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Patient Recruitment in Clinical Trials: Areas of Challenges and Success, a Practical Aspect at the Private Research Site
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作者 Pranali M. Wandile 《Journal of Biosciences and Medicines》 2023年第10期103-113,共11页
Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical cen... Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful. 展开更多
关键词 clinical trial Recruitment clinical trial Retention clinical trial Participants clinical trial Termination Study Budget clinical trial Enrollment Challenges
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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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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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Knowledge and Attitudes of Oncology Nurses Toward Clinical Trials-A Secondary Publication
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作者 Jin Sil Bae Jeong Hye Kim 《Journal of Clinical and Nursing Research》 2024年第1期209-221,共13页
Purpose:The purpose of this study was to identify the knowledge and attitudes of oncology nurses toward clinical trials and to provide evidence for the development of clinical trial education programs for oncology nur... Purpose:The purpose of this study was to identify the knowledge and attitudes of oncology nurses toward clinical trials and to provide evidence for the development of clinical trial education programs for oncology nurses.Methods:The study was conducted on 142 nurses who had more than six months of nursing experience working with cancer patients at a tertiary hospital in Seoul,Korea.A structured questionnaire was used to measure the knowledge and attitudes of oncology nurses toward clinical trials.Results:The participants scored an average of 15.03±3.52 out of 19 in terms of knowledge about clinical trials.In terms of attitudes toward clinical trials,the participants scored an average of 5.91±1.37 out of 8.There was a significant positive correlation between the knowledge and attitudes of the participants toward clinical trials(r=0.23,P=0.007).Conclusion:This study found that there was a relationship between the knowledge and attitudes of oncology nurses toward clinical trials.To improve the competency of oncology nurses and provide high-quality care to patients participating in clinical trials,more systematic and sustainable education is required. 展开更多
关键词 clinical trial Nurses Knowledge ATTITUDE NEOPLASMS
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Analysis of the Current Situation of Drug Clinical Trial Institutions in Shaanxi Province
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作者 Yurong Zhang Qi Zhang +4 位作者 Li Wang Rui Xu Lili Zhao Enze Li Xin Wang 《Journal of Clinical and Nursing Research》 2024年第1期78-87,共10页
To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on... To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province. 展开更多
关键词 Drug clinical trial Institution registration Registered majors Current situation analysis Professional group Shaanxi Province
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An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China
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作者 Lin Hansen Tian Lijuan 《Asian Journal of Social Pharmacy》 2024年第1期50-57,共8页
Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature... Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature research,case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines.Results and Conclusion From the perspective of the sponsor,investigators and the thirdparty technical service company,the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found.Then,the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed,including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel. 展开更多
关键词 therapeutic vaccine clinical trial quality management good clinical practice(GCP)
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Problems and Countermeasures to Improve Clinical Trial Participants’Compensation Rights in China
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作者 Yang Xiuqiao Wen Ping +2 位作者 Lin Hong Chen Wenhuan Chen Yuwen 《Asian Journal of Social Pharmacy》 2024年第1期58-63,共6页
Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right t... Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants. 展开更多
关键词 clinical trial PARTICIPANT compensation right
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Comparative Study on the Policy of Multiplicity Issues in Clinical Trials at Home and Abroad
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作者 Gong Jingran Chang Yingnan +1 位作者 Qiao Jiahui Chen Yuwen 《Asian Journal of Social Pharmacy》 2024年第1期43-49,共7页
Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the sim... Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards. 展开更多
关键词 clinical trial multiplicity issue solution strategy
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Advances and key focus areas in gastric cancer immunotherapy:A comprehensive scientometric and clinical trial review(1999-2023) 被引量:3
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作者 Yao-Nan Li Bin Xie +5 位作者 Ying Zhang Ming-Hua He Yang Xing Dong-Mei Mu Hong Wang Rui Guo 《World Journal of Gastroenterology》 SCIE CAS 2023年第40期5593-5617,共25页
BACKGROUND Gastric cancer(GC)is the sixth most common cancer and third leading cause of cancer-related deaths worldwide.Current treatments mainly rely on surgery-and chemotherapy-based systemic;however,the prognosis r... BACKGROUND Gastric cancer(GC)is the sixth most common cancer and third leading cause of cancer-related deaths worldwide.Current treatments mainly rely on surgery-and chemotherapy-based systemic;however,the prognosis remains poor for advanced disease.Recent studies have suggested that immunotherapy has significant potential in cancer therapy;thus,GC immunotherapy may improve quality of life and survival for patients with this disease.AIM To provide a comprehensive overview of the knowledge structure and research hotspots of GC immunotherapy.METHODS We conducted a bibliometric analysis of publications on immunotherapy related to GC in the Web of Science Core Collection database.We analyzed 2013 publications from 1999 to February 1,2023,using the VOSviewer and CiteSpace software.We assessed publication and citation distributions using the WoS platform and explored research countries,institutions,journals,authors,references,and keywords(co-occurrence,timeline view,and burst analysis).In addition,we examined 228 trials on immunotherapy,137 on adoptive cell therapy,274 on immune checkpoint inhibitors(ICIs),and 23 on vaccines from ClinicalTrials.gov and the International Clinical Trials Registry Platform.The Impact Index Per Article for the top ten high-cited papers collected from Reference Citation Analysis(RCA)are presented.RESULTS Our bibliometric analysis revealed that the study of immunotherapy in GC has developed rapidly in recent years.China accounted for almost half the publications,followed by the United States.The number of publications in recent years has been growing continuously,and most institutions and authors with the most publications are from China.The main keywords or clusters identified were“tumor microenvironment”,“adoptive immunotherapy”,“dendritic therapy”,and“microsatellite instability”.CONCLUSION Our analysis of 2013 publications indicated that immunotherapy for GC has led to several new developments in recent years.Considerable progress has been made in vaccinations,immune checkpoint therapy,and adoptive cellular therapy.In particular,ICIs and chimeric antigen receptor T-cells are novel options for the treatment of GC.We suggest that the combination of ICIs,chemotherapy,targeted therapy,and other immunotherapies should be the primary research direction in the future. 展开更多
关键词 IMMUNOTHERAPY Gastric cancer clinical trials Scientometric analysis Visualization
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Injectable collagen scaffold with human umbilical cordderived mesenchymal stem cells promotes functional recovery in patients with spontaneous intracerebral hemorrhage:phase Ⅰ clinical trial
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作者 Xiao-Yin Li Wu-Sheng Deng +6 位作者 Zi-Qi Wang Zheng-Chao Li Shu-Lian Chen Zhen Song Quan Zhang Jin Liang Xu-Yi Chen 《Neural Regeneration Research》 SCIE CAS CSCD 2023年第9期1999-2004,共6页
Animal expe riments have shown that injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can promote recovery from spinal cord injury.To investigate whether injectable collagen scaffol... Animal expe riments have shown that injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can promote recovery from spinal cord injury.To investigate whether injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can be used to treat spontaneous intracerebral hemorrhage,this non-randomized phase I clinical trial recruited patients who met the inclusion criteria and did not meet the exclusion crite ria of spontaneous intracerebral hemorrhage treated in the Characteristic Medical Center of Chinese People’s Armed Police Force from May 2016 to December 2020.Patients were divided into three groups according to the clinical situation and patient benefit:control(n=18),human umbilical cord-derived mesenchymal stem cells(n=4),and combination(n=8).The control group did not receive any transplantation.The human umbilical cord-derived mesenchymal stem cells group received human umbilical cord-derived mesenchymal stem cell transplantation.The combination group received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells.Patients who received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells had more remarkable improvements in activities of daily living and cognitive function and smaller foci of intra cerebral hemorrhage-related encephalomalacia.Severe adve rse events associated with cell transplantation were not observed.Injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells appears to have great potential treating spontaneous intracerebral hemorrhage. 展开更多
