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Dataset related to article "Functional changes in the lower extremity after non-immersive virtual reality and physiotherapy following stroke"

DATASET #1 Variable description of the dataset from publication DOI: 10.2340/16501977-2763 ID_PATIENT = unique identifier of subject in the original clinical database ID_EVO4 = unique identifier of subject in the original device database for kinematic analysis AGE = given age of the subject at the time of assessment GENDER = given gender of the subject at the time of assessment ID_LESION = unique identifier of aetiology of the brain lesion (1 = ischemic lesion; 2 = haemorrhagic lesion) LESION_SIDE = unique identifier of hemisphere affected by the brain lesion (1 = right; 2 = left) MONTHS FROM LESION = time distance between time of assessment and stroke onset FM LE_PRE = Fugl-Meyer Assessment scale, lower limb section detected before treatment. This outcome measure assesses the impairment of motor function at the lower limb after stroke. MAS_PRE = FM LE_PRE = Modified Ashworth Scale at the ankle, knee and hip, detected before treatment. This outcome measure assesses the reaction to fast elongation of muscles. FIM_pre = Functional Independence Measure detected before treatment. This outcome measure assesses independence of the subject in the activities of daily living. 10MTWT_PRE = 10 meters walking test detected before treatment. This outcome measure assesses the time needed to cover 10 meters by walking. BERG_PRE = Berg Balance Scale detected before treatment. This outcome measure assesses impairment of balance function. FAC_PRE = BERG_PRE = Functional Ambulation Category detected before treatment. This outcome measure classifies autonomy in ambulation function. FM LE_POST = Fugl-Meyer Assessment scale, lower limb section detected after treatment. This outcome measure assesses the impairment of motor function at the lower limb after stroke. MAS_ POST = FM LE_PRE = Modified Ashworth Scale at the ankle, knee and hip, detected after treatment. This outcome measure assesses the reaction to fast elongation of muscles. FIM_ POST = Functional Independence Measure detected after treatment. This outcome measure assesses independence of the subject in the activities of daily living. 10MTWT_ POST = 10 meters walking test detected after treatment. This outcome measure assesses the time needed to cover 10 meters by walking. BERG_ POST = Berg Balance Scale detected after treatment. This outcome measure assesses impairment of balance function. FAC_ POST = BERG_PRE = Functional Ambulation Category detected after treatment. This outcome measure classifies autonomy in ambulation function. spatial error_PRE = this kinematic measure is the difference (computed as an area, mm2) between the trajectory performed by the patient in executing a standard motor task and the ideal one that should be performed. Time_PRE = this kinematic measure is the overall time (s) needed by the patient to perform a standard motor task, before the treatment. Lenght_PRE = this kinematic measure is the overall distance (mm) covered by the patient to perform a standard motor task, before the treatment. speed_PRE = this kinematic measure is the mean velocity (m/s) expressed by the patient to perform a standard motor task, before the treatment. peak_PRE = this kinematic measure is the jerk (m/s2) expressed by the patient to perform a standard motor task, before the treatment. spatial error_POST = this kinematic measure is the difference (computed as an area, mm2) between the trajectory performed by the patient in executing a standard motor task and the ideal one that should be performed. Time_ POST = this kinematic measure is the overall time (s) needed by the patient to perform a standard motor task, before the treatment. Lenght_ POST = this kinematic measure is the overall distance (mm) covered by the patient to perform a standard motor task, before the treatment. speed_ POST = this kinematic measure is the mean velocity (m/s) expressed by the patient to perform a standard motor task, before the treatment. peak_ POST = this kinematic measure is the jerk (m/s2) expressed by the patient to perform a standard motor task, before the treatment.

