Introduction to Trials Published

A systematic literature search was also performed to identify new evidence from the randomized controlled trials published within 2014-2021.

Methods: A systematic literature search of electronic databases (PubMed, Cochrane Library, and EMBASE) was performed to locate randomized controlled trials published through March 2019 that compared PRP with control treatment.

Ten electronic databases were searched to identify randomized controlled trials published from inception to July 31, 2020.

These databases will be searched to identify randomized controlled trials published January 1, 1980, and January 20, 2021.

Method: Integrative literature review, including randomized controlled clinical trials published in the following databases: CINAHL, BVS, PUBMED, Web of Science, Embase and Google Scholar.

Randomized controlled clinical trials published in the last five years that included T2D subjects and evaluated the composition of the gut microbiome alongside metabolic outcomes before and after conventional or alternative glucose lowering therapy were selected.

This cross-sectional study assesses the frequency and thoroughness of reporting of sociodemographic variables in randomized clinical trials published in 5 high-impact health journals from January 2014 to July 2020.

STUDY DESIGN This was a cross-sectional study of obstetrics and gynecology trials published between 2017 and 2019 in six journals (AJOG, BJOG, Obstetrics and Gynecology, JAMA, The Lancet, NEJM).

Randomized controlled trials published in journals were included irrespective of blinding and language used.

Eligibility criteria for including studies reviewed was randomized and non-randomized controlled trials published in English language.

Clinical trials published from 2011 to 2020 (March) were included.

Methods: Relevant randomized controlled trials (RCTs) and prospective controlled clinical trials published in PubMed, Google Scholar, Excerpt Medica Database, Medline, Cochrane Library, Web of Science, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database and Wanfang Database will be systematic searched to identify eligible studies from their establishment to December 2020.

Methods and analysis We will search in the medical databases and International Clinical Trials Registry Platform databases for randomised clinical trials and quasi-randomised trials published from December 2019.

A summary-level meta-analysis of randomised trials published in 2018 demonstrated that paclitaxel-coated devices were associated with an increased all-cause mortality in those who underwent treatment at 2 years and 5 years.

METHODS For the initial meta-analysis, nine randomized trials published between1980 and 2012 comparing aspirin with placebo/control were considered.

Observational trials in humans suggest a survival benefit from fever, and randomized trials published before COVID-19 do not support fever reduction in patients with infection.

METHODS We conducted a meta-analysis on randomized control trials published during 1 January 2000 through 31 December 2019, from PubMed, Cochrane Library databases, EMBASE, Medline (ProQuest), CINAHL, PsycINFO, Chinese Electronic Periodical Service and Wan Fan Data with prespecified searching criteria.

Only randomized control trials published in English or French were included and had to compare yoga to another intervention group or a control group.

systematically reviewed the results from observational studies and intervention trials published in the last 5 years focusing on the associations between dietary patterns and biomarkers of oxidative stress and inflammation [7].

We aimed to systematically review the results from observational studies and intervention trials published in the last 5 years on the associations between dietary patterns and biomarkers of oxidative stress and inflammation.