关键词 clinical trial collagen scaffold efficacy human umbilical cord-derived mesenchymal stem cells human SAFE neurological recovery spontaneous intracerebral hemorrhage TRANSPLANTATION
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Probiotics supplementation for management of type Ⅱ diabetes risk factors in adults with polycystic ovarian syndrome: a meta-analysis of randomized clinical trial
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作者 Chengcheng Zhang Yingyue Sheng +7 位作者 Jinchi Jiang Yuzheng Xue Leilei Yu Fengwei Tian Jianxin Zhao Hao Zhang Jian Jin Qixiao Zhai 《Food Science and Human Wellness》 SCIE CSCD 2023年第4期1053-1063,共11页
This meta-analysis of randomized controlled trials aimed to evaluate the effects of probiotic supplementation on glucose homeostasis in patients with polycystic ovary syndrome(PCOS).The meta-analysis was performed in ... This meta-analysis of randomized controlled trials aimed to evaluate the effects of probiotic supplementation on glucose homeostasis in patients with polycystic ovary syndrome(PCOS).The meta-analysis was performed in accordance with the Cochrane Handbook guidelines and relevant the preferred reporting items for systematic reviews and meta-analyses(PRISMA)statement criteria.Of 825 identified reports,11 randomized clinical trials were included in the meta-analysis.An analysis of pooled extracted data revealed that supplementation with probiotics significantly decreased fasting blood glucose(FBG,n=7;standardized mean difference(SMD)=−0.40;95%confidence interval(CI):−2.02,−0.02;P=0.04)and insulin levels(n=6;SMD=−0.57;95%CI:−0.89,−0.25;P=0.0004)and the homeostatic model assessment of insulin resistance(n=7;SMD=−0.64;95%CI:−0.96,−0.31;P=0.0001)while increasing the quantitative insulin sensitivity check index(QUICKI,n=5;SMD=0.58;95%CI:0.08,1.09;P=0.02)in patients with PCOS.The FBG-reducing effect decreased as the baseline body mass index(BMI)and mean age of the participants increased.Indeed,a greater number of bacterial species and a higher bacterial dose were shown to reduce QUICKI effectively.The systematic review indicated that probiotic supplementation may help to control glucose homeostasis in adults with polycystic ovarian syndrome. 展开更多
关键词 Polycystic ovary syndrome Type 2 diabetes Glucose homeostasis Probiotic META-ANALYSIS Randomized clinical trial
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A randomized clinical trial assessing the efficacy of single and multiple intralesional collagenase injections for treating contracted scars
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作者 Shuangbai Zhou Poh-Ching Tan +4 位作者 Cheng-An Chiang Yun Xie Peiqi Zhang Qingfeng Li Kai Liu 《Chinese Journal Of Plastic and Reconstructive Surgery》 2023年第3期120-125,共6页
Background:Scar contractions caused by trauma or burns can cause secondary physical dysfunction and disfigurement.Many minimally invasive methods for scar contraction have shown limited applicability and efficacy.This... Background:Scar contractions caused by trauma or burns can cause secondary physical dysfunction and disfigurement.Many minimally invasive methods for scar contraction have shown limited applicability and efficacy.This study investigated the feasibility and efficacy of intralesional collagenase injections for scar contraction treatment.Methods:Patients with contracted scars who had limited joint movement and physical disfiguration for>1 year were enrolled in this single-blind,randomized clinical trial from July 2017 to February 2018 at Shanghai Ninth People’s Hospital.Collagenase was injected into the firm-contracted scar(15 U/cm^(2))three times at 4-week intervals in the multiple treatment group and once in the single treatment group,and a placebo injection was performed in the control group.Scar length and skin texture were documented at the 4-and 12-week follow-ups.The safety of the collagenase treatment was also evaluated.Results:The contracted scar was significantly elongated after both single and multiple collagenase treatments.The results showed that,compared to a one-time treatment,repeated injections were more effective at 12 weeks,with an average improvement of 26.83(15.79%).At 12 weeks,78.9% of the patients in the multiple group and 52.9%in the single group achieved significant improvement at 12 weeks.No severe adverse events were observed.Conclusion:Intralesional collagenase injection showed promising results in improving scar contraction and provides an alternative treatment for patients. 展开更多
