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Knowledge and Attitudes of Knust Pre-Clinical Dental Students towards Orthodontic Treatment
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作者 Ama Agyeibea Amuasi Ama B. Yeboah Daniel K. Sabbah 《Open Journal of Stomatology》 2024年第1期1-13,共13页
Background: Orthodontics is a dental specialty focusing on correcting dental irregularities and malocclusion. Knowledge and attitudes towards orthodontic treatment are crucial for promoting oral health and overall wel... Background: Orthodontics is a dental specialty focusing on correcting dental irregularities and malocclusion. Knowledge and attitudes towards orthodontic treatment are crucial for promoting oral health and overall well-being. Education and awareness play a vital role in ensuring optimal treatment outcomes and improving quality of life. Aim: This study aims to determine the knowledge and attitudes of Kwame Nkrumah University of Science and Technology (KNUST) pre-clinical dentistry students concerning orthodontic therapy. Methodology: This research is a quantitative descriptive cross-sectional study. The research used a non-random convenience sampling method to form the desired sample. For data collection, an interview-administered questionnaire was used over one month. The study set its sights on pre-clinical dental students in KNUST. A total of 150 questionnaires were printed to meet the sample size. Results: The results of the research showed that the knowledge level of KNUST pre-clinical students on orthodontic treatment and its nuances is quite limited. They however had a fair level of knowledge on the disease or ailment that orthodontic treatments solved (especially malocclusion). Their interest in orthodontic treatments on the other hand was quite significant, with a large number having interest in it. Conclusion: To conclude, KNUST pre-clinical students in Ghana although having a limited level of knowledge on orthodontic treatments have a keen interest in undergoing them regardless of the discomforts or the length of time. 展开更多
关键词 Orthodontic Therapy pre-clinical Dentistry Students Quantitative Study Convenience Sampling Interview-Administered Questionnaire MALOCCLUSION
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基于Clinical Trials数据库的癌性疼痛治疗药物临床试验分析
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作者 储召群 马菁文 +3 位作者 尚天则 余早勤 何光照 王忱诚 《医药导报》 CAS 北大核心 2024年第10期1640-1645,共6页
目的了解近年来癌性疼痛(癌痛)治疗药物临床试验的趋势和特点,为癌痛治疗药物的开发和临床研究提供参考依据。方法从Clinical Trials数据库中检索1987—2022年癌痛治疗药物临床试验的相关信息,从试验类型、备案时间、申报地区、癌痛类... 目的了解近年来癌性疼痛(癌痛)治疗药物临床试验的趋势和特点,为癌痛治疗药物的开发和临床研究提供参考依据。方法从Clinical Trials数据库中检索1987—2022年癌痛治疗药物临床试验的相关信息,从试验类型、备案时间、申报地区、癌痛类型、癌痛治疗药物等角度进行描述性分析。结果筛选出临床试验376项,由研究者发起的试验(IIT)项目数多于注册类试验(IST),其中北美洲的总项目数、IIT和IST项目数最多;试验总项目数和IST项目数先增长后回落,IIT的试验项目数稳步增长。针对慢性癌痛、爆发性癌痛和重度癌痛的研究相对较多。研究对象以阿片类药物尤其是芬太尼的占比最高。结论癌痛治疗药物临床试验对推进癌痛治疗药物治疗发挥了重要作用,未来有待进一步加强IST在新型癌痛治疗药物的研究和开展更多IIT研究,以更好地优化癌痛治疗效果。 展开更多
关键词 药物临床试验 癌性疼痛 研究者发起的试验 注册类试验
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Withania somnifera: a pre-clinical study on neuroregenerative therapy for stroke 被引量:1
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作者 Aparna Raghavan Zahoor A. Shah 《Neural Regeneration Research》 SCIE CAS CSCD 2015年第2期183-185,共3页
Stroke management exerts insurmountable societal and economic burden on the patient as well as their caregivers. In the year 2010 alone, the direct and indirect costs of stroke care amounted to 36.5 billion dollars (... Stroke management exerts insurmountable societal and economic burden on the patient as well as their caregivers. In the year 2010 alone, the direct and indirect costs of stroke care amounted to 36.5 billion dollars (Go et al., 2014). Despite concentrated efforts to develop a safe, effective drug for stroke, we have not discovered one since the introduction of recombinant tissue plasminogen activator (rtPA)--the standalone FDA-approved therapy for stroke. While rtPA is highly effective, it needs to be given within 3-4.5 hours of the onset of stroke symptoms (Zivin, 2009). This is often complicated by the delay in the commencement of treatment due to preliminary inclusion parameters that are required to be ascertained before rtPA administration. 展开更多
关键词 Withania somnifera a pre-clinical study on neuroregenerative therapy for stroke MCAO PARP WS
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Molecular insights into clinical trials for immune checkpoint inhibitors in colorectal cancer:Unravelling challenges and future directions 被引量:2
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作者 Samantha Sharma Naresh Singh +5 位作者 Anita Ahmed Turk Isabella Wan Akshay Guttikonda Julia Lily Dong Xinna Zhang Mateusz Opyrchal 《World Journal of Gastroenterology》 SCIE CAS 2024年第13期1815-1835,共21页