Dataset related to article: "Diffuse idiopathic skeletal hyperostosis in subjects with congestive heart failure undergoing cardiac rehabilitation: A decision tree analysis"

We provide the raw data used for the following article: <ul> <li> Ambrosino P, Scrutinio D, De Campi M, Miniero E, Formisano R, Spedicato GA, Iannuzzi GL, Pappone N. Diffuse idiopathic skeletal hyperostosis in subjects with congestive heart failure undergoing cardiac rehabilitation: A decision tree analysis. "J Rehabil Med". 2020 Mar 18;52(3):jrm00030. doi: 10.2340/16501977-2658. PMID: 32104899. </li> </ul>   Abstract Objective: To assess the prevalence of diffuse idiopathic skeletal hyperostosis and its relationship with vascular risk factors among patients with congestive heart failure. Design: Population-based cross-sectional study. Participants: A total of 584 consecutive patients admitted to a Rehabilitative Cardiology Unit. Methods: Chi-square Automatic Interaction Detector (CHAID) decision tree analysis was used to build a predictive model. Results: The mean age (standard deviation) of the study population was 68.1 years (standard deviation 12.3), and 77.7% of the subjects were men. The overall prevalence of diffuse idiopathic skeletal hyperostosis in the cohort was 49.8%. Logistic regression analysis showed that age was a predictor of diffuse idiopathic skeletal hyperostosis (odds ratio: 1.034; 95% confidence interval 1.021-1.047, p < 0.001), with increasing odds ratios for increasing age tertiles. The CHAID prediction model identified 2 age "buckets": < 69 and ≥ 69 years. Patients ≥ 69 years had a diffuse idiopathic skeletal hyperostosis prevalence of 60.1%, compared with 39.2% among those < 69 years. Notably, body mass index was a predictor of diffuse idiopathic skeletal hyperostosis in this younger subset of patients (p = 0.028), with 2 body mass index "buckets", ≤ 23.3 and > 23.3 kg/m2, the latter showing more than twice the prevalence of diffuse idiopathic skeletal hyperostosis (43.2% vs 20%). Conclusion: Diffuse idiopathic skeletal hyperostosis is extremely frequent among patients with congestive heart failure, with age and body mass index being the strongest predictors.

Dataset related to article: "Smart Flow for the evaluation of the hemodialysis arteriovenous fistula"

We provide the raw data used for the following article: <ul> <li>Colucci M, Torreggiani M, Bernardi I, Stangalino S, Catucci D, Esposito V, Sileno G, Esposito C. Smart Flow for the evaluation of the hemodialysis arteriovenous fistula. "J Vasc Access". 2020 Sep;21(5):652-657. doi: 10.1177/1129729819897171. Epub 2020 Jan 2. PMID: 31894718.</li> </ul> Background: Smart Flow is an innovative tool available on the Carestream Touch Prime Ultrasound machines, which provides automated blood flow measurement and shows the vectors that form the blood flow in the vessel. We compared the use of Smart Flow with traditional Duplex Doppler Ultrasound to evaluate blood flow of arteriovenous fistulas in prevalent hemodialysis patients. Methods: A total of 31 chronic patients on hemodialysis were enrolled. Blood flow was measured on the brachial artery with Smart Flow and duplex Doppler ultrasound. In a subset of 26 patients, a video of the juxta-anastomotic efferent vein was recorded and analyzed to calculate an index of flow turbulence. Results: We enrolled 21 males and 10 females aged 68.52±11.64 years at the time of evaluation with an average arteriovenous fistulas vintage of 50.23±47.42 months and followed them up for 18.03±5.18 months. Smart Flow and Duplex Doppler Ultrasound blood flow measurements positively correlated (p<0.0001) in the same patient but Smart Flow gave higher blood flow values (995.0 vs 730.3mL/min, p<0.0001), and the Duplex Doppler Ultrasound blood flow standard deviation was similar to Smart Flow (125.4 vs 114.4mL/min, p<0.0001). The time needed to evaluate arteriovenous fistulas with Smart Flow was significantly shorter than Duplex Doppler Ultrasound (67.58±19.89 vs 146.3±26.35 s, p<0.0001). No correlation was found between blood flow turbulence and the subsequent access failure. Conclusion: Smart Flow is reliable, reproducible, and faster than traditional duplex ultrasound. However, the additional information given by the Smart Flow technique does not seem to add any further benefits in terms of prediction of the access failure

Dataset related to article: "Laser photocoagulation therapy for thyroid nodules: long-term outcome and predictors of efficacy"

