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Author(s):  
N. V. Mikhailova ◽  
I. I. Petrunko

Aim: Evaluate the relationship of Smoking with fatty liver disease (FLD) of various etiologies.Materials and Methods: Out of1568 residents of the rural therapeutic area agreed to participate in the study of 1123 residents of the rural medical area with negative markers of hepatitis B and / or C. The survey included the collection of anamnesis for smoking and alcohol consumption. An objective, laboratory (complete blood count, biochemical liver function tests) and instrumental examination, including ultrasound examination of the abdominal organs, were carried out.Results: Non-alcoholic fatty liver disease (NAFLD) was detected in 247 (22.0%) people, alcoholic liver disease (ALD) — in 276 (24.6%) (p>0.05). 542 people smoked of the surveyed. Among patients with NAFLD, Smoking was 20.2%, their Smoking experience was 35.1±11.5 years, and the Smoking index was 24.5±10.9. Among patients with ALP, Smoking is higher-93.1% (p<0.05), Smoking experience is less — 29.5±9.8 years (p<0.05), as is the Smoking index of 21.8±7.7 (p<0.05). Among smokers, 56.8% had FLD, 83.8% of them were of alcoholic etiology, and 16.2% were non — alcoholic (p<0.05). Among non-smokers, compared with smokers, FLD was detected less frequently — in 37.2% of people (p<0.05), of which alcohol etiology — in 8.8% (p<0.05), non — alcoholic-in 91.2% (p<0.05).Conclusion: In the rural therapeutic area, 93.1% of ALD sufferers smoke, and 20.2% of NAFLD patients smoke (p<0.05). In patients with NAFLD, the duration of smoking was longer (35.1 ± 11.5) than in patients with ALD — 29.5 ± 9.8 years (p <0.05); the smoking index was 24.5 ± 10.9 and 21.8 ± 7.7 pack-years (p<0.05), respectively. In smokers, FLD was more common (56.8%) than in non-smokers (37.2%) (p<0.05). FLD in smokers was of alcoholic etiology more often (83.8%) than non-alcoholic (16.2%) (p<0.05), in non-smokers non-alcoholic etiology prevailed (91.2%) (p<0.05).


2021 ◽  
Vol 8 ◽  
Author(s):  
Chen Chen ◽  
Ning Lou ◽  
Xin Zheng ◽  
Shasha Wang ◽  
Haizhu Chen ◽  
...  

Background: In recent years, the number of clinical trials initiated in China has increased rapidly. The aim of this study was to overview the changing landscape of phase I clinical trials in mainland China from 2011 to 2020.Methods: We analyzed phase I clinical trials registered on 3 websites including the Chinese Clinical Trial Registry, ClinicalTrials.gov, and the China National Medical Products Administration Center for Drug Evaluation platform.Findings: A total of 2,842 phase I clinical trials were posted from January 1, 2011, to December 31, 2020. The overall number of clinical trials for innovative drugs was 1,497, accounting for half of all the phase I clinical trials (53%). Among these 1,486 innovative drug clinical trials, 924 were newly tested drugs with an average annual growth rate of 59%. Biological drug research increased significantly from 22.6% during 2011–2015 to 33.3% during 2016–2020. These principal investigators (PIs) of these clinical trials were mainly from Beijing (n = 871), followed by Shanghai (n = 496) and Jiangsu (n = 281). As for the therapeutic area of phase I clinical trials, cancer took up the most percentage of all the clinical trials (35%), followed by infectious disease (9%), nervous system disease (9%), etc. Most phase I clinical trials are conducted on healthy volunteers (n = 1,642, 57.8%), some cancer drugs are conducted in patients with cancer (n = 846, 29.8%), and only a few clinical trials were conducted in the elderly (n = 7). Among these clinical trials of the newly tested innovative drugs, the first in human (FIH) clinical trials accounted for 82% (744), and the First in Chinese (FIC) clinical trials only took up 18% (167). Only a small number of drugs could be made the transition to phase II (n = 207, 22%). In addition, despite the number of newly tested drugs during 2011–2015 (n = 163) was much less than that in 2016–2020 (n = 761), the percentage of drugs that could enter into phase II clinical trials in 2011–2015 (34%) was higher than that in 2016–2020 (20%).Conclusion: In the past 10 years, the development of phase I clinical trials has achieved great progress in mainland China due to the novel design and drug innovation policy. Nevertheless, future efforts are needed to make for improving the phase transition success rate of innovative drugs.


