Clinical trial comparing three types of cryotherapy in non-pregnant women

O estudo teve como objetivo comparar três modalidades de crioterapia em mulheres saudáveis e não grávidas. Trata-se de um ensaio clínico randomizado, não controlado, com 32 alunas do curso de graduação de uma faculdade de enfermagem particular da cidade de São Paulo, divididas em três grupos (gelo água, gelo mole, gelo gel). Foram verificadas as temperaturas (axilar, coxa e das três bolsas de gelo) entre zero e vinte minutos. As temperaturas das bolsas foram: gelo mole de 9°C negativos a 2°C, gelo água de 0°C a 8°C e gelo gel de 11°C negativos a 2°C. Houve diferença significativa entre as médias das temperaturas da coxa com 10 minutos (p=0,007), 15 minutos (p=0,003) e 20 minutos (p=0,005). O gel foi mais eficiente no resfriamento comparado aos outros dois métodos. As três modalidades de crioterapia atingem a temperatura recomendada para analgesia e podem ser aplicadas em puérperas com dor perineal após o parto normal.El estudio tuvo como objetivo comparar tres modalidades de crioterapia en mujeres saludables y no grávidas. Se trató de un ensayo clínico randomizado no controlado con 32 alumnas del curso de graduación de una facultad de enfermería particular de la ciudad de São Paulo (Brasil). Las alumnas fueron divididas en tres grupos (agua helada, hielo blando, gel helado). Fueron verificadas las temperaturas (axilar, del muslo y de las tres bolsas de hielo) entre cero y veinte minutos. Las temperaturas de las bolsas fueron: hielo blando, de -9°C a 2°C; agua helada, de 0°C a 8°C; gel helado, de -11°C a 2°C. Hubo diferencia significativa entre las medias de las temperaturas del muslo tomadas a los 10 minutos (p=0,007), 15 minutos (p=0,003) y 20 minutos (p=0,005). El gel fue más eficiente en el enfriamiento comparado con los otros dos métodos. Las tres modalidades de crioterapia alcanzan la temperatura recomendada para la analgesia y pueden ser aplicadas en mujeres con dolor perineal posparto.The objective of the present study was to compare three methods of cryotherapy in healthy non-pregnant women. This is a randomized controlled clinical trial that was conducted by 32 undergraduates of a private nursing college in the city of Sao Paulo, divided into three groups (iced water, soft ice, ice gel). The temperatures were verified (axillary, thigh, of the three ice packs) between zero and twenty minutes. The temperatures of the packs were the following: soft ice, from negative 9°C to 2°C; iced water, from 0°C to 8°C; and ice gel from negative 11°C to 2°C. There was a significant difference between the average thigh temperature values at 10 minutes (p=0.007), 15 minutes (p=0.003) and 20 minutes (p=0.005). The gel was the most efficient cooling method. The three cryotherapy methods achieved the recommended temperature for analgesia and may be tested in women with perineal pain after childbirth

Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial

Background and purpose Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials. Methods This was a phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial. Participants diagnosed with definite, probable or probable laboratory-supported ALS were assigned to receive RNS60 or placebo administered for 24 weeks intravenously (375 ml) once a week and via nebulization (4 ml/day) on non-infusion days, followed by an additional 24 weeks off-treatment. The primary objective was to measure the effects of RNS60 treatment on selected biomarkers of inflammation and neurodegeneration in peripheral blood. Secondary objectives were to measure the effect of RNS60 on functional impairment (ALS Functional Rating Scale-Revised), a measure of self-sufficiency, respiratory function (forced vital capacity, FVC), quality of life (ALS Assessment Questionnaire-40, ALSAQ-40) and survival. Tolerability and safety were assessed. Results Seventy-four participants were assigned to RNS60 and 73 to placebo. Assessed biomarkers did not differ between arms. The mean rate of decline in FVC and the eating and drinking domain of ALSAQ-40 was slower in the RNS60 arm (FVC, difference 0.41 per week, standard error 0.16, p = 0.0101; ALSAQ-40, difference -0.19 per week, standard error 0.10, p = 0.0319). Adverse events were similar in the two arms. In a post hoc analysis, neurofilament light chain increased over time in bulbar onset placebo participants whilst remaining stable in those treated with RNS60. Conclusions The positive effects of RNS60 on selected measures of respiratory and bulbar function warrant further investigation