Colorectal cancer(CRC)is a complex disease with diverse etiologies and clinical outcomes.Despite considerable progress in development of CRC therapeutics,challenges remain regarding the diagnosis and management of adv... Colorectal cancer(CRC)is a complex disease with diverse etiologies and clinical outcomes.Despite considerable progress in development of CRC therapeutics,challenges remain regarding the diagnosis and management of advanced stage metastatic CRC(mCRC).In particular,the five-year survival rate is very low since mCRC is currently rarely curable.Over the past decade,cancer treatment has significantly improved with the introduction of cancer immunotherapies,specifically immune checkpoint inhibitors.Therapies aimed at blocking immune checkpoints such as PD-1,PD-L1,and CTLA-4 target inhibitory pathways of the immune system,and thereby enhance anti-tumor immunity.These therapies thus have shown promising results in many clinical trials alone or in combination.The efficacy and safety of immunotherapy,either alone or in combination with CRC,have been investigated in several clinical trials.Clinical trials,including KEYNOTE-164 and CheckMate 142,have led to Food and Drug Administration approval of the PD-1 inhibitors pembrolizumab and nivolumab,respectively,for the treatment of patients with unresectable or metastatic microsatellite instability-high or deficient mismatch repair CRC.Unfortunately,these drugs benefit only a small percentage of patients,with the benefits of immunotherapy remaining elusive for the vast majority of CRC patients.To this end,primary and secondary resistance to immunotherapy remains a significant issue,and further research is necessary to optimize the use of immunotherapy in CRC and identify biomarkers to predict the response.This review provides a comprehensive overview of the clinical trials involving immune checkpoint inhibitors in CRC.The underlying rationale,challenges faced,and potential future steps to improve the prognosis and enhance the likelihood of successful trials in this field are discussed. 展开更多
关键词 Colorectal cancer Immune checkpoint inhibitors Clinical trials Immunotherapy Microsatellite instability Microsatellite stability DNA mismatch repair
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基于ClinicalTrials.gov及WHO ICTRP的中日诱导多能干细胞临床研究现状的比较研究
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作者 杜慧 肖宇锋 张玢 《中国医药导报》 CAS 2024年第28期32-36,共5页
目的基于ClinicalTrials.gov和WHO ICTRP比较研究中日诱导多能干细胞(iPSC)的临床研究现状。方法检索ClinicalTrials.gov和WHO ICTRP平台,对建库至2024年3月中日iPSC临床试验数据进行采集,利用文献计量学方法,从注册数量、申办机构、疾... 目的基于ClinicalTrials.gov和WHO ICTRP比较研究中日诱导多能干细胞(iPSC)的临床研究现状。方法检索ClinicalTrials.gov和WHO ICTRP平台,对建库至2024年3月中日iPSC临床试验数据进行采集,利用文献计量学方法,从注册数量、申办机构、疾病分类和研究类型及分期等角度,对中日该领域的临床试验注册现状进行比较研究。结果中国注册iPSC临床试验15项,日本53项;中日临床试验申办者均以高校、医院等科研院所为主,中国企业表现也较为活跃;中国临床试验覆盖的疾病范围小于日本;中日两国临床试验均以实验性研究为主。结论中国的iPSC技术还有较大的发展空间,未来发展需要进一步完善监管政策,建立严格的质量控制体系,合理规划和建设临床级i PS细胞库,综合高校、科研院所、企业三者iPSC研发与应用优势,加强资源合作,促进技术成果转化,推动技术的进步和应用的拓展。 展开更多
关键词 诱导多能干细胞 Clinicaltrials.gov WHO ICTRP 临床试验 文献计量
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Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia
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作者 TATIANA KURILO REBECCA D.PENTZ 《Oncology Research》 SCIE 2024年第9期1401-1406,共6页
Objectives:Rural patients have poor cancer outcomes and clinical trial(CT)enrollment compared to urban patients due to attitudinal,awareness,and healthcare access differential.Knowledge of cancer survival disparities ... Objectives:Rural patients have poor cancer outcomes and clinical trial(CT)enrollment compared to urban patients due to attitudinal,awareness,and healthcare access differential.Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers.The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients.Our hypotheses are that for both cancer types,urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties.Methods:We compared breast and lung cancer patients’survival rates and enrollment ratios in clinical trials between rural(RUCC 4-9)and urban counties in Georgia at a Comprehensive Cancer Center(CCC).To assess these differences,we carried out a series of independent samples t-tests and Chi-Square tests.Results:The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients,failing to substantiate our hypothesis.While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC,no significant variation was observed based on rural or urban classification.Conclusion:These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers.Further,the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities. 展开更多
关键词 CANCER Cancer survival rates Clinical trial enrollment Rural patients Health disparities Barriers to clinical trial participation Geographic disparities
