021,"2020;138:1160-1166.Hatt SR, Leske DA, Iezzi R Jr, Holmes JM.","['in acquired ptosis', 'acute migraine', 'patients referred for myasthenic ptosis', 'patients with epiretinal membrane']","['oxymetazoline hydrochloride, 0.1%, solution administration with visual field', 'topical β-blockers (timolol maleate ophthalmic solution', 'Binocular interference vs diplopia']","['CB, Foster S, Jaros M, Kannarr SR, Korenfeld MS, Smyth-Medina R, Wirta DL', 'Butzkueven H, Van der Walt A, Horakova D, Jokubaitis VG']","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}]","[{'cui': 'C0357797', 'cui_str': 'Oxymetazoline hydrochloride'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}]","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0557775', 'cui_str': 'Van'}]",,0.0997979,"2020;138:1160-1166.Hatt SR, Leske DA, Iezzi R Jr, Holmes JM.",[],Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society,['10.1097/WNO.0000000000001201']
1441,33581476,Effect of augmented reality books in salivary cortisol levels in hospitalized pediatric patients: A randomized cross-over trial.,"OBJECTIVE


This study sought to assess the effect of reading augmented reality (AR) books on salivary cortisol levels in hospitalized pediatric patients compared to reading a standard children's book.
METHODS


This was a randomized, two-period, cross-over trial in hospitalized children aged 7-11 years. AR books currently in the market were used as intervention. Complete block randomization was used to randomize the order of the intervention. Children allocated to the 'AR-first' group received the book, a tablet and were left to interact independently with the technology for an hour. After a 48 -h wash-out period, children received a standard book. 'Standard-book-first' group received only the standard book and after wash-out received the tablet and the AR book. Salivary cortisol and a validated visual analogue scale (VAS) for psychological stress were assessed at the beginning and at the end of each intervention.
RESULTS


A total of 29 children were recruited in the study. One was lost during follow up. Cortisol levels decreased after the AR intervention (P = 0.019). Nevertheless, the decrease was not greater than the one associated to reading the standard book. VAS scores increased after the AR intervention (P < 0.001).
DISCUSSION


There is evidence of order and sequence effects that might explain results. First assessment of AR-based interventions on stress. Results justify further research.
CONCLUSIONS


There was no evidence that reading AR books diminished cortisol levels more than reading a standard book. AR-books improved VAS score for psychological stress compared to a standard book.",2021,"VAS scores increased after the AR intervention (P < 0.001).
","['hospitalized children aged 7-11 years', '29 children were recruited in the study', 'hospitalized pediatric patients']","['reading augmented reality (AR) books', 'augmented reality books']","['Cortisol levels', 'VAS scores', 'cortisol levels', 'salivary cortisol levels', 'VAS score', 'Salivary cortisol and a validated visual analogue scale (VAS) for psychological stress']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0006002', 'cui_str': 'Book'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]",29.0,0.0428494,"VAS scores increased after the AR intervention (P < 0.001).
","[{'ForeName': 'Dulce E', 'Initials': 'DE', 'LastName': 'Alarcón-Yaquetto', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Ciencias Biológicas y Fisiológicas, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru. Electronic address: dulce.alarcon@upch.pe.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Tincopa', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru; Laboratorio de Ingeniería Biomédica, Escuela de Ingeniería, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Guillén-Pinto', 'Affiliation': 'Facultad de Medicina Alberto Hurtado, Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Nacional Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Bailon', 'Affiliation': 'Departamento de Ciencias Biológicas y Fisiológicas, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'César P', 'Initials': 'CP', 'LastName': 'Cárcamo', 'Affiliation': 'Unidad de Informática Biomédica en Salud Global, Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2021.104404']
1442,33581014,Greater effects of high- compared with moderate-intensity interval training on thyroid hormones in overweight/obese adolescent girls.,"OBJECTIVES


To investigate the effects of 12-week high-intensity- (HIIT)  vs.  moderate-intensity-interval training (MIIT) on thyroid stimulating hormone (TSH) and thyroxine (T4) and insulin-resistance in overweight/obese adolescent girls.
METHODS


Twenty four adolescent girls (age 16.5±1.36 yrs) were randomly allocated into three groups: (1) HIIT (2 blocks per session of 6-8 bouts of 30 s runs at 100-110% maximal aerobic speed (MAS), with 30 s active recovery between bouts at 50% MAS; n=8), (2) MIIT (2 blocks per session of 6-8 bouts of 30 s runs at 70-80% MAS, with 30 s active recovery between bouts at 50% MAS; n=8) and (3) control group (no exercise, n=8). Each training groups engaged in three sessions per week during three months. Anthropometric parameters, aerobic capacity, homeostasis model assessment index for insulin resistance (HOMA-IR) as well as plasma TSH and T4 levels were assessed in all subjects before- and after-training.
RESULTS


Following both training programs, body mass, body mass index Z-score, waist circumference and body fat decreased, while aerobic capacity increased. However, TSH and T4 concentrations decreased only after the HIIT (-30.47%, p<0.05, ES=1.42 and -12.86%, p<0.05, ES=1.18; respectively). The HOMA-IR decreased in both training groups (-26.25%, p<0.05, ES=1.87 for MIIT and -21.72%, p<0.05, ES=2.14 for HIIT).
CONCLUSION


Twelve weeks of HIIT was effective in reducing circulating TSH and T4 levels, unlike MIIT, in overweight/obese adolescent girls. These findings indicated that the stimulation of pituitary-thyroid function is more sensitive to training intensity than training duration. Further studies are needed to confirm this conclusion.",2020,"The HOMA-IR decreased in both training groups (-26.25%, p<0.05, ES=1.87 for MIIT and -21.72%, p<0.05, ES=2.14 for HIIT).
","['overweight/obese adolescent girls', 'Twenty four adolescent girls (age 16.5±1.36\xa0yrs']","['moderate-intensity interval training', '12-week high-intensity- (HIIT)  vs.  moderate-intensity-interval training (MIIT']","['HOMA-IR', 'circulating TSH and T4 levels, unlike MIIT', 'TSH and T4 concentrations', 'thyroid stimulating hormone (TSH) and thyroxine (T4) and insulin-resistance', 'thyroid hormones', 'Anthropometric parameters, aerobic capacity, homeostasis model assessment index for insulin resistance (HOMA-IR', 'plasma TSH and T4 levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",24.0,0.0222737,"The HOMA-IR decreased in both training groups (-26.25%, p<0.05, ES=1.87 for MIIT and -21.72%, p<0.05, ES=2.14 for HIIT).
","[{'ForeName': 'Wissal', 'Initials': 'W', 'LastName': 'Abassi', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia.'}, {'ForeName': 'Nejmeddine', 'Initials': 'N', 'LastName': 'Ouerghi', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Ghouili', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Haouami', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia.'}, {'ForeName': 'Anissa', 'Initials': 'A', 'LastName': 'Bouassida', 'Affiliation': 'Research Unit, Sportive Performance and Physical Rehabilitation, High Institute of Sports and Physical Education of Kef, University of Jendouba, Kef, Tunisia.'}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2020-0031']
1443,33588490,[Comparison between navigated and conventional percutaneous screw fixation of non-displaced scaphoid fractures].,"BACKGROUND


Incorrect screw placement and penetration in screw fixation of scaphoid fractures are found in 5 to 30 %. Therefore, optimizing of screw placement is desirable, especially because an exact central position of the screw in the proximal fragment leads to a significant higher stability as a more peripheral position.
PATIENTS UND METHODS


36 patients with an acute non-displaced scaphoid fracture were included in this randomized prospective study. 18 patients underwent navigated, the other 18 conventional percutaneous screw fixation of an acute non-displaced scaphoid fracture through a dorsal approach. Operation time and x-ray dose were measured. In both groups the position of the screw in the scaphoid was calculated on CT scans and compared with each other. Clinically, 17 patients with navigated and 11 with conventional percutaneous screw fixation with an average age of 52 resp. 43.2 years were available for follow-up examination including Krimmer- and DASH-score.
RESULTS


All scaphoids healed within an adequate time. Two cases of navigated screw fixation have been converted to conventional percutaneous screw fixation. The average operation time in the navigated group was 83.2 minutes, in the conventional group 42.1 minutes. X-ray dose measured 106,5 ± 19,9cGy/cm 2  in the navigated group and 45,6 ± 8,0cGy/cm 2  in the conventional group. Screw penetration using an intraosseous compression screw (HSC) was observed in 5 conventionally fixed scaphoids, 4 distally (2,27 ± 1,47 mm), 1 proximally. In the navigated group there were 11 screw penetrations, 4 proximally (2,01 ± 0,81 mm) and distally (1,21 ± 0,64 mm), 3 distally (1,18 ± 0,44 mm), and 4 proximally (1,61 ± 0,57 mm). Axial screw position was more accurate in the conventional group. The 17 navigated patients averaged a Krimmer-Score of 83.6 and a DASH-score of 5,6 points at follow-up. The 11 conventional treated patients averaged a Krimmer-Score of 95 and a DASH-score of 8.0 points at follow-up.
CONCLUSION


In this study navigated screw fixation of acute non-displaced scaphoid fractures was not superior to conventional percutaneous screw fixation, neither for screw position, screw penetration nor with respect to the clinical outcome.",2021,"In this study navigated screw fixation of acute non-displaced scaphoid fractures was not superior to conventional percutaneous screw fixation, neither for screw position, screw penetration nor with respect to the clinical outcome.","['non-displaced scaphoid fractures', '17 patients with navigated and 11 with conventional percutaneous screw fixation with an average age of 52 resp', '36 patients with an acute non-displaced scaphoid fracture', '18 patients underwent navigated, the other 18']","['Screw penetration using an intraosseous compression screw (HSC', 'navigated screw fixation', 'navigated and conventional percutaneous screw fixation', 'conventional percutaneous screw fixation of an acute non-displaced scaphoid fracture through a dorsal approach', 'conventional percutaneous screw fixation', 'Axial screw position']","['Operation time and x-ray dose', 'average operation time']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441553', 'cui_str': 'Percutaneous fixation using screw'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0595613', 'cui_str': 'Intraosseous route'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441553', 'cui_str': 'Percutaneous fixation using screw'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0272654', 'cui_str': 'Fracture of scaphoid bone of wrist'}, {'cui': 'C0589468', 'cui_str': 'Dorsal approach'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",17.0,0.0297038,"In this study navigated screw fixation of acute non-displaced scaphoid fractures was not superior to conventional percutaneous screw fixation, neither for screw position, screw penetration nor with respect to the clinical outcome.","[{'ForeName': 'Kukuh Aji', 'Initials': 'KA', 'LastName': 'Prabowo', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lopatta', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lenz', 'Affiliation': 'Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Reinhardt', 'Initials': 'R', 'LastName': 'Friedel', 'Affiliation': 'Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Marintschev', 'Affiliation': 'Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Graul', 'Affiliation': 'Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Jena, Friedrich-Schiller-Universität, Jena.'}]","Handchirurgie, Mikrochirurgie, plastische Chirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Handchirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Mikrochirurgie der Peripheren Nerven und Gefasse : Organ der V...",['10.1055/a-1276-1364']
1444,33588379,Cold-Water Effects on Energy Balance in Healthy Women During Aqua-Cycling.,"BACKGROUND


While the popularity of aquatic physical activities continues to grow among women, the effects on energy expenditure (EE) and appetite control remain unknown. The objective of this study was to examine the effect of water temperature during aqua-cycling session on EE, rate of perceived exertion, energy intake, appetite sensations, and food reward in healthy premenopausal women.
METHODS


Participants completed three experimental sessions, in the postprandial condition, in a randomized order: a land control session (CON), an aqua-cycling session in 18 °C (EXO18), and an aqua-cycling session in 27 °C (EXO27). The EE, food intake, appetite sensations, and food reward were investigated for each condition.
RESULTS


EXO18 induced a significant increase in EE (p < .001) and oxygen consumption (p < .01) compared with EXO27. The carbohydrate oxidation was higher in EXO18 session compared with EXO27 and CON (p < .05 and p < .001, respectively). While fat oxidation was higher in exercise sessions compared with CONT (p < .01), no difference was observed between EXO18 and EXO27. Exercise sessions did not alter absolute energy intake session but induced a decrease in relative energy intake (p < .001) and in hunger, desire to eat, and prospective food consumption compared with CON (p < .001). The authors also show here that cold-water exposure can increase EE while rate of perceived exertion is lower at the end of exercise session compared with same exercise at 27 °C (p < .05).
CONCLUSION


An exposure to a moderately cold-water during aqua-cycling is an efficient strategy to promote increased EE and decreased hunger, which may be effective for energy balance management in healthy premenopausal women.",2021,"Exercise sessions did not alter absolute energy intake session but induced a decrease in relative energy intake (p < .001) and in hunger, desire to eat, and prospective food consumption compared with CON (p < .001).","['healthy premenopausal women', 'Healthy Women']","['water temperature during aqua-cycling session', 'land control session (CON), an aqua-cycling session in 18 °C (EXO18), and an aqua-cycling session']","['hunger, desire to eat, and prospective food consumption', 'EE, rate of perceived exertion, energy intake, appetite sensations, and food reward', 'relative energy intake', 'Energy Balance', 'EE, food intake, appetite sensations, and food reward', 'While fat oxidation', 'EE', 'carbohydrate oxidation', 'oxygen consumption', 'absolute energy intake session']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.128282,"Exercise sessions did not alter absolute energy intake session but induced a decrease in relative energy intake (p < .001) and in hunger, desire to eat, and prospective food consumption compared with CON (p < .001).","[{'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Metz', 'Affiliation': 'Clermont Auvergne University.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Isacco', 'Affiliation': 'Clermont Auvergne University.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'University of Leeds.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Clermont-Ferrand University Hospital.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Clermont-Ferrand University Hospital.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0177']
1445,33588378,Exercise Plus Presleep Protein Ingestion Increases Overnight Muscle Connective Tissue Protein Synthesis Rates in Healthy Older Men.,"Protein ingestion and exercise stimulate myofibrillar protein synthesis rates. When combined, exercise further increases the postprandial rise in myofibrillar protein synthesis rates. It remains unclear whether protein ingestion with or without exercise also stimulates muscle connective tissue protein synthesis rates. The authors assessed the impact of presleep protein ingestion on overnight muscle connective tissue protein synthesis rates at rest and during recovery from resistance-type exercise in older men. Thirty-six healthy, older men were randomly assigned to ingest 40 g intrinsically L-[1-13C]-phenylalanine and L-[1-13C]-leucine-labeled casein protein (PRO, n = 12) or a nonprotein placebo (PLA, n = 12) before going to sleep. A third group performed a single bout of resistance-type exercise in the evening before ingesting 40 g intrinsically-labeled casein protein prior to sleep (EX+PRO, n = 12). Continuous intravenous infusions of L-[ring-2H5]-phenylalanine and L-[1-13C]-leucine were applied with blood and muscle tissue samples collected throughout overnight sleep. Presleep protein ingestion did not increase muscle connective tissue protein synthesis rates (0.049 ± 0.013 vs. 0.060 ± 0.024%/hr in PLA and PRO, respectively; p = .73). Exercise plus protein ingestion resulted in greater overnight muscle connective tissue protein synthesis rates (0.095 ± 0.022%/hr) when compared with PLA and PRO (p < .01). Exercise increased the incorporation of dietary protein-derived amino acids into muscle connective tissue protein (0.036 ± 0.013 vs. 0.054 ± 0.009 mole percent excess in PRO vs. EX+PRO, respectively; p < .01). In conclusion, resistance-type exercise plus presleep protein ingestion increases overnight muscle connective tissue protein synthesis rates in older men. Exercise enhances the utilization of dietary protein-derived amino acids as precursors for de novo muscle connective tissue protein synthesis during overnight sleep.",2021,"Presleep protein ingestion did not increase muscle connective tissue protein synthesis rates (0.049 ± 0.013 vs. 0.060 ± 0.024%/hr in PLA and PRO, respectively; p = .73).","['Healthy Older Men', 'Thirty-six healthy, older men', 'older men']","['single bout of resistance-type exercise in the evening before ingesting 40\xa0g intrinsically-labeled casein protein', 'ingest 40\xa0g intrinsically L-[1-13C]-phenylalanine and L-[1-13C]-leucine-labeled casein protein (PRO, n = 12) or a nonprotein placebo (PLA, n = 12) before going to sleep', 'Exercise Plus Presleep Protein Ingestion', 'L-[ring-2H5]-phenylalanine and L-[1-13C]-leucine', 'Protein ingestion and exercise', 'Exercise plus protein ingestion']","['incorporation of dietary protein-derived amino acids into muscle connective tissue protein', 'overnight muscle connective tissue protein synthesis rates', 'muscle connective tissue protein synthesis rates']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}]","[{'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0301698', 'cui_str': 'Connective tissue protein'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0133159,"Presleep protein ingestion did not increase muscle connective tissue protein synthesis rates (0.049 ± 0.013 vs. 0.060 ± 0.024%/hr in PLA and PRO, respectively; p = .73).","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Trommelen', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Imre W K', 'Initials': 'IWK', 'LastName': 'Kouw', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Senden', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Joy P B', 'Initials': 'JPB', 'LastName': 'Goessens', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Janneau', 'Initials': 'J', 'LastName': 'van Kranenburg', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Annemie P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'Maastricht University Medical Centre.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Maastricht University Medical Centre.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0222']
1446,33588138,Evaluation and comparison of the efficacy of long-acting betamethasone and dexamethasone as injections in the treatment of idiopathic sudden hearing loss.,"INTRODUCTION & OBJECTIVE


The aim of the present study was to determine the efficacy of long-acting betamethasone, and its comparison with Dexamethasone as an intratympanic injection in the treatment of Sudden Sensorineural Hearing Loss (SSNHL).
MATERIALS AND METHODS


Thirty-one patients who do not respond to systemic steroids and poor prognosis patients were enrolled in this study. The patients divided randomly into two groups: 1- Dexamethasone and 2- Long acting betamethasone. Dexamethasone (0.4 ml/mg) or long-acting betamethasone (0.1 ml/mg) was slowly injected (0.4 to 0.6 cc) into the superior-anterior area of the tympanic membrane as 6 injections twice a week for a total of 3 weeks. Right after the treatment and one, two and six months after completion of treatment, an audiometry was performed and compared with the pre-injection values.
RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline. Speech Discrimination Score (SDS) also improved in both groups directly after treatment and at one-month follow-up. The hearing improvement in the Dexamethasone group was clinically better than in the Beta group, but due to the non-parametric data, it was not possible to analyze the hearing improvement process in the variable group.
CONCLUSION


According to the results obtained in this study, intratympanic corticosteroid injection in the treatment of patients with SSNHL has positive and promising results on improving hearing level.",2021,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","['Sudden Sensorineural Hearing Loss (SSNHL', 'idiopathic sudden hearing loss', 'Thirty-one patients who do not respond to systemic steroids and poor prognosis patients']","['betamethasone', 'Dexamethasone (0.4\xa0ml/mg) or long-acting betamethasone', 'Dexamethasone and 2- Long acting betamethasone', 'Dexamethasone', 'long-acting betamethasone and dexamethasone']","['Speech Discrimination Score (SDS', 'hearing level', 'hearing improvement process', 'hearing improvement', 'Speech Reception Threshold (SRT']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0011057', 'cui_str': 'Sudden hearing loss'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C0175841', 'cui_str': 'Hearing level'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}]",31.0,0.0155399,"RESULTS


Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline.","[{'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Erfanian', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: r_erfanian@sina.tums.ac.ir.""}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Yazdani', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n_yazdani@tums.ac.ir.""}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Hajbegloo', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ardavan', 'Initials': 'A', 'LastName': 'Tajdini', 'Affiliation': ""Otorhinolaryngology Research Center, Sa'adi Street, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-tajdini@sina.tums.ac.ir.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2021.102955']
1447,33588113,Decoding the Evolutionary Response to Ensartinib in ALK-Positive Non-Small-Cell Lung Cancer Patients by Dynamic Circulating Tumor DNA Sequencing.,"INTRODUCTION


By implementing dynamic circulating tumor DNA (ctDNA) analysis, we explored impact of TP53 mutations on tumor evolution and resistance mechanisms to ensartinib in ALK-positive non-small-cell lung cancer (NSCLC) patients.
METHODS


In a multicenter phase 2 trial, ALK-positive NSCLC patients who progressed on crizotinib were treated with ensartinib. Blood samples for ctDNA analysis were collected at baseline, cycle 3 day 1 (C3D1) and disease progression (PD) and analyzed with a 212-gene panel.
RESULTS


440 samples were collected from 168 patients. Baseline TP53 mutations (20.2%) significantly correlated with inferior PFS (4.2 months vs 11.7 months, p < 0.0001). Patients with TP53 mutations had higher mutation load than those without TP53 mutations at baseline (13.79 ± 3.72 vs 4.67 ± 0.39, p < 0.001). Although there was no significant difference in mutation load between these groups at C3D1 (5.89 ± 2.25 vs 3.72 ± 0.62, p = 0.425), patients with mutated TP53 developed more mutations at PD (7.07 ± 1.25 vs 3.20 ± 0.33, p = 0.003). Frequency and abundance of secondary ALK mutations G1269A, G1202R and E1210K increased significantly at PD than baseline. In patients without secondary ALK mutations, we identified ALK-independent resistance mechanisms including bypass signaling activation, downstream effector protein reactivation, epithelial-mesenchymal transformation and epigenetic dysregulation.
CONCLUSIONS


Our study highlighted the advantage of ctDNA analysis for monitoring tumor evolution. TP53 mutations promoted genetic evolution and accelerated occurrence of resistance. We also unveiled ALK-dependent resistance mechanisms, mainly by G1269A, G1202R and E1210K mutations, and ALK-independent resistance mechanisms to ensartinib.",2021,"Frequency and abundance of secondary ALK mutations G1269A, G1202R and E1210K increased significantly at PD than baseline.","['positive NSCLC patients who progressed on crizotinib were treated with ensartinib', '440 samples were collected from 168 patients']",['ALK'],"['Frequency and abundance of secondary ALK mutations G1269A, G1202R and E1210K', 'inferior PFS', 'mutation load', 'Baseline TP53 mutations']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4524311', 'cui_str': 'ensartinib'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}]",440.0,0.1078,"Frequency and abundance of secondary ALK mutations G1269A, G1202R and E1210K increased significantly at PD than baseline.","[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: yangyp@sysucc.org.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: huangjie@sysucc.org.cn.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Hangzhou Repugene Technology, Hangzhou, China. Electronic address: tao.wang@repugene.com.'}, {'ForeName': 'Jianya', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. Electronic address: zhoujy@zju.edu.cn.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. Electronic address: 06yxsyzj@163.com.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. Electronic address: fjif@vip.sina.com.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China. Electronic address: zhuangwu2008@126.com.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, China. Electronic address: cjh_1000@163.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China. Electronic address: ohjerry@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Department of Pulmonary Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. Electronic address: zw_pumch@126.com.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Respiratory Department of Internal Medicine, Henan Provincial Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. Electronic address: 13938252350@163.com.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. Electronic address: zyp352@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Division of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. Electronic address: yong_song6310@yahoo.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Chinese PLA General Hospital, Beijing, China. Electronic address: huyi0401@aliyun.com.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China. Electronic address: yuzhuang2002@163.com.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China. Electronic address: gongyouling@hotmail.com.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: chengyuan008@163.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Teaching Hospital of Fujian Medical University, Xiamen, China. Electronic address: yefengdoctor@sina.com.'}, {'ForeName': 'Shucai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China. Electronic address: sczhang6304@163.com.'}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Respiratory Medicine, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei, China. Electronic address: sycaolejie@163.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. Electronic address: fanyun@zjcc.org.cn.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: xhzlwg@163.com.'}, {'ForeName': 'Yubiao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Pulmonary & Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. Electronic address: guoyubiao@hotmail.com.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Respiratory Medicine Department, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: doctorzcz@163.com.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China. Electronic address: makw@jlu.edu.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China. Electronic address: fangjian5555@163.com.'}, {'ForeName': 'Weineng', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Department of Head and Neck and Thoracic Medical Oncology, The First People's Hospital Of Foshan, Foshan, China. Electronic address: fengweineng@163.com.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Oncology Medicine, The First Hospital of China Medical University, Shenyang, China. Electronic address: cmu_trial@163.com.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Oncology Department, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: mylonzzdong@163.com.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': '2nd Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming, China. Electronic address: ligaofenghl@126.com.'}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. Electronic address: wanghj98@hotmail.com.'}, {'ForeName': 'Shundong', 'Initials': 'S', 'LastName': 'Cang', 'Affiliation': ""Medical oncology, Henan Provincial People's Hospital, Henan, China. Electronic address: cangshundong@163.com.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'PET-CT Center & Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. Electronic address: cjr.wuning@vip.163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. Electronic address: cjr.songwei@vip.163.com.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary Oncology, The Fifth Medical Centre Chinese PLA General Hospital, Beijing, China. Electronic address: liuxq@medmail.com.cn.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. Electronic address: shijunzhao@aliyun.com.'}, {'ForeName': 'Lieming', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, China. Electronic address: li.mao@bettapharma.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, China. Electronic address: lieming.ding@bettapharma.com.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Selvaggi', 'Affiliation': 'X-covery Holdings, Palm Beach Gardens, FL, USA. Electronic address: giovanni@xcovery.com.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, China. Electronic address: larry.zhu@bettapharma.com.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Hangzhou Repugene Technology, Hangzhou, China. Electronic address: shanshan.xiao@repugene.com.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, China. Electronic address: xiaobin.yuan@bettapharma.com.'}, {'ForeName': 'Zhilin', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Betta Pharmaceuticals Co., Ltd, Hangzhou, China. Electronic address: zhilin.shen@bettapharma.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: zhangli@sysucc.org.cn.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2021.01.1615']
1448,33588112,Comparative Effectiveness of a Lymph Node Collection kit Versus 'Heightened Awareness' on Lung Cancer Surgery Quality and Outcomes.,"BACKGROUND


The adverse prognostic impact of poor pathologic nodal staging has stimulated efforts to heighten awareness of the problem through guidelines, without guidance on processes to overcome it. We compared 'heightened awareness' of nodal staging quality versus a lymph node collection kit.
METHODS


We categorized curative-intent lung cancer resections from 2009-2020 in a population-based non-randomized stepped wedge implementation study of both interventions, into pre-intervention baseline, heightened awareness and kit sub-cohorts. We used differences in proportion and hazard ratios across the sub-cohorts, to estimate the effect of the interventions on poor quality (non-examination of nodes [pNX] or mediastinal nodes [pNX med ]) and attainment of quality recommendations of the National Comprehensive Cancer Network (NCCN), the Commission on Cancer (CoC) and the proposed complete (R0) resection definition of the International Association for the Study of Lung Cancer (IASLC) across the three cohorts.
RESULTS


Of 3734 resections: 39% were pre-intervention; 40% kit; and 21%, heightened awareness cases. COHORT PROPORTIONS WITH: pNX were 11% (baseline) versus 0% (kit) versus 9% (heightened awareness); pNX med , 27% versus 1% versus 22%; CoC benchmark attainment, 14% versus 77% versus 30%; IASLC-defined R0 resection, 11% versus 58% versus 24%; NCCN attainment, 23% versus 79% versus 35%; (p:<0.001 for all, except pNX rate baseline versus heightened awareness). Survival rate was significantly higher for both interventions compared to baseline.
CONCLUSION


Resections with heightened awareness or the kit significantly improved surgical quality and outcomes, but the kit was more effective. We propose to conduct a prospective, institutional cluster randomized clinical trial comparing both interventions.",2021,"Survival rate was significantly higher for both interventions compared to baseline.
",[],"['National Comprehensive Cancer Network (NCCN', 'categorized curative-intent lung cancer resections', ""Lymph Node Collection kit Versus 'Heightened Awareness""]","['Lung Cancer Surgery Quality and Outcomes', 'Survival rate', 'surgical quality and outcomes']",[],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",,0.0413072,"Survival rate was significantly higher for both interventions compared to baseline.
","[{'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Ray', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Fehnel', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Olawale', 'Initials': 'O', 'LastName': 'Akinbobola', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Faris', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA; Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Pacheco', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Smeltzer', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, Tennessee, USA.'}, {'ForeName': 'Raymond U', 'Initials': 'RU', 'LastName': 'Osarogiagbon', 'Affiliation': 'Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee, USA; Multidisciplinary Thoracic Oncology Program, Baptist Cancer Center, Memphis, Tennessee, USA. Electronic address: rosarogi@bmhcc.org.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2021.01.1618']
1449,33588088,Amino acids and vitamins status during continuous renal replacement therapy: an ancillary prospective observational study of a randomised control trial.,"BACKGROUND


Continuous renal replacement therapy (CRRT) is associated with micronutrients loss. Current recommendations are to administer 1-1.5g/kg/day of proteins during CRRT. We aim to evaluate the net effect of CRRT on amino acids (AA), vitamins A and C (Vit A, Vit C) levels.
METHODS


This is a prospective observational study embedded within a randomised controlled trial comparing two CRRT doses in patients with septic shock. CRRT was provided in continuous veno-venous haemofiltration mode at a dose of either 35ml/kg/h or 70ml/kg/h. All patients received parenteral nutrition with standard trace elements and vitamins (protein intake 1g/kg/d). We measured serum levels of glutamine, valine and alanine as well as Vit A and Vit C upon randomisation, study day four and eight. In addition, we measured a larger panel of AA in a subset of 11 patients.
RESULTS


We included 30 patients (17 allocated to 70ml/kg/h and 13 to 35ml/kg/h CRRT). Before CRRT initiation, mean plasma levels of glutamine and valine, Vit A and Vit C were low. CRRT was not associated with any significant change in AA levels except for a decrease in cystein. It was associated with an increase in Vit A and a decrease in Vit C levels. CRRT dose had no impact on those nutrients blood levels.
CONCLUSIONS


Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA. Further studies should focus on lean mass wasting during CRRT.",2021,"CONCLUSIONS


Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA.","['30 patients (17 allocated to 70ml/kg/h and 13 to 35ml/kg/h CRRT', 'patients with septic shock']","['CRRT', 'continuous renal replacement therapy', 'parenteral nutrition with standard trace elements and vitamins (protein intake', 'Amino acids and vitamins status', 'Continuous renal replacement therapy (CRRT']","['AA levels', 'amino acids (AA), vitamins A and C', 'cysteine and Vit C', 'serum levels of glutamine, valine and alanine', 'mean plasma levels of glutamine and valine, Vit A and Vit C', 'Vit C levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0042285', 'cui_str': 'Valine'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",30.0,0.133403,"CONCLUSIONS


Irrespective of dose, CRRT was associated with a decrease in cysteine and Vit C and an increase in Vit A with no significant change in other AA.","[{'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': 'Adult Intensive care unit and burn centre, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Picard', 'Affiliation': 'Service de réanimation, Hôpital F. Mitterrand, 4, boulevard Hauterive, 64046 Pau, France.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Honoré', 'Affiliation': 'Intensive Care Department, Centre Hospitalier Universitaire Brugmann-Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dewitte', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France; Inserm, UMR 1034, Biology of Cardiovascular Diseases, Pessac, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mesli', 'Affiliation': 'CHU de Bordeaux, Hôpital Pellegrin, Département de Biochimie, Bordeaux, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Redonnet-Vernhet', 'Affiliation': 'CHU de Bordeaux, Hôpital Pellegrin, Département de Biochimie, Bordeaux, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fleureau', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ouattara', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France; Inserm, UMR 1034, Biology of Cardiovascular Diseases, Pessac, France.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Berger', 'Affiliation': 'Adult Intensive care unit and burn centre, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Joannes-Boyau', 'Affiliation': 'CHU de Bordeaux, Service Anesthésie et Réanimation SUD, Centre médico-chirurgical Magellan, Bordeaux, France. Electronic address: olivier.joannes-boyau@chu-bordeaux.fr.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2021.100813']
1450,33588077,Rationale and protocol for a randomized waitlist controlled trial of videoconference delivered cognitive behaviour therapy for insomnia (CBT-I) to improve perceived cognitive impairment (PCI) among cancer survivors.,"Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this will need to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at pre (baseline), mid (4 weeks), post treatment (8 weeks), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy - Cognitive Function. Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options.",2021,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"['124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6\u202fmonths prior, report PCI and meet criteria for insomnia disorder', 'cancer survivors', 'cancer patients']","['videoconference-delivered CBT-I', 'videoconference delivered cognitive behaviour therapy', 'Cognitive-behaviour therapy', 'PCI']","['Functional Assessment of Cancer Therapy - Cognitive Function', 'Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",124.0,0.109037,Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning.,"[{'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University of Newfoundland, Newfoundland, Canada; Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada. Electronic address: Sheila.garland@mun.ca.'}, {'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'École de psychologie, Université Laval and CHU de Québec-Université Laval Research Center, Quebec, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Nyissa A', 'Initials': 'NA', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University of Newfoundland, Newfoundland, Canada; Beatrice Hunter Cancer Research Institute, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Seal', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rash', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Sondria', 'Initials': 'S', 'LastName': 'Browne', 'Affiliation': 'Department of Psychology, Faculty of Science, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Urquhart', 'Affiliation': 'Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thoms', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Veeresh', 'Initials': 'V', 'LastName': 'Gadag', 'Affiliation': 'Division of Community Health and Humanities, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Laing', 'Affiliation': 'Discipline of Oncology, Faculty of Medicine, Memorial University of Newfoundland, Newfoundland, Canada.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106322']
1451,33588061,The effect of prophylaxis with ertapenem versus cefuroxime/metronidazole on intestinal carriage of carbapenem-resistant or third-generation cephalosporin-resistant Enterobacterales after colorectal surgery.,"OBJECTIVES


Compared to cephalosporin-based prophylaxis, ertapenem prophylaxis lowers the risk of surgical site infection among carriers of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) undergoing colorectal surgery. We aimed to determine whether ertapenem prophylaxis leads to increased post-operative colonization with carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (3GCR-E).
METHODS


This study was nested within a quality improvement study of prophylaxis for ESBL-PE carriers undergoing colorectal surgery. Patients were screened 4-6 days after surgery for carriage of ESBL-PE or other 3GCR-E and CRE. When CRE were detected, pre- and post-surgical clones were compared using FT-IR spectroscopy.
RESULTS


The sample consisted of 56 patients who carried ESBL-PE before surgery and received cefuroxime/metronidazole prophylaxis (Group 1), 66 who carried ESBL-PE before surgery and received ertapenem (Group 2), and 103 ESBL-PE non-carriers who received cefuroxime/metronidazole prophylaxis (Group 3). CRE carriage was detected post-operatively in 1 patient (1.5%) in Group 2 versus 8 patients (14.3%) in Group 1 (RD:-12.8%; 95% CI:-22.4%- -3.1). For 7/9 patients, pre-operative ESBL-PE and post-operative CRE isolates were compared; in 5 of them, the pre- and post-operative clones were identical. Post-operative 3GCR-E carriage was detected in 37 patients (56.1%) in Group 2 versus 46 patients in Group 1 (82.1%) (aRD: -20.7%, 95% CI: -37.3%- -4.1%).
CONCLUSIONS


Among ESBL-PE carriers undergoing colorectal surgery, detection of short-term post-surgical colonization by CRE and 3GCR-E was significantly lower among patients who received ertapenem prophylaxis than those who received cephalosporin-metronidazole prophylaxis. Resistance development in a colonizing bacterial clone, rather than carbapenemase acquisition, was the major mechanism of carbapenem resistance.",2021,CRE carriage was detected post-operatively in 1 patient (1.5%) in Group 2 versus 8 patients (14.3%) in Group 1 (RD:-12.8%; 95% CI:-22.4%- -3.1).,"['56 patients who carried ESBL-PE before surgery and received', 'ESBL-PE carriers undergoing colorectal surgery', 'carriers of extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-PE) undergoing colorectal surgery', 'intestinal carriage of carbapenem-resistant or third-generation cephalosporin-resistant Enterobacterales after colorectal surgery']","['ESBL-PE non-carriers who received cefuroxime/metronidazole prophylaxis', 'cefuroxime/metronidazole prophylaxis', 'carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (3GCR-E', 'cephalosporin-based prophylaxis, ertapenem prophylaxis', 'cephalosporin-metronidazole prophylaxis', 'cefuroxime/metronidazole']","['CRE carriage', 'Post-operative 3GCR-E carriage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}]","[{'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0304320', 'cui_str': 'Third generation cephalosporin'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}]","[{'cui': 'C0006968', 'cui_str': 'Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0691421,CRE carriage was detected post-operatively in 1 patient (1.5%) in Group 2 versus 8 patients (14.3%) in Group 1 (RD:-12.8%; 95% CI:-22.4%- -3.1).,"[{'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Hoffman', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health; Infectious Disease Unit, Meir Medical Center.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lellouche', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nutman', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health; Sackler Faculty of Medicine, Tel Aviv University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Temkin', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Frenk', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Program, Geneva University Hospitals and Faculty of Medicine, WHO Collaborating Center.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Carevic', 'Affiliation': 'Department of Hospital Epidemiology, Clinical Center of Serbia.'}, {'ForeName': 'Shimrit', 'Initials': 'S', 'LastName': 'Cohen-Percia', 'Affiliation': 'National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Kariv', 'Affiliation': 'Department of Surgery, Tel-Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Noga', 'Initials': 'N', 'LastName': 'Fallach', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Klausner', 'Affiliation': 'Department of Surgery, Tel-Aviv Sourasky Medical Center, Israel.'}, {'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center; National Institute for Antibiotic Resistance and Infection Control, Israel Ministry of Health; Sackler Faculty of Medicine, Tel Aviv University. Electronic address: yehudac@tlvmc.gov.il.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2021.02.002']
1452,33588060,Combination of 5-Aminolevulinic acid photodynamic therapy and isotretinoin to treat moderate-to-severe acne.,"BACKGROUND


In China, photodynamic therapy(PDT) has been widely accepted in the treatment of acne. However, there are few studies on PDT combined with isotretinoin of moderate to severe acne.
AIMS


To evaluate the efficacy and safety of PDT combined with isotretinoin in the treatment of moderate to severe acne.
METHODS


70 cases of moderate and severe acne patients were randomly divided into PDT group and combination group. In combination group, patients were treated with PDT, once/2weeks, for 3 times; and oral isotretinoin, 10 mg twice a day for 3 months. The PDT group was treated with PDT alone. The skin lesions were counted before treatment and in the 4th, 6th, 8th, and 12th weeks to evaluate the clinical efficacy. Adverse reactions during the treatment were recorded. We monitored the liver function of the combination group once a month. The recurrence rate was recorded 6 months after treatment.
RESULTS


A total of 67 patients completed the study. The effective rates of combination group in the 4th, 6th, 8th, and 12th weeks of treatment were 28.6%, 71.4%, 91.4%, and 94.1%, respectively; the effective rates of PDT group in the 4th, 6th, 8th, and 12th weeks of treatment were 22.9%, 54.3%, 74.3%, and 78.8%, respectively; the effective rates of two groups were statistically significant in the 6th, 8th, and 12th weeks of treatment (P < 0.05). There was no significant difference in pain score between two groups during the photodynamic therapy(P＞0.05). Adverse reactions, such as erythema and pustule during photodynamic therapy in both groups were tolerable. The pigmentation subsided in about 3 months. The recurrence rate of combination group was significantly lower than that of PDT group(7% VS 24%,P＜0.05).
CONCLUSION


PDT combined with isotretinoin has higher effective rate and lower recurrence rate than single PDT, is a new choice for the treatment of moderate to severe acne.",2021,"The recurrence rate of combination group was significantly lower than that of PDT group(7% VS 24%,P＜0.05).
","['67 patients completed the study', 'moderate to severe acne', '70 cases of moderate and severe acne patients']","['PDT combined with isotretinoin', 'PDT group and combination group', '5-Aminolevulinic acid photodynamic therapy and isotretinoin', 'photodynamic therapy(PDT', 'PDT']","['liver function', 'pain score', 'Adverse reactions', 'recurrence rate', 'effective rates', 'effective rate and lower recurrence rate', 'efficacy and safety', 'Adverse reactions, such as erythema and pustule', 'clinical efficacy', 'skin lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}]",67.0,0.022169,"The recurrence rate of combination group was significantly lower than that of PDT group(7% VS 24%,P＜0.05).
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Dermato-venereology, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan, Shandong, 250033, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of ultrasound, the people's hospital of Zhangqiu area, Jinan, Shandong, 250200, China.""}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Department of Dermato-venereology, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan, Shandong, 250033, China.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Dermato-venereology, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan, Shandong, 250033, China.'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermato-venereology, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan, Shandong, 250033, China. Electronic address: cmzhang1878@163.com.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermato-venereology, The Second Hospital, Cheeloo college of Medicine, Shandong University, Jinan, Shandong, 250033, China. Electronic address: aliu133@163.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2021.102215']
1453,32696396,A Small-Scale Medication of Leflunomide as a Treatment of COVID-19 in an Open-Label Blank-Controlled Clinical Trial.,"We recently reported that inhibitors against human dihydroorotate dehydrogenase (DHODH) have broad-spectrum antiviral activities including their inhibitory efficacies on SARS-CoV-2 replication in infected cells. However, there are limited data from clinical studies to prove the application of DHODH inhibitors in Coronavirus disease 2019 (COVID-19) patients. In the present study, we evaluated Leflunomide, an approved DHODH inhibitor widely used as a modest immune regulator to treat autoimmune diseases, in treating COVID-19 disease with a small-scale of patients. Cases of 10 laboratory-confirmed COVID-19 patients of moderate type with obvious opacity in the lung were included. Five of the patients were treated with Leflunomide, and another five were treated as blank controls without a placebo. All the patients accepted standard supportive treatment for COVID-19. The patients given Leflunomide had a shorter viral shedding time (median of 5 days) than the controls (median of 11 days, P = 0.046). The patients given Leflunomide also showed a significant reduction in C-reactive protein levels, indicating that immunopathological inflammation was well controlled. No obvious adverse effects were observed in Leflunomide-treated patients, and they all discharged from the hospital faster than controls. This preliminary study on a small-scale compassionate use of Leflunomide provides clues for further understanding of Leflunomide as a potential antiviral drug against COVID-19.",2020,"The patients given Leflunomide had a shorter viral shedding time (median of 5 days) than the controls (median of 11 days, P = 0.046).",[],"['Leflunomide', 'placebo']","['shorter viral shedding time', 'obvious adverse effects', 'C-reactive protein levels']",[],"[{'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",,0.0481495,"The patients given Leflunomide had a shorter viral shedding time (median of 5 days) than the controls (median of 11 days, P = 0.046).","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China. huke-rmhospital@163.com.'}, {'ForeName': 'Mengmei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Xiaochen', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Shaolin', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.'}, {'ForeName': 'Honglin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Key Laboratory of New Drug Design, State Key Laboratory of Bioreactor Engineering, School of Pharmacy, East China University of Science and Technology, Shanghai, 200237, China. hlli@ecust.edu.cn.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Virology, College of Life Sciences, Wuhan University, Wuhan, 430072, China. xuke03@whu.edu.cn.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Lan', 'Affiliation': 'State Key Laboratory of Virology, College of Life Sciences, Wuhan University, Wuhan, 430072, China. klan@whu.edu.cn.'}]",Virologica Sinica,['10.1007/s12250-020-00258-7']
1454,33481257,Brain blood and cerebrospinal fluid flow dynamics during rhythmic handgrip exercise in young healthy men and women.,"KEY POINTS


The cerebral fluid response to exercise, including the arterial and venous cerebral blood flow (CBF) and cerebrospinal fluid (CSF), currently remains unknown. We used time-resolved phase-contrast magnetic resonance imaging to assess changes in CBF and CSF flow dynamics during moderate-intensity rhythmic handgrip (RHG) exercise in young healthy men and women. Our data demonstrated that RHG increases the cerebral arterial inflow and venous outflow while decreasing the pulsatile CSF flow during RHG. Furthermore, changes in blood stroke volume at the measured arteries, veins, and sinuses and CSF stroke volume at the cerebral aqueduct were positively correlated with each other during RHG. Male and female participants exhibited distinct blood pressure responses to RHG, but their cerebral fluid responses were similar. These results collectively suggest that RHG influences both CBF and CSF flow dynamics in a way that is consistent with the Monro-Kellie hypothesis to maintain intracranial volume-pressure homeostasis in young healthy adults.
ABSTRACT


Cerebral blood flow (CBF) increases during exercise, but its impact on cerebrospinal fluid (CSF) flow remains unknown. This study investigated CBF and CSF flow dynamics during moderate-intensity rhythmic handgrip (RHG) exercise in young healthy men and women. Twenty-six participants (12 women) underwent the RHG and resting control conditions in random order. Participants performed 3 sets of RHG, during which cine phase-contrast magnetic resonance imaging (PC-MRI) was performed to measure blood stroke volume (SV) and flow rate in the internal carotid (ICA) and vertebral (VA) arteries, the internal jugular vein (IJV), the superior sagittal (SSS) and straight sinuses (SRS), and CSF SV and flow rate in the cerebral aqueduct of Sylvius. Blood pressure, end-tidal CO 2  (EtCO 2  ), heart rate (HR), and respiratory rate were simultaneously measured during cine PC-MRI scans. Compared with control conditions, RHG showed significant elevations of HR, mean arterial pressure, and respiratory rate with a mild reduction of EtCO 2  (all P < 0.05). RHG decreased blood SV in the measured arteries, veins, and sinuses and CSF SV in the aqueduct (all P < 0.05). Conversely, RHG increased blood flow in the ICA, VA, and IJV (all P < 0.05). At the aqueduct, RHG decreased the absolute CSF flow rate (P = 0.0307), which was calculated as a sum of the caudal and cranial CSF flow rates. Change in the ICA SV was positively correlated with changes in the IJV, SSS, SRS, and aqueductal SV during RHG (all P < 0.05). These findings demonstrate a close coupling between the CBF and CSF flow dynamics during RHG in young healthy adults.",2021,"Conversely, RHG increased blood flow in the ICA, VA, and IJV (all P < 0.05).","['Male and female participants exhibited', 'young healthy men and women', 'young healthy adults', 'Twenty-six participants (12 women) underwent the']","['rhythmic handgrip exercise', 'RHG', 'CBF and CSF flow dynamics during moderate-intensity rhythmic handgrip (RHG) exercise', 'moderate-intensity rhythmic handgrip (RHG) exercise']","['distinct blood pressure responses', 'IJV, SSS, SRS, and aqueductal SV during RHG', 'CBF and CSF flow dynamics', 'arterial and venous cerebral blood flow (CBF) and cerebrospinal fluid (CSF', 'pulsatile CSF flow', 'blood stroke volume (SV) and flow rate in the internal carotid (ICA) and vertebral (VA) arteries, the internal jugular vein (IJV), the superior sagittal (SSS) and straight sinuses (SRS), and CSF SV and flow rate in the cerebral aqueduct of Sylvius', 'blood stroke volume at the measured arteries, veins, and sinuses and CSF stroke volume', 'Blood pressure, end-tidal CO 2  (EtCO 2  ), heart rate (HR), and respiratory rate', 'ICA SV', 'blood SV', 'elevations of HR, mean arterial pressure, and respiratory rate', 'blood flow', 'absolute CSF flow rate', 'cerebral arterial inflow and venous outflow']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0234557', 'cui_str': 'Cerebrospinal fluid circulation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0226862', 'cui_str': 'Structure of straight sinus'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0234557', 'cui_str': 'Cerebrospinal fluid circulation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0007769', 'cui_str': 'Structure of cerebral aqueduct'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",26.0,0.0264341,"Conversely, RHG increased blood flow in the ICA, VA, and IJV (all P < 0.05).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yamabe', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Fukuie', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology and Cognitive Imaging Research Center, Michigan State University, East Lansing, Michigan, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Texas, USA.'}, {'ForeName': 'Shigehiko', 'Initials': 'S', 'LastName': 'Ogoh', 'Affiliation': 'Department of Biomedical Engineering, Toyo University, Kawagoe-shi, Saitama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sugawara', 'Affiliation': 'Human Informatics and Interaction Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan.'}]",The Journal of physiology,['10.1113/JP281063']
1455,31233321,"The influence of experiences of stigma on recovery: Mediating roles of internalized stigma, self-esteem, and self-efficacy.","OBJECTIVE


Experiencing stigmatization regarding mental illness has harmful effects on recovery from serious mental illness (SMI). Stigma experiences can also lead to internalized stigma, the cognitive and emotional internalization of negative stereotypes, and application of those stereotypes to one's self. Internalized stigma may lead to additional harms, including decrements in self-esteem and self-efficacy. Therefore, this study examined the effects of stigmatization experiences on recovery-related outcomes through internalized stigma, self-esteem, and self-efficacy in a single comprehensive model.
METHODS


Adults with SMI (n = 516) completed standardized measures assessing the variables of interest during baseline assessments for 2 randomized controlled trials. In a secondary analysis of the trial data, separate serial mediation models were tested for recovery orientation, perceived quality of life, and social withdrawal as outcomes, with experiences of stigma as the predictor variable and internalized stigma, self-esteem, and self-efficacy as serial mediators in that order. Alternate order and parallel mediation models were also tested to evaluate directionality.
RESULTS


The serial mediation model was the best fit, although self-efficacy was not found to be a critical mediator. Experiences of stigma led to internalized stigma, which influenced self-esteem and recovery-related outcomes, consistent with the social-cognitive model of internalized stigma.
CONCLUSION


This indicates that internalized stigma is an essential target for reducing the negative impact of stigmatization on recovery. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The serial mediation model was the best fit, although self-efficacy was not found to be a critical mediator.",['Adults with SMI (n = 516'],[],"['internalized stigma, self-esteem, and self-efficacy', 'recovery orientation, perceived quality of life, and social withdrawal as outcomes, with experiences of stigma as the predictor variable and internalized stigma, self-esteem, and self-efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0429046,"The serial mediation model was the best fit, although self-efficacy was not found to be a critical mediator.","[{'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Jahn', 'Affiliation': 'Center for Acute Recovery Empowerment, Orlando VA Medical Center.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Leith', 'Affiliation': 'VA Maryland Health Care System.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5) Mental Illness Research, Education, and Clinical Center (MIRECC), U.S. Department of Veterans Affairs.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5) Mental Illness Research, Education, and Clinical Center (MIRECC), U.S. Department of Veterans Affairs.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drapalski', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5) Mental Illness Research, Education, and Clinical Center (MIRECC), U.S. Department of Veterans Affairs.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hack', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5) Mental Illness Research, Education, and Clinical Center (MIRECC), U.S. Department of Veterans Affairs.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lucksted', 'Affiliation': 'VA Capitol Healthcare Network (VISN 5) Mental Illness Research, Education, and Clinical Center (MIRECC), U.S. Department of Veterans Affairs.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000377']
1456,33567390,Descriptives and baseline ecological momentary assessed predictors of weight change over the course of psychological treatments for binge eating disorder.,"OBJECTIVE


The objectives were to examine individual variability in weight change across psychological treatments for binge-eating disorder (BED) and to examine baseline predictors (i.e., BED symptoms, affect, and appetite) of weight change using ecological momentary assessment (EMA).
METHOD


Adults with BED (N = 110) enrolled in a randomized clinical trial in which they received one of two psychological treatments for BED. At baseline, participants completed a 7-day EMA protocol measuring BED symptoms, affect, and appetite. Height and weight were measured at baseline, mid-treatment, end-of-treatment, and follow-up, and body mass index (BMI) was calculated.
RESULTS


On average, participants evidenced a 2% increase in BMI at end-of-treatment and a 1% increase between end-of-treatment and 6-month follow-up assessments. Although results showed that BMI increased over time, the quadratic term reflected a deceleration in this effect. There were interactions between positive affect and the linear trajectory across time predicting BMI, indicating that individuals reporting higher positive affect at baseline evidenced a flatter trajectory of weight gain. There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI. Individuals who reported greater overeating at baseline had higher BMI across time. However, the BMI of individuals with lower overeating increased linearly, and increases in BMI among those with average or high rates of overeating appeared to stabilize over time.
CONCLUSION


Despite the variability in weight change, baseline positive affect and overeating may be ecological targets for improving weight outcomes in psychological treatments for BED.",2021,There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI.,"['binge-eating disorder (BED', 'binge eating disorder', 'Adults with BED']",[],"['weight gain', 'Height and weight', 'BMI', '7-day EMA protocol measuring BED symptoms, affect, and appetite']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}]",110.0,0.0695477,There was a main effect of overeating as assessed by EMA and interactions between overeating and linear and quadratic trajectories across time predicting BMI.,"[{'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, United States of America. Electronic address: tylermas@usc.edu.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, CA, United States of America.'}, {'ForeName': 'Gail A', 'Initials': 'GA', 'LastName': 'Williams-Kerver', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, MN, United States of America.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Department of Biobehavioral Research, Sanford Health, Fargo, ND, United States of America; Department of Psychiatry and Behavioral Science, University of North Dakota School of Medicine and Health Sciences, Fargo, ND, United States of America.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, MN, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2021.110373']
1457,33576820,Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: The COVID A to Z Randomized Clinical Trial.,"Importance


There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression.
Objective


To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection.
Design, Setting, and Participants


This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020.
Intervention


Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care.
Outcomes


The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements.
Results


A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups.
Conclusions and Relevance


In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care.
Trial Registration


ClinicalTrials.gov Identifier: NCT04342728.",2021,"There was no significant difference in secondary outcomes among the treatment groups.
","['214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women', 'ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose', '214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida', 'Ambulatory Patients With SARS-CoV-2 Infection', 'April 27, 2020, to October 14, 2020', 'ambulatory patients with SARS-CoV-2 infection']","['usual care without supplementation', 'High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care', 'zinc gluconate', 'ascorbic acid', 'zinc gluconate, ascorbic acid', 'high-dose zinc and/or high-dose ascorbic acid']","['severity or duration of symptoms', 'days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements', 'number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom', 'duration of symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0149381', 'cui_str': 'Zinc Gluconate'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",214.0,0.248764,"There was no significant difference in secondary outcomes among the treatment groups.
","[{'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Divyang', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Bittel', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Qiuqing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': ""Il'Giovine"", 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'McWilliams', 'Affiliation': 'Department of Infectious Diseases, Cleveland Clinic Florida, Weston.'}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Milind Y', 'Initials': 'MY', 'LastName': 'Desai', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA network open,['10.1001/jamanetworkopen.2021.0369']
1458,33574070,Chest x-ray or CT for COVID-19 pneumonia? Comparative study in a simulated triage setting.,"INTRODUCTION


for the management of patients referred to respiratory triage during the early stages of the SARS-CoV-2 pandemic, either chest radiograph (CXR) or computed tomography (CT) were used as first-line diagnostic tools. The aim of this study was to compare the impact on triage, diagnosis and prognosis of patients with suspected COVID-19 when clinical decisions are derived from reconstructed CXR or from CT.
METHODS


we reconstructed CXR (r-CXR) from high-resolution CT (HRCT) scan. Five clinical observers independently reviewed clinical charts of 300 subjects with suspected COVID-19 pneumonia, integrated with either r-CXR or HRCT report in two consecutive blinded and randomised sessions: clinical decisions were recorded for each session. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and prognostic value were compared between r-CXR and HRCT. The best radiological integration was also examined to develop an optimised respiratory triage algorithm.
RESULTS


interobserver agreement was fair (Kendall's  W =0.365; p<0.001) by r-CXR-based protocol and good (Kendall's  W =0.654; p<0.001) by CT-based protocol. NPV assisted by r-CXR (31.4%) was lower than that of HRCT (77.9%). In case of indeterminate or typical radiological appearence for COVID-19 pneumonia, extent of disease on r-CXR or HRCT were the only two imaging variables that were similarly linked to mortality by adjusted multivariable models CONCLUSIONS: the present findings suggest that clinical triage is safely assisted by CXR. An integrated algorithm using first-line CXR and contingent use of HRCT can help optimise management and prognostication of COVID-19.",2021,interobserver agreement was fair (Kendall's  W =0.365; p<0.001) by r-CXR-based protocol and good (Kendall's  W =0.654; p<0.001) by CT-based protocol.,"['patients referred to respiratory triage during the early stages of the SARS-CoV-2 pandemic, either', 'patients with suspected COVID-19 when clinical decisions are derived from reconstructed CXR or from CT', '300 subjects with suspected COVID-19 pneumonia, integrated with either r-CXR or HRCT report']","['Chest x-ray or CT', 'chest radiograph (CXR) or computed tomography (CT', 'HRCT']","['Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and prognostic value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006888', 'cui_str': 'Christmas Island'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",300.0,0.0273358,interobserver agreement was fair (Kendall's  W =0.365; p<0.001) by r-CXR-based protocol and good (Kendall's  W =0.654; p<0.001) by CT-based protocol.,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sverzellati', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy nicola.sverzellati@unipr.it.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Ryerson', 'Affiliation': ""Department of Medicine, University of British Columbia and Centre for Heart Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Milanese', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Elisabetta A', 'Initials': 'EA', 'LastName': 'Renzoni', 'Affiliation': 'Interstitial Lung Disease Unit, Royal Brompton Hospital, Imperial College, London, UK.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Volpi', 'Affiliation': '1st Anesthesia and Intensive Care Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Spagnolo', 'Affiliation': 'Respiratory Disease Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padua, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'Center for Interstitial and rare Lung Diseases, Pneumology Department, Ruhrandklinik University Hospital, University of Duiburg-Essen, Essen, Germany.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Comelli', 'Affiliation': ""Unità Operativa Pronto Soccorso e Medicina d' Urgenza, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Affanni', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Veronesi', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Carmelinda', 'Initials': 'C', 'LastName': 'Manna', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ciuni', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Sartorio', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Tringali', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Silva', 'Affiliation': 'Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, University-Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Michieletti', 'Affiliation': 'Department of Radiological Functions, Radiology Unit, ""Guglielmo da Saliceto"" Hospital, Piacenza, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Colombi', 'Affiliation': 'Department of Radiological Functions, Radiology Unit, ""Guglielmo da Saliceto"" Hospital, Piacenza, Italy.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'Interstitial Lung Disease Unit, Royal Brompton Hospital, Imperial College, London, UK.'}]",The European respiratory journal,['10.1183/13993003.04188-2020']
1459,33580054,"Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study.","FLU-v, developed by PepTcell (SEEK), is a peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B. A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted. One hundred and fifty-three healthy individuals 18-55 years of age were randomized to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms. Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035). FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza.",2020,Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035).,['One hundred and fifty-three healthy individuals 18-55 years of age'],"['placebo', 'adjuvanted FLU-v or adjuvanted placebo', 'California/04/2009/H1N1 human influenza A challenge virus', 'FLU-v, a broad-spectrum influenza vaccine']",['develop MMID'],"[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",[],153.0,0.144139,Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035).,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD, UK.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Lopes', 'Affiliation': 'h-VIVO Services Ltd, London, UK.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': 'Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cleath', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Edwards', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Neitzey', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Gu', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jeffery K', 'Initials': 'JK', 'LastName': 'Taubenberger', 'Affiliation': 'Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK Central Point, 45 Beech Street, London, EC2Y 8AD, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20892, USA. memolim@niaid.nih.gov.'}]",NPJ vaccines,['10.1038/s41541-020-0174-9']
1460,33580046,Brief communication: immunogenicity of measles vaccine when co-administered with 10-valent pneumococcal conjugate vaccine.,"This brief communication describes the findings from a randomised controlled trial in Vietnam that co-administration of measles vaccine (MV) with 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix®, GSK) does not affect the immunogenicity of MV. These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.",2020,These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.,[],"['10-valent pneumococcal conjugate vaccine', 'measles vaccine (MV) with 10-valent pneumococcal conjugate vaccine (PCV10, Synflorix®, GSK']",['immunogenicity of MV'],[],"[{'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3252923', 'cui_str': 'synflorix'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.355424,These findings are most relevant for low- and middle-income countries (LMICs) in Asia considering PCV introduction.,"[{'ForeName': 'Zheng Quan', 'Initials': 'ZQ', 'LastName': 'Toh', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Temple', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Tran Ngoc', 'Initials': 'TN', 'LastName': 'Huu', 'Affiliation': 'Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vo Thi Trang', 'Initials': 'VTT', 'LastName': 'Dai', 'Affiliation': 'Microbiology and Immunology, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Trong', 'Initials': 'NT', 'LastName': 'Toan', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Doan Y', 'Initials': 'DY', 'LastName': 'Uyen', 'Affiliation': 'Department of Disease Control and Prevention, Pasteur Institute of Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Bright', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Lien Anh Ha', 'Initials': 'LAH', 'LastName': 'Do', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'E Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia.""}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Licciardi', 'Affiliation': ""New Vaccines, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, VIC, Australia. paul.licciardi@mcri.edu.au.""}]",NPJ vaccines,['10.1038/s41541-020-00225-z']
1461,33580033,One-year randomized trial comparing virtual reality-assisted therapy to cognitive-behavioral therapy for patients with treatment-resistant schizophrenia.,"The gold-standard cognitive-behavioral therapy (CBT) for psychosis offers at best modest effects. With advances in technology, virtual reality (VR) therapies for auditory verbal hallucinations (AVH), such as AVATAR therapy (AT) and VR-assisted therapy (VRT), are amid a new wave of relational approaches that may heighten effects. Prior trials have shown greater effects of these therapies on AVH up to a 24-week follow-up. However, no trial has compared them to a recommended active treatment with a 1-year follow-up. We performed a pilot randomized comparative trial evaluating the short- and long-term efficacy of VRT over CBT for patients with treatment-resistant schizophrenia. Patients were randomized to VRT (n = 37) or CBT (n = 37). Clinical assessments were administered before and after each intervention and at follow-up periods up to 12 months. Between and within-group changes in psychiatric symptoms were assessed using linear mixed-effects models. Short-term findings showed that both interventions produced significant improvements in AVH severity and depressive symptoms. Although results did not show a statistically significant superiority of VRT over CBT for AVH, VRT did achieve larger effects particularly on overall AVH (d = 1.080 for VRT and d = 0.555 for CBT). Furthermore, results suggested a superiority of VRT over CBT on affective symptoms. VRT also showed significant results on persecutory beliefs and quality of life. Effects were maintained up to the 1-year follow-up. VRT highlights the future of patient-tailored approaches that may show benefits over generic CBT for voices. A fully powered single-blind randomized controlled trial comparing VRT to CBT is underway.",2021,"Although results did not show a statistically significant superiority of VRT over CBT for AVH, VRT did achieve larger effects particularly on overall AVH (d = 1.080 for VRT and d = 0.555 for CBT).","['auditory verbal hallucinations (AVH', 'patients with treatment-resistant schizophrenia']","['CBT', 'technology, virtual reality (VR) therapies', 'gold-standard cognitive-behavioral therapy (CBT', 'VRT over CBT', 'VRT', 'VR-assisted therapy (VRT', 'virtual reality-assisted therapy to cognitive-behavioral therapy']","['psychiatric symptoms', 'persecutory beliefs and quality of life', 'AVH severity and depressive symptoms', 'overall AVH']","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0430904,"Although results did not show a statistically significant superiority of VRT over CBT for AVH, VRT did achieve larger effects particularly on overall AVH (d = 1.080 for VRT and d = 0.555 for CBT).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dellazizzo', 'Affiliation': 'Research center of the Institut Universitaire en Santé Mentale de Montréal, Montreal, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Potvin', 'Affiliation': 'Research center of the Institut Universitaire en Santé Mentale de Montréal, Montreal, Canada.'}, {'ForeName': 'Kingsada', 'Initials': 'K', 'LastName': 'Phraxayavong', 'Affiliation': 'Services et Recherches Psychiatriques AD, Montreal, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Dumais', 'Affiliation': 'Research center of the Institut Universitaire en Santé Mentale de Montréal, Montreal, Canada. alexandre.dumais@umontreal.ca.'}]",NPJ schizophrenia,['10.1038/s41537-021-00139-2']
1462,33580032,"Intermittent theta burst stimulation for negative symptoms of schizophrenia-A double-blind, sham-controlled pilot study.","Optimal noninvasive brain stimulation parameters for the treatment of negative symptoms of schizophrenia remain unclear. Here, we aimed to investigate the clinical and biological effects of intermittent theta burst transcranial magnetic stimulation (iTBS) in patients with treatment-resistant negative symptoms of schizophrenia (NCT00875498). In a randomized sham-controlled 2-arm study, 22 patients with schizophrenia and treatment-resistant negative symptoms received 20 sessions of either active (n = 12) or sham (n = 10) iTBS. Sessions were delivered twice a day on 10 consecutive working days. Negative symptom severity was assessed 5 times using the Scale for the Assessment of Negative Symptoms (SANS): before iTBS, after iTBS, and 1, 3, and 6 months after iTBS. As a secondary objective, we explored the acute effects of iTBS on functional connectivity of the left dorsolateral prefrontal cortex (DLPFC) using seed-based resting-state functional connectivity MRI (rsFC fMRI) images acquired before and after iTBS. Active iTBS over the left DLPFC significantly decreased negative symptoms severity compared to sham iTBS (F (3,60)  = 3.321, p = 0.026). Post hoc analyses revealed that the difference between groups was significant 6 months after the end of stimulation sessions. Neuroimaging revealed an increase in rsFC between the left DLPFC and a brain region encompassing the right lateral occipital cortex and right angular gyrus and a right midbrain region that may encompass dopamine neuron cell bodies. Thus, iTBS over the left DLPFC can alleviate negative symptoms of schizophrenia. The effect might be driven by significant modulation of dopamine transmission.",2021,"Active iTBS over the left DLPFC significantly decreased negative symptoms severity compared to sham iTBS (F (3,60)  = 3.321, p = 0.026).","['22 patients with schizophrenia and treatment-resistant negative symptoms received 20 sessions of either', 'patients with treatment-resistant negative symptoms of schizophrenia (NCT00875498']","['intermittent theta burst transcranial magnetic stimulation (iTBS', 'Intermittent theta burst stimulation', 'active (n\u2009=\u200912) or sham (n\u2009=\u200910) iTBS', 'seed-based resting-state functional connectivity MRI (rsFC fMRI', 'iTBS']","['Negative symptom severity', 'negative symptoms severity', 'rsFC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",22.0,0.0981003,"Active iTBS over the left DLPFC significantly decreased negative symptoms severity compared to sham iTBS (F (3,60)  = 3.321, p = 0.026).","[{'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Bation', 'Affiliation': 'INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, Lyon, France.'}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Magnin', 'Affiliation': 'INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Poulet', 'Affiliation': 'INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, Lyon, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Mondino', 'Affiliation': 'INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Brunelin', 'Affiliation': 'INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, PSYR2 Team, Lyon, France. jerome.brunelin@ch-le-vinatier.fr.'}]",NPJ schizophrenia,['10.1038/s41537-021-00138-3']
1463,33579966,A randomized intervention involving family to improve communication in breast cancer care.,"We examined the effects of a communication intervention to engage family care partners on patient portal (MyChart) use, illness understanding, satisfaction with cancer care, and symptoms of anxiety in a single-blind randomized trial of patients in treatment for breast cancer. Patient-family dyads were recruited and randomly assigned a self-administered checklist to clarify the care partner role, establish a shared visit agenda, and facilitate MyChart access (n = 63) or usual care (n = 55). Interviews administered at baseline, 3, 9 (primary endpoint), and 12 months assessed anxiety (GAD-2), mean FAMCARE satisfaction, and complete illness understanding (4 of 4 items correct). Time-stamped electronic interactions measured MyChart use. By 9 months, more intervention than control care partners registered for MyChart (77.8 % vs 1.8%; p < 0.001) and logged into the patient's account (61.2% vs 0% of those registered; p < 0.001), but few sent messages to clinicians (6.1% vs 0%; p = 0.247). More intervention than control patients viewed clinical notes (60.3% vs 32.7%; p = 0.003). No pre-post group differences in patient or care partner symptoms of anxiety, satisfaction, or complete illness understanding were found. Intervention patients whose care partners logged into MyChart were more likely to have complete illness understanding at 9 months (changed 70.0% to 80.0% vs 69.7% to 54.6%; p = 0.03); symptoms of anxiety were numerically lower (16.7% to 6.7% vs 15.2% to 15.2%; p = 0.24) and satisfaction numerically higher (15.8-16.2 vs 18.0-17.4; p = 0.25). A brief, scalable communication intervention led to greater care partner MyChart use and increased illness understanding among patients with more engaged care partners (NCT03283553).",2021,"No pre-post group differences in patient or care partner symptoms of anxiety, satisfaction, or complete illness understanding were found.","['patients in treatment for breast cancer', 'Patient-family dyads', 'patients with more engaged care partners (NCT03283553']","['self-administered checklist to clarify the care partner role, establish a shared visit agenda, and facilitate MyChart access (n\u2009=\u200963) or usual care', 'scalable communication intervention', 'communication intervention']","['patient portal (MyChart) use, illness understanding, satisfaction with cancer care, and symptoms of anxiety', 'symptoms of anxiety', 'clinical notes', 'anxiety (GAD-2), mean FAMCARE satisfaction, and complete illness understanding (4 of 4 items correct', 'complete illness understanding', 'patient or care partner symptoms of anxiety, satisfaction, or complete illness understanding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}]","[{'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C5197676', 'cui_str': 'GAD-2'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",,0.0286174,"No pre-post group differences in patient or care partner symptoms of anxiety, satisfaction, or complete illness understanding were found.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'Roger C. Lipitz Center for Integrated Health Care, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. jwolff2@jhu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Aufill', 'Affiliation': 'Roger C. Lipitz Center for Integrated Health Care, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Echavarria', 'Affiliation': 'Roger C. Lipitz Center for Integrated Health Care, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Blackford', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Roisin M', 'Initials': 'RM', 'LastName': 'Connolly', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Fetting', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Jelovac', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Papathakis', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Riley', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vered', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Zafman', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Thorner', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Howard P', 'Initials': 'HP', 'LastName': 'Levy', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Guo', 'Affiliation': 'Roger C. Lipitz Center for Integrated Health Care, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Sydney M', 'Initials': 'SM', 'LastName': 'Dy', 'Affiliation': 'Roger C. Lipitz Center for Integrated Health Care, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, MD, USA. awolff@jhmi.edu.'}]",NPJ breast cancer,['10.1038/s41523-021-00217-9']
1464,33579199,The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial.,"BACKGROUND


Rebound pain after a single-shot nerve block challenges the real benefit of this technique. We aimed to investigate whether perineural dexamethasone addition decreased the incidence of rebound pain after a single-shot nerve block.
METHODS


We randomly allocated 132 patients scheduled for open reduction internal fixation of an upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups. Patients in the dexamethasone group received nerve block with 0.375% ropivacaine and 8 mg dexamethasone, while those in the control group received ropivacaine only. Sixty-three patients in the dexamethasone group and 60 patients in the control group were analyzed for the incidence of rebound pain 48 h after block administration, which was the primary outcome. The secondary outcomes included the highest self-reported numeric rating scale (NRS) pain score, and NRS at 8, 12, 24, and 48 h after the block, sufentanil consumption, sleep quality on the night of surgery, patient satisfaction with the pain therapy, blood glucose at 6 h after the block, pain and paresthesia at 30 days after surgery.
RESULTS


The incidence of rebound pain was significantly lower in the dexamethasone group (7 [11.1%] of 63 patients) than in the control group (28 [48.8%] of 60 patients [RR = 0.238, 95% CI (0.113-0.504), p = 0.001]. Dexamethasone decreased opioid consumption in 24 h after surgery (p < 0.001) and improved the sleep quality score on the night of surgery (p = 0.01) and satisfaction with pain therapy (p = 0.001). Multivariate logistic regression analysis showed that only group allocation was associated with the occurrence of rebound pain [OR = 0.062, 95% CI (0.015-0.256)]. Patients in the dexamethasone group reported later onset pain (19.7 ± 6.6 h vs 14.7 ± 4.8 h since block administration, mean ± SD, p < 0.001) and lower peak NRS scores [5 (3, 6) vs 8 (5, 9), median (IQR), p < 0.001] than those in the control group.
CONCLUSIONS


The perineural administration of 8 mg dexamethasone reduces rebound pain after a single-shot nerve block in patients receiving ORIF for an upper limb fracture.
TRIAL REGISTRATION


This study was retrospectively registered in the Chinese Clinical Trial Registry ( ChiCTR-IPR-17011365 ) on May 11th, 2017.",2021,Dexamethasone decreased opioid consumption in 24 h after surgery (p < 0.001) and improved the sleep quality score on the night of surgery (p = 0.01) and satisfaction with pain therapy (p = 0.001).,"['single-injection nerve block', 'patients receiving ORIF for an upper limb fracture', '132 patients scheduled for']","['perineural dexamethasone', 'nerve block with 0.375% ropivacaine', 'open reduction internal fixation of an upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups', 'ropivacaine', 'Dexamethasone', 'dexamethasone']","['opioid consumption', 'incidence of rebound pain', 'later onset pain', 'highest self-reported numeric rating scale (NRS) pain score, and NRS at 8, 12, 24, and 48\u2009h after the block, sufentanil consumption, sleep quality on the night of surgery, patient satisfaction with the pain therapy, blood glucose at 6\u2009h after the block, pain and paresthesia', 'peak NRS scores', 'sleep quality score', 'rebound pain', 'occurrence of rebound pain', 'satisfaction with pain therapy']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0196694', 'cui_str': 'Nerve injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178316', 'cui_str': 'Fracture of upper limb'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C1297885', 'cui_str': 'Open reduction with internal fixation'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0016659', 'cui_str': 'Fracture, closed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",132.0,0.289474,Dexamethasone decreased opioid consumption in 24 h after surgery (p < 0.001) and improved the sleep quality score on the night of surgery (p = 0.01) and satisfaction with pain therapy (p = 0.001).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuncen', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhanggang', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cang', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China. zhang.xiaoguang@zs-hospital.sh.cn.'}]",BMC anesthesiology,['10.1186/s12871-021-01267-z']
1465,33579050,Nutritional Intervention Contributes to the Improvement of Symptoms Related to Quality of Life in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial.,"During breast cancer treatment, worsening quality of life (QoL) and the presence of toxicities are common, but healthy eating practices are associated with better clinical results. Thus, this study aims to evaluate the effect of a nutritional intervention on QoL and on gastrointestinal and hematological toxicities resulting from chemotherapy in women with breast cancer. A randomized clinical trial was performed at the beginning of neoadjuvant chemotherapy treatment for women with breast cancer. All participants received nutritional advice on healthy eating practices, but only the intervention group (IG) received an individualized diet plan. The study enrolled 34 women, 19 in the IG and 15 in the control group (CG). During the study, the CG significantly presented a reduction (from 21.6 ± 5.9 kg to 18.8 ± 4.0 kg,  p  = 0.009) in handgrip strength (HGS), while the IG did not present changes in this variable. Regarding QoL, the IG preserved the role function during treatment and presented better results for nausea/vomiting and loss of appetite compared to the CG. In gastrointestinal and hematological toxicities, the IG had lower frequencies of leukopenia and abdominal pain. The nutritional intervention preserved the role function of QoL and HGS, reduced the occurrence of nausea/vomiting, loss of appetite and the frequency of leukopenia and abdominal pain.",2021,"Regarding QoL, the IG preserved the role function during treatment and presented better results for nausea/vomiting and loss of appetite compared to the CG.","['Breast Cancer Patients', '34 women, 19 in the IG and 15 in the control group (CG', 'women with breast cancer']","['nutritional intervention', 'Neoadjuvant Chemotherapy', 'individualized diet plan', 'Nutritional Intervention', 'nutritional advice']","['nausea/vomiting and loss of appetite', 'leukopenia and abdominal pain', 'gastrointestinal and hematological toxicities', 'nausea/vomiting, loss of appetite and the frequency of leukopenia and abdominal pain', 'worsening quality of life (QoL', 'handgrip strength (HGS', 'QoL and on gastrointestinal and hematological toxicities']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1568891', 'cui_str': 'HGS protein, human'}]",34.0,0.0220174,"Regarding QoL, the IG preserved the role function during treatment and presented better results for nausea/vomiting and loss of appetite compared to the CG.","[{'ForeName': 'Ana Priscilla Silva de', 'Initials': 'APS', 'LastName': 'Souza', 'Affiliation': 'Postgraduate Program in Nutrition, Health Sciences Center, Federal University of Rio Grande do Norte, Natal 59078-970, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Luciana Câmara da', 'Initials': 'LCD', 'LastName': 'Silva', 'Affiliation': 'Liga Norteriograndense Contra o Câncer, Natal 59075-740, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': 'Postgraduate Program in Nutrition, Health Sciences Center, Federal University of Rio Grande do Norte, Natal 59078-970, Rio Grande do Norte, Brazil.'}]",Nutrients,['10.3390/nu13020589']
1466,33579045,Preventing Myocardial Injury Following Non-Cardiac Surgery: A Potential Role for Preoperative Antioxidant Therapy with Ubiquinone.,"Over 240 million non-cardiac operations occur each year and are associated with a 15-20% incidence of adverse perioperative cardiovascular events. Unfortunately, preoperative therapies that have been useful for chronic ischemic heart diseases, such as coronary artery revascularization, antiplatelet agents, and beta-blockers have failed to improve outcomes. In a pre-clinical swine model of ischemic heart disease, we showed that daily administration of ubiquinone (coenzyme Q 10 , CoQ 10 ) enhances the antioxidant status of mitochondria within chronically ischemic heart tissue, potentially via a PGC1α-dependent mechanism. In a randomized controlled trial, among high-risk patients undergoing elective vascular surgery, we showed that NT Pro-BNP levels are an important means of risk-stratification during the perioperative period and can be lowered with administration of CoQ 10  (400 mg/day) for 3 days prior to surgery. The review provides background information for the role of oxidant stress and inflammation during high-risk operations and the potential novel application of ubiquinone as a preoperative antioxidant therapy that might reduce perioperative adverse cardiovascular outcomes.",2021,Over 240 million non-cardiac operations occur each year and are associated with a 15-20% incidence of adverse perioperative cardiovascular events.,"['Non-Cardiac Surgery', 'high-risk patients undergoing elective vascular surgery']",[],"['adverse perioperative cardiovascular events', 'NT Pro-BNP levels', 'Myocardial Injury']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]",[],"[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",,0.0759113,Over 240 million non-cardiac operations occur each year and are associated with a 15-20% incidence of adverse perioperative cardiovascular events.,"[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Virginia Commonwealth University Medical Center, Richmond, VA 23219, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': 'Cardiology-Cardiac Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hocum-Stone', 'Affiliation': 'Cardiology-Cardiac Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lesnefsky', 'Affiliation': 'Virginia Commonwealth University Medical Center, Richmond, VA 23219, USA.'}, {'ForeName': 'Rosemary F', 'Initials': 'RF', 'LastName': 'Kelly', 'Affiliation': 'Cardiology-Cardiac Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'McFalls', 'Affiliation': 'Cardiology-Cardiac Surgery, University of Minnesota, Minneapolis, MN 55455, USA.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox10020276']
1467,33578513,Integrated cognitive behavioral therapy for chronic pain: An open-labeled prospective single-arm trial.,"BACKGROUND