Racial differences in systemic sclerosis disease presentation: a European Scleroderma Trials and Research group study

Objectives. Racial factors play a significant role in SSc. We evaluated differences in SSc presentations between white patients (WP), Asian patients (AP) and black patients (BP) and analysed the effects of geographical locations.Methods. SSc characteristics of patients from the EUSTAR cohort were cross-sectionally compared across racial groups using survival and multiple logistic regression analyses.Results. The study included 9162 WP, 341 AP and 181 BP. AP developed the first non-RP feature faster than WP but slower than BP. AP were less frequently anti-centromere (ACA; odds ratio (OR) = 0.4, P < 0.001) and more frequently anti-topoisomerase-I autoantibodies (ATA) positive (OR = 1.2, P = 0.068), while BP were less likely to be ACA and ATA positive than were WP [OR(ACA) = 0.3, P < 0.001; OR(ATA) = 0.5, P = 0.020]. AP had less often (OR = 0.7, P = 0.06) and BP more often (OR = 2.7, P < 0.001) diffuse skin involvement than had WP.AP and BP were more likely to have pulmonary hypertension [OR(AP) = 2.6, P < 0.001; OR(BP) = 2.7, P = 0.03 vs WP] and a reduced forced vital capacity [OR(AP) = 2.5, P < 0.001; OR(BP) = 2.4, P < 0.004] than were WP. AP more often had an impaired diffusing capacity of the lung than had BP and WP [OR(AP vs BP) = 1.9, P = 0.038; OR(AP vs WP) = 2.4, P < 0.001]. After RP onset, AP and BP had a higher hazard to die than had WP [hazard ratio (HR) (AP) = 1.6, P = 0.011; HR(BP) = 2.1, P < 0.001].Conclusion. Compared with WP, and mostly independent of geographical location, AP have a faster and earlier disease onset with high prevalences of ATA, pulmonary hypertension and forced vital capacity impairment and higher mortality. BP had the fastest disease onset, a high prevalence of diffuse skin involvement and nominally the highest mortality

ATLANTIC EPIPHYTES: a data set of vascular and non-vascular epiphyte plants and lichens from the Atlantic Forest

Epiphytes are hyper-diverse and one of the frequently undervalued life forms in plant surveys and biodiversity inventories. Epiphytes of the Atlantic Forest, one of the most endangered ecosystems in the world, have high endemism and radiated recently in the Pliocene. We aimed to (1) compile an extensive Atlantic Forest data set on vascular, non-vascular plants (including hemiepiphytes), and lichen epiphyte species occurrence and abundance; (2) describe the epiphyte distribution in the Atlantic Forest, in order to indicate future sampling efforts. Our work presents the first epiphyte data set with information on abundance and occurrence of epiphyte phorophyte species. All data compiled here come from three main sources provided by the authors: published sources (comprising peer-reviewed articles, books, and theses), unpublished data, and herbarium data. We compiled a data set composed of 2,095 species, from 89,270 holo/hemiepiphyte records, in the Atlantic Forest of Brazil, Argentina, Paraguay, and Uruguay, recorded from 1824 to early 2018. Most of the records were from qualitative data (occurrence only, 88%), well distributed throughout the Atlantic Forest. For quantitative records, the most common sampling method was individual trees (71%), followed by plot sampling (19%), and transect sampling (10%). Angiosperms (81%) were the most frequently registered group, and Bromeliaceae and Orchidaceae were the families with the greatest number of records (27,272 and 21,945, respectively). Ferns and Lycophytes presented fewer records than Angiosperms, and Polypodiaceae were the most recorded family, and more concentrated in the Southern and Southeastern regions. Data on non-vascular plants and lichens were scarce, with a few disjunct records concentrated in the Northeastern region of the Atlantic Forest. For all non-vascular plant records, Lejeuneaceae, a family of liverworts, was the most recorded family. We hope that our effort to organize scattered epiphyte data help advance the knowledge of epiphyte ecology, as well as our understanding of macroecological and biogeographical patterns in the Atlantic Forest. No copyright restrictions are associated with the data set. Please cite this Ecology Data Paper if the data are used in publication and teaching events. © 2019 The Authors. Ecology © 2019 The Ecological Society of Americ

