scholarly journals Evaluation of the methodologies used in clinical trials and effectiveness of chemo-mechanical caries removal with CarisolvTM

2006 ◽  
Vol 20 (4) ◽  
pp. 364-371 ◽  
Author(s):  
Marcela Marquezan ◽  
Italo Medeiros Faraco Junior ◽  
Carlos Alberto Feldens ◽  
Maximiano Ferreira Tovo ◽  
Andréia Bertani Ottoni
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Scientific Evidence ◽  
Study Groups ◽  
Mechanical Methods ◽  
Caries Removal ◽  
Methodological Principles ◽  
Mean Time ◽  
Evidence Generation

This investigation aims to discuss the methodologies applied in clinical trials published about CarisolvTM, in order to assess the best scientific evidence concerning chemo-mechanical caries removal. Papers concerning the use of CarisolvTM were sought using a search strategy. The titles and abstracts of all the reports identified through the search were analyzed by a single reviewer. The inclusion criterion involved: clinical trials having CarisolvTM in one of the study groups. Then, those that fulfilled the inclusion criterion underwent methodology assessment and data extraction. Only 12 papers met the inclusion criterion. It was observed that none of these studies complied with all the evaluated research methodological principles required in order to have power of evidence generation. CarisolvTM proved to be effective in caries removal. Appointment mean time was greater, but the perceived time was shorter than that using conventional techniques due to patients' perception of more comfort and a reduction of anesthesia needs. There were no adverse effect in long-term assessments. In studies with microbiological evaluation of the remaining dentine, it was observed that both the conventional and chemo-mechanical methods produced statistically significant reduction on counts of viable microorganisms.

Natural Products and the Athlete: Facts and Folklore

1993 ◽  
Vol 27 (5) ◽  
pp. 607-615 ◽  
Author(s):  
Richard L. Barron ◽  
Gordon J. Vanscoy
Keyword(s):  
Clinical Trials ◽  
Natural Products ◽  
Natural Product ◽  
Sports Medicine ◽  
Animal Studies ◽  
Data Extraction ◽  
Scientific Evidence ◽  
Pharmacy Practice ◽  
Health Food ◽  
Medline Search

OBJECTIVE: To contrast scientific facts with suggested manufacturers' claims regarding food supplements (natural products) marketed for enhanced athletic prowess. DATA SOURCES: A MEDLINE search was performed to obtain documentation supporting the claims of natural-product manufacturers. In addition, several references pertaining to pharmacognosy, natural products, herbs, pharmacy practice, and sports medicine were reviewed. Claims were obtained from promotional advertisements in bodybuilding magazines, product labels, and fact sheets for sales representatives in nutrition and health-food stores. DATA EXTRACTION: We reviewed all of the clinical trials, published between 1966 and 1992, relative to the manufacturers' claims regarding these products. DATA SYNTHESIS: Pertinent human and/or animal studies supporting each natural product were compared with the manufacturers' claims. CONCLUSIONS: We found that there was no published scientific evidence to support the promotional claims for a large proportion of the products (8/19,42 percent). Only 4 of 19 products (21 percent) were associated with any documented human clinical trials supporting their promotional claims. Six of 19 agents (32 percent) had some scientific documentation to support their promotional claims; however, these products were judged to be marketed in a misleading manner.

scholarly journals Oral Immunotherapy for Food-Allergic Children: A Pro-Con Debate

2021 ◽  
Author(s):  
Francesca Mori ◽  
Mattia Giovannini ◽  
Simona Barni ◽  
Rodrigo Jiménez-Saiz ◽  
Daniel Munblit ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Food Allergy ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Standard Of Care ◽  
Oral Immunotherapy ◽  
Patient Reported

The prevalence of food allergy has increased in recent years, especially in children. Food allergen avoidance and symptomatic drugs in case of an allergic reaction remain the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanuts, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.