We aimed to examine the feasibility of our newly-developed, integrated, and high-intensity individual cognitive behavioral therapy (CBT) protocol for treatment-resistant chronic pain.
METHODS


We conducted an open-labeled prospective single-arm trial for patients aged 18 years and above, suffering from chronic pain, and diagnosed with somatic symptom disorder with predominant pain. We provided 16 weekly sessions of CBT, each lasting for 50 minutes, which included 4 new strategies: attention shift, memory work, mental practice, and video feedback. For comparison, the study had a pre-test post-test design. The primary outcome was the change from baseline (week 1) to 16, as indicated by the Numerical Rating Scale and Pain Catastrophizing Scale. In addition, we evaluated depression, anxiety, disability, and quality of life as secondary outcomes.
RESULTS


Sixteen patients with chronic pain underwent our CBT program. Though there was no reduction in pain intensity, catastrophic cognition showed statistically significant improvement with a large effect size. Depression, anxiety, and disability demonstrated statistically significant improvements, with small to moderate effect sizes. No adverse events were reported.
CONCLUSION


Our newly integrated CBT program for chronic pain may improve catastrophic cognition, depression, anxiety, and disability. Large-scale randomized controlled studies are necessary to investigate the program's effectiveness in the future.",2021,"No adverse events were reported.
","['chronic pain', 'patients aged 18 years and above, suffering from chronic pain, and diagnosed with somatic symptom disorder with predominant pain', 'Sixteen patients with chronic pain underwent our CBT program']","['Integrated cognitive behavioral therapy', 'cognitive behavioral therapy (CBT) protocol']","['depression, anxiety, disability, and quality of life as secondary outcomes', 'Numerical Rating Scale and Pain Catastrophizing Scale', 'Depression, anxiety, and disability', 'pain intensity, catastrophic cognition', 'adverse events', 'catastrophic cognition, depression, anxiety, and disability']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",16.0,0.0770307,"No adverse events were reported.
","[{'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Taguchi', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Numata', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Takanashi', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Takemura', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo.'}, {'ForeName': 'Tokiko', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Research Center for Child Mental Development, Chiba University, Chiba.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Kutsuzawa', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Health Care Management Center, Chiba University Hospital.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cognitive Behavioral Physiology, Chiba University Graduate School of Medicine.'}]",Medicine,['10.1097/MD.0000000000023859']
1468,33578359,Short and long versions of a 12-week netball specific neuromuscular warm-up improves landing technique in youth netballers.,"OBJECTIVE


To investigate the efficacy of two 'NetballSmart', netball specific warm-ups in improving landing technique measures in New Zealand secondary school netball players.
DESIGN


Multi-site cluster experimental trial.
PARTICIPANTS


77 youth participants, mean ± SD age = 15.8 ± 0.9 were recruited from secondary school netball teams.
SETTING


12 teams from 6 schools performed either the NetballSmart Dynamic Warm-up (NSDW) (n = 37); or Power warm-up (PWU) (n = 40), three times a week for 12 weeks. All players within a school (2 teams) were assigned the same warm-up, avoiding treatment contamination.
MAIN OUTCOME MEASURES


A series of unilateral and bilateral drop vertical jumps on to a portable force plate were completed by all participants. Measures included peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings. Paired t-tests were used to assess mean differences pre and post the warm-up. Generalised linear mixed effects models were developed to evaluate the effects between the NSDW and PWU groups.
RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = -0.6 to -1.1; FPPA = 0.8 to 1.2; LESS = -1.6 to-3.2; p < 0.05). Results of mixed effects models revealed that there was only a significantly greater improvement in LESS for the PWU group (β = -0.30, p = 0.001).
CONCLUSION


Results show both warm-ups can improve landing technique measures in youth secondary school netball players. It is recommended that coaches should consider implementing one of the two warm-ups in their netball programmes. Their choice of warm-up will likely be dependent on their environment and time demands.",2021,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","['12 teams from 6 schools performed either the', 'All players within a school (2 teams', 'youth secondary school netball players', '77 youth participants, mean\xa0±', 'New Zealand secondary school netball players', 'SD age\xa0', '15.8\xa0±\xa00.9 were recruited from secondary school netball teams', 'youth netballers']","[""two 'NetballSmart', netball specific warm-ups"", 'NetballSmart Dynamic Warm-up (NSDW) (n\xa0=\xa037); or Power warm-up (PWU']","['LESS', 'landing technique measures', 'peak vertical ground reaction force (GRF) for single-leg and bilateral landings; frontal plane projection angle (FPPA) for right and left single-leg landings and Landing error scoring system (LESS) for bilateral landings', 'landing technique outcome measures']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0840974', 'cui_str': 'Netball'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",77.0,0.0207781,"RESULTS


Significant improvements were found in all the landing technique outcome measures for both warm-up groups (ES Range- GRF = ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Belcher', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand; Netball New Zealand, Auckland, New Zealand. Electronic address: Suzanne.belcher@netballnorthern.co.nz.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whatman', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Brughelli', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borotkanics', 'Affiliation': 'Sports Performance Research Institute New Zealand, School of Sport and Recreation, Faculty of Health and Environmental Sciences, Auckland University of Technology, New Zealand.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2021.01.016']
1469,33578349,Not all types of meditation are the same: Mediators of change in mindfulness and compassion meditation interventions.,"BACKGROUND


The general aim of the study was to examine the relative effectiveness and mediators of change in standardized mindfulness and compassion interventions.
METHODS


A sample of 431 participants enrolled in a Mindfulness-Based Stress Reduction program (MBSR = 277) and a Compassion Cultivation Training (CCT = 154). The assessment before and after the program included a set of outcomes and mediators measures. A three-step data analysis plan was followed: ANCOVAs, Reliable Change Index, and mediations (simple and multiple).
RESULTS


Both interventions yielded increased mindfulness, decentering, body awareness, and self-compassion. Yet, present-moment awareness improvements (i.e., decentering, and body awareness) were significantly larger in the MBSR than in CCT, whereas socio-emotional changes (i.e., common humanity and empathic concern) were larger in the CCT than in MBSR. The magnitude of effect sizes ranged from medium to large. Furthermore, both mindfulness and compassion interventions yielded similar changes in psychological distress (i.e., stress, anxiety, and depression), maladaptive cognitive processes (i.e., rumination and thought suppression), and well-being. The mediation models showed that although the MBSR program seemingly relies on changes in present-moment awareness mechanisms (i.e., decentering and body awareness) to reduce psychological distress and to improve well-being, the CCT program seemingly achieves the same positive outcomes through changes in socio-emotional mechanisms (i.e., common-humanity and empathy concern).
LIMITATIONS


Due to our naturalistic design in real-world community setting, it was infeasible to randomly assign participants to conditions.
CONCLUSIONS


Our results suggest that mindfulness and compassion programs operate through different pathways to reduce psychological distress and to promote well-being.",2021,"Furthermore, both mindfulness and compassion interventions yielded similar changes in psychological distress (i.e., stress, anxiety, and depression), maladaptive cognitive processes (i.e., rumination and thought suppression), and well-being.",['431 participants enrolled in a'],['Mindfulness-Based Stress Reduction program (MBSR\xa0=\xa0277) and a Compassion Cultivation Training (CCT\xa0=\xa0154'],"['psychological distress (i.e., stress, anxiety, and depression), maladaptive cognitive processes (i.e., rumination and thought suppression), and well-being', 'socio-emotional changes', 'mindfulness, decentering, body awareness, and self-compassion', 'psychological distress', 'ANCOVAs, Reliable Change Index, and mediations (simple and multiple']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",431.0,0.0179399,"Furthermore, both mindfulness and compassion interventions yielded similar changes in psychological distress (i.e., stress, anxiety, and depression), maladaptive cognitive processes (i.e., rumination and thought suppression), and well-being.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roca', 'Affiliation': 'School of Psychology, Complutense University of Madrid, Spain. Electronic address: pabloroc@ucm.es.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Vazquez', 'Affiliation': 'School of Psychology, Complutense University of Madrid, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Diez', 'Affiliation': 'Nirakara Lab, Complutense University of Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Brito-Pons', 'Affiliation': 'Nirakara Lab, Complutense University of Madrid, Spain.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McNally', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2021.01.070']
1470,33578328,Efficacy of a new dispatcher-assisted cardiopulmonary resuscitation protocol with audio call-to-video call transition.,"BACKGROUND


Video call based dispatcher-assisted cardiopulmonary resuscitation (V-DACPR) has been suggested to improve the quality of bystander cardiopulmonary resuscitation. In the current system, dispatchers must convert the audio calls to video calls to provide V-DACPR. We aimed to develop new audio call-to-video call transition protocols and test its efficacy and safety compared to conventional DACPR(C-DACPR).
METHODS


This was a randomized controlled simulation trial that compared the quality of bystander chest compression that was performed under three different DACPR protocols: C-DACPR, V-DACPR with rapid transition, and V-DACPR with delayed transition. Adult volunteers excluding healthcare providers were recruited for the trial. The primary outcome of the study was the mean proportion of adequate hand positioning during chest compression.
RESULTS


Simulation results of 131 volunteers were analyzed. The mean proportion of adequate hand positioning was highest in V-DACPR with rapid transition (V-DACPR with rapid transition vs. C-DACPR: 92.7% vs. 82.4%, p = 0.03). The mean chest compression depth was deeper in both V-DACPR groups than in the C-DACPR group (V-DACPR with rapid transition vs. C-DACPR: 40.7 mm vs. 35.9 mm, p = 0.01, V-DACPR with delayed transition vs. C- DACPR: 40.9 mm vs. 35.9 mm, p = 0.01). Improvement in the proportion of adequate hand positioning was observed in the V-DACPR groups (r = 0.25, p < 0.01 for rapid transition and r = 0.19, p < 0.01 for delayed transition).
CONCLUSION


Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.",2021,Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.,"['131 volunteers were analyzed', 'Adult volunteers excluding healthcare providers']","['Video call based dispatcher-assisted cardiopulmonary resuscitation (V-DACPR', 'DACPR', 'new dispatcher-assisted cardiopulmonary resuscitation protocol with audio call-to-video call transition', 'conventional DACPR(C-DACPR']","['quality chest compression', 'mean proportion of adequate hand positioning', 'compression depth', 'proportion of adequate hand positioning', 'mean chest compression depth', 'mean proportion of adequate hand positioning during chest compression']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",131.0,0.044295,Participants in the V-DACPR groups performed higher quality chest compression with higher appropriate hand positioning and deeper compression depth compared to the C-DACPR group.,"[{'ForeName': 'Stephen Gyung Won', 'Initials': 'SGW', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: leestephengyungwon@gmail.com.'}, {'ForeName': 'Tae Han', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: adoong01@snu.ac.kr.'}, {'ForeName': 'Hee Soon', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'EMS Situation Management Center, Seoul Emergency Operation Center, Seoul Metropolitan Fire & Disaster Headquarters, Republic of Korea. Electronic address: namsan1004@seoul.go.kr.'}, {'ForeName': 'Sang Do', 'Initials': 'SD', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: sdshin@snu.ac.kr.'}, {'ForeName': 'Kyoung Jun', 'Initials': 'KJ', 'LastName': 'Song', 'Affiliation': 'Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: skciva@gmail.com.'}, {'ForeName': 'Ki Jeong', 'Initials': 'KJ', 'LastName': 'Hong', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: emkjhong@gmail.com.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul, Korea; Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute. Electronic address: 83191@snuh.org.'}, {'ForeName': 'Yong Joo', 'Initials': 'YJ', 'LastName': 'Park', 'Affiliation': 'Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute; National EMS Control Center, National Fire Agency, Sejong, Korea. Electronic address: parkyongjoo@gmail.com.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2021.01.049']
1471,33577181,Dye-Based Chromoendoscopy in Patients With Lynch Syndrome: An Individual Patient Data Meta-Analysis of Randomized Trials.,"INTRODUCTION


The additional diagnostic value of dye-based chromoendosocpy (CE) for surveillance of patients with Lynch syndrome is subject of debate.
METHODS


To clarify this debate, we performed an individual patient data meta-analysis of randomized studies that compared CE with WLE for the detection of adenomas in patients with Lynch syndrome.
RESULTS


Three randomized studies comprising 533 patients were included. The adenoma detection rate was 74/265 (28%) in patients randomized to WLE compared with 83/266 (31%) in patients randomized to CE (odds ratio 1.17; 95% confidence interval 0.81-1.70).
DISCUSSION


Based on low-quality evidence, CE showed no apparent increase in adenoma detection compared to WLE during surveillance of patients with Lynch syndrome.",2021,"The adenoma detection rate was 74/265 (28%) in patients randomized to WLE compared with 83/266 (31%) in patients randomized to CE (odds ratio 1.17; 95% confidence interval 0.81-1.70).
","['533 patients were included', 'patients with Lynch syndrome', 'Patients With Lynch Syndrome']","['Dye-Based Chromoendoscopy', 'CE with WLE', 'dye-based chromoendosocpy (CE', 'WLE']","['adenoma detection', 'adenoma detection rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}]","[{'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",533.0,0.0867166,"The adenoma detection rate was 74/265 (28%) in patients randomized to WLE compared with 83/266 (31%) in patients randomized to CE (odds ratio 1.17; 95% confidence interval 0.81-1.70).
","[{'ForeName': 'Britt B S L', 'Initials': 'BBSL', 'LastName': 'Houwen', 'Affiliation': ""Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam Cancer Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, University of Bonn, Bonn, Germany; National Center for Hereditary Tumor Syndromes, University Hospital Bonn, Bonn, Germany; Department of Hematology and Oncology, Klinikum Coburg, Coburg, Germany; Department of Gastroenterology, Hospital Clinic of Barcelona, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universitat de Barcelona, Barcelona, Spain; Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA; Division of Cancer Genetics and Prevention, Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA; Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Center, Radboud University of Nijmegen, Nijmegen, the Netherlands.""}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mostafavi', 'Affiliation': ''}, {'ForeName': 'Jasper L A', 'Initials': 'JLA', 'LastName': 'Vleugels', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hüneburg', 'Affiliation': ''}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Lamberti', 'Affiliation': ''}, {'ForeName': 'Liseth', 'Initials': 'L', 'LastName': 'Rivero-Sánchez', 'Affiliation': ''}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Pellisé', 'Affiliation': ''}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Stoffel', 'Affiliation': ''}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Syngal', 'Affiliation': ''}, {'ForeName': 'Jasmijn F', 'Initials': 'JF', 'LastName': 'Haanstra', 'Affiliation': ''}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Koornstra', 'Affiliation': ''}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': ''}, {'ForeName': 'Yark', 'Initials': 'Y', 'LastName': 'Hazewinkel', 'Affiliation': ''}]",The American journal of gastroenterology,['10.14309/ajg.0000000000001138']
1472,33573693,Utility of self-rated adherence for monitoring dietary and physical activity compliance and assessment of participant feedback of the Healthy Diet and Lifestyle Study pilot.,"BACKGROUND


We examined the utility of self-rated adherence to dietary and physical activity (PA) prescriptions as a method to monitor intervention compliance and facilitate goal setting during the Healthy Diet and Lifestyle Study (HDLS). In addition, we assessed participants' feedback of HDLS. HDLS is a randomized pilot intervention that compared the effect of intermittent energy restriction combined with a Mediterranean diet (IER + MED) to a Dietary Approaches to Stop Hypertension (DASH) diet, with matching PA regimens, for reducing visceral adipose tissue area (VAT).
METHODS


Analyses included the 59 (98%) participants who completed at least 1 week of HDLS. Dietary and PA adherence scores were collected 8 times across 12 weeks, using a 0-10 scale (0 = not at all, 4 = somewhat, and 10 = following the plan very well). Adherence scores for each participant were averaged and assigned to high and low adherence categories using the group median (7.3 for diet, 7.1 for PA). Mean changes in VAT and weight from baseline to 12 weeks are reported by adherence level, overall and by randomization arm. Participants' feedback at completion and 6 months post-intervention were examined.
RESULTS


Mean ± SE, dietary adherence was 6.0 ± 0.2 and 8.2 ± 0.1, for the low and high adherence groups, respectively. For PA adherence, mean scores were 5.9 ± 0.2 and 8.5 ± 0.2, respectively. Compared to participants with low dietary adherence, those with high adherence lost significantly more VAT (22.9 ± 3.7 cm 2  vs. 11.7 ± 3.9 cm 2  [95% CI, - 22.1 to - 0.3]) and weight at week 12 (5.4 ± 0.8 kg vs. 3.5 ± 0.6 kg [95% CI, - 3.8 to - 0.0]). For PA, compared to participants with low adherence, those with high adherence lost significantly more VAT (22.3 ± 3.7 cm 2  vs. 11.6 ± 3.6 cm 2  [95% CI, - 20.7 to - 0.8]). Participants' qualitative feedback of HDLS was positive and the most common response, on how to improve the study, was to provide cooking classes.
CONCLUSIONS


Results support the use of self-rated adherence as an effective method to monitor dietary and PA compliance and facilitate participant goal setting. Study strategies were found to be effective with promoting compliance to intervention prescriptions.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03639350 . Registered 21st August 2018-retrospectively registered.",2021,"For PA, compared to participants with low adherence, those with high adherence lost significantly more VAT (22.3 ± 3.7 cm 2  vs. 11.6 ± 3.6 cm 2  [95% CI, - 20.7 to - 0.8]).",['Analyses included the 59 (98%) participants who completed at least 1 week of HDLS'],"['HDLS', 'intermittent energy restriction combined with a Mediterranean diet (IER + MED', 'dietary and physical activity (PA) prescriptions']","['visceral adipose tissue area (VAT', 'Adherence scores', 'Mean ± SE, dietary adherence', 'Mean changes in VAT and weight', 'Dietary and PA adherence scores', 'VAT']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0608309,"For PA, compared to participants with low adherence, those with high adherence lost significantly more VAT (22.3 ± 3.7 cm 2  vs. 11.6 ± 3.6 cm 2  [95% CI, - 20.7 to - 0.8]).","[{'ForeName': 'Holly', 'Initials': 'H', 'LastName': ""O'Reilly"", 'Affiliation': 'The Technological University Dublin and The University of Dublin, Trinity College, 191 North Circular Road, D07 EWV4, Dublin, Ireland.'}, {'ForeName': 'Chloe E', 'Initials': 'CE', 'LastName': 'Panizza', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Unhee', 'Initials': 'U', 'LastName': 'Lim', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Yonemori', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Lynne R', 'Initials': 'LR', 'LastName': 'Wilkens', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Yurii B', 'Initials': 'YB', 'LastName': 'Shvetsov', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Harvie', 'Affiliation': 'Manchester University Hospital Foundation NHS Trust, Cobbett House, Oxford Road, Manchester, M13 9WL, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shepherd', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Fengqing Maggie', 'Initials': 'FM', 'LastName': 'Zhu', 'Affiliation': 'Purdue University, 610 Purdue Mall, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Le Marchand', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Boushey', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA.""}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Cassel', 'Affiliation': ""University of Hawai'i Cancer Center, University of Hawaii at Manoa, 701 Ilalo Street, Honolulu, HI, 96813, USA. kevin@cc.hawaii.edu.""}]",Pilot and feasibility studies,['10.1186/s40814-021-00786-3']
1473,33573674,"M.I.C.E-Mental Health Intervention for Children with Epilepsy: a randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy-study protocol.","BACKGROUND


Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone.
METHODS


In total, 334 participants aged 3-18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children's Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed.
DISCUSSION


This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions.
TRIAL REGISTRATION


ISRCTN ISRCTN57823197 . Registered on 25 February 2019.",2021,"Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population.","['334 participants aged 3-18\u2009years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA', 'common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders', 'Children with Epilepsy', 'children and young people with common mental health disorders and epilepsy-study protocol', 'mental health disorders in children and young people with epilepsy', 'children and young people with other long-term conditions', 'children and young people']","['modular psychological intervention', 'usual care alone', 'M.I.C.E-Mental Health Intervention', 'Evidence-based psychological treatments', 'MATCH-ADTC', 'modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6\u2009months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone']","[""parent-reported mental health measures such as the Revised Children's Anxiety and Depression Scale, quality of\xa0life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale"", 'SDQ']","[{'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012734', 'cui_str': 'Disruptive behavior disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4305166', 'cui_str': ""RCADS - Revised Children's Anxiety and Depression Scale""}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}]",334.0,0.103398,"Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population.","[{'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Bennett', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Cross', 'Affiliation': 'Great Ormond Street Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Coughtrey', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Heyman', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Ford', 'Affiliation': 'Department of Psychiatry, Cambridge University, Cambridge, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'UCLA , California, Los Angeles, USA.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dalrymple', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'National Centre for Young People with Epilepsy, Surrey, UK.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Stephenson', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Varadkar', 'Affiliation': 'Great Ormond Street Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Blackstone', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Poushali', 'Initials': 'P', 'LastName': 'Ganguli', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Deane', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK. r.shafran@ucl.ac.uk.'}]",Trials,['10.1186/s13063-020-05003-9']
1474,33579332,Effectiveness of attachment-based family therapy compared to treatment as usual for depressed adolescents in community mental health clinics.,"BACKGROUND


Major Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent's quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent-child relationship.
OBJECTIVE


To study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD.
METHOD


Sixty adolescents (86.7% girls), aged 13-18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles.
RESULTS


At post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher's exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X 2 [2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment.
CONCLUSION


ABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study's small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013.",2021,"In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment.
","['depressed adolescents in community mental health clinics', 'adolescents with MDD', 'Sixty adolescents (86.7% girls), aged 13-18\xa0years (M\u2009=\u200914.9, SD\u2009=\u20091.35), with MDD referred to two CAMHS']","['ABFT or TAU', 'Attachment-Based Family Therapy (ABFT', 'usual (TAU) delivered within child- and adolescent mental health services (CAMHS', 'ABFT', 'attachment-based family therapy']","['depressive symptoms', 'clinician-rated remission rates on the HAMD', 'Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms', 'Remission and response rates', 'Hamilton Depression Scale (HAMD']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}]",,0.116834,"In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment.
","[{'ForeName': 'Luxsiya', 'Initials': 'L', 'LastName': 'Waraan', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, P.O. 1000, 1478, Lørenskog, Norway. lusi@ahus.no.'}, {'ForeName': 'Erling W', 'Initials': 'EW', 'LastName': 'Rognli', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Nikolai Olavi', 'Initials': 'NO', 'LastName': 'Czajkowski', 'Affiliation': 'PROMENTA Research Center, Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Aalberg', 'Affiliation': 'Division of Mental Health Services, Akershus University Hospital, P.O. 1000, 1478, Lørenskog, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Mehlum', 'Affiliation': 'National Centre for Suicide Research and Prevention, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",Child and adolescent psychiatry and mental health,['10.1186/s13034-021-00361-x']
1475,33579327,"Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study).","BACKGROUND


Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of cancer cells during resection and the consequent seeding into the bladder mucosa is the main cause of post-TURBT intravesical recurrence. Although the tumor dissemination is inevitable during conventional TURBT (cTURBT), this drawback can be overcome by tumor resection in one piece with intact surrounding normal tissues, referred to as en bloc resection. We previously described the photodynamic diagnosis (PDD)-assisted en bloc TURBT (EBTUR) technique and its favorable outcomes. Based on our preliminary studies, this randomized controlled trial was designed to evaluate the superiority of PDD-EBTUR to PDD-cTURBT.
METHODS


The FLEBER study is a single-center randomized controlled trial in NMIBC patients who require TURBT. The longest diameter of the tumor must be between 6 and 30 mm. A total of 160 eligible patients will be enrolled after screening and randomly allocated to the PDD-EBTUR (experimental) and PDD-cTURBT (control) groups in a 1:1 ratio (80 cases to 80 cases). All patients will be treated using a single, immediate postoperative intravesical chemotherapy with epirubicin. The primary endpoint of this trial is the 2-year recurrence-free survival after surgery in pathologically proven low- or intermediate-risk NMIBC. All patients will be monitored by cystoscopy and urine cytology every 3 months for 2 years. Patient data including adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires will be collected before and after the TURBT at indicated visits.
DISCUSSION


The goal of this trial is to determine the potential benefits of PDD-cTURBT and PDD-EBTUR followed by a single immediate postoperative intravesical chemotherapy in patients with low- or intermediate-risk NMIBC who undergo TURBT. Ultimately, our findings will lead to the development of better interventions and potentially change the standard of care.
TRIAL REGISTRATION


This clinical trial was prospectively registered with the UMIN Clinical Trials Registry on 1 August 2020. The reference number is UMIN000041273 , and the Ethics Committee of Nara Medical University Approval ID is 2702.",2021,"Patient data including adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires will be collected before and after the TURBT at indicated visits.
","['NMIBC patients who require TURBT', 'patients with non-muscle invasive bladder cancer', 'patients with low- or intermediate-risk NMIBC who undergo TURBT', '160 eligible patients will be enrolled after screening and randomly allocated to the PDD-EBTUR (experimental) and PDD-cTURBT (control) groups in a 1:1 ratio (80 cases to 80 cases']","['Transurethral resection of bladder tumor (TURBT', 'photodynamic diagnosis (PDD)-assisted en bloc TURBT (EBTUR) technique', 'intravesical chemotherapy with epirubicin', 'conventional transurethral resection', 'Fluorescent cystoscopy-assisted en bloc transurethral resection']","['2-year recurrence-free survival', 'adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",160.0,0.112911,"Patient data including adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires will be collected before and after the TURBT at indicated visits.
","[{'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan. makitomiyake@yahoo.co.jp.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Nishimura', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Institute for Clinical and Translational Science, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Diagnostic Pathology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Owari', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shunta', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Toritsuka', 'Affiliation': 'Department of Psychiatry, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Cardiovascular Medicine, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Orthopedic Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Anai', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Torimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.'}]",Trials,['10.1186/s13063-021-05094-y']
1476,33579326,User training for machine learning controlled upper limb prostheses: a serious game approach.,"BACKGROUND


Upper limb prosthetics with multiple degrees of freedom (DoFs) are still mostly operated through the clinical standard Direct Control scheme. Machine learning control, on the other hand, allows controlling multiple DoFs although it requires separable and consistent electromyogram (EMG) patterns. Whereas user training can improve EMG pattern quality, conventional training methods might limit user potential. Training with serious games might lead to higher quality EMG patterns and better functional outcomes. In this explorative study we compare outcomes of serious game training with conventional training, and machine learning control with the users' own one DoF prosthesis.
METHODS


Participants with upper limb absence participated in 7 training sessions where they learned to control a 3 DoF prosthesis with two grips which was fitted. Participants received either game training or conventional training. Conventional training was based on coaching, as described in the literature. Game-based training was conducted using two games that trained EMG pattern separability and functional use. Both groups also trained functional use with the prosthesis donned. The prosthesis system was controlled using a neural network regressor. Outcome measures were EMG metrics, number of DoFs used, the spherical subset of the Southampton Hand Assessment Procedure and the Clothespin Relocation Test.
RESULTS


Eight participants were recruited and four completed the study. Training did not lead to consistent improvements in EMG pattern quality or functional use, but some participants improved in some metrics. No differences were observed between the groups. Participants achieved consistently better results using their own prosthesis than the machine-learning controlled prosthesis used in this study.
CONCLUSION


Our explorative study showed in a small group of participants that serious game training seems to achieve similar results as conventional training. No consistent improvements were found in either group in terms of EMG metrics or functional use, which might be due to insufficient training. This study highlights the need for more research in user training for machine learning controlled prosthetics. In addition, this study contributes with more data comparing machine learning controlled prosthetics with Direct Controlled prosthetics.",2021,Our explorative study showed in a small group of participants that serious game training seems to achieve similar results as conventional training.,"['Eight participants were recruited and four completed the study', 'Participants with upper limb absence participated in 7 training sessions where they learned to control a 3 DoF prosthesis with two grips which was fitted']","[""serious game training with conventional training, and machine learning control with the users' own one DoF prosthesis"", 'Conventional training', 'game training or conventional training']","['EMG pattern quality', 'EMG metrics, number of DoFs used, the spherical subset of the Southampton Hand Assessment Procedure and the Clothespin Relocation Test', 'EMG pattern quality or functional use']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",8.0,0.0159006,Our explorative study showed in a small group of participants that serious game training seems to achieve similar results as conventional training.,"[{'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. more-ten@protonmail.com.'}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Franzke', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Raoul M', 'Initials': 'RM', 'LastName': 'Bongers', 'Affiliation': 'Department of Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wand', 'Affiliation': 'IDSIA, USI & SUPSI, Manno-Lugano, Switzerland.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Murgia', 'Affiliation': 'Department of Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Corry K', 'Initials': 'CK', 'LastName': 'van der Sluis', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-021-00831-5']
1477,33579317,Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS): a double-blind randomised placebo-controlled crossover trial.,"BACKGROUND


Glucagon-like peptide-1 receptor (GLP-1R) activation may improve myocardial performance in the context of ischaemia, independent of glycaemic control, in individuals with and without type 2 diabetes mellitus.
METHODS


The LIONESS trial was a single-centre randomised double-blind placebo-controlled crossover study to determine whether prolonged GLP-1R activation could improve exercise haemodynamics in chronic stable angina patients. Eligibility criteria comprised angiographic evidence of obstructive coronary artery disease (CAD) and an abnormal baseline exercise tolerance test (ETT) demonstrating > 0.1 mV of planar or downsloping ST-segment depression (STD). Those randomised to active agent started with a 1-week run-in phase of 0.6 mg liraglutide daily, an established injectable GLP-1R agonist, followed by 1 week of 1.2 mg liraglutide, after which patients performed a week 2 ETT. Patients then self-administered 1.8 mg liraglutide for a week before completing a week 3 ETT. The placebo arm received visually and temporally matched daily saline injections. Participants then crossed over to a 3-week course of saline injections interspersed with a week 5 ETT and week 6 ETT and vice versa. Co-primary endpoints were rate pressure product (RPP) at 0.1 mV STD and magnitude of STD at peak exercise.
RESULTS


Twenty-two patients (21 without diabetes) were randomised. There was no significant difference between saline versus liraglutide in the co-primary endpoints of RPP achieved at 0.1 mV STD (saline vs. liraglutide 1.2 mg p = 0.097; saline vs. liraglutide 1.8 mg p = 0.48) or the degree of STD at peak exercise (saline vs. liraglutide 1.2 mg p = 0.68; saline vs. liraglutide 1.8 mg p = 0.57). Liraglutide did not cause symptomatic hypoglycaemia, renal dysfunction, acute pancreatitis or provoke early withdrawal from the trial. Liraglutide significantly reduced weight (baseline 88.75 ± 16.5 kg vs. after liraglutide 87.78 ± 16.9 kg; p = 0.0008) and improved the lipid profile (mean total cholesterol: at baseline 3.97 ± 0.88 vs. after liraglutide 3.56 ± 0.71 mmol/L; p < 0.0001).
CONCLUSION


Liraglutide did not enhance exercise tolerance or haemodynamics compared with saline placebo during serial treadmill testing in patients with established obstructive CAD. It did, however, significantly reduce weight and improve the lipid profile. Trial Registration ClinicalTrials.gov Identifier NCT02315001. Retrospectively registered on 11th December 2014.",2021,Liraglutide did not enhance exercise tolerance or haemodynamics compared with saline placebo during serial treadmill testing in patients with established obstructive CAD.,"['Eligibility criteria comprised angiographic evidence of obstructive coronary artery disease (CAD) and an abnormal baseline exercise tolerance test (ETT) demonstrating\u2009>\u20090.1\xa0mV of planar or downsloping ST-segment depression (STD', 'Twenty-two patients (21 without diabetes', 'patients with established\xa0obstructive CAD', 'chronic stable angina patients', 'individuals with and without type 2 diabetes mellitus']","['liraglutide', 'placebo', 'saline placebo', 'Liraglutide', 'GLP-1R activation', 'Glucagon-like peptide-1 receptor (GLP-1R) activation']","['reduced weight', 'rate pressure product (RPP', 'exercise tolerance or haemodynamics', 'weight and improve the lipid profile', 'degree of STD at peak exercise', 'lipid profile (mean total cholesterol', 'RPP', 'symptomatic hypoglycaemia, renal dysfunction, acute pancreatitis or provoke early withdrawal', 'exercise haemodynamics', 'corONary haemodynamics']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.491193,Liraglutide did not enhance exercise tolerance or haemodynamics compared with saline placebo during serial treadmill testing in patients with established obstructive CAD.,"[{'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Myat', 'Affiliation': ""King's College London British Heart Foundation Centre of Research Excellence, The Rayne Institute, Cardiovascular Division, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. aung.myat@kcl.ac.uk.""}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Redwood', 'Affiliation': ""King's College London British Heart Foundation Centre of Research Excellence, The Rayne Institute, Cardiovascular Division, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Satpal', 'Initials': 'S', 'LastName': 'Arri', 'Affiliation': ""King's College London British Heart Foundation Centre of Research Excellence, The Rayne Institute, Cardiovascular Division, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Centre and Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Marber', 'Affiliation': ""King's College London British Heart Foundation Centre of Research Excellence, The Rayne Institute, Cardiovascular Division, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}]",Diabetology & metabolic syndrome,['10.1186/s13098-021-00635-6']
1478,33578661,A Randomized Clinical Trial Preventive Outreach Targeting Dental Caries and Oral-Health-Related Quality of Life for Refugee Children.,"Objective:  The study assessed a preventive outreach educational intervention targeting improvements in dental caries and oral-health-related quality of life in the children of refugee families by comparing pre- and postintervention outcomes.  Methods:  This randomized controlled clinical trial assessed the outcomes at baseline and three times over six months using the WHO oral health assessment form (DMFT/dmft) and the parent version of the Michigan Oral-Health-Related Quality of Life scale. Children and at least one of their parents/caretakers were educated on oral health topics in two one-hour sessions.  Results:  Of the 66 enrolled families, 52 (72%) completed the six-month follow-up. DMFT/dmft scores increased significantly in both the control and intervention groups ( p  < 0.05); differences in the changes in the DMFT/dmft and MOHRQoL-P scores from baseline to the three- and six-month follow-up visits between groups were not significant ( p  > 0.05).  Conclusions:  Oral health education programs targeting a diverse group of refugee children and their parents/caregivers single-handedly did not reduce the increased number of caries lesions or improve oral-health-related quality of life.",2021,DMFT/dmft scores increased significantly in both the control and intervention groups ( p  < 0.05); differences in the changes in the DMFT/dmft and MOHRQoL-P scores from baseline to the three- and six-month follow-up visits between groups were not significant ( p  > 0.05).  ,"['66 enrolled families, 52 (72%) completed the six-month follow-up', 'Refugee Children']",['preventive outreach educational intervention'],"['number of caries lesions or improve oral-health-related quality of life', 'DMFT/dmft and MOHRQoL-P scores', 'DMFT/dmft scores', 'dental caries and oral-health-related quality of life', 'Michigan Oral-Health-Related Quality of Life scale', 'oral health topics']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]",66.0,0.071171,DMFT/dmft scores increased significantly in both the control and intervention groups ( p  < 0.05); differences in the changes in the DMFT/dmft and MOHRQoL-P scores from baseline to the three- and six-month follow-up visits between groups were not significant ( p  > 0.05).  ,"[{'ForeName': 'Murad', 'Initials': 'M', 'LastName': 'Alrashdi', 'Affiliation': 'Department of Orthodontic and Paediatric Dentistry, College of Dentistry, Qassim University, KSA, Qassim 51452, Saudi Arabia.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Cervantes Mendez', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry at the University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}, {'ForeName': 'Moshtagh R', 'Initials': 'MR', 'LastName': 'Farokhi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry at the University of Texas Health Science Center at San Antonio, San Antonio, TX 78229, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph18041686']
1479,33578597,"Comparison of the effects of shortening rest intervals on the quality of cardiopulmonary resuscitation, physiological parameters, and hemodynamic parameters in well-trained rescuers: Randomized simulation study.","BACKGROUND


Cardiopulmonary resuscitation (CPR) performance depends on individual ability and training. Well-trained or professional rescuers can maintain high-quality CPR for longer than laypeople. This study aimed to examine the effects of reducing resting intervals on CPR performance, physiological parameters, and hemodynamic parameters during prolonged CPR in well-trained providers.
METHODS


The study enrolled 90 volunteers from the paramedic students of our institution. They were randomly divided into 3 groups: 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds rest groups. Each participant performed 5 cycles of chest compression only CPR (2 min/cycle) with different resting intervals according to grouping. CPR quality, physiological variations, and hemodynamic variations were measured for each cycle and compared across the groups.
RESULTS


Of the 90 volunteers, 79 well-trained providers were finally included. The variation of the average chest compression depth across the 5 cycles showed significant differences between the 3 groups: from cycle 1 to 2: 1.2 (3.1) mm, -0.8 (2.0) mm, and -2.0 (3.0) mm in the 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds groups, respectively (P < .001); from cycle 1 to 3: 0.0 (3.0) mm, -0.7 (3.2) mm, and -2.6 (3.9) mm, respectively (P = .030). However, all 3 groups maintained the recommended rate and chest compression depth for all 5 cycles. Physiological and hemodynamic parameters showed no significant differences between the groups.
CONCLUSIONS


Well-trained providers were able to maintain high-quality CPR despite reducing rest intervals. Adjusting the rest interval may help maintain overall CPR quality in special situations or where layperson rescuers are involved.",2021,"The variation of the average chest compression depth across the 5 cycles showed significant differences between the 3 groups: from cycle 1 to 2: 1.2 (3.1) mm, -0.8 (2.0) mm, and -2.0 (3.0) mm in the 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds groups, respectively (P < .001); from cycle 1 to 3: 0.0 (3.0) mm, -0.7 (3.2) mm, and -2.6 (3.9) mm, respectively (P = .030).","['well-trained rescuers', '90 volunteers from the paramedic students of our institution', '90 volunteers, 79 well-trained providers were finally included']",[],"['CPR performance, physiological parameters, and hemodynamic parameters', 'rate and chest compression depth', 'Physiological and hemodynamic parameters', 'CPR quality, physiological variations, and hemodynamic variations', 'average chest compression depth', 'quality of cardiopulmonary resuscitation, physiological parameters, and hemodynamic parameters']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",90.0,0.0218274,"The variation of the average chest compression depth across the 5 cycles showed significant differences between the 3 groups: from cycle 1 to 2: 1.2 (3.1) mm, -0.8 (2.0) mm, and -2.0 (3.0) mm in the 2 minutes, 1 minute 45 seconds, and 1 minute 30 seconds groups, respectively (P < .001); from cycle 1 to 3: 0.0 (3.0) mm, -0.7 (3.2) mm, and -2.6 (3.9) mm, respectively (P = .030).","[{'ForeName': 'Dong Hun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medical Technology, Gyeongbuk Provincial College, Yecheon-gun, Gyeongsangbuk-do.'}, {'ForeName': 'Sang-Min', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, Gyeongbuk Provincial College, Yecheon-gun, Gyeongsangbuk-do.'}, {'ForeName': 'Gyun Moo', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Ko', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Ye Jin', 'Initials': 'YJ', 'LastName': 'Oh', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Seo', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Suk Hee', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Tae Chang', 'Initials': 'TC', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000024666']
1480,33578583,"Application of digital practice to improve head movement, visual perception and activities of daily living for subacute stroke patients with unilateral spatial neglect: Preliminary results of a single-blinded, randomized controlled trial.","BACKGROUND


Virtual reality (VR) based digital practice is an attractive way to provide a patient engagement, motivation and adaptable environment for stroke rehabilitation. However, clinical evidence of efficacy with VR-based digital practice is very limited. In this study, we investigated the effects of VR-based digital practice program on unilateral spatial neglect (USN) rehabilitation in patients with subacute stroke.
METHODS


Twenty-four subacute stroke patients with USN were enrolled and randomly assigned to digital practice group (n = 12) and control group (n = 12). Patients in digital practice group received training programs with VR-based applications with leap motion environment. Control group received conventional USN specific training programs. All patients were underwent 4 week practice program (3 sessions/week, a half-hour/session). We analyzed training effects before and after training by assessing the line bisection test, Catherine Bergego Scale, modified Barthel index, Motor-Free Visual Perception Test Vertical Version (MVPT-V), and horizontal head movements (rotation degree and velocity during the VR-based applications), and compared the results between the two groups.
RESULTS


Compared to control group, digital practice group showed significantly greater improvements in the line bisection test (P = .020), and visual perceptual tasks (MVPT-V, responded more on left visual task, P = .024; correctly respond more on both left and right visual tasks, P = .024 and P = .014, respectively; and faster response time, P = .014). Additionally, horizontal head movement of rotation degree and velocity during the VR based practice in the digital practice group were significantly increased more than control group (P = .007 and P = .001, respectively).
CONCLUSIONS


VR-based digital practice program might be an affordable approach for visual perception and head movement recovery for subacute stroke patients with USN.",2021,"Compared to control group, digital practice group showed significantly greater improvements in the line bisection test (P = .020), and visual perceptual tasks (MVPT-V, responded more on left visual task, P = .024; correctly respond more on both left and right visual tasks, P = .024 and P = .014, respectively; and faster response time, P = .014).","['patients with subacute stroke', 'subacute stroke patients with USN', 'subacute stroke patients with unilateral spatial neglect', 'Twenty-four subacute stroke patients with USN']","['digital practice', 'conventional USN specific training programs', 'training programs with VR-based applications with leap motion environment', 'VR-based digital practice program', 'digital practice group']","['horizontal head movement of rotation degree and velocity during the VR based practice', 'visual perceptual tasks (MVPT-V, responded more on left visual task', 'line bisection test', 'line bisection test, Catherine Bergego Scale, modified Barthel index, Motor-Free Visual Perception Test Vertical Version (MVPT-V), and horizontal head movements (rotation degree and velocity during the VR-based applications', 'unilateral spatial neglect (USN) rehabilitation', 'head movement, visual perception and activities of daily living']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0376591', 'cui_str': 'Head Movements'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1300593', 'cui_str': 'Motor free visual perception test'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0184905', 'cui_str': 'Bisection'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",24.0,0.0183919,"Compared to control group, digital practice group showed significantly greater improvements in the line bisection test (P = .020), and visual perceptual tasks (MVPT-V, responded more on left visual task, P = .024; correctly respond more on both left and right visual tasks, P = .024 and P = .014, respectively; and faster response time, P = .014).","[{'ForeName': 'Ho-Suk', 'Initials': 'HS', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Asan Institute for Life Sciences, Asan Medical Center, Seoul.'}, {'ForeName': 'Won-Seob', 'Initials': 'WS', 'LastName': 'Shin', 'Affiliation': 'Department of Physical Therapy, Collage of Health and Medical Science, Daejeon University, Daejeon.'}, {'ForeName': 'Dae-Hyouk', 'Initials': 'DH', 'LastName': 'Bang', 'Affiliation': 'Department of Physical Therapy, Oriental Hospital, Wonkwang University, Ik-San, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000024637']
1481,33578519,The effect of a micro-visual intervention on the accelerated recovery of patients with kinesiophobia after total knee replacement during neo-coronary pneumonia.,"BACKGROUND


The global neo-coronary pneumonia epidemic has increased the workload of healthcare institutions in various countries and directly affected the physical and psychological recovery of the vast majority of patients requiring hospitalization in China. We anticipate that post-total knee arthroplasty kinesiophobia may have an impact on patients' postoperative pain scores, knee function, and ability to care for themselves in daily life. The purpose of this study is to conduct a micro-video intervention via WeChat to verify the impact of this method on the rapid recovery of patients with kinesiophobia after total knee arthroplasty during neo-coronary pneumonia.
METHODS


Using convenience sampling method, 78 patients with kinesiophobia after artificial total knee arthroplasty who met the exclusion criteria were selected and randomly grouped, with the control group receiving routine off-line instruction and the intervention group receiving micro-video intervention, and the changes in the relevant indexes of the two groups of patients at different time points on postoperative day 1, 3 and 7 were recorded and analyzed.
RESULTS


There were no statistical differences in the scores of kinesiophobia, pain, knee flexion mobility (ROM) and ability to take care of daily life between the two groups on the first postoperative day (P > .05). On postoperative day 3 and 7, there were statistical differences in Tampa Scale for kinesiophobia, pain, activities of daily living scale score and ROM between the two groups (P < .01), and the first time of getting out of bed between the two groups (P < .05), and by repeated-measures ANOVA, there were statistically significant time points, groups and interaction effects of the outcome indicators between the 2 groups (P < .01), indicating that the intervention group reconstructed the patients' postoperative kinesiophobiaand hyperactivity. The level of pain awareness facilitates the patient's acquisition of the correct functional exercises to make them change their misbehavior.
CONCLUSIONS


WeChat micro-video can reduce the fear of movement score and pain score in patients with kinesiophobia after unilateral total knee arthroplasty, shorten the first time out of bed, and improve their joint mobility and daily living ability.
ETHICS


This study has passed the ethical review of the hospital where it was conducted and has been filed, Ethics Approval Number: 20181203-01.",2021,"There were no statistical differences in the scores of kinesiophobia, pain, knee flexion mobility (ROM) and ability to take care of daily life between the two groups on the first postoperative day (P > .05).","['patients with kinesiophobia after total knee replacement during neo-coronary pneumonia', 'patients with kinesiophobia after unilateral total knee arthroplasty', 'patients requiring hospitalization in China', '78 patients with kinesiophobia after artificial total knee arthroplasty who met the exclusion criteria', 'patients with kinesiophobia after total knee arthroplasty during neo-coronary pneumonia']","['control group receiving routine off-line instruction and the intervention group receiving micro-video intervention', 'WeChat micro-video', 'micro-visual intervention']","['first time of getting out of bed', 'scores of kinesiophobia, pain, knee flexion mobility (ROM) and ability to take care of daily life', 'fear of movement score and pain score', 'Tampa Scale for kinesiophobia, pain, activities of daily living scale score and ROM', 'joint mobility and daily living ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C3536597', 'cui_str': 'Patient requires hospitalization'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",78.0,0.0310913,"There were no statistical differences in the scores of kinesiophobia, pain, knee flexion mobility (ROM) and ability to take care of daily life between the two groups on the first postoperative day (P > .05).","[{'ForeName': 'Guanzhen', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopaedics, Huzhou Central Hospital, Zhejiang Province AND Central Hospital affiliated to Huzhou University.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Zhejiang Province, First Affiliated Hospital of Wenzhou Medical University.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedics, Huzhou Central Hospital, Zhejiang Province AND Central Hospital affiliated to Huzhou University.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, Huzhou Central Hospital, Zhejiang Province AND Central Hospital affiliated to Huzhou University.'}, {'ForeName': 'Lingmei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopaedics, Huzhou Central Hospital, Zhejiang Province AND Central Hospital affiliated to Huzhou University.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of Orthopaedics, Huzhou Central Hospital, Zhejiang Province AND Central Hospital affiliated to Huzhou University.'}]",Medicine,['10.1097/MD.0000000000024141']
1482,33577618,Effects of Adachi Rehabilitation Programme on older adults under long-term care: A multi-centre controlled trial.,"OBJECTIVES


We developed the Adachi Rehabilitation Programme (ARP), a community rehabilitation program. Under the supervision of professional caregivers, older adults cleaned and planted flowers in the park and they walked and shopped in the community. We examined the effects of ARP on individuals receiving small-group multifunctional at-home care at community facilities.
METHODS


This was a multi-centre controlled trial at thirteen small multifunctional at-home care facilities in Adachi, Tokyo. The primary outcomes of the study were daily step counts and timed up & go (TUG). Secondary outcomes included gait speed, step length, Barthel Index for Activities of Daily Living, Functional Independence Measure, Mini-Mental State Examination (MMSE) and EuroQOL 5 Dimension.
RESULTS


Ninety-six individuals at thirteen small multifunctional at-home care facilities were recruited for participation in December 2017. They were allocated to intervention (38) and control (40) groups. The average daily step count of the control group decreased from 852 to 727, but it increased by approximately 650 steps, from 990 to 1635, for the intervention group. Average TUG decreased from 16.1 s to 14.0 s and MMSE score increased from 15.9 to 16.3 for the intervention group, but a significant interaction was not found. On non-intervention home days, the daily step counts of the intervention group increased significantly from 908 steps to 1485 steps, while those of the control group decreased from 865 steps to 722 steps.
CONCLUSIONS


ARP may have effectively increased the physical activity of older adults under long-term care by increasing motivation and changing behaviour.",2021,"Secondary outcomes included gait speed, step length, Barthel Index for Activities of Daily Living, Functional Independence Measure, Mini-Mental State Examination (MMSE) and EuroQOL 5 Dimension.
","['thirteen small multifunctional at-home care facilities in Adachi, Tokyo', 'individuals receiving small-group multifunctional at-home care at community facilities', 'older adults under long-term care', 'Ninety-six individuals at thirteen small multifunctional at-home care facilities were recruited for participation in December 2017']","['ARP', 'Adachi Rehabilitation Programme', 'Adachi Rehabilitation Programme (ARP']","['gait speed, step length, Barthel Index for Activities of Daily Living, Functional Independence Measure, Mini-Mental State Examination (MMSE) and EuroQOL 5 Dimension', 'MMSE score', 'Average TUG', 'physical activity', 'average daily step count', 'daily step counts and timed up & go (TUG']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.0352163,"Secondary outcomes included gait speed, step length, Barthel Index for Activities of Daily Living, Functional Independence Measure, Mini-Mental State Examination (MMSE) and EuroQOL 5 Dimension.
","[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Faculty of Medicine, Kyorin University School of Medicine, Mitaka, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Ooyama', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Hospital, Sendai, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tazawa', 'Affiliation': 'Sendai Orthopaedic Hospital, Sendai, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kohzuki', 'Affiliation': 'Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",PloS one,['10.1371/journal.pone.0245646']
1483,33577586,Measurement properties of the one-minute sit-to-stand test in children and adolescents with cystic fibrosis: A multicenter randomized cross-over trial.,"BACKGROUND


Functional exercise capacity assessment is recommended in children with cystic fibrosis (CF). The six-minute walk test (6MWT) is a valid evaluation of exercise capacity but can be technically complex. Inversely, the sit-to-stand test (STST) is a simple method to evaluate exercise capacity, and is validated in healthy children and adults with CF. This study aimed to evaluate STST measurement properties in children and adolescents with CF.
METHODS


In this multicenter study, children with CF (6 to 18 years) performed two iterations of both the STST and the 6MWT in a randomized order. Criterion validity was determined by assessing correlations between STST repetitions and 6MWT distance (6MWD). Intra-rater reliability, test-retest repeatability, mean bias and limits of agreement were also assessed. Relationships with other outcomes (i.e. respiratory and quadriceps muscle strength) and cardio-respiratory responses were analysed for both tests.
RESULTS


Thirty-six children with CF were included (mean age 12.0 ±3.5 years and FEV1 95.8 ±25.0%). On average, 39.6 ±10.5 repetitions were performed during the STST and mean 6MWD was 596.0 ±102.6 meters. STST number of repetitions was significantly correlated with 6MWD (r = 0.48; p<0.01). Both tests had very good intra-rater reliability (ICCSTST = 0.91 (95%CI 0.76-0.96) and ICC6MWT = 0.94 (95%CI 0.85-0.97)), and a significant test-retest learning effect. The number of STST repetitions was not correlated with quadriceps or respiratory muscle strength test, and the STST induced fewer cardio-respiratory responses than the 6MWT.
CONCLUSIONS


The STST is an easy-to-use functional test with moderate criterion validity when compared to the 6MWT in children with CF, probably because both tests measure different components of functional exercise capacity. The STST is useful when the 6MWT is unfeasible, however further investigations are required to explore the clinical implications of STST results in children with CF.
CLINICAL TRIAL REGISTRATION


NCT03069625.",2021,"The STST is an easy-to-use functional test with moderate criterion validity when compared to the 6MWT in children with CF, probably because both tests measure different components of functional exercise capacity.","['children with cystic fibrosis (CF', 'Thirty-six children with CF', 'children and adolescents with CF', 'healthy children and adults with CF', 'children and adolescents with cystic fibrosis', 'children with CF', 'children with CF (6 to 18 years']","['STST and the 6MWT', 'STST']","['STST number of repetitions', 'cardio-respiratory responses', 'Criterion validity', 'number of STST repetitions', 'STST repetitions and 6MWT distance (6MWD', 'good intra-rater reliability', 'Intra-rater reliability, test-retest repeatability, mean bias and limits of agreement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",36.0,0.106436,"The STST is an easy-to-use functional test with moderate criterion validity when compared to the 6MWT in children with CF, probably because both tests measure different components of functional exercise capacity.","[{'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Pediatric Department, Le Havre Hospital, Le Havre, Normandie, France.'}, {'ForeName': 'Fairuz', 'Initials': 'F', 'LastName': 'Boujibar', 'Affiliation': 'INSERM U1096, UNIROUEN, Normandie Univ, Rouen University Hospital, Rouen, Normandie, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gennari', 'Affiliation': 'Cystic Fibrosis Department, Pediatric Section, Caen University Hospital, Caen, Normandie, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Pulmonology Department, Le Havre Hospital, Le Havre, Normandie, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Sicinski', 'Affiliation': 'Pediatric Cystic Fibrosis Department, Pediatric Section, Rouen University Hospital, Rouen, Normandie, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'ADIR Association, Rouen University Hospital, Rouen, Normandie, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'ADIR Association, Rouen University Hospital, Rouen, Normandie, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Laurans', 'Affiliation': 'Cystic Fibrosis Department, Pediatric Section, Caen University Hospital, Caen, Normandie, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Marguet', 'Affiliation': 'Pediatric Cystic Fibrosis Department, Pediatric Section, Rouen University Hospital, Rouen, Normandie, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Le Roux', 'Affiliation': 'Pediatric Department, Le Havre Hospital, Le Havre, Normandie, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Pulmonology Department, Le Havre Hospital, Le Havre, Normandie, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Research and Clinical Experimentation Institute (IREC), Pulmonology, ORL and Dermatology, Louvain Catholic University, Brussels, Brussels Capital Region, Belgium.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Research and Clinical Experimentation Institute (IREC), Pulmonology, ORL and Dermatology, Louvain Catholic University, Brussels, Brussels Capital Region, Belgium.'}]",PloS one,['10.1371/journal.pone.0246781']
1484,33577486,ASSESSMENT OF QUALITY OF LIFE OF PATIENTS AFTER SURGERY MADE BY THE IN-HOUSE DEVICES AND METHODS.,"OBJECTIVE


The aim: To estimate the patients' quality of life after surgery made by the in-house devices and methods.
PATIENTS AND METHODS


Materials and methods: According to the peculiarities of surgical treatment, the set of instruments used and the methods of its application during surgery, all patients were assigned into two groups: group І (comparison group, or retrospective group) involved 48 (58.5%) patients who received treatment at the Vascular Surgery Department and had contraindications to endovascular laser and radiofrequency ablation, as evidenced by ultrasonographic color angioscanning (USCAS). These patients underwent typical phlebectomies, which were performed using a standard set of instruments; group ІІ (prospective) involved 34 (41.5%) patients treated in the Surgery Department. Patients of this group also had contraindications to endovenous laser and radiofrequency ablation, which was confirmed by USCAS data.
RESULTS


Results: It has been found that following the six months after treatment, no patient in Group II and Group I measured the quality of life unsatisfactory. Satisfactory measures were made by 6 (12.5%) and 2 (5.9%) patients in Group I and Group II, respectively. Good scores of quality of life was established in 33 (68.75%) and 19 (55.9%) patients, respectively. Excellent scores were observed in patients of Group I (9 (18.75%)) and Group II (13 (38.2%)). In addition, in our survey, patients' responses were divided into three categories: ""Never"", ""Rarely"", ""Quite often"", ""Very often"", ""Constantly"". That is, with a negative outcome (incomplete disappearance of the symptom, its apparent reduction), we can observe the dynamics of positive changes.
CONCLUSION


Conclusions: Patients of Group II had a higher rates of quality of life, because the process of ulcer healing was faster, pain was reducing, contributing to improvement of the patient's psycho-emotional state. In addition, the examined 29 (85.3%) patients of Group II noted that even with the preservation of some symptoms, their subjective manifestations were reducing leading to health improvement. All this contributes to improving the quality of life of patients with trophic ulcers of the lower extremities, which were treated according to our methods.",2020,Excellent scores were observed in patients of Group I (9 (18.75%)) and Group II (13 (38.2%)).,['patients with trophic ulcers of the lower extremities'],"['Vascular Surgery Department and had contraindications to endovascular laser and radiofrequency ablation, as evidenced by ultrasonographic color angioscanning (USCAS', 'endovenous laser and radiofrequency ablation']","['Good scores of quality of life', ""patients' quality of life"", 'quality of life unsatisfactory', 'Excellent scores', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0587532', 'cui_str': 'Vascular surgery department'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0009393', 'cui_str': 'Color'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439856', 'cui_str': 'Unsatisfactory'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}]",48.0,0.0228546,Excellent scores were observed in patients of Group I (9 (18.75%)) and Group II (13 (38.2%)).,"[{'ForeName': 'Nataliia О', 'Initials': 'NО', 'LastName': 'Riabushko', 'Affiliation': 'UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY, POLTAVA, UKRAINE.'}, {'ForeName': 'Roman М', 'Initials': 'RМ', 'LastName': 'Riabushko', 'Affiliation': 'UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY, POLTAVA, UKRAINE.'}, {'ForeName': 'Mykola М', 'Initials': 'MМ', 'LastName': 'Riabushko', 'Affiliation': 'UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY, POLTAVA, UKRAINE.'}, {'ForeName': 'Olena B', 'Initials': 'OB', 'LastName': 'Riabushko', 'Affiliation': 'UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY, POLTAVA, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
1485,33577476,EVALUATION OF EFFECTIVENESS OF TREATMENT-AND-PROPHYLACTIC COMPLEX IN TOBACCO-ADDICTED PATIENTS WITH CHRONIC GENERALIZED PERIODONTITIS ON THE BACKGROUND OF CHRONIC HYPERACID GASTRITIS.,"OBJECTIVE


The aim: To evaluate the clinical efficacy of treatment-and-prophylactic complex in patients addicted to tobacco with chronic generalized periodontitis with chronic hyperacid gastritis.
PATIENTS AND METHODS


Materials and methods: 68 patients (men and women) aged 25-44 years were examined. They were distributed into two groups: the main group - 48 patients addicted to tobacco with chronic generalized 1 degree periodontitis and chronic hyperacid gastritis, associated with Helicobacter pylori, the control group - 20 healthy individuals without bad habits. Patients of the main group were distributed at random into 2 subgroups (1.1, 1.2) depending on the chosen therapy. The patients of the subgroup 1.1 received the basic therapy and the developed treatment and prophylactic complex, the subgroup 1.2 received the basic therapy and the ultraphonophoresis procedures with placebo. Assessment of the effectiveness of therapy was carried out by determining hygienic index OHI-S and periodontal indices (PI, PMA index and Muhlemann bleeding index (MBI)).
RESULTS


Results: The usage of the treatment-and-prophylactic complex resulted in improvement of the hygienic index OHI-S and periodontal indices (PI, PMA index and MBI) at the immediate and late observation period.
CONCLUSION


Conclusions: Results of the study confirmed the effectiveness of the proposed treatment-and-prophylactic complex in therapy of chronic generalized 1 degree periodontitis in patients addicted to tobacco smoking with chronic hyperacid gastritis.",2020,"The usage of the treatment-and-prophylactic complex resulted in improvement of the hygienic index OHI-S and periodontal indices (PI, PMA index and MBI) at the immediate and late observation period.
","['patients addicted to tobacco with chronic generalized periodontitis with chronic hyperacid gastritis', 'Materials and methods: 68 patients (men and women) aged 25-44 years', 'patients addicted to tobacco smoking with chronic hyperacid gastritis', '48 patients addicted to tobacco with chronic generalized 1 degree periodontitis and chronic hyperacid gastritis, associated with Helicobacter pylori, the control group - 20 healthy individuals without bad habits']","['treatment-and-prophylactic complex', 'ultraphonophoresis procedures with placebo']","['hygienic index OHI-S and periodontal indices (PI, PMA index and Muhlemann bleeding index (MBI', 'hygienic index OHI-S and periodontal indices (PI, PMA index and MBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031092', 'cui_str': 'Periodontal Indexes'}, {'cui': 'C0039654', 'cui_str': '12-O-Tetradecanoyl Phorbol 13-Acetate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}]",68.0,0.0221049,"The usage of the treatment-and-prophylactic complex resulted in improvement of the hygienic index OHI-S and periodontal indices (PI, PMA index and MBI) at the immediate and late observation period.
","[{'ForeName': 'Olena L', 'Initials': 'OL', 'LastName': 'Zolotukhina', 'Affiliation': 'ODESSA NATIONAL MEDICAL UNIVERSITY, ODESA, UKRAINE.'}, {'ForeName': 'Iuliia G', 'Initials': 'IG', 'LastName': 'Romanova', 'Affiliation': 'LVIV MEDICAL INSTITUTE, LVIV, UKRAINE.'}, {'ForeName': 'Tetyana O', 'Initials': 'TO', 'LastName': 'Pyndus', 'Affiliation': 'LVIV MEDICAL INSTITUTE, LVIV, UKRAINE.'}, {'ForeName': 'Georgy O', 'Initials': 'GO', 'LastName': 'Romanov', 'Affiliation': 'ODESSA NATIONAL MEDICAL UNIVERSITY, ODESA, UKRAINE.'}, {'ForeName': 'Iryna M', 'Initials': 'IM', 'LastName': 'Tkachenko', 'Affiliation': 'UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY"", POLTAVA, UKRAINE.'}]","Wiadomosci lekarskie (Warsaw, Poland : 1960)",[]
1486,33577465,Correction: Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/25291.].,2021,[This corrects the article DOI: 10.2196/25291.].,['Chronic Low Back Pain'],['Behavioral Skills-Based At-Home Virtual Reality Therapy'],[],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Therapy'}]",[],,0.119815,[This corrects the article DOI: 10.2196/25291.].,"[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Garcia', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'C T Bauer College of Business, Houston, TX, United States.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Mackey', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Sackman', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Louis', 'Affiliation': 'Division of Neurosurgery, Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, CA, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Maddox', 'Affiliation': 'Research and Development, AppliedVR Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Birckhead', 'Affiliation': 'Division of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.'}]",JMIR research protocols,['10.2196/27652']
1487,33587135,Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial.,"Importance


Previous studies that have shown tai chi to improve sleep were mainly based on subjective assessments, which might have produced results confounded by self-reporting bias.
Objective


To compare the effectiveness of tai chi for improving sleep in older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements.
Design, Setting, and Participants


This randomized, 3-arm, parallel group, assessor-masked clinical trial was conducted at a single research unit in Hong Kong between August 2014 and August 2018. Eligible participants, aged 60 years or older and with chronic insomnia, were randomly allocated into tai chi training, exercise, and control groups.
Interventions


12-week tai chi training, 12-week conventional exercise, and no intervention control.
Main Outcomes and Measures


Primary outcomes were measures taken from actigraphy sleep assessment. Secondary outcomes included remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary. Assessments were performed at baseline, end of the intervention (postintervention), and 24 months after the intervention (follow-up). Data analysis was performed from September 2018 to August 2020.
Results


A total of 320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women) were randomly allocated into control (110 participants), exercise (105 participants), and tai chi (105 participants) groups and included in the data analysis. Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups. The actigraphy-assessed beneficial effects were maintained in both intervention groups at follow-up.
Conclusions and Relevance


Conventional exercise and tai chi improved sleep and the beneficial effects sustained for 24 months, although the absolute improvements in sleep parameters were modest. Improvements in objective sleep parameters were not different between the tai chi and exercise groups, suggesting that tai chi can be an alternative approach for managing insomnia.
Trial Registration


ClinicalTrials.gov Identifier: NCT02260843.",2021,"Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups.","['single research unit in Hong Kong between August 2014 and August 2018', 'Eligible participants, aged 60 years or older and with chronic insomnia', 'older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements', '320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women', 'Older Adults With Insomnia']","['tai chi training, 12-week conventional exercise, and no intervention control', 'tai chi training, exercise, and control groups', 'Tai Chi or Exercise', 'tai chi']","['remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary', 'objective sleep parameters', 'sleep efficiency', 'reductions of wake time after sleep onset', 'measures taken from actigraphy sleep assessment', 'number of awakenings', 'actigraphy-assessed beneficial effects']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",320.0,0.106652,"Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups.","[{'ForeName': 'Parco M', 'Initials': 'PM', 'LastName': 'Siu', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Angus P', 'Initials': 'AP', 'LastName': 'Yu', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Bjorn T', 'Initials': 'BT', 'LastName': 'Tam', 'Affiliation': 'Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, Canada.'}, {'ForeName': 'Edwin C', 'Initials': 'EC', 'LastName': 'Chin', 'Affiliation': 'Division of Kinesiology, School of Public Health, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Doris S', 'Initials': 'DS', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Ka-Fai', 'Initials': 'KF', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Stanley S', 'Initials': 'SS', 'LastName': 'Hui', 'Affiliation': 'Department of Sports Science and Physical Education, Faculty of Education, the Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, the Chinese University of Hong Kong, Shatin, Hong Kong, China.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Fong', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Pokfulam, Hong Kong, China.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Faculty of Health and Social Sciences, the Hong Kong Polytechnic University, Hung Hom, Hong Kong, China.'}, {'ForeName': 'Gao X', 'Initials': 'GX', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.37199']
1488,33587132,Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.,"Importance


Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations.
Objective


To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay).
Design, Setting, and Participants


This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020.
Interventions


Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials.
Main Outcomes and Measures


The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use.
Results


Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose.
Conclusions and Relevance


This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement.
Trial Registration


ClinicalTrials.gov Identifier: NCT01763203.",2021,"Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0];","['Inclusion criteria were age 40 years or older', 'February 2014 to September 2018, and data were analyzed from October 2018 to November 2020', '487 participants included', 'participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial', '246 participants were randomized to usual care, and 241 participants', 'mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian', 'Patients With Stroke or Transient Ischemic Attack', '887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion']","['physician team intervention', 'control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials', 'Coordinated Community and Chronic Care Model Team Intervention vs Usual Care', 'transient ischemic attack (TIA', 'multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools']","['Systolic Blood Pressure', 'change in systolic BP', 'non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months', 'Mean (SD) systolic BP', 'serum CRP level', 'care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use', 'systolic blood pressure (BP', 'self-reported salt intake']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",246.0,0.139094,"Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0];","[{'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCreath', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razmara', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bryg', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Shlee S', 'Initials': 'SS', 'LastName': 'Song', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Willis', 'Affiliation': 'Watts Labor Community Action Committee, Los Angeles, California.'}, {'ForeName': 'Shinyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'University of Washington School of Public Health, Seattle.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Community Partners International, San Francisco, California.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Wacksman', 'Affiliation': 'Dimagi, Cambridge, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mittman', 'Affiliation': 'Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Renee R', 'Initials': 'RR', 'LastName': 'Johnson', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ediss', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sivers-Teixeira', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Shaby', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, California.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Montoya', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mojarro-Huang', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Muñoz', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Diamond', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lopez', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Valdez', 'Affiliation': 'Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Hilary R', 'Initials': 'HR', 'LastName': 'Haber', 'Affiliation': 'Dimagi, Cambridge, Massachusetts.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Hill', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Neal M', 'Initials': 'NM', 'LastName': 'Rao', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Martinez', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Lillie', 'Initials': 'L', 'LastName': 'Hudson', 'Affiliation': 'University of Southern California, Los Angeles.'}, {'ForeName': 'Natalie P', 'Initials': 'NP', 'LastName': 'Valle', 'Affiliation': 'St Jude Medical Center, Fullerton, California.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.36227']
1489,33587126,Effects of different lingual retainers on periodontal health and stability.,"OBJECTIVES


To evaluate the effects of different lingual retainers on periodontal health and stability of mandibular anterior teeth at the 1-year follow-up.
MATERIALS AND METHODS


One hundred thirty-two patients were randomly allocated to four groups using different lingual retainers: group 1, 0.016 × 0.022-in dead-soft wire; group 2, 0.0215-in 5-strand stainless steel wire; group 3, 0.014 × 0.014-in computer-aided design/computer-aided manufacturing nitinol retainer (Memotain); group 4, connected bonding pads. Plaque, gingival, and calculus indexes were used to evaluate periodontal health, and Little's irregularity index, intercanine width, and arch length measurements were performed to evaluate stability. All measurements were performed at each time point (debonding and 3, 6, 9, and 12 months).
RESULTS


The mean value of the gingival index obtained in group 3 was lower than the mean value for all other groups. The mean value of the calculus index was the lowest in group 3, and there was a significant difference between group 3 and groups 1 and 2. No differences were found among the groups in terms of plaque index, intercanine width, and arch length. The least irregularity was obtained in groups 2 and 3. There were no significant differences between these groups and groups 1 and 4.
CONCLUSIONS


Gingival inflammation and calculus accumulation were the lowest in group 3 (Memotain). The irregularity for Memotain and stainless steel retainers was less than or the other groups. However, no clinically significant worsening of periodontal health or relapse were seen in any groups after 1 year.",2021,"The mean value of the calculus index was the lowest in group 3, and there was a significant difference between group 3 and groups 1 and 2.",['One hundred thirty-two patients'],"['lingual retainers', 'lingual retainers: group 1, 0.016 × 0.022-in dead-soft wire; group 2, 0.0215-in 5-strand stainless steel wire; group 3, 0.014 × 0.014-in computer-aided design/computer-aided manufacturing nitinol retainer (Memotain); group 4, connected bonding pads']","['mean value of the gingival index', 'Gingival inflammation and calculus accumulation', 'mean value of the calculus index', 'periodontal health and stability', ""periodontal health, and Little's irregularity index, intercanine width, and arch length measurements"", 'periodontal health or relapse', 'plaque index, intercanine width, and arch length', 'periodontal health and stability of mandibular anterior teeth', 'Plaque, gingival, and calculus indexes']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517399', 'cui_str': '0.022'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C5191068', 'cui_str': '0.014'}, {'cui': 'C0162517', 'cui_str': 'Computer-Assisted Design'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}]",132.0,0.0173005,"The mean value of the calculus index was the lowest in group 3, and there was a significant difference between group 3 and groups 1 and 2.","[{'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Adanur-Atmaca', 'Affiliation': ''}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Çokakoğlu', 'Affiliation': ''}, {'ForeName': 'Fırat', 'Initials': 'F', 'LastName': 'Öztürk', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/110220-904.1']
1490,33587122,Impact of meningococcal B vaccine on invasive meningococcal disease in adolescents.,"BACKGROUND


From 2017 a state-wide cluster randomized trial was conducted in South Australia to assess the impact of the meningococcal B vaccine 4CMenB on pharyngeal N. meningitidis carriage in adolescents. Senior schools were randomized to receive the vaccine in 2017 (intervention) or 2018 (control). In this study we report the vaccine impact of 4CMenB on serogroup B invasive meningococcal disease (IMD) in 16-19 year old adolescents in South Australia.
METHODS


This observational time series analysis of serogroup B IMD cases compares the 14 years prior to the commencement of the trial (2003-2016) with the two years following 4CMenB vaccination of the 2017 adolescent cohort.
RESULTS


Approximately 62% of year 10 and 11 students (15-16 years old) in South Australia enrolled in the trial. A total of 30,522 year 10-12 students received at least 1 dose of 4CMenB. The number of serogroup B IMD cases in 16-19 year old adolescents in South Australia increased on average by 10% per year from 2003 to 2016 (95% confidence interval [CI] 6%-15%, p<0·001), peaking with 10 cases in 2015. Serogroup B IMD cases reduced to 5 in 2017/18 and 1 in 2018/19, below the expected numbers of 9·9 (95% prediction interval [PI], 3·9-17·5) and 10·9 (95% PI, 4·4-19·1), respectively. This translated to an overall reduction in the number of serogroup B IMD cases of 71% (95% CI, 15%-90%, p=0·02). There were no serogroup B IMD cases in vaccinated adolescents.
CONCLUSIONS


Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia.",2021,"CONCLUSIONS


Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia.","['Senior schools', 'Approximately 62% of year 10 and 11 students (15-16 years old) in South Australia enrolled in the trial', '16-19 year old adolescents in South Australia', 'pharyngeal N. meningitidis carriage in adolescents', 'serogroup B IMD cases compares the 14 years prior to the commencement of the trial (2003-2016) with the two years following 4CMenB vaccination of the 2017 adolescent cohort', 'adolescents', 'A total of 30,522 year 10-12 students']","['meningococcal B vaccine', '4CMenB', 'meningococcal B vaccine 4CMenB', 'vaccine']","['serogroup B invasive meningococcal disease (IMD', 'number of serogroup B IMD cases']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C3873491', 'cui_str': 'Invasive meningococcal disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C3859491', 'cui_str': 'meningococcal group B vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C3873491', 'cui_str': 'Invasive meningococcal disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.171338,"CONCLUSIONS


Vaccinating adolescents with 4CMenB was associated with a reduction in group B meningococcal disease in South Australia.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McMillan', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.""}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Koehler', 'Affiliation': 'Communicable Disease Control Branch, SA Health, Adelaide, South Australia, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women & Kids, South Australian Health & Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Marshall', 'Affiliation': ""Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, South Australia, Australia.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1636']
1491,33587007,Saving patient x: A quasi-experimental study of teamwork and performance in simulation following an interprofessional escape room.,"Graduates of health professions programs are required to work collaboratively as part of interprofessional healthcare teams. The purpose of this study was to create and test the use of an interprofessional escape room, as a method to improve teamwork, prior to interprofessional simulation. The study evaluated performance in simulation with the Observed Interprofessional Collaboration tool and self-reported attitudes toward teamwork using the Interprofessional Socialization and Valuing Scale. A total of 233 students from professional nursing (n of 118) and pharmacy students (n of 115) were split into groups of four (two nursing, two pharmacy students). Groups were randomized to participate in the escape room first followed by simulation, or simulation first followed by the escape room. Results indicated median scores in simulation performance were higher for students who participated in an escape room before simulation compared to an escape room after simulation. There was no difference in the mean change in perceptions of teamwork from pre to post between students who participated in an escape room before simulation. Escape rooms can, in a brief period of time, improve teamwork and consequently performance during simulation. Findings support the use of escape rooms in interprofessional education curriculum as a method to promote teamwork.",2021,There was no difference in the mean change in perceptions of teamwork from pre to post between students who participated in an escape room before simulation.,['233 students from professional nursing (n of 118) and pharmacy students (n of 115'],[],['median scores in simulation performance'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C4517540', 'cui_str': '115'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",233.0,0.0149385,There was no difference in the mean change in perceptions of teamwork from pre to post between students who participated in an escape room before simulation.,"[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Foltz-Ramos', 'Affiliation': 'Department of Biobehavioral Health and Clinical Sciences, University at Buffalo School of Nursing , Buffalo, NY, USA.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Fusco', 'Affiliation': 'Department of Pharmacy Practice, University at Buffalo School of Pharmacy , Buffalo, NY, USA.'}, {'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Paige', 'Affiliation': 'Department of Nursing, Milwaukee School of Engineering , Milwaukee, WI, USA.'}]",Journal of interprofessional care,['10.1080/13561820.2021.1874316']
1492,33586858,Home-based multimodal exercise program in older people with Alzheimer disease: Randomized controlled trial protocol.,"BACKGROUND


At-home physical exercise may be an important intervention strategy for older people with Alzheimer disease (AD) due to the greater adherence and ease for the caregivers.
PURPOSE


Determine the effects home-based multimodal exercise program in older people with AD on muscle strength, balance, functioning, cognition, dual task performance, frailty, and physical activity level.
METHODS


This is a trial with 40 older people with mild and moderate AD, randomized into intervention group (IG) and control group (CG). The participants will be evaluated by blinded examiners at baseline and after 16 weeks of training. The evaluations will investigate functioning (Timed Up and Go test, Direct Assessment of Functional Status, WHO Disability Assessment Schedule, Short Physical Performance Battery, and Activities of Daily Living Questionnaire), muscle strength (manual dynamometer and Sit-to-Stand test), frailty (FRAIL Scale and Edmonton Frail Scale), cognition (Addenbrooke's Cognitive Examination, Trail Making Test, Walking Trail-Making Test, and Frontal Assessment Battery), balance (force platform, Figure-of-Eight Walking Test, Functional Reach Test, Alternate Step Test, and Calf-Raise Senior), dual task (force platform), and physical activity level (Modified Baecke Questionnaire and Life-Space Assessment). The IG will perform 16 weeks of exercise at home that involve functioning, strength, balance, and aerobic endurance in 60-min sessions three times a week. The CG will not undergo any intervention.
CONCLUSION