关键词 Contracted scar COLLAGENASE Intralesional injection Functional improvement clinical trial
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The Status Quo and Enlightenment of the Foreign Extended Clinical Trial System
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作者 Teng Xinyi Tian Lijuan 《Asian Journal of Social Pharmacy》 2023年第4期335-344,共10页
Objective To study the extended clinical trial systems in the United States,the European Union and Australia,and to provide a reference for the improvement of China’s extended clinical trial system.Methods Literature... Objective To study the extended clinical trial systems in the United States,the European Union and Australia,and to provide a reference for the improvement of China’s extended clinical trial system.Methods Literature research method,risk management analysis method and comparative research were used in this paper to analyze the development history,scope of use,status quo of the extended clinical trial systems in the United States,the European Union,and Australia.Then,the current situation and shortcomings of China’s extended clinical trial system were compare with these foreign countries so as to put forward some suggestions for improvement.Results and Conclusion China should improve existing laws and regulations by establishing a fast application procedure,increasing application channels,and providing an information disclosure platform to meet the needs of patients in extended clinical trials. 展开更多
关键词 extended clinical trial regime application process development history
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The progression of clinical trials in Indonesia:an observational study of records from clinical trial registries databases
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作者 Marlinang Diarta Siburian Sifa Marie Joelle Muchanga +2 位作者 Antonio Fredelindo Dela Resma Villanueva Rianto Setiabudy Iiyama Tatsuo 《Global Health Journal》 2020年第3期87-95,共9页
Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,... Objective:This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods:Study records that were registered up to December 26,2018,were extracted from three clinical trial registries(ClinicalTrials.gov,ISRCTN registry,and EudraCT)and a clinical trial register(WHO International Clinical Trials Registry Platform(ICTRP))with the keyword“Indonesia”.A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed.Results:The top five noncommunicable diseases(NCDs)studied were cancers,diabetes,cardiac diseases,hypertension,and gastrointestinal diseases,while the top five infectious diseases(IDs)were malaria,tuberculosis,vaccines for IDs,HIV,and dengue.Remarkably,the proportion of regional studies(within Indonesia only)was higher than that of multiregional studies(including areas outside of Indonesia)in general.This trend became most apparent after the issuance of national regulations on Material Transfer Agreements(MTA)and other rules.Upon closer scrutiny,regional clinical trials and multiregional clinical trials(MRCTs)in Indonesia differed in terms of sponsorship,target population and size,interventions,and study phases.Conclusions:The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country.Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs.Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials,to better address the national health issues,and to cope with the regulations. 展开更多
关键词 Indonesia clinical trials Multiregional clinical trials clinical trial registries Material Transfer Agreement
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International Comparison of Data from International Clinical Trials Registry Platform-Registered Clinical Trials
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作者 Hitoshi Fujii Keiko Yukawa Hajime Sato 《Health》 CAS 2016年第15期1759-1765,共7页
Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registr... Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registry, and try to find and evaluate the factors determining that percentage. Design and Methods: The present study is a cross-sectional study using data from clinical trials registered from January 1, 2011, to December 31, 2015. Only countries with more than 2000 registered trials were included for further study. Ten countries met that criterion: United States, Japan, Iran, Australia, New Zealand, China, India, Germany, United Kingdom, and Netherland. The percentage of clinical trials that were registered in each country’s registry was calculated, and the factors determining that percentage were sought and analyzed through an exploratory approach. Results: The chi-squared test of independence indicated that the rate of clinical trial registration significantly differed between countries. From the adjusted standardized residuals, the percentage of clinical trials that were registered in the country of origin was higher in the United States, India, Japan, and Australia/New Zealand than in the European Union and China. Conclusion: The United States requires that informed consent documents for clinical trials contain clinical trial registration numbers from ClinicalTrials.gov, which could be the reason for the extremely high percentage of registered clinical trials (94%). Since the European Union does not have this requirement, clinical trials conducted in the European Union do not have to be registered in the countries in which they are conducted. 展开更多
关键词 clinical trial Registration International clinical trials Registry Platform
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Progress in clinical trials of cell transplantation for the treatment of spinal cord injury:how many questions remain unanswered? 被引量:18
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作者 Xu-Chang Hu Yu-Bao Lu +4 位作者 Yong-Na Yang Xue-Wen Kang Yong-Gang Wang Bing Ma Shuai Xing 《Neural Regeneration Research》 SCIE CAS CSCD 2021年第3期405-413,共9页
Spinal cord injury can lead to severe motor,sensory and autonomic nervous dysfunctions.However,there is currently no effective treatment for spinal cord injury.Neural stem cells and progenitor cells,bone marrow mesenc... Spinal cord injury can lead to severe motor,sensory and autonomic nervous dysfunctions.However,there is currently no effective treatment for spinal cord injury.Neural stem cells and progenitor cells,bone marrow mesenchymal stem cells,olfactory ensheathing cells,umbilical cord blood stem cells,adipose stem cells,hematopoietic stem cells,oligodendrocyte precursor cells,macrophages and Schwann cells have been studied as potential treatments for spinal cord injury.These treatments were mainly performed in animals.However,subtle changes in sensory function,nerve root movement and pain cannot be fully investigated with animal studies.Although these cell types have shown excellent safety and effectiveness in various animal models,sufficient evidence of efficacy for clinical translation is still lacking.Cell transplantation should be combined with tissue engineering scaffolds,local drug delivery systems,postoperative adjuvant therapy and physical rehabilitation training as part of a comprehensive treatment plan to provide the possibility for patients with SCI to return to normal life.This review summarizes and analyzes the clinical trials of cell transplantation therapy in spinal cord injury,with the aim of providing a rational foundation for the development of clinical treatments for spinal cord injury. 展开更多
关键词 central nervous system clinical trials injury PLASTICITY protection regeneration repair spinal cord stem cells
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Progress in clinical trials of stem cell therapy for cerebral palsy 被引量:4
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作者 Zhong-Yue Lv Ying Li Jing Liu 《Neural Regeneration Research》 SCIE CAS CSCD 2021年第7期1377-1382,共6页
Cerebral palsy is the most common disease in children associated with lifelong disability in many countries.Clinical research has demonstrated that traditional physiotherapy and rehabilitation therapies cannot alone c... Cerebral palsy is the most common disease in children associated with lifelong disability in many countries.Clinical research has demonstrated that traditional physiotherapy and rehabilitation therapies cannot alone cure cerebral palsy.Stem cell transplantation is an emerging therapy that has been applied in clinical trials for a variety of neurological diseases because of the regenerative and unlimited proliferative capacity of stem cells.In this review, we summarize the design schemes and results of these clinical trials.Our findings reveal great differences in population characteristics, stem cell types and doses, administration methods, and evaluation methods among the included clinical trials.Furthermore, we also assess the safety and efficacy of these clinical trials.We anticipate that our findings will advance the rational development of clinical trials of stem cell therapy for cerebral palsy and contribute to the clinical application of stem cells. 展开更多