We provide the raw data used for the following article: <ul> <li>Magri F, Chytiris S, Molteni M, Croce L, Coperchini F, Rotondi M, Fonte R, Chiovato L. Laser photocoagulation therapy for thyroid nodules: long-term outcome and predictors of efficacy. "J Endocrinol Invest". 2020 Jan;43(1):95-100. doi: 10.1007/s40618-019-01085-8. Epub 2019 Jul 18. PMID: 31321758</li> </ul>   Abstract Purpose: The aim of the present study was to retrospectively evaluate the efficacy of interstitial laser photocoagulation (ILP) ablation of thyroid nodules during a 6-year follow-up period and to identify possible predictors of the final outcome. Methods: Forty-three outpatients (38 women) were assigned to ILP therapy. The study group included euthyroid patients with benign thyroid nodules. Thyroid size, nodule volume and features, and autoimmune test were collected at baseline. Patients underwent US control after the ILP procedure and 1 month, 6 months, 12 months later and then annually. Results: During the follow-up, two distinct groups of patients emerged: the responders (N = 33) and the non-responder (N = 10) ones to ILP. In the responder group, the nodule volume significantly decreased during the follow-up, but a trend toward a slight increase in nodule volume was recorded up to the end of follow-up. No significant decrease in nodule volume was observed in the non-responder group. Neither baseline clinical nor demographic features were significantly different between responders and non-responders groups. In the whole group of patients, the energy delivered per mL of nodule tissue was significantly correlated with the percent volume decrease at the end of follow-up. Conclusions: Interstitial laser photocoagulation is a safe technique able to reduce byabout 50% the volume of benign thyroid nodules in the majority of treated patients. However, due to the great variability of results, an active follow-up is required. The only independent predictor of ILP outcome is the energy delivered per mL of nodule tissue.

Dataset related to article: "Therapist Driven Rehabilitation Protocol for Patients with Chronic Heart and Lung Diseases: A Real-Life Study"

We provide the raw data used for the following article: <ul> <li>Simonelli C, Vitacca M, Ambrosino N, Scalvini S, Rivadossi F, Saleri M, Fokom AG, Speltoni I, Ghirardi R, Paneroni M. Therapist Driven Rehabilitation Protocol for Patients with Chronic Heart and Lung Diseases: A Real-Life Study. "Int J Environ Res Public Health". 2020 Feb 5;17(3):1016. doi: 10.3390/ijerph17031016. PMID: 32033505; PMCID: PMC7037983.</li> </ul> Abstract Therapist driven protocols may help to tailor rehabilitation programs to individual patients. We aimed to test the feasibility, safety, and clinical usefulness of a therapist driven protocol for rehabilitation including exercise training of patients with heart or lung diseases. An internal audit elaborated the Cardio-Respiratory Exercise Maugeri Algorithm (CREMA) based on: (a) standardized baseline assessments, (b) decision-making pathways, and (c) frequency/intensity/time/type (FITT) of prescription for each exercise. Outpatients (n = 620) with chronic heart disease (CHD), recent myocardial revascularization (REVASC), chronic airway (Obstructive), and restrictive lung (Restrictive) diseases underwent exercise training according to CREMA during 4 years. Peripheral muscle strengthening was the most prescribed exercise (83.6%), while arm endurance training was the least frequently (0.75%). Exercise prescription varied widely among the disease groups (interval training 19-47%, balance 35-49%, lower limb muscle training 6-15%). After training, REVASC patients were the best improvers in the 6 min walking distance (+48.7 (56.1) m), maximal inspiratory pressure (+9.6 (15.4) cmH2O), and daily steps (+1087.2 (3297.1) n/day). Quadriceps and biceps strength, maximal expiratory pressure, and balance improved in all groups, without significant differences. Minor side effects were observed in 11.2% of the patients. The CREMA therapist driven protocol was feasible, safe, and useful for prescribing tailored training programs. Exercise prescriptions and training response differed among diseases.

