The Sun et al's training program for clinical research nurses(CRNs)in the World Journal of Clinical Cases is a comprehensive and scientific approach.It includes structured frameworks for CRN training,aiming to imp...The Sun et al's training program for clinical research nurses(CRNs)in the World Journal of Clinical Cases is a comprehensive and scientific approach.It includes structured frameworks for CRN training,aiming to improve CRN competency.This program emphasizes practical abilities,updates training content,and improves evaluation methods.The cultivation of CRN talents focuses on enhancing the training system,establishing a multifaceted evaluation framework,and continuously refining the training programs.Regular feedback and evalua-tion are essential to improve CRNs'competency in practical settings.展开更多
Introduction: Near-infrared fluorescence imaging is a technique that will establish itself in the short term at the international level because it is recognized for its potential to improve the performance of surgical...Introduction: Near-infrared fluorescence imaging is a technique that will establish itself in the short term at the international level because it is recognized for its potential to improve the performance of surgical interventions, its moderate investment and operating costs and its portability. Although the technology is now mature, there is currently the problem of the availability of contrast agents to be injected IV. The aim of this methodology article is to propose an alternative solution to the need for contrast agents for clinical research, particularly in oncology. Methodology: They consist of coupling a fluorescent marker in the form of an NHS derivative, such as IR DYE manufactured in compliance with GMP, with therapeutic monoclonal antibodies having marketing authorization for molecular imaging. For a given antibody, the marking procedure must be the subject of a validation file on the final preparation filtered on a sterilizing membrane at 0.22 μm. Once the procedure has been validated, it would be unnecessary to repeat the tests before each clinical research examination. A check of the marking by thin-layer chromatography (TLC) and place it in a sample bank at +4˚C for 1 month of each injected formulation would be sufficient for additional tests if necessary. Conclusion: Molecular near-infrared fluorescence imaging is experiencing development, the process of which could be accelerated by greater availability of clinical contrast agents. Alternative solutions are therefore necessary to promote clinical research in this area. These methods must be shared to make it easier for researchers.展开更多
With the upsurge of artificial intelligence(AI)technology in the medical field,its application in ophthalmology has become a cutting-edge research field.Notably,machine learning techniques have shown remarkable achiev...With the upsurge of artificial intelligence(AI)technology in the medical field,its application in ophthalmology has become a cutting-edge research field.Notably,machine learning techniques have shown remarkable achievements in diagnosing,intervening,and predicting ophthalmic diseases.To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI,the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification.The main content includes the background and method of developing this guideline,an introduction to international guidelines on the clinical research evaluation of AI,and the evaluation methods of clinical ophthalmic AI models.This guideline introduces general evaluation methods of clinical ophthalmic AI research,evaluation methods of clinical ophthalmic AI models,and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail,and amply elaborates the evaluation methods of clinical ophthalmic AI trials.This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI,promote the development of regularization and standardization,and further improve the overall level of clinical ophthalmic AI research evaluations.展开更多
Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Su...Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.展开更多
Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and littl...Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.展开更多
Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strateg...Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.展开更多
AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS: We analyzed Russian legislation and ethical regulations about drug and devices ap...AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS: We analyzed Russian legislation and ethical regulations about drug and devices approval,clinical research registration and the results availability.In August 2012,we searched International Clinical Trials Registry Platform and clinicaltrials.gov to find all registered studies that had an investigational site in the territory of the Russian Federation.To find publication status,we searched the Pub Med and Scirus bibliographical databases with trial registration number to find journal publications of the registered studies.RESULTS: We identified 2062 registered research protocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies.The number of the studies enrolling Russian subjects increased dramatically from three studies in 2002 to 252 studies in 2012.Most studies(92%) were funded exclusively by industry,were interventions(94.6%),examined drugs(87%) and enrolled exclusively adults(86%) of both genders(89%).Only 383(19%) of multinational studies and two(4.4%) of exclusively Russian studies werepublished.Posting of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study funded exclusively by Russian sponsors.Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts.Federal laws require clinical study registration and conflict of interest disclosure.However,routine monitoring of compliance to clinical research policy is not available.CONCLUSION: Russian legislation does not guarantee the availability of clinical research results.Russian legislation should mandate transparent evidence- based market approval of the drugs and devices.展开更多
