18 results on '"Palmisano, Lucia"'
Search Results
2. Soluble CD14 levels in plasma and breastmilk of Malawian HIV+ women: Lack of association with morbidity and mortality in their exposed infants
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Baroncelli, Silvia, Galluzzo, Clementina M., Liotta, Giuseppe, Andreotti, Mauro, Ciccacci, Fausto, Mancinelli, Sandro, Tolno, Victor T., Gondwe, Jane, Amici, Roberta, Marazzi, Maria C., Vella, Stefano, Giuliano, Marina, Palombi, Leonardo, and Palmisano, Lucia
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- 2018
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3. European survey on national harmonization in clinical research
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Magnin, Annette, Iversen, Valentina Cabral, Calvo, Gonzalo, Čečetková, Beata, Dale, Ola, Demlová, Regina, Blaskó, György, Keane, Fionnuala, Kovacs, Gabor L., Levy‐Marchal, Claire, Monteiro, Emilia C., Palmisano, Lucia, Pella, Daniel, Portolés, Antonio, Rascol, Olivier, Schmid, Caecilia, Tay, Fabian, von der Leyen, Heiko, Ohmann, Christian, and NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
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Research Report ,Medicine (General) ,R5-920 ,clinical research ,EU 536/2014 ,harmonization of processes ,Research Reports ,survey ,clinical trial ,ECRIN ,clinical study ,Public aspects of medicine ,RA1-1270 - Abstract
Background Clinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action. Results Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know‐how and documents. Since harmonization was mainly a bottom‐up approach up until now, the extent and topics dealt with are diverse and there is only little cross‐networking and cross‐country exchange so far. Conclusions Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.
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- 2021
4. Clinical Characteristics of Hospitalized Individuals Dying with COVID-19 by Age Group in Italy
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Palmieri, Luigi, Vanacore, Nicola, Donfrancesco, Chiara, Lo Noce, Cinzia, Canevelli, Marco, Punzo, Ornella, Raparelli, Valeria, Pezzotti, Patrizio, Riccardo, Flavia, Bella, Antonio, Fabiani, Massimo, D’Ancona, Fortunato Paolo, Vaianella, Luana, Tiple, Dorina, Colaizzo, Elisa, Palmer, Katie, Rezza, Giovanni, Piccioli, Andrea, Brusaferro, Silvio, Onder, Graziano, Andrianou, Xanthi, Barbariol, Pierfrancesco, Bella, Antonino, Bellino, Stefania, Benelli, Eva, Bertinato, Luigi, Boros, Stefano, Brambilla, Gianfranco, Calcagnini, Giovanni, Rita Castrucci, Maria, Censi, Federica, Ciervo, Alessandra, D’Ancona, Fortunato, Del Manso, Martina, Facchiano, Francesco, Filia, Antonietta, Floridia, Marco, Galati, Fabio, Giuliano, Marina, Grisetti, Tiziana, Kodra, Yllka, Langer, Martin, Lega, Ilaria, Maiozzi, Pietro, Malchiodi Albedi, Fiorella, Manno, Valerio, Martini, Margherita, Mateo Urdiales, Alberto, Mattei, Eugenio, Meduri, Claudia, Meli, Paola, Minelli, Giada, Nebuloni, Manuela, Nisticò, Lorenza, Nonis, Marino, Palmisano, Lucia, Petrosillo, Nicola, Pricci, Flavia, Puro, Vincenzo, Cristina Rota, Maria, Salerno, Paolo, Serra, Debora, Siddu, Andrea, Stefanelli, Paola, De Bella, Manuela Tamburo, Unim, Brigid, Vichi, Monica, Rocco Villani, Emanuele, and Zona, Amerigo
