Analysis on the Registration of Clinical Trials of Headache Treated by TCM / 中国中医药信息杂志

Objective To analyze the registered clinical trials of headache treated by TCM;To discuss the current research status;To provide reference for the optimization of subsequent clinical trial research plans.Methods All clinical trials of headache treated by TCM were retrieved from the ChiCTR and the ClinicalTrials.The retrieval time was from the database establishment to May 22,2023.The general characteristics,study types,intervention measures and outcome indicators of the trials were analyzed respectively.Results A total of 104 registered studies were included,with the number of registered studies increasing since 2004 and reaching a peak in 2020,involving 25 provincial administrative regions or countries and 69 clinical trial institutions;the funding sources were mainly scientific research funds of universities,national finance and local finance.The research type was mainly intervention research;the designing scheme was mainly randomized parallel control study;the high frequency random method was simple random method;45 registered studies used blind methods.Exploratory studies/pre-trials were the most commonly used in the phases of clinical researches.Most of the registered studies were single-center clinical trials with a total sample size of 9 648 patients.The main interventions were acupuncture and oral Chinese medicines.The high frequency outcome indicators included life quality of score,headache attack frequency,headache attack days and headache severity,etc.There were some problems in outcome indicators,such as non-standard,lack of TCM characteristic advantages,and insufficient patient participation.Conclusion The number of registered studies of headache treated by TCM has increased by year,but there are some problems in design elements,such as random method,blind method,number of research centers,sample size and the setting of outcome indicator.

Non-drug rehabilitation for gait abnormality of Parkinson's disease: a review based on ClinicalTrials.gov / 中国康复理论与实践

ObjectiveTo investigate the current trend of non-drug therapy for gait abnormality of Parkinson's disease. MethodsThe clinical trials about non-drug therapy for gait abnormality of Parkinson's disease were retrieved from the clinical trial registration platform ClinicalTrials.gov, from inception to October 25th, 2022. The records were screened by two researchers independently, and the registration time, registration count, sample sizes, interventions, primary outcome measurements and study design, etc., were summarized and analyzed, according to the PICOS principle. ResultsA total of 218 eligible records were included. The registration count increased in recently years. Almost all of the trials (93.6%) were with a relatively small sample size less than 100, mainly 21 to 30 cases. The major intervention approach was the neuromodulation technique, however, virtual reality and robot-assisted gait training were coming to use in recent years. The primary outcome measurements were the clinical scales, the questionnaires and the exercise examinations. Randomized parallel controlled trials were the most (111, 50.9%). ConclusionThe number of non-drug therapy for gait abnormality of Parkinson's disease increased year by year. The new technologies such as virtual reality and robot-assisted gait training may be used more in the future.

Effect of metformin and rosiglitazone in non-obese polycystic ovary syndrome women with insulin resistance / 中华妇产科杂志

Objective:To investigate effects of metformin and rosiglitazone in non-obese polycystic ovary syndrome (PCOS) women with insulin resistance.Methods:Totally 200 non-obese PCOS women with insulin resistance in West China Second Hospital of Sichuan University were enrolled into this study from Sep. 2013 to Jun. 2016, and were randomly divided into two treatment groups: metformin group (1 500 mg/d) and rosiglitazone group (4 mg/d). The treatment lasted for 6 months. Their clinical and biochemical parameters were collected and compared.Results:In both groups, menstrual cycles [metformin group (37±4) days, rosiglitazone group (35±4) days] were shorter after treatment for 6 months (both P<0.01). After treatment for 6 months, body mass index [metformin group (21.6±1.6) kg/m 2, rosiglitazone group (21.7±1.7) kg/m 2] decreased in both groups (both P<0.01); decreased LH/FSH ratio (metformin group 1.67±0.80, rosiglitazone group 1.70±0.83) was also observed (both P<0.05). After treatment for 6 months, fasting insulin level [metformin group (13.5±5.1) mU/L, rosiglitazone group (12.7±5.6) mU/L] and homeostasis model assessment-insulin resistance index (metformin group 3.0±1.2, rosiglitazone group 2.8±1.2) were decreased in both groups (all P<0.01). Conclusions:For non-obese PCOS insulin resistance patients, screening of anthropometric and metabolic parameters is necessary. For PCOS with insulin resistance, lifestyle plus insulin sensitizers such as metformin could improve their clinical symptoms, correct the biochemical and metabolic dysfunction.