Improvements in the aspects evaluated are expected in the IG compared to CG. The protocol will provide a theoretical basis for the creation of clinical interventions and health promotion measures for older people with AD.",2021,"Timed Up and Go test, Direct Assessment of Functional Status, WHO Disability Assessment Schedule, Short Physical Performance Battery, and Activities of Daily Living Questionnaire), muscle strength (manual dynamometer and Sit-to-Stand test), frailty (FRAIL Scale and Edmonton Frail Scale), cognition (Addenbrooke's Cognitive Examination, Trail Making Test, Walking Trail-Making Test, and Frontal Assessment Battery), balance (force platform, Figure-of-Eight Walking Test, Functional Reach Test, Alternate Step Test, and Calf-Raise Senior), dual task (force platform), and physical activity level (Modified Baecke Questionnaire and Life-Space Assessment).","['older people with Alzheimer disease', 'older people with AD', 'older people with Alzheimer disease (AD', '40 older people with mild and moderate AD']","['intervention group (IG) and control group (CG', 'multimodal exercise program', 'Home-based multimodal exercise program']","['muscle strength, balance, functioning, cognition, dual task performance, frailty, and physical activity level', ""Timed Up and Go test, Direct Assessment of Functional Status, WHO Disability Assessment Schedule, Short Physical Performance Battery, and Activities of Daily Living Questionnaire), muscle strength (manual dynamometer and Sit-to-Stand test), frailty (FRAIL Scale and Edmonton Frail Scale), cognition (Addenbrooke's Cognitive Examination, Trail Making Test, Walking Trail-Making Test, and Frontal Assessment Battery), balance (force platform, Figure-of-Eight Walking Test, Functional Reach Test, Alternate Step Test, and Calf-Raise Senior), dual task (force platform), and physical activity level (Modified Baecke Questionnaire and Life-Space Assessment""]","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C2732353', 'cui_str': 'Frontal assessment battery'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",40.0,0.0537135,"Timed Up and Go test, Direct Assessment of Functional Status, WHO Disability Assessment Schedule, Short Physical Performance Battery, and Activities of Daily Living Questionnaire), muscle strength (manual dynamometer and Sit-to-Stand test), frailty (FRAIL Scale and Edmonton Frail Scale), cognition (Addenbrooke's Cognitive Examination, Trail Making Test, Walking Trail-Making Test, and Frontal Assessment Battery), balance (force platform, Figure-of-Eight Walking Test, Functional Reach Test, Alternate Step Test, and Calf-Raise Senior), dual task (force platform), and physical activity level (Modified Baecke Questionnaire and Life-Space Assessment).","[{'ForeName': 'Natália Oiring de Castro', 'Initials': 'NOC', 'LastName': 'Cezar', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Juliana Hotta', 'Initials': 'JH', 'LastName': 'Ansai', 'Affiliation': 'Graduate Program in Movement Sciences, Federal University of Mato Grosso do Sul (UFMS), Campo Grande, Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Larissa Pires', 'Initials': 'LP', 'LastName': 'de Andrade', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1899']
1493,33586819,Internet-based CBT Program with and without videoconference guidance sessions: A Randomized Controlled Trial to treat work-related symptoms of anxiety and depression.,"This study provides the results from the implementation of a highly structured therapist-guided iCBT program for people with work-related anxiety and depression, in terms of program efficacy, participants' adherence and satisfaction. Seventy-seven national police-workers were randomly allocated to one of two groups: without additional videoconference sessions (web platform with guidance of therapist), and with additional videoconference sessions (same intervention as the previous group, plus two videoconference guidance sessions with a psychologist). The intervention was comprised of 12 sessions and took place for 17-20 weeks. We found an adherence rate of 36.4%, with no differences between groups. All participants endorsed lower depression [BDI-II F(1) = 36.98, ρ < .001; ATQ F(1) = 24.22, ρ < .001], and anxiety [STAI-State F(1) = 76.62, ρ < .001] after the program. As a variable related to anxiety and depression in workplace, participants also showed higher assertiveness levels [RAS F(1) = 8.96, ρ < .001]. A significant reduction of the mean level of anxiety perceived by participants as the intervention program progressed was observed in both groups (F(2)=7.44; p=.003). Participants were satisfied with the therapists' intervention and with the program. No significant group effects were found for any of the measures. Reduction in depression levels was maintained in the 12 months follow-up, but levels of anxiety increased. This study is innovative, as it is the first controlled trial to analyze the effect of two added videoconference sessions, and it includes short and long term measures, which is not usual. The results are discussed to clarify the role of the contact with the therapist to improve treatment adherence.",2021,"All participants endorsed lower depression [BDI-II F(1) = 36.98, ρ < .001; ATQ F(1) = 24.22, ρ < .001], and anxiety [STAI-State F(1) = 76.62, ρ < .001] after the program.",['Seventy-seven national police-workers'],"['videoconference sessions (web platform with guidance of therapist), and with additional videoconference sessions (same intervention as the previous group, plus two videoconference guidance sessions with a psychologist', 'structured therapist-guided iCBT program', 'videoconference sessions', 'Internet-based CBT Program with and without videoconference guidance sessions']","['mean level of anxiety', 'depression levels', 'adherence rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0335234,"All participants endorsed lower depression [BDI-II F(1) = 36.98, ρ < .001; ATQ F(1) = 24.22, ρ < .001], and anxiety [STAI-State F(1) = 76.62, ρ < .001] after the program.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Calero Elvira', 'Affiliation': 'Departamento de Psicología Biológica y de la Salud. Universidad Autónoma de Madrid, Madrid, (España).'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santacreu Ivars', 'Affiliation': 'Facultad de Ciencias Biomédicas. Universidad Europea de Madrid. Villaviciosa de Odón, Madrid, (España).'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marchena Giráldez', 'Affiliation': 'Facultad de Educación y Psicología. Universidad Francisco de Vitoria. Pozuelo de Alarcón, Madrid, (España).'}, {'ForeName': 'Pei-Chun', 'Initials': 'PC', 'LastName': 'Shih', 'Affiliation': 'Departamento de Psicología Biológica y de la Salud. Universidad Autónoma de Madrid, Madrid, (España).'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2571']
1494,33586783,"The use of amnion-derived cellular cytokine solution for the treatment of gingivitis: A two week safety, dose-ranging, proof-of-principle randomized trial.","BACKGROUND


A 6-week Phase I clinical trial was performed to primarily evaluate the safety and secondarily determine the preliminary efficacy of a novel biological solution, ST266, comprised of a mixture of cytokines, growth factors, nucleic acids, and lipids secreted by cultured Amnion-derived Multi-potent Progenitor cells on gingival inflammation.
METHODS


Fifty-four adults with gingivitis/periodontitis were randomly assigned to 1X ST266 or diluted 0.3X ST266 or saline topically applied on facial/lingual gingiva (20μL/tooth). Safety was assessed through oral soft/hard tissue exam, adverse events, and routine laboratory tests. Efficacy was assessed by modified gingival index (MGI), bleeding on probing (BOP), plaque index (PI), pocket depth (PD) and clinical attachment level (CAL). Assessments were performed on Day 0, 8, 12 and 42. ST266 and saline applied daily starting at Day 0 through Day-12 except weekend days. Plasma was analyzed for safety and pro-inflammatory cytokines, interleukin 1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon gamma (IFN-γ). Gingival crevicular fluid (GCF) was analyzed for the same cytokines. Subgingival plaque was primarily analyzed by Checkerboard DNA-DNA hybridization. Comparisons with saline were modeled through a generalized estimating equations method adjusting for baseline.
RESULTS


No safety concern was found related to ST266. Statistically significant reduction in MGI was noted at Day 42 by 1X ST266 compared with saline (p = 0.044). PD and CAL were reduced by both doses of ST266 at Day 42 (p<0.01) and by 1X ST266 at Day 12 (p<0.05). GCF IL-1β and IL-6 levels were reduced by both doses of ST266 at Day 12 (p<0.05, p<0.01, respectively). IL-6 was also significantly reduced in plasma of both ST266 groups (p<0.05). Significant reductions in red complex bacteria were detected in both ST266 doses.
CONCLUSIONS


In this ""first in human oral cavity"" study, topical ST266 was safe and effective in reducing gingival inflammation in 6 weeks. Longitudinal studies with large sample sizes are warranted to assess the therapeutic value of this novel host modulatory compound in the treatment of periodontal diseases. This article is protected by copyright. All rights reserved.",2021,"GCF IL-1β and IL-6 levels were reduced by both doses of ST266 at Day 12 (p<0.05, p<0.01, respectively).","['Fifty-four adults with gingivitis/periodontitis', 'gingivitis']","['amnion-derived cellular cytokine solution', 'ST266 and saline', '1X ST266 or diluted 0.3X ST266 or saline topically applied on facial/lingual gingiva (20μL/tooth']","['Efficacy', 'Subgingival plaque', 'MGI', 'oral soft/hard tissue exam, adverse events, and routine laboratory tests', 'red complex bacteria', 'Gingival crevicular fluid (GCF', 'PD and CAL', 'gingival inflammation', 'IL-6', 'safety and pro-inflammatory cytokines, interleukin 1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon gamma (IFN-γ', 'GCF IL-1β and IL-6 levels', 'modified gingival index (MGI), bleeding on probing (BOP), plaque index (PI), pocket depth (PD) and clinical attachment level (CAL']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0008684', 'cui_str': 'Chronic gingivitis'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",54.0,0.208493,"GCF IL-1β and IL-6 levels were reduced by both doses of ST266 at Day 12 (p<0.05, p<0.01, respectively).","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Hasturk', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steed', 'Affiliation': 'Noveome Biotherapeutics, Inc., Pittsburgh, PA.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Tosun', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Martins', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Constantinos', 'Initials': 'C', 'LastName': 'Floros', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nguyen', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Maryann', 'Initials': 'M', 'LastName': 'Cugini', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Starr', 'Affiliation': ""Brigham and Women's Hospital, Channing Division of Network Medicine, Boston, MA.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Van Dyke', 'Affiliation': 'The Forsyth Institute, Center for Clinical and Translational Research, Cambridge, MA.'}]",Journal of periodontology,['10.1002/JPER.20-0800']
1495,33586578,Personal listening device usage among Canadians and audiometric outcomes among 6-29 year olds.,"OBJECTIVE


To describe personal listening device (PLD) usage and sociodemographic variables among a nationally representative sample of Canadians and examine audiometric outcomes among a subsample.
DESIGN


Audiometry and in-person questionnaires were used to evaluate hearing and PLD usage across age, sex, household income/education level. PLD exposure was quantified using a common occupational noise limit.
STUDY SAMPLE


A randomised sample of 10,460 respondents, aged 6-79, with audiometric analysis of a subsample (n = 4807), aged 6-29, tested between 2012 and 2015.
RESULTS


Loud PLD usage was reported by19.5% of Canadians. The highest prevalence was among teenagers (44.2%) and young adults (36.3%). Among children, 13.1% of users listened at loud volumes. High PLD usage (equivalent to or above 85 dBA, LEX 40) among 12-19 year olds was double that of 20-29 year olds: 10.2% versus 5.1% E . Five years or more of loud PLD usage was associated with significantly higher mean hearing thresholds compared to less years. No association between loud or high PLD usage and mean thresholds were found.
CONCLUSION


The majority used PLDs safely, however a small proportion reported high risk usage which will impact hearing should this pattern persist over many years.",2021,Five years or more of loud PLD usage was associated with significantly higher mean hearing thresholds compared to less years.,"['10,460 respondents, aged 6-79, with audiometric analysis of a subsample (n\u2009=\u20094807), aged 6-29, tested between 2012 and 2015', 'nationally representative sample of Canadians and examine audiometric outcomes among a subsample', 'Canadians and audiometric outcomes among 6-29 year olds']",['personal listening device (PLD'],['mean hearing thresholds'],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}]",10460.0,0.117563,Five years or more of loud PLD usage was associated with significantly higher mean hearing thresholds compared to less years.,"[{'ForeName': 'Katya', 'Initials': 'K', 'LastName': 'Feder', 'Affiliation': 'Non-Ionizing Radiation, Health Sciences Division, Health Canada, Ottawa, ON, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McNamee', 'Affiliation': 'Non-Ionizing Radiation, Health Sciences Division, Health Canada, Ottawa, ON, Canada.'}, {'ForeName': 'Leonora', 'Initials': 'L', 'LastName': 'Marro', 'Affiliation': 'Environmental Health Science and Research Bureau, Health Canada, Ottawa, ON, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Portnuff', 'Affiliation': 'UCHealth Hearing and Balance Clinic, Aurora, CO, USA.'}]",International journal of audiology,['10.1080/14992027.2021.1878398']
1496,33586572,Prolonged second stage effect on pelvic floor dysfunction: a follow up survey to a randomized controlled trial.,"BACKGROUND


Pelvic floor dysfunction is a group of disorders that can significantly impact quality of life due to persistent urinary and anal incontinence. Data evaluating the effect of prolonged second stage of labor and postpartum pelvic floor dysfunction is heterogenous and limited.
OBJECTIVE


To evaluate whether extending the length of labor in nulliparous women with prolonged second stage affects the presence of self-reported pelvic floor dysfunction after a randomized controlled trial of prolonged second stage.
STUDY DESIGN


We conducted a planned follow up survey to our randomized controlled trial of prolonged second stage of labor using the Pelvic Floor Distress Inventory-20 (PFDI-20). The primary outcome was the PFDI-20 summary score. Secondary outcomes included urinary and fecal incontinence, prolapse, and patient satisfaction. Women surveyed were nulliparous patients with epidural anesthesia, previously enrolled in a randomized controlled trial that assigned them to  extended labor , at least 1 additional hour in the second stage if they were undelivered after three hours, or to  usual labor , defined as expedited delivery after three hours in the second stage. Women were surveyed at 12 - 36 months postpartum.
RESULTS


Thirty-four of the seventy-eight women responded to the survey (43.6%). 17 women (50.0%) were from the extended labor group and 17 from the usual labor group (50.0%). Maternal demographic data were not significantly different between groups. The PFDI-20 summary score was 13.8 ± 23.3 in the extended labor group and 13.1 ± 20.9 in the usual labor group ( p  = 0.9). The Pelvic Organ Prolapse Distress Inventory-6 was 1.2 ± 2.9 in the extended labor group and 2.7 ± 6.4 in the usual labor group ( p  = 0.4). The Colorectal-Anal Distress Inventory-8 was 0.8 ± 2.8 in the extended labor group and 2.1 ± 4.0 in the usual labor group ( p  = 0.6). The Urinary Distress Inventory-6 was 11.8 ± 21.1 in the extended labor group and 8.3 ± 14.5 in the usual labor group ( p  = 0.6). Maternal and neonatal outcomes, as well as patient satisfaction, were not statistically significantly different between groups.
CONCLUSION


Extending the length of labor in nulliparas with singleton gestations, epidural anesthesia, and prolonged second stage did not have an impact on PFDI-20 scores at 12-36 months postpartum. However, our study was underpowered to detect small, but potentially clinically important, differences.
CLINICAL TRIAL NUMBER


NCT02101515 (Study Registration Date March 28, 2014) https://clinicaltrials.gov/ct2/show/NCT02101515.",2021,"Maternal and neonatal outcomes, as well as patient satisfaction, were not statistically significantly different between groups.
","['nulliparous women with prolonged second stage affects the presence of self-reported pelvic floor dysfunction after a randomized controlled trial of prolonged second stage', 'Women surveyed were nulliparous patients with', '17 women (50.0%) were from the extended labor group and 17 from the usual labor group (50.0', 'Thirty-four of the seventy-eight women responded to the survey (43.6']",['epidural anesthesia'],"['PFDI-20 summary score', 'PFDI-20 scores', 'Urinary Distress Inventory-6', 'Maternal and neonatal outcomes', 'Maternal demographic data', 'urinary and fecal incontinence, prolapse, and patient satisfaction', 'pelvic floor dysfunction', 'Pelvic Organ Prolapse Distress Inventory-6']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C4041537', 'cui_str': 'Pelvic floor dysfunction'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}]",17.0,0.190902,"Maternal and neonatal outcomes, as well as patient satisfaction, were not statistically significantly different between groups.
","[{'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Gimovsky', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, The George Washington University School of Medicine and Health Sciences, Washington DC, USA.'}, {'ForeName': 'Jaclyn M', 'Initials': 'JM', 'LastName': 'Phillips', 'Affiliation': ""Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Women's Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Amero', 'Affiliation': 'Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'Alexandria Health, Cambridge, MA, USA.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2021.1887122']
1497,33586543,Development and feasibility of the prenatal video-feedback intervention to promote positive parenting for expectant fathers.,"Objective : the transition period in which men become fathers might provide an important window of opportunity for parenting interventions that may produce long-term positive effects on paternal care and, consequently, child development. Existing prenatal programs traditionally focus on maternal and infant health and seldom involve the father.  Study design : This paper describes an interaction-based prenatal parenting intervention program for first-time fathers using ultrasound images, the Prenatal video Feedback Intervention to promote Positive Parenting (VIPP-PRE). We randomised a group of expectant fathers ( N  = 73) to either the VIPP-PRE or a control condition.  Results : Expectant fathers thought the VIPP-PRE was more helpful and influenced their insights into their babies to a greater extent than the control condition. Expectant fathers receiving the VIPP-PRE reported that they particularly liked seeing and interacting with their unborn children as well as receiving feedback on these interactions. The intervention was well received and was considered feasible by both expectant fathers and sonographers and midwives.  Discussion : We discuss the VIPP-PRE based on the experiences and perspectives of fathers, interveners, and sonographers and midwives.",2021,Expectant fathers thought the VIPP-PRE was more helpful and influenced their insights into their babies to a greater extent than the control condition.,"['Expectant fathers receiving the', 'expectant fathers', 'expectant fathers ( N  =\xa073', 'Discussion ']","['interaction-based prenatal parenting intervention program', 'VIPP-PRE or a control condition', 'prenatal video-feedback intervention', 'VIPP-PRE', 'Prenatal video Feedback Intervention']",[],"[{'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],,0.0179079,Expectant fathers thought the VIPP-PRE was more helpful and influenced their insights into their babies to a greater extent than the control condition.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Alyousefi-van Dijk', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioural and Movement Sciences, Vrije Universiteit , Amsterdam, The Netherlands.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'de Waal', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioural and Movement Sciences, Vrije Universiteit , Amsterdam, The Netherlands.'}, {'ForeName': 'Marinus H', 'Initials': 'MH', 'LastName': 'van IJzendoorn', 'Affiliation': 'Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam , Rotterdam, The Netherlands.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Bakermans-Kranenburg', 'Affiliation': 'Clinical Child & Family Studies, Faculty of Behavioural and Movement Sciences, Vrije Universiteit , Amsterdam, The Netherlands.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2021.1886258']
1498,33586526,Line- and Point-Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Placebo-Controlled RCT Study.,"BACKGROUND


Extracorporeal shock wave therapy (ESWT) is a widely considered treatment option for Achilles tendinopathy. Line-focused ESWT is a novel technique treating a larger tendon area than point-focused ESWT. Monitoring capacities of clinical symptoms with ultrasound under ESWT treatment are unknown.
HYPOTHESIS


Point- and line-focused ESWT have a superior outcome than placebo ESWT. ESWT leads to morphological tendon changes detectable with ultrasound.
STUDY DESIGN


Single-blinded placebo-controlled randomized contolled trial.
LEVEL OF EVIDENCE


Level 1.
METHODS


The study was conducted in 3 cohorts, namely ESWT point (n = 21), ESWT line (n = 24), and ESWT placebo (n = 21). Victorian Institute of Sports Assessment-Achilles (VISA-A) score was measured before the intervention (T0), after 6 weeks (T1), and after 24 weeks (T2). All cohorts performed daily physiotherapy for 24 weeks and received 4 sessions of point-focused, line-focused, or placebo ESWT in the first 6 weeks. Ultrasound was performed with B-mode, power Doppler, shear wave elastography (SWE) at T0 and T2 and with ultrasound tissue characterization (UTC) at T0, T1, and T2. Data were analyzed with a mixed analysis of variance and  t  test.
RESULTS


There was a significant VISA-A improvement over time for all groups ( P  < 0.001). ESWT point had the strongest VISA-A score improvement +23 (ESWT line: +18; ESWT placebo: +15), but there was no significant interaction between time and any of the groups:  F (4, 116) = 1.393;  P  = 0.24. UTC, power Doppler, and B-mode could not show significant alterations over time. SWE revealed a significant increase of elastic properties for ESWT point in the insertion ( t  = -3.113,  P  = 0.03) and midportion ( t  = -2.627,  P  = 0.02) over time.
CONCLUSION


There is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo. Tendon adaptation could only be detected with SWE for ESWT point.
CLINICAL RELEVANCE


The present study could not detect any statistically relevant effect of ESWT compared to placebo. SWE is able to demonstrate tendon adaptation.",2021,There is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo.,"['Achilles Tendinopathy', '3 cohorts, namely ESWT point (n = 21), ESWT line (n = 24), and', 'n = 21']","['Line-focused ESWT', 'ESWT placebo', 'ESWT', 'placebo', 'placebo ESWT', 'Line- and Point-Focused Extracorporeal Shock Wave Therapy', 'SWE', 'Victorian Institute of Sports Assessment-Achilles', 'Placebo', 'Extracorporeal shock wave therapy (ESWT']","['Tendon adaptation', 'VISA-A) score', 'elastic properties']","[{'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0713169,There is a significant VISA-A score improvement for all study groups without a statistically significant benefit for ESWT point or ESWT line compared with ESWT placebo.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gatz', 'Affiliation': 'Department of Orthopaedic Surgery, RWTH Aachen University Clinic, Aachen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schweda', 'Affiliation': 'Department of Orthopaedic Surgery, RWTH Aachen University Clinic, Aachen, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Betsch', 'Affiliation': 'Department of Orthopaedic Surgery, RWTH Aachen University Clinic, Aachen, Germany.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Dirrichs', 'Affiliation': 'Department of Radiology, RWTH Aachen University Clinic, Aachen, Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'de la Fuente', 'Affiliation': 'Chair of Medical Engineering, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Reinhardt', 'Affiliation': 'Chair of Medical Engineering, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Quack', 'Affiliation': 'Department of Orthopaedic Surgery, RWTH Aachen University Clinic, Aachen, Germany.'}]",Sports health,['10.1177/1941738121991791']
1499,33586478,Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients.,"Background Asymptomatic proximal deep vein thrombosis (DVT) is an end point frequently used to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Recently, the clinical relevance of asymptomatic DVT has been challenged. Methods and Results The objective of this study was to evaluate the relationship between asymptomatic proximal DVT and all-cause mortality (ACM) using a cohort analysis of a randomized trial for the prevention of venous thromboembolism (VTE) in acutely ill medical patients. Patients who received at least 1 dose of study drug and had an adequate compression ultrasound examination of the legs on either day 10 or day 35 were categorized into 1 of 3 cohorts: no VTE, asymptomatic proximal DVT, or symptomatic DVT. Cox proportional hazards model, with adjustment for significant independent predictors of mortality, were used to compare the incidences of ACM. Of the 7036 patients, 6776 had no VTE, 236 had asymptomatic DVT, and 24 had symptomatic VTE. The incidence of ACM was 4.8% in patients without VTE. Both asymptomatic proximal DVT (mortality, 11.4%; hazard ratio [HR], 2.31; 95% CI, 1.52-3.51;  P <0.0001) and symptomatic VTE (mortality, 29.2%; HR, 9.42; 95% CI, 4.18-21.20;  P <0.0001) were independently associated with significant increases in ACM. The analysis was post hoc, and ultrasound results were not available for all patients. Adjustment for baseline variables significantly associated with ACM may not fully compensate for differences. Conclusions Asymptomatic proximal DVT is associated with higher ACM than no VTE and remains a relevant end point to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00571649.",2021,"Both asymptomatic proximal DVT (mortality, 11.4%; hazard ratio [HR], 2.31; 95% CI, 1.52-3.51;  P <0.0001) and symptomatic VTE (mortality, 29.2%; HR, 9.42; 95% CI, 4.18-21.20;  P <0.0001) were independently associated with significant increases in ACM.","['7036 patients, 6776 had no VTE, 236 had asymptomatic DVT, and 24 had symptomatic VTE', 'Patients who received at least 1 dose of study drug and had an adequate compression ultrasound examination of the legs on either day 10 or day 35 were categorized into 1 of 3 cohorts: no VTE, asymptomatic proximal DVT, or symptomatic DVT', 'acutely ill medical patients', 'medical patients', 'Acutely Ill Medical Patients']","[' Asymptomatic proximal deep vein thrombosis (DVT', 'venous thromboembolism (VTE']","['ACM', 'incidence of ACM', 'symptomatic VTE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",7036.0,0.0917011,"Both asymptomatic proximal DVT (mortality, 11.4%; hazard ratio [HR], 2.31; 95% CI, 1.52-3.51;  P <0.0001) and symptomatic VTE (mortality, 29.2%; HR, 9.42; 95% CI, 4.18-21.20;  P <0.0001) were independently associated with significant increases in ACM.","[{'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public HealthUniversity of Oklahoma Health Sciences Center Oklahoma City OK.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'The Feinstein Institutes for Medical Research and Zucker School of Medicine at Hofstra/Northwell Anticoagulation and Clinical Thrombosis Services Department of Medicine Northwell Health at Lenox Hill Hospital New York NY.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Hematological Medicine Guys and St Thomas/NHS Foundation Trust, King's College London London United Kingdom.""}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and the Thrombosis and Atherosclerosis Research Institute Hamilton Ontario Canada.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery University of Insubria Varese Italy.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'De Sanctis', 'Affiliation': 'Statistics and Data Insights Bayer US LLC Whippany NJ.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Biostatistics Department Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Biostatistics Department Janssen Research and Development LLC Raritan NJ.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Albanese', 'Affiliation': 'Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sugarmann', 'Affiliation': 'Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Lipardi', 'Affiliation': 'Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer US, LLC Whippany NJ.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Cardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJ.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.019459']
1500,33586476,"Description of content, structure and theoretical model of a group-based pain management programme in the treatment of patients with persistent non-specific low back pain and psychological risk factors in a secondary sector setting.","OBJECTIVE


To present the theoretical foundation and methodological considerations for a group-based pain management programme for patients with persistent non-specific low back pain and psychosocial risk factors.
METHOD


The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework for describing the content, structure and context of the program. The theoretical rationale underlying the pain management programme was described using the first three steps of the Intervention Mapping framework. The Fear-avoidance model and the Self-efficacy Theory were identified as the two main theories. These were used to establish specific factors addressed by the pain management programme as well as expected outcomes.
INTERVENTION DESCRIPTION


A multidisciplinary, group-based programme using a cognitive-behavioural approach was developed. The programme consisting of six sessions of two hours duration, took place at a spine clinic at a regional hospital in Denmark. Psychoeducation and cognitive restructuring were specific strategies hypothesised to induce changes in outcome measures. The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity. A pilot study was performed, subsequent adjustments made and the final content and educational materials completed by January 2017.
CONCLUSION


The theoretical foundation and underlying evidence for the hypothesised change mechanisms in the use of a cognitive-behavioural approach was presented. A theoretically sound and practically feasible intervention has been developed and its effectiveness is being determined in a randomised controlled trial, including 130 low back pain patients, which is currently underway.",2021,"The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity.","['patients with persistent non-specific low back pain and psychological risk factors in a secondary sector setting', '130 low back pain patients', 'patients with persistent non-specific low back pain and psychosocial risk factors']",['pain management programme'],"['disability, quality of life, sick leave and physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",130.0,0.0281036,"The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity.","[{'ForeName': 'Mette Høj', 'Initials': 'MH', 'LastName': 'Skovbo', 'Affiliation': 'Spine Clinic, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Agerbo', 'Affiliation': 'Spine Clinic, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Clinical Social Medicine and Rehabilitation, Gødstrup Hospital, Herning, Denmark.'}, {'ForeName': 'Stine Aalkjær', 'Initials': 'SA', 'LastName': 'Clausen', 'Affiliation': 'Spine Clinic, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Langagergaard', 'Affiliation': 'Department of Clinical Social Medicine and Rehabilitation, Gødstrup Hospital, Herning, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Spine Clinic, Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}]",Clinical rehabilitation,['10.1177/0269215521995185']
1501,33586475,"The effect of foot orthoses on balance, foot function, and mobility in rheumatoid arthritis: A randomized controlled clinical trial.","OBJECTIVES


To compare balance, foot function and mobility in patients with rheumatoid arthritis with and without foot orthoses.
DESIGN


Randomized controlled trial.
SETTING


Outpatient rheumatology clinic.
SUBJECTS


A total of 94 subjects with rheumatoid arthritis were randomized; of these, 81 were included in the analyses (Intervention group: 40; Control group: 41).
INTERVENTION


The Intervention Group received custom-made foot orthoses while the Control Group received none intervention.
MAIN MEASURE


The ""Foot Function Index,"" the ""Berg Balance Scale,"" and the ""Timed-up-and-go Test"" were assessed at baseline an after four weeks. The chosen level of significance was  P  < 0.05.
RESULTS


Average (standard deviation) participant age was 56.7 (±10.6) years old and average disease duration (standard deviation) was 11.4 (± 7.2) years. Groups were similar at baseline, except for comorbidity index and race. After four weeks, significant interaction group versus time was observed for Foot Function Index (change: Intervention group: -1.23 ± 1.58; Control group: -0.12 ± 1.16 -  P  = 0.0012) and for Berg Balance Scale (change: Intervention group: 2 ± 3; Control group: 0 ± 3 -  P  = 0.0110), but not for the Timed-up-and-go Test (change: Intervention group: -1.34 ± 1.99; Control group: -0.84 ± 2.29 -  P  = 0.0799).
CONCLUSION


Foot orthoses improved foot function and balance in patients with rheumatoid arthritis.",2021,"Intervention group: 2 ± 3; Control group: 0 ± 3 -  P  = 0.0110), but not for the Timed-up-and-go Test (change: Intervention group: -1.34 ± 1.99; Control group: -0.84 ± 2.29 -  P  = 0.0799).
","['94 subjects with rheumatoid arthritis were randomized; of these, 81 were included in the analyses (Intervention group: 40; Control group: 41', 'patients with rheumatoid arthritis', 'Average (standard deviation) participant age was 56.7 (±10.6)\u2009years old and average disease duration (standard deviation) was 11.4 (± 7.2)\u2009years', 'patients with rheumatoid arthritis with and without foot orthoses', 'Outpatient rheumatology clinic', 'rheumatoid arthritis']","['foot orthoses', 'Intervention group: 2\u2009±\u20093; Control group: 0\u2009±\u20093 -  P \u2009=\u20090.0110), but not for the Timed-up-and-go Test (change: Intervention group: -1.34\u2009±\u20091.99; Control group: -0.84\u2009±\u20092.29 -  P \u2009=\u20090.0799', 'Foot orthoses', 'custom-made foot orthoses while the Control Group received none intervention']","['Foot Function Index (change', 'foot function and balance', 'balance, foot function, and mobility']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",94.0,0.0411686,"Intervention group: 2 ± 3; Control group: 0 ± 3 -  P  = 0.0110), but not for the Timed-up-and-go Test (change: Intervention group: -1.34 ± 1.99; Control group: -0.84 ± 2.29 -  P  = 0.0799).
","[{'ForeName': 'Juliana Zonzini', 'Initials': 'JZ', 'LastName': 'Gaino', 'Affiliation': 'Department of Internal Medicine, Rheumatology, Faculty of Medical Sciences, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Manoel Barros', 'Initials': 'MB', 'LastName': 'Bértolo', 'Affiliation': 'Department of Internal Medicine, Rheumatology, Faculty of Medical Sciences, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Caroline Silva', 'Initials': 'CS', 'LastName': 'Nunes', 'Affiliation': 'Orthoses and Prostheses Unit, Clinical Hospital, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Cecília de Morais', 'Initials': 'CM', 'LastName': 'Barbosa', 'Affiliation': 'Department of Internal Medicine, Gerontology, Faculty of Medical Sciences, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Síbila Floriano', 'Initials': 'SF', 'LastName': 'Landim', 'Affiliation': 'Department of Internal Medicine, Rheumatology, Faculty of Medical Sciences, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Zoraida', 'Initials': 'Z', 'LastName': 'Sachetto', 'Affiliation': 'Department of Internal Medicine, Rheumatology, Faculty of Medical Sciences, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Eduardo de Paiva', 'Initials': 'EP', 'LastName': 'Magalhães', 'Affiliation': 'Orthoses and Prostheses Unit, Clinical Hospital, State University of Campinas-Unicamp, Campinas, São Paulo, Brazil.'}]",Clinical rehabilitation,['10.1177/0269215521993316']
1502,33586474,"The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial.","OBJECTIVE


To use secondary data from the Taking Charge after Stroke study to explore mechanisms for the positive effect of the Take Charge intervention on physical health, advanced activities of daily living and independence for people after acute stroke.
DESIGN


An open, parallel-group, randomised trial with two active and one control intervention and blinded outcome assessment.
SETTING


Community.
PARTICIPANTS


Adults ( n  = 400) discharged to community, non-institutional living following acute stroke.
INTERVENTIONS


One, two, or zero sessions of the Take Charge intervention, a self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery.
MEASURES


Twelve months after stroke: Mood (Patient Health Questionnaire-2, Mental Component Summary of the Short Form 36); 'ability to Take Charge' using a novel measure, the Autonomy-Mastery-Purpose-Connectedness (AMP-C) score; activation (Patient Activation Measure); body mass index (BMI), blood pressure (BP) and medication adherence (Medication Adherence Questionnaire).
RESULTS


Follow-up was near-complete (388/390 (99.5%)) of survivors at 12 months. Mean age (SD) was 72.0 (12.5) years. There were no significant differences in mood, activation, 'ability to Take Charge', medication adherence, BMI or BP by randomised group at 12 months. There was a significant positive association between baseline AMP-C scores and 12-month outcome for control participants (1.73 (95%CI 0.90 to 2.56)) but not for the Take Charge groups combined (0.34 (95%CI -0.17 to 0.85)).
CONCLUSION


The mechanism by which Take Charge is effective remains uncertain. However, our findings support a hypothesis that baseline variability in motivation, mastery and connectedness may be modified by the Take Charge intervention.",2021,"There were no significant differences in mood, activation, 'ability to Take Charge', medication adherence, BMI or BP by randomised group at 12 months.","['Mean age (SD) was 72.0 (12.5) years', 'people after acute stroke', 'Adults ( n \u2009=\u2009400) discharged to community, non-institutional living following acute stroke', 'Community']","['Take Charge intervention', 'Charge intervention']","[""mood, activation, 'ability to Take Charge', medication adherence, BMI or BP"", ""stroke: Mood (Patient Health Questionnaire-2, Mental Component Summary of the Short Form 36); 'ability to Take Charge' using a novel measure, the Autonomy-Mastery-Purpose-Connectedness (AMP-C) score; activation (Patient Activation Measure); body mass index (BMI), blood pressure (BP) and medication adherence (Medication Adherence Questionnaire"", 'physical health, advanced activities of daily living and independence', 'baseline AMP-C scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2706101', 'cui_str': 'PHQ-2'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2.0,0.188185,"There were no significant differences in mood, activation, 'ability to Take Charge', medication adherence, BMI or BP by randomised group at 12 months.","[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'McNaughton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Department of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'McPherson', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fu', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Taylor', 'Affiliation': 'Rehabilitation Teaching and Research Unit, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thomson', 'Affiliation': 'Hutt Valley District Health Board, Lower Hutt, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gommans', 'Affiliation': 'Hawkes Bay District Health Board, Hastings, New Zealand.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Green', 'Affiliation': 'Counties-Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Matire', 'Initials': 'M', 'LastName': 'Harwood', 'Affiliation': 'Te Kupenga Hauora Māori, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Annemarei', 'Initials': 'A', 'LastName': 'Ranta', 'Affiliation': 'Department of Medicine, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Hanger', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}]",Clinical rehabilitation,['10.1177/0269215521993648']
1503,33591012,Prior Exposure to Angiotensin II Receptor Blockers in Patients With Septic Shock to Individualize Mean Arterial Pressure Target? A Post Hoc Analysis of the SEPSISPAM Trial.,"OBJECTIVES


Individualizing a target mean arterial pressure is challenging during the initial resuscitation of patients with septic shock. The SEPSISPAM trial suggested that targeting high mean arterial pressure might reduce the occurrence of acute kidney injury among those included patients with a past history of chronic hypertension. We investigated whether the class of antihypertensive medications used before the ICU stay in chronic hypertensive patients was associated with the severity of acute kidney injury occurring after inclusion, according to mean arterial pressure target.
DESIGN


Post hoc analysis of the SEPSISPAM trial.
SETTING


The primary outcome was the occurrence of severe acute kidney injury during the ICU stay defined as kidney disease improving global outcome stage 2 or higher. Secondary outcomes were mortality at day 28 and mortality at day 90.
PATIENTS


All patients with chronic hypertension included in SEPSISPAM with available antihypertensive medications data in the hospitalization report were included.
MEASUREMENTS AND MAIN RESULTS


We analyzed 297 patients. Severe acute kidney injury occurred in 184 patients, without difference according to pre-ICU exposure to antihypertensive medications. Patients with pre-ICU exposure to angiotensin II receptor blockers had significantly less severe acute kidney injury in the high mean arterial pressure target group (adjusted odd ratio 0.24 with 95% CI [0.09-0.66]; p = 0.006). No statistically significant association was found after adjustment for pre-ICU exposure to antihypertensive medications and survival.
CONCLUSIONS


Our results suggest that patients with septic shock and chronic hypertension treated with angiotensin II receptor blocker may benefit from a high mean arterial pressure target to reduce the risk of acute kidney injury occurrence.",2021,Patients with pre-ICU exposure to angiotensin II receptor blockers had significantly less severe acute kidney injury in the high mean arterial pressure target group (adjusted odd ratio 0.24 with 95% CI [0.09-0.66]; p = 0.006).,"['patients with septic shock and chronic hypertension', 'Patients With Septic Shock to Individualize Mean Arterial Pressure Target', 'chronic hypertensive patients', 'patients with septic shock', 'All patients with chronic hypertension included in SEPSISPAM with available antihypertensive medications data in the hospitalization report were included']","['Angiotensin II Receptor Blockers', 'angiotensin II receptor blockers', 'angiotensin II receptor blocker']","['mortality at day 28 and mortality', 'Severe acute kidney injury', 'severe acute kidney injury', 'occurrence of severe acute kidney injury during the ICU stay defined as kidney disease improving global outcome stage 2 or higher']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}]",297.0,0.122298,Patients with pre-ICU exposure to angiotensin II receptor blockers had significantly less severe acute kidney injury in the high mean arterial pressure target group (adjusted odd ratio 0.24 with 95% CI [0.09-0.66]; p = 0.006).,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Demiselle', 'Affiliation': ""Department of Medical Intensive Care, University Hospital of Angers, Angers, France. Service de Biométrie, Institut de Cancérologie de l'Ouest, Centre Paul Papin, Angers, France. Department of Medical Intensive Care, University Hospital of Strasbourg, Nouvel Hôpital Civil, Strasbourg, France. INSERM (French National Institute of Health and Medical Research), UMR 1260, Regenerative Nanomedicine (RNM), FMTS, Strasbourg, France. Medical and Surgical Intensive Care Unit, Le Mans Hospital, Le Mans, France. Department of Medical and Toxicological Intensive Care, Lariboisière University Hospital, University of Paris, INSERM UMRS-1144, Paris, France. Department of Medical Intensive Care, Bicêtre University Hospital, AP-HP, Paris-Saclay University, Le Kremlin Bicêtre, France. Department of Medical Intensive Care, Cochin University Hospital, Paris, France. Department of Medical Intensive Care, Tours University Hospital, Tours, France. Department of Surgical Intensive Care, University Hospital of Angers, Angers, France. Department of Medical Intensive Care, Georges Pompidou European Hospital, Paris, France. Department of Medical Intensive Care, Saint Brieuc Hospital, Saint Brieuc, France. Department of Infectious Diseases and Medical Intensive Care, Rennes University Hospital, Rennes, France. Department of Medical Intensive Care, Nancy University Hospital, Nancy, France. Department of Medical Intensive Care, Université de Poitiers, CHU Poitiers, Poitiers, France. Department of Medical and Surgical Intensive Care, Avicenne Teaching Hospital, Bobigny, France. Department of Medical Intensive Care, Nantes University Hospital, Nantes, France. Department of Medical Intensive Care, Rouen University Hospital, Rouen, France. Department of Medical Intensive Care, Brest University Hospital, Brest, France. Department of Medical and Surgical Intensive Care, Versailles Hospital, Versailles, France. Department of Intensive Care, Saint Philibert hospital, Catholic university of Lille, Lille, France. Department of Medical and Surgical Intensive Care, Boulogne Billancourt University Hospital, Boulogne Billancourt, France. Inserm U1018, Center for Research in Epidemiology and Population Health (CESP), Faculty of Paris Saclay, Villejuif, France. Department of Intensive Care, Saint Louis Hospital, Paris, France. Department of Intensive Care, Avignon Hospital, Avignon, France. Department of Medical and Surgical Intensive Care, La Rochelle Saint Louis Hospital, La Rochelle, France. Department of Medico-Surgical Intensive Care, Université de Paris, Assistance Publique - Hôpitaux de Paris, Louis Mourier Hospital, Colombes, France. Department of Medical and Surgical Intensive Care, Quimper Hospital, Quimper, France. Department of Medical Intensive Care, Caen University Hospital, Caen, France. Department of Medical Intensive Care, Edouard Herriot Hospital, Lyon, France. ImmunoRhumatologie Moléculaire, INSERM UMR_S1109, LabEx TRANSPLANTEX, Centre de Recherche d'Immunologie et d'Hématologie, Faculté de Médecine, Fédération Hospitalo-Universitaire (FHU) OMICARE, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg (UNISTRA), Strasbourg, France. Institut für Anästhesiologische Pathophysiologie und Verfahrensentwicklung, Universitätsklinikum, Helmholtzstrasse 8-1, Ulm, Germany.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Seegers', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lemerle', 'Affiliation': ''}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': ''}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Grelon', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Anguel', 'Affiliation': ''}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': ''}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dequin', 'Affiliation': ''}, {'ForeName': 'Soizic', 'Initials': 'S', 'LastName': 'Gergaud', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'Francçois', 'Initials': 'F', 'LastName': 'Legay', 'Affiliation': ''}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Le Tulzo', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Conrad', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Gonzalez', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Tamion', 'Affiliation': ''}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Tonnelier', 'Affiliation': ''}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bédos', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Van Der Linden', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Vieillard-Baron', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Mariotte', 'Affiliation': ''}, {'ForeName': 'Gaël', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lesieur', 'Affiliation': ''}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': ''}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Hervé', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'du Cheyron', 'Affiliation': ''}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Guerin', 'Affiliation': ''}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Teboul', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Helms', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Radermacher', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004872']
1504,33591006,Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study.,"OBJECTIVES


To determine the safety and efficacy of human chorionic gonadotropin hormone-derivative EA-230 in cardiac surgery patients. Cardiac surgery induces systemic inflammation and may impair renal function, affecting patient outcome. EA-230 exerted immunomodulatory and renoprotective effects in preclinical models and was safe and showed efficacy in phase I and II human studies.
DESIGN


Double-blinded, placebo-controlled, randomized study.
SETTING


Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands.
PATIENTS


One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery.
INTERVENTIONS


Ninety mg/kg/hr EA-230 or placebo administered during surgery.
MEASUREMENTS AND MAIN RESULTS


During the study, no safety concerns emerged. EA-230 did not modulate interleukin-6 plasma concentrations (area under the curve 2,730 pg/mL × hr [1,968-3,760] vs 2,680 pg/mL × hr [2,090-3,570] for EA-230 and placebo group, respectively; p = 0.80). Glomerular filtration rate increased following surgery (mean ± SEM increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01). The ""injury"" stage of the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease criteria for acute kidney injury was 7% in the EA-230 group versus 18% in the placebo group (p = 0.07). In addition, EA-230-treated patients had a less positive fluid balance compared with placebo-treated patients (217 ± 108 vs 605 ± 103 mL; p = 0.01), while the use of vasoactive agents was similar in both groups (p = 0.39). Finally, hospital length of stay was shorter in EA-230 treated patients (8 d [7-11] vs 10 d [8-12]; p = 0.001). Efficacy results were more pronounced in patients that had longer duration of surgery and thus longer duration of study drug infusion.
CONCLUSIONS


EA-230 was safe in patients undergoing on-pump cardiac surgery. It did not modulate interleukin-6 plasma concentrations but appeared to exert beneficial renal and cardiovascular effects and shortened in-hospital length of stay.",2021,Glomerular filtration rate increased following surgery (mean ± SEM increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01).,"['cardiac surgery patients', 'Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands', 'One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery', 'patients undergoing on-pump cardiac surgery', 'Cardiac Surgery Patients']","['placebo', 'Human Chorionic Gonadotropin Hormone-Derivative EA-230', 'EA-230 and placebo', 'EA-230 or placebo', 'human chorionic gonadotropin hormone-derivative EA-230', 'Placebo']","['interleukin-6 plasma concentrations', 'hospital length of stay', 'Glomerular filtration rate', 'safety and efficacy', 'glomerular filtration rate', 'glomerular filtration rateiohexol', 'positive fluid balance', 'Safety and Efficacy']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C4079739', 'cui_str': 'EA-230'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}]",180.0,0.573229,Glomerular filtration rate increased following surgery (mean ± SEM increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01).,"[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'van Groenendael', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, Nijmegen, The Netherlands. Radboud Institute for Molecular Life Sciences (RIMLS), Radboud University Medical Center, Nijmegen, The Netherlands. Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Department of Cardiothoracic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands. Exponential Biotherapies, Inc. (EBI), The Hague, The Netherlands.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Beunders', 'Affiliation': ''}, {'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Hemelaar', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hofland', 'Affiliation': ''}, {'ForeName': 'Wim J', 'Initials': 'WJ', 'LastName': 'Morshuis', 'Affiliation': ''}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': ''}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Gerretsen', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Wensvoort', 'Affiliation': ''}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Kooistra', 'Affiliation': ''}, {'ForeName': 'Wout J', 'Initials': 'WJ', 'LastName': 'Claassen', 'Affiliation': ''}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Waanders', 'Affiliation': ''}, {'ForeName': 'Maud G A', 'Initials': 'MGA', 'LastName': 'Lamberts', 'Affiliation': ''}, {'ForeName': 'Leonie S E', 'Initials': 'LSE', 'LastName': 'Buijsse', 'Affiliation': ''}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': ''}, {'ForeName': 'Lucas T', 'Initials': 'LT', 'LastName': 'van Eijk', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004847']
1505,33591004,von Willebrand Factor Multimer Formation Contributes to Immunothrombosis in Coronavirus Disease 2019.,"OBJECTIVES


Prevention and therapy of immunothrombosis remain crucial challenges in the management of coronavirus disease 2019, since the underlying mechanisms are incompletely understood. We hypothesized that endothelial damage may lead to substantially increased concentrations of von Willebrand factor with subsequent relative deficiency of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13).
DESIGN


Prospective controlled cross-over trial.
SETTING


Blood samples of patients with confirmed coronavirus disease 2019 and healthy controls were obtained in three German hospitals and analyzed in a German hemostaseologic laboratory.
PATIENTS


Seventy-five patients with confirmed coronavirus disease 2019 of mild to critical severity and 30 healthy controls.
MEASUREMENTS AND MAIN RESULTS


von Willebrand factor antigen, ADAMTS13, and von Willebrand factor multimer formation were analyzed. von Willebrand factor antigen was 4.1 times higher in COVID-19 patients compared with healthy controls (p < 0.0001), whereas ADAMTS13 activities were not significantly different (p = 0.18). The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001). Fourteen patients (18.7%) undercut a critical ratio of 10 as described in thrombotic thrombocytopenic purpura. Gel analysis of multimers resembled a thrombotic thrombocytopenic purpura pattern with loss of the largest multimers in 75% and a smeary triplet pattern in 39% of the patients. The ADAMTS13/von Willebrand factor antigen ratio decreased continuously from mild to critical disease (analysis of variance p = 0.026). Furthermore, it differed significantly between surviving patients and those who died from COVID-19 (p = 0.001) yielding an area under the curve of 0.232 in receiver operating characteristic curve curve analysis.
CONCLUSION


COVID-19 is associated with a substantial increase in von Willebrand factor levels, which can exceed the ADAMTS13 processing capacity resulting in the formation of large von Willebrand factor multimers indistinguishable from thrombotic thrombocytopenic purpura. The ADAMTS13/von Willebrand factor antigen ratio is an independent predictor of severity of disease and mortality. These findings provide a rationale to consider plasma exchange as a therapeutic option in COVID-19 and to include von Willebrand factor and ADAMTS13 in the diagnostic workup.",2021,The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001).,"['patients with confirmed coronavirus disease 2019 and healthy controls were obtained in three German hospitals and analyzed in a German hemostaseologic laboratory', 'Seventy-five patients with confirmed coronavirus disease 2019 of mild to critical severity and 30 healthy controls']",['ADAMTS13'],"['thrombotic thrombocytopenic purpura', 'ADAMTS13/von Willebrand factor antigen ratio', 'activities', 'von Willebrand factor antigen', 'von Willebrand factor antigen, ADAMTS13, and von Willebrand factor multimer formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",[],"[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0370148', 'cui_str': 'von Willebrand factor multimer'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",75.0,0.0414936,The ADAMTS13/von Willebrand factor antigen ratio was significantly lower in COVID-19 than in the control group (24.4 ± 20.5 vs 82.0 ± 30.7; p < 0.0001).,"[{'ForeName': 'Adrian A N', 'Initials': 'AAN', 'LastName': 'Doevelaar', 'Affiliation': 'Medical Department I, University Hospital Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany. Department of Intensive Care and Ventilatory Medicine, Asklepios Klinikum Hamburg Harburg, Hamburg, Germany. Department of Infectiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Department of Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Department of Microbiology and Molecular Genetics, Michigan State University, East Lansing, MI. Department of Hemostaseology, MEDILYS Laborgesellschaft mbH, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': ''}, {'ForeName': 'Bodo', 'Initials': 'B', 'LastName': 'Hölzer', 'Affiliation': ''}, {'ForeName': 'Felix S', 'Initials': 'FS', 'LastName': 'Seibert', 'Affiliation': ''}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Rohn', 'Affiliation': ''}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': ''}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Dittmer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': ''}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Dittmer', 'Affiliation': ''}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Schneppenheim', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Babel', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Budde', 'Affiliation': ''}, {'ForeName': 'Timm H', 'Initials': 'TH', 'LastName': 'Westhoff', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004918']
1506,33590999,The Impact of Preintubation Noninvasive Ventilation on Outcomes in Pediatric Acute Respiratory Distress Syndrome.,"OBJECTIVES


There is evidence that noninvasive ventilation decreases the need for invasive mechanical ventilation. However, children with pediatric acute respiratory distress syndrome who fail noninvasive ventilation may have worse outcomes than those who are intubated without exposure to noninvasive ventilation. Our objective was to evaluate the impact of preintubation noninvasive ventilation on children with pediatric acute respiratory distress syndrome.
DESIGN


Secondary analysis of data from the Randomized Evaluation of Sedation Titration for Respiratory Failure trial.
SETTING


Thirty-one PICUs in the United States.
PATIENTS


Children 2 weeks to 17 years old with pediatric acute respiratory distress syndrome receiving invasive mechanical ventilation, excluding those admitted with tracheostomies.
INTERVENTIONS


None.
MEASUREMENTS AND MAIN RESULTS


Of 2,427 subjects receiving invasive mechanical ventilation, preintubation noninvasive ventilation was used in 995 (41%). Compared with subjects without preintubation noninvasive ventilation use, subjects with preintubation noninvasive ventilation use were more likely to have a history of seizures (10% vs 8%; p = 0.04) or cancer (11% vs 6%; p < 0.001) and have moderate or severe pediatric acute respiratory distress syndrome by the end of their first full day of invasive mechanical ventilation (68% vs 60%; p < 0.001). Adjusting for age, severity of illness on PICU admission, and baseline functional status, preintubation noninvasive ventilation use resulted in longer invasive mechanical ventilation duration (median 7.0 vs 6.0 d), longer PICU (10.8 vs 8.9 d), and hospital (17 vs 14 d) lengths of stay, and higher 28-day (5% vs 4%) and 90-day (8% vs 5%) inhospital mortalities (all comparisons p < 0.001). Longer duration of noninvasive ventilation before intubation was associated with worse outcomes.
CONCLUSIONS


In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use. These data can be used to inform the design of clinical studies to evaluate best noninvasive ventilation practices in children with pediatric acute respiratory distress syndrome.",2021,"In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use.","['2,427 subjects receiving', 'children with pediatric acute respiratory distress syndrome', 'Thirty-one PICUs in the United States', 'Pediatric Acute Respiratory Distress Syndrome', 'Children 2 weeks to 17 years old with pediatric acute respiratory distress syndrome receiving invasive mechanical ventilation, excluding those admitted with tracheostomies']","['noninvasive ventilation', 'preintubation noninvasive ventilation', 'Preintubation Noninvasive Ventilation']","['longer PICU', 'history of seizures', 'inhospital mortalities', 'moderate or severe pediatric acute respiratory distress syndrome', 'invasive mechanical ventilation duration', 'Longer duration of noninvasive ventilation', 'invasive mechanical ventilation, preintubation noninvasive ventilation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",2427.0,0.134644,"In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use.","[{'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Kopp', 'Affiliation': ""Department of Pediatrics, Sacred Hearts Children's Hospital, Spokane, WA. Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI. Section of, Critical Care, Children's Hospital of Wisconsin, Milwaukee, WI. Department of Cardiology, Boston Children's Hospital, Boston, MA. Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA. Department of Pediatrics, Harvard Medical School, Boston, MA. Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA. Department of Anesthesia and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Rainer G', 'Initials': 'RG', 'LastName': 'Gedeit', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Asaro', 'Affiliation': ''}, {'ForeName': 'Gwenn E', 'Initials': 'GE', 'LastName': 'McLaughlin', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ''}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004819']
1507,33590955,Successful improved peripheral tissue perfusion was seen in patients with atherosclerosis after 12 months of treatment with aged garlic extract.,"Patients with arteriolosclerosis have impaired microvascular perfusion leading to impaired wound healing. Aged garlic extract has shown to have a positive impact on vascular elasticity. The present study aimed to assess the effect of long-term treatment with AGE on peripheral tissue perfusion in patients with confirmed atherosclerosis. Ninety three patients with a CT-scan confirmed coronary artery arteriolosclerosis were randomised in a double-blind manner to placebo or 2400 mg AGE daily for 1 year. Peripheral tissue perfusion was evaluated at 0- and 12-months using Laser Speckle Contrast Imaging. Measurement of post occlusive reactive hyperemia (PORH) and cutaneous vascular conductance (CVC) using acetylcholine iontophoresis (Ach) was conducted. After 12 months a significant increase of 21.6% (95% CI 3.2%-40.0%, P < .05) was seen in the relative change of PORH in the AGE compared with the placebo group. The same response was seen for CVC and Ach with an increase of 21.4% (95% CI 3.4%-39.4%, P < .05) in the AGE group compared with the placebo group. Aged garlic extract regenerated peripheral tissue perfusion and increase microcirculation in patients with arteriolosclerosis. Adequate peripheral tissue perfusion and tissue oxygen tension are important prerequisites for successful tissue repair. Restored microcirculation in patients could hypothetically facilitate wound healing.",2021,"After 12 months a significant increase of 21.6% (95% CI 3.2%-40.0%, P < .05) was seen in the relative change of PORH in the AGE compared with the placebo group.","['Ninety three patients with a CT-scan confirmed coronary artery arteriolosclerosis', 'patients with confirmed atherosclerosis', 'patients with arteriolosclerosis']","['acetylcholine iontophoresis (Ach', 'placebo', 'aged garlic extract', 'Aged garlic extract', 'AGE']","['Measurement of post occlusive reactive hyperemia (PORH) and cutaneous vascular conductance (CVC', 'Peripheral tissue perfusion', 'peripheral tissue perfusion and increase microcirculation', 'peripheral tissue perfusion']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0878486', 'cui_str': 'Arteriolosclerosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0429877', 'cui_str': 'Tissue perfusion measure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}]",93.0,0.255947,"After 12 months a significant increase of 21.6% (95% CI 3.2%-40.0%, P < .05) was seen in the relative change of PORH in the AGE compared with the placebo group.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lindstedt', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Science, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Martiné', 'Initials': 'M', 'LastName': 'Wlosinska', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Science, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Science, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hlebowicz', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Fakhro', 'Affiliation': 'Department of Cardiothoracic Surgery and Transplantation, Clinical Science, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Sheikh', 'Affiliation': 'Department of Ophthalmology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.'}]",International wound journal,['10.1111/iwj.13570']
1508,33590950,A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis.,"OBJECTIVE


The objective of this study was to assess the efficacy of self-administered patient educational tools in improving knowledge and behaviors for the management of knee osteoarthritis.
METHODS


We conducted a randomized clinical trial in patients with knee osteoarthritis to assess the efficacy of providing a video for entertainment education, in combination with two booklets, compared with providing the booklets alone. We evaluated changes in scores on a patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self-Efficacy Scale, and the Effective Consumer Scale between baseline and same day, 3 months, and 6 months post intervention. We used linear regression models to explore associations between demographic characteristics and outcomes, testing for interactions.
RESULTS


Two hundred nineteen participants were randomly assigned to receive the video + booklets (n = 109) or the booklets alone (n = 110). The mean age of participants was 64.6 (±8.3) years. At 6 months, statistically significant improvements were observed in knowledge and decisional conflict scores for both groups, and statistically significant improvements in the behavior to participate in their health care were observed in the video + booklets group. The video + booklets group was more knowledgeable immediately post intervention than the booklet group (mean difference 0.39 [95% confidence interval 0.02-0.76]). No other significant changes in outcomes were observed at 6 months between the two groups. The video + booklets combination was associated with decreased decisional conflict in Spanish speakers and increased self-efficacy in those with less than a high school education.
CONCLUSION


Although both education strategies were associated with improved knowledge and reduced decisional conflict at 6 months, receiving the video + booklets in combination, compared with receiving the booklets alone, proved to be more effective in changing behaviors and appeared to have some advantages for Spanish speakers and those who were less educated.",2021,"We evaluated changes in scores on a patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self-Efficacy Scale, and the Effective Consumer Scale between baseline and same day, 3 months, and 6 months post intervention.","['The mean age of participants was 64.6 (±8.3) years', 'patients with knee osteoarthritis', 'Patients With Knee Osteoarthritis', 'Two hundred nineteen participants']","['booklets alone', 'self-administered patient educational tools', 'video + booklets']","['knowledge and behaviors', 'behavior to participate in their health care', 'knowledge and decisional conflict scores', 'patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self-Efficacy Scale, and the Effective Consumer Scale', 'self-efficacy', 'knowledge and reduced decisional conflict', 'decisional conflict']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",219.0,0.0641655,"We evaluated changes in scores on a patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self-Efficacy Scale, and the Effective Consumer Scale between baseline and same day, 3 months, and 6 months post intervention.","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lopez-Olivo', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Jude K', 'Initials': 'JK', 'LastName': 'des Bordes', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Rizvi', 'Affiliation': 'Memorial Hermann, Houston, Texas.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Suarez-Almazor', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston.'}]",ACR open rheumatology,['10.1002/acr2.11222']
1509,33590829,Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE.,"OBJECTIVE


To evaluate the impact of upadacitinib vs placebo and adalimumab treatment, on patient-reported outcomes (PROs) in SELECT-COMPARE in an active RA population with inadequate responses to methotrexate (MTX-IR).
METHODS


PROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included PtGA and pain by VAS, HAQ-DI, 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, FACIT-F, and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) and scores ≥ normative values were evaluated.
RESULTS


Upadacitinib and adalimumab resulted in greater LSM changes from baseline vs placebo across all PROs (p < 0.05) at week 12, and pain and AM stiffness severity (p < 0.05) at week 2. More upadacitinib- vs placebo-treated (p < 0.05) and similar percentages of upadacitinib- vs adalimumab-treated patients reported improvements ≥ MCID across all PROs at week 12. Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and SF-36 Physical Component Summary (PCS) (all p < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients reported scores ≥ normative values in HAQ-DI and SF-36 PCS (p < 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients maintained clinically meaningful improvements in PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness through 48 weeks.
CONCLUSION


In MTX-IR patients with RA, treatment with upadacitinib resulted in statistically significant and clinically meaningful improvements in PROs equivalent to or greater than with adalimumab.",2021,"Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and SF-36 Physical Component Summary (PCS) (all p < 0.05) at week 12.","['patients with rheumatoid arthritis', 'patients receiving']","['upadacitinib vs placebo and adalimumab', 'placebo', 'adalimumab', 'upadacitinib (15\u2009mg QD), placebo, or adalimumab (40\u2009mg EOW', 'upadacitinib- vs placebo', 'upadacitinib- vs adalimumab', 'methotrexate (MTX-IR', 'Upadacitinib vs adalimumab']","['scores ≥ normative values in HAQ-DI and SF-36 PCS ', 'PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and SF-36 Physical Component Summary (PCS', 'PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness', 'PtGA and pain by VAS, HAQ-DI, 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, FACIT-F, and work instability', 'PROs equivalent', 'pain and AM stiffness severity', 'Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) and scores ≥ normative values', 'LSM changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",,0.142443,"Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and SF-36 Physical Component Summary (PCS) (all p < 0.05) at week 12.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Tundia', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ostor', 'Affiliation': 'Cabrini Medical Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Durez', 'Affiliation': 'Rheumatology, Cliniques universitaires Saint-Luc-Université catholique de Louvain-Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Enejosa', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Schlacher', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Analysis Group, Inc, Boston, MA, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, MCRC, Dallas, TX, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keab158']
1510,33590823,Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder.,"STUDY OBJECTIVES


Changes to sleep architecture that occur as a result of the normal aging process may also exacerbate insomnia in older individuals. Therefore, this study assessed the impact of lemborexant compared with placebo and zolpidem tartrate extended release on objective sleep architecture parameters, as measured by PSG, in older (≥ 55 years) adults with insomnia disorder from study 304.
METHODS


Study E2006-G000-304 (Study 304; SUNRISE-1; NCT02783729) was a global, multicenter, randomized, double-blind, placebo-controlled, active comparator (zolpidem)-controlled, parallel-group study comparing 2 dose levels of lemborexant (5 mg and 10 mg). Sleep architecture was measured using PSG. Assessments were collected at baseline during a single-blind placebo run-in, and during the first 2 nights (Nights 1/2) and last 2 nights (Nights 29/30) of treatment. Mean values for each sleep stage were based on the 2 consecutive PSGs.
RESULTS


Treatment with lemborexant resulted in significantly greater increases from baseline in total sleep time compared with both placebo and zolpidem. Significant increases from baseline in rapid eye movement sleep (stage R sleep), and significant decreases from baseline in latency to stage R sleep, were also observed with lemborexant compared with placebo and zolpidem.
CONCLUSIONS


These findings suggest that treatment with lemborexant may address some of the alterations in sleep architecture normally observed in older individuals with insomnia.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1); Identifier: NCT02783729; URL: https://clinicaltrials.gov/ct2/show/NCT02783729.",2021,"RESULTS


Treatment with lemborexant resulted in significantly greater increases from baseline in total sleep time compared with both placebo and zolpidem.","['Study E2006-G000-304', 'older adults with insomnia disorder', 'Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1', 'older individuals with insomnia', 'older individuals', 'older (≥ 55 years) adults with insomnia disorder from study 304']","['zolpidem', 'placebo', 'lemborexant', 'placebo-controlled, active comparator (zolpidem)-controlled, parallel-group study comparing 2 dose levels of lemborexant', 'lemborexant with placebo and zolpidem tartrate', 'placebo and zolpidem tartrate', 'Lemborexant']","['rapid eye movement sleep (stage R sleep', 'objective sleep architecture parameters', 'sleep architecture', 'latency to stage R sleep', 'Mean values', 'Sleep architecture', 'total sleep time']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}]","[{'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0475286', 'cui_str': 'Residual tumor stage'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.246789,"RESULTS


Treatment with lemborexant resulted in significantly greater increases from baseline in total sleep time compared with both placebo and zolpidem.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'Community Research, Cincinnati, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9150']
1511,33590781,What faculty write versus what students see? Perspectives on multiple-choice questions using Bloom's taxonomy.,"BACKGROUND


Using revised Bloom's taxonomy, some medical educators assume they can write multiple choice questions (MCQs) that specifically assess higher (analyze, apply) versus lower-order (recall) learning. The purpose of this study was to determine whether three key stakeholder groups (students, faculty, and education assessment experts) assign MCQs the same higher- or lower-order level.
METHODS


In Phase 1, stakeholders' groups assigned 90 MCQs to Bloom's levels. In Phase 2, faculty wrote 25 MCQs specifically intended as higher- or lower-order. Then, 10 students assigned these questions to Bloom's levels.
RESULTS


In Phase 1, there was low interrater reliability within the student group (Krippendorf's alpha = 0.37), the faculty group (alpha = 0.37), and among three groups (alpha = 0.34) when assigning questions as higher- or lower-order. The assessment team alone had high interrater reliability (alpha = 0.90). In Phase 2, 63% of students agreed with the faculty as to whether the MCQs were higher- or lower-order. There was low agreement between paired faculty and student ratings (Cohen's Kappa range .098-.448, mean .256).
DISCUSSION


For many questions, faculty and students did not agree whether the questions were lower- or higher-order. While faculty may try to target specific levels of knowledge or clinical reasoning, students may approach the questions differently than intended.",2021,"There was low agreement between paired faculty and student ratings (Cohen's Kappa range .098-.448, mean .256).
",[],[],['low interrater reliability'],[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0243744,"There was low agreement between paired faculty and student ratings (Cohen's Kappa range .098-.448, mean .256).
","[{'ForeName': 'Seetha U', 'Initials': 'SU', 'LastName': 'Monrad', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan Medical School (UMMS), Ann Arbor, MA, USA.'}, {'ForeName': 'Nikki L', 'Initials': 'NL', 'LastName': 'Bibler Zaidi', 'Affiliation': 'RISE innovation unit, University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Karri L', 'Initials': 'KL', 'LastName': 'Grob', 'Affiliation': 'Office of Medical School Education, University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Kurtz', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Tai', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hortsch', 'Affiliation': 'Department of Cell and Developmental Biology, University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Gruppen', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MA, USA.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Santen', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}]",Medical teacher,['10.1080/0142159X.2021.1879376']
1512,33590594,"The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-blind, Randomized Cross-over Study.","AIMS AND OBJECTIVES


The aim of this study was to assess the effect of vibration stimulation application in ventrogluteal region on intramuscular injection pain and patient satisfaction.
BACKGROUND


Intramuscular injection pain caused distress for the patients and affected their compliance with the treatment.
DESIGN


This was a prospective, single-blind, crossover study. The study complied with the guidelines of Consolidated Standards of Reporting Trials (CONSORT).
METHODS


Eighty-four patients who applied to the adult emergency department received an intramuscular injection of amoxicillin\ cefuroxime sodium to the ventrogluteal site with and without vibration in a random order following a standard procedure by the same investigator. Pain and satisfaction were assessed immediately after the injection with Visual Analogue Scale (VAS), by a researcher blinded to the study. The data were evaluated using mean, standard deviation, percentage, Student t test, Paired Sample T test, Linear Regression Analysis and Generalized Linear Mixed Model.
RESULTS


A total of 174 injections were analyzed. The result of the study revealed that vibration decreased the severity of pain and increased the patient satisfaction.
CONCLUSIONS


Vibration is a non-pharmacologic approach, which can be effective in decreasing the injection pain and increasing patient satisfaction.
RELEVANCE TO CLINICAL PRACTICE


Intramuscular injection is the most frequently used nursing practice in the clinic. The use of vibration in decreasing pain due to intramuscular applications can help increase the self-confidence of nurses and the quality of the care they provide.",2021,The use of vibration in decreasing pain due to intramuscular applications can help increase the self-confidence of nurses and the quality of the care they provide.,['Eighty-four patients who applied to the adult emergency department received an'],"['Vibration Stimulation', 'vibration stimulation application', 'intramuscular injection of amoxicillin\\ cefuroxime sodium to the ventrogluteal site with and without vibration']","['Pain and satisfaction', 'Intramuscular Injection Pain and Patient Satisfaction', 'Visual Analogue Scale (VAS', 'severity of pain']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0701852', 'cui_str': 'Cefuroxime sodium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",174.0,0.0597249,The use of vibration in decreasing pain due to intramuscular applications can help increase the self-confidence of nurses and the quality of the care they provide.,"[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Dincer', 'Affiliation': 'Istanbul Medeniyet University Faculty of Health Sciences, Department of Internal Medicine Nursing,Istanbul Medeniyet University, Health Science Faculty, Cevizli Yerleşkesi.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yıldırım', 'Affiliation': 'İstanbul Sabahattin Zaim University, Faculty of Health Sciences, Department of Nursing, Halkalı Street No:2, Halkalı Küçükçekmece/ İstanbul, Turkey.'}]",Journal of clinical nursing,['10.1111/jocn.15715']
1513,33590582,Invited Commentary: A randomized trial comparing prescribed light exercise to standard management for emergency department patients with acute mild TBI.,"Persistent post-concussion symptoms (PCS) after a mild traumatic brain injury (mTBI) or concussion do not occur in the majority of patients sustaining such injuries, but when they do occur, they have significant functional consequences for patients. Delays in return to school, work, recreational, and social activities can deeply impact quality of life and have major long-term negative life consequences that are anything but mild, despite the classification of the initial injury. Predictive abilities to determine which patients will suffer PCS are currently poor, although certain presentation characteristics may be associated, such as age at injury, the occurrence and timing of prior concussions, the mechanism of injury, and others. Research into utilization of various biomarkers as predictive tools is underway but clear answers are still forthcoming.",2021,"Predictive abilities to determine which patients will suffer PCS are currently poor, although certain presentation characteristics may be associated, such as age at injury, the occurrence and timing of prior concussions, the mechanism of injury, and others.",['emergency department patients with acute mild TBI'],['light exercise'],[],"[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0446987,"Predictive abilities to determine which patients will suffer PCS are currently poor, although certain presentation characteristics may be associated, such as age at injury, the occurrence and timing of prior concussions, the mechanism of injury, and others.","[{'ForeName': 'Shelly D', 'Initials': 'SD', 'LastName': 'Timmons', 'Affiliation': 'Professor and Betsey Barton Chair of Neurological Surgery, Chair, Department of Neurosurgery, Co-Director, Neuroscience Institute, Indiana University School of Medicine, Indiana University Health and IU Health Physicians, 355 West 16th Street, Suite 5100, Indianapolis, IN, 46202, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14233']
1514,33590499,Assessment of sensory outcomes after successful fingertip replantation with or without nerve repair according to amputation level.,"BACKGROUND


Good sensory outcome in fingertip replantation is a major part of the success of reconstruction and using the finger. Although some sensorial outcomes have been reported in various series in the literature, there is no controlled study, which demonstrates the anatomical levels where nerve repair should or should not be performed. We aimed to assess sensorial outcomes of fingertip amputations with or without nerve coaptation according to amputation level.
METHODS


Between January 2013 and July 2018, patients with Tamai Zone 1 and Zone 2 amputations underwent replantation. The patients were divided two main groups. Patients underwent nerve coaptation were grouped as Group 1, and those coaptation not performed as Group 2. In addition, subgroups were designed according to level of the amputation. Tamai zone 1 amputations were grouped as groups 1a and 2a. Tamai zone 2 amputations were grouped as groups 1b and 2b. The mean age was 30.8 ± 30.8 years in Group 1a, 33.2 ± 12.6 years in Group 1b, 34.1 ± 13.6 years in Group 2a, 34.3 ± 11.1 years in Group 2b. Type of injury were evaluated as clean cut (with knife, saw etc.), moderately crushed, and severely crushed and/or avulsion. In Group 1a, one prominent branch of the nerve was repaired, and in Group 1b, the nerve in both side was repaired. The mean duration of replantation in Group 1a was 1 h and 40 min (1 h and 15 min-2 h), whereas this time was 1 h and 15 min (1 h - 1 h and 35 min) in Group 2a. Then, 2 h 15 min (1 h and 55 min-2 h and 50 min) in Group 1b, and 2 h (1 h and 45-2 h 25 min) in Group 2b. Mean age, type of injury and length of follow-up were statistically compared. Sensorial outcome was evaluated by 2-point discrimination test and the Semmes-Weinstein test.
RESULTS


According to the Semmes-Weinstein test, 33% of the fingers tested were normal, 58% had diminished light touch, 8% had diminished protective sensation, and 0% had loss of protective sensation in Group 1a; In Group 1b, these values were 35% (7/20), 55% (11/20), 10% (2/20), 0%; in Group 2a, 38% (6/16), 56% (9/16), 6% (1/16), 0%; in Group 2b, 25% (4/16), 44% (7/16), %25 (4/16), 6% (1/16), respectively Mean static two-point discriminations in Groups 1a, 1b, 2a, and 2b were 4.17 ± 0.58, 4.55 ± 0.69, 4.25 ± 0.68, and 5.9 ± 1.26 mm, respectively. The mean follow-up duration was 24 months in Group 1a, 24 months in Group 1b, 26 months in Group 2a, 21 months in Group 2b. Then, 17 (3 in Group 1a, 6 in Group 1b, 4 in Group 2a, 4 in Group 2b) of the 64 fingers were clean cut amputation, 45 (9 in Group 1a, 14 in Group 1b, 11 in Group 2a, 11 in Group 2b) were moderately crushed amputation, and 2 (1 in Group 2a, 1 in Group 2b) were severely crushed and/or avulsion injury. There was no statistically significant difference between groups 1a and 2a (p = .71). On the other hand, there was a statistically significant increase in sensory outcomes of patients in Group 1b compared to Group 2b (p = .009). There was no statistically significant between the groups in terms of mean age, type of injury and length of follow-up.
CONCLUSION


We think that nerve repair does not have a positive effect on sensorial recovery in Tamai Zone 1 amputations, but nerve coaptation should be performed in Tamai Zone 2 replantations if possible for better sensorial result.",2021,"There was no statistically significant between the groups in terms of mean age, type of injury and length of follow-up.
","['Between January 2013 and July 2018, patients with Tamai Zone 1 and Zone 2 amputations underwent replantation', 'The mean age was 30.8\u2009±\u200930.8\u2009years in Group 1a, 33.2\u2009±\u200912.6\u2009years in Group 1b, 34.1\u2009±\u200913.6\u2009years in Group 2a, 34.3\u2009±\u200911.1\u2009years in Group 2b']","['fingertip amputations with or without nerve coaptation', 'successful fingertip replantation with or without nerve repair']","['light touch', 'protective sensation', 'mean age, type of injury and length of follow-up', 'mean follow-up duration', 'sensory outcomes', 'mean duration of replantation', 'loss of protective sensation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191358', 'cui_str': '30.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441862', 'cui_str': 'Group 1A'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0441863', 'cui_str': 'Group 1B'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0441866', 'cui_str': 'Group 2A'}, {'cui': 'C0441867', 'cui_str': 'Group 2B'}]","[{'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0196775', 'cui_str': 'Neuroplasty'}]","[{'cui': 'C0423553', 'cui_str': 'Light touch'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449499', 'cui_str': 'Type of injury'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",,0.0282877,"There was no statistically significant between the groups in terms of mean age, type of injury and length of follow-up.
","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Dadaci', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Mehmet Emin Cem', 'Initials': 'MEC', 'LastName': 'Yildirim', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Kendir', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Bilsev', 'Initials': 'B', 'LastName': 'Ince', 'Affiliation': 'Department of Plastic Reconstructive and Aesthetic Surgery, Necmettin Erbakan University, Konya, Turkey.'}]",Microsurgery,['10.1002/micr.30721']
1515,33590487,Effects of Prekindergarten Curricula: Tools of the Mind as a Case Study.,"Research demonstrates that children's participation in quality early childhood care and education often has immediate positive effects on their social-emotional, self-regulation, and achievement outcomes. Most of the research on the impacts of early child care and education has focused narrowly on the United States, but advocacy for economic and social investment in early childhood care and education to support future children's growth and well-being now exists on an international scale. The longer-term outcomes from prekindergarten programs have not been as strong. To improve children's long-term outcomes, one suggested strategy is an intentional, scripted curriculum. Our goal in this monograph is to provide a fully integrated and comprehensive account of a large-scale, longitudinal, field-based randomized control trial of the Tools of the Mind (Internal consistency of the Tools) prekindergarten curriculum that occurred in the United States. Our intent is twofold. First, we examine the impact of the Tools curriculum itself, addressing both the potential impacts of the curriculum to improve prekindergarten quality and children's academic, executive function, self-regulation, and social outcomes. Second, we consider the broader question of whether the use of intentional, scripted curricula during early education can, more generally, enhance both short- and long-term outcomes in children. Developed from a Vygotskian framework, Tools focuses on equipping children with cognitive tools for learning that they can then apply to the task of acquiring and sustaining academic knowledge as well as behavioral competencies. Thus, Tools is an integrated, comprehensive curriculum, not a supplementary one. The Tools approach follows from a socio-cultural perspective on child development that emphasizes children's acquisition of skills and cultural tools in collaboration with knowledgeable others. The methodology of the 4-year longitudinal cluster randomized control trial is described in detail. We provide comprehensive information about recruitment, randomization of treatment condition, child assessment instrumentation and procedures, as well as observational assessments, including fidelity of implementation and teacher and child classroom behaviors. We provide results comparing 32 classrooms assigned to the Tools condition and 28 assigned to the business-as-usual control condition for children's academic, executive function, self-regulation, and social gains from prekindergarten to the end of first grade. Developers of the curriculum specifically expected to see benefits on these measures. There were no positive effects for Tools on any of the outcomes. The lack of expected curriculum effects required careful consideration and raised more general questions about how curriculum experiences manifest themselves in assessed skills. As a first step to understanding the findings, we focused on teachers who were implementing Tools and examined the degree to which the curriculum was delivered as intended and the relations between fidelity of implementation and children's outcomes in prekindergarten. Results indicated a wide variation in observed fidelity of implementation but no consistent associations between fidelity of implementation and any child outcomes. In terms of more general practices and interactions associated with positive student outcomes, developers of the curriculum hypothesized that implementing Tools would enhance classroom practices and teacher-child interactions. Among the aspects they expected to be affected were the amount of non-instructional behaviors, teacher-led and child-directed activities, teacher and child talk, social learning interactions, classroom emotional climate, quality of teacher instruction, and children's level of involvement. Teachers varied as much within treatment and control classrooms as they did between conditions on most of the aspects examined. We found no differences between experimental conditions on most practices and interactions. Curricula vary in scope and content, but they are universally intended to change classroom processes in ways that in turn will facilitate the development of targeted skills. For this mediational hypothesis to hold, the targeted classroom processes must be associated with child outcomes. We examined the associations between the classroom processes and children's prekindergarten and kindergarten gains and found support for their importance in early childhood classrooms. These findings demonstrate the value of identifying strategies to enhance these classroom practices and interactions. We situate the findings of our study within the larger context of early childhood education expansion policies and practices, and we offer a set of lessons learned. The study we report is a single evaluation of a single curriculum, yet we hold that the lessons learned are general and shed light on understanding why evaluations of curriculum have yielded such mixed results.",2021,There were no positive effects for Tools on any of the outcomes.,"['children', 'early childhood classrooms']",[],"[""prekindergarten quality and children's academic, executive function, self-regulation, and social outcomes""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0279535,There were no positive effects for Tools on any of the outcomes.,"[{'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Nesbitt', 'Affiliation': 'Human Development and Family Studies, University of New Hampshire.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Farran', 'Affiliation': 'Peabody College, Vanderbilt University.'}]",Monographs of the Society for Research in Child Development,['10.1111/mono.12425']
1516,33590280,Initial clinical experience with the new thulium fiber laser: first 50 cases.,"OBJECTIVE