Dataset related to article: "Nocturnal Hypoxemia Impacts Right Ventricle Diastolic Function in Obstructive Sleep Apnea: A Retrospective Observational Study"

We provide the raw data used for the following article: <ul> <li>Scotti C, Porta R, Olivares A, Comini L, Cinelli A, Scalvini S, Vitacca M. Nocturnal Hypoxemia Impacts Right Ventricle Diastolic Function in Obstructive Sleep Apnea: A Retrospective Observational Study. "J Clin Med." 2020 Jan 7;9(1):162. doi: 10.3390/jcm9010162. PMID: 31936097; PMCID: PMC7019852.</li> </ul>   Abstract Obstructive sleep apnea (OSA), although a growing healthcare problem and documented risk factor for cardiovascular diseases, is still under-diagnosed in cardiac patients. To investigate the correlation between OSA and echocardiographic parameters of right ventricle diastolic (RVD) dysfunction, in particular trans-tricuspid E-wave deceleration time (EDT), we retrospectively analyzed data of 103 pure (comorbidity-free) OSA patients with comprehensive echocardiographic examination (ETT). Apnea/hypopnea index (AHI), oxygen desaturation index (ODI), mean nighttime oxyhemoglobin saturation (SpO2), time elapsed with SpO2 < 90% (T90) and mean peak desaturation of nocturnal events (Mdes, graded as mild, medium or severe) were compared with echocardiographic parameters. We found RVD dysfunction present in 58.3% of patients. Altered EDT correlated significantly with mean SpO2, T90, and Mdes (p < 0.01, all). Nocturnal desaturators had a significantly worse EDT than non-desaturators (p = 0.027) and a higher risk of prolonged EDT (odds ratio, OR = 2.86). EDT differed significantly according to Mdes severity (p = 0.005) with a higher risk of prolonged EDT in medium/severe vs. mild Mdes (OR = 3.44). EDT detected the presence of RVD dysfunction in 58.3% of our pure OSA patients. It correlated poorly with AHI severity but strongly with nocturnal desaturation severity, independently of age. This ETT marker may be useful for deciding appropriate diagnostic and therapeutic strategies.

Dataset related to article: "Exercise capacity and comorbidities in patients with obstructive sleep apnea"

We provide the raw data used for the following article: <ul> <li> Vitacca M, Paneroni M, Braghiroli A, Balbi B, Aliani M, Guido P, Fanfulla F, Pertosa M, Ceriana P, Zampogna E, Raccanelli R, Sarno N, Spanevello A, Maniscalco M, Malovini A, Ambrosino N. Exercise capacity and comorbidities in patients with obstructive sleep apnea. "J Clin Sleep Med". 2020 Apr 15;16(4):531-538. doi: 10.5664/jcsm.8258. PMID: 32003743; PMCID: PMC7161454. </li> </ul>   Abstract Study objectives: There are few studies evaluating (1) exercise capacity as assessed by the 6-minute walking distance (6MWD) test in large populations with obstructive sleep apnea (OSA); and (2) correlations with patients' comorbidities. Methods: This study presents a cluster analysis performed on the data of 1,228 patients. Severity of exercise limitation was defined on the basis of 6MWD. Results: Sixty-one percent showed exercise limitation (29.2% and 31.9% mild and severe exercise limitation, respectively). About 60% and 40% of patients were included in cluster 1 (CL1) and 2 (CL2), respectively. CL1 included younger patients with high prevalence of apneas, desaturations, and hypertension with better exercise tolerance. CL2 included older patients, all with chronic obstructive pulmonary disease (COPD), high prevalence of chronic respiratory failure (CRF), fewer apneas but severe mean desaturation, daytime hypoxemia, more severe exercise limitation, and exercise-induced desaturations. Only CRF and COPD significantly (P < .001) correlated with 6MWD < 85% of predicted value. 6MWD correlated positively with apnea-hypopnea index, oxygen desaturation index, nocturnal pulse oxygen saturation (SpO₂), resting arterial oxygen tension, mean SpO₂ on exercise, and negatively with age, body mass index, time spent during night with SpO₂ < 90%, mean nocturnal desaturation, arterial carbon dioxide tension, and number of comorbidities. Patients without severe comorbidities had higher exercise capacity than those with severe comorbidities, (P < .001). Exercise limitation was significantly worse in OSA severity class I when compared to other classes (P < .001). Conclusions: A large number of patients with OSA experience exercise limitation. Older age, comorbidities such as COPD and CRF, OSA severity class I, severe mean nocturnal desaturation, and daytime hypoxemia are associated with worse exercise tolerance.