关键词 adverse events brain cell transplantation central nervous system cerebral palsy clinical trials PLASTICITY REGENERATION stem cell
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Transcranial direct current stimulation for auditory verbal hallucinations:a systematic review of clinical trials 被引量:4
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作者 Samaneh Rashidi Myles Jones +3 位作者 Eric Murillo-Rodriguez Sergio Machado Youguo Hao Ali Yadollahpour 《Neural Regeneration Research》 SCIE CAS CSCD 2021年第4期666-671,共6页
Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallu... Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallucination(AVH).This study aims to review the effects of tDCS on AVH in patients with schizophrenia through combining the evidence from randomized clinical trials(RCTs).The databases of PsycINFO(2000–2019),PubMed(2000–2019),EMBASE(2000–2019),CINAHL(2000–2019),Web of Science(2000–2019),and Scopus(2000–2019)were systematically searched.The clinical trials with RCT design were selected for final analysis.A total of nine RCTs were eligible and included in the review.Nine RCTs were included in the final analysis.Among them,six RCTs reported a significant reduction of AVH after repeated sessions of tDCS,whereas three RCTs did not show any advantage of active tDCS over sham tDCS.The current studies showed an overall decrease of approximately 28%of AVH after active tDCS and 10%after sham tDCS.The tDCS protocols targeting the sensorimotor frontal-parietal network showed greater treatment effects compared with the protocols targeting other regions.In this regard,cathodal tDCS over the left temporoparietal area showed inhibitory effects on AVHs.The most effective tDCS protocol on AVHs was twice-daily sessions(2 mA,20-minute duration)over 5 consecutive days(10 sessions)with the anode over the left dorsolateral prefrontal cortex and the cathode over the left temporal area.Some patient-specific and diseasespecific factors such as young age,nonsmoking status,and higher frequencies of AVHs seemed to be the predictors of treatment response.Taken together,the results of tDCS as an alternative treatment option for AVH show controversy among current literatures,since not all studies were positive.However,the studies targeting the same site of the brain showed that the tDCS could be a promising treatment option to reduce AVH.Further RCTs,with larger sample sizes,should be conducted to reach a conclusion on the efficacy of tDCS for AVH and to develop an effective therapeutic protocol for clinical setting. 展开更多
关键词 auditory verbal hallucinations dorsolateral prefrontal cortex effective protocol randomized clinical trial schizophrenia temporoparietal area transcranial direct current stimulation treatment efficacy
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Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets(Quiklean®)with a polyethylene glycol/bisacodyl kit 被引量:4
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作者 Shih-Ya Hung Hung-Chang Chen +10 位作者 Tao-Wei Ke Jiann-Hwa Chen Koung-Hung Hsiao Hwei-Ming Wang Hua-Che Chiang Sheng-Chi Chang Yi-Chang Chen Ming-Hao Hsieh Yuan-Yao Tsai Yo-Wen Hsieh William Tzu-Liang Chen 《World Journal of Gastroenterology》 SCIE CAS 2021年第5期428-441,共14页
BACKGROUND Efficient bowel cleansing is essential for a successful colonoscopy,but the ideal cleansing agent,volume,and pharmaceutical dosage form have yet to be determined.Small-volume cleansers enhance patient compl... BACKGROUND Efficient bowel cleansing is essential for a successful colonoscopy,but the ideal cleansing agent,volume,and pharmaceutical dosage form have yet to be determined.Small-volume cleansers enhance patient compliance.AIM To compare the bowel cleansing efficacy of 32-tablet sodium phosphate(Quiklean®)with 2-L polyethylene glycol(PEG)/bisacodyl(Klean-Prep/Dulcolax®)under identical dietary recommendations.METHODS This multicenter,randomized,parallel-group,noninferiority clinical trial enrolled 472 outpatients,randomized 456 subjects,and scheduled 442 subjects to undergo colonoscopy(Quiklean®=222 and Klean-Prep/Dulcolax®=220).After bowel preparation,a colonoscopist performed the colonoscopy with video recorded for rating.The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale.The secondary endpoints were the bowel cleansing efficacy of three colon segments,tolerability and acceptability,safety using the Ottawa bowel preparation scale,questionnaires by subjects,and monitoring of adverse events.RESULTS Success rates(Excellent+Good)of the bowel cleansing quality by Aronchick Scale were 98.6%(n=205)and 97.6%(n=204)in the Quiklean®and Klean-Prep/Dulcolax®groups,respectively.Quiklean®demonstrated