1.Comparison of regulatory framework of clinical trial with genetically modified organism-containing vaccines in the Europe, Australia, and Switzerland
Clinical and Experimental Vaccine Research 2021;10(2):93-105
New vaccines production and manufacture have revolutionized by recombinant technology. Various regulatory associations are engaged with the appraisal of a clinical trial with genetically modified organisms. At present safe, effective vaccines are needed in order to control the various emerging diseases which are a major cause of mortality. In reality, most vaccines raise biosafety worries with respect to human wellbeing. “Federal Office for Environment” is the competent authority for environmental risk assessments in Switzerland. Gene Technology Act 2000 is the fundamental direction that provides the necessary information to carry the clinical trials with genetically modified organism-containing vaccines. In addition, regulatory framework for “clinical trial with genetically modified organisms-containing vaccines” is stringent and partially harmonized in Switzerland, the European Union and Australia. In this study, we mainly concerned with regulatory aspects of “clinical trial with genetically modified organism” containing vaccine in three regions. This review includes various aspects like ethics, guidelines related to clinical trials of vaccines with genetically modified organisms.
2.Mid-foot retinaculum: an unrecognized entity.
SWATHI ; Geetha Gangadaran NELLITHALA ; Sunita Arvind ATHAVALE
Anatomy & Cell Biology 2017;50(3):171-174
Retinacula are thickenings of deep fascia in the region of joints that hold down the tendons preventing them from bowing out of position. In the region of ankle, number of such retinacula have been described. Retinacula like superior and inferior extensor retinacula have been described which hold down the tendons of leg muscles passing to the foot beneath them. As the extensor tendons of the leg have more distal attachment to the toes, the present study was conducted to ascertain the presence of any additional retinaculum in the mid-foot region, which would tie down the tendons for their effective action at the distal joints. The aim was also to determine the attachments of the retinaculum, if present as well as the structures passing beneath them. Fifty cadaveric feet were dissected carefully for this purpose. Presence of an additional extensor retinaculum distal to the inferior band of inferior extensor retinaculum in the mid-foot region was found in 22 feet. Besides the extensor tendons, medial terminal branch of deep peroneal nerve and dorsalis pedis artery was found to pass beneath the retinaculum. A partial or complete mid-foot retinaculum existed in the mid-foot region covering the tarsometatarsal joints in about half of study population. Functionally, this retinaculum may prevent bowstringing of the extensor tendons, clinically it may predispose to entrapment of deep peroneal nerve mimicking anterior tarsal tunnel syndrome.
Ankle
;
Arteries
;
Cadaver
;
Fascia
;
Foot
;
Joints
;
Leg
;
Muscles
;
Peroneal Nerve
;
Tarsal Tunnel Syndrome
;
Tendons
;
Toes
3.The Role of N-Acetyl Transferases on Isoniazid Resistance from Mycobacterium tuberculosis and Human: An In Silico Approach.
Ameeruddin Nusrath UNISSA ; Swathi SUKUMAR ; Luke Elizabeth HANNA
Tuberculosis and Respiratory Diseases 2017;80(3):255-264
BACKGROUND: N-acetyl transferase (NAT) inactivates the pro-drug isoniazid (INH) to N-acetyl INH through a process of acetylation, and confers low-level resistance to INH in Mycobacterium tuberculosis (MTB). Similar to NAT of MTB, NAT2 in humans performs the same function of acetylation. Rapid acetylators, may not respond to INH treatment efficiently, and could be a potential risk factor, for the development of INH resistance in humans. METHODS: To understand the contribution of NAT of MTB and NAT2 of humans in developing INH resistance using in silico approaches, in this study, the wild type (WT) and mutant (MT)-NATs of MTB, and humans, were modeled and docked, with substrates and product (acetyl CoA, INH, and acetyl INH). The MT models were built, using templates 4BGF of MTB, and 2PFR of humans. RESULTS: On the basis of docking results of MTB-NAT, it can be suggested that in comparison to the WT, binding affinity of MT-G207R, was found to be lower with acetyl CoA, and higher with acetyl-INH and INH. In case of MT-NAT2 from humans, the pattern of score with respect to acetyl CoA and acetyl-INH, was similar to MT-NAT of MTB, but revealed a decrease in INH score. CONCLUSION: In MTB, MT-NAT revealed high affinity towards acetyl-INH, which can be interpreted as increased formation of acetyl-INH, and therefore, may lead to INH resistance through inactivation of INH. Similarly, in MT-NAT2 (rapid acetylators), acetylation occurs rapidly, serving as a possible risk factor for developing INH resistance in humans.
Acetyl Coenzyme A
;
Acetylation
;
Computer Simulation*
;
Humans*
;
Isoniazid*
;
Mycobacterium tuberculosis*
;
Mycobacterium*
;
Risk Factors
;
Transferases*
4.Barriers to breast cancer screening in Singapore: A literature review.
Priyanka RAJENDRAM ; Prachi SINGH ; Kok Teng HAN ; Vasuki UTRAVATHY ; Hwee Lin WEE ; Anand JHA ; Shyamala THILAGARATNAM ; Swathi PATHADKA
Annals of the Academy of Medicine, Singapore 2022;51(8):493-501
INTRODUCTION:
Breast cancer is a leading cause of cancer death among women, and its age-standardised incidence rate is one of the highest in Asia. We aimed to review studies on barriers to breast cancer screening to inform future policies in Singapore.
METHOD:
This was a literature review of both quantitative and qualitative studies published between 2012 and 2020 using PubMed, Google Scholar and Cochrane databases, which analysed the perceptions and behaviours of women towards breast cancer screening in Singapore.