dataset related to article "Dynamic expression of NR2F1 and SOX2 in developing and adult human cortex: comparison with cortical malformations"

Main data of the human brain material; Table of the cases, Row data of the immunohistochemical quantifications

restrictedOct 2021View details →

Dataset related to the article "Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study"

This record contains raw data related to the article "Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study" Abstract Purpose We present the preliminary results of the STRA-MI-VT Study (NCT04066517), a spontaneous, phase Ib/II study, designed to prospectively test the safety and efficacy of stereotactic body radiotherapy (SBRT) in patients (pts) with advanced cardiac disease and intractable ventricular tachycardia (VT). Methods Cardiac computed tomography (CT) integrated by electroanatomical mapping was used for substrate identification and merged with dedicated CT scans for treatment plan preparation. A single 25-Gy radioablation dose was delivered by a LINAC-based volumetric modulated arc therapy technique in a non-invasive matter. The primary safety endpoint was treatment-related adverse effects during acute and long-term follow-up (FU), obtained by regular in-hospital controls and implantable cardioverter defibrillator (ICD) remote monitoring. The primary efficacy endpoint was the reduction at 3 and 6 months of VT episodes and ICD shocks. Results Seven out of eight patients (men; age, 70 ± 7 years; ejection fraction, 27 ± 11%; 3 ischemic, 4 non-ischemic cardiomyopathies) underwent SBRT. At a median 8-month FU, no treatment-related serious adverse event occurred. Three patients died from non-SBRT-related causes. Four patients completed the 6-month FU: the number of VT decreased from 29 ± 33 to 11 ± 9 (p = .05) and 2 ± 2 (p = .08), at 3 and 6 months, respectively; shocks decreased from 11 to 0 and 2, respectively. At 6 months, all pts. showed a significant reduction of VT episodes and no electrical storm recurrence, with the complete regression of iterative VTs in 2/2 pts. Conclusion The STRA-MI-VT Study suggests that SBRT can be considered an alternative option for the treatment of VT in patients with structural heart disease and highlights the need for further clinical investigation addressing safety and efficacy. Keywords Ventricular tachycardia/ventricular arrhythmias · Stereotactic body radiotherapy/radioablation · Catheter ablation · Structural heart disease/dilated cardiomyopathy · Multimodal imaging

restrictedOct 2021View details →

Dataset related to the article "Cardiac Reverse Remodelling by 2D and 3D Echocardiography in Heart Failure Patients Treated with Sacubitril/Valsartan"

This record contains raw data related to the article "Cardiac Reverse Remodelling by 2D and 3D Echocardiography in Heart Failure Patients Treated with Sacubitril/Valsartan". Abstract: In terms of sacubitril/valsartan (S/V)-induced changes in heart failure with reduced ejection fraction (HFrEF) via three-dimensional (3D) transthoracic echocardiography (TTE) and S/V effects based on HF aetiology, data are lacking. We prospectively enrolled 51 HFrEF patients (24 ischaemic, 27 non-ischaemic). At baseline and at 6-month follow-up (6MFU) after S/V treatment optimisation, we assessed the N-terminal pro-B-type natriuretic peptide (NT-proBNP), and cardiac remodelling by two-dimensional (2D) and 3DTTE. In non-ischaemic patients, 2D and 3DTTE showed an improvement in left ventricular (LV) size and biventricular function at 6MFU vs. baseline: 3D-LV end-diastolic volume (EDV) 103 ± 30 vs. 125 ± 32 mL/m2 (p < 0.05), 3D-LV ejection fraction (EF) 40 ± 9 vs. 32 ± 5% (p < 0.05), right ventricular (RV) 3D-EF 48.4 ± 6.5 vs. 44.3 ± 7.5% (p < 0.05); only the 3D method detected RV size reduction: 3D-RVEDV 63 ± 27 vs. 71 ± 30 mL/m2 (p < 0.05). In ischaemic patients, only 3DTTE showed biventricular size and LV function improvement: 3D-LVEDV 112 ± 29 vs. 121 ± 27 mL/m2 (p < 0.05), 3D-LVEF 35 ± 6 vs. 32 ± 5% (p < 0.05), 3D-RVEDV 57 ± 11 vs. 63 ± 14 mL/m2 (p < 0.05); RV function did not ameliorate. In both ischaemic and nonischaemic patients, diastolic function and NT-proBNP significantly improved. In HFrEF patients treated with S/V, 3DTTE helps to ascertain subtle changes in heart chambers’ size and function, which have a major impact on HFrEF prognosis. S/V has significantly different effects on LV function in non-ischaemic vs. ischaemic patients.