To evaluate the efficacy, safety, and laser settings of thulium fiber laser (TFL) in laser lithotripsy during retrograde intrarenal surgery (RIRS) for ureteral and renal stones.
METHODS


A prospective study of the first 50 patients with ureteral and renal stones who underwent RIRS using TFL (SOLTIVE Premium, Olympus, Japan) was performed. 200 and 150 µm laser fibers were used for ureteral and renal stones, respectively. Stone size, stone density, laser-on time (LOT), and laser settings were recorded. We also assessed the ablation speed (mm 3 /s), laser power (W), and Joules/mm 3  values for each lithotripsy.
RESULTS


A total of 50 patients were included in the study with a median (IQR) age of 66 (55.5-74) years old for patients with ureteral stones and 55 (44-61.5) years old for patients with renal stones. Most of the patients had a Charlson comorbidity index score of 0. Median (IQR) stone volume for ureteral stones was 486 (332-1250) mm 3  and for renal stones was 1800 (682.8-2760) mm 3 . Median (IQR) stone density for ureteral and renal stones was 998 (776-1300) HU and 1200 (750-1300) HU, respectively. Median (IQR) pulse energy for ureteral stones was 0.4 (0.2-0.4) J; and for renal stones, 0.3 (0.2-0.6) J. Median pulse frequency, laser power, and laser operative time were higher in the renal stones group. The overall complication rate was low in both groups.
CONCLUSION


TFL is a safe and effective modality for lithotripsy during RIRS with minimal complication rates.",2021,"The overall complication rate was low in both groups.
","['50 patients with ureteral and renal stones who underwent RIRS using TFL (SOLTIVE Premium, Olympus, Japan) was performed', 'A total of 50 patients were included in the study with a median (IQR) age of 66 (55.5-74) years old for patients with ureteral stones and 55 (44-61.5) years old for patients with renal stones']","['new thulium fiber laser', 'laser lithotripsy during retrograde intrarenal surgery (RIRS', 'TFL', 'thulium fiber laser (TFL']","['Charlson comorbidity index score', 'Median (IQR) stone volume for ureteral stones', 'Median pulse frequency, laser power, and laser operative time', 'Median (IQR) stone density for ureteral and renal stones', 'Median (IQR) pulse energy for ureteral stones', 'Stone size, stone density, laser-on time (LOT), and laser settings', 'overall complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0300642,"The overall complication rate was low in both groups.
","[{'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Sorbonne University GRC Urolithiasis No. 20 Tenon Hospital, 75020, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': 'Sorbonne University GRC Urolithiasis No. 20 Tenon Hospital, 75020, Paris, France. olivier.traxer@aphp.fr.'}]",World journal of urology,['10.1007/s00345-021-03616-6']
1517,33590270,How Many Maneuvers Should We Do for Maximal Inspiratory and Expiratory Muscle Pressure Testing in Children: A Retrospective Review in Children with Cystic Fibrosis.,"OBJECTIVES


Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) could be useful clinical parameters in monitoring many conditions including cystic fibrosis (CF). However, current protocols for undertaking the measurements lack standardization including the number of repeated attempts to achieve best values. We aimed to (a) determine the optimum number of attempts to achieve best MIP/MEP values, and (b) evaluate if the number of attempts is consistent across two different test days.
METHODS


We analyzed data of a previous randomized controlled trial involving the effect of singing on respiratory muscle strength in 35 children with CF. On two different days (T1, T2) children performed MIP/MEP with at least ten attempts each to achieve < 10% repeatability.
RESULTS


All children achieved repeatable MIP/MEP values within 10-11 attempts with 24 (68.6%) and 26 (74.3%) of these achieving best values of MIP and MEP, respectively, at attempts 6-11. Median values of the pressures by three, five, eight and all attempts significantly increased with more attempts (all p < 0.05). At T2, 56% required fewer attempts to achieve best values, but 32% required more attempts, indicating that the number of attempts required was inconsistent between test days.
CONCLUSION


It is likely that at least ten attempts (best two within < 10% variability) is required to achieve best and reliable MIP/MEP in children with CF. A larger sample size in children with CF and various conditions is required to consolidate these findings.",2021,"All children achieved repeatable MIP/MEP values within 10-11 attempts with 24 (68.6%) and 26 (74.3%) of these achieving best values of MIP and MEP, respectively, at attempts 6-11.","['Children with Cystic Fibrosis', 'Children', 'cystic fibrosis (CF', 'children with CF', '35 children with CF']","['singing', 'Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP']","['Median values of the pressures', 'respiratory muscle strength', 'repeatable MIP/MEP values']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}]",35.0,0.0627763,"All children achieved repeatable MIP/MEP values within 10-11 attempts with 24 (68.6%) and 26 (74.3%) of these achieving best values of MIP and MEP, respectively, at attempts 6-11.","[{'ForeName': 'Wicharn', 'Initials': 'W', 'LastName': 'Boonjindasup', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia. elm.boonjindasup@menzies.edu.au.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Marchant', 'Affiliation': 'Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'J Yoon', 'Initials': 'JY', 'LastName': 'Irons', 'Affiliation': 'Health and Social Care Research Centre, University of Derby, Derby, UK.'}, {'ForeName': 'Margaret S', 'Initials': 'MS', 'LastName': 'McElrea', 'Affiliation': 'Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}]",Lung,['10.1007/s00408-021-00422-0']
1518,33589771,Three-year effects of bariatric surgery on obstructive sleep apnea in patients with obesity grade 1 and 2: a sub-analysis of the GATEWAY trial.,"BACKGROUND


Most of the evidence on bariatric surgery on obstructive sleep apnea (OSA) is based on observational studies and/or short-term follow-up in patients with obesity grade 3.
SUBJECTS/METHODS


This randomized study compared the effects of roux-en-Y gastric bypass (RYGB) or usual care (UC) on OSA severity in patients with obesity grade 1-2. Mild, moderate, and severe OSA was defined by the apnea-hypopnoea index (AHI): 5-14.9; 15-29.9, and ≥30 events/h, respectively. OSA remission was defined by converting any form of OSA into normal AHI (<5 events/h).
RESULTS


After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/m 2 , respectively. The AHI increased by 5 (-4.2; 12.7) in the UC group while reduced in the RYGB group to -13.2 (-22.7; -7) events/h. UC significantly increase the frequency of moderate OSA (from 15.4 to 46.2%). In contrast, RYGB had a huge impact on reaching no OSA status (from 4.2 to 70.8%) in parallel to a decrease of moderate (from 41.7 to 8.3%) and severe OSA (from 20.8 to 0%).
CONCLUSIONS


RYGB is an attractive strategy for mid-term OSA remission or decrease moderate-to-severe forms of OSA in patients with obesity grade 1-2.",2021,"After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/","['obstructive sleep apnea (OSA', 'patients with obesity grade 3', 'patients with obesity grade 1 and 2', 'patients with obesity grade 1-2']","['roux-en-Y gastric bypass (RYGB) or usual care (UC', 'bariatric surgery']","['OSA remission', 'reaching no OSA status', 'severe OSA', 'frequency of moderate OSA', 'Mild, moderate, and severe OSA', 'body-mass index', 'AHI', 'obstructive sleep apnea']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0207901,"After 3-year of follow-up, the body-mass index increased in the UC while decreased in the RYGB group: +1.7 (-1.9; 2.7) versus -10.6 (-12.7; -9.2) kg/","[{'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Furlan', 'Affiliation': 'Program in Cardiology, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'Hypertension Unit, University of São Paulo Medical School, São Paulo, Brazil. luciano.drager@incor.com.br.'}, {'ForeName': 'Renato Nakagawa', 'Initials': 'RN', 'LastName': 'Santos', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Angela Cristine', 'Initials': 'AC', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Tamiris A', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Rachel Helena V', 'Initials': 'RHV', 'LastName': 'Machado', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Eliana V', 'Initials': 'EV', 'LastName': 'Santucci', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Hypertension Unit, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Sleep Laboratory, Pulmonary Division, Heart Institute (InCor), São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'Research Institute, Heart Hospital (HCor), São Paulo, Brazil. cschiavon@hcor.com.br.'}]",International journal of obesity (2005),['10.1038/s41366-021-00752-2']
1519,33589759,Home blood pressure monitors owned by participants in a large decentralised clinical trial in hypertension: the Treatment In Morning versus Evening (TIME) study.,"Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihypertensive medication dosing time on cardiovascular outcomes in adults with hypertension. No HBPMs were provided to participants in this trial but patients were asked to report if they already owned one. We identified the model of HBPM reported by participants, then cross-referenced this against lists of validated HBPMs produced by dabl Educational Trust and the British and Irish Hypertension Society (BIHS). Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM. 7464 (71.3%) of these participants owned a monitor that could be identified from the participants' entry. Of these, 6066 (81.3%) participants owned a monitor listed as validated by either dabl (n = 5903) or BIHS (n = 5491). Some were listed as validated by both. 1398 (18.7%) participants owned an identifiable HBPM that lacked clear evidence of validation. 6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM. Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation. A significant number of participants own HBPMs lacking evidence of validation.",2021,Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation.,"['1398', '6963 (93.3%) participants owned an upper arm HBPM and 501 (6.7%) owned a wrist HBPM', 'adults with hypertension', '6066 (81.3%) participants owned a monitor listed as validated by either dabl (n\u2009=\u20095903) or BIHS (n\u2009=\u20095491', 'Of 21,104 participants, 10,464 (49.6%) reported their model of HBPM']","['HBPMs', 'antihypertensive medication']","['median online retail price', 'cardiovascular outcomes']","[{'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0649948', 'cui_str': '4-(2-(4-hydroxybenzyl)-phenoxy)-N-methylbutylamine'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",21104.0,0.133014,Validated HBPMs had a higher median online retail price of £45.00 compared to £20.00 for HBPMs lacking clear evidence of validation.,"[{'ForeName': 'Thineskrishna', 'Initials': 'T', 'LastName': 'Anbarasan', 'Affiliation': 'Medical Student, University of Dundee, Dundee, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Clinical Research Fellow, University of Dundee, Dundee, UK. a.rogers@dundee.ac.uk.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Rorie', 'Affiliation': 'Senior Software Developer, University of Dundee, Dundee, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Kerr Grieve', 'Affiliation': 'Clinical Research Fellow, University of Dundee, Dundee, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'Professor of Clinical Pharmacology and Pharmacoepidemiology, University of Dundee, Dundee, UK.'}, {'ForeName': 'Isla S', 'Initials': 'IS', 'LastName': 'Mackenzie', 'Affiliation': 'Professor of Cardiovascular Medicine, MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.'}]",Journal of human hypertension,['10.1038/s41371-021-00496-6']
1520,33588596,"Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial.","BACKGROUND AND PURPOSE


Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS).
METHODS


A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization.
RESULTS


One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12-1.81];  P =0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49-3.43 versus 1.14, 0.85-1.52).
CONCLUSIONS


When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02430350.",2021,"The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12-1.81];  P =0.004).","['Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset', '48 hospitals in China between May 2015 and December 2016', 'female patients', 'One thousand one hundred sixty-five AIS patients', 'patients with acute ischemic stroke (AIS', 'Acute Ischemic Stroke']","['edaravone dexborneol versus edaravone', 'Edaravone Dexborneol Versus Edaravone Alone', 'edaravone', 'edaravone dexborneol or edaravone injection', 'edaravone dexborneol']","['proportion of patients with modified Rankin Scale score', '90-day functional outcome', 'proportion of patients experiencing good functional outcomes']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0450385', 'cui_str': '65'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C4475574', 'cui_str': 'edaravone Injection'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.147469,"The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12-1.81];  P =0.004).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Anxin', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Gulbahram', 'Initials': 'G', 'LastName': 'Yalkun', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Anding', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Guangzhou, China (A.X.).'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Nanjing Medical University, China (Z.G.).'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The General Hospital of Shenyang Military, China (H.C.).'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Neurology, Tianjin Huanhu Hospital, China (Y.J.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Neurology, Subei People's Hospital of Jiangsu Province, Yangzhou, China (Jun Xu).""}, {'ForeName': 'Deqin', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Xuzhou Medical University, China (D.G.).'}, {'ForeName': 'Runxiu', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Department of Neurology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, China (R.Z.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, China (B.L.).'}, {'ForeName': 'Aiqin', 'Initials': 'A', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, Cangzhou Central Hospital, China (A.D.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mu', 'Affiliation': 'State Key Laboratory of Translational Medicine and Innovative Drug Development, Nanjing, China (H.M., Z.L.).'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory of Translational Medicine and Innovative Drug Development, Nanjing, China (H.M., Z.L.).'}, {'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Huaguang', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.031197']
1521,33588594,Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis.,"BACKGROUND AND PURPOSE


We assessed the outcomes of dabigatran versus aspirin in a prespecified subgroup analysis of East Asian patients with embolic stroke of undetermined source in the RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source).
METHODS


Patients with a recent embolic stroke of undetermined source were randomized to dabigatran (150 or 110 mg BID) or aspirin (100 mg QD). The primary efficacy outcome was recurrent stroke; the primary safety outcome was major bleeding. The East Asia cohort was compared with patients from all other countries (non-East Asia cohort).
RESULTS


Overall, 988 of 5390 patients (18%) were randomized in East Asia. During a median follow-up of 18.8 months, there was no statistically significant difference in recurrent stroke (hazard ratio, 0.65 [95% CI, 0.41-1.03]) or major bleeding (hazard ratio, 1.04 [95% CI, 0.57-1.91]) in East Asian patients receiving dabigatran versus aspirin. Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32-12.01]).
CONCLUSIONS


The treatment effect of dabigatran versus aspirin was consistent between cohorts, with no apparent superiority for dabigatran over aspirin in preventing recurrent stroke in patients with embolic stroke of undetermined source. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239120.",2021,"Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32-12.01]).
","['East Asian Patients With Embolic Stroke of Undetermined Source', 'Patients With Embolic Stroke of Undetermined Source', '988 of 5390 patients (18%) were randomized in East Asia', 'Patients with a recent embolic stroke of undetermined source', 'East Asian patients with embolic stroke of undetermined source in the RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention', 'patients with embolic stroke of undetermined source']","['Dabigatran or Aspirin', 'dabigatran', 'aspirin', 'Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'dabigatran versus aspirin']","['major bleeding', 'recurrent stroke', 'Death', 'recurrent stroke; the primary safety outcome was major bleeding']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",5390.0,0.325096,"Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32-12.01]).
","[{'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'Clinical Research Centre for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan (K.T.).'}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Seoul, South Korea (B.-C.L.).'}, {'ForeName': 'Chia-Wei', 'Initials': 'CW', 'LastName': 'Liou', 'Affiliation': 'Department of Neurology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan (C.-W.L.).'}, {'ForeName': 'Lawrence Ka Sing', 'Initials': 'LKS', 'LastName': 'Wong', 'Affiliation': 'Division of Neurology, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin (L.K.S.W.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Department of Cardiometabolic Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany (M.B.).'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': 'Biostatistics and Data Sciences, Nippon Boehringer Ingelheim Co, Ltd, Tokyo, Japan. (A.T.).'}, {'ForeName': 'Yasuhisa', 'Initials': 'Y', 'LastName': 'Urano', 'Affiliation': 'Primary Care Medicine, Nippon Boehringer Ingelheim Co, Ltd, Tokyo, Japan. (Y.U.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.031891']
1522,33588590,Does Intravenous Thrombolysis Within 4.5 to 9 Hours Increase Clot Migration Leading to Endovascular Inaccessibility?,"BACKGROUND AND PURPOSE


Distal clot migration is a recognized event following intravenous thrombolysis (IVT) in the setting of acute ischemic stroke. Of note, clots that were initially retrievable by endovascular thrombectomy may migrate to a distal nonretrievable location and compromise clinical outcome. We investigated the incidence of clot migration leading to clot inaccessibility following IVT in the time window of 4.5 to 9 hours.
METHODS


We performed a retrospective analysis of the EXTEND trial (Extending the Time for Thrombolysis in Emergency Neurological Deficits) data. Baseline and 12- to 24-hour follow-up clot location was determined on computed tomography angiogram or magnetic resonance angiogram. The incidence of clot migration leading to a change from retrievable to nonretrievable location was identified and compared between the two treatment groups (IVT versus placebo).
RESULTS


Two hundred twenty patients were assessed. Clot migration from a retrievable to nonretrievable location occurred in 37 patients: 21 patients (19.3%) in the placebo group and 16 patients (14.4%) in the IVT group. No significant difference was identified in the incidence of clot migration leading to inaccessibility between groups ( P =0.336).
CONCLUSIONS


Our results did not show increased clot migration leading to clot inaccessibility in patients treated with IVT.",2021,"No significant difference was identified in the incidence of clot migration leading to inaccessibility between groups ( P =0.336).
",['Two hundred twenty patients were assessed'],"['IVT', 'intravenous thrombolysis (IVT', 'placebo']","['clot migration', 'incidence of clot migration', 'Clot migration']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",220.0,0.11364,"No significant difference was identified in the incidence of clot migration leading to inaccessibility between groups ( P =0.336).
","[{'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, Australia (J.C.L., R.J.D., P.J.M.).'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Australia. (L.C.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, Australia (J.C.L., R.J.D., P.J.M.).'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, Australia (J.C.L., R.J.D., P.J.M.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Australia. (A.B., H.M., B.C.V.C., M.W.P., S.M.D., G.A.D., B.Y.).'}]",Stroke,['10.1161/STROKEAHA.120.030661']
1523,33588513,Using the Repeat-Recall Test to Examine Factors Affecting Context Use.,"BACKGROUND


The effect of context on speech processing has been studied using different speech materials and response criteria. The Repeat-Recall Test (RRT) evaluates listener performance using high context (HC) and low context (LC) sentences; this may offer another platform for studying context use (CU).
OBJECTIVE


This article aims to evaluate if the RRT may be used to study how different signal-to-noise ratios (SNRs), hearing aid technologies (directional microphone and noise reduction), and listener working memory capacities (WMCs) interact to affect CU on the different measures of the RRT.
DESIGN


Double-blind, within-subject repeated measures design.
STUDY SAMPLE


Nineteen listeners with a mild-to-moderately severe hearing loss.
DATA COLLECTION


The RRT was administered with participants wearing the study hearing aids under two microphone (omnidirectional vs. directional) by two noise reduction (on vs. off) conditions. Speech was presented from 0 degree at 75 dB sound pressure level and a continuous speech-shaped noise from 180 degrees at SNRs of 0, 5, 10, and 15 dB. The order of SNR and hearing aid conditions was counterbalanced across listeners. Each test condition was completed twice in two 2-hour sessions separated by 1 month.
RESULTS


CU was calculated as the difference between HC and LC sentence scores for each outcome measure (i.e., repeat, recall, listening effort, and tolerable time). For all outcome measures, repeated measures analyses of variance revealed that CU was significantly affected by the SNR of the test conditions. For repeat, recall, and listening effort measures, these effects were qualified by significant two-way interactions between SNR and microphone mode. In addition, the WMC group significantly affected CU during recall and rating of listening effort, the latter of which was qualified by an interaction between the WMC group and SNR. Listener WMC affected CU on estimates of tolerable time as qualified by significant two-way interactions between SNR and microphone mode.
CONCLUSION


The study supports use of the RRT as a tool for measuring how listeners use sentence context to aid in speech processing. The degree to which context influenced scores on each outcome measure of the RRT was found to depend on complex interactions between the SNR of the listening environment, hearing aid features, and the WMC of the listeners.",2021,"For all outcome measures, repeated measures analyses of variance revealed that CU was significantly affected by the SNR of the test conditions.",['Nineteen listeners with a mild-to-moderately severe hearing loss'],"['RRT', 'WMC', 'participants wearing the study hearing aids under two microphone (omnidirectional vs. directional) by two noise reduction', 'Repeat-Recall Test (RRT) evaluates listener performance using high context (HC) and low context (LC) sentences']","['HC and LC sentence scores', 'repeat, recall, listening effort, and tolerable time']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3874334', 'cui_str': 'Severe hearing loss'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",19.0,0.0240752,"For all outcome measures, repeated measures analyses of variance revealed that CU was significantly affected by the SNR of the test conditions.","[{'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Kuk', 'Affiliation': 'WS Audiology, Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slugocki', 'Affiliation': 'WS Audiology, Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'WS Audiology, Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois.'}]",Journal of the American Academy of Audiology,['10.1055/s-0040-1719136']
1524,33588491,[Input of the start on the result of a special interdisciplinary rehabilitation program for work-related injuries of the hand].,"PURPOSE


The objective of this study was to evaluate the outcome of a special interdisciplinary hand therapy program depending on the time interval between trauma and rehabilitation.
PATIENTS AND METHODS


With use of self-assessed scores (Disability of the Arm, Shoulder and Hand Score [DASH-Score], European Quality of Life 5 Dimensions [EQ-5D]) and objective functional parameters (TAM = Total Active Motion for finger injuries, ROM = Range of Motion for wrist injuries, grip strength) the outcome of 76 patients with injuries of the fingers, wrist or a complex regional pain syndrome (CRPS) was analysed at the begin and end of an inpatient rehabilitation and at a follow-up examination after 12 to 16 weeks. The patients were divided into groups with an early (< 120 days after trauma) or late beginning of their rehabilitation.
RESULTS


At the follow-up examination early beginners had a significant better DASH-Score as well as a ROM. At the end of the rehabilitation program and at the time of the follow-up examination significant more patients with an early as patients with a late start of the rehabilitation were back to work. Especially patients with CRPS and finger injuries benefit from an early start of the rehabilitation.
CONCLUSION


Compared to a late start an early start of a rehabilitation program after finger and hand injuries and a CRPS leads to better functional with special benefit for patients with a CRPS.",2021,At the follow-up examination early beginners had a significant better DASH-Score as well as a ROM.,"['76 patients with injuries of the fingers, wrist or a complex regional pain syndrome (CRPS', 'patients with a CRPS']","['special interdisciplinary hand therapy program', 'special interdisciplinary rehabilitation program']","['DASH-Score], European Quality of Life 5 Dimensions [EQ-5D]) and objective functional parameters (TAM = Total Active Motion for finger injuries, ROM = Range of Motion for wrist injuries, grip strength', 'DASH-Score', 'scores (Disability of the Arm, Shoulder and Hand Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0458219', 'cui_str': 'Complex regional pain syndrome'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231481', 'cui_str': 'Active movement'}, {'cui': 'C0016124', 'cui_str': 'Injury of finger'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0043264', 'cui_str': 'Injury of wrist'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",76.0,0.0124239,At the follow-up examination early beginners had a significant better DASH-Score as well as a ROM.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millrose', 'Affiliation': 'BG Unfallklinik Murnau Abteilung für Unfallchirurgie und Sporttraumatologie.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Ernst-Moritz-Arndt Universitat Greifswald Klinik und Poliklinik für Unfall-, Wiederherstellungschirurgie und Rehabilitative Medizin.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eichenauer', 'Affiliation': 'Unfallkrankenhaus Berlin Abteilung für Hand-, Replantations- und Mikrochirurgie.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gesslein', 'Affiliation': 'Paracelsus Medizinische Privatuniversitat - Nürnberg Klinik für Orthopädie und Unfallchirurgie.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eisenschenk', 'Affiliation': 'Unfallkrankenhaus Berlin Abteilung für Hand-, Replantations- und Mikrochirurgie.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Asmus', 'Affiliation': 'Unfallkrankenhaus Berlin Abteilung für Hand-, Replantations- und Mikrochirurgie.'}]","Handchirurgie, Mikrochirurgie, plastische Chirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Handchirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Mikrochirurgie der Peripheren Nerven und Gefasse : Organ der V...",['10.1055/a-1344-8928']
1525,33588377,Effect of 10 Weeks of Complex Training on Speed and Power in Academy Soccer Players.,"PURPOSE


This study investigated the effects of complex-paired and reverse-contrast 10-week training programs on sprint, power, and change-of-direction speed performance of elite academy soccer players.
METHODS


Seventeen elite academy soccer players each performed assessments of the 10- and 40-m sprint, Abalakov vertical jump, seated medicine-ball throw, and Arrowhead change-of-direction speed test, both prior to and after a twice-weekly 10-week resistance-training program. The participants were randomly split into 2 groups; the complex-paired training group (CPT, n = 9) performed 4 different complex pairs (heavy-resistance exercises paired with plyometric and Olympic lifting-style exercises), with each pair being interspersed with an 8-minute recovery period in line with recommended guidelines. The comparative group-the reverse-contrast training group (RCT, n = 8)-performed the same exercises; however, all of the plyometric and Olympic lifting exercises preceded the heavy-resistance exercises.
RESULTS


Both groups achieved postintervention increases in the seated medicine-ball throw test (CPT +1.8% and RCT +1.6%, P < .05), whereas VJ performance improved only in the CPT group (+3.4%, P = .003). No significant improvements were observed in either the 10- and the 40-m sprint or Arrowhead change-of-direction speed test for either group.
CONCLUSIONS


The CPT experienced a small but significant within-group improvement in jump performance. However, no significant between-groups differences were observed in any of the testing variables postintervention. Subsequently, for academy soccer athletes, the CPT approach did not produce meaningful benefits to performance compared with a more time-efficient reverse-contrast approach.",2021,"No significant improvements were observed in either the 10- and the 40-m sprint or Arrowhead change-of-direction speed test for either group.
","['elite academy soccer players', 'Academy Soccer Players', 'academy soccer athletes', 'Seventeen elite academy soccer players each performed assessments of the 10- and']","['complex-paired and reverse-contrast 10-week training programs', 'CPT', '40-m sprint, Abalakov vertical jump, seated medicine-ball throw, and Arrowhead change-of-direction speed test, both prior to and after a twice-weekly 10-week resistance-training program', 'complex-paired training group (CPT, n = 9) performed 4 different complex pairs (heavy-resistance exercises paired with plyometric and Olympic lifting-style exercises), with each pair being interspersed with an 8-minute recovery period in line with recommended guidelines', 'reverse-contrast training group (RCT, n = 8)-performed the same exercises; however, all of the plyometric and Olympic lifting exercises preceded the heavy-resistance exercises', 'Complex Training']","['VJ performance', 'jump performance', '40-m sprint or Arrowhead change-of-direction speed test']","[{'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0453107', 'cui_str': 'Arrowhead'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0449250', 'cui_str': 'Speed of test'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0453107', 'cui_str': 'Arrowhead'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0449250', 'cui_str': 'Speed of test'}]",17.0,0.0120473,"No significant improvements were observed in either the 10- and the 40-m sprint or Arrowhead change-of-direction speed test for either group.
","[{'ForeName': 'Thomas I', 'Initials': 'TI', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harsley', 'Affiliation': ''}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Bishop', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0139']
1526,33588293,Effect of Smartphone Laparoscopy Simulator on Laparoscopic Performance in Medical Students.,"BACKGROUND


This study aims to investigate if a smartphone laparoscopy simulator, SimuSurg, is effective in improving laparoscopic skills in surgically inexperienced medical students.
METHODS


This is a single-blinded randomized controlled trial featuring 30 preclinical medical students without prior laparoscopic simulation experience. The students were randomly allocated to a control or intervention group (n = 15 each) and 28 students completed the study (n = 14 each). All participants performed three validated exercises in a laparoscopic box trainer and repeated them after 1 week. The intervention group spent the intervening time completing all levels in SimuSurg, whereas the control group refrained from any laparoscopic activity. A prestudy questionnaire was used to collect data on age, sex, handedness, and experience with gaming.
RESULTS


The total score improved significantly between the two testing sessions for the intervention group (n = 14, median change [MC] = 182.00, P = 0.009) but not for the control group (n = 14, MC = 161.50, P = 0.08). Scores for the nondominant hand improved significantly in the intervention group (MC = 66.50, P = 0.008) but not in the control group (MC = 9.00, P = 0.98). There was no improvement in dominant hand scores for either the intervention (MC = 62.00, P = 0.08) or control (MC = 26.00, P = 0.32) groups. Interest in surgery (β = -234.30, P = 0.02) was positively correlated with the baseline total scores; however, age, sex, and experience with video games were not.
CONCLUSIONS


The results suggest that smartphone applications improve laparoscopic skills in medical students, especially for the nondominant hand. These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.",2021,These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.,"['group (n\xa0=\xa015 each) and 28 students completed the study (n\xa0=\xa014 each', '30 preclinical medical students without prior laparoscopic simulation experience', 'medical students', 'Medical Students', 'surgically inexperienced medical students']","['Smartphone Laparoscopy Simulator', 'smartphone laparoscopy simulator', 'smartphone', 'control or intervention']","['total score', 'laparoscopic skills', 'Laparoscopic Performance']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",30.0,0.0325935,These simulators may be a cost-effective and accessible adjunct for laparoscopic training among surgically inexperienced students and clinicians.,"[{'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Awal', 'Affiliation': 'Gold Coast University Hospital, Southport, Queensland, Australia. Electronic address: wasim.awal123@gmail.com.'}, {'ForeName': 'Lakal', 'Initials': 'L', 'LastName': 'Dissabandara', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Arunan', 'Initials': 'A', 'LastName': 'Jeyakumar', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Malak', 'Initials': 'M', 'LastName': 'Habib', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Byfield', 'Affiliation': 'School of Medicine, Griffith University, Southport, Queensland, Australia.'}]",The Journal of surgical research,['10.1016/j.jss.2021.01.003']
1527,33588227,Bifactor model of cognition in schizophrenia: Evidence for general and specific abilities.,"BACKGROUND


Despite extensive study of cognition in schizophrenia, it remains unclear as to whether cognitive deficits and their latent structure are best characterized as reflecting a generalized deficit, specific deficits, or some combination of general and specific constructs.
METHOD


To clarify latent structure of cognitive abilities, confirmatory factor analysis was used to examine the latent structure of cognitive data collected for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for Schizophrenia study. Baseline assessment data (n = 813) were randomly divided into calibration (n = 413) and cross-validation samples (n = 400). To examine whether generalized or specific deficit models provided better explanation of the data, we estimated first-order, hierarchical, and bifactor models.
RESULTS


A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
CONCLUSIONS


These findings lend support for a replicable bifactor model of cognition in schizophrenia, characterized by both a general cognitive factor and specific domains. This suggests that cognitive deficits in schizophrenia might be best understood by separate general and specific contributions.",2021,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
",['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],813.0,0.0242855,"A bifactor model with seven specific factors and one general factor provided the best fit to the data for both the calibration and cross-validation samples.
","[{'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Becker', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Ahmed', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Benning', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Barchard', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'John', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA; Department of Brain Health, University of Nevada, Las Vegas, Las Vegas, NV, USA.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Nevada, Las Vegas, Las Vegas, NV, USA. Electronic address: daniel.allen@unlv.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2021.01.051']
1528,33588196,"Combining compensatory cognitive training and medication self-management skills training, in inpatients with schizophrenia: A three-arm parallel, single-blind, randomized controlled trial.","OBJECTIVE


Cognitive impairment has a critical impact on functional outcomes in patients with schizophrenia. Compensatory cognitive training (CCT) has shown promise as a cognitive rehabilitation tool but little is known about its effectiveness when combined with medication self-management skills training (MSST) in patients with schizophrenia. Thus, this study compared the effects of a combined CCT and MSST with CCT and treatment as usual (TAU) on cognitive function, symptoms, and medication adherence.
METHOD


Eighty-seven inpatients with schizophrenia were randomly assigned to the TAU, CCT, or CCT + MSST groups. Assessments of cognitive function using the Brief Assessment of Cognition in Schizophrenia, symptoms using the Positive and Negative Syndrome Scale, and medication adherence using the Medication Adherence Questionnaire, were administered to all participants at baseline and at post-intervention.
RESULTS


Compared with the TAU group, the CCT group had significant improvements in verbal fluency, total cognitive function and medication adherence, and the CCT + MSST group had significant improvements in verbal fluency, total cognitive function, positive symptoms, and medication adherence. Compared with the CCT group, the CCT + MSST group had significant improvements in total cognitive function.
CONCLUSIONS


These results indicate that the integrated intervention may be more advantageous than CCT alone in improving total cognitive function and positive symptoms. Future research should seek to further explore the long-term effects of such a joint intervention.",2020,"Compared with the TAU group, the CCT group had significant improvements in verbal fluency, total cognitive function and medication adherence, and the CCT + MSST group had significant improvements in verbal fluency, total cognitive function, positive symptoms, and medication adherence.","['patients with schizophrenia', 'Eighty-seven inpatients with schizophrenia', 'inpatients with schizophrenia']","['compensatory cognitive training and medication self-management skills training', 'CCT\xa0+\xa0MSST', 'Compensatory cognitive training (CCT', 'combined CCT and MSST with CCT', 'CCT', 'TAU, CCT, or CCT\xa0+\xa0MSST groups', 'TAU']","['total cognitive function', 'Cognition in Schizophrenia, symptoms using the Positive and Negative Syndrome Scale, and medication adherence using the Medication Adherence Questionnaire', 'total cognitive function and positive symptoms', 'cognitive function, symptoms, and medication adherence', 'verbal fluency, total cognitive function and medication adherence', 'verbal fluency, total cognitive function, positive symptoms, and medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]",87.0,0.0240876,"Compared with the TAU group, the CCT group had significant improvements in verbal fluency, total cognitive function and medication adherence, and the CCT + MSST group had significant improvements in verbal fluency, total cognitive function, positive symptoms, and medication adherence.","[{'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Nursing Fundamentals, School of Nursing, Shandong University, Wenhua Xi Road #44, Shandong, China; Division of Nursing Fundamentals, School of Nursing, Ningxia Medical University, Shengli Road #1160, Ningxia, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Inpatient Department, Ningxia Min-Kang Hospital, Huanghe Dong Road #878, Ningxia, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Chang', 'Affiliation': 'Division of Nursing Fundamentals, School of Nursing, Ningxia Medical University, Shengli Road #1160, Ningxia, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Division of Nursing Fundamentals, School of Nursing, Ningxia Medical University, Shengli Road #1160, Ningxia, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Division of Nursing Fundamentals, School of Nursing, Ningxia Medical University, Shengli Road #1160, Ningxia, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Division of Anatomy, School of Basic Medical Sciences, Ningxia Medical University, Shengli Road #1160, Ningxia, China. Electronic address: ryuken0518@163.com.'}, {'ForeName': 'Kefang', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Division of Nursing Fundamentals, School of Nursing, Shandong University, Wenhua Xi Road #44, Shandong, China. Electronic address: wangkf@sdu.edu.cn.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.12.012']
1529,33588150,"Afatinib plus gemcitabine versus gemcitabine alone as first-line treatment of metastatic pancreatic cancer: The randomised, open-label phase II ACCEPT study of the Arbeitsgemeinschaft Internistische Onkologie with an integrated analysis of the 'burden of therapy' method.","BACKGROUND


Targeting the epidermal growth factor receptor pathway remains controversial in pancreatic cancer. Afatinib is an oral irreversible ErbB family blocker approved in non-small-cell lung cancer. This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic pancreatic cancer.
PATIENTS AND METHODS


Patients were randomised in a 2:1 ratio to either Gem (1000 mg/m 2  weekly for three weeks followed by one week of rest, repeated every four weeks) and afatinib (40 mg orally once daily) or Gem alone. Overall survival (OS) was the primary study end-point. The novel BOTh©™ methodology was implemented to derive a quantitative estimate for the 'Burden of Therapy/Toxicity' (BOTh) for each patient on every day during the clinical study.
RESULTS


One hundred nineteen patients from 25 centres were randomised, 79 patients for Gem/afatinib and 40 for Gem. Median OS was 7.3 months in the Gem/afatinib arm versus 7.4 months in the Gem-alone arm (hazard ratio [HR]: 1.06, p = 0.80). Median progression-free survival was identical in both arms (3.9 months versus 3.9 months, HR: 0.85, p = 0.43). Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%). The BOTh©™ analysis revealed a significantly higher burden of toxicity in the combination arm (p = 0.0005).
CONCLUSION


The addition of afatinib to Gem did not improve treatment efficacy and was more toxic. The BOTh©™ methodology allowed a detailed insight into the course of treatment-related adverse events over the study period. The trial was registered at clinicaltrials.gov (NCT01728818) and Eudra-CT (2011-004063-77).",2021,"Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%).","['One hundred nineteen patients from 25 centres were randomised, 79 patients for Gem/afatinib and 40 for Gem', 'metastatic pancreatic cancer', 'Patients']","['gemcitabine alone', 'afatinib (40\xa0mg orally once daily) or Gem alone', 'Gem', 'gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone', 'Afatinib', 'Afatinib plus gemcitabine']","['skin rash', 'Overall survival (OS', 'Median OS', 'Adverse events', 'burden of toxicity', 'diarrhoea', 'Median progression-free survival']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",119.0,0.0472573,"Adverse events were more frequent in the Gem/afatinib arm, especially diarrhoea (71% vs. 13%) and skin rash (65% vs. 5%).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany. Electronic address: michael.haas@med.uni-muenchen.de.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Waldschmidt', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Department of Medical Oncology, Evang. Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department of Hematology and Oncology, St. Josef Hospital, Ruhr University Bochum, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Practice for Hematology and Oncology, Dresden, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Oncology, Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK & K Studien GbR, Landshut, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kanzler', 'Affiliation': 'Department of Internal Medicine II, Leopoldina Krankenhaus Schweinfurt, Schweinfurt, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Frickhofen', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Helios Dr. Horst-Schmidt-Kliniken, Wiesbaden, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Seufferlein', 'Affiliation': 'Department of Internal Medicine I, University of Ulm, Ulm, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dechow', 'Affiliation': 'Practice for Hematology and Oncology, Ravensburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mahlberg', 'Affiliation': 'Department of Internal Medicine I, Klinikum Mutterhaus der Borromaeerinnen, Trier, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Malfertheiner', 'Affiliation': 'Otto von Guericke University Magdeburg, Clinic of Gastroenterology, Hepatology, and Infectious Diseases, Magdeburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Illerhaus', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kubicka', 'Affiliation': 'Cancer Center Reutlingen, Reutlingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdul-Ahad', 'Affiliation': 'BoTh Analytics GmbH, Munich, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snijder', 'Affiliation': 'BoTh Analytics GmbH, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kruger', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Westphalen', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'von Bergwelt-Baildon', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.12.029']
1530,33588087,"A Phase 2b Randomized Trial of Lorecivivint, a Novel Intra-articular CLK2/DYRK1A Inhibitor and Wnt Pathway Modulator for Knee Osteoarthritis.","OBJECTIVE


Lorecivivint (LOR; SM04690), an investigational Wnt pathway modulator, previously demonstrated patient-reported and radiographic outcome improvements versus placebo in clinically relevant subjects with moderate to severe knee osteoarthritis (OA). This study's objective was to identify effective LOR doses.
DESIGN


Subjects in this 24-week, Phase 2b, multicenter, randomized, double-blind, placebo (PBO)-controlled trial received an intra-articular injection of 2 mL LOR (0.03, 0.07, 0.15, or 0.23 mg), PBO, or dry-needle sham. The primary efficacy endpoints were changes in Pain NRS [0-10], WOMAC Pain [0-100], WOMAC Function [0-100], and radiographic mJSW outcomes, which were measured using baseline-adjusted analysis of covariance at Week 24. Multiple Comparison Procedure-Modeling (MCP-Mod) was performed for dose modeling.
RESULTS


In total, 695/700 subjects were treated. Pain NRS showed significant improvements versus PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P=0.001; -0.78, [-1.39, -0.17], P=0.012) and 24 (-0.70, [-1.34, -0.06], P=0.031; -0.82, [-1.51, -0.12], P=0.022). Additionally, 0.07 mg LOR significantly improved WOMAC Pain and Function subscores versus PBO at Week 12 (P=0.04, P=0.021), and 0.23 mg LOR significantly improved both WOMAC subscores at Week 24 (P=0.031, P=0.017). No significant differences from PBO were observed for other doses. No radiographic progression was observed in any group at Week 24. MCP-Mod identified 0.07 mg LOR as the lowest effective dose.
CONCLUSION


This 24-week Phase 2b trial demonstrated the efficacy of LOR on PROs in knee OA subjects. The optimal dose for future studies was identified as 0.07 mg LOR.",2021,"Pain NRS showed significant improvements versus PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P=0.001; -0.78, [-1.39,","['knee OA subjects', 'clinically relevant subjects with moderate to severe knee osteoarthritis (OA', '695/700 subjects were treated', 'Knee Osteoarthritis']","['placebo', 'intra-articular injection of 2 mL LOR', 'PBO, or dry-needle sham', 'Multiple Comparison Procedure-Modeling (MCP-Mod', 'LOR', 'MCP-Mod identified 0.07 mg LOR']","['changes in Pain NRS [0-10], WOMAC Pain [0-100], WOMAC Function [0-100], and radiographic mJSW outcomes', 'WOMAC Pain and Function subscores versus PBO', 'WOMAC subscores', 'PBO', 'radiographic progression']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4518239', 'cui_str': '0.07'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0436033,"Pain NRS showed significant improvements versus PBO after treatment with 0.07 mg and 0.23 mg LOR at Weeks 12 (-0.96, 95% CI [-1.54, -0.37], P=0.001; -0.78, [-1.39,","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yazici', 'Affiliation': 'Samumed, LLC, San Diego, CA; New York University School of Medicine, New York, NY. Electronic address: yusuf@samumed.com.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Gibofsky', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'University of California Davis Medical School, Burlingame, CA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': 'University of Kentucky, Lexington, KY.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Skrepnik', 'Affiliation': 'Tucson Orthopaedic Institute, Tucson, AZ.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Swearingen', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Simsek', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Ghandehari', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'DiFrancesco', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Jamielle', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Jeyanesh', 'Initials': 'J', 'LastName': 'Tambiah', 'Affiliation': 'Samumed, LLC, San Diego, CA.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland, College Park, MD.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.02.004']
1531,33588086,Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial.,"OBJECTIVE


To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis.
DESIGN


This was a randomised, sham-controlled, participant- and assessor-blinded trial. One hundred participants with first metatarsophalangeal joint osteoarthritis received rehabilitation therapy and were randomised to receive either carbon fibre shoe-stiffening inserts (n=49) or sham inserts (n=51). The primary outcome measure was the Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks.
RESULTS


All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women) were included in the analysis of the primary outcome. At the 12 week primary endpoint, there were 13 drop-outs (7 in the sham insert group and 6 in the shoe-stiffening insert group), giving completion rates of 86 and 88%, respectively. Both groups demonstrated improvements in the FHSQ pain domain score at each follow-up period, and there was a significant between-group difference in favour of the shoe-stiffening insert group (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, p=0.030). There were no between-group differences for the secondary outcomes, although global improvement was more common in the shoe-stiffening insert group compared to the sham insert group (61 versus 34%, RR 1.73, 95% CI 1.05 to 2.88, p=0.033; number needed to treat 4, 95% CI 2 to 16).
CONCLUSION


Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks. These results support the use of shoe-stiffening inserts for the management of this condition, although due to the uncertainty around the effect on the primary outcome, some individuals may not experience a clinically worthwhile improvement.",2021,"CONCLUSION


Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks.","['One hundred participants with first metatarsophalangeal joint osteoarthritis received', 'first metatarsophalangeal joint osteoarthritis', 'All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women', 'individuals with first metatarsophalangeal joint osteoarthritis']","['carbon-fibre shoe-stiffening inserts', 'carbon fibre shoe-stiffening inserts', 'rehabilitation therapy']","['global improvement', 'FHSQ pain domain score', 'Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks', 'foot pain', 'giving completion rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0108411', 'cui_str': 'Carbon fiber'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",100.0,0.290855,"CONCLUSION


Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks.","[{'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Landorf', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Jodie A', 'Initials': 'JA', 'LastName': 'McClelland', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; Discipline of Physiotherapy, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, United Kingdom; Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Haywood Hospital, Burslem, Staffordshire, ST6 7AG, United Kingdom.'}, {'ForeName': 'Flavia M', 'Initials': 'FM', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Victoria 3004, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Shiell', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Auhl', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Jamie J', 'Initials': 'JJ', 'LastName': 'Allan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Buldt', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia; Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, United Kingdom. Electronic address: h.menz@latrobe.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2021.02.002']
1532,33588084,The cross-sectional and longitudinal associations of dietary patterns with knee symptoms and MRI detected structure in patients with knee osteoarthritis.,"OBJECTIVES


To examine the cross-sectional and longitudinal associations of dietary patterns with knee symptoms and structures in patients with knee osteoarthritis (OA).
METHODS


Participants with symptomatic knee OA were recruited from a randomised, placebo-controlled trial conducted in Tasmania (N=259) and Victoria (N=133). Diet was assessed by the Anti-Cancer Council of Victoria food frequency questionnaire. Factor analysis was used to identify dietary patterns. Knee symptoms were assessed using Western Ontario and McMaster Universities Arthritis Index (WOMAC) and structures using MRI. Multivariable linear regressions were used to examine associations.
RESULTS


Three dietary patterns (""high-fat"", ""healthy"" and ""mixed"") were identified in whole sample. Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months. Three (""western"", ""vegetable and meat"" and ""mediterranean"") and two (""processed"" and ""vegetable"") patterns were identified in Tasmania and Victoria, respectively. Cross-sectionally, only ""mediterranean pattern"" and ""vegetable pattern"" scores were significantly and negatively associated with total WOMAC or function scores. Longitudinally, participants with higher ""western pattern"" had worsening function (β: 0.35, 95%CI: 0.03, 0.67) and total WOMAC (β: 0.40, 95%CI: 0.07, 0.72) scores; furthermore, ""vegetable pattern"" was associated with decreased WOMAC stiffness score (β: -0.47, 95%CI: -0.93, -0.02). In contrast, dietary patterns were largely not associated with structural changes.
CONCLUSION


Some healthy dietary patterns were associated with reduced joint symptoms but dietary patterns were not associated with joint structure in this sample with knee OA. Further studies are required to confirm these findings.",2021,"Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months.","['Participants with symptomatic knee OA', 'patients with knee osteoarthritis', 'N=259) and Victoria (N=133', 'patients with knee osteoarthritis (OA']","['placebo', 'Tasmania']","['total WOMAC or function scores', 'Knee symptoms', 'total WOMAC', 'worsening function', 'total WOMAC, pain, function and stiffness scores', 'mediterranean pattern"" and ""vegetable pattern"" scores', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) and structures using MRI', 'WOMAC stiffness score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",,0.0336802,"Participants with higher ""healthy pattern"" score had lower total WOMAC, pain, function and stiffness scores at baseline but the associations were not significant over 24 months.","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Feitong', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'Anita E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Victoria, Australia.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Department of Rheumatology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China. Electronic address: Changhai.Ding@utas.edu.au.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.12.023']
1533,33588078,The multi-ethnic study of atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study.,"The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D 3  supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response.",2021,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","['2210 MESA participants approached for screening, and 96% of those found to be eligible', '666 racially and ethnically diverse participants from January 2017 to April 2019']","['vitamin D 3  supplementation', 'vitamin D supplementation', 'VITamin D (INVITe', 'placebo']",['median adherence'],"[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2210.0,0.263891,"The final study visit was attended by 611 participants (92%), and median adherence was 98%.","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: deboer@uw.edu.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Prince', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Kayleen', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Norrina B', 'Initials': 'NB', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Burke', 'Affiliation': 'Division of Public Health Sciences Wake Forest School of Medicine, Winston-Salem, NC, United States of America.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Kiang J', 'Initials': 'KJ', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL, United States of America.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'McClelland', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Michos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America; Department of Epidemiology and the Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Psaty', 'Affiliation': 'Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology and Health Services, University of Washington, Seattle, WA, United States of America; Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, United States of America; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States of America.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Rice', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Jerome I', 'Initials': 'JI', 'LastName': 'Rotter', 'Affiliation': 'The Institute for Translational Genomics and Population Sciences, Department of Pediatrics, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siscovick', 'Affiliation': 'New York Academy of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'Departments of Pathology & Laboratory Medicine, and Biochemistry, University of Vermont Larner College of Medicine, Burlington, VT, United States of America.'}, {'ForeName': 'Karol E', 'Initials': 'KE', 'LastName': 'Watson', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Kestenbaum', 'Affiliation': 'Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2021.106318']
1534,33242697,"Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation.","Asthma remains one of the most important challenges to pediatric public health in the US. A large majority of children with persistent and chronic asthma demonstrate aeroallergen sensitization, which remains a pivotal risk factor associated with the development of persistent, progressive asthma throughout life. In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma. The cascade of biological responses to allergens is primarily mediated through IgE antibodies and their production is further stimulated by IgE responses to antigen exposure. In addition, circulating IgE impairs innate anti-viral immune responses. The latter effect could magnify the effects of another early life exposure associated with increased risk of the development of asthma - viral infections. Omalizumab binds to circulating IgE and thus ablates antigen signaling through IgE-related mechanisms. Further, it has been shown restore IFN-α response to rhinovirus and to reduce asthma exacerbations during the viral season. We therefore hypothesized that early blockade of IgE and IgE mediated responses with omalizumab would prevent the development and reduce the severity of asthma in those at high risk for developing asthma. Herein, we describe a double-blind, placebo-controlled trial of omalizumab in 2-3 year old children at high risk for development of asthma to prevent the development and reduce the severity of asthma. We describe the rationale, methods, and lessons learned in implementing this potentially transformative trial aimed at prevention of asthma.",2021,"In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma.","['children with persistent and chronic asthma', '2-3\u202fyear old children at high risk for development of asthma']","['placebo', 'Omalizumab', 'omalizumab']","['circulating IgE impairs innate anti-viral immune responses', 'risk of the development of asthma - viral infections']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0877430', 'cui_str': 'Asthma chronic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]",,0.103326,"In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma.","[{'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: wanda.phipatanakul@childrens.harvard.edu.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Pennsylvania State University, Hershey, PA, United States of America.'}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Washington University and St. Louis Children's Hospital, St. Louis, MO, United States of America.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': 'University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Martinez', 'Affiliation': 'Asthma and Airway Research Center, University of Arizona, Tucson, AZ, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Emory University, Department of Pediatrics Atlanta, Georgia.'}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kunselman', 'Affiliation': 'Pennsylvania State University, Hershey, PA, United States of America.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wheatley', 'Affiliation': 'NIH/National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ, United States of America.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': ""Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States of America.""}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Geng', 'Affiliation': ""Rady Children's Hospital, UC San Diego, San Diego, CA, United States of America.""}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Kloepfer', 'Affiliation': 'Riley Hospital for Children at IU Health, Indiana University School of Medicine, Indianapolis, IN, United States of America.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Lapin', 'Affiliation': ""Connecticut Children's Medical Center, Division of Pulmonary Hartford, CT, United States of America.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Liu', 'Affiliation': ""Children's Hospital Colorado, University of Colorado, Aurora, CO, United States of America.""}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Ann and Robert Lurie Children's Hospital of Chicago, Chicago, IL, United States of America.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Teach', 'Affiliation': ""Children's National Hospital, Washington, DC, United States of America.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chmiel', 'Affiliation': 'NIH/National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Gaffin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Boston Children's Hospital, Division of Pulmonary Medicine, Boston, MA, United States of America.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Children's Hospital Colorado, University of Colorado, Aurora, CO, United States of America.""}, {'ForeName': 'Meera R', 'Initials': 'MR', 'LastName': 'Gupta', 'Affiliation': ""Baylor College of Medicine, Texas Children's Hospital, Houston, TX, United States of America.""}, {'ForeName': 'Peggy S', 'Initials': 'PS', 'LastName': 'Lai', 'Affiliation': 'Harvard Medical School, Boston, MA, United States of America; Massachusetts General Hospital, Division of Pulmonary and Critical Care, Boston, MA, United States of America.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'University of Wisconsin, Madison, WI, United States of America.'}, {'ForeName': 'Wayne J', 'Initials': 'WJ', 'LastName': 'Morgan', 'Affiliation': 'Asthma and Airway Research Center, University of Arizona, Tucson, AZ, United States of America.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sheehan', 'Affiliation': ""Children's National Hospital, Washington, DC, United States of America.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Stokes', 'Affiliation': ""Washington University and St. Louis Children's Hospital, St. Louis, MO, United States of America.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'University of Iowa, College of Public Health, Department of Occupational and Environmental Health, Iowa City, IA, United States of America.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Oettgen', 'Affiliation': ""Boston Children's Hospital, Division of Allergy and Immunology, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Brigham and Women's Hospital, Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Boston, MA, United States of America.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106228']
1535,33248361,A few more steps lead to improvements in endothelial function in severe and very severe COPD.,"INTRODUCTION


Cardiovascular disease is among the most prevalent concomitant chronic diseases in COPD. Physical activity (PA) modifies endothelial function and is commonly impaired in COPD. However, studies directly investigating the effects of increased PA on endothelial function in COPD are lacking. We investigated the effect of changes in PA on endothelial function in patients with severe to very severe COPD. Furthermore, we determined which variables modify this effect.
MATERIALS AND METHODS


This is a secondary outcome analysis from a randomised controlled trial investigating the effects of combined PA counselling and pedometer-based feedback in COPD. We analysed the change in PA based on three visits during one year. We measured PA using a validated triaxial accelerometer, and endothelial function using flow-mediated dilation.
RESULTS


Data was analysed from 54 patients, which provided 101 change scores. Multiple regression modelling, including adjustment for baseline step count, showed strong evidence for an association between changes in flow-mediated dilation and changes in PA (p < 0.001). The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred. (p = 0.735).
CONCLUSION


We found strong evidence that increasing steps per day ameliorates the heavily impaired endothelial function in patients with severe and very severe COPD. Further studies should examine which factors influence this relationship in a positive or negative manner.",2021,"The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred.","['patients with severe and very severe COPD', 'patients with severe to very severe COPD']",['combined PA counselling and pedometer-based feedback'],"['exacerbation frequency', 'Physical activity (PA) modifies endothelial function', 'severity of airflow obstruction', 'endothelial function', 'PA and endothelial function: smoking status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0949538,"The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Kohlbrenner', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Clarenbach', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Roeder', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland. Electronic address: noriane.sievi@usz.ch.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106246']
1536,33238805,Visual Attention to the Use of #ad versus #sponsored on e-Cigarette Influencer Posts on Social Media: A Randomized Experiment.,"Youth and young adults are the largest consumers of social media content. Individuals with large followers are paid to share social media content using specific products for compensation. This type of activity is considered commercial sponsorship and requires a disclosure in order to comply with Federal Trade Commission regulations. Between July and August 2019, youth and young adult (ages 16-24; n = 200) participants were recruited into an eye-tracking laboratory to view their native Instagram feed on a mobile device where a set of posts from e-cigarette influencers were inserted with one of the two potential labeling strategies: #ad and #sponsored. Participants spent an average of 6.6 seconds viewing e-cigarette influencer posts. Youth and young adults spent 3.1 seconds on the area labeled #ad, compared to 2.2 seconds on the area of interest labeled #sponsored ( p  = .03). After accounting for age, current tobacco use, and dependence, #ad drew 0.93 seconds more than #sponsored on influencer posts ( p  = .02). Both labeling strategies drew visual attention to Instagram e-cigarette influencer posts, with nearly 1 second more attention paid to the presence of #ad. Labeling commercially sponsored content on social media is a viable strategy to attract the attention of youth and young adults.",2020,"After accounting for age, current tobacco use, and dependence, #ad drew 0.93 seconds more than #sponsored on influencer posts ( p  = .02).","['youth and young adults', 'Participants spent an average of 6.6\xa0seconds viewing e-cigarette influencer posts', 'Between July and August 2019, youth and young adult (ages 16-24; n =\xa0200) participants were recruited into an eye-tracking laboratory to view their native Instagram feed on a mobile device where a set of posts from e-cigarette influencers', 'Youth and young adults']",[],[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",[],[],200.0,0.0183349,"After accounting for age, current tobacco use, and dependence, #ad drew 0.93 seconds more than #sponsored on influencer posts ( p  = .02).","[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Klein', 'Affiliation': 'Division of Health Behavior & Health Promotion, Ohio State University College of Public Health , Columbus, Ohio, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Czaplicki', 'Affiliation': 'Truth Initiative , Washington, District of Columbia, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'Division of Health Services, Management and Policy, Ohio State University College of Public Health , Columbus, Ohio, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'Social Data Collaboratory, NORC at the University of Chicago , Chicago, Illinois, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schillo', 'Affiliation': 'Truth Initiative , Washington, District of Columbia, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1849464']
1537,33244711,"A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma.","INTRODUCTION


Pharmacotherapy to lower intraocular pressure (IOP) is a mainstay of treatment aimed at delaying progression of visual field loss in ocular hypertension (OHT) and open-angle glaucoma (OAG), but some topical treatments are less effective in controlling IOP at night. Peak IOP may be related to glaucoma progression and can occur outside office hours. A phase 2 study was conducted to evaluate the IOP-lowering efficacy of netarsudil across the diurnal and nocturnal periods.
METHODS


This was a randomized, double-masked, single-center, vehicle-controlled, 9-day study. After washout of any prior ocular hypotensive agents, 12 patients with OHT or OAG underwent baseline IOP assessment at 15:00, 18:00, 21:00, 00:00, 03:00, 06:00, 09:00, and 12:00 h on day 1/day 2. Participants were then randomized in a 2:1 ratio to netarsudil ophthalmic solution 0.02% (n = 8) or vehicle (n = 4) for 7 days of self-administered dosing each evening. IOP was assessed at the same time points on day 8/day 9. All measurements were conducted with a Perkins tonometer in habitual positions by day (seated) and at night (supine).
RESULTS


Baseline mean 24-h IOP was 22.4 mmHg in the netarsudil group and 22.9 mmHg in the vehicle group. Netarsudil was associated with a reduction in mean nocturnal IOP (measurements at 21:00, 00:00, 03:00, 06:00 h) of 3.5 mmHg, which was significant relative to baseline nocturnal IOP (P < 0.001) and the reduction in the vehicle group (0.4 mmHg; P < 0.001 vs. netarsudil). Reduction in mean diurnal IOP with netarsudil (3.5 mmHg) was the same as the nocturnal reduction and statistically significant versus baseline (P < 0.001) and the vehicle group (0.9 mmHg; P < 0.01). The magnitude of IOP reductions with netarsudil was consistent at each time point assessed over the 24-h period. No adverse events were reported.
CONCLUSION


Netarsudil exhibited consistent IOP-lowering efficacy over a 24-h period in this short-term study.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT02874846.",2021,"Netarsudil was associated with a reduction in mean nocturnal IOP (measurements at 21:00, 00:00, 03:00, 06:00 h) of 3.5 mmHg, which was significant relative to baseline nocturnal IOP (P < 0.001) and the reduction in the vehicle group (0.4 mmHg; P < 0.001 vs. netarsudil).","['Ocular Hypertension and Open-Angle Glaucoma', '12 patients with']","['Pharmacotherapy to lower intraocular pressure (IOP', 'OHT or OAG', 'Perkins tonometer in habitual positions by day (seated) and at night (supine', 'Netarsudil', 'netarsudil ophthalmic solution 0.02% (n\u2009=\u20098) or vehicle']","['mean diurnal IOP with netarsudil', 'nocturnal reduction', 'IOP', 'Baseline mean 24-h IOP', 'baseline nocturnal IOP', 'mean nocturnal IOP', 'adverse events', 'IOP reductions']","[{'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028841', 'cui_str': 'Hypotony of eye'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0183969', 'cui_str': 'Tonometer'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C4535721', 'cui_str': 'netarsudil Ophthalmic Solution'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",12.0,0.220749,"Netarsudil was associated with a reduction in mean nocturnal IOP (measurements at 21:00, 00:00, 03:00, 06:00 h) of 3.5 mmHg, which was significant relative to baseline nocturnal IOP (P < 0.001) and the reduction in the vehicle group (0.4 mmHg; P < 0.001 vs. netarsudil).","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Peace', 'Affiliation': 'United Medical Research Institute, Inglewood, CA, USA. drpeace@drjamespeace.com.'}, {'ForeName': 'Hayley J', 'Initials': 'HJ', 'LastName': 'McKee', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, NC, USA.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Durham, NC, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00322-1']
1538,33250082,Effects of Netarsudil on the Corneal Endothelium: Three-Month Findings from a Phase 3 Trial.,"PURPOSE


To describe the changes in endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (%HEX) after 3 months of therapy with netarsudil (Rhopressa; Aerie Pharmaceuticals Inc, Durham, NC) 0.02% dosed once daily (QD) or twice daily (BID) and to compare these changes with those seen with timolol 0.5% BID in eyes with ocular hypertension (OHTN) or open-angle glaucoma (OAG).
DESIGN


Post hoc analysis of data from a phase 3 evaluation of the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil 0.02% versus timolol 0.5%.
PARTICIPANTS


A subset of study subjects underwent corneal endothelial cell imaging by specular microscopy at baseline and after 3 months of therapy.
METHODS


Images were evaluated in a masked fashion at an independent reading center. The ECD, CV, and %HEX were determined using a standardized protocol for image analysis.
MAIN OUTCOME MEASURES


Changes in ECD, CV, and %HEX from baseline to 3 months were compared between treatment groups using 2-sample t tests.
RESULTS


Data from 386 subjects from whom analyzable specular microscopy images were obtained at both baseline and month 3 were included in this analysis. Mean ECD, CV, and %HEX values were comparable between groups at baseline. There were no statistically significant between-group differences in changes from baseline to month 3 in ECD, CV, or %HEX between either of the netarsudil groups and the timolol group. Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group. These small changes were unlikely to be of clinical significance. No statistically significant changes in ECD were seen in any group.
CONCLUSIONS


Netarsudil 0.02% showed no clinically significant effects on ECD, CV, or %HEX when dosed QD or BID for 3 months in eyes with OHTN or OAG.",2020,"Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group.","['Images were evaluated in a masked fashion at an independent reading center', '386 subjects from whom analyzable specular microscopy images', 'eyes with ocular hypertension (OHTN) or open-angle glaucoma (OAG']","['Netarsudil', 'corneal endothelial cell imaging by specular microscopy', 'timolol']","['ECD, CV, or %HEX', 'intraocular pressure (IOP)-lowering efficacy and safety', 'HEX', 'ECD', 'Changes in ECD, CV, and %HEX', 'Mean ECD, CV, and %HEX values', 'endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (%HEX', 'Corneal Endothelium', 'CV']","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}]","[{'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0014259', 'cui_str': 'Structure of corneal endothelium'}]",386.0,0.119236,"Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mundorf', 'Affiliation': 'Mundorf Eye Center, Charlotte, North Carolina. Electronic address: tommundorf@aol.com.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Mah', 'Affiliation': 'Scripps Clinic, La Jolla, California.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Irvine, California.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Irvine, California.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.04.014']
1539,33245533,Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study.,"INTRODUCTION


MATCH was a randomized, double-blind, placebo-controlled study enrolling Japanese and Korean men aged ≥ 40 years who still had overactive bladder (OAB) symptoms while receiving tamsulosin. After a 4-week single-blind screening period in which patients received placebo and tamsulosin, patients were randomized to mirabegron 50 mg + tamsulosin or placebo + tamsulosin for 12 weeks (n = 568). This post hoc analysis investigated the proportion of treatment responders for each treatment group and for subgroups stratified by age based on voiding diaries and patient-reported outcomes (PROs).
METHODS


Responders were defined as those achieving normalization or clinically meaningful improvements in efficacy, or clinically important differences in PROs [≥ 10-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by ≥ 3 points at EoT [minimally clinically important change (MCIC)]].
RESULTS


At EoT, micturition frequency normalization was achieved by 30.7% of tamsulosin + mirabegron patients and 18.6% of tamsulosin + placebo patients. Normalization of urgency and incontinence was 19.1% and 60.7% for tamsulosin + mirabegron and 18.2% and 60.0% for tamsulosin + placebo. Normalization of OAB symptoms based on OABSS was 17.1% for tamsulosin + mirabegron and 14.5% for tamsulosin + placebo. Higher proportions of patients in the mirabegron add-on group versus the placebo group reported clinically meaningful improvements in micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales. Double- and triple-responder findings were as predicted by the results of single-responder analyses. These results were mirrored in the age groups using cut-offs of 65 and 75 years.
CONCLUSION


Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS).
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02656173.",2021,"Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS).
","['40\xa0years who still had overactive bladder (OAB) symptoms while receiving', 'enrolling Japanese and Korean men aged\u2009≥', 'Men with Overactive Bladder']","['tamsulosin', 'placebo', 'Tamsulosin', 'tamsulosin\u2009+\u2009placebo', 'mirabegron 50\xa0mg\u2009+\u2009tamsulosin or placebo\u2009+\u2009tamsulosin', 'tamsulosin\u2009', 'placebo and tamsulosin']","['micturition frequency normalization', 'Normalization of OAB symptoms based on OABSS', 'urgency', 'micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales', 'Normalization of urgency and incontinence', 'PROs [≥\u200910-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by\u2009≥\u20093 points at EoT [minimally clinically important change (MCIC']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.210468,"Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS).
","[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katou', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. daisuke.katou@astellas.com.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamamoto', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Budiwan', 'Initials': 'B', 'LastName': 'Sumarsono', 'Affiliation': 'Astellas Pharma, Singapore, Singapore.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uno', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Bioengineering and LUTD Research, Nihon University School of Engineering, Koriyama, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01517-5']
1540,33245618,"Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant.","Individually tailoring education over time may help more patients, especially racial/ethnic minorities, get waitlisted and pursue deceased and living donor kidney transplant (DDKT and LDKT, respectively). We enrolled 802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial. We compared the effectiveness of Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates) over 8 months. Survey outcomes were collected prior to evaluation and at 4 and 8 months. Time to waitlisting or LDKT was assessed with at least 18 months of follow-up. At 8 months, compared to SOC, the YPT group demonstrated increased LDKT readiness (47% vs 33%, P = .003) and transplant knowledge (effect size [ES] = 0.41, P < .001). Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002). A focused, coordinated education effort can improve transplant-seeking behaviors and waitlisting rates. ClinicalTrials.gov registration: NCT02181114.",2020,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","['802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial', 'Your Path to Transplant']","['YPT', 'tailored expert system intervention', 'Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates']","['LDKT readiness', 'transplant knowledge', 'transplant-seeking behaviors and waitlisting rates', 'knowledge, attitudes, and pursuit of kidney transplant', 'Time to waitlisting or LDKT', 'Transplant pursuit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1141889', 'cui_str': 'Transplant evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0015324', 'cui_str': 'Expert Systems'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",802.0,0.0353113,"Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002).","[{'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Waterman', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Peipert', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Beaumont', 'Affiliation': 'Terasaki Institute of Biomedical Innovation, Los Angeles, California, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paiva', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Lipsey', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'Division of Nephrology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, The University of Rhode Island, Kingston, Rhode Island, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16262']
1541,33245631,A Mobile Healing Program Using Virtual Reality for Sexual Violence Survivors: A Randomized Controlled Pilot Study.,"BACKGROUND


Many young women suffer from sexual violence, but few practice self-healing activities.
AIMS


This study evaluated the feasibility and preliminary effects of a mobile virtual intervention, Sister, I will tell you!©, to heal young women after sexual violence in South Korea.
METHODS


A mobile virtual intervention, Sister, I will tell you!©, was developed based on a literature review and preliminary studies. In collaboration with sexual violence survivors and experts, eight modules for reflective writing and six modules for mindfulness meditation were included in this 4-week mobile virtual intervention. Thirty-four female sexual violence survivors were randomly assigned to either experimental (n = 19) or control groups (n = 15). The experimental group practiced reflective writing and mindfulness meditation, guided by the mobile virtual intervention. The control group practiced audio-guided mindfulness meditation. Pretest, posttest, and post-4-week evaluations with standardized instruments measured perceived support, negative impact from sexual violence, and suicidal ideation. Descriptive and inferential statistics were used to analyze survey data and content analysis to analyze reflective writing.
RESULTS


Among 34 enrolled participants, 26 completed the 4-week intervention and posttest evaluations; 24 completed post-4-week evaluations. Significant improvements were found among participants in the areas of perceived support, negative impact from sexual violence, and suicidal ideation. The effect size of the intervention was moderate. Four themes that emerged from reflective writings were objectifying sexual violence, healing beginning with action, confronting issues, and sharing experiences.
LINKING EVIDENCE TO ACTION


The intervention showed potential for initiating young women's engagement in healing from sexual violence. A simple mobile audio intervention without human interaction could benefit sexual violence survivors.",2021,"Significant improvements were found among participants in the areas of perceived support, negative impact from sexual violence, and suicidal ideation.","['young women suffer from sexual violence', 'Sexual Violence Survivors', 'Thirty-four female sexual violence survivors', '34 enrolled participants, 26 completed the 4-week intervention and posttest evaluations; 24 completed post-4-week evaluations', 'heal young women after sexual violence in South Korea']","['reflective writing and mindfulness meditation, guided by the mobile virtual intervention', 'mobile audio intervention without human interaction', 'mobile virtual intervention, Sister, I will tell you', 'control group practiced audio-guided mindfulness meditation']","['objectifying sexual violence, healing beginning with action, confronting issues, and sharing experiences', 'areas of perceived support, negative impact from sexual violence, and suicidal ideation', 'healing from sexual violence', 'Pretest, posttest, and post-4-week evaluations with standardized instruments measured perceived support, negative impact from sexual violence, and suicidal ideation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0337514', 'cui_str': 'Sister'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",34.0,0.0276868,"Significant improvements were found among participants in the areas of perceived support, negative impact from sexual violence, and suicidal ideation.","[{'ForeName': 'Mi-Ran', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Chiyoung', 'Initials': 'C', 'LastName': 'Cha', 'Affiliation': 'College of Nursing, Ewha Research Institute of Nursing Science, & System Health & Engineering major in graduate school, Ewha Womans University, Seoul, South Korea.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12478']
1542,33244149,"Placebo response mitigation with a participant-focused psychoeducational procedure: a randomized, single-blind, all placebo study in major depressive and psychotic disorders.","The remarkably high and growing placebo response rates in clinical trials for CNS indications, such as depression and schizophrenia, constitute a major challenge for the drug development enterprise. Despite extensive literature on participant expectancies and other potent psychosocial factors that perpetuate placebo response, no empirically validated participant-focused strategies to mitigate this phenomenon have been available. This study evaluated the efficacy of the Placebo-Control Reminder Script (PCRS), a brief interactive procedure that educates participants about factors known to cause placebo response, which was administered prior to the primary outcome assessments to subjects with major depressive or psychotic disorders who had at least moderate depression. Participants were informed they would participate in a 2-week randomized clinical trial with a 50% chance of receiving either an experimental antidepressant medication or placebo. In actuality, all participants received placebo. Participants randomly assigned to receive the PCRS (n = 70) reported significantly smaller reductions (i.e., less placebo response) in depression than those who did not receive the PCRS (n = 67). The magnitude of this effect was medium (Cohen's d = 0.40) and was not significantly impacted by diagnostic status. The number of adverse events (i.e., nocebo effect) was also lower in the PCRS group, particularly in the first week of the study. These findings suggest that briefly educating participants about placebo response factors can help mitigate the large placebo response rates that are increasingly seen in failed CNS drug development programs.",2021,"The number of adverse events (i.e., nocebo effect) was also lower in the PCRS group, particularly in the first week of the study.","['major depressive and psychotic disorders', 'subjects with major depressive or psychotic disorders who had at least moderate depression']","['Placebo-Control Reminder Script (PCRS', 'placebo', 'PCRS', 'experimental antidepressant medication or placebo', 'Placebo']",['number of adverse events'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.30173,"The number of adverse events (i.e., nocebo effect) was also lower in the PCRS group, particularly in the first week of the study.","[{'ForeName': 'Elan A', 'Initials': 'EA', 'LastName': 'Cohen', 'Affiliation': 'Hassman Research Institute, Marlton, NJ, USA.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Hassman', 'Affiliation': 'Hassman Research Institute, Marlton, NJ, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Ereshefsky', 'Affiliation': 'Hassman Research Institute, Marlton, NJ, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Walling', 'Affiliation': 'Collaborative NeuroScience Research, Garden Grove, CA, USA.'}, {'ForeName': 'Vera M', 'Initials': 'VM', 'LastName': 'Grindell', 'Affiliation': 'Collaborative NeuroScience Research, Garden Grove, CA, USA.'}, {'ForeName': 'Richard S E', 'Initials': 'RSE', 'LastName': 'Keefe', 'Affiliation': 'VeraSci, Durham, NC, USA. richard.keefe@duke.edu.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'The City University of New York, New York, NY, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Horan', 'Affiliation': 'VeraSci, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00911-5']
1543,33249630,"Randomised clinical trial: safety, efficacy and pharmacokinetics of HS-10234 versus tenofovir for the treatment of chronic hepatitis B infection.","BACKGROUND


HS-10234 is a novel prodrug of tenofovir developed to increase anti-viral potency and to reduce systemic toxicities.
AIMS


To evaluate the tolerability, pharmacokinetics and anti-viral efficacy of HS-10234 in patients with chronic hepatitis B (CHB) infection METHODS: Treatment-naïve subjects with non-cirrhotic CHB were divided into three groups (n = 12/group) and randomised within each group to receive 10, 25 or 40 mg of HS-10234, or 300 mg of tenofovir disoproxil fumarate (TDF) once a day for 28 days.
RESULTS


Among 36 enrolled subjects, 33.3% were hepatitis B e antigen-negative with a mean hepatitis B virus (HBV) DNA level of 6.32-7.42 log 10   IU/mL. Nephrotoxicity and serious adverse events were not observed; all adverse events were mild or moderate and non-specific. The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10   IU/mL for treatment with 10, 25 or 40 mg HS-10234, and 300 mg TDF, respectively. HS-10234 and its metabolite TFV showed linear, dose-proportional pharmacokinetics. The concentrations of active TFV-DP in peripheral blood mononuclear cells were higher (approximately 2- to 11-fold increase) and TFV in plasma were lower (approximately 4.5- to 25-fold reduction) in subjects taking HS-10234 than those in the TDF group.
CONCLUSIONS


HS-10234 was well tolerated during a 4-week course. TDF and HS-10234 had comparable potency in inhibiting HBV replication. A daily dose of 10-25 mg of HS-10234 is recommended for CHB treatment. (Chinese Drug Trial Identifier: CTR20161077).",2021,"The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10   ","['Treatment-naïve subjects with non-cirrhotic CHB', 'chronic hepatitis B infection', 'patients with chronic hepatitis B']","['tenofovir', 'HS-10234 versus tenofovir', 'HS-10234', 'HS-10234, or 300\xa0mg of tenofovir disoproxil fumarate (TDF']","['Nephrotoxicity and serious adverse events', 'concentrations of active TFV-DP in peripheral blood mononuclear cells', 'hepatitis B e antigen-negative with a mean hepatitis B virus (HBV) DNA level', 'serum HBV DNA', 'TFV in plasma', 'tolerability, pharmacokinetics and anti-viral efficacy']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",36.0,0.136687,"The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10   ","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Chengjiao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16196']
1544,33249467,Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial.,"AIMS 


This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy.
METHODS AND RESULTS 


Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0-3.0). Uninterrupted anticoagulation was mandated for 21-28 days' pre-ablation and 90 days' post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300-400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1-Q3) time from last dose to ablation procedure was 14.8 (13.3-16.5) vs. 16.5 (14.8-19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value < 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU).
CONCLUSION 


The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.",2021,The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.,"['614 randomized patients, 553 received study drug and underwent', 'atrial fibrillation (AF) patients undergoing ablation with uninterrupted', 'Patients']","['unfractionated heparin (UFH', 'catheter ablation (edoxaban', 'edoxaban or vitamin K antagonist (VKA) therapy', 'edoxaban', 'edoxaban 60\u2009mg (or dose-reduced 30\u2009mg) or dose-adjusted VKA', 'edoxaban vs. VKA', 'edoxaban vs. vitamin K antagonists']","['Mean ACT (SD) ≥300\u2009s', 'rate of procedure-related major/clinically relevant non-major bleeding', 'activated clotting time (ACT', 'procedure-related bleeds', 'median (Q1-Q3) time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427611', 'cui_str': 'Coagulation time, activated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0368930', 'cui_str': 'Coagulation time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",614.0,0.123206,The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.,"[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Department of Cardiology, Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, Blackshaw Road, London SW17 0QT, UK.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cappato', 'Affiliation': 'Department of Cardiovascular Diseases, Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano, Milan 20089, Italy.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Medical Faculty, University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': 'Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Department of Cardiology, Cardiovascular CIBER, Hospital Clinic, University of Barcelona, Carrer de Villarroel 170, 08003 Barcelona, Spain.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Rauer', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Department of Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, Czech Republic.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa199']
1545,33257457,Influence of polypharmacy on patients with heart failure with preserved ejection fraction: a retrospective analysis on adverse outcomes in the TOPCAT trial.,"BACKGROUND


Polypharmacy is common in heart failure (HF), whereas its effect on adverse outcomes in patients with HF with preserved ejection fraction (HFpEF) is unclear.
AIM


To evaluate the prevalence, prognostic impacts, and predictors of polypharmacy in HFpEF patients.
DESIGN AND SETTING


A retrospective analysis performed on patients in the Americas region (including the US, Canada, Argentina, and Brazil) with symptomatic HF and a left ventricular ejection fraction ≥45% in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial, an international, randomised, double-blind, placebo-controlled study conducted during 2006-2013 in six countries.
METHOD


Patients were categorised into four groups: controls (<5 medications), polypharmacy (5-9 medications), hyperpolypharmacy, (10-14 medications), and super hyperpolypharmacy (≥15 medications). The outcomes and predictors in all groups were assessed.
RESULTS


Of 1761 participants, the median age was 72 years; 37.5% were polypharmacy, 35.9% were hyperpolypharmacy, and 19.6% were super hyperpolypharmacy, leaving 7.0% having a low medication burden. In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation. Furthermore, several comorbidities (dyslipidemia, thyroid diseases, diabetes mellitus, and chronic obstructive pulmonary disease), a history of angina pectoris, diastolic blood pressure <80 mmHg, and worse heart function (the New York Heart Association functional classification level III and IV) at baseline were independently associated with a high medication burden among patients with HFpEF.
CONCLUSION