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Research Report ,Male ,Aging ,Complications ,HIV Infections ,Comorbidity ,030204 cardiovascular system & hematology ,Chronic liver disease ,Kidney Failure ,AcademicSubjects/MED00280 ,0302 clinical medicine ,Elderly ,Risk Factors ,Cause of Death ,Prevalence ,030212 general & internal medicine ,Viral ,Chronic ,Stroke ,Cause of death ,COPD ,covid-19 ,epidemiology ,mortality ,Age Factors ,Atrial fibrillation ,Middle Aged ,Hospitalization ,Italy ,Cardiovascular Diseases ,Female ,Coronavirus Infections ,medicine.medical_specialty ,Pneumonia, Viral ,NO ,03 medical and health sciences ,Betacoronavirus ,Internal medicine ,Correspondence ,medicine ,Dementia ,Humans ,Mortality ,Pandemics ,Aged ,business.industry ,SARS-CoV-2 ,COVID-19 ,Kidney Failure, Chronic ,Pneumonia ,medicine.disease ,Ageing ,Comorbidity, Complications, COVID-19, Elderly, Mortality ,Heart failure ,AcademicSubjects/SCI00960 ,Geriatrics and Gerontology ,business - Abstract
Background Aim of the present study is to describe characteristics of COVID-19-related deaths and to compare the clinical phenotype and course of COVID-19-related deaths occurring in adults ( Method Medical charts of 3,032 patients dying with COVID-19 in Italy (368 aged < 65 years and 2,664 aged ≥65 years) were revised to extract information on demographics, preexisting comorbidities, and in-hospital complications leading to death. Results Older adults (≥65 years) presented with a higher number of comorbidities compared to those aged Conclusions Individuals dying with COVID-19 present with high levels of comorbidities, irrespective of age group, but a small proportion of deaths occur in healthy adults with no preexisting conditions. Non-respiratory complications are common, suggesting that the treatment of respiratory conditions needs to be combined with strategies to prevent and mitigate the effects of non-respiratory complications.
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- 2020
5. Prevalence of acquired resistance mutations in a large cohort of perinatally infected HIV-1 patients
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Giacometti, Andrea, Butini, Luca, del Gobbo, Romana, Bagnarelli, Patrizia, Tacconi, Danilo, Corbelli, Giovanni, Zanussi, Stefania, Monno, Laura, Punzi, Grazia, Maggiolo, Franco, Calza, Leonardo, Carla Re, Maria, Pristera, Raffaele, Turconi, Paola, Mandas, Antonella, Tini, Sauro, Zoncada, Alessia, Paolini, Elisabetta, Amadio, Giorgio, Sighinolfi, Laura, Corsi, Paola, Galli, Luisa, Di Pietro, Massimo, Colao, Grazia, Tosti, Andrea, Setti, Maurizio, Bruzzone, Bianca, Di Biagio, Antonio, Cenderello, Giovanni, Trezzi, Michele, Orani, Anna, Arcidiacono, Irene, Degiuli, Alberto, De Gennaro, Michele, Chiodera, Alessandro, Scalzini, Alfredo, Palvarini, Loredana, Todaro, Giovanni, Rusconi, Stefano, Gismondo, Maria Rita, Micheli, Valeria, Biondi, Maria Luisa, Capetti, Amedeo, Meraviglia, Paola, Boeri, Enzo, Mussini, Cristina, Pecorari, Monica, Soria, Alessandro, Vecchi, Laura, Santirocchi, Maurizio, Brustia, Diego, Ravanini, Paolo, Dal Bello, Federico, Romano, Nino, Mancuso, Salvatrice, Calzetti, Carlo, Maserati, Renato, Filice, Gaetano, Baldanti, Fausto, Francisci, Daniela, Parruti, Giustino, Polilli, Ennio, Sacchini, Daria, Martinelli, Chiara, Consolini, Rita, Vatteroni, Linda, Vivarelli, Angela, Nerli, Alessandro, Lenzi, Lucia, Magnani, Giacomo, Ortolani, Patrizia, Andreoni, Massimo, Fimiani, Caterina, Palmisano, Lucia, Di Giambenedetto, Simona, Vullo, Vincenzo, Turriziani, Ombretta, Montano, Marco, Antinori, Andrea, Zaccarelli, Mauro, Dentone, Chiara, Gonnelli, Angela, De Luca, Andrea, Palumbo, Michele, Ghisetti, Valeria, Bonora, Stefano, Delle Foglie, Palma, Rossi, Cristina, Mondino, Vincenzo, Malena, Marina, Grossi, Paolo, Seminari, Elena, Poletti, Federica, Ungaro, R., Taramasso, L., Bruzzone, B., Vicenti, I., Galli, L., Borghi, V., Francisci, D., Pecorari, M., Zoncada, A., Callegaro, A.P., Paolini, E., Monno, L., Bonora, S., and Di Biagio, A.
