13 research outputs found
Concurrent Weekly Cisplatin and Simultaneous Integrated Boost-IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma—An Institutional Experience
No full textIntroduction Concurrent chemoradiation with weekly cisplatin in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is widely practiced in India. Radiation with simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) has the advantage of executing IMRT in single phase with better dose distribution.
Material and Methods 150 patients with LA-HNSCC treated between April 2015 and December 2019 were retrospectively evaluated. All patients received 70Gy in 33 to 35 fractions with SIB-IMRT and concurrent weekly cisplatin at a dose of 40 mg/m2. Treatment compliance and toxicities were assessed. Overall survival (OS) was evaluated using Kaplan-Meier estimates; univariate and multivariate analysis of prognostic factors were also evaluated.
Results Median age was 58.5 years. Forty-five percent had primary oropharyngeal cancer. Sixty-two percent had T3 disease, 41% had N2 disease, and 51% had stage IV disease. All patients received 70Gy dose of RT. Median chemotherapy cycles were six, 84.7% received 200 mg/m2. Acute grade 2 xerostomia was seen in 79%, grade 3 neutropenia, mucositis and pharyngitis were seen in 11, 15, and 21%, respectively. Complete response was seen in 66.6%. At median follow-up of 21.4 months (3–71) OS was 60% and median OS was 33.2 months. Estimated 2 and 3 year OS was 56 and 48%. On univariate analysis, absence of node, N0–N1, stage III, cisplatin use, dose per fraction 2.12Gy ,and complete response showed good OS (p <0.05). On multivariate analysis dose per fraction 2.12Gy and complete response showed good OS (p <0.05).
Conclusion Definitive chemoradiation with weekly cisplatin and SIB-IMRT in LA-HNSCC is well tolerated with good clinical outcomes
The Carpooling System
No full textWith the enormous increase in number of vehicles on road, people around the country especially in metro cities have started facing problem now due to increase in traffic which added an hour or so to their daily travelling time. Out of few, one of the methods to reduce this misery of travelers is to make them share cars. We intent to make an ANDROID application, carpooling, which is an application of car-sharing (also called lift-sharing or ride-sharing) in which drivers (alone-riders) who are traveling to work alone can ask for fellow passengers through our application. For those who use public-transport system to go to work daily can use this application to find drivers who are travelling to the same destination and willing to share ride. This will not only get rid of the extra journey time of passengers but will also help environment by reducing pollution and traffic on roads. This social networking application is also called fare-sharing and time sharing as you are you are sharing both with fellow travelers. This paper will also cover security issues with woman travelers in mind.
DOI: 10.17762/ijritcc2321-8169.16044
Development and Validation of Calculation Data Sheets to Ensure the Accuracy and Security of Pharmaceutical Data Through Qa Procedures (Qaps)
No full textIntroduction: Quality stands as an essential prerequisite in the evaluation of any product and especially true for pharmaceuticals, for stringent standards of quality during their manufacturing process. In this consideration, the Food and Drug Administration introduced good manufacturing practices (GMP) and viewed validation as an integral part of cGMP. Validation studies have been conducted for a long time in industries. In recent times to better the quality of pharmaceutical products, industries emphasize quality assurance programs.
Objectives: This research has introduced a simplified and efficient method for validating Excel spreadsheets. The sheets are designed to fulfil the regulatory requirement, easy to use and developed itself by the users to assure the accuracy, integrity and quality of their data. This sheet should be validated and strictly follow the GMP and FDA 21 CFR part 11 regulations.
Methods: All the sheets are designed in Excel- 2013 following the regulatory requirements. The data is collected from the analytical laboratories following the standard procedures to perform the test.
Results: The sheets should validate and every action should be documented and all the sheets are assured to present the quality data with complete maintenance of the security, accuracy and integrity of the data. By following these principles, it is possible to fully validate and implement a standard spreadsheet in very less time.
