19 results on '"Plano F"'
Search Results
2. Idiopathic chronic inflammatory demyelinating polyneuropathy: an epidemiological study in Italy
- Author
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Chio, A., Cocito, D., Bottacchi, E., Buffa, C., Leone, M., Plano, F., Mutani, R., and Calvo, A.
- Subjects
Guillain-Barre syndrome -- Diagnosis ,Guillain-Barre syndrome -- Care and treatment ,Epidemiology -- Research ,Immunological adjuvants -- Dosage and administration ,Health ,Psychology and mental health - Published
- 2007
3. Comorbidity between CIDP and diabetes mellitus: only a matter of chance?
- Author
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Chiò, A., Plano, F., Calvo, A., Leone, M., Mutani, R., and Cocito, D.
- Published
- 2009
- Full Text
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4. Reply to “Misconceptions in the assessment of cough peak flow measurements for extubation or decanulation protocols”
- Author
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Winck, J.C., primary, LeBlanc, C., additional, Soto, J.L., additional, and Plano, F., additional
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- 2015
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5. The value of cough peak flow measurements in the assessment of extubation or decannulation readiness
- Author
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Winck, J.C., primary, LeBlanc, C., additional, Soto, J.L., additional, and Plano, F., additional
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- 2015
- Full Text
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6. Comorbidity between CIDP and diabetes mellitus: only a matter of chance?
- Author
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Chio', Adriano, Plano, F, Calvo, Andrea, Leone, M, Mutani, Roberto, Cocito, D, Terreni, Aa, Calvo, A, Ghiglione, P, Mutani, R, Sciolla, R, Durelli, Luca, Gaviani, P, Monaco, Francesco, Comitangelo, R, Sosso, L, Gionco, M, Nobili, M, Appendino, L, Buffa, C, Cavallo, R, Oddenino, E, Ferrari, G, Favero, M, Doriguzzi Bozzo, C, Santamaria, P, Massazza, U, Villani, A, Conti, R, Mora, G, Palermo, M, Vergnano, F, Aguggia, M, Penza, Mt, Fassio, F, Di Vito, N, Meineri, P, Seliak, D, Dutto, A, Dotta, M, Astegiano, G, Corso, G, and Bottacchi, E.
- Subjects
Adult ,Male ,medicine.medical_specialty ,Time Factors ,Population ,Chronic inflammatory demyelinating polyneuropathy ,Comorbidity ,Diabetes Complications ,Age Distribution ,Risk Factors ,Internal medicine ,Diabetes mellitus ,Epidemiology ,medicine ,Diabetes Mellitus ,Prevalence ,Humans ,Age of Onset ,Sex Distribution ,education ,Aged ,education.field_of_study ,business.industry ,Clinical course ,Cerebrospinal Fluid Proteins ,Middle Aged ,medicine.disease ,Confidence interval ,Surgery ,Causality ,Early Diagnosis ,Neurology ,Italy ,Polyradiculoneuropathy, Chronic Inflammatory Demyelinating ,Disease Progression ,Female ,Neurology (clinical) ,Age of onset ,business - Abstract
Background and purpose: It is well known that chronic inflammatory demyelinating polyneuropathy (CIDP) and diabetes mellitus (DM) are often associated, but it is not clear if these two disorders are patogenetically correlated. Methods: An epidemiological study on CIDP in two Italian regions (population 4 334 225) was performed, using multiple concurrent sources of cases. The presence of DM was assessed on basis of the data reported in the clinical records of each patient. Standardized morbidity ratio (SMR) was calculated, using as reference the prevalence of DM in northern Italy. Results: At the prevalence day 155 patients with CIDP resident in Piemonte and Valle d’Aosta were found. Of these, 14 were also affected by either type 1 or type 2 DM. The number of expected individuals with associated DM was 13.03, corresponding to a SMR of 1.07 [95% confidence intervals (CI), 0.58–1.80]. Patients with CIDP associated with DM had a higher level of CSF proteins and a longer delay from onset to diagnosis than patients without DM, but did not differ for age of onset, gender distribution, and type of clinical course. Conclusions: Our epidemiological findings do not support a pathogenetic correlation between DM and CIDP.