RESULTS:
Through a thematic analysis based on the Health Belief Model, significant themes associated with low breast cancer screening uptake in Singapore were identified. The themes are: (1) high perceived barriers versus benefits, including fear of the breast cancer screening procedure and its possible outcomes, (2) personal challenges that impede screening attendance and paying for screening and treatment, and (3) low perceived susceptibility to breast cancer.
CONCLUSION
Perceived costs/barriers vs benefits of screening appear to be the most common barriers to breast cancer screening in Singapore. Based on the barriers identified, increasing convenience to get screened, reducing mammogram and treatment costs, and improving engagement with support groups are recommended to improve the screening uptake rate in Singapore.
Breast Neoplasms/epidemiology*
;
Early Detection of Cancer
;
Female
;
Health Knowledge, Attitudes, Practice
;
Humans
;
Mammography
;
Mass Screening
;
Singapore/epidemiology*
5.Posterior superior alveolar nerve block alone in the extraction of upper third molars: a prospective clinical study
Swathi TUMMALAPALLI ; Ravi Sekhar M ; Naga Malleswara Rao INTURI ; Venkata Ramana MURTHY V ; Rama Krishna SUVVARI ; Lakshmi Prasanna POLAMARASETTY
Journal of Dental Anesthesia and Pain Medicine 2023;23(4):213-220
Background:
Third molar extraction is the most commonly performed minor oral surgical procedure in outpatient settings and requires regional anesthesia for pain control. Extraction of the maxillary molars commonly requires both posterior superior alveolar nerve block (PSANB) and greater palatine nerve block (GPNB), depending on the nerve innervations of the subject teeth. We aimed to study the effectiveness of PSANB alone in maxillary third molar (MTM) extraction.
Methods:
A sample size comprising 100 erupted and semi-erupted MTM was selected and subjected to study for extraction. Under strict aseptic conditions, the patients were subjected to the classical local anesthesia technique of PSANB alone with 2% lignocaine hydrochloride and adrenaline 1:80,000. After a latency period of 10 min, objective assessment of the buccal and palatal mucosa was performed. A numerical rating scale and visual analog scale were used.
Results:
In the post-latency period of 10 min, the depth of anesthesia obtained in our sample on the buccal side extended from the maxillary tuberosity posteriorly to the mesial of the first premolar (15%), second premolar (41%), and first molar (44%). This inferred that anesthesia was effectively high until the first molars and was less effective further anteriorly due to nerve innervation. The depth of anesthesia on the palatal aspect was up to the first molar (33%), second molar (67%), and lateromedially; 6% of the patients received anesthesia only to the alveolar region, whereas 66% received up to 1.5 cm to the mid-palatal raphe. In 5% of the cases, regional anesthesia was re-administered. An additional 1.8 ml PSANB was required in four patients, and another patient was administered a GPNB in addition to the PSANB during the time of extraction and elevation.
Conclusion
The results of our study emphasize that PSANB alone is sufficient for the extraction of MTM in most cases, thereby obviating the need for poorly tolerated palatal injections.
6.Burning measure for burning mouth syndrome: a systematic review
Sunny Priyatham TIRUPATHI ; Sardhar MALOTHU ; Udaikiran ALLAPARTHI ; Swathi VELVALURI ; Lamea AFNAN ; Shraddha BUDIA ; Muskaan SACHDEV
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2024;50(2):63-69
This current systematic review aimed to evaluate the current evidence on the effect of topical capsaicin application to alleviate symptoms related to burning mouth syndrome (BMS). PubMed, Ovid SP, and Cochrane were searched from 1980 to 2022 to identify relevant literature. A total of 942 titles (PubMed, 84; Ovid SP, 839; Cochrane, 19) was retrieved, of which 936 were excluded based on the title and abstract. A total of 11 studies were further evaluated for full text analysis, of which 7 were excluded. As a result, 4 articles were included for qualitative synthesis of data. Capsaicin as a mouthwash can have potential application in the treatment of symptoms related to burning mouth. The quality of available studies is moderate to low, and a well-designed randomized multicentric study comparing capsaicin with other active agents is planned to obtain more definitive conclusions.
7.Preclinical evaluation of Hibiscus cannabinus Linn. in the treatment of urolithiasis and cholelithiasis
Swathi Suresh ; Ankul Singh S ; Chitra Vellapandian
Digital Chinese Medicine 2023;6(2):189-197
【Objective】 To investigate the therapeutic effect of Hibiscus cannabinus Linn. (H. cannabinus)
leaves on cholelithiasis and urolithiasis.
【Methods】 The study evaluated the effect of aqueous leaf extract of H. cannabinus on thiouracil
and cholesterol cholic acid diet induced cholelithiasis in BALB/c mice and ethylene glycol induced urolithiasis in Wistar rats. Three doses of aqueous extract (40, 80, and 160 mg/kg) were selected to evaluate the effectiveness in cholelithiasis in mice; another three doses of aqueous extract (400, 800, and 1 600 mg/kg) were administered for evaluating the effect on urolithiasis in rats. Biochemical parameters such as biliary cholesterol, biliary phospholipid, and bile acid were determined in cholelithiasis model. Similarly, 24-hour urine output, urinary parameters such as creatinine, uric acid, protein, urea, presence of calcium oxalate crystals, red blood cells (RBCs), and pyuria were determined in urolithiasis model.
【Results】 Statistically significant differences were noted in the biliary and urinary parameters after administrating three test doses of H. cannabinus aqueous extract (P < 0.05).
【Conclusion】 H. cannabinus was found to be effective against high fat lithogenic diet urolithiasis and cholelithiasis.