scholarly journals Industry sponsorship and selection of comparators in randomized clinical trials

2010 ◽  
Vol 40 (2) ◽  
pp. 172-182 ◽  
Author(s):  
D. N. Lathyris ◽  
N. A. Patsopoulos ◽  
G. Salanti ◽  
J. P. A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Industry Sponsorship ◽  
Selection Of

PILONIDAL DISEASE: CHANGES IN UNDERSTANDING OF ETIOLOGY, PATHOGENESIS AND APPROACH TO TREATMENT

2019 ◽  
Vol 72 (8) ◽  
pp. 1559-1565
Author(s):  
Viktor Konoplitskyi ◽  
Ruslan Shavliuk ◽  
Dmytro Dmytriiev ◽  
Kostiantyn Dmytriiev ◽  
Oleksii Kyrychenko ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pilonidal Sinus ◽  
Randomized Clinical Trials ◽  
Web Of Science ◽  
Surgical Intervention ◽  
Pilonidal Disease ◽  
Treatment Methods ◽  
Principles Of Treatment ◽  
Selection Of

Data from Web of Science, SCOPUS, Pub Med, Medline, E-library, and other sources was used in writing this article. The main focus was directed towards literature written in English. The selection of literature was based on such concepts as: etiopathogenesis, historical principles of treatment, methods of surgical and non-surgical intervention. Data from metanalysis publications and randomized clinical trials pertaining to the treatment of the pilonidal sinus at various stages of its formation was used, as well.

Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study

2020 ◽  
pp. 109-114
Author(s):  
Alan D. Penman ◽  
Kimberly W. Crowder ◽  
William M. Watkins
Keyword(s):  
Clinical Trials ◽  
Intraocular Pressure ◽  
Data Analysis ◽  
High Risk ◽  
Randomized Clinical Trials ◽  
De Novo ◽  
Glaucoma Surgery ◽  
Pooled Data ◽  
The Individual ◽  
Selection Of

Data from 2 independent randomized clinical trials, the Ahmed Baerveldt Comparison (ABC) Study and the Ahmed Versus Baerveldt (AVB) Study, were pooled for analysis to determine whether the Ahmed-FP7 or the Baerveldt BG101-350 implant was more efficacious in the treatment of refractory or high-risk glaucoma. Both devices lowered intraocular pressure (IOP) and decreased the need for glaucoma medications. The Baerveldt group had a lower failure rate, lower rate of de novo glaucoma surgery, and lower mean IOP on fewer medications than the Ahmed group. However, Baerveldt implantation carried a higher risk of hypotony. The authors recommended that the selection of a device for a patient should be based on target IOP, compliance with medications, urgency for IOP lowering, surgeon familiarity with each device, and the surgeon’s personal outcomes with the individual devices.

scholarly journals The Challenges of Designing and Implementing Clinical Trials With Broccoli Sprouts… and Turning Evidence Into Public Health Action

2021 ◽  
Vol 8 ◽  
Author(s):  
Jed W. Fahey ◽  
Thomas W. Kensler
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Randomized Clinical Trials ◽  
Public Health Action ◽  
Broccoli Sprouts ◽  
Health Action ◽  
Inflammatory Processes ◽  
Broccoli Sprout ◽  
Selection Of

Broccoli sprouts are a convenient and rich source of the glucosinolate glucoraphanin, which can generate the chemopreventive agent sulforaphane through the catalytic actions of plant myrosinase or β-thioglucosidases in the gut microflora. Sulforaphane, in turn, is an inducer of cytoprotective enzymes through activation of Nrf2 signaling, and a potent inhibitor of carcinogenesis in multiple murine models. Sulforaphane is also protective in models of diabetes, neurodegenerative disease, and other inflammatory processes, likely reflecting additional actions of Nrf2 and interactions with other signaling pathways. Translating this efficacy into the design and implementation of clinical chemoprevention trials, especially food-based trials, faces numerous challenges including the selection of the source, placebo, and dose as well as standardization of the formulation of the intervention material. Unlike in animals, purified sulforaphane has had very limited use in clinical studies. We have conducted a series of clinical studies and randomized clinical trials to evaluate the effects of composition (glucoraphanin-rich [± myrosinase] vs. sulforaphane-rich or mixture beverages), formulation (beverage vs. tablet) and dose, on the efficacy of these broccoli sprout-based preparations to evaluate safety, pharmacokinetics, pharmacodynamic action, and clinical benefit. While the challenges for the evaluation of broccoli sprouts in clinical trials are themselves formidable, further hurdles must be overcome to bring this science to public health action.