- Published
- 2009
7. Validity of hospital morbidity records for amyotrophic lateral sclerosis. A population-based study
- Author
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Chio', Adriano, Ciccone, G, Calvo, Andrea, Vercellino, M, Di Vito, N, Ghiglione, Paolo, Mutani, Roberto, Plano, F, Bertolotto, A, Bottacchi, E, Cocito, D, Giordana, Maria Teresa, Leone, M, Mazzini, L, Mora, G, Terreni, A, Schiffer, D, Bergamasco, B, Rainero, Innocenzo, Tribolo, A, Sciolla, R, Mondino, F, Gaviani, P, Monaco, F, De Mattei, M, Morgando, E, Sosso, L, Gionco, M, Morino, U, Nobili, M, Appendino, L, Piazza, D, Oddenino, E, Liboni, W, Vaula, G, Ferrari, G, Favero, M, Doriguzzi Bozzo, C, Santamaria, P, Massazza, U, Bollani, E, Villani, A, Conti, R, Balzarini, C, Palermo, M, Vergnano, F, Cordera, S, Buffa, C, Penza, Mt, Fassio, F, Meineri, P, Cognazzo, A, Mocellini, C, Dutto, A, Cucatto, A, Cavestro, C, Troni, W, and Corso, G.
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Adult ,Aged, 80 and over ,Male ,Amyotrophic Lateral Sclerosis ,Middle Aged ,Sensitivity and Specificity ,Medical Records ,Patient Discharge ,Hospitalization ,Italy ,Humans ,amyotrophic lateral sclerosis ,hospital morbidity ,Female ,Forms and Records Control ,Prospective Studies ,Registries ,Aged - Abstract
The validity of discharge diagnosis of amyotrophic lateral sclerosis (ALS) and of the main procedures performed during hospitalization was assessed using as gold standard the data from the Piemonte and Valle d'Aosta Register for ALS (PARALS), a collaborative population-based registry aimed at determining prospectively the incidence and the factors related to ALS outcome. All patients discharged with ICD code 335.2 (primary and secondary diagnoses) in the period 1995-1996 in Piemonte, Italy, were considered. Out of the 1,049 cases identified, 433 remained after excluding patients not resident in Piemonte and repeated admissions. Of these, 258 had a correct diagnosis of ALS (168 incident and 90 prevalent cases) after a review of clinical records. The sensitivity of discharge diagnoses was 78.9%, and the positive predictive value was 38.8%. The sensitivity for main procedures (percutaneous endoscopic gastrostomy, noninvasive ventilation, and tracheostomy) ranged between 76 and 100%. ICD codes allowed to identify 22 cases that had not been ascertained with other sources. In conclusion, hospital discharge records appear to poorly reflect the incidence of ALS, and can be used only after clinical verification of the diagnosis.
- Published
- 2002
8. Prescription of Antibiotics in Intensive Care Units in Latin America: An Observational Study
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Curcio, D., primary, Alí, A., additional, Duarte, A., additional, Defilippi Pauta, A., additional, Ibáñez-Guzmán, C., additional, Chung Sang, M., additional, Valencia, E., additional, Plano, F., additional, Paredes Oña, F., additional, Arancibia, F., additional, Montufar Andrade, F., additional, Morales Alava, F., additional, Cañarte Bermudez, G., additional, La Fuente Zerain, G., additional, Alanis Mirones, V., additional, Rojas Suarez, J., additional, Guzmán Torrico, J., additional, Silva, J., additional, Vergara Centeno, J., additional, Medina, J.C., additional, Marín, K., additional, Caero, L.A., additional, Durán Crespo, L., additional, Gómez Duque, M., additional, Játiva, M., additional, Belloni, R., additional, Romero, R., additional, Aguilera Perrogón, R., additional, Camacho Alarcón, R., additional, Camargo, R., additional, Cevallos, S., additional, Intriago Cedeño, V., additional, and Urbina Contreras, Z., additional
- Published
- 2009
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9. Cortical pathology in multiple sclerosis: expression of glutamate transporter EAAT2
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Vercellino, M., Merola, A., Masera, S., Plano, F., Votta, B., Capello, E., giovanni luigi mancardi, Giordana, M. T., Mutani, R., and Cavalla, P.
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multiple sclerosis ,neuropathology ,cortical damage
10. Measurable therapeutic antibody in serum as potential predictive factor of response to anti-CD38 therapy in non-IgG-k myeloma patients.
