scholarly journals Severe Persistent Eczema in a Recipient of the Gam-COVID-Vac vaccine

2022 ◽  
Author(s):  
Maryam Ameri ◽  
Meysam Abolmaali ◽  
Sayed Mohammed Jawad Alwedaie ◽  
Mohammad Nabavi ◽  
Neda Rahimian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Allergic Reaction ◽  
Healthcare Worker ◽  
Side Effect ◽  
Severe Allergic Reaction ◽  
Potential Side Effect

Since the beginning of the COVID-19 pandemic, efforts have been made to design safe and effective vaccines against SARS-CoV-2. Numerous vaccines have been designed and tested in limited clinical trials in various countries. Among them, the Sputnik V vaccine has shown a relatively safe profile and, to our knowledge, has no associated major side effects. We describe the case of a 40-year-old female healthcare worker who developed severe persistent eczematous lesions on the second day after she received the first dose of the Sputnik vaccine. The eczematous lesions were refractory to an antihistamine and persisted at the 1 month follow-up. Severe persistent eczematous lesions should be viewed as a potential side effect of vaccination with the Sputnik V vaccine. Moreover, a severe allergic reaction to a COVID-2019 vaccine may indicate the vaccine is ineffective in the recipient.

scholarly journals Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Statistical Power ◽  
Controlled Trial ◽  
Treatment Options ◽  
Cognitive Remediation ◽  
Negative Effects ◽  
Metacognitive Training ◽  
To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

scholarly journals Outcome of Essential Tremors with Stereotactic Thalamotomy: Noble Art of Lesioning

2020 ◽  
Vol 24 (3) ◽  
Author(s):  
AURANGZEB KALHORO ◽  
ABID SALEEM ◽  
ABDUL S ATTAR M. HASHIM
Keyword(s):  
Side Effects ◽  
Essential Tremor ◽  
Side Effect ◽  
Marked Improvement ◽  
Contralateral Side ◽  
Remarkable Improvement ◽  
Post Procedure ◽  
Stereotactic Thalamotomy ◽  
Duration Of Disease

Objective:  Objective of study is to identify the effects of Stereotactic thalamotomy of the nucleus ventral intermediate (VIM) for treatment of essential tremor. Material and Methods:  This is a descriptive study.It was performed at NCCI, Karachi, duration of study was 7 years, from 2-10-2012 to 7-10-2019. Those patients were included who were with tremors refractory to medication, their duration of disease was > 3 years, and with grade 4 tremors. The thalamotomy was performed in all cases, and follow-up was conducted at 3, 6, and 12 months respectively. The success of the surgery was measured in the form of a reduction in medication number and reduction in dose >50% and by calculating the Essential Tremor Rating Assessment Scale (tetras). Results:  Total of 26 patients were included. All patients showed remarkable improvement post-procedure at 12 month follow-up. 20 (77%) patient required no medications. In 6 (23%) patients, the dose of medication was reduced to less than half post-treatment. The tetras score showed marked improvement in all a patient; 4 (15%) patients who had grade 4 tremor, showed the symptoms of minimal tremors graded 0.5 on last visit 3rd visit. Side effect post-procedure were mild transient numbness on the contralateral side was observed in 11 (42.3%) patient, 1 (3.8%) patient had dysarthria. Conclusion:  We concluded that stereostatic Ventral intermedius nucleus thalamotomy was effective in reducing tremor grades and improved all functionality with few mild side effects.

MEDICAL METHODS OF ABORTION (MMA), HOW SAFE?

