scholarly journals Randomized clinical trials in ANCA-associated vasculitis: a systematic analysis of the WHO - International Clinical Trials Registry Platform.

2020 ◽  
Author(s):  
Michele IUDICI ◽  
Xavier Puéchal ◽  
Alejandro Brigante ◽  
Ignacio Atal ◽  
Cem Gabay
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
Eligibility Criteria ◽  
Systematic Analysis ◽  
Disease States ◽  
Anca Associated Vasculitis ◽  
Number Of Patients ◽  
Definition Of ◽  
Clinical Trials Registry

Abstract Background. The analysis of the main features of randomized controlled trials (RCTs) on ANCA-associated vasculitis (AAV) can inform future study design.Methods. We searched within the International Clinical Trials Registry Platform all registered RCTs on AAV from October 2008 to December 2018. Two reviewers selected studies according to pre-specified eligibility criteria. We retrieved information including countries, funding, design, sample sizes, eligibility criteria, primary outcomes (POs), and treatments.Results. Among the 40 RCTs identified, 22 (38%) were conducted in Europe, 29 (72%) in a single country, 14 (35%) were industry-funded. The median number of patients planned to enrol was 68 (IQR 36-138). Only 28% of RCTs targeted a single vasculitis and ANCA negative patients were not included in 40% of studies. Interventions investigated were mainly drugs given to induce (40%) or maintain (32%) remission. Eighty-five percent of POs were considered being ‘patient-important’, but discrepancies in definition of disease states such as remission or relapse were observed. Glucocorticoids use was part of the PO in <25% of studies. The number of trials targeting a single disease, non-industry funded, incorporating glucocorticoids in PO, as well as the planned sample size increased over time.Conclusion. Despite the important achievements in the field, the design of RCTs on AAV could be further improved.

scholarly journals Randomized clinical trials in ANCA-associated vasculitis: a systematic analysis of the WHO - International Clinical Trials Registry Platform.

2020 ◽  
Author(s):  
Michele IUDICI ◽  
Xavier Puéchal ◽  
Alejandro Brigante ◽  
Ignacio Atal ◽  
Cem Gabay
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
Eligibility Criteria ◽  
Systematic Analysis ◽  
Disease States ◽  
Anca Associated Vasculitis ◽  
Number Of Patients ◽  
Definition Of ◽  
Clinical Trials Registry

Abstract Background. The analysis of the main features of randomized controlled trials (RCTs) on ANCA-associated vasculitis (AAV) can inform future study design.Methods. We searched within the International Clinical Trials Registry Platform all registered RCTs on AAV from October 2008 to December 2018. Two reviewers selected studies according to pre-specified eligibility criteria. We retrieved information including countries, funding, design, sample sizes, eligibility criteria, primary outcomes (POs), and treatments.Results. Among the 40 RCTs identified, 22 (38%) were conducted in Europe, 29 (72%) in a single country, 14 (35%) were industry-funded. The median number of patients planned to enrol was 68 (IQR 36-138). Only 28% of RCTs targeted a single vasculitis and ANCA negative patients were not included in 40% of studies. Interventions investigated were mainly drugs given to induce (40%) or maintain (32%) remission. Eighty-five percent of POs were considered being ‘patient-important’, but discrepancies in definition of disease states such as remission or relapse were observed. Glucocorticoids use was part of the PO in <25% of studies. The number of trials targeting a single disease, non-industry funded, incorporating glucocorticoids in PO, as well as the planned sample size increased over time.Conclusion. Despite the important achievements in the field, the design of RCTs on AAV could be further improved.

scholarly journals Clinical trial research on COVID-19 in Germany – a systematic analysis

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 913
Author(s):  
Julian Hirt ◽  
Abeelan Rasadurai ◽  
Matthias Briel ◽  
Pascal Düblin ◽  
Perrine Janiaud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Agenda ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
First Year ◽  
Industry Funding ◽  
Systematic Analysis ◽  
Clinical Trial Research ◽  
German Contribution

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345).  From the planned German participants, 13.4%  were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

scholarly journals Mouth-rinses and SARS-CoV-2 viral load in saliva: A living systematic review

2021 ◽  
Author(s):  
Akram Hernández-Vásquez ◽  
Antonio Barrenechea-Pulache ◽  
Daniel Comandé ◽  
Diego Azañedo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Viral Load ◽  
Randomized Clinical Trials ◽  
Risk Of Bias ◽  
Control Group ◽  
Sterile Water ◽  
Eligibility Criteria ◽  
Mouth Rinses ◽  
Number Of Patients