- Author
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Gigliotta E, Plano F, Corsale G, Corsale AM, Aquilina C, Speciale M, Rizzuto A, Martino EA, Leotta D, Solimando AG, Ria R, Gentile M, Siragusa S, and Botta C
- Abstract
Multiple myeloma (MM) is a hematologic malignancy characterized by abnormal plasma cell proliferation in the bone marrow. Recent advancements in anti-CD38 monoclonal antibody therapies, such as daratumumab and isatuximab, have significantly improved MM patient survival. However, the lack of predictive factors of response to these therapies remains a challenge. Notably, anti-CD38 antibodies can interfere with laboratory tests, complicating response assessment. We conducted a retrospective study to evaluate the association between the appearance of positive IgGk (therapeutic antibody) on immunofixation/immunosubtraction (IF) and clinical parameters in 87 non-IgGk MM patients treated with anti-CD38 therapy. Positive IgGk IF was observed in 42 patients after a median of three treatment courses. Patients with positive IgGk IF had higher rates of complete/very good partial responses (p = 0.03) and improved progression-free survival (median not reached vs. 21.83 months, p < 0.01). High BMI (p = 0.03), higher hemoglobin (p = 0.02), lower CRP (p = 0.04), and lower monoclonal protein levels (p = 0.03) were associated with positive IgGk IF. Our findings suggest that monitoring therapeutic antibody appearance on IF may predict and optimize anti-CD38 therapy in MM. Potential explanations include the impact of patient factors (e.g. BMI) on drug pharmacokinetics, the relationship between antibody levels and immune response, and the influence of tumor biology. Further research is needed to elucidate the underlying mechanisms and clinical utility of this biomarker. Nonetheless, our results highlight the importance of considering therapeutic antibody detection when interpreting laboratory tests and managing MM patients receiving anti-CD38 therapies., (© 2024. The Author(s).)
- Published
- 2024
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11. A Multicentric Castleman Disease Associated with Mixed Warm and Cold Antibody-Mediated AHA Responsive to Siltuximab.
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Plano F, Mancuso S, Camarda GM, Butera MG, Sucato G, Alecci G, Florena AM, Perrone S, and Siragusa SM
- Subjects
- Male, Humans, Rituximab therapeutic use, Antibodies, Monoclonal therapeutic use, Hemoglobins, Castleman Disease diagnosis, Castleman Disease drug therapy, Castleman Disease complications
- Abstract
Castleman disease is non-clonal lymphoproliferative disorders defined by hypertrophy of lymph nodes. The multicentric form (MCD), in which multiple lymph node stations are involved, is not associated with HHV8 infection, but considered idiopathic, although IL-6 appears to play a central role in its pathogenesis. Here, we report the case of a patient who presented with mixed autoimmune hemolytic anemia (AIHA) and adenopathy that was very challenging to diagnose due to very low values of hemoglobin and refractoriness of obtaining any improvement of AIHA with standard first and second lines of therapy (steroids, rituximab, immunoglobulin, erythropoietin, and cyclosporine). When we safely proceeded to lymph node biopsy, a diagnosis of MCD was established. This permitted the treatment with siltuximab, an anti-IL-6 monoclonal antibody. After only 1 week, hemoglobin raised and he was discharged. After 1 year, he was still in remission. This case underlines the challenges in diagnosis of MCD, and the first case of response to siltuximab after the failure of rituximab to relieve mixed AIHA., (© 2023 S. Karger AG, Basel.)
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- 2024
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12. Humoral and Cell-Mediated Responses to SARS-CoV-2 Vaccination in a Cohort of Immunodeficient Patients.
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Plano F, Shekarkar Azgomi M, Corsale AM, Spoto C, Caccamo N, Meraviglia S, Dieli F, D'Angelo P, Trizzino A, and Siragusa S
- Abstract
This study delves into the intricate landscape of SARS-CoV-2 vaccine response in immunodeficient patients, focusing on the dynamics of both humoral and cell-mediated immunity. The cohort includes patients with common variable immunodeficiency (CVI), agammaglobulinemia (XLA), and combined immunodeficiency (CI). The findings reveal varying degrees of antibody production, with XLA patients exhibiting no measurable response but displaying a robust T-cell-mediated response. The study emphasizes the importance of considering both arms of the immune system in assessing vaccine immunogenicity, particularly in the context of immunodeficiency. The results challenge conventional measures of vaccine efficacy only based on antibody titers, highlighting the need for a more comprehensive understanding of the immune response in this vulnerable population. This research contributes valuable insights to guide clinical decisions regarding vaccination strategies, booster doses, and overall protection in immunodeficient individuals.