A patient-reported outcome (PRO) is a measurement of the patient’s condition, reported directly by the patient, without the interpretation by a clinician or anyone else [1] Recently, there has been a growing interest in the integration of PROs as part of data collection about toxicity and symptoms experienced by patients with cancer This integration could have relevant implications not only for a more accurate reporting of adverse events and definition of quality of life (QoL) within clinical trials [2], but also for a better patients’ management in routine clinical practice [3] Many tools and questionnaires have been validated to properly measure QoL and symptoms in patients with lung cancer The inclusion of these measures in clinical trials has several important advantages It allows providing a patient-focused assessment of the burden and the impact of disease Moreover, it allows completely assessing the clinical benefit of a therapy, by complementing the information provided by commonly used efficacy endpoints, including overall survival, and the traditional description of safety based on physicians’ assessment Furthermore, the availability of QoL data from trials could allow a more accurate patient-physician communication about the treatment strategies offered in clinical practice However, a systematic review that we performed in order to evaluate the adoption of QoL among endpoints in randomized phase III trials conducted in lung cancer, published between 2012 and 2018 in 11 major journals, showed quite disappointing findings [4] Beyond the importance in clinical trials, PROs can play an important role in clinical practice Several studies have demonstrated a clear benefit in terms of patients’ QoL [5,6] Our experience, focused on the adoption of PROs in patients receiving active anticancer treatment at Mauriziano Hospital in Turin, showed that the introduction of PROs, thanks to an active role of nurses, was feasible, produced high patients’ satisfaction and a significant QoL improvement compared to the traditional modality of visit [6] In details, we compared 2 groups: patients in the control group underwent “usual” visits, while patients in the “PRO” group received a paper questionnaire by a dedicated nurse before each visit, in order to provide information about symptoms and toxicities After 1 month, mean change from baseline of global QoL was significantly better in the PRO group, and significantly higher proportion of patients obtained a clinically significant improvement in global QoL score In addition to QoL benefit, several studies have shown a significant improvement in overall survival with the adoption of electronic PROs in patients with lung cancer [7-9] In a pivotal randomized trial involving US patients with different solid tumors (including lung cancer) undergoing chemotherapy, patients assigned to the control arm received usual care, while subjects assigned to experimental arm could report their symptoms remotely from home, using tablet computers or computer kiosks [5,7] Doctors received a report of symptoms referred by patients during visits, and nurses received email alerts when patients reported severe or worsening symptoms Beyond the QoL improvement (the primary endpoint of the trial), a significantly longer life expectancy in the experimental arm (median 31 2 months) compared to the usual care arm (26 0 months) was reported [7] A French randomized trial, conducted in lung cancer patients without evidence of disease progression after or during initial treatment, compared a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every 3-6 months according to the disease stage (control arm) [8] In the experimental arm, the oncologist received automatically an alert email when self-scored symptoms matched predefined criteria Notably, a significant improvement in overall survival was found in patients assigned to experimental arm [9] The adoption of electronic PROs in clinical practice could have many advantages [10] Regular discussion of PROs questionnaires, filled out electronically by patients and received by nurses or doctors, could allow a systematic check of the clinical trend of symptoms and side-effects The early, proactive identification of worsening symptoms and toxicities could help prevent the occurrence of severe adverse events needing ER access and hospitalization Adoption and discussion of PROs would reasonably have a positive psychological impact on patients, increasing their satisfaction with healthcare services While the adoption of electronic PROs could initially appear as a challenging organizational effort, we believe that their benefits will definitely be evident in the long-term The use of PROs may allow a significant benefit in terms of patients’ QoL, and this should be more than enough to consider its adoption in clinical practice, which - overall survival benefit or not – is worth the trouble References: 1 Di Maio M, et al Patient-reported outcomes in the evaluation of toxicity of anticancer treatments Nat Rev Clin Oncol 2016;13(5):319-25 2 Marandino L, et al Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016 Ann Oncol 2018;29:2288-2295 3 Sperti E, Di Maio M Outcomes research: Integrating PROs into the clinic - overall survival benefit or not, it's worth the trouble Nat Rev Clin Oncol 2017;14(9):529-530 4 Reale ML, et al Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018 Lung Cancer 2020 Jan;139:47-54 5 Basch E, et al Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial J Clin Oncol 2016;34(6):557-65 6 Baratelli C, et al The role of patient-reported outcomes in outpatients receiving active anti-cancer treatment: impact on patients' quality of life Support Care Cancer 2019;27(12):4697-4704 7 Basch E, et al Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment JAMA 2017;318(2):197-198 8 Denis F, et al Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients J Natl Cancer Inst 2017 Sep 1;109(9) 9 Denis F, et al Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer JAMA 2019;321(3):306-307 10 Marandino L, et al COVID-19 Emergency and the Need to Speed Up the Adoption of Electronic Patient-Reported Outcomes in Cancer Clinical Practice JCO Oncol Pract 2020;16(6):295-298 Keywords: patient-reported outcomes, health-related quality of life, ePROs.

A thorough analysis of 21 phase III trials published in advanced HCC demonstrated a moderate correlation between progression-free survival (PFS) or time to progression (TTP) and OS (R = 0.

Screening and treatment trials published during the past 3 decades have provided critical insights into our understanding of the natural history of PSA identified cancers and the impact of treatment.

The only somatic treatment trials published since 2015 have assessed bright light therapy, with positive findings but methodological limitations.

Studies were experimental trials published in English language, objectively (polysomnography, actigraphy) and/or subjectively assessed sleep after evening HIE in sedentary and physically fit, good sleepers (aged 18-50 y old).

Five databases were searched for peer‐reviewed randomized controlled or quasi‐experimental trials published 2000–2020.

A search of MEDLINE and Embase identified eligible trials published between inception and June 29, 2020.

Eligible trials published between January 1, 1985, and May 30, 2019 were retrieved from five electronic databases.

METHODS We retrieved all the relevant trials published from 15th June 2008 to 24th February 2021, evaluating immune-based combinations in treatment-naïve mRCC through PubMed/MEDLINE, Cochrane library, and EMBASE; additionally, proceedings of the main international oncological meetings were also searched for relevant abstracts.

This review discusses landmark and other clinically relevant trials published in the last 18 months.

Third, after repeating the research methods reported in this review, we identified another two trials published in Chinese.

AUTHORS' CONCLUSIONS Based on the two trials published to date, there is some evidence that screening may reduce malaria transmission and malaria infection in people living in the house.

Data Sources MEDLINE was searched for acute stroke therapeutic trials published between January 1, 2010, and June 11, 2020.

METHODS We identified all pre-clinical neuro-oncology therapeutic trials published in four high-impact journals between 11/2018 and 4/2019 and assigned a level of evidence (LOE) to each study using the American Academy of Neurology evidence classification system.

None of the included trials published their recruitment strategies.

We included trials published between 1 January 2015 and 22 October 2020 to reflect currently available FDA-approved technologies.

Emerging data from clinical trials published since 2017 show that successful treatments need to be tailored to specific groups of patients.

Recent findings Randomized controlled trials published since 1 January 2017 that related to vitamin D doses in infancy were reviewed.

Here we present clinical trials published within the last 5—7 years assessing cytokines/chemokines and neuron-specific proteins in children with various forms of convulsive syndrome, including epilepsy.

All English language randomized controlled trials published within the last 20 years were eligible for inclusion.

Randomized controlled trials published prior to April 2020 in English or German were considered eligible if any results regarding the cost-effectiveness of PN for stroke survivors were reported.

METHODS Web of Science, MEDLINE, Embase, Cochrane Library, six other English databases and three Chinese databases (CNKI, VIP, Wan Fang) were searched for randomized controlled trials published prior to December 13, 2020 in English or Chinese on the use of kinesiology tape for hemiplegic shoulder pain.

Eleven trials published data on child weight-related outcomes to date, though most were not sufficiently powered to detect significant effects.

Two small trials published data on survival in patients with recurrent glioblastoma multiforme.