restrictedOct 2022View details →

Dataset related to the article "Outcomes and mechanical complications of acute myocardial infarction during the second wave pandemic in a Milan HUB center for cardiac emergencies"

This record contains raw data related to the article "Outcomes and mechanical complications of acute myocardial infarction during the second wave pandemic in a Milan HUB center for cardiac emergencies"

Data set - From plagiarism to scientific paper mills: a profile of retracted articles within the SciELO Brazil collection

Data set - From plagiarism to scientific paper mills: a profile of retracted articles within the SciELO Brazil collection, published in Ethics & Behavior journal (<a href="https://doi.org/10.1080/10508422.2022.2141747">https://doi.org/10.1080/10508422.2022.2141747</a>)

Particial Dataset to the article: Bedrock meadows: a distinct vegetation type in northwestern North America

This dataset is part of the data used in the article "Bedrock meadows: a distinct vegetation type in northwestern North America" published in the Journal "Applied Vegetation Science". It includes several datasets that are already merged: <ol> <li>Fairbarns, 2001-2009, Unpublished data provided by Matt Fairbarns</li> <li>Roemer, 1996/97, Unpublished data provided by Hans Roemer</li> <li>Wagner, V., Spribille, T., Abrahamczyk, S. & Bergmeier, E. (2014) Timberline meadows along a 1000-km transect in NW North America: Species diversity and community patterns. Applied Vegetation Science, 17: 129–141. https://doi.org/10.1111/avsc.12045</li> <li>Zapisocki, Z. (2021) Patterns of non-native plants among native grasslands in Alberta, Canada. Master thesis, University of Alberta, Edmonton, Alberta, Canada.</li> <li>Zapisocki, Z., Murillo, R.A. & Wagner, V. (2022) Non-native plant invasions in prairie grasslands of Alberta, Canada. Rangeland Ecology & Management, 83: 20–30. https://doi.org/10.1016/j.rama.2022.02.011</li> </ol> Further data used in the article can be retrieved from the original sources (Damm, 2001; Waterton-Glacier National Park, 1994-2002; Hop et al., 2007).

Dataset related to article "Are nephrometry scores accurate for the prediction of outcomes in patients with renal angiomyolipoma treated with robot-assisted partial nephrectomy? A multi-institutional analysis "

This record contains raw data related to article “Are nephrometry scores accurate for the prediction of outcomes in patients with renal angiomyolipoma treated with robot-assisted partial nephrectomy? A multi-institutional analysis" Purpose: Prediction of complications and surgical outcomes is of outmost importance even in patients with benign renal masses. The aim of our study is to test the PADUA, SPARE and R.E.N.A.L. scores to predict nephron sparing surgery (NSS) outcomes in patients presenting with renal angiomyolipoma (RAML). Methods: We retrospectively analyzed the clinical and pathological data of 93 patients with AML treated with robot-assisted partial nephrectomy (RAPN) at three tertiary care referral centers. Renal masses were classified according to the PADUA, SPARE and R.E.N.A.L. nephrometry scores. Surgical success was defined according to the novel Trifecta score. Logistic regression models (LRM) were fitted to predict the achievement of novel Trifecta and the risk of high-grade Clavien-Dindo (CD) complication. The receiver operating characteristics (ROC) curve analysis was used to estimate the accuracy of LRMs. Results: Of 93 patients, 66 (69.9%) were females; median tumor size was 42 (36-48) mm. Novel Trifecta was achieved in 79 patients (84.9%) and post-operative complications classified as CD>2 occurred in 7 (7.5%) patients. At univariate and multivariate LRMs all three nephrometry scores were significantly associated with novel Trifecta achievement. Similar findings were observed for the prediction of CD>2 complications. The AUCs to predict optimal surgical outcomes and CD>2 complications were 0.791 and 0.912 for PADUA, 0.767 and 0.836 for SPARE and 0.756 and 0.842 for RENAL score, respectively. Conclusions: RAPN appears to be a feasible and safe surgical technique for the treatment of RAML. PADUA, SPARE and RENAL scores can be safely adopted to predict surgical outcomes, with the first one showing a higher accuracy.

