scholarly journals COVID-19 and Cardiovascular System. Part 3. COVID-19 Current Treatment Approaches: Evidence-Based Review

2021 ◽  
Vol 10 (3) ◽  
pp. 438-451
Author(s):  
M. K. Vasilchenko ◽  
A. A. Ivannikov ◽  
A. N. Yesaulenko ◽  
Kh. G. Alidzhanova ◽  
S. S. Petrikov
Keyword(s):  
Clinical Trials ◽  
Cardiovascular System ◽  
Mechanism Of Action ◽  
Treatment Strategy ◽  
Large Scale ◽  
Management Plan ◽  
Current Treatment ◽  
Evidence Based ◽  
Potential Mechanism ◽  
System Part

Unified management plan and treatment strategy for COVID-19 patients are yet to be discovered. Many trials on COVID-19 interventions have been registered or are ongoing. In this article the results of large-scale clinical trials on COVID-19 treatment are presented, the potential mechanism of action of some drugs is discussed, the features of the main pharmacological and non-pharmacological therapeutic options for COVID-19 patients are described.

scholarly journals Safety and Efficacy of Acamprosate for the Treatment of Alcohol Dependence

2013 ◽  
Vol 7 ◽  
pp. SART.S9345 ◽  
Author(s):  
Stephanie L. Yahn ◽  
Lucas R. Watterson ◽  
M. Foster Olive
Keyword(s):  
Clinical Trials ◽  
Amino Acid ◽  
Mechanism Of Action ◽  
Patient Preference ◽  
Mechanisms Of Action ◽  
Potential Mechanism ◽  
Addiction Medicine ◽  
Safety And Efficacy ◽  
Pharmacokinetic Properties ◽  
Alcohol Dependent

Acamprosate (calcium acetylhomotaurine) is an amino acid modulator that has displayed efficacy in some clinical trials in reducing craving and promoting abstinence in alcohol dependent patients following detoxification. While acamprosate is safe and generally well-tolerated, not all studies have demonstrated clinical efficacy that is superior to placebo. In addition, the precise neurochemical mechanisms of action of acamprosate have still not yet been identified. In this review, we summarize current clinical data on the safety, efficacy, and pharmacokinetic properties of acamprosate, as well theories on its potential mechanism of action. We also discuss tolerability and patient preference issues and conclude with a discussion of the place of acamprosate in addiction medicine and therapy.

scholarly journals Diagnosis and Treatment of Femoral Head Osteonecrosis: A Protocol for Development of Evidence Based Clinical Practice Guidelines

2020 ◽  
Author(s):  
Edward Cheng ◽  
Michael A. Mont ◽  
Stuart B. Goodman ◽  
Rafael J Sierra ◽  
Quanjun Cui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Femoral Head ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Treatment Strategy ◽  
Large Scale ◽  
Patient Specific ◽  
Evidence Based ◽  
Femoral Head Osteonecrosis

Abstract Background: There are many treatment options for patients who have osteonecrosis of the femoral head (ONFH) and management strategies vary widely both among and within individual countries. Although many researchers have attempted to elucidate the optimal strategies for managing this disease, the lack of large-scale randomized control trials and the lack of agreement on disease staging have curtailed the development of clear-cut guidelines.Methods: The Association Research Circulation Osseous (ARCO) group sought to address three questions for the management of patients who have ONFH: (1) What imaging studies are most sensitive and specific for the diagnostic evaluation of patients who have ONFH?; (2)What is the best treatment strategy for preventing disease progression in patients who have pre-collapse lesions?; and (3) What is the best treatment strategy for patients who have post-collapse disease? The PICO (Patient, Intervention, Comparison, and Outcome) format was used to formulate the search strategy for each research question. A systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. ARCO participants have been allocated to three groups, each representing one of the PICO questions. After qualitative and quantitative analysis of the data extracted from studies pertaining to each of the three research questions, a set of evidence-based clinical practice guidelines will be proposed for the management of patients who have ONFH. Discussion: It is not always clear which treatment method is optimal for the management of ONFH. Thus, many surgeons have developed and performed various procedures based on various patient-specific factors. As there is no consensus on the optimal treatment for various stages of disease, it was clear that developing evidence-based clinical practice guidelines would provide more structure and uniformity to management of these patients. Therefore, the results of this systematic review will lead to the development guidelines that may improve patient-care strategies and result in better outcomes for patients who have ONFH.Systematic Review Registration: Registration with PROSPERO has been submitted and is pending.