Re-investigation after 8 years on the publication of Chinese clinical trials after registration / 中华医学科研管理杂志

Objective To investigate the publication status and quality in registration centers and journals of Chinese clinical trials after registration.Methods The Chinese clinical trials registered on the US Clinical Trial Registration website (www.clinicaltrials.gov) before July 24,2009 were searched.China Knowledge Network (CNKI),Wanfang Database,VIP Database,PubMed,and EMbase Database were searched by computer from inception to December 31,2017,to investigate the outcome publication of these clinical trials in the registration center and journals.Results A total number of 654 clinical trials were included in this study.Only 25 clinical trials,accounted for 3.8％,published trial outcome on the US Clinical Trials Register,74 clinical trials,accounted for 11.3％,were published in the journals (effective literature).Most of the trials took 2 to 3 and in both from registration to completion and study closure to outcome publication.Conclusions The proportion and quali ty of clinical trial outcome publication in China were low,which alerting us that researcher should pay more attention to the trial outcome publication.

Clinical Trials Registry in the Field of Rehabilitation Medicine / The Japanese Journal of Rehabilitation Medicine

Objective：To investigate the characteristics of studies registered in the field of rehabilitation medicine.Methods：The university hospital medical information network clinical trials registry database was searched for domestic clinical trials associated with rehabilitation medicine that were registered after June 2005. We extracted information about studies and analyzed their registration trends and overall characteristics.Results：Among the 21,410 registered trials, we found 529 trials associated with rehabilitation. The purpose of this study was to investigate efficacy in 65％ of the studies. Among these studies, 54％ were parallel-group comparison studies, 50％ were registered retrospectively, and 85％ did not publish any results. In comparison studies, 86％ were randomized controlled studies, and 47％ were open-label trials.Conclusion：An increasing trend of registration was observed. However, we found several problems in registration. Prospective registration is important to decrease publication and outcome reporting biases. Education for the relevant study protocol and registration might improve the quality of clinical study in domestic rehabilitation medicine.

Compartir datos: una nueva iniciativa editorial del Comité Internacional de Editores de Revistas Médicas. Implicancias para la Red de Editores / Sharing data: a new editorial initiative of the International Committee of Medical Journal Editors. Implications for the Editors Network

El Comité Internacional de Editores de Revistas Médicas (ICMJE, por su sigla en inglés) elabora recomendaciones para mejorar las normas editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones van desde uniformizar los requisitos técnicos hasta cuestiones editoriales más complejas e imprecisas, incluyendo aspectos éticos del proceso científico. Recientemente se han propuesto medidas como el registro de ensayos clínicos, la declaración de conflictos de interés y nuevos criterios para la autoría, resaltando la importancia de la responsabilidad y la rendición de cuentas. El año pasado se lanzó una nueva iniciativa editorial para compartir los datos de los ensayos clínicos. La presente revisión analiza esta innovadora iniciativa con el objetivo de sensibilizar a los lectores, investigadores, autores y editores de la Red de Editores de la Sociedad Europea de Cardiología. Data Sharing: a new editorial initiative of the international committee of medical journal editors. Implications for the Editors´ Network

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network / Compartir los datos de los estudios: Una nueva iniciativa editorial del Comité Internacional de Editores de Revistas Médicas. Implicaciones para la red europea de editores cardiovasculares

Abstract: The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Resumen: El Comite internacional de editores de revistas medicas (CIERM) propone recomendaciones para mejorar los standares editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones abarcan desde requerimeintos ténicos uniformados a temas editoriales mas complejos y evasivos, como los aspectos bioéticos relacionados con el proceso científico. Recientemente se han propuesto algunas iniciativas editoriales, como el registro de los ensayos clinicos, la declaración de los conflictos de interés y los nuevos criterios para autoría (que destacan la responsabilidad de los autores sobre el estudio). El año pasado se presentó una nueva iniciativa editorial para resaltar la importancia de compartir los datos generados en los estudios clinicos. En este artículo se discute esta nueva iniciativa editorial, con la idea de difundir su conocimiento entre los lectores, investigadores, autores y editores de la red de editores de revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network / Compartilhamento de dados: Nova Iniciativa Editorial do Comitê Internacional de Editores de Revistas Médicas. Implicações para a Rede de Editores

Abstract The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.

Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.

Data Sharing: a New Editorial Initiative from the International Committee of Medical Journal Editors. Implications for the Editors' Network

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship-emphasizing the importance of responsibility and accountability-, have been proposed. This year a new editorial initiative to foster sharing of clinical trial data has been launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and Editors of the Editors' Network of the European Society of Cardiology.

Hypertension Prevalence in the US Population Varies with Difference in Alpha-1 Antitrypsin Genotype: A Cross Sectional Study.

