Pharmacologic Neuroprotection

2017 ◽  
Author(s):  
Nino Stocchetti ◽  
Marco Carbonara
Keyword(s):  
Clinical Trials ◽  
Molecular Mechanisms ◽  
Neuronal Damage ◽  
Experimental Models ◽  
Cerebral Injury ◽  
Controlled Trials ◽  
Neuroprotective Agents ◽  
Randomized Controlled ◽  
Ischemic Encephalopathy ◽  
Over Time

Acute cerebral injury sets into motion a cascade of deleterious biochemical events that cause further neuronal damage and amplify deleterious effects. This cascade develops over time and potentially may be attenuated or limited by pharmacologic manipulation. The neuroprotective properties of several molecules have been clearly demonstrated in experimental models of various pathologies. Based on these findings, many promising compounds have been tested in clinical trials. Large randomized controlled trials, however, have repeatedly failed to provide evidence of clinical efficacy. The authors present an overview of neuroprotective agents studied in traumatic brain injury, subarachnoid hemorrhage, ischemic stroke, and hypoxic-ischemic encephalopathy in adults due to cardiac arrest. They review the molecular mechanisms involved in secondary neuronal injury and how drugs targeting these mechanisms have been evaluated in clinical trials. Finally, the chapter briefly analyzes the possible reasons for repeated failures in translating experimental success into clinical benefit.

PTSD Treatment Research: An Overview and Evaluation

2020 ◽  
Author(s):  
Paula P. Schnurr ◽  
Jessica L. Hamblen
Keyword(s):  
Clinical Trials ◽  
Treatment Outcome ◽  
Controlled Trials ◽  
Comorbid Conditions ◽  
Design Elements ◽  
Ptsd Treatment ◽  
Design Considerations ◽  
Randomized Controlled ◽  
Key Concepts ◽  
Treatment Research

This chapter provides an overview of key concepts in designing and evaluating clinical trials, with a focus on randomized controlled trials for PTSD. The first section discusses design elements and how they influence the conclusions that can be drawn from a study. Examples from the trauma literature are provided when available to illustrate concepts. The second section explores newer developments in PTSD treatment trials. Specifically, it discusses treatment and design considerations related to common comorbid conditions of PTSD, adapting treatments for low-resource environments and optimizing treatment outcome. The chapter’s goal is to improve the ability of both clinicians and researchers to critically review PTSD clinical trials.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

scholarly journals A Review of Marital Intimacy-Enhancing Interventions among Married Individuals

2015 ◽  
Vol 8 (8) ◽  
pp. 74 ◽  
Author(s):  
Maryam Kardan-Souraki ◽  
Zeinab Hamzehgardeshi ◽  
Ismail Asadpour ◽  
Reza Ali Mohammadpour ◽  
Soghra Khani
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Main Concern ◽  
Care Providers ◽  
Marital Intimacy ◽  
Randomized Controlled ◽  
The Impact

<p><strong>BACKGROUND:</strong> Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage.</p><p><strong>SEARCH METHODS:</strong> In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, <a href="http://www.cochranelibrary.com/">Cochrane Library</a>, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study.</p><p><strong>MAIN RESULTS:</strong> 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy.</p><p><strong>AUTHORS’ CONCLUSIONS:</strong> Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.</p>

scholarly journals High-cited favorable studies for COVID-19 treatments ineffective in large trials

2022 ◽  
Author(s):  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Wide Dissemination ◽  
Highly Cited Articles ◽  
Highly Cited

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.

scholarly journals Network Meta-Analysis of Different Clinical Commonly Used Drugs for the Treatment of Hypertrophic Scar and Keloid

2021 ◽  
Vol 8 ◽  
Author(s):  
Sha Yang ◽  
Yujia J. Luo ◽  
Cong Luo
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Topical Treatment ◽  
Hypertrophic Scar ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Silicone Gels