Integration of the cancer registry and clinical research departments can have a significant impact on the accreditation process of a Commission on Cancer(Co C) Program.Here in we demonstrate that the integration of bo...Integration of the cancer registry and clinical research departments can have a significant impact on the accreditation process of a Commission on Cancer(Co C) Program.Here in we demonstrate that the integration of both departments will benefit as there is increased knowledge, manpower and crossover in job responsibilities in our Co C-accredited Academic Comprehensive Cancer Center.In our model this integration has led to a more successful cooperative interaction among departments, which has in turn created an enhanced combined effect on overall output and productivity.More manpower for the cancer registry has led to increased caseloads, decreased time from date of first contact to abstraction, quality of data submissions, and timely follow-up of all patients from our reference date for accurate survival analysis along with completeness of data.In 2016, our Annual Facility report showed an additional 163 cases over prediction by the state of Maryland Cancer Registry and a 39% increase in case completeness.As proof of the synergetic effectiveness of our model within one year of its implementation, the cancer center was able to apply for, and was awarded membership from Alliance for Clinical Trials in Oncology, Central IRB, and in turn led to increased clinical trial accrual from 2.8% in 2014 compared to 13.2% currently.Our cancer registry in year one submitted over 150 more cases than predicted, improved quality outcome measures displayed by our Cancer Program Practice Profile reports and had more timely and complete data submissions to national and state registries.This synergetic integration has led to a better understanding, utilization and analysis of data by an integrated team with Clinical Research expertise.展开更多
Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billio...Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billion. Around 75% of the cost is spent on the Phase I-IV clinical research process. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). In the research, the estimated cost of drugs used in the clinical trials for the Turkish reimbursement agency (SGK) was calculated to show the cost of medicines acquired through clinical research. Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. Conclusion: Despite the limitations of the study, the findings are unique for Turkey. The results can lead to revisiting the importance and economic value of clinical trials in Turkey.展开更多
Traumatic brain injury is a brain injury caused by biomechanics effects on brain tissue,In addition to primary brain injury,secondary brain injury caused by local brain injury,edema and high intracranial pressure on s...Traumatic brain injury is a brain injury caused by biomechanics effects on brain tissue,In addition to primary brain injury,secondary brain injury caused by local brain injury,edema and high intracranial pressure on surrounding brain tissue further aggravates the disease.The improvement of modern medical equipment and medical technology can provide early intervention treatment for patients.However,due to the particularity of the disease and the complexity of pathological and physiological reactions,irreversible damage often occurs in the central nervous system,with high disability rate and mortality.In recent years,it has been found that the related biological markers in the process of TBI are related to brain tissue injury and neurological function,and have important clinical application value in judging the severity of brain injury and prognosis evaluation,which has been widely studied.This paper intends to summarize the clinical research progress of TBI-related prognostic markers.展开更多
Gastric dyskinesis functional dyspepsia is a commonly clinical condition characterized as epigastric discomfort,distension after meals,early satiety and belching,which are commonly associated with the dysfunction of g...Gastric dyskinesis functional dyspepsia is a commonly clinical condition characterized as epigastric discomfort,distension after meals,early satiety and belching,which are commonly associated with the dysfunction of gastrointestinal motility.展开更多
