scholarly journals Preoperative CT versus Intraoperative Hybrid DynaCT Imaging for Localization of Small Pulmonary Nodules: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Yin Kai Chao ◽  
Kuang-Tse Pan ◽  
Chih-Tsung Wen ◽  
Hsin-Yueh Fang ◽  
Ming-Ju Hsieh
Keyword(s):  
Computed Tomography ◽  
Operating Room ◽  
Controlled Trial ◽  
Operating Time ◽  
Pulmonary Nodules ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Intraoperative Computed Tomography ◽  
Randomized Controlled ◽  
Lesion Localization

Abstract Background Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is concerned, the most common workflow consists of preoperative computed tomography (POCT) imaging-guided tumor marking (performed in an interventional CT suite) followed by their removal in an operating room (OR). However, the advent of hybrid ORs has allowed intraoperative computed tomography (IOCT)-guided lesion localization. This single center, open-label, randomized, controlled clinical trial aims to compare the efficacy and safety of IOCT versus POCT. Methods/design The study sample will consist of patients presenting with small and/or deep pulmonary nodules who will be randomly allocated to either POCT or IOCT. The time required to complete lesion localization will be the primary efficacy outcome. The following parameters will serve as secondary endpoints: rate of successful targeting during localization and in the operating field, time at risk, operating time, length of time under anesthesia, global operating room utilization time, complication (pneumothorax and hemorrhage) rates, and radiation exposure. Discussion Owing to the increased availability of HORs, our data will be crucial to clarify the feasibility and safety of IOCT versus the traditional POCT approach.

scholarly journals Preoperative CT versus Intraoperative Hybrid DynaCT Imaging for Localization of Small Pulmonary Nodules: A Randomized Controlled Trial

2018 ◽  
Author(s):  
Yin Kai Chao ◽  
Kuang-Tse Pan ◽  
Chih-Tsung Wen ◽  
Hsin-Yueh Fang ◽  
Ming-Ju Hsieh
Keyword(s):  
Controlled Trial ◽  
Pulmonary Nodules ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Intraoperative Computed Tomography ◽  
Randomized Controlled ◽  
Efficacy Outcome ◽  
Preoperative Ct ◽  
Time Required ◽  
Small Pulmonary Nodules

Abstract Background Small and/or deep pulmonary nodules have been traditionally localized using preoperative CT (POCT) imaging. However, the advent of hybrid operating rooms (ORs) has allowed intraoperative computed tomography (IOCT)-guided lesion localization. This single center, open-label, randomized, controlled clinical trial aims to compare the efficacy and safety of IOCT versus POCT. Methods/design The study sample will consist of patients presenting with small and/or deep pulmonary nodules who will be randomly allocated to either POCT or IOCT. The time required for identifying the lesion will be the primary efficacy outcome. The following parameters will serve as secondary endpoints: rate of successful targeting in the operating field, time at risk, complication (pneumothorax and hemorrhage) rates, and radiation exposure. Discussion Owing to the increased availability of HORs, our data will be crucial to clarify the feasibility and safety of IOCT versus the traditional POCT approach.

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Randomized Controlled Clinical Trial of bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children

2020 ◽  
Author(s):  
Beckie N Tagbo ◽  
Harish Verma ◽  
Zubairu M Mahmud ◽  
Kolade Ernest ◽  
Roosevelt O Nnani ◽  
...  
Keyword(s):  
African Country ◽  
Controlled Trial ◽  
Oral Poliovirus Vaccine ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Open Label ◽  
Nigerian Children ◽  
Randomized Controlled ◽  
Sub Saharan

Abstract Background We conducted a trial in Nigeria to assess the immunogenicity of the new bOPV + IPV immunization schedule and gains in type 2 immunity with addition of second dose of IPV. The trial was conducted in August 2016-March 2017 period, well past the tOPV-bOPV switch in April 2016. Methods This was an open-label, two-arm, non-inferiority, multi-center, randomized controlled trial. We enrolled 572 infants of age ≤14 days and randomized them into two arms. Arm A received bOPV at birth, 6 and 10 weeks, bOPV+IPV at week 14 and IPV at week 18. Arm B received IPV each at 6, 10, 14 weeks and bOPV at 18 weeks of age. Results Seroconversion rates for poliovirus types 1 and 3, respectively, were 98.9% (95%CI:96.7-99.8) and 98.1% (95%CI:88.2-94.8) in Arm A, and 89.6% (95%CI:85.4-93.0) and 98.5% (95%CI:96.3-99.6) in Arm B. Type 2 seroconversion with one dose IPV in Arm A was 72.0% (95%CI:66.2-77.3), which increased significantly with addition of second dose to 95.9% (95%CI:92.8-97.9). Conclusion This first trial on the new EPI schedule in a sub-Saharan African country demonstrated excellent immunogenicity against poliovirus types 1 and 3, and substantial/enhanced immunogenicity against poliovirus type 2 after 1 to 2 doses of IPV respectively.

