scholarly journals The Efficacy and Safety of Indocyanine green- hyaluronic acid mixture (LuminoMarkTM) for Localization in Patients with Non-palpable Breast Lesions: A Multi-center Open-label Parallel Phase-2 Clinical trial

2021 ◽  
Author(s):  
isaac kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Skin Pigmentation ◽  
Test Group ◽  
Acid Mixture ◽  
Control Group ◽  
Breast Lesions ◽  
Efficacy And Safety ◽  
Open Label ◽  
Palpable Breast

Abstract Backgrounds With increasing screening for breast cancer, non-palpable breast lesions are detected more frequently. A preoperative localization is very important for a minimal but accurate excision of a non-palpable breast lesion. The purpose of this study was to evaluate the efficacy and safety of indocyanine green(ICG)-hyaluronic acid mixture injection as a novel material for localization. Methods We performed prospective clinical trial with female patients who underwent surgery for non-palpable breast lesion. All patients were sequentially assigned to the control group(localization with activated charcoal), test group 1(ICG-hyaluronic acid mixture 0.1ml), or test group 2(ICG-hyaluronic acid mixture 0.2ml) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (control group = 14, test 1 group = 15, test 2 group = 15 patients ). Among all patients, Fibroadenoma accounted for the largest share (38.6%, 17/44) and malignancy accounted for 11.4% (5/44). There was no difference in baseline characteristics in three groups. The marking rate was over 86% in all groups, and there was no difference. However, skin pigmentation was only in the control group and the accuracy of resection (the greatest length in cm of the excised specimen divided by the greatest length in cm on the pre-operation ultrasound image, the value closer to 1 meant resection as much as the size on ultrasound image) was different significantly. The average was 3.7 in control group and 2.2 in test 1 group and 2.1 in test 2 group. ( p-value was 0.037 between control and test 1 group, 0.744 between test 1 and test 2 group, 0.026 between control and test2 group respectively. ) Conclusion ICG-hyaluronic acid mixture injection is a new method for localization with non-palpable breast lesions, as well as a better method with higher accuracy of resection, lower skin pigmentation. Further research is required to apply this method to malignant breast lesions.Trial registration “A Multi-center Open-label Parallel Phase-2 Clinical trial to evaluate the efficacy and safety of LuminoMarkTM for Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259).

scholarly journals The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark™) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isaac Kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Test Group ◽  
Acid Mixture ◽  
Control Group ◽  
Breast Lesions ◽  
Efficacy And Safety ◽  
Group 2 ◽  
Palpable Breast ◽  
Group 1

Abstract Background Increasing rates of breast cancer screening have been associated with an increasing frequency of non-palpable breast lesions detection. Preoperative breast lesion localization is essential for optimizing excision accuracy. This study aimed to evaluate the efficacy and safety of indocyanine green (ICG) hyaluronic acid injection as a novel mixture for localization. Methods We performed a prospective clinical trial with female patients who underwent surgery for non-palpable breast lesions. All patients were sequentially assigned to the control group (localization with activated charcoal), Test Group 1 (ICG-hyaluronic acid mixture 0.1 mL), or Test Group 2 (ICG-hyaluronic acid mixture 0.2 mL) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (Control Group = 14, Test Group 1 = 15, Test Group 2 = 15 patients). Fibroadenoma (n = 17, 38.6%) accounted for the largest proportion of diagnoses, and five patients (11.4%) were diagnosed with malignancies. There were no statistically significant differences in baseline characteristics among the three groups. The marking rate was over 86% in all groups, with no significant intergroup differences. Skin pigmentation was only observed in the control group. The mean accuracy of resection (the greatest diameter of the excised specimen divided by the greatest diameter of the preoperative lesion as observed using ultrasonography, with values closer to 1 reflecting a higher accuracy) was 3.7 in the control group, 2.2 in Test Group 1, and 2.1 in Test Group 2 (p = 0.037 between Controls and Test Group 1, p = 0.744 between Test Group 1 and Test Group 2, and p = 0.026 between Controls and Test Group 2). Conclusion ICG-hyaluronic acid injection is a novel method that was shown to accurately localize non-palpable breast lesions and was associated with no skin pigmentation. Further research is required to apply this method to malignant breast lesions. Trial registration “A Multicenter Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark™ Inj. (Conc. for Fluorescence) Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259)

scholarly journals The Efficacy and Safety of Indocyanine green- hyaluronic acid mixture (LuminoMarkTM) for Localization in Patients with Non-palpable Breast Lesions: A Multi-center Open-label Parallel Phase-2 Clinical trial

2020 ◽  
Author(s):  
Isaac Kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Breast Lesion ◽  
Ultrasound Image ◽  
Test Group ◽  
Acid Mixture ◽  
Control Group ◽  
Breast Lesions ◽  
Efficacy And Safety ◽  
Palpable Breast

