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

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 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.

scholarly journals Strategies to enhance recruitment methods in phantom limb pain clinical trials

2017 ◽  
Vol 4 (2) ◽  
pp. 72 ◽  
Author(s):  
Camila Bonin Pinto ◽  
Faddi Ghassan Saleh Vélez ◽  
Melanie N. French ◽  
Dian Zeng ◽  
David Crandell ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Phantom Limb Pain ◽  
Phantom Limb ◽  
Institutional Review Boards ◽  
Recruitment Strategies ◽  
Limb Pain ◽  
Recruitment Methods ◽  
Institutional Review

<p class="abstract">Phantom limp pain (PLP) was first described in 1551. To date, its mechanisms and novel interventions remain mostly untested. Only limited conclusions can be drawn from few and small sized randomized clinical trials (RCTs) on PLP. In this scenario, enhanced recruitment strategies are crucial in order to overcome inherent challenges to recruit and enroll PLP subjects for clinical trials. Although there are many general methods to enhance recruitment and also retention, in this article we discuss these methods based on a common topic; dissemination. We summarize and discuss ten strategies of recruitment related to the dissemination of information based on the notion that increased trial awareness may lead to both improved recruitment and also external generalizability. In addition, we include insights based on our experience recruiting PLP patients for the purposes of a large-scale and on-going NIH-sponsored clinical trial. Although specific regulatory considerations need to be considered when choosing the methods of recruitment (which may vary across different countries and Institutional Review Boards (IRBs)), these strategies may be applicable to most research settings.</p>

scholarly journals Innovation in the design of large-scale hybrid randomized clinical trials

2020 ◽  
Vol 99 ◽  
pp. 106178
Author(s):  
Pamela M. Rist ◽  
Howard D. Sesso ◽  
JoAnn E. Manson
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Randomized Clinical Trials

Designing a clinical trial for neurorehabilitation

2015 ◽  
pp. 35-45
Author(s):  
Bruce Dobkin ◽  
Andrew Dorsch
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.

A review: quality of life of patients with allergic rhinitis receiving various treatment

2020 ◽  
Vol 75 (2) ◽  
pp. 106-114
Author(s):  
Denis S. Tyufilin ◽  
Ivan A. Deev ◽  
Olga S. Kobyakova ◽  
Ekaterina K. Tagina ◽  
Evgeny S. Kulikov
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Disease Control ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Negative Impact ◽  
Assessment Procedure ◽  
Allergen Specific Immunotherapy

The high prevalence of allergic rhinitis in a population, the link between this disease and asthma, and a significantly higher economic burden of the disease, causing a negative impact on the patients quality of life, have resulted in increased attention to the problem of allergic rhinitis at the global level. Nowadays optimal allergic rhinitis treatment and management include disease control, consisting of assessing the level of disease control and selecting a treatment scheme based on this assessment. Current studies are focused on the development of questionnaires and testing systems for assessing the level of disease control, especially given the absence of a standardized control assessment procedure tool. Studies also address the possibility of using the indicators of quality of life to measure the level of disease control. The present review deals with the issue of understanding of using this parameter to measure the effectiveness of pharmacotherapy of different groups of patients with allergic rhinitis. The review includes randomized clinical trials covering the period 20102019 including the following keywords: Rhinitis Quality of Life, Allergic Rhinitis Quality of Life, Allergic Rhinitis Questionnaire, RQLQ. In total, 4.407 publications were identified and analyzed, only 60 publications were selected for comparative analysis after a second review. According to the results, in general, it can be concluded that the indicator of the quality of life allows us to identify the advantages of pharmacotherapeutic regimens in the long term (for example, allergen-specific immunotherapy, alternative therapy). Moreover, it demonstrates a correlation with objectivistic indicators in randomized clinical trials of standard treatment. It is still necessary, however, to address the question of whether it would be possible to use the assessment of the quality of life as a part of allergic rhinitis treatment in everyday clinical practice to select a group of drugs, their dosages, and correct regimes in dynamics. Using the indicator of the quality of life for managing patients with allergic rhinitis in Russia requires tremendous work in terms of cross-cultural adaptation of questionnaires and large-scale population-based pharmacoepidemiological studies.

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.

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