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Ensaio clínico comparando três modalidades de crioterapia em mulheres não grávidas Ensayo clínico comparando tres tipos de crioterapia en mujeres no embarazadas Clinical trial comparing three types of cryotherapy in non-pregnant women

O estudo teve como objetivo comparar três modalidades de crioterapia em mulheres saudáveis e não grávidas. Trata-se de um ensaio clínico randomizado, não controlado, com 32 alunas do curso de graduação de uma faculdade de enfermagem particular da cidade de São Paulo, divididas em três grupos (gelo água, gelo mole, gelo gel). Foram verificadas as temperaturas (axilar, coxa e das três bolsas de gelo) entre zero e vinte minutos. As temperaturas das bolsas foram: gelo mole de 9°C negativos a 2°C, gelo água de 0°C a 8°C e gelo gel de 11°C negativos a 2°C. Houve diferença significativa entre as médias das temperaturas da coxa com 10 minutos (p=0,007), 15 minutos (p=0,003) e 20 minutos (p=0,005). O gel foi mais eficiente no resfriamento comparado aos outros dois métodos. As três modalidades de crioterapia atingem a temperatura recomendada para analgesia e podem ser aplicadas em puérperas com dor perineal após o parto normal.<br>El estudio tuvo como objetivo comparar tres modalidades de crioterapia en mujeres saludables y no grávidas. Se trató de un ensayo clínico randomizado no controlado con 32 alumnas del curso de graduación de una facultad de enfermería particular de la ciudad de São Paulo (Brasil). Las alumnas fueron divididas en tres grupos (agua helada, hielo blando, gel helado). Fueron verificadas las temperaturas (axilar, del muslo y de las tres bolsas de hielo) entre cero y veinte minutos. Las temperaturas de las bolsas fueron: hielo blando, de -9°C a 2°C; agua helada, de 0°C a 8°C; gel helado, de -11°C a 2°C. Hubo diferencia significativa entre las medias de las temperaturas del muslo tomadas a los 10 minutos (p=0,007), 15 minutos (p=0,003) y 20 minutos (p=0,005). El gel fue más eficiente en el enfriamiento comparado con los otros dos métodos. Las tres modalidades de crioterapia alcanzan la temperatura recomendada para la analgesia y pueden ser aplicadas en mujeres con dolor perineal posparto.<br>The objective of the present study was to compare three methods of cryotherapy in healthy non-pregnant women. This is a randomized controlled clinical trial that was conducted by 32 undergraduates of a private nursing college in the city of Sao Paulo, divided into three groups (iced water, soft ice, ice gel). The temperatures were verified (axillary, thigh, of the three ice packs) between zero and twenty minutes. The temperatures of the packs were the following: soft ice, from negative 9°C to 2°C; iced water, from 0°C to 8°C; and ice gel from negative 11°C to 2°C. There was a significant difference between the average thigh temperature values at 10 minutes (p=0.007), 15 minutes (p=0.003) and 20 minutes (p=0.005). The gel was the most efficient cooling method. The three cryotherapy methods achieved the recommended temperature for analgesia and may be tested in women with perineal pain after childbirth

Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well-tolerated in ALS subjects in previous early phase trials

Recommendations for self-monitoring in pediatric diabetes: A consensus statement by the ISPED

