Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension

2021 ◽  
Author(s):  
Yu Sato ◽  
Rika Kawakami ◽  
Atsushi Sakamoto ◽  
Anne Cornelissen ◽  
Masayuki Mori ◽  
...  
Keyword(s):  
Renal Denervation ◽  
Arterial Wall ◽  
Treatment Approach ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Novel Treatment ◽  
Treatment Of Hypertension ◽  
The Usa ◽  
Device Approval

Catheter-based renal denervation is a novel treatment approach for patients with hypertension and initial unblinded trials have shown promising results. The Paradise™ Ultrasound Renal Denervation System (ReCor Medical, CA, USA) is an ultrasound-based catheter with a distal balloon that acts as a coolant to protect the renal arterial wall. This device received CE-mark in 2012. Randomized, sham-controlled trials and postmarket studies have shown promising efficacy and safety results. Currently, three additional ongoing randomized, sham-controlled trials are underway in the USA, Europe, Japan and Korea, and the results will be pivotal in device approval in some of these countries. These studies with larger numbers of patients and longer duration of follow-up are needed to further confirm the safety and efficacy of this device.

scholarly journals Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta

2021 ◽  
Author(s):  
Jon Havelock ◽  
Anna-Karina Aaris Henningsen ◽  
Bernadette Mannaerts ◽  
Joan-Carles Arce ◽  
Keyword(s):  
Ovarian Stimulation ◽  
Implantation Rate ◽  
Neonatal Outcomes ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Relative Contribution ◽  
Follitropin Alfa ◽  
Start Up ◽  
Comparative Trials

Abstract Purpose To describe the pregnancy and neonatal outcomes using fresh and vitrified/warmed blastocysts obtained from ovarian stimulation with follitropin delta in controlled trials versus follitropin alfa. Methods This investigation evaluated the outcome from 2719 fresh and frozen cycles performed in 1326 IVF/ICSI patients who could start up to three ovarian stimulations in the ESTHER-1 (NCT01956110) and ESTHER-2 (NCT01956123) trials, covering 1012 fresh cycles and 341 frozen cycles with follitropin delta and 1015 fresh cycles and 351 frozen cycles with follitropin alfa. Of the 1326 first cycle patients, 513 continued to cycle 2 and 188 to cycle 3, and 441 patients started frozen cycles after the fresh cycles. Pregnancy follow-up was continued until 4 weeks after birth. Results The overall cumulative take-home baby rate after up to three stimulation cycles was 60.3% with follitropin delta and 60.7% with follitropin alfa (−0.2% [95% CI: −5.4%; 5.0%]), of which the relative contribution was 72.8% from fresh cycles and 27.2% from frozen cycles in each treatment group. Across the fresh cycles, the ongoing implantation rate was 32.1% for follitropin delta and 32.1% for follitropin alfa, while it was 27.6% and 27.8%, respectively, for the frozen cycles. Major congenital anomalies among the live-born neonates up until 4 weeks were reported at an incidence of 1.6% with follitropin delta and 1.8% with follitropin alfa (−0.2% [95% CI: −1.9%; 1.5%]). Conclusions Based on comparative trials, the pregnancy and neonatal outcomes from fresh and frozen cycles provide reassuring data on the efficacy and safety of follitropin delta. Trial registration ClinicalTrials.gov Identifier: NCT01956110 registered on 8 October 2013; NCT01956123 registered on 8 October 2013.

Efficacy and safety of drug-eluting balloon-only strategy (DEB-only) for de novo coronary artery disease: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W.Y Zhang ◽  
M.D Zhang ◽  
J.F Tian ◽  
M Zhang ◽  
Y Zhou ◽  
...  
Keyword(s):  
De Novo ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Late Lumen Loss ◽  
Drug Eluting ◽  
Coronary Lesions ◽  
Artery Disease ◽  
Drug Eluting Balloon