A high prevalence of high medication burden at baseline was reported in patients with HFpEF. The high medication burden might increase the risk of hospital readmission, but not the mortality.",2021,"In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation.","['patients with HF with preserved ejection fraction (HFpEF', 'HFpEF patients', '1761 participants', 'patients in the Americas region (including the US, Canada, Argentina, and Brazil) with symptomatic HF and a left ventricular ejection fraction', 'patients with heart failure with preserved ejection fraction', 'Patients were categorised into four groups: controls (<5 medications), polypharmacy (5-9 medications), hyperpolypharmacy, (10- 14 medications), and super hyperpolypharmacy (≥15 medications', 'patients with HFpEF', '2006-2013 in six countries']","['polypharmacy', 'TOPCAT', 'placebo']","['risk of hospital readmission', 'several comorbidities (dyslipidemia, thyroid diseases, diabetes mellitus, and chronic obstructive pulmonary disease', 'risks of HF hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0766551,"In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation.","[{'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Wengen', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Fangfei', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, PR China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp21X714245']
1546,33450430,"Effects of recreational team handball on bone health, postural balance and body composition in inactive postmenopausal women - A randomised controlled trial.","This study reports the effects of a recreational team handball exercise programme (randomised controlled trial, RCT) on bone health, postural balance and body composition in inactive postmenopausal women without previous experience of the sport. Sixty-seven postmenopausal women (68.3 ± 6.2 years, stature 156.9 ± 5.8 cm, body mass 65.6 ± 9.6 kg, body fat 40.9 ± 5.9%, VO 2peak  25.2 ± 3.6 mL·min -1 ·kg -1 ) were randomised into team handball (THG, n = 41) and control (CG, n = 26) groups. During the 16-week intervention period, THG performed two to three 60-min training sessions per week, while CG continued with their habitual physical activity. Bone mineral density (BMD) and content (BMC), biochemical bone formation (osteocalcin (OC), procollagen type-1 amino-terminal propeptide (P1NP)) and resorption (carboxy-terminal type-1 collagen crosslinks (CTX)) markers, postural balance, body fat and lean mass were evaluated at baseline and post intervention. A time x group interaction (p ≤ 0.02) was shown for lumbar spine BMD (+1.5%) and BMC (+2.3%), P1NP (+37.6 ± 42.4%), OC (+41.9 ± 27.0%) and postural balance (-7 ± 37% falls), in favour of THG with no changes in CG. This RCT showed that short-term recreational team handball practice had an impact on bone turnover and was effective for improving bone health and postural balance in postmenopausal women without previous experience of the sport, hence potentially helping to reduce the risk of falls and fractures.",2021,"A time x group interaction (p≤0.02) was shown for lumbar spine BMD (+1.5%) and BMC (+2.3%), P1NP (+37.6±42.4%), OC (+41.9±27.0%) and postural balance (-7±37% falls), in favour of THG with no changes in CG.","['postmenopausal women', 'inactive postmenopausal women ', 'Sixty-seven postmenopausal women without previous experience of team handball practice (68.3±6.2 years, stature 156.9±5.8 cm, body mass 65.6±9.6 kg, body fat 40.9±5.9%, VO 2peak  25.2±3.6 mL ', 'untrained postmenopausal women without previous experience of the sport']","['RCT', 'recreational team handball exercise programme']","['postural balance', 'lumbar spine BMD', 'Bone mineral density (BMD) and content (BMC), biochemical bone formation (osteocalcin (OC), procollagen type-1 amino-terminal propeptide (P1NP)) and resorption markers (carboxy-terminal type-1 collagen crosslinks (CTX)), postural balance, body fat and lean mass', 'OC', 'bone health and postural balance', 'BMC', 'bone turnover', 'P1NP', 'bone health, postural balance and body composition']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",67.0,0.0610324,"A time x group interaction (p≤0.02) was shown for lumbar spine BMD (+1.5%) and BMC (+2.3%), P1NP (+37.6±42.4%), OC (+41.9±27.0%) and postural balance (-7±37% falls), in favour of THG with no changes in CG.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Metabolism and Exercise (LaMetEx), Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark; Sport and Health Sciences, University of Exeter, Exeter, UK; Shanghai University of Sport (SUS), Shanghai, China.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Castagna', 'Affiliation': 'Fitness Training and Biomechanics Laboratory, Italian Football Federation (FIGC), Technical Department, Coverciano, Florence, Italy; University of Roma Tor Vergata, Rome, Italy.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Coelho', 'Affiliation': 'Porto Sports Medicine Center (IPDJ, IP), Portugal.'}, {'ForeName': 'Rute', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal; Directorate-General of Health, National Physical Activity Promotion Program, Lisbon, Portugal.'}, {'ForeName': 'Eva Wulff', 'Initials': 'EW', 'LastName': 'Helge', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Magalhães', 'Affiliation': 'Laboratory of Metabolism and Exercise (LaMetEx), Research Centre in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sport, University of Porto, Porto, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Póvoas', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark; Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University Institute of Maia, ISMAI, Maia, Portugal. Electronic address: spovoas@ismai.pt.'}]",Bone,['10.1016/j.bone.2021.115847']
1547,33254048,Does valence contribute to the effects of dual tasking in aversive autobiographical memory? Some unexpected findings.,"BACKGROUND AND OBJECTIVES


Lab experiments show that engaging in a working memory task while recalling an aversive memory reduces emotionality and vividness of memories. Studies targeting lab induced negative memory with valenced secondary tasks show promise, but work is needed on autobiographical memories to make it more in line with the original dual tasking research and PTSD treatment in clinical populations. In this study, we address this gap by evaluating differential effectiveness of valenced dual tasks on emotionality and vividness of aversive autobiographical memories.
METHODS


University students (N = 178) recalled an aversive autobiographical memory while rating either positive pictures, negative pictures, or while looking at a cross in the exposure only condition. Participants were randomized to one of three aforementioned conditions and rated their memories before and after each intervention on emotionality and vividness.
RESULTS


Against expectations, memories became more emotional and vivid regardless of condition. With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions. All effect sizes were small.
LIMITATIONS


Working memory load in the dual tasking conditions might have been insufficient.
CONCLUSIONS


The current study did not extend findings with regard to (valenced) dual tasking and revealed a possible sensitization effect of script driven autobiographical memory induction. Our study highlights the importance of aspects such as the total amount of exposure and characteristics of memory induction, specifically the addition of a script driven approach to the usual self-initiated memory activation in dual tasking research.",2020,"With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions.",['University students (N\xa0=\xa0178) recalled an'],"['valenced dual tasks', 'aversive autobiographical memory while rating either positive pictures, negative pictures, or while looking at a cross in the exposure only condition']",[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],,0.0360541,"With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'IJdema', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands. Electronic address: t.ijdema@uvt.nl.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Laceulle', 'Affiliation': 'Department of Developmental Psychology, Utrecht University, PO Box 80140, 3508, TC Utrecht, the Netherlands. Electronic address: o.m.laceulle@uu.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karreman', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands. Electronic address: a.karreman@uvt.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands; Department of Medical Psychology, Elisabeth-Tweesteden Hospital, Tilburg, Postbus 90151, 5000, LC Tilburg, the Netherlands. Electronic address: j.devries@uvt.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands; Department of Anxiety and Obsessive Compulsive Disorders, PsyQ, Lijnbaan 4, 2512, VA, The Hague, the Netherlands. Electronic address: c.w.korrelboom@uvt.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101616']
1548,33253973,Cognitive function following pulmonary rehabilitation and post-discharge recovery from exacerbation in people with COPD.,"BACKGROUND


Cognitive impairment (CI) is prevalent in COPD and is associated with poor health-related quality of life. Recovery of cognition following an acute exacerbation of COPD (AECOPD), the impact of CI on pulmonary rehabilitation (PR) uptake and the effect of PR on CI are not fully understood.
METHODS


This 6-week prospective study analysed 67 people with stable COPD symptoms who completed PR (PR group) and the recovery of 45 people admitted for AECOPD (AECOPD group). All participants were assessed for cognitive function (Montreal Cognitive Assessment [MoCA]), health status (COPD Assessment Test, Chronic Respiratory Questionnaire), lower extremity function (Short Physical Performance Battery), and psychological well-being (Hospital Anxiety and Depression Score). Follow up assessments were carried out after a 6-week recovery post-discharge in AECOPD group and after PR in the PR group.
RESULTS


AECOPD group showed no improvement in MoCA following a 6-week recovery post-discharge (Δ-0.8 ± 3.2, p = 0.205), despite improvements in all other clinical outcomes. PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325). Participants in the PR group with CI at baseline showed a significant improvement in MoCA score following PR (Δ1.6 ± 2.4, p = 0.004).
CONCLUSIONS


Cognition does not improve following 6-week recovery post-AECOPD, and CI may influence patients' response to PR referral as an inpatient. PR improves cognition in people with stable COPD symptoms and CI. People with AECOPD should be actively encouraged to attend PR irrespective of mild-moderate cognition but may require additional support or opportunities to take part.",2021,PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325).,"['people with COPD', 'people with stable COPD symptoms and CI', '67 people with stable COPD symptoms who completed PR (PR group) and the recovery of 45 people admitted for AECOPD (AECOPD group']",['AECOPD'],"['MoCA score', 'Cognitive function', 'MoCA', 'PR uptake', 'pulmonary rehabilitation (PR) uptake', 'cognitive function (Montreal Cognitive Assessment [MoCA]), health status (COPD Assessment Test, Chronic Respiratory Questionnaire), lower extremity function (Short Physical Performance Battery), and psychological well-being (Hospital Anxiety and Depression Score', 'PR improves cognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",67.0,0.0571883,PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325).,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'France', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: Grace.France@uhl-tr.nhs.uk.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Orme', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: mwo4@leicester.ac.uk.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Greening', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: neil.greening@leicester.ac.uk.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Steiner', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: ms346@leicester.ac.uk.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Chaplin', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: emma.chaplin@uhl-tr.nhs.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Clinch', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: lisa.clinch@uhl-tr.nhs.uk.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: sally.singh@uhl-tr.nhs.uk.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106249']
1549,33253664,Retinal Fluid Volatility Associated With Interval Tolerance and Visual Outcomes in Diabetic Macular Edema in the VISTA Phase III Trial.,"PURPOSE


To describe longitudinal retinal fluid dynamics on spectral domain OCT and to identify imaging biomarkers that predict the worsening of DME with interval extension during anti-vascular endothelial growth factor (VEGF) therapy.
DESIGN


A post hoc sub-analysis of phase III, VISTA-DME study.
METHODS


Eyes received either intravitreal aflibercept injection 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly injections (2q8), and eyes imaged with the Cirrus HD-OCT system were included. The macular cube was analyzed for 10 time-points from baseline through week 100. Retinal OCT images were evaluated using a novel software platform to extract retinal fluid features for calculation of volumetric fluid parameters, including the retinal fluid index (RFI): the percentage of retinal volume that was occupied by intraretinal fluid.
RESULTS


Fifty-five eyes were included in the 2q4 group, and 58 eyes were included in the 2q8 group. Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
CONCLUSIONS


Early fluid dynamics as measured by (1) early RFI volatility and (2) cumulative RFI instability with aggregate increased RFI were associated with intolerance of interval extension.",2020,"Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
","['Fifty-five eyes were included in the 2q4 group, and 58 eyes were included in the 2q8 group']",['intravitreal aflibercept injection'],"['RFI volatility and (2) cumulative RFI instability', 'Early RFI volatility with a central macular RFI increase', 'cumulative RFI volatility', 'worsening of DME and visual acuity', 'macular RFI', 'macular cube']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",55.0,0.096759,"Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
","[{'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address: ehlersj@ccf.org.'}, {'ForeName': 'Atsuro', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Duriye Damla', 'Initials': 'DD', 'LastName': 'Sevgi', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reed', 'Affiliation': 'Regeneron, Tarrytown, New York, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Berliner', 'Affiliation': 'Regeneron, Tarrytown, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron, Tarrytown, New York, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Regeneron, Tarrytown, New York, USA.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.11.010']
1550,33258422,African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.,"BACKGROUND


Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge.
OBJECTIVES


Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs.
METHODS


This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials.
RESULTS


Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%;  P   FDR  = .001), were younger (62.7  +  8;  P   FDR  = .03), had a lower ejection fraction (39.1  +  15.4;  P FDR  = .03), were more likely to be single ( P   FDR  = .001), and lack an advanced directive (16.4%;  P   FDR  < .001). AAs reported higher goal setting (3.3  +  1.3;  P   FDR  = .007), care coordination (2.8  +  1.3;  P   FDR  = .001) and used more ""denial"" coping strategies (0.8  +  1;  P   FDR  = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores.
CONCLUSION


ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02505425.",2020,"AAs reported higher goal setting (3.3  +  1.3;  P   FDR  = .007), care coordination (2.8  +  1.3;  P   FDR  = .001) and used more ""denial"" coping strategies (0.8  +  1;  P   FDR  = .001).","['Patients and Caregivers', 'African Americans', '785 patients screened', '566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226', 'African Americans (AAs']",['RCT'],"['lower ejection fraction', 'care coordination', 'denial"" coping strategies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0011317', 'cui_str': 'Denial - mental defense mechanism'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",566.0,0.290085,"AAs reported higher goal setting (3.3  +  1.3;  P   FDR  = .007), care coordination (2.8  +  1.3;  P   FDR  = .001) and used more ""denial"" coping strategies (0.8  +  1;  P   FDR  = .001).","[{'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Department of Medicine, Geriatrics, Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Raegan', 'Initials': 'R', 'LastName': 'Durant', 'Affiliation': 'Division of Preventative Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Department of Medicine, Geriatrics, Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Tucker', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of palliative care,['10.1177/0825859720975978']
1551,7795251,Wider benefits of leukodepletion of blood products.,,1995,,[],[],[],[],[],[],,0.045174,,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Copplestone', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Norfolk', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Morgenstern', 'Affiliation': ''}, {'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Wimperis', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Williamson', 'Affiliation': ''}]",Blood,[]
1552,4516522,Comparison of two methods of preventing central nervous system leukemia.,,1973,,[],[],[],[],[],[],,0.018446,,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Aur', 'Affiliation': ''}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Hustu', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Verzosa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': ''}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Simone', 'Affiliation': ''}]",Blood,[]
1553,9694737,Long-term follow-Up of a randomized trial of two irradiation regimens for patients receiving allogeneic marrow transplants during first remission of acute myeloid leukemia.,,1998,,['patients receiving allogeneic marrow transplants during first remission of acute myeloid leukemia'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]",[],[],,0.0444129,,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}]",Blood,[]
1554,6953986,Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study.,"A randomized comparison of the relative efficacy and toxicity of daunorubicin (DNR) at 30 or 45 mg/sq m or adriamycin (ADM) at 30 mg/sq m, given on the first 3 days of a 7-day continuous infusion of cytosine arabinoside (ara-C) at 100 mg/sq m/day, shows the outcome to be dependent on anthracycline, dose, and patient age. DNR 45 is significantly better than DNR 30 or ADM 30 for inducing complete remissions (CR) in patients younger than 60 yr, (72%, 59%, 58% CRs, respectively). DNR 30 is better than DNR 45 or ADM 30 for inducing CR in patients older than 60 yr (47%, 31%, 35%, respectively). There was a corresponding shift in the induction mortality for the age, dose, and anthracycline groups. Adriamycin was significantly more toxic to the gastrointestinal tract than daunorubicin. The duration of complete remission, with cyclic courses of maintenance therapy, was independent of the patient's age, the dose, or choice of anthracycline used in induction, and of whether the maintenance courses were given every 4 wk or every 8 wk.",1982,"DNR 45 is significantly better than DNR 30 or ADM 30 for inducing complete remissions (CR) in patients younger than 60 yr, (72%, 59%, 58% CRs, respectively).",['acute myelocytic leukemia'],"['Cytosine arabinoside with daunorubicin or adriamycin', 'daunorubicin (DNR) at 30 or 45 mg/sq m or adriamycin (ADM', 'Adriamycin', 'cytosine arabinoside (ara-C', 'daunorubicin']","['complete remissions (CR', 'induction mortality', 'duration of complete remission']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0549125,"DNR 45 is significantly better than DNR 30 or ADM 30 for inducing complete remissions (CR) in patients younger than 60 yr, (72%, 59%, 58% CRs, respectively).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Glidewell', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wiernik', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Steinberg', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dosik', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hoagland', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cornell', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Berenberg', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Raich', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nissen', 'Affiliation': ''}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Ellison', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Frelick', 'Affiliation': ''}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Falkson', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Haurani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Leone', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Holland', 'Affiliation': ''}]",Blood,[]
1555,9746769,A special fluorescent in situ hybridization technique to study peripheral blood and assess the effectiveness of interferon therapy in chronic myeloid leukemia.,"Using a highly sensitive fluorescence in situ hybridization method with probes for BCR and ABL1 (D-FISH), we studied 37 paired sets of bone marrow and blood specimens, collected within 24 to 96 hours of each other, from 10 patients before and during treatment for chronic myeloid leukemia (CML). The normal range for 500 interphase nuclei was </=4 (</=0.8%) nuclei based on 10 bone marrow and 10 blood specimens from normal individuals. The percentage of neoplastic nuclei was usually lower in blood than bone marrow. However, changes in the percentage of neoplastic nuclei in blood and bone marrow tracked closely over the course of therapy and with the results of quantitative cytogenetic studies on bone marrow. This result indicates that D-FISH is useful to test blood from patients with CML to monitor therapy. Moreover, by analysis of 6,000 nuclei with D-FISH, residual disease was identified in bone marrow and blood for patients in complete cytogenetic remission. Consequently, D-FISH analyses of interphase nuclei from blood could substitute for Q-cytogenetic studies on bone marrow. Thus, it may not be necessary to collect bone marrow samples so frequently to monitor therapy in CML.",1998,The percentage of neoplastic nuclei was usually lower in blood than bone marrow.,['chronic myeloid leukemia'],['interferon therapy'],['percentage of neoplastic nuclei'],"[{'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0279030', 'cui_str': 'Interferon therapy'}]","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}]",6000.0,0.0339191,The percentage of neoplastic nuclei was usually lower in blood than bone marrow.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Buño', 'Affiliation': 'Division of Laboratory Genetics and Section of Biostatistics, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wyatt', 'Affiliation': ''}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Zinsmeister', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dietz-Band', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Dewald', 'Affiliation': ''}]",Blood,[]
1556,6414555,"Autoplex versus proplex: a controlled, double-blind study of effectiveness in acute hemarthroses in hemophiliacs with inhibitors to factor VIII.","In view of uncontrolled observations and anecdotal reports suggesting that the activated PCC, Autoplex, was much more effective than standard (non-activated) PCC in controlling bleeding in hemophiliacs with inhibitors, a controlled double-blind study was designed to compare the effectiveness of Autoplex and Proplex. Acute hemarthrosis was chosen for study as this common but non-life-threatening lesion lends itself well to controlled study. A single dose of ""unknown"" product (Autoplex 75 FECU/kg; Autoplex 50 FECU/kg; or Proplex 75 FIX U/kg) was given, and effectiveness was judged at 6 hr. By all criteria of efficacy, there were no significant differences between the products. It is noteworthy that a single dose of PCC was judged effective in 50% of episodes, a figure that is consistent with other published clinical trials. In this model, no additional benefit was derived from using the activated PCC, Autoplex, in either dosage.",1983,"By all criteria of efficacy, there were no significant differences between the products.",['acute hemarthroses in hemophiliacs with inhibitors to factor VIII'],"['Autoplex versus proplex', 'PCC', 'standard (non-activated) PCC']",[],"[{'cui': 'C0018924', 'cui_str': 'Hemarthrosis'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]","[{'cui': 'C0950461', 'cui_str': 'Proplex'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],,0.13432,"By all criteria of efficacy, there were no significant differences between the products.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lusher', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Blatt', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Penner', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Aledort', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Levine', 'Affiliation': ''}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Warrier', 'Affiliation': ''}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Whitehurst', 'Affiliation': ''}]",Blood,[]
1557,31310839,How to improve the clinical experience for dermatology patients requiring a genital examination: A randomized trial of deodorizing wipes versus standard of care.,,2020,,['Dermatology Patients Requiring a Genital Examination'],['Deodorizing Wipes versus Standard of Care'],[],"[{'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}]",[],,0.02847,,"[{'ForeName': 'Susruthi', 'Initials': 'S', 'LastName': 'Rajanala', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Burdine', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Mayra B C', 'Initials': 'MBC', 'LastName': 'Maymone', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts.'}, {'ForeName': 'Neelam A', 'Initials': 'NA', 'LastName': 'Vashi', 'Affiliation': 'Department of Dermatology, Boston University School of Medicine, Boston, Masschusetts; US Department of Veterans Affairs, Boston Health Care System, Boston, Massachusetts. Electronic address: nvashi@bu.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.026']
1558,18205573,"Acupuncture for persistent allergic rhinitis: a randomised, sham-controlled trial.",,2008,,['persistent allergic rhinitis'],['Acupuncture'],[],"[{'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.506641,,"[{'ForeName': 'Edzard', 'Initials': 'E', 'LastName': 'Ernst', 'Affiliation': ''}]",The Medical journal of Australia,[]
1559,10627126,Long-term follow-up of a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide for patients receiving allogenic marrow transplants during chronic phase of chronic myeloid leukemia.,,1999,,['patients receiving allogenic marrow transplants during chronic phase of chronic myeloid leukemia'],['cyclophosphamide and total body irradiation with busulfan and cyclophosphamide'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]",[],,0.0263693,,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}]",Blood,[]
1560,32090748,Glycyrrhizic acid as an adjunctive treatment for depression through anti-inflammation: A randomized placebo-controlled clinical trial.,"BACKGROUND


Recently, abundant evidence indicated proinflammatory cytokines might play a crucial role in pathophysiology and treatment of depression. According to our preclinical research, we propose glycyrrhizic acid (GZA) for an adjunctive treatment owing to its safety, economical and anti-inflammatory profile.
METHODS


Eligible participants were recruited and randomly allocated into independent treatment groups of SSRI+GZA (n = 30) and SSRI+PBO (placebo, n = 26). Depressive symptoms and specific serum biomarkers were detected during the 4-week treatment course. Afterward, the relationships between biomarkers and clinical effects were explored.
RESULTS


Depressive symptoms relieved more in SSRI+GZA than SSRI+PBO, both at week 2 (P = 0.003) and week 4 (P = 0.016). Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO. Mediation analysis further demonstrated that TNF-α reduction mediated the association between GZA treatment and clinical improvement, the indirect effect lay between 0.124 and 3.514 (95% CI). The exploratory analysis also suggested that the symptomatic improvement existed in patients with high-inflammation (baseline CRP > 3 mg/L) rather than those with low-inflammation (baseline CRP ≤ 3 mg/L).
LIMITATIONS


The sample size in this study was not large enough and the follow-up duration was relatively short.
CONCLUSIONS


This study offers a novel strategy for the diagnosis, categorization, individualization and prognosis regarding upgrading traditional antidepressant therapy, which is from biomarkers to diagnostic indicator and therapeutic target. Patients are necessary to be classified according to the inflammatory state, those with high levels of baseline inflammation should receive combined treatment with anti-inflammatory agents like GZA.",2020,"Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO.","['depression through anti-inflammation', 'Eligible participants']","['SSRI+PBO (placebo', 'glycyrrhizic acid (GZA', 'Glycyrrhizic acid', 'placebo', 'SSRI+GZA', 'anti-inflammatory agents like GZA']","['Depressive symptoms and specific serum biomarkers', 'response rate', 'Depressive symptoms', 'remission rate']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061751', 'cui_str': 'glycyrrhizin'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.159878,"Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO.","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Cao', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China; Department of Psychiatry, The 904th Hospital of PLA, 55 North Heping Road, Changzhou, China.'}, {'ForeName': 'Yun-Zi', 'Initials': 'YZ', 'LastName': 'Liu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Jia-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Ruan', 'Affiliation': 'Department of Health Statistics, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Yan', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Shi-Yang', 'Initials': 'SY', 'LastName': 'Zhong', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China; Department of Nursing, The 474th Hospital of PLA, 757 Beijing Road, Urumqi, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Bi', 'Affiliation': 'Department of Neurology, Changhai Hospital, 168 Changhai Road, Shanghai, China.'}, {'ForeName': 'Yun-Xia', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Su', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China. Electronic address: suwenjun1992@163.com.'}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Jiang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China. Electronic address: cljiang@vip.163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.048']
1561,7980802,Questions about the role of granulocyte-macrophage colony-stimulating factor as adjunct to non-Hodgkin's lymphoma chemotherapy.,,1994,,[],['granulocyte-macrophage colony-stimulating factor'],[],[],"[{'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}]",[],,0.00995801,,"[{'ForeName': 'U S', 'Initials': 'US', 'LastName': 'Schuler', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lüdtke', 'Affiliation': ''}]",Blood,[]
1562,4322483,Central nervous system therapy and combination chemotherapy of childhood lymphocytic leukemia.,,1971,,['childhood lymphocytic leukemia'],['Central nervous system therapy and combination chemotherapy'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0023448', 'cui_str': 'Leukemia, Lymphocytic'}]","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]",[],,0.0220621,,"[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Aur', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simone', 'Affiliation': ''}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Hustu', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Walters', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Borella', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pratt', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pinkel', 'Affiliation': ''}]",Blood,[]
1563,31840247,High-definition transcranial direct current stimulation dissociates fronto-visual theta lateralization during visual selective attention.,"KEY POINTS


Visual attention involves discrete multispectral oscillatory responses in visual and 'higher-order' prefrontal cortices. Prefrontal cortex laterality effects during visual selective attention are poorly characterized. High-definition transcranial direct current stimulation dynamically modulated right-lateralized fronto-visual theta oscillations compared to those observed in left fronto-visual pathways. Increased connectivity in right fronto-visual networks after stimulation of the left dorsolateral prefrontal cortex resulted in faster task performance in the context of distractors. Our findings show clear laterality effects in theta oscillatory activity along prefrontal-visual cortical pathways during visual selective attention.
ABSTRACT


Studies of visual attention have implicated oscillatory activity in the recognition, protection and temporal organization of attended representations in visual cortices. These studies have also shown that higher-order regions such as the prefrontal cortex are critical to attentional processing, but far less is understood regarding prefrontal laterality differences in attention processing. To examine this, we selectively applied high-definition transcranial direct current stimulation (HD-tDCS) to the left or right dorsolateral prefrontal cortex (DLPFC). We predicted that HD-tDCS of the left versus right prefrontal cortex would differentially modulate performance on a visual selective attention task, and alter the underlying oscillatory network dynamics. Our randomized crossover design included 27 healthy adults that underwent three separate sessions of HD-tDCS (sham, left DLPFC and right DLPFC) for 20 min. Following stimulation, participants completed an attention protocol during magnetoencephalography. The resulting oscillatory dynamics were imaged using beamforming, and peak task-related neural activity was subjected to dynamic functional connectivity analyses to evaluate the impact of stimulation site (i.e. left and right DLPFC) on neural interactions. Our results indicated that HD-tDCS over the left DLPFC differentially modulated right fronto-visual functional connectivity within the theta band compared to HD-tDCS of the right DLPFC and further, specifically modulated the oscillatory response for detecting targets among an array of distractors. Importantly, these findings provide network-specific insight into the complex oscillatory mechanisms serving visual selective attention.",2020,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,['27 healthy adults'],"['high-definition transcranial direct-current stimulation (HD-tDCS', 'HD-tDCS (sham, left- and right-DLPFC', 'attention paradigm during magnetoencephalography (MEG']","['faster task performance', 'HD-tDCS dynamically modulated right-lateralized fronto-visual theta oscillations', 'right fronto-visual functional connectivity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",27.0,0.0470895,Increased connectivity in right fronto-visual networks after stimulation of the left DLPFC resulted in faster task performance in the context of distractors.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Spooner', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Eastman', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rezich', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}, {'ForeName': 'Tony W', 'Initials': 'TW', 'LastName': 'Wilson', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 68198, USA.'}]",The Journal of physiology,['10.1113/JP278788']
1564,3888312,Cyclosporine as prophylaxis for graft-versus-host disease: a randomized study in patients undergoing marrow transplantation for acute nonlymphoblastic leukemia.,"Seventy-five patients, 13 to 49 years of age, with acute nonlymphoblastic leukemia in first remission were treated with cyclophosphamide, fractionated total body irradiation, and marrow transplantation from an HLA-identical sibling and randomized to receive either cyclosporine (CSP) (n = 36) or methotrexate (MTX) (n = 39) as prophylaxis for graft-v-host disease (GVHD). All patients engrafted, and 22 who were given CSP and 21 who were given MTX, are alive at 20 to 47 (median, 35) months (P = .5). Engraftment as assessed by granulocyte recovery (P less than .0005) and platelet transfusion requirement (P = .01) was faster in patients on CSP. Twelve patients (33%) on CSP and 22 (56%) on MTX developed acute GVHD of grades II through IV (P = .07) and 15 of 30 on CSP and 14 of 32 on MTX that were at risk developed chronic GVHD. The most frequent causes of death were interstitial pneumonitis and marrow relapse of leukemia, which occurred with similar frequency in both groups. Beneficial effects observed in patients on CSP included less severe mucositis and shorter duration of hospitalization; adverse effects included renal function impairment and hypertension. These data confirm that CSP is a useful immunosuppressant in patients undergoing marrow transplantation but fail to show a significant improvement in survival as compared with the standard regimen of MTX.",1985,Engraftment as assessed by granulocyte recovery (P less than .0005) and platelet transfusion requirement (P = .01) was faster in patients on CSP.,"['patients undergoing marrow transplantation', 'Seventy-five patients, 13 to 49 years of age, with acute nonlymphoblastic leukemia in first remission were treated with', 'patients undergoing marrow transplantation for acute nonlymphoblastic leukemia']","['CSP', 'Cyclosporine', 'MTX', 'cyclophosphamide, fractionated total body irradiation, and marrow transplantation from an HLA-identical sibling and randomized to receive either cyclosporine (CSP', 'methotrexate (MTX']","['granulocyte recovery', 'severe mucositis', 'renal function impairment and hypertension', 'platelet transfusion requirement', 'acute GVHD', 'survival', 'interstitial pneumonitis and marrow relapse of leukemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}]",,0.0308312,Engraftment as assessed by granulocyte recovery (P less than .0005) and platelet transfusion requirement (P = .01) was faster in patients on CSP.,"[{'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Flournoy', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kennedy', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Banaji', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}]",Blood,[]
1565,32091268,Force magnitude as a variable in maxillary buccal segment intrusion in adult patients with skeletal open bite:  A double-blind randomized clinical trial .,"OBJECTIVES


To compare the effects of two different force magnitudes on maxillary posterior segment intrusion using mini-screws. The null hypothesis was that there would be no difference between the two force magnitudes.
MATERIALS AND METHODS


Adult patients with skeletal open bite and a dental open bite ranging from 3 to 8 mm were recruited for this trial. The comparator group had 200 g of intrusive force applied for posterior segment intrusion, whereas 400 g of force was applied in the intervention group. Primary outcomes were the amount of posterior teeth intrusion and anterior open bite closure.
RESULTS


Twenty-two subjects were randomized to include 11 participants in each group. One participant dropped out in each group, leaving us with 10 subjects to be analyzed per group. There was statistically significant posterior teeth intrusion of 2.42 ± 2.06 and 2.26 ± 1.87 mm for the comparator and intervention groups, respectively, with no difference between them. Statistically significant open bite closure was achieved in both groups, measuring 2.24 ± 1.18 and 3.15 ± 1.06 mm in the comparator and intervention groups, respectively, with no difference between them.
CONCLUSIONS


Both the 200 g and 400 g intrusive forces yielded similar outcomes in terms of posterior teeth intrusion and anterior open bite closure.",2020,Both the 200 g and 400 g intrusive forces yielded similar outcomes in terms of posterior teeth intrusion and anterior open bite closure.,"['Adult patients with skeletal open bite and a dental open bite ranging from 3 to 8 mm were recruited for this trial', 'Twenty-two subjects were randomized to include 11 participants in each group', 'adult patients with skeletal open bite']",[],"['posterior teeth intrusion and anterior open bite closure', 'open bite closure', 'amount of posterior teeth intrusion and anterior open bite closure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266061', 'cui_str': 'Apertognathia'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0436039', 'cui_str': 'Tooth Intrusion'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite (disorder)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0266061', 'cui_str': 'Apertognathia'}]",22.0,0.141837,Both the 200 g and 400 g intrusive forces yielded similar outcomes in terms of posterior teeth intrusion and anterior open bite closure.,"[{'ForeName': 'Heba E', 'Initials': 'HE', 'LastName': 'Akl', 'Affiliation': ''}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Abouelezz', 'Affiliation': ''}, {'ForeName': 'Fouad A', 'Initials': 'FA', 'LastName': 'El Sharaby', 'Affiliation': ''}, {'ForeName': 'Amr R', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': ''}, {'ForeName': 'Mohamed Abd', 'Initials': 'MA', 'LastName': 'El-Ghafour', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/082819-558.1']
1566,32090766,Factors associated with engagement in online self-help programs among people with suicidal thoughts.,"BACKGROUND


The effectiveness of internet-based self-help programs for mental health may be limited by low engagement. Identifying factors associated with engagement in online interventions assists in developing strategies to improve efficacy through greater engagement. The aim of the current study was to identify factors associated with engagement among people with suicidal thoughts who completed an online program.
METHOD


418 adults with suicidal ideation were recruited online into a randomized controlled trial of a 6-week internet-based self-help program. Program usage for the intervention and active control conditions was measured as the number of logins and modules accessed. Predictors of program usage and between-group differences were examined, including sociodemographic variables, user preferences and mental health status.
RESULTS


Both the control group and the intervention group accessed approximately three modules (M = 3.1, SD = 2.0 v. M = 2.8, SD = 2.1, respectively), although participants in the intervention group had a significantly higher number of logins (17.3 vs 9.7, p < 0.001). Across both conditions, individuals with more severe suicidal thoughts had better engagement with their respective program. More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
LIMITATIONS


Metrics of adherence may not directly reflect engagement with the program. There may be additional unmeasured factors associated with engagement.
CONCLUSIONS


The findings suggest that different engagement strategies may be required depending on sociodemographic and clinical characteristics. Tailoring interventions to at-risk subgroups may optimise health and functional outcomes.",2020,"More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
","['people with suicidal thoughts who completed an online program', 'people with suicidal thoughts', '418 adults with suicidal ideation']",['6-week internet-based self-help program'],"['number of logins', 'sociodemographic variables, user preferences and mental health status']","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",418.0,0.0695005,"More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia. Electronic address: philip.batterham@anu.edu.au.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia; Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.044']
1567,32090767,The accuracy of depression risk perception in high risk Canadians.,"BACKGROUND


Prevention and early detection of depression is a top public health priority. Accurate perception of depression risk may play an important role in health behavior change and prevention of depression. However, the way in which people in the community perceive their risk of developing depression is currently unknown.
METHODS


We analyzed the baseline data from a randomized controlled trial in 358 men and 356 women who are at high risk of having a major depressive episode (MDE). The predicted risk was assessed by sex-specific multivariable risk predictive algorithms for MDE. We compared participants' perceived risk and their predicted risk. Accurate risk perception was defined as perceived risk is in the range of predicted risk ± 10%.
RESULTS


In men, 29.7% perceived their risk accurately; 47.5% overestimated their risk; 22.8% underestimated their risk. In women, the proportions were 21.7%, 59.6% and 18.7%, respectively. Compared to men, women were more likely to overestimate their risk and less likely to be accurate. Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
CONCLUSIONS


Individuals who are at high risk of developing depression tend to overestimate their risk, especially women. Inaccurate depression risk perception is related to people's health status. Educational interventions are needed to enhance the accuracy of risk perception to encourage positive behavior change and uptake of preventive strategies.",2020,"Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
","['high risk Canadians', '358 men and 356 women who are at high risk of having a major depressive episode (MDE']",[],"['Accurate risk perception', 'Inaccurate depression risk perception', 'accuracy of depression risk perception']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443236', 'cui_str': 'Inaccurate (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",358.0,0.0515085,"Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
","[{'ForeName': 'JianLi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jianli.wang@theroyal.ca.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smail-Crevier', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Manuel', 'Affiliation': 'School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Family Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'MacQueen', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, McGill University, Montreal, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.099']
1568,3281724,Efficacy of high-dose methotrexate in childhood acute lymphocytic leukemia: analysis by contemporary risk classifications.,"High-dose methotrexate (HDMTX) added to a basic regimen of chemotherapy proved superior to cranial irradiation and sequentially administered drug pairs (RTSC) in prolonging complete remissions in children with ""standard-risk"" acute lymphocytic leukemia. To extend this result to more contemporary risk groups, we reclassified the patients according to methods of the Pediatric Oncology Group (POG), the Childrens Cancer Study Group (CCG), the Rome workshop, and St Jude Total Therapy Study XI. By life table analysis, 70% to 78% of patients with a favorable prognosis would remain in continuous complete remission (CCR) at 4 years if treated with HDMTX. Uniformly lower CCR rates could be expected with RTSC, especially in St Jude better-risk patients. HDMTX also would show greater efficacy than RTSC in the CCG average-risk and POG poor-risk groups, but the results appear inferior to those being achieved with intensified regimens for high-risk leukemia. Although both therapies would provide adequate CNS prophylaxis in favorable-risk groups, RTSC would offer greater protection in patients classified as being in a worse-risk group by St Jude criteria. We conclude that HDMTX-based therapy, as described in this report, would be most effective in patients with a presenting leukocyte count of less than 25 x 10(9)/L, of the white race, aged 2 to 10 years, and having leukemic cell hyperdiploidy without translocations.",1988,"HDMTX also would show greater efficacy than RTSC in the CCG average-risk and POG poor-risk groups, but the results appear inferior to those being achieved with intensified regimens for high-risk leukemia.","['children with ""standard-risk"" acute lymphocytic leukemia', 'childhood acute lymphocytic leukemia', 'patients with a presenting leukocyte count of less than 25 x 10(9)/L, of the white race, aged 2 to 10 years, and having leukemic cell hyperdiploidy without translocations']","['high-dose methotrexate', 'HDMTX', 'HDMTX-based therapy', 'drug pairs (RTSC', 'methotrexate (HDMTX', 'RTSC']",['CCR rates'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1305143', 'cui_str': 'Hyperploidy (morphologic abnormality)'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",[],,0.0204702,"HDMTX also would show greater efficacy than RTSC in the CCG average-risk and POG poor-risk groups, but the results appear inferior to those being achieved with intensified regimens for high-risk leukemia.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abromowitch', 'Affiliation': ""Department of Hematology-Oncology, St. Jude Children's Research Hospital, Memphis, TN 38101.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ochs', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fairclough', 'Affiliation': ''}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Rivera', 'Affiliation': ''}]",Blood,[]
1569,3521761,Marrow transplantation for severe aplastic anemia: methotrexate alone compared with a combination of methotrexate and cyclosporine for prevention of acute graft-versus-host disease.,"Forty-six patients with severe aplastic anemia (median age, 23 years) were treated with high-dose cyclophosphamide followed by infusion of marrow from an HLA-identical family member. To evaluate postgrafting prophylaxis for graft-v-host disease (GVHD), they were entered into a prospective randomized trial comparing the effect of a combination of methotrexate and cyclosporine (n = 22) to that of methotrexate alone (n = 24). Forty-four of the forty-six patients had evidence of sustained marrow engraftment. Only one patient in each of the two study groups showed graft rejection. A significant reduction in the cumulative incidence of grades II to IV acute GVHD was seen in patients given methotrexate/cyclosporine (18%) compared with those given methotrexate alone (53%) (P = .012). In three patients given methotrexate alone, grade III developed, and in six, grade IV acute GVHD developed, compared with none given methotrexate/cyclosporine. Eighteen of the 22 patients given methotrexate/cyclosporine and 15 of the 24 given methotrexate alone are alive between 5.5 and 44.5 months (median, 18 months), with actuarial survival rates at 2 years of 82% and 60%, respectively (P = .062). The incidence of fatal infections was higher in patients given methotrexate alone, whereas there are as yet no significant differences in the incidence of chronic GVHD. We conclude that methotrexate/cyclosporine treatment resulted in a significant decrease in the incidence and severity of acute GVHD in patients who received transplants for severe aplastic anemia and thus an improvement in survival.",1986,A significant reduction in the cumulative incidence of grades II to IV acute GVHD was seen in patients given methotrexate/cyclosporine (18%) compared with those given methotrexate alone (53%) (P = .012).,"['graft-v-host disease (GVHD', 'Forty-six patients with severe aplastic anemia (median age, 23 years', 'severe aplastic anemia']","['methotrexate/cyclosporine', 'methotrexate', 'methotrexate alone', 'cyclophosphamide', 'methotrexate and cyclosporine', 'Marrow transplantation']","['graft rejection', 'severe aplastic anemia', 'actuarial survival rates', 'evidence of sustained marrow engraftment', 'incidence and severity of acute GVHD', 'survival', 'incidence of fatal infections', 'cumulative incidence of grades II to IV acute GVHD', 'incidence of chronic GVHD']","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",,0.0508041,A significant reduction in the cumulative incidence of grades II to IV acute GVHD was seen in patients given methotrexate/cyclosporine (18%) compared with those given methotrexate alone (53%) (P = .012).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beatty', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': ''}]",Blood,[]
1570,3513867,Controlled trial of desmopressin in liver cirrhosis and other conditions associated with a prolonged bleeding time.,"The synthetic vasopressin derivative desmopressin (DDAVP) shortens a prolonged bleeding time (BT) in patients with uremia, congenital platelet dysfunction, and von Willebrand disease. To establish the limits of the clinical usefulness of DDAVP, a controlled randomized study was carried out in 53 patients and ten volunteers with different conditions that have in common a prolonged BT. DDAVP significantly shortened the BT in 21 cirrhotics (P less than .01), in eight patients with unclassified prolonged BT (P less than .05) and in ten volunteers taking the antiplatelet drugs aspirin (P less than .05) and ticlopidine. The BT changes were not statistically significant in 15 patients with severe thrombocytopenia nor in nine with congenital platelet dysfunction, even though a few patients with storage pool deficiency responded with a marked BT shortening. Our findings indicate that DDAVP might be given when biopsies or other surgical procedures must be carried out in patients with prolonged BT. However, the compound is often ineffective in patients with thrombocytopenia or congenital platelet dysfunction.",1986,"DDAVP significantly shortened the BT in 21 cirrhotics (P less than .01), in eight patients with unclassified prolonged BT (P less than .05) and in ten volunteers taking the antiplatelet drugs aspirin (P less than .05) and ticlopidine.","['patients with prolonged BT', 'patients with uremia, congenital platelet dysfunction, and von Willebrand disease', '53 patients and ten volunteers with different conditions that have in common a prolonged BT', 'patients with thrombocytopenia or congenital platelet dysfunction', '15 patients with']","['synthetic vasopressin derivative desmopressin (DDAVP', 'desmopressin', 'DDAVP', 'ticlopidine']","['bleeding time (BT', 'severe thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0041948', 'cui_str': 'Uremia'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0679429', 'cui_str': 'Platelet dysfunction'}, {'cui': 'C0042974', 'cui_str': ""Von Willebrand's Factor Deficiency""}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]","[{'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0701195', 'cui_str': 'DDAVP'}, {'cui': 'C0040207', 'cui_str': 'Ticlopidine'}]","[{'cui': 'C0005729', 'cui_str': 'Bleeding Time'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",53.0,0.0172007,"DDAVP significantly shortened the BT in 21 cirrhotics (P less than .01), in eight patients with unclassified prolonged BT (P less than .05) and in ten volunteers taking the antiplatelet drugs aspirin (P less than .05) and ticlopidine.","[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vicente', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vianello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Alberca', 'Affiliation': ''}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Coccato', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Faioni', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mari', 'Affiliation': ''}]",Blood,[]
1571,3276360,Cyclosporine v methotrexate for graft-v-host disease prevention in patients given marrow grafts for leukemia: long-term follow-up of three controlled trials.,"One hundred seventy-nine patients with acute nonlymphoblastic leukemia in first remission (n = 75), chronic myelocytic leukemia in chronic or accelerated phase (n = 48) or leukemia in advanced stage (n = 56) were given HLA-identical marrow grafts and randomized to receive methotrexate or cyclosporine for prevention of graft-v-host disease (GVHD). The current report updates the three prospective trials with follow-ups ranging from 3.2 to 6.2 years after marrow grafting. Results were analyzed separately for each individual study and for all three studies combined. Overall, 40% of patients given cyclosporine and 55% of those given methotrexate developed acute GVHD (P = .13); the incidence of chronic GVHD was 42% and 48%, respectively (P = .67). Twenty-two percent of cyclosporine-treated patients and 30% of methotrexate-treated patients developed interstitial pneumonia of any etiology (P = .25), and the figures for cytomegalovirus pneumonia were 18% and 20%, respectively (P = .41). The overall incidence of leukemic relapse was 31% in cyclosporine-treated patients and 36% in methotrexate-treated patients (P = .75). The probabilities of survival for cyclosporine-v methotrexate-treated patients were comparable for all three study groups: 52% v 48% in patients with acute nonlymphoblastic leukemia (P = .42), 55% v 60% for those with chronic myelocytic leukemia (P = .61), 12% and 12% for those with advanced leukemia (P = .93), and 39% v 38% overall (P = .72). We conclude that cyclosporine and methotrexate are comparable regarding the likelihood of acute/chronic GVHD, interstitial pneumonia, leukemic relapse, and long-term survival.",1988,The overall incidence of leukemic relapse was 31% in cyclosporine-treated patients and 36% in methotrexate-treated patients (P = .75).,"['One hundred seventy-nine patients with acute nonlymphoblastic leukemia in first remission (n = 75), chronic myelocytic leukemia in chronic or accelerated phase (n = 48) or leukemia in advanced stage (n = 56) were given HLA-identical marrow grafts and randomized to receive', 'patients given marrow grafts for leukemia']","['methotrexate', 'methotrexate or cyclosporine', 'cyclosporine and methotrexate', 'cyclosporine', 'Cyclosporine v methotrexate', 'cyclosporine-v methotrexate']","['acute nonlymphoblastic leukemia', 'overall incidence of leukemic relapse', 'chronic myelocytic leukemia', 'probabilities of survival', 'figures for cytomegalovirus pneumonia', 'acute GVHD', 'interstitial pneumonia of any etiology', 'incidence of chronic GVHD']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",56.0,0.0700049,The overall incidence of leukemic relapse was 31% in cyclosporine-treated patients and 36% in methotrexate-treated patients (P = .75).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': 'Division of Oncology, Fred Hutchinson Cancer Research Center, Seattle, WA 98104.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Irle', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGuffin', 'Affiliation': ''}]",Blood,[]
1572,3282572,Prevention of refractoriness and HLA-alloimmunization using filtered blood products.,"Depletion of leukocytes from all blood products may decrease the incidence of alloimmunization to HLA antigens present on the white cells and thus delay the onset of refractoriness to random donor platelet support. In order to test this hypothesis, 54 patients with hematologic malignancy or marrow aplasia were entered on a prospective randomized trial using cotton-wool filtration as a method of leukocyte depletion of red cell and platelet concentrates. Forty patients were considered evaluable; 20 patients received filtered products and 20 patients in the control group received standard unfiltered products. The filter was 99% efficient in removal of leukocytes (average number of WBC/platelet product, 6 X 10(6)). Platelet loss by this technique was 8%. Alloimmunization was assessed by detection of de novo formed lymphocytotoxic and platelet specific antibodies by microcytotoxicity test, Staph A protein radioimmunoassay, and solid phase red cell adherence test. In the group receiving filtered products, three of 20 (15%) patients developed lymphocytotoxic antibodies while ten of 20 (50%) patients in the control group developed cytotoxic antibodies (P = .01 by actuarial methods). Platelet antibodies were detected in seven of ten alloimmunized patients in the control group and three of three patients in the study group. Clinical evidence of refractoriness was seen in three of 20 patients in the filtered group and ten of 20 in the control group (P = .01 by actuarial methods). The cost of filtration was a fraction of the cost of a plateletpheresis product. Filtration appears to be an effective and economical method for reducing alloimmunization and clinical refractoriness to random donor platelets in patient receiving long-term transfusion support.",1988,Filtration appears to be an effective and economical method for reducing alloimmunization and clinical refractoriness to random donor platelets in patient receiving long-term transfusion support.,"['Forty patients were considered evaluable; 20 patients received filtered products and 20 patients in the', '54 patients with hematologic malignancy or marrow aplasia']","['cotton-wool filtration', 'control group received standard unfiltered products']","['Alloimmunization', 'Platelet loss', 'lymphocytotoxic antibodies', 'cytotoxic antibodies', 'Platelet antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}]","[{'cui': 'C0440207', 'cui_str': 'Cotton wool (physical object)'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",40.0,0.0228849,Filtration appears to be an effective and economical method for reducing alloimmunization and clinical refractoriness to random donor platelets in patient receiving long-term transfusion support.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sniecinski', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA 91010.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nowicki', 'Affiliation': ''}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hill', 'Affiliation': ''}]",Blood,[]
1573,31957686,A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial.,"BACKGROUND


Youth with bipolar disorder (BP) exhibit poor medication adherence, contributing to affective recurrence. Brief Motivational Interventions (BMIs) improve adherence among adolescents with chronic conditions.
METHODS


In an open pilot series, we developed a 3-session BMI for BP adolescents targeting medication adherence and conducted a pilot randomized trial comparing Standard Care (SC) versus SC+BMI. Participants include 43 adolescents with BP prescribed psychotropic medications. We assessed medication adherence objectively via bluetooth-enabled electronic pillbox (MedTracker). A blinded evaluator assessed mood symptoms at intake, 3- and 6-months.
RESULTS


The BMI was well-received. Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone (p < 0.0001). Adolescents' baseline self-rated expectation of improvement with treatment moderated the effect of treatment on improvement in adherence over time (p = 0.003). Across groups, poor adherence predicted increased likelihood of depression and hypo/mania symptoms in the subsequent two weeks; medication adherence mediated the effect of the BMI on the likelihood of depressive symptoms (p = 0.007).
LIMITATIONS


Electronic pillbox use (across groups) may enhance adherence, resulting in overestimates compared with naturalistic conditions. This pilot randomized trial may have been underpowered to detect some group differences.
CONCLUSIONS


A BMI offers promise as a disseminable adjunctive intervention for improving medication adherence for adolescents with BP. Future studies with larger samples can establish efficacy. NCT03203720.",2020,"Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone","['Participants include 43 adolescents with BP prescribed psychotropic medications', 'adolescents with bipolar disorder', 'adolescents with chronic conditions', 'Youth with bipolar disorder (BP', 'adolescents with BP']","['bluetooth-enabled electronic pillbox (MedTracker', 'Standard Care (SC) versus SC+BMI', 'SC-Alone', '3-session BMI', 'motivational intervention', 'Brief Motivational Interventions (BMIs']","['likelihood of depression and hypo/mania symptoms', 'Average objective medication adherence', 'likelihood of depressive symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",43.0,0.122982,"Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone","[{'ForeName': 'Tina R', 'Initials': 'TR', 'LastName': 'Goldstein', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States. Electronic address: goldsteintr@upmc.edu.""}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Krantz', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Rachael K', 'Initials': 'RK', 'LastName': 'Fersch-Podrat', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Nina J', 'Initials': 'NJ', 'LastName': 'Hotkowski', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Merranko', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Sobel', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Axelson', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, United States.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}]",Journal of affective disorders,['10.1016/j.jad.2020.01.015']
1574,3278754,Randomized study of 13-cis retinoic acid v placebo in the myelodysplastic disorders.,"A double-blind, placebo-controlled randomized trial of 13-cis retinoic acid was performed to determine if the drug has a therapeutic effect in patients with myelodysplastic syndromes (MDS). Sixty-eight evaluable patients with MDS were randomized to receive a single, daily oral dose of either 13-cis retinoic acid (13-CRA, 100 mg/m2) or matching placebo. Treatment was continued, when possible, for a period of 6 months. Determination of response to treatment was based on clinical course, repeat bone marrow biopsies, and aspirates and blood counts (CBC) with WBC differential, platelet, and reticulocyte numbers at specified intervals. No significant difference was noted between the two treatment groups in response to test drug (P = .66). One patient (3%) in the 13-CRA group and two patients (6%) in the placebo group had a minor response. Approximately 30% of patients in both groups had progression of their disease, and progression-free survival was nearly identical. Greater than 90% of the patients receiving 13-CRA developed mild or moderate skin toxicity that was reversible with decreasing or discontinuing the drug. Our study did not find that 13-CRA exerts a beneficial therapeutic effect in patients with MDS.",1988,No significant difference was noted between the two treatment groups in response to test drug (P = .66).,"['patients with MDS', 'Sixty-eight evaluable patients with MDS', 'myelodysplastic disorders', 'patients with myelodysplastic syndromes (MDS']","['13-cis retinoic acid (13-CRA, 100 mg/m2) or matching placebo', 'placebo', '13-cis retinoic acid v placebo', '13-CRA', '13-cis retinoic acid']","['clinical course, repeat bone marrow biopsies, and aspirates and blood counts (CBC) with WBC differential, platelet, and reticulocyte numbers', 'progression of their disease, and progression-free survival', 'mild or moderate skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}]","[{'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449259', 'cui_str': 'Clinical course (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0005954', 'cui_str': 'Bone marrow sampling (procedure)'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",68.0,0.279942,No significant difference was noted between the two treatment groups in response to test drug (P = .66).,"[{'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Koeffler', 'Affiliation': 'Department of Medicine, UCLA Medical Center.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Heitjan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mertelsmann', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Kolitz', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schulman', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Itri', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gunter', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Besa', 'Affiliation': ''}]",Blood,[]
1575,32071176,Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial.,"INTRODUCTION


Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called  open-label placebos  (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles. Although premenstrual syndrome (PMS) seems to be considerably susceptible to placebo effects, no study has examined open-OLP responses on PMS.
METHODS AND ANALYSIS


To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: (1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).",2020,These so-called  open-label placebos  (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles.,"['spring 2018 and patients will be included until a maximum of 150 participants are randomised', 'women suffering from PMS', 'women with premenstrual syndrome']","['Open-label placebo', 'OLPs']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],2.0,0.446556,These so-called  open-label placebos  (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles.,"[{'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Frey Nascimento', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland antje.freynascimento@unibas.ch.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kossowsky', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Division of Clinical Psychology and Epidemiology, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2019-032868']
1576,3259441,Changes in von Willebrand factor during cardiac surgery: effect of desmopressin acetate.,"Patients who receive desmopressin acetate (dDAVP) after cardiopulmonary bypass bleed less during operation and in the first 24 hours after operation than do patients who receive a placebo. To study the mechanism of improved hemostasis in bypass patients, we examined the relationship between von Willebrand factor (vWF) and blood loss in 70 cardiopulmonary bypass patients, one-half of whom received desmopressin intraoperatively. vWF concentration and multimeric composition were analyzed before and after bypass, after drug treatment, and 24 hours after operation. Before operation, patients with valvular disease had lower percentages of vWF high-mol-wt multimers (HMWMs) than did healthy subjects or patients with coronary artery disease, but subsequent blood loss, vWF activity, and bleeding times were not related to this finding. Irrespective of drug treatment, patients who had low preoperative vWF and who had a net loss of the protein during bypass bled more after bypass than did similar patients who had a net increase of vWF during bypass. HMWMs rose to above normal levels after bypass regardless of desmopressin infusion. Differences in the concentration of vWF between desmopressin and placebo patients after receipt of the drug, although small, were better correlated with reduced blood loss than were differences in HMWM distribution. We conclude that the beneficial effect of desmopressin on hemostasis following cardiopulmonary bypass cannot be attributed to a drug-induced change in HMWM distribution but may be related to an increase in overall vWF concentration.",1988,HMWMs rose to above normal levels after bypass regardless of desmopressin infusion.,"['70 cardiopulmonary bypass patients, one-half of whom received', 'bypass patients']","['desmopressin', 'placebo', 'desmopressin acetate', 'desmopressin acetate (dDAVP']","['concentration of vWF', 'von Willebrand factor (vWF) and blood loss', 'vWF high-mol-wt multimers (HMWMs', 'blood loss, vWF activity, and bleeding times', 'blood loss', 'overall vWF concentration']","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086135', 'cui_str': 'Desmopressin Acetate'}, {'cui': 'C0701195', 'cui_str': 'DDAVP'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.0151141,HMWMs rose to above normal levels after bypass regardless of desmopressin infusion.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weinstein', 'Affiliation': 'William B. Castle Hematology Research Laboratory, Department of Medicine, Boston City Hospital, MA 02118.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ware', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troll', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salzman', 'Affiliation': ''}]",Blood,[]
1577,31818628,Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY.,"BACKGROUND


The clinical benefit of extending prophylaxis for venous thromboembolism (VTE) beyond hospital discharge after laparoscopic surgery for cancer is undefined. Extended prophylaxis with rivaroxaban is effective in reducing post-operative VTE after major orthopedic surgery without safety concern.
METHODS


PROLAPS II is an investigator-initiated, randomized, double-blind study aimed at assessing the efficacy and safety of extended antithrombotic prophylaxis with rivaroxaban compared with placebo after laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with low molecular-weight heparin for 7 ± 2 days (NCT03055026). Patients are randomized to receive rivaroxaban (10 mg once daily) or placebo for 3 weeks (up to day 28 ± 2 from surgery). The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT or VTE-related death at 28 ± 2 days from laparoscopic surgery. The primary safety outcome is major bleeding defined according to the International Society of Thrombosis and Haemostasis. Symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT, major bleeding or death by day 28 ± 2 and by day 90 from surgery are secondary outcomes. Assuming an 8% event rate with placebo and 60% reduction in the primary study outcome with rivaroxaban, 323 patients per group are necessary to show a statistically significant difference between the study groups.
DISCUSSION


The PROLAPS II is the first study with an oral anti-Xa agent in cancer surgery. The study has the potential to improve clinical practice by answering the question on the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal cancer.",2020,The study has the potential to improve clinical practice by answering the question on the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal cancer.,"['colorectal cancer', 'colorectal cancer in patients who had received antithrombotic prophylaxis with low molecular-weight heparin for 7\xa0±\xa02 days (NCT03055026']","['placebo', 'Rivaroxaban', 'oral anti-Xa agent', 'rivaroxaban']","['composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT or VTE-related death at 28\xa0±\xa02 days from laparoscopic surgery', 'Symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected DVT, major bleeding or death', 'major bleeding defined according to the International Society of Thrombosis and Haemostasis']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",,0.443846,The study has the potential to improve clinical practice by answering the question on the clinical benefit of extending prophylaxis after laparoscopic surgery for colorectal cancer.,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Department of Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Italy. Electronic address: Cecilia.becattini@unipg.it.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Pace', 'Affiliation': 'National Cancer Institute, ""G. Pascale"" Foundation, Napoli, Italy. Electronic address: ugo.pace@yahoo.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Rondelli', 'Affiliation': 'Department of General Surgery, S. Giovanni Battista Hospital, Foligno, Italy. Electronic address: rondellif@hotmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Delrio', 'Affiliation': 'National Cancer Institute, ""G. Pascale"" Foundation, Napoli, Italy. Electronic address: delrio.paolo@gmail.com.'}, {'ForeName': 'Graziano', 'Initials': 'G', 'LastName': 'Ceccarelli', 'Affiliation': 'Department of General Surgery, S. Donato Hospital, Arezzo, Italy. Electronic address: g.cecca2003@libero.it.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Boncompagni', 'Affiliation': 'Department of General Surgery, S. Maria della Misericordia Hospital, Perugia, Italy. Electronic address: michela.bcp@gmail.com.'}, {'ForeName': 'Luigina', 'Initials': 'L', 'LastName': 'Graziosi', 'Affiliation': 'Department of Oncology Surgery, University of Perugia, Perugia, Italy. Electronic address: luiginagraziosi@yahoo.it.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Visonà', 'Affiliation': 'Department of Vascular Medicine, S.Giacomo Apostolo Hospital, Catelfranco Veneto, Treviso, Italy. Electronic address: adrianavisona@gmail.com.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Chiari', 'Affiliation': 'Department of General Surgery, Istituto Clinico Humanitas Mater Domini, Castellanza, Varese, Italy. Electronic address: damiano.chiari@materdomini.it.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Avruscio', 'Affiliation': 'Department of Cardiac, Thoracic and Vascular Sciences, Unit of Angiology, University Hospital of Padua, Padua, Italy. Electronic address: giampiero.avruscio@gmail.com.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Frasson', 'Affiliation': 'Research Department, FADOI Foundation, Milan, Italy. Electronic address: stefania.frasson@fadoi.org.'}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': 'Research Department, FADOI Foundation, Milan, Italy. Electronic address: gualberto.gussoni@gmail.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Biancafarina', 'Affiliation': 'Department of General Surgery, S. Donato Hospital, Arezzo, Italy. Electronic address: alessia.biancafarina@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Camporese', 'Affiliation': 'Department of Cardiac, Thoracic and Vascular Sciences, Unit of Angiology, University Hospital of Padua, Padua, Italy. Electronic address: giuseppe.camporese@aopd.veneto.it.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Donini', 'Affiliation': 'Department of Oncology Surgery, University of Perugia, Perugia, Italy. Electronic address: annibale.donini@unipg.it.'}, {'ForeName': 'Andrea Fares', 'Initials': 'AF', 'LastName': 'Bucci', 'Affiliation': 'National Cancer Institute, ""G. Pascale"" Foundation, Napoli, Italy. Electronic address: andrea.faresbucci@gmail.com.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': 'Department of Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Italy. Electronic address: giancarlo.agnelli@unipg.it.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.11.015']
1578,32060547,"When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training.","INTRODUCTION


Military personnel are at high risk for tobacco use, particularly during the first year of military service. Technical Training follows an 8½ week tobacco ban during basic military training and is a vulnerable time for personnel to both reinitiate and initiate tobacco use. Thus, this can be a crucial time to promote tobacco policies and interventions. However, there is limited research examining when, how, and where personnel access tobacco during the first year of service, particularly among users of newer products (eg, electronic cigarettes[e-cigarettes]). Thus, the purpose of the current study is to explore the timing, source, and location of tobacco use during Technical Training across all types of products. Furthermore, this study will examine differences in demographic characteristics and prior tobacco history in relationship to these tobacco behaviors.
MATERIALS AND METHODS


Participants were U.S. Air Force recruits completing Technical Training (2017-2018). Protocol was approved by the Institutional Review Board at the 59th Medical Wing of the U.S. Air Force. During the first week of Technical Training, Airmen were consented to participate in the study and completed a questionnaire about demographics and tobacco use history. Next, Airmen were randomized to receive one of three tobacco prevention interventions as part of military training. At a 3-month follow-up, during the last week of Technical Training, consented participants completed a questionnaire about current tobacco use. Airmen reported when (ie, first month vs. after), how (ie, ""bummed"" from another airman, bought on or off base, received from the internet or event), and where (ie, designated smoking areas on base, off base, bar or club, friend's house, cigar lounge, hookah bar, or vape shop) they used tobacco during Technical Training. Descriptive statistics were used to examine these behaviors across all tobacco products. Additionally, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests compared differences in demographic characteristics and baseline tobacco use in relationship to these tobacco behaviors.
RESULTS


No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use. Additionally, how and where Airmen first used tobacco during Technical Training differed across products. Cigarettes and smokeless tobacco were equally likely to be bought on or off base and most commonly first used at a designated smoking area on base. However, e-cigarettes, cigarillos/little cigars, and hookah were more likely to be bought off base, and first used at a specialty store (ie, vape shop, hookah bar, or cigar lounge).
CONCLUSIONS


Tobacco use behaviors during Technical Training differed depending on the type of product. Specifically, new and emerging products were more likely to be bought off base and first used at a specialty store. Thus, military polices regulating on base tobacco pricing might not reduce the growing prevalence of e-cigarettes. Future policies might consider addressing the density of off-base tobacco retailers to reduce the high rates of tobacco use in this population.",2020,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.",['Participants were U.S. Air Force recruits completing Technical Training (2017-2018'],['tobacco prevention interventions as part of military training'],['Tobacco Initiation and Relapse Occur'],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0301639,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.","[{'ForeName': 'Margaret Celice', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology; 400 Innovation Drive, Memphis, TN 38111, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tubman', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'University of Tennessee Health Science Center, Department of Preventive Medicine; 66 N Pauline Street Memphis, TN 38163, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}]",Military medicine,['10.1093/milmed/usaa016']
1579,2930837,Acute promyelocytic leukemia: treatment results during a decade at Memorial Hospital.,"Fifty-seven adult patients with acute promyelocytic leukemia (APL) were treated between 1974 and 1984 with daunorubicin (DNR) or 4-(9-acridinylamino)methanesulfan-m-anisidide (AMSA) in combination with arabinosylcytosine (Ara-C) and 6-thioguanine (TG); they also received prophylactic heparin. Forty-one patients (72%) achieved complete remission (CR), including 11 of 12 patients who received the AMSA-containing regimen. The incidence of early fatal hemorrhage was 14%, lower than that of earlier studies or other published reports. Elevated WBC and serum lactate dehydrogenase levels at diagnosis were associated with an increased incidence of life-threatening hemorrhage and shorter remission duration. Advanced age was an unfavorable prognostic factor for male patients. Both DNR and AMSA in combination protocols are effective treatments for APL. The incidence of CR is similar to that achieved in other types of acute nonlymphoblastic leukemia (ANLL) with the same protocols, but the median duration of remission is significantly longer in APL (24 v 9 months) and the percentage of remissions longer than 60 months is also higher in APL (35% v 5%).",1989,Elevated WBC and serum lactate dehydrogenase levels at diagnosis were associated with an increased incidence of life-threatening hemorrhage and shorter remission duration.,"['male patients', 'Fifty-seven adult patients with acute promyelocytic leukemia (APL) were treated between 1974 and 1984 with', 'Acute promyelocytic leukemia']","['prophylactic heparin', 'daunorubicin (DNR) or 4-(9-acridinylamino)methanesulfan-m-anisidide (AMSA) in combination with arabinosylcytosine (Ara-C) and 6-thioguanine (TG', 'DNR and AMSA']","['incidence of early fatal hemorrhage', 'median duration of remission', 'percentage of remissions longer', 'Elevated WBC and serum lactate dehydrogenase levels', 'complete remission (CR']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0456588', 'cui_str': '1974 (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",57.0,0.0254876,Elevated WBC and serum lactate dehydrogenase levels at diagnosis were associated with an increased incidence of life-threatening hemorrhage and shorter remission duration.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York 10021.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Reich', 'Affiliation': ''}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Kempin', 'Affiliation': ''}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Naval', 'Affiliation': ''}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Clarkson', 'Affiliation': ''}]",Blood,[]
1580,2862933,Marrow transplantation for chronic myelocytic leukemia: a controlled trial of cyclosporine versus methotrexate for prophylaxis of graft-versus-host disease.,"Forty-eight patients with chronic myelocytic leukemia, aged 11 to 47, were treated with high-dose cyclophosphamide and fractionated total body irradiation, followed by infusion of marrow from HLA-identical siblings. They were randomized to receive either methotrexate (MTX) (n = 23) or cyclosporine (CSP) (n = 25) as postgrafting prophylaxis for graft-v-host disease (GVHD). All patients had evidence of sustained hematopoietic engraftment. Seventeen of the 25 patients receiving CSP and 17 of the 23 patients receiving MTX are alive between one and almost four (median, 1.7) years, with an actuarial survival rate at three years of 62% and 66%, respectively (P = .60). Also, with respect to most other parameters studied, the two drugs were identical. The probability of acute GVHD was .42 and .46, respectively (P = .70), that of chronic GVHD, .50 and .63 (P = .44), and that of death from transplant-related causes, .30 and .24 (P = .51). There were no differences in the speed of granulocyte and platelet engraftment (P = .82 and .94, respectively), and the duration of hospitalization was comparable (P = .58). Patients receiving MTX required red cell transfusions for a shorter period of time (P = .02), but had a slightly increased morbidity from early oral mucositis. The leukemia recurrence rates were comparable (P = .60). With the regimens used in this study, we conclude that CSP failed to reduce the incidence of GVHD and improve the survival of patients with chronic myelocytic leukemia when compared to results with standard MTX.",1985,There were no differences in the speed of granulocyte and platelet engraftment (P = .82,"['patients with chronic myelocytic leukemia', 'Forty-eight patients with chronic myelocytic leukemia, aged 11 to 47', 'chronic myelocytic leukemia', 'Seventeen of the 25 patients receiving CSP and 17 of the 23 patients receiving']","['methotrexate', 'CSP', 'Marrow transplantation', 'MTX', 'cyclophosphamide and fractionated total body irradiation, followed by infusion of marrow from HLA-identical siblings', 'cyclosporine', 'standard MTX', 'cyclosporine (CSP', 'methotrexate (MTX']","['red cell transfusions', 'actuarial survival rate', 'duration of hospitalization', 'incidence of GVHD', 'morbidity from early oral mucositis', 'speed of granulocyte and platelet engraftment', 'leukemia recurrence rates', 'probability of acute GVHD', 'sustained hematopoietic engraftment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0353011,There were no differences in the speed of granulocyte and platelet engraftment (P = .82,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Cheever', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Flournoy', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Kennedy', 'Affiliation': ''}]",Blood,[]
1581,32060605,Mastopexy with Autologous Augmentation in Women After Massive Weight Loss: A Randomized Clinical Trial.,"BACKGROUND


Breast reshaping or mastopexy following massive weight loss can be challenging. The LOPOSAM (lower pole subglandular advancement mastoplasty) technique has shown promising results for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss.
MATERIALS AND METHODS


We compared the LOPOSAM technique to the mastopexy technique after massive weight loss described by Rubin JP, in a randomized trial. The main outcome measure was the total operative time. Secondary outcomes measures were socio-economic factors; length of hospital stay, numbers of sutures used, secondary corrective procedures, post-operative sick leave and surgeon- and patient-reported appearance of the breasts.
RESULTS


We included 22 women: 11 operated on by the LOPOSAM technique and 11 by the technique described by Rubin JP. The total operative time was 84.8 (SD 12.2) minutes in the LOPOSAM group and 99.1 (SD 23.5) in the Rubin JP group (p = 0.074). There were no differences related to days with drains, length of hospital stay or sick leave between the two groups. The surgeon- and the patient-reported appearance of the breasts changed significantly between the pre-operative and the 12-month post-operative assessments.
CONCLUSION


The LOPOSAM technique is a safe and quick surgical procedure for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss and seems to provide results comparable to the better-known Rubin JP's technique. There was a trend that the LOPOSAM technique was faster to perform, however, not significant. The breast appearance improved significantly using both techniques when assessed by both surgeons and patients.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2021,"The LOPOSAM technique is a safe and quick surgical procedure for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss and seems to provide results comparable to the better-known Rubin JP's technique.","['After Massive Weight Loss', '22 women: 11 operated on by the LOPOSAM technique and 11 by the technique described by Rubin JP', 'Women']","['Mastopexy with Autologous Augmentation', 'IV']","['days with drains, length of hospital stay or sick leave', 'total operative time', 'socio-economic factors; length of hospital stay, numbers of sutures used, secondary corrective procedures, post-operative sick leave and surgeon- and patient-reported appearance of the breasts', 'breast appearance']","[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0191918', 'cui_str': 'Fixation of pendulous breast (procedure)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0180499', 'cui_str': 'Drain, device (physical object)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205749', 'cui_str': 'Factors, Economic'}, {'cui': 'C0457280', 'cui_str': 'Number of sutures (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]",22.0,0.0838096,"The LOPOSAM technique is a safe and quick surgical procedure for correction of ptotic, wide, lateralized and deflated breasts following massive weight loss and seems to provide results comparable to the better-known Rubin JP's technique.","[{'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Ikander', 'Affiliation': 'Department of Plastic Surgery, Odense University Hospital and OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark, J. B. Winsløws Vej 4, 5000, Odense, Denmark. peder.ikander@gmail.com.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Sørensen', 'Affiliation': 'Department of Plastic Surgery, Odense University Hospital and OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark, J. B. Winsløws Vej 4, 5000, Odense, Denmark.'}, {'ForeName': 'Jørn B', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Department of Plastic Surgery, Odense University Hospital and OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark, J. B. Winsløws Vej 4, 5000, Odense, Denmark.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01642-0']
1582,3058228,A multicenter trial of antithymocyte globulin in aplastic anemia and related diseases.,"One hundred fifty patients with bone marrow failure were treated in three groups with antithymocyte globulin (ATG; Upjohn, Kalamazoo, MI) in a multicenter trial. Patients were assessed at 3, 6, and 12 months after initiation of treatment by three criteria: transfusion independence, clinical improvement, and blood counts. Group I consisted of 77 patients with acute severe aplastic anemia, randomized to receive either ten or 28 days of ATG. There was no significant difference between the two arms of this protocol: 47% of all patients were clinically improved and 31% were transfusion independent at 3 months. Of the severely affected patients, 27% died before 3 months; most deaths occurred early in treatment. Factors associated with survival in severely affected patients included male sex, age less than 40 years, absolute neutrophil count greater than 200/microL, and idiopathic etiology. Neutrophil counts generally increased by 8 weeks after treatment, but patients continued to show improvement to 1 year posttreatment. In Group II, 44 patients with moderate or chronic severe aplastic anemia were randomized to receive either ten days of ATG or 3 months of high-dose nandrolone decanoate. No patient initially treated with androgens recovered, but 28% of ATG-treated cases achieved transfusion independence at 3 months. Group III consisted of patients with a variety of bone marrow failure syndromes. Patients with pancytopenia and cellular bone marrow showed response rates similar to those of patients with chronic or moderate aplastic anemia.",1988,There was no significant difference between the two arms of this protocol: 47% of all patients were clinically improved and 31% were transfusion independent at 3 months.,"['77 patients with acute severe aplastic anemia', 'aplastic anemia and related diseases', 'patients with a variety of bone marrow failure syndromes', '44 patients with moderate or chronic severe aplastic anemia', 'One hundred fifty patients with bone marrow failure']","['nandrolone decanoate', 'ATG', 'antithymocyte globulin (ATG; Upjohn, Kalamazoo, MI', 'antithymocyte globulin']","['Neutrophil counts', 'transfusion independence, clinical improvement, and blood counts', 'deaths', 'transfusion independence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1855710', 'cui_str': 'Bone marrow failure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0068395', 'cui_str': 'nandrolone decanoate'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}]","[{'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005771', 'cui_str': 'Blood Cell Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",77.0,0.132517,There was no significant difference between the two arms of this protocol: 47% of all patients were clinically improved and 31% were transfusion independent at 3 months.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Clinical Hematology Branch, NHLBI, Bethesda, MD 20892.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Griffith', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Brittain', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Elfenbein', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Harmon', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hewlett', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fay', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mangan', 'Affiliation': ''}]",Blood,[]
1583,3042041,Prednisone and azathioprine compared with prednisone and placebo for treatment of chronic graft-v-host disease: prognostic influence of prolonged thrombocytopenia after allogeneic marrow transplantation.,"We conducted a randomized, double-blind comparison of prednisone and placebo (group I) v prednisone and azathioprine (1.5 mg/kg/day) (group II) as early treatment of extensive chronic graft-v-host disease (GVHD). Patients with platelet counts less than 100,000/microL were placed into therapy with prednisone alone (group III). All three groups received identical doses of prednisone (1 mg/kg every other day) and one double-strength trimethoprim-sulfamethoxazole (TMP-SMX) tablet twice daily. Between January 1980 and December 1983, 179 previously untreated patients were enrolled and 164 were evaluable. Patients randomized to group I (n = 63) and group II (n = 63) were well matched for prognostic factors; those placed into group III (n = 38) had more frequent acute GVHD and progressive onset of chronic GVHD. Median duration of therapy was 2 years. Complications included diabetes (5%), aseptic necrosis (5%) and infection. For groups I, II, and III, the respective incidence of infection was disseminated varicella, 11%, 24%, 34%; bacteremia, 6%, 11%, 34%; and interstitial pneumonia, 5%, 14%, 18%. Recurrent malignancy was the most frequent cause of death and did not differ significantly across the groups. Nonrelapse mortality, however, did differ: 21% in group I, 40% in group II, and 58% in group III (I v II, P = .003; I v III, P = .001). Forty patients in group I, 30 in group II, and 10 in group III survive with a minimum follow-up of 3.8 years. Karnofsky performance scores for 68 survivors are 90% to 100%, scores for seven survivors are 70% to 89% and scores for five survivors are less than 70%. Actuarial survival at 5 years after transplant is 61% in group I, 47% in group II, and 26% in group III (I v II, P = .03; I v III, P = .0001). Treatment with prednisone alone results in fewer infections and better survival than prednisone and azathioprine in standard-risk chronic GVHD. Treatment with prednisone alone is less effective in high-risk patients with thrombocytopenia, and other strategies are required.",1988,"Actuarial survival at 5 years after transplant is 61% in group I, 47% in group II, and 26% in group III","['Between January 1980 and December 1983, 179 previously untreated patients were enrolled and 164 were evaluable']","['Prednisone and azathioprine', 'prednisone and azathioprine', 'prednisone', 'prednisone and placebo', 'trimethoprim-sulfamethoxazole (TMP-SMX) tablet twice daily', 'prednisone alone', 'allogeneic marrow transplantation']","['Recurrent malignancy', 'frequent acute GVHD and progressive onset of chronic GVHD', 'Actuarial survival', 'fewer infections and better survival', 'interstitial pneumonia', 'aseptic necrosis', 'Nonrelapse mortality', 'Karnofsky performance scores', 'Median duration of therapy']","[{'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}, {'cui': 'C0085660', 'cui_str': 'Aseptic necrosis (morphologic abnormality)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}]",63.0,0.0357837,"Actuarial survival at 5 years after transplant is 61% in group I, 47% in group II, and 26% in group III","[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Department of Medicine Seattle, WA 98104.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Witherspoon', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Weiden', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Flournoy', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dahlberg', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'K C', 'Initials': 'KC', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}]",Blood,[]
1584,31759672,Treating depressive disorders with the Unified Protocol: A preliminary randomized evaluation.,"OBJECTIVES


This study aims to examine the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) for individuals diagnosed with a depressive disorder.
METHOD