Treatment of Infantile Spasms

1994 ◽  
Vol 28 (6) ◽  
pp. 779-791 ◽  
Author(s):  
Stuart T. Haines ◽  
Daniel T. Casto
Keyword(s):  
Clinical Trials ◽  
Clinical Features ◽  
Hormonal Therapy ◽  
Intellectual Development ◽  
Data Extraction ◽  
Hormonal Treatment ◽  
Infantile Spasms ◽  
Recent Theory ◽  
Long Term Prognosis

OBJECTIVE: To summarize and evaluate the literature regarding the clinical features, epidemiology, etiology, pathophysiology, and treatment of infantile spasms. DATA SOURCES: A literature search of articles from January 1966 to July 1993 using MEDLINE, EM-Base, and Current Concepts/Life Sciences, as well as bibliographies of relevant articles. STUDY SELECTION: All identified original and review publications regarding the clinical features, epidemiology, etiology, pathophysiology, and treatment of infantile spasms were reviewed. Emphasis was placed on original studies published since 1975. DATA EXTRACTION: Data from published research were extracted and evaluated according to study design, sample size, dosing regimen, outcome measures, and treatment efficacy and safety. DATA SYNTHESIS: Infantile spasms constitute a rare epileptic syndrome with a poor long-term prognosis for normal intellectual development. The spasms are characterized by a brief symmetric contraction of the muscles of the neck, trunk, and/or extremities, often occurring in a series of 2 to more than 100 spasms during a single episode. The disorder is age-specific, with the peak onset of symptoms occurring between 2 and 8 months of age. Spasms of no identifiable cause in infants with normal development prior to the onset of infantile spasms are classified as cryptogenic or idiopathic, whereas those with an identifiable cause are classified as symptomatic. Long-term prognosis is best in cryptogenic cases, with 30–70 percent attaining normal intellect compared with 5–19 percent in symptomatic cases. The etiology and pathophysiology are not well understood. Recent theory postulates that infantile spasms may be caused by an excess of corticotropin-releasing hormone activity during infancy. The suspected association between the whole-cell pertussis vaccine and infantile spasms is coincidental. Few well-designed, prospective, controlled clinical trials for the treatment of infantile spasms have been conducted. CONCLUSIONS: Standard anticonvulsants such as phenytoin, the barbiturates, carbamazepine, and the succinimides have been ineffective. Of the anticonvulsants, only the benzodiazepines, valproic acid, and vigabatrin have shown efficacy in reducing spasm frequency and severity. Hormonal therapy with adrenocorticotropic hormone (ACTH) and/or prednisone has been the most frequently studied treatment modality and appears to be the most effective. Hormonal therapy achieves complete spasm control in 50?75 percent of infants within four weeks of initiation. Opinions differ regarding the relative efficacy between ACTH and prednisone, the need for early initiation of hormonal treatment, and the benefits of high dosages of ACTH (>40 units/d). No treatment has been shown conclusively to improve the long-term intellectual development of these infants. Neurosurgery may be the treatment of choice in select cases when a localized central nervous system abnormality can be demonstrated. Well-designed, blind, prospective clinical trials are needed to answer definitively many lingering questions regarding the treatment of infantile spasms.

scholarly journals Oral Immunotherapy for Food-Allergic Children: A Pro-Con Debate

2021 ◽  
Vol 12 ◽  
Author(s):  
Francesca Mori ◽  
Mattia Giovannini ◽  
Simona Barni ◽  
Rodrigo Jiménez-Saiz ◽  
Daniel Munblit ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Food Allergy ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Standard Of Care ◽  
Oral Immunotherapy ◽  
Patient Reported

The prevalence of food allergy has increased in recent years, especially in children. Allergen avoidance, and drugs in case of an allergic reaction, remains the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanut, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization through the consumption of an increasing amount of a food allergen, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current pediatric OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, pediatric OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.

scholarly journals Access to routinely collected health data for clinical trials – review of successful data requests to UK registries