Abstract Background Many clinical trials have demonstrated the value of drug-eluting balloon (DEB) for in-stent restenosis. Recently, DEB for de novo lesions has also attracted more attention. There have been promising results of PCI using DEB alone in selected de novo coronary diseases (small vessels, bifurcating lesions, acute myocardial infarction). However, the application of DEB for patients with de novo coronary artery disease remains controversial due to relatively limited evidence. Purpose The purpose of this study was to evaluate the efficacy and safety DEB-only strategy (bail-out stents were allowed when required) compared with other modalities for the treatment of de novo coronary lesions. Methods We searched PubMed, Embase, Web of Science and Cochrane Library Central Register of Controlled Trials (CENTRAL) electronic databases for randomized controlled trials as well as observational studies published up to Jan 22, 2020. Studies which compared DEB-only approach with other PCI strategies for treatment of any type of de novo coronary lesions were identified. The primary outcome was late lumen loss (LLL) during angiographic follow up. The secondary outcomes were major adverse cardiac events (MACE), target lesion revascularisation (TLR) and binary in-segment restenosis. Results Nineteen studies (eleven randomised controlled trials and eight observational studies) with a total of 3,356 patients were included in this meta-analysis. Angiographic observations were obtained at 6 or 9 months and clinical follow-up duration ranged from 6 months to 36 months. Among the overall studies, the results indicated that DEB-only strategy was superior to the control groups for LLL (mean difference (MD) = −0.30mm; 95% confidence interval (CI), −0.41 to −0.19; P<0.001). DEBs were associated with a similar risk of MACE (risk ratio (RR): 0.84, 95% CI: 0.64, 1.11, P=0.22), TLR (RR: 0.79, 95% CI: 0.53, 1.16, P=0.23) and binary restenosis (RR: 0.68, 95% CI: 0.35, 1.31, P=0.25) compared with the control groups. In subgroup analysis, DEB-only strategy showed significantly better outcomes for most endpoints compared to POBA. Compared with DES, there were also significant favorable effects associated with treatment of DEB-only on LLL (MD: −0.14, 95% CI: −0.23, −0.04, P=0.005), while insignificant inter-strategy differences were observed in other endpoints. Vessel diameter did not have a significant influence on the result. Conclusion DEB-only intervention is an effective treatment associated with a significant reduction in late loss late lumen loss compared to other options. The efficacy and safety of DEB alone are comparable to those of DES and superior to POBA for treatment of selected de novo coronary lesions. Additional evidence is still warranted to confirm value of DEB before a widespread clinical utilization can be recommended. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Beijing Lab for Cardiovascular Precision Medicine

scholarly journals Efficacy and Safety of Bevacizumab in the Treatment of Pterygium: An Updated Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Yi Sun ◽  
Bowen Zhang ◽  
Xiuhua Jia ◽  
Shiqi Ling ◽  
Juan Deng
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Complication Rates ◽  
Efficacy And Safety ◽  
Conjunctival Autograft ◽  
Randomized Controlled ◽  
Significant Difference

Purpose. Studies investigating efficacy and safety of bevacizumab in pterygium have increased and reported controversial results. Thus, we updated this meta-analysis to clarify the issue. Methods. Studies were selected through search of the databases Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) from their inception up until June 2017. The pooled risk ratio (RR) and 95% confidence interval (CI) were calculated for recurrence and complication rates by using random effects model. Results. 1045 eyes in 18 randomized controlled trials (RCTs) enrolled. Overall, the pooled estimate showed a statistically significant effect of bevacizumab on the reduction of recurrence (RR 0.74, 95% CI 0.56–0.97, P=0.03). Subgroup analyses presented significant results beneficial to bevacizumab (primary pterygium group, RR 0.53, 95% CI 0.33–0.83, P=0.006; conjunctival autograft group, RR 0.48, 95% CI 0.25–0.91, P=0.02; and follow-up longer than 12 months group, RR 0.36, 95% CI 0.13–0.99, P=0.05). No statistically significant difference was observed in complication rates. Conclusions. Application of bevacizumab showed a statistically significant decrease in recurrence rate following removal of primary pterygia, or in cases with conjunctival autograft, or with follow-up longer than 12 months, while complications were not increased.

Comparative Efficacy and Safety of Nonsurgical Treatment Options for Enthesopathy of the Extensor Carpi Radialis Brevis: A Systematic Review and Meta-analysis of Randomized Placebo-Controlled Trials

2018 ◽  
Vol 47 (12) ◽  
pp. 3019-3029 ◽  
Author(s):  
Jayson Lian ◽  
Amin Mohamadi ◽  
Jimmy J. Chan ◽  
Phillip Hanna ◽  
David Hemmati ◽  
...  
Keyword(s):  
Pain Relief ◽  
Meta Analysis ◽  
Treatment Options ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Long Term Follow Up ◽  
Extensor Carpi Radialis

Background: Numerous treatment options have been proposed for enthesopathy of the extensor carpi radialis brevis (eECRB). Purpose: To (1) compare the efficacy and safety of nonsurgical treatment options for eECRB described in randomized placebo-controlled trials at short-term, midterm, and long-term follow-up and (2) evaluate outcomes in patients receiving placebo. Study Design: Systematic review and meta-analysis. Methods: Following PRISMA guidelines, 4 electronic databases were searched for randomized placebo-controlled trials for eECRB. Studies reporting visual analog scale (VAS) for pain scores and/or grip strength were included. Random- or fixed-effects meta-analysis was employed to compare treatments with at least 2 eligible studies using the standardized mean difference and odds ratio. The study protocol was registered at PROSPERO (ID: CRD42018075009). Results: Thirty-six randomized placebo-controlled trials, evaluating 11 different treatment modalities, with a total of 2746 patients were included. At short-term follow-up, only local corticosteroid injection improved pain; however, it was associated with pain worse than placebo at long-term follow-up. At midterm follow-up, laser therapy and local botulinum toxin injection improved pain. At long-term follow-up, extracorporeal shock wave therapy provided pain relief. With regard to grip strength, only laser therapy showed better outcomes in comparison with placebo. While there was no difference among various treatments in the odds ratio of an adverse event, they all increased adverse events compared with placebo. In placebo-receiving patients, a sharp increase in the percentage of patients reporting mild pain or less was observed from 2% at short-term follow-up to 92% at midterm follow-up. Conclusion: Most patients experienced pain resolution after receiving placebo within 4 weeks of follow-up. At best, all treatments provided only small pain relief while increasing the odds of adverse events. Therefore, if clinicians are inclined to provide a treatment for particular patients, they may consider a pain relief regimen for the first 4 weeks of symptom duration. Patient-specific factors should be considered when deciding on treatment or watchful waiting.