2021 ◽  
Vol 13 (47) ◽  
pp. 140-140
Author(s):  
Anatoly A Komissarenko

Biological activity of medical remedies varies depending on the dosage of the medicinal substance. As we analyze the results of the medicinal effect we can determine three areas of its effect. First of all, this is a therapeutic area where its dose-dependent medical effect is demonstrated. When a certain amount of drug in the body it exceeded this causes transition to the toxic area where every medicine causes certain pathological manifestations. Significant decrease of the drug dose demonstrates the area of no effect on the body. At the same time similar body reaction can be observed with homeopathic remedies in ultrahigh dilutions. Classical definition of a dose as an amount of substance introduced into the body is not suitable for homeopathic remedies that often don’t have drug substance molecules at all. The presence of areas of different reaction is explained by the effect of electromagnetic wave emissions of drug substances. It is known that molecules of all medicinal substances have certain frequencies that come into resonance with different body structures, including genes that have similar oscillatory characteristics. This causes expression of certain genes and increase of their activities. Increase of an allopathic substance dose causes voltage increase it its wave and consequently an increase of the effect on the genes. However overdose causes hyperstimulation and exhaustion of the gene under expression and consequently pathological symptoms develop. On the other hand a dose too small cannot stimulate gene activity and this causes a lack of medical effect. As demonstrated by long-term studies, the activity of potentiated remedies (in ultrahigh dilutions) is related to development of coherence. Coherence is a phasic shift of the medicinal wave that occurs with potentiation of a remedy. As the potency is increased, every step, i.e. coherent wave shift decreases, thus increasing the probability of exact coincidence of the drug and gene waves and their contraposition to the wave of a xenobiotic. Wave shift by have the phase of a xenobiotic wave makes them opposite in terms of amplitude. They begin to damp each other and thus pathogenic effects of a xenobiotic are neutralized. In such a way, drug activity on the body is determined by wave characteristics of the medicinal substance molecules. Activity of allopathic medications depends on the dose, e.g. the number of drug substance molecules. Activity of homeopathic medications depends on the degree of their potentiation.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Fiona Taylor ◽  
Cem Akin ◽  
Roger E. Lamoureux ◽  
Brad Padilla ◽  
Tanya Green ◽  
...  

Abstract Background Advanced systemic mastocytosis (AdvSM), indolent systemic mastocytosis (ISM), and smoldering systemic mastocytosis (SSM) are rare diseases characterized by neoplastic mast cell infiltration of more than one organ. A content-valid patient-reported outcome (PRO) questionnaire that assesses relevant signs and symptoms that are important and understandable to individuals with a condition is critical for assessing new treatment benefit as well as supporting product labeling claims. Notably, no such PRO questionnaire has been developed in accordance with regulatory and scientific guidelines for use in AdvSM, ISM, and SSM patient populations. To fill that gap, this study documents the development and content validity of instruments evaluating signs and symptoms of systemic mastocytosis. Methods A review of peer-reviewed literature, advice meetings with clinical therapeutic area experts, patient concept elicitation interviews, concept selection and questionnaire construction meetings, and patient cognitive debriefing interviews were conducted, and regulatory feedback was incorporated. Results For AdvSM, 26 sign- and symptom-level concepts were identified in literature, 39 by clinicians, and 33 by patients. For ISM/SSM, 38 sign- and symptom-level concepts were identified in the literature, 39 by clinicians, and 57 by patients. Two patient-reported instruments, the Advanced Systemic Mastocytosis Symptom Assessment Form (AdvSM-SAF) and Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF)(©Blueprint Medicines Corporation), were developed based on consolidated findings. Cognitive debriefing interviews with AdvSM and ISM patients showed the AdvSM-SAF and ISM-SAF were understood and interpreted as intended by the majority of patients. Conclusion The AdvSM-SAF and ISM-SAF are content-valid tools measuring symptoms from AdvSM and ISM patients’ perspective.


2021 ◽  
Vol 34 (13) ◽  
Author(s):  
Maria Pinheiro Andrade ◽  
Daniela Matias ◽  
Joana Batuca ◽  
Nélia Gouveia ◽  
Hélder Mota-Filipe ◽  
...  