Abstract Backgrounds With increasing screening for breast cancer, non-palpable breast lesions are detected more frequently. A preoperative localization is very important for a minimal but accurate excision of a non-palpable breast lesion. The purpose of this study was to evaluate the efficacy and safety of indocyanine green(ICG)-hyaluronic acid mixture injection as a novel material for localization. Methods We performed prospective clinical trial with female patients who underwent surgery for non-palpable breast lesion. 44 patients were sequentially assigned to the control group(localization with activated charcoal), test group 1(ICG-hyaluronic acid mixture 0.1ml), or test group 2(ICG-hyaluronic acid mixture 0.2ml) by 1:1:1 ratio. Results Most were over 40 years old, and there were no differences between three groups in age distribution. According to the pathologic results, fibroadenoma accounted for the largest share (38.6%, 17/44) and malignancy accounted for 11.4% (5/44). The marking rate on both breast lesions and excised specimens was over 86% in all groups, and there was no difference. However, skin pigmentation was only in the control group and the accuracy of resection (the greatest length in cm of the excised specimen divided by the greatest length in cm on the pre-operation ultrasound image, the value closer to 1 meant resection as much as the size on ultrasound image) was different significantly. The average was 3.7(range 1.2-13.3) in control group and 2.2 (1.0-4.2) in test 1 group and 2.1(1.0-4.2) in test 2 group. Conclusion ICG-hyaluronic acid mixture injection was superior to activated charcoal for localization in patients with non-palpable breast lesions.

scholarly journals The Efficacy and Safety of Indocyanine green- hyaluronic acid mixture (LuminoMarkTM) for Localization in Patients with Non-palpable Breast Lesions: A Multi-center Open-label Parallel Phase-2 Clinical trial

2020 ◽  
Author(s):  
isaac kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Breast Lesion ◽  
Ultrasound Image ◽  
Test Group ◽  
Acid Mixture ◽  
Control Group ◽  
Breast Lesions ◽  
Efficacy And Safety ◽  
Palpable Breast

Abstract Backgrounds With increasing screening for breast cancer, non-palpable breast lesions are detected more frequently. A preoperative localization is very important for a minimal but accurate excision of a non-palpable breast lesion. The purpose of this study was to evaluate the efficacy and safety of indocyanine green(ICG)-hyaluronic acid mixture injection as a novel material for localization. Methods We performed prospective clinical trial with female patients who underwent surgery for non-palpable breast lesion. 44 patients were sequentially assigned to the control group(localization with activated charcoal), test group 1(ICG-hyaluronic acid mixture 0.1ml), or test group 2(ICG-hyaluronic acid mixture 0.2ml) by 1:1:1 ratio. Results Most were over 40 years old, and there were no differences between three groups in age distribution. According to the pathologic results, fibroadenoma accounted for the largest share (38.6%, 17/44) and malignancy accounted for 11.4% (5/44). The marking rate on both breast lesions and excised specimens was over 86% in all groups, and there was no difference. However, skin pigmentation was only in the control group and the accuracy of resection (the greatest length in cm of the excised specimen divided by the greatest length in cm on the pre-operation ultrasound image, the value closer to 1 meant resection as much as the size on ultrasound image) was different significantly. The average was 3.7(range 1.2-13.3) in control group and 2.2 (1.0-4.2) in test 1 group and 2.1(1.0-4.2) in test 2 group. Conclusion ICG-hyaluronic acid mixture injection was superior to activated charcoal for localization in patients with non-palpable breast lesions.

scholarly journals Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

2021 ◽  
Vol 43 (1) ◽  
Author(s):  
Jeong Joon Han ◽  
Ah. Ryum Chang ◽  
Jaemyung Ahn ◽  
Seunggon Jung ◽  
Jongrak Hong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Alveolar Bone ◽  
Test Group ◽  
Control Group ◽  
Ridge Preservation ◽  
Alveolar Ridge ◽  
Efficacy And Safety ◽  
Open Label ◽  
Alveolar Ridge Preservation ◽  
Bone Height

Abstract Background The aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation. Materials and methods Eighty-four subjects from three centers were enrolled in this clinical trial. After tooth extraction, rhBMP-2/β-TCP (n = 41, test group) or β-TCP (n = 43, control group) were grafted to the extraction socket with an absorbable barrier membrane for alveolar ridge preservation. Using computed tomography images obtained immediately after and 12 weeks after surgery, changes in the alveolar bone height and width were analyzed for each group and compared between the two groups. Results Both the test and control groups showed a significant decrease in alveolar bone height in the 12 weeks after surgery (both groups, p < 0.0001). However, the test group exhibited a significantly lower decrease in alveolar bone height than the control group (p = 0.0004). Alveolar bone width also showed significantly less resorption in the test group than in the control group for all extraction socket levels (ESL) (p = 0.0152 for 75% ESL; p < 0.0001 for 50% ESL; p < 0.0001 for 25% ESL). There were no statistically significant differences in the incidence of adverse events between the two groups. No severe adverse events occurred in either group. Conclusions The results of this study suggest that rhBMP-2/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction. Trial registration Clinicaltrials.gov, NCT02714829, Registered 22 March 2016