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- 2023
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13. Ferritin Metabolism Reflects Multiple Myeloma Microenvironment and Predicts Patient Outcome.
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Plano F, Gigliotta E, Corsale AM, Azgomi MS, Santonocito C, Ingrascì M, Di Carlo L, Augello AE, Speciale M, Vullo C, Rotolo C, Camarda GM, Caccamo N, Meraviglia S, Dieli F, Siragusa S, and Botta C
- Subjects
- Humans, Ferritins genetics, Ferritins metabolism, Bone Marrow metabolism, Gene Expression Profiling, Tumor Microenvironment genetics, Multiple Myeloma pathology, Monoclonal Gammopathy of Undetermined Significance pathology
- Abstract
Multiple myeloma (MM) is a hematologic malignancy with a multistep evolutionary pattern, in which the pro-inflammatory and immunosuppressive microenvironment and genomic instability drive tumor evolution. MM microenvironment is rich in iron, released by pro-inflammatory cells from ferritin macromolecules, which contributes to ROS production and cellular damage. In this study, we showed that ferritin increases from indolent to active gammopathies and that patients with low serum ferritin had longer first line PFS (42.6 vs. 20.7 months and, p = 0.047, respectively) and OS (NR vs. 75.1 months and p = 0.029, respectively). Moreover, ferritin levels correlated with systemic inflammation markers and with the presence of a specific bone marrow cell microenvironment (including increased MM cell infiltration). Finally, we verified by bioinformatic approaches in large transcriptomic and single cell datasets that a gene expression signature associated with ferritin biosynthesis correlated with worse outcome, MM cell proliferation, and specific immune cell profiles. Overall, we provide evidence of the role of ferritin as a predictive/prognostic factor in MM, setting the stage for future translational studies investigating ferritin and iron chelation as new targets for improving MM patient outcome.
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- 2023
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14. Monoclonal Gammopathies and the Bone Marrow Microenvironment: From Bench to Bedside and Then Back Again.
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Plano F, Corsale AM, Gigliotta E, Camarda G, Vullo C, Di Simone M, Shekarkar Azgomi M, Speciale M, Carlisi M, Caccamo N, Dieli F, Meraviglia S, Siragusa S, and Botta C
- Abstract
Multiple myeloma (MM) is an incurable hematologic malignancy characterized by a multistep evolutionary pathway, with an initial phase called monoclonal gammopathy of undetermined significance (MGUS), potentially evolving into the symptomatic disease, often preceded by an intermediate phase called "smoldering" MM (sMM). From a biological point of view, genomic alterations (translocations/deletions/mutations) are already present at the MGUS phase, thus rendering their role in disease evolution questionable. On the other hand, we currently know that changes in the bone marrow microenvironment (TME) could play a key role in MM evolution through a progressive shift towards a pro-inflammatory and immunosuppressive shape, which may drive cancer progression as well as clonal plasma cells migration, proliferation, survival, and drug resistance. Along this line, the major advancement in MM patients' survival has been achieved by the introduction of microenvironment-oriented drugs (including immunomodulatory drugs and monoclonal antibodies). In this review, we summarized the role of the different components of the TME in MM evolution from MGUS as well as potential novel therapeutic targets/opportunities.
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- 2023
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15. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial.
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Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Medina MF, Achinelli F, Guglielmone HA, Ojeda J, Farizano Salazar D, Andino G, Kawerin P, Dellamea S, Aquino AC, Flores V, Martemucci CN, Martinez SM, Segovia JE, Reynoso PI, Sosa NC, Robledo ME, Guarrochena JM, Vernengo MM, Ruiz Diaz N, Meza E, and Aguirre MG
- Subjects
- Adult, Antiviral Agents adverse effects, COVID-19 etiology, COVID-19 virology, COVID-19 Nucleic Acid Testing, Double-Blind Method, Female, Hospitalization, Humans, Ivermectin adverse effects, Length of Stay, Male, Middle Aged, Nasopharynx virology, Placebos, Treatment Outcome, Antiviral Agents therapeutic use, Ivermectin therapeutic use, COVID-19 Drug Treatment
- Abstract
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients., Objective: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19., Design, Setting and Participants: A randomized, double-blind, placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021., Intervention: Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days., Main Outcomes and Measures: The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points., Results: The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3-6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32-1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes., Limitations: Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population., Conclusion: Ivermectin had no significant effect on preventing hospitalization of patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in their treatment. No significant differences were observed in any of the other secondary outcomes., Trial Registration: ClinicalTrials.gov NCT04529525 .