Neuroimaging is a booming research area at the moment,from micro to macro,from physics to technology,from basic research to clinical application.Advanced neuroimaging technology allows the structure or function of a n...Neuroimaging is a booming research area at the moment,from micro to macro,from physics to technology,from basic research to clinical application.Advanced neuroimaging technology allows the structure or function of a neurological examination to be a visible presentation,in which a neurological disorder can be deeply investigated.The goal of this special section展开更多
Objective To systematically review the published clinical and economic research on liposomal irinotecan in combination with 5-FU/LV for metastatic pancreatic ductal adenocarcinoma(mPDAC)at home and abroad.Methods PubM...Objective To systematically review the published clinical and economic research on liposomal irinotecan in combination with 5-FU/LV for metastatic pancreatic ductal adenocarcinoma(mPDAC)at home and abroad.Methods PubMed,Cochrane Library,Embase,CBM,CNKI,Wan Fang data,CRD database and health technology assessment official websites were searched to collect clinical and economic studies on liposomal irinotecan for mPDAC.Results and Conclusion Nine clinical studies and four economic studies were included.The result of clinical studies showed that liposomal irinotecan in combination with 5-FU/LV could extend survival with good drug compliance in patients with mPDAC who progressed on prior gemcitabine-based therapy.This agent represented a new treatment option for second-line chemotherapy in these patients.The results of the economic evaluations failed to reach a consistent conclusion due to different economic levels in various countries.展开更多
Objective:To contribute to the development of clinical research on novel coronavirus by analyzing the clinical research data of COVID-19.Methods:Searches were performed on the database of“National Health Insurance In...Objective:To contribute to the development of clinical research on novel coronavirus by analyzing the clinical research data of COVID-19.Methods:Searches were performed on the database of“National Health Insurance Information Platform Medical Research Registration Information System”using the keywords“COVID-19”and“Novel coronavirus.”The search was performed till 31 December 2022.This paper presents a statistical analysis of the status quo of the registered projects in terms of the number of registered projects,the types of projects,the levels of the institutions,the types of research,the intervention measures,the research design,the main objectives of the research,and so on.Results:A total of 823 investigator-initiated clinical studies of COVID-19 were documented,and the number of studies registered peaked on December 31,2020,and December 31,2022.Among them,there were 819 items from general medical research(99.5%),812 items from medical institutions(98.7%),and 713 items from Medical Grade III,and Class A hospitals(86.6%).Among these items,534(64.9%)were observational studies.The most common intervention method used was administering existing drugs,with 140 studies utilizing them.This data analysis also included 128 case-control studies and 247 treatment-oriented studies.Conclusion:Researchers in local medical institutions have been actively carrying out clinical research related to COVID-19.However,they should refer to registered research to avoid duplicate research.展开更多
Zhuang medicine medicated thread moxibustion is a kind of external therapy with ethnic medicine characteristics that spreads in Guangxi Zhuang region.It has a wide range of clinical application and significant curativ...Zhuang medicine medicated thread moxibustion is a kind of external therapy with ethnic medicine characteristics that spreads in Guangxi Zhuang region.It has a wide range of clinical application and significant curative effect,and can be used to treat diseases such as internal medicine,surgery,dermatology,gynecology,pediatrics,and five sense organs.Through reviewing and combing the literature on the Zhuang medicine medicated thread moxibustion in recent years,this paper summarizes and prospects its clinical application,with a view to further explaining the basic principles and application rules of Zhuang medicine medicated thread moxibustion and digging its clinical value.展开更多
Obesity is recognized as the second highest risk factor for cancer. The pathogenic mechanisms underlying tobaccorelated cancers are well characterized and efective programs have led to a decline in smoking and related...Obesity is recognized as the second highest risk factor for cancer. The pathogenic mechanisms underlying tobaccorelated cancers are well characterized and efective programs have led to a decline in smoking and related cancers, but there is a global epidemic of obesity without a clear understanding of how obesity causes cancer. Obesity is heterogeneous, and approximately 25% of obese individuals remain healthy(metabolically healthy obese, MHO), so which fat deposition(subcutaneous versus visceral, adipose versus ectopic) is "malignant"? What is the mechanism of carcinogenesis? Is it by metabolic dysregulation or chronic inflammation? Through which chemokines/genes/signaling pathways does adipose tissue influence carcinogenesis? Can selective inhibition of these pathways uncouple obesity from cancers? Do all obesity related cancers(ORCs) share a molecular signature? Are there common(overlapping) genetic loci that make individuals susceptible to obesity, metabolic syndrome, and cancers? Can we identify precursor lesions of ORCs and will early intervention of high risk individuals alter the natural history? It appears unlikely that the obesity epidemic will be controlled anytime soon; answers to these questions will help to reduce the adverse efect of obesity on human condition.展开更多
