Progress in human ovarian rejuvenation: Current platelet-rich plasma and condensed cytokine research activity by scope and international origin

Objective: As clinicians and patients await consensus on intraovarian platelet-rich plasma (PRP) treatment, this project evaluated contemporary research trends in the literature. Methods: A PubMed/NLM search aggregated all ovarian PRP-related publications (n=54) to evaluate their scope, abstract utility, submission-to-publication interval, journal selected, article processing charge (APC), free reader access to full-text manuscripts, number and nationality of authors, and inclusion of international collaborators. The NIH Clinical Trials database was also audited. Results: Published output on intraovarian PRP has increased consistently since 2016, especially among investigators in Greece, Iran, USA, and Turkey. Between 2013 and 2021, 42 articles met the relevancy criteria, of which 40.5% reported clinical studies, small series, or case reports, 33% described experimental animal models, and 23.8% were opinion/review papers. Only two works included a placebo control group. The submission-to-publication interval (mean±standard deviation) was 130±96 days, there were 5.9±3.2 authors per project, and journals invoiced US $1,642±1,466 (range, $0–$3,860) for APCs. Conclusion: There was no correlation between APC and time to publish (Pearson’s r=–0.01). Abstract content was inconsistent; sample size and patient age were often missing, yet free full-text “open access” was available for most publications (59.5%). The NIH Clinical Trials portal lists eight registered studies on “ovarian rejuvenation,” of which two are actively recruiting patients, while four have been terminated or have an uncertain status. Two studies have concluded, with results from one posted to the NIH website. PRP and its derivatives for ovarian treatment show early promise, but require further investigation. Research is accelerating and should be encouraged, particularly placebo-controlled randomized clinical trials.

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Use of a placebo in clinical trials

European Psychiatry ◽

10.1016/s0924-9338(98)80031-x ◽

1998 ◽

Vol 13 (5) ◽

pp. 254-263 ◽

Cited By ~ 2

Author(s):

G Emilien ◽

JM Maloteaux ◽

A Seghers ◽

G Charles

Keyword(s):

Clinical Trials ◽

Placebo Response ◽

Drug Efficacy ◽

Placebo Treatment ◽

High Response Rate ◽

Experimental Methodology ◽

Necessary Condition ◽

Control Group ◽

Placebo Control ◽

Experimental Drug

SummaryThe use of a placebo control group in the evaluation of a new product is today considered by most as a necessary condition of experimental drug research. Placebo response is an essential consideration in all clinical trials. If not properly controlled, incorrect and dangerous conclusion may be inferred for a product efficacy and safety profile. However, the inclusion of a placebo group in clinical trials in neuropsychiatric research raises several ethical and scientific questions. Whereas in certain indications, such as suicidal patients and severe and psychotic depression, the use of a placebo is generally not accepted, it is difficult to assess drug efficacy. This article discusses the concept of placebo in clinical trials, the occurrence of adverse events after placebo treatment and the high response rate of placebo in neuropsychiatric clinical research. The experimental methodology to adequately control all the factors involved is also analysed and discussed.

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Brain Metastases Research 1990–2010: Pattern of Citation and Systematic Review of Highly Cited Articles

The Scientific World JOURNAL ◽

10.1100/2012/721598 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Carsten Nieder ◽

Anca L. Grosu ◽

Minesh P. Mehta

Keyword(s):

Clinical Trials ◽

Brain Metastases ◽

Randomized Clinical Trials ◽

Citation Rate ◽

Prognostic Score ◽

Median Number ◽

Research Activity ◽

Secondary Endpoints ◽

Number Of Citations

Background. High and continuously increasing research activity related to different aspects of prevention, prediction, diagnosis and treatment of brain metastases has been performed between 1990 and 2010. One of the major databases contains 2695 scientific articles that were published during this time period. Different measures of impact, visibility, and quality of published research are available, each with its own pros and cons. For this overview, article citation rate was chosen.Results. Among the 10 most cited articles, 7 reported on randomized clinical trials. Nine covered surgical or radiosurgical approaches and the remaining one a widely adopted prognostic score. Overall, 30 randomized clinical trials were published between 1990 and 2010, including those with phase II design and excluding duplicate publications, for example, after longer followup or with focus on secondary endpoints. Twenty of these randomized clinical trials were published before 2008. Their median number of citations was 110, range 13–1013, compared to 5-6 citations for all types of publications. Annual citation rate appeared to gradually increase during the first 2-3 years after publication before reaching high levels.Conclusions. A large variety of preclinical and clinical topics achieved high numbers of citations. However, areas such as quality of life, side effects, and end-of-life care were underrepresented. Efforts to increase their visibility might be warranted.

