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 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

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 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 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 Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals Effect of a 0.5% chlorhexidine gel on dental plaque superinfecting microorganisms in mentally handicapped patients

2003 ◽  
Vol 17 (3) ◽  
pp. 228-233 ◽  
Author(s):  
Cláudio Mendes Pannuti ◽  
Roberto Fraga Moreira Lotufo ◽  
Silvana Cai ◽  
Maria da Conceição Saraiva ◽  
Nívea Maria de Freitas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Dental Plaque ◽  
Test Group ◽  
Control Group ◽  
Mentally Handicapped ◽  
Bacterial Populations ◽  
Gram Negative ◽  
Supragingival Plaque ◽  
Chlorhexidine Gel

A randomized clinical trial was conducted to investigate the effect of a 0.5% chlorhexidine (CHX) gel on dental plaque superinfecting microorganisms in mentally handicapped patients. Thirty inmates from the institution "Casas André Luiz" were assigned to either test group (CHX gel, n = 15) or control group (placebo gel, n = 15). The gel was administered over a period of 8 weeks. Supragingival plaque samples were collected at baseline, after gel use (8 weeks) and 16 weeks after baseline. The presence of Gram-negative Enterobacteriaceae, Staphylococcus and yeasts was evaluated. No significant growth of any superinfecting microorganism was observed in the CHX group, when compared to the placebo group. The results indicated that the 0.5% chlorhexidine gel did not produce an undesirable shift in these bacterial populations.

scholarly journals Intravesical Instillation of Sodium Hyaluronate (Cystistat®) for the Treatment of Patients with Radiation Cystitis-Randomized Clinical Trial

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
Farzad Allameh ◽  
Abbas Basiri ◽  
Saleh Ghiasy ◽  
Atefeh Javadi ◽  
Seyyed Ali Hojjati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Sodium Hyaluronate ◽  
Intravesical Instillation ◽  
Control Group ◽  
Radiation Cystitis ◽  
Vas Score ◽  
The Mean

Background: Radiotherapy (RT) is a choice to manage pelvic organ malignancies that can affect bladder; therefore, it causes radiation cystitis with some bothering urinary symptoms and decreasing the patient’s quality of life. Intravesical hyaluronic acid (HA) is an agent with promising results in some studies for cystitis, and Cystistat is a derivative of hyaluronic acid. Objectives: This clinical trial aimed at evaluating the effects of intravesical instillation of Cystistat on symptoms of radiation cystitis and quality of life (QOL). Methods: A total of 58 patients with radiation cystitis were randomized in 2 groups (case: 30, control: 28). One group received intravesical Cystistat, the other received normal saline weekly for up to 4 weeks and then monthly for up to 2 months. Hematuria, Visual Analog scale (VAS) and QOL based on King’s Health questionnaire were compared before and 3, 6 and 9 months after intravesical instillation. Results: The mean age of the patients was 63.93 ± 10.89 years old. The mean of each sub-category of QOL and total score of QOL, as well as, VAS score were significantly improved in comparison to the control group at each time of follow-ups (P < 0.05). Hematuria was significantly different in the 3rd, 6th and 9th month of follow-ups (P < 0.05). Conclusions: Findings showed that patients with radiation cystitis could significantly benefit from intravesical instillation of HA, their hematuria would be successfully resolved rather than control group in addition to lowering the VAS score, so their QOL would be improved.

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