1.Introduction Eating disorders(ED)are the most common psychiatric disorders afflicting young women^1 and contribute to great detriments in psychological,social,and physical health.^(2,3)Unfortunately,ED treatments te...1.Introduction Eating disorders(ED)are the most common psychiatric disorders afflicting young women^1 and contribute to great detriments in psychological,social,and physical health.^(2,3)Unfortunately,ED treatments tend to be long lasting,intensive,and expensive.~4Additionally,individuals with ED seeking treatment use healthcare services more frequently than non-ED individu-展开更多
文摘The Sun et al's training program for clinical research nurses(CRNs)in the World Journal of Clinical Cases is a comprehensive and scientific approach.It includes structured frameworks for CRN training,aiming to improve CRN competency.This program emphasizes practical abilities,updates training content,and improves evaluation methods.The cultivation of CRN talents focuses on enhancing the training system,establishing a multifaceted evaluation framework,and continuously refining the training programs.Regular feedback and evalua-tion are essential to improve CRNs'competency in practical settings.
文摘Introduction: Near-infrared fluorescence imaging is a technique that will establish itself in the short term at the international level because it is recognized for its potential to improve the performance of surgical interventions, its moderate investment and operating costs and its portability. Although the technology is now mature, there is currently the problem of the availability of contrast agents to be injected IV. The aim of this methodology article is to propose an alternative solution to the need for contrast agents for clinical research, particularly in oncology. Methodology: They consist of coupling a fluorescent marker in the form of an NHS derivative, such as IR DYE manufactured in compliance with GMP, with therapeutic monoclonal antibodies having marketing authorization for molecular imaging. For a given antibody, the marking procedure must be the subject of a validation file on the final preparation filtered on a sterilizing membrane at 0.22 μm. Once the procedure has been validated, it would be unnecessary to repeat the tests before each clinical research examination. A check of the marking by thin-layer chromatography (TLC) and place it in a sample bank at +4˚C for 1 month of each injected formulation would be sufficient for additional tests if necessary. Conclusion: Molecular near-infrared fluorescence imaging is experiencing development, the process of which could be accelerated by greater availability of clinical contrast agents. Alternative solutions are therefore necessary to promote clinical research in this area. These methods must be shared to make it easier for researchers.
基金Supported by National Natural Science Foundation of China(No.61906066)the San Ming Project of Medicine in Shenzhen(No.SZSM202011015)Shenzhen Science and Technology Program(No.KCXFZ20211020163813019).
文摘With the upsurge of artificial intelligence(AI)technology in the medical field,its application in ophthalmology has become a cutting-edge research field.Notably,machine learning techniques have shown remarkable achievements in diagnosing,intervening,and predicting ophthalmic diseases.To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI,the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification.The main content includes the background and method of developing this guideline,an introduction to international guidelines on the clinical research evaluation of AI,and the evaluation methods of clinical ophthalmic AI models.This guideline introduces general evaluation methods of clinical ophthalmic AI research,evaluation methods of clinical ophthalmic AI models,and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail,and amply elaborates the evaluation methods of clinical ophthalmic AI trials.This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI,promote the development of regularization and standardization,and further improve the overall level of clinical ophthalmic AI research evaluations.
文摘Esophageal cancer is one of the most common malignant tumors in the world. In recent years, the incidence and mortality of esophageal cancer have increased year by year, which has seriously threatened human health. Surgery, chemotherapy and radiotherapy, as the primary treatments of Western medicine, have achieved specific results in the clinic, but each has its limitations, this is mainly related to their side effects. The diversified treatment methods of traditional Chinese medicine have visible clinical effects, especially in terms of reducing toxicity and increasing efficiency. This present review reviews the research progress of esophageal cancer in terms of traditional Chinese medicine treatment, including the application of Chinese medicine extract, Chinese herbal compound, Chinese patent medicine and TCM external treatment in clinical practice, may provide valuable information for the adjuvant treatment of esophageal cancer with traditional Chinese medicine.