Dataset related to article "Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: A 192 weeks multicentric retrospective study-IL PSO (Italian landscape psoriasis)"

This record contains raw data related to article “Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: A 192 weeks multicentric retrospective study-IL PSO (Italian landscape psoriasis)"   Abstract: Psoriasis is one of the commonest inflammatory skin diseases determining a very high impact on patients' quality of life and daily activities and relationships. Several biologic therapies have been approved through the years for the treatment of moderate-to-severe plaque psoriasis, and efficacy and safety profile have been analyzed in clinical trials. Ixekizumab is an immunoglobulin G subclass 4 monoclonal antibody that selectively targets and binds IL-17A with high specificity and affinity. Inhibiting IL-17A activity, ixekizumab reduces and turns down levels of inflammation, resulting in the clinical improvement of the disease. Long-term efficacy and safety profile of ixekizumab have been investigated and reported in the UNCOVER trials, but in literature there are only few studies based on real life experience. We present the efficacy and safety profile of ixekizumab in a cohort of 779 patients affected by moderate-to-severe plaque psoriasis and treated with ixekizumab in 11 Italian dermatology hospitals, with a follow-up of care until 192 weeks.

Dataset related to article "Impact of second-degree related donor on the outcomes of T cell-replete haploidentical transplantation with post-transplant cyclophosphamide "

This record contains raw data related to article “Impact of second-degree related donor on the outcomes of T cell-replete haploidentical transplantation with post-transplant cyclophosphamide" Abstract Donor selection may contribute to improve clinical outcomes of T cell-replete haploidentical stem cell transplantation (Haplo-SCT) with post-transplant cyclophosphamide (PT-Cy). Impact of second-degree related donor (SRD) was not fully elucidated in this platform. We retrospectively compared the outcome of patients receiving Haplo-SCT either from a SRD (n = 31) or a first-degree related donor (FRD, n = 957). Median time to neutrophil and platelet recovery did not differ between a SRD and a FRD transplant (p = 0.599 and 0.587). Cumulative incidence of grade II-IV acute graft-versus host disease (GVHD) and moderate-severe chronic GVHD was 13% and 19% after SRD vs 24% (p = 0.126) and 13% (p = 0.395) after FRD transplant. One-year cumulative incidence of non-relapse mortality (NRM) was 19% for SRD and 20% for FRD (p = 0.435) cohort. The 3-year probability of overall survival (OS) and progression-free survival (PFS) was 42% vs 55% (p = 0.273) and 49% vs 35% (p = 0.280) after SRD and FRD transplant, respectively. After propensity score adjustment or matched pair analysis, the outcome of patients receiving Haplo-SCT from a SRD or a FRD did not differ in terms of NRM, OS, PFS, acute and chronic GVHD. Our results suggest that a SRD is a viable option for Haplo-SCT with PT-Cy when a FRD is not available.