Conclusions: The sheets provide the accuracy maintenance of data and calculations in order to protect the data from any unauthorised access. The good documentation and manufacturing practices alongwith the regulatory authorities made it important for getting regulatory compliance. Validation of process, equipment plays important role in assuring the quality of product while the excel sheets ensure the data integrity and protection from any modification. Therefore it necessary to validate the excel sheets as per the reference documents and to assure quality of the data
Development and Validation of Calculation Data Sheets to Ensure the Accuracy and Security of Pharmaceutical Data Through Qa Procedures (Qaps)
No full textIntroduction: Quality stands as an essential prerequisite in the evaluation of any product and especially true for pharmaceuticals, for stringent standards of quality during their manufacturing process. In this consideration, the Food and Drug Administration introduced good manufacturing practices (GMP) and viewed validation as an integral part of cGMP. Validation studies have been conducted for a long time in industries. In recent times to better the quality of pharmaceutical products, industries emphasize quality assurance programs.
Objectives: This research has introduced a simplified and efficient method for validating Excel spreadsheets. The sheets are designed to fulfil the regulatory requirement, easy to use and developed itself by the users to assure the accuracy, integrity and quality of their data. This sheet should be validated and strictly follow the GMP and FDA 21 CFR part 11 regulations.
Methods: All the sheets are designed in Excel- 2013 following the regulatory requirements. The data is collected from the analytical laboratories following the standard procedures to perform the test.
Results: The sheets should validate and every action should be documented and all the sheets are assured to present the quality data with complete maintenance of the security, accuracy and integrity of the data. By following these principles, it is possible to fully validate and implement a standard spreadsheet in very less time.
Conclusions: The sheets provide the accuracy maintenance of data and calculations in order to protect the data from any unauthorised access. The good documentation and manufacturing practices alongwith the regulatory authorities made it important for getting regulatory compliance. Validation of process, equipment plays important role in assuring the quality of product while the excel sheets ensure the data integrity and protection from any modification. Therefore it necessary to validate the excel sheets as per the reference documents and to assure quality of the data. 
Correlation of placental thickness with gestational age in second and third trimester using ultrasonography
No full textAbstract Background The accuracy of currently established parameters in estimating gestational age decreases as pregnancy advances. With advancing gestational age, there is an expected linear increase in placental thickness. Placental thickness may thus be used to reliably predict gestational age, especially in later stages. Aim Our study aimed to determine the relationship between placental thickness and gestational age and routinely used fetal growth parameters in the second and third trimesters. Additionally, we aimed to see if the placental thickness was lower in small for gestational fetuses. Methods This study was performed at a tertiary care center and was a prospective observational study. We recruited consecutive 200 pregnant women fulfilling inclusion and exclusion criteria. Using routine antenatal ultrasonography, we obtained several measurements of placental thickness, BPD, HC, FL, and AC. The placental thickness was measured at the level of umbilical cord insertion. The gestational age was calculated using last menstrual period. Results There was a strong correlation between placental thickness and gestational age (p < 0.001), BPD (p < 0. 001), HC (p < 0. 001), FL (p < 0. 001), and AC (p < 0.001) in both trimesters combined. In the second trimester, there was a strong correlation between placental thickness and gestational age (p < 0.001), BPD (p < 0.01), HC (p < 0.001), and AC (p < 0.001). In the third trimester, there was a strong correlation between placental thickness and gestational age (p < 0.001), BPD (p < 0.001), HC (p < 0.001), FL (p < 0.001) and AC (p < 0. 001). Patients delivering Small for gestational age (SGA) babies had significantly thinner placentas as compared to those with normal-weight babies (p < 0.001). Conclusions Placental thickness has a strong correlation with gestation age as well as BPD, HC, and AC in the second and third trimesters. Placental thickness is significantly lower in small for gestational age babies. Routine measurement of antenatal placental thickness using ultrasound can help predict gestational age and detect small for gestational age babies
Diagnosis of cancer of the cervix by targeting VPAC receptors on exfoliated cervical cells
No full textIntroduction: Cervical cancer is a major cause of cancer morbidity and mortality in women. Screening for cervical cancer reduces mortality through early detection and treatment. The success of the screening for cervical cancer has been largely attributed to the use of Pap smear (Papanicolaou). The objective of this study was to assess the feasibility of detecting cervical cancer by targeting genomic VPAC receptors and compare the results with those of Pap-test.
Material and Methods: Women ≥40 years of age underwent routine screening for cervical cancer. The cellular material obtained from the cervix was gently smeared on a clean glass slide. The slides were then stained according to Papanicolaou’s technique. Similarly, another set of prepared smears were used for VPAC receptor detection. Histopathological examination of the cervical biopsy was done and the results of all three tests were compared.
Results: A total of 114 women attending the Gynaecology outpatient department of our hospital were included in the study. Histopathological examination (HPR) of the cervical biopsy revealed that 25 patients had cervical cancer and the remaining 89 were negative for cervical cancer. The Pap smear gave positivity for malignant cells in 20 (80%) of cases reconfirmed on HPR. The false positive rate and false negative rates were 4.5% and 20%, respectively. The VPAC receptors were positive in 23 (92%) of the 25 cases with cancer of the cervix. The false positive and false negative rates were 2.2% and 8%, respectively.
Conclusions: Diagnosis of cancer of the cervix can be reliably made by targeting the genomic VPAC receptors. The test is simple to perform, reliable, reproducible and with minimal false positivity having a higher diagnostic accuracy
Concurrent weekly cisplatin and radiation in squamous cell carcinoma esophagus: A simplistic approach
No full textDiagnosis of Oral Cancers by Targeting VPAC Receptors: Preliminary Report
No full textIntroduction: Oral cancer is a major health problem. The study of exfoliative cytology material helps in the differentiation of premalignant and malignant alterations of oral lesions. The objective of this study was to assess the feasibility of detecting oral cancer by targeting genomic VPAC (combined vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase-activating peptide) receptors expressed on malignant oral cancer cells.
Patients & methods: All patients with suspected oral cavity cancers/lesions formed the study group. The samples from the oral cavity lesion or suspicious area were collected with a cytology brush. The harvested material was examined for malignant cells by 1. the standard PAP stain and 2. targeting the VPAC receptors on the cell surface using a fluorescent microscope. Similarly, malignant cells were identified from cells shed in oral gargles.
Results: A total of 60 patients with oral lesions were included in the study. The histopathological diagnosis was squamous cell carcinoma in 30 of these. The VPAC receptor positivity both on the brush cytology staining as well oral gargle staining was more sensitive than the brush cytology PAP staining. The accuracy of the various techniques was as follows, brush cytology PAP staining at 86.67%, brush cytology VPAC staining at 91.67% and oral gargle VPAC staining at 95%.
Conclusions: This preliminary study validates our belief that malignant cells in the saliva can be identified by targeting the VPAC receptors. The test is simple, easy, non-invasive and reliable in the detection of oral cancers
D2 lymphadenectomy is not only safe but necessary in the era of neoadjuvant chemotherapy
No full textAbstract Background Patients with locally advanced resectable gastric cancers are increasingly offered neoadjuvant chemotherapy (NACT) following the MAGIC and REAL-2 trials. However, information on the toxicity of NACT, its effects on perioperative surgical outcomes and tumor response is not widely reported in literature. Methods Analysis of a prospective database of gastric cancer patients undergoing radical D2 gastrectomy over 2 years was performed. Chemotherapy-related toxicity, perioperative outcomes and histopathological responses to NACT were analyzed. The data is presented and compared to a cohort of patients undergoing upfront surgery in the same time period. Results In this study, 139 patients (42 female and 97 male patients, median age 53 years) with gastric adenocarcinoma received NACT. Chemotherapy-related toxicity was noted in 32% of patients. Of the 139 patients, 129 underwent gastrectomy with D2 lymphadenectomy, with 12% morbidity and no mortality. Major pathological response of primary tumor was noted in 22 patients (17%). Of these 22 patients, lymph node metastases were noted in 12 patients. The median blood loss and lymph node yield was not significantly different to the 62 patients who underwent upfront surgery. Patients who underwent upfront surgery were older (58 vs. 52 years, P P P Conclusions Perioperative outcomes of gastrectomy with D2 lymphadenectomy for locally advanced, resectable gastric cancer were not influenced by NACT. The number of lymph nodes harvested was unaltered by NACT but, more pertinently, metastases to lymph nodes were noted even in patients with a major pathological response of the primary tumor. D2 lymphadenectomy should be performed in all patients irrespective of the degree of response to NACT.</p