基金The study was supported by the Tianjin municipal health and Health Committee and Tianjin Administration of traditional Chinese Medicine(Scientific research project of integrated traditional Chinese and Western Medicine NO.2019027).
文摘Dry eye is a common and frequently occurring ophthalmology disease with complex etiology and easy recurrence.Oral administration of traditional Chinese medicine has the characteristicsof high curative effect and little toxic and side effect in the treatment of dry eye.This paper collates the domestic reported clinical studies on the oral administration of traditional Chinese medicine in the treatment of dry eye,which are discussed from four aspects:special prescription for specific disease,addition and subtraction of main prescription,treatment based on syndrome differentiation and proprietary Chinese medicine.The curative effect and advantages of traditional Chinese medicine in the treatment of dry eye are demonstrated,providing a reference for the treatment of dry eye in the future.
基金financially supported by the National Natural Science Foundation of China(81874356)the Open Project of Hubei Key Laboratory of Wudang Local Chinese Medicine Research from Hubei University of Medicine(WDCM2018002,WDCM201917,WDCM201918)+1 种基金the Chinese Medicine Project of Health Commission of Hubei Province(ZY2021010)the Foundation for Innovative Research Team of Hubei University of Medicine(2018YHKT01)。
文摘Primary liver cancer(PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines(TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure(CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups(i.e. treatment with Western medicines alone)(65.11% vs.44.31%, P <.05). Among the 33 selected articles, 11 were investigated for TCM preparation(marketed drugs) and 22 for TCM formulas. In total, 102 types of TCM(single herbs) were used to treat PLC. The top five most frequently used TCM were Poria(14.71%), Astragali radix(13.73%), Atractylodis Macrocephalae Rhizoma(12.75%), Bupleuri radix(12.75%), and Glycyrrhizae radix et Rhizoma(11.76%). Of the 102 types of TCM, tonics were the most frequently used categories, followed by heat-clearing medicines, blood-invigorating medicines, and stasis-resolving medicines. Of 207 papers, 174(84.06%) could not be subjected to statistical analysis due to research quality. Further high-quality research on herb sources, formula components and dosage, toxicology, and ethics of TCM is necessary. In conclusion, TCM play a promising role in the treatment and management of PLC, although further investigations are warranted.
文摘AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS: We analyzed Russian legislation and ethical regulations about drug and devices approval,clinical research registration and the results availability.In August 2012,we searched International Clinical Trials Registry Platform and clinicaltrials.gov to find all registered studies that had an investigational site in the territory of the Russian Federation.To find publication status,we searched the Pub Med and Scirus bibliographical databases with trial registration number to find journal publications of the registered studies.RESULTS: We identified 2062 registered research protocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies.The number of the studies enrolling Russian subjects increased dramatically from three studies in 2002 to 252 studies in 2012.Most studies(92%) were funded exclusively by industry,were interventions(94.6%),examined drugs(87%) and enrolled exclusively adults(86%) of both genders(89%).Only 383(19%) of multinational studies and two(4.4%) of exclusively Russian studies werepublished.Posting of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study funded exclusively by Russian sponsors.Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts.Federal laws require clinical study registration and conflict of interest disclosure.However,routine monitoring of compliance to clinical research policy is not available.CONCLUSION: Russian legislation does not guarantee the availability of clinical research results.Russian legislation should mandate transparent evidence- based market approval of the drugs and devices.