Background: There is no uniform treatment for pathological scars, including keloids and hypertrophic scars, in clinic currently. Previously, multiple randomized controlled trials have examined the clinical efficacy of different treatments. Nonetheless, the results are inconsistent, and many treatments have not been directly compared. This makes it difficult to conclude which approach is more favorable, in terms of efficacy and safety, for the treatment of pathological scarring. This study aimed at evaluating the efficacy of different injection and topical treatment strategies for hypertrophic scar and keloid.Methods: Relevant literature from PubMed, Medline, Embase, Scopus, the Cochrane Central Register of Controlled Trials (CCRCT), and WHO International Clinical Trials Registry Platform (WHO-ICTRP) were searched, from database inception through November 2020. Randomized clinical trials evaluating different treatment strategies of pathological scars, including triamcinolone acetonide (TAC), verapamil (VER), 5-fluorouracil (5-FU), botulinum toxin A (BTA), bleomycin (BLM), and silicone gels were included in the study.Results: The network meta-analysis included a total of 2,009 patients from 29 studies. A network meta-analysis of injection and topical treatment strategies showed that the efficacy of TAC combined with BTA was best in the treatment of pathological scars. Combination therapies of TAC with 5-FU and TAC with BTA significantly improved the clinical efficiency. However, there was no statistically significant difference between other treatment strategies. The order of efficacy predicted by the surface under the cumulative ranking (SUCRA) curve was as follows: TAC+BTA (82.2%) &gt; TAC+5-FU (69.8%) &gt; BTA (67.3%) &gt; 5-FU+silicone (59.4%) &gt; TAC+silicone (58.3%) &gt; 5-FU (49.8%) &gt; BLM (42.0%) &gt; TAC (26.7%) &gt; VER (26.2%) &gt; silicone (18.3%). There was no publication bias revealed based on the funnel diagram.Conclusion: This study recommends intralesional injection of TAC-BTA and TAC-5-FU combined therapies. But for patients who cannot tolerate the side effects, the use of silicone gels in combination with TAC is recommended. However, these conclusions need to be further confirmed by more randomized controlled trials.

scholarly journals Stability of ARDS subphenotypes over time in two randomised controlled trials

Thorax ◽  
2018 ◽  
Vol 73 (5) ◽  
pp. 439-445 ◽  
Author(s):  
Kevin Delucchi ◽  
Katie R Famous ◽  
Lorraine B Ware ◽  
Polly E Parsons ◽  
B Taylor Thompson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Randomised Controlled Trials ◽  
Latent Class ◽  
Lung Protective Ventilation ◽  
Controlled Trials ◽  
Transition Analysis ◽  
Class 1 ◽  
Randomised Controlled ◽  
Over Time

RationaleTwo distinct acute respiratory distress syndrome (ARDS) subphenotypes have been identified using data obtained at time of enrolment in clinical trials; it remains unknown if these subphenotypes are durable over time.ObjectiveTo determine the stability of ARDS subphenotypes over time.MethodsSecondary analysis of data from two randomised controlled trials in ARDS, the ARMA trial of lung protective ventilation (n=473; patients randomised to low tidal volumes only) and the ALVEOLI trial of low versus high positive end-expiratory pressure (n=549). Latent class analysis (LCA) and latent transition analysis (LTA) were applied to data from day 0 and day 3, independent of clinical outcomes.Measurements and main resultsIn ALVEOLI, LCA indicated strong evidence of two ARDS latent classes at days 0 and 3; in ARMA, evidence of two classes was stronger at day 0 than at day 3. The clinical and biological features of these two classes were similar to those in our prior work and were largely stable over time, though class 2 demonstrated evidence of progressive organ failures by day 3, compared with class 1. In both LCA and LTA models, the majority of patients (>94%) stayed in the same class from day 0 to day 3. Clinical outcomes were statistically significantly worse in class 2 than class 1 and were more strongly associated with day 3 class assignment.ConclusionsARDS subphenotypes are largely stable over the first 3 days of enrolment in two ARDS Network trials, suggesting that subphenotype identification may be feasible in the context of clinical trials.