Introduction: The aim of this study was to investigate the Portuguese authorship in publications resulting from trials initiated by the industry or investigators and run in Portugal.Material and Methods: Clinical trials with Portuguese institutions as sponsor or recruiting centers, and registered in four clinical trial registries, in the last 14 years, were assessed. Publications of completed trials, from both the initiative of the industry and investigatorswere screened and compared.Results: The percentage of published trials initiated by industry and investigators was similar (28.0%). However, the percentage of completed investigator-initiated trials (43.6%) was lower when compared to industry trials (69.7%). There was a higher percentage of Portuguese authorship in published investigator-initiated trials when compared with industry-initiated trials (47.1% vs 8.5%, respectively). Moreover, industry-initiated trials with Portuguese authors were published in journals with lower journal impact factor when compared with those published without authorship of Portuguese investigators. Oncology was the therapeutic area with the highest number of clinical trial registrations and publications. However, in publications with Portuguese authors, industry Initiated trials mainly focused on neurology while investigator-initiated trials had a higher number of papers in the fields of gastroenterology and infection diseases. Published trials with Portuguese authorship, initiated by the industry or investigators, also targeted different populations and had different purposes. In both cases, no significant differences were observed in terms of the journal impact factor or in the alignment of the published randomized trials with the respective reporting guidelines.Discussion: When compared with previous publications, this study showed an increasing trend in the number of clinical trials in Portugal, published within similar timeframes, after trial conclusion. Even though both industry and investigator trials are published within the standards for reporting trials, the low number of Portuguese authorships in industry publications might underline the need for invigorating these independent clinical trials in Portugal by capacitating and empowering national clinical research teams.Conclusion: This study confirmed that even though all registered trials had the involvement of Portuguese institutions as a recruiting center, not all the published trials had Portuguese investigators as authors, mainly those initiated by the industry.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Al-Arkee ◽  
J Mason ◽  
L Fabritz ◽  
W Chua ◽  
D.A Lane ◽  
...  

Abstract Introduction AF increases the risk of stroke by a factor of five [1], oral anticoagulants (OACs) can reduce stroke by ∼60% and death by ∼25% [2]. Pharmacists, especially those based in primary care are well placed to support patients in this therapeutic area. However, research indicates that pharmacists do not always feel confident in supporting patients on OACs, which are the mainstay of AF management [3]. Purpose The aim of this pilot study is to assess pharmacists' knowledge prior to an educational session on AF and its management. Training was provided on AF, its management and the use of an associated app, AF Manager (Figure) with the intention to re-assess pharmacists' knowledge and use of the app 3, 6 and 12-months post-training. Here, we report the assessment of pharmacist baseline knowledge. Methods Various social media platforms were used to invite UK-based, practicing primary care pharmacists to an educational session. Training was developed in collaboration with consultant pharmacists from an Academic Health Science Network, AF Programme. Participant knowledge was assessed immediately before the educational session by use of the Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), adapted for use with pharmacists. Quantitative data were analysed using SPSS version 27. Results Twenty UK-based practicing pharmacists attended the educational session. Four pharmacists were excluded from analysis as they were not based in primary care. The mean practice experience of participants was 14.6±10.5 years; 62.5% were female and 50% had undertaken postgraduate qualifications. For this group of pharmacists, out of a maximum of 19 points, the mean score for the adapted JAKQ was 13.7±2.5. General knowledge about OACs (i.e. that which might be used to counsel patients taking OACs, such as time of day to take the medicines, side effects, drug interactions/contraindications) was high with knowledge about the different types of OACs similar (vitamin K antagonists (VKAs) 66.7±25.3% versus non-vitamin K antagonist oral anticoagulants (NOACs) 66.7±41.6%). However, several important knowledge gaps about AF and its management were identified. Only half of the participants knew that patients taking OACs for AF would continue to experience AF and only five participants (31.3%) knew that AF symptoms could be self-managed. Knowledge of INR monitoring frequency for VKAs and the use of NOAC patient alert cards was also lacking, with nine (56.2%) and thirteen (81.2%) of participants unable to answer these questions, respectively. Conclusions Primary care pharmacists are knowledgeable about the medicines used in AF management. However, there are specific knowledge gaps around AF management that need to be addressed via educational interventions to enable pharmacists to support patients effectively. Our follow-up research will investigate knowledge retention post-training and assess app usability for pharmacists in the management of patients with AF. FUNDunding Acknowledgement Type of funding sources: None. Figure 1. Screenshots of the AF Manager app


2021 ◽  
Vol 3 ◽  
Author(s):  
Sofoklis Kyriazakos ◽  
Aristodemos Pnevmatikakis ◽  
Alfredo Cesario ◽  
Konstantina Kostopoulou ◽  
Luca Boldrini ◽  
...  