Identifying Enablers of Participant Engagement in Clinical Trials of Consumer Health Technologies: A Qualitative Study of flu@home (Preprint)

2020 ◽  
Author(s):  
Spurthy Dharanikota ◽  
Cynthia M LeRouge ◽  
Victoria Lyon ◽  
Polina Durneva ◽  
Matthew Thompson
Keyword(s):  
Clinical Trials ◽  
Technology Acceptance ◽  
Attribution Theory ◽  
Financial Incentives ◽  
Large Scale ◽  
Digital Health ◽  
Drop Out ◽  
Evidence Based ◽  
Structured Interviews ◽  
Health Technologies

BACKGROUND Clinical trials are fraught with challenges such as inadequate enrollment, lack of fidelity to interventions, and high drop-out rates. However, such trials are essential to support large-scale implementation of crucial consumer healthcare technologies (CHTs) such as smartphone supported home diagnostic tests (Smart-HT). A rise in the recent trend of self-managing health using CHTs highlights the importance of efficient and successful CHT trials. Understanding the reasons underlying individuals’ participation in trials could inform the design and execution of future trials of CHTs. OBJECTIVE We aimed to identify the enablers of participation in clinical trials of CHTs and summarize our findings in an evidence-based framework. We used an instantiation of a specific CHT currently in trial, Smart-HT, which is an app accompanied by home-based diagnostic testing of influenza called flu@home. METHODS Based on the digital health engagement model (DIEGO) and technology acceptance model (TAM), we proposed a preliminary research framework of enablers for participants’ engagement in trials of CHTs. Further, based on the attribution theory, we categorized the enablers into dispositional and situational factors. The framework guided the confidential and semi-structured interviews and resultant transcript coding. 31 individuals who previously participated in the diagnostic accuracy pilot study of flu@home were recruited to complete the semi-structured interviews via email and received a 25$ gift card once completing the interview. RESULTS In addition to finding support and a detailed understanding of the proposed preliminary framework, we identified new themes in our analysis that extend our evidence-based framework. Situationally, we found that financial incentives and insurance status influenced trial engagement for flu@home. Motivation to advance medical research, personal innovativeness, altruism, curiosity, positive attitude, and potential to minimize doctor’s visits emerged as new dispositional enablers for trial engagement in our study. CONCLUSIONS Our findings and proposed framework provide insights into the context of trial engagement for CHTs that require testing, particularly an instantiation of Smart-HT involving testing for influenza. We suggest several trial design and trial engagement strategies to enhance these trials' financial and scientific viability, paving the way for advancements in patient care. Furthermore, our study also offers practical strategies to trial organizers to enhance participants’ enrollment and engagement in clinical trials of CHTs.

Chinese Pharmacopoeia Revisited: A Review of Anti-Depression Herbal Sources

2021 ◽  
Vol 16 (12) ◽  
pp. 1934578X2110593
Author(s):  
Dongyi Hu ◽  
Jiayu Gao ◽  
Xiao Yang ◽  
Ying Liang
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Life Quality ◽  
Herbal Medicines ◽  
Antidepressant Drugs ◽  
New Drugs ◽  
Chinese Herbs ◽  
Evidence Based ◽  
Chinese Pharmacopoeia ◽  
Bupleuri Radix