Participants included 44 adults who met criteria for major depressive disorder, persistent depressive disorder, or another specified depressive disorder according to the Anxiety Disorder Interview Schedule (ADIS). These individuals represent a subset of patients from a larger clinical trial comparing the UP to single-disorder protocols (SDPs) for discrete anxiety disorders and a waitlist control (WLC) condition (Barlow et al., 2017); inclusion criteria for the parent study required participants to have a principal anxiety disorder.
RESULTS


Significant reductions in depressive symptoms were observed within the UP condition across clinician-rated and self-report measures of depression from baseline to post-treatment, as well as to the 12-month follow-up assessment. Compared to the WLC group, individuals in the UP condition demonstrated significantly lower levels on our continuous, clinician-rated measure of depressive symptoms at post-treatment. There were no differences between the UP and SDP conditions on depressive symptoms at post-treatment or at the 12-month follow-up timepoint.
CONCLUSIONS


In this exploratory set of analyses, the UP evidenced efficacy for reduction of depressive symptoms, adding to the growing support for its utility in treating depression.",2020,"RESULTS


Significant reductions in depressive symptoms were observed within the UP condition across clinician-rated and self-report measures of depression from baseline to post-treatment, as well as to the 12-month follow-up assessment.","['Participants included 44 adults who met criteria for major depressive disorder, persistent depressive disorder, or another specified depressive disorder according to the Anxiety Disorder Interview Schedule (ADIS', 'individuals diagnosed with a depressive disorder']",['WLC'],['depressive symptoms'],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4087263', 'cui_str': 'Persistent depressive disorder'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",44.0,0.0335995,"RESULTS


Significant reductions in depressive symptoms were observed within the UP condition across clinician-rated and self-report measures of depression from baseline to post-treatment, as well as to the 12-month follow-up assessment.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, U.S.A. Electronic address: ssz@uky.edu.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, U.S.A.'}, {'ForeName': 'Stephanie Jarvi', 'Initials': 'SJ', 'LastName': 'Steele', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Julianne Wilner', 'Initials': 'JW', 'LastName': 'Tirpak', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Amantia A', 'Initials': 'AA', 'LastName': 'Ametaj', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nauphal', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Cardona', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Mengxing', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA, U.S.A.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.072']
1585,32056766,Visually mediated functioning improves following treatment of hoarding disorder.,"BACKGROUND


Hoarding disorder (HD) is a highly debilitating psychiatric disorder that affects 2-6% of adults. Neuropsychological deficits in visual memory, detection, and categorization have been reported in HD. To date, no study has examined the relationship between neurocognitive functioning and treatment for HD. We aim to determine the association between neurocognitive functioning and treatment outcomes, as well as the impact of HD-specific treatment on cognitive functioning.
METHODS


323 individuals with HD were randomized to 20 weeks of peer- or clinician-led group behavioral treatment. 242 participants completed pre- and post-treatment neuropsychological testing covering eight neurocognitive domains. Rates of cognitive impairment (CI) were assessed for each neurocognitive domain. The association of baseline neurocognitive function on treatment response was examined using multiple regression. MANOVA and post-hoc tests were used to determine neurocognitive performance change pre- to post treatment.
RESULTS


Sixty-seven percent of participants had CI on ≥1 cognitive domain. There was no significant effect of pre-treatment neurocognitive functioning on treatment outcome. Post-treatment improvements were observed in visual memory, visual detection, decision making, information processing speed, visuospatial processing, attention/working memory (p≤.001). Declines in performance were found in visual reaction time and categorization.
LIMITATIONS


This was a non-inferiority trial to examine two treatment types with no normative comparison group. Treatment seeking individuals are more likely to be insightful, motivated, and have other features which limit generalizability.
CONCLUSIONS


Patterns of cognitive impairment in HD are similar to previous reports. Pre-treatment neurocognitive functioning did not impact treatment response. Neuropsychological functioning improved across multiple domains following targeted treatment.",2020,"Post-treatment improvements were observed in visual memory, visual detection, decision making, information processing speed, visuospatial processing, attention/working memory (p≤.001).","['242 participants completed pre- and post-treatment neuropsychological testing covering eight neurocognitive domains', '323 individuals with HD']",['peer- or clinician-led group behavioral treatment'],"['visual reaction time and categorization', 'Rates of cognitive impairment (CI', 'Neuropsychological functioning', 'visual memory, visual detection, decision making, information processing speed, visuospatial processing, attention/working memory (p≤.001']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",323.0,0.145604,"Post-treatment improvements were observed in visual memory, visual detection, decision making, information processing speed, visuospatial processing, attention/working memory (p≤.001).","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'J Zakrzewski', 'Affiliation': 'Department of Psychiatry, Center for OCD, Anxiety, and Related Disorders, College of Medicine, University of Florida, 100 S Newell Drive, L4-100, Gainesville FL 32610, USA.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'A Gillett', 'Affiliation': 'Department of Psychiatry, Center for OCD, Anxiety, and Related Disorders, College of Medicine, University of Florida, 100 S Newell Drive, L4-100, Gainesville FL 32610, USA.'}, {'ForeName': 'Ofilio', 'Initials': 'O', 'LastName': 'R Vigil', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'C Smith', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'Kiya', 'Initials': 'K', 'LastName': 'Komaiko', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Chou', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Y Uhm', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'L David', 'Initials': 'LD', 'LastName': 'Bain', 'Affiliation': 'Mental Health Association of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'J Stark', 'Affiliation': 'Mental Health Association of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gause', 'Affiliation': 'Sonoma County Community Development Commission, USA.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Howell', 'Affiliation': 'Mental Health Association of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Mental Health Association of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Mental Health Association of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'B Eckfield', 'Affiliation': 'Department of Nursing, California State University, East Bay, CA, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Y Tsoh', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Mackin', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco and San Francisco VA Medical Center, 401 Parnassus Avenue, San Francisco, CA 94143-0984, USA. Electronic address: Scott.mackin@ucsf.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'A Mathews', 'Affiliation': 'Department of Psychiatry, Center for OCD, Anxiety, and Related Disorders, College of Medicine, University of Florida, 100 S Newell Drive, L4-100, Gainesville FL 32610, USA. Electronic address: carolmathews@ufl.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2019.12.030']
1586,32056750,Repetitive transcranial magnetic stimulation for the treatment of postpartum depression.,"BACKGROUND


Postpartum depression (PPD) is a common and gravely disabling health concern. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for major depression and may be a valuable tool in the treatment of PPD. The treatment effect of rTMS is rapid, generally well tolerated, without systemic effects, and without medication exposure to a fetus and/or breastfed infant.
METHODS


Six women with PPD received 20 sessions of 10 Hz rTMS over the left dorsolateral prefrontal cortex (DLPFC) over a 4 week period. Psychiatric rating scales (BDI, EPDS, STATI), cognitive assessments (MMSE, Trails B, List Generation) and breastfeeding practices were surveyed at baseline and post rTMS treatment. BDI and EPDS were obtained weekly, as well as 3 months and 6 months post study conclusion.
RESULTS


Average BDI, EPDS, and STAI scores declined over the 4-week duration of rTMS treatment. Of the six patients, four achieved remission as assessed by EPDS and one achieved remission and two responded as assessed by BDI. Mean BDI and EPDS scores at 3 and 6 months follow-up remained below levels at study entry. No evidence of cognitive changes or breastfeeding disruptions.
LIMITATIONS


This was an exploratory study with small sample size with no sham control arm. Daily administration of rTMS provides potential for confounding of behavioral activation in the otherwise often isolative postpartum period.
CONCLUSIONS


rTMS was safe and well tolerated among participants with evidence of sustained improvements in depression and anxiety scores. This study supports rTMS as a promising non-pharmacologic treatment modality for perinatal depression.",2020,"The treatment effect of rTMS is rapid, generally well tolerated, without systemic effects, and without medication exposure to a fetus and/or breastfed infant.
","['Six women with PPD', 'postpartum depression']","['Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', '10\xa0Hz rTMS', 'Repetitive transcranial magnetic stimulation']","['BDI and EPDS', 'Average BDI, EPDS, and STAI scores', 'depression and anxiety scores', 'Psychiatric rating scales (BDI, EPDS, STATI), cognitive assessments (MMSE, Trails B, List Generation) and breastfeeding practices', 'Mean BDI and EPDS scores', 'safe and well tolerated']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",6.0,0.0907316,"The treatment effect of rTMS is rapid, generally well tolerated, without systemic effects, and without medication exposure to a fetus and/or breastfed infant.
","[{'ForeName': 'E Q', 'Initials': 'EQ', 'LastName': 'Cox', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: elizabeth_cox@med.unc.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Killenberg', 'Affiliation': 'Disability Determination Services, 40 Fountain Street, Providence, RI 02903, United States. Electronic address: susan.killenberg@ssa.gov.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Frische', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: rachel_frische@med.unc.edu.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: robert_mcclure@med.unc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: mick_hill@med.unc.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jenson', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: james_jenson@med.unc.edu.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pearson', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: brenda_pearson@med.unc.edu.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, 101 Manning Drive Campus Box 7160, Chapel Hill, NC 27514, United States. Electronic address: samantha_meltzer-brody@med.unc.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.069']
1587,32050214,Prospective Randomized Comparative Trial: Visual Performance Comparison Of Two Enhanced Depth Of Focus IOLs - Symfony and IC-8.,"PURPOSE


To compare the visual acuity and satisfaction outcomes of two different concepts of enhanced depth of focus intraocular lenses (EDOF IOLs).
SETTING


University Eye Hospital Bochum, Germany DESIGN:: Prospective randomized comparative clinical trial METHODS:: This study included a sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts. In the first group (IC-8 group) a monofocal 1-piece Tecnis Z B00 IOL (Johnson & Johnson Vision) was implanted in the dominant eye and an IC-8 IOL (AcuFocus) was implanted in the non-dominant eye. In the second group (Symfony group) a Tecnis Symfony IOL (Johnson & Johnson Vision) was implanted in both eyes. The target refraction of the dominat eye was emmetropia and slight myopia (mini-monovision; -0.75 D) in the non-dominant eye. Visual and refractive outcomes and patient satisfaction rates were evaluated 3 months after surgery.
RESULTS


In both groups no intra- or postoperative complications occurred. The target refraction was reached in both groups without statistical significant differences. The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02 (photopic); IC-8 group 0.12 ± 0.09, Symfony group 0.22 ± 0.1, p-value <0.01 (mesopic)). Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) were also good in both groups without significant differences (UIVA IC-8 group 0.01 ± 0.07, Symfony group -0.01 ± 0.08, p-value 0.35; UNVA IC-8 group 0.14 ± 0.11, Symfony group 0.09 ± 0.08, p-value 0.14). Subjective satisfaction was high in both groups.
CONCLUSION


Both EDOF IOLs provided a very good UDVA with superior results in the IC-8 group, good UIVA and UNVA under photopic light conditions. Subjective patient satisfaction was higher in the IC-8 group.",2020,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","['sample of 76 eyes of 38 patients undergoing cataract surgery with the implantation of two different EDOF concepts', 'University Eye Hospital Bochum, Germany DESIGN']","['enhanced depth of focus intraocular lenses (EDOF IOLs', 'Two Enhanced Depth Of Focus IOLs - Symfony and IC-8', 'Tecnis Symfony IOL (Johnson & Johnson Vision']","['target refraction', 'uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions', 'visual acuity and satisfaction outcomes', 'postoperative complications', 'Visual and refractive outcomes and patient satisfaction rates', 'Binocular uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA', 'Subjective patient satisfaction', 'Subjective satisfaction']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]","[{'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",38.0,0.0530222,"The uncorrected distance visual acuity (UDVA, photopic and mesopic light conditions) was excellent in both groups with statistically significant better results in the IC-8 goup (logMAR; IC-8 group -0.1 ± 0.07, Symfony group 0.07 ± 0.1, p-value 0.02","[{'ForeName': 'Merita', 'Initials': 'M', 'LastName': 'Schojai', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Tim Schultz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Corinna Jerke', 'Affiliation': ''}, {'ForeName': 'Dipl Ing', 'Initials': 'DI', 'LastName': 'Jörg Böcker', 'Affiliation': ''}, {'ForeName': 'H Burkhard', 'Initials': 'HB', 'LastName': 'Dick', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000068']
1588,2669998,Prognostic importance of the pre-B-cell immunophenotype and other presenting features in B-lineage childhood acute lymphoblastic leukemia: a Pediatric Oncology Group study.,"We report the prognostic significance of the pre-B-cell immunophenotype and other presenting features, including blast cell karyotype, in a randomized clinical trial conducted from 1981 to 1986 for children with early pre-B (n = 685) or pre-B (n = 222) acute lymphoblastic leukemia (ALL). Patients greater than or equal to 1 year and less than or equal to 21 years of age who attained complete remission were stratified by conventional risk criteria and immunophenotype and then randomized to receive continuation therapy with either of two regimens of intensive chemotherapy, designated S (standard) and SAM (standard plus intermediate-dose methotrexate, 1 g/m2 every 8 weeks). The proportions of subjects achieving complete remission in the two phenotypically defined subgroups were identical, 96%. At a median follow-up time of 42 months, the overall probability of 4-year event-free survival (+/- SE) was 63% +/- 2% (pre-B = 51% +/- 5% and early pre-B = 66% +/- 3%). Children with pre-B ALL had significantly shorter durations of continuous complete remission (P = .0004); this association included both bone marrow and CNS remissions (P = .0004 and P = .02, respectively). In a univariate Cox regression analysis of potentially important prognostic factors, the pre-B immunophenotype was significantly related to a poorer outcome, as were other recognized biologic and clinical features (eg, pseudodiploidy, older age, male sex, black race, and a higher WBC). It retained its prognostic strength in a multivariate model based on age, WBC, ploidy, and sex. The risk of failure at any point in the clinical course of a child with the pre-B immunophenotype was 1.8 times as great as that in a patient lacking this feature but otherwise having an equivalent risk status. It should be stressed that the predictive value of any of the significant characteristics identified in this study could diminish in the context of another, more effective treatment program. Nevertheless, our major conclusion, that children with pre-B ALL fare worse than those with early pre-B disease in a contemporary clinical trial has implications for stratified randomization of patients and the design of risk-specific treatment protocols.",1989,"Children with pre-B ALL had significantly shorter durations of continuous complete remission (P = .0004); this association included both bone marrow and CNS remissions (P = .0004 and P = .02, respectively).","['1981 to 1986 for children with early pre-B (n = 685) or pre-B (n = 222) acute lymphoblastic leukemia (ALL', 'B-lineage childhood acute lymphoblastic leukemia', 'Patients greater than or equal to 1 year and less than or equal to 21 years of age who attained complete remission']","['pre-B-cell immunophenotype', 'intensive chemotherapy, designated S (standard) and SAM (standard plus intermediate-dose methotrexate']","['shorter durations of continuous complete remission', 'complete remission', 'bone marrow and CNS remissions', 'overall probability of 4-year event-free survival']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0312738', 'cui_str': 'Precursor B-Cells'}, {'cui': 'C0079611', 'cui_str': 'Subtypings, Immunologic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",,0.0322214,"Children with pre-B ALL had significantly shorter durations of continuous complete remission (P = .0004); this association included both bone marrow and CNS remissions (P = .0004 and P = .02, respectively).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Crist', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boyett', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vietti', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borowitz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chauvenet', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Head', 'Affiliation': ''}]",Blood,[]
1589,32056776,Effects of a transdiagnostic cognitive behaviour therapy-based programme on the natural course of anxiety symptoms in adolescence.,"BACKGROUND


Anxiety disorders frequently have an onset during adolescence, which when left untreated could lead to a chronic course and outcome. This study aimed to examine the way in which a cognitive behaviour therapy-based programme (Super Skills for Life - adolescent version; SSL-A) could change the course of anxiety symptoms through adolescent's behavioural performance and cardiac function.
METHOD


Sixty-one adolescents at risk of developing an anxiety disorder (45.30% boys; M = 13.76 years, SD = 0.32) were randomly assigned to either an intervention (IG), placebo (PG), or a waitlist group (WG). Adolescents in the IG participated in SSL-A over an 8-week period. Adolescents in the PG participated in an 8-session school-work programme. Adolescents in the WG did not receive any intervention. Anxiety symptoms were assessed every six months, twice before the intervention, as well as at the post-intervention and six months after the intervention. Participants in the IG additionally underwent a stressful task to assess behavioural performance and cardiac adjustment.
RESULTS


Adolescents in the IG significantly reported lower levels of social phobia and generalised anxiety symptoms at the follow-up assessment compared to the adolescents in the PG and the WG. They also showed a significant improvement in vocal quality and lower discomfort during a stressful task at post-intervention, and showed attenuated cardiac recovery indexes, in terms of sample entropy.
LIMITATIONS


The study has a small sample size.
CONCLUSION


SSL-A changed the natural course of anxiety symptoms, as shown by a significant reduction in social phobia and generalised anxiety symptoms, and a significant improvement in behaviour and physiological (cardiac) function during a stressful situation.",2020,"RESULTS


Adolescents in the IG significantly reported lower levels of social phobia and generalised anxiety symptoms at the follow-up assessment compared to the adolescents in the PG and the WG.","['Adolescents in the PG participated in an 8-session school-work programme', 'Sixty-one adolescents at risk of developing an anxiety disorder (45.30% boys; M\u202f=\u202f13.76 years, SD\u202f=\u202f0.32', 'anxiety symptoms in adolescence']","['intervention (IG), placebo (PG), or a waitlist group (WG', 'transdiagnostic cognitive behaviour therapy-based programme', 'cognitive behaviour therapy-based programme (Super Skills for Life - adolescent version; SSL-A']","['cardiac recovery indexes', 'behavioural performance and cardiac adjustment', 'behaviour and physiological (cardiac) function', 'social phobia and generalised anxiety symptoms', 'Anxiety symptoms', 'vocal quality and lower discomfort']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517448', 'cui_str': 'Zero point three two'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0042943', 'cui_str': 'Voice Quality'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}]",61.0,0.0479259,"RESULTS


Adolescents in the IG significantly reported lower levels of social phobia and generalised anxiety symptoms at the follow-up assessment compared to the adolescents in the PG and the WG.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'de la Torre-Luque', 'Affiliation': 'Department of Psychiatry. Autonomous University of Madrid, Spain Centre for Biomedical Research in Mental Health. CIBERSAM, Spain.'}, {'ForeName': 'Aina', 'Initials': 'A', 'LastName': 'Fiol-Veny', 'Affiliation': 'Research Institute of Health Sciences. University of the Balearic Islands, Spain.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: c.essau@roehampton.ac.uk.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Balle', 'Affiliation': 'Research Institute of Health Sciences. University of the Balearic Islands, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bornas', 'Affiliation': 'Research Institute of Health Sciences. University of the Balearic Islands, Spain.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.078']
1590,2645950,Alternating v repeated postremission treatment in adult acute myelogenous leukemia: a randomized phase III study (AML6) of the EORTC Leukemia Cooperative Group.,"The value of a postremission treatment in acute myelogenous leukemia (AML), with alternating combinations of non-cross-resistant drugs, has been prospectively assessed. Of 515 evaluable patients, 347 (67.4%) entered into complete remission (CR), following induction treatment with daunorubicin (DNR), vincristine (VCR), and cytosine arabinoside (ara-C). After one consolidation course, 248 patients were randomized for six courses of intensive maintenance: either repeated treatment with DNR-VCR-ara-C, or alternating treatment where amsacrine (AMSA) was combined with high dose ara-C on cycle 1,3, and 5 and with 5-azacytidine on cycle 2, 4, and 6. Ninety-nine patients were not randomized: 57 were introduced in a bone marrow transplantation (BMT) program, and 42 went off study, mainly for treatment toxicity or refusal. The main prognostic factors for achievement of CR were performance status, cytogenetics, and age, and for the disease-free survival (DFS): age and number of courses to CR. The rate of second remission was fairly high (64%) for patients relapsing off therapy. The DFS appeared identical (median, 53 weeks), in the two randomized arms, the alternating treatment not showing superiority to the repeated one, in spite of an increased toxicity. The median overall survival for patients achieving a CR was 90 weeks. The reason for the failure of alternating maintenance treatment to improve the DFS is probably related to an insufficient dose intensity: five patients who relapsed during maintenance arm B achieved a second CR with a more intensive combination of high-dose ara-C and AMSA. In addition, 60 patients underwent a BMT (43 allogeneic and 17 autologous). The DFS of patients treated with allogeneic BMT tended to be superior to the one obtained with the chemotherapy program. However the overall survival, as well as the event-free survival, seemed equivalent, including patients who relapsed before the planned BMT. Comparisons between allogeneic BMT, autologous BMT, and intensive consolidation during first CR deserve further prospective studies in AML.",1989,"The DFS appeared identical (median, 53 weeks), in the two randomized arms, the alternating treatment not showing superiority to the repeated one, in spite of an increased toxicity.","['Ninety-nine patients were not randomized: 57 were introduced in a bone marrow transplantation (BMT) program, and 42 went off study, mainly for treatment toxicity or refusal', 'adult acute myelogenous leukemia', '60 patients underwent a BMT (43 allogeneic and 17 autologous', '248 patients', 'acute myelogenous leukemia (AML', '515 evaluable patients, 347 (67.4%) entered into complete remission (CR), following induction treatment with']","['allogeneic BMT, autologous BMT', 'intensive maintenance: either repeated treatment with DNR-VCR-ara-C, or alternating treatment where amsacrine (AMSA) was combined with high dose ara-C on cycle 1,3, and 5 and with 5-azacytidine', 'allogeneic BMT', 'Alternating v repeated postremission treatment', 'daunorubicin (DNR), vincristine (VCR), and cytosine arabinoside (ara-C']","['rate of second remission', 'toxicity', 'median overall survival', 'overall survival']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",99.0,0.0896896,"The DFS appeared identical (median, 53 weeks), in the two randomized arms, the alternating treatment not showing superiority to the repeated one, in spite of an increased toxicity.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zittoun', 'Affiliation': ""Service d'Hématologie, Hôtel-Dieu, Paris, France.""}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Jehn', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fière', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Haanen', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Willemze', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abels', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bury', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peetermans', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayat', 'Affiliation': ''}]",Blood,[]
1591,31759660,Attempted suicide short intervention program influences coping among patients with a history of attempted suicide.,"BACKGROUND


The development of individual coping strategies for suicidal crises is essential for suicide prevention. However, the influence of a brief intervention and the effect on coping strategies is largely unknown. This study aimed to investigate the influence of the Attempted Suicide Short Intervention Program on the development of coping strategies, in comparison to a control group.
METHOD


In this secondary analysis of a 24-month follow-up randomised controlled study, 120 patients (55% female; mean age of 36) with a history of suicide attempts were randomly allocated to either the ASSIP group or to a control group, in addition to treatment as usual.
RESULTS


The present study identified 11% less dysfunctional coping in the ASSIP group and 6% more problem-focussed coping compared to the control group after 24-months. The analysis of broader strategies showed a statistically significant group difference regarding self-distraction (after 12-months) and self-blame (after 24-months). In regard to the long-term association between coping strategies and suicidal ideation, active coping and substance use were negatively associated with suicidal ideation in the ASSIP group. Whereas, in the control group, behavioural disengagement and positive reframing were positively and self-distraction was negatively related to suicidal ideation.
LIMITATION


The receipt of a clinical interview and suicide risk assessment in the control group could have potentially had an effect on participants' coping mechanisms.
CONCLUSION


These results indicate that ASSIP may have an impact on the development of problem-focussed coping strategies. Although a reduction in dysfunctional coping seems to be essential in overcoming suicidal crises.",2020,"Whereas, in the control group, behavioural disengagement and positive reframing were positively and self-distraction was negatively related to suicidal ideation.
","['patients with a history of attempted suicide', '120 patients (55% female; mean age of 36) with a history of suicide attempts']","['Suicide Short Intervention Program', 'ASSIP']","['suicidal ideation', 'self-distraction', 'behavioural disengagement and positive reframing', 'dysfunctional coping']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0455507', 'cui_str': 'H/O: attempted suicide'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",120.0,0.0201768,"Whereas, in the control group, behavioural disengagement and positive reframing were positively and self-distraction was negatively related to suicidal ideation.
","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gysin-Maillart', 'Affiliation': 'Translational Research Centre, University Hospital of Psychiatry, University of Bern, Switzerland; University of Leipzig, Department of Medical Psychologie and Medical Sociology, Germany. Electronic address: anja.gysin@upd.unibe.ch.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Soravia', 'Affiliation': 'Translational Research Centre, University Hospital of Psychiatry, University of Bern, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schwab', 'Affiliation': 'Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.059']
1592,2403824,Randomized prospective trial comparing the native prothrombin antigen with the prothrombin time for monitoring oral anticoagulant therapy.,"The dosage of the anticoagulant warfarin sodium is based upon the prolongation of the prothrombin time into an optimal therapeutic range. We have developed a new assay for the native prothrombin antigen that measures the fully gamma-carboxylated prothrombin using a radioimmunoassay. Based on preliminary data that indicated that the native prothrombin antigen predicted both bleeding and thrombotic complications more accurately than the prothrombin time in patients anticoagulated with warfarin sodium, we have performed a randomized prospective trial comparing the complication rate in warfarin-treated patients monitored with the native prothrombin antigen or the prothrombin time. Patients with indications for anticoagulation were randomized to be monitored by the native prothrombin antigen (therapeutic range, 12 to 24 micrograms/mL) or the prothrombin time index (therapeutic range, 1.5 to 2.0). Of the prothrombin time group (N = 80), seven (8.8%) had bleeding or thrombotic complications, with a complication rate of 9.5%/patient-year. In the native prothrombin antigen group (N = 76), one subject (1.3%) had a bleeding complication. The complication rate per patient-year was 1.5%. These results indicate an 85% reduction in the complication rate of the native prothrombin antigen group compared with the complication rate of the prothrombin time group. This difference is statistically significant by the Fisher exact test (P = .037) and by Kaplan Meier survival analysis (P = .040). This study suggests that the use of the native prothrombin antigen assay has the potential to decrease the complications associated with anticoagulation therapy with warfarin sodium.",1990,This difference is statistically significant by the Fisher exact test (P = .037) and by Kaplan Meier survival analysis (P = .040).,"['Patients with indications for anticoagulation', 'patients anticoagulated with']","['warfarin sodium', 'anticoagulant warfarin sodium', 'native prothrombin antigen with the prothrombin time', 'native prothrombin antigen']","['bleeding or thrombotic complications', 'complication rate', 'bleeding and thrombotic complications', 'bleeding complication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}]","[{'cui': 'C0376218', 'cui_str': 'Warfarin Sodium'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0369902', 'cui_str': 'Prothrombin antigen'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0254488,This difference is statistically significant by the Fisher exact test (P = .037) and by Kaplan Meier survival analysis (P = .040).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Furie', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, New England Medical Center, Boston, MA 02111.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Diuguid', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Diuguid', 'Affiliation': ''}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Furie', 'Affiliation': ''}]",Blood,[]
1593,2462943,Toward comprehensive management tailored to prognostic factors of patients with clinical stages I and II in Hodgkin's disease. The EORTC Lymphoma Group controlled clinical trials: 1964-1987.,"From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin's disease in which 1,579 patients were entered. From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy (RT). Therefore, several prognostic indicators were prospectively registered and progressively used in the trial protocols for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value. In the H2 trial (1972 to 1976), the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators. In the H5 trial (1977 to 1982), patients were subdivided into two subgroups according to six prognostic indicators. Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients were randomized between mantle field RT and mantle field plus paraaortic RT. Disease free survival (DFS) and total survival (S) were similar in the two arms. Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation. Nevertheless, in patients below the age of 40, the overall survival rates were equivalent in the two arms. In the H6 trial, the delineation of the favorable subgroup was based on (a) absence of systemic symptoms and elevated ESR, (b) no more than one or two lymph node areas involved. The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy. At a 4-year follow-up, no difference in survival was evidenced. In patients with unfavorable prognostic indicators, 3 MOPP-RT-3 MOPP were compared with 3 ABVD-RT-3 ABVD. From H1 to H5 trials, the proportion of patients having received CT during the course of the disease gradually decreased; the data suggest that a further reduction in the proportion of patients aggressively treated is conceptually possible. On the basis of the prognostic factors identified, one can delineate three subsets of patients and modulate toxic cost of the initial treatment according to the characteristics of these subsets. In the most favorable subgroup, RT alone produces high survival and CT is not justified.(ABSTRACT TRUNCATED AT 400 WORDS)",1989,"Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation.","['From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages', ""I and II Hodgkin's disease in which 1,579 patients were entered"", 'patients with clinical stages', 'Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients']","['mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT', 'CT', 'regional radiotherapy (RT', 'mantle field RT and mantle field plus paraaortic RT']","['Disease free survival (DFS) and total survival (S', 'overall survival rates', 'toxic cost', 'survival']","[{'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0025033', 'cui_str': 'chlormethine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1579.0,0.0336708,"Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tubiana', 'Affiliation': 'Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Henry-Amar', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Carde', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Burgers', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayat', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van der Schueren', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Noordijk', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanguy', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Meerwaldt', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': ''}]",Blood,[]
1594,2492832,Crossover study of immunoglobulin replacement therapy in patients with low-grade B-cell tumors.,A randomized crossover study of prophylactic immunoglobulin (IgG) therapy was performed in patients with chronic lymphocytic leukaemia (CLL) or non-Hodgkin's lymphoma (NHL). Twelve patients with hypogammaglobulinemia or a history of recurrent infections received infusions of IgG or placebo intravenously (IV) every 3 weeks for 1 year. They were then switched to the alternative preparation for another year. The number of serious bacterial infections was significantly less (P = .001; Mainland's cross-over method) in the months in which patients received IgG. Serious bacterial infections showed a trend to be associated with an IgG level less than 6.4 g/L (P = .046; Fisher's exact test).,1989,The number of serious bacterial infections was significantly less (P = .001; Mainland's cross-over method) in the months in which patients received IgG. Serious bacterial infections showed a trend to be associated with an IgG level less than 6.4 g/L (P = .046;,"[""patients with chronic lymphocytic leukaemia (CLL) or non-Hodgkin's lymphoma (NHL"", 'Twelve patients with hypogammaglobulinemia or a history of recurrent infections', 'patients with low-grade B-cell tumors']","['immunoglobulin replacement therapy', 'IgG or placebo', 'prophylactic immunoglobulin (IgG) therapy']",['number of serious bacterial infections'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0086438', 'cui_str': 'Hypogammaglobulinemia'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0021022', 'cui_str': 'Immunoglobulin Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}]",12.0,0.0395426,The number of serious bacterial infections was significantly less (P = .001; Mainland's cross-over method) in the months in which patients received IgG. Serious bacterial infections showed a trend to be associated with an IgG level less than 6.4 g/L (P = .046;,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Griffiths', 'Affiliation': 'Department of Immunology, John Radcliffe Hospital, Oxford, England.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Brennan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lea', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bunch', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chapel', 'Affiliation': ''}]",Blood,[]
1595,2451549,"Low doses v conventional doses of corticoids in immune thrombocytopenic purpura (ITP): results of a randomized clinical trial in 160 children, 223 adults.","A randomized clinical trial was performed in 160 children and 223 adults with acute immune thrombocytopenic purpura (ITP). The role of corticoids at this phase of the disease is still controversial. Therefore, patients were randomized to receive either conventional doses (1 mg/kg/day) of corticotherapy or low doses (0.25 mg/kg/day) for 3 weeks. The remission, defined by platelet count superior to 100,000/microliter was studied for adults and children after 6 months and 12 months, respectively. The statistical analysis showed no significant difference between the two corticotherapy regimens neither in children nor in adults. Overall, 74% of children and 41% of adults were in remission. For the first time in acute ITP, a randomized prospective trial showed that both in children and adults low dose corticotherapy (0.25 mg/kg/day) proves to have the same efficacy as conventional doses (1 mg/kg/day).",1988,The statistical analysis showed no significant difference between the two corticotherapy regimens neither in children nor in adults.,"['160 children, 223 adults', '160 children and 223 adults with acute immune thrombocytopenic purpura (ITP', 'immune thrombocytopenic purpura (ITP']","['corticotherapy or low doses', 'Low doses v conventional doses of corticoids']",[],"[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0398650', 'cui_str': 'Autoimmune Thrombocytopenia'}, {'cui': 'C0021540', 'cui_str': 'ITP'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001617', 'cui_str': 'Corticoids'}]",[],160.0,0.0436435,The statistical analysis showed no significant difference between the two corticotherapy regimens neither in children nor in adults.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bellucci', 'Affiliation': ""Department d'Hématologie, Hôpital Lariboisière, France.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Charpak', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chastang', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tobelem', 'Affiliation': ''}]",Blood,[]
1596,32052026,Efficacy and Spatial Extent of Yard-Scale Control of Aedes (Stegomyia) albopictus (Diptera: Culicidae) Using Barrier Sprays and Larval Habitat Management.,"The Asian tiger mosquito, Aedes (Stegomyia) albopictus (Skuse), is a peridomestic, container-ovipositing mosquito commonly found throughout the southeastern United States. In the United States, Ae. albopictus is typically considered a nuisance pest; however, it is capable of transmitting multiple pathogens. Ae. albopictus is an important pest species and the target of numerous mosquito control efforts in the United States. Here, we evaluate the effectiveness and spatial extent of Ae. albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting. Sixteen pairs of adjoining neighbors were randomly assigned to treatment groups with one neighbor receiving a treatment and the other monitored for evidence of a spillover effect of the treatments. Ae. albopictus populations in both yards were monitored for 33 d, with treatments occurring on the eighth day. Barrier sprays, both alone and combined with LHM, resulted in a significant reduction in Ae. albopictus abundance posttreatment. While LHM alone did not result in a significant reduction over the entire posttreatment period, Ae. albopictus populations were observed to be in decline during this period. No treatments were observed to have any reduction in efficacy 25 d posttreatment, with treatments involving LHM having a significantly increased efficacy. Yards neighboring treated yards were also observed to have reduced population sizes posttreatment, but these differences were rarely significant. These results provide insights into the population dynamics of Ae. albopictus following two common treatments and will be useful for integrated pest management plans.",2020,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.",['Sixteen pairs of adjoining neighbors'],"['bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM', 'Yard-Scale Control of Aedes (Stegomyia) albopictus ', 'LHM', 'Barrier Sprays and Larval Habitat Management']",['efficacy'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1553702', 'cui_str': 'Neighbor (person)'}]","[{'cui': 'C0390645', 'cui_str': 'bifenthrin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0871648', 'cui_str': 'Habitat'}, {'cui': 'C0560016', 'cui_str': 'yd3'}, {'cui': 'C0222045'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0261689,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Hawkins', 'Affiliation': 'The Mosquito Authority, LLC, Morrisville, NC.'}, {'ForeName': 'Alun L', 'Initials': 'AL', 'LastName': 'Lloyd', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Reiskind', 'Affiliation': 'Department of Entomology and Plant Pathology, North Carolina State University, Raleigh, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa016']
1597,2405920,Prognostic value of pretreatment serum beta 2 microglobulin in myeloma: a Southwest Oncology Group Study.,"Six hundred twelve eligible, previously untreated patients with active multiple myeloma and at least some data available for analysis were entered into a randomized trial (Southwest Oncology Group [SWOG] Phase III myeloma study 8229/30), in which the prognostic significance of pretreatment serum beta 2 microglobulin levels was evaluated. Because there was no statistically significant survival difference between the alternating and syncopating VMCP/VBAP regimens, it was possible to evaluate serum beta 2 microglobulin for the total population all together. The serum beta 2 microglobulin measurements showed the highest significance of any prognostic factor, both in the bivariate and multivariate regression analyses. The median survival was 36 months for the 322 patients with pretreatment serum beta 2 microglobulin values of less than 6 micrograms/mL, as compared with a median survival of 23 months for the 225 patients with a beta 2 level of greater than or equal to 6 mcg/mL (P less than .0001). The stepwise multiple regression model first contained serum beta 2 microglobulin, followed by serum albumin, serum calcium, age, and serum creatinine. Serum beta 2 microglobulin was highly correlated with stage: median values ranged from 3.7 micrograms/mL for stage IA, to 10.1 for stage IIIB. It was possible to stratify myeloma patients based on combinations of serum beta 2 microglobulin with both albumin and age, producing excellent separation of patients into low-, intermediate-, and high-risk categories. It is concluded that serum beta 2 microglobulin is the most powerful prognostic factor currently available for multiple myeloma and that it can be used alone or in combination with other variables for pretreatment stratification.",1990,"The serum beta 2 microglobulin measurements showed the highest significance of any prognostic factor, both in the bivariate and multivariate regression analyses.","['Six hundred twelve eligible, previously untreated patients with active multiple myeloma and at least some data available for analysis', 'myeloma']",[],"['median survival', 'Serum beta 2 microglobulin', 'survival difference']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}]",,0.0155073,"The serum beta 2 microglobulin measurements showed the highest significance of any prognostic factor, both in the bivariate and multivariate regression analyses.","[{'ForeName': 'B G', 'Initials': 'BG', 'LastName': 'Durie', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stock-Novack', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Salmon', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Finley', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beckord', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Crowley', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Coltman', 'Affiliation': ''}]",Blood,[]
1598,2403818,Etoposide in acute nonlymphocytic leukemia. Australian Leukemia Study Group.,"Previously untreated patients with acute nonlymphocytic leukemia (ANLL) aged 15 to 70 years were randomized to either cytosine arabinoside 100 mg/m2/d continuous intravenous (IV) infusion days 1 through 7, daunorubicin 50 mg/m2/d IV days 1 through 3 (7-3), or the same drugs intensified with etoposide 75 mg/m2/d IV days 1 through 7 (7-3-7) as induction therapy. Patients achieving complete remission (CR) received two courses of consolidation therapy (5-2 or 5-2-5) followed by maintenance therapy. Of 264 eligible patients, CR occurred in 56% of 7-3 and 59% of 7-3-7 patients; 7-3-7 significantly improved remission duration (P = .01). The median remission duration was 12 months for 7-3 and 18 months for 7-3-7. Survival was similar when the two arms were compared overall. Subset analysis performed to identify patients with the most benefit showed that etoposide significantly prolonged remission duration in younger patients (less than 55 years) with a median of 12 months for 7-3 and 27 months for 7-3-7 (P = .01). Survival appeared to be prolonged with 7-3-7 in patients aged less than 55 years, with a median of 9 months for 7-3 as compared with 17 months for 7-3-7 (P = .03). In older patients (aged greater than or equal to 55 years), 7-3-7 was more toxic, with significantly more severe [World Health Organization (WHO) grade 3 or 4] stomatitis (P = .02) and no additional clinical benefit. Hematologic toxicity for induction courses was similar, with granulocytopenia less than 0.5 x 10(9)/L for a median of 16 days per course for 7-3 and 15 days for 7-3-7. Hematologic toxicity was more severe for 5-2-5 consolidation courses (P = .003). Induction and consolidation therapy intensified with etoposide resulted in significantly improved remission duration but not survival.",1990,"Of 264 eligible patients, CR occurred in 56% of 7-3 and 59% of 7-3-7 patients; 7-3-7 significantly improved remission duration (P = .01).","['Previously untreated patients with acute nonlymphocytic leukemia (ANLL) aged 15 to 70 years', 'older patients (aged greater than or equal to 55 years', 'acute nonlymphocytic leukemia']","['cytosine arabinoside 100 mg/m2/d continuous intravenous (IV) infusion days 1 through 7, daunorubicin', 'consolidation therapy', 'Etoposide', 'etoposide']","['severe [World Health Organization (WHO) grade 3 or 4] stomatitis', 'Hematologic toxicity', 'Survival', 'remission duration', 'complete remission (CR', 'CR', 'median remission duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",264.0,0.0558466,"Of 264 eligible patients, CR occurred in 56% of 7-3 and 59% of 7-3-7 patients; 7-3-7 significantly improved remission duration (P = .01).","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Bishop', 'Affiliation': 'Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Lowenthal', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Joshua', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Matthews', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Todd', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cobcroft', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Whiteside', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kronenberg', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dodds', 'Affiliation': ''}]",Blood,[]
1599,2265248,Thrombin generation is not increased in the blood of hemophilia B patients after the infusion of a purified factor IX concentrate.,"Prothrombin complex concentrates (PCC), licensed for the treatment of hemophilia B, are known to carry a significant risk of thromboembolic complications. Although the reasons for thrombogenicity are not completely understood, several manufacturers have developed purified factor IX concentrates that contain negligible amounts of the other vitamin K-dependent factors. To evaluate whether or not the infusion of such a factor IX concentrate is followed by lesser activation of the hemostatic system than by the infusion of a PCC, we performed a series of coagulation assays on 11 hemophilia B patients before and after the administration of these two types of concentrate using a randomized cross-over design. The levels of prothrombin fragment F1 + 2, a sensitive measure of the in vivo cleavage of prothrombin by factor Xa, was significantly increased in plasma after PCC, but not after factor IX concentrate. Plasma fibrinopeptide A, a sensitive index of the enzymatic activity of thrombin on fibrinogen, also increased significantly after PCC but not after factor IX concentrate. The fragment B beta 15-42, a sensitive index of the enzymatic action of plasmin on fibrin II, did not change after either concentrate. There were also no differences in less sensitive coagulation measurements, such as plasma fibrinogen, antithrombin III, and fibrin monomers, nor in indices of platelet activation, such as beta-thromboglobulin and platelet factor 4. These findings show that the infusion of a purified factor IX concentrate can result in substantially less activation of the coagulation cascade than may be seen with PCC.",1990,"The fragment B beta 15-42, a sensitive index of the enzymatic action of plasmin on fibrin II, did not change after either concentrate.",['11 hemophilia B patients'],['Prothrombin complex concentrates (PCC'],"['sensitive coagulation measurements, such as plasma fibrinogen, antithrombin III, and fibrin monomers, nor in indices of platelet activation, such as beta-thromboglobulin and platelet factor 4', 'levels of prothrombin fragment F1 + 2, a sensitive measure of the in vivo cleavage of prothrombin by factor Xa']","[{'cui': 'C0008533', 'cui_str': 'Christmas Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0060327', 'cui_str': 'fibrinmonomer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0005286', 'cui_str': 'beta-Thromboglobulin'}, {'cui': 'C0522872', 'cui_str': 'Platelet factor 4 assay (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033706', 'cui_str': 'coagulation factor II'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015520', 'cui_str': 'Factor 10A'}]",,0.0402235,"The fragment B beta 15-42, a sensitive index of the enzymatic action of plasmin on fibrin II, did not change after either concentrate.","[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': 'A. Bianchi Bonomi Hemophilia and Thrombosis Center, University of Milan, Italy.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gringeri', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barzegar', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bottasso', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Simoni', 'Affiliation': ''}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Rosenberg', 'Affiliation': ''}]",Blood,[]
1600,32007170,Deep learning for prediction of colorectal cancer outcome: a discovery and validation study.,"BACKGROUND


Improved markers of prognosis are needed to stratify patients with early-stage colorectal cancer to refine selection of adjuvant therapy. The aim of the present study was to develop a biomarker of patient outcome after primary colorectal cancer resection by directly analysing scanned conventional haematoxylin and eosin stained sections using deep learning.
METHODS


More than 12 000 000 image tiles from patients with a distinctly good or poor disease outcome from four cohorts were used to train a total of ten convolutional neural networks, purpose-built for classifying supersized heterogeneous images. A prognostic biomarker integrating the ten networks was determined using patients with a non-distinct outcome. The marker was tested on 920 patients with slides prepared in the UK, and then independently validated according to a predefined protocol in 1122 patients treated with single-agent capecitabine using slides prepared in Norway. All cohorts included only patients with resectable tumours, and a formalin-fixed, paraffin-embedded tumour tissue block available for analysis. The primary outcome was cancer-specific survival.
FINDINGS


828 patients from four cohorts had a distinct outcome and were used as a training cohort to obtain clear ground truth. 1645 patients had a non-distinct outcome and were used for tuning. The biomarker provided a hazard ratio for poor versus good prognosis of 3·84 (95% CI 2·72-5·43; p<0·0001) in the primary analysis of the validation cohort, and 3·04 (2·07-4·47; p<0·0001) after adjusting for established prognostic markers significant in univariable analyses of the same cohort, which were pN stage, pT stage, lymphatic invasion, and venous vascular invasion.
INTERPRETATION


A clinically useful prognostic marker was developed using deep learning allied to digital scanning of conventional haematoxylin and eosin stained tumour tissue sections. The assay has been extensively evaluated in large, independent patient populations, correlates with and outperforms established molecular and morphological prognostic markers, and gives consistent results across tumour and nodal stage. The biomarker stratified stage II and III patients into sufficiently distinct prognostic groups that potentially could be used to guide selection of adjuvant treatment by avoiding therapy in very low risk groups and identifying patients who would benefit from more intensive treatment regimes.
FUNDING


The Research Council of Norway.",2020,A clinically useful prognostic marker was developed using deep learning allied to digital scanning of conventional haematoxylin and eosin stained tumour tissue sections.,"['All cohorts included only patients with resectable tumours, and a formalin-fixed, paraffin-embedded tumour tissue block available for analysis', 'very low risk groups and identifying patients who would benefit from more intensive treatment regimes', 'patients with early-stage colorectal cancer', '920 patients with slides prepared in the UK, and then independently validated according to a predefined protocol in 1122 patients treated with single-agent capecitabine using slides prepared in Norway', '828 patients from four cohorts had a distinct outcome and were used as a training cohort to obtain clear ground truth', 'More than 12\u2008000', '1645 patients had a non-distinct outcome and were used for tuning']","['primary colorectal cancer resection by directly analysing scanned conventional haematoxylin and eosin stained sections using deep learning', 'Deep learning']",['cancer-specific survival'],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0085185', 'cui_str': 'Paraffin Embedding'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441633'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0523207', 'cui_str': 'Hematoxylin and eosin stain'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",920.0,0.04516,A clinically useful prognostic marker was developed using deep learning allied to digital scanning of conventional haematoxylin and eosin stained tumour tissue sections.,"[{'ForeName': 'Ole-Johan', 'Initials': 'OJ', 'LastName': 'Skrede', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Sepp', 'Initials': 'S', 'LastName': 'De Raedt', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kleppe', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tarjei S', 'Initials': 'TS', 'LastName': 'Hveem', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Liestøl', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Maddison', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne A', 'Initials': 'HA', 'LastName': 'Askautrud', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Pradhan', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'John Arne', 'Initials': 'JA', 'LastName': 'Nesheim', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Albregtsen', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inger Nina', 'Initials': 'IN', 'LastName': 'Farstad', 'Affiliation': 'Department of Pathology, Division of Laboratory Medicine, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Domingo', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Church', 'Affiliation': 'Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK; National Institute of Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Nesbakken', 'Affiliation': 'Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway; KG Jebsen Colorectal Cancer Research Centre, Oslo, Norway.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Shepherd', 'Affiliation': 'Gloucestershire Cellular Pathology Laboratory, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kerr', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Novelli', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway; Research Department of Pathology, University College London Medical School, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kerr', 'Affiliation': 'Nuffield Division of Clinical Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Håvard E', 'Initials': 'HE', 'LastName': 'Danielsen', 'Affiliation': 'Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway; Department of Informatics, University of Oslo, Oslo, Norway; Nuffield Division of Clinical Laboratory Sciences, University of Oxford, Oxford, UK. Electronic address: hdaniels@labmed.uio.no.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32998-8']
1601,2378982,Philadelphia chromosome positive childhood acute lymphoblastic leukemia: clinical and cytogenetic characteristics and treatment outcome. A Pediatric Oncology Group study.,"Among 3,638 children with acute lymphoblastic leukemia (ALL) entered on Pediatric Oncology Group (POG) protocols between June 1981 and April 1989, successful cytogenetic studies were available for 2,519, 58 (2.3%) of which had the Philadelphia (Ph) chromosome detected. Features associated with the presence of the Ph chromosome were high leukocyte count (median, 33 x 10(9)/L), older age median, 9.6 years), a higher proportion of French-American-British L2 morphology, and a lower frequency of mediastinal mass. Immunologic marker studies at diagnosis in 56 Ph+ cases identified early pre-B ALL in 42 cases (75%), pre-B-cell in 9 (16%), and T-cell in 5 (9%). This distribution is similar to that found in Ph+ ALL. Intensive multiagent chemotherapy induced complete remissions in only 78% of eligible Ph+ patients compared with 96% of those without an identified Ph chromosome (P less than .001). Of 44 eligible Ph+ patients treated on POG frontline protocols for children with non-T, non-B-cell ALL, 27 have failed therapy, compared with 520 of 1,892 without an identified Ph chromosome (logrank P less than .001). Ph+ ALL is an aggressive form of acute leukemia that frequently presents in older children with a high leukocyte count, FAB L2 morphology, and a pseudodiploid karyotype, and becomes multidrug-resistant early. Thus, Ph+ cases require early identification to permit treatment with intensive induction regimens and experimental approaches such as bone marrow transplantation.",1990,Intensive multiagent chemotherapy induced complete remissions in only 78% of eligible Ph+ patients compared with 96% of those without an identified Ph chromosome (P less than .001).,"['Philadelphia chromosome positive childhood acute lymphoblastic leukemia', '3,638 children with acute lymphoblastic leukemia (ALL) entered on Pediatric Oncology Group (POG) protocols between June 1981 and April 1989, successful cytogenetic studies were available for 2,519, 58 (2.3%) of which had the Philadelphia (Ph) chromosome detected']","['Ph', 'Intensive multiagent chemotherapy']",['complete remissions'],"[{'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0200896', 'cui_str': 'Cytogenetic procedure'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0031526', 'cui_str': 'Ph1 Chromosome'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",3638.0,0.0262064,Intensive multiagent chemotherapy induced complete remissions in only 78% of eligible Ph+ patients compared with 96% of those without an identified Ph chromosome (P less than .001).,"[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Crist', 'Affiliation': ""St Jude Children's Research Hospital.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Head', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Borowitz', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Behm', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Steuber', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': ''}]",Blood,[]
1602,31170845,Risk factors associated with prolonged neonatal intensive care unit stay after threatened late preterm birth.,"OBJECTIVE


To identify risk factors associated with neonatal intermediate or intensive care unit (NICU) stay ≥3 days among women with threatened late preterm birth (PTB).
STUDY DESIGN


Secondary analysis of women with nonanomalous, singleton gestations enrolled in multicenter trial of betamethasone versus placebo for late PTB. Maternal and obstetric characteristics at time of presentation with threatened PTB were compared between those with and without NICU stay ≥3 days. Multivariable logistic regression identified risk factors for NICU stay ≥3 days.
RESULT


Of 2795 eligible mother-neonate dyads, 962 (34%) had NICU stay ≥3 days. Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).
CONCLUSION


Maternal and obstetric characteristics at the time of admission for threatened late PTB should be considered when counseling patients about the probability of NICU stay ≥3 days.",2021,Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).  ,"['2795 eligible mother-neonate dyads', 'women with threatened late preterm birth (PTB', 'women with nonanomalous, singleton gestations enrolled in multicenter trial of']","['betamethasone', 'neonatal intermediate or intensive care unit (NICU) stay ≥3\xa0days', 'placebo']","['Maternal and obstetric characteristics', 'Gestational age and fetal growth restriction']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]",2795.0,0.0780269,Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).  ,"[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Angelica V', 'Initials': 'AV', 'LastName': 'Glover', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Vladutiu', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Aliaga', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Manuck', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1623777']
1603,32032096,"Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium: A Mediation Analysis.","BACKGROUND


Postoperative delirium is a common complication that hinders recovery after surgery. Intraoperative electroencephalogram suppression has been linked to postoperative delirium, but it is unknown if this relationship is causal or if electroencephalogram suppression is merely a marker of underlying cognitive abnormalities. The hypothesis of this study was that intraoperative electroencephalogram suppression mediates a nonzero portion of the effect between preoperative abnormal cognition and postoperative delirium.
METHODS


This is a prespecified secondary analysis of the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) randomized trial, which enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018. Patients were randomized to electroencephalogram-guided anesthesia or usual care. Preoperative abnormal cognition was defined as a composite of previous delirium, Short Blessed Test cognitive score greater than 4 points, or Eight Item Interview to Differentiate Aging and Dementia score greater than 1 point. Duration of intraoperative electroencephalogram suppression was defined as number of minutes with suppression ratio greater than 1%. Postoperative delirium was detected via Confusion Assessment Method or chart review on postoperative days 1 to 5.
RESULTS


Among 1,113 patients, 430 patients showed evidence of preoperative abnormal cognition. These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001). Of this 17.2% total effect size (99.5% CI, 9.3 to 25.1%), an absolute 2.4% (99.5% CI, 0.6 to 4.8%) was an indirect effect mediated by electroencephalogram suppression, while an absolute 14.8% (99.5% CI, 7.2 to 22.5%) was a direct effect of preoperative abnormal cognition. Randomization to electroencephalogram-guided anesthesia did not change the mediated effect size (P = 0.078 for moderation).
CONCLUSIONS


A small portion of the total effect of preoperative abnormal cognition on postoperative delirium was mediated by electroencephalogram suppression. Study precision was too low to determine if the intervention changed the mediated effect.",2020,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","['1,113 patients, 430 patients', 'patients with preexisting cognitive impairment', 'enrolled patients age 60 yr or older undergoing surgery with general anesthesia at a single academic medical center between January 2015 and May 2018']","['Intraoperative electroencephalogram suppression', 'Electroencephalography Guidance of Anesthesia', 'electroencephalogram-guided anesthesia or usual care', 'intraoperative electroencephalogram suppression']","['Postoperative delirium', 'Duration of intraoperative electroencephalogram suppression', 'incidence of postoperative delirium', 'Preoperative abnormal cognition', 'preoperative abnormal cognition', 'postoperative delirium', 'Preoperative Cognitive Abnormality, Intraoperative Electroencephalogram Suppression, and Postoperative Delirium']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.120379,"These patients had an increased incidence of postoperative delirium (151 of 430 [35%] vs.123 of 683 [18%], P < 0.001).","[{'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Fritz', 'Affiliation': 'From the Department of Anesthesiology (B.A.F., C.R.K., A.B., A.M.M., T.P.B., J.O., D.P., H.R.M., T.S.W., M.S.A) the Division of Biostatistics (N.L.), Washington University School of Medicine, St. Louis, Missouri the Department of Mathematics and Statistics, Washington University in St. Louis, St. Louis, Missouri (N.L.). Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri Department of Anesthesiology, University of Manitoba, Winnipeg, Canada Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Medicine, Beth Israel-Deaconess Medical Center, Boston, Massachusetts Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Occupational Therapy, Washington University School of Medicine, St. Louis, Missouri Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Arbi', 'Initials': 'A', 'LastName': 'Ben Abdallah', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Mickle', 'Affiliation': ''}, {'ForeName': 'Thaddeus P', 'Initials': 'TP', 'LastName': 'Budelier', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Oberhaus', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Maybrier', 'Affiliation': ''}, {'ForeName': 'Troy S', 'Initials': 'TS', 'LastName': 'Wildes', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': ''}, {'ForeName': 'Ginika', 'Initials': 'G', 'LastName': 'Apakama', 'Affiliation': ''}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Aranake-Chrisinger', 'Affiliation': ''}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bolzenius', 'Affiliation': ''}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Burton', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Emmert', 'Affiliation': ''}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Goswami', 'Affiliation': ''}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Graetz', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kronzer', 'Affiliation': ''}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'McKinnon', 'Affiliation': ''}, {'ForeName': 'Maxwell R', 'Initials': 'MR', 'LastName': 'Muench', 'Affiliation': ''}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Palanca', 'Affiliation': ''}, {'ForeName': 'Aamil', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Strutz', 'Affiliation': ''}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tedeschi', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Torres', 'Affiliation': ''}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': ''}, {'ForeName': 'Ravi T', 'Initials': 'RT', 'LastName': 'Upadhyayula', 'Affiliation': ''}, {'ForeName': 'Anke C', 'Initials': 'AC', 'LastName': 'Winter', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jacobsohn', 'Affiliation': ''}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Fong', 'Affiliation': ''}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': ''}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': ''}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Schmitt', 'Affiliation': ''}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerville', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stark', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': ''}, {'ForeName': 'Spencer J', 'Initials': 'SJ', 'LastName': 'Melby', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tappenden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003181']
1604,32045298,Effects of adhesive flash-free brackets on enamel demineralization and periodontal status.,"OBJECTIVES


To evaluate the effects of adhesive precoated (APC) flash-free brackets on enamel demineralization and periodontal status in patients during fixed orthodontic treatment.
MATERIALS AND METHODS


Thirty patients, age 12 to 18 years, who had Angle Class I or Class II malocclusion with mild to moderate crowding in the permanent dentition were selected for this study. APC flash-free and conventional ceramic brackets were bonded for a split-mouth study design. The quadrant allocation was randomized. Demineralization records were obtained immediately after bonding (T0), 1 month after bonding (T1), and 6 months after bonding (T2). Clinical periodontal measurements, including gingival index, plaque index, and bleeding upon probing, were obtained before bonding (T0) and at the same time points (T1 and T2). Data were analyzed using Mann-Whitney  U  and Friedman tests to compare parameters between groups and times.
RESULTS


Demineralization values decreased on most sides of the brackets for both groups between T0 and T1. In the conventional group, there was significantly higher demineralization on more sides compared with flash-free brackets between T1 and T2. With one exception, the decreased values were found in the incisal/occlusal sides of all brackets at T2. All periodontal parameters showed significant increases after 6 months of treatment in both groups. Intergroup comparison showed no significant differences in demineralization or periodontal measurements at any of the time points.
CONCLUSIONS