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- 2019
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6. Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis
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Solari, Alessandra, Giordano, Andrea, Patti, Francesco, Grasso, Maria Grazia, Confalonieri, Paolo, Palmisano, Lucia, Ponzio, Michela, Borreani, Claudia, Rosato, Rosalba, Veronese, Simone, Zaratin, Paola, and Battaglia, Mario Alberto
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Multiple sclerosis ,caregivers ,symptom burden ,palliative care ,quality of life ,randomized controlled trial - Published
- 2017
7. Immune Activation and Microbial Translocation Markers in HIV-Exposed Uninfected Malawian Infants in the First Year of Life.
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Baroncelli, Silvia, Galluzzo, Clementina Maria, Liotta, Giuseppe, Andreotti, Mauro, Mancinelli, Sandro, Mphwere, Robert, Bokola, Enok, Amici, Roberta, Marazzi, Maria Cristina, Palombi, Leonardo, Palmisano, Lucia, and Giuliano, Marina
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INFANTS ,FATTY acid-binding proteins ,MALARIA ,MICROBIAL products ,RESPIRATORY infections - Abstract
Background: HIV-exposed uninfected (HEU) infants show a high rate of morbidity. We aimed to investigate on biomarkers of immune activation/microbial translocation in HEU infants, evaluating the impact that infections/malnutrition can have on biomarker levels during the first year of life.Methods: Clinical data of 72 Malawian infants were recorded monthly and correlated with levels of soluble CD14 (sCD14), lipopolysaccharide-binding protein (LBP) and intestinal fatty acid-binding protein (I-FABP), analyzed longitudinally.Results: Levels of sCD14 and LBP showed a significant age-related increase. Higher levels of LBP (19.4 vs. 15.2 μg/ml) were associated with stunting, affecting 30% of the infants. The association remained statistically significant after adjusting for cytomegalovirus acquisition, malaria and respiratory infections (p = 0.031). I-FABP levels were significantly increased in infants experiencing gastrointestinal infections (1442.8 vs. 860.0 pg/ml, p = 0.018).Conclusion: We provide evidence that stunting is associated with an enhanced inflammatory response to microbial products in HEU children, suggesting that malnutrition status should be taken into consideration to better understand the alteration of the immune profile of HEU infants living in poor socioeconomic settings. [ABSTRACT FROM AUTHOR]- Published
- 2019
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8. Home-based palliative approach for people with severe multiple sclerosis and their carers: Study protocol for a randomized controlled trial
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Solari, Alessandra, Giordano, Andrea, Grasso, Maria Grazia, Confalonieri, Paolo, Patti, Francesco, Lugaresi, Alessandra, Palmisano, Lucia, Amadeo, Roberta, Martino, Giovanni, Ponzio, Michela, Casale, Giuseppe, Borreani, Claudia, Causarano, Renzo, Veronese, Simone, Zaratin, Paola, Battaglia, MARIO ALBERTO, Radice, D., Oliver, D. J., Pucci, E., Tesio, L., Cugno, C., Morino, P., Lopes de Carvalho, M. L., Giuntoli, M., Motta, R., Stefanelli, M. C., Bianchi, E., Giovannetti, A., Torri Clerici, V., Rossetti, E., Totis, A., Campanella, A., Martini, F., Fittipaldo, A., Ferrari, G., Mantegazza, R., Rossi, I., Troisi, E., Pompa, A., Tucci, L., Ippoliti, F., Morone, G., Fusco, A., Da Col, D., Lissoni, B., Pietrolongo, E., Onofrj, M., Cilia, S., Leone, C., Cascio, V., Cimino, V., Occhipinti, G., Pappalardo, A., Cavallaro, C., Zagari, F., and Alessandra Solari, Andrea Giordano, Maria Grazia Grasso, Paolo Confalonieri, Francesco Patti, Alessandra Lugaresi, Lucia Palmisano, Roberta Amadeo, Giovanni Martino, Michela Ponzio, Giuseppe Casale, Claudia Borreani, Renzo Causarano, Simone Veronese, Paola Zaratin, Mario Alberto Battaglia, PeNSAMI project
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Complex intervention ,Multiple sclerosis ,Palliative care ,Qualitative research ,Randomized controlled trial ,Home Care Service ,Pediatrics ,medicine.medical_specialty ,Medicine (miscellaneous) ,law.invention ,Quality of life (healthcare) ,law ,Intervention (counseling) ,Multiple Sclerosi ,medicine ,Single-Blind Method ,Pharmacology (medical) ,Clinical Protocol ,business.industry ,Caregiver ,Focus group ,Clinical trial ,Mood ,Family medicine ,business ,Human - Abstract
Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient’s caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner’s visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients’ caring physicians). The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention. The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124 ) on 19 June 2014.