Depression, which can be accompanied by many fatal diseases and a low life quality, has become the leading cause of ill health and disability worldwide. However, Chinese Pharmacopoeia, the most authoritative and evidence-based encyclopedia of Traditional Chinese Medicine (TCM), could contain leads and insights into the development of new antidepressant drugs. In this work, nine herbal medicines with ‘dispel melancholy functions’ specifically documented in Chinese Pharmacopoeia have been comprehensively reviewed with respect to clinical trials, and phytochemical and pharmacological aspects. The nine drugs are Rosae Chinensis Flos, Croci Stigma, Albiziae Cortex and Flos, Roase Rugosae Flos, Curcumae Radix, Hyperici Perforati Herba, Cyperi Rhizoma and Bupleuri Radix. The mechanisms of action of their functional antidepressant compounds, including gallic acid, hypericin, kaempferol, crocetin, crocin, quercetin, luteolin, isorhamnetin, curcumin, hyperforin, adhyperforin, catechin, rutin, puerarin, and saikosaponins A and D, have been collected and discussed. These traditional Chinese herbs and their active compounds provide a promising resource to develop effective new antidepressant drugs in future. Moreover, mechanistic investigations, safety verification and large-scale clinical trials are still expected to finally transform such TCM-based antidepressant resources to new drugs for patients suffering from depression.

Natalizumab (Tysabri®) - Re-defining Efficacy in Multiple Sclerosis - Data from Clinical Trials to Post-marketing Experience

2009 ◽  
Vol 4 (2) ◽  
pp. 58
Author(s):  
David Bates ◽  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Disease Progression ◽  
Large Scale ◽  
Rare Event ◽  
Management Plan ◽  
Social Consequences ◽  
Substantial Impact ◽  
Natalizumab Treatment ◽  
Post Marketing

Multiple sclerosis (MS) is a chronic, disabling condition with severe clinical and social consequences. Current first-line disease-modifying treatments have limited efficacy and do not halt long-term disease progression in the majority of patients. Natalizumab (Tysabri®) is the only monoclonal antibody licensed for use in relapsing–remitting MS (RRMS). It is regarded by many neurologists as the most effective MS drug on the market today, and has the potential to re-define successful MS therapy. Its efficacy has been demonstrated both in large-scale clinical trials and in post-marketing settings. Beneficial effects include reduction of relapse rates and disease progression and magnetic resonance imaging (MRI) measures of disease activity. Natalizumab treatment has a substantial impact on patient quality of life. Moreover, patients have shown significant improvement following natalizumab treatment, making continuing clinical remission a realistic goal in MS for the first time. However, the benefits of natalizumab must be balanced against risk. Progressive multifocal leukoencephalopathy (PML) is a rare event associated with natalizumab treatment that may be minimised with a risk management plan to educate physicians on patient selection and management.

scholarly journals Evidence-based approaches to comparing the effectiveness of modern cardiology interventions: trends, bias and prospects

2020 ◽  
Vol 25 (8) ◽  
pp. 4037
Author(s):  
S. R. Gilyarevsky ◽  
Yu. N. Belenkov
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Drug Use ◽  
Propensity Score ◽  
Observational Studies ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Improved Methods

The article discusses the limitations of the evidence from observational studies. Modern approaches to reducing bias in observational studies are discussed in detail, in particular, propensity score matching, which has become popular in recent years. The main differences between randomized and observational studies are discussed. Arguments against the observational studies and improved methods of analysis to compare the treatments’ effectiveness in clinical practice are presented. The role of observational studies as a source of evidence is discussed. The article points out the validity of performing large-scale prospective observational studies to assess the effects of postmarketing drug use in clinical practice, as well as to obtain data on drug use in patients that differ from those in randomized clinical trials.