- Published
- 2021
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16. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial.
- Author
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Vallejos J, Zoni R, Bangher M, Villamandos S, Bobadilla A, Plano F, Campias C, Chaparro Campias E, Achinelli F, Guglielmone HA, Ojeda J, Medina F, Farizano Salazar D, Andino G, Ruiz Diaz NE, Kawerin P, Meza E, Dellamea S, Aquino A, Flores V, Martemucci CN, Vernengo MM, Martinez SM, Segovia JE, and Aguirre MG
- Subjects
- Adult, Antiparasitic Agents administration & dosage, Argentina epidemiology, COVID-19 epidemiology, COVID-19 virology, Case-Control Studies, Double-Blind Method, Female, Hospitalization statistics & numerical data, Humans, Ivermectin administration & dosage, Male, Pandemics prevention & control, Placebos administration & dosage, Prospective Studies, Time Factors, Antiparasitic Agents therapeutic use, Ivermectin therapeutic use, SARS-CoV-2 genetics, COVID-19 Drug Treatment
- Abstract
Objectives: To assess the efficacy of ivermectin in addition to standard treatment compared to standard treatment alone in reducing hospitalizations in the COVID-19 patient population., Trial Design: IVERCOR-COVID19 will be a single-center, prospective, randomized, double-blind, parallel group (1:1 ratio), placebo-controlled study., Participants: Patients who meet the following criteria will be invited to participate: Inclusion criteria: (1) Over 18 years of age who reside in the province of Corrientes at the time of diagnosis. (2) Confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test for detection of SARS-CoV2 in the last 48 h. (3) In the case of women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study and for the entire period of time for the duration of the study and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study). (4) Weight at the time of inclusion greater than 48 kg. (5) That they sign the informed consent for participation in the study., Exclusion Criteria: (1) pregnant or breastfeeding women; (2) known allergy to ivermectin or some of the components of ivermectin tablets or placebo; (3) current use of home oxygen; (4) require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19; (5) presence of mal-absorptive syndrome; (6) presence of any other concomitant acute infectious disease; (7) known history of severe liver disease, for example liver cirrhosis; (8) need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19; (9) need or use of hydroxychloroquine or chloroquine; (10) use of ivermectin up to 7 days prior to randomization; (11) patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months; and (12) current participation or in the last 30 days in a research study that has included the administration of a drug (Table 1). Table 1 Ivermectin/placebo dose according to patient weight Patient weight Ivermectin/placebo dose Total dose (mg) Equal to or greater than 48 kg and less than 80 kg 2 tablets of 6 mg each at the time of inclusion and 2 tablets 24 h after the first intake 24 Equal or greater than 80 kg and less than 110 kg 3 tablets of 6 mg each at the time of inclusion and 3 tablets 24 h after the first intake 36 Equal or greater than 110 kg 4 tablets of 6 mg each at the time of inclusion and 4 tablets 24 h after the first intake 48 The study will be carried out by the Ministry of Public Health of the Province of Corrientes (Argentina) in coordination with the Institute of Cardiology of Corrientes in the Province of Corrientes, Argentina., Intervention and Comparator: Intervention group: patients who are randomized to ivermectin will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg ivermectin; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of ivermectin; patients weighing more than 110 kg will receive 4 tablets of 6 mg ivermectin) the day they enter the study and the same dose 24 h after the first dose., Control Group: patients who are randomized to placebo will receive the dose according to their weight (patients up to 80 kg will receive 2 tablets of 6 mg placebo; patients with more than 80 kg and up to 110 kg will receive 3 tablets of 6 mg of placebo; patients weighing more than 110 kg will receive 4 tablets of 6 mg placebo) on the day they enter the study and the same dose 24 h after the first dose (Table 2). Table 2 Inclusion and exclusion criteria Inclusion criteria Exclusion criteria 1. Over 18 years of age who reside in the province of Corrientes at the time of diagnosis 1. Pregnant or breastfeeding women 2.Confirmed diagnosis of COVID-19 by polymerase chain reaction test for detection of SARS-CoV2 in the last 48 h 2. Known allergy to ivermectin or some of the components of