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EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

10.1101/2021.10.21.21265199 ◽

2021 ◽

Author(s):

Iury Gomes Batista ◽

Osmar Cleyton Person ◽

Fernando Veiga Angelico Junior ◽

Priscila Bogar

Keyword(s):

Clinical Trials ◽

Allergic Rhinitis ◽

Randomized Clinical Trials ◽

Nasal Congestion ◽

Control Group ◽

Cochrane Central Register ◽

Level Of Evidence ◽

Runny Nose ◽

Trial Quality ◽

Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

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Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

Medical Decision Making ◽

10.1177/0272989x20973160 ◽

2020 ◽

Vol 41 (1) ◽

pp. 9-20

Author(s):

Louise B. Russell ◽

Laurie A. Norton ◽

David Pagnotti ◽

Christianne Sevinc ◽

Sophia Anderson ◽

...

Keyword(s):

Clinical Trials ◽

Financial Incentives ◽

Behavioral Interventions ◽

Randomized Clinical Trials ◽

Financial Incentive ◽

Trial Data ◽

Control Group ◽

Cost Information ◽

Billing Data ◽

Pragmatic Clinical Trials

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

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Limited Evidence Suggests Benefits of Single Visit Revascularization Endodontic Procedures - A Systematic Review

Brazilian Dental Journal ◽

10.1590/0103-6440201902670 ◽

2019 ◽

Vol 30 (6) ◽

pp. 527-535 ◽

Cited By ~ 2

Author(s):

Giampiero Rossi-Fedele ◽

Bill Kahler ◽

Nagendrababu Venkateshbabu

Keyword(s):

Clinical Trials ◽

Animal Studies ◽

Randomized Clinical Trials ◽

Case Reports ◽

Risk Of Bias ◽

Permanent Teeth ◽

Single Visit ◽

Multiple Treatment ◽

High Concentrations

Abstract Revascularization endodontic procedures commonly require multiple treatment sessions. However, single visit procedures may be advantageous from the clinical and patient management standpoints. The purpose of this review was to evaluate the outcomes of single-visit revascularization endodontic procedures for the management of immature permanent teeth with non-vital pulp. Two electronic databases (Scopus and PubMed) were searched, from their inception to July 2018, for studies that assessed clinical and/or radiographic and/or histologic outcomes of single-visit revascularization endodontic procedures performed in immature permanent teeth with non-vital pulp. Case reports, animal studies and clinical trials were included. The quality of case reports was appraised by Joanna Briggs Institute Critical Appraisal Checklist for Case Reports. The quality of randomized clinical trials was assessed by the revised Cochrane risk of bias tool for randomized trials. The risk of bias for animal studies was assessed using SYRCLE’s risk of bias tool. Tabulation followed by narrative synthesis was used to draw conclusions. Seven studies satisfied the selection criteria. Five were classified as case reports, one as a randomized clinical trial and one as animal study. The latter presented with a high risk of bias, whilst the remaining showed a low risk. The evidence supporting the potential use of single-visit revascularization endodontic procedures is scarce. Successful single-visit revascularization endodontic procedures commonly include the use of high concentrations of sodium hypochlorite and EDTA combined with the use of agitation systems. Further clinical trials with long term follow up are needed to confirm the results of the current review.

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The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies

Materials ◽

10.3390/ma15020655 ◽

2022 ◽

Vol 15 (2) ◽

pp. 655

Author(s):

Elisabet Roca-Millan ◽

Enric Jané-Salas ◽

Antonio Marí-Roig ◽

Álvaro Jiménez-Guerra ◽

Iván Ortiz-García ◽

...

Keyword(s):

Clinical Trials ◽

Survival Rate ◽

Tricalcium Phosphate ◽

Randomized Clinical Trials ◽

Systematic Evaluation ◽

Control Group ◽

Cochrane Central Register ◽

Graft Material ◽

Synthetic Graft ◽

Implant Dentistry

The demand for synthetic graft materials in implant dentistry is rising. This systematic review aims to evaluate the survival rate of dental implants placed simultaneously with bone regeneration procedures using the material β-tricalcium phosphate, one of the most promising synthetic graft materials. The electronic search was conducted in PubMed, Scielo, and the Cochrane Central Register of Controlled Trials. There were five randomized clinical trials, one of which was a non-randomized controlled clinical trial and four of which were observational studies without a control group included. Implant survival rate and other clinical, radiographic, and histological parameters did not differ from those of implants placed simultaneously with another type of graft material, or placed in blood clots or natural alveolar ridges. Based on the available literature, β-tricalcium phosphate seems to be a promising graft material in implant dentistry. Nevertheless, more randomized clinical trials, with long follow-up periods, preoperative and postoperative CBCT, and histological analysis, are necessary to assess its long-term behavior.