The effects of APC flash-free and conventional brackets on enamel demineralization and periodontal health did not differ from each other.",2020,The effects of APC flash-free and conventional brackets on enamel demineralization and periodontal health did not differ from each other.,"['patients during fixed orthodontic treatment', 'Thirty patients, age 12 to 18 years, who had Angle Class I or Class II malocclusion with mild to moderate crowding in the permanent dentition were selected for this study']","['adhesive flash-free brackets', 'adhesive precoated (APC) flash-free brackets', 'APC flash-free and conventional brackets']","['demineralization or periodontal measurements', 'Clinical periodontal measurements, including gingival index, plaque index, and bleeding upon probing', 'enamel demineralization and periodontal status', 'Demineralization values', 'enamel demineralization and periodontal health', 'demineralization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0399523', 'cui_str': 'Angle Class I'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.0253323,The effects of APC flash-free and conventional brackets on enamel demineralization and periodontal health did not differ from each other.,"[{'ForeName': 'Ayten', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Çokakoğlu', 'Affiliation': ''}]",The Angle orthodontist,['10.2319/80819-518.1']
1605,2224134,Allogeneic marrow transplantation in patients with acute myeloid leukemia in first remission: a randomized trial of two irradiation regimens.,"A randomized trial of 12.0 Gy versus 15.75 Gy of total body irradiation (TBI) was performed in patients with acute myeloid leukemia undergoing allogeneic marrow transplantation while in first complete remission. All patients received 120 mg/kg cyclophosphamide followed by TBI and marrow from HLA-identical siblings. Cyclosporine and methotrexate were used for prophylaxis against acute graft-versus-host disease (GVHD). Thirty-four patients received 2.0-Gy fractions of irradiation daily for 6 days and 37 received 2.25-Gy fractions daily for 7 days. The 3-year actuarial probabilities for relapse-free survival were 0.58 for the patients who received 12.0 Gy and 0.59 for those who received 15.75 Gy. The 3-year probabilities of relapse were 0.35 for the 12.0 Gy group and 0.12 for the 15.75 Gy group (P = .06). The 3-year probabilities of transplant-related mortality were 0.12 and 0.32, respectively (P = .04). The probability of moderate to severe acute GVHD was 0.21 for the 12.0 Gy group and 0.48 for the 15.75 Gy group (P = .02). Patients exposed to the higher irradiation dose received less immunoprophylaxis against, and had a higher incidence of, acute GVHD. The increased dose of TBI significantly reduced the probability of relapse but did not improve survival because of increased mortality from causes other than relapse.",1990,The probability of moderate to severe acute GVHD was 0.21 for the 12.0 Gy group and 0.48 for the 15.75 Gy group (P = .02).,"['patients with acute myeloid leukemia undergoing allogeneic marrow transplantation while in first complete remission', 'patients with acute myeloid leukemia in first remission']","['Cyclosporine and methotrexate', '12.0 Gy versus 15.75 Gy of total body irradiation (TBI', 'cyclophosphamide', 'Allogeneic marrow transplantation']","['3-year probabilities of transplant-related mortality', '3-year probabilities of relapse', 'probability of moderate to severe acute GVHD', '3-year actuarial probabilities for relapse-free survival', 'probability of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4517580', 'cui_str': '15.75 (qualifier value)'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0705897,The probability of moderate to severe acute GVHD was 0.21 for the 12.0 Gy group and 0.48 for the 15.75 Gy group (P = .02).,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Veterans Administration Medical Center, Seattle, WA 98104-2092.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Bearman', 'Affiliation': ''}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beatty', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}]",Blood,[]
1606,2203481,What role for prednisone in prevention of acute graft-versus-host disease in patients undergoing marrow transplants?,"One hundred forty-seven consecutive patients with leukemia, myelodysplastic syndrome, or aplastic anemia were treated by marrow grafts from genotypically HLA-identical siblings (n = 122) or HLA-haploidentical family members (n = 25). Haploidentical recipients differed from their donors for no more than one HLA locus on the nonshared haplotype. All were given postgrafting immunosuppression with a combination of methotrexate and cyclosporine. In a randomized study we explored whether prednisone administered from day 0 through 35 along with methotrexate/cyclosporine could improve prevention of acute graft-versus-host disease (GVHD). The GVHD incidence in patients not given prednisone was comparable with that previously reported with methotrexate/cyclosporine. Unexpectedly, significant increases in acute and also chronic GVHD were seen in HLA-identical recipients administered prednisone, but not in the small number of patients administered HLA-nonidentical grafts. However, the resultant increase in transplant-related mortality in patients administered prednisone was offset by an increase in leukemic relapse in patients not administered prednisone, presumably related to the absence of a graft-versus-leukemia effect. Therefore, overall disease-free survival of the two groups of patients was comparable, with slightly more than 50% of the patients being alive at more than 2 years after transplantation. We speculated that prednisone adversely affected GVHD prophylaxis, interfering with methotrexate's cell cycle-dependent suppression of donor lymphocyte proliferation in response to host antigens. In a pilot study we explored whether beginning prednisone on day 15, after completion of methotrexate administration, would avoid this adverse effect. The GVHD incidence in patients administered methotrexate/cyclosporine along with ""late"" prednisone was comparable with that in patients not administered prednisone. We conclude that methotrexate/cyclosporine is effective in decreasing the incidence of grade II through IV GVHD, and that the addition of prednisone to this regimen is not beneficial in recipients of HLA-identical marrow grafts.",1990,"However, the resultant increase in transplant-related mortality in patients administered prednisone was offset by an increase in leukemic relapse in patients not administered prednisone, presumably related to the absence of a graft-versus-leukemia effect.","['patients undergoing marrow transplants', 'One hundred forty-seven consecutive patients with leukemia, myelodysplastic syndrome, or aplastic anemia were treated by marrow grafts from genotypically HLA-identical siblings (n = 122) or HLA-haploidentical family members (n = 25']","['methotrexate/cyclosporine', 'methotrexate and cyclosporine', 'prednisone', 'methotrexate']","['transplant-related mortality', 'acute and also chronic GVHD', 'overall disease-free survival', 'prevention of acute graft-versus-host disease (GVHD', 'GVHD incidence', 'leukemic relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",147.0,0.0364871,"However, the resultant increase in transplant-related mortality in patients administered prednisone was offset by an increase in leukemic relapse in patients not administered prednisone, presumably related to the absence of a graft-versus-leukemia effect.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': 'Division of Clinical Research Fred Hutchinson Cancer Research Center, Seattle, WA 98104.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pepe', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beatty', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Witherspoon', 'Affiliation': ''}]",Blood,[]
1607,1627810,Long-term follow-up of a controlled trial comparing a combination of methotrexate plus cyclosporine with cyclosporine alone for prophylaxis of graft-versus-host disease in patients administered HLA-identical marrow grafts for leukemia.,,1992,,['patients administered HLA-identical marrow grafts for leukemia'],['methotrexate plus cyclosporine with cyclosporine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]",[],,0.0390784,,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pepe', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Deeg', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bensinger', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Cliff', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Doney', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': ''}]",Blood,[]
1608,1657248,Identification of risk factors for bleeding during treatment of acute venous thromboembolism with heparin or low molecular weight heparin.,"In a prospective double-blind trial, we treated 194 patients with acute venous thromboembolism with heparin or low molecular weight heparin (LMWH; Fragmin). To evaluate the most important prognostic factors for bleeding, the presenting clinical features of the patients, the patients' anticoagulant responses, and the doses of the drugs were analyzed using univariate and multivariate regression analyses. No significant differences in clinical risk factors associated with bleeding were observed between heparin and LMWH. The univariate analyses ranked the parameters in the following order of importance: World Health Organization (WHO) performance status, history of bleeding tendency, cardiopulmonary resuscitation, recent trauma or surgery, leukocyte counts, platelet counts, duration of symptoms, and body surface area. Patients with WHO grade 4 had an eightfold increase in risk of bleeding as compared with WHO grade 1. Assessment of the individual contribution of each variable using multivariate regression analysis showed that the WHO performance status was the most important independent factor predicting major bleeding. A history of a bleeding tendency, recent trauma or surgery, and body surface area were also independent risk factors. The risk of bleeding was influenced by two factors related to the treatment, the patient's anticoagulant response as measured with the anti-Xa assay and the dose of the drug expressed as U/24 h/m2. An increased risk of bleeding was only observed at mean anti-Xa levels greater than 0.8 U/mL for both drugs. Significantly more major bleedings occurred in patients treated with high doses of the drugs, an observation that was independent of the concomitant anti-Xa levels. It should be considered whether choosing an appropriate initial dose adapted to the patient's body surface area and clinical risk factors can improve the efficacy to safety ratio of heparin treatment.",1991,"Significantly more major bleedings occurred in patients treated with high doses of the drugs, an observation that was independent of the concomitant anti-Xa levels.",['194 patients with acute venous thromboembolism with heparin or low molecular weight heparin (LMWH; Fragmin'],['heparin'],"['clinical risk factors associated with bleeding', 'Health Organization (WHO) performance status, history of bleeding tendency, cardiopulmonary resuscitation, recent trauma or surgery, leukocyte counts, platelet counts, duration of symptoms, and body surface area', 'risk of bleeding', 'major bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0917726', 'cui_str': 'Fragmin'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1458140', 'cui_str': 'Tendency to bleed (observable entity)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332665', 'cui_str': 'Recent injury (morphologic abnormality)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",194.0,0.0320313,"Significantly more major bleedings occurred in patients treated with high doses of the drugs, an observation that was independent of the concomitant anti-Xa levels.","[{'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Department of Hematology, University Hospital Utrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albada', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Banga', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sixma', 'Affiliation': ''}]",Blood,[]
1609,1730080,Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia.,"The purpose of this study was to determine the relative merits of idarubicin and daunorubicin in acute myeloid leukemia (AML) therapy. Thirty-two sites provided 214 previously untreated adults with AML aged 15 years or more who were randomized to receive for induction therapy cytarabine 100 mg/m2/d as a continuous 7-day infusion plus either daunorubicin 45 mg/m2/d (A + D) or idarubicin 13 mg/m2/d (A + I), daily on the first three days of treatment. Postremission therapy consisted of two courses of the induction regimen at the same daily doses, with the anthracycline administered for 2 days and cytarabine for 5. The complete response (CR) rates for evaluable patients were 70% (A + I) and 59% (A + D) (P = .08). The difference in CR rates was significant in patients aged 18 to 50 years (88% for A + I, 70% for A + D, P = .035). Resistant disease was a significantly more frequent cause of induction therapy failure with A + D than with A + I. Hyperleukocytosis (white blood cell count greater than 50,000/microL) unfavorably affected the attainment of CR with A + D but not with A + I. CR duration was significantly greater after A + I. CR duration was significantly greater after A + I treatment, and the survival of all randomized patients treated with A + I was significantly better than that observed after A + D treatment (median 12.9 months v 8.7 months, respectively, P = .038). Toxicity of the two treatments was similar, although A + I patients experienced more prolonged myelosuppression during consolidation therapy, and a greater incidence of mild chemical hepatitis was observed in the A + I group. It is concluded that, at the doses and schedule used in this study, A + I is superior to A + D for induction therapy of AML in adults.",1992,"Toxicity of the two treatments was similar, although A + I patients experienced more prolonged myelosuppression during consolidation therapy, and a greater incidence of mild chemical hepatitis was observed in the A + I group.","['patients aged 18 to 50 years (88% for A', 'previously untreated adult patients with acute myeloid leukemia', 'adults', 'Thirty-two sites provided 214 previously untreated adults with AML aged 15 years or more who', 'acute myeloid leukemia (AML) therapy']","['anthracycline', 'idarubicin and daunorubicin', 'daunorubicin 45 mg/m2/d (A + D) or idarubicin', 'cytarabine', 'Cytarabine plus idarubicin or daunorubicin', 'induction therapy cytarabine', 'Hyperleukocytosis']","['prolonged myelosuppression', 'complete response (CR) rates', 'Toxicity', 'CR rates', 'mild chemical hepatitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324336', 'cui_str': 'Hyperleukocytosis'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}]",214.0,0.114292,"Toxicity of the two treatments was similar, although A + I patients experienced more prolonged myelosuppression during consolidation therapy, and a greater incidence of mild chemical hepatitis was observed in the A + I group.","[{'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': 'Albert Einstein Cancer Center, Montefiore Medical Center, Bronx, NY 10467.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Banks', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Case', 'Affiliation': ''}, {'ForeName': 'Z A', 'Initials': 'ZA', 'LastName': 'Arlin', 'Affiliation': ''}, {'ForeName': 'P O', 'Initials': 'PO', 'LastName': 'Periman', 'Affiliation': ''}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Todd', 'Affiliation': ''}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Ritch', 'Affiliation': ''}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Enck', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Weitberg', 'Affiliation': ''}]",Blood,[]
1610,2015395,Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia.,"4'-Demethoxydaunorubicin (idarubicin [IDR]) is a new anthracycline that differs from its parent compound by the deletion of a methoxy group at position 4 of the chromophore ring. This minor structural modification results in a more lipophilic compound with a unique metabolite that has a prolonged plasma half-life as well as in vitro and in vivo antileukemia activity. To determine its activity in acute myelogenous leukemia (AML), 130 consecutive adult patients between the ages of 16 and 60 with newly diagnosed disease were randomized in a single institution study to receive either IDR in combination with cytosine arabinoside (Ara-C) or standard therapy with daunorubicin (DNR) and Ara-C. The trial was analyzed using the O'Brien-Fleming multiple testing design that allowed for periodic inspection of the data at specific patient accession points. After accrual of 60 patients per arm, analysis showed that patients who received IDR/Ara-C had a superior response compared with those who received standard therapy: 48 of 60 patients (80%) achieved complete remission on the former arm compared with 35 of 60 patients on the latter (58%, P = .005). Logistic regression analysis of factors associated with complete response indicated that treatment with IDR/Ara-C offered a significant advantage to patients who presented with a high initial white blood cell count compared with treatment with DNR/Ara-C. The degree of marrow aplasia was approximately the same on each arm as was nonhematologic toxicity. Overall survival for patients on the IDR/Ara-C arm was 19.5 months compared with 13.5 months on the DNR/Ara-C arm (P = .025) at a median follow-up of 2.5 years. We conclude that IDR/Ara-C can effectively replace standard therapy with DNR/Ara-C in adult patients less than age 60 with newly diagnosed AML.",1991,Logistic regression analysis of factors associated with complete response indicated that treatment with IDR/Ara-C offered a significant advantage to patients who presented with a high initial white blood cell count compared with treatment with DNR/Ara-C.,"['adult patients with newly diagnosed acute myelogenous leukemia', 'adult patients less than age 60 with newly diagnosed AML', 'acute myelogenous leukemia (AML), 130 consecutive adult patients between the ages of 16 and 60 with newly diagnosed disease']","[""4'-Demethoxydaunorubicin (idarubicin [IDR"", 'IDR/Ara-C', 'idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside', 'IDR in combination with cytosine arabinoside (Ara-C) or standard therapy with daunorubicin (DNR) and Ara-C']","['nonhematologic toxicity', 'superior response', 'degree of marrow aplasia', 'Overall survival', 'complete remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",130.0,0.0620318,Logistic regression analysis of factors associated with complete response indicated that treatment with IDR/Ara-C offered a significant advantage to patients who presented with a high initial white blood cell count compared with treatment with DNR/Ara-C.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Berman', 'Affiliation': 'Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY 10021.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Santorsa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McKenzie', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kempin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kolitz', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gabrilove', 'Affiliation': ''}]",Blood,[]
1611,2015394,Allogeneic marrow transplantation in patients with chronic myeloid leukemia in the chronic phase: a randomized trial of two irradiation regimens.,A randomized trial was performed to compare two regimens of total body irradiation in patients with chronic myeloid leukemia treated by allogeneic marrow transplantation while in the chronic phase. All patients received cyclophosphamide 120 mg/kg followed by total body irradiation and marrow from HLA-identical siblings. Cyclosporine and methotrexate were used for prophylaxis against acute graft-versus-host disease. Fifty-seven patients were randomized to receive 2.0 Gy fractions of irradiation daily for 6 days and 59 were randomized to receive 2.25 Gy fractions daily for 7 days. The probabilities of relapse at 4 years were 0.25 for the 12.0 Gy group and 0.00 for the 15.75 Gy group (P = .008). The actuarial probabilities of survival and relapse-free survival at 4 years were 0.60 and 0.58 among the patients who received 12.0 Gy compared with 0.66 and 0.66 for those who received 15.75 Gy. The 4-year probabilities of transplant-related mortality were 0.24 and 0.34 respectively (P = .13) while the probability of moderate to severe acute graft-versus-host disease was 0.33 for the 12.0 Gy group and 0.44 for the 15.75 Gy group (P = .15). The lower relapse probability in the patients receiving the higher dose of total body irradiation did not result in improved survival because mortality from causes other than relapse was increased.,1991,The lower relapse probability in the patients receiving the higher dose of total body irradiation did not result in improved survival because mortality from causes other than relapse was increased.,"['Fifty-seven patients', 'patients with chronic myeloid leukemia in the chronic phase', 'patients with chronic myeloid leukemia treated by allogeneic marrow transplantation while in the chronic phase']","['Cyclosporine and methotrexate', 'total body irradiation', 'cyclophosphamide 120 mg/kg followed by total body irradiation and marrow from HLA-identical siblings', 'Allogeneic marrow transplantation']","['actuarial probabilities of survival and relapse-free survival', 'relapse probability', 'survival because mortality', '4-year probabilities of transplant-related mortality', 'probability of moderate to severe acute graft-versus-host disease', 'probabilities of relapse']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]",57.0,0.0763283,The lower relapse probability in the patients receiving the higher dose of total body irradiation did not result in improved survival because mortality from causes other than relapse was increased.,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA 98104.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Appelbaum', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Bearman', 'Affiliation': ''}, {'ForeName': 'F B', 'Initials': 'FB', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Beatty', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Bensinger', 'Affiliation': ''}]",Blood,[]
1612,1995100,"Comparison of the hemostatic effects of fresh whole blood, stored whole blood, and components after open heart surgery in children.","In a double-blind study, we compared the postoperative (post-op) blood loss in 161 children undergoing open heart surgery with cardiopulmonary bypass whose immediate post-op transfusion requirements were met with either very fresh whole blood (VFWB), 24- to 48-hour-old whole blood or reconstituted whole blood (packed red blood cells, fresh frozen plasma [FFP], and platelets). Assignment to treatment groups was not strictly random but dependent, in part, on the ability of families to provide directed donors for fresh blood. The three patient groups were comparable with respect to patient age, pre-op coagulation profiles (bleeding time, prothrombin time, activated partial thromboplastin time, platelet count, fibrin split products, fibrinogen, and platelet aggregation tests) difficulty of operative procedures and time spent on CPB. Mean 24-hour post-op blood loss in milliliters per kilogram was 50.9 +/- 9.3 in the VFWB group, 44.8 +/- 6.0 in the 24- to 48-hour-old group, and 74.2 +/- 8.9 in the reconstituted group (p = .03). When blood loss was compared in the 93 children less than 2 years of age, mean blood loss was 52.3 +/- 10.8 in the VFWB group, 51.7 +/- 7.4 in the 24- to 48-hour-old group, and 96.2 +/- 10.7 in the reconstituted group (P = .001). For subjects who had received reconstituted blood, 30-minute and 3-hour post-op platelet aggregation responses to adenosine diphosphate (10 mumol/L) and 30-minute aggregation response to epinephrine (2.5 mumol/L) were more depressed than in the VFWB and 24- to 48-hour groups (P less than .001, P = .005, and P = .02). Comparison of other post-op coagulation tests could not explain the increased blood loss in the reconstituted group. We conclude that the transfusion of less than 48 hours old whole blood is associated with significantly less post-op blood loss than the transfusion of packed red blood cells, FFP, and platelets in children under 2 years old who underwent complex cardiac surgery. The blood losses associated with the transfusion of VFWB and 24- to 48-hour-old blood are comparable and may be, in part, due to better functioning platelets.",1991,"24- to 48-hour groups (P less than .001, P = .005, and P = .02).","['161 children undergoing open heart surgery with cardiopulmonary bypass whose immediate post-op transfusion requirements were met with either', '93 children less than 2 years of age, mean blood loss was 52.3 ', 'children', 'children under 2 years old who underwent complex cardiac surgery']","['very fresh whole blood (VFWB), 24- to 48-hour-old whole blood or reconstituted whole blood (packed red blood cells, fresh frozen plasma [FFP], and platelets', 'VFWB', 'epinephrine', 'adenosine diphosphate']","['Mean 24-hour post-op blood loss', 'pre-op coagulation profiles (bleeding time, prothrombin time, activated partial thromboplastin time, platelet count, fibrin split products, fibrinogen, and platelet aggregation tests) difficulty of operative procedures and time spent on CPB', 'blood loss', 'blood losses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma (product)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0163275', 'cui_str': 'Fibrin Fibrinogen Split Products'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test (procedure)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",161.0,0.0281861,"24- to 48-hour groups (P less than .001, P = .005, and P = .02).","[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Manno', 'Affiliation': ""Clinical Laboratories, Children's Hospital of Philadelphia, PA 19104.""}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Hedberg', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Bunin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicolson', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jobes', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'W I', 'Initials': 'WI', 'LastName': 'Norwood', 'Affiliation': ''}]",Blood,[]
1613,1824248,Low-dose versus high-dose methotrexate during remission induction in childhood acute lymphoblastic leukemia (Protocol 81-01 update).,"We evaluated event-free survival (EFS) and leukemia-free interval (LFI) of children treated for acute lymphoblastic leukemia (ALL). Patients were randomized to receive either a low dose or high dose of methotrexate (MTX) as a single agent at the time of diagnosis. Five days later, multidrug therapy was begun. We assessed the early antileukemic efficacy of the two doses of MTX, as well as toxicity and long-term efficacy. An increase in cell kill, as indicated by a larger decrease in the percentage of viable cells in the bone marrow between days 0 and 5, was observed for the high-dose MTX group when compared with the low-dose MTX group (P = .04). At 7.1 years of median follow-up, the 38 children randomized to receive high-dose MTX had a better EFS and LFI compared with the 39 patients randomized to receive low-dose MTX. The 7-year percentages (+/- SE) for EFS were 82% +/- 6% for high-dose MTX and 69% +/- 7% for low-dose MTX (P = .13). The 7-year percentages for LFI were 91% +/- 5% and 69% +/- 7%, respectively (P = .01). We recommend that high-dose MTX be considered as an effective addition to induction therapy in childhood ALL.",1991,"An increase in cell kill, as indicated by a larger decrease in the percentage of viable cells in the bone marrow between days 0 and 5, was observed for the high-dose MTX group when compared with the low-dose MTX group (P = .04).","['childhood acute lymphoblastic leukemia (Protocol 81-01 update', 'children treated for acute lymphoblastic leukemia (ALL']","['Low-dose versus high-dose methotrexate', 'MTX', 'methotrexate (MTX']","['antileukemic efficacy', 'percentage of viable cells', 'cell kill', 'event-free survival (EFS) and leukemia-free interval (LFI', 'toxicity and long-term efficacy']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",38.0,0.058918,"An increase in cell kill, as indicated by a larger decrease in the percentage of viable cells in the bone marrow between days 0 and 5, was observed for the high-dose MTX group when compared with the low-dose MTX group (P = .04).","[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA 02115.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': ''}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Tarbell', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Clavell', 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Blattner', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Sallan', 'Affiliation': ''}]",Blood,[]
1614,1824249,A comparative study of two different doses of cytarabine for acute myeloid leukemia: a phase III trial of Cancer and Leukemia Group B.,"Between 1982 and 1986, 326 evaluable patients with acute myeloid leukemia (AML) were randomized to receive cytarabine (Ara-C) at 200 mg/m2 (A200) or 100 mg/m2 (A100) for induction and maintenance therapy. Cycle 1 of induction therapy consisted of 7 days of continuous intravenous (IV) Ara-C and 3 days of i.v. daunorubicin (DNR); cycle 2, if needed, consisted of 5 days of Ara-C and 2 days of DNR. Complete responders (CR) then received monthly subcutaneous (SC) Ara-C at the respective doses (A100 or A200) with 6-thioquanine (6TG) at months 1 and 5, with vincristine (VCR) and prednisone at months 2, 4, 6, and 8, and with DNR at months 3 and 7. Complete response rates were 58% (A100) and 64% (A200) (P = .29). Median survival was 46 weeks (A100) and 38 weeks (A200) (P = .64); 5-year survival was 10% (A200) and 8% (A100). Median time to remission was 6.7 weeks (A200) and 8.1 weeks (A100) (P = .18). Median disease-free survival was 41 weeks (A200) and 44 weeks (A100) (P = .86). Deaths were attributed to therapy-related toxicities in 21% (A200) and 13% (A100) (P = .05). The 5-year survival was 15% for patients with performance status (PS) 0, 8% for PS 1 to 2, and 2% for PS 3 to 4, 18% for patients less than 40 years, 8% for ages 40 to 59, and 3% for age 60 or greater. Stratification of data by age and PS suggested that A200 may improve survival in patients less than 60 years with a good PS 0 (P = .05). This trial does not support the superiority of A200 over A100 in the treatment of AML.",1991,Complete response rates were 58% (A100) and 64% (A200) (P = .29).,"['patients less than 60 years with a good PS 0', 'acute myeloid leukemia', 'Between 1982 and 1986, 326 evaluable patients with acute myeloid leukemia (AML']","['cytarabine', 'cytarabine (Ara-C', '6-thioquanine (6TG) at months 1 and 5, with vincristine (VCR) and prednisone', 'daunorubicin (DNR']","['Deaths', 'toxicities', '5-year survival', 'Complete response rates', 'Median time to remission', 'Median disease-free survival', 'Median survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0456590', 'cui_str': '1982 (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0733521', 'cui_str': 'Ara-C'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.0897363,Complete response rates were 58% (A100) and 64% (A200) (P = .29).,"[{'ForeName': 'R O', 'Initials': 'RO', 'LastName': 'Dillman', 'Affiliation': 'University of California San Diego School of Medicine.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Gottlieb', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Caplan', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kopel', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Preisler', 'Affiliation': ''}, {'ForeName': 'O R', 'Initials': 'OR', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schiffer', 'Affiliation': ''}]",Blood,[]
1615,1730079,Iron chelation with desferrioxamine B in adults with asymptomatic Plasmodium falciparum parasitemia.,"To determine if iron chelation therapy has activity against human malaria, we administered desferrioxamine B in amounts of 100 mg/kg per day by continuous 72-hour subcutaneous infusions to 28 volunteers with asymptomatic Plasmodium falciparum infection in a randomized, double-blind, placebo-controlled crossover trial. Peripheral blood concentrations of P falciparum ring forms were determined at 12-hour intervals in all subjects and serum concentrations of desferrioxamine B + ferrioxamine (the iron complex of desferrioxamine B) were measured in 26 subjects. Geometric mean concentrations of asexual intraerythrocytic parasites decreased with both chelator and placebo treatment, but the decrement with desferrioxamine B was significantly greater than that with placebo (P less than .006) during both the initial and crossover periods. Compared with placebo, desferrioxamine B treatment was associated with an almost 10-fold enhancement of the rate of parasite clearance during both phases of the trial (P less than .007). Mean +/- SEM steady state concentrations of desferrioxamine B + ferrioxamine were 6.90 +/- 0.60 mumol/L at 36 hours and 7.72 +/- 0.68 mumol/L at 72 hours; in vitro, the ID50 has been reported to be approximately 4 to 20 mumol/L. No drug toxicity was detected. Parasitemia recurred in 19 of 24 participants followed-up over 1 to 6 months. We conclude that desferrioxamine B enhances the clearance of P falciparum parasitemia and that iron chelation may provide a new strategy to be developed for the treatment of malaria.",1992,"Compared with placebo, desferrioxamine B treatment was associated with an almost 10-fold enhancement of the rate of parasite clearance during both phases of the trial (P less than .007).","['adults with asymptomatic Plasmodium falciparum parasitemia', '28 volunteers with asymptomatic Plasmodium falciparum infection']","['placebo', 'iron chelation therapy', 'desferrioxamine B + ferrioxamine', 'placebo, desferrioxamine B', 'desferrioxamine', 'desferrioxamine B', 'Iron chelation with desferrioxamine B']","['Parasitemia', 'Peripheral blood concentrations', 'clearance of P falciparum parasitemia', 'Mean ', 'Geometric mean concentrations of asexual intraerythrocytic parasites', 'rate of parasite clearance', 'desferrioxamine B', 'drug toxicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0060255', 'cui_str': 'ferroxamine'}]","[{'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0521066', 'cui_str': 'parasites'}, {'cui': 'C0011145', 'cui_str': 'Deferoxamine'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}]",28.0,0.252121,"Compared with placebo, desferrioxamine B treatment was associated with an almost 10-fold enhancement of the rate of parasite clearance during both phases of the trial (P less than .007).","[{'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Gordeuk', 'Affiliation': 'Department of Medicine, MetroHealth Medical Center, Cleveland, OH 44109.'}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Thuma', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Brittenham', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zulu', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Simwanza', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mhangu', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Flesch', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Parry', 'Affiliation': ''}]",Blood,[]
1616,2009366,Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia.,"Eighty-one patients with acute myeloid leukemia (ANLL, n = 44) or acute lymphoblastic leukemia (ALL, n = 37), aged 10 to 50 years were randomized to receive 1 mg/kg per day (n = 41, group A) or 5 mg/kg per day (n = 40, group B) of cyclosporine A (CyA) from day -1 to day +20 after bone marrow transplant (BMT). All patients received CyA orally thereafter. All patients were prepared with cyclophosphamide (CY) 120 mg/kg and fractionated total body irradiation (TBI), and received unfractionated BM from an HLA-identical sibling. The two groups were comparable for diagnosis, disease status, French-American-British (FAB) classification, WBC count at diagnosis, cytogenetic abnormalities, extramedullary disease before BMT, donor/recipient age and sex, number of cells infused, and number of days with intravenous (IV) CyA. Median follow-up for surviving patients in group A was 983 v 632 days in group B. Patients in group A had lower serum levels of CyA (295 v 686 ng/mL, P = .004), lower bilirubin levels (1.9 v 2.6 mg/dL, P = .07), lower creatinine levels (0.9 v 1.4 mg/dL, P = .06), and a lower proportion of CD8+ cells in the peripheral blood (PB) within day +21 (19% v 28%, P = .07). First day to 0.5 x 10(9)/L neutrophils was comparable in the two groups (13 v 14 days; P = .1). In a Cox model, the actuarial risk of acute graft-v-host disease (GVHD) grade II+, after stratification for age (less than 20 years greater than) was significantly lower in group B patients (0.54, P = .04). The actuarial risk of developing chronic GVHD was comparable (P = .9). Actuarial transplant-related mortality (TRM) at 240 days was 28% and 26% (P = .8) in group A and B: the major cause of death was GVHD in group A (P = .02) and multiorgan toxicity in group B (P = .07). The actuarial risk of relapse at 2 years overall was 20% in group A and 52% in group B (P = .001); it was 9% v 43%, respectively, for patients in first remission (P = .0001) and 48% v 63% for patients in non-first complete remission (CR) (P = .1). Actuarial 2-year disease-free survival (DFS) in group A and B was 58% v 32% (P = .02) for all patients, 71% v 35% (P = .01), in first remissions, and 30% v 23% (P = .2) in advanced disease.(ABSTRACT TRUNCATED AT 400 WORDS)",1991,the major cause of death was GVHD in group A (P = .02) and multiorgan toxicity in group B (P = .07).,"['Eighty-one patients with acute myeloid leukemia (ANLL, n = 44) or acute lymphoblastic leukemia (ALL, n = 37), aged 10 to 50 years', 'A after allogeneic marrow transplantation for acute leukemia']","['cyclophosphamide (CY) 120 mg/kg and fractionated total body irradiation (TBI), and received unfractionated BM', 'cyclosporine', 'cyclosporine A (CyA']","['Increased risk of leukemia relapse', 'Actuarial transplant-related mortality (TRM', 'lower creatinine levels', 'actuarial risk of relapse', 'Actuarial 2-year disease-free survival (DFS', 'death', 'serum levels of CyA', 'multiorgan toxicity', 'diagnosis, disease status, French-American-British (FAB) classification, WBC count at diagnosis, cytogenetic abnormalities, extramedullary disease before BMT', 'actuarial risk of developing chronic GVHD', 'actuarial risk of acute graft-v-host disease (GVHD) grade II', 'proportion of CD8+ cells', 'lower bilirubin levels']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia, morphology, including blast cell OR undifferentiated leukemia (morphologic abnormality)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0920028', 'cui_str': 'Leukaemia recurrent'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4316924', 'cui_str': 'Cell positive for CD8 antigen'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}]",,0.07208,the major cause of death was GVHD in group A (P = .02) and multiorgan toxicity in group B (P = .07).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': 'Department of Hematology, Ospedale San Martino Genova, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Van Lint', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Occhini', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gualandi', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lamparelli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sogno', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tedone', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Frassoni', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Marmont', 'Affiliation': ''}]",Blood,[]
1617,1742480,A randomized comparison of two doses of human lymphoblastoid interferon-alpha in hairy cell leukemia. Wellcome HCL Study Group.,"One hundred thirty-eight patients with hairy cell leukemia were randomized to receive either a dose of 2.0 megaunits (MU)/m2 or a 10-fold lower dose of 0.2 MU/m2 of a highly purified natural alpha-interferon, administered daily for 28 days followed by a three times a week schedule. Ninety-seven of these patients had previously undergone splenectomy, but otherwise none of the patients had received prior therapy for their leukemia. The two doses were comparable in their effect on improving the neutrophil and platelet count, whereas the higher dose had a greater beneficial effect on the hemoglobin level and a greater antileukemic effect on the marrow. Acute toxicity in the form of a flu-like syndrome, neurologic side effects, neutropenia, and the need for platelet transfusions was observed less frequently in the low-dose group, as was the chronic fatigue syndrome. No neutralizing antibody activity was seen in the sera from 61 patients examined. Because of its beneficial effect on the neutrophil and platelet count and a lower degree of toxicity (ie, a superior therapeutic/toxicity ratio), the low dose is recommended as initial therapy in patients with hairy cell leukemia. This therapy may be followed by dose escalation once clinical improvement is observed.",1991,"The two doses were comparable in their effect on improving the neutrophil and platelet count, whereas the higher dose had a greater beneficial effect on the hemoglobin level and a greater antileukemic effect on the marrow.","['One hundred thirty-eight patients with hairy cell leukemia', 'hairy cell leukemia', 'patients with hairy cell leukemia', 'Ninety-seven of these patients had previously undergone splenectomy, but otherwise none of the patients had received prior therapy for their leukemia']","['2.0 megaunits (MU)/m2 or a 10-fold lower dose of 0.2 MU/m2 of a highly purified natural alpha-interferon', 'human lymphoblastoid interferon-alpha']","['neutrophil and platelet count', 'hemoglobin level', 'neutralizing antibody activity', 'antileukemic effect', 'Acute toxicity']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023443', 'cui_str': 'Reticuloendotheliosis, Leukemic'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}]","[{'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1532981', 'cui_str': 'Million units/square meter'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",138.0,0.0414446,"The two doses were comparable in their effect on improving the neutrophil and platelet count, whereas the higher dose had a greater beneficial effect on the hemoglobin level and a greater antileukemic effect on the marrow.","[{'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Smalley', 'Affiliation': 'University of Wisconsin, Madison.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Tuttle', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Connors', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Thurmond', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Castle', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Magers', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Whisnant', 'Affiliation': ''}]",Blood,[]
1618,1742482,Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex.,"To evaluate the effect of recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) on patients with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC) who were intolerant to zidovudine because of neutropenia, we performed a randomized, open-label study in which patients were assigned to one of two groups. Zidovudine was discontinued in group A patients before instituting GM-CSF treatment and was restarted in a graduated fashion over 4 weeks. Group B patients continued on full-dose (1,200 mg/d) zidovudine therapy while beginning GM-CSF therapy. A total of 17 patients were entered, eight in group A and nine in group B. Five of eight patients in group A and seven of nine in group B had a history of Pneumocystis carinii pneumonia (PCP). All were homosexual males, except one female in group A who was the sex partner of a bisexual male with AIDS. All patients had neutropenia (absolute neutrophil count [ANC] less than 1,000/microL) while taking full-dose zidovudine. The mean CD4 (+/- SD) lymphocyte level was 37 (+/- 29)/microL and 39 (+/- 44)/microL in groups A and B, respectively. After randomization, patients were begun on subcutaneous GM-CSF at a dose of 1.0 microgram/kg/d. Patients in group A received 2 weeks of daily GM-CSF, at which time zidovudine was restarted if the ANC was greater than 1,000/microL; if the ANC was less than 1,000/microL, the dose of GM-CSF was increased to 3.0 micrograms/kg, and at 2-week intervals either zidovudine was restarted or the dose of GM-CSF was increased to 5 micrograms/kg and then 10 micrograms/kg, to maintain the ANC greater than 1,000/microL. Group B patients received full-dose zidovudine concurrently with GM-CSF administration. The dose of GM-CSF was increased every 2 weeks if necessary to keep the ANC greater than 1,000/microL while maintaining full-dose zidovudine therapy. Patients in each group showed an increase in total white blood cell (WBC) count. Neutrophils and eosinophils were responsible for the majority of this increase. Patients in group A had a more rapid increase in WBC than those in group B; however, by week 8, the WBC in each group was essentially equal. Viral replication as measured by human immunodeficiency virus (HIV) p24 antigen (Ag) was decreased in four patients in each group, increased in one patient in each group, and remained unchanged in the remainder. The ability to culture virus from peripheral blood mononuclear cells was not changed by the regimen. The major toxicities of the regimen were fever and malaise.(ABSTRACT TRUNCATED AT 400 WORDS)",1991,"Viral replication as measured by human immunodeficiency virus (HIV) p24 antigen (Ag) was decreased in four patients in each group, increased in one patient in each group, and remained unchanged in the remainder.","['A total of 17 patients', 'All were homosexual males, except one female in group A who was the sex partner of a bisexual male with AIDS', '29)/microL and 39 ', 'patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex', 'patients with acquired immunodeficiency syndrome (AIDS) or AIDS-related complex (ARC) who were intolerant to zidovudine because of neutropenia']","['Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine', 'zidovudine therapy', 'Zidovudine', 'recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF', 'daily GM-CSF', 'zidovudine therapy while beginning GM-CSF therapy', 'GM-CSF', 'zidovudine']","['mean CD4 ', 'human immunodeficiency virus (HIV) p24 antigen (Ag', 'neutropenia (absolute neutrophil count [ANC', 'history of Pneumocystis carinii pneumonia (PCP', 'WBC', 'total white blood cell (WBC) count', 'SD) lymphocyte level', 'Neutrophils and eosinophils', 'Viral replication']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870597', 'cui_str': 'Gay male'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C2129310', 'cui_str': 'Bisexual (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001175', 'cui_str': 'Immunologic Deficiency Syndrome, Acquired'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0021051', 'cui_str': 'Immunological Deficiency Syndromes'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]","[{'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0860381', 'cui_str': 'Granulocyte-macrophage colony stimulating factor therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085219', 'cui_str': 'HIV Major Core Protein p24'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1535939', 'cui_str': 'Pneumocystis jirovecii Pneumonia'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C1271681', 'cui_str': 'Total white blood count'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}]",17.0,0.0177405,"Viral replication as measured by human immunodeficiency virus (HIV) p24 antigen (Ag) was decreased in four patients in each group, increased in one patient in each group, and remained unchanged in the remainder.","[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Levine', 'Affiliation': 'Department of Medicine, New England Deaconess Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Allan', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Tessitore', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Falcone', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Galasso', 'Affiliation': ''}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Israel', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Groopman', 'Affiliation': ''}]",Blood,[]
1619,1742488,Prognostic correlation of plasma cell acid phosphatase and beta-glucuronidase in multiple myeloma: a Southwest Oncology Group study.,"In 1982 a randomized trial of either alternating or syncopated VMCP/VBAP regimens for the treatment of active multiple myeloma was begun (Southwest Oncology Group Study 8229/30). A concurrent investigation was undertaken to evaluate the clinical importance and significance of cytochemically stainable plasma cell acid phosphatase (AP) and beta-glucuronidase enzymes (BG). Pretreatment bone marrow aspirates were available for analysis from 399 patients for AP and 398 patients for BG. The AP scores ranged between 42 and 395, and the BG scores ranged between 1 and 346. There was a significant increase of AP (P = .001) and BG (P = .002) in multiple myeloma as compared with a set of patients with benign plasmacytosis. The enzyme scores did not significantly relate to Ig idiotype of myeloma or other prognostic variables except that the BG scores varied significantly with the level of albumin (P = .03) and hemoglobin (P = .01). Analysis of patient groups with different levels of enzyme scores showed that 61 of 398 patients with an AP score of less than 130 had a poorer median survival of 1.7 versus 2.8 years for patients with higher scores (P = .001). In the multivariate analysis of survival, low AP score was an important prognostic factor (P = .006), but BG did not contribute significantly. It is suggested that the subset of patients presenting with low AP should be considered for specialized or more aggressive therapy.",1991,There was a significant increase of AP (P = .001) and BG (P = .002) in multiple myeloma as compared with a set of patients with benign plasmacytosis.,"['399 patients for AP and 398 patients for BG', 'multiple myeloma']",['alternating or syncopated VMCP/VBAP'],"['median survival', 'survival, low AP score', 'BG', 'AP scores', 'BG scores', 'hemoglobin', 'AP', 'enzyme scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}]",398.0,0.025758,There was a significant increase of AP (P = .001) and BG (P = .002) in multiple myeloma as compared with a set of patients with benign plasmacytosis.,"[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Saeed', 'Affiliation': 'Henry Ford Hospital, Detroit, MI.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stock-Novack', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pohlod', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Crowley', 'Affiliation': ''}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Salmon', 'Affiliation': ''}]",Blood,[]
1620,1648976,Use of leukocyte-depleted platelets and cytomegalovirus-seronegative red blood cells for prevention of primary cytomegalovirus infection after marrow transplant.,"Seventy-seven cytomegalovirus (CMV)-seronegative marrow transplant patients were randomized in a prospective controlled trial comparing the use of leukocyte-depleted platelets plus CMV-seronegative red blood cells with standard unscreened blood products for the prevention of primary CMV infection during the first 100 days after transplant. Eligible patients included CMV-seronegative patients undergoing autologous transplant or seronegative patients undergoing allogeneic transplant for aplastic anemia or non-hematologic malignancy who had seronegative marrow donors. Patients and marrow donors were serologically screened for CMV and randomized before conditioning for transplant and followed for CMV infection with weekly cultures of throat, urine, and blood and with weekly CMV serologies until day 100 after transplant. Leukocyte-depleted platelets were prepared by centrifugation, a procedure that removed greater than 99% of leukocytes. There were no CMV infections observed in 35 evaluable treatment patients compared with seven infections in 30 evaluable control patients (P = .0013). There was no statistically significant difference in the mean number of platelet concentrates in the treatment patients (164 concentrates) compared with the control patients (126 concentrates). Leukocyte-depleted platelets plus CMV-seronegative red blood cells are highly effective in preventing primary CMV infection after marrow transplant.",1991,There was no statistically significant difference in the mean number of platelet concentrates in the treatment patients (164 concentrates) compared with the control patients (126 concentrates).,"['primary cytomegalovirus infection after marrow transplant', 'Patients and marrow donors', 'Eligible patients included CMV-seronegative patients undergoing autologous transplant or seronegative patients undergoing allogeneic transplant for aplastic anemia or non-hematologic malignancy who had seronegative marrow donors', 'Seventy-seven cytomegalovirus (CMV)-seronegative marrow transplant patients']","['leukocyte-depleted platelets and cytomegalovirus-seronegative red blood cells', 'leukocyte-depleted platelets plus CMV-seronegative red blood cells with standard unscreened blood products']","['CMV infections', 'mean number of platelet concentrates']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}]","[{'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}]",,0.0286109,There was no statistically significant difference in the mean number of platelet concentrates in the treatment patients (164 concentrates) compared with the control patients (126 concentrates).,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bowden', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Program in Infectious Diseases, Seattle, WA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Slichter', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Sayers', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cays', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Meyers', 'Affiliation': ''}]",Blood,[]
1621,1878583,Six-year experience with a comprehensive approach to the treatment of recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85). A relapse study of the BFM group.,"Between April 1985 and March 1987 130 children and adolescents up to 18 years of age with first relapse of acute lymphoblastic leukemia (ALL) were registered on the stratified and randomized multicentric trial ALL-REZ BFM 85 designed for patients pretreated with intensive front-line therapies. Stratification criteria were time and site of relapse: bone marrow (BM) relapse on or up to 6 months after stopping front-line therapy (group A), BM relapse beyond 6 months after therapy (group B), and isolated extramedullary relapse at any time (group C). Treatment consisted of alternating courses of polychemotherapy including randomly administered high- or intermediate-dose methotrexate (HDMTX:12 g/m2 as 4-hour infusion; IDMTX: 1 g/m2 as 36-hour infusion). During maintenance therapy the patients received daily oral thioguanine and biweekly intravenous (IV) MTX. The overall second complete remission (CR) rate was 92% (groups A, B, and C: 88%, 92%, and 100%), and the probability of event-free survival (EFS) at 6 years is 0.31 +/- 0.04 (groups A, B, and C: 0.18 +/- 0.05, 0.30 +/- 0.07, and 0.72 +/- 0.11). HDMTX did not prove to be superior to IDMTX, which led to premature stopping of randomization. Risk factor analyses showed early relapse, particularly BM relapse within 18 months, and T-cell phenotype to be independent predictors of poor outcome. The incidence of central nervous system (CNS) relapses following BM relapse was 19%, indicating that reprophylaxis to the CNS with IV/intrathecal (IT) MTX was insufficient. For 17 children who received bone marrow transplantation in second CR from HLA-compatible siblings the EFS was 0.53 +/- 0.12 at 5 years. Their outcome was not influenced by the above-mentioned risk factors. With the proposed treatment regimen long-lasting second remissions can be achieved in about one third of patients even after intensive front-line treatment.",1991,"Risk factor analyses showed early relapse, particularly BM relapse within 18 months, and T-cell phenotype to be independent predictors of poor outcome.","['Between April 1985 and March 1987 130 children and adolescents up to 18 years of age with first relapse of acute lymphoblastic leukemia (ALL', 'recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85', '17 children who received']","['HDMTX', 'intensive front-line therapies', 'intrathecal (IT) MTX', 'BFM', 'bone marrow transplantation', 'polychemotherapy including randomly administered high- or intermediate-dose methotrexate (HDMTX:12 g/m2 as 4-hour infusion; IDMTX', 'daily oral thioguanine and biweekly intravenous (IV) MTX']","['early relapse, particularly BM relapse', 'probability of event-free survival (EFS', 'overall second complete remission (CR) rate', 'incidence of central nervous system (CNS) relapses following BM relapse', 'time and site of relapse: bone marrow (BM) relapse']","[{'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C2717829', 'cui_str': 'Polychemotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1300564', 'cui_str': 'gm/m2'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}]",130.0,0.0359535,"Risk factor analyses showed early relapse, particularly BM relapse within 18 months, and T-cell phenotype to be independent predictors of poor outcome.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Henze', 'Affiliation': ""Department of Hematology and Oncology, University Children's Hospital, Berlin, Germany.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fengler', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hartmann', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kornhuber', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Janka-Schaub', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Niethammer', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riehm', 'Affiliation': ''}]",Blood,[]
1622,1831059,Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia. NHF-ACTG 036 Study Group.,"One hundred ninety-three asymptomatic patients with hereditary coagulation disorders and human immunodeficiency virus (HIV) infection were studied in a controlled trial of zidovudine (ZDV) versus a placebo (with an average of 9.7 months on study). Pretreatment characteristics were well balanced between the placebo and drug-treated groups, including CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents. At the time of analysis, 161 patients either were still receiving treatment or had previously reached an endpoint of disease progression while receiving treatment. Twenty-five patients withdrew voluntarily. The toxic effects noted included granulocytopenia and anemia, especially in older patients, and subjective symptoms of asthenia, malaise, and nausea, consistent with the known consequences of treatment with 300 mg ZDV five times daily. There was a trend toward more diagnoses of acquired immunodeficiency syndrome (AIDS), advanced or early AIDS-related complex (ARC), single ARC symptoms, or death in placebo recipients as compared with those receiving ZDV (22 v 13). Because older patients with hemophilia have more rapid disease progression, the same efficacy analysis was performed in the 89 patients aged more than 30 years who were receiving treatment. In this subgroup, there was a similar trend (11 v 6). With regard to the most advanced problems of the infection among the older patients, there were five patients who were newly diagnosed with AIDS or died in the placebo group versus none in the ZDV group (P = .02) among the older patients. The pretreatment distribution of CD4 counts for the placebo and ZDV groups were similar, but patients aged more than 30 years had significantly (P less than .049) fewer CD4 cells than patients aged less than 30 years. A beneficial ZDV effect is also supported by a trend toward higher CD4 counts (a 48-cell increase in the ZDV group at 24 weeks as compared with a four-cell increase in the placebo group) and a significant (P = .03) difference in weight gain in the ZDV patients aged more than 30 years (8 pounds) as compared with the older placebo patients (aged more than 30 years) (2 pounds) at week 24. The findings in the asymptomatic hemophilic patients aged more than 30 years support a useful effect of ZDV, which is similar to observations in the larger study of its use in asymptomatic, nonhemophilic patients.",1991,"Pretreatment characteristics were well balanced between the placebo and drug-treated groups, including CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents.","['One hundred ninety-three asymptomatic patients with hereditary coagulation disorders and human immunodeficiency virus (HIV) infection', 'asymptomatic patients with hemophilia', 'ZDV patients aged more than 30 years (8 pounds) as compared with the older placebo patients (aged more than 30 years) (2 pounds) at week 24', 'older patients with hemophilia', '89 patients aged more than 30 years who were receiving treatment']","['ZDV', 'zidovudine', 'placebo', 'Placebo', 'zidovudine (ZDV']","['diagnoses of acquired immunodeficiency syndrome (AIDS), advanced or early AIDS-related complex (ARC), single ARC symptoms, or death', 'granulocytopenia and anemia', 'CD4 cells', 'subjective symptoms of asthenia, malaise, and nausea', 'CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents', 'weight gain', 'disease progression', 'CD4 counts']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0852077', 'cui_str': 'Hereditary Coagulation Disorders'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001175', 'cui_str': 'Immunologic Deficiency Syndrome, Acquired'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001824', 'cui_str': 'Granulocytopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0231218', 'cui_str': 'Undifferentiated illness: Vague ill health'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",89.0,0.200537,"Pretreatment characteristics were well balanced between the placebo and drug-treated groups, including CD4 distributions, types of clotting disorders, transaminase abnormalities, and use of various hemostatic agents.","[{'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Merigan', 'Affiliation': 'Center for AIDS Research, Stanford University School of Medicine, CA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Amato', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Balsley', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Benoit', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perez-Michael', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brownstein', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kramer', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brettler', 'Affiliation': ''}]",Blood,[]
1623,1822966,"The impact of a very high purity factor VIII concentrate on the immune system of human immunodeficiency virus-infected hemophiliacs: a randomized, prospective, two-year comparison with an intermediate purity concentrate.","Pathophysiologic considerations as well as non-comparative clinical results suggest that very high purity concentrates may slow immunologic deterioration in human immunodeficiency virus (HIV)-infected hemophiliacs. In an attempt to evaluate this hypothesis, we prospectively compared CD4 cell counts, skin testing responses, and changes of the clinical status in 20 asymptomatic HIV-positive hemophiliacs, randomly assigned to continue the treatment with an intermediate purity concentrate or to receive a very high purity product, purified by immunoaffinity chromatography with monoclonal antibodies. In the group switched to the very high purity concentrate there was no significant change of the CD4 cell counts over the 96-week follow-up period, whereas in the group continued on the intermediate purity concentrate, a highly significant decline was detected (P less than .013). Furthermore, in the very high purity group, four of six anergic patients at entry acquired reactivity to skin testing. The results of this study clearly support the use of very high purity concentrates for the replacement therapy of HIV-infected hemophiliacs.",1991,"In the group switched to the very high purity concentrate there was no significant change of the CD4 cell counts over the 96-week follow-up period, whereas in the group continued on the intermediate purity concentrate, a highly significant decline was detected (P less than .013).","['human immunodeficiency virus (HIV)-infected hemophiliacs', 'human immunodeficiency virus-infected hemophiliacs', '20 asymptomatic HIV-positive hemophiliacs']","['intermediate purity concentrate or to receive a very high purity product, purified by immunoaffinity chromatography with monoclonal antibodies', 'purity factor VIII concentrate']",['CD4 cell counts'],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0008550', 'cui_str': 'Chromatography'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",20.0,0.0269955,"In the group switched to the very high purity concentrate there was no significant change of the CD4 cell counts over the 96-week follow-up period, whereas in the group continued on the intermediate purity concentrate, a highly significant decline was detected (P less than .013).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Biasi', 'Affiliation': ""Divisione di Ematologia-Centro di Medicina Sociale per l'Emofilia, Ospedale Nuovo Pellegrini, Naples, Italy.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rocino', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miraglia', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mastrullo', 'Affiliation': ''}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Quirino', 'Affiliation': ''}]",Blood,[]
1624,1596562,Comparison of four virus-inactivated plasma concentrates for treatment of severe von Willebrand disease: a cross-over randomized trial.,"Until recently, cryoprecipitate has been the treatment of choice in patients with severe von Willebrand disease (vWD) because it can transiently correct low plasma levels of factor VIII coagulant activity (FVIII:C) and shorten or normalize the prolonged bleeding time (BT), the two laboratory hallmarks of the disease. However, cryoprecipitate may still transmit blood-borne viruses, whereas the development of virucidal methods have rendered plasma concentrates containing FVIII:C and von Willebrand factor (vWF) safer. To establish their potential usefulness in the treatment of vWD, we compared the effect of four virus-inactivated concentrates on FVII:C and vWF plasma levels and the BT (template method) in 10 patients with severe vWD using a crossover randomized design. The concentrates were an intermediate-purity, pasteurized FVIII-vWF concentrate; an intermediate-purity, dry-heated FVIII-vWF concentrate; a solvent/detergent-treated vWF concentrate, containing little FVIII; and a high-purity solvent/detergent-treated FVIII-vWF concentrate. All concentrates were equally effective in attaining normal and sustained levels of FVIII:C postinfusion, although peak levels were more delayed after the vWF concentrate. The effect of concentrates on the BT, however, was less uniform and satisfactory. The pasteurized FVIII-vWF concentrate transiently corrected, completely or partially, the BT in 8 of 10 patients, the dry-heated and solvent/detergent FVIII/vWF concentrates in five, whereas in no patient did the vWF concentrate correct the BT according to the criteria used in this study. These effects on the BT were not related to the plasma levels of ristocetin cofactor activity-attained postinfusion (100 U/dL or more in the majority of patients) or to the multimeric structure of vWF in concentrates (defective in larger multimers in all cases). In conclusion, even though virus-inactivated concentrates can be used to increase FVIII:C levels in patients with severe vWD, none of the concentrates studied by us consistently normalizes the BT in a sustained fashion.",1992,"The pasteurized FVIII-vWF concentrate transiently corrected, completely or partially, the BT in 8 of 10 patients, the dry-heated and solvent/detergent FVIII/vWF concentrates in five, whereas in no patient did the vWF concentrate correct the BT according to the criteria used in this study.","['severe von Willebrand disease', 'patients with severe vWD', 'patients with severe von Willebrand disease (vWD', '10 patients with severe vWD']",['four virus-inactivated plasma concentrates'],"['attaining normal and sustained levels of FVIII', 'FVIII:C levels']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042974', 'cui_str': ""Von Willebrand's Factor Deficiency""}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",10.0,0.0168046,"The pasteurized FVIII-vWF concentrate transiently corrected, completely or partially, the BT in 8 of 10 patients, the dry-heated and solvent/detergent FVIII/vWF concentrates in five, whereas in no patient did the vWF concentrate correct the BT according to the criteria used in this study.","[{'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': 'Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, IRCCS Policlinico Hospital, Milan, Italy.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Tenconi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Castaman', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rodeghiero', 'Affiliation': ''}]",Blood,[]
1625,1596572,Trisomy of leukemic cell chromosomes 4 and 10 identifies children with B-progenitor cell acute lymphoblastic leukemia with a very low risk of treatment failure: a Pediatric Oncology Group study.,"To account for the superior prognosis of hyperdiploid, B-progenitor acute lymphoblastic leukemia (ALL), we investigated the influence of trisomy in 1021 children greater than or equal to 1 year old by recursive partitioning analysis. The patients were treated according to a stratified, randomized study testing antimetabolite-based therapies. Trisomies of several individual chromosomes were associated with a better prognosis in a univariate statistical analysis. Of greater importance, trisomy of both chromosomes 4 and 10 identified a subgroup of patients (n = 180) with an extremely favorable 4-year event-free survival (EFS). Combined trisomy of chromosomes 4 and 10 retained its prognostic significance after stratification of patients by DNA index, age, and leukocyte count. Among patients with a DNA index greater than 1.16, patients with trisomies of both chromosomes 4 and 10 had a 4-year EFS of 96.6% (n = 161, SE = 3.8%), whereas patients with neither or only one of these trisomies had a 4-year EFS of 70.4% (n = 73, SE = 11.5%). All 19 patients with a DNA index less than or equal to 1.16 but with trisomies of chromosomes 4 and 10 remain in remission, suggesting that favorable chromosome trisomy dominates in a situation in which the cellular DNA content of less than or equal to 1.16 predicts a less favorable outcome. We conclude that combined trisomy of chromosomes 4 and 10 independently predicts EFS among children with B-progenitor ALL. Patients within the B-progenitor group who have this feature (about 20% of those with clonal abnormalities) are likely to be cured with antimetabolite-based chemotherapy--an approach that should produce few significant late effects.",1992,"All 19 patients with a DNA index less than or equal to 1.16 but with trisomies of chromosomes 4 and 10 remain in remission, suggesting that favorable chromosome trisomy dominates in a situation in which the cellular DNA content of less than or equal to 1.16 predicts a less favorable outcome.","['children with B-progenitor cell acute lymphoblastic leukemia with a very low risk of treatment failure', '1021 children greater than or equal to 1 year old by recursive partitioning analysis', 'children with B-progenitor ALL']",[],"['4-year EFS', '4-year event-free survival (EFS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1021.0,0.0288133,"All 19 patients with a DNA index less than or equal to 1.16 but with trisomies of chromosomes 4 and 10 remain in remission, suggesting that favorable chromosome trisomy dominates in a situation in which the cellular DNA content of less than or equal to 1.16 predicts a less favorable outcome.","[{'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Harris', 'Affiliation': ""Tomorrows Children's Institute, Hackensack Medical Center, NJ.""}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Shuster', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Look', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': ''}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Crist', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nitschke', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pullen', 'Affiliation': ''}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Steuber', 'Affiliation': ''}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Land', 'Affiliation': ''}]",Blood,[]
1626,861375,"Prognostic classification of Hodgkin disease in pathologic stage III, based on anatomic considerations.","Fifty-two patients with pathologic stage III Hodgkin disease were studied in an effort to determine whether location of involved abdominal nodes influenced survival. Treatment consisted of total nodal radiotherapy with or without subsequent combination chemotherapy. Th initial radiation field was the ""extended mantle,"" which included supradiaphragmatic nodes, the splenic hilar area, and paraaortic nodes to the level of L2-L4. Subsequently, lower paraaortic and iliac regions were treated (""lower inverted Y""). Patients with disease limited to the spleen and/or splenic, celiac, or portal nodes (""anatomic substage"" III1) had a more favorable 5-yr survival than did patients with involvement of paraaortic, iliac, or mesenteric nodes (""anatomic substage"" III2): 93% versus 57%, respectively (p less than 0.05). The addition of combination chemotherapy to total nodal irradiation was associated with improved survival of patients in stage III2, but not of those in stage III1.",1977,"The addition of combination chemotherapy to total nodal irradiation was associated with improved survival of patients in stage III2, but not of those in stage III1.",['Fifty-two patients with pathologic stage III Hodgkin disease'],['total nodal radiotherapy with or without subsequent combination chemotherapy'],"['survival', 'favorable 5-yr survival']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019829', 'cui_str': 'Lymphogranuloma, Malignant'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0687985,"The addition of combination chemotherapy to total nodal irradiation was associated with improved survival of patients in stage III2, but not of those in stage III1.","[{'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Desser', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Golomb', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Ultmann', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Ferguson', 'Affiliation': ''}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Griem', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vardiman', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Oetzel', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sweet', 'Affiliation': ''}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Lester', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Kinzie', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Blough', 'Affiliation': ''}]",Blood,[]
1627,1515637,Recombinant human granulocyte-macrophage colony-stimulating factor after high-dose chemotherapy and autologous bone marrow transplantation with unpurged and purged marrow in non-Hodgkin's lymphoma: a double-blind placebo-controlled trial.,"The toxicity of autologous bone marrow transplantation (ABMT) is correlated to neutropenia. Although recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) seems to hold promise in accelerating neutrophil recovery, few analyses from randomized studies are presently available. Ninety-one patients with non-Hodgkin's lymphoma receiving high-dose ablative chemotherapy followed by ABMT with unpurged or purged marrow were included in a randomized, double-blind, placebo-controlled trial. Forty-four patients received 250 micrograms rhu GM-CSF (Escherichia coli)/m2 and 47 patients received placebo. Treatment was administered daily as continuous infusion from day of ABMT until the absolute neutrophil count (ANC) reached 0.5 x 10(9)/L for 7 days or until day 30, whichever was first. With rhu GM-CSF, 50% of the patients reached an ANC count greater than 0.5 x 10(9)/L at day 14 as opposed to day 21 with placebo (P less than .0001). Patients transplanted with marrow purged by mafosfamide also recovered earlier when treated with rhu GM-CSF (16 v 20.5 days, P = .013). The hospitalization duration was shorter in the rhu GM-CSF group (median, 23 v 28 days, P less than .05). No difference was observed in fever, number of infections, and antibiotic administration between the two groups. The major adverse event ascribed to rhu GM-CSF was a capillary leak syndrome in three patients graded as severe in two patients, moderate in one, and reversible in all three patients. In addition, one patient in the rhu GM-CSF group died suddenly with no explanation. In long term follow-up, the relapse rate was identical in both groups and there was no significant difference in the number of deaths at 1 year (12 with rhu GM-CSF v 9 with placebo), although deaths seemed to occur slightly earlier in the rhu GM-CSF group. We conclude that after ABMT with purged or unpurged marrow, rhu GM-CSF (E coli) significantly reduces neutropenia duration and hospitalization stay. A positive causative relation between the study drug and/or its mode of application with an increased toxicity as compared with GM-CSF from other sources and/or other modes of application cannot be deduced from the experiences in this study. Additional randomized trials would be necessary for an appropriate answer.",1992,"In long term follow-up, the relapse rate was identical in both groups and there was no significant difference in the number of deaths at 1 year (12 with rhu GM-CSF v 9 with placebo), although deaths seemed to occur slightly earlier in the rhu GM-CSF group.","[""Ninety-one patients with non-Hodgkin's lymphoma receiving high-dose ablative chemotherapy followed by ABMT with unpurged or purged marrow"", ""non-Hodgkin's lymphoma""]","['placebo', 'Recombinant human granulocyte-macrophage colony-stimulating factor after high-dose chemotherapy and autologous bone marrow transplantation with unpurged and purged marrow', 'recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF', '250 micrograms rhu GM-CSF ', 'autologous bone marrow transplantation (ABMT']","['relapse rate', 'toxicity', 'number of deaths', 'ANC count', 'hospitalization duration', 'neutropenia duration and hospitalization stay', 'capillary leak syndrome', 'fever, number of infections, and antibiotic administration']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0855227', 'cui_str': 'Purging'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'microgram'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0343084', 'cui_str': 'Clarkson Disease'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",44.0,0.143198,"In long term follow-up, the relapse rate was identical in both groups and there was no significant difference in the number of deaths at 1 year (12 with rhu GM-CSF v 9 with placebo), although deaths seemed to occur slightly earlier in the rhu GM-CSF group.","[{'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Gorin', 'Affiliation': 'Department of Hematology, Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hayat', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fouillard', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kuentz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flesch', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Colombat', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Boivin', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Slavin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Philip', 'Affiliation': ''}]",Blood,[]
1628,1586709,Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors.,"The safety and possible efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) were evaluated in 40 consecutive patients who received transplants from unrelated donors. rhGM-CSF was administered by 2-hour daily intravenous infusion from day 0 to day 20 or day 27 after the marrow infusion. These patients were compared with 78 historical patients who received transplants from unrelated donors who did not receive rhGM-CSF. The rhGM-CSF-treated patients were older (P = .037) and were treated less frequently in laminar air flow rooms (P = .005) than were control patients. However, the rhGM-CSF-treated group had a higher proportion of ""good risk"" patients with chronic myelogenous leukemia in chronic phase (P = .006) than did the comparison group (P = .017), rendering comparisons of transplant-related complications not meaningful. rhGM-CSF was well tolerated and did not adversely increase the incidence of graft rejection or increase the incidence and severity of acute graft-versus-host disease. The median day the absolute neutrophil count reached 500/mm3 in patients who received rhGM-CSF was day 21, which was not different from that of historical patients. Nevertheless, the numbers of febrile days and septicemic episodes within the first 28 days in patients who received rhGM-CSF were less than in historical patients. The probability of nonrelapse mortality at 1 year in patients who received rhGM-CSF was 22%. In view of the retrospective nature of the control group, we cannot conclusively determine whether rhGM-CSF administration was beneficial. A prospective, randomized controlled study of rhGM-CSF is required to confirm these suggestive data.",1992,rhGM-CSF was well tolerated and did not adversely increase the incidence of graft rejection or increase the incidence and severity of acute graft-versus-host disease.,"['78 historical patients who received transplants from unrelated donors who did not receive rhGM-CSF', 'patients undergoing allogeneic bone marrow transplantation from unrelated donors', '40 consecutive patients who received transplants from unrelated donors']","['recombinant human granulocyte-macrophage colony-stimulating factor', 'rhGM-CSF', 'recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF']","['numbers of febrile days and septicemic episodes', 'incidence of graft rejection', 'median day the absolute neutrophil count', 'probability of nonrelapse mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3179133', 'cui_str': 'Unrelated Donors'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",40.0,0.018183,rhGM-CSF was well tolerated and did not adversely increase the incidence of graft rejection or increase the incidence and severity of acute graft-versus-host disease.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nemunaitis', 'Affiliation': 'Veterans Affairs Medical Center, Seattle, WA 98108.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Bianco', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Onetto', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': ''}]",Blood,[]
1629,1586710,Allogeneic bone marrow transplantation for acute myeloid leukemia in first remission: a randomized trial of a busulfan-Cytoxan versus Cytoxan-total body irradiation as preparative regimen: a report from the Group d'Etudes de la Greffe de Moelle Osseuse.,"From October 1987 to December 1990, 101 patients with acute myeloid leukemia (AML) were randomized to be transplanted in first complete remission (CR1). Preparative regimen including Cytoxan (120 mg/kg) with total body irradiation (CYTBI) (N = 50) or busulfan (16 mg/kg) (BUSCY) (N = 51) was followed by allogeneic bone marrow transplantation (BMT) from an HLA-identical sibling. Mean time between diagnosis and BMT was 119 days. The outcome for CYTBI at 2 years is better for probability of disease-free survival (DFS) (72% v 47%) (P less than .01), survival (75% v 51%) (P less than .02), relapse (14% v 34%) (P less than .04), and transplant mortality (8% v 27%) (P less than .06). In multivariable analysis, higher relapse and decreased survival and DFS were associated with BUSCY regimen, while chronic graft-versus-host disease also influenced independently the probability of relapse. This demonstrates the present limitation of busulfan use in this setting, possibly due to probable individual variations in biodisponibility. Furthermore, besides the anti-leukemic effect of preparative regimens, this trial points out the progress accomplished in BMT management (transplant mortality = 8% in CYTBI) over the last 20 years as well as the effectiveness of transplant in early first CR after CYTBI (DFS = 72% at 2 years).",1992,"The outcome for CYTBI at 2 years is better for probability of disease-free survival (DFS) (72% v 47%) (P less than .01), survival (75% v 51%)","['acute myeloid leukemia in first remission', 'From October 1987 to December 1990, 101 patients with acute myeloid leukemia (AML']","['allogeneic bone marrow transplantation (BMT', 'busulfan-Cytoxan versus Cytoxan-total body irradiation', 'Cytoxan', 'total body irradiation (CYTBI', 'Allogeneic bone marrow transplantation', 'busulfan']","['survival and DFS', 'transplant mortality', 'survival', 'Mean time', 'probability of disease-free survival (DFS', 'relapse']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0699319', 'cui_str': 'Cytoxan'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",101.0,0.0410988,"The outcome for CYTBI at 2 years is better for probability of disease-free survival (DFS) (72% v 47%) (P less than .01), survival (75% v 51%)","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': 'Statistical Department, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Maraninchi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Archimbaud', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reiffers', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Devergie', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Jouet', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Milpied', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michallet', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ifrah', 'Affiliation': ''}]",Blood,[]
1630,1586733,"Prevention of hepatic veno-occlusive disease after bone marrow transplantation by continuous infusion of low-dose heparin: a prospective, randomized trial.","Hepatic veno-occlusive disease (VOD) is a major regimen-related toxicity after bone marrow transplantation (BMT). Endothelial injury, leading to deposition of coagulation factors within the terminal hepatic venules, is believed to be the key event in the pathogenesis of VOD. To evaluate the benefit and the safety of a VOD prophylaxis with anticoagulants, we conducted a prospective randomized trial of continuous infusion of low-dose heparin among 161 patients under-going either allogeneic (n = 79) or autologous BMT (n = 81). Patients were randomized to receive (n = 81) or not receive (n = 80) prophylactic heparin 100 U/kg/d by continuous infusion from day -8 until day +30 post-BMT. Heparin was found to be highly effective in preventing VOD, which occurred in 11 of 80 patients (13.7%) in the control group versus 2 of 81 (2.5%) in the heparin group (P less than .01). Furthermore, none of the 39 patients in the heparin group developed VOD after allogeneic BMT, versus 7 of 38 (18.4%) in the control group (P less than .01). This prophylactic effect was achieved without added risk of bleeding. Indeed, the low-dose heparin we used did not prolong the partial thromboplastin time and did not increase the red blood cell and platelet requirements. It is therefore recommended that heparin prophylaxis be part of early mortality prevention programs after BMT.",1992,"Heparin was found to be highly effective in preventing VOD, which occurred in 11 of 80 patients (13.7%) in the control group versus 2 of 81 (2.5%) in the heparin group (P less than .01).","['n = 81', '161 patients under-going either allogeneic (n = 79) or']","['prophylactic heparin', 'Heparin', 'autologous BMT', 'bone marrow transplantation by continuous infusion of low-dose heparin', 'heparin', 'continuous infusion of low-dose heparin']","['VOD', 'red blood cell and platelet requirements', 'VOD after allogeneic BMT', 'partial thromboplastin time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}]",161.0,0.0393493,"Heparin was found to be highly effective in preventing VOD, which occurred in 11 of 80 patients (13.7%) in the control group versus 2 of 81 (2.5%) in the heparin group (P less than .01).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Attal', 'Affiliation': 'Department of Hematology, Chu Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huguet', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rubie', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huynh', 'Affiliation': ''}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Charlet', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Payen', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Voigt', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Brousset', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Selves', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Muller', 'Affiliation': ''}]",Blood,[]
1631,1056801,BCG in the treatment of acute lymphocytic leukemia.,"Children with acute lymphocytic leukemia, who were in remission after induction with prednisone and vincristine and consolidation with intravenous methotrexate, were randomized into three groups receiving (1) no further therapy, (2) BCG, and (3) chemotherapy with biweekly methotrexate and monthly prednisone and vincristine. Children continuing in remission after 8 mo on chemotherapy in group 3 were rerandomized into three similar groups, i.e., no therapy, BCG, and chemotherapy. In the primary randomization, the median duration of remission was identical in the groups receiving no therapy or BCG, (4 and 4.3 mo respectively), and both were significantly less than the median duration of remission on chemotherapy which had not been reached prior to secondary randomization at 8 mo. Results of secondary randomization were similar to those of primary randomization. As used in this study, BCG was ineffective in prolonging drug-induced remissions either early in remission or when the leukemic cell population might have been further reduced after 8 mo of maintenance chemotherapy.",1975,"In the primary randomization, the median duration of remission was identical in the groups receiving no therapy or BCG, (4 and 4.3 mo respectively), and both were significantly less than the median duration of remission on chemotherapy which had not been reached prior to secondary randomization at 8 mo.","['acute lymphocytic leukemia', 'Children with acute lymphocytic leukemia, who were in remission after induction with']","['no therapy, BCG, and chemotherapy', 'chemotherapy', 'prednisone and vincristine and consolidation with intravenous methotrexate', 'receiving (1) no further therapy, (2) BCG, and (3) chemotherapy with biweekly methotrexate and monthly prednisone and vincristine', 'BCG']",['median duration of remission'],"[{'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0162277,"In the primary randomization, the median duration of remission was identical in the groups receiving no therapy or BCG, (4 and 4.3 mo respectively), and both were significantly less than the median duration of remission on chemotherapy which had not been reached prior to secondary randomization at 8 mo.","[{'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Heyn', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karon', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nesbit', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Breslow', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reed', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': ''}]",Blood,[]
1632,31810741,Treating periodontal disease in patients with myocardial infarction: A randomized clinical trial.,"BACKGROUND


Periodontitis has been associated with coronary artery disease, but the impact of a periodontal treatment on the endothelial function of patients with a recent ST-segment elevation myocardial infarction (STEMI) was not investigated.
METHODS


Randomized controlled trial (NCT02543502). Patients admitted between August 2012 and January 2015 were included. Patients were screened during the index hospitalization for STEMI, and those with severe periodontal disease were randomized 2 weeks later to periodontal treatment or to control. The primary endpoint of this trial was the between group difference in the variation of flow-mediated vasodilation (FMD) in the brachial artery assessed by ultrasound from baseline to the 6-month follow-up. Secondary outcomes were cardiovascular events, adverse effects of periodontal treatment and inflammatory markers.
RESULTS


Baseline characteristics were balanced between patients in the intervention (n = 24) and control groups (n = 24). There was a significant FMD improvement in the intervention group (3.05%; p = .01), but not in the control group (-0.29%; p = .79) (p = .03 for the intergroup comparison). Periodontal treatment was not associated with any adverse events and the inflammatory profile and cardiovascular events were not significantly different between both groups.
CONCLUSIONS


Treatment of periodontal disease improves the endothelial function of patients with a recent myocardial infarction, without adverse clinical events. Larger trials are needed to assess the benefit of periodontal treatment on clinical outcomes.
CLINICAL TRIAL REGISTRATION


NCT02543502 (https://clinicaltrials.gov/ct2/show/NCT02543502?term=NCT02543502&rank=1).",2020,"Periodontal treatment was not associated with any adverse events and the inflammatory profile and cardiovascular events were not significantly different between both groups.
","['Patients admitted between August 2012 and January 2015 were included', 'Patients were screened during the index hospitalization for STEMI, and those with severe periodontal disease', 'patients with a recent myocardial infarction', 'patients with myocardial infarction']",[],"['FMD improvement', 'cardiovascular events, adverse effects of periodontal treatment and inflammatory markers', 'endothelial function', 'adverse events and the inflammatory profile and cardiovascular events', 'variation of flow-mediated vasodilation (FMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction (situation)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],"[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}]",,0.136165,"Periodontal treatment was not associated with any adverse events and the inflammatory profile and cardiovascular events were not significantly different between both groups.
","[{'ForeName': 'Marcelo G', 'Initials': 'MG', 'LastName': 'Lobo', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Schmidt', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA; Federal University of São Paulo (USP), São Paulo, Brazil; Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dipp', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Ivan P', 'Initials': 'IP', 'LastName': 'Feijó', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Karine E S', 'Initials': 'KES', 'LastName': 'Schmidt', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Cristina A', 'Initials': 'CA', 'LastName': 'Gazeta', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Mariana L', 'Initials': 'ML', 'LastName': 'Azeredo', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Markoski', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Lucia C', 'Initials': 'LC', 'LastName': 'Pellanda', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Carlos A M', 'Initials': 'CAM', 'LastName': 'Gottschall', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Quadros', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia (IC/FUC), Porto Alegre, Brazil. Electronic address: consult.asq@gmail.com.'}]",European journal of internal medicine,['10.1016/j.ejim.2019.08.012']
1633,1381626,Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: a randomized controlled trial.,"The effect of granulocyte colony-stimulating factor (G-CSF) on neutropenia, infection, and cytotoxic chemotherapy administration was studied in a randomized trial in patients receiving intensive weekly chemotherapy for non-Hodgkin's lymphoma (NHL). Eighty patients (aged 16 to 71 years) with high-grade NHL (Kiel) of any stage were randomized to receive VAPEC-B chemotherapy alone (39 patients) or with G-CSF administered as a daily subcutaneous dose of 230 micrograms/m2 (41 patients). Prophylactic ketoconazole and cotrimoxazole were administered to all patients throughout treatment. The protocol specified identical dose modification and antibiotic treatment criteria bor both groups. Neutropenia (absolute neutrophil count [ANC] less than 1.0 x 10(9)/L) occurred in 15 of 41 (37%) of the G-CSF-treated patients and in 33 of 39 (85%) of the controls, giving a relative risk for control patients of 2.31 (95% confidence interval [CI], [1.51, 3.54]; P = .00001). Fever (greater than or equal to 37.5 degrees C) with neutropenia (ANC less than 1.0 x 10(9)/L) occurred in 9 of 41 (22%) of the G-CSF group and in 17 of 39 (44%) of the controls (relative risk for control, 2.26; 95% CI [1.01, 5.06]; P = .04). There were fewer treatment delays, with shorter duration (P = .01) in patients receiving G-CSF. Chemotherapy doses were reduced in 4 of 41 (10%) of the G-CSF patients and 13 of 39 (33%) of the controls (P = .01). The dose intensity of cytotoxic chemotherapy was significantly increased in patients receiving G-CSF (median of 95% in G-CSF group compared with 83% in control patients). Three vascular deaths occurred in the G-CSF group. Delays in the control group most commonly resulted from neutropenia (19 patients, compared with 2 patients in the G-CSF-treated group, P = .000007). Severe mucositis was the major dose-limiting toxicity in G-CSF-treated patients, but did not occur more frequently than in controls (15 patients in each group). Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.",1992,"Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.","['Eighty patients (aged 16 to 71 years) with high-grade NHL (Kiel) of any stage', ""patients receiving intensive weekly chemotherapy for non-Hodgkin's lymphoma (NHL"", ""non-Hodgkin's lymphoma""]","['Prophylactic ketoconazole and cotrimoxazole', 'G-CSF', 'granulocyte colony-stimulating factor (G-CSF', 'Granulocyte colony-stimulating factor', 'VAPEC-B chemotherapy alone (39 patients) or with G-CSF']","['Severe mucositis', 'neutropenia', 'vascular deaths', 'drug toxicity', 'dose intensity of cytotoxic chemotherapy', 'Neutropenia (absolute neutrophil count [ANC', 'Fever', 'intravenous antibiotic usage, or hospitalization']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",,0.0576554,"Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': 'Cancer Research Campaign Department of Medical Oncology, Christie Hospital NHS Trust, Manchester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Radford', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Deakin', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'James', 'Affiliation': ''}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Wilkinson', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kane', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bentley', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crowther', 'Affiliation': ''}]",Blood,[]
1634,1064434,Chemotherapy of the blastic phase of chronic granulocytic leukemia: hypodiploidy and response to therapy.,"Thirty-two patients in the blastic phase of Philadelphia chromosome-positive chronic granulocytic leukemia (CGL) were studied in a prospective randomized trial in which vincristine--prednisone (19 patients) was compared with cytosine arabinoside--6-thioguanine (13 patients). Seven remissions (37%), including two complete remissions, were achieved in the vincristine--prednisone group. Three of the five with predominant hypodiploid blast cell lines treated with vincristine--prednisone had complete or partial remissions. Both complete remitters presented with hypodiploidy consisting of 44 chromosomes. Four patients (30%) who were treated with cytosine arabinoside--6-thioguanine responded with one complete remission. The median survival of the responders was 8 mo, as compared to 1--2 mo for the nonresponders. Crossover to the opposite regimen as secondary therapy following refractoriness or resistance resulted in only 3 partial responses out of 21 treated. All three had previously responded to vincristine--prednisone. Of the 32 cases, 14 had an elective splenectomy during the chronic phase of the disease. Prior splenectomy did not influence the response to chemotherapy, as all three complete remitters occurred in the nonsplenectomized group. Similarly, survival in the blastic phase was not affected by prior splenectomy.",1976,"The median survival of the responders was 8 mo, as compared to 1--2 mo for the nonresponders.","['Of the 32 cases, 14 had an elective splenectomy during the chronic phase of the disease', 'chronic granulocytic leukemia', 'Thirty-two patients in the blastic phase of Philadelphia chromosome-positive chronic granulocytic leukemia (CGL']","['Chemotherapy', 'cytosine arabinoside--6-thioguanine', 'vincristine--prednisone']","['median survival', 'complete or partial remissions', 'survival']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1292771', 'cui_str': 'Chronic myelogenous leukemia, t(9;22)(q34;q11)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0274218,"The median survival of the responders was 8 mo, as compared to 1--2 mo for the nonresponders.","[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Canellos', 'Affiliation': ''}, {'ForeName': 'V T', 'Initials': 'VT', 'LastName': 'DeVita', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Whang-Peng', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Chabner', 'Affiliation': ''}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Schein', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Young', 'Affiliation': ''}]",Blood,[]
1635,1562720,Varying intensity of postremission therapy in acute myeloid leukemia.,"The Eastern Cooperative Oncology Group (ECOG) conducted a randomized trial in patients less than or equal to 65 years old (median, 44 years) to determine whether increasing the intensity of postremission therapy in acute myeloid leukemia (AML) would improve the outcome. After uniform induction therapy, patients in complete remission (CR) who were less than 41 years old and who had a histocompatible sibling underwent allogeneic bone marrow transplantation (alloBMT) (54 patients). The remainder of patients in CR were randomized to receive either 2 years of continuous outpatient maintenance therapy with cytarabine and 6-thioguanine (83 patients) or a single course of inpatient consolidation therapy consisting of 6 days of high-dose cytarabine plus 3 days of amsacrine (87 patients). The median duration of follow-up is now 4 years, and patients are included in the analyses of outcome regardless of whether they relapsed before starting the intended treatment. Four-year event-free survival (EFS) was 27% +/- 10% for consolidation therapy versus 16% +/- 8% for maintenance therapy (P = .068) and 28% +/- 11% versus 15% +/- 9% (P = .047) in patients less than 60 years old. The outcome for patients receiving alloBMT was compared with the subset of patients less than 41 years old who received consolidation therapy (N = 29) or maintenance therapy (N = 21). Four-year EFS was 42% +/- 13% for alloBMT, 30% +/- 17% for consolidation therapy, and 14% +/- 15% for maintenance therapy. AlloBMT had a significantly better EFS (P = .013) than maintenance therapy, but was not different from consolidation therapy. In patients less than 41 years old, 4-year survival after alloBMT (42% +/- 14%) did not differ from consolidation therapy (43% +/- 18%), but both were significantly better than maintenance therapy (19% +/- 17%), P = .047 and .043, respectively. The mortality rate for maintenance therapy was 0%, consolidation therapy, 21%; and alloBMT, 36%. Consolidation therapy caused an especially high mortality rate in the patients greater than or equal to 60 years old (8 of 14 or 57%). The toxicity of combined high-dose cytarabine and amsacrine is unacceptable, especially in older patients, and alternative approaches to consolidation therapy such as high-dose cytarabine alone need to be tested. In AML, a single course of consolidation therapy or alloBMT after initial CR produces better results than lengthy maintenance therapy. Although EFS and survival of alloBMT and consolidation therapy do not differ significantly, a larger number of patients need to be studied before concluding that they are equivalent.",1992,"AlloBMT had a significantly better EFS (P = .013) than maintenance therapy, but was not different from consolidation therapy.","['patients in complete remission (CR) who were less than 41 years old and who had a histocompatible sibling underwent allogeneic bone marrow transplantation (alloBMT) (54 patients', 'older patients', 'acute myeloid leukemia', 'patients less than or equal to 65 years old (median, 44 years']","['cytarabine plus 3 days of amsacrine', 'consolidation therapy', 'maintenance therapy', 'Consolidation therapy', 'cytarabine', 'continuous outpatient maintenance therapy with cytarabine and 6-thioguanine', 'alloBMT', 'cytarabine and amsacrine']","['toxicity', '4-year survival after alloBMT', 'mortality rate', 'EFS', 'free survival (EFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677874', 'cui_str': 'In full remission (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0039902', 'cui_str': 'tioguanine'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0334969,"AlloBMT had a significantly better EFS (P = .013) than maintenance therapy, but was not different from consolidation therapy.","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Cassileth', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lynch', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Hines', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Oken', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Mazza', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'McGlave', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Edelstein', 'Affiliation': ''}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': ""O'Connell"", 'Affiliation': ''}]",Blood,[]
1636,1330079,Circulating cytomegalovirus (CMV) neutralizing activity in bone marrow transplant recipients: comparison of passive immunity in a randomized study of four intravenous IgG products administered to CMV-seronegative patients.,"Forty-two cytomegalovirus (CMV)-seronegative bone marrow transplant (BMT) recipients were randomized in a double-blind fashion to receive one of four commercially available intravenous Ig (IVIgG) products (Gamimmune N, Immune Globulin Intravenous, Gammagard, or Sandoglobulin) at a dose of 500 mg/kg every other week. The four treatment groups were similar in distribution of patient ages, weights, autologous versus allogeneic donor type, and underlying diseases. Every other week administration of IVIgG provided total serum IgG levels within the physiologic range for age. CMV titers by latex agglutination were stable (average geometric mean titer of 18.4 after the second IVIgG dose), with no statistically significant differences among the four product groups. CMV neutralizing activity (CMVNA) and CMV enzyme-linked immunosorbent assay (ELISA) titers were determined on a subset of sera from 27 study patients representing the four product groups. Patient serum samples obtained before IVIgG infusions and 2 weeks after the second IVIgG dose (ie, 3 weeks post-BMT) were assayed for CMVNA and CMV ELISA titers. Geometric mean titers of CMVNA and CMV ELISA varied among the product groups. The highest mean 50% CMVNA was 1:43 for product B, whereas the lowest mean 50% CMVNA was 1:14 for product A; two of the IVIgG product groups showed intermediate 50% mean titers of 1:27 (product C) and 1:26 (product D) for an overall P = .02. CMV ELISA titers (expressed as Paul Ehrlich International units [PEI U]) also showed the highest mean of 2.95 PEI U/mL for product B and the lowest mean of 1.34 PEI U/mL for product A. Intermediate mean values of 2.27 PEI U/mL and 2.03 PEI U/mL were obtained with products C and D, respectively (overall P = .003). The CMV ELISA titers show a minimal correlation (r = .566) to the observed CMVNA titers. We conclude that commercially available IVIgG products provide passive CMVNA, and that the level of circulating CMVNA is affected by the IVIgG product used.",1992,"CMV titers by latex agglutination were stable (average geometric mean titer of 18.4 after the second IVIgG dose), with no statistically significant differences among the four product groups.","['Forty-two cytomegalovirus (CMV)-seronegative bone marrow transplant (BMT) recipients', 'bone marrow transplant recipients', 'CMV-seronegative patients']","['IVIgG', 'intravenous Ig (IVIgG) products (Gamimmune N, Immune Globulin Intravenous, Gammagard, or Sandoglobulin']","['CMV neutralizing activity (CMVNA) and CMV enzyme-linked immunosorbent assay', 'CMV ELISA titers', 'distribution of patient ages, weights, autologous versus allogeneic donor type, and underlying diseases', 'Circulating cytomegalovirus (CMV) neutralizing activity', 'CMV titers by latex agglutination', 'Geometric mean titers of CMVNA and CMV ELISA', 'ELISA) titers', 'total serum IgG levels']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C4545296', 'cui_str': 'Bone marrow transplant recipient'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0162507', 'cui_str': 'Gamimune N'}, {'cui': 'C3494178', 'cui_str': 'Immune Globulin Intravenous (Human)'}, {'cui': 'C0086333', 'cui_str': 'Gammagard'}, {'cui': 'C0086952', 'cui_str': 'Sandoglobulin'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0023117', 'cui_str': 'Latex Agglutination Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",27.0,0.0947428,"CMV titers by latex agglutination were stable (average geometric mean titer of 18.4 after the second IVIgG dose), with no statistically significant differences among the four product groups.","[{'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Filipovich', 'Affiliation': 'Division of Immunology (Department of Pediatrics), University of Minnesota, Minneapolis.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Peltier', 'Affiliation': ''}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Bechtel', 'Affiliation': ''}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Dirksen', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Strauss', 'Affiliation': ''}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ''}]",Blood,[]
1637,1421390,"A controlled trial of recombinant human granulocyte-macrophage colony-stimulating factor after total body irradiation, high-dose chemotherapy, and autologous bone marrow transplantation for acute lymphoblastic leukemia or malignant lymphoma.","Infections during granulocytopenia are major complications of autologous bone marrow transplantation (ABMT). Since recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF) has proved to accelerate bone marrow recovery after cytostatic chemotherapy, we studied its effects on hematopoietic regeneration and on infectious complications after total body irradiation (TBI) and high-dose chemotherapy followed by ABMT. Eighty-one patients with acute lymphoblastic leukemia (ALL) in complete remission (CR) or with non-Hodgkin's lymphoma (NHL) in CR or partial remission were randomized in a double-blind, placebo-controlled trial. They received either rhuGM-CSF 250 micrograms/m2 (Escherichia coli-derived) daily by continuous infusion after ABMT, or placebo. Treatment was continued until the neutrophil counts reached greater than 500/microL for 1 week. The maximum treatment duration was 30 days. Thirty-nine patients in the rhuGM-CSF group and 40 patients in the placebo group were evaluable. The median time needed to reach a neutrophil count of 500/microL was 15 days with rhuGM-CSF and 28 days with placebo (P = .0001). Bacterial infections occurred in 14 (35.9%) of the patients with rhuGM-CSF and in 25 (62.5%) of the patients given the placebo (P = .024). Nine of the 14 bacterial infections in the rhuGM-CSF group and 20 of the 25 infections in the placebo group were diagnosed within the first 10 days after ABMT. Capillary leakage and a reversible fluid retention were seen in five of the rhuGM-CSF-treated patients. Patients treated with rhuGM-CSF had lower serum protein and albumin levels than patients in the placebo group. There was no statistically relevant difference in overall survival between the two groups (P = .47). Relapse occurred in 14 (34%) patients with rhuGM-CSF and in 18 (45%) patients with placebo. We conclude that continuous infusion of rhuGM-CSF after ABMT accelerates the regeneration of granulocytes and reduces the number of bacterial infections.",1992,There was no statistically relevant difference in overall survival between the two groups (P = .47).,"['Thirty-nine patients in the rhuGM-CSF group and 40 patients in the', 'acute lymphoblastic leukemia or malignant lymphoma', ""Eighty-one patients with acute lymphoblastic leukemia (ALL) in complete remission (CR) or with non-Hodgkin's lymphoma (NHL) in CR or partial remission""]","['rhuGM-CSF 250 micrograms/m2 (Escherichia coli-derived) daily by continuous infusion after ABMT, or placebo', 'rhuGM-CSF', 'placebo', 'recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF', 'autologous bone marrow transplantation (ABMT', 'recombinant human granulocyte-macrophage colony-stimulating factor after total body irradiation, high-dose chemotherapy, and autologous bone marrow transplantation']","['median time needed to reach a neutrophil count of 500/microL', 'Relapse', 'Capillary leakage and a reversible fluid retention', 'Bacterial infections', 'overall survival', 'serum protein and albumin levels', 'neutrophil counts', 'number of bacterial infections']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0677874', 'cui_str': 'In full remission (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0218633', 'cui_str': 'recombinant human GM-CSF'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0268000', 'cui_str': 'Body fluid retention (disorder)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036825', 'cui_str': 'Serum Proteins'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",81.0,0.176193,There was no statistically relevant difference in overall survival between the two groups (P = .47).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Department of Hematology and Oncology, Medizinische Hochschule Hannover, Germany.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boogaerts', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Carella', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ferrant', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gadner', 'Affiliation': ''}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Gorin', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Harabacz', 'Affiliation': ''}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Harousseau', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hervé', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Holldack', 'Affiliation': ''}]",Blood,[]
1638,1054609,Dibromomannitol in the treatment of chronic granulocytic leukemia: a prospective randomized comparison with busulfan.,"Dibromomannitol (DBM) is a new agent for the treatment of chronic granulocytic leukemia. A propsective evaluation of the drug was undertaken in a randomized comparison with busulfan. Forty previously untreated, Philadelphia chromosome-positive cases were treated, with 20 patients in each treatment group. The protocol provided for continuous maintenance therapy after remission induction, with a crossover to the opposite drug in patients who became refractory to the primary agent but are without evidence of blastic tranformation. There were 14 remissions in the DBM group and 15 in those treated with busulfan. The rate of decrease of the elevated leukocyte count was more rapid with DBM, but prolonged disease control off treatment occurred in only three of 14 cases as opposed to nine of fifteen busulfan-treated patients who required a median delay of 12 mo before maintenance could be initiated. Hypoplasia occurred in one DBM patient and two busulfan cases. Following recovery, crossover to the opposite drug in two cases again resulted in hypopllasia. Increased skin pigmentation, amenorrhea, pulmonary fibrosis, and cytologic dysplasia, commonly associated with busulfan adminstration, were also noted with DBM. The median duration of disease control with busulfan was 34 mo and 26 mo with DBM. There was no signigicant difference in the incidence of blastic transformation, and median survival for both groups was 44 mo. DBM appears to be as effective as busulfan in the treatment of the chronic phase of CGL but with a more predictable myelosuppressive action. The principal advantage of busulfan over DBM is the fact that more than half the busulfan-treated patients experienced prolonged disease control off treatment.",1975,"There was no signigicant difference in the incidence of blastic transformation, and median survival for both groups was 44 mo.","['patients who became refractory to the primary agent but are without evidence of blastic tranformation', 'chronic granulocytic leukemia']","['DBM', 'Dibromomannitol', 'Dibromomannitol (DBM', 'busulfan']","['hypopllasia', 'disease control off treatment', 'incidence of blastic transformation, and median survival', 'median duration of disease control', 'Hypoplasia', 'elevated leukocyte count', 'Increased skin pigmentation, amenorrhea, pulmonary fibrosis, and cytologic dysplasia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}]","[{'cui': 'C0026236', 'cui_str': 'Mitobronitol'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0243069', 'cui_str': 'Hypoplasia (morphologic abnormality)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1269684', 'cui_str': 'Skin pigmented'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0034069', 'cui_str': 'Pulmonary Fibrosis'}, {'cui': 'C0205471', 'cui_str': 'Cytologic (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}]",40.0,0.0239518,"There was no signigicant difference in the incidence of blastic transformation, and median survival for both groups was 44 mo.","[{'ForeName': 'G P', 'Initials': 'GP', 'LastName': 'Canellos', 'Affiliation': ''}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Neiman', 'Affiliation': ''}, {'ForeName': 'V T', 'Initials': 'VT', 'LastName': 'DeVita', 'Affiliation': ''}]",Blood,[]
1639,830372,Effect of induced fever on serum iron and ferritin concentrations in man.,"Previous reports have shown that endotoxin decreases serum iron in experimental animals. In this study fever was produced in nine female and nine male normal subjects in order to define the temporal and quantitative changes in serum iron and ferritin concentrations. Six volunteers were randomly given bacterial endotoxin (5 ng/kg) or saline intravenously and received the alternative compound a week later. Serial blood samples were drawn at 4-hr intervals for a 24-hr period, beginning when the compound was administered, for the determination of serum iron and ferritin concentrations. The same study was performed with intramuscular etiocholanolone (0.3 mg/kg) or the vehicle, propylene glycol, as a control, but the first blood sample was obtained 9 hr after the compound was given. In addition, blood samples were obtained at 12-hr intervals in six volunteers for 11 days after an intramuscular injection of etiocholanolone. The results showed a significant increase (p less than 0.005 for etiocholanolone, P less than 0.01 for endotoxin) in serum ferritin and a significant decrease (p less than 0.005 for etiocholanolone, p less than 0.001 for endotoxin) in serum iron for both pyrogenic compounds compared with the control compounds. However, the amount of fever and the changes in the iron parameters were greater with etiocholanolone. One episode of induced fever with etiocholanolone effected changes in serum ferritin and iron concentrations that lasted 10 days. Thus this study demonstrated that a single episode of fever in man produced rapid and prolonged changes in serum iron and ferritin concentrations.",1977,"The results showed a significant increase (p less than 0.005 for etiocholanolone, P less than 0.01 for endotoxin) in serum ferritin and a significant decrease (p less than 0.005 for etiocholanolone, p less than 0.001 for endotoxin) in serum iron for both pyrogenic compounds compared with the control compounds.","['man', 'Six volunteers', 'nine female and nine male normal subjects']","['intramuscular etiocholanolone', 'saline', 'bacterial endotoxin', 'endotoxin', 'vehicle, propylene glycol', 'etiocholanolone']","['serum iron and ferritin concentrations', 'serum ferritin', 'serum ferritin and iron concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0015124', 'cui_str': '5-beta-Androsterone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C4046690', 'cui_str': 'propylene glycol, (S)-'}]","[{'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]",6.0,0.0247784,"The results showed a significant increase (p less than 0.005 for etiocholanolone, P less than 0.01 for endotoxin) in serum ferritin and a significant decrease (p less than 0.005 for etiocholanolone, p less than 0.001 for endotoxin) in serum iron for both pyrogenic compounds compared with the control compounds.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Elin', 'Affiliation': ''}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Finch', 'Affiliation': ''}]",Blood,[]
1640,779871,Severe aplastic anemia: a prospective study of the effect of early marrow transplantation on acute mortality.,"A prospective randomized trial of therapy for severe aplastic anemia was designed to compare early bone marrow transplantation with conventional treatments. All patients with a sibling matched at the major histocompatibility region were transplanted. Transplantation was performed with 17-100 (median 33) days of original diagnosis. Conventional treatments included transfusion support with or without androgens. Twenty-four of 36 patients intered on the transplant arm are alive after 4-20 (median 9) mo with full marrow reconstitution. Only two are limited by chronic graft-versus-host disease. In contrast only 12 of 31 conventionally treated patients are alive. Six of these survivors have improved, five incompletely. The 19 nontransplant deaths have occurred within 1-11 (median 3) mo of diagnosis. Compared to nontransplant regimens, early transplantation more effectively restores normal marrow function and decreases the acute mortality of severe marrow aplasia (p = 0.006). Pending longer follow-up, early marrow transplantation appears to be the most effective available treatment for severe aplastic anemia.",1976,"Compared to nontransplant regimens, early transplantation more effectively restores normal marrow function and decreases the acute mortality of severe marrow aplasia (p = 0.006).","['All patients with a sibling matched at the major histocompatibility region were transplanted', 'Twenty-four of 36 patients intered on the transplant arm are alive after 4-20 (median 9) mo with full marrow reconstitution', 'severe aplastic anemia']","['early marrow transplantation', 'transfusion support with or without androgens']","['normal marrow function', 'acute mortality of severe marrow aplasia', 'acute mortality', 'Severe aplastic anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019627', 'cui_str': 'Tissue Compatibility'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0334079', 'cui_str': 'aplasia'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}]",,0.0251941,"Compared to nontransplant regimens, early transplantation more effectively restores normal marrow function and decreases the acute mortality of severe marrow aplasia (p = 0.006).","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Camitta', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Gordon-Smith', 'Affiliation': ''}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Rappeport', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}]",Blood,[]
1641,638249,"""Concentration x time"" methotrexate via a subcutaneous reservoir: a less toxic regimen for intraventricular chemotherapy of central nervous system neoplasms.","Neurotoxicity associated with intrathecal methotrexate therapy has been shown to correlate with elevated concentrations of the drug in the cerebrospinal fluid as well as with the total cumulative dosage. In our study 19 patients with meningeal leukemia were randomized to receive courses of intraventricular methotrexate via an Ommaya reservoir consisting of either single injections of 12 mg/sq m/dose or a low-dose ""concentration x time"" (C x T) schedule of 1 mg every 12 hr for 3 days. There were no significant differences between the two treatment groups in the rate of remission induction, the number of relapses, or the durations of remission. The mean (+/- 1 SD) cumulative methotrexate dose was 66 +/- 41 mg/sq m in the C x T group and 173 +/- 64 mg/sq m in the 12 mg/sq m/dose group (p less than 0.005). Neurologic toxicity occurred in one of the eight patients in the C x T group and in seven of ten patients in the 12 mg/sq m/dose group (p less than 0.05). These observations suggest that the C x T dosage schedule is less neurotoxic and equally effective in the treatment of central nervous system leukemia.",1978,"There were no significant differences between the two treatment groups in the rate of remission induction, the number of relapses, or the durations of remission.","['intraventricular chemotherapy of central nervous system neoplasms', '19 patients with meningeal leukemia']","['intrathecal methotrexate therapy', 'Concentration x time"" methotrexate via a subcutaneous reservoir', 'intraventricular methotrexate']","['Neurologic toxicity', 'Neurotoxicity', 'rate of remission induction, the number of relapses, or the durations of remission']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085136', 'cui_str': 'Tumors, Central Nervous System'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948840', 'cui_str': 'Leukemic meningitis'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1283116', 'cui_str': 'Subcutaneous reservoir'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",19.0,0.0348094,"There were no significant differences between the two treatment groups in the rate of remission induction, the number of relapses, or the durations of remission.","[{'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Bleyer', 'Affiliation': ''}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Poplack', 'Affiliation': ''}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Simon', 'Affiliation': ''}]",Blood,[]
1642,769864,Treatment of advanced non-Hodgkin's lymphomas with favorable histologies: preliminary results of a prospective trial.,"From July 1971 to August 1975, 63 previously untreated patients with stage IV non-Hodgkin's lymphomas with favorable histologies were prospectively randomized to three treatment programs: cyclophosphamide, vincristine, and prednisone alone (CVP); split course CVP and total lymphoid irradiation (CVP-TLI); or single alkylating agent (SA) therapy. More than 95% of all patients responded to therapy, and pathologically documented complete remissions were achieved in 78.3% of CV, 65% OF CVP-TLI, and 55% of SA patients (p greater greater than 0.2). The actuarial probability of obtaining a complete remission was the same (greater than 80%) for SA patients as it was for those receiving CV or CVP-TLI, but the time required to achieve a complete remission was more prolonged for SA patients (up to 40 mo). Only six (14.3%) complete responders have relapsed; the others have remained relapse-free for periods of 1-35 mo. There have been no statistically significant differences noted among the groups in terms of the probability of disease-free survival or survival, and 82.7% of all patients are alive at 30 mo (84.6% CVP, 73% CVP-TLI, and 90% sa). all three treatment programs have thus been highly effective in achieving excellent responses and prolonged disease-free survivals in patients with stage IV non-Hodgkins lymphomas with favorable histologies. Over the 4-yr period of study, single agent therapy has been associated with as good or better overall survival when compared to the more aggressive treatment programs (CVP and CVP-TLI).",1976,"There have been no statistically significant differences noted among the groups in terms of the probability of disease-free survival or survival, and 82.7% of all patients are alive at 30 mo (84.6% CVP, 73% CVP-TLI, and 90% sa).","[""From July 1971 to August 1975, 63 previously untreated patients with stage IV non-Hodgkin's lymphomas with favorable histologies"", ""advanced non-Hodgkin's lymphomas with favorable histologies"", 'patients with stage IV non-Hodgkins lymphomas with favorable histologies']","['cyclophosphamide, vincristine, and prednisone alone (CVP); split course CVP and total lymphoid irradiation (CVP-TLI); or single alkylating agent (SA) therapy']","['actuarial probability of obtaining a complete remission', 'probability of disease-free survival or survival', 'overall survival', 'complete remissions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0024230', 'cui_str': 'Lymphoid Irradiation'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",63.0,0.030236,"There have been no statistically significant differences noted among the groups in terms of the probability of disease-free survival or survival, and 82.7% of all patients are alive at 30 mo (84.6% CVP, 73% CVP-TLI, and 90% sa).","[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Portlock', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Rosenberg', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Glatstein', 'Affiliation': ''}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Kaplan', 'Affiliation': ''}]",Blood,[]
1643,577889,Combination intrathecal therapy for meningeal leukemia: two versus three drugs.,"The comparative effectiveness of intrathecal (IT) combination chemotherapy using two agents, methotrexate (MTX) and hydrocortisone (HDC), and three agents, MTX, HDC, and cytosine arabinoside (CA), in treating meningeal leukemia was determined in a randomized Southwest Oncology Group study. Following central nervous system (CNS) remission induction the same regimen was used for periodic maintenance until CNS relapse supervened. Complete CNS remission was achieved in 100% of 43 children given two-agent therapy and in 96% of 48 children given three-agent therapy. Length of CNS remission for two-agent therapy was 1-150+ wk, median 47.2 wk; for three-agent therapy, remissions were 1-190+ wk, median 64.6 wk. Differences in length of remission curves were not of statistical significance (p=0.71). Toxicity of combination IT chemotherapy in the two- and three-agent regimens was reduced compared to that of IT MTX alone for CNS remission induction and maintenance. The additive effects of the IT drug combinations have been less than expected. The cytocidal activity of these agents when administered simultaneously of sequentially is not fully understood. Further studies are clearly indicated to determine optimum doses, schedules, and sequences for the chemotherapeutic agents which can be given intrathecally in combination.",1977,Complete CNS remission was achieved in 100% of 43 children given two-agent therapy and in 96% of 48 children given three-agent therapy.,['meningeal leukemia'],"['combination IT chemotherapy', 'intrathecal (IT) combination chemotherapy', 'methotrexate (MTX) and hydrocortisone (HDC), and three agents, MTX, HDC, and cytosine arabinoside (CA', 'IT MTX']","['Toxicity', 'Length of CNS remission', 'Complete CNS remission', 'length of remission curves']","[{'cui': 'C0948840', 'cui_str': 'Leukemic meningitis'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0310547,Complete CNS remission was achieved in 100% of 43 children given two-agent therapy and in 96% of 48 children given three-agent therapy.,"[{'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Sullivan', 'Affiliation': ''}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Trueworthy', 'Affiliation': ''}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Vietti', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Humphrey', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Komp', 'Affiliation': ''}]",Blood,[]
1644,760861,Treatment of acute nonlymphocytic leukemia: use of anthracycline-cytosine arabinoside induction therapy and comparison of two maintenance regimens.,"Patients with acute nonlymphocytic leukemia were given remission induction therapy consisting of cytosine arabinoside and an anthracycline. Those patients who experienced complete remission received two courses of consolidation therapy and were randomized to receive maintenance therapy consisting of either daily chemotherapy with reinforcements every 3 mo or reinforcement therapy only every 6 wk. The overall complete remission rate was 66%, with 80% complete remission for previously untreated patients less than 60 yr of age who did not have a prior history of malignancy. Remission durations were the same for patients treated with both maintenance regimens. The major determinant for successful remission induction therapy was patient age, with older patients frequently succumbing to intercurrent infection. Documented leukemic cell resistance to the therapy employed was only rarely encountered. Once remission was achieved, age was no longer a determinant of patient survival, since duration of remission was independent of age. Remission durations were directly related to leukemic cell retention of cytosine arabinoside triphosphate. Hence therapy for acute nonlymphocytic leukemia can be divided into two separate areas: remission induction and remission maintenance.",1979,"Once remission was achieved, age was no longer a determinant of patient survival, since duration of remission was independent of age.","['Patients with acute nonlymphocytic leukemia', 'acute nonlymphocytic leukemia']","['anthracycline-cytosine arabinoside induction therapy', 'cytosine arabinoside and an anthracycline', 'maintenance therapy consisting of either daily chemotherapy with reinforcements every 3 mo or reinforcement therapy', 'consolidation therapy']","['patient survival, since duration of remission', 'overall complete remission rate', 'Remission durations', 'leukemic cell resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",,0.0171575,"Once remission was achieved, age was no longer a determinant of patient survival, since duration of remission was independent of age.","[{'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Preisler', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rustum', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bjornsson', 'Affiliation': ''}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Creaven', 'Affiliation': ''}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Higby', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gailani', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Naeher', 'Affiliation': ''}]",Blood,[]
1645,31791675,Comprehensive assessment of side effects associated with a single dose of ketamine in treatment-resistant depression.,"BACKGROUND


