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Background: Selective publication of studies has important scientific, ethical, and public health implications. Aim: We studied selective publication among mood disorder research protocols registered in the Clinical Trials Registry of India (CTRI) database. We also examined the frequency and nature of protocol deviations among the published articles. Methods: Using a systematic search strategy, we examined the publication status of all mood disorder-related research protocols registered in the CTRI database from inception till December 31, 2019. Logistic regression analysis was used to identify variables associated with selective publication. Results: Of 129 eligible protocols identified, only a third (n = 43, 33.3%) were published in literature; among those published, only 28 (21.7%) were placed in MEDLINE indexed journals. Protocol deviations were observed in more than half of the published papers (n = 25, 58.1%); many of these (41.9%) were related to sample size deviations, though, importantly, deviations in primary and secondary outcomes were also noted (16.2%). Retrospective registration of trials (odds ratio, 2.98, 95% confidence interval, 1.32--6.71) was significantly associated with publication; other variables, such as funding status or multicentric sampling, were not associated with eventual publication. Conclusions: Two out of three mood disorder research protocols registered in India do not translate into published research. These findings from a low- and middle-income country with limited spending on health care research and development represent wastage of resources and raise scientific and ethical concerns about unpublished data and futile patient participation in research. [ABSTRACT FROM AUTHOR]

Introduction: In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for "Clinical Trials" and "Biomedical and Health Research." As a result, guidelines issued by Indian Council of Medical Research were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry. However, conducting an ACT can pose challenges. We assessed the level of awareness, knowledge, and challenges faced by investigators. Our aim is to overcome some of these challenges and encourage more academic studies for the betterment of healthcare and scientific knowledge in India. Methodology: The study was conducted in two phases after obtaining approval from the Institutional Ethics Committee (EC) of three tertiary care hospitals in Mumbai. In the first phase, the number of ACTs was assessed from the clinical trial registry India website, while the number of registered and re-registered ECs were assessed from the CDSCO website. The second phase involved assessing investigator awareness and knowledge about ACTs using a prevalidated questionnaire with a content validity index score of 0.93. Results: In 2020, the highest numbers of studies were registered, with the highest numbers of registered and re-registered ECs from Maharashtra. All participants completed the questionnaire and were aware of the need to follow guidelines for clinical trials. Sixty-seven percent of participants knew that the guidelines for ACTs differed from those of sponsored clinical trials, but only 58% were aware of the exact definition of an ACT as per NDCTR, 2019. Eighty-five percent of participants knew who could initiate an ACT, but only 27% knew about the applicability of results of an ACT and 33% had in-depth knowledge about the required approvals, while only 10% knew the archival period. Although 71% of participants had knowledge about serious adverse event reporting, few answered in-depth questions correctly. Only 31 participants reported facing varied challenges. Conclusion: To conduct ACTs effectively and contribute to healthcare and scientific advancement, it is crucial to enhance investigators' existing knowledge about ACTs. [ABSTRACT FROM AUTHOR]

While many studies suggested the isolated effects of plyometric and whole-body vibration exercises on physical performance variables, only few studies have compared the acute effects of plyometric and whole-body vibration on the occurrence of post-activation potentiation and the resultant improvements in performance. Therefore, we aimed to compare the acute effects of plyometric exercises and whole-body vibration training on physical performance in collegiate basketball players. Twenty-four collegiate male basketball players (age 20.8 ± 2.02 years, height 1.79 ± 0.7 m, and weight 71.2 ± 7.6 kg) participated in this randomized crossover study. Subjects were received both plyometric and whole-body vibration exercises after a 48-h washed-out period. Countermovement Jump height, sprint, and agility time were measured at baseline, 4- and 12-min post-plyometric, and whole-body vibration exercises. The result suggests a positive effect of both the plyometric and whole-body vibration exercises on countermovement jump and agility time (p = 0.001). While the countermovement jump height and agility were higher in the plyometric group (mean difference 1.60 cm and 0.16 s, respectively), the sprint performance was higher in the whole-body vibration group. However, these differences were statistically non-significant between the two groups (p > 0.05). This study suggests that both plyometric and whole-body vibration exercises may improve post-activation potentiation, which leads to better physical performance. Trial registration CTRI/2019/05/019059. Registered with the Clinical trials registry, India on 10/05/2019. http://ctri.nic.in/Clinicaltrials/advsearch.php. [ABSTRACT FROM AUTHOR]