2021 ◽  
pp. 51-52
Author(s):  
Anita Pathak
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Unsafe Abortion ◽  
Self Administration ◽  
Mortality And Morbidity ◽  
Incomplete Abortion ◽  
Referral Practices ◽  
Maternal Mortality And Morbidity ◽  
Insight Into

Unsafe abortion is important and preventable cause of maternal mortality and morbidity. Medical method of abortion is a safe efcient and affordable method of abortion. However incomplete abortion is known side effect. An insight into the referral practices in cases of incomplete abortion following medical method of abortion will give an idea of the safety prole of medical methods of abortion. 150 women with incomplete abortion following medical method of abortion were administered a questionnaire which included information regarding onset of bleeding, treatment received, use of medication for abortion, its prescription, and administration. 90% of incomplete abortion following medical method of abortion were due to self-administration or prescription by unregistered practitioners, lack of examinations and lack of follow up. Complications such as collapse, blood requirement and fever were signicantly higher in these patients. The side effects of incomplete abortion following medical method of abortion can be minimized by following the standard guidelines.

scholarly journals A comparision of efficacy of risperidone and olanzapine in schizophrenia patients

2012 ◽  
Vol 7 (3) ◽  
pp. 29-35
Author(s):  
SK Shah ◽  
SP Ojha ◽  
NR Koirala ◽  
VD Sharma ◽  
B Yengkokpam
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Drop Out ◽  
Medical Sciences ◽  
Open Label ◽  
General Psychopathology ◽  
Sexual Side Effects ◽  
Significant Difference

Schizophrenia is a leading worldwide mental health problem. It is also one of the common and challenging problems in Nepal. Risperidone and olanzapine is one of the major antipsychotic drug used for schizophrenia patients, however their efficacy is not compared in Nepal.To assess the efficacy of risperidone and olanzapine in schizophrenia patients in Nepalese context. An open-label, randomized, comparative, prospective study was done for 6 weeks. Total of 63 patients attending Psychiatry OPD in Jan to July 2008 at TUTH who could be available for close follow up were enrolled with consent. Risperidone was given in dose of 3-6 mg and Olanzapine in the dose of 15-20 mg per day. Efficacy and tolerability was assessed using PANSS, CGI, and UKU side-effect checklist. Both groups showed improvement in the entire positive, negative and general psychopathology subscales without significant difference in the two groups. Regarding tolerability, olanzapine was found to have significant sedation, weight gain while with risperidone extrapyramidal side-effects, palpitations, sexual side-effects were significant. Risperidone and olanzapine both are efficacious in the treatment of schizophrenia. Both the drugs have their own side-effects. Long-term efficacy and tolerability needs to be studied. As it has been seen in the ongoing studies, long-term use and side-effect profile, drop-out rates and the increase in metabolic syndromes need more consideration.DOI: http://dx.doi.org/10.3126/jcmsn.v7i3.6706 Journal of College of Medical Sciences-Nepal, 2011, Vol-7, No-3, 29-35

scholarly journals Patient-Reported Outcomes in Online Communications on Statins, Memory, and Cognition: Qualitative Analysis Using Online Communities (Preprint)

2019 ◽  
Author(s):  
Farris Timimi ◽  
Sara Ray ◽  
Erik Jones ◽  
Lee Aase ◽  
Kathleen Hoffman
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Online Communities ◽  
Side Effect ◽  
Online Communication ◽  
Linguistic Analysis ◽  
Control Group ◽  
Patient Reported ◽  
Hands On ◽  
The Impact

BACKGROUND In drug development clinical trials, there is a need for balance between restricting variables by setting eligibility criteria and representing the broader patient population that may use a product once it is approved. Similarly, although recent policy initiatives focusing on the inclusion of historically underrepresented groups are being implemented, barriers still remain. These limitations of clinical trials may mask potential product benefits and side effects. To bridge these gaps, online communication in health communities may serve as an additional population signal for drug side effects. OBJECTIVE The aim of this study was to employ a nontraditional dataset to identify drug side-effect signals. The study was designed to apply both natural language processing (NLP) technology and hands-on linguistic analysis to a set of online posts from known statin users to (1) identify any underlying crossover between the use of statins and impairment of memory or cognition and (2) obtain patient lexicon in their descriptions of experiences with statin medications and memory changes. METHODS Researchers utilized user-generated content on Inspire, looking at over 11 million posts across Inspire. Posts were written by patients and caregivers belonging to a variety of communities on Inspire. After identifying these posts, researchers used NLP and hands-on linguistic analysis to draw and expand upon correlations among statin use, memory, and cognition. RESULTS NLP analysis of posts identified statistical correlations between statin users and the discussion of memory impairment, which were not observed in control groups. NLP found that, out of all members on Inspire, 3.1% had posted about memory or cognition. In a control group of those who had posted about TNF inhibitors, 6.2% had also posted about memory and cognition. In comparison, of all those who had posted about a statin medication, 22.6% (<italic>P</italic>&lt;.001) also posted about memory and cognition. Furthermore, linguistic analysis of a sample of posts provided themes and context to these statistical findings. By looking at posts from statin users about memory, four key themes were found and described in detail in the data: memory loss, aphasia, cognitive impairment, and emotional change. CONCLUSIONS Correlations from this study point to a need for further research on the impact of statins on memory and cognition. Furthermore, when using nontraditional datasets, such as online communities, NLP and linguistic methodologies broaden the population for identifying side-effect signals. For side effects such as those on memory and cognition, where self-reporting may be unreliable, these methods can provide another avenue to inform patients, providers, and the Food and Drug Administration.