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How completely are randomized controlled trials of non-pharmacological interventions following concussion reported? A systematic review
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作者 Jacqueline Josee van Ierssel Olivia Galea +8 位作者 Kirsten Holte Caroline Luszawski Elizabeth Jenkins Jennifer O’Neil Carolyn A Emery Rebekah Mannix Kathryn Schneider Keith Owen Yeates Roger Zemek 《Journal of Sport and Health Science》 SCIE CAS CSCD 2024年第4期537-547,共11页
Purpose:The study aimed to examine the reporting completeness of randomized controlled trials(RCTs)of non-pharmacological interventions following concussion.Methods:We searched MEDLINE,Embase,PsycInfo,CINAHL,and Web o... Purpose:The study aimed to examine the reporting completeness of randomized controlled trials(RCTs)of non-pharmacological interventions following concussion.Methods:We searched MEDLINE,Embase,PsycInfo,CINAHL,and Web of Science up to May 2022.Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication(TIDieR),Consensus on Exercise Reporting Template(CERT),and international Consensus on Therapeutic Exercise aNd Training(i-CONTENT)checklists.Additional information was sought my study authors where reporting was incomplete.Risk of bias(ROB)was assessed with the Cochrane ROB-2 Tool.RCTs examining non-pharmacological interventions following concussion.Results:We included 89 RCTs(n=53 high ROB)examining 11 different interventions for concussion:sub-symptom threshold aerobic exercise,cervicovestibular therapy,physical/cognitive rest,vision therapy,education,psychotherapy,hyperbaric oxygen therapy,transcranial magnetic stimulation,blue light therapy,osteopathic manipulation,and head/neck cooling.Median scores were:TIDieR 9/12(75%;interquartile range(IQR)=5;range:5-12),CERT 17/19(89%;IQR=2;range:10-19),and i-CONTENT 6/7(86%;IQR=1;range:5-7).Percentage of studies completely reporting all items was TIDieR 35%(31/89),CERT 24%(5/21),and i-CONTENT 10%(2/21).Studies were more completely reported after publication of TIDieR(t_(87)=2.08;p=0.04)and CERT(t_(19)=2.72;p=0.01).Reporting completeness was not strongly associated with journal impact factor(TIDieR:rs=0.27;p=0.01;CERT:r_(s)=-0.44;p=0.06;i-CONTENT:r_(s)=-0.17;p=0.48)or ROB(TIDieR:rs=0.11;p=0.31;CERT:rs=0.04;p=0.86;i-CONTENT:rs=0.12;p=0.60).Conclusion:RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness,but are often missing key components,particularly modifications,motivational strategies,and qualified supervisor.Reporting completeness improved after TIDieR and CERT publication,but publication in highly cited journals and low ROB do not guarantee reporting completeness. 展开更多
关键词 CONCUSSION INTERVENTION Randomized controlled trial Systematic review
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Efficacy of a Nutritional Cream Intervention to Treat Depression in Rescuers:A Randomized Controlled Trial
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作者 Qiao Wang Hengyu Luan +4 位作者 Chunyan Li Rufang Gong Qiongxuan Li Jiayi Deng Xiaoyong Sai 《Biomedical and Environmental Sciences》 SCIE CAS CSCD 2024年第7期754-761,共8页
Objective To explore the effectiveness of a nutritional intervention in rescuers who screened positive for depression.Methods A randomized controlled trial design was employed.From June to August,2022,4,460 rescuers w... Objective To explore the effectiveness of a nutritional intervention in rescuers who screened positive for depression.Methods A randomized controlled trial design was employed.From June to August,2022,4,460 rescuers were screened using the Self-Rating Depression Scale(SDS),and 1,615 positive cases were identified.Thirty-one volunteers were recruited and randomly divided into a nutritional intervention group and a control group.The intervention group received health education and nutritional intervention(a compound paste therapy primarily composed of red roses and Seville orange flowers),while the control group received psychological education.SDS scores were assessed before and after the intervention.Results There was a statistically significant decline in SDS scores in the nutritional intervention group after the intervention(P<0.05).Furthermore,the SDS scores of the intervention group were significantly lower than those of the control group,both before and after the intervention(P<0.05).No severe adverse reactions were observed during safety evaluation.Conclusion The nutritional intervention effectively reduced the depression scores in rescuers.Early nutritional intervention is recommended for rescuers who initially screen positive for depression. 展开更多
关键词 Nutritional intervention Rescuers DEPRESSION Randomized controlled trial