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- 2015
9. Microbial translocation and T cell activation are modified by direct‐acting antiviral therapy in HCV‐infected patients.
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Lattanzi, Barbara, Baroncelli, Silvia, De Santis, Adriano, Galluzzo, Clementina Maria, Mennini, Gianluca, Michelini, Zuleika, Lupo, Marinella, Ginanni Corradini, Stefano, Rossi, Massimo, Palmisano, Lucia, and Merli, Manuela
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GUT microbiome ,HEPATITIS C ,ANTIVIRAL agents ,LIVER transplantation ,LIPOPOLYSACCHARIDES - Abstract
Summary: Background: Microbial translocation from the gut lumen has been involved in the pathogenesis of liver damage in hepatitis C virus (HCV) infection. Aim: To investigate the impact of direct‐acting antiviral treatment on microbial translocation and T‐cell activation, in patients with hepatitis C‐related liver disease. Methods: We enrolled two groups of HCV‐infected patients undergoing direct‐acting antiviral treatment: patients with fibrosis ≥F3 according to Metavir (Group ≥F3); patients with hepatitis C recurrence after liver transplantation and Metavir ≥F2 (Group Liver Transplantation + ≥F2). All patients were treated with direct‐acting antivirals based on ongoing guidelines. Surrogate biomarkers of microbial translocation (plasma concentrations of soluble‐CD14, lipopolysaccharide‐binding protein and intestinal fatty acid‐binding protein) were evaluated at baseline, at first month, at the end of treatment and 3 months later. T‐cell activation was measured by expression of CD38+ HLA‐DR at the same time points, only in Group ≥F3. Results: There were 32 patients in Group ≥F3 and 13 in Group LT + ≥F2. At baseline, levels of soluble‐CD14 and lipopolysaccharide‐binding protein were significantly higher in both groups vs healthy controls. Baseline soluble‐CD14 correlated with glutamic‐oxalacetic transaminase (r = 0.384, P = 0.009) and glutamic‐pyruvic transaminase (r = 0.293, P = 0.05). A significant decrease in plasma levels of surrogate microbial translocation biomarkers was observed during and after treatment in the two groups although values were not normalised. In Group ≥F3, CD38+ HLADR+ T‐cell expression was significantly decreased by direct‐acting antiviral treatment. Relapsers (9%) showed higher soluble‐CD14 levels at baseline. Conclusion: Surrogate microbial translocation markers and T cell activation are increased in HCV‐infected patients with liver fibrosis and decrease during direct‐acting antiviral treatment. [ABSTRACT FROM AUTHOR]
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- 2018
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10. Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis.
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Solari, Alessandra, Giordano, Andrea, Patti, Francesco, Grasso, Maria Grazia, Confalonieri, Paolo, Palmisano, Lucia, Ponzio, Michela, Borreani, Claudia, Rosato, Rosalba, Veronese, Simone, Zaratin, Paola, and Battaglia, Mario Alberto
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PALLIATIVE treatment ,MULTIPLE sclerosis ,HEALTH outcome assessment ,QUALITY of life ,DYADS ,PATIENTS - Abstract
Background: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce. Objective: To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers. Methods: Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients). Results: Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC (p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis (p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes. Conclusion: HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes. [ABSTRACT FROM AUTHOR]
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- 2018
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11. Reduced Plasma Levels of sCD14 and I-FABP in HIV-infected Patients with Mesalazine-treated Ulcerative Colitis.