Natalizumab (Tysabri®)—Re-defining Efficacy in Multiple Sclerosis—Data from Clinical Trials to Post-marketing Experience

US Neurology ◽  
2010 ◽  
Vol 05 (02) ◽  
pp. 72
Author(s):  
David Bates ◽  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Disease Progression ◽  
Large Scale ◽  
Rare Event ◽  
Management Plan ◽  
Social Consequences ◽  
Substantial Impact ◽  
Natalizumab Treatment ◽  
Post Marketing

Multiple sclerosis (MS) is a chronic, disabling condition with severe clinical and social consequences. Current first-line disease-modifying treatments have limited efficacy and do not halt long-term disease progression in the majority of patients. Natalizumab (Tysabri®) is the only monoclonal antibody licensed for use in relapsing–remitting MS (RRMS). It is regarded by many neurologists as the most effective MS drug on the market today, and has the potential to re-define successful MS therapy. Its efficacy has been demonstrated both in large-scale clinical trials and in post-marketing settings. Beneficial effects include reduction of relapse rates and disease progression, as well as magnetic resonance imaging (MRI) measures of disease activity. Natalizumab treatment has a substantial impact on patient quality of life. Moreover, patients have shown significant improvement following natalizumab treatment, making continuing clinical remission a realistic goal in MS for the first time. However, the benefits of natalizumab must be balanced against risk. Progressive multifocal leukoencephalopathy (PML) is a rare event associated with natalizumab treatment that may be minimized with a risk management plan to educate physicians on patient selection and management.

scholarly journals Vércukorcsökkentő gyógyszerek biztonságossága szívelégtelenségben

2017 ◽  
Vol 158 (5) ◽  
pp. 163-171 ◽  
Author(s):  
Attila Frigy ◽  
Márta Germán-Salló ◽  
Lehel Máthé ◽  
Mónika Szabó
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Cardiovascular System ◽  
Mechanism Of Action ◽  
Clinical Course ◽  
Harmful Effect ◽  
Cardiovascular Effects ◽  
The Other ◽  
Beneficial Effects ◽  
The Everyday

Abstract: The association of diabetes and heart failure is very common, furthermore, the pathophysiology and clinical course of the two entities have many crossing-points. Today, the spectrum of available anti-diabetic drugs is extremely wide, ranging from the classical (insulin, biguanides, sulphonylureas) to the most recent agents (gliptins, gliflozins). The cardiovascular effects of these drugs are multiple, their knowledge is important in the everyday practice, as the use of safe drugs regarding of heart failure is preferred. Our work provides an overview of each class of drugs after the presentation of the mechanism of action and the main representatives, the effects on the cardiovascular system, including those on heart failure will be described, mentioning the results of the most important clinical trials. The available data confirm the beneficial effects of metformin and gliflozins and the harmful effect of thiazolidinediones in heart failure. The other classes of drugs are permitted in heart failure, but it is important to continuously monitor the signs of decompensation. Orv. Hetil., 2017. 158(5), 163–171.

scholarly journals Lichen Planus and Its Management: An Update and Observation

2018 ◽  
Vol 3 (1) ◽  
Keyword(s):  
Lichen Planus ◽  
Large Scale ◽  
Treatment Options ◽  
Current Treatment ◽  
Evidence Based ◽  
Aggressive Treatment ◽  
Ongoing Trial ◽  
Or Management ◽  
Cutaneous Disease ◽  
Different Types

Lichen planus (LP) is an inflammatory muco-cutaneous disease characterised by shiny, flat-topped papules and plaques. It affects around 1% of the population. The disease is usually self-limiting and benign in nature. However, some varieties of LP may cause considerable discomfort and recalcitrant in nature. So, treatment depends on appreciating the type, severity and nature of the disease. There are a good numbers of options for treating different types of LP. Few types of LP are difficult to treat and needs aggressive treatment to prevent complications like hair or nail loss. Author examined and summarized the published literature involving the treatment or management of LP. It is found that the large scale, evidence based trials are only few in number. At present, it is quite difficult to standardisation of treatment. This review outlines the ongoing trial and current treatment options. It is needed to assimilation and summarization of the recent findings to treat the critical cases in a more effective way

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