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Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment
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作者 Jia-En Liang Meng-Yin Liang +11 位作者 En-En Zhang Yu-Ying Peng Ling-Ling Chen Jia-Yu Deng Ting Lin Jun Fu Jia-Ni Zhang Shao-Li Li Fei Li Hui-Ming Xaio Wen-Min Huang Yu-Hong Liu 《International Journal of Ophthalmology(English edition)》 SCIE CAS 2024年第1期157-163,共7页
AIM:To explore the factors influencing individuals’willingness to participate in ophthalmic clinical trials.METHODS:A questionnaire survey was conducted from January to April 2021 among patients and their family memb... AIM:To explore the factors influencing individuals’willingness to participate in ophthalmic clinical trials.METHODS:A questionnaire survey was conducted from January to April 2021 among patients and their family members at Zhongshan Ophthalmic Center,Sun Yat-sen University,in Guangzhou,China.The survey gathered data on respondents’willingness,demographic and socioeconomic profiles,as well as their reasons and concerns regarding engagement in clinical trials.RESULTS:Of the 1078 residents surveyed(mean age 31.2±13.1y;65.8%females)in Guangzhou,749(69.5%)expressed a willingness to participate in future ophthalmic clinical trials.Specific characteristics associated with greater willingness included a younger age,lower annual income,higher education,prior participation experience,previous ophthalmic treatment,and a better understanding of clinical trials.With the exception of age,these characteristics were significantly linked to a higher willingness.The primary barrier to participation,expressed by 64.8%of those willing and 54.4%of those unwilling,was“Uncertain efficacy”.In terms of motivations,the willing group ranked“Better therapeutic benefits”(35.0%),“Professional monitoring”(34.3%),and“Trust in healthcare professionals”(33.1%)as their top three reasons,whereas the unwilling participants indicated“Full comprehension of the protocol”(46.2%)as the key facilitator.CONCLUSION:This study reveals a substantial willingness to participate in ophthalmic clinical trials and demonstrates the predictive role of demographic and socioeconomic factors.Variations in motivators and concerns between willing and unwilling participants highlight the significance of tailored recruitment strategies.Importantly,the need for and trust in healthcare professionals stand out as powerful motivations,underscoring the importance of enhancing physician-patient relationships,adopting patient-centered communication approaches,and addressing individualized needs to improve accrual rates. 展开更多
关键词 participation willingness recruitment strategy ophthalmic clinical trial
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Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis:A meta-analysis and trial sequential analysis
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作者 Xin-Yu Yang Yun-Feng Yu +3 位作者 Ke-Ke Tong Gang Hu Rong Yu Lian-Jun Su 《World Journal of Clinical Cases》 SCIE 2024年第21期4703-4716,共14页
BACKGROUND The benefits and risks of Xileisan(XLS)in the treatment of ulcerative colitis(UC)remain unclear.AIM The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when ... BACKGROUND The benefits and risks of Xileisan(XLS)in the treatment of ulcerative colitis(UC)remain unclear.AIM The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC.METHODS We searched eight databases for clinical trials evaluating the combination of XLS and mesalazine in the treatment of UC,up to January 2024.Meta-analysis and trial sequential analysis(TSA)were performed using Revman 5.3 and TSA 0.9.5.10 beta,respectively.RESULTS The present study included 13 clinical studies involving 990 patients,of which 501 patients received XLS combined with mesalazine while 489 patients received mesalazine alone.The meta-analysis showed that,in terms of efficacy,the combination of XLS and mesalazine significantly improved the clinical efficacy rate by 22%[risk ratio(RR)=1.22;95%CI:1.15–1.28;P<0.00001]and mucosal improvement rate by 25%(RR=1.25;95%CI:1.12–1.39;P=0.0001),while significantly reducing the duration of abdominal pain by 2.25 days[mean difference(MD)=-2.25;95%CI:-3.35 to-1.14;P<0.0001],diarrhea by 2.06 days(MD=-2.06;95%CI:-3.92 to-0.20;P=0.03),hematochezia by 2.32 days(MD=-2.32;95%CI:-4.02 to-0.62;P=0.008),tumor necrosis factor alpha by 16.25 ng/mL(MD=-16.25;95%CI:-20.48 to-12.01;P<0.00001),and interleukin-6 by 14.14 ng/mL(MD=-14.14;95%CI:-24.89 to-3.39;P=0.01).The TSA indicated conclusiveness in the meta-analysis of the efficacy endpoints.In terms of safety,the meta-analysis revealed that the combination of XLS and mesalazine did not increase the occurrence of total and gastrointestinal adverse events,abdominal distension,and erythema(P>0.05).The TSA showed non conclusive findings in the meta-analysis of the safety endpoints.Harbord’s test showed no publication bias(P=0.734).CONCLUSION Treatment with XLS alleviated the clinical symptoms,intestinal mucosal injury,and inflammatory response in patients with UC,while demonstrating good safety. 展开更多