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Michelini, Zuleika, Baroncelli, Silvia, Fantauzzi, Alessandra, Pasquale, Chiara, Galluzzo, Clementina Maria, Sanchez, Massimo, Gatto, Manuela, Amici, Roberta, Franco, Marina, d'Ettorre, Gabriella, Fimiani, Caterina, Mezzaroma, Ivano, Vullo, Vincenzo, Merli, Manuela, and Palmisano, Lucia
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ULCERATIVE colitis ,COLITIS treatment ,MESALAMINE ,HIV-positive persons ,CD14 antigen ,FATTY acid-binding proteins ,BLOOD plasma ,THERAPEUTICS - Abstract
Background:Microbial translocation (MT) is a shared feature of HIV infection and inflammatory bowel disease (IBD).Aims:This study was conducted to assess the impact of IBD (and particularly ulcerative colitis, UC) on plasma markers of MT and immune activation in HIV+ subjects. Methods:A cross-sectional study was conducted in 3 groups of patients: HIV+/UC+(group HIV/UC); HIV+/UC- (group HIV); HIV-/UC+(group UC). Plasma levels of soluble CD14 (sCD14), intestinal fatty acid-binding protein (I-FABP), and endotoxin core antibodies (endoCAB) were measured as plasma markers of MT. Inflammation and immune activation were evaluated by measuring plasma levels of IL-6, IL-21, TNF-alpha, and high-sensitivity C-reactive protein (hs-CRP). T- and B-cells subpopulations were characterized by FACS analysis. Results:Seven patients were enrolled in group HIV/UC, 9 in HIV, and 10 in UC. All HIV-positive patients had plasma values of HIV-1 RNA < 37 copies/mL for at least 12 months and good immunological recovery. All patients with UC were treated with oral mesalazine. Markers of MT, immune activation, and inflammation were not increased in subjects with HIV/UC. In fact, they had lower levels of I-FABP (p = 0.001) and sCD14 (p = 0.007) when compared to other patients groups. Positive correlations were found between I-FABP and sCD14 (r = .355,p = 0.076). Frequency of T- and B-cell subsets did not differ among groups. Conclusions:Our results suggest that UC does not worsen MT, inflammation, or immune activation in HIV-infected subjects. The anti-inflammatory activity of chronic mesalazine administration on intestinal mucosa may contribute to this finding. [ABSTRACT FROM AUTHOR]
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- 2016
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12. Unmet Needs of People with Severe Multiple Sclerosis and Their Carers: Qualitative Findings for a Home-Based Intervention.
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Borreani, Claudia, Bianchi, Elisabetta, Pietrolongo, Erika, Rossi, Ilaria, Cilia, Sabina, Giuntoli, Miranda, Giordano, Andrea, Confalonieri, Paolo, Lugaresi, Alessandra, Patti, Francesco, Grasso, Maria Grazia, de Carvalho, Laura Lopes, Palmisano, Lucia, Zaratin, Paola, Battaglia, Mario Alberto, and Solari, Alessandra
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MULTIPLE sclerosis ,STAKEHOLDERS ,DISEASE progression ,PALLIATIVE treatment ,HOME care services - Abstract
Background: Few data on services for people with severe multiple sclerosis (MS) are available. The Palliative Network for Severely Affected Adults with MS in Italy (PeNSAMI) developed a home palliative care program for MS patients and carers, preceded by a literature review and qualitative study (here reported). Objective: To identify unmet needs of people with severe MS living at home by qualitative research involving key stakeholders, and theorize broad areas of intervention to meet those needs. Method: Data were collected from: at least 10 personal interviews with adults with severe MS (primary/secondary progressive, EDSS≥8.0); three focus group meetings (FGs) of carers of people with severe MS; and two FGs of health professionals (HPs). Grounded theory guided the analysis of interview and FG transcripts, from which the areas of intervention were theorized. Results: Between October 2012 and May 2013, 22 MS patients, 30 carers and 18 HPs participated. Forty-eight needs themes were identified, grouped into 14 categories and four domains. Seven, highly interdependent intervention areas were theorized. Patients had difficulties expressing needs; experiences of burden and loneliness were prominent, chiefly in dysfunctional, less affluent families, and among parent carers. Needs differed across Italy with requirements for information and access to services highest in the South. All participants voiced a strong need for qualified personnel and care coordination in day-to-day home care. Personal hygiene emerged as crucial, as did the need for a supportive network and preservation of patient/carer roles within family and community. Conclusions: Unmet needs transcended medical issues and embraced organizational and psychosocial themes, as well as health policies. The high interdependence of the seven intervention areas theorized is in line with the multifaceted approach of palliative care. At variance with typical palliative contexts, coping with disability rather than end-of-life was a major concern of patients and carers. [ABSTRACT FROM AUTHOR]
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- 2014
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13. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial.