2020 ◽  
Author(s):  
Sarah Lensen ◽  
Archie Macnair ◽  
Sharon B Love ◽  
Victoria Yorke-Edwards ◽  
Nurulamin M Noor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Health Data ◽  
Lack Of Information ◽  
Routinely Collected Health Data ◽  
Long Term Follow Up ◽  
Randomised Controlled ◽  
The Uk

ABSTRACTBackgroundClinical trials generally each collect their own data despite routinely-collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.MethodsWe conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013-2018, for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction was undertaken between Jan-2019 and May-2019.ResultsWe identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (approximately 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.ConclusionsIn the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined up thinking between the registries and the regulatory authorities.RegistrationPROSPERO CRD42019123088

Treatment and secondary prevention of venous thromboembolism in cancer patients

2012 ◽  
Vol 03 (03) ◽  
pp. 121-125
Author(s):  
I. Pabinger ◽  
C. Ay
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
New Oral Anticoagulants ◽  
Phase Iii ◽  
Patients With Cancer ◽  
Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

Apophysites – Revue de la littérature et ­nouvelles directions

2014 ◽  
Vol 62 (3) ◽  
Keyword(s):  
Scientific Evidence ◽  
Ossification Center ◽  
Health Staff ◽  
Optimal Management ◽  
Long Term Effect ◽  
High Incidence ◽  
Youth Athlete ◽  
Pathology Education ◽  
Main Factor

Apophysitis are part of the growth-related diseases within youth athlete population. Despite their high incidence within this growing cohort, many doubts remain. The physiopathology is still debated. Initially, the fragmentation of the ossification center was seen as the main factor of the disease. For few years, this theory has been questioned due to consistent signs of tendon suffering. Apophysitis may have some negative long-term effect on a sporting career. There is currently poor scientific evidence on the optimal management and no treatment has been widely accepted. Prevention remains the most powerful intervention in this particular pathology. Education of the athlete’s sporting entourage (family, coaches and health staff) and the athlete himself is necessary to act quickly and adapt the training load to decrease mechanical stress on the suffering apophysis.

scholarly journals Surveillance System in Smart Cities: A Dependability Evaluation Based on Stochastic Models

Electronics ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 876
Author(s):  
Igor Gonçalves ◽  
Laécio Rodrigues ◽  
Francisco Airton Silva ◽  
Tuan Anh Nguyen ◽  
Dugki Min ◽  
...  
Keyword(s):  
Surveillance System ◽  
Smart Cities ◽  
Heterogeneous Data ◽  
Time To Failure ◽  
Video Streams ◽  
Dependability Evaluation ◽  
The Mean ◽  
Mean Time ◽  
The Internet Of Things

Surveillance monitoring systems are highly necessary, aiming to prevent many social problems in smart cities. The internet of things (IoT) nowadays offers a variety of technologies to capture and process massive and heterogeneous data. Due to the fact that (i) advanced analyses of video streams are performed on powerful recording devices; while (ii) surveillance monitoring services require high availability levels in the way that the service must remain connected, for example, to a connection network that offers higher speed than conventional connections; and that (iii) the trust-worthy dependability of a surveillance system depends on various factors, it is not easy to identify which components/devices in a system architecture have the most impact on the dependability for a specific surveillance system in smart cities. In this paper, we developed stochastic Petri net models for a surveillance monitoring system with regard to varying several parameters to obtain the highest dependability. Two main metrics of interest in the dependability of a surveillance system including reliability and availability were analyzed in a comprehensive manner. The analysis results show that the variation in the number of long-term evolution (LTE)-based stations contributes to a number of nines (#9s) increase in availability. The obtained results show that the variation of the mean time to failure (MTTF) of surveillance cameras exposes a high impact on the reliability of the system. The findings of this work have the potential of assisting system architects in planning more optimized systems in this field based on the proposed models.

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