scholarly journals Progress in trial registration in Latin America and the Caribbean, 2007–2013

2017 ◽  
Vol 41 ◽  
pp. 1 ◽  
Author(s):  
Pablo Rodríguez-Feria ◽  
Luis Gabriel Cuervo
Keyword(s):  
Clinical Trial ◽  
Latin America ◽  
Trial Registration ◽  
World Health ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Publication Rates ◽  
Clinical Trial Registries ◽  
The Caribbean ◽  
Health Organization

This descriptive study identifies trends in clinical trial registration in the World Health Organization International Clinical Trial Registry Platform (ICTRP) for Latin America and the Caribbean (LAC), from 2007–2013, and provides adjusted estimates for registration rates by population and publications (2007–2011). Trends and data are presented by subregion and language in interactive graphs, including annual registration rates by population (2007–2011) and publications (LILACS and MEDLINE) listed in SCIENTI Network (Science and Technology Indicators). Of the 11 945 clinical trials involving LAC countries, 8 282 were in South America, with Brazil leading at 4 070 (49%); 2 421 in North and Central America, with Mexico leading at 1 886 (78%); and 1 242 in the Caribbean, with Puerto Rico leading at 857 (69%). After adjusting by population and publication rates Chile, Panama, Argentina, and Peru led registration rates per 1 million inhabitants. Variations in the number of trials per year are quite substantial. Clinical trial registration increased in a steady yet inconsistent way. The implementation of the Policy on Research for Health has been followed by an increase in countries that require registration and have established clinical trial registries. However, there is room for improvement in adherence throughout LAC. Trial registration is offered gratis by Brazilian, Cuban, Peruvian, and United States registries, among others.

scholarly journals Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiqian Yang ◽  
Hesong Xiao ◽  
Yi Zeng ◽  
Liangliang Huang ◽  
Ke Ji ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Intestinal Flora ◽  
World Health ◽  
Control Group ◽  
Metagenomic Sequencing ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Faecalibacterium Prausnitzii ◽  
Health Organization

Study Objectives. To study the relationship between perimenopausal insomnia (PI) and intestinal flora and the potential mechanism of Tianwang Buxin granules (TWBXG) in exerting its clinical efficacy. Methods. The subjects included 13 PI patients from the Hubei Provincial Hospital of TCM, Hubei University of TCM, and Wuhan Traditional Chinese Medicine Hospital, and the corresponding noninsomniac spouses of the patients were selected as controls. TWBXG was continuously administered for 4 weeks. The feces of PI patients and their noninsomniac spouses before and after treatment with TWBXG were collected. The intestinal flora composition of each group was detected by metagenomic sequencing, and the efficacy of TWBXG was evaluated by the PSQI scale. Results. Compared with the control group, the model group showed an increase in the abundance of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum, while those of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii were decreased. Compared with pretreatment, the PSQI score was significantly reduced ( P < 0.05 ), the abundance of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii increased, and that of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum decreased after treatment. However, there was still a certain gap in the abundance of related flora in the treatment group compared with the control. Conclusion. PI is associated with disturbances in the intestinal flora and is mainly related to the disorders of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, Blautia obeum, Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii. TWBXG can effectively treat PI, and its effect may be achieved by regulating the disordered intestinal flora. Clinical Trials. The study was registered in the Chinese clinical trial registry and approved by the World Health Organization clinical trial registration platform (Effects of the modified Tianwang Buxin granule and modified Tianwang Buxin decoction pieces on insomnia: a randomized, controlled trial, ChiCTR-IPR-17011549).

scholarly journals Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015

2018 ◽  
pp. 1-9 ◽  
Author(s):  
Pilar García-Vello ◽  
Emma Smith ◽  
Vanessa Elias ◽  
Carlos Florez-Pinzon ◽  
Ludovic Reveiz
Keyword(s):  
Clinical Trial ◽  
Latin America ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
The Caribbean

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals

2013 ◽  
Vol 29 (6) ◽  
pp. 1095-1100 ◽  
Author(s):  
Ludovic Reveiz ◽  
Eleana Villanueva ◽  
Chimaraoke Iko ◽  
Iveta Simera
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latin American ◽  
Randomized Clinical Trials ◽  
Reporting Guidelines ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Biomedical Journals ◽  
The Caribbean ◽  
Latin American And Caribbean

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

scholarly journals Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

Trials ◽  
2009 ◽  
Vol 10 (1) ◽  
Author(s):  
Lorenzo P Moja ◽  
Ivan Moschetti ◽  
Munira Nurbhai ◽  
Anna Compagnoni ◽  
Alessandro Liberati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
World Health Organization ◽  
World Health ◽  
Minimum Data Set ◽  
Data Set ◽  
Clinical Trial Registries ◽  
Minimum Data ◽  
The World ◽  
Health Organization

scholarly journals Mental health in Latin America and the Caribbean

2014 ◽  
Vol 11 (1) ◽  
pp. 6-8
Author(s):  
Jorge J. Rodriguez
Keyword(s):  
Mental Health ◽  
Latin America ◽  
Mental Illnesses ◽  
World Health ◽  
Paper Briefly ◽  
Mental Health Reform ◽  
Pan American ◽  
The Caribbean ◽  
Health Organization ◽  
Made In