关键词 Xileisan MESALAZINE Ulcerative colitis META-ANALYSIS trial sequential analysis
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Pain Efficacy of a Home-Based Low-Intensity Continuous Ultrasound Stimulator for Knee Arthritis: A Single-Arm, Open-Label, Prospective Clinical Trial
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作者 Md. Habibur Rahman Yeon-Gyu Jang +8 位作者 Johny Bajgai Subham Sharma Kchorng Vira Abdul-Nasir Sofian Seong Hoon Goh Yundeok Kim Cheol-Su Kim Doo-Sup Kim Kyu-Jae Lee 《Health》 2024年第7期703-716,共14页
1) Background: Osteoarthritis (OA) is defined as a degenerative joint disease that mainly affects the bone. This study aims to evaluate the effect of low-intensity continuous ultrasound (LICUS) treatment on the knee o... 1) Background: Osteoarthritis (OA) is defined as a degenerative joint disease that mainly affects the bone. This study aims to evaluate the effect of low-intensity continuous ultrasound (LICUS) treatment on the knee of osteoarthritis patients through home-based intervention using the LICUS medical device. 2) Methods: The clinical trials were designed in a single-arm, open-label, and intervention study. Thirty-five participants, including those who dropped out (12%), were screened and enrolled. The patients received LICUS (1.1 MHz, 1.5 W/cm2, collimated beams) on the knee by the instructions of the investigator at home (5 min/session, 3 times/day, for four-weeks). Outcome measures were assessed using the Visual Analog Scale (VAS) as a primary endpoint and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a secondary endpoint to evaluate pain relief and functional recovery of the knee between pre-treatment (baseline) and post-treatment (four-weeks). 3) Results: Knee pain scores measured using the VAS and WOMAC indices were significantly reduced after a four-week treatment with LICUS compared to baseline. Knee stiffness and functional capacity were significantly reduced after the LICUS application. In addition, there were no reports of adverse effects during the study period. 4) Conclusion: Long-term and home-based application of LICUS can be recommended as an alternative option for the treatment of OA patients, as evidenced by the effect of pain relief and knee function recovery. 展开更多
关键词 Knee Osteoarthritis Low-Intensity Continuous Ultrasound Stimulator Clinical trial Visual Analogue Scale Western Ontario and McMaster Universities Osteoarthritis Index
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Nab-paclitaxel plus capecitabine as first-line treatment for advanced biliary tract cancers:An open-label,non-randomized,phase II clinical trial
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作者 Ling-Xiao Xu Jia-Jia Yuan +1 位作者 Ran Xue Jun Zhou 《World Journal of Gastroenterology》 SCIE CAS 2024年第30期3564-3573,共10页
BACKGROUND Biliary tract cancers(BTCs)are a heterogeneous group of tumors with high malignancy,poor prognosis,and limited treatment options.AIM To explore the efficacy and safety of nab-paclitaxel plus capecitabine as... BACKGROUND Biliary tract cancers(BTCs)are a heterogeneous group of tumors with high malignancy,poor prognosis,and limited treatment options.AIM To explore the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic BTCs.METHODS This open-label,non-randomized,double-center,phase II clinical trial recruited systemic therapy-naive patients with unresectable or metastatic BTCs between April 2019 and June 2022 at Beijing Cancer Hospital and the First Hospital of China Medical University.Eligible patients were administered nab-paclitaxel(150 mg/m^(2),day 1)and capecitabine(2000 mg/m^(2),twice daily,days 1-7)in 14-day cycles until experiencing intolerable toxicity or disease progression.The primary outcome was the objective response rate(ORR).The secondary outcomes included the disease control rate(DCR),overall survival(OS),progression-free survival(PFS),and safety.RESULTS A total of 44 patients successfully completed the trial,with a median age of 64.00 years(interquartile range,35.00-76.00),and 26(59.09%)were females.Tumor response assessment was impeded for one patient due to premature demise from tumor hemorrhage.Among the remaining 43 patients undergoing at least one imaging assessment,the ORR was 23.26%[95%confidence interval(CI):11.80%-38.60%],and the DCR was 69.77%(95%CI:53.90%-82.80%).The median OS was 14.1 months(95%CI:8.3-19.9),and the median PFS was 4.4 months(95%CI:2.5-6.3).A total of 41 patients(93.18%)experienced at least one adverse event(AE),with 10 patients(22.73%)encountering grade≥3 AEs,and the most frequent AEs of any grade were alopecia(79.50%),leukopenia(54.55%),neutropenia(52.27%),and liver dysfunction(40.91%),and no treatment-related deaths were documented.CONCLUSION Nab-paclitaxel plus capecitabine may be an effective and safe first-line treatment strategy for patients with advanced or metastatic BTCs. 展开更多