scholarly journals Safety of Hydroxychloroquine among Outpatient Clinical Trial Participants for COVID-19

2020 ◽  
Author(s):  
SARAH M LOFGREN ◽  
Melanie R Nicol ◽  
Ananta S Bangdiwala ◽  
Katelyn A Pastick ◽  
Elizabeth C Okafor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Side Effect ◽  
Randomized Clinical Trials ◽  
Safety Data ◽  
Post Exposure Prophylaxis ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Gastrointestinal Side Effects ◽  
Exposure Prophylaxis

Introduction: Use of hydroxychloroquine in hospitalized patients with COVID-19, especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from three outpatient randomized clinical trials. Methods: We conducted three randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, post-exposure prophylaxis and early treatment for COVID-19. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. Results: We enrolled 2,795 participants. The median age of research participants was 40 (IQR 34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2,324 (84%) participants reported side effect data, and 638 (27%) reported at least one medication side effect. Side effects were reported in 29% with daily, 36% with twice weekly, 31% with once weekly hydroxychloroquine compared to 19% with placebo. The most common side effects were upset stomach or nausea (25% with daily, 18% with twice weekly, 16% with weekly, vs. 10% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for daily, 16% twice weekly, 12% weekly, vs. 6% for placebo). Two individuals were hospitalized for atrial arrhythmias, one on placebo and one on twice weekly hydroxychloroquine. No sudden deaths occurred. Conclusion: Data from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19.

scholarly journals The Geometric Sparse Matrix Completion Model for Predicting Drug Side effects

2019 ◽  
Author(s):  
Diego Galeano ◽  
Alberto Paccanaro
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Side Effect ◽  
Large Scale ◽  
Learning Algorithm ◽  
Sparse Matrix ◽  
Matrix Completion ◽  
Optimal Solution ◽  
Drug Side Effects ◽  
Chemical Structures

AbstractPair-input associations for drug-side effects are obtained through expensive placebo-controlled experiments in human clinical trials. An important challenge in computational pharmacology is to predict missing associations given a few entries in the drug-side effect matrix, as these predictions can be used to direct further clinical trials. Here we introduce the Geometric Sparse Matrix Completion (GSMC) model for predicting drug side effects. Our high-rank matrix completion model learns non-negative sparse matrices of coefficients for drugs and side effects by imposing smoothness priors that exploit a set of pharmacological side information graphs, including information about drug chemical structures, drug interactions, molecular targets, and disease indications. Our learning algorithm is based on the diagonally rescaled gradient descend principle of non-negative matrix factorization. We prove that it converges to a globally optimal solution with a first-order rate of convergence. Experiments on large-scale side effect data from human clinical trials show that our method achieves better prediction performance than six state-of-the-art methods for side effect prediction while offering biological interpretability and favouring explainable predictions.

scholarly journals Amisulpride augmentation in clozapine-unresponsive schizophrenia (AMICUS): a double-blind, placebo-controlled, randomised trial of clinical effectiveness and cost-effectiveness

