1.Observational Study for Clinical Trials Participation in Malaysia
Sunil Kumar Prajapati ; Wing Yin Chin ; Jin Yi Choo ; Pushpraj S Gupta ; Satendra Singh ; Promod Kumar Yadav
Malaysian Journal of Medicine and Health Sciences 2024;20(No.2):26-33
Introduction: This observational study was conducted to assess the knowledge, attitudes, and perceptions (KAP) of
Malaysians toward participating in clinical trials. It also aimed to look for factors that will influence people’s willingness to participate in trials. We planned and developed future outreach, education tools, and recruitment strategies
to increase clinical trial enrolment. Methods: A cross-sectional study was carried out on a randomly selected sample
of 398 Malaysian literate adults. An online questionnaire was created and distributed to the respondents. Descriptive
statistics were presented in the form of frequency and percentages. The chi-square test was employed to find the
association between independent variables. Results: The majority had good knowledge (61.3%) and high awareness
(88.7%) of clinical trials. However, most of them were not willing to take part in a clinical trial if they were assigned
to a group of unlicensed drugs (90.2%) or randomly assigned (66.1%). The main reasons for participating in trials
were recommendations from doctors (46.5%) and the potential for their own benefit (45.7%). Younger age was
positively associated with the necessity and confidentiality of clinical trials. Most respondents indicated negative
perceptions towards the safety of clinical trials regardless of demographic variables. Conclusion: We gained a better
understanding of Malaysian people who are potential participants in a future clinical trial. These findings could help
clinical researchers improve their understanding of the participants and develop effective outreach strategies for
clinical trial recruitment and retention.
2.Three-dimensional computer navigation in the reconstruction of complex unilateral orbital fractures: evaluation and review of applications
Parampreet Singh SAINI ; Rajesh KUMAR ; Manu SAINI ; Tarush GUPTA ; Sunil GABA ; Ramesh Kumar SHARMA
Archives of Craniofacial Surgery 2024;25(4):161-170
Background:
The eyes are the central aesthetic unit of the face. Maxillofacial trauma can alter facial proportions and affect visual function with varying degrees of severity. Conventional approaches to reconstruction have numerous limitations, making the process challenging. The primary objective of this study was to evaluate the application of three-dimensional (3D) navigation in complex unilateral orbital reconstruction.
Methods:
A prospective cohort study was conducted over 19 months (January 2020 to July 2021), with consecutive enrollment of 12 patients who met the inclusion criteria. Each patient was followed for a minimum period of 6 months. The principal investigator carried out a comparative analysis of several factors, including fracture morphology, orbital volume, globe projection, diplopia, facial morphic changes, lid retraction, and infraorbital nerve hypoesthesia.
Results:
Nine patients had impure orbital fractures, while the remainder had pure fractures. The median orbital volume on the normal side (30.12 cm3; interquartile range [IQR], 28.45–30.64) was comparable to that of the reconstructed orbit (29.67 cm3; IQR, 27.92–31.52). Diplopia improved significantly (T(10) = 2.667, p = 0.02), although there was no statistically significant improvement in globe projection. Gross symmetry of facial landmarks was achieved, with comparable facial width-to-height ratio and palpebral fissure lengths. Two patients reported infraorbital hypoesthesia at presentation, which persisted at the 6-month follow-up. Additionally, five patients developed lower lid retraction (1–2 mm), and one experienced implant impingement at the infraorbital border.
Conclusion
Our study provides level II evidence supporting the use of 3D navigation to improve surgical outcomes in complex orbital reconstruction.
3.Quality by Design approach for the investigation of critical characteristics of Phyllanthus emblica from different vicinities
Prakash Ramakrishnan ; Priya Masand ; Pooja Dhama ; Anurag ; Sunil Gupta ; Alok Sharma
Digital Chinese Medicine 2023;6(3):272-284
[Objective] To explore the application of Quality by Design (QbD) tools in assessing geographical variations of Phyllanthus emblica (P. emblica) from five distinct Indian states.
[Methods] In the current experiment, the Box-Behnken design with a reduced quartic model and 105 runs was employed with the use of the Design Expert software for randomized response surface mapping. Three different extraction methods (Soxhlet, maceration, and sonication) along with three solventst [distilled water, methanol, and water-methanol mixture (50 : 50 v/v)] were considered in the present study. The anti-oxidant activities, total flavonoid content (TFC), and total phenolic content (TPC) in the P. emblica were determined and analysed by gas chromatography-mass spectrometry (GC-MS) to identify the major components.
