scholarly journals Understanding COVID-19 in Wuhan From the Perspective of Cold-Dampness: Clinical Evidences and Mechanisms

2021 ◽  
Vol 8 ◽  
Author(s):  
Yujiao Zheng ◽  
De Jin ◽  
Jiaran Lin ◽  
Yuehong Zhang ◽  
Jiaxing Tian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Immune Responses ◽  
Retrospective Cohort ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Close Association ◽  
Animal Experiments ◽  
Wuhan City ◽  
Retrospective Cohort Studies

Traditional Chinese medicine (TCM) has played a significant role in the treatment of coronavirus disease 2019 (COVID-19) in Wuhan City. During the epidemic, Academician Tong Xiaolin suggested a close association of COVID-19 with cold-dampness, an etiological factor in TCM, by summarizing the characteristics of the COVID-19 patients in Wuhan. and the theory of Cold-dampness Plague was proposed. Based on the Cold-dampness Plague theory, a series of TCM drugs, such as Huoxiang Zhengqi Dropping Pills, Lianhua Qingwen Granules Hanshiyi Formula, and Tongzhi Granule were developed for the different stages, namely mild, moderate, severe, recovery, of the COVID-19. In addition, clinical evidences were obtained through randomized clinical trials or retrospective cohort studies. The Anti-SARS-CoV-2 mechanism of the TCM prescriptions were then summarized from the four aspects: targeting the ACE2 and 3CLPro, targeting cytokines, targeting acute immune responses to SARS-CoV-2, and targeting pulmonary fibrosis. Despite the clinical efficacy and therapeutic pharmacology speculation, more studies such as large-scale randomized clinical trials, cell and animal experiments are needed to further verify the theory of the Cold-dampness Plague in COVID-19 patients.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

Designing a clinical trial for neurorehabilitation

2020 ◽  
pp. 47-60
Author(s):  
Bruce Dobkin ◽  
Clarisa Martinez
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Trial Design ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Neurological Diseases ◽  
Parallel Group ◽  
Study Participants ◽  
Parallel Group Trial ◽  
Group Trial

The design, implementation, and analysis of clinical trials for the types of complex therapies needed to lessen impairments and disabilities that result from neurological diseases are reviewed. A multistep progression from feasibility testing in small groups of selected participants to the demonstration of efficacy in large-scale, multicentre randomized clinical trials is presented. Designs other than the ‘gold standard’ parallel-group trial can be used to optimize the contents of a new therapeutic strategy. Emphasis is placed on defining clinical characteristics and establishing a stable functional baseline for study participants. How the choices of outcome measure and comparison intervention affect the statistical and clinical significance of trial results are highlighted. Discussion of methodological concerns about randomization and blinded outcome assessment is followed by a review of common statistical confounders in neurorehabilitation trials. The use of consensus standards about trial reporting provides a valuable checklist for basic decisions in trial design.

scholarly journals Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Mengzhu Xue ◽  
Shoude Zhang ◽  
Chaoqian Cai ◽  
Xiaojuan Yu ◽  
Lei Shan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural Products ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Drug Safety ◽  
Large Scale ◽  
Drug Candidate ◽  
Topology Analysis ◽  
Drug Safety Surveillance ◽  
Approved Drugs

As the major issue to limit the use of drugs, drug safety leads to the attrition or failure in clinical trials of drugs. Therefore, it would be more efficient to minimize therapeutic risks if it could be predicted before large-scale clinical trials. Here, we integrated a network topology analysis with cheminformatics measurements on drug information from the DrugBank database to detect the discrepancies between approved drugs and withdrawn drugs and give drug safety indications. Thus, 47 approved drugs were unfolded with higher similarity measurements to withdrawn ones by the same target and confirmed to be already withdrawn or discontinued in certain countries or regions in subsequent investigations. Accordingly, with the 2D chemical fingerprint similarity calculation as a medium, the method was applied to predict pharmacovigilance for natural products from an in-house traditional Chinese medicine (TCM) database. Among them, Silibinin was highlighted for the high similarity to the withdrawn drug Plicamycin although it was regarded as a promising drug candidate with a lower toxicity in existing reports. In summary, the network approach integrated with cheminformatics could provide drug safety indications effectively, especially for compounds with unknown targets or mechanisms like natural products. It would be helpful for drug safety surveillance in all phases of drug development.

scholarly journals Inverse Vaccination to Silence Immunity to Myelin in Multiple Sclerosis