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Menichetti, Francesco, Popoli, Patrizia, Puopolo, Maria, Spila Alegiani, Stefania, Tiseo, Giusy, Bartoloni, Alessandro, De Socio, Giuseppe Vittorio, Luchi, Sauro, Blanc, Pierluigi, Puoti, Massimo, Toschi, Elena, Massari, Marco, Palmisano, Lucia, Marano, Giuseppe, Chiamenti, Margherita, Martinelli, Laura, Franchi, Silvia, Pallotto, Carlo, Suardi, Lorenzo Roberto, and Luciani Pasqua, Barbara
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- 2021
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14. Low quality of life and psychological wellbeing contrast with moderate perceived burden in carers of people with severe multiple sclerosis.
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Giordano, Andrea, Cimino, Vincenzo, Campanella, Angela, Morone, Giovanni, Fusco, Augusto, Farinotti, Mariangela, Palmisano, Lucia, Confalonieri, Paolo, Lugaresi, Alessandra, Grasso, Maria Grazia, Ponzio, Michela, Veronese, Simone, Patti, Francesco, and Solari, Alessandra
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MULTIPLE sclerosis , *MULTIPLE sclerosis treatment , *QUALITY of life , *PSYCHOLOGICAL well-being , *MEDICAL care , *PALLIATIVE treatment , *PATIENTS , *PHYSIOLOGY - Abstract
Background Few studies have investigated wellbeing and burden in carers of people with severe multiple sclerosis (PwSMS). Objectives To assess the impact of providing care to PwSMS, and explore variables associated with perceived carer burden. Methods Cross-sectional assessment of health-related quality of life (HRQOL), mood symptoms (Hospital Anxiety and Depression Scale, HADS), and perceived carer burden (22-item Zarit Burden Interview, ZBI) in 78 PwSMS carers. Multivariate linear regression explored carer and PwSMS factors associated with ZBI score. Results Carers (61% women, mean age 60.2 years, 53% spouse/partner) had significantly lower HRQOL (all SF-36 scales) than the norm, especially for Role Limitation Emotional/Physical, and Emotional Wellbeing. Sixty-eight percent had pathologic (≥ 8) Anxiety, and 44% had pathologic Depression scores on HADS. Nonetheless, perceived carer burden was only moderate (mean ZBI score 35.6, SD 14.3). High carer anxiety (p < 0.0001), low household income (p = 0.009), and living with the PwSMS (p = 0.02) were independent predictors of perceived burden. Conclusions Caring for PwSMS has a detrimental effect on HRQOL and psychological wellbeing. High carer anxiety, low economic status, and living in predict higher burden. It is crucial to recognize PwSMS carers as full partners in the provision of care, and to respond to their own needs. [ABSTRACT FROM AUTHOR]
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- 2016
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15. Low quality of life and psychological wellbeing contrast with moderate perceived burden in carers of people with severe multiple sclerosis
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Giordano, A, Cimino, V, Campanella, A, Morone, G, Fusco, A, Farinotti, Palmisano, L, Confalonieri, P, Lugaresi, A, Grasso, Mg, Ponzio, M, Veronese, S, Patti, Francesco, Solari, A, on behalf of the, Pensami, Project, Giordano, Andrea, Cimino, Vincenzo, Campanella, Angela, Morone, Giovanni, Fusco, Augusto, Farinotti, Mariangela, Palmisano, Lucia, Confalonieri, Paolo, Lugaresi, Alessandra, Grasso, Maria Grazia, Ponzio, Michela, Veronese, Simone, Patti, Francesco, Solari, Alessandra, and PeNSAMI project
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Male ,Palliative care ,health care facilities, manpower, and services ,Hospital Anxiety and Depression Scale ,Severity of Illness Index ,Outcome measure ,0302 clinical medicine ,Primary progressive multiple sclerosis ,Cost of Illness ,Surveys and Questionnaires ,Medicine ,030212 general & internal medicine ,Depression (differential diagnoses) ,health care economics and organizations ,Aged, 80 and over ,Secondary progressive multiple sclerosis ,Illness burden ,Middle Aged ,humanities ,Caregivers ,Neurology ,Spouse ,behavior and behavior mechanisms ,Anxiety ,Secondary progressive multiple sclerosi ,Female ,medicine.symptom ,Clinical psychology ,Adult ,Employment ,Quality of life ,Multiple Sclerosis ,03 medical and health sciences ,Young Adult ,Quality of life (healthcare) ,Humans ,Socioeconomic status ,Aged ,Psychiatric Status Rating Scales ,business.industry ,social sciences ,Caregiver ,Mood ,Cross-Sectional Studies ,Primary progressive multiple sclerosi ,Socioeconomic Factors ,Multivariate Analysis ,Linear Models ,Perception ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Background: Few studies have investigated wellbeing and burden in carers of peoplewith severe multiple sclerosis (PwSMS). Objectives: To