[Results] The QbD overlay plot showed that the extractive value of the P. emblica was no less than 30% w/w, 2,2-diphenyl-1-picrylhydrazyl (DPPH) no less than 60% mcg/mL (micrograms per millilitre), TFC no less than 75 mg QE/g (milligrams of quercetin equivalents per gram), and TPC no less than 80 mg GAE/g (milligrams of gallic acid equivalents per gram). Moreover, the GC-MS data confirmed the presence of variation in the bioactives of P. emblica extracts.
[Conclusion] The model was significant in describing the variation in extractive value, DPPH, TFC, and TPC. The QbD approach may tend to prioritize thoroughness in the extraction process, ultimately resulting in improved quality in the extracted products.
4.Comparison of Midazolam and Propofol Infusion to Suppress Stress Response in Patients With Severe Traumatic Brain Injury: A Prospective, Randomized Controlled Trial
Mallikarjun KURNI ; Narender KALORIA ; Amarjyoti HAZARIKA ; Kajal JAIN ; Sunil Kumar GUPTA ; Rama WALIA
Korean Journal of Neurotrauma 2023;19(1):70-81
Objective:
The stress response following traumatic brain injury (TBI) is a preventable cause of secondary brain injury. This can be prevented using sedation in the intensive care unit (ICU). To date, the choice of sedative agent for preventing stress response is not well-studied in literature.
Methods:
This prospective randomized controlled trial included 60 patients with severe TBI admitted to ICU. The patients were randomized into 2 study groups according to the choice of sedation: propofol (group I) and midazolam infusion (group II). The serum cortisol was measured as the primary outcome at admission to ICU and 48 hours following sedation infusion. The baseline Glasgow coma scale, hemodynamic, optic nerve sheath diameter (ONSD), and computed tomography scan findings were noted at admission. Glasgow outcome scale (GOS) was measured as a neurological outcome at discharge from ICU.
Results:
There was a statistically significant reduction in serum cortisol level in both the study groups (Δ cortisol, p-value=134.91 (50.5,208.2), 0.00 and 118.8 (42.6,160.4), 0.00, in group I and II, respectively). Serum cortisol levels were comparable among both groups at baseline and 48 hours. Similarly, there was a statistically significant difference in ONSD in both groups, but there was no difference in ONSD value between the groups at 48 hours. The GOS was also similar in both groups at discharge from ICU.
Conclusion
The study demonstrated a similar reduction in serum cortisol levels following 48 hours of propofol or midazolam infusion in patients with severe TBI.
5.Exposure to Atmospheric Particulates and Associated Respirable Deposition Dose to Street Vendors at the Residential and Commercial Sites in Dehradun City
Vignesh PRABHU ; Sunil K GUPTA ; Sandeep MADHWAL ; Vijay SHRIDHAR
Safety and Health at Work 2019;10(2):237-244
BACKGROUND: Street vendors spend relatively more time near roadways and are vulnerable to air pollution related health disorders. However, there is limited information on the quality of the air they breathe. The objectives of this present study were to calculate the mass concentration of atmospheric particulate matter (PM) in eight size fractions (PM0.4–0.7, PM0.7–1.1, PM1.1–2.1, PM2.1–3.3, PM3.3–4.7, PM4.7–5.8, PM5.8–9.0, and PM9.0-–0µm) at commercial (CML) and residential site (RSL) in Dehradun city from November 2015 to May 2016. To estimate the corresponding respiratory deposition dose (RDDs) in alveolar (AL), tracheobronchial (TB), and head airway (HD) region on street vendors working at CML and RSL. To find the association of atmospheric PM with RDDs and the incidence of respiratory related disorders among street vendors. METHODS: Andersen cascade impactor was employed for calculating the PM mass concentration. Questionnaire based health survey among street vendors were carried out through personal interview. RESULTS: A significant difference (p < 0.05; t-test) between the mean PM0.4–10µm mass concentration at CML and RSL was observed with (mean±SD) 84.05±14.5 and 77.23±11.7 µgm−3, respectively. RDDs in AL, TB and HD region at CML was observed to be 9.9, 7.8, and 7.3% higher than at RSL, respectively. Health survey revealed 1.62, 0.96, 0.04, and 0.57 times higher incidence of cold, cough, breathlessness, and chest pain, respectively with street vendors at CML compared to RSL. CONCLUSION: The site characteristics plays a major role in the respiratory health status of street vendors at Dehradun.