none165noScaramuzza, Andrea; Cherubini, Valentino; Tumini, Stefano; Bonfanti, Riccardo; Buono, Pietro; Cardella, Francesca; D’Annunzio, Giuseppe; Frongia, Anna Paola; Lombardo, Fortunato; Monciotti, Anna Carla Maria; Rabbone, Ivana; Schiaffini, Riccardo; Toni, Sonia; Zucchini, Stefano; Frontino, Giulio; Iafusco, Dario; Arnaldi, Claudia; Banin, Patrizia; Barbetti, Fabrizio; Beccaria, Luciano; Benelli, Marzia; Berardi, Rosario; Biagioni, Martina; Bianchi, Giuliana; Bizzarri, Carla; Blasetti, Annalisa; Bobbio, Adriana; Boccato, Stefano; Bontempi, Franco; Bruzzese, Mariella; Cadario, Francesco; Calcaterra, Valeria; Cannatà, Alessandra; Cappa, Marco; Cardani, Roberta; Cardinale, Giuliana Marcella; Carloni, Ines; Castaldo, Vincenzo; Cauvin, Vittoria; Cerutti, Franco; Cester, Anna Maria; Chessa, Margherita; Chiarelli, Francesco; Chiari, Giovanni; Chiumello, Giuseppe; Cicchetti, Mario; Cirillo, Dante; Citriniti, Felice; Citro, Giuseppe; Coccioli, Maria Susanna; Cotellessa, Mario; Crinò, Antonino; De Berardinis, Fiorella; De Filippo, Gianpaolo; De Giorgi, Giovanni; De Luca, Filippo; De Marco, Rosaria; Delvecchio, Maurizio; Faleschini, Elena; Federico, Giovanni; Fifi, Anna Rita; Fontana, Franco; Franzese, Adriana; Frezza, Elda; Frongia, Annapaola; Gaiero, Alberto; Galderisi, Alfonso; Gallo, Francesco; Gargantini, Luigi; Ghione, Silvia; Giorgetti, Chiara; Gualtieri, Antonella; Guasti, Monica; Guerraggio, Lucia; Iannilli, Antonio; Ingletto, Dario; Iossa, Carmine; Iovene, Brunella; Iughetti, Lorenzo; Kaufmann, Peter; La Loggia, Alfonso; Lazzaro, Nicola; Lenzi, Lorenzo; Lera, Riccardo; Lia, Rosanna; Lo Presti, Donatella; Lorini, Renata; Lucchesi, Sonia; Luceri, Sergio; Madeo, Simona Filomena; Maffeis, Claudio; Mainetti, Benedetta; Mammi, Francesco; Manca Bitti, Maria Luisa; Marigliano, Marco; Marinari, Alessandra; Marinaro, Anna Maria; Meloni, Gianfranco; Marsciani, Alberto; Mastrangelo, Lisa; Mastrangelo, Costanzo; Meschi, Franco; Minasi, Domenico; Minenna, Adelaide; Minuto, Nicola; Monciotti, Carlamaria; Morganti, Gianfranco; Mozzillo, Enza; Nugnes, Rosa; Paradiso, Emanuela; Pardi, Daniela; Pasquino, Bruno; Patrizia Patera, Ippolita; Pennati, Cristina; Pepe, Rossella; Piccini, Barbara; Perrotta, Angelo; Piccinno, Elvira; Pinelli, Leonardo; Piredda, Gavina; Pocecco, Mauro; Ponzi, Giuseppe; Prandi, Elena; Predieri, Barbara; Prisco, Francesco; Quinci, Maria; Ricciardi, Maria Rossella; Rigamonti, Andrea; Ripoli, Carlo; Sabbion, Alberto; Salardi, Silvana; Salvatoni, Alessandro; Salvo, Caterina; Salzano, Giuseppina; Saporiti, Anna; Sardi, Rita; Schieven, Eleonardo; Scipione, Mirella; Soci, Cristina; Soro, Miriam; Spallino, Luisa; Stamati, Filomena; Suprani, Tosca; Savastio, Silvia; Taccardi, Rosa Anna; Tarchini, Luis; Tomaselli, Letizia; Tonini, Giorgio; Torelli, Cataldo; Tornese, Gianluca; Trada, Michela; Valerio, Giuliana; Vanelli, Maurizio; Vanini, Roberto; Vascotto, Marina; Vergerio, Amedeo; Viscardi, Matteo; Zaffani, Silvana; Zampolli, Maria; Zanatta, Manuela; Zanette, Giorgio; Zanfardino, Angela; Zecchino, Clara; Zedda, Maria Antonietta; Zuccotti, Gian