Background: The prevalence of hypertension (HTN) associated with alpha-1 antitrypsin deficiency (AATD) has been studied with indeterminate results. The aim of the study was to prospectively compare the prevalence of HTN before testing in 3 groups of individuals with subsequently normal, moderately deficient, and severely deficient genotypes of AATD with adjustment for differences in demographics and clinical variables. Methods: We performed a cross sectional study using data from the Alpha-1 Coded Testing (ACT) study. The univariate demographic and clinical factors associated with HTN were further analyzed by logistic regression analysis. Results: The prevalence of HTN was 27.2%, 20.6%, and 27.9% for individuals with normal, moderate and severe AATD, respectively (p<0.02). The prevalence of HTN increased with age and an interaction between age, alpha-1 antitrypsin deficiency genotype and HTN was identified. The relative risk of HTN among young moderately deficient individuals was 0.53 (95% CI 0.37-0.76) the risk of young PiMM and PiMS (normal genotype) individuals. There was no significant difference in the risk in older moderately deficient individuals 1.02 (95% CI 0.76-1.37) and individuals with severe AATD 1.10 (95% CI 0.71-1.68) when compared to normal genotypes. Conclusion: Moderate deficiency genotypes (PiMZ, PiSS, PiMNull) have less HTN than normal or severe deficiency genotypes, particularly in young individuals. We speculate that protease inhibitor deficiency over a lifetime allows unopposed proteolysis of vascular connective tissue.Measured comorbidities do not explain these findings. Validation of this data should occur in other AATD cohorts.

Reporting Results of Research Involving Human Subjects: An Ethical Obligation

Researchers have an ethical responsibility to report the results of research involving human subjects. Dissemination of results ensures that patient care is based on good science and that the field of medicine advances based on complete and accurate knowledge. However, current evidence suggests that publication is often neglected or substantially delayed, especially in the case of negative and inconclusive results. Researchers, editors and reviewers should value all high-quality research regardless of the conclusiveness of the results and ensure that all research involving human subjects is registered in a publicly accessible database.

Registration and Reporting Guidelines for Clinical Trials / 대한내과학회지

Selective outcome reporting is a major problem because it has a negative impact on our scientific knowledge and is unethical as it involves research on human subjects. And inadequate quality of trials may distort the results from systematic reviews and meta-analyses. Thus, Clinical medicine tries to solve the problem of trials by making public registration before patient enrollment mandatory and encouraging to report the research outcomes by a specific guidelines. In the past few years, the registration of clinical trials and the reporting system has become routine, supported by the International Committee of Medical Journal Editors. In Korea, the clinical research registry named 'Clinical Research Information Service (CRiS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. To expand the registration system and to operate them successfully and comprehensively, active participations of researchers as well as the government supports are required.

Primary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS)

Publication bias has a negative impact on the ability of healthcare providers and consumers to make unbiased healthcare decisions. The demand for greater transparency of clinical trials has increased and a prospective registry has been suggested by the International Committee of Medical Journal Editors. By 2008, prospective registration was considered as an ethical requirement within the Declaration of Helsinki. In Korea, the clinical research registry named 'Clinical Research Information Service (CRIS)' was recently established and became a data provider as a primary registry to the World Health Organization (WHO) International Clinical Trial Registry Platform search portal. This means that CRIS conforms to the WHO registry criteria and that registering trials with the CRIS satisfies the trial registration policies of many medical journals. To improve the comprehensiveness and completeness of registered clinical research data, it is necessary to communicate and raise awareness of the need to register clinical trials, as well as to establish national policies on clinical trial registration.

Current clinical research environment: focus on psychiatry

The introduction of international guidelines on Good Clinical Practices (GCP) in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.

A introdução de diretrizes internacionais de Boas Práticas Clínicas, em 1996, imediatamente seguida pela publicação da Resolução do Conselho Nacional de Saúde 196/96, abriu uma grande oportunidade para a participação de centros de pesquisa brasileiros em estudos internacionais. Tais estudos devem ser estritamente monitorados, a fim de assegurar a adesão às legislações, assim como garantir a segurança dos pacientes envolvidos. A fim de evitar possíveis conflitos de interesse durante e após o estudo, todos os aspectos relacionados devem ser claramente definidos previamente entre o pesquisador, o patrocinador e a instituição. Aspectos operacionais, tais como tempo para aprovação regulatória do estudo, métodos de recrutamento e retenção de pacientes e a logística em geral, também são importantes. Em 2005, a Rede Nacional de Pesquisa Clínica foi criada no Brasil, somando a experiência de vários centros de pesquisa ligados a hospitais de ensino. Seu objetivo é reforçar a atividade de pesquisa clínica no país, com práticas atualizadas e adequado treinamento técnico-científico. O desenvolvimento de protocolos de pesquisa que foquem as prioridades de saúde do país é outro objetivo fundamental da Rede. Aspectos gerais da pesquisa clínica e algumas particularidades em Psiquiatria são discutidos no artigo. O objetivo final de todo o trabalho nesta área de pesquisa é, sem dúvida, a busca de melhores condições de saúde e qualidade de vida da população.