2010 ◽  
Vol 37 (S2) ◽  
pp. S49-S58 ◽  
Author(s):  
Lawrence Steinman
Keyword(s):  
Multiple Sclerosis ◽  
Immune Response ◽  
Clinical Trials ◽  
Immune Responses ◽  
Large Scale ◽  
Adaptive Immune Response ◽  
Antibody Responses ◽  
Myelin Proteins ◽  
Adaptive Immune ◽  
Key Drivers

ABSTRACT:The adaptive immune response in multiple sclerosis is complex. We have devised large scale arrays to measure the antibody response to myelin proteins and lipids. Despite the widespread immune responses to myelin, we have devised an inverse vaccine aimed at turning off key drivers of this diverse response. Clinical trials in patients with multiple sclerosis show that it is possible to constrain antibody responses to myelin on a large scale with this approach.

scholarly journals Assessing Depression in the Wild: Insights From Two Large-Scale Fully Mobile Randomized Clinical Trials

Iproceedings ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. e46
Author(s):  
Abhishek Pratap ◽  
Joaquin A Anguera ◽  
Brenna N Renn ◽  
Joshua Volponi ◽  
David C Atkins ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
In The Wild

A Short History of Bernard Fisher’s Contributions to Randomized Clinical Trials

2022 ◽  
pp. 174077452110664
Author(s):  
Stewart Anderson
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Cancer Metastasis ◽  
Randomized Clinical Trials ◽  
Early Stage ◽  
Animal Experiments ◽  
Scientific Work ◽  
Medical Community ◽  
New Paradigm ◽  
New Treatments

Dr. Bernard Fisher (1918-2019) was an early proponent of evidence-based medicine using the mechanism of prospective, multicenter, randomized clinical trials to test biological and clinical hypotheses. In this article, I trace how his early scientific work in striving to understand the nature of cancer metastasis through animal experiments led to a new, testable, clinical hypothesis: that surgery to remove only the tumor and a small amount of tissue around it was as effective as the more disfiguring operations that were then the standard treatment. Fisher’s work with the National Surgical Adjuvant Breast and Bowel Project (NSABP) using large, randomized clinical trials to demonstrate the veracity of this hypothesis led to a new paradigm in which the emphasis was placed on how systemic therapies used at an early stage of disease could effectively eradicate breast cancer for many patients. This new therapeutic approach led to the successful development of new treatments, many of which are widely used today. Ultimately, the new paradigm led to successfully preventing breast cancer in women who were at high risk for the disease but who had not yet been diagnosed with the disease. Throughout his entire career, Fisher championed the use of large prospective, randomized clinical trials despite criticism from many in the medical community who strongly criticized his use of randomization as a mechanism for testing clinical hypotheses. The approach he and the NSABP employed is still considered to be the highest standard of evidence in conducting clinical studies.

scholarly journals Laparoscopic surgery for colon cancer

2020 ◽  
Vol 42 (5) ◽  
pp. 413-420 ◽  
Author(s):  
Vinzenz Völkel ◽  
Teresa Draeger ◽  
Michael Gerken ◽  
Monika Klinkhammer-Schalke ◽  
Stefan Benz ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Practice ◽  
Laparoscopic Surgery ◽  
Cohort Studies ◽  
Retrospective Cohort ◽  
Randomized Clinical Trials ◽  
Postoperative Mortality ◽  
Duration Of Surgery ◽  
Retrospective Cohort Studies

Abstract Background To evaluate a new procedure in daily clinical practice, it might not be sufficient to rely exclusively on the findings of randomized clinical trials (RCTs). This is the first systematic review providing a synthesis of the most important RCTs and relevant retrospective cohort studies on short- and long-term outcomes of laparoscopic surgery in colon cancer patients. Materials and methods In a literature search, more than 1800 relevant publications on the topic were identified. Relevant RCTs and representative high-quality retrospective studies were selected based on the widely accepted Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. Finally, 9 RCTs and 14 retrospective cohort studies were included. Results Laparoscopic surgery for colon cancer is associated with a slightly longer duration of surgery, but a variety of studies show an association with a lower rate of postoperative complications and a shorter duration of hospital stay. Particularly in older patients with more frequent comorbidities, laparoscopy seems to contribute to decreasing postoperative mortality. Concerning long-term oncologic outcomes, the laparoscopic and open techniques were shown to be at least equivalent. Conclusion The findings of the existing relevant RCTs on laparoscopic surgery for colon cancer are mostly confirmed by representative retrospective cohort studies based on real-world data; therefore, its further implementation into clinical practice can be recommended.

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