ivermectin tablets or placebo 3. In case of being women of childbearing age, they must be using a contraceptive method of proven efficacy and safety (barrier, hormonal, or permanent contraceptives) for at least 3 months prior to inclusion in the present study, during the entire period of time for the duration of the study, and until at least 30 days after the end of this study. A woman will be considered to have no reproductive capacity if she is postmenopausal (at least 2 years without her menstrual cycles) or if she has undergone surgical sterilization (at least 1 month before the time of inviting her to participate in this study) 3. Current use of home oxygen 4. Weight at the time of inclusion equal to or greater than 48 kg 4. That require hospitalization due to COVID-19 at the time of diagnosis or history of hospitalization for COVID-19 5. That they sign the informed consent for participation in the study 5. Presence of mal-absorptive syndrome 6. Presence of any other concomitant acute infectious disease 7. Known history of severe liver disease, for example liver cirrhosis 8. Need or use of antiviral drugs at the time of admission for another viral pathology other than COVID-19 9. Need or use of hydroxychloroquine or chloroquine 10. Use of ivermectin up to 7 days prior to randomization 11. Patients on dialysis or who have required it in the last 2 months or who plan to do it in the next 2 months 12. Current participation or in the last 30 days in a research study that has included the administration of a drug MAIN OUTCOMES: Primary outcome will be the percentage of hospitalizations in patients with COVID-19 in the intervention and control groups., Secondary Outcomes: time to hospitalization in each of the arms of the study: number of days elapsed from the inclusion in the study until the hospitalization of the patient; percentage of use of invasive mechanical ventilation in each of the study arms: every patient who is connected to invasive mechanical ventilation after signing the informed consent and before the final study visit; time to invasive mechanical ventilation in each of the arms of the study: number of days elapsed from inclusion in the study to connection to invasive mechanical ventilation of the patient; percentage of patients requiring dialysis in each of the study arms: all patients who require renal replacement therapy of any kind, temporary or permanent, and which begins after signing the informed consent and before the final visit; mortality from all causes in each of the two trial groups: death of the patient, from any cause. Negative PCR swab at 3 ± 1 and 12 ± 2 days after entering the study. Ivermectin safety: it will be analyzed according to the incidence of adverse events that patients present in the intervention and control groups. The end of study (EOS) is recorded as the day the patient is discharged or death. Discharge will be granted according to the current recommendations of the Ministry of Public Health of the Province of Corrientes. A follow-up visit (EOF) will be made by phone 30 days after the EOS when vital status will be verified., Randomization: Randomization will be done through a web system with randomly permuted blocks. Randomization will be carried out by one of the investigators who will not participate in the inclusion of patients or in the delivery of medication (Table 3). Table 3 EOS end of study, EOF end of follow-up Visit Basal and randomization, day 0 Day 3 ± 1 Day 12 ± 2 V#1 V#2 V#3 EOS EOF Informed consent X - - - - Inclusion/exclusion criteria X - - - - Demographic data and medical history X - - - - Concomitant medication X - - - - Vital signs* X X - - - Anthropometric data
^ X - - - - Basal laboratory X - - - - PCR swab - X X - - Assessment of adverse events - X X X - Final objective evaluation - X X X X Randomization X - - - - Adherence to treatment X X - - - *Includes heart rate, temperature, and oxygen saturation by a digital saturometer ^Includes weight and height BLINDING (MASKING): The participants, investigators, care providers, and outcome assessors will be blinded., Numbers to Be Randomized (sample Size): We will include a total of 500 patients (250 patients in each group)., Trial Status: This is version 1.0, 17 August 2020. The recruitment started on 19 August 2020, and we anticipate the trial will finish recruitment on 31 December 2020., Trial Registration: ClinicalTrials.gov NCT04529525 . Registered on 26 August 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.- Published
- 2020
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17. Validation of the Multi-INdependence Dimensions (MIND) questionnaire for prolonged mechanically ventilated subjects.
