14 research outputs found

    A qualitative study exploring women´s journeys to becoming smokers in the social context of urban India

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    Background In India, the prevalence of smoking among women is increasing, and the reasons behind this are unclear. We aimed to study the factors leading to initiation and maintenance of the smoking habit in women in Pune, India. Methods Twenty-seven urban women smokers, ranging from 21 to 60 years of age (31.96 ± 10.70 years), were interviewed between September 2015 and February 2016. The in-depth interviews consisted of questions on pre-decided categories, including initiation, motivation to continue smoking, and risk perception. They were asked to describe their first smoking experience, factors that trigger them to smoke and the benefits that they seek from smoking. Results Thematic analysis revealed that peer pressure, curiosity, fascination, experimentation, and belonging to a group were factors that led to initiation, while lack of alternatives for stress relief, work environments, and lack of leisure time activities provided circumstances to continue smoking. Participants recognized a sense of liberation and independence from smoking cigarettes and perceived health risks as minor and distant. Conclusions Social factors, apart from peer influence, were important for initiation of smoking among this study's participants, while individual or personal factors, such as stress and habit, determined motivation to continue. Low awareness of health risks, perceived emotional benefits and misconceptions of being in control of the habit led to further addiction. These factors should be kept in mind when designing smoking prevention and cessation interventions

    Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators

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    Background: Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry. Objective: To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines. Methods: We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey. Results: Central registration of Ethics Committees (ECs) was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's). The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7%) disagreed to the introduction of audio-video (AV) recording of informed consent, 36.6% agreed and 12.7% were neutral. Discussion: Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same. Conclusion: Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines

    A CEACAM6-high airway neutrophil phenotype and CEACAM6-high epithelial cells are features of severe asthma

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    Severe asthma represents a major unmet clinical need; understanding the pathophysiology is essential for the development of new therapies. Using microarray analysis, we previously found three immunological clusters in asthma: Th2-high, Th17-high, and Th2/17-low. Although new therapies are emerging for Th2-high disease, identifying molecular pathways in Th2-low disease remains an important goal. Further interrogation of our previously described microarray dataset revealed upregulation of gene expression for carcinoembryonic Ag cell adhesion molecule (CEACAM) family members in the bronchi of patients with severe asthma. Our aim was therefore to explore the distribution and cellular localization of CEACAM6 using immunohistochemistry on bronchial biopsy tissue obtained from patients with mild-to-severe asthma and healthy control subjects. Human bronchial epithelial cells were used to investigate cytokine and corticosteroid in vitro regulation of CEACAM6 gene expression. CEACAM6 protein expression in bronchial biopsies was increased in airway epithelial cells and lamina propria inflammatory cells in severe asthma compared with healthy control subjects. CEACAM6 in the lamina propria was localized to neutrophils predominantly. Neutrophil density in the bronchial mucosa was similar across health and the spectrum of asthma severity, but the percentage of neutrophils expressing CEACAM6 was significantly increased in severe asthma, suggesting the presence of an altered neutrophil phenotype. CEACAM6 gene expression in cultured epithelial cells was upregulated by wounding and neutrophil elastase. In summary, CEACAM6 expression is increased in severe asthma and primarily associated with airway epithelial cells and tissue neutrophils. CEACAM6 may contribute to the pathology of treatment-resistant asthma via neutrophil and airway epithelial cell–dependent pathways
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