VincenzoScaramuzza, Andrea; Cherubini, Valentino; Tumini, Stefano; Bonfanti, Riccardo; Buono, Pietro; Cardella, Francesca; D’Annunzio, Giuseppe; Frongia, Anna Paola; Lombardo, Fortunato; Monciotti, Anna Carla Maria; Rabbone, Ivana; Schiaffini, Riccardo; Toni, Sonia; Zucchini, Stefano; Frontino, Giulio; Iafusco, Dario; Arnaldi, Claudia; Banin, Patrizia; Barbetti, Fabrizio; Beccaria, Luciano; Benelli, Marzia; Berardi, Rossana; Biagioni, Martina; Bianchi, Giuliana; Bizzarri, Carla; Blasetti, Annalisa; Bobbio, Adriana; Boccato, Stefano; Bontempi, Franco; Bruzzese, Mariella; Cadario, Francesco; Calcaterra, Valeria; Cannatà, Alessandra; Cappa, Marco; Cardani, Roberta; Cardinale, Giuliana Marcella; Carloni, Ines; Castaldo, Vincenzo; Cauvin, Vittoria; Cerutti, Franco; Cester, Anna Maria; Chessa, Margherita; Chiarelli, Francesco; Chiari, Giovanni; Chiumello, Giuseppe; Cicchetti, Mario; Cirillo, Dante; Citriniti, Felice; Citro, Giuseppe; Coccioli, Maria Susanna; Cotellessa, Mario; Crinò, Antonino; De Berardinis, Fiorella; De Filippo, Gianpaolo; De Giorgi, Giovanni; De Luca, Filippo; De Marco, Rosaria; Delvecchio, Maurizio; Faleschini, Elena; Federico, Giovanni; Fifi, Anna Rita; Fontana, Franco; Franzese, Adriana; Frezza, Elda; Frongia, Annapaola; Gaiero, Alberto; Galderisi, Alfonso; Gallo, Francesco; Gargantini, Luigi; Ghione, Silvia; Giorgetti, Chiara; Gualtieri, Antonella; Guasti, Monica; Guerraggio, Lucia; Iannilli, Antonio; Ingletto, Dario; Iossa, Carmine; Iovene, Brunella; Iughetti, Lorenzo; Kaufmann, Peter; La Loggia, Alfonso; Lazzaro, Nicola; Lenzi, Lorenzo; Lera, Riccardo; Lia, Rosanna; Lo Presti, Donatella; Lorini, Renata; Lucchesi, Sonia; Luceri, Sergio; Madeo, Simona Filomena; Maffeis, Claudio; Mainetti, Benedetta; Mammi, Francesco; Manca Bitti, Maria Luisa; Marigliano, Marco; Marinari, Alessandra; Marinaro, Anna Maria; Meloni, Gianfranco; Marsciani, Alberto; Mastrangelo, Lisa; Mastrangelo, Costanzo; Meschi, Franco; Minasi, Domenico; Minenna, Adelaide; Minuto, Nicola; Monciotti, Carlamaria; Morganti, Gianfranco; Mozzillo, Enza; Nugnes, Rosa; Paradiso, Emanuela; Pardi, Daniela; Pasquino, Bruno; Patrizia Patera, Ippolita; Pennati, Cristina; Pepe, Rossella; Piccini, Barbara; Perrotta, Angelo; Piccinno, Elvira; Pinelli, Leonardo; Piredda, Gavina; Pocecco, Mauro; Ponzi, Giuseppe; Prandi, Elena; Predieri, Barbara; Prisco, Francesco; Quinci, Maria; Ricciardi, Maria Rossella; Rigamonti, Andrea; Ripoli, Carlo; Sabbion, Alberto; Salardi, Silvana; Salvatoni, Alessandro; Salvo, Caterina; Salzano, Giuseppina; Saporiti, Anna; Sardi, Rita; Schieven, Eleonardo; Scipione, Mirella; Soci, Cristina; Soro, Miriam; Spallino, Luisa; Stamati, Filomena; Suprani, Tosca; Savastio, Silvia; Taccardi, Rosa Anna; Tarchini, Luis; Tomaselli, Letizia; Tonini, Giorgio; Torelli, Cataldo; Tornese, Gianluca; Trada, Michela; Valerio, Giuliana; Vanelli, Maurizio; Vanini, Roberto; Vascotto, Marina; Vergerio, Amedeo; Viscardi, Matteo; Zaffani, Silvana; Zampolli, Maria; Zanatta, Manuela; Zanette, Giorgio; Zanfardino, Angela; Zecchino, Clara; Zedda, Maria Antonietta; Zuccotti, Gian Vincenz