关键词 NAB-PACLITAXEL CAPECITABINE Biliary tract cancer Objective response rate Phase II clinical trial
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Can Tibetan medicine Honghua Ruyi pills relieve endometriosisassociated dysmenorrhea?Protocol for a randomized placebocontrolled trial
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作者 Mei Han Jiahui Cao +7 位作者 Jiali Wei Hui Luo Chaoqin Yu Xuefang Liang Nyangmotse Guoyan Yang Huilan Du Jianping Liu 《Journal of Traditional Chinese Medical Sciences》 CAS 2024年第1期78-85,共8页
Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-... Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis. 展开更多
关键词 ENDOMETRIOSIS DYSMENORRHEA Honghua Ruyi pills Randomized controlled trial Traditional Chinese medicine
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Current clinical trials on gastric cancer surgery in China
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作者 Shun Zhang Ren-Hao Hu +2 位作者 Xi-Mao Cui Chun Song Xiao-Hua Jiang 《World Journal of Gastrointestinal Oncology》 SCIE 2024年第11期4369-4382,共14页
Gastric cancer(GC)is the leading diagnosed malignancy worldwide,especially in China.Radical surgery is the cornerstone of GC treatment.We reviewed previous clinical trials and aimed to provide an update on the factors... Gastric cancer(GC)is the leading diagnosed malignancy worldwide,especially in China.Radical surgery is the cornerstone of GC treatment.We reviewed previous clinical trials and aimed to provide an update on the factors related to the surgical treatment of GC.The number of registered clinical trials in the field of GC surgery is rapidly increasing.With the development and popularization of endoscopic,laparoscopic,and robotic techniques,GC surgery has gradually entered a new era of precise minimally invasive surgery.Postoperative quality of life has become a major issue in addition to surgical oncological safety.Although great progress has been made in clinical research on GC in China,there are still deficiencies.Many studies enrolled large numbers of patients,but the research data were not of high quality.The characteristics of GC in China include a high incidence,large population,and large proportion of patients with advanced GC,which provides sufficient reason for studying this disease.There is still a need for well-designed,large,randomized clinical trials to improve our knowledge of the surgical treatment of GC. 展开更多
关键词 Gastric cancer Clinical trial SURGERY China Minimally invasive surgery Quality of life
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基于ClinicalTrials.gov的全球数字疗法临床试验注册现状研究
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作者 卢岩 杨涛 +3 位作者 陈娟 张婷 严舒 欧阳昭连 《中国医疗设备》 2024年第10期17-22,共6页
目的研究全球数字疗法临床试验注册现状,为数字疗法的临床研究及应用提供参考。方法在ClinicalTrials.gov中检索数字疗法相关临床试验,运用文献计量学方法,分析全球数字疗法临床试验的注册数量和年度变化趋势、国家/地区分布及合作情况... 目的研究全球数字疗法临床试验注册现状,为数字疗法的临床研究及应用提供参考。方法在ClinicalTrials.gov中检索数字疗法相关临床试验,运用文献计量学方法,分析全球数字疗法临床试验的注册数量和年度变化趋势、国家/地区分布及合作情况、申办者类型及构成情况、研究类型及试验分期、适应证分类和特征。结果全球数字疗法相关临床试验共2960项,其中美国最为活跃,远超其他国家/地区,与德国同处国际合作的中心,申办者中64.79%是高校/医院,美国高校/医院表现突出。85.44%是干预性研究,大多数属于设备和行为干预,适应证集中于精神疾病、慢性病和神经系统疾病领域,包括焦虑症(109项)、抑郁症(103项)和肥胖(101项)。截至检索日期,我国数字疗法相关临床试验为143项,与美国存在较大差距。结论全球数字疗法临床试验呈现逐年增长趋势,受COVID-19大流行影响,2020年后增长显著。我国数字疗法尚处于起步阶段,全面推广及应用尚需时间。 展开更多
关键词 数字疗法 临床试验注册 Clinicaltrials.gov 文献计量 注册数量 年度变化趋势 适应证 循证治疗
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Anti-oxidative stress treatment and current clinical trials
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作者 Chun-Ye Zhang Ming Yang 《World Journal of Hepatology》 2024年第2期294-299,共6页
Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic disea... Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic diseases.Upon exposure to oxidative stress or the inducers of ROS,the cellular nucleus undergoes some biological processes via different signaling pathways,such as stress adaption through the forkhead box O signaling pathway,inflammatory response through the IκB kinase/nuclear factor-κB signaling pathway,hypoxic response via the hypoxia-inducible factor/prolyl hydroxylase domain proteins pathway,DNA repair or apoptosis through the p53 signaling pathway,and antioxidant response through the Kelch-like ECH-associated protein 1/nuclear factor E2-related factor 2 signaling pathway.These processes are involved in many diseases.Therefore,oxidative stress has gained more attraction as a targeting process for disease treatment.Meanwhile,anti-oxidative stress agents have been widely explored in pre-clinical trials.However,only limited clinical trials are performed to evaluate the efficacy of anti-oxidative stress agents or antioxidants in diseases.In this letter,we further discuss the current clinical trials related to anti-oxidative stress treatment in different diseases.More pre-clinical studies and clinical trials are expected to use anti-oxidative stress strategies as disease treatment or dietary supplementation to improve disease treatment outcomes. 展开更多
关键词 Anti-oxidative stress treatment Clinical trials DRUGS Dietary invention Reactive oxygen species
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Preliminary evidence of renal function improvement in chronic progressive kidney disease using autologous CD34+cell therapy:A clinical trial
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作者 Takayasu Ohtake Tsutomu Sato +12 位作者 Toshitaka Tsukiyama Suguru Muraoka Ayaka Mitomo Haruka Maruyama Mizuki Yamano Yasuhiro Mochida Kunihiro Ishioka Machiko Oka Hidekazu Moriya Sumi Hidaka Haruchika Masuda Takayuki Asahara Shuzo Kobayashi 《World Journal of Stem Cells》 SCIE 2024年第12期1012-1021,共10页
BACKGROUND To date,no specific treatment has been established to reverse progressive chronic kidney disease(CKD).AIM To evaluate the safety and efficacy of autologous CD34^(+)cell transplantation in CKD patients who e... BACKGROUND To date,no specific treatment has been established to reverse progressive chronic kidney disease(CKD).AIM To evaluate the safety and efficacy of autologous CD34^(+)cell transplantation in CKD patients who exhibited a progressive decline in renal function.METHODS The estimated glomerular filtration rate(eGFR)at the beginning of the study was 15.0-28.0 mL/minute/1.73 m^(2).After five days of treatment with the granulocyte colony-stimulating factor,mononuclear cells were harvested and CD34^(+)cells were magnetically collected.CD34^(+)cells were directly injected into the bilateral renal arteries twice(at 0 and 3 months),and their safety and efficacy were evaluated for 6 months.RESULTS Four patients were enrolled and completed the study.Three of four patients showed improvement in eGFR slope(eGFR slope>0 mL/minute/1.73 m^(2)),with the monthly slope of eGFR(delta eGFR)changing from-1.36±1.1(pretreatment)to^(+)0.22±0.71(at 6 months)mL/minute/1.73 m^(2)/month(P=0.135)after cell therapy.Additionally,intrarenal resistive index(P=0.004)and shear wave velocity(P=0.04)were significantly improved after cell therapy.One patient experienced transient fever after cell therapy,and experienced bone pain during granulocyte colony-stimulating factor administration.However,no severe adverse events were reported.CONCLUSION In conclusion,our findings suggest that repetitive peripheral blood-derived autologous CD34^(+)cell transplantation into the renal arteries is safe,feasible,and may be effective for patients with progressive CKD.However,a large-scale clinical trial is warranted to validate the efficacy of repetitive regenerative cell therapy using autologous CD34^(+)cells in patients with progressive CKD. 展开更多
关键词 CD34+cell Chronic kidney disease Clinical trial Granulocyte colony-stimulating factor Regenerative therapy
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A Rumsfeld Matrix test for acupuncture clinical trials
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作者 GONG Changzhen 《Digital Chinese Medicine》 CAS CSCD 2024年第3期209-223,共15页
This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British ... This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community. 展开更多
关键词 ACUPUNCTURE Randomized clinical trials(RCTs) Rumsfeld Matrix Placebo effect Control group design Therapeutic potential
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Electroacupuncture with different waveforms for primary dysmenorrhea:A randomized controlled trial
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作者 Xiaona Wu Jingxue Yuan +5 位作者 Jinxia Ni Xiuli Ma Ziniu Zhang Yini Hua Juwei Dong Bob Peng Wang 《Journal of Traditional Chinese Medical Sciences》 CAS 2024年第3期357-362,共6页