Air Pollution
;
Chest Pain
;
Commerce
;
Cough
;
Dyspnea
;
Head
;
Health Surveys
;
Humans
;
Incidence
;
Particulate Matter
6.Lateral arthroplasty along with buccal fat pad inter-positioning in the management of Sawhney type III temporomandibular joint ankylosis
Vijay Laxmy MALHOTRA ; Virendra SINGH ; JK Dayashankara RAO ; Sunil YADAV ; Pranav GUPTA ; Radhey SHYAM ; Shruti KIRTI
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2019;45(3):129-134
OBJECTIVES: The objective of this study was to highlight the role of lateral arthroplasty along with interposition of the buccal fat pad (BFP) in the management of Sawhney type III temporomandibular joint (TMJ) ankylosis. MATERIALS AND METHODS: Ten patients with TMJ ankylosis (7 unilateral and 3 bilateral, total of 13 joints) were treated with lateral arthroplasty and BFP interposition. The bony bridge of the ankylotic mass on the lateral aspect was resected, leaving a distance of 1.5 to 2.0 cm from the base of the skull to the neck of the condyle. The condyle was left intact. Coronoidectomy was performed on the ipsilateral side via the same approach in all cases. The inter-incisal opening was measured at that time, and if it was less than 35 mm, contralateral coronoidectomy was performed by using the intra-oral approach. After satisfactory inter-incisal mouth opening (≥35 mm) was achieved, the TMJ surgical site was revisited, and BFP was retrieved and used to cover the lateral aspect of the medially placed condyle. RESULTS: With lateral arthroplasty, the medially displaced condyle can be left in-situ to maintain the mandibular ramal height and function and to act as a growth center in children. Interposition of the BFP prevents reformation of the lateral bony bridge that was removed. CONCLUSION: Lateral arthroplasty along with interpositioning of the BFP is a novel technique for managing Sawhney type III ankylosis that achieves management goals while avoiding complex and advanced reconstructive surgical procedures.
Adipose Tissue
;
Ankylosis
;
Arthroplasty
;
Child
;
Humans
;
Mouth
;
Neck
;
Reconstructive Surgical Procedures
;
Skull
;
Temporomandibular Joint
7.Lateral arthroplasty along with buccal fat pad inter-positioning in the management of Sawhney type III temporomandibular joint ankylosis
Vijay Laxmy MALHOTRA ; Virendra SINGH ; JK Dayashankara RAO ; Sunil YADAV ; Pranav GUPTA ; Radhey SHYAM ; Shruti KIRTI
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2019;45(3):129-134
OBJECTIVES:
The objective of this study was to highlight the role of lateral arthroplasty along with interposition of the buccal fat pad (BFP) in the management of Sawhney type III temporomandibular joint (TMJ) ankylosis.
MATERIALS AND METHODS:
Ten patients with TMJ ankylosis (7 unilateral and 3 bilateral, total of 13 joints) were treated with lateral arthroplasty and BFP interposition. The bony bridge of the ankylotic mass on the lateral aspect was resected, leaving a distance of 1.5 to 2.0 cm from the base of the skull to the neck of the condyle. The condyle was left intact. Coronoidectomy was performed on the ipsilateral side via the same approach in all cases. The inter-incisal opening was measured at that time, and if it was less than 35 mm, contralateral coronoidectomy was performed by using the intra-oral approach. After satisfactory inter-incisal mouth opening (≥35 mm) was achieved, the TMJ surgical site was revisited, and BFP was retrieved and used to cover the lateral aspect of the medially placed condyle.
RESULTS:
With lateral arthroplasty, the medially displaced condyle can be left in-situ to maintain the mandibular ramal height and function and to act as a growth center in children. Interposition of the BFP prevents reformation of the lateral bony bridge that was removed.
CONCLUSION
Lateral arthroplasty along with interpositioning of the BFP is a novel technique for managing Sawhney type III ankylosis that achieves management goals while avoiding complex and advanced reconstructive surgical procedures.