Quality of surgical randomized controlled trials in hand surgery: a systematic review

2018 ◽  
Vol 43 (8) ◽  
pp. 801-807 ◽  
Author(s):  
Chao Long ◽  
Heather E. desJardins-Park ◽  
Rita Popat ◽  
Paige M. Fox
Keyword(s):  
Randomized Controlled Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Jadad Score ◽  
Surgical Interventions ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis ◽  
Over Time

We assessed the quantity, quality and trends of randomized controlled trials comparing hand surgical interventions. Study characteristics were collected for 125 randomized controlled trials comparing hand surgical interventions. The Jadad scale (0–5), which assesses methodological quality of trials, was calculated. Logistic regressions were conducted to determine associations with the Jadad score. The studies were published between 1981 and 2015, with an increase over time, most often in Journal of Hand Surgery (European). Mean study size was 68 patients. Mean Jadad score was 2.1, without improvement over time. Thirty percent conducted a power analysis and 8% an intention-to-treat analysis. Studies conducted in the United Kingdom and with smaller sample sizes, power analysis and intention-to-treat analysis were associated with a higher Jadad score. The quantity of trials has increased over time while methodological quality has remained low, indicating a need to improve quality of trials in hand surgery literature.

Electro Acupuncture Combined Methadone for Withdrawal Symptoms of Opioid Addiction: A Protocol for Systematic Review and Meta Analysis

2021 ◽  
Author(s):  
Tianyao Zhang ◽  
Xiaoyan He ◽  
Lijuan Wu ◽  
Xianrong Feng ◽  
Yu Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Depression Scale ◽  
Opioid Addiction ◽  
Withdrawal Symptoms ◽  
Opiate Withdrawal ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Hamilton Depression Scale ◽  
Randomized Controlled

Opioid addiction is a chronic brain disorder characterized by a series of withdrawalsymptoms in behavioral, psychological, and neurobiological manifestations.Withdrawal symptoms are the main causeof relapse after periods of abstinence; thus,the treatment is focused on abstinence symptoms. Due to most of all types of opioidagonist drugs carry a potential for addiction and exacerbation of withdrawalsymptoms, nondrug methods have great potentials i n clinical applications.Electro acupuncture (EA), as a novel nonpharmacological approach, combined withmethadone has a long term positive efficacy on treating addict ion . Therefore, we designed a protocol to evaluate the adjuvant effect of EA for treating withdrawalsymptoms of opioid addiction addiction.MethodTo review reports of relevant clinical trials, we will searchEnglish language databases(EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials) andChinese databases (Chinese Biomedical Lit eratures, China National KnowledgeInfrastructure, Wanfang, and VIP). We will collect documents from the earliestpossible date up t to May 2020. We will also search online trial registries such as ClinicalTrials.gov (ClinicalTrials.gov/), the European Medicine Agency(www.ema.europa.eu/ema/), and WHO International Clinical Trials Registry Platform(www.who.int/ictrp). We will select randomized controlled trials RCT forwithdrawal from opioid addiction involving EA methadone and methadone alonetreatment. W e will use psychological assessment scales to evaluate treatment majoroutcomes which include numerous components such as OWS, VAS, HAMD, HAMA;then u rinalysis and m ethadone dosage also will be measure as the additional outcomes.Finally, RevMan5 software will be used for literature quality evaluation and dataana lysis.Result: To evaluate the efficacy of EA in combination therapy by observing the outcomes of corresponding scale, urinalysis and decreasing methadone.Conclusion: This protocol will be used to evaluate the efficacy and safety of EA in combination with methadone in treatment of opioid addiction withdrawal symptomsAbbreviationsOpioid dependence, OWS=Opiate Withdrawal Scale, VAS=Craving Visual Analog Scale, PWSS=Post-withdrawal symptoms Scale, HAMD=Hamilton Depression Scale, HAMA=Hamilton Anxiety Scale, RCTs =Randomized Controlled Trials, EA=Electrical Acupuncture, PRISMA=Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

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