Objective:To observe and compare the clinical effects of different electroacupuncture waveforms on primary dysmenorrhea.Methods: This was a prospective,randomized,three-group,parallel-controlled trial.Participants wit... Objective:To observe and compare the clinical effects of different electroacupuncture waveforms on primary dysmenorrhea.Methods: This was a prospective,randomized,three-group,parallel-controlled trial.Participants with primary dysmenorrhea were randomly divided into dense-sparse wave,continuous wave,and discontinuous wave groups in a 1:1:1 ratio.Two lateral Ciliao(BL 32)points were used.All three groups started treatment 3–5 days before menstruation,once a day for six sessions per course of treatment,one course of treatment per menstrual cycle,and three menstrual cycles.The primary outcome measure was the proportion with an average visual analog scale(VAS)score reduction of≥50%from baseline for dysmenorrhea in the third menstrual cycle during treatment.The secondary outcome measures included changes in dysmenorrhea VAS scores,Cox Menstrual Symptom Scale scores and the proportion of patients taking analgesic drugs.Results: The proportion of cases where the average VAS score for dysmenorrhea decreased by≥50%from baseline in the third menstrual cycle was not statistically significant(P>.05).Precisely 30 min after acupuncture and regarding immediate analgesia on the most severe day of dysmenorrhea,there was a statistically significant difference in the dense-sparse wave group compared with the other two groups during the third menstrual cycle(P<.05).Additionally,there was a statistically significant difference between the dense-sparse wave and discontinuous wave groups 24 h after acupuncture(P<.05).Conclusions: Waveform electroacupuncture can alleviate primary dysmenorrhea and its related symptoms in patients.The three groups showed similar results in terms of short-and long-term analgesic efficacy and a reduction in the number of patients taking analgesic drugs.Regarding achieving immediate analgesia,the dense-sparse wave group was slightly better than the other two groups. 展开更多
关键词 WAVEFORMS Ciliao(BL 32) ELECTROACUPUNCTURE Primary dysmenorrhea Randomized controlled trial Dense-sparse waves Continuous waves Discontinuous waves
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Coronary artery disease and heart failure:Late-breaking trials presented at American Heart Association scientific session 2023
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作者 Avilash Mondal Sashwath Srikanth +4 位作者 Sanjana Aggarwal Naga R Alle Olufemi Odugbemi Ikechukwu Ogbu Rupak Desai 《World Journal of Cardiology》 2024年第7期389-396,共8页
The late-breaking science presented at the 2023 scientific session of the American Heart Association paves the way for future pragmatic trials and provides meaningful information to guide management strategies in coro... The late-breaking science presented at the 2023 scientific session of the American Heart Association paves the way for future pragmatic trials and provides meaningful information to guide management strategies in coronary artery disease and heart failure(HF).The dapagliflozin in patient with acute myocardial infarction(DAPA-MI)trial showed that dapagliflozin use among patients with acute MI without a history of diabetes mellitus or chronic HF has better cardiometabolic outcomes compared with placebo,with no difference in cardiovascular outcomes.The MINT trial showed that in patients with acute MI and anemia(Hgb<10 g/dL),a liberal transfusion goal(Hgb≥10 g/dL)was not superior to a restrictive strategy(Hgb 7-8 g/dL)with respect to 30-day all-cause death and recurrent MI.The ORBITA-2 trial showed that among patients with stable angina and coronary stenoses causing ischemia on little or no antianginal therapy,percutaneous coronary intervention results in greater improvements in anginal frequency and exercise times compared with a sham procedure.The ARIES-HM3 trial showed that in patients with advanced HF who received a HeartMate 3 levitated left ventricular assist device and were anticoagulated with a vitamin K antagonist,placebo was noninferior to daily aspirin with respect to the composite endpoint of bleeding and thrombotic events at 1 year.The TEAMMATE trial showed that everolimus with low-dose tacrolimus is safe in children and young adults when given≥6 months after cardiac transplantation.Providing patients being treated for HF with reduced ejection fraction(HFrEF)with specific out-of-pocket(OOP)costs for multiple medication options at the time of the clinical encounter may reduce‘contingency planning’and increase the extent to which patients are taking the medications decided upon.The primary outcome,which was cost-informed decisionmaking,defined as the clinician or patient mentioning costs of HFrEF medication,occurred in 49%of encounters with the checklist only control group compared with 68%of encounters in the OOP cost group. 展开更多
关键词 Heart failure Coronary artery disease Clinical trials Myocardial infarction Cardiovascular outcome Percutaneous coronary intervention Blood transfusion Cardiac transplant
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