ABSTRACTObjectiveTo conduct a living systematic review of the clinical evidence regarding the effect of different mouth-rinses on the viral load of SARS-CoV-2 in the saliva of infected patients. The viral load in aerosols, the duration of the reduction in viral load, viral clearance, SARS-CoV-2 cellular infectivity, and salivary cytokine profiles were also evaluated.Materials and methodsThis study was reported using the PRISMA guidelines. An electronic search was conducted in seven databases and in preprint repositories. We included human clinical trials that evaluated the effect of mouth-rinses with antiseptic substances on the viral load of SARS-CoV-2 in the saliva of children or adults that tested positive for SARS-CoV-2 using reverse transcriptase polymerase chain reaction (RT-PCR). Risk of bias was assessed using the ROBINS-I tool. PROSPERO registration number CRD42021240561.ResultsFour studies matching eligibility criteria were selected for evaluation (n=32 participants). Study participants underwent oral rinses with hydrogen peroxide (H2O2) at 1 %, povidone–iodine (PI) at 0.5% or 1%, chlorhexidine gluconate (CHX) at 0.2% or 0.12% or cetylpyridinium chloride (CPC) at 0.075%. Only one study included a control group with sterile water. Three of the studies identified a significant reduction in viral load up to 3, 4, and 6 hours after the use of mouthwashes with PI, CHX, and CPC or PI vs. sterile water, respectively, while one study did not identify a significant reduction in viral load after the use of H2O2 rinses.ConclusionsAccording to the present systematic review, the effect of the use of mouth-rinses on SARS-CoV-2 viral load in the saliva of COVID-19 patients remains uncertain. This is mainly due to the limited number of patients included and a high risk of bias present in the studies analyzed. Evidence from well-designed randomized clinical trials is required for further and more objective evaluation of this effect.

scholarly journals Efficacy and Safety of Intravenous rtPA in Ischemic Strokes Due to Small-Vessel Occlusion: Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Bartosz Karaszewski ◽  
Adam Wyszomirski ◽  
Bartosz Jabłoński ◽  
David J. Werring ◽  
Dominika Tomaka
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Randomized Clinical Trials ◽  
Small Vessel Disease ◽  
Small Vessel ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Vessel Occlusion ◽  
Excellent Outcome ◽  
Symptomatic Intracerebral Hemorrhage

AbstractIntravenous recombinant tissue plasminogen activator (iv-rtPA) has been routinely used to treat ischemic stroke for 25 years, following large clinical trials. However, there are few prospective studies on the efficacy and safety of this therapy in strokes attributed to cerebral small vessel disease (SVD). We evaluated functional outcome (modified Rankin scale, mRS) and symptomatic intracerebral hemorrhage (sICH) using all available data on the effects of iv-rtPA in SVD-related ischemic stroke (defined either using neuroimaging, clinical features, or both). Using fixed-effect and random-effects models, we calculated the pooled effect estimates with regard to excellent and favorable outcomes (mRS=0–1 and 0–2 respectively, at 3 months), and the rate of sICH. Twenty-three studies fulfilled the eligibility criteria, 11 of which were comparative, and there were only 3 randomized clinical trials. In adjusted analyses, there was an increased odds of excellent outcome (adjusted OR=1.53, 95% CI: 1.29–1.82, I2: 0%) or favorable outcome (adjusted OR=1.68, 95% CI: 1.31–2.15,I2: 0%) in patients who received iv-rtPA compared with placebo. Across the six studies which reported it, the incidence of sICH was higher in the treatment group (M-H RR = 8.83, 95% CI: 2.76–28.27). The pooled rate of sICH in patients with SVD administered iv-rtPA was only 0.72% (95% CI: 0.12%–1.64%). We conclude that when ischemic stroke attributed to SVD is considered separately, available data on the effects of iv-rtPA therapy are insufficient for the highest level of recommendation, but it seems to be safe. Although further therapeutic trials in SVD-related ischemic stroke appear to be justified, our findings should not prevent its continued use for this group of patients in clinical practice.

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

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
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.

scholarly journals Surveillance in inflammatory bowel disease: is chromoendoscopy the only way to go? A systematic review and meta-analysis of randomized clinical trials

2020 ◽  
Vol 08 (05) ◽  
pp. E578-E590
Author(s):  
Ricardo Hannum Resende ◽  
Igor Braga Ribeiro ◽  
Diogo Turiani Hourneaux de Moura ◽  
Facundo Galetti ◽  
Rodrigo Silva de Paula Rocha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Narrow Band ◽  
Narrow Band Imaging ◽  
Meta Analysis ◽  
Mean Difference ◽  
Procedure Time ◽  
High Definition ◽  
Number Of Patients