Mental illnesses are a growing health problem and reducing the treatment gap in Latin America and the Caribbean is a great challenge. Evaluations conducted by the Pan American Health Organization (PAHO) and World Health Organization (WHO) have shown that the responsiveness of health services is still limited. Nonetheless, from an evaluation of how mental health reform has progressed in the region following the historical benchmark of the Caracas Declaration (1990), it is clear that – despite the limitations, shortcomings and challenges – significant progress has been made in most countries. This paper briefly reviews this progress.

scholarly journals Assessing electronic immunization registries: the Pan American Health Organization experience

2019 ◽  
Vol 43 ◽  
pp. 1 ◽  
Author(s):  
M. Carolina Danovaro-Holliday ◽  
Marcela P. Contreras ◽  
Dalys Pinto ◽  
Ida Berenice Molina-Aguilera ◽  
Diana Miranda ◽  
...  
Keyword(s):  
Latin America ◽  
Information Systems ◽  
Assessment Tool ◽  
World Health ◽  
Middle Income ◽  
Evaluation Approach ◽  
Health Authorities ◽  
Pan American ◽  
The Caribbean ◽  
Health Organization

Objective.To develop a methodology to assess electronic immunization registries (EIRs) in low- and middle-income countries (LMICs) in Latin America and the Caribbean.Methods.A team from the Immunization Unit at the Pan American Health Organization (PAHO) reviewed existing methodologies to evaluate health information systems, particularly the Performance of Routine Information System Management (PRISM) framework and methodologies used to assess information systems. In 2014, the PAHO team convened a small working group to develop an evaluation approach to be added to the existing World Health Organization immunization data quality self-assessment (DQS) tool. The resulting DQS with an added EIR component was named “DQS Plus.” The DQS Plus methodology was used in Panama in May 2014 and in Honduras in November 2015.Results.The DQS Plus tool proved feasible and easy to implement in Panama and Honduras, including by not adding much time or resources to those needed for a usual DQS. The information obtained from the DQS Plus assessment was practical and helped provide health authorities with recommendations to update and improve their EIR, strengthen the use of the registry, and enhance the data the assessment produced, at all levels of the health system. These recommendations are currently being implemented in the two countries.Conclusions.The DQS Plus proved to be a practical and useful approach for assessing an EIR in an LMIC and generating actionable recommendations. Further work on defining operational and related EIR functional standards in LMICs will help develop an improved EIR assessment tool for Latin America and the Caribbean, and potentially elsewhere.

Migration, Migrants, and Health in Latin America and the Caribbean

2021 ◽  
Author(s):  
Deisy Ventura ◽  
Jameson Martins da Silva ◽  
Leticia Calderón ◽  
Itzel Eguiluz
Keyword(s):  
Human Rights ◽  
Latin America ◽  
Low Income ◽  
Healthcare Services ◽  
Developed Countries ◽  
The United States ◽  
World Health ◽  
Mexico Border ◽  
The Caribbean ◽  
Health Organization

The World Health Organization has recognized health as a right of migrants and refugees, who are entitled to responsive healthcare policies, due to their particular social determinants of health. Migrants’ and refugees’ health is not only related to transmissible diseases but also to mental health, sexual and reproductive health, and non-communicable diseases, such as diabetes. Historically, however, migration has been linked to the spread of diseases and has often artificially served as a scapegoat to local shortcomings, feeding on the xenophobic rhetoric of extremist groups and political leaders. This approach fosters the criminalization of migrants, which has led to unacceptable violations of human rights, as demonstrated by the massive incarceration and deportation policies in developed countries, for example, the United States under the Trump administration. In Latin America and the Caribbean, in particular, there have been legal developments, such as pioneering national legislation in Argentina in 2004 and Brazil in 2017, which suggest some progress in the direction of human rights, although in practice drawbacks abound in the form of countless barriers for migrants to access and benefit from healthcare services in the context of political turmoil and severe socioeconomic inequality. The COVID-19 pandemic has exposed and enhanced the effects of such inequality in the already frail health conditions of the most disenfranchised, including low-income migrants and refugees; it has both caused governments in Latin America to handle the crisis in a fragmented and unilateral fashion, ignoring opportunities to cooperate and shield the livelihoods of the most vulnerable, and served as a pretext to sharpen the restrictions to cross-border movement and, ultimately, undermine the obligation to protect the dignity of migrants, as the cases of Venezuela and the U.S.-Mexico border illustrate. Still, it could represent an opportunity to integrate the health of migrants to the public health agenda as well as restore cooperation mechanisms building on previous experiences and the existing framework of human rights organizations.

scholarly journals Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Heba Omar ◽  
Wessam Adel Aboella ◽  
Mohammed Mahmoud Hassan ◽  
Amany Hassan ◽  
Passaint Hassan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Magnesium Sulfate ◽  
Spinal Anaesthesia ◽  
Sedation Score ◽  
Trial Registration ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Hyperbaric Bupivacaine ◽  
Clinical Trial Registration ◽  
Group D

Abstract Background Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. Methods This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 μg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. Results Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. Conclusions Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. Trial registration Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727; January 2018, “retrospectively registered”.

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