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Winck JC, Gilet H, Kalin P, Murcia J, Plano F, Regnault A, Dreher M, Vitacca M, and Ambrosino N
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- Adult, Aged, Argentina, Colombia, Female, Germany, Health Status, Humans, Longitudinal Studies, Male, Middle Aged, Multivariate Analysis, Prospective Studies, Regression Analysis, Reproducibility of Results, Severity of Illness Index, Critical Illness therapy, Psychometrics instrumentation, Respiration, Artificial methods, Surveys and Questionnaires
- Abstract
Background: Evaluating severity of illness of patients with prolonged mechanical ventilation (PMV) is important to adopt the best appropriate care management for each individual. Yet, no severity-of-illness scoring system has been specifically designed for this type of patients. The aim of this study was to develop and validate a new instrument, the Multi-INdependence Dimensions (MIND) questionnaire designed to comprehensively measure the severity of illness of patients under PMV., Methods: The validation of the MIND questionnaire was performed during a longitudinal observational study conducted with PMV subjects in weaning facilities in three countries (Argentina, Colombia and Germany). The questionnaire validity was tested in 3 stages: 1) Specification of components, with description of item responses, inter-item and Cronbach alpha correlations; 2) Creation of the composite scores; 3) Measurement properties determination including test-retest reliability after 30 days, clinical validity (Medical Research Council (MRC) muscle strength score, Sepsis-related Organ Failure Assessment (SOFA), Glasgow Coma Scale (GCS), Dependence Nursing Scale and EuroQol-5 Dimension evaluated at inclusion), and ability to detect change., Results: A total of 128 subjects participated in the validation study. Eleven component scores and four composite scores were created. MIND scores significantly correlated with MRC muscle strength, SOFA, DNS, GCS and EQ-5D, supporting the validity of the new scores. Intraclass Correlation Coefficient greater than 0.82 were observed for all composite scores, indicating good test-retest reliability. MIND scores were able to detect improvement in subject severity of illness., Conclusion: The MIND questionnaire is a valid and reliable instrument for measuring comprehensively the multiple dimensions characterizing the severity of illness of PMV patients., Trial Registration: NCT02255058 .
- Published
- 2019
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18. Grey matter pathology in multiple sclerosis.
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Vercellino M, Plano F, Votta B, Mutani R, Giordana MT, and Cavalla P
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- Adult, Aged, Apoptosis, Brain metabolism, Brain pathology, Brain physiopathology, Cell Count, Female, Humans, Male, Middle Aged, Multiple Sclerosis physiopathology, Myelin Sheath pathology, Neurons pathology, Staining and Labeling, Ubiquitin metabolism, Multiple Sclerosis pathology, Periaqueductal Gray pathology
- Abstract
The aim of our study is to evaluate the extent and distribution of grey matter demyelinating lesions in multiple sclerosis (MS), addressing also neuronal loss and synaptic loss. Whole coronal sections of 6 MS brains and 6 control brains were selected. Immunohistochemistry was performed for myelin basic protein, neurofilaments, synaptophysin, ubiquitin, and activated caspase-3. Neuronal density and optical density of synaptophysin staining were estimated in cortical lesions and compared with those observed in corresponding areas of normal (i.e. nondemyelinated) cortex in the same section. Demyelinating lesions were observed in the cerebral cortex, in the thalamus, basal ganglia, and in the hippocampus. The percentage of demyelinated cortex was remarkable in 2 cases of secondary progressive MS (48% and 25.5%, respectively). Neuronal density was significantly reduced in cortical lesions (18-23% reduction), if compared with adjacent normal cortex, in the 2 cases showing the higher extent of cortical demyelination; in the same cases, very rare apoptotic neurons expressing caspase-3 were observed in cortical lesions and not in adjacent normal cortex. No significant decrease in optical density of synaptophysin staining was observed in cortical lesions. Grey matter demyelination and neuronal loss could contribute to disability and cognitive dysfunctions in MS.
- Published
- 2005
- Full Text
- View/download PDF
19. Conjugal amyotrophic lateral sclerosis: suggestion for the implication of environmental factors.
- Author
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Chiò A, Herrero Hernandez E, Discalzi G, Ghiglione P, Di Vito N, Calvo A, Vercellino M, Plano F, and Mutani R
- Subjects
- Amyotrophic Lateral Sclerosis blood, Amyotrophic Lateral Sclerosis urine, Female, Humans, Male, Metals analysis, Middle Aged, Soil analysis, Water analysis, Amyotrophic Lateral Sclerosis epidemiology, Environmental Exposure adverse effects, Spouses statistics & numerical data
- Published
- 2001
- Full Text
- View/download PDF
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