Abstract Background and study aims Ulcerative colitis (UC) and Crohn’s disease (CD) have higher risk of colorectal cancer (CRC). Guidelines recommend dysplasia surveillance with dye-spraying chromoendoscopy (DCE). The aim of this systematic review and meta-analysis was to review all randomized clinical trials (RCTs) available and compare the efficacy of different endoscopic methods of surveillance for dysplasia in patients with UC and CD. Methods Databases searched were Medline, EMBASE, Cochrane and SCIELO/LILACS. It was estimated the risk difference (RD) for dichotomous outcomes (number of patients diagnosed with one or more dysplastic lesions, total number of dysplastic lesions diagnosed and number of dysplastic lesions detected by targeted biopsies) and mean difference for continuous outcomes (procedure time). Results This study included 17 RCTs totaling 2,457 patients. There was superiority of DCE when compared to standard-definiton white light endoscopy (SD-WLE). When compared with high-definition (HD) WLE, no difference was observed in all outcomes (number of patients with dysplasia (RD 0.06; 95 % CI [–0.01, 0.13])). Comparing other techniques, no difference was observed between DCE and virtual chromoendoscopy (VCE – including narrow-band imaging [NBI], i-SCAN and flexible spectral imaging color enhancement), in all outcomes except procedure time (mean difference, 6.33 min; 95 % CI, 1.29, 11.33). DCE required a significantly longer procedure time compared with WLE (mean difference, 7.81 min; 95 % CI, 2.76, 12.86). Conclusions We found that dye-spraying chromoendoscopy detected more patients and dysplastic lesions than SD-WLE. Although no difference was observed between DCE and HD-WLE or narrow-band imaging, the main outcomes favored numerically dye-spraying chromoendoscopy, except procedure time. Regarding i-SCAN, FICE and auto-fluorescence imaging, there is still not enough evidence to support or not their recommendation.

The Chymopapain Clinical Trials

Neurosurgery ◽  
1985 ◽  
Vol 17 (1) ◽  
pp. 107-110 ◽  
Author(s):  
Stephen J. Haines
Keyword(s):  
Clinical Trials ◽  
Outcome Assessment ◽  
Therapeutic Efficacy ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Successful Outcome ◽  
Relative Efficacy ◽  
Number Of Patients ◽  
Current Controversy ◽  
Probability Of Success

Abstract The three published randomized clinical trials of chymopapain injection vs. placebo injection for the treatment of herniated lumbar discs are reviewed. Despite some differences, the similarities in selection criteria, technique, and outcome assessment are great enough to justify pooling the results to obtain an overall assessment of chymopapain efficacy. These pooled results suggest that the odds of successful outcome (at least some improvement in symptoms after injection) are 2.6 times as great with chymopapain injection as those after placebo injection. This corresponds to a 50% greater probability of success with chymopapain than with placebo or a 23% increase in the number of patients successfully treated with chemonucleolysis over those successfully treated with placebo. The fact that data from 234 patients evaluated in randomized clinical trials could resolve a controversy over therapeutic efficacy that the uncontrolled evaluation of over 20,000 patients could not answer suggests that the current controversy over the relative efficacy of chymopapain and discectomy should be studied in the same way. The difficulties of such a study are discussed. (Neurosurgery 17:107-110, 1985)

A multicentered population-based analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) who do not meet eligibility criteria for clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 353-353 ◽  
Author(s):  
Daniel Yick Chin Heng ◽  
Toni K. Choueiri ◽  
Jae-Lyun Lee ◽  
Lauren Christine Harshman ◽  
Georg A. Bjarnason ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Brain Metastases ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Progression Free Survival ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Number Of Patients

353 Background: Clinical trials have strict eligibility criteria to maintain internal validity. These criteria exclude many patients to whom the trial results are later applied to in clinical practice. Patients that do not meet eligibility criteria are poorly characterized. Methods: mRCC patients treated with VEGF targeted therapy were retrospectively deemed ineligible for clinical trials (according to commonly used inclusion/exclusion criteria) if they had a Karnofsky Performance Status (KPS) < 70%, brain metastases, non-clear cell histology, hemoglobin ≤ 9 g/dL, creatinine > 2x the upper limit of normal, platelet count of < 100x103/uL, neutrophil count < 1500/mm3 or corrected calcium ≤ 12 mg/dL. Results: 894/2076 (43%) patients were deemed ineligible for clinical trials by the above criteria. Between ineligible versus eligible patients, the response rate, median progression free survival (PFS) and median overall survival of first-line targeted therapy were 21% vs 29%, 5.2 vs 8.8 months and 14.5 vs 28.8 months (all p < 0.0001), respectively. Second-line PFS (if applicable) was 3.2 months in the trial ineligible vs 4.4 months in the trial eligible patients (p = 0.0074). When adjusted by the Heng et al prognostic categories, the hazard ratio for death between trial ineligible vs trial eligible patients was 1.621 (95% CI = 1.431–1.836, p < 0.0001). If only KPS, brain metastases and non-clear cell histology were used as exclusion criteria, 672 (32%) patients were excluded and the results were similar. Conclusions: The number of patients that are ineligible for clinical trials is high and their outcomes are inferior. Designing more inclusive clinical trials for this “ineligible” patient population are needed. [Table: see text]

scholarly journals Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

2018 ◽  
Vol 06 (06) ◽  
pp. E637-E645 ◽  
Author(s):  
Julio Aquino ◽  
Wanderley Bernardo ◽  
Diogo de Moura ◽  
Flávio Morita ◽  
Rodrigo Rocha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Ambient Air ◽  
Quality Analysis ◽  
Cochrane Library ◽  
Eligibility Criteria ◽  
Co2 Insufflation ◽  
Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

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