文摘Integration of the cancer registry and clinical research departments can have a significant impact on the accreditation process of a Commission on Cancer(Co C) Program.Here in we demonstrate that the integration of both departments will benefit as there is increased knowledge, manpower and crossover in job responsibilities in our Co C-accredited Academic Comprehensive Cancer Center.In our model this integration has led to a more successful cooperative interaction among departments, which has in turn created an enhanced combined effect on overall output and productivity.More manpower for the cancer registry has led to increased caseloads, decreased time from date of first contact to abstraction, quality of data submissions, and timely follow-up of all patients from our reference date for accurate survival analysis along with completeness of data.In 2016, our Annual Facility report showed an additional 163 cases over prediction by the state of Maryland Cancer Registry and a 39% increase in case completeness.As proof of the synergetic effectiveness of our model within one year of its implementation, the cancer center was able to apply for, and was awarded membership from Alliance for Clinical Trials in Oncology, Central IRB, and in turn led to increased clinical trial accrual from 2.8% in 2014 compared to 13.2% currently.Our cancer registry in year one submitted over 150 more cases than predicted, improved quality outcome measures displayed by our Cancer Program Practice Profile reports and had more timely and complete data submissions to national and state registries.This synergetic integration has led to a better understanding, utilization and analysis of data by an integrated team with Clinical Research expertise.
文摘Introduction: Clinical research is a key component of drug development with a significant economic value. It has been reported that the development of a new molecule requires 10 - 15 years and costs almost $1.3 billion. Around 75% of the cost is spent on the Phase I-IV clinical research process. This study aimed to show the economic value of clinical research in Turkey. Methods: Clinical trial budgets were estimated from the raw data of the Report of Istanbul Medical Faculty Clinical Research (ITFKAR). In the research, the estimated cost of drugs used in the clinical trials for the Turkish reimbursement agency (SGK) was calculated to show the cost of medicines acquired through clinical research. Results: The total budget for sponsored pharmaceutical research was $107 million in Turkey, and the government saved close to $311,096,130 during 2006-2010, due to not reimbursing the patients for the drugs in the clinical trials. Conclusion: Despite the limitations of the study, the findings are unique for Turkey. The results can lead to revisiting the importance and economic value of clinical trials in Turkey.
基金Hainan Health and Family Planning Industry Research Project(No.19A200017)。
文摘Traumatic brain injury is a brain injury caused by biomechanics effects on brain tissue,In addition to primary brain injury,secondary brain injury caused by local brain injury,edema and high intracranial pressure on surrounding brain tissue further aggravates the disease.The improvement of modern medical equipment and medical technology can provide early intervention treatment for patients.However,due to the particularity of the disease and the complexity of pathological and physiological reactions,irreversible damage often occurs in the central nervous system,with high disability rate and mortality.In recent years,it has been found that the related biological markers in the process of TBI are related to brain tissue injury and neurological function,and have important clinical application value in judging the severity of brain injury and prognosis evaluation,which has been widely studied.This paper intends to summarize the clinical research progress of TBI-related prognostic markers.
文摘Gastric dyskinesis functional dyspepsia is a commonly clinical condition characterized as epigastric discomfort,distension after meals,early satiety and belching,which are commonly associated with the dysfunction of gastrointestinal motility.
文摘Neuroimaging is a booming research area at the moment,from micro to macro,from physics to technology,from basic research to clinical application.Advanced neuroimaging technology allows the structure or function of a neurological examination to be a visible presentation,in which a neurological disorder can be deeply investigated.The goal of this special section
文摘Objective To systematically review the published clinical and economic research on liposomal irinotecan in combination with 5-FU/LV for metastatic pancreatic ductal adenocarcinoma(mPDAC)at home and abroad.Methods PubMed,Cochrane Library,Embase,CBM,CNKI,Wan Fang data,CRD database and health technology assessment official websites were searched to collect clinical and economic studies on liposomal irinotecan for mPDAC.Results and Conclusion Nine clinical studies and four economic studies were included.The result of clinical studies showed that liposomal irinotecan in combination with 5-FU/LV could extend survival with good drug compliance in patients with mPDAC who progressed on prior gemcitabine-based therapy.This agent represented a new treatment option for second-line chemotherapy in these patients.The results of the economic evaluations failed to reach a consistent conclusion due to different economic levels in various countries.