Dataset related to article "Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis) "

This record contains raw data related to article “Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis)" Abstract Background: Tildrakizumab is a humanized monoclonal antibody that binds selectively the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. Objectives: We conducted a 52-week retrospective study to assess the effectiveness and safety of tildrakizumab in a real-life setting. Methods: Our retrospective study included 237 consecutive adults with moderate-to-severe plaque psoriasis, enrolled in 10 different Italian centres, treated with tildrakizumab up to Week 52. Patient characteristics, comorbidities, previous treatments and the PASI (Psoriasis Area and Severity Index) score at each visit (baseline, Week 16, Week 28 and Week 52) were retrieved from the electronic medical records. The percentages of patients achieving 75%, 90% and 100% (PASI 75, PASI 90 and PASI 100) improvement in PASI with respect to baseline PASI were registered. Results: At Week 52, 90.91%, 73.55% and 58.68% of patients achieved a PASI reduction ≥75% (PASI 75), PASI 90 and PASI 100, respectively. An absolute PASI ≤ 2 was reached by 85.95% at Week 52. Compared with Phase 3 clinical trials, we observed similar rates of PASI 75/90 responses and higher percentages of patients achieving PASI 100. Patients who had not responded to previous biologic treatments and patients with cardio-metabolic comorbidities were significantly more likely to achieve PASI 100 at Week 28 and PASI 90 at Week 52. The higher body mass index did not interfere with the odds of reaching PASI 75/90/100 at each time point. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment because of adverse events. Conclusion: Our data suggest that the efficacy of tildrakizumab for plaque psoriasis in 'real-life' clinical practice is comparable with Phase 3 clinical trials with higher percentages of patients achieving complete skin clearance (PASI 100) at Weeks 16, 28 and 52.

Dataset related to article "Real-World Effectiveness of Denosumab and Bisphosphonates on Risk of Vertebral Fractures in Women with Breast Cancer Undergoing Treatment with Aromatase Inhibitors "

This record contains raw data related to article “Real-World Effectiveness of Denosumab and Bisphosphonates on Risk of Vertebral Fractures in Women with Breast Cancer Undergoing Treatment with Aromatase Inhibitors" Abstract Bone-active drugs are recommended to protect the skeleton from detrimental actions of aromatase inhibitors (AIs). However, most of literature data are focused on bone mineral density (BMD), whereas data on fractures are scant. The aim of this prospective study was to investigate the real-life effectiveness of denosumab, oral bisphosphonates (BPs) and intravenous zoledronate on risk of vertebral fractures (VFs) induced by AIs. 567 consecutive women (median age 62 years, range 28-83) with early breast cancer undergoing treatment with AIs were evaluated for morphometric VFs and BMD at baseline and after 18-24 months of follow-up. After enrollment, 268 women (47.3%) started denosumab 60 mg subcutaneously every 6 months, 115 (20.3%) BPs (59 with oral BPs and, 56 with intravenous zoledronate 5 mg/12 months), whereas 184 women (32.5%) were not treated with bone-active drugs for several reasons. During follow-up, 54 women (9.5%) developed incident VFs in association with age of subjects (P < 0.001), baseline FRAX scores for major fractures (P < 0.001) and hip fractures (P = 0.003), pre-existing VFs (P < 0.001), change in BMD at lumbar spine (P = 0.015), femoral neck (P = 0.003) and total hip (P < 0.001). Risk of VFs was higher in subjects who were untreated as compared to those treated with bone-active drugs (32/184 vs. 22/383; P < 0.001). Specifically, fracture risk was significantly decreased by denosumab [odds ratio (OR) 0.22; P < 0.001] and zoledronate (OR 0.27; P = 0.035), but not by oral BPs (P = 0.317). These data suggest that in real-world clinical practice, denosumab and zoledronate can reduce AI-related risk of VFs after only 24 months of treatment.

Dataset related to article "Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial "

This record contains raw data related to article “Preservation of Axillary Lymph Nodes Compared with Complete Dissection in T1-2 Breast Cancer Patients Presenting One or Two Metastatic Sentinel Lymph Nodes: The SINODAR-ONE Multicenter Randomized Clinical Trial" Abstract Background: The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936). Conclusions: The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.

Dataset related to the article: "Anxiety as a risk factor for postoperative complications after colorectal surgery: new area for perioperative optimization"

This record contains data related to the article: "Anxiety as a risk factor for postoperative complications after colorectal surgery: new area for perioperative optimization" No abstract available