scholarly journals Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3379-3385 ◽  
Author(s):  
Anahita Sadeghi ◽  
Ali Ali Asgari ◽  
Alireza Norouzi ◽  
Zahedin Kheiri ◽  
Amir Anushirvani ◽  
...  
Keyword(s):  
Standard Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
University Hospitals ◽  
Open Label ◽  
Serious Adverse Events ◽  
Clinical Recovery ◽  
Randomized Controlled

Abstract Background Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. Methods This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. Results Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4–8)] than the control group [8 days (IQR 5–13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray’s P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. Conclusions The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

scholarly journals Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. Methods/design This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. Discussion The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Randomized Controlled ◽  
Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Efficacy and safety of Guhong injection for treating the Coronary microvascular disease: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Jieqin Zhuang ◽  
Shuling Liu ◽  
Hairong Cai ◽  
Xingzhen Dai ◽  
Yanhong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiovascular Diseases ◽  
Controlled Trial ◽  
Microvascular Disease ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background: Coronary microvascular disease (CMVD) refers to cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculation lesions, often presenting as angina pectoris attack. Coronary artery of microtubules dysfunction is one of the pathogenesis of coronary heart disease,but the occurrence and development and the current of CMVD intervention therapy remains to be further researched.Chinese traditional medicine (TCM)has advantages in the treatment of cardiovascular diseases, therefore, this article describes an ongoing randomized controlled clinical trial, based on the theory of TCM, for the purpose of evaluating the efficacy and safety of Guhong injection ,a Chinese patent medicine,compared with placebo in patients suffering from CMVD. Methods/design: This is a multicenter, randomized, parallel arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, with a 8-week follow-up. The primary outcome is the frequency of angina attacks, Secondary outcomes include myocardial metabolites, ecg changes, quantitative score of TCM syndromes, inflammatory response and endothelial function indicators. Discussion: This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. Trial registration: Chinese Clinical Trials Registry, ChiCTR1900022902. Registered on 27 April 2019.

scholarly journals Efficacy and Safety of Preoperative vs. Intraoperative Computed Tomography-Guided Lung Tumor Localization: A Randomized Controlled Trial

2022 ◽  
Vol 8 ◽  
Author(s):  
Hsin-Yueh Fang ◽  
Kuei-An Chen ◽  
Yu-Wen Wen ◽  
Chih-Tsung Wen ◽  
Kuang-Tse Pan ◽  
...  
Keyword(s):  
Operating Room ◽  
Pulmonary Nodules ◽  
Single Step ◽  
Ct Guided ◽  
Randomized Controlled ◽  
Step Procedure ◽  
Procedural Time ◽  
Time Required ◽  
Small Pulmonary Nodules ◽  
Lesion Localization

Background: Thoracoscopic removal of small pulmonary nodules is traditionally accomplished through a two-step approach—with lesion localization in a CT suite as the first step followed by lesion removal in an operating room as the second step. While the advent of hybrid operating rooms (HORs) has fostered our ability to offer a more patient-tailored approach that allows simultaneous localization and removal of small pulmonary nodules within a single-step, randomized controlled trials (RCTs) that compared the two techniques (two- vs. single-step) are still lacking.Methods: This is a RCT conducted in an academic hospital in Taiwan between October 2018 and December 2019. To compare the outcomes of traditional two-step preoperative CT-guided small pulmonary nodule localization followed by lesion removal vs. single-step intraoperative CT-guided lesion localization with simultaneous removal performed by a dedicated team of thoracic surgeons. The analysis was conducted in an intention-to-treat fashion. The primary study endpoint was the time required for lesion localization. Secondary endpoints included radiation doses, other procedural time indices, and complication rates.Results: A total of 24 and 25 patients who received the single- and two-step approach, respectively, were included in the final analysis. The time required for lesion localization was significantly shorter for patients who underwent the single-step procedure (median: 13 min) compared with the two step-procedure (median: 32 min, p < 0.001). Similarly, the radiation dose was significantly lower for the former than the latter (median: 5.64 vs. 10.65 mSv, respectively, p = 0.001).Conclusions: The single-step procedure performed in a hybrid operating room resulted in a simultaneous reduction of both localization procedural time and radiation exposure.

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