scholarly journals Embedding surveillance into clinical care to detect serious adverse events in pregnancy

Vaccine ◽  
2015 ◽  
Vol 33 (47) ◽  
pp. 6466-6468 ◽  
Author(s):  
Anna C. Seale ◽  
Hellen C. Barsosio ◽  
Angela C. Koech ◽  
James A. Berkley
2018 ◽  
Vol 88 (2) ◽  
Author(s):  
Agata Buonacera ◽  
Benedetta Stancanelli ◽  
Lorenzo Malatino

Despite the effectiveness of anti-hypertensive therapy is well recognized, the most adequate target to achieve in the management of hypertension in the elderly is still under debate. Indeed, looking at the balance between benefits and risks, accumulating evidence has recently specifically addressed this issue, focusing on controversies. Evidence surrounding a more aggressive treatment may lead to a turnaround in the clinical care of older adult hypertensives, but a balanced trade-off between benefits and risks needs to be programmed and achieved, particularly in this clinical setting. We argue whether and how the results from recent trials could influence the management of hypertension in older people.


Author(s):  
Sarada Mamilla ◽  
Harikishan Boorugu ◽  
Ramya Bharghavi B. P. L. ◽  
Bhavana Priya Kodam ◽  
Sandhya Rani Adapa ◽  
...  

Numerous therapeutic strategies are proposed and tested for SARS CO-V2 infection. Remdesivir is researched and proposed by various societies. Studies about efficacy and safety in pregnancy are limited. A case series of 22 pregnant women effected with severe COVID disease and who received remdesivir, over a period of 1 year from May 2020 to May 2021 is presented. The 12 antenatal and 10 post-partum women were included. Demographic factors, baseline, day 3 and day 7 blood values of haemoglobin, total leukocyte count, platelets, liver enzymes, serum creatinine and D-dimers were collected. Adverse events were reported. Pregnancy complications and foetal and neonatal complications were studied. Pre-eclampsia was the most common comorbidity. The 99% of pregnant women and 100% of postpartum women recovered from COVID disease after remdesivir use. Lab investigations did not change considerably during the week of remdesivir use, suggesting its safety. Incidence of adverse events reported is 36.3%, of these 9% are serious adverse events. There are no antenatal or post-natal complications. No incidence of teratogenicity, foetal or neonatal complications. Incidence of feto-maternal transmission was 9%. Remdesivir is effective in treating severe SARS-CoV2 infection and has safety profile in pregnancy with regard to maternal and foetal effects.


2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh

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.


2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  

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.


2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  

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.


2020 ◽  
Vol 44 (3) ◽  
pp. 151221 ◽  
Author(s):  
Emily A. Pinheiro ◽  
Catherine S. Stika
Keyword(s):  

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