noninferiority over Klean-Prep/Dulcolax®in colon cleansing efficacy.Quicken showed better tolerability and acceptability in the overall experience(was rated as excellent;24.0%vs 17.2%;P=0.0016)and the taste of the study preparation(was rated as excellent,23.1%vs 13.4%;P<0.0001)than Klean-Prep/Dulcolax®.Safety profiles did not differ between the two groups.Our data indicate that Quiklean®is an adequate,well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax®.CONCLUSION Quiklean®is sodium phosphate tablets available on Taiwan’s market for bowel preparation;it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may,therefore,increase positive attitudes toward colonoscopies and participation rates. 展开更多
关键词 Bowel preparation clinical trial COLONOSCOPY Polyethylene glycol Sodium phosphate
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Safety and efficacy of a nerve matrix membrane as a collagen nerve wrapping: a randomized, single-blind, multicenter clinical trial 被引量:3
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作者 Yong-Bin Gao Zhi-Gang Liu +8 位作者 Guo-Dong Lin Yang Guo Lei Chen Bo-Tao Huang Yao-Bin Yin Chen Yang Li-Ying Sun Yan-Bo Rong Shanlin Chen 《Neural Regeneration Research》 SCIE CAS CSCD 2021年第8期1652-1659,共8页
A new nerve matrix membrane derived from decellularized porcine nerves has been shown to retain the major extracellular matrix components, and to be effective in preventing adhesion between the nerve anastomosis sites... A new nerve matrix membrane derived from decellularized porcine nerves has been shown to retain the major extracellular matrix components, and to be effective in preventing adhesion between the nerve anastomosis sites and the surrounding tissues in a rat sciatic nerve transection model, thereby enhancing regeneration of the nerve. The effectiveness of the membrane may be attributed to its various bioactive components. In this prospective, randomized, single-blind, parallel-controlled multicenter clinical trial, we compared the safety and efficacy of the new nerve matrix membrane with a previously approved bovine tendon-derived type I collagen nerve wrapping. A total of 120 patients with peripheral nerve injury were recruited from Beijing Jishuitan Hospital, The First Bethune Hospital of Jilin University, and Yantai Yuhuangding Hospital, China. The patients were randomly assigned to undergo end-to-end and tension-free neurorrhaphy with nerve matrix membrane(n = 60, 52 male, 8 female, mean age 41.34 years, experimental group) or tendon-derived collagen nerve wrapping(n = 60, 42 male, 18 female, mean age 40.17 years, control group). Patients were followed-up at 14 ± 5, 30 ± 7, 90 ± 10 and 180 ± 20 days after the operation. Safety evaluation included analyses of local and systemic reactions, related laboratory tests, and adverse reactions. Efficacy evaluation included a static 2-point discrimination test, a moving 2-point discrimination test, and a Semmes–Weinstein monofilament examination. Sensory nerve function was evaluated with the British Medical Research Council Scale and Semmes–Weinstein monofilament examination. The ratio(percentage) of patients with excellent to good results in sensory nerve recovery 180 ± 20 days after the treatment was used as the primary effectiveness index. The percentages of patients with excellent to good results in the experimental and control groups were 98.00% and 94.44%, respectively, with no significant difference between the two groups. There were no significant differences in the results of routine blood tests, liver and renal function tests, coagulation function tests, or immunoglobulin tests at 14 and 180 days postoperatively between the two groups. These findings suggest that the novel nerve matrix membrane is similar in efficacy to the commercially-available bovine-derived collagen membrane in the repair of peripheral nerve injury, and it may therefore serve as an alternative in the clinical setting. The clinical trial was approved by the Institutional Ethics Committee of Beijing Jishuitan Hospital, China(approval No. 20160902) on October 8, 2016, the Institutional Ethics Committee of the First Bethune Hospital of Jilin University, China(approval No. 160518-088) on December 14, 2016, and the Institutional Ethics Committee of Yantai Yuhuangding Hospital, China(approval No. 2016-10-01) on December 9, 2016. The clinical trial was registered with the Chinese Clinical Trial Registry(registration number: Chi CTR2000033324) on May 28, 2020. 展开更多
关键词 clinical trial extracellular matrix nerve conduit nerve matrix nerve repair neural regeneration NEURORRHAPHY peripheral nerve injury sensory nerve recovery
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