2017 ◽  
Vol 21 (49) ◽  
pp. 1-56 ◽  
Author(s):  
Thomas RE Barnes ◽  
Verity C Leeson ◽  
Carol Paton ◽  
Louise Marston ◽  
Linda Davies ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Side Effects ◽  
Side Effect ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Treatment Resistant ◽  
Double Blind ◽  
Insufficient Response ◽  
Economic Analyses

BackgroundWhen treatment-refractory schizophrenia shows an insufficient response to a trial of clozapine, clinicians commonly add a second antipsychotic, despite the lack of robust evidence to justify this practice.ObjectivesThe main objectives of the study were to establish the clinical effectiveness and cost-effectiveness of augmentation of clozapine medication with a second antipsychotic, amisulpride, for the management of treatment-resistant schizophrenia.DesignThe study was a multicentre, double-blind, individually randomised, placebo-controlled trial with follow-up at 12 weeks.SettingsThe study was set in NHS multidisciplinary teams in adult psychiatry.ParticipantsEligible participants were people aged 18–65 years with treatment-resistant schizophrenia unresponsive, at a criterion level of persistent symptom severity and impaired social function, to an adequate trial of clozapine monotherapy.InterventionsInterventions comprised clozapine augmentation over 12 weeks with amisulpride or placebo. Participants received 400 mg of amisulpride or two matching placebo capsules for the first 4 weeks, after which there was a clinical option to titrate the dosage of amisulpride up to 800 mg or four matching placebo capsules for the remaining 8 weeks.Main outcome measuresThe primary outcome measure was the proportion of ‘responders’, using a criterion response threshold of a 20% reduction in total score on the Positive and Negative Syndrome Scale.ResultsA total of 68 participants were randomised. Compared with the participants assigned to placebo, those receiving amisulpride had a greater chance of being a responder by the 12-week follow-up (odds ratio 1.17, 95% confidence interval 0.40 to 3.42) and a greater improvement in negative symptoms, although neither finding had been present at 6-week follow-up and neither was statistically significant. Amisulpride was associated with a greater side effect burden, including cardiac side effects. Economic analyses indicated that amisulpride augmentation has the potential to be cost-effective in the short term [net saving of between £329 and £2011; no difference in quality-adjusted life-years (QALYs)] and possibly in the longer term.LimitationsThe trial under-recruited and, therefore, the power of statistical analysis to detect significant differences between the active and placebo groups was limited. The economic analyses indicated high uncertainty because of the short duration and relatively small number of participants.ConclusionsThe risk–benefit of amisulpride augmentation of clozapine for schizophrenia that has shown an insufficient response to a trial of clozapine monotherapy is worthy of further investigation in larger studies. The size and extent of the side effect burden identified for the amisulpride–clozapine combination may partly reflect the comprehensive assessment of side effects in this study. The design of future trials of such a treatment strategy should take into account that a clinical response may be not be evident within the 4- to 6-week follow-up period usually considered adequate in studies of antipsychotic treatment of acute psychotic episodes. Economic evaluation indicated the need for larger, longer-term studies to address uncertainty about the extent of savings because of amisulpride and impact on QALYs. The extent and nature of the side effect burden identified for the amisulpride–clozapine combination has implications for the nature and frequency of safety and tolerability monitoring of clozapine augmentation with a second antipsychotic in both clinical and research settings.Trial registrationEudraCT number 2010-018963-40 and Current Controlled Trials ISRCTN68824876.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 49. See the NIHR Journals Library website for further project information.

scholarly journals Patient-Reported Outcomes in Online Communications on Statins, Memory, and Cognition: Qualitative Analysis Using Online Communities

10.2196/14809 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14809 ◽  
Author(s):  
Farris Timimi ◽  
Sara Ray ◽  
Erik Jones ◽  
Lee Aase ◽  
Kathleen Hoffman
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Online Communities ◽  
Side Effect ◽  
Online Communication ◽  
Linguistic Analysis ◽  
Control Group ◽  
Patient Reported ◽  
Hands On ◽  
The Impact