scholarly journals Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026662 ◽  
Author(s):  
Vishal M Bulsara ◽  
Max K Bulsara ◽  
Emma Lewis
Keyword(s):  
Pilot Study ◽  
Hyperbaric Oxygen ◽  
Controlled Trials ◽  
Early Management ◽  
Intention To Treat ◽  
Treatment Standard ◽  
The Usa ◽  
Pre Treatment ◽  
Randomised Controlled

IntroductionOsteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the mainstay of the early management of ORN. Literature about the efficacy of HBO is contentious. Recently, Oral and Maxillofacial surgical units in France and UK have trialled a combination of medications to treat ORN, also known as PENTOCLO (PENtoxifylline+TOcopherol±CLOdronate). This regime has shown promising results to date however randomised controlled trials in the area comparing HBO against PENTOCLO are lacking and there are no current trials registered in Europe, UK, Australia and the USA. The purpose of this pilot study is to generate a hypothesis that can be tested in large multi-centre controlled trials.Methods and analysisFor this pilot study we will recruit 16 patients who will be randomly allocated to one of either HBO or PENTOCLO. After a 4 week period of uniform ‘pre-treatment’ medication patients will be commenced on their allocated treatment. Standard follow-up examination, imaging and photographs will be taken and de-identified and then presented to two Oral and Maxillofacial surgeons for allocation of a Notani & Lyons classification score. Data for each patient will be tracked over the 18 months of treatment and follow-up. The results will then be analysed using descriptive statistics and all patients included in an intention to treat analysis.Ethics and disseminationEthical approval for this study has been granted by the South Metropolitan Health Service HREC (PRN RGS0000001193). Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications.Trial registration numberACTRN12618001099213; Pre-results.

scholarly journals Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

2013 ◽  
Vol 29 (suppl 1) ◽  
pp. s17-s31 ◽  
Author(s):  
Cassyano Januário Correr ◽  
Inajara Rotta ◽  
Thaís de Souza Teles ◽  
Rangel Ray Godoy ◽  
Bruno Salgado Riveros ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Biological Agents ◽  
Severe Psoriasis ◽  
Biological Agent ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

scholarly journals Comparison of efficacy and safety of complementary and alternative therapies for essential hypertension with anxiety or depression disorder

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254699
Author(s):  
Xueyan Han ◽  
Xinxin Liu ◽  
Fengxing Zhong ◽  
Yiguo Wang ◽  
Qiming Zhang
Keyword(s):  
Meta Analysis ◽  
Alternative Therapies ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Clinical Practices ◽  
Complementary And Alternative Therapies ◽  
Randomized Controlled ◽  
Treatment Of Hypertension ◽  
Depression Disorder ◽  
Complementary And Alternative

Background Essential hypertension (EH) with anxiety or depression belongs to the category of psycho-cardiology. Hypertension is closely related to anxiety and depression. The adverse reactions of Western medicine are apparent and the compliance is poor. Supplementary and replacement therapies have accumulated rich experience in clinical practices, which can reduce side effects and improve clinical efficacy. This study intends to use the Bayesian network meta-analysis (NMA) analysis method for the first time to gather randomized controlled trials (RCTs) related to complementary and alternative therapies in the treatment of hypertension with anxiety or depression disorder and rank efficacy and safety, to provide a reference basis for the treatment of hypertension with anxiety or depression disorder. Methods All randomized controlled trials (RCTs) and registered and ongoing trials of Chinese and English databases, related to supplementation and replacement therapies of EH with anxiety or depression disorder, published from initial state to February 2021, will be collected in the form of computer retrieval. Two researchers will independently screen the literature, extracting data, assessing bias risk and assessing heterogeneity. We will use software WinBUGS 1.4.3 and Stata 16.0 for pairwise meta-analysis and NMA to comprehensively evaluate various interventions. The quality of evidence will be evaluated through the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results This NMA will comprehensively compare and rank the efficacy and safety of a series of complementary and alternative therapies in treating EH with anxiety or depression disorder. Conclusion Supplementary and replacement therapies have accumulated rich experience of clinical practices in improving EH with anxiety or depression disorder. We expect that this NMA will guide practice and research by providing reliable evidence of evidence-based medicine for the treatment of EH with anxiety or depression disorder. Protocol registration number INPLASY202120068.

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