scholarly journals Consensus on COVID-19 vaccination in pediatric oncohematological patients, on behalf of infectious working group of Italian Association of Pediatric Hematology Oncology

2022 ◽  
Author(s):  
Simone Cesaro ◽  
Paola Muggeo ◽  
Daniele Zama ◽  
Monica Cellini ◽  
Katia Perruccio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Hospital Admissions ◽  
Prevention Measures ◽  
Serious Adverse Events ◽  
Treatment Delays ◽  
Pediatric Subject ◽  
Pediatric Hematology ◽  
Consensus Document ◽  
Oncological Diseases ◽  
Correct Communication

Vaccines represent the best tool to prevent the severity course and fatal consequences of pandemic by new Coronavirus 2019 infection (SARS CoV 2). Considering the limited data on vaccination of pediatric oncohematological patients, we develop a Consensus document to support the Italian pediatric hematological oncological (AIEOP) centers in a scientifically correct communication with families and patients and to promote vaccination. The topics of the Consensus were: SARS CoV 2 infection and disease (COVID 19) in the pediatric subject s; COVID 19 vaccines (type, schedule); which and when to vaccinate; contraindications and risk of serious adverse events; rare adverse events; third dose and vaccination after COVID 19; and other general prevention measures. Using the Delphi methodology fo r Consensus, 21 statements and their corresponding rationale were elaborated and discussed with the representatives of 31 centers, followed by voting. AIEOP Centers showed an overall agreement on all the statements that were therefore approved. This consensus document highlights that children and adolescents affected by hematological and oncological diseases are a fragile category. Vaccination plays an important role to prevent COVID19, to permit the regular administration of chemotherapy or other treatmen ts, to perform control visits and hospital admissions, and to prevent treatment delays.

scholarly journals A156 LOW COMPLICATION RATE IN THE OUTPATIENT INTRAJEJUNAL LEVODOPA/CARBIDOPA INTESTINAL GEL CLINICAL PROGRAM

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 20-21
Author(s):  
N Al Yatama ◽  
C H Parker ◽  
Y Tse ◽  
T Naranian ◽  
A Fasano ◽  
...  
Keyword(s):  
Data Collection ◽  
Adverse Events ◽  
Hospital Admissions ◽  
Retrospective Chart Review ◽  
Current Method ◽  
Final Analysis ◽  
Outpatient Setting ◽  
Fistula Formation ◽  
Serious Adverse Events

Abstract Background Levodopa/carbidopa intestinal gel (LCIG) is a formulation that is delivered continuously through a percutaneous endoscopy gastro-jejunal tube (PEG-J) for the treatment of patients with advanced Parkinson’s disease (PD). LCIG significantly reduces periods of increased motor symptoms without troublesome dyskinesia. Adverse events related to this treatment have been attributed to PEG-J insertion and the device used for LCIG delivery, rather than to the LCIG preparation itself. To date, the data evaluating long-term efficacy and safety of PEG-J insertion for LCIG administration in the outpatient setting is limited. Aims The aim of this study is to describe short and long-term adverse events (AEs) associated with outpatient PEG-J tube insertion for LCIG administration at our centre. Methods A retrospective chart review was performed of all PD patients who underwent PEG-J insertion for LCIG therapy at Toronto Western Hospital from March 2011 to October 2019. All AEs associated with PEG-J insertion were collected including procedure and tube related complications, hospital admissions, emergency room (ER) visits and deaths. Data was analyzed using descriptive statistics. Results A total of 58 patients were identified and included in the final analysis. 37 (64%) male, with a mean age of 74 years +/-6.17. The mean duration of PD diagnosis prior to PEG-J insertion was 16.5 years +/-2.0. Mean time from PEG-J insertion to data collection was 37.5 months +/- 19.3. 30 (51%) patients had post-procedural abdominal pain or site pain. This pain improved with over the counter analgesics. 9 (16%) had possible site infection; 6 received oral antibiotics and 3 had the tube replaced. 19 (33%) developed granulation tissue, with only 2 patients requiring tube exchange. 32 (55%) had their tube removed or exchanged secondary to PEG-J malfunction. No ER visits related to the PEG-J were recorded. During the data collection period, 12 (21%) patients died for reasons unrelated to PEG-J insertion. There were no reported serious adverse events (SAEs), including post-procedure perforation, bleeding, fistula formation, development of intra-abdominal collections or buried bumper syndrome. Conclusions This study demonstrates the absence of serious AEs associated with outpatient PEG-J insertion for LCIG administration in patients with advanced PD. The most common short-term AE was post-procedural pain. The most common long-term AE was related to PEG-J malfunction requiring replacement. This study supports that the current method of outpatient PEG-J insertion for the administration of LCIG is safe in patients with advanced PD. Funding Agencies None

scholarly journals CRP-guided antibiotic treatment in acute exacerbations of COPD in hospital admissions