New designs for the selection of treatments to be tested in randomized clinical trials

1994 ◽  
Vol 13 (5-7) ◽  
pp. 417-429 ◽  
Author(s):  
R. Simon ◽  
P. F. Thall ◽  
S. S. Ellenberg
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Selection Of

APPENDECTOMY AT THE CONTEMPORARY STAGE (LITERATURE REVIEW)

Vestnik ◽  
2021 ◽  
pp. 198-205
Author(s):  
А.Т. Джумабеков ◽  
А.Т. Бабаханов ◽  
С.М. Жарменов ◽  
Н.У. Ауелов ◽  
А.Д. Серикбаев ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Literature Review ◽  
Acute Appendicitis ◽  
Systematic Reviews ◽  
Laparoscopic Appendectomy ◽  
Randomized Clinical Trials ◽  
Open Appendectomy ◽  
Optimal Choice ◽  
Search And Selection ◽  
Selection Of

В первую очередь, острый аппендицит (ОА) - клинический диагноз. Согласно проведенному обзору, по всему миру заболеваемость острым аппендицитом составляет около 100 случаев на 100 тыс. населения в год. Острый аппендицит чаще встречается у пациентов от подросткового возраста и до 50 лет. Также определяется незначительное преобладание мужчин над женщинами. В 1894 г. McBurney описал новую по тем временам технику лечения острого аппендицита. Данный метод до сих пор используется, а во многих странах является золотым стандартом при оперативном лечении острого аппендицита. В 1981 году Семмом была произведена первая лапароскопическая аппендэктомия. В настоящее время хирургия с использованием эндовидео технологий приобретает первостепенное значение во многих хирургических учреждениях. Однако, даже с учетом большого количества проведенных операций и клинических исследований, среди хирургов возникает вопрос: является ли лапароскопическая операция оптимальным выбором при аппендэктомии. Цель. Сравнить лапароскопическую аппендектомию с открытой аппендектомией. Материалы и методы. Для поиска и отбора статей использовался принцип PRISMA (Предпочтительный Метод Отчета Для Систематических Обзоров и Метаанализов). В настоящем обзоре были использованы базы данных MedLine, Cochrane, PubMEd. Глубина поиска составила 10 лет, за исключением исторических данных. Все источники изучены без лимитирования по языку. Обзор литературы проводился в электронном и в ручном режимах. Для обзора были отобраны статьи, соответствующие ключевым словам - острый аппендицит, лапароскопическая аппендэктомия, открытая аппендэктомия. Было найдено 389 статьи, в поиск включались систематические обзоры, метаанализы, рандомизированные клинические исследования. Для удаления дубликатов и отбора статей использовался ресурс «https://rayyan.ai/» После отбора статей было выбрано 119 источников, которые были включены в итоговый синтез. Вывод. Лапароскопическая аппендектомия показывает преимущество перед открытой аппендектомией по интенсивности боли в первый день, раневым инфекциям, продолжительности пребывания в больнице и времени до возвращения к нормальной активности у взрослых. В нескольких исследованиях сообщалось о более высоких показателях качества жизни у взрослых. Однако, некоторые клинические эффекты лапароскопической аппендектомии описаны авторами как небольшие и имеющие ограниченное клиническое значение. Необходимы крупные исследования, направленные на снижение уровня систематической ошибки. First of all, acute appendicitis (OA) is a clinical diagnosis. According to the survey, the worldwide incidence of acute appendicitis is about 100 cases per 100 thousand rubles. population per year. Acute appendicitis is more common in patients from adolescence to 50 years of age. There is also a decisive predominance of men over women. In 1894, McBurney described a new technique for the treatment of acute appendicitis. This method is still used, it is used by the gold standard in the surgical treatment of acute appendicitis. In 1981, Semm performed the first laparoscopic appendectomy. Nowadays, surgery using endovideo technology is gaining paramount importance in many surgical institutions. However, even taking into account the large number of operations performed and clinical trials, the question arises among surgeons: is laparoscopic surgery the optimal choice for appendectomy? Target. Compare laparoscopic appendectomy with open appendectomy. Materials and methods. For the search and selection of articles, the PRISMA principle (Preferred Reporting Method for Systematic Reviews and Meta-analyzes) was used. In this review, the databases MedLine, Cochrane, PubMEd were used. Search depth excludes 10 years. All sources have been studied without language limitation. The literature review was carried out in electronic and manual modes. For were selected articles, the relevant keywords - acute appendicitis, laparoscopic appendectomy, open appendectomy. 389 articles were found, systematic reviews, meta-analyzes, randomized clinical trials were included in the search. To remove duplicates and select articles, the resource "https://rayyan.ai/" was used for the selection of articles, 119 sources were selected, which were included in the final synthesis. Output. Laparoscopic appendectomy shows an advantage over open appendectomy in first day pain, wound infections, length of hospital stay, and time to return to normal activity in adults. Several studies have reported higher rates of quality of life in adults. However, some of the authors' approximating effects of laparoscopic vendectomy are small and of limited clinical relevance. Large studies are needed, the error is to lower the systematic level.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

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.

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