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

Efficacy and Safety of Traditional Chinese Medicine in COVID-2019: A Study Protocol for an Open-Label, Multicenter Randomized Controlled Trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Zhengzhong Yuan ◽  
Xiaoqiong Pan ◽  
Jizhou Zhang ◽  
Jiahui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Lung Injury Score ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Introduction: The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. It directly leads to high morbidity and mortality, but also results in a devastating effect on the global economy. Unfortunately, there are no effective therapies or vaccines for it. Hence, we designed a randomized trial to evaluate the efficacy and safety of Traditional Chinese Medicine for treating patients with COVID-19.Methods and analysis: This is an open-label, multicenter randomized controlled clinical trial. One hundred and twelve patients infected by SARS-CoV-2 will be randomly assigned to the experimental or the control group in an equal ratio. The patients in control group will accept routine supportive clinically care including the therapies of anti-viral, anti-bacterial and ameliorating the related symptoms, while patients in the experimental group will be asked to take traditional Chinese medicine depending on the different stages of the disease for consecutive 14 days in addition to supportive care. All data will be gathered at baseline and on days 3, 7, 10 and 14. The primary outcome measures will be the time of Reverse Transcription PCR testing of respiratory tract sample turns to be negative. Secondary outcome measures will include Murray lung injury score, MuLBSTA score and TCM ( Traditional Chinese Medicine ) Syndrome Scoring System. A laboratory test will be taken before and after treatment to assess the safety of TCM.Discussion: The study may help to identify the the efficacy and safety of Traditional Chinese Medicine in treating COVID-2019.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030759.Registered on March 13th 2020-Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals The Efficacy and Safety of a Herbal Toothpaste in Reducing Gingivitis: A Double-Blind, Randomized, Placebo-Controlled, Parallel Allocation Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Jinfeng He ◽  
Yalan Deng ◽  
Fangzhi Zhu ◽  
Ting Zhong ◽  
Nanyu Luo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Control Groups ◽  
Double Blind ◽  
Rhizoma Chuanxiong ◽  
Baseline Status ◽  
Main Components ◽  
And Control

Aim. To examine the efficacy and safety of the toothpaste containing Rhizoma Chuanxiong and Rhizoma Imperatae extracts in reducing gingivitis. Method. A double-blind clinical trial was conducted, in which 120 volunteers were randomly assigned to the test group (N = 60) or the control group (N = 60). Tetramethylpyrazine, senkyunolide A, ferulic acid, and ligustilide are the main effective components of Rhizoma Chuanxiong and Rhizoma Imperatae contains the main components of cylindrin, carotene, 5-hydroxytryptamine, potassium, and calcium. The control group used placebo toothpaste containing neither Rhizoma Chuanxiong extract nor Rhizoma Imperatae extract. Plaque, gingivitis, and bleeding were assessed at the baseline, prior to the supragingival scaling, and at 4, 8, and 12 weeks. Results. During the trial, both test and control groups showed a decreasing trend compared to the baseline. At the end of 12 weeks, with respect to Gingival Index (GI), Bleeding Index (BI), and Bleeding on Probing percentage (BOP%) scores, there were significant differences between test and control groups (GI, P<0.001, BI, P<0.001, and BOP%, P<0.001, resp.). After 4 weeks of usage, there were no statistically significant differences in all of GI, BI, and BOP% scores between the two groups. However, the decrease became statistically significant at next two intervals (GI, P<0.001, BI, P<0.001, and BOP%, P<0.001, resp.) in the efficiency of GI, BI, and BOP% which was 8.04%, 11.02%, and 37.16%, respectively. There were no treatment-related adverse events reported. Conclusion. The toothpaste containing Rhizoma Chuanxiong and Rhizoma Imperatae extracts was well tolerated and significantly reduced gingivitis and bleeding after usage for 12 weeks. There was better improvement at molars, and the more serious the baseline status was, the better the efficacy was.

scholarly journals Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039951
Author(s):  
Rafael León López ◽  
Sheila Cárcel Fernández ◽  
Laura Limia Pérez ◽  
Alberto Romero Palacios ◽  
María Concepción Fernández-Roldán ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Cytokine Release ◽  
Cytokine Release Syndrome ◽  
Open Label ◽  
Early Administration ◽  
Hospitalised Patients

IntroductionAbout 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).Methods and analysisPhase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm).Ethics and disseminationThe clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.Trial registration numberNCT04357860.

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

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