Discovery of biomarkers is a continuous activity of the research community in the clinical domain that recently shifted its focus toward digital, non-traditional biomarkers that often use physiological, psychological, social, and environmental data to derive an intermediate biomarker. Such biomarkers, by triggering smart services, can be used in a clinical trial framework and eHealth or digital therapeutic services. In this work, we discuss the APACHE trial for determining the quality of life (QoL) of cervical cancer patients and demonstrate how we are discovering a biomarker for this therapeutic area that predicts significant QoL variations. To this extent, we present how real-world data can unfold a big potential for detecting the cervical cancer QoL biomarker and how it can be used for novel treatments. The presented methodology, derived in APACHE, is introduced by Healthentia eClinical solution, and it is beginning to be used in several clinical studies.


Author(s):  
Michele Ann O’Connell ◽  
Thomas P Nguyen ◽  
Astrid Ahler ◽  
S Rachel Skinner ◽  
Ken C Pang

Abstract Internationally, increasing numbers of children and adolescents with gender dysphoria are presenting for care. In response, gender affirming therapeutic interventions that seek to align bodily characteristics with an individual’s gender identity are more commonly being employed. Depending on a young person’s circumstances and goals, hormonal interventions may aim to achieve full pubertal suppression, modulation of endogenous pubertal sex hormone effects and/or development of secondary sex characteristics congruent with their affirmed gender. This is a relatively novel therapeutic area and, while short-term outcomes are encouraging, longer-term data from prospective longitudinal adolescent cohorts are still lacking, which may create clinical and ethical decision-making challenges. Here we review current treatment options, reported outcomes, and clinical challenges in the pharmacological management of trans and gender diverse adolescents.


Cancers ◽  
2021 ◽  
Vol 13 (17) ◽  
pp. 4444
Author(s):  
Kathy Matuszewska ◽  
Madison Pereira ◽  
Duncan Petrik ◽  
Jack Lawler ◽  
Jim Petrik

A basic requirement of tumorigenesis is the development of a vascular network to support the metabolic requirements of tumor growth and metastasis. Tumor vascular formation is regulated by a balance between promoters and inhibitors of angiogenesis. Typically, the pro-angiogenic environment created by the tumor is extremely aggressive, resulting in the rapid vessel formation with abnormal, dysfunctional morphology. The altered morphology and function of tumor blood and lymphatic vessels has numerous implications including poor perfusion, tissue hypoxia, and reduced therapy uptake. Targeting tumor angiogenesis as a therapeutic approach has been pursued in a host of different cancers. Although some preclinical success was seen, there has been a general lack of clinical success with traditional anti-angiogenic therapeutics as single agents. Typically, following anti-angiogenic therapy, there is remodeling of the tumor microenvironment and widespread tumor hypoxia, which is associated with development of therapy resistance. A more comprehensive understanding of the biology of tumor angiogenesis and insights into new clinical approaches, including combinations with immunotherapy, are needed to advance vascular targeting as a therapeutic area.


2021 ◽  
Vol 12 ◽  
Author(s):  
Michael Kossmeier ◽  
Madeleine Themanns ◽  
Lena Hatapoglu ◽  
Bernhard Kogler ◽  
Simon Keuerleber ◽  
...  

Objectives: Reimbursement decisions on new medicines require an assessment of their value. In Austria, when applying for reimbursement of new medicines, pharmaceutical companies are also obliged to submit forecasts of future sales. We systematically examined the accuracy of these pharmaceutical sales forecasts and hence the usefulness of these forecasts for reimbursement evaluations. Methods: We retrospectively analyzed reimbursement applications of 102 new drugs submitted between 2005 and 2014, which were accepted for reimbursement outside of hospitals, and for which actual reimbursed sales were available for at least 3 years. The main outcome variable was the accuracy ratio, defined as the ratio of forecasted sales submitted by pharmaceutical companies when applying for reimbursement to actual sales from reimbursement data. Results: The median accuracy ratio [95% confidence interval] was 1.33 [1.03; 1.74, range 0.15–37.5], corresponding to a median overestimation of actual sales by 33%. Forecasts of actual sales for 55.9% of all examined products either overestimated actual sales by more than 100% or underestimated them by more than 50%. The accuracy of sales forecasts did not show systematic change over the analyzed decade nor was it discernibly influenced by reimbursement status (restricted or unrestricted), the degree of therapeutic benefit, or the therapeutic area of the pharmaceutical product. Sales forecasts of drugs with a higher degree of innovation and those within a dynamic market tended to be slightly more accurate. Conclusions: The majority of sales forecasts provided by applicants for reimbursement evaluations in Austria were highly inaccurate and were on average too optimistic. This is in line with published results for other jurisdictions and highlights the need for caution when using such forecasts for reimbursement procedures.


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