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Effectiveness of Dentist-Prescribed, Home-Applied Tooth Whitening, A Meta-analysis

The Journal of Contemporary Dental Practice ◽

10.5005/jcdp-1-4-34 ◽

1999 ◽

Vol 1 (4) ◽

pp. 34-49 ◽

Cited By ~ 11

Author(s):

Richard Niederman ◽

Maggie C. Tantraphol ◽

Patricia Slnin ◽

Catherine Hayes ◽

Suzy Conway

Keyword(s):

Clinical Trials ◽

Meta Analysis ◽

Control Group ◽

Placebo Control ◽

List Type ◽

Tooth Whitening ◽

Clinical Applicability ◽

Placebo Control Group ◽

The People ◽

Shade Guide

Abstract Introduction Common clinical experience suggests that tooth whitening agents are 100% effective. This study uses meta-analysis of data from published randomized controlled clinical trials to determine the efficacy of tooth whitening agents. Methods A MEDLINE search strategy was developed and implemented to systematically identify clinical trials on dentist-prescribed, home-applied tooth whitening agents, using 10% carbamide peroxide, published between 1989-1999. Inclusion criteria (e.g., in English, human clinical trials) and exclusion criteria (e.g., not placebo controlled) were established and clinical trials that met these criteria were critically appraised for validity and clinical applicability. Meta-analysis was then used to quantitatively integrate the findings. Results Seven studies were identified that met the inclusion and validity criteria. These studies indicated that: Whitening results in a significant mean change of 6 4 shade guide units (p < 0.01), while the placebo control group exhibited little change (0.7 0.6, p > 0.05). 93% of the bleached patients exhibited 2 shade guide unit change, while 20% of the placebo control group exhibited this change. The brand of bleaching agent had a significant effect on tooth whitening, but the daily application time and duration of treatment did not. Whitening is maintained for 6 months for 1/2 of the people treated. Neither gingival indices nor plaque indices were adversely or favorably affected by bleaching. Clinical Applicability The data from the reviewed studies indicate that rather than being 100% effective, on average: 73% (93% for bleached group minus 20% placebo group) of people who whiten their teeth will exhibit a whitening that is 2 shade guide units greater than the placebo. 20% of the people who use dentist-prescribed, home-applied bleaching will achieve a mean whitening effect of 5 shade guide units. Re-treatment for 50% of people may be necessary to maintain this effect longer than 6 months. The methods used here are Internet applicable for other clinical topics.

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Profile of Scientific Production on Ankyloglossia

International Journal of Medical and Surgical Sciences ◽

10.32457/ijmss.v8i1.592 ◽

2020 ◽

pp. 1-13

Author(s):

Roberta Lopes de Castro Martinelli ◽

Reinaldo Jordão Gusmão ◽

María Paz Moya Daza ◽

Irene Queiroz Marchesan ◽

Giédre Berretin-Felix

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Case Reports ◽

Case Series ◽

Scientific Production ◽

Publication Type ◽

Level Of Evidence ◽

First Results ◽

Bibliometric Review

This work aims to describe the profile of scientific production referring to ankyloglossia. For this an investigation was carried out by searching for scientific articles indexed in the electronic databases LILACS and PUBMED. For the bibliometric review, the data referring to the year of publication, type of study and level of evidence were examined and tabulated. The data were discussed on the quantitative and representative values optics. The first results allowed to analyzic 651 published studies were analyzed. Most of the research on tongue tie found correspond to descriptive studies and case series (49.31%), followed by case reports, in vitro research, in animals and literature review (24.27%), cohort and cases and controls (11.98%), specialist opinion (11.68%), randomized clinical trials (1.54%) and systematic reviews (1.22%). Few studies addressed complications during or after lingual frenulum release surgery. In conclusion Scientific production on ankyloglossia has shown an increasing increase in the last 28 years, with studies with evidence levels 1, 2 and 3 being published, whose main focus was the performance of surgery to release the lingual frenulum.

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Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients.