8.Multiple bilateral lower limb fractures in a 2-year-old child: previously unreported injury with a unique mechanism.
Basant REPSWAL ; Anuj JAIN ; Sunil GUPTA ; Aditya AGGARWAL ; Tushar KOHLI ; Devendra PATHROT
Chinese Journal of Traumatology 2014;17(5):298-300
Fall from height is a common cause of unintentional injuries in children and accounts for 6% of all trauma-related childhood deaths, usually from head injury. We report a case of a 2-year-old child with multiple fractures of the bilateral lower limbs due to this reason. A child fell from a height of around 15 feet after toppling from a balcony. He developed multiple fractures involving the right femoral shaft, right distal femoral epiphysis (Salter Harris type 2), right distal metaphysis of the tibia and fibula, and undisplaced Salter Harris type 2 epiphyseal injury of the left distal tibia. There were no head, abdominal or spinal injuries. The patient was taken into emergency operation theatre after initial management which consisted of intravenous fluids, blood transfusion, and splintage of both lower limbs. Fracture of the femoral shaft was treated by closed reduction and fixation using two titanium elastic nails. Distal femoral physeal injury required open reduction and fixation with K wires. Distal tibia fractures were closely reduced and managed nonoperatively in both the lower limbs. All the fractures united in four weeks. At the last follow-up, the child had no disability and was able to perform daily activities comfortably. We also proposed the unique mechanism of injury in this report.
Accidental Falls
;
Femoral Fractures
;
therapy
;
Fibula
;
injuries
;
Fracture Fixation
;
methods
;
Humans
;
Infant
;
Male
;
Multiple Trauma
;
Tibial Fractures
;
therapy
9.Ipsilateral open anterior hip dislocation and open posterior elbow dislocation in an adult.
Sunil KUMAR ; Akhilesh RATHI ; Sunil SEHRAWAT ; Vikas GUPTA ; Jatin TALWAR ; Sumit ARORA
Chinese Journal of Traumatology 2014;17(1):60-62
Open anterior dislocation of the hip is a very rare injury, especially in adults. It is a hyperabduction, external rotation and extension injury. Its combination with open posterior dislocation of the elbow has not been described in English language-based medical literature. Primary resuscitation, debridement, urgent reduction of dislocation, and adequate antibiotic support resulted in good clinical outcome in our patient. At 18 months follow-up, no signs of avascular necrosis of the femoral head or infection were observed.
Accidents, Traffic
;
Elbow Joint
;
injuries
;
Hip Dislocation
;
complications
;
pathology
;
Humans
;
Joint Dislocations
;
complications
;
Male
;
Soft Tissue Injuries
;
complications
;
Young Adult
10. Formulation and evaluation of novel stomach specific floating microspheres bearing famotidine for treatment of gastric ulcer and their radiographic study
Rishikesh GUPTA ; Sunil Kumar PRAJAPATI ; Peeyush BHARDWAJ ; Snigdha PATTNAIK
Asian Pacific Journal of Tropical Biomedicine 2014;4(9):729-735
Objective: To develop and characterize multiple-unit-type oral floating microsphere of famotidine to prolong gastric residence time and to target stomach ulcer. Methods: The floating microspheres were prepared by modified solvent evaporation method. Eudragit S-100 was used as polymer. Microspheres were characterized for the micromeritic properties, floating behavior, entrapment efficiency and scanning electron microscopy. The in-vitro release studies and floating behavior were studied in simulated gastric fluid at pH 1.2. Different drug release kinetics models were also applied for all the batches. Selected formulations were also subjected for X-ray radiographic study. Results: Floating microspheres were successfully prepared by modified solvent evaporation technique. Microspheres showed passable flow properties. The maximum yield of microspheres was up to (95.11±0.35)%. On the basis of optical microscopy particle size range was found to be ranging from (52.18±182.00) to (91.64±5.16) μm. Scanning electron microscopy showed their spherical size, perforated smooth surface and a cavity inside microspheres. Microspheres were capable to float up to 20 h in simulated gastric fluid. X-ray radiographic studies also proved its better retention in the stomach. Conclusions: On the basis of the results, such dosage forms may be a good candidate for stomach targeting and may be dispensed in hard gelatin capsules.


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