Concerns about ketamine for treating depression include abuse potential and the occurrence of psychotomimetic effects. This study sought to comprehensively assess side effects (SEs) associated with a single subanesthetic-dose intravenous ketamine infusion. A secondary aim was to examine the relationship between Clinician-Administered Dissociative States Scale (CADSS) scores and dissociative symptoms reported on a comprehensive, clinician-administered SE questionnaire.
METHODS


Data from 188 participants were pooled from four placebo-controlled, crossover ketamine trials and one open-label study (n = 163 with either treatment-resistant major depressive disorder or bipolar disorder and 25 healthy controls). SEs were actively solicited in a standardized fashion and monitored over the time-course of each study. Statistical analyses assessed the effect of drug (ketamine, placebo) on SEs and measured the relationship between CADSS total score and SEs contemporaneously endorsed during structured interviews.
RESULTS


Forty-four of 120 SEs occurred in at least 5% of participants over all trials. Thirty-three of these 44 SEs were significantly associated with active drug administration (versus placebo). The most common SE was feeling strange/weird/loopy. Most SEs peaked within an hour of ketamine administration and resolved completely by two hours post-infusion. No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed. A positive correlation was found between dissociative SEs and total CADSS score.
LIMITATIONS


The post-hoc nature of the analysis; the limited generalizability of a single subanesthetic-dose ketamine infusion; and the lack of formal measures to assess ketamine's cognitive, urological, or addictive potential.
CONCLUSIONS


No long-lasting significant SEs occurred over the approximately three-month follow-up period.",2020,No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed.,"['Data from 188 participants were pooled from four placebo-controlled, crossover ketamine trials and one open-label study (n\u202f=\u202f163 with either treatment-resistant major depressive disorder or bipolar disorder and 25 healthy controls']","['drug (ketamine, placebo', 'ketamine']","['side effects (SEs', 'dissociative SEs and total CADSS score', 'Clinician-Administered Dissociative States Scale (CADSS) scores and dissociative symptoms']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0851878', 'cui_str': 'Dissociative states'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",188.0,0.142965,No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed.,"[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: elia.acevedodiaz@nih.gov.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.028']
1646,272207,Intermittent combination chemotherapy with adriamycin for childhood acute lymphoblastic leukemia: clinical results.,"One hundred thirty-seven children with previously untreated acute lymphoblastic leukemia were entered into a new program that included intermittent combination chemotherapy featuring Adriamycin. Remission induction was initially randomized to vincristine and prednisone with or without an anthracycline. All children received asparaginase consolidation and central nervous system prophylaxis with cranial irradiation and intrathecal methotrexate. There were no primary failures of CNS prophylaxis. Complications were primarily infectious. Clinical evidence of cardiotoxicity and leukoencephalopathy were not observed. The time to enter complete remission and the presence of an anterior mediastinal mass at diagnosis were found to be statistically significant adverse prognostic factors, whereas presenting age and white blood count were not. With a median follow-up of 26 mo, and using life plot analysis, 65% of the children have remianed in continuous complete remission.",1978,"The time to enter complete remission and the presence of an anterior mediastinal mass at diagnosis were found to be statistically significant adverse prognostic factors, whereas presenting age and white blood count were not.","['One hundred thirty-seven children with previously untreated acute lymphoblastic leukemia', 'childhood acute lymphoblastic leukemia']","['vincristine and prednisone with or without an anthracycline', 'new program that included intermittent combination chemotherapy featuring Adriamycin', 'asparaginase consolidation and central nervous system prophylaxis with cranial irradiation and intrathecal methotrexate', 'Intermittent combination chemotherapy with adriamycin']",['CNS prophylaxis'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",137.0,0.0302041,"The time to enter complete remission and the presence of an anterior mediastinal mass at diagnosis were found to be statistically significant adverse prognostic factors, whereas presenting age and white blood count were not.","[{'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Sallan', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Cammita', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Cassady', 'Affiliation': ''}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Frei', 'Affiliation': ''}]",Blood,[]
1647,31087164,Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses.,"PURPOSE


The purpose of this study is to establish a new method to reduce the radiation dose during puncture and cannulation in percutaneous endoscopic lumbar discectomy (PELD).
METHODS


Sixty patients with lumbar disk herniation undergoing PELD were prospectively enrolled and randomly divided into an ultrasound (US) guidance group and an X-ray guidance group. The puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose were recorded in both groups. The factors influencing the operation were analyzed. The clinical effect of PELD was evaluated using the straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI). The researchers who collected and analyzed the data were blinded to the group assignments.
RESULTS


The puncture, cannulation and operation times in the US group were comparable to those in the X-ray group. The patients in the US group received 2.13 ± 0.35 fluoroscopy shots and a radiation dose of 5.34 ± 0.63 (mSV), which were significantly lower than the values in the X-ray group (7.57 shots ± 2.99 shots and 18.25 mSV ± 10.52 mSV) (P < 0.001). In the US group, the puncture time was significantly longer at the L5-S1 level, in patients with a BMI greater than 28 kg/m 2  and in patients with a high iliac crest. The US and X-ray groups had comparable VAS and ODI scores 1 h and 3 months after PELD, and the VAS scores were significantly lower after PELD (all P < 0.001). No complications were observed in either group.
CONCLUSIONS


US guidance is a new method that reduces the radiation dose required during puncture and cannulation in PELD. These slides can be retrieved under Electronic Supplementary Material.",2019,The US and X-ray groups had comparable VAS and ODI scores,['Sixty patients with lumbar disk herniation undergoing PELD'],"['ultrasound (US) guidance group and an X-ray guidance group', 'percutaneous endoscopic lumbar discectomy (PELD', 'Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy']","['VAS and ODI scores', 'puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose', 'VAS scores', 'puncture time', 'puncture, cannulation and operation times', 'straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",60.0,0.0167607,The US and X-ray groups had comparable VAS and ODI scores,"[{'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Pain, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shoupeng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, General Hospital of Chinese PLA, No. 28, Fuxing Road, Haidian District, Beijing, 100853, China. harryhp@vip.sina.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05980-9']
1648,476300,Alloimmunization following prophylactic granulocyte transfusion.,"Nineteen noninfected adults receiving initial induction chemotherapy for acute nonlymphocytic leukemia (ANLL) were randomized to receive either prophylactic granulocyte transfusion or platelet transfusion alone on an alternate-day schedule. An average of 11 granulocyte transfusions (range 3--19) were administered/patient with a mean dose of 11.5 X 10(9) granulocytes/transfusion. The groups were identical with respect to age, sex, number of days on study, granulocytopenic days, percent of days receiving systemic antibiotics, febrile days, complete remission rate, and incidence of minor infection. Significant transfusion reactions were much increased in the granulocyte transfusion group (7/10 versus 1/9 in controls) and were associated with the development of lymphocytotoxic antibodies (7/10 versus 4/9 controls), refractoriness to platelet transfusion, repeated fevers, and a pulmonary infiltrate in one patient. Alloimmunization to granulocytes occurred as early as the second week in some  patients complicating platelet support during induction and maintenance. No severe infections occurred in the granulocyte transfusion group while three fungal infections occurred in the controls. The high rate of alloimmunization suggests that histocompatibility considerations indicate that prophylactic granulocyte transfusion should not be routine therapy and should be studied only in investigational settings.",1979,"Significant transfusion reactions were much increased in the granulocyte transfusion group (7/10 versus 1/9 in controls) and were associated with the development of lymphocytotoxic antibodies (7/10 versus 4/9 controls), refractoriness to platelet transfusion, repeated fevers, and a pulmonary infiltrate in one patient.",['Nineteen noninfected adults receiving initial induction chemotherapy for acute nonlymphocytic leukemia (ANLL'],"['prophylactic granulocyte transfusion or platelet transfusion alone', 'granulocyte transfusion', 'prophylactic granulocyte transfusion']","['Alloimmunization', 'systemic antibiotics, febrile days, complete remission rate, and incidence of minor infection', 'Significant transfusion reactions', 'development of lymphocytotoxic antibodies', 'fungal infections', 'severe infections', 'Alloimmunization to granulocytes']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}]","[{'cui': 'C0948201', 'cui_str': 'Alloimmunisation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0274435', 'cui_str': 'Blood Transfusion-Associated Adverse Reactions'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0024284', 'cui_str': 'Lymphocytotoxic Antibodies'}, {'cui': 'C0026946', 'cui_str': 'Fungal Infections'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}]",,0.0130421,"Significant transfusion reactions were much increased in the granulocyte transfusion group (7/10 versus 1/9 in controls) and were associated with the development of lymphocytotoxic antibodies (7/10 versus 4/9 controls), refractoriness to platelet transfusion, repeated fevers, and a pulmonary infiltrate in one patient.","[{'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Schiffer', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aisner', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Daly', 'Affiliation': ''}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Schimpff', 'Affiliation': ''}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Wiernik', 'Affiliation': ''}]",Blood,[]
1649,444661,Improved survival of increased-risk myeloma patients on combined triple-alkylating-agent therapy: a study of the CALGB.,"Two hundred fifty-two previously untreated evaluable patients with multiple myeloma were entered into a study testing a regimen of three intravenous alkylating agents, melphalan, cyclophosphamide, and carmustine (BCNU), given in combination (BCMP) against a regimen employing oral melphalan (MP). Both regimens included a tapering course of prednisone. Objective responses based on the Myeloma Task Force criteria were significantly more frequent in the group receiving BCMP. Survival for the entire group of BCMP-treated patients was not significantly better than that for MP-treated patients (p = 0.62). However, when the survival of the poor-risk (high tumor cell load) group of patients treated with BCMP was compared with the survival of the poor-risk (high tumor cell load) group of patients treated with MP, an improvement in survival attributable to BCMP therapy was seen (p = 0.049 and 0.02, respectively). In the good-risk (low and intermediate tumor cell load) group, BCMP treatment resulted in a trend toward poorer survival, but this did not achieve statistical significance (p = 0.080 and 0.23, respectively). These results indicate that optimal therapy in myeloma may be dependent on the extent of disease at the time of first treatment. Additional studies to explore the effects of treatment intensity and duration are needed in order to design improved myeloma treatment based on the patient's extent of disease.",1979,Survival for the entire group of BCMP-treated patients was not significantly better than that for MP-treated patients (p = 0.62).,['Two hundred fifty-two previously untreated evaluable patients with multiple myeloma'],"['combined triple-alkylating-agent therapy', 'intravenous alkylating agents, melphalan, cyclophosphamide, and carmustine (BCNU), given in combination (BCMP) against a regimen employing oral melphalan (MP', 'BCMP', 'prednisone']","['survival of the poor-risk', 'Survival', 'survival', 'poorer survival', 'Improved survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0635089', 'cui_str': 'BCMP'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",252.0,0.02092,Survival for the entire group of BCMP-treated patients was not significantly better than that for MP-treated patients (p = 0.62).,"[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Harley', 'Affiliation': ''}, {'ForeName': 'T F', 'Initials': 'TF', 'LastName': 'Pajak', 'Affiliation': ''}, {'ForeName': 'O R', 'Initials': 'OR', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kochwa', 'Affiliation': ''}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Cooper', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cuttner', 'Affiliation': ''}]",Blood,[]
1650,356916,Primary systemic amyloidosis: comparison of melphalan and prednisone versus placebo.,"Satisfactory treatment for primary amyloidosis does not exist. Because the amyloid fibrils consist of a portion of a monoclonal light chain, it appears reasonable to treat amyloidosis with alkylating agents that are effective against the plasma cells that synthesize monoclonal light chains. Fifty-five patients with primary systemic amyloidosis were randomized (double blind) to melphalan-prednisone or placebo. In comparison with the placebo group, patients given melphalan-prednisone were able to continue on treatment for a longer time and to receive larger doses before the code was broken. Among this group, the nephrotic syndrome disappeared in two patients and urinary excretion of protein was reduced by more than 50% in eight others. Of 13 patients who received melphalan-prednisone for more than 12 mo, 6 improved, 3 were stable, and 4 had progression of disease. Survival did not differ significantly between the groups.",1978,Survival did not differ significantly between the groups.,['Fifty-five patients with primary systemic amyloidosis'],"['placebo', 'melphalan-prednisone', 'melphalan and prednisone versus placebo', 'melphalan-prednisone or placebo']","['Survival', 'nephrotic syndrome', 'urinary excretion of protein', 'progression of disease']","[{'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0268381', 'cui_str': 'AL Amyloidosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",55.0,0.144307,Survival did not differ significantly between the groups.,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Kyle', 'Affiliation': ''}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Greipp', 'Affiliation': ''}]",Blood,[]
1651,32048028,The impact of platelet-rich fibrin (PRF) on olfactory function and pain after septoplasty operations.,"BACKGROUND


We aimed to investigate the effect of platelet-rich fibrin (PRF) on olfactory function and pain score in patients who underwent septoplasty.
METHODS


This prospective randomized observational study was performed between 2018 January and 2019 April with 148 patients who had septoplasty operation. Patients were divided two groups and 74 patients were placed in group 1 to which PRF was applied after the completion of septoplasty whereas 67 patients were put in group 2 which did not undergo PRF. Sniffin' Sticks test was applied to all patients at pre-op, post-op 1-week, 6-week, and 6-month. Pain scores of patients were measured with visual analogue scale at 1 and 3 week.
RESULTS


The distribution of patients according to pre-op olfactory function (normo-hypo-anosmia), there was no significant differences statistically (p > 0.05). When we compared the 1-week post-op results of Sniffin' Sticks test of patients, we found differences between the groups (p < 0.05). It was observed in the early postoperative period that according to the Sniffin' Sticks test scores, the results of the PRF group were better than those of the non-PRF group. At 6-week and 6-month, between the groups; there was no differences in terms of olfactory function. When we looked at the pain score of patients at 1 and 3 week after septoplasty; significant differences were obtained between groups.
CONCLUSION


The application of PRF to the mucosal surface after the completion of septoplasty, has positive effect on olfactory function and pain especially in the early postoperative period. During the healing process, it was observed that prf maintained better odor functions. It is a minimally invasive technique with low risks and satisfactory clinical results.",2020,"When we looked at the pain score of patients at 1 and 3 week after septoplasty; significant differences were obtained between groups.
","['patients who underwent septoplasty', '2018 January and 2019 April with 148 patients who had septoplasty operation']",['platelet-rich fibrin (PRF'],"['visual analogue scale', 'olfactory function', 'olfactory function and pain', 'pain score', 'Pain scores', 'olfactory function and pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439826', 'cui_str': 'Olfactory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0173434,"When we looked at the pain score of patients at 1 and 3 week after septoplasty; significant differences were obtained between groups.
","[{'ForeName': 'Belgin', 'Initials': 'B', 'LastName': 'Tutar', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey. belgintutar@gmail.com.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Ekincioglu', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Semih', 'Initials': 'S', 'LastName': 'Karaketir', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Güler', 'Initials': 'G', 'LastName': 'Berkiten', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Saltürk', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Melis Ece', 'Initials': 'ME', 'LastName': 'Arkan', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ayşe Enise', 'Initials': 'AE', 'LastName': 'Göker', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Uyar', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Okmeydani Training and Research Hospital, Istanbul, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-05839-6']
1652,32112496,"Efficacy of cognitive-behavioral group therapy in patients at risk for serious mental illness presenting with subthreshold bipolar symptoms: Results from a prespecified interim analysis of a multicenter, randomized, controlled study.","OBJECTIVE


Most patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode. Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI) require effective and safe treatment. Cognitive-behavioral psychotherapy (CBT) has shown promising results in early stages of BD and in patients at high risk for psychosis. We aimed to investigate whether group CBT can improve symptoms and functional deficits in young patients at risk for SMI presenting with subthreshold bipolar symptoms.
METHOD


In a multicenter, randomized, controlled trial, patients at clinical risk for SMI presenting with subthreshold bipolar symptoms aged 15-30 years were randomized to 14 weeks of at-risk for BD-specific group CBT or unstructured group meetings. Primary efficacy endpoints were differences in affective symptomatology and psychosocial functioning at 14 weeks. At-risk status was defined as a combination of subthreshold bipolar symptomatology, reduction of psychosocial functioning and a family history for (schizo)affective disorders. A prespecified interim analysis was conducted at 75% of the targeted sample.
RESULTS


Of 128 screened participants, 75 were randomized to group CBT (n = 38, completers = 65.8%) vs unstructured group meetings (n = 37, completers = 78.4%). Affective symptomatology and psychosocial functioning improved significantly at week 14 (P < .001) and during 6 months (P < .001) in both groups, without significant between-group differences. Findings are limited by the interim character of the analysis, the use of not fully validated early detection interviews, a newly adapted intervention manual, and the substantial drop-outs.
CONCLUSIONS


Results suggest that young patients at-risk for SMI presenting with subthreshold bipolar symptoms benefit from early group sessions. The degree of specificity and psychotherapeutic interaction needed requires clarification.",2020,"Affective symptomatology and psychosocial functioning improved significantly at week 14 (p<0.001) and during 6-months (p<0.001) in both groups, without significant between-group differences.","['Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI', 'patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode', '128 screened participants', 'young patients at risk for SMI presenting with subthreshold bipolar symptoms', 'patients at clinical risk for SMI presenting with subthreshold bipolar symptoms aged 15-30 years', 'patients at risk for serious mental illness presenting with subthreshold bipolar symptoms']","['cognitive-behavioral group therapy', 'CBT', 'Cognitive-behavioral psychotherapy (CBT']","['symptoms and functional deficits', 'Affective symptomatology and psychosocial functioning', 'affective symptomatology and psychosocial functioning']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C3494358', 'cui_str': 'Prodromal Syndromes'}, {'cui': 'C0349208', 'cui_str': 'Manic episode'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",128.0,0.0582601,"Affective symptomatology and psychosocial functioning improved significantly at week 14 (p<0.001) and during 6-months (p<0.001) in both groups, without significant between-group differences.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Leopold', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Vivantes Klinikum Am Urban, Berlin, Germany.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Psychiatry and Molecular Medicine Hofstra Northwell School of Medicine, Hempstead, NY, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, LWL-University Hospital Hamm, Ruhr-University, Bochum, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, LWL- University Hospital Bochum, Ruhr-University, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas HSC at Houston, Houston, TX, USA.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kittel-Schneider', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stamm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Rottmann-Wolf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Mathiebe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Eva L', 'Initials': 'EL', 'LastName': 'Kellmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ritter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Seza', 'Initials': 'S', 'LastName': 'Krüger-Özgürdal', 'Affiliation': 'Department of Psychiatry and Psychotherapy, LWL- University Hospital Bochum, Ruhr-University, Bochum, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Karow', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lene-Marie', 'Initials': 'LM', 'LastName': 'Sondergeld', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Roessner', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Cathrin', 'Initials': 'C', 'LastName': 'Sauer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pfennig', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}]",Bipolar disorders,['10.1111/bdi.12894']
1653,31055663,New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data.,"PURPOSE


Few retrospective studies have addressed Modic changes (MC) following lumbar spine surgery, though it is usually assumed that MC increase in grade and incidence. To test this conventional wisdom, we investigated the natural course of MC following primary lumbar limited discectomy with two-year follow-up. In addition, a possible clinical relevance to those changes was assessed.
METHODS


The data of the control group (278 subjects) of a prospective randomized, controlled trial (RCT) were evaluated retrospectively.
RESULTS


We did not observe a simple increase in MC with regard to grade. There is variable activity observed in Type 2 (at 12 months) and in Type 1 (at 24 months). Conversion from one grade to another may occur and may be upward or downward. The incidence of MC increased slightly over time, as after surgery a decreasing percentage of the study group remained without MC over two years (1 year: 34% (85/250); 2 years: 30% (72/237)). Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes. Lastly, we found that neither the different MC types nor their changes were correlated with clinical parameters (VAS back, VAS leg, ODI score) preoperatively or during follow-up.
CONCLUSION


The pattern of Modic changes following lumbar limited discectomy is complex, not simply increasing. There is variable activity in MC Types 1 and 2 at the different time points of follow-up, and conversion from a higher grader to a lower one or vice versa is possible. These slides can be retrieved under Electronic Supplementary Material.",2019,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.",[],[],"['incidence of MC', 'clinical parameters (VAS back, VAS leg, ODI score', 'Radiological parameters (rotation, translation, and spondylolisthesis']",[],[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0038016', 'cui_str': 'Spondylisthesis'}]",,0.0423849,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany. richard.bostelmann@med.uni-duesseldorf.de.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Petridis', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Katinka', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Mathematical Institute, Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Barth', 'Affiliation': 'Department of Neurosurgery, Klinikum Frankfurt Höchst, Frankfurt, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05988-1']
1654,31993664,Compliance in Controlled E-cigarette Studies.,"INTRODUCTION


E-cigarette studies have found that the use of a variety of flavors and customizable devices results in greater use frequency and user satisfaction. However, standardized research e-cigarettes are being developed as closed systems with limited flavor options, potentially limiting user satisfaction. In this study, we explore protocol compliance in an e-cigarette study using a standardized, assigned device with puff time and duration tracking (controlled e-cigarette) and potential limitations that controlled devices and e-liquids can introduce.
METHODS


In a crossover study, 49 young adult e-cigarette users were recruited using convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols. E-cigarette use frequency (number of puffs per day, collected from the device) and serum cotinine levels were obtained at each of three study visits over 3 weeks. The correlation of cotinine and e-cigarette use over the preceding week was calculated at each study visit.
RESULTS


Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (R2 = 0.53 and p ≤ .01 in week 1, R2 < 0.5 and p > .05 for remaining weeks).
CONCLUSIONS


There is an emerging need for controlled e-cigarette exposures studies, but low compliance in the use of assigned devices and e-liquids may be a limitation that needs to be mitigated in future studies.
IMPLICATIONS


This study is the first to analyze compliance with instructions to use a standardized e-cigarette device with puff time and duration tracking (controlled e-cigarette) across all subjects and an assigned e-liquid flavor over a 3-week period. We find that protocol compliance, as measured by correlations between e-cigarette use measures and cotinine levels, was only achieved in the first week of the study and declined thereafter. These findings indicate that the assignment of a study device and instruction to only use the study device with assigned e-liquid flavor may not be sufficient to ensure participant compliance with the study protocol. We suggest that additional measures, including behavioral and biological markers, are needed to ensure sole use of the study e-cigarette and e-liquid and to be able to interpret results from controlled e-cigarette studies.",2021,"RESULTS


Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (",['forty-nine young adult e-cigarette users'],['convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols'],"['serum cotinine levels', 'serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",49.0,0.0258947,"RESULTS


Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (","[{'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Rebuli', 'Affiliation': 'Curriculum in Toxicology and Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urman', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Sandrah P', 'Initials': 'SP', 'LastName': 'Eckel', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'McConnell', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Jaspers', 'Affiliation': 'Curriculum in Toxicology and Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa017']
1655,336116,Comparison of daily versus intermittent chlorambucil and prednisone therapy in the treatment of patients with chronic lymphocytic leukemia.,"Ninety-six patients with stage III and stage IV chronic lymphocytic leukemia (CLL) were randomized into one of three treatment schedules. Prednisone was common to all three schedules and was given daily in an initial dosage of 0.8 mg/kg for the first 14 days, with successive halving of the daily dose on days 15 and 29 for a total 6-wk course. Prednisone was then given once a month at 0.8 mg/kg once a day for each of 7 consecutive days. Schedule I was prednisone plus chlorambucil (CLB) given as a once-a-month dose of 0.4-0.8 mg/kg; schedule II was both drugs, but the CLB was given as a daily dose of 0.08 mg/kg; schedule III was prednisone alone. Complete and partial remission (CR + PR) was 47% for schedule I, 38% for schedule II, and 11% for schedule III. Patients who responded (CR + PR) in each of the treatment schedules survived longer than the nonresponders. Complete remission was obtained in both CLB treatment schedules, but not with the prednisone alone regimen. Although overall survival was best in the intermittent CLB arm, there was no significant difference in survival time between the three treatment schedules. Toxicity was minimal in all three regimens. Augmentation of the intermittent monthly CLB, even to 1.5 and 2.0 mg/kg, was tolerated without undue marrow toxicity. About 22% of these patients either had diabetes mellitus at the time of entry on the study or manifested hyperglycemia during the course of treatment and observation.",1977,"Although overall survival was best in the intermittent CLB arm, there was no significant difference in survival time between the three treatment schedules.","['patients with chronic lymphocytic leukemia', 'Ninety-six patients with stage III and stage IV chronic lymphocytic leukemia (CLL']","['prednisone plus chlorambucil (CLB', 'Prednisone', 'intermittent chlorambucil and prednisone therapy', 'prednisone']","['tolerated without undue marrow toxicity', 'manifested hyperglycemia', 'diabetes mellitus', 'overall survival', 'Complete and partial remission (CR + PR', 'Toxicity', 'Complete remission', 'survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",96.0,0.0391492,"Although overall survival was best in the intermittent CLB arm, there was no significant difference in survival time between the three treatment schedules.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sawitsky', 'Affiliation': ''}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Glidewell', 'Affiliation': ''}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Silver', 'Affiliation': ''}]",Blood,[]
1656,11859,Aplastic anemia treated by allogeneic bone marrow transplantation: a report on 49 new cases from Seattle.,"Forty-nine patients with severe aplastic anemia, 33 due to unknown cause, 11 drug or chemical related, 2 associated with hepatitis, 1 with paroxysmal nocturnal hemoglobinuria, and 2 possibly associated with Fanconi syndrome did not show recovery after 0.5-96 (median 2) mo of conventional therapy. Twenty-two were infected and 21 were refractory to random platelet transfusions at the time of admission. All were given marrow grafts from HLA-identical siblings. Forty-five were conditioned for grafting by cyclophosphamide (CY), 50 mg/kg on each of 4 successive days, and four by 1000 rad total body irradiation. All were given intermittent methotrexate therapy within the first 100 days of grafting to modify graft-versus-host disease (GVHD). Three patients died from infection too early to evaluate (days 1-8). Forty-six had marrow engraftment. Of these, 20 are surviving with good peripheral blood counts between 186 and 999 days, and 18 have returned to normal activities. Chronic GCHD is a problem in five. Twelve patients died of infection following rejection of the marrow graft. Twelve patients died with bacterial or fungal infections or interstitial pneumonia and active GVHD or soon following resolution of GVHD. Two patients died with marrow engraftment and no GVHD, one with an interstitial, and the other with a bacterial pneumonia. Thirty-six patients who had received random donor blood transfusions were randomly assigned to receive either CY or procarbazine-antithymocyte globulin-CY as conditioning regimens to test whether the incidence of graft rejection could be decreased. There was no difference in the incidence of graft rejection between the two regimens. In 13 patients with rejection, second transplants were attempted either with the original marrow donor (9 patients) or another HLA-identical sibling (4 patients). Three of these transplants were not evaluable, seven were unsuccessful and three were successful with only one of the three surviving for more than 468 days. In conclusion, the long-term survival of 41% of the patients in the present study is similar to that achieved in our first 24 patients, and confirms the importance of marrow transplantation for the treatment of severe aplastic anemia. Marrow graft rejection, GVHD, and infections continue to be the major causes of failure.",1976,There was no difference in the incidence of graft rejection between the two regimens.,"['Forty-nine patients with severe aplastic anemia, 33 due to unknown cause, 11 drug or chemical related, 2 associated with hepatitis, 1 with paroxysmal nocturnal hemoglobinuria, and 2 possibly associated with Fanconi syndrome did not show recovery after 0.5-96 (median 2) mo of conventional therapy', 'Twelve patients died with bacterial or fungal infections or interstitial pneumonia and active GVHD or soon following resolution of GVHD', 'Twelve patients died of infection following rejection of the marrow graft', '13 patients with rejection, second transplants', 'Thirty-six patients who had received random donor blood transfusions']","['CY or procarbazine-antithymocyte globulin-CY', 'cyclophosphamide (CY', 'allogeneic bone marrow transplantation']","['marrow engraftment', 'incidence of graft rejection', 'Aplastic anemia', 'peripheral blood counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0015624', 'cui_str': 'Proximal Renal Tubular Dysfunction'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C0026946', 'cui_str': 'Fungal Infections'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]","[{'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0003442', 'cui_str': 'Lymphocyte Immune Globulin, Anti-Thymocyte Globulin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0149615', 'cui_str': 'Allogeneic bone marrow transplantation (procedure)'}]","[{'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0002874', 'cui_str': 'Aplastic Anemia'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",13.0,0.0291781,There was no difference in the incidence of graft rejection between the two regimens.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Storb', 'Affiliation': ''}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Weiden', 'Affiliation': ''}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Clift', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fefer', 'Affiliation': ''}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Fernando', 'Affiliation': ''}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Giblett', 'Affiliation': ''}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Goodell', 'Affiliation': ''}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Lerner', 'Affiliation': ''}, {'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Neiman', 'Affiliation': ''}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': ''}]",Blood,[]
1657,31915170,Rationale and design of the Web-basEd soCial media tecHnology to improvement in Adherence to dual anTiplatelet Therapy following Drug-Eluting Stent Implantation (WECHAT): protocol for a randomised controlled study.,"BACKGROUND


Dual antiplatelet therapy (DAPT) is frequently discontinued after drug-eluting stent (DES) implantation, which could increase the risk of major adverse cardiovascular events (MACEs). Few studies have attempted to improve DAPT adherence through web-based social media.
OBJECTIVE


To explore the effect of social media on DAPT adherence following DES implantation.
METHODS/DESIGN


The WeChat trial is a multicentre, single-blind, randomised study (1:1). It will recruit 760 patients with DES who require 12 months of DAPT. The control group will only receive usual care and general educational messages on medical knowledge. The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages. The primary endpoint will be the discontinuation rate which is defined as the cessation of any dual antiplatelet drug owing to the participants' discretion within 1 year of DES implantation. The secondary endpoints will include medication adherence and MACEs. Both groups will receive messages or reminders four times a week with follow-ups over 12 months.
ETHICS AND DISSEMINATION


Ethical approval was granted by Ethics Committee of Guangdong Provincial People's Hospital (GDREC2018327H). Results will be disseminated via peer-reviewed publications and presentations at international conferences.
TRIAL REGISTRATION NUMBER


NCT03732066.",2020,"The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages.",['760 patients with DES who require 12 months of DAPT'],"['personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages', 'social media', 'usual care and general educational messages on medical knowledge', 'antiplatelet therapy (DAPT']","['DAPT adherence', 'medication adherence and MACEs', ""discontinuation rate which is defined as the cessation of any dual antiplatelet drug owing to the participants' discretion within 1\u2009year of DES implantation""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",760.0,0.11816,"The intervention group will receive a personalised intervention, including interactive responses and medication and follow-up reminders beyond the general educational messages.","[{'ForeName': 'Guo-Li', 'Initials': 'GL', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yibo', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou, China.'}, {'ForeName': 'Lihao', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Shi-Qun', 'Initials': 'SQ', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Maoming General Hospital, Guangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': ""Department of Cardiology, Dongguan People's Hospital, Dongguan, China.""}, {'ForeName': 'Yunzhao', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, First People's Hospital, Shunde, China.""}, {'ForeName': 'Guoqin', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Guangzhou Panyu Central Hospital, Guangzhou, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial People's Hospital affiliated with South China University of Technology, Guangzhou, China liuyong2099@126.com.""}]",BMJ open,['10.1136/bmjopen-2019-033017']
1658,31915173,"Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS).","INTRODUCTION


Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources.
METHOD AND ANALYSIS


In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of -4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay.
ETHICS AND DISSEMINATION


The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.
TRIAL REGISTRATION NUMBER


NCT03690128.",2020,Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient.,"['150 000 unique patients', 'patients with clinical deterioration']","['NEWS in combination with the Capital Region of Denmark NEWS Override System', 'TTSs', 'Track and trigger systems (TTSs']","['average number of times per day a patient is NEWS', 'length of stay', 'cause mortality']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}]","[{'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.070485,Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient.,"[{'ForeName': 'Pernille B', 'Initials': 'PB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark pernille.brok.nielsen@regionh.dk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Caroline Sophie', 'Initials': 'CS', 'LastName': 'Langkjaer', 'Affiliation': 'Department of Emergency Medicine, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Kodal', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Niels Egholm', 'Initials': 'NE', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'John Asger', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Department of Day Surgery, Amager and Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael Dan', 'Initials': 'MD', 'LastName': 'Arvig', 'Affiliation': 'Department of Emergency Medicine, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christian Sahlholt', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital, Hillerod, Denmark.'}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Hølge-Hazelton', 'Affiliation': 'Research Support Unit, Zealand University Hospital Roskilde, Roskilde, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Bunkenborg', 'Affiliation': 'Department of Anesthesiology, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lippert', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Herlev, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars Simon', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper Karmark', 'Initials': 'KK', 'LastName': 'Iversen', 'Affiliation': 'Department of Emergency Medicine, Herlev-Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033676']
1659,32144172,'I can do this': a qualitative exploration of acceptability and experiences of a physical activity behaviour change intervention in people with multiple sclerosis in the UK.,"OBJECTIVES


The purpose of this study was to explore the experiences of people with multiple sclerosis (MS) who participated in iStep-MS, a feasibility randomised controlled trial of a behaviour change intervention that aimed to increase physical activity and reduce sedentary behaviour.
DESIGN


A qualitative approach was undertaken embedded in the feasibility randomised controlled trial. One-to-one semi-structured interviews were conducted and analysed using Framework analysis.
SETTING


Participants were recruited from a single MS therapy centre in the southeast of England, UK.
PARTICIPANTS


Sixty people with MS were randomly allocated in a 1:1 ratio to the intervention or usual care. Following a purposive sampling strategy, 15 participants from the intervention arm undertook 1:1 semi-structured interviews.
INTERVENTIONS


The iStep-MS intervention consisted of four therapist-led sessions over 12 weeks, supported by a handbook and pedometer.
RESULTS


Three themes were identified from the data.  ""I can do this"": developing competence in physical activity  highlights the enhanced physical activity confidence gained through goal setting and accomplishment. "" I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship. Finally, "" What can I do?"": empowered enactment  describes the transition from the supported iStep-MS intervention to intrinsically motivated physical activity enactment.
CONCLUSIONS


Overall, this study supports the acceptability of the iStep-MS intervention and identified key areas that supported participants to be physically active.
TRIAL REGISTRATION NUMBER


ISRCTN15343862.",2020,"I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship.","['Sixty people with MS', 'Participants were recruited from a single MS therapy centre in the southeast of England, UK', 'people with multiple sclerosis (MS) who participated in iStep-MS', 'people with multiple sclerosis in the UK']","['behaviour change intervention', 'physical activity behaviour change intervention', 'iStep-MS intervention']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],60.0,0.109974,"I felt valued"": the nurturing culture  provides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fortune', 'Affiliation': 'University of Dublin Trinity College, Dublin, Ireland fortunej@tcd.ie.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stennett', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'MS Therapy Centre, Norwich, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'de Souza', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdul', 'Affiliation': 'The Berkshire MS Therapy Centre, Reading, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Brewin', 'Affiliation': '10 Minute CBT, London, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'David', 'Affiliation': '10 Minute CBT, London, UK.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': 'Health Economics Research Group, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Victor', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ryan', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, Uxbridge, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029831']
1660,31187344,Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial.,"BACKGROUND


Unhealthy alcohol use has adverse effects on HIV treatment. Screening, brief intervention, and referral to treatment (SBIRT) has some evidence of efficacy but may not be sufficient for those with low motivation or comorbid substance use.
OBJECTIVE


To examine the effectiveness of motivational interviewing (MI) and emailed feedback (EF) among primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT.
DESIGN


Randomized clinical trial.
PARTICIPANTS


Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use.
INTERVENTION


Participants were randomized to either three sessions of MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone. MI and EF participants who reported unhealthy alcohol use at 6 months were offered additional MI and EF treatment, respectively.
MAIN MEASURES


Participant-reported unhealthy alcohol use (defined as ≥ 4/≥ 5 drinks per day for women/men), alcohol problems at 12 months, based on blinded telephone interviews. Secondary outcomes included drug use and antiretroviral (ART) adherence.
KEY RESULTS


At 12 months, there were no overall group differences, but in all three arms, there were declines in unhealthy alcohol use and alcohol-related problems (p < 0.001). Participants reporting low motivation to reduce drinking at baseline were less likely to report unhealthy alcohol use if they received MI vs. EF and UC (p = 0.013). At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012). There were no differences in ART adherence between groups.
CONCLUSIONS


In a randomized trial of HIV-positive patients using two behavioral interventions compared with SBIRT alone, participants in all three conditions reduced unhealthy alcohol use. MI may provide added benefit for patients with low motivation or who report illegal drug use/misuse of prescription drugs.
TRIAL REGISTRATION


NCT01671501 ( ClinicalTrials.gov ).",2019,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","['Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use', 'HIV-positive patients using two', 'primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT', 'patients with low motivation or who report illegal drug use/misuse of prescription drugs', 'Primary Care Patients with HIV']","['MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone', 'motivational interviewing (MI) and emailed feedback (EF', 'behavioral interventions', 'SBIRT alone']","['illegal drug use/misuse of prescription drugs', 'ART adherence', 'unhealthy alcohol use and alcohol-related problems', 'drug use and antiretroviral (ART) adherence']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]",614.0,0.193652,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, 2450 48th Street, Suite 2600, Sacramento, CA, 95817, USA.'}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Kaiser Permanente San Francisco Medical Center, 2238 Geary Blvd, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Lam', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Weisner', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 East Jefferson, Rockville, MD, 20852, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'AIDS Research Institute, University of California, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05065-9']
1661,31915160,Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol.,"INTRODUCTION


Fracture healing can fail in up to 10% of cases despite appropriate treatment. While lithium has been the standard treatment for bipolar disorder, it may also have a significant impact to increase bone healing in patients with long bone fractures. To translate this knowledge into clinical practice, a randomised clinical trial (RCT) is proposed.
METHODS AND ANALYSIS


A multicentre double blind, placebo-controlled RCT is proposed to evaluate the efficacy of lithium to increase the rate and predictability of long bone fracture healing in healthy adults compared to lactose placebo treatment. 160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible. Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury. The primary outcome measure will be radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score. Secondary outcome measures will include functional assessment and pain scoring.
ETHICS AND DISSEMINATION


Participant confidentiality will be maintained with publication of results. Research Ethics Board Approval: Sunnybrook Research Institute (REB # 356-2016). Health Canada Approval (HC6-24-C201560). Results of the main trial and secondary endpoints will be submitted for publication in a peer-reviewed journal and presented at conferences.
TRIAL REGISTRATION NUMBER


NCT02999022.",2020,Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury.,"['160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible', 'healthy adults', 'patients with long bone fractures']","['lactose placebo', 'placebo-controlled RCT', 'lithium', 'placebo (lactose) or treatment (300\u2009mg lithium carbonate', 'Lithium']","['functional assessment and pain scoring', 'bone healing', 'rate and predictability of long bone fracture healing', 'radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0016068', 'cui_str': 'Fibula'}, {'cui': 'C0020164', 'cui_str': 'Humerus'}, {'cui': 'C0008913', 'cui_str': 'Clavicle'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}]","[{'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}]","[{'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0222647', 'cui_str': 'Structure of long bone'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0376154', 'cui_str': 'Callosities'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",160.0,0.522837,Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury.,"[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada diane.nam@sunnybrook.ca.'}, {'ForeName': 'Phumeena', 'Initials': 'P', 'LastName': 'Balasuberamaniam', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kunz', 'Affiliation': 'Division of Orthopaedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Kathak', 'Initials': 'K', 'LastName': 'Vachhani', 'Affiliation': 'Orthopaedic Biomechanics Lab, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Research Design and Biostatistics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Whyne', 'Affiliation': 'Orthopaedic Biomechanics Lab, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-031545']
1662,31915163,Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial.,"INTRODUCTION


Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned study aims to clarify the protective effect of antibiotics against CSD and to assess the effectiveness of adjunctive azithromycin prophylaxis for CSD.
METHODS AND ANALYSIS


This study is a double-blind, parallel-control randomised clinical trial that will be carried out at the International Peace Maternity and Child Health Hospital. A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision. The evaluation criteria are the prevalence and characteristics of CSD as assessed by transvaginal ultrasound (TVU) and saline infusion sonohysterography (SIS) at 42 days, 6 months and 12 months after delivery. The primary outcome will be the prevalence of CSD, and the characteristics of CSD will be assessed by TVU and SIS 42 days after delivery; all other outcomes are secondary.
ETHICS AND DISSEMINATION


This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 25 April 2018 (approval no. GKLW2017-84). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER


ChiCTR-INR-17013272.",2020,A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision.,"['International Peace Maternity and Child Health Hospital', 'caesarean scar defect', '220 eligible patients']","['adjunctive azithromycin', 'azithromycin', 'antibiotics against CSD', 'cephalosporin prophylaxis', 'azithromycin prophylaxis', 'adjunctive azithromycin or single-dose cephalosporin 30\u2009min before the incision', 'cephalosporin']","['prevalence of CSD, and the characteristics of CSD']","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4706514', 'cui_str': 'Cephalosporin product'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}]",220.0,0.334947,A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision.,"[{'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Yiru', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Ultrasound, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Ultrasound, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Obstetrics and Gynecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, Shanghai, China dingding123hos@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-032379']
1663,32034015,Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study.,"INTRODUCTION


Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.
METHODS AND ANALYSIS


This study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.
ETHICS AND DISSEMINATION


This study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.
TRIAL REGISTRATION NUMBER


University Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.",2020,"Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment.","['patients with chronic thromboembolic pulmonary hypertension', 'Subjects with inoperable CTEPH', 'Keio University School of Medicine and each participating institution', 'inoperable chronic thromboembolic pulmonary hypertension (CTEPH']","['balloon pulmonary angioplasty and riociguat', 'BPA and riociguat (a soluble guanylate-cyclase stimulator', 'BPA or riociguat', 'balloon pulmonary angioplasty (BPA']","['mean pulmonary arterial pressure', 'pulmonary arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363973', 'cui_str': 'Thromboembolic pulmonary hypertension (disorder)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}]",,0.200436,"Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawakami', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan kawakami.1650@gmail.com.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Matsubara', 'Affiliation': 'Department of Cardiology and Department of Clinical Science, National Hospital Organization Okayama Medical Center, Okayama, Japan.'}, {'ForeName': 'Kohtaro', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Department of Cardiovascular Medicine, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Kataoka', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University, Tokyo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University, School of Medicine, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-028831']
1664,32034019,"Antiviral therapy: Valacyclovir Treatment of Alzheimer's Disease (VALAD) Trial: protocol for a randomised, double-blind,placebo-controlled, treatment trial.","INTRODUCTION


After infection, herpes simplex virus-1 (HSV1) becomes latent in the trigeminal ganglion and can enter the brain via retrograde axonal transport. Recurrent reactivation of HSV1 may lead to neurodegeneration and Alzheimer's disease (AD) pathology. HSV1 (oral herpes) and HSV2 (genital herpes) can trigger amyloid beta-protein (Aβ) aggregation and HSV1 DNA is common in amyloid plaques. Anti-HSV drugs reduce Aβ and phosphorylated tau accumulation in cell-culture models. Cognitive impairment is greater in patients with HSV seropositive, and antiviral drugs show robust efficacy against peripheral HSV infection. Recent studies of electronic health records databases demonstrate that HSV infections increase dementia risk, and that antiviral medication treatment reduces this risk. The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD.
METHODS AND ANALYSIS


In patients with mild AD who test positive for HSV1 or HSV2 serum antibodies, valacyclovir, repurposed as an anti-AD drug, will be compared with placebo (lactose pills) in 130 patients (65 valacyclovir and 65 placebo) in a randomised, double-blind, 78-week phase II proof-of-concept trial. Patients on valacyclovir, dose-titrated from 2 g to a targeted oral dose of 4 g daily, compared with placebo, are hypothesised to show smaller cognitive and functional decline, and, using  18 F-Florbetapir positron emission tomography (PET) and  18 F-MK-6240 PET imaging, to show less amyloid and tau accumulation, respectively. In the lumbar puncture subsample, cerebrospinal fluid acyclovir will be assayed to assess central nervous system valacyclovir penetration.
ETHICS AND DISSEMINATION


The trial is being overseen by the New York State Psychiatric Institute Institutional Review Board (protocol 7537), the National Institute on Ageing, and the Data Safety Monitoring Board. Written informed consent is obtained for all subjects. Results will be disseminated via publication, clinicaltrials.gov, media and conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier (NCT03282916) Pre-results.",2020,"The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD.
","['patients with mild AD who test positive for HSV1 or HSV2 serum antibodies', '130 patients (65', ""Alzheimer's Disease (VALAD"", 'patients with HSV seropositive']","['valacyclovir and 65 placebo', 'Antiviral therapy: Valacyclovir', 'placebo', 'placebo (lactose pills', 'valacyclovir', 'HSV1 (oral herpes) and HSV2 (genital herpes']",['Cognitive impairment'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}]","[{'cui': 'C0249458', 'cui_str': 'valacyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}, {'cui': 'C3216529', 'cui_str': 'Lactose Pill'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.646693,"The generic antiviral drug valacyclovir was superior to placebo in improving memory in a schizophrenia pilot trial but has not been tested in AD.
","[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA dpd3@cumc.columbia.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Andrews', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Kreisl', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Qolamreza', 'Initials': 'Q', 'LastName': 'Razlighi', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gershon', 'Affiliation': 'Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Stern', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Akiva', 'Initials': 'A', 'LastName': 'Mintz', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wisniewski', 'Affiliation': 'Center for Cognitive Neurology, Departments of Neurology, New York University Medical Center, New York, New York, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Acosta', 'Affiliation': 'Department of Pharmacology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Pollina', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Mariasofia', 'Initials': 'M', 'LastName': 'Katsikoumbas', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Bell', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Gregory H', 'Initials': 'GH', 'LastName': 'Pelton', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Deliyannides', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Prasad', 'Affiliation': 'Departments of Psychiatry and Bioengineering, University of Pittsburgh Swanson School of Engineering, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Huey', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-032112']
1665,2180493,A randomized clinical trial of chlorambucil versus COP in stage B chronic lymphocytic leukemia. The French Cooperative Group on Chronic Lymphocytic Leukemia.,"In 1980, the French Cooperative Group on Chronic Lymphocytic Leukemia started a randomized clinical trial in which intermediate prognosis patients (stage B) received either an indefinite course of chlorambucil (0.1 mg/kg/d) or 12 cycles of the COP regimen (vincristine, cyclophosphamide, and prednisone). We present the results of the third interim analysis based on 291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987. At this date, 129 deaths were observed, 65 in the chlorambucil group and 64 in the COP group; there was no improvement in overall survival with the COP regimen (P = .44) even after adjusting for both prognostic and imbalanced factors (P = .24). The 3-year and 5-year overall survival rates were, respectively, 69% and 44% in the chlorambucil group as compared with 73% and 43% in the COP group. The median survival times were 58 months in the chlorambucil group and 57 months in the COP group. Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.",1990,"Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.","['stage B chronic lymphocytic leukemia', '291 patients (151 in the chlorambucil group and 140 in the COP group) with a mean follow-up of 53 months at the reference date of June 1, 1987']","['chlorambucil versus COP', 'chlorambucil', 'COP regimen (vincristine, cyclophosphamide, and prednisone']","['treatment response, 9-month status, time to disease progression to stage C, or causes of death', 'Chronic Lymphocytic Leukemia', 'overall survival', 'median survival times', '3-year and 5-year overall survival rates']","[{'cui': 'C0441781', 'cui_str': 'Stage B (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0441785', 'cui_str': 'Stage C (qualifier value)'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0413074,"Moreover, no significant difference was observed between the two treatment groups in terms of either treatment response, 9-month status, time to disease progression to stage C, or causes of death.",[],Blood,[]
1666,31725105,Cognitive Effects of a Ketogenic Diet on Neurocognitive Impairment in Adults Aging With HIV: A Pilot Study.,"We assessed a ketogenic diet (KD) intervention protocol and the cognitive effects of KD in older adults with HIV-associated neurocognitive impairment. Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment were randomized to either a KD or a patient-choice diet for 12 weeks followed by a 6-week washout period. A neurocognitive battery was administered at baseline, Week 12, and Week 18. Paired t tests compared groups at baseline, and multivariate analyses of covariance were used to assess between-group differences on primary outcome variables at Weeks 12 and 18. We enrolled 17 participants, and 14 completed the study. No between-group baseline differences were noted. The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets. Our study supports the potential efficacy of a KD for the treatment of HIV-associated neurocognitive impairment.",2020,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","['Adults Aging With HIV', 'Adults older than 50 years and living with HIV and mild-to-moderate neurocognitive impairment', 'HIV-associated neurocognitive impairment', 'older adults with HIV-associated neurocognitive impairment', 'We enrolled 17 participants, and 14 completed the study']","['KD or a patient-choice diet', 'ketogenic diet (KD) intervention protocol', 'KD', 'Ketogenic Diet']","['Neurocognitive Impairment', 'executive function and speed of processing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",17.0,0.0596428,"The KD group demonstrated improved executive function and speed of processing at Week 12, which were negated after participants resumed their usual diets.","[{'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Pariya L', 'Initials': 'PL', 'LastName': 'Fazeli', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gower', 'Affiliation': ''}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Willig', 'Affiliation': ''}, {'ForeName': 'Jarred', 'Initials': 'J', 'LastName': 'Younger', 'Affiliation': ''}, {'ForeName': 'N Markie', 'Initials': 'NM', 'LastName': 'Sneed', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Vance', 'Affiliation': ''}]",The Journal of the Association of Nurses in AIDS Care : JANAC,['10.1097/JNC.0000000000000110']
1667,32112254,A secondary learning curve in 3D versus 2D imaging in laparoscopic training of surgical novices.,"BACKGROUND


Stereoscopic (3D) imaging can be used to facilitate the learning of basic laparoscopic tasks. Its advantages over traditional endoscopic (2D) imaging include better depth perception and spatial orientation. However, the transition between 3D and 2D imaging systems has not been previously studied. This study compares the acquisition of basic laparoscopic skills in a laparoscopic-naïve population using both imaging systems, and explores the possibility of a secondary learning curve in the transition between systems.
METHODS


26 novice learners were randomly allocated into two arms and taught to perform two basic laparoscopic tasks adopted from the fundamentals of laparoscopic surgery (FLS) curriculum, peg transfer (T1) and pattern cutting (T2) using either 2D or 3D imaging systems. These tasks were repeated until proficiency was achieved. Participants in each arm then repeated the tasks in the other viewing system (2D/3D vs 3D/2D). The parameters measured were: (a) time taken to complete the task and (b) number of attempts to achieve proficiency.
RESULTS


There was a significant shortening of time required to achieve proficiency in T2 using a 3D system (mean difference-in-differences =  - 65.4, 95% CI - 103.6 to - 27.2, t(24) =  - 3.5, p value = 0.002) but no difference between 2D and 3D imaging systems for T1, a simpler task. Sub-group analysis of T1 and T2 between the 2D/3D and 3D/2D arms showed the presence of a secondary learning curve in the 2D/3D arm for both tasks, (T1: β-estimate - 2.68, 95% CI - 3.68 to - 1.68, p value = 0.0003; T2: β-estimate - 2.45, 95% CI - 3.75 to - 1.14, p value 0.004), but in the 3D/2D arm there was a secondary learning curve only for T2. (β-estimate 2.60, 95% CI 1.45-3.76, p value 0.001) CONCLUSION: 3D imaging can be an effective tool to speed the acquisition of proficiency in basic laparoscopic tasks for novice learners, especially in more complex tasks such as pattern cutting. The skills learned in 3D imaging can translate into 2D, albeit with a secondary learning curve.",2021,"3D imaging can be an effective tool to speed the acquisition of proficiency in basic laparoscopic tasks for novice learners, especially in more complex tasks such as pattern cutting.",['26 novice learners'],"['basic laparoscopic tasks adopted from the fundamentals of laparoscopic surgery (FLS) curriculum, peg transfer (T1) and pattern cutting (T2) using either 2D or 3D imaging systems', 'traditional endoscopic (2D) imaging']","['time taken to complete the task and (b) number of attempts to achieve proficiency', 'shortening of time required to achieve proficiency in T2 using a 3D system']",[],"[{'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0578916,"3D imaging can be an effective tool to speed the acquisition of proficiency in basic laparoscopic tasks for novice learners, especially in more complex tasks such as pattern cutting.","[{'ForeName': 'Min Li', 'Initials': 'ML', 'LastName': 'Kang', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, Jurong Health Services, 1 Jurong East Street 21, Singapore, 609606, Singapore.'}, {'ForeName': 'Chiew Meng Johnny', 'Initials': 'CMJ', 'LastName': 'Wong', 'Affiliation': 'Clinical Research Unit, Ng Teng Fong General Hospital, Jurong Health Services, Singapore, Singapore.'}, {'ForeName': 'Hiangjin', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, Jurong Health Services, 1 Jurong East Street 21, Singapore, 609606, Singapore.'}, {'ForeName': 'Azri', 'Initials': 'A', 'LastName': 'Bohari', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, Jurong Health Services, 1 Jurong East Street 21, Singapore, 609606, Singapore.'}, {'ForeName': 'Tun Oo', 'Initials': 'TO', 'LastName': 'Han', 'Affiliation': 'Clinical Research Unit, Ng Teng Fong General Hospital, Jurong Health Services, Singapore, Singapore.'}, {'ForeName': 'Yuen', 'Initials': 'Y', 'LastName': 'Soon', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, Jurong Health Services, 1 Jurong East Street 21, Singapore, 609606, Singapore. yuen_soon@juronghealth.com.sg.'}]",Surgical endoscopy,['10.1007/s00464-020-07466-y']
1668,10961868,Weekly polyethylene glycol conjugated L-asparaginase compared with biweekly dosing produces superior induction remission rates in childhood relapsed acute lymphoblastic leukemia: a Pediatric Oncology Group Study.,"The relapse rate in childhood acute lymphoblastic leukemia (ALL) is approximately 30% but few reinduction regimens have investigated the intensive use of polyethylene glycol Escherichia coli asparaginase (PEG-Asp). Therefore, we assessed the pharmocokinetics and efficacy of PEG-Asp in this setting. Children with B-precursor ALL, in first marrow and/or extramedullary relapse were eligible. Reinduction included doxorubicin on day 1, prednisone for 28 days, vincristine weekly for 4 weeks, and PEG-Asp either weekly or biweekly by randomization. Asparaginase levels and antibody to both E coli asparaginase and PEG-asp were measured weekly just before each PEG-asp dose. Overall, 129 of 144 patients (pts) (90%) achieved a complete remission (CR). There was a highly significant difference in CR rates between weekly (69 of 71; 97%) and biweekly (60 of 73; 82%) PEG-Asp dosing (P =.003). Grade 3 or 4 infectious toxicity was common (50%), but only 4 pts died of sepsis during induction. Other toxicities were infrequent and hypersensitivity was rare (6 of 144; 4%). Low asparaginase levels were associated with high antibody titers to either native (P =.024) or PEG asp (P =.0013). The CR rate was significantly associated with higher levels of asparaginase (P =. 012). Patients with ALL in first relapse receiving weekly PEG-Asp had a higher rate of second remission compared with biweekly dosing. Low levels of asparaginase were associated with high antibody titers. Increased asparaginase levels may correlate with an improved CR rate. The use of intensive PEG-Asp should be explored further in the treatment of ALL. (Blood. 2000;96:1709-1715)",2000,Low asparaginase levels were associated with high antibody titers to either native (P =.024) or PEG asp (P =.0013).,"['childhood acute lymphoblastic leukemia (ALL', 'childhood relapsed acute lymphoblastic leukemia', 'Children with B-precursor ALL, in first marrow and/or extramedullary relapse were eligible']","['doxorubicin', 'Weekly polyethylene glycol conjugated L-asparaginase', 'prednisone', 'vincristine', 'polyethylene glycol Escherichia coli asparaginase (PEG-Asp']","['Low asparaginase levels', 'relapse rate', 'Grade 3 or 4 infectious toxicity', 'toxicities', 'rate of second remission', 'complete remission (CR', 'CR rates', 'CR rate']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C1269691', 'cui_str': 'Escherichia coli asparaginase'}, {'cui': 'C0647096', 'cui_str': 'monomethoxypolyethylene glycol-conjugated asparaginase'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0282092,Low asparaginase levels were associated with high antibody titers to either native (P =.024) or PEG asp (P =.0013).,"[{'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Abshire', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Pollock', 'Affiliation': ''}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Billett', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Buchanan', 'Affiliation': ''}]",Blood,[]
1669,6575836,Comparison of central nervous system prophylaxis with cranial radiation and intrathecal methotrexate versus intrathecal methotrexate alone in acute lymphoblastic leukemia.,"In acute lymphoblastic leukemia (ALL), central nervous system (CNS) prophylaxis with cranial irradiation plus 5 doses of intrathecal methotrexate (i.t. MTX) reduces the incidence of CNS relapse to 7%-15%. However, increased evidence of CNS delayed toxicity started to be recognized as CT scan abnormalities and neuropsychologic alterations, mainly in children. Two questions were analyzed in the present report: (1) Will further doses of i.t. methotrexate and dexamethasone (i.t. MTX-DMT) decrease the incidence of CNS relapse in patients treated early in remission with cranium irradiation plus i.t. MTX-DMT even more? (2) Is i.t. MTX-DMT given during induction and maintenance equally as effective as cranium irradiation plus i.t. MTX-DMT? A randomized study was designed to answer the first question. Incidence of primary CNS relapse in i.t. MTX-DMT-treated patients with a WBC count less than 50,000 was 11% (15 of 135 patients) and was 11% (17 of 150) in the untreated group. In patients with a WBC count greater than 50,000, it was 16% (6/37) in the treated group and 19% (6/31) in the control group. No difference was observed according to treatment in both prognostic groups. Patients in this study were retrospectively compared with a consecutive protocol in which patients received 3 doses of i.t. MTX-DMT alone during induction plus 3 doses weekly during the first month of remission and every 3 mo thereafter. The incidence of primary CNS leukemia at 60 mo in patients with a WBC count less than 50,000 was 20% in the irradiated group and 32% in the group with i.t. MTX-DMT alone. This difference was not significant. However, the relapse-free survival at 60 mo was 26% and 41%, respectively, (p less than 0.0005). The incidence of primary CNS relapse in patients with a WBC count more than 50,000 at 48 mo was 28% in the irradiated group and 42% in the nonirradiated group. The difference was not significant. The duration of complete remission was similar, remaining at 15% and 16% of patients disease-free at 48 mo, respectively. We conclude that (A) after cranial irradiation plus i.t. MTX-DMT X 5, the use of additional doses of i.t. MTX-DMT is not of further benefit in preventing CNS relapse; (B) the use of i.t. MTX-DMT alone compares similarly with cranial irradiation plus i.t. MTX-DMT in the incidence of CNS relapse; and (C) relapse-free survival and survival in patients with a WBC count less than 50,000 were significantly longer in those without cranial irradiation.",1983,MTX-DMT given during induction and maintenance equally as effective as cranium irradiation plus i.t. MTX-DMT?,['acute lymphoblastic leukemia'],"['intrathecal methotrexate (i.t. MTX', 'MTX-DMT', 'cranial radiation and intrathecal methotrexate', 'intrathecal methotrexate alone', 'methotrexate and dexamethasone']","['relapse-free survival', 'CNS relapse; and (C) relapse-free survival and survival', 'CNS relapse', 'duration of complete remission']","[{'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0555889,MTX-DMT given during induction and maintenance equally as effective as cranium irradiation plus i.t. MTX-DMT?,"[{'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Muriel', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Svarch', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pavlovsky', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Eppinger-Helft', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Braier', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vergara', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Garay', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kvicala', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Divito', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Failace', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dibar', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': ''}]",Blood,[]
1670,32116098,Which factors impact on quality of life for adults with blepharospasm and hemifacial spasm?,"Purpose : Benign essential blepharospasm (BEB) and hemifacial spasm (HFS) are debilitating conditions causing spasms to the eyes and/or face and can significantly impact on quality of life (QoL). Initial research has highlighted potential factors impacting on QoL in BEB, but there remains a wealth of demographic, clinical, and psychosocial factors that may contribute to QoL but have not received attention.  Methods : Cross-sectional baseline data were collected before a single-masked randomised controlled trial from 130 adults with BEB and HFS recruited from botulinum toxin clinics at Moorfields Eye Hospital, London. QoL was measured using the 24-item Craniocervical Dystonia Questionnaire (CDQ24), which provides a total score and five subscale scores relating to  Stigma, Emotional state, Pain, Activities of daily living (ADL) , and  Social/family life . Treating clinicians provided clinical data. Hierarchical multiple regressions were performed on this baseline data to identify significant predictors of QoL.  Results :  ADL  and  Stigma  were the areas most impacted upon whilst patients experienced better adjustment in relation to  Pain, Social/family life , and  Emotional state. CDQ24 Total  scores were explained by the model (80% variance) and were significantly associated with appearance concerns, emotional representations, perceived negative consequences of the condition, mood, and dose of botulinum toxin.  Conclusions : Patients with BEB and HFS report a detrimental impact on ADL and perceived stigma in relation to their condition. Predominantly, individual perceptions and mood are associated with QoL in this population, rather than demographic and clinical factors, signifying areas to target in the design of future healthcare services or interventions.",2021,"CDQ24 Total  scores were explained by the model (80% variance) and were significantly associated with appearance concerns, emotional representations, perceived negative consequences of the condition, mood, and dose of botulinum toxin.","['adults with blepharospasm and hemifacial spasm', '130 adults with BEB and HFS recruited from botulinum toxin clinics at Moorfields Eye Hospital, London']",[],"['QoL', 'appearance concerns, emotional representations, perceived negative consequences of the condition, mood, and dose of botulinum toxin', 'quality of life', '24-item Craniocervical Dystonia Questionnaire (CDQ24', 'total score and five subscale scores relating to  Stigma, Emotional state, Pain, Activities of daily living (ADL) , and  Social/family life ', 'Pain, Social/family life , and  Emotional state', 'CDQ24 Total  scores', 'quality of life (QoL']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0278152', 'cui_str': 'Facial Spasm, Unilateral'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}]",[],"[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0034380'}, {'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",130.0,0.0421321,"CDQ24 Total  scores were explained by the model (80% variance) and were significantly associated with appearance concerns, emotional representations, perceived negative consequences of the condition, mood, and dose of botulinum toxin.","[{'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Lawes-Wickwar', 'Affiliation': 'Centre for Health Services Research, City, University of London , London, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McBain', 'Affiliation': 'Centre for Health Services Research, City, University of London , London, UK.'}, {'ForeName': 'Shashivadan P', 'Initials': 'SP', 'LastName': 'Hirani', 'Affiliation': 'Centre for Health Services Research, City, University of London , London, UK.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Hurt', 'Affiliation': 'Centre for Health Services Research, City, University of London , London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dunlop', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust , London, UK.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Solly', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust , London, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Crampton', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust , London, UK.'}, {'ForeName': 'Stanton P', 'Initials': 'SP', 'LastName': 'Newman', 'Affiliation': 'Centre for Health Services Research, City, University of London , London, UK.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Ezra', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust , London, UK.'}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1733028']
1671,31942818,Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training in Children with Unilateral Cerebral Palsy.,"AIMS


To quantify the changes in joint movement control and motor planning of the more-affected upper extremity (UE) during a reach-grasp-eat task in children with Unilateral Spastic Cerebral Palsy (USCP) after either constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT).
METHODS


Twenty children with USCP (average age 7.7; MACS levels I-II) were randomized into either a CIMT or HABIT group. Both groups received intensive training 6 h a day for 15 days. Children performed a reach-grasp-eat task before and after training with their more-affected hand using 3D kinematic analysis.
RESULTS


Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05). Additionally, both intensive training approaches improved joint control with decreased trunk involvement, greater elbow, and wrist excursions during the reaching phase, and greater elbow excursion during the eating phase ( p  < 0.05). However, only the CIMT group decreased hand curvature during reaching, lowered hand position at grasp, and decreased head rotation during the eating phase ( p  < 0.05).
CONCLUSIONS


The current findings showed that both CIMT and HABIT improved UE joint control, but there were greater effects of CIMT on the more-affected UE motor planning and head control for children with USCP.",2020,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","['children with Unilateral Spastic Cerebral Palsy (USCP) after either', 'Children with Unilateral Cerebral Palsy', 'children with USCP', 'Twenty children with USCP (average age 7.7; MACS levels I-II']","['Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training', 'intensive training', 'constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT', 'CIMT or HABIT', 'CIMT']","['joint control with decreased trunk involvement, greater elbow, and wrist excursions', 'CIMT and HABIT improved UE joint control', 'elbow excursion', 'shorter movement time during reaching, grasping, and eating phases', 'hand curvature during reaching, lowered hand position at grasp, and decreased head rotation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",20.0,0.0133344,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Spingarn', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Friel', 'Affiliation': 'Neuroscience, Burke Medical Research Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1712513']
1672,31112512,Quadratus lumborum block for postoperative analgesia after full abdominoplasty: a randomized controlled trial.,"BACKGROUND AND AIMS


The quadratus lumborum block (QLB) provides regional analgesia of the anterior abdominal wall, theoretically matching the postoperative pain after postbariatric standard full abdominoplasty. We investigated the effectiveness of a QLB as an addition to the current multimodal analgesia regimen in postbariatric patients treated with standard full abdominoplasty.
METHODS


Randomized, placebo-controlled, triple blinded study ( n  = 50). All patients received perioperative paracetamol and intraoperative local anesthetic infiltration. QLB was administered bilaterally before induction of general anesthesia with 2 × 20 mL of either ropivacaine 3.75 mg/mL ( n  = 25) or placebo (saline 9 mg/mL) ( n  = 25). Patients received intravenous patient controlled opioid analgesia postoperatively. The primary endpoint was opioid use during the first 24 postoperative hours. Secondary endpoints were acute and chronic postoperative pain, postoperative nausea and vomiting, and other side effects.
RESULTS


Patient characteristics were similar between groups. The primary endpoint in morphine equivalent units was similar between groups during the first 24 h with mean (SD) of 26 (25) vs. 33 (33) mg ( p  = 0.44) in the ropivacaine and placebo group, respectively. The observed effect was smaller, and SD larger than assumed in the sample size estimation. Linear mixed effects modeling indicated a minimal inter-group difference. No differences were found for secondary endpoints.
CONCLUSIONS


The QLB did not provide significant additional benefit in terms of reduced opioid requirements or secondary endpoints when administered as part of a multimodal pain regimen to postbariatric patients undergoing standard full abdominoplasty. A minimal difference of little clinical importance the first 12 postoperative hours may have been missed.
IMPLICATIONS


Including the QLB in the current multimodal pain regimen cannot be recommended based on these findings. The study does not preclude QLB use in individual cases where the multimodal regimen is inadequate or contraindicated. The effectiveness of the QLB for supraumbilical pain remains undocumented.",2019,The QLB did not provide significant additional benefit in terms of reduced opioid requirements or secondary endpoints when administered as part of a multimodal pain regimen to postbariatric patients undergoing standard full abdominoplasty.,['postbariatric patients treated with standard full abdominoplasty'],"['intravenous patient controlled opioid analgesia postoperatively', 'QLB', 'Quadratus lumborum block', 'placebo', 'ropivacaine 3.75 mg/mL', 'quadratus lumborum block (QLB', 'ropivacaine', 'placebo (saline 9 mg/mL', 'perioperative paracetamol and intraoperative local anesthetic infiltration']","['opioid use during the first 24 postoperative hours', 'morphine equivalent units', 'acute and chronic postoperative pain, postoperative nausea and vomiting, and other side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0651569', 'cui_str': ""9-(1'-hydroxy-2'-(hydroxymethyl)ethoxy)methylguanine""}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2074900', 'cui_str': 'Chronic postoperative pain (finding)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.471645,The QLB did not provide significant additional benefit in terms of reduced opioid requirements or secondary endpoints when administered as part of a multimodal pain regimen to postbariatric patients undergoing standard full abdominoplasty.,"[{'ForeName': 'Thor W', 'Initials': 'TW', 'LastName': 'Bjelland', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergencies, Baerum Hospital, Vestre Viken HT, Sandvika, Norway.'}, {'ForeName': 'Thomas G R', 'Initials': 'TGR', 'LastName': 'Yates', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergencies, Baerum Hospital, Vestre Viken HT, Sandvika, Norway.'}, {'ForeName': 'Morten W', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Frøyen', 'Affiliation': 'Department of Plastic Surgery, Baerum Hospital, Vestre Viken HT, Sandvika, Norway.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Lysebråten', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergencies, Baerum Hospital, Vestre Viken HT, Sandvika, Norway.'}, {'ForeName': 'Ulrich J', 'Initials': 'UJ', 'LastName': 'Spreng', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergencies, Baerum Hospital, Vestre Viken HT, Sandvika, Norway.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0013']