Background In drug development clinical trials, there is a need for balance between restricting variables by setting eligibility criteria and representing the broader patient population that may use a product once it is approved. Similarly, although recent policy initiatives focusing on the inclusion of historically underrepresented groups are being implemented, barriers still remain. These limitations of clinical trials may mask potential product benefits and side effects. To bridge these gaps, online communication in health communities may serve as an additional population signal for drug side effects. Objective The aim of this study was to employ a nontraditional dataset to identify drug side-effect signals. The study was designed to apply both natural language processing (NLP) technology and hands-on linguistic analysis to a set of online posts from known statin users to (1) identify any underlying crossover between the use of statins and impairment of memory or cognition and (2) obtain patient lexicon in their descriptions of experiences with statin medications and memory changes. Methods Researchers utilized user-generated content on Inspire, looking at over 11 million posts across Inspire. Posts were written by patients and caregivers belonging to a variety of communities on Inspire. After identifying these posts, researchers used NLP and hands-on linguistic analysis to draw and expand upon correlations among statin use, memory, and cognition. Results NLP analysis of posts identified statistical correlations between statin users and the discussion of memory impairment, which were not observed in control groups. NLP found that, out of all members on Inspire, 3.1% had posted about memory or cognition. In a control group of those who had posted about TNF inhibitors, 6.2% had also posted about memory and cognition. In comparison, of all those who had posted about a statin medication, 22.6% (P<.001) also posted about memory and cognition. Furthermore, linguistic analysis of a sample of posts provided themes and context to these statistical findings. By looking at posts from statin users about memory, four key themes were found and described in detail in the data: memory loss, aphasia, cognitive impairment, and emotional change. Conclusions Correlations from this study point to a need for further research on the impact of statins on memory and cognition. Furthermore, when using nontraditional datasets, such as online communities, NLP and linguistic methodologies broaden the population for identifying side-effect signals. For side effects such as those on memory and cognition, where self-reporting may be unreliable, these methods can provide another avenue to inform patients, providers, and the Food and Drug Administration.

Leksell gamma knife treatment of uveal melanoma

2002 ◽  
Vol 97 ◽  
pp. 635-639 ◽  
Author(s):  
Gabriela s˘imonová ◽  
Josef Novotný ◽  
Roman Lis˘c˘ák ◽  
Jir˘í Pilbauer
Keyword(s):  
Side Effects ◽  
Mr Imaging ◽  
Gamma Knife ◽  
Uveal Melanoma ◽  
Side Effect ◽  
Maximum Dose ◽  
Treatment Variable ◽  
Content Type ◽  
Fine Print

Object. The purpose of this study was to analyze treatment results, radiation-induced side effects, and prognostic survival factors for patients with uveal melanoma. Methods. Eighty-one patients with uveal melanoma were treated using the Leksell gamma knife during a period of 6 years (1996–2001). There were 45 men and 36 women with a median age of 59 years (range 22–85 years). Seventyfive of these patients underwent minimal follow up 10 months after treatment. After patient eye immobilization, magnetic resonance (MR) imaging was performed to enable stereotactic localization. A scoring system was used to measure radiation side effects. The median target volume was 640 mm3, and the median applied minimal dose was 31.4 Gy. All patients were examined by an ophthalmologist and with MR imaging at regular intervals. Factors influencing posttreatment survival and side effects were statistically analyzed. Conclusions. Local tumor control in the 75 patients who underwent minimal follow up after 10 months was achieved in 63 patients (84%), whereas progression was observed in 12 patients (16%). The most frequent side effect was secondary glaucoma, which was detected in 18 patients (25%). The incidence of this side effect was significantly higher when the total volume of peripheral isodose was greater than 1000 mm3 (p = 0.015). Toxicity in the optic nerve here was also significantly higher when the maximum dose to this structure was higher than 9 Gy (p = 0.011), in the cornea when the maximum dose was higher than 15 Gy (p = 0.010), and in the lens when the maximum dose was higher than 10 Gy (p = 0.035). Altogether three pretreatment variables (patient age, tumor location, and dissemination of the disease) and one treatment variable (the minimum dose applied) were identified as having a significant influence on a patient's survival.

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