assess the impact of providing care to PwSMS, and explore variables associated with perceived carer burden. Methods: Cross-sectional assessment of health-related quality of life (HRQOL), mood symptoms (Hospital Anxiety and Depression Scale, HADS), and perceived carer burden (22-item Zarit Burden Interview, ZBI) in 78 PwSMS carers. Multivariate linear regression explored carer and PwSMS factors associated with ZBI score. Results: Carers (61%women, mean age 60.2 years, 53% spouse/partner) had significantly lower HRQOL (all SF-36 scales) than the norm, especially for Role Limitation Emotional/Physical, and Emotional Wellbeing. Sixty-eight percent had pathologic (≥8) Anxiety, and 44% had pathologic Depression scores on HADS. Nonetheless, perceived carer burdenwas only moderate (mean ZBI score 35.6, SD 14.3). High carer anxiety (p < 0.0001), low household income (p= 0.009), and living with the PwSMS (p= 0.02) were independent predictors of perceived burden. Conclusions: Caring for PwSMS has a detrimental effect on HRQOL and psychological wellbeing. High carer anxiety, loweconomic status, and living in predict higher burden. It is crucial to recognize PwSMS carers as full partners in the provision of care, and to respond to their own needs.
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- 2016
16. European survey on national harmonization in clinical research.
- Author
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Magnin A, Iversen VC, Calvo G, Čečetková B, Dale O, Demlová R, Blaskó G, Keane F, Kovacs GL, Levy-Marchal C, Monteiro EC, Palmisano L, Pella D, Portolés A, Rascol O, Schmid C, Tay F, von der Leyen H, and Ohmann C
- Abstract
Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe., Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action., Results: Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know-how and documents. Since harmonization was mainly a bottom-up approach up until now, the extent and topics dealt with are diverse and there is only little cross-networking and cross-country exchange so far., Conclusions: Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country., Competing Interests: The authors affirm that they have no conflicts of interest to disclose. This survey was conducted with no external funding or specific internal funding and was done within the usual employment contracts., (© 2020 The Authors. Learning Health Systems published by Wiley Periodicals, Inc. on behalf of the University of Michigan.)
- Published
- 2020
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17. Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis.
- Author
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Solari A, Giordano A, Patti F, Grasso MG, Confalonieri P, Palmisano L, Ponzio M, Borreani C, Rosato R, Veronese S, Zaratin P, and Battaglia MA
- Subjects
- Activities of Daily Living, Aftercare, Aged, Caregivers, Disease Progression, Female, Homebound Persons, Humans, Italy, Male, Middle Aged, Multiple Sclerosis mortality, Multivariate Analysis, Quality of Life, Severity of Illness Index, Treatment Outcome, Home Care Services, Multiple Sclerosis pathology, Multiple Sclerosis therapy, Palliative Care methods
- Abstract
Background: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce., Objective: To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers., Methods: Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients)., Results: Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC ( p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis ( p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes., Conclusion: HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.
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- 2018
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18. Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.
- Author
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Solari A, Giordano A, Grasso MG, Confalonieri P, Patti F, Lugaresi A, Palmisano L, Amadeo R, Martino G, Ponzio M, Casale G, Borreani C, Causarano R, Veronese S, Zaratin P, and Battaglia MA
- Subjects
- Caregivers, Humans, Single-Blind Method, Clinical Protocols, Home Care Services, Multiple Sclerosis therapy, Palliative Care
- Abstract
Background: Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers., Methods/design: This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient's caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner's visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients' caring physicians)., Discussion: The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention., Trial Registration: The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.
- Published
- 2015
- Full Text
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