10.21203/rs.3.rs-100994/v1 ◽

2020 ◽

Author(s):

Flavio A. Cadegiani ◽

Andy Goren ◽

Carlos G. Wambier ◽

John McCoy

Keyword(s):

Safety Profile ◽

Randomized Clinical Trials ◽

Clinical Symptoms ◽

Early Stage ◽

Control Group ◽

Placebo Control ◽

Control Groups ◽

Persistent Symptoms ◽

Number Of Patients ◽

Outpatient Settings

Abstract Background: While there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. The unexpected apparent positive results led to ethical questions on the employment of further full placebo-control studies in early stage COVID-19. The objective of the present study was to elucidate whether the conduction of a full placebo-control RCT was still ethically viable, through a comparative analysis with two control-groups.Materials and methods: Active group (AG) consisted of mild-to-moderate early stage COVID-19 patients enrolled in the Pre AndroCoV-Trial, treated with nitazoxanide ivermectin, or hydroxychloroquine in selected cases, in association with azithromycin. Vitamin D, vitamin C, zinc, glucocorticoids and anticoagulants, when clinically recommended. Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients from the same population as those from the Pre-AndroCoV Trial, and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes, based on a thorough and structured review of articles indexed in PubMed and MEDLINE and statements by official government agencies and specific medical societies. For both CGs, patients were matched for proportion between sex, age, obesity and other comorbidities. Results: Compared to CG1 and CG2, AG showed a reduction of 31.5 to 36.5% in viral shedding (p < 0.0001), 70 to 85% and 70 to 73% in duration of COVID-19 clinical symptoms when including and not including anosmia and ageusia, respectively ((p < 0.0001 for both), and 100% in respiratory complications through the parameters of the Brescia COVID-19 Respiratory Scale (p < 0.0001). For every 1,000 confirmed cases for COVID-19, a minimum of 140 patients were prevented from hospitalization (p < 0.0001), 50 from mechanical ventilation, and five deaths, when comparing to age-, sex- and comorbidity-matched non-treated patients with similar initial disease severity at the moment of diagnosis.Conclusion: Apparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients. The potential benefits could allow a large number of patients prevented from hospitalizations, deaths and persistent symptoms after COVID-19 remission. The potential impact on COVID-19 disease course and numbers of negative outcomes and the well-established safety profile of the drugs proposed by the Pre-AndroCoV Trial led to ethical questions regarding the conduction of further placebo control randomized clinical trials (RCTs) for early COVID-19. Early pharmacological approaches including azithromycin in combination with any of the options between nitazoxanide, ivermectin or optionally hydroxychloroquine should be considered for those diagnosed with COVID-19 presenting less than seven days of symptoms. Of the three drugs, we opted for nitazoxanide, due to more extensive demonstration of in vitro and in vivoantiviral activity, proven efficacy against other viruses in humans, and steadier safety profile.

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Recent Research Trends in Moxibustion Treatment in Korea

Journal of Acupuncture Research ◽

10.13045/jar.2019.00227 ◽

2020 ◽

Vol 37 (1) ◽

pp. 1-12

Author(s):

Ju-Hyeon Lee ◽

Doo-ree Hwang ◽

Seung-Hyo Hong

Keyword(s):

Clinical Trials ◽

Assessment Tool ◽

Case Reports ◽

Randomized Study ◽

Risk Of Bias ◽

Control Group ◽

Bias Assessment ◽

Korean Traditional Medicine ◽

Study Type ◽

Circulatory Diseases

A total of 1,235 studies were retrieved on June 23, 2019, from 3 databases. Selected 59 studies were evaluated by year of publication, study type, subject condition/disease, acupoint, standards for reporting interventions in clinical trials of moxibustion (STRICTOM), Cochrane risk of bias (RoB), and risk of bias assessment tool for non-randomized study (RoBANS). Most studies were conducted in 2011, after which the number of studies decreased. The most common study type was 25 case reports (CR), 16 uncontrolled clinical trials (UCT), 11 randomized controlled trials (RCT), and 7 controlled clinical trials (CCT). Moxibustion treatment was mainly used for musculoskeletal and circulatory diseases/conditions. A total of 83 acupoints were used, A-shi points being the most used. As for STRICTOM, an average of 7.4 items were satisfactory for UCT and CR without a control group, and an average of 9.4 items were satisfactory for RCT and CCT. RCT was assessed using the RoB, and many items were rated as uncertain. In this study, the need for RCT of moxibustion treatment in Korea was identified. The detailed description of study methods and results will provide evidence for the efficacy of moxibustion treatment in preventive and therapeutic aspects of Korean traditional medicine.

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