基金This study was supported by the Project of Xi’an Science and Technology Plan(23YXYJ0163)the Education and Teaching Reform Research Project of Xi’an Medical University in 2023(S202311840061)funds from the First Affiliated Hospital of Xi’an Medical University of China(XYYFY-2023-01).
文摘Objective:To contribute to the development of clinical research on novel coronavirus by analyzing the clinical research data of COVID-19.Methods:Searches were performed on the database of“National Health Insurance Information Platform Medical Research Registration Information System”using the keywords“COVID-19”and“Novel coronavirus.”The search was performed till 31 December 2022.This paper presents a statistical analysis of the status quo of the registered projects in terms of the number of registered projects,the types of projects,the levels of the institutions,the types of research,the intervention measures,the research design,the main objectives of the research,and so on.Results:A total of 823 investigator-initiated clinical studies of COVID-19 were documented,and the number of studies registered peaked on December 31,2020,and December 31,2022.Among them,there were 819 items from general medical research(99.5%),812 items from medical institutions(98.7%),and 713 items from Medical Grade III,and Class A hospitals(86.6%).Among these items,534(64.9%)were observational studies.The most common intervention method used was administering existing drugs,with 140 studies utilizing them.This data analysis also included 128 case-control studies and 247 treatment-oriented studies.Conclusion:Researchers in local medical institutions have been actively carrying out clinical research related to COVID-19.However,they should refer to registered research to avoid duplicate research.
基金"Zhuang medicine",a key discipline of traditional Chinese medicine in Guangxi(No.GZXK-Z-20-60),the project to improve the basic scientific research ability of young and middle-aged teachers in Guangxi universities(No.2020KY07023),and the scientific research project of Guangxi Zhuang Autonomous Region Administration of Traditional Chinese Medicine(No.GXZYZ20210456).
文摘Zhuang medicine medicated thread moxibustion is a kind of external therapy with ethnic medicine characteristics that spreads in Guangxi Zhuang region.It has a wide range of clinical application and significant curative effect,and can be used to treat diseases such as internal medicine,surgery,dermatology,gynecology,pediatrics,and five sense organs.Through reviewing and combing the literature on the Zhuang medicine medicated thread moxibustion in recent years,this paper summarizes and prospects its clinical application,with a view to further explaining the basic principles and application rules of Zhuang medicine medicated thread moxibustion and digging its clinical value.
文摘Obesity is recognized as the second highest risk factor for cancer. The pathogenic mechanisms underlying tobaccorelated cancers are well characterized and efective programs have led to a decline in smoking and related cancers, but there is a global epidemic of obesity without a clear understanding of how obesity causes cancer. Obesity is heterogeneous, and approximately 25% of obese individuals remain healthy(metabolically healthy obese, MHO), so which fat deposition(subcutaneous versus visceral, adipose versus ectopic) is "malignant"? What is the mechanism of carcinogenesis? Is it by metabolic dysregulation or chronic inflammation? Through which chemokines/genes/signaling pathways does adipose tissue influence carcinogenesis? Can selective inhibition of these pathways uncouple obesity from cancers? Do all obesity related cancers(ORCs) share a molecular signature? Are there common(overlapping) genetic loci that make individuals susceptible to obesity, metabolic syndrome, and cancers? Can we identify precursor lesions of ORCs and will early intervention of high risk individuals alter the natural history? It appears unlikely that the obesity epidemic will be controlled anytime soon; answers to these questions will help to reduce the adverse efect of obesity on human condition.
文摘1.Introduction Eating disorders(ED)are the most common psychiatric disorders afflicting young women^1 and contribute to great detriments in psychological,social,and physical health.^(2,3)Unfortunately,ED treatments tend to be long lasting,intensive,and expensive.~4Additionally,individuals with ED seeking treatment use healthcare services more frequently than non-ED individu-
