The Cuban Public Registry of Clinical Trials: primary registry of World Health Organization.

Jiménez, Gladys; Pascual, María Amparo; Fors, Martha; Cobas, José; Torres, Ania; Cachimaille, Yamilé; Rodríguez, J.; López, Isabel

doi:10.1111/j.1756-5391.2011.01140.x

Cited by 4 publications

(4 citation statements)

References 7 publications

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“…Some of those studies were performed for the evaluation of health technologies and to search evidence for public health decisions. The activities of CENCEC were carried out according to international standards: Quality Assurance System Certificated (ISO 9001:2008), Cuban Public Registry of Clinical Trials (WHO Primary registry [4] and role as regional coordinator of Good Clinical Practices Working Group (PANDRHA) among others.…”

Section: Resultsmentioning

confidence: 99%

Public health approach of clinical trials: Cuban’s experience of research translation into clinical practice

Pascual¹,

Fors²,

Jiménez³

et al. 2014

BMC Health Serv Res

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Section: Resultsmentioning

confidence: 99%

Public health approach of clinical trials: Cuban’s experience of research translation into clinical practice

Pascual¹,

Fors²,

Jiménez³

et al. 2014

BMC Health Serv Res

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“…The trial was conducted at the Allergy and Immunology Service of the "Calixto García" University Hospital in Havana (Code in the Cuban Public Registry of Clinical Trials: RPCEC00000026). 22 The study was designed and conducted according to international guidelines for Good Clinical Practice and was approved by the Research Ethics Committee of the clinical site and the Cuban medicine regulatory authority (CECMED).…”

Section: Methodsmentioning

confidence: 99%

Subcutaneous allergen immunotherapy for asthma: A randomized, double-blind, placebo-controlled study with a standardized Blomia tropicalis vaccine

Castro-Almarales¹,

Ronquillo-Díaz²,

Álvarez-Castelló

et al. 2020

World Allergy Organization Journal

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Background: Sensitization to Blomia tropicalis (Bt) is very frequent in the tropics, and particularly in Cuba, being a significant cause of allergic asthma. Allergen immunotherapy (AIT) with Bt can be a therapeutic option, however, placebo-controlled clinical trials have not been reported.Objective: To assess the therapeutic effect and safety of AIT for asthma using a standardized allergen vaccine of B. tropicalis by subcutaneous route, in allergic asthmatic patients exposed and sensitized to this mite species.Methods: A double-blind, placebo-controlled Phase II trial was conducted in 35 adults (18 with treatment and 17 with placebo), with mild to moderate asthma, predominantly sensitized to Bt. AIT was administered subcutaneously in increasing doses from 4 to 6000 Biological Units using a locally manufactured standardized extract (BIOCEN, Cuba). Patient assessment was performed using symptom-medication score (SMS), peak expiratory flow and skin reactivity relative to Histamine as measured by skin prick test (SPT). Results:The 12-month treatment achieved a significant (p < 0.001) decrease of SMS. Symptom score showed only 41% (CI: 26-61) of placebo values, whereas medication was 34.5% (22.4%-63.3%). Treatment was regarded clinically effective in 67% of patients (OR 32; 95%CI: 17 to 102). The effect size on symptoms and medication was higher than has been reported with equivalent allergen dosages of D. pteronyssinus and D. siboney in Cuban asthmatic patients. Skin reactivity to Bt was also significantly reduced (p ¼ 0.0001), increasing 148-fold the allergen threshold to elicit a positive skin test. This desensitization effect was specific to Bt and did not modify the reactivity to Dermatophagoides. The change of specific skin reactivity was significantly (p < 0.05) correlated to clinical improvement. All adverse events were local with a frequency of 2.4% of injections.Conclusions: Subcutaneous AIT with Blomia tropicalis was effective and safe in asthmatic adults exposed and sensitized to this mite species in a tropical environment.

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“…Only one (4.55%) RCT provided the registration number and name of the trial registry [7]. The World Health Organization states that registering all interventional trials should be a scienti c, ethical and moral responsibility [33]. On the one hand, clinical trial registration can protect the intellectual property rights of investigators.…”

Section: Other Informationmentioning

confidence: 99%

Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture Combined with Other Treatments for Facial Paralysis with CONSORT Statement and STRICTA Standard

Zhou

Ding

et al. 2023

Preprint

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Objective: The current study aims to assess the reporting quality and its correlation with randomized controlled trials (RCTs) on acupuncture associated with other treatments for facial paralysis. Methods: Original articles were retrieved from the China National Knowledge Infrastructure (CNKI), the China Science and Technology Journal Database (VIP), the Wanfang Database (WF), SinoMed, PubMed, and the Web of Science (WOS). The literature was published between 2020 and 2021 in Chinese and English. Results: A total of 22 articles were included, and the reporting rate of CONSORT items for 22 RCTs ranged from 16.22% to 40.54%. There were 23 entries with a reporting rate below 10%. Additionally, the reporting rate of STRICTA entries for the 22 RCTs ranged from 41.18% to 94.12%. Of all the STRICTA entries, five entries reported rates below or equal to 50%. No literature complies with the CONSORT statement, and none satisfies the STRICTA standard. Conclusion: The quality of randomized controlled trials of acupuncture combined with other treatments for facial paralysis was generally low. The future trial design of acupuncture and other methods for facial paralysis should be standardized to improve the reporting quality based on the CONSORT statement and the STRICTA standard.

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The Cuban Public Registry of Clinical Trials: primary registry of World Health Organization.

Cited by 4 publications

References 7 publications

Public health approach of clinical trials: Cuban’s experience of research translation into clinical practice

Public health approach of clinical trials: Cuban’s experience of research translation into clinical practice

Subcutaneous allergen immunotherapy for asthma: A randomized, double-blind, placebo-controlled study with a standardized Blomia tropicalis vaccine

Assessment of Reporting Quality in Randomized Controlled Trials of Acupuncture Combined with Other Treatments for Facial Paralysis with CONSORT Statement and STRICTA Standard

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