2019 ◽  
Vol 53 (5) ◽  
pp. 1802014 ◽  
Author(s):  
H.J. Prins ◽  
Ruud Duijkers ◽  
Paul van der Valk ◽  
Marianne Schoorl ◽  
Johannes M.A. Daniels ◽  
...  
Keyword(s):  
Adverse Events ◽  
Antibiotic Treatment ◽  
Hospital Admissions ◽  
Day Treatment ◽  
Controlled Trial ◽  
Chronic Obstructive Lung Disease ◽  
Chronic Obstructive ◽  
Serious Adverse Events ◽  
Patient Reported ◽  
Acute Exacerbations

The role of antibiotics in acute exacerbations of chronic obstructive pulmonary disease (COPD) is controversial and a biomarker identifying patients who benefit from antibiotics is mandatory. We performed a randomised, controlled trial in patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy, in order to show a reduction in antibiotic prescription.Patients hospitalised with acute exacerbations of COPD were randomised to receive antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50 mg·L−1).In total, 101 patients were randomised to the CRP group and 119 to the GOLD group. Fewer patients in the CRP group were treated with antibiotics compared to the GOLD group (31.7% versus 46.2%, p=0.028; adjusted odds ratio (OR) 0.178, 95% CI 0.077–0.411, p=0.029). The 30-day treatment failure rate was nearly equal (44.5% in the CRP group versus 45.5% in the GOLD-group, p=0.881; adjusted OR 1.146, 95% CI 0.649–1.187, p=0.630), as was the time to next exacerbation (32 days in the CRP group versus 28 days in the GOLD group, p=0.713; adjusted hazard ratio 0.878, 95% CI 0.649–1.187, p=0.398). Length of stay was similar in both groups (7 days in the CRP group versus 6 days in the GOLD group, p=0.206). On day-30, no difference in symptom score, quality of life or serious adverse events was detected.Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment. In the present study, no differences in adverse events between both groups were found. Further research is needed for the generalisability of these findings.

scholarly journals Breastfeeding mother-child clinical outcomes after COVID-19 vaccination

2021 ◽  
Author(s):  
Jia Ming Low ◽  
Le Ye Lee ◽  
Yvonne Peng Mei Ng ◽  
Youjia Zhong ◽  
Zubair Amin
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Side Effect ◽  
Prospective Cohort ◽  
Hospital Admissions ◽  
Vaccine Dose ◽  
Common Side Effect ◽  
Serious Adverse Events ◽  
Lactating Women ◽  
Structured Questionnaire

This is a prospective cohort study of 88 lactating women in Singapore who received two doses of BNT162b2 vaccination (Pfizer/BioNTech), whereby outcomes of mother-child dyads within 28 days after the second vaccine dose were determined through a structured questionnaire. Minimal effects related to breastfeeding were reported in this cohort; 3 of 88 (3.4%) women had mastitis with 1 of 88 (1.1%) women experiencing breast engorgement. We report an incidence of lymphadenopathy in our cohort at 5 of 88 (5.7%). Reassuringly, there was no change in reported breastmilk supply after vaccination. The most common side effect was pain/redness/swelling at the injection site, which was experienced by 57 of 88 (64.8%) women. There were no serious adverse events of anaphylaxis and hospital admissions. No adverse symptoms were reported in 67 of 88 (76.1%) breastfed children.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  
Keyword(s):  
Visual Cortex ◽  
Adverse Events ◽  
Clinical Intervention ◽  
Occipital Cortex ◽  
Neuronal Population ◽  
Serious Adverse Events ◽  
Stimulation Parameters